issue-1996-07-25•Federal Register final rules — 1996-07-25
Federal Register final rules — 1996-07-25
issue-1996-07-25Federal Register final rules — 1996-07-25Regulation
Published Federal Register documents, not public-inspection drafts. The GPO XML/text rendition is a research aid; the linked complete official PDF retains the printed layout and all graphics. Graphics are retained in that PDF and are not independently reproduced in this text rendition. Publication does not establish that every provision remains legally in force.
FR Doc. 96-18944 Hydrochloric Acid; Toxic Chemical Release Reporting; Community Right-to-Know
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38600-38605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18944]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400062A; FRL-5372-3]
Hydrochloric Acid; Toxic Chemical Release Reporting; Community
Right-to-Know
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is modifying the listing for hydrochloric acid on the list
of toxic chemicals subject to the reporting requirements under section
313 of the Emergency Planning and Community Right-to-Know Act of 1986
(EPCRA) and section 6607 of the Pollution Prevention Act of 1990 (PPA).
Specifically, EPA is deleting non-aerosol forms of hydrochloric acid
because the Agency has concluded that the non-aerosol forms of
hydrochloric acid meet the section 313(d)(3) deletion criterion. By
promulgating this rule, EPA is relieving facilities of their obligation
to report releases of and other waste management information on non-
aerosol forms of hydrochloric acid that occurred during the 1995
reporting year, and for activities in the future.
DATES: This rule is effective July 25, 1996.
FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Acting Petitions
Coordinator, 202-260-3882, e-mail: bushman.daniel @epamail.epa.gov, for
specific information on this final rule, or for more information on
EPCRA section 313, the Emergency Planning and Community Right-to-Know
Hotline, Environmental Protection Agency, Mail Code 5101, 401 M St.,
SW., Washington, DC 20460, Toll free: 1-800-535-0202, in Virginia and
Alaska: 703-412-9877, or Toll free TDD: 1-800-553-7672.
SUPPLEMENTARY INFORMATION:
[[Page 38601]]
I. Introduction
A. Affected Entities
Entities potentially affected by this action are those which
manufacture, process, or otherwise use hydrochloric acid and which are
subject to the reporting requirements of section 313 of the Emergency
Planning and Community Right-to-Know Act of 1986 (EPCRA), 42 U.S.C.
11023, and section 6607 of the Pollution Prevention Act of 1990 (PPA),
42 U.S.C. 13106. Some of the affected categories and entities include:
------------------------------------------------------------------------
Examples of affected
Category entities
------------------------------------------------------------------------
Industry Facilities in the
manufacturing sector
(Standard Industrial
Classification codes 20-39)
that manufacture, process
or otherwise use
hydrochloric acid.
Federal Government Federal Agencies that
manufacture, process, or
otherwise use hydrochloric
acid.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists the types of entities that EPA is now aware
could potentially be affected by this action. Other types of entities
not listed in the table could also be affected. To determine whether
your facility is affected by this action, you should carefully examine
the applicability criteria in part 372 subpart B of Title 40 of the
Code of Federal Regulations.
B. Statutory Authority
This action is taken under sections 313(d) and (e)(1) of EPCRA.
EPCRA is also referred to as Title III of the Superfund Amendments and
Reauthorization Act of 1986 (SARA) (Pub. L. 99-499).
C. Background
Section 313 of EPCRA requires certain facilities manufacturing,
processing, or otherwise using listed toxic chemicals to report their
environmental releases of such chemicals annually. Beginning with the
1991 reporting year, such facilities must also report pollution
prevention and recycling data for such chemicals, pursuant to section
6607 of PPA. When enacted, section 313 established an initial list of
toxic chemicals that was comprised of more than 300 chemicals and 20
chemical categories. Hydrochloric acid was included in the initial list
of chemicals and chemical categories. Section 313(d) authorizes EPA to
add chemicals to or delete chemicals from the list, and sets forth
criteria for these actions. Under section 313(e)(1), any person may
petition EPA to add chemicals to or delete chemicals from the list. EPA
has added and deleted chemicals from the original statutory list.
Pursuant to EPCRA section 313(e)(1), EPA must respond to petitions
within 180 days either by initiating a rulemaking or by publishing an
explanation of why the petition has been denied.
EPA issued a statement of petition policy and guidance in the
Federal Register of February 4, 1987 (52 FR 3479), to provide guidance
regarding the recommended content and format for petitions. On May 23,
1991 (56 FR 23703), EPA issued a statement of policy and guidance
regarding the recommended content of petitions to delete individual
members of the section 313 metal compound categories. EPA has published
a statement clarifying its interpretation of the section 313(d)(2) and
(3) criteria for adding and deleting chemicals from the section 313
toxic chemical list (59 FR 61439, November 30, 1994) (FRL-4922-2).
II. Description of Petition and Proposed Action
On September 11, 1991, EPA received a petition from BASF
Corporation, E.I. duPont de Nemours, Monsanto Company, and Vulcan
Materials Company to qualify the listing for hydrochloric acid by
requiring release reporting only for hydrochloric acid aerosols and
deleting other forms of hydrochloric acid from the list of chemicals
under EPCRA section 313. The petitioners maintain that non-aerosol
forms of hydrochloric acid do not meet the statutory criteria under
EPCRA section 313 for acute, chronic, or environmental effects.
There are precedents for qualified chemical listings under EPCRA
section 313. The original list established by Congress contained a
number of qualified listings including: aluminum (fume or dust),
ammonium nitrate (solution), asbestos (friable), phosphorus (yellow or
white), vanadium (fume or dust), and zinc (fume or dust). Also EPA
recently modified the sulfuric acid listing (60 FR 34182, June 30,
1995) (FRL-4946-3) by exempting non-aerosol forms of sulfuric acid
exactly as is being done in today's action. As with this list
modification, EPA found that non-aerosol forms of sulfuric acid do not
meet the toxicity criteria of section 313(d)(2). Other qualified
listings include those for fibrous aluminum oxide (55 FR 5220, February
14, 1990) and water dissociable nitrate compounds (59 FR 61432,
November 30, 1994) (FRL-4922-2).
Following a review of the petition, EPA granted the petition and
issued a proposed rule in the Federal Register on November, 15, 1995
(60 FR 57383) (FRL-4045-4), proposing to delete non-aerosol forms of
hydrochloric acid from the list of toxic chemicals under EPCRA section
313. EPA's proposal was based on its conclusion that these forms of
hydrochloric acid meet the EPCRA section 313(d)(3) criterion for
deletion from the list. EPCRA provides at section 313(d)(3) that ``[a]
chemical may be deleted if the Administrator determines there is not
sufficient evidence to establish any of the criteria described in
paragraph [(d)(2)(A)-(C)].'' Specifically, in the proposed rule, EPA
preliminarily concluded that there is not sufficient evidence to
establish that non-aerosol forms of hydrochloric acid cause adverse
acute human health effects at concentration levels that are reasonably
likely to exist beyond facility site boundaries, chronic human health
effects, or environmental toxicity. This preliminary conclusion, which
is detailed in the proposed rule, was based on the Agency's review of
the petition, as well as other relevant materials included in the
rulemaking record for this action. For the purposes of this final rule,
EPA considers the term aerosol to cover any generation of airborne
hydrochloric acid (including mists, vapors, gas, or fog) without regard
to particle size.
On February 1, 1993 (58 FR 6609), EPA issued a notice announcing
that a public hearing would be held to address petitions to modify the
listings for both hydrochloric and sulfuric acids (on December 24,
1990, a petition was received from the Environmental Policy Center on
behalf of American Cyanamid to modify the listing of sulfuric acid to
include only aerosol forms of this chemical). In the February 1, 1993
notice, EPA requested comment on a number of the issues raised by
commenters in response to the proposed rule to modify the listing for
sulfuric acid (56 FR 34156, July 26, 1991). The Agency believed that
these issues were also relevant to hydrochloric acid. Specifically,
these issues were: (1) The extent to which EPA should rely on existing
regulatory controls under other statutes to support a determination
that continuous, or frequently recurring, releases of these acids are
unlikely to cause adverse acute human health effects or significant
adverse
[[Page 38602]]
environmental effects; (2) the sufficiency of the evidence required to
determine if the non-aerosol forms of these acids meet the EPCRA
section 313(d)(2)(A) and (C) criteria; (3) whether EPA should consider
accidental release data in making a finding for environmental effects
under EPCRA section 313(d)(2)(C); (4) the relevance of release
reporting under other statutory provisions to the issue of whether non-
aerosol forms of these acids meet the listing criteria; and (5) other
reporting options.
The public meeting was held on March 3, 1993. At this meeting, EPA
discussed the specific issues described in the February 1, 1993 notice
and presented data on accidental and routine releases of sulfuric and
hydrochloric acids. Comments were then presented by the public. One
comment presented at the public meeting specific to hydrochloric acid
came from the Great Lakes Chemical Company. This commenter stated that
hydrochloric acid does not meet either of the listing criteria set
forth in EPCRA section 313(d)(2)(A) or (C). The commenter discussed at
length the lack of environmental risks posed by deep well injection of
hydrochloric acid in oil and gas operations. EPA agrees with the
commenter that non-aerosol forms of hydrochloric acid do not meet the
EPCRA section 313 listing criteria and therefore none of the
environmental releases, including deep well injection, of these non-
aerosol forms should be reported under EPCRA section 313.
At the public meeting, EPA received other comments that pertained
to both the non-aerosol forms of hydrochloric and sulfuric acid. The
major comments received concerned the reporting of accidental releases,
effects of the removal of these chemicals on the Right-to-Know program,
reliance on other regulatory mechanisms for reporting, and the effects
delisting would have on pollution prevention. A brief summary of the
major comments received that are relevant to hydrochloric acid and
EPA's responses to those comments follow. More detailed responses to
the major issues raised by the comments presented and/or submitted at
the public meeting can be found in the final rulemaking delisting non-
aerosol forms of sulfuric acid (60 FR 34182, June 30, 1995) (FRL-4946-
3).
EPA received comments citing concerns for accidental releases of
non-aerosol forms of hydrochloric acid and the environmental damages
that have resulted. As discussed further in Unit III.B. of this
preamble, the Agency believes that the limited number of accidental
releases of non-aerosol forms of hydrochloric acid do not result in
significant adverse effects of sufficient seriousness to warrant
continued listing under EPCRA section 313.
Several commenters stated their opposition to removing non-aerosol
forms of hydrochloric acid from reporting under EPCRA section 313
because it defeats the intent of the Right-to-Know program. These
commenters contend that removing reporting for non-aerosol forms of
hydrochloric acid under EPCRA section 313 will result in a significant
information gap regarding ``routine'' releases of the chemical.
EPA agrees that by delisting non-aerosol forms of hydrochloric
acid, information on the management of these forms of the chemical may
be more difficult to obtain. However, EPA believes that adequate
information on non-aerosol forms of hydrochloric acid will still be
available through other sources.
EPA received a comment stating that it is inappropriate for the
Agency to rely solely on regulations developed under other statutes to
determine whether significant adverse human health or environmental
effects result from releases that are reported under EPCRA section 313.
While EPA does not rely solely on data as collected under other
regulations, the Agency does believe that data collected under other
regulations can assist in listing and delisting decisions. In the
Agency's review of non-aerosol forms of hydrochloric acid, EPA has not
uncovered any information to indicate that non-aerosol forms of this
chemical cause significant adverse human health or environmental
effects of sufficient seriousness to warrant reporting.
A number of comments received from industry contend that any
significant adverse effects that may be caused from releases of non-
aerosol forms of hydrochloric acid are already addressed through
several other regulations. Additional comments from industry asserted
that non-compliance with other statutes must be addressed through the
enforcement mechanisms of those statutes and should not be considered
in EPCRA section 313 listing or delisting decisions.
EPA agrees with the commenters that non-compliance with other
statutes should be addressed through those regulations. However, the
Agency has also found that the EPCRA section 313 data are useful in
identifying facilities that may not be in compliance with a particular
statute.
EPA received comments that stated that the removal of non-aerosol
forms of hydrochloric acid will have the effect of removing industry's
incentive for conducting pollution prevention efforts for their uses of
this chemical which is contrary to the intent of the PPA.
EPA does not agree that this delisting action will undermine
pollution prevention efforts. There are numerous other incentives for
facilities to reduce their releases of a specific chemical, including
financial incentives. In addition, facilities will be able to focus
their pollution prevention efforts and report their progress on the
forms of hydrochloric acid that pose the greatest hazard, the aerosol
forms.
III. Final Rule and Rationale for Delisting
A. Comments on the Proposed Modification to Delete Non-Aerosol Forms of
Hydrochloric Acid
EPA received 21 written comments (i.e., in addition to those
received at the public meeting) on the proposed deletion of non-aerosol
forms of hydrochloric acid from the EPCRA section 313 toxic chemical
list, all of which supported the proposed action. All 21 comments were
from industry representatives. All commenters supported the listing
modification on the grounds that non-aerosol forms do not meet the
statutory criteria of section 313(d)(2)(A)-(C). One commenter from the
International Dairy Foods Association requested that this listing
modification be extended to include non-aerosol forms of phosphoric and
nitric acids. Specifically, the commenter ``support[s] an alternative
listing option that eliminates the reporting requirement for all
transfers to Publicly Owned Treatment Works (POTW) of all non-aerosol
forms of mineral acids.''
The commenter refers to an issue raised at the March 3, 1993 public
meeting regarding the health and safety of POTW workers that may be
jeopardized as a result of transfers of mineral acids to POTWs. The
commenter contends that the effluent guidelines, issued under 40 CFR
part 403, prohibit an effluent discharge to a POTW with a pH below 5.
The commenter continues, ``EPA has stated that a pH between 6 and 9 is
neutral, therefore, the only concern is for discharges [within effluent
guidelines] between pH 5 and pH 6.'' The commenter compares this range
with that of acid rain. The commenter further states that he is
``unaware of any human health hazard associated with direct contact
with acid rain, and therefore, continuing to report releases between a
pH of 5 and 6 provides no benefit to POTW workers.''
[[Page 38603]]
The Agency is currently reviewing the toxicity hazards associated
with phosphoric and nitric acid to determine if any modification to the
EPCRA section 313 reporting requirements for these acids is
appropriate. However, in response to a petition that was withdrawn, EPA
has published an analysis of the hazards associated with phosphoric
acid (55 FR 25876, June 25, 1990). There are also additional concerns
for nitric acid. In addition to exhibiting the characteristic of
acidity, nitric acid, when neutralized, exhibits the toxicity of a
nitrate compound. On November 30, 1994 (59 FR 61432), EPA added a
nitrate compounds category to the EPCRA section 313 list of toxic
chemicals based on the toxicity of nitrate. EPA believes that water
dissociable nitrate compounds meet the criteria of EPCRA section
313(d)(2)(B).
B. Rationale for Delisting and Conclusions
EPA has concluded that the assessment set out in the proposed rule
should be affirmed. Specifically, hydrochloric acid aerosols meet the
toxicity criteria of section 313(d)(2), while non-aerosol forms of the
acid do not. EPA's decision to delete non-aerosol forms of hydrochloric
acid is based on the Agency's evaluation of the toxicity of non-aerosol
forms of hydrochloric acid and the levels of hydrochloric acid exposure
to which humans and the environment may be subject (Ref. 1). The non-
aerosol forms of hydrochloric acid are acutely toxic at low pH;
however, there is no information to indicate that non-aerosol forms of
hydrochloric acid present a health or environmental risk as a result of
continuous, or frequently recurring, releases from facilities.
EPA has concluded that non-aerosol forms of hydrochloric acid do
not meet the statutory criterion of section 313(d)(2)(A) regarding
acute human health effects; specifically, that the ``chemical is known
to cause or can reasonably be anticipated to cause significant adverse
acute human health effects at concentration levels that are reasonably
likely to exist beyond facility boundaries as a result of continuous,
or frequently recurring, releases.'' EPA's review of the toxicity and
exposure information indicates that although hydrochloric acid in
concentrated forms is acutely toxic, it is unlikely that persons will
be exposed to acutely toxic concentration levels beyond facility
boundaries as ``a result of continuous, or frequently recurring,
releases.''
Rather than being dependent upon average dose over time, e.g.,
quantity ingested as milligrams/kilogram/day (mg/kg/day), the chronic
toxicity hazard of non-aerosol forms of hydrochloric acid is primarily
dependent on the pH of the solution which is directly related to the
concentration of hydrochloric acid in the solution. Only solutions of
high hydrochloric acid concentration (i.e., solutions with a pH of
approximately 1 or lower) express this chronic toxicity hazard. The
physical and chemical properties of hydrochloric acid (Ref. 2) are such
that, in the environment, highly concentrated solutions (i.e.,
solutions with low pH) are not anticipated to be sustained for any
significant period of time, particularly in water. Therefore,
concentrations of non-aerosol forms of hydrochloric acid that can
express a chronic toxicity hazard are unlikely to exist in the
environment, particularly in water. Because the physical and chemical
properties of non-aerosol forms of hydrochloric acid limit its
existence as highly concentrated solutions in the environment and
because only highly concentrated solutions result in a pH low enough to
cause chronic toxicity, non-aerosol forms of hydrochloric acid pose a
low chronic toxicity hazard to human health. Therefore, EPA has
concluded that non-aerosol forms of hydrochloric acid do not meet the
chronic toxicity listing criterion in section 313(d)(2)(B), because the
chemical in its non-aerosol forms is not known to cause nor can
reasonably be anticipated to cause chronic health effects.
As with chronic human health effects, the adverse environmental
effects of non-aerosol forms of hydrochloric acid are dependent on the
pH of the solution which is directly related to the concentration of
hydrochloric acid in the solution. Adverse environmental effects are
observed at pH levels below approximately 5.0. Based on the amount of
hydrochloric acid required to maintain a pH of 5.0 or less, the non-
aerosol forms of hydrochloric acid are considered to pose a moderate
hazard to aquatic organisms. Given the regulatory restrictions
governing handling and environmental releases of concentrated
hydrochloric acid, exposures to pH levels below 5.0 are primarily a
result of accidental releases. The data indicate that accidental
releases of hydrochloric acid to surface waters are infrequent and
isolated occurrences. In only a few circumstances could evidence of
adverse environmental effects (e.g., fish kills) be found. Chronic
aquatic toxicity is not expected to occur since any pH excursions are
expected to dissipate rapidly due to the physical and chemical
properties of non-aerosol forms of hydrochloric acid (Ref. 2).
Therefore, the environmental listing criterion, 313(d)(2)(C), is not
met because the non-aerosol forms of hydrochloric acid are not known to
cause nor can they be reasonably anticipated to cause a significant
adverse effect on the environment of sufficient seriousness to warrant
release reporting.
Although not a factor in the delisting decision, deleting non-
aerosol forms of hydrochloric acid from the section 313 list will not
result in any significant reduction in the information now available to
the public concerning spills of hydrochloric acid. Since reporting of
spills under section 313 is only required to be submitted to EPA as
part of an overall annual release number, no direct and immediate
notice to the public of such an accidental release or spill of
hydrochloric acid is available through section 313 reports or through
the Toxic Release Inventory (TRI) data base, i.e., only annual release
figures are available. In addition, other statutory mechanisms exist by
which information on spills of hydrochloric acid will be made available
to the public. These mechanisms, which are the same as for sulfuric
acid, are detailed in Unit III.A. of the preamble to the Final Rule on
sulfuric acid (60 FR 34183).
Therefore, EPA is modifying the listing for hydrochloric acid by
deleting non-aerosol forms of hydrochloric acid. For the purposes of
this deletion, EPA considers the term aerosol to cover any generation
of airborne hydrochloric acid (including mists, vapors, gas, or fog)
without regard to particle size. This action to delete non-aerosol
forms of hydrochloric acid from the section 313 list is not meant to
suggest that the Agency considers hydrochloric acid to be a ``safe''
chemical. Rather, this action reflects the fact that non-aerosol forms
of the chemical do not meet the toxicity criteria set forth in EPCRA
section 313(d)(2). Nor is today's action intended, or should it be
inferred, to affect the status of non-aerosol forms of hydrochloric
acid under any other statute or program other than the reporting
requirements under EPCRA section 313.
C. Reporting Aerosol Forms of Hydrochloric Acid
For purposes of threshold determination under 40 CFR 372.25, any
generation of airborne hydrochloric acid (including mists, vapors, gas,
or fog) without regard to particle size, is considered manufacture of
hydrochloric acid aerosols. The quantity of airborne hydrochloric acid
manufactured, not the amount released, would be compared
[[Page 38604]]
with the reporting thresholds in EPCRA section 313(f).
Generation of airborne hydrochloric acid is expected to occur from,
but is not limited to: The reaction of alkali metal chlorides (e.g.,
sodium chloride, potassium chloride) by strong acids (e.g., sulfuric
acid); the reaction of alkali metal chlorides with sulfur dioxide in
the presence of air and water; the reaction of hydrogen with chlorine;
syntheses of organic compounds that require the use of chlorine or
chloride-containing substances; combustion of organic chlorides or
inorganic chlorides; production or processing of solutions of
hydrochloric acid; and volatilization or vaporization of hydrochloric
acid from manufacture or processing. EPA will be developing a guidance
document to assist facilities in determining whether the facilities are
manufacturing, processing or otherwise using aerosol forms of
hydrochloric acid as defined under EPCRA section 313.
IV. Effective Date
This action becomes effective July 25, 1996, thus the last year in
which facilities had to file a TRI report for non-aerosol forms of
hydrochloric acid was 1995, covering releases and other activities that
occurred in 1994. Section 313(d)(4) provides that ``[a]ny revision'' to
the section 313 list of toxic chemicals shall take effect on a delayed
basis. EPA interprets this delayed effective date provision to apply
only to actions that add chemicals to the section 313 list. For
deletions, EPA may, in its discretion, make such actions immediately
effective. An immediate effective date is authorized, in these
circumstances, under 5 U.S.C. section 553(d)(1) because a deletion from
the section 313 list relieves a regulatory restriction.
EPA believes that where the Agency has determined, as it has with
these non-aerosol forms of hydrochloric acid, that a chemical does not
satisfy any of the criteria of section 313(d)(2)(A)-(C), no purpose is
served by requiring facilities to collect data or file TRI reports for
that chemical, or, therefore, by leaving that chemical on the section
313 list for any additional period of time. This construction of
section 313(d)(4) is consistent with previous rules deleting chemicals
from the section 313 list. For further discussion of the rationale for
immediate effective dates for EPCRA section 313 delistings, see 59 FR
33205 (June 28, 1994).
V. Additional Time to Report for 1995
EPA recognizes that today's action has come so close to the
extended August 1, 1996, deadline for filing TRI reports for the 1995
reporting year (see 61 FR 2721, January 29, 1996) that facilities that
have not yet filed their report for hydrochloric acid may not have
sufficient time to reassess their threshold determinations and release
estimates based on the new reporting requirements for hydrochloric
acid. Therefore, in order to avoid inaccurate and unnecessary reporting
and to reduce the reporting burden associated with the filing of
revised reports, EPA is allowing an additional two weeks, until August
15, 1996, for facilities to file their TRI reports for hydrochloric
acid (acid aerosols). TRI Reports on hydrochloric acid (acid aerosols)
for the 1995 reporting year that are filed after August 15, 1996, will
be subject to EPA enforcement action, where appropriate. This 2-week
extension applies only to TRI reports for hydrochloric acid; reports
for all other chemicals subject to the reporting requirements of EPCRA
section 313 and PPA section 6607 are still subject to the August 1,
1996 reporting deadline.
Facilities that have already filed a Form R report for hydrochloric
acid covering Reporting Year 1995 may wish to either: (1) Revise this
report, or (2) submit a withdrawal request if the facility did not
exceed the appropriate threshold for the aerosol forms of the chemical,
or (3) submit a withdrawal request if the threshold determinations were
made on non-aerosol forms of hydrochloric acid only. Revisions and
withdrawal requests must be submitted no later than October 15, 1996.
Unless EPA receives a revision or withdrawal request by October 15,
1996, EPA will include, in the TRI under the hydrochloric acid (acid
aerosols) listing, all hydrochloric acid release and waste management
information as reported on each Form R received. This will include any
quantities of the non-aerosol forms of hydrochloric acid that where
included on a facility's Form R report.
This allowance of additional time for reporting on hydrochloric
acid applies only to the EPCRA section 313/PPA section 6607 reporting
obligations for TRI reports otherwise due on August 1, 1996, covering
calendar year 1995. Nothing in this notice regarding extension of
reporting deadlines shall be construed to apply to any other EPCRA
reporting obligations, or to any TRI reports due for past or future
reporting years. Further, this allowance of additional time for
reporting applies only to the federal EPCRA section 313/PPA section
6607 reporting obligation; it does not apply to independent obligations
under State laws which also require TRI-type reports. However, EPA
encourages the States with similar requirements that relate to federal
TRI reporting to embrace this allowance of additional time.
To the extent that this action extending the reporting deadline
might be construed as rulemaking subject to section 553 of the
Administrative Procedure Act, for the reasons stated above, EPA has
determined that notice and an opportunity for public comment are
impracticable and unnecessary. Providing for public comment might
further delay reporting, and, because there is no substantive change in
the reporting obligation, other than allowing an additional 2 weeks,
the public will continue to receive the same information, though
slightly delayed. Also, public comment would not further inform EPA's
decision because the event giving rise to the need to provide extra
time for reporting on hydrochloric acid has already occurred. In
addition, additional notice and comment procedures in this situation
would be contrary to the public interest in timely and accurate
reporting of data under EPCRA section 313 and PPA section 6607.
VI. Rulemaking Record
The record supporting this decision is contained in docket control
number OPPTS-400062A. All documents, including an index of the docket
and the references listed in Unit VI. of this preamble, are available
in the TSCA Nonconfidential Information Center (NCIC), also known as,
TSCA Public Docket Office from 12 noon to 4 p.m., Monday through
Friday, excluding legal holidays. TSCA NCIC is located at EPA
Headquarters, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
VII. References
1. USEPA. 1995. Technical Support Document for the Petition to
Delist Non-aerosol Forms of Hydrochloric Acid from EPCRA Section 313.
2. Brady, J.E., Humiston, G.E. General Chemistry Principles and
Structure. John Wiley & Sons, New York, (1978), pp. 394-431.
VIII. Regulatory Assessment Requirements
It has been determined that this action is not a ``significant
regulatory action'' within the meaning of Executive Order 12866 (58 FR
51735, October 4, 1993), because this action eliminates an existing
regulatory requirement. The Agency estimates the cost savings to
industry from this action to be between $4.9 and $7.6 million per year.
The cost savings to EPA is estimated at $135,000 to $201,000 per year.
The lower bound estimate of the total annual savings for
[[Page 38605]]
industry and EPA from this action is $5,035,000 and the upper bound
estimate is $7,801,000.
This action does not impose any Federal mandate on State, local or
tribal governments or the private sector within the meaning of the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). And, given its
deregulatory nature, I hereby certify pursuant to the Regulatory
Flexibility Act (5 U.S.C. 605(b)), that this action does not have a
significant economic impact on a substantial number of small entities.
As required, information to this effect has been forwarded to the Small
Business Administration.
This action does not have any information collection requirements
subject to the provisions of the Paperwork Reduction Act of 1980, 44
U.S.C. 3501 et seq. The elimination of the information collection
components for this action is expected to result in the elimination of
92,000 to 141,000 paperwork burden hours.
In addition, pursuant to Executive Order 12898 (59 FR 7629,
February 16, 1994), entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations,'' the
Agency has determined that there are no environmental justice related
issues with regard to this action since this final rule simply
eliminates reporting requirements for a chemical that, under the
criteria of EPCRA section 313, does not pose a concern for human health
or the environment.
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 372
Environmental protection, Community right-to-know, Reporting and
recordkeeping requirements, Toxic chemicals.
Dated: July 19, 1996.
Lynn R. Goldman,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR part 372 is amended as follows:
1. The authority citation for part 372 continues to read as
follows:
Authority: 42 U.S.C. 11023 and 11048.
Sec. 372.65 [Amended]
2. Sections 372.65(a) and (b) are amended by adding the
parenthetical to the entry for hydrochloric acid to read ``Hydrochloric
acid (acid aerosols including mists, vapors, gas, fog, and other
airborne forms of any particle size)'' under paragraph (a) and for CAS
number entry 7647-01-0 under paragraph (b).
[FR Doc. 96-18944 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-18935 Approval and Promulgation of Implementation Plans; California State Implementation Plan Revision, Kern County Air Pollution Control District, Placer County Air Pollution Control District, Ventura County Air Pollution Control District, and San Joaquin Valley Unified Air Pollution Control District
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38571-38574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18935]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[CA 057-0009a; FRL-5527-6]
Approval and Promulgation of Implementation Plans; California
State Implementation Plan Revision, Kern County Air Pollution Control
District, Placer County Air Pollution Control District, Ventura County
Air Pollution Control District, and San Joaquin Valley Unified Air
Pollution Control District
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is taking direct final action on revisions to the
California State Implementation Plan (SIP). The revisions concern rules
from the following Districts: Kern County Air Pollution Control
District (KNCAPCD), Placer County Air Pollution Control District
(PLCAPCD), Ventura County Air Pollution Control District (VTCAPCD), and
San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD).
This approval action will incorporate these rules into the federally
approved SIP. The intended effect of approving these rules is to
regulate emissions of volatile organic compounds (VOCs) in accordance
with the requirements of the Clean Air Act, as amended in 1990 (CAA or
the Act). The revised rules control VOC emissions from surface coating
of metal parts and products, semiconductor manufacturing, fugitive
emissions of reactive organic compounds (ROC) at petroleum refineries
and chemical plants, polyester resin material operations, and
decontamination of soil. Thus, EPA is finalizing the approval of these
revisions into the California SIP under provisions of the CAA regarding
EPA action on SIP submittals, SIPs for national primary and secondary
ambient air quality standards and plan requirements for nonattainment
areas.
DATES: This action is effective on September 23, 1996 unless adverse or
critical comments are received by August 26, 1996. If the effective
date is delayed, a timely notice will be published in the Federal
Register.
ADDRESSES: Copies of the rule revisions and EPA's evaluation report for
each rule are available for public inspection at EPA's Region IX office
during normal business hours. Copies of the submitted rule revisions
are available for inspection at the following locations:
Rulemaking Section (A-5-3), Air and Toxics Division, U.S. Environmental
Protection Agency, Region IX, 75 Hawthorne Street, San Francisco, CA
94105
Environmental Protection Agency, Air Docket (6102), 401 ``M'' Street,
S.W., Washington, D.C. 20460
California Air Resources Board, Stationary Source Division, Rule
Evaluation Section, 2020 ``L'' Street, Sacramento, CA 92123-1095
Kern County Air Pollution Control District, 2700 ``M'' Street, Suite
290, Bakersfield, CA 93301
Placer County Air Pollution Control District, 11464 B Avenue, Auburn,
CA 95603
Ventura County Air Pollution Control District, 669 County Square Drive,
Ventura, CA 93003
San Joaquin Valley Unified Air Pollution Control District, 1999
Tuolumne Street, Suite 200, Fresno, CA 93721
FOR FURTHER INFORMATION CONTACT: Daniel A. Meer, Chief, Rulemaking
Section (A-5-3), Air and Toxics Division, U.S. Environmental Protection
Agency, Region IX, 75 Hawthorne Street, San Francisco, CA 94105,
Telephone: (415) 744-1185.
SUPPLEMENTARY INFORMATION:
Applicability
The rules being approved into the California SIP include: KNCAPCD's
Rule 410.4, Surface Coating of Metal Parts and Products; PLCAPCD's Rule
244, Semiconductor Manufacturing Operations; VTCAPCD's Rules 74.7,
Fugitive Emissions of Reactive Organic Compounds (ROC) at Petroleum
Refineries and Chemical Plants, and 74.14, Polyester Resin Material
Operations; and SJVUAPCD's Rule 4651, Volatile Organic Compound
Emissions from Decontamination of Soil. These rules were submitted by
the California Air Resources Board (CARB) to EPA on May 25, 1995
(410.4), May 24, 1995 (244), March 26, 1996 (74.7), September 14, 1992
(74.14), and December 22, 1994 (4651).
Background
On March 3, 1978, EPA promulgated a list of ozone nonattainment
areas under the provisions of the Clean Air Act, as amended in 1977
(1977 Act or pre-amended Act), that included the San Joaquin Valley Air
Basin, Ventura County and the Sacramento Metro Area, which includes a
portion of Placer County. 43 FR 8964, 40 CFR 81.305. On May 26, 1988,
EPA notified the Governor of California, pursuant to section
110(a)(2)(H) of the 1977 Act, that the above districts' portions of the
California SIP were inadequate to attain
[[Page 38572]]
and maintain the ozone standard and requested that deficiencies in the
existing SIP be corrected (EPA's SIP-Call). On November 15, 1990, the
Clean Air Act Amendments of 1990 were enacted. Pub. L. 101-549, 104
Stat. 2399, codified at 42 U.S.C. 7401-7671q. In amended section
182(a)(2)(A) of the CAA, Congress statutorily adopted the requirement
that nonattainment areas fix their deficient reasonably available
control technology (RACT) rules for ozone and established a deadline of
May 15, 1991 for states to submit corrections of those deficiencies.
Section 182(a)(2)(A) applies to areas designated as nonattainment
prior to enactment of the amendments and classified as marginal or
above as of the date of enactment. It requires such areas to adopt and
correct RACT rules pursuant to pre-amended section 172(b) as
interpreted in pre-amendment guidance.1 EPA's SIP-Call used that
guidance to indicate the necessary corrections for specific
nonattainment areas. Ventura County and the Sacramento Metro Area are
classified as severe, the San Joaquin Valley Air Basin and all of Kern
County is classified as serious, therefore, these areas were subject to
the RACT fix-up requirement and the May 15, 1991 deadline. However, the
Southeast Desert Air Basin portion of Kern County was not a pre-
amendment nonattainment area and, therefore was not designated and
classified upon enactment of the amended Act. For this reason, KCAPCD
is not subject to section 182(a)(2)(A) RACT fix-up requirement. The
KCAPCD is, however, still subject to the requirements of EPA's SIP-Call
because the SIP-Call included all of Kern County.2
---------------------------------------------------------------------------
\1\ Among other things, the pre-amendment guidance consists of
those portions of the proposed Post-1987 ozone and carbon monoxide
policy that concern RACT, 52 FR 45044 (November 24, 1987); ``Issues
Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,
Clarification to Appendix D of November 24, 1987 Federal Register
Notice'' (Blue Book) (notice of availability was published in the
Federal Register on May 25, 1988); and the existing control
technique guidelines (CTGs).
\2\ Ventura County, the Sacramento Metro Area and the San
Joaquin Valley Air Basin retained their designation of nonattainment
and were classified by operation of law pursuant to sections 107(d)
and 181(a) upon the date of enactment of the CAA. The Southeast
Desert Airbasin portion of the KCAPCD was designated nonattainment
on November 6, 1991. See 56 FR 56694 (November 6, 1991). However on
April 25, 1995, EPA published a final rule granting the State's
request to reclassify the Sacramento Metro Area to severe from
serious (60 CFR 20237). This reclassification became effective on
June 1, 1995.
---------------------------------------------------------------------------
The State of California submitted many revised RACT rules for
incorporation into its SIP on September 14, 1992, December 22, 1994,
May 24, 1995, May 25, 1995, and March 26, 1996, including the rules
being acted on in this document. This document addresses EPA's direct-
final action for KNCAPCD's Rule 410.4, Surface Coating of Metal Parts
and Products; PLCAPCD's Rule 244, Semiconductor Manufacturing
Operations; VTCAPCD's Rules 74.7, Fugitive Emissions of Reactive
Organic Compounds (ROC) at Petroleum Refineries and Chemical Plants,
and 74.14, Polyester Resin Material Operations; and SJVUAPCD's Rule
4651, Volatile Organic Compound Emissions from Decontamination of Soil.
KNCAPCD adopted Rule 410.4 on April 6, 1995, PLCAPCD adopted Rule 244
on February 9, 1995, VTCAPCD adopted Rules 74.7 on October 10, 1995,
74.14 on May 26, 1992, and SJVUAPCD adopted Rule 4651 on December 17,
1992. These submitted rules were found to be complete on November 20,
1992 (74.14), January 3, 1995 (4651), July 24, 1995 (410.4 and 244),
and May 15, 1996, (74.7) pursuant to EPA's completeness criteria that
are set forth in 40 CFR part 51, appendix V 3 and are being
finalized for approval into the SIP.
---------------------------------------------------------------------------
\3\ EPA adopted the completeness criteria on February 16, 1990
(55 FR 5830) and, pursuant to section 110(k)(1)(A) of the CAA,
revised the criteria on August 26, 1991 (56 FR 42216).
---------------------------------------------------------------------------
These rules control VOC emissions from surface coating of metal
parts and products, semiconductor manufacturing, polyester resin
material operations, marine coatings, soil decontamination and fugitive
ROC emissions at petroleum refineries and chemical plants. VOCs and
ROCs contribute to the production of ground level ozone and smog. These
rules were originally adopted as part of the efforts of these air
pollution control districts to achieve the National Ambient Air Quality
Standard (NAAQS) for ozone and in response to EPA's SIP-Call and the
section 182(a)(2)(A) CAA requirement. The following is EPA's evaluation
and final action for these rules.
EPA Evaluation and Action
In determining the approvability of a VOC rule, EPA must evaluate
the rule for consistency with the requirements of the CAA and EPA
regulations, as found in section 110 and part D of the CAA and 40 CFR
part 51 (Requirements for Preparation, Adoption, and Submittal of
Implementation Plans). The EPA interpretation of these requirements,
which forms the basis for today's action, appears in the various EPA
policy guidance documents listed in footnote 1. Among those provisions
is the requirement that a VOC rule must, at a minimum, provide for the
implementation of RACT for stationary sources of VOC emissions. This
requirement was carried forth from the pre-amended Act.
For the purpose of assisting state and local agencies in developing
RACT rules, EPA prepared a series of Control Technique Guideline (CTG)
documents. The CTGs are based on the underlying requirements of the Act
and specify the presumptive norms for what is RACT for specific source
categories. Under the CAA, Congress ratified EPA's use of these
documents, as well as other Agency policy, for requiring States to
``fix-up'' their RACT rules. See section 182(a)(2)(A). The CTG
applicable to KNCAPCD's Rule 410.4 is entitled: ``Control of Volatile
Organic Emissions from Existing Stationary Sources-- Volume VI: Surface
Coating of Miscellaneous Metal Parts and Products'', (EPA-450/2-015).
The CTG applicable to VTCAPCD's Rule 74.7 is entitled: ``Control of
Volatile Organic Compound Leaks from Synthetic Organic Chemical and
Polymer Manufacturing Equipment'', (EPA-450/3-83-006). PLCAPCD's Rule
244, VTCAPCD's Rule 74.14, and SJVUAPCD's Rule 4651 control emissions
from source categories for which EPA has not issued CTGs. Accordingly
these rules were evaluated for consistency with the general RACT
requirements of the Clean Air Act (CAA Section 110 and part D). Further
interpretations of EPA policy are found in the Blue Book, referred to
in footnote 1. In general, these guidance documents have been set forth
to ensure that VOC rules are fully enforceable and strengthen or
maintain the SIP.
KNCAPCD's submitted Rule 410.4, Surface Coating of Metal Parts and
Products, is a revised rule which includes the following significant
changes from the current SIP:
Clarified definitions,
Lower VOC limits for baked extreme performance and for
both baked and air-dried pretreatment wash primer coatings,
A capture efficiency requirement of at least 85% and a
control efficiency requirement of 90%,
New VOC limits and vapor pressure requirements for solvent
usage,
New prohibitions of sale and specifications
Record keeping provisions that require daily records, as
well as more specific information about the coating applied,
New test methods.
PLCAPCD's Rule 244, Semiconductor Manufacturing Operations, is a
new rule
[[Page 38573]]
which includes the following significant provisions:
A requirement that all precursor VOCs from solvent
cleaning stations be vented to control devices that reduce the total
emissions by at least 90% by weight,
In lieu of the above, a requirement that solvent cleaning
stations be equipped with full covers, and a definition of freeboard
ratio for solvent cleaning station sinks/reservoirs,
A requirement that all precursor VOC emissions from
negative photoresist operations be vented to control devices that
reduce total emissions by at least 90% by weight,
A list of test methods and record keeping requirements.
VTCAPCD's Rule 74.7, Fugitive Emissions of Reactive Organic
Compounds (ROC) at Petroleum Refineries and Chemical Plants, is a
revised rule which includes the following significant changes from the
SIP:
The applicability of the rule was expanded to include
additional chemical plants,
The definition section has been expanded,
The operations requirement section was broadened,
New inspection requirements were added,
The repair requirements were revised,
The Operator Management Plan was amended to reflect the
new requirement and exemptions in the rule,
The recordkeeping and reporting requirements were revised.
VTCAPCD's Rule 74.14, Polyester Resin Material Operations, is a new
rule which includes the following significant provisions:
Limits the ROC loss rate during resin polymerization to 60
grams per square meter of exposed area,
Limits the monomer content of specialty and non-specialty,
clear and pigmented gel coats, or requires the use of a closed mold
system,
Requires specified transfer efficient application methods,
Limits ROC content of clean-up solvents,
Add-on control equipment is specified when using non-
compliant resin material,
When compliant resin materials are used, records may be
kept at weekly intervals, but daily records are required when using
non-compliant resin material and/or an add-on control system,
Test methods are included to verify rule compliance.
SJVUAPCD's Rule 4651, Volatile Organic Compound Emissions from
Decontamination of Soil, is a new rule which includes the following
significant provisions:
A definition of contaminated soil,
An exemption for soil quantities of less than one cubic
yard,
A definition of the conditions allowing limited aeration,
The requirements for decontamination systems,
Test methods to be employed, and soil sampling procedures
to be followed to verify compliance.
EPA has evaluated the submitted rules and has determined that they
are consistent with the CAA, EPA regulations, and EPA policy.
Therefore, KNCAPCD's Rule 410.4, Surface Coating of Metal Parts and
Products; PLCAPCD's Rule 244, Semiconductor Manufacturing Operations;
VTCAPCD's Rules 74.7, Fugitive Emissions of Reactive Organic Compounds
(ROC) at Petroleum Refineries and Chemical Plants; 74.14, Polyester
Resin Material Operations; and SJVUAPCD's Rule 4651, Volatile Organic
Compound Emissions from Decontamination of Soils are being approved
under section 110(k)(3) of the CAA as meeting the requirements of
section 110(a) and part D.
Nothing in this action should be construed as permitting or
allowing or establishing a precedent for any future implementation
plan. Each request for revision to the state implementation plan shall
be considered separately in light of specific technical, economic, and
environmental factors and in relation to relevant statutory and
regulatory requirements.
EPA is publishing this document without prior proposal because the
Agency views this as a noncontroversial amendment and anticipates no
adverse comments. However, in a separate document in this Federal
Register publication, the EPA is proposing to approve the SIP revision
should adverse or critical comments be filed. This action will be
effective September 23, 1996, unless, by August 26, 1996, adverse or
critical comments are received.
If the EPA receives such comments, this action will be withdrawn
before the effective date by publishing a subsequent document that will
withdraw the final action. All public comments received will then be
addressed in a subsequent final rule based on this action serving as a
proposed rule. The EPA will not institute a second comment period on
this action. Any parties interested in commenting on this action should
do so at this time. If no such comments are received, the public is
advised that this action will be effective September 23, 1996.
Regulatory Process
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises and
government entities with jurisdiction over population of less than
50,000.
SIP approvals under sections 110 and 301(a) and subchapter I, Part
D of the CAA do not create any new requirements, but simply approve
requirements that the State is already imposing. Therefore, because the
Federal SIP-approval does not impose any new requirements, I certify
that it does not have a significant impact on any small entities
affected. Moreover, due to the nature of the Federal-state relationship
under the CAA, preparation of a regulatory flexibility analysis would
constitute Federal inquiry into the economic reasonableness of state
action. The CAA forbids EPA to base its actions concerning SIPs on such
grounds. Union Electric Co. v. U.S. E.P.A., 427 U.S. 246, 256-66 (S.
Ct. 1976); 42 U.S.C. 7410 (a)(2).
Unfunded Mandates
Under Sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 22,
1995, EPA must undertake various actions in association with proposed
or final rules that include a Federal mandate that may result in
estimated costs of $100 million or more to the private sector or to
State, local, or tribal governments in the aggregate.
Through submission of this state implementation plan or plan
revision, the State and any affected local or tribal governments have
elected to adopt the program provided for under Part D of the Clean Air
Act. These rules may bind State, local, and tribal governments to
perform certain actions and also require the private sector to perform
certain duties. The rules being approved by this action will impose no
new requirements because affected sources are already subject to these
regulations under State law. Therefore, no additional costs to State,
local, or tribal governments or to the private sector result from this
action. EPA has also determined that this final action does not include
a mandate that may result in estimated costs of $100
[[Page 38574]]
million or more to State, local, or tribal governments in the aggregate
or to the private sector.
Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of this rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
This action has been classified as a Table 3 action for signature
by the Regional Administrator under the procedures published in the
Federal Register on January 19, 1989 (54 FR 2214-2225), as revised by a
July 10, 1995 memorandum from Mary Nichols, Assistant Administrator for
Air and Radiation. The Office of Management and Budget (OMB) has
exempted this regulatory action from Executive Order 12866 review.
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Hydrocarbons,
Incorporation by reference, Intergovernmental relations, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.
Note: Incorporation by reference of the State Implementation
Plan for the State of California was approved by the Director of the
Federal Register on July 1, 1982.
Dated: June 17, 1996.
Felicia Marcus,
Regional Administrator.
Subpart F of part 52, chapter I, title 40 of the Code of Federal
Regulations is amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Subpart F--California
Authority: 42 U.S.C. 7401-7671q.
2. Section 52.220 is amended by adding paragraphs
(c)(189)(i)(B)(3), (210)(i)(E), (220)(i)(B)(3), (221)(i)(A)(2), (229)
and (230) to read as follows:
Sec. 52.220 Identification of plan.
* * * * *
(c) * * *
(189) * * *
(i) * * *
(B) * * *
(3) Rule 74.14, adopted on May 26, 1992.
* * * * *
(210) * * *
(i) * * *
(E) San Joaquin Valley Unified Air Pollution Control District.
(1) Rule 4651, adopted on December 17, 1992.
* * * * *
(220) * * *
(i) * * *
(B) * * *
(3) Rule 244, adopted on February 9, 1995.
* * * * *
(221) * * *
(i) * * *
(A) * * *
(2) Rule 410.4, adopted on April 6, 1995.
* * * * *
(229) (Reserved)
(230) New and amended regulations for the following APCDs were
submitted on March 26, 1996, by the Governors designee.
(i) Incorporation by reference.
(A) Ventura County Air Pollution Control District.
(1) Rule 74.7, adopted on October 10, 1995.
* * * * *
[FR Doc. 96-18935 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-W
Complete official Federal Register PDF
FR Doc. 96-18922 Inspection/Maintenance Flexibility Amendments (Ozone Transport Region)
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 39032-39037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18922]
[[Page 39031]]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 51
_______________________________________________________________________
Inspection/Maintenance Flexibility Amendments (Ozone Transport Region);
Final Rule
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules
and Regulations
[[Page 39032]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 51
[FRL-5541-3]
RIN 2060-AG11
Inspection/Maintenance Flexibility Amendments (Ozone Transport
Region)
AGENCY: Environmental Protection Agency.
ACTION: Supplemental final rule.
-----------------------------------------------------------------------
SUMMARY: Today's action revises the motor vehicle Inspection/
Maintenance (I/M) requirements by adding a special low enhanced
performance standard for qualified areas in Ozone Transport Regions
(OTR). This additional performance standard applies to certain
attainment, marginal and moderate areas in the OTR. The purpose of this
action is to allow OTR qualifying areas the flexibility to implement a
broader range of I/M programs than is currently permitted.
EFFECTIVE DATE: This rule will take effect on September 23, 1996.
ADDRESSES: Materials relevant to this rulemaking are contained in the
Public Docket No. A-95-08. The docket is located at the Air Docket,
Room M-1500 (6102), Waterside Mall SW, Washington, DC 20460. The docket
may be inspected between 8:30 a.m. and 12 noon and between 1:30 p.m.
until 5:30 p.m. on weekdays. A reasonable fee may be charged for
copying docket material. Electronic copies of the preamble and the
regulatory text of this rulemaking are available on the Office of Air
Quality Planning and Standards (OAQPS) Technology Transfer Network
Bulletin Board System (TTN BBS) and the Office of Mobile Sources' World
Wide Web cite, http://www.epa.gov/OMSWWW/.
FOR FURTHER INFORMATION CONTACT: Leila Cook, Office of Mobile Sources,
National Vehicle and Fuel Emissions Laboratory, 2565 Plymouth Road, Ann
Arbor, Michigan, 48105. Telephone (313) 741-7820.
SUPPLEMENTARY INFORMATION:
I. Table of Contents
II. Summary of Rule
III. Authority
IV. Public Participation
A. Increased Flexibility
B. Clarification of 200,000 Population Requirement
C. Duplicate Requirements
D. Emission Reduction Credits
E. Comparability of Basic Programs
F. Effectiveness of RSD
G. Retests for RSD Failures
H. OBD Tests
I. Other Comments
V. Economic Costs and Benefits
VI. Administrative Requirements
A. Administrative Designation
B. Reporting and Recordkeeping Requirement
C. Regulatory Flexibility Act
D. Unfunded Mandates Act
E. Small Business Regulatory
Enforcement Fairness Act
II. Summary of Rule
Under the Clean Air Act as amended in 1990 (the Act), 42 U.S.C.7
401 et seq., the U.S. Environmental Protection Agency (EPA) published
in the Federal Register on November 5, 1992 (40 CFR part 51, subpart S)
rules related to plans for Motor Vehicle Inspection and Maintenance (I/
M) programs (hereafter referred to as the I/M rule; see 57 FR 52950).
Today, EPA is revising this rule to provide greater flexibility to
certain Ozone Transport Region (OTR) areas.
Section 182 of the Act is prescriptive regarding the various
elements that are required as part of an enhanced Inspection/
Maintenance (I/M) performance standard. It also provides states with
flexibility in meeting the numerical performance standards for enhanced
or basic I/M programs. States in the Ozone Transport Region (OTR)
requested additional flexibility in implementing I/M in areas which are
in attainment, which are areas designated and classified as marginal
ozone areas, or which are designated and classified as moderate ozone
areas under 200,000 in population. These three types of areas would be
exempt from all I/M requirements but for their location in the OTR.
These areas are included in the OTR enhanced I/M requirements to help
achieve overall attainment and maintenance goals for the region, which
includes serious and severe ozone nonattainment areas.
With today's action, EPA is establishing an additional enhanced I/M
performance standard for qualified areas in the Northeast OTR,
hereafter referred to as the OTR low enhanced performance standard. The
emission reduction targets for this program are less than both the low
enhanced performance standard and the basic performance standard. There
are two qualifications to be eligible for the OTR low enhanced
performance standard. First, the standard applies only in attainment
areas, marginal ozone nonattainment areas and certain moderate ozone
nonattainment areas under 200,000 in an OTR. Moderate areas of that
size that were not previously required to, or had not in fact,
implemented a basic I/M program under the pre-1990 Act can take
advantage of the OTR low enhanced performance standard. The savings
clause in section 182(a)(2)(B)(i) requires areas that had or were
required to have I/M programs before 1990 to retain programs of at
least that stringency. Because, as explained below, EPA believes the
Act requires an enhanced I/M program to be an enhancement over
otherwise applicable I/M requirements, areas subject to basic I/M or
the savings clause cannot adopt a less stringent program. Any moderate
area with urbanized areas having a total population of over 200,000
would also be required to implement basic I/M under section 182(b)(4)
and therefore is ineligible for the OTR low enhanced performance
standard. Second, the OTR low enhanced program must be supplemented by
other measures in order to achieve emission reductions equal to or
greater than that which would have occurred had a regular low enhanced
I/M program been implemented (as defined by 40 CFR 51.351(g), see 60 FR
48029). This is because the primary goal of the Act in establishing the
OTR provisions and requiring enhanced I/M in areas with a population of
100,000 or more in the OTR was to contribute to regional attainment.
EPA believes that an area should be able to qualify for the additional
flexibility provided under the OTR low enhanced standard only if it
achieves, in some other way, the additional reductions that the
otherwise applicable low enhanced I/M program would achieve. Thus, the
total emission reductions from the OTR low enhanced I/M program plus
the additional measures must equal the tonnage reduction that a regular
low enhanced program would have generated. However, since local
reductions are not the crucial factor, a state may bubble surplus
reductions from other areas not required to implement I/M in the state.
For example, a state could implement a statewide reformulated gasoline
(RFG) program plus an OTR low enhanced I/M program in subject areas or
statewide and potentially achieve comparable reductions to a regular
low enhanced program because of the additional reductions RFG would
achieve in areas not otherwise required to have RFG. Equality of
emission reductions must be demonstrated over a time period which
aligns with the attainment deadlines of all OTR areas: from 2000
through 2007. Note that an I/M program that meets the OTR low enhanced
performance standard must be implemented even if other measures could
achieve comparable emission reductions because the Act specifically
[[Page 39033]]
requires an enhanced I/M program in metropolitan areas with 100,000
population in the OTR. Also, measures to fill the gap between OTR low
and regular low enhanced I/M may not be otherwise required by the Clean
Air Act.
The OTR low enhanced performance standard model program is composed
of the following elements: Annual testing of 1968 and newer light duty
vehicles and light duty trucks, OBD checks for 1996 and newer vehicles,
remote sensing of 1968-1995 vehicles, catalyst checks on 1975 and newer
vehicles, and PCV valve checks on pre-1975 vehicles. These elements
collectively satisfy the Act's requirements for an enhanced I/M program
performance standard. As with other performance standards, EPA does not
necessarily recommend implementing this particular program but rather
encourages states to design a program that will achieve equal or
greater emission reductions than the performance standard while
providing for the specific needs of the area.
In the proposal, EPA noted that the emission reduction targets
generated by this model program could not yet be precisely modeled but
EPA estimated the targets to be less than those for the basic I/M
program standard (which are approximately 6.3% for HC, 10.8% for CO,
and 0.7% for NOX). EPA expects to issue draft guidance on remote
sensing credits in the Summer of 1996. As soon as a final guidance is
issued, an analysis of the emission reduction targets generated by this
model program will be placed in the docket. Even though the estimated
emission reduction targets for the OTR low enhanced standard are less
than those for basic I/M, EPA believes this standard meets the
requirement of the Act for ``enhanced'' I/M. There are two important
facts to consider in this regard: first, neither the Act nor the
legislative history specifies that the emission reduction targets for
enhanced I/M must be greater than basic in all cases. EPA believes the
Act provides the agency latitude in establishing multiple performance
standards to meet a wide range of state and local needs and conditions.
Second, the areas eligible to take advantage of this performance
standard were not required to nor did they implement I/M programs prior
to 1990. So, in all cases, this standard establishes a program target
that is indeed enhanced relative to what was present or required for
the area before enactment of the 1990 Clean Air Act Amendments or is
otherwise required after the 1990 Clean Air Act Amendments. EPA did not
receive any public comments disagreeing with this legal interpretation.
As is the case with all performance standard model programs, EPA
does not necessarily recommend implementation of the model program,
since it is constrained in composition by law (e.g., EPA recommends not
testing cars until they reach 4 years of age and recommends biennial
testing as more cost-effective; by contrast, all of the enhanced I/M
performance standards are required by the Act to reflect a model
program that includes annual testing of all vehicles). In that the
emission reduction targets for the OTR low enhanced performance
standard are below the basic level, the standard provides the broadest
possible latitude in program design. For example, some states in the
OTR have existing decentralized, safety inspection programs.
Comprehensive visual checks of emission control devices, a gas cap
pressure test, the Act-mandated OBD check, and the Act-mandated on-road
testing could be added to these programs which should then meet the OTR
low enhanced standard, as long as a proper enforcement mechanism was in
place. Many other possibilities exist for program designs that could
also meet this performance standard.
While the OTR low enhanced performance standard is less demanding
than the existing performance standard applicable to the affected
areas, today's action still ensures that enhanced I/M programs in these
areas meet all statutory criteria for EPA approval. A state's OTR low
enhanced program is required, under section 182(c)(3)(C) of the Clean
Air Act, to include computerized analyzers and on-road testing devices;
computerized equipment and on-road testing devices are required by the
current rule and apply to the OTR low enhanced program. A state's OTR
low enhanced program shall also include a regulatory framework for
waivers, if waivers are to be issued, and an enforcement system through
registration denial, (except for any program in operation before
November 15, 1990 whose enforcement mechanism has been demonstrated to
be more effective than registration denial). Today's amendments leave
requirements in this regard the same as for other enhanced I/M areas.
As mandated by the Act, in an OTR low enhanced program, vehicle
emissions shall be tested annually unless biennial testing will equal
or exceed the reductions that can be obtained from annual inspections.
A program could combine biennial inspections on the vehicles equipped
with on-board diagnostic computers (OBD) with biennial evaporative
system checks to achieve the necessary additional reductions. The OTR
low enhanced performance standard is based on centralized inspections
of OBD-equipped vehicles and on-road remote sensing testing; EPA
believes that this meets the specific requirement that the performance
standard be based on centralized testing.
Today's action also establishes quality assurance requirements for
OTR low enhanced I/M programs that are commensurate with the emission
reductions which the programs are intended to achieve. In particular,
current rules require enhanced I/M programs to be evaluated by
conducting test-only IM240s on a random representative sample of the
fleet (a minimum of 0.1%) to verify that the emission reductions are
occurring. EPA believes that the emission reductions from an OTR low
enhanced program are small enough that this level of effort is not
justified. The routine quality assurance requirements of the original
I/M rule are also not necessarily appropriate in light of the low level
of benefits of the program.
This action also modifies the geographic exclusion rule for
counties within Metropolitan Statistical Areas (MSAs) in the Ozone
Transport Region. The modification allows states to exclude counties
that comprise less than 1% of the population of the MSA from program
coverage. Inclusion of such a small fraction of the population is not
worth the significant cost of expanding geographic coverage of the
program to include such a county.
This action requires that the implementation date for full testing
in areas opting for the OTR low performance standard be no later than
the latest date by which full testing can commence and still achieve
sufficient reductions for all OTR areas to meet the performance
standard by the Act's attainment and reasonable further progress
deadlines, including the end of 1999 attainment date for serious ozone
nonattainment areas. This will generally mean a start date no later
than January 1, 1999, for annual testing programs, although EPA will
accept field testing commencing as late as July 1, 1999 if the full I/M
reductions can be achieved by the serious area attainment deadline.
Note that the performance standard model program assumes a start date
of January 1, 1999 because EPA believes Congress intended that the
performance standard be based on at least one complete annual test
cycle. With the requirement to offset the emissions difference between
OTR low and regular low enhanced with other measures, this
[[Page 39034]]
date ensures that attainment in the region is not impaired.
Today's action also serves to provide other flexibilities to non-
OTR states in designing quality assurance programs. The intent is to
allow alternative quality assurance procedures that are as effective as
or better than those specified in the original I/M rule.
III. Authority
Authority for the action proposed in this notice is granted to EPA
by section 182 of the Clean Air Act as amended (42 U.S.C. 7401, et
seq.).
IV. Public Participation
A. Increased Flexibility
All the commenters agreed with EPA's effort to provide states with
greater flexibility and almost all felt that the new OTR low enhanced
performance standard was necessary to meet the unique needs of states
within the Ozone Transport Region.
B. Clarification of 200,000 Population Requirement
1. Summary of Proposal
The proposal allowed attainment areas, marginal ozone nonattainment
areas and moderate ozone nonattainment areas with a 1980 Census
population of less than 200,000 in the urbanized area to use the new
OTR low enhanced performance standard.
2. Summary of Comments
One commenter asked for clarification of how the 200,000 urbanized
area population criteria would be applied. Specifically, the commenter
asked whether the population criteria applied to urbanized areas within
each Metropolitan Statistical Area (MSA) or urbanized areas within the
entire attainment or non-attainment area.
3. Response to Comments
Within the OTR, enhanced I/M programs are required in MSA's with
populations of 100,000 or more. However, the OTR, like the rest of the
country, is also subject to the basic I/M requirements that an
urbanized area with a population of 200,000 or more that is classified
as moderate ozone nonattainment must implement a basic I/M program.
Thus, moderate ozone areas in the OTR with an MSA population of greater
than 100,000 but an urbanized area population of less than 200,000 are
eligible for the OTR low enhanced performance standard. In contrast,
moderate ozone areas with MSA populations of greater than 100,000 and
urbanized area populations of greater than 200,000 must meet the basic
performance standard. If a state within the OTR falls into this later
category which has to implement a basic I/M program in the urbanized
area (with a population of 200,000 or more) it can still implement an
OTR low enhanced program in any portion of the MSA which falls into an
urbanized area with a population of less than 200,000.
C. Duplicate Requirements
1. Summary of Proposal
The proposal did not exempt states that implement an OTR low
enhanced performance program from most of the general requirements for
enhanced I/M programs in the original I/M rule.
2. Summary of Comments
Two commenters addressed this issue. The first felt that the
inclusion of on-road testing and OBD testing in the OTR low enhanced
performance standard is duplicative of the on-road and OBD testing
requirements in the original rule, 40 CFR 51.351 (b) and (c). The
second commenter felt that several sections of the I/M rule dealing
with data collection and data analysis and reporting, 40 CFR 51.365 and
51.366, should not be applicable to OTR low enhanced programs.
3. Response to Comments
The Clean Air Act requires OBD as part of any basic or enhanced
performance standard. Additionally, RSD is required as part of any
enhanced I/M performance standard. Section 51.351(b) requires that on-
road testing of either 0.5% of the subject vehicle population or 20,000
vehicles (whichever is less) be included in any enhanced I/M
performance standard. The OBD requirements were reserved by EPA in the
original I/M rule and are expected to be published in 1996. EPA
cautions commenters to remember that performance standards merely
establish the minimum target a certain program must meet. They do not
conclusively establish the elements of the program. Thus, the
Sec. 51.351(h)(6) establishment of RSD and OBD as the exhaust emission
test types under the OTR low enhanced performance standard is not a
duplication of Secs. 51.351 (b) and (c) because these are separate
standards which OTR low areas do not otherwise have to meet.
EPA agrees with the comment that certain portions of sections
51.365 and 51.366 regarding data collection, analysis and reporting are
inapplicable to OTR low enhanced performance states. Certain ``high''
enhanced program elements, such as evaporative system checks, will not
apply in an OTR low enhanced program. However, the Clean Air Act and
the I/M rule require each state to report emissions reductions
achieved, based on data collected during the inspection and repair of
vehicles. Furthermore, depending on the program design which these
areas elect to implement, varying types of data and reporting might or
might not apply. Obviously a state cannot collect, analyze and report
data which its program does not generate. Therefore, while the data
collection and reporting requirements of sections 51.365 and 51.366
must still apply to OTR low enhanced areas, states need only submit
program-applicable data and reports.
D. Emission Reduction Credits
1. Summary of Proposal
The preamble for the proposal acknowledged that EPA had not
finalized emission reduction credits for the OTR low enhanced
performance standard because EPA is still in the process of finalizing
the credits for RSD. However, the preamble did note that EPA expected
these benefits to be less than those achieved by the basic performance
standard.
2. Summary of Comments
Several commenters noted that it is difficult for a state to
finalize an OTR low enhanced program until EPA issues emission
reduction credits for the program.
3. Response to Comments
EPA is preparing to issue a draft guidance on RSD credits in the
Summer of 1996. After the draft guidance is issued, EPA will take
public comments before issuing final guidance. While EPA cannot give a
specific date by which final guidance will be issued, stakeholders can
be assured that EPA realizes the importance of issuing RSD credits and
is working to issue them as soon as possible.
E. Comparability of Basic Programs
1. In the proposal, EPA stated that the emission reductions from
the new OTR low enhanced performance standard will actually be less
than the emission reductions obtained from a basic I/M program. EPA
noted that the Act in no way prohibits the creation of multiple
enhanced performance standards to meet a wide variety of state and
local needs and conditions. In fact, the Clean Air Act does not require
emission reductions targets for enhanced I/M programs to be greater
than those for basic programs. Furthermore, all the areas eligible to
use the OTR low enhanced performance standard were
[[Page 39035]]
not required and did not implement I/M programs before 1990. Thus, the
OTR low enhanced performance standard is an enhancement for these areas
compared to what was required and present before the 1990 amendments to
the Act.
2. Summary of Comments
One commenter believes that any existing basic program in an
attainment or marginal non-attainment area should meet the OTR low
enhanced performance standard. This commenter did not believe that
existing programs should have to be supplemented to meet the new
performance standard.
3. Response to Comments
From an emission reduction point of view, any existing basic
program that meets the basic performance standard will also meet the
emission reduction targets established by the OTR low enhanced
performance standard. The only changes existing programs will have to
make is to include any element which is required for an enhanced
program which it currently does not include; for instance, OBD checks
and 0.5% on-road testing.
F. Effectiveness of RSD
1. Summary of Rule
The performance standard created by today's action requires RSD
testing of 1968 to 1995 vehicles beginning in 1999.
2. Summary of Comments
One commenter was very concerned that RSD testing will actually
increase consumer inconvenience if RSD has a high false failure rate.
If this is the case and the state requires retests for vehicles that
fail the RSD test, many consumers may be needlessly required to go to a
test station to get another emission test.
3. Response to Comments
The goal of this action is to increase flexibility to the states so
that they can design an I/M program which they feel is most effective
for their area and convenient for their citizens. This performance
standard merely establishes the target level of emission reductions
that an OTR low enhanced program must achieve and in no way mandates
the type of test a state must implement. Thus, states concerned about
false failures need not rely heavily on RSD testing. States may
implement any type of test they choose so long as it meets the emission
reduction target of the OTR low enhanced performance standard. The
requirement to perform on-road testing on at least 0.5% of the fleet
remains, although RSD is not required for this purpose.
G. Retests for RSD Failures
1. Summary of Proposal
The OTR low enhanced performance standard requires RSD testing of
1968-1995 vehicles with a carbon monoxide standard of 7.5%. A vehicle
must have two separate readings above 7.5% to establish a failure
thereby requiring a retest.
2. Summary of Comments
One commenter noted their opinion that RSD is useful at targeting
vehicles with excess emissions but that RSD cannot substitute for a
traditional tail-pipe exhaust test. Therefore, the commenter believed
that RSD must be used in conjunction with a traditional exhaust
emissions re-test.
3. Response to Comments
EPA agrees with this comment but again points out that this rule
only establishes a performance standard and is not guidance or a
mandate for RSD usage. EPA believes that it would be unwise for states
to require emission related repairs based solely on an RSD reading.
Indeed, EPA believes that states are aware of this and will perform
confirmatory emission re-tests using proven methods on vehicles that
fail RSD in order to avoid useless repairs.
H. OBD tests
1. Summary of Rule
Among other requirements, the OTR low enhanced performance standard
requires a start date of January 1, 1999 and OBD tests on all 1996 and
newer vehicles.
2. Summary of Comments
One state commented that it was reluctant to require repairs based
solely on OBD test failure in 1999 because of the relative newness of
OBD technology. The state commented that it preferred to wait and not
require repairs based on OBD test failure until there is more data
available on OBD's effectiveness at correctly identifying emission
component failures.
3. Response to Comments
EPA proposed an OBD rule in the Federal Register on August 18, 1995
(60 FR 43092). Currently, EPA is finalizing the OBD rule which is
expected to be published in the Summer of 1996. In the OBD rule, EPA
will address the concerns of this and several other comments about the
novelty of OBD and the need for a phase-in period prior to requiring
repairs.
I. Other Comments
EPA received several other comments which dealt with I/M issues
that were not specific to this rulemaking. EPA responded to these
unrelated comments in a response document which it placed in the
docket.
V. Economic Costs and Benefits
Today's revisions provide states additional flexibility that
lessens rather than increases the potential burden on states.
Furthermore, states are under no obligation, legal or otherwise, to
modify existing plans meeting the previously applicable requirements as
a result of today's action.
VI. Administrative Requirements
A. Administrative Designation
It has been determined that this amendment to the I/M rule is not a
significant regulatory action under the terms of Executive Order 12866
and has been waived from OMB review. Any impacts associated with these
revisions do not constitute additional burdens when compared to the
existing I/M requirements published in the Federal Register on November
5, 1992 (57 FR 52950) as amended. Nor do today's amendments create an
annual effect on the economy of $100 million or more or otherwise
adversely affect the economy or the environment. It is not inconsistent
with, nor does it interfere with, actions by other agencies. It does
not alter budgetary impacts of entitlements or other programs, and it
does not raise any new or unusual legal or policy issues.
B. Reporting and Recordkeeping Requirement
There are no information requirements in this supplemental final
rule which require the approval of the Office of Management and Budget
under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act, 5
U.S.C. 605(b), the Administrator certifies that this action will not
have a significant economic impact on a substantial number of small
entities and, therefore, is not subject to the requirement of a
Regulatory Impact Analysis. A small entity may include a small
government entity or jurisdiction. A small government jurisdiction is
defined as ``governments of cities, counties, towns, townships,
villages, school districts, or special districts, with a population of
less than 50,000.'' This certification is based on the fact that the I/
M areas
[[Page 39036]]
impacted by this rulemaking do not meet the definition of a small
government jurisdiction, that is, ``governments of cities, counties,
towns, townships, villages, school districts, or special districts,
with a population of less than 50,000.'' Furthermore, the impact
created by this action does not increase the pre-existing burden which
this proposal seeks to amend.
D. Unfunded Mandates Act
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule where the estimated costs to State, local, or tribal
governments, or to the private sector, will be $100 million or more.
Under Section 205, EPA must select the most cost-effective and least
burdensome alternative that achieves the objective of the rule and is
consistent with statutory requirements. Section 203 requires EPA to
establish a plan for informing and advising any small governments that
may be significantly impacted by the rule.
To the extent that the rules in this action would impose any
mandate at all as defined in Section 101 of the Unfunded Mandates Act
upon the state, local, or tribal governments, or the private sector, as
explained above, this rule is not estimated to impose costs in excess
of $100 million. Therefore, EPA has not prepared a statement with
respect to budgetary impacts. As noted above, this rule offers
opportunities to states that would enable them to lower economic
burdens from those resulting from the currently existing I/M rule.
E. Small Business Regulatory Enforcement Fairness Act
Under section 801(a)(1)(A) of the Administrative Procedures Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of the rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
List of Subjects in 40 CFR Part 51
Environmental protection, Administrative practice and procedure,
Air pollution control, Carbon monoxide, Transportation.
Dated: July 16, 1960.
Fred Hansen,
Acting Administrator.
For the reasons set out in the preamble, part 51 of title 40 of the
Code of Federal Regulations is amended to read as follows:
PART 51--[AMENDED]
1. The authority citation for part 51 continues to read as follows:
Authority: 42 U.S.C. 740l-7671q.
2. Section 51.350 is amended by revising paragraph (b)(1) and by
adding paragraph (b)(5) to read as follows:
Sec. 51.350 Applicability.
* * * * *
(b) * * * (1) In an ozone transport region, the program shall cover
all counties within subject MSAs or subject portions of MSAs, as
defined by OMB in 1990, except largely rural counties having a
population density of less than 200 persons per square mile based on
the 1990 Census and counties with less than 1% of the population in the
MSA may be excluded provided that at least 50% of the MSA population is
included in the program. This provision does not preclude the voluntary
inclusion of portions of an excluded county. Non-urbanized islands not
connected to the mainland by roads, bridges, or tunnels may be excluded
without regard to population.
* * * * *
(5) Notwithstanding the limitation in paragraph (b)(3) of this
section, in an ozone transport region, states which opt for a program
which meets the performance standard described in Sec. 51.351(h) and
claim in their SIP less emission reduction credit than the basic
performance standard for one or more pollutants, may apply a geographic
bubble covering areas in the state not otherwise subject to an I/M
requirement to achieve emission reductions from other measures equal to
or greater than what would have been achieved if the low enhanced
performance standard were met in the subject I/M areas. Emissions
reductions from non-I/M measures shall not be counted towards the OTR
low enhanced performance standard.
* * * * *
3. Section 51.351 is amended by adding paragraph (h) to read as
follows:
Sec. 51.351 Enhanced I/M performance standards.
* * * * *
(h) Ozone Transport Region Low-Enhanced Performance Standard. An
attainment area, marginal ozone area, or moderate ozone area with a
1980 Census population of less than 200,000 in the urbanized area, in
an ozone transport region, that is required to implement enhanced I/M
under section 184(b)(1)(A) of the Clean Air Act, but was not previously
required to or did not in fact implement basic I/M under the Clean Air
Act as enacted prior to 1990 and is not subject to the requirements for
basic I/M programs in this subpart, may select the performance standard
described below in lieu of the standard described in paragraph (f) or
(g) of this section as long as the difference in emission reductions
between the program described in paragraph (g) and this paragraph are
made up with other measures, as provided in Sec. 51.350(b)(5).
Offsetting measures shall not include those otherwise required by the
Clean Air Act in the areas from which credit is bubbled. The program
elements for this alternate OTR enhanced I/M performance standard are:
(1) Network type. Centralized testing.
(2) Start date. January 1, 1999.
(3) Test frequency. Annual testing.
(4) Model year coverage. Testing of 1968 and newer vehicles.
(5) Vehicle type coverage. Light duty vehicles, and light duty
trucks, rated up to 8,500 pounds GVWR.
(6) Exhaust emission test type. Remote sensing measurements on
1968-1995 vehicles; on-board diagnostic system checks on 1996 and newer
vehicles.
(7) Emission standards. For remote sensing measurements, a carbon
monoxide standard of 7.5% (with at least two separate readings above
this level to establish a failure).
(8) Emission control device inspections. Visual inspection of the
catalytic converter on 1975 and newer vehicles and visual inspection of
the positive crankcase ventilation valve on 1968-1974 vehicles.
(9) Waiver rate. A 3% waiver rate, as a percentage of failed
vehicles.
(10) Compliance rate. A 96% compliance rate.
(11) Evaluation dates. Enhanced I/M program areas subject to the
provisions of this paragraph shall be shown to obtain the same or lower
VOC and NOX emission levels as the model program described in this
paragraph by January 1, 2000, 2003, 2006, and 2007. Equality of
substituted emission reductions to the benefits of the low enhanced
performance standard must be demonstrated for the same evaluation
dates.
4. Section 51.353 is amended by adding paragraph (c)(5) to read as
follows:
[[Page 39037]]
Sec. 51.353 Network type and program evaluation.
* * * * *
(c) * * *
(5) Areas that qualify for and choose to implement an OTR low
enhanced I/M program, as established in Sec. 51.351(h), and that
claim in their SIP less emission reduction credit than the basic
performance standard for one or more pollutants, are exempt from the
requirements of paragraphs (c)(1) through (c)(4) of this section. The
reports required under Sec. 51.366 of this part shall be sufficient in
these areas to satisfy the requirements of Clean Air Act for program
reporting.
* * * * *
5. Section 51.364 is amended by adding paragraphs (e) and (f) to
read as follows:
Sec. 51.364 Enforcement against contractors, stations and inspectors.
* * * * *
(e) Alternative quality assurance procedures or frequencies that
achieve equivalent or better results may be approved by the
Administrator. Statistical process control shall be used whenever
possible to demonstrate the efficacy of alternatives.
(f) Areas that qualify for and choose to implement an OTR low
enhanced I/M program, as established in Sec. 51.351(h), and that claim
in their SIP less emission reduction credit than the basic performance
standard for one or more pollutants, are not required to meet the
oversight specifications of this section.
6. Section 51.373 is amended by adding paragraph (f) to read as
follows:
Sec. 51.373 Implementation deadlines.
* * * * *
(f) Areas that choose to implement an enhanced I/M program only
meeting the requirements of Sec. 51.351(h) shall fully implement the
program no later than July 1, 1999. The availability and use of this
late start date does not relieve the area of the obligation to meet the
requirements of Sec. 51.351(h)(11) by the end of 1999.
[FR Doc. 96-18922 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-18900 Oil Pipeline Cost-of-Service Filing Requirements
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38567-38569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18900]
-----------------------------------------------------------------------
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
18 CFR Part 346
[Docket No. RM96-10-000; Order No. 588]
Oil Pipeline Cost-of-Service Filing Requirements
Issued July 19, 1996.
AGENCY: Federal Energy Regulatory Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Federal Energy Regulatory Commission (Commission) is
amending Part 346 of its regulations to make the cost-of-service filing
requirements of that Part applicable to the Trans-Alaska Pipeline
System (TAPS) carriers and carriers delivering oil directly or
indirectly to TAPS. These carriers were inadvertently excluded from the
streamlined procedural rules in Part 346 required by the Energy Policy
Act of 1992.
EFFECTIVE DATE: August 26, 1996.
FOR FURTHER INFORMATION CONTACT: Jacob Silverman, Office of the General
Counsel Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, Telephone: (202) 208-2078.
SUPPLEMENTARY INFORMATION: In addition to publishing the full text of
this document of the Federal Register, the Commission also provides all
interested persons an opportunity to inspect or copy the contents of
this document during normal business hours in Room 2-A, 888 First
Street, NE., Washington, DC 20426.
The Commission Issuance Posting System (CIPS), an electronic
bulletin board service, provides access to the texts of formal
documents issued by the Commission. CIPS is available at no charge to
the user and may be accessed using a personal computer with a modem by
dialing (202) 208-1397 if dialing locally or 1-800 856-3920 if dialing
long distance. To access CIPS, set your communication software to
19200, 14400, 12000, 9600, 7200, 4800, 2400 or 1200bps, full duplex, no
parity, 8 data bits, and 1 stop bit. The full text of this document
will be available on CIPS indefinitely in ASCII and WordPerfect 5.1
format for one year. The complete text on diskette in WordPerfect
format may also be purchased from the Commission's copy contractor, La
Dorn Systems Corporation, also located in Room 2-A, 888 First Street,
NE., Washington, DC 20426.
The Commission's bulletin board system can also be accessed through
the FedWorld system directly by modem or through the Internet. To
access the FedWorld system by modem:
Dial (703) 321-3339 and logon to the FedWorld system.
1/2 After Logging on, type: /go FERC
To access the FedWorld system, through the Internet:
1/2 Telnet to : Fedworld. gov
1/2 Select the option: [1] FedWorld
The Federal Energy Regulatory Commission (Commission) is revising
Part 346 of its regulations to make the cost-of-service filing
requirements of that Part applicable to the Trans-Alaska Pipeline
System (TAPS) and carriers delivering oil directly or indirectly to
TAPS. The revision is necessary to correct the inadvertent exclusion of
these carriers from the procedural requirements of Part 346.
I. Background
The Commission issued Order No. 561 1 to comply with the
Energy Policy Act of 1992 (Act of 1992),2 which required the
Commission to establish a simplified and generally applicable
methodology for oil pipelines and to streamline its procedures relating
to oil pipeline rates. The Act of 1992 excluded TAPS from its
provisions for ratemaking purposes. Thus, Order No. 561 stated that
TAPS and the other excluded pipelines would continue to be governed by
their existing rate methodologies, but also would be subject to the
Commission's new procedural rules. Thereafter, as a companion to Order
No. 561, the Commission issued Order No. 571, establishing in Part 346
of its regulations cost-of-service filing requirements for oil
pipelines.3 These procedural requirements include all the
information that is necessary to support a rate filing under the
Opinion No. 154-
[[Page 38568]]
B methodology.4 The existing provisions of Part 346, however, do
not apply to TAPS or its feeder lines.5
---------------------------------------------------------------------------
\1\ Revisions to Oil Pipeline Regulations Pursuant to the Energy
Policy Act of 1992, Order No. 561, FERC Statutes & Regulations para.
30,985 (1993); Order on Rehearing, Order No. 561-A, FERC Statutes &
Regulations para. 31,000 (1994).
\2\ 42 U.S.C. 7172 note (West Supp. 1993).
\3\ Cost-of-Service Reporting and Filing Requirements for Oil
Pipelines, FERC Statutes & Regulations para. 31,006 (1994).
\4\ Williams Pipeline Company, 31 FERC para. 61,377 (1985).
\5\ See, Milne Point Pipeline Company, 75 FERC para. 61,050
(1996).
---------------------------------------------------------------------------
It has always been the Commission's intent to exclude TAPS and its
feeder lines only from the simplified ratemaking methodology adopted in
Order No. 561, not from the streamlined procedural rules required by
the Act of 1992. Accordingly, on April 29, 1996, the Commission issued
a Notice of Proposed Rulemaking (NOPR) in this docket 6 to amend
Part 346 to make it applicable to TAPS and its feeder lines.
---------------------------------------------------------------------------
\6\ Oil Pipeline Cost-of-Service Filing Requirements, FERC
Statutes & Regulations para. 32,518, 61 FR 19878 (May 3, 1996).
---------------------------------------------------------------------------
The TAPS Carriers 7 were the only parties filing comments in
response to the NOPR.
---------------------------------------------------------------------------
\7\ The TAPS Carriers, each of which owns an undivided joint
interest in the Trans Alaska Pipeline System (TAPS), are: Amerada
Hess Pipeline Corporation, ARCO Transportation Alaska, Inc., BP
Pipelines (Alaska) Inc., Exxon Pipeline Company, Mobil Alaska
Pipeline Company, Phillips Alaska Pipeline Corporation and Unocal
Pipeline Company.
---------------------------------------------------------------------------
II. Public Reporting Burden
The Commission estimates the public reporting burden for the
collection of information under the final rule will remain unchanged
for rate filings, since what the Commission is codifying as the
information to be provided is that which the Commission's staff
routinely has requested of oil pipelines for cost-of-service rate
filings in the past. The information will be collected on FERC-550,
``Oil Pipeline Rates: Tariff Filings.'' 8 This estimate includes
the time for reviewing instructions, researching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information. The current annual reporting burden
associated with this information collection requirement was described
in Order No. 571 and included the burden attributable to all oil
pipelines, including TAPS and its feeder lines, as follows: FERC-550:
5,350 hours, 535 responses, and 140 respondents.
---------------------------------------------------------------------------
\8\ FERC-550 is the designation covering oil pipeline tariff
filings made to the Commission.
---------------------------------------------------------------------------
Comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing this
burden, can be sent to the Federal Energy Regulatory Commission, 888
First Street, N.E., Washington, DC 20426 [Attention: Michael Miller,
Information Services Division, (202) 208-1415]; and to the Office of
Information and Regulatory Affairs of OMB (Attention: Desk Officer for
Federal Energy Regulatory Commission), FAX: (202) 395-5167.
III. Discussion
As the NOPR explained, since TAPS was excluded from the ratemaking
provisions of the Act of 1992, Order No. 561 specifically stated:
9
\9\ FERC Statutes & Regulations para. 30,985 at 30,961.
---------------------------------------------------------------------------
for ratemaking purposes, TAPS and those excluded pipelines [the TAPS
feeder lines] will continue to be regulated under the ratemaking
standards that are currently in effect. However, it is the
Commission's judgment that such exclusion [of TAPS and its feeder
lines from the provisions of the Energy Policy Act of 1992] was
intended to apply only to the simplified and generally applicable
rate methodology, not to the procedural rules that the Act of 1992
required the Commission to consider. Otherwise, the Commission would
be required to enforce one set of procedural rules for TAPS and
excluded pipelines, and another for all other pipelines under its
jurisdiction under the ICA. This would not be consistent with
Congress' intent for the Commission to streamline its procedures for
oil pipelines.
As the NOPR pointed out, the Commission meant the procedural rules
of Part 346 to apply to TAPS and its feeder lines. This is the
interpretation that is consistent with the mandate of the Act of 1992
that the Commission streamline its procedures in order to avoid
unnecessary regulatory costs and delay, and with the Commission's
explicit desire to enforce one set of the procedural rules for all
pipelines.
The revision adopted here will require the TAPS Carriers and the
TAPS feeder carriers to comply with the cost-of-service filing
requirements of Part 346 when they seek to establish rates under the
Opinion No. 154-B methodology. As the NOPR explained, these
requirements are no more than a codification of the information that
these carriers now must provide routinely in response to the Commission
staff's requests for information to support their cost-of-service rate
filings. Thus, it should not create any additional burden for carriers
making cost-of-service filings. Inclusion of cost-of-service supporting
information with carriers' initial filings, rather than at a later time
in the regulatory process, also will satisfy the requirement of the Act
of 1992 to avoid unnecessary regulatory costs and delays.
In their comments, the TAPS Carriers state that they do not oppose
the proposed revision to the extent it simply seeks to make the cost-
of-service filing requirements consistent as between excluded and non-
excluded oil pipelines. However, they seek to clarify that nothing in
the proposed revision is intended to undermine or supplant the
Commission-approved settlements already in place for TAPS, and certain
TAPS feeder pipelines, including the TAPS Settlement Agreement. Thus,
the TAPS Carriers seek assurance that, consistent with the Commission's
discussion in Order Nos. 561 and 561-A, excluded pipelines, such as
TAPS, can continue to file tariffs that are within the ceilings imposed
by existing settlements without requiring a separate Opinion No. 154-B
submission.
The TAPS Carriers state that there is a possible ambiguity in the
proposed language in the NOPR that might require TAPS Carriers that
make filings under an existing settlement methodology, such as the TAPS
Settlement methodology, to also include the Opinion No. 154-B schedules
specified in section 346.2. The TAPS Carriers assert that no meaningful
purpose would be served by such filings, since the TAPS Settlement
Agreement already imposes cost-based ceilings on the TAPS rates. The
TAPS Carriers have proposed language that removes that ambiguity by
making clear that the filing requirement under a Commission-approved
settlement remains the same.
In response to the TAPS Carriers' concern, the Commission will
include language in the revised regulations to make it clear that the
TAPS Carriers and the TAPS feeder carriers need file the Opinion No.
154-B schedules specified in section 346.2 only if they make filings to
establish or change rates under the Opinion No. 154-B methodology, and
not when they file pursuant to a Commission-approved settlement.
IV. Environmental Analysis
The Commission is required to prepare an Environmental Assessment
or an Environmental Impact Statement for any action that may have a
significant adverse effect on the human environment.10 The
Commission has categorically excluded certain actions from these
requirements as not having a significant effect on the human
environment.11 The action proposed here is procedural in nature
and therefore falls within the categorical exclusions provided in the
Commission's regulations.12 Therefore, neither an environmental
impact statement nor an environmental
[[Page 38569]]
assessment is necessary, and neither will be prepared in this
rulemaking.
---------------------------------------------------------------------------
\10\ Order No. 486, Regulations Implementing the National
Environmental Policy Act, 52 FR 47897 (Dec. 17, 1987), FERC Statutes
& Regulations (Regulations Preambles 1986-1990) para. 30,783 (1987).
\11\ 18 CFR 380.4.
\12\ See, 18 CFR 380.4(a)(2)(ii).
---------------------------------------------------------------------------
V. Regulatory Flexibility Act Certification
The Regulatory Flexibility Act 13 generally requires the
Commission to describe the impact that a proposed rule would have on
small entities or to certify that the rule will not have a significant
economic impact on a substantial number of small entities. An analysis
is not required if a proposed rule will not have such an impact.14
---------------------------------------------------------------------------
\13\ 5 U.S.C.601-612.
\14\ 5 U.S.C. 605(b).
---------------------------------------------------------------------------
Pursuant to section 605(b), the Commission certifies that the
proposed rules and amendments, if promulgated, will not have a
significant adverse economic impact on a substantial number of small
entities.
VI. Information Collection Requirements
Office of Management and Budget (OMB) regulations require OMB to
approve certain information collection requirements imposed by an
agency.15 The information collection requirements in the final
rule are contained in FERC-550 ``Oil Pipeline Rates: Tariff filing''
(1902-0089).
---------------------------------------------------------------------------
\15\ 5 CFR 1320.11.
---------------------------------------------------------------------------
The Commission's Office of Pipeline Regulation uses the data
collected in these information requirements filings to investigate the
rates charged by oil pipeline companies subject to its jurisdiction, to
determine the reasonableness of rates, and when appropriate, prescribe
just and reasonable rates.
The final rule will not change the reporting requirements of FERC-
550. This rule therefore is not subject to OMB review. The Commission
is submitting a copy of the proposed rule to OMB for information
purposes. Interested persons may obtain information on these reporting
requirements by contacting the Federal Energy Regulatory Commission,
888 First Street, N.E., Washington, DC 20426 [Attention: Michael
Miller, Information Services Division, (202) 208-1415]. Comments on the
requirements of this rule can be sent to the Office of Information and
Regulatory Affairs of OMB [Attention: Desk Officer for the Federal
Energy Regulatory Commission].
VII. Effective Date
This final rule will be effective August 26, 1996. The Commission
has determined, with the concurrence of the Administrator of the Office
of Information and Regulatory Affairs of OMB, that this rule is not a
``major rule'' as defined in section 351 of the Small Business
Regulatory Enforcement Fairness Act of 1996.
List of Subjects in 18 CFR Part 346
Pipelines, Reporting and recordkeeping requirements.
By the Commission.
Lois D. Cashell,
Secretary.
In consideration of the foregoing, Part 346, Chapter I, Title 18,
Code of Federal Regulations, is amended, as set forth below.
PART 346--OIL PIPELINE COST-OF-SERVICE FILING REQUIREMENTS
1. The authority citation for Part 346 continues to read as
follows:
Authority: 42 U.S.C. 7101-7352; 49 U.S.C. 60502; 49 App. U.S.C.
1-85.
2. Section 346.1 introductory text is revised to read as follows:
Sec. 346.1 Content of filing for cost-of-service rates.
A carrier that seeks to establish rates pursuant to Sec. 342.2(a)
of this chapter, or a carrier that seeks to change rates pursuant to
Sec. 342.4(a) of this chapter, or a carrier described in Sec. 342.0(b)
that seeks to establish or change rates by filing cost, revenue, and
throughput data supporting such rates, other than pursuant to a
Commission-approved settlement, must file:
* * * * *
3. Section 346.2 introductory text is revised to read as follows:
Sec. 346.2 Material in support of initial rates or change in rates.
A carrier that files for rates pursuant to Sec. 342.2(a) or
Sec. 342.4(a) of this chapter, or a carrier described in Sec. 342.0(b)
that files to establish or change rates by filing cost, revenue, and
throughput data supporting such rates, other than pursuant to a
Commission-approved settlement, must file the following statements,
schedules, and supporting workpapers. The statement, schedules, and
workpapers must be based upon an appropriate test period.
* * * * *
[FR Doc. 96-18900 Filed 7-24-96; 8:45 am]
BILLING CODE 6717-01-P
Complete official Federal Register PDF
FR Doc. 96-18899 Filing and Reporting Requirements for Interstate Natural Gas Company Rate Schedules and Tariffs
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38565-38567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18899]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules
and Regulations
[[Page 38565]]
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
18 CFR Part 154
[Docket No. RM95-3-002; Order No. 582]
Filing and Reporting Requirements for Interstate Natural Gas
Company Rate Schedules and Tariffs
Issued July 19, 1996.
AGENCY: Federal Energy Regulatory Commission, DOE.
ACTION: Final rule; order on clarification.
-----------------------------------------------------------------------
SUMMARY: The Federal Energy Regulatory Commission is issuing an order
clarifying Order No. 582, the final rule amending part 154 of the
Commission's regulations under the Natural Gas Act. Pursuant to Order
No. 582, two working groups were established to resolve electronic
filing issues. The order on clarification makes clear that formulas
contained in an electronic filing must be manipulable; it also
clarifies that if there are no underlying software ``links'' used to
develop a spreadsheet, links need not be created for a filing.
EFFECTIVE DATE: July 19, 1996.
FOR FURTHER INFORMATION CONTACT: Richard A. White, Office of the
General Counsel, Federal Energy Regulatory Commission, 888 First
Street, N.E., Washington, DC 20426, (202) 208-0491.
SUPPLEMENTARY INFORMATION: In addition to publishing the full text of
this document in the Federal Register, the Commission also provides all
interested persons an opportunity to inspect or copy the contents of
this document during normal business hours at 888 First Street, N.E.,
Washington, DC 20426.
The Commission Issuance Posting System (CIPS), an electronic
bulletin board service, provides access to the texts of formal
documents issued by the Commission. CIPS is available at no charge to
the user and may be accessed using a personal computer with a modem by
dialing (202) 208-1397 if dialing locally or 1-800-856-3720 if dialing
long distance. To access CIPS, set your communications software to use
19200, 14400, 12000, 9600, 7200, 4800, 2400, or 1200bps, full duplex,
no parity, 8 data bits, and 1 stop bit. The full text of this document
will be available on CIPS indefinitely in ASCII and WordPerfect 5.1
format for one year. The complete text on diskette in WordPerfect
format may also be purchased from the Commission's copy contractor, La
Dorn Systems Corporation, also located in the Public Reference Room at
888 First Street, N.E., Washington, DC 20426.
Before Commissioners: Elizabeth Anne Moler, Chair; Vicky A.
Bailey, James J. Hoecker, William L. Massey, and Donald F. Santa,
Jr.
Filing and Reporting Requirements for Interstate Natural Gas
Company Rate Schedules and Tariffs
Docket No. RM95-3-002
Order on Clarification
Issued July 19, 1996.
This order responds to requests for clarification of Order No. 582
1 filed by Associated Gas Distributors (AGD) and The Process Gas
Consumer Group, the America Iron and Steel Institute, and the Georgia
Industrial Group (Industrials).2
---------------------------------------------------------------------------
\1\ Filing and Reporting Requirements for Interstate Natural Gas
Companies Rate Schedules and Tariffs, Order No. 582, 60 FR 52960
(October 11, 1995), II FERC Stats. & Regs. para. 19,100-19,183
(1995) (regulatory text), III FERC Stats. & Regs. para. 31,025
(1995) (preamble).
\2\ The Industrials further request that the Commission give
additional directions to the Working Group, as may be required in
light of these clarifications.
---------------------------------------------------------------------------
I. Background
Order No. 582 updated procedural rules governing the form and
composition of interstate natural gas pipeline tariffs and the filing
of rates and charges for the transportation of natural gas in
interstate commerce under sections 4 and 5 of the Natural Gas Act (NGA)
and section 311 of the Natural Gas Policy Act. Among other things,
Order No. 582 directed Commission staff to convene informal conferences
with natural gas industry members to resolve outstanding electronic
filing issues. Two working groups were established--one to complete
work on Form Nos. 2, 2A and 11 and one to complete work on rate case
filings. The working groups met on December 1 and 12, 1995, February 7,
1996 and February 8, 1996.
Questions have arisen in the working groups concerning the use of
``password protection'' 3 and ``links.'' 4
---------------------------------------------------------------------------
\3\ Present technology allows formulas used in preparing a rate
filing to be embedded into the electronic file such that a user may
have the software perform the calculations using alternate factors.
Spreadsheet software also commonly provides the option of assigning
password protection to a file. Such protection allows subsequent
users without the password to have ``read only'' access to the file;
that is, the subsequent user is able to read the file and view
formulas, but cannot modify or copy the file.
\4\ A link is a software feature that allows a user to insert or
adjust an item once and have the new or adjusted item automatically
inserted in other designated locations.
---------------------------------------------------------------------------
II. Password Protection
AGD requests clarification that (1) in requiring pipelines to file
native spreadsheet formats with links and formulas, the Commission
intended to provide pipeline customers and other interested parties
with a useful tool to fully analyze the pipeline's filing, and (2) any
efforts by the pipelines to undermine this intent--such as the use of
password protection to limit the usefulness of electronic data--are
prohibited as inconsistent with the Commission's orders.
The Industrials request clarification that Statements H, I and J be
fully accessible to the public, with spreadsheet formulas and links
intact. Also, the Industrials request clarification that the issue of
password protection (or any other form of security) was intended to be
addressed by the Working Group on Filings, not as a means to block such
public access to the data and formulas, but to ensure public
participation in rate cases while accommodating the legitimate needs of
pipelines to ensure the security of confidential data and the integrity
of the formulas.
a. Positions of Participants
The issue presented here is whether Order No. 582 requires that the
formulas contained in the electronic filing be mere readable symbols,
as in a hard
[[Page 38566]]
copy, or should be manipulable such that pipeline customers or other
interested parties may analyze such files by inserting different
factors. That is, does Order No. 582 provide for an electronic tool for
analyzing the pipeline's filing that is not provided by the hard copy.
Industrials state that password protection must be discussed in
terms of balancing the pipeline's need for security and the public's
right to utilize the spreadsheet formulas and data. Industrials argue
that only such balancing will ensure meaningful public participation in
pipeline rate cases.
Industrials argue that the password protection issue was delegated
to the Working Groups to determine how the pipeline's legitimate desire
to prevent the release of confidential data and to protect the
integrity of formulas could be accommodated in the Commission's rule
allowing full accessibility to the data and formulas. Industrials point
out that the Commission explained that the electronic filing could
always be checked against the paper copy filed by the pipeline for
security purposes to ensure that the filing's data and formulas have
not been tampered with.5
---------------------------------------------------------------------------
\5\ III FERC Stats. & Regs. at 31,437.
---------------------------------------------------------------------------
Industrials state that the ready electronic availability of
spreadsheet data and formulas will greatly ease the burden on
intervenors to analyze a pipeline's rate filing. Because intervenors
and protestors face a short period within which to file interventions
and protests, Industrials state that such facilitation is necessary to
allow the interventions and protests to be meaningful.6 Unless the
filed spreadsheet data is served in a manipulable version, intervenors
will still have to re-input the data and formulas themselves.
Industrials state that this task is extremely time-consuming and would
lead to continued delays in analysis and development of positions.
Industrials state that intervenors would be deprived of the opportunity
to bring matters to the attention of the Commission in their
interventions, which matters might be capable of summary disposition in
the suspension order or other fast track decision making. Further,
Industrials state, re-inputting data almost inevitably will lead to the
introduction of errors. This is expensive and redundant. Industrials
state that, unless a non-password protected version of all spreadsheet
data is served on all parties as part of the original filing, most of
the time savings and efficiency gains achieved by the Commission's
orders will be undermined.
---------------------------------------------------------------------------
\6\ In light of the short time period in which the Commission
and interested parties have to review the filing, several items have
been added to speed processing of the filing and minimize additional
requests for information. III FERC Stats. & Regs. at 31,388.
---------------------------------------------------------------------------
The Industrials state that, though the pipelines need to file a
fixed version of spreadsheet data that conforms to the paper copy to
ensure the accuracy of the data and integrity of the formulas, a
blanket denial of access to the data and formulas is not the solution.
Industrials state that one solution is to require the filing of two
sets of electronic spreadsheet data and formulas: One set password-
protected for security purposes, and the other, without such password
protection, available to the public for use in evaluating the filing.
Industrials state that its proposed solution balances the interests of
all parties involved.
AGD argues that if a pipeline imposes password protection on its
electronic rate filings, such files will be of value only in
understanding the logic underlying the pipeline's proposed rate design.
AGD states that such files will not allow the pipeline's customers or
other interested parties to fully analyze such files or even to copy
data.
b. Discussion
The aspect of ``protecting'' data was discussed in two sections of
Order No. 582. In the section titled ``Dissemination of Data by the
Commission,'' the Commission stated:
Password protection or other forms of security should be
discussed at the conference. However, as long as a paper copy is
available, there is a reliable way to check the accuracy of the
electronic data. Both the electronic data and the paper version of
the filing are part of the official filing and should contain the
same information.7
---------------------------------------------------------------------------
\7\ III FERC Stats. & Regs. at 31,437.
In the section titled ``Appropriate Format for Numeric Data,'' the
---------------------------------------------------------------------------
Commission stated:
One of the stated goals of the conference was to ensure that all
spreadsheets contain the underlying formulas and links. Delimited
formats are not capable of transmitting formulas and equations. The
Commission agrees with the parties arguing for a spreadsheet format
where the formulas in the workpaper or statement are important to
the understanding of the pipeline's filing. To be useful, the data,
required in subpart D, by Statements I and J and the state tax
formulations in Statement H, must be received with the formulas
included. These formulas are necessary to understand the pipeline's
position with respect to cost allocation and rate design. In section
4 rate cases, the Commission has routinely obtained the formulas
through data requests asking that the information be in spreadsheet
form. The requirement that the initial filing be in spreadsheet
format avoids the burden of having the same data submitted once as a
tab delimited file and again, in response to a data request, in
spreadsheet form, in order to capture the formulas. Accordingly,
Statements I and J and a portion of H, containing state tax
formulations submitted pursuant to subpart D, must be filed in the
same format generated by the spreadsheet software used to create the
statement or workpaper. These spreadsheets must include all the
formulas and all links to other spreadsheets filed in the same rate
case.8
---------------------------------------------------------------------------
\8\ III FERC Stats. & Regs. at 31,435.
The first passage above clearly directs staff to develop ways to
assure the accuracy of data filed electronically: to protect against
the accidental or intentional alteration of a filing. However, when the
Commission grants confidential treatment of data, the data must not be
made public and must not be in the public electronic data bases.
Methods for maintaining the confidentiality of information filed
electronically for which confidential treatment has been sought and
granted must be addressed at future meetings.
The Industrials' discussion of the need for non-password protected
files to achieve time-saving and efficiency is consistent with the
purposes of Order No. 582. The formulas are critical for Staff and
intervenors to understand the pipeline's position on cost allocation
and rate design.9 The Commission intended that spreadsheet data,
and underlying formulas and links to other spreadsheets, be accessible
to the public. In Order No. 582, the Commission agreed with parties
that having PC-compatible spreadsheet files with formulas and linkages
intact available to customers and intervenors will speed the processing
of rate cases and allow many issues to be resolved in the suspension
order.10 Requiring parties, including staff, to input all the
figures from the rate case and spend weeks and rounds of discovery to
recreate the pipeline's computations is grossly inefficient and unduly
burdensome. Receiving the rate case in a manipulable format is critical
given the 12-day period for comment and protest.
---------------------------------------------------------------------------
\9\ III FERC Stats. & Regs. at 31,435.
\10\ III FERC Stats. & Regs. at 31,434-5.
---------------------------------------------------------------------------
The Commission clarifies its intent to utilize the electronic
format to facilitate more efficient and speedy analyses of rate filings
by requiring that all formulas be manipulable as described herein.
III. Links
As noted above, Order No. 582 requires pipelines to submit their
filings in native spreadsheet format with links
[[Page 38567]]
and formulas. The issue has been raised as to whether a pipeline that
prepares two separate files for a Statement, without links between such
files (perhaps because the two files were prepared by different
individuals) must, nonetheless, create such links for the filing.
AGD states that by separating a filing (e.g., Statements J and K)
into multiple files, pipelines would minimize the usefulness of such
information and deprive interested parties of the ability to engage in
meaningful analysis. AGD requests clarification that pipelines cannot
avoid the requirements of Order No. 582--in particular, the requirement
that pipelines must submit rate filings in native spreadsheet format
with links and formulas--by submitting the relevant information in
separate files without links.
The Commission does not agree with AGD that the absence of such
links will deprive interested parties of the ability to engage in
meaningful analysis. Upon examination, a reviewer will be able to
locate links between two or more spreadsheets whether or not the link
is electronic. If there is no direct link between two spreadsheets
showing progressive calculations, an explanation of the relationship
between the two spreadsheets is required.11 The reviewer's
analysis will not be significantly compromised because two spreadsheets
showing progressive calculations are not linked electronically.
---------------------------------------------------------------------------
\11\ Section 154.201(b)(5) requires that ``[w]here workpapers
show progressive calculations, any discontinuity between one working
paper and another must be explained.''
---------------------------------------------------------------------------
A pipeline must support its rate adjustments with step-by-step
mathematical calculations accompanied by narrative explanations
sufficient to permit the Commission and interested parties to duplicate
the company's calculations.12 This may be done, in part, by
placing links in the spreadsheets or it may be done other ways. AGD has
provided insufficient reasons for limiting the pipelines' options when
complying with the regulations.
---------------------------------------------------------------------------
\12\ 18 CFR 154.201(b)(2).
---------------------------------------------------------------------------
If a pipeline creates a link in the preparation of its rate filing,
that link may not be severed prior to submitting the rate filing to the
Commission. The Commission strongly encourages the use of electronic
links. However, the Commission clarifies that if there are no
underlying links used to develop the spreadsheet, as in the example
above, links need not be created for the filing.
The Commission orders:
The requests for clarification of Order No. 582, the final rule
issued in this docket on September 28, 1995, are granted and denied as
discussed in the text of this order.
By the Commission.
Lois D. Cashell,
Secretary.
[FR Doc. 96-18899 Filed 7-24-96; 8:45 am]
BILLING CODE 6717-01-P
Complete official Federal Register PDF
FR Doc. 96-18871 Part-Time Career Employment Program
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38570-38571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18871]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 1
RIN 2900-AH75
Part-Time Career Employment Program
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) pursuant to 5 U.S.C.
3402 is required to maintain a program for part-time career employment
within VA. VA has established regulations concerning this mandate (38
CFR 1.891 through 1.897). These regulations currently require field
stations to provide a manual report to VA Central Office semiannually
containing information concerning the number of part-time permanent
positions established during the reporting period and the number of
conversions from full-time to part-time. The purpose of the report is
to monitor progress in attaining part-time career employment goals.
This requirement for field stations to provide a semiannual report is
deleted since the same information is available through the automated
personnel system. The part-time career employment program will be
reviewed through regular employment reports to determine levels of
part-time employment. This program will also be designated an item of
special interest to be reviewed during personnel management reviews.
The authority citation is also changed to state the correct citation.
EFFECTIVE DATE: July 25, 1996.
FOR FURTHER INFORMATION CONTACT: Ellen Kollar, Title 5 Staffing
Division (054C), Employment and Training Service, Office of Human
Resources Management, Office of Human Resources and Administration,
Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC
20420, (202) 273-9748.
SUPPLEMENTARY INFORMATION:
Administrative Procedure Act
This final rule consists of nonsubstantive changes and, therefore,
is not subject to the notice and comment, and effective date provisions
of 5 U.S.C. 553.
Regulatory Flexibility Act
The Secretary certifies that this final rule will not have a
significant economic impact on a substantial number of small entities
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. This rule sets forth nonsubstantive changes. Therefore, pursuant
to 5 U.S.C. 605(b), this amendment is exempt from the initial and final
regulatory flexibility analysis requirements of sections 603 and 604.
List of Subjects in 38 CFR Part 1
Administrative practice and procedure, Archives and records,
Cemeteries, Claims, Courts, Flags, Freedom of information, Government
contracts, Government employees, Government property, Infants and
children, Inventions and patents, Investigations, Parking, Penalties,
Postal Service, Privacy, Reporting and recordkeeping requirements,
Seals and insignia, Security measures, Wages.
Approved: July 17, 1996.
Jesse Brown,
Secretary of Veterans Affairs.
For the reasons set out in the preamble, 38 CFR part 1 is amended
as set forth below:
[[Page 38571]]
PART 1--GENERAL PROVISIONS
1. The authority citation for part 1 continues to read as follows:
Authority: 38 U.S.C. 501(a), unless otherwise noted.
2. In Sec. 1.891, the authority citation is revised to read as
follows:
Sec. 1.891 Purpose of program.
* * * * *
(Authority: 5 U.S.C. 3401 note)
3. In Secs. 1.892 through 1.894, the authority citations are
revised to read as follows:
Sec. 1.892 Review of positions.
* * * * *
(Authority: 5 U.S.C. 3402)
Sec. 1.893 Establishing and converting part-time positions.
* * * * *
(Authority: 5 U.S.C. 3402)
Sec. 1.894 Annual goals and time tables.
* * * * *
(Authority: 5 U.S.C. 3402)
4. Section 1.895 is revised to read as follows:
Sec. 1.895 Review and evaluation.
The part-time career employment program will be reviewed through
regular employment reports to determine levels of part-time employment.
This program will also be designated an item of special interest to be
reviewed during personnel management reviews.
(Authority: 5 U.S.C. 3402)
5. In Secs. 1.896 and 1.897, the authority citations are revised to
read as follow:
Sec. 1.896 Publicizing vacancies.
* * * * *
(Authority: 5 U.S.C. 3402)
Sec. 1.897 Exceptions.
* * * * *
(Authority: 5 U.S.C. 3402)
[FR Doc. 96-18871 Filed 7-24-96; 8:45 am]
BILLING CODE 8320-01-P
Complete official Federal Register PDF
FR Doc. 96-18861 Paroling, Recommitting, and Supervising Federal Prisoners: Transfer Treaty Cases
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38569-38570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18861]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Parole Commission
28 CFR Part 2
Paroling, Recommitting, and Supervising Federal Prisoners:
Transfer Treaty Cases
AGENCY: United States Parole Commission, Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The U.S. Parole Commission is amending its regulations on
transfer treaty cases by reducing the number of hearing examiners
required to conduct a hearing for a prisoner transferred to the United
States pursuant to treaty. The number is reduced from two hearing
examiners to one hearing examiner. The recommended decision of the
hearing examiner shall be reviewed by the executive hearing examiner,
and the Commission will not act upon the case until a panel
recommendation consisting of two concurring examiner votes is obtained.
This change will not otherwise affect the procedures followed at a
special transferee hearing. This procedural rule is necessary for the
Commission to operate within the substantially reduced Congressional
appropriation anticipated for Fiscal Year 1997.
EFFECTIVE DATE: August 26, 1996.
FOR FURTHER INFORMATION CONTACT: Pamela A. Posch, Office of General
Counsel, 5550 Friendship Blvd, Chevy Chase, Maryland 20815, Telephone
(301) 492-5959.
SUPPLEMENTARY INFORMATION: This is a procedural rule change affecting
only those prisoners who are transferred to the United States, pursuant
to treaty, to serve a sentence imposed in the transferring country. For
a prisoner who is serving a foreign sentence for a crime that was
committed on or after November 1, 1987, the Parole Commission is
obliged to conduct a special transferee hearing upon his return to the
United States, and to determine a period of imprisonment and a period
of supervised release, within the framework of the foreign sentence,
according to the rules and guidelines of the U.S. Sentencing
Commission. See 18 U.S.C. 4106A (1988).
Until now, the regulation governing such cases, 28 CFR 2.62, has
required that special transferee hearings be conducted by panels of two
hearing examiners. In all other hearings conducted by the Commission
(including parole and parole revocation hearings for domestic
prisoners) hearings are conducted by a single
[[Page 38570]]
examiner. The recommended decision of the hearing examiner is reviewed
by the executive hearing examiner, and the Commission is presented with
a panel recommendation pursuant to 28 CFR 2.23. The same procedure is
now extended to special transferee hearings.
The Commission originally decided to require panel-conducted
hearings for transfer treaty prisoners because of the complexity of
sentencing guideline issues and the absence of any statutorily-
authorized administrative remedy procedure. The determination of the
Commission becomes subject to direct appeal to a United States Court of
Appeals pursuant to 18 U.S.C. 4106A(b)(2)(A). However, the Commission
has improved its pre-hearing assessment procedure, and has added a
review by its Office of General Counsel before each case is submitted
to the Commission for decision. These additional safeguards have
reduced the possibility of error which diminishes the need for two
hearing examiners to conduct each hearing. Moreover, the Commission
anticipates a severely reduced Congressional appropriation for Fiscal
Year 1997, and it can no longer afford to send panels of hearing
examiners to conduct each special transferee hearing. With the
additional safeguards described above, the Commission believes that the
hearing and decision making process for transfer treaty prisoners will
continue to be as error-free as possible.
Implementation
This procedural rule change will apply to all special transferee
hearings conducted on or after the effective date shown above.
Executive Order 12866 and Regulatory Flexibility Statement:
The U.S. Parole Commission has determined that this rule is not a
significant regulatory action for the purposes of Executive Order
12866, and the rule has, accordingly, not been reviewed by the Office
of Management and Budget. The rule will not have a significant economic
impact upon a substantial number of small entities within the meaning
of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
List of Subjects in 28 CFR Part 2
Administrative practice and procedure, Probation and parole,
Prisoners.
The Final Rule
Accordingly, the U.S. Parole Commission makes the following changes
to 28 CFR part 2:
(1) The authority citation for 28 CFR part 2 continues to read as
follows:
Authority: 18 U.S.C. 4203(a)(1) and 4204(a)(6).
Sec. 2.62 [Amended]
(2) Section 2.62 is amended by substituting ``a hearing examiner''
for ``a panel of examiners'' in paragraph (h), introductory text; by
substituting ``The examiner'' for ``The examiner panel'' in paragraph
(h)(1) introductory text; by substituting ``The examiner'' for ``The
examiner panel'' in paragraph (h)(5).
(3) Section Sec. 2.62(h)(6) is revised to read as follows:
Sec. 2.62 Prisoners transferred pursuant to treaty.
* * * * *
(h) Hearing procedures. * * *
(6) The transferee shall be notified of the examiner's recommending
findings of fact, and the examiner's recommended determination and
reasons therefore, at the conclusion at the hearing. The case shall
thereafter be reviewed by the Executive Hearing Examiner pursuant to
Sec. 2.23, and the Commission shall make its determination upon a panel
recommendation.
* * * * *
Dated: July 12, 1996.
Edward F. Reilly, Jr.,
Chairman, U.S. Parole Commission.
[FR Doc. 96-18861 Filed 7-24-96; 8:45 am]
BILLING CODE 4410-01-P
Complete official Federal Register PDF
FR Doc. 96-18851 Atlantic Tuna Fisheries; Atlantic Bluefin Tuna Angling Category
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Page 38656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18851]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 285
[Docket No. 960416112-6164-02; ID# 071996B]
RIN 0648-AI29
Atlantic Tuna Fisheries; Atlantic Bluefin Tuna Angling Category
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Closure.
-----------------------------------------------------------------------
SUMMARY: NMFS closes the fishery for school Atlantic bluefin tuna (ABT)
conducted by Angling category fishermen in the waters off Delaware and
states south. Closure of this fishery is necessary because the annual
quota of 65 metric tons (mt) of school ABT allocated for this
subcategory in waters off Delaware and states south is projected to be
attained by July 25, 1996. The intent of this action is to prevent
overharvest of the quota established for this fishery.
EFFECTIVE DATE: The closure is effective from 2330 hours local time
July 25 through December 31, 1996.
FOR FURTHER INFORMATION CONTACT: Bill Hogarth, 301-713-2347.
SUPPLEMENTARY INFORMATION: Regulations promulgated under the authority
of the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq.) regulating
the harvest of ABT by persons and vessels subject to U.S. jurisdiction
are found at 50 CFR part 285.
Section 285.22(d)(1) of the regulations provides for an annual
quota of 65 mt of school ABT to be harvested from waters off Delaware
and states south by individuals in the Angling category. The Assistant
Administrator for Fisheries, NOAA (AA), is authorized under
Sec. 285.20(b)(1) to monitor the catch and landing statistics and, on
the basis of those statistics, to project a date when the catch of ABT
will equal any quota under Sec. 285.22. The AA is further authorized
under Sec. 285.20(b)(1) to prohibit fishing for, or retention of,
Atlantic bluefin tuna by those fishing in the category subject to the
quota when the catch of tuna equals the quota established under
Sec. 285.22. The AA has determined, based on the reported catch and
estimated fishing effort, that the annual quota of school ABT for those
fishing in waters off Delaware and states south will be attained by
July 25, 1996. Fishing for, catching, possessing, or landing any school
ABT in the closed area must cease at 2330 hours local time on July 25,
1996. In addition, landing any school ABT in or from the closed area is
prohibited.
However, anglers may continue to tag and release fish less than 47
inches (119 cm) curved fork length under the NMFS tag-and-release
program (50 CFR 285.27). The Angling category fishery for bluefin tuna
in the large school and small medium classes (47 inches to less than 59
inches (119 cm to less than 150 cm), and 59 inches to less than 73
inches (150 cm to less than 185 cm) curved fork length, respectively)
is regulated under a separate quota and is not affected by this
closure. Anglers, therefore, may continue to fish for these larger size
classes. The 73 metric ton quota of school ABT for the waters off New
Jersey and states north is not affected by this closure, and remains
open.
Classification
This action is required by 50 CFR 285.20(b)(1) and complies with
E.O. 12866.
Authority: 16 U.S.C. 971 et seq.
Dated: July 19, 1996.
Richard H. Schaefer,
Director, Office of Fisheries Conservation and Management, National
Marine Fisheries Service.
[FR Doc. 96-18851 Filed 7-19-96; 4:21 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-18850 Groundfish of the Gulf of Alaska; Northern Rockfish in the Central Gulf of Alaska
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Page 38656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18850]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
50 CFR Part 679
[Docket No. 960129018-6018-01; I.D. 071996A]
Groundfish of the Gulf of Alaska; Northern Rockfish in the
Central Gulf of Alaska
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Closure.
-----------------------------------------------------------------------
SUMMARY: NMFS is prohibiting directed fishing for northern rockfish in
the Central Regulatory Area of the Gulf of Alaska (GOA). This action is
necessary to prevent exceeding the northern rockfish total allowable
catch (TAC) in this area.
EFFECTIVE DATE: 1200 hrs, Alaska local time (A.l.t.), July 20, 1996,
until 2400 hrs, A.l.t., December 31, 1996.
FOR FURTHER INFORMATION CONTACT: Mary Furuness, 907-586-7228.
SUPPLEMENTARY INFORMATION: The groundfish fishery in the GOA exclusive
economic zone is managed by NMFS according to the Fishery Management
Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North
Pacific Fishery Management Council under authority of the Magnuson
Fishery Conservation and Management Act. Fishing by U.S. vessels is
governed by regulations implementing the FMP at subpart H of 50 CFR
part 600 and part 679.
The northern rockfish TAC for the Central Regulatory Area was
established by the Final 1996 Harvest Specifications of Groundfish (61
FR 4304, February 5, 1996) as 4,610 metric tons (mt). (See
Sec. 679.20(c)(3)(ii).)
The Director, Alaska Region, NMFS (Regional Director), established
a directed fishing allowance for northern rockfish of 4,360 mt, with
consideration that 250 mt will be taken as incidental catch in directed
fishing for other species in this area. (See Sec. 679.20(d)(1).) The
Regional Director has determined that this directed fishing allowance
has been reached. Consequently, NMFS is prohibiting directed fishing
for northern rockfish in the Central Regulatory Area.
The maximum retainable bycatch amounts at Sec. 679.20(e) apply to a
fishery that is closed to directed fishing.
Classification
This action is taken under 50 CFR 679.20 and is exempt from review
under E.O. 12866.
Authority: 16 U.S.C. 1801 et seq.
Dated: July 19, 1996.
Richard W. Surdi,
Acting Director, Office of Fisheries Conservation and Management,
National Marine Fisheries Service.
[FR Doc. 96-18850 Filed 7-19-96; 4:17 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-18823 Federal Railroad Administration Enforcement of the Hazardous Materials Regulations: Penalty Guidelines
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38644-38656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18823]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Railroad Administration
49 CFR Part 209
RIN 2130-AB00
Federal Railroad Administration Enforcement of the Hazardous
Materials Regulations: Penalty Guidelines
AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).
ACTION: Policy statement; final rule.
-----------------------------------------------------------------------
SUMMARY: FRA is publishing the penalty guideline amounts it uses in
initial determinations of proposed civil penalty assessments for
documented violations of DOT's Hazardous Materials Regulations. This
action will make those against whom FRA enforces the Hazardous
Materials Regulations more aware of the potential consequences for
documented violations. FRA intends the publication of these penalty
guidelines to increase compliance with the Hazardous Materials
Regulations and, thereby, to enhance safety. FRA is also revising its
enforcement procedures to reflect the current statutory minimum and
maximum penalties for violations of the Federal hazardous materials
transportation safety laws.
EFFECTIVE DATE: These guidelines, and the final rule amendments, are
effective July 25, 1996.
FOR FURTHER INFORMATION CONTACT: Raymond V. Kasey, Hazardous Materials
Specialist, Office of Safety Assurance and Compliance, (202) 366-6769;
or Thomas A. Phemister, Trial Attorney, Office of the Chief Counsel,
(202) 366-0628, Federal Railroad Administration, U.S. Department of
Transportation, 400 Seventh Street, S.W., Washington, D.C. 20590.
SUPPLEMENTARY INFORMATION: FRA promulgates and enforces regulations
implementing the Federal railroad safety laws, 49 U.S.C. 20101 et seq.;
49 CFR 1.49, Parts 209, 213-240. For railroads and those who ship
hazardous materials by railroad, FRA enforces regulations implementing
the Federal hazardous materials transportation safety laws, 49 U.S.C.
5101 et seq.; 49 CFR 1.49(s), 107, 171-180. FRA works with its partner
DOT agency, the Research and Special Programs Administration (RSPA), in
the promulgation of railroad-oriented regulations implementing the
Federal hazardous materials transportation law.
In all areas of its railroad safety enforcement authority except
hazardous materials, FRA's traditional practice has been to issue a
penalty schedule
[[Page 38645]]
assigning to each particular regulation specific dollar amounts for
initial penalty assessments. The schedules generally constitute a
statement of agency policy and are ordinarily issued as an appendix to
the relevant part of the Code of Federal Regulations. The same has not
been true for FRA's enforcement of the Hazardous Materials Regulations
against railroads and those who ship by rail. Two main reasons
supported this policy. First, the Research and Special Programs
Administration (RSPA), in partnership with FRA, issues the Hazardous
Materials Regulations promulgated by the Department. On March 6, 1995,
RSPA published its own penalty guidelines (60 FR 12139), taking an
appropriate lead in this area. The guidelines issued by FRA today
complement RSPA's penalty guidelines, which together provide clear
direction to carriers and shippers in this unique intermodal area.
Second, the nature of hazardous materials transportation is such that a
simple penalty schedule (a violation of Sec. X equates to a penalty of
$Y), as used by FRA in most other areas of its enforcement activities,
can only cover the broad categories of violation and does not account
for the vast differences in the hazards between, for instance,
liquefied carbon dioxide and hydrocyanic acid. With the publication of
the guidelines in this document, FRA believes it has given its
customers counsel and direction that a mere schedule of monetary
penalties cannot convey.
Following discussions among the administrations and in response to
a request contained in Senate Report 103-150 that accompanied the
Department of Transportation and Related Agencies Appropriations Act,
1994, FRA has decided to publish an additional appendix to its
enforcement procedures at 49 CFR Part 209. Appendix A--Statement of
Agency Policy Concerning Enforcement of the Federal Railroad Safety
Laws--will continue as the fundamental repository of agency enforcement
policy; Appendix B, published with this notice, will augment it with
penalty guideline information specific to violations of the Hazardous
Materials Regulations. FRA's customers in the regulated community will
now be more aware of the specific potential civil penalty consequences
of not following the regulations, and teams from FRA's Office of Safety
Assurance and Compliance will have a flexible tool to foster
consistency in their recommendations for civil penalties.
FRA does not necessarily take a formal enforcement action every
time it discovers a deviation from the Federal railroad safety laws.
Under the Safety Assurance and Compliance Program announced by FRA in
1995, FRA's efforts are focused on producing safety results, not
imposing punishment. Many deficiencies can be corrected through a
simple conversation between the inspector and the shipper or carrier
personnel on scene. Correction of others may become the focus of FRA
outreach meetings or may be worked into corporate safety action plans.
However, when these efforts do not produce regulatory compliance and
safe practices or when FRA decides that enforcement action is called
for, it has a range of enforcement tools and has the authority to
choose those best suited to the circumstances. One of these tools (the
emergency order, under 49 U.S.C. 20104(a)) can be used to address an
immediate hazard even if no existing law has been violated.
Wide discretion in choosing the means of enforcement calls for
general guidelines to ensure effectiveness, fairness, and an acceptable
level of consistency. The purpose of guidelines is not to dictate
absolutely identical treatment of identical situations; that would be
an unrealistic ideal based on the false assumption that each of the
many variables going into an enforcement decision could objectively and
accurately be quantified. Instead, the purpose of the agency's
hazardous materials civil penalty guidelines is to control the
necessarily subjective elements of this process as much as is feasible
by requiring that those making enforcement decisions weigh the same
factors and make full use of objective information bearing on those
factors. In this way, the appropriate enforcement tool is applied,
responsible discretionary judgments are made, and an acceptable level
of consistency in similar situations is achieved.
FRA's Statement of Agency Policy Concerning Enforcement of the
Federal Railroad Safety Laws (49 CFR Part 209, Appendix A) stresses
that discretion begins at the field and regional levels: Inspectors
make initial determinations on the need for enforcement action, and
regional specialists play an active role in reviewing those
determinations with an eye toward effectiveness and consistency. Office
of Safety Assurance and Compliance headquarters personnel are
responsible for spotting national trends in the data that require
enforcement action and for providing guidance to the regional and field
staffs on difficult enforcement policy issues.
FRA's policy statement sets forth seven factors to be considered in
making enforcement decisions:
The inherent seriousness of the condition or action.
The kind and degree of potential safety hazard the
condition or action poses in light of the immediate factual situation.
Any actual harm to persons or property already caused by
the condition or action.
The offending person's general level of current compliance
as revealed by the inspection as a whole.
The person's recent history of compliance with the
relevant set of regulations, especially at the specific location (or
division of the railroad involved).
Which enforcement remedy is most appropriate under the
circumstances.
Such other factors as the immediate circumstances make
relevant.
Just as there are a series of considerations that inform the
decision to take enforcement action, so there are considerations to be
applied to determining the amount of a civil penalty. By statute, the
following are considered: (a) The nature, circumstances, extent, and
gravity of the violation; (b) with respect to the violator, the degree
of culpability, any history of violations, the ability to pay, and any
effect on the ability to continue to do business; and (c) other matters
as justice requires. (49 U.S.C. Secs. 5123(c) and 21301(a)(3).) FRA has
developed penalty guidelines for hazardous materials cases to aid in
applying these assessment criteria at the initial penalty assessment
stage, based on the information known about a particular case. Because
the guidelines in this notice are merely a general statement of agency
policy and practice, are non-binding, and are periodically updated,
they are being published as an informational appendix to FRA's
enforcement regulations, as Appendix B to 49 CFR Part 209. They are
published without public notice or comment because they are merely
informational, are not finally determinative of any issues or rights,
and do not have the force of law. For a discussion of relevant case
law, see the preamble to RSPA's publication of its penalty guidelines,
60 FR 12139.
The guidelines published in this notice are a preliminary
assessment tool used by FRA personnel, and they create no rights in any
party. They contain baseline amounts for violations that frequently
have been cited by FRA hazardous materials inspectors. When a violation
not described in the guidelines is encountered, a new guideline is
developed, typically by analogy to a similar violation in the
guidelines. Their application is a starting point to
[[Page 38646]]
promote consistency. No two cases are identical. The baseline amount or
range is an initial reflection of the nature, extent, circumstances,
and gravity of the violation as compared with other types of
violations. The FRA attorney can vary from the guidelines as necessary
to reflect a case's particular facts. This notice publishes the
guidelines as they existed on March 31, 1996; FRA plans to publish
updated and revised guidelines from time to time.
A respondent receives the first notice that FRA may be seeking
civil penalties when the FRA inspector informs him/her that a violation
will be recommended. If the inspector's report is approved by the
regional office and passes legal review in the Office of Chief Counsel,
the respondent will receive a Notice of Probable Violation (NOPV) in
which a charge of violation is made, accompanied by a summary of the
alleged violations and the penalty amounts FRA proposes. A separate
document sent with the NOPV lists the respondent's three options: Pay
the penalty proposed, seek an informal conference, or request a formal
hearing before a hearing officer. The election to pursue informal
resolution does not preclude respondent from later seeking a formal
hearing.
During the informal resolution process, the respondent and the FRA
attorney assigned to the case review any defenses or mitigating
information presented. The new information presented and arguments made
since the initial penalty assessment often leads to a re-evaluation of
the penalty in light of statutory considerations. One very important
factor is any remedial action taken by the respondent to prevent a
recurrence of similar violations. Following discussions between the FRA
attorney and the respondent, they typically reach an agreement on the
amount of penalty, if any, to be paid. FRA's findings of fact and the
agreement on the penalty amount are then memorialized in an Order
Assessing Civil Penalty. The respondent pays the penalty, and the case
is closed. Under FRA's procedures, the respondent who will not agree to
a compromise settlement can request a formal hearing.
If the respondent makes such a request, the matter is assigned to a
hearing officer who hears both sides and renders a decision. FRA
retains the right to amend its NOPV prior to hearing and to seek the
maximum statutory amount for each violation. If the decision is against
the respondent, the hearing officer is bound only by the statutory
maximum and minimum civil penalty amounts and the statutory penalty
considerations.
To summarize, the FRA guidelines consist of a listing of violations
and the baseline penalty, or range of penalties, proposed for each as
of March 31, 1996. The guidelines presuppose flexibility in their
application, and FRA proposes to re-publish the then-current guidelines
as appropriate.
The Hazardous Materials Transportation Uniform Safety Act of 1990
(P.L. 101-615), March 16, 1990) amended the penalty provisions for
violations of the Federal hazardous materials transportation safety
laws. The maximum penalty had been $10,000; the 1990 Act increased it
to $25,000 and established a minimum of $250. Accordingly, FRA is
amending the statutory references and minimum and maximum penalty
amounts in its enforcement procedures to reflect current law. FRA also
clarifies that its authority to amend an NOPV at any time prior to
issuance of an order includes authority to amend the proposed penalty
to the statutory maximum. Finally, FRA makes technical amendments to
reflect recodification of the Federal railroad safety laws by Pub. L.
103-272. These amendments affect 49 CFR 209.101, 209.103, 209.105,
209.131, 209.133, and 209.201.
Rulemaking Analyses and Notices
Executive Order 12866 and DOT Regulatory Policies and Procedures
This final rule is not considered a significant regulatory action
under section 3(f) of Executive Order 12866. This rule is not
significant under the Regulatory Policies and Procedures of the
Department of Transportation (44 FR 11034). The economic impact of this
final rule is minimal to the extent that preparation of a regulatory
evaluation is not warranted.
Executive Order 12612
This final rule merely updates recodified statutory references in a
portion of the CFR; no requirements are changed as a result. The policy
statement is an informational appendix and imposes no requirements.
Thus, preparation of a federalism assessment is not warranted.
Regulatory Flexibility Act
I certify that this final rule will not have a significant economic
impact on a substantial number of small entities. This rule applies to
shippers of hazardous materials by railroad, to manufacturers of
packagings used for the transportation of hazardous materials by
railroad, and to railroads. Some of these are small entities; however,
there will be no significant economic impact.
Paperwork Reduction Act
There are no new information requirements in this final rule.
List of Subjects in 49 CFR Part 209
Administrative practices and procedure, Hazardous materials
transportation, Penalties, Reporting and recordkeeping requirements.
In consideration of the foregoing, 49 CFR Part 209 is amended as
follows:
PART 209--RAILROAD SAFETY ENFORCEMENT PROCEDURES
1. The authority citation for part 209 continues to read as
follows:
Authority: 49 U.S.C. Chs. 51, 57, 201, and 213; 49 CFR 1.49.
2. Section 209.101(a) is revised to read as follows:
Sec. 209.101 Civil penalties generally.
(a) Sections 209.101 through 209.121 prescribe rules of procedure
for the assessment of civil penalties pursuant to the Federal hazardous
materials transportation safety law, 49 U.S.C. Chapter 51.
* * * * *
3. Section 209.103 is revised to read as follows:
Sec. 209.103 Minimum and maximum penalties.
A person who knowingly violates a requirement of subchapter A or C
of chapter I, Subtitle B of this title is liable for a civil penalty of
at least $250 but not more than $25,000 for each violation. When the
violation is a continuing one, each day of the violation constitutes a
separate offense. 49 U.S.C. 5123.
4. Section 209.105 is amended by revising paragraphs (a) and (c) to
read as follows:
Sec. 209.105 Notice of probable violation.
(a) FRA, through the Chief Counsel, begins a civil penalty
proceeding by serving a notice of probable violation on a person
charging him or her with having violated one or more provisions of
subchapter A or C of chapter I, subtitle B of this title. Appendix B to
this part contains guidelines used by the chief counsel in making
initial penalty assessments.
* * * * *
(c) The FRA may amend the notice of probable violation at any time
prior to the entry of an order assessing a civil penalty. If the
amendment contains any
[[Page 38647]]
new material allegation of fact, the respondent is given an opportunity
to respond. In an amended notice, FRA may change the penalty amount
proposed to be assessed up to and including the maximum penalty amount
of $25,000 for each violation.
5. Section 209.131 is revised to read as follows:
Sec. 209.131 Criminal penalties generally.
The Federal hazardous materials transportation safety laws (49
U.S.C. 5124) provide a criminal penalty of a fine under title 18,
United States Code, and imprisonment for not more than 5 years, or
both, for any person who knowingly violates 49 U.S.C. 5104(b) or who
willfully violates chapter 51 of title 49, United States Code, or a
regulation prescribed or order issued under that chapter.
6. Section 209.133 is revised to read as follows:
Sec. 209.133 Referral for prosecution.
If an inspector, including a certified state inspector under Part
212 of this chapter, or other employee of FRA becomes aware of a
possible willful violation of the Federal hazardous materials
transportation safety laws (49 U.S.C. Chapter 51) or a regulation
issued under those laws for which FRA exercises enforcement
responsibility, he or she reports it to the Chief Counsel. If evidence
exists tending to establish a prima facie case, and if it appears that
assessment of a civil penalty would not be an adequate deterrent to
future violations, the Chief Counsel refers the report to the
Department of Justice for criminal prosecution of the offender.
7. Section 209.201 is revised to read as follows:
Sec. 209.201 Compliance orders generally.
(a) This subpart prescribes rules of procedure leading to the
issuance of compliance orders pursuant to the Federal railroad safety
laws at 49 U.S.C. 5121(a) and/or 20111(b).
(b) The FRA may commence a proceeding under this subpart when FRA
has reason to believe that a person is engaging in conduct or a pattern
of conduct that involves one or more violations of the Federal railroad
safety laws or any regulation or order issued under those laws for
which FRA exercises enforcement authority.
8. Appendix B is added to Part 209 to read as follows:
Appendix B to Part 209--Federal Railroad Administration Guidelines
for Initial Hazardous Materials Assessments
These guidelines establish benchmarks to be used in determining
initial civil penalty assessments for violations of the Hazardous
Materials Regulations (HMR). The guideline penalty amounts reflect
the best judgment of the FRA Office of Safety Assurance and
Compliance (RRS) and of the Safety Law Division of the Office of
Chief Counsel (RCC) on the relative severity, on a scale of $250 to
$25,000, of the various violations routinely encountered by FRA
inspectors. (49 U.S.C. 5123) Unless otherwise specified, the
guideline amounts refer to average violations, that is, violations
involving a hazardous material with a medium level of hazard, and a
violator with an average compliance history. In an ``average
violation,'' the respondent has committed the acts due to a failure
to exercise reasonable care under the circumstances (``knowingly'').
For some sections, the guidelines contain a breakdown according to
relative severity of the violation, for example, the guidelines for
shipping paper violations at 49 CFR Secs. 172.200-.203. All
penalties in these guidelines are subject to change depending upon
the circumstances of the particular case. The general duty sections,
for example Secs. 173.1 and 174.7, are not ordinarily cited as
separate violations; they are primarily used as explanatory
citations to demonstrate applicability of a more specific section
where applicability is otherwise unclear.
FRA believes that infractions of the regulations that lead to
personal injury are especially serious; this is directly in line
with Department of Transportation policy that hazardous materials
are only safe for transportation when they are securely sealed in a
proper package. (Some few containers, such as tank cars of carbon
dioxide, are designed to vent off excess internal pressure. They are
exceptions to the ``securely sealed'' rule.) ``Personal injury'' has
become somewhat of a term of art, especially in the fields of
occupational safety and of accident reporting. To avoid confusion,
these penalty guidelines use the notion of ``human contact'' to
trigger penalty aggravation. In essence, any contact by a hazardous
material on a person during transportation is a per se injury and
proof will not be required regarding the extent of the physical
contact or its consequences. When a violation of the Hazardous
Materials Regulations causes a death or serious injury, the maximum
penalty of $25,000 shall always be assessed initially.
These guidelines are a preliminary assessment tool for FRA's
use. They create no rights in any party. FRA is free to vary from
them when it deems appropriate and may amend them from time to time
without prior notice. Moreover, FRA is not bound by any amount it
initially proposes should litigation become necessary. In fact, FRA
reserves the express authority to amend the NOPV to seek a penalty
of up to $25,000 for each violation at any time prior to issuance of
an order.
Penalty Assessment Guidelines
------------------------------------------------------------------------
Emergency orders Guideline
------------------------------------------------------------------------
EO16............................... Penalties for 5,000
violations of EO16
vary depending on the
circumstances.
EO17............................... Penalties for (\1\)
violations of EO17
vary depending on the
circumstances.
Failure to file annual 5,000
report.
------------------------------------------------------------------------
\1\ Varies.
------------------------------------------------------------------------
49 CFR section Description Guideline
------------------------------------------------------------------------
PART 107
------------------------------------------------------------------------
107.608............................ Failure to register or 1,000
to renew
registration. (Note:
registration--or
renewal--is
mitigation.).
------------------------------------------------------------------------
PART 171
------------------------------------------------------------------------
171.2(c)........................... Representing (marking, 8,000
certifying, selling,
or offering) a
packaging as meeting
regulatory
specification when it
does not.
171.2(f)(2)........................ Billing, marking, etc. 2,000
for the presence of
HM when no HM is
present. (Mitigation
required for
shipments smaller
than a carload, i.e.,
single drum penalty
is 1,000).
171.12............................. Import shipments-- 4,000
Importer not
providing shipper and
forwarding agent with
US requirements.
Cannot be based on
inference.
Import shipments-- 2,000
Failure to certify by
shipper or forwarding
agent.
171.15............................. Failure to provide 6,000
immediate notice of
certain hazardous
materials incidents.
[[Page 38648]]
171.16............................. Failure to file 4,000
incident report (form
DOT 5800.1). (Note:
Multiple failures
will aggravate the
penalty; see the
expert attorney.).
------------------------------------------------------------------------
PART 172
------------------------------------------------------------------------
Shipping Papers:
172.200--.203.................. Offering hazardous
materials for
transportation when
the material is not
properly described on
the shipping paper as
required by Secs.
172.200--.203. (The
``shipping paper'' is
the document tendered
by the shipper/
offeror to the
carrier. The original
shipping paper
contains the
shipper's
certification at Sec.
172.204.).
--Information on the 15,000
shipping paper is
wrong to the extent
that it caused or
materially
contributed to a
reaction by emergency
responders that
aggravated the
situation or caused
or materially
contributed to
improper handling by
the carrier that led
to or materially
contributed to a
product release.
--Total lack of 7,500
hazardous materials
information on
shipping paper. (Some
shipping names alone
contain sufficient
information to reduce
the guideline to the
next lower level, but
they may be such
dangerous products
that aggravation
needs to be
considered.).
--Some information is 5,000
present but the
missing or improper
description could
cause mishandling by
the carrier or a
delay or error in
emergency response.
--When the improper 2,000
description is not
likely to cause
serious problem
(technical defect).
--Shipping paper 7,500
includes a hazardous
materials description
and no hazardous
materials are present.
Note: Failure to
include emergency
response information
is covered at Secs.
172.600-604; while
the normal unit of
violation for
shipping papers is
the whole document,
failure to provide
emergency response
information is a
separate violation.
172.204........................ Shipper's failure to 2,000
certify.
172.205........................ Hazardous waste 4,000
manifest. (Applies
only to defects in
the Hazardous Waste
Manifest form [EPA
Form 8700-22 and 8700-
22A]; shipping paper
defects are cited and
penalized under Sec.
172.200-.203.).
Marking............................ The guidelines for
``marking''
violations
contemplate a total
lack of the
prescribed mark.
Obviously, where the
package (including a
whole car) is
partially marked,
mitigation should be
applied.
172.301........................ Failure to mark a non- 1,000
bulk package as
required (e.g., no
commodity name on a
55-gallon drum).
(Shipment is the unit
of violation.).
172.302........................ Failure to follow 2,000
standards for marking
bulk packaging.
(Note: If a more
specific section
applies, cite it and
its penalty
guideline.).
172.302(a)..................... ID number missing or 2,500
in improper location.
(The guideline is for
a portable tank; for
smaller bulk
packages, the
guideline should be
mitigated downward.).
172.302(b)..................... Failure to use the 2,000
correct size of
markings. (Note: If
Sec. 172.326(a) is
also cited, it takes
precedence and
.302(b) is not cited.
Note also: the
guideline is for a
gross violation of
marking size--\1/2\''
where 2'' is
required--and
mitigation should be
considered for
markings approaching
the required size.).
172.302(c)..................... Failure to place 2,000
exemption number
markings on bulk
package.
172.303........................ Prohibited marking.
(Package is marked
for a hazardous
material and contains
either another
hazardous material or
no hazardous
material.)
--The marking is wrong 10,000
and caused or
contributed to a
wrong emergency
response.
--Inconsistent 5,000
marking; e.g.,
Shipping name and ID
number do not agree.
--Marked as a 2,000
hazardous material
when package does not
contain a hazardous
material.
172.313........................ ''Inhalation Hazard'' 2,500
not marked.
172.322........................ Failure to mark for 1,500
MARINE POLLUTANT
where required.
172.325(a)..................... Improper, or missing, 1,500
HOT mark for elevated
temperature material.
172.326(a)..................... Failure to mark a 2,500
portable tank with
the commodity name.
172.326(b)..................... Owner's/lessee's name 500
not displayed.
172.326(c)..................... Failure to mark 2,500
portable tank with ID
number.
172.330(a)(1)(i)............... Offering/transporting 2,500
hazardous materials
in a tank car that
does not have the
required shipping
name or common name
stenciled on the car;
include reference to
section requiring
stenciling, such as
Sec. 173.314(b) (5)
or (6).
172.330(a)(1)(ii).............. Offering/transporting 2,500
hazardous materials
in a tank car that
does not have the
required ID number
displayed on the car.
172.331(b)..................... Offering bulk 2,500
packaging other than
a portable tank,
cargo tank, or tank
car (e.g., a hopper
car) not marked with
UN/NA number. (I.e.,
a hopper car carrying
a hazardous
substance, where a
placard is not
required).
172.332........................ Improper display of 2,000
identification number
markings. Note:
Citation of this
section and Secs.
172.326 (portable
tanks), 172.328
(cargo tanks), or
172.330 (tank cars)
does not create two
separate violations.
172.334(a)..................... Displaying ID numbers 4,000
on a RADIOACTIVE,
EXPLOSIVES
1.1,1.2,1.3,1.4,1.5,
or 1.6, or DANGEROUS,
or subsidiary hazard
placard.
172.334(b)..................... --Improper display of 15,000
ID number that caused
or contributed to a
wrong emergency
response.
--Improper display of 5,000
ID number that could
cause carrier
mishandling or minor
error in emergency
response.
--Technical error..... 2,000
172.334(f)..................... Displaying ID number 1,500
on orange panel not
in proximity to the
placard.
Labeling:
172.400-.450................... Failure to label 2,500
properly. (See also
Sec. 172.301
regarding the marking
of packages.).
[[Page 38649]]
Placarding......................... The guidelines for
``placarding''
violations
contemplate a total
lack of the
prescribed placard.
Obviously, where the
package (including a
whole car) is
partially placarded,
mitigation should be
applied.
172.502........................ --Placarded as 2,000
hazardous material
when car does not
contain a hazardous
material.
--Placard does not 2,000
represent hazard of
the contents.
--Display of sign or 2,000
device that could be
confused with
regulatory placard.
Photograph or good,
clear description
necessary.
172.503........................ Improper display of ID (\1\)
number on placards.
(Note: Do not cite
this section; cite
Sec. 172.334.).
172.504(a)..................... Failure to placard;
affixing or
displaying wrong
placard. (See also
Secs. 172.502(a),
172.504(a), 172.505,
172.510(c), 172.516,
174.33, 174.59,
174.69; all
applicable sections
should be cited, but
the penalty should be
set at the amount for
the violation most
directly in point.)
(Generally, the car
is the unit of
violation, and
penalties vary with
the number of errors,
typically at the rate
of $1,000 per
placard.)
--Complete failure to 7,500
placard.
--One placard missing 1,000
(add $1,000 per
missing placard up to
a total of three;
then use the
guideline above).
-- Complete failure to 2,500
placard, but only 2
placards are required
(e.g., intermediate
bulk containers
[IBCs]).
172.504(b)..................... Improper use of 5,000
DANGEROUS placard for
mixed loads.
172.504(c)..................... Placarded for wrong 2,000
hazard class when no
placard was required
due to 1,001 pound
exemption.
172.504(e)..................... Use of placard other
than as specified in
the table:
--Improper placard 15,000
caused or contributed
to improper reaction
by emergency response
forces or caused or
contributed to
improper handling by
carrier that led to a
product release.
--Improper placard 5,000
that could cause
improper emergency
response or handling
by carrier.
--Technical violation. 2,500
172.505........................ Improper application 5,000
of placards for
subsidiary hazards.
(Note: This is in
addition to any
violation on the
primary hazard
placards.).
172.508(a)..................... Offering hazardous 7,500
material for rail
transportation
without affixing
placards. (Note: The
preferred section for
a total failure to
placard is
172.504(a); only one
section should be
cited to avoid a dual
penalty.) (Note also:
Persons offering
hazardous materials
for rail movement
must affix placards;
if offering for
highway movement, the
placards must be
tendered to the
carrier. Sec.
172.506.).
Placards OK, except 500
they were IMDG labels
instead of 10''
placards. (Unit of
violation is the
packaging, usually a
portable tank.).
Placards on TOFC/COFC (\2\)
units not readily
visible. (Note: Do
not cite this
section, cite Sec.
172.516 instead.).
172.508(b)..................... Accepting hazardous 5,000
material for rail
transportation
without placards
affixed.
172.510(a)..................... EXPLOSIVES 1.1, 5,000
EXPLOSIVES 1.2,
POISON GAS, POISON
GAS-RESIDUE,
(Division 2.3, Hazard
Zone A), POISON, or
POISON-RESIDUE
(Division 6.1,
Packing Group I,
Hazard Zone A)
placards displayed
without square
background.
172.510(c)..................... Improper use of
RESIDUE placard.
--Placarded RESIDUE 4,000
when loaded.
--Placarded loaded 1,000
when car contains
only a residue.
--Placarded EMPTY when 500
RESIDUE is required.
172.514........................ Improper placarding of 2,000
bulk packaging other
than a tank car: For
the ``exception''
packages in
174.514(c). Note: Use
the regular
placarding sections
for the guideline
amounts for larger
bulk packages.
172.516........................ Placard not readily 1,000
visible, improperly
located or displayed,
or deteriorated. Good
color photos
``essential'' to
prove deterioration,
and considerable
weathering is
permissible. Placard
is the unit of
violation.
--When placards on an 2,000
intermodal container
are not visible, for
instance, because the
container is in a
well car. Container
is the unit of
violation, and, as a
matter of enforcement
policy, FRA accepts
the lack of
visibility of the end
placards.
Emergency Response Information..... Violations of Secs.
172.600-.604 are in
addition to shipping
paper violations. In
citing a carrier, if
the railroad's
practice is to carry
an emergency response
book or to put the E/
R information as an
attachment to the
consist, the unit of
violation is
generally the train
(or the consist).
``Telephone number''
violations are
generally best cited
against the shipper;
if against a
railroad, there
should be proof that
the number was given
to the railroad, that
is, it was on the
original shipping
document.
172.600-.602................... Where improper 15,000
emergency response
information has
caused an improper
reaction from
emergency forces and
the improper response
has aggravated the
situation. Note:
Proof of this will be
rigorous. For
instance, if the
emergency response
forces had chemical
information with the
correct response and
they relied, instead,
on shipper/carrier
information to their
detriment; the
$15,000 penalty
guideline applies.
Bad, missing, or 4,000
improper emergency
response information.
(Be careful in
transmitting
violations of this
section against a
railroad; there are
many sources of E/R
information and it
does not necessarily
``travel'' with the
shipping documents.).
172.602(c)..................... Failure to have 15,000
emergency response
information
``immediately
accessible''.
172.604........................ Improper or missing 2,500
emergency response
telephone number.
Training:
172.702(a)..................... General failure to 5,000
train hazmat
employees.
172.702(b)..................... Hazmat employee 1,000
performing covered
function without
training. (Unit of
violation is the
employee; see the
expert attorney if
more than 10
employees are
involved.).
172.704(a)..................... Failure to train in 2,500
the required areas:
--General awareness/
familiarization
[[Page 38650]]
--Function-specific
--Safety
(Unit of violation is
the ``area,'' and,
for a total failure
to train, cite
172.702(a) and use
that penalty instead
of 172.704.)
172.704(c)..................... Initial and recurrent (\3\)
training. (Note: Cite
this and the relevant
substantive section,
e.g., 172.702(a), and
use penalty provided
there.).
172.704(d)..................... Failure to maintain 2,500
record of training.
(Unit of violation is
the record.).
------------------------------------------------------------------------
PART 173
------------------------------------------------------------------------
173.1.............................. General duty section 2,000
applicable to
shippers; also
includes subparagraph
(b), the requirement
to train employees
about applicable
regulations. (Cite
the appropriate
section in the
172.700-.704 series
for training
violations.).
173.9(a)........................... Early delivery of 5,000
transport vehicle
that has been
fumigated. (48 hours
must have elapsed
since fumigation.).
173.9(b)........................... Failure to display 1,000
fumigation placard.
(Ordinarily cited
against shipper only,
not against
railroad.).
173.10............................. Delivery requirements 3,000
for gases and for
flammable liquids.
See also 174.204 and
174.304.
173.22............................. Shipper (\4\)
responsibility: This
general duty section
should ordinarily be
cited only to support
a more specific
charge.
173.22a............................ Improper use of 2,500
packagings authorized
under exemption.
Failure to maintain 1,000
copy of exemption as
required..
173.24(b)(1) & 173.24(b)(2) and Securing closures:
173.24(f)(1) & 173.24(f)(1)(ii). These subsections are
the general ``no
leak'' standard for
all packagings. Sec.
173.24(b) deals
primarily with
packaging as a whole,
while Sec. 173.24(f)
focuses on closures.
Cite the sections
accordingly, using
both the leak/non-
leak criteria and the
package size
considerations to
reach the appropriate
penalty. Any actual
leak will aggravate
the guideline by,
typically, 50%; a
leak with contact
with a human being
will aggravate by at
least 100%, up to the
maximum of $25,000 if
the HMR violation
causes the injury.
With tank cars, Sec.
173.31(b) applies,
and IM portable tanks
[Sec. 173.32c], and
other tanks of that
FR Doc. 96-18823 Federal Railroad Administration Enforcement of the Hazardous Materials Regulations: Penalty Guidelines
size range, should
use the tank car
penalty amounts,
stated in reference
to that section.
--Small bottle or box. 1,000
--55-gallon drum...... 2,500
--Larger container, 5,000
e.g., IBC; not
portable tank or tank
car.
173.24(c).......................... Use of package not
meeting
specifications,
including required
stencils and
markings. The most
specific section for
the package involved
should be cited (see
below). The penalty
guideline should be
adjusted for the size
of the container. Any
actual leak will
aggravate the
guideline by,
typically, 50%; a
leak with contact
with a human being
will aggravate by at
least 100%, up to the
maximum of $25,000 if
the HMR violation
causes the injury.
--Small bottle or box. 1,000
--55-gallon drum...... 2,500
--Larger container, 5,000
e.g., IBC; not
portable tank or tank
car.
For more specific
sections: Tank cars--
Sec. 173.31(a),
portable tanks--Sec.
173.32, and IM
portable tanks--Secs.
173.32a, .32b, and
.32c, q.v
173.24a(a)(3)...................... Non-bulk packagings: 1,000
Failure to secure and
cushion inner
packagings.
--Causes leak......... 3,000
--Leak with any 10,000
contact between
product and any human
being.
173.24a(b)&(d)..................... Non-bulk packagings: 1,000
Exceeding filling
limits.
--Causes leak......... 3,000
--Leak with any 10,000
contact between
product and any human
being.
173.24b(a) Insufficient outage:.. 3,000
--<1%
--Causes leak......... 5,000
--Leak with any 10,000
contact between
product and any human
being.
173.24b(a)(3)...................... Outage <5% on PIH 5,000
material.
--Causes leak......... 7,500
--Leak with any 10,000
contact between
product and any human
being.
173.26............................. Loaded beyond gross 5,000
weight or capacity as
stated in
specification.
(Applies only if
quantity limitations
do not appear in
packaging
requirements of Part
173.).
173.28............................. Improper reuse, 1,000
reconditioning, or
remanufacture of
packagings..
173.29(a).......................... Offering residue tank
car for
transportation when
openings are not
tightly closed (Sec.
174.67(k) is also
usually applicable).
The regulation
requires offering
``in the same manner
as when'' loaded and
may be cited when a
car not meeting
specifications (see
Sec. 173.31(a)(1))
is released back into
transportation after
unloading; same
guideline amount.
Guidelines vary with
the type of commodity
involved:
--Hazardous material 2,000
with insignificant
vapor pressure and
without
classification as
``poison'' or
``inhalation hazard''.
--With actual leak.... 5,000
--With leak allowing 15,000
the product to
contact any human
being.
--Hazardous material 5,000
with vapor pressure
(essentially any gas
or compressed gas)
and/or with
classification as
``poison'' or
``inhalation
hazard.''.
--With actual leak.... 7,500
--With leak allowing 15,000
the product (or fumes
or vapors) to contact
any human being. (In
the case of fumes,
the ``contact'' must
be substantial.).
--Where only violation 1,000
is failure to secure
a protective housing,
e.g., the covering
for the gaging device.
[[Page 38651]]
173.30............................. A general duty section
that should be cited
with the explicit
statement of the
duty.
173.31(a)(1)....................... Use of a tank car not
meeting
specifications and
the ``Bulk
packaging''
authorization in
Column 8 of the Sec.
172.101 Hazardous
Materials Table
reference is:
Sec. 173.240......... 1,000
Sec. 173.241......... 2,500
Sec. 173.242......... 5,000
Sec. 173.243......... 5,000
Sec. 173.244......... 7,500
Sec. 173.245......... 7,500
Sec. 173.247......... 1,000
Sec. 173.314, .315... 5,000
--Minor defect not 500
affecting the ability
of the package to
contain a hazardous
material, e.g., no
chain on a bottom
outlet closure plug.
Tank meets 1,000
specification, but
specification is not
stenciled on car.
Note: Sec. 179.1(e)
implies that only the
builder has the duty
here, but it is the
presence of the
stencil that gives
the shipper the right
to rely on the
builder. (See Sec.
173.22(a)(3).).
Tank car not stenciled
``Not for flammable
liquids,'' and it
should be. (AAR Tank
Car Manual, Appendix
C, C3.03(a)5.)
--Most cars........... 2,500
--Molten sulfur car... 500
--If flammable liquid 5,000
is actually in the
car.
173.31(a)(4)....................... Use of a tank car 5,000
stenciled for one
commodity to
transport another.
173.31(a)(5)....................... Use of DOT- 10,000
specification tank
car without shelf
couplers. (Note:
prior to November 15,
1992, this did not
apply to a car not
carrying hazardous
materials.).
--Against a carrier, 6,000
cite Sec. 174.3 and
this section.
173.31(a)(6)....................... Use of non-DOT 10,000
specification car
without shelf
couplers to carry
hazardous materials.
(Applies only since
November 15, 1990.).
--Against a carrier, 6,000
cite Sec. 174.3 and
this section.
173.31(a)(7)....................... Use of tank car 5,000
without air brake
support attachments
welded to pads.
(Effective July 1,
1991).
173.31(a)(15)...................... Tank car with 7,500
nonreclosing pressure
relief device used to
transport Class 2
gases, Class 3 or 4
liquids, or Division
6.1 liquids, PG I or
II.
173.31(a)(17)...................... Tank car with interior 7,500
heating coils used to
transport Division
2.3 or Division 6.1,
PG I, based on
inhalation toxicity.
173.31(b)(1), 173.31(b)(3)......... Shipper failure to 5,000
determine (to the
extent practicable)
that tank, safety
appurtenances, and
fittings are in
proper condition for
transportation;
failure to properly
secure closures.
(Sections
173.31(b)(1) &
.31(b)(3), often
cited as together for
loose closure
violations, are taken
as one violation.)
The unit of violation
is the car,
aggravated if
necessary for truly
egregious condition.
Sections 173.24(b) &
(f) establish a ``no-
leak'' design
standard, and 173.31
imposes that standard
on operations.
--With actual leak of 10,000
product.
--With actual leak 15,000
allowing the product
(or fumes or vapors)
to contact any human
being. (With safety
vent, be careful
because carrier might
be at fault.).
--Minor violation, 1,000
e.g., bottom outlet
cap loose on tank car
of molten sulfur
(because product is a
solid when shipped).
--Failure (.31(b)(1)) 1,000
to have bottom outlet
cap off during
loading.
173.31(b)(4)....................... Filling and offering 6,000
for transportation a
tank car overdue for
retest of tank,
interior heater
system, and/or safety
relief valve. Note
that the car may be
filled while in-date,
held, and then
shipped out-of-date.
(Adjust penalty if
less than one month
or more than one year
overdue.).
173.31(c)(1)....................... Tank, interior heater
system, and/or safety
valve overdue for
retest. If these
conditions exist, the
violation is of Sec.
173.31(b)(4). If the
violation is for
improperly conducting
the test(s), see the
expert attorney.
173.31(c)(10)...................... Failure to properly 1,000
stencil a retest that
was performed.
173.32c............................ Loose closures on an 5,000
IM portable tank
(Sec. 173.24
establishes the
``tight closure''
standard; Sec.
172.32c applies it to
IM portable tanks.)
(The scale of
penalties is the same
as for tank cars.).
--With actual leak of 10,000
product.
--With actual leak and 15,000
human being contact.
--Minor violation..... 1,000
173.314(b)(5)...................... No commodity stencil, 2,500
compressed gas tank
car. (See also Sec.
172.330).
173.314(c)......................... Compressed gas loaded 6,000
in excess of filling
density (same basic
concept as
insufficient outage).
--``T'' car with 5,000
excessive voids in
the thermal coating,
such that the car no
longer complies with
the DOT
specification.
Section 173.31(a)(1)
requires tank cars
used to transport
hazardous materials
to meet the
requirements of the
applicable
specification and
this section (Sec.
173..314(c)) lists
112T/114T cars as
allowed for
compressed gases.
------------------------------------------------------------------------
PART 174
------------------------------------------------------------------------
General Requirements:
174.3.......................... Acceptance of
improperly prepared
shipment. This
general duty section
must be accompanied
by a citation to the
specific section
violated.
174.7.......................... Carrier's failure to (\5\)
instruct employees;
cannot be based on
inference; Secs.
172.700-.704 are
preferred citations.
174.8(b)....................... --Failure to inspect 4,000
hazardous materials
(and adjacent) cars
at point where train
is required to be
inspected. (Unit of
violation is the
train.) (Note: For
all ``failure to
inspect'' citations,
the mere presence of
a nonconforming
condition does not
prove a failure to
inspect.).
[[Page 38652]]
--Allowing unsafe 8,000
loaded placarded car
to continue in
transportation beyond
point where
inspection was
required). (Unit of
violation is the
car.).
--Failure to determine 5,000
whether placards are
in place and conform
to shipping papers
(at a required
inspection point).
(Unit of violation is
the car.).
174.9(a)....................... Failure to properly 4,000
inspect loaded,
placarded tank car at
origin or interchange.
174.9(b)....................... Loose or insecure 1,000
closures on tank car
containing a residue
of a hazardous
material. (FRA policy
is that, against a
railroad, this
violation must be
observable from the
ground because, for
reasons of safety,
railroad inspectors
do not climb on cars
absent an indication
of a leak.).
174.9(c)....................... Failure to ``card'' a 3,000
tank car overdue for
tank retest.
174.10(c)...................... Offering a 3,000
noncomplying shipment
in interchange.
174.10(d)...................... Offering leaking car 10,000
of hazardous
materials in
interchange.
174.12......................... Improper performance 3,000
of intermediate
shipper/carrier
duties; applies to
forwarders and
highway carriers
delivering TOFC/COFC
shipments to
railroads.
174.14......................... Failure to expedite: 1,000
violation of ``48-
hour rule.'' Note:
does not apply to
cars ``held short''
of destination or
constructively placed.
General Operating Requirements..... Note: This subpart
(Subpart B) of Part
174 has three
sections referring to
shipment
documentation: Sec.
174.24 relating to
accepting documents,
Sec. 174.25 relating
to the preparation of
movement documents,
and Sec. 174.26
relating to movement
documents in the
possession of the
train crew. Only the
most relevant section
should be cited. In
most cases, the unit
of violation is the
shipment, although
where a unified
consist is used to
give notice to the
crew, there is some
justification for
making it the train,
especially where the
discrepancy was
generated using
automated data
processing and the
error is repetitious.
174.24......................... Accepting hazardous
materials shipment
without properly
prepared shipping
paper. (Note: The
carrier's duty
extends only to the
document received,
that is, a shipment
of hazardous
materials in an
unplacarded transport
vehicle with a
shipping paper
showing other than a
hazardous material is
not a violation
against the carrier
unless knowledge of
the contents of the
vehicle is proved.
Likewise, receipt of
a tank car placarded
for Class 3 with a
shipping paper
indicating a
flammable liquid does
not create a carrier
violation if the car,
in fact, contains a
corrosive. On the
other hand, receipt
of a placarded
trailer with a
shipping paper
listing only FAK
(``freight-all-
kinds''), imposes a
duty on the carrier
to inquire further
and to reject the
shipment if it is
improperly billed.)
--Improper hazardous 7,500
materials information
that could cause
delay or error in
emergency response.
--Total absence of 5,000
hazardous materials
information.
--Technical errors, 1,000
not likely to cause
problems, especially
with emergency
response.
--Minor errors not 500
relating to hazardous
materials emergency
response, e.g., not
listing an exemption
number and the
exemption is not one
affecting emergency
response.
174.25......................... Preparing improper
movement documents.
(Similar to the
requirements in Sec.
174.24, here the
carrier is held
responsible for
preparing a movement
document that
accurately reflects
the shipping paper
tendered to it. With
no hazardous
materials information
on the shipper's bill
of lading, the
carrier is not in
violation--absent
knowledge of
hazardous contents--
for preparing a
nonhazardous movement
document. While
``movement
documents'' in the
rail industry used to
be waybills or switch
tickets (almost
exclusively),
carriers are now
incorporating the
essential information
into a consist,
expanded from its
former role as merely
a listing of the cars
in the train.)
--Information on the 15,000
movement document is
wrong to the extent
that it actually
caused or materially
contributed to a
reaction by emergency
responders that
aggravated the
situation or caused
or materially
contributed to
improper handling by
the carrier that led
to or materially
contributed to a
product release.
--Total lack of 7,500
hazardous materials
information on
movement document.
(Some shipping names
alone contain
sufficient
information to reduce
the guideline to the
next lower level, but
they may be such
dangerous products
that aggravation
needs to be
considered.).
--Some information is 5,000
present, but the
missing or improper
description could
cause mishandling by
the carrier or a
delay or error in
emergency response,
including missing
RESIDUE description
required by Sec.
174.25(c).
--Missing/improper 3,500
endorsement, unless
on a switch ticket as
allowed under Sec.
174.25(b).
--Movement document 2,500
does not indicate,
for a flatcar
carrying trailers or
containers, which
trailers or
containers contain
hazardous materials.
(If all trailers or
containers on the
flatcar contain
hazardous materials,
there is no
violation.).
--When the improper 1,000
description is not
likely to cause
serious problem
(technical defect).
--Minor errors not 500
related to hazardous
materials emergency
response, e.g., not
listing an exemption
number and the
exemption is not one
affecting emergency
response.
Note: Failure to
include emergency
response information
is covered at Sec.
172.600-604; while
the normal unit of
violation for
movement documents is
the whole document,
failure to provide
emergency response
information is a
separate violation.
174.26(a)...................... Failure to execute the 5,000
required POISON GAS
and EXPLOSIVES 1.1/
1.2 notices. (The
notice is the unit of
violation, because
one notice can cover
several shipments.).
Failure to deliver the 5,000
required POISON GAS
and EXPLOSIVES 1.1/
1.2 notices to train
and engine crew.
(Cite this, or the
above, as
appropriate.).
Failure to transfer 3,000
notice from crew to
crew. (Note that this
is very likely an
individual liability
situation; the
penalty guideline
listed here, however,
presumes action
against a railroad.).
Failure to keep copy 1,000
of notice on file.
174.26(b)...................... Train crew does not 6,000
have a document
indicating position
in train of each
loaded, placarded
car. Aggravate by 50%
for Poison Gas, 2.3,
and Explosives, 1.1
and 1.2. (Train is
the unit of
violation.).
--Technical violation, 1,000
e.g., car is listed
in correct relative
order, but not in
exact numerical
order, usually
because of addition
of car or cars to
head or tail of
train. (Note: Applies
only if the actual
location is off by 10
or fewer cars.).
[[Page 38653]]
174.26(c)...................... Improper paperwork in
possession of train
crew. (If the
investigation of an
accident reveals a
violation of this
section and Sec.
174.25, cite this
section.) (Shipment
is unit of violation,
although there is
justification for
making it the train
if a unified consist
is used to carry this
information and the
violation is a
pattern one
throughout all, or
almost all, of the
hazardous materials
shipments. For
intermodal traffic,
``shipment'' can mean
the container or
trailer--e.g., a UPS
trailer with several
non-disclosed
hazardous materials
packages would be one
unit.)
--Information on the 15,000
document possessed by
the train crew is
wrong to the extent
that it caused or
materially
contributed to a
reaction by emergency
responders that
aggravated the
situation or caused
or materially
contributed to
improper handling by
the carrier that led
to or materially
contributed to a
product release.
--Total lack of 7,500
hazardous materials
information on
movement document.
(Some shipping names
alone contain
sufficient
information to reduce
the guideline to the
next lower level, but
they may be such
dangerous products
that aggravation
needs to be
considered.).
--Some information is 5,000
present but the
error(s) could cause
mishandling by the
carrier or a delay or
error in emergency
response. Includes
missing RESIDUE
description required
by Sec. 174.25(c).
--Improper 3,500
information, but the
hazardous materials
are small shipments
(e.g., UPS moves) and
PG III (e.g., the
``low hazard''
materials allowed in
TOFC/COFC service
without an exemption
since HM-197).
--Technical defect not 1,000
likely to cause delay
or error in emergency
response or carrier
handling.
--Minor error not 500
relating to emergency
response or carrier
handling, e.g., not
listing the exemption
number on document
and the exemption is
not one affecting
emergency response.
174.33......................... --Failure to maintain
``an adequate supply
of placards.'' [The
violation is for
``failure to
replace''; if missing
placards are
replaced, the supply
is obviously
adequate, if not,
failure to have a
placard is not a
separate violation
from failure to
replace it.]
--Failure to replace 1,000
lost or destroyed
placards based on
shipping paper
information. (This is
in addition to the
basic placarding
mistakes in, for
instance, Sec.
172.504.).
Note: A railroad's
placarding duties are
to not accept a car
without placards
[Sec. 172.508(b)];
to maintain an
``adequate supply''
of placards and to
replace them based on
shipping paper
information [Sec.
174.33]; and to not
transport a car
without placards
[Sec. 174.59]. At
each inspection
point, a railroad
must determine that
all placards are in
place. [Sec.
172.8(b)] The ``next
inspection point''
replacement
requirement in Sec.
174.59, q.v., refers
to placards that
disappear between
inspection points; a
car at an inspection
point must be
placarded because it
is in transportation,
even if held up at
that point. [49
U.S.C. 5102(12)]
174.45......................... Failure to report
hazardous materials
accidents or
incidents. Cite Secs.
171.15 or 171.16 as
appropriate.
174.50......................... Moving leaking tank 7,500
car unnecessarily.
Failure to stencil 3,500
leaking tank car.
Loss of product 15,000
resulted in human
being contact because
of improper carrier
handling.
174.55......................... Failure to block and
brace as prescribed.
(See also Secs.
174.61, .63, .101,
.112, .115; where
these more specific
sections apply, cite
them.) Note: The
regulatory
requirement is that
hazardous materials
packages be loaded
and securely blocked
and braced to prevent
the packages from
changing position,
falling to the floor,
or sliding into each
other. If the load is
tight and secure,
pieces of lumber or
other materials may
not be necessary to
achieve the ``tight
load'' requirement.
Be careful on these
and consult freely
with the expert
attorney and
specialists in the
Hazardous Materials
Division.
--General failure to 5,000
block and brace.
--Inadequate blocking 2,500
and bracing (an
attempt was made but
blocking/bracing was
insufficient.).
--Inadequate blocking 7,500
and bracing leading
to a leak.
--Inadequate blocking 15,000
and bracing leading
to a leak and human
being contact.
174.59......................... Marking and
placarding. Note: As
stated elsewhere, a
railroad's placarding
duties are to not
accept a car without
placards [Sec.
172.508(b)], to
maintain an
``adequate supply''
of placards and to
replace them based on
shipping paper
information [Sec.
174.33], and to not
transport a car
without placards
[Sec. 174.59]. At
each inspection
point, a railroad
must determine that
all placards are in
place. [Sec.
172.8(b)] The ``next
inspection point''
replacement
requirement in this
section refers to
placards that
disappear between
inspection points. A
car at an inspection
point must be
placarded because it
is in transportation
[49 U.S.C. 5102(12)],
even if held up at
that point. Because
the statute creates
civil penalty
liability only if a
violation is
``knowing,'' that is,
``a reasonable person
knew or should have
known that an act
performed by him was
in violation of the
HMR,'' and because
railroads are not
under a duty to
inspect hazardous
materials cars merely
standing in a yard,
violations written
for unplacarded cars
in yards must include
proof that the
railroad knew about
FR Doc. 96-18823 Federal Railroad Administration Enforcement of the Hazardous Materials Regulations: Penalty Guidelines
the unplacarded cars
and took no
corrective action
within a reasonable
time. (Note also that
the real problem with
unplacarded cars in a
railyard may be a
lack of emergency
response information,
Secs. 172.600-.604,
and investigation may
reveal that those
sections should be
cited instead of this
one.)
--Complete failure to 7,500
placard.
--One placard missing 1,000
(add $1,000 per
missing placard up to
a total of three;
then use the
guideline above).
For other placarding
violations, see Secs.
172.500-.560 and
determine if one of
them more correctly
states the violation.
174.61......................... Improper 3,000
transportation of
transport vehicle or
freight container on
flat car. (Note: If
improper lading
restraint is the
violation, see Sec.
174.55; if improper
restraint of a bulk
packaging inside a
closed transport
vehicle is the
violation, see Sec.
174.63(b).).
174.63(a) & (c)................ --Improper 3,000
transportation of
portable tank or
other bulk packaging
in TOFC/COFC service.
--Improper 7,500
transportation
leading to a release
of product.
[[Page 38654]]
--Improper 15,000
transportation
leading to a release
and human being
contact.
174.63(b)...................... Improper securement of
bulk packaging inside
enclosed transport
vehicle or freight
container.
--General failure to 5,000
secure.
--Inadequate 2,500
securement (an
attempt to secure was
made but the means of
securement were
inadequate).
--Inadequate 7,500
securement leading to
a leak.
--Inadequate 15,000
securement leading to
a leak and human
being contact.
174.63(e)...................... Transportation of 7,500
cargo tank or multi-
unit tank car tank
without authorization
and in the absence of
an emergency.
174.67(a)(1)................... Tank car unloading 2,500
operations performed
by persons not
properly instructed
(case cannot be based
on inference).
174.67(a)(2)................... Unloading without
brakes set and/or
wheels blocked. (The
enforcement standard,
as per 1995 Hazardous
Materials Technical
Resolution Committee,
is that sufficient
handbrakes must be
applied on one or
more cars to prevent
movement and each car
with a handbrake set
must be blocked in
both directions. The
unloading facility
must make a
determination on how
many brakes to set.)
--No brakes set, no 5,000
wheels blocked, or
fewer brakes set/
wheels blocked than
facility's operating
plan.
--No brakes set, but 3,000
wheels blocked.
--Brakes set, but 4,000
wheels not blocked.
174.67(a)(3)................... Unloading without 2,000
cautions signs
properly displayed.
(See Part 218,
Subpart B).
174.67(c)(2)................... Failure to use non-
metallic block to
prop manway cover
open while unloading
through bottom outlet.
--Flammable or 3,000
combustible liquid,
or other product with
a vapor flash point
hazard.
--Material with no 500
vapor flammability
hazard.
174.67(h)...................... Insecure unloading 10,000
connections, such
that product is
actually leaking.
174.67(i)...................... Unattended unloading.. 5,000
174.67(j)...................... Discontinued unloading 2,000
without disconnecting
all unloading
connections,
tightening valves,
and applying closures
to all other
openings. (Note: If
the car is attended,
this subsection does
not apply.).
174.67(k)...................... Preparation of car
after unloading:
Removal of unloading
connections is
required, as is the
closing of all
openings with a
``suitable tool.''
Note: This subsection
requires unloading
connections to be
``removed'' when
unloading is
complete, Sec.
174.67(j) requires
them to be
``disconnected'' for
a temporary cessation
of unloading. The
penalties recommended
here mirror those in
Sec. 173.29, dealing
with insecure
closures generally.
--Hazardous material 2,000
with insignificant
vapor pressure and
without
classification as
``poison'' or
``inhalation hazard''.
--With actual leak.... 5,000
--With leak allowing 15,000
the product to
contact any human
being.
--Hazardous material 5,000
with vapor pressure
(essentially any gas
or compressed gas)
and/or with
classification as
``poison'' or
``inhalation hazard''.
--With actual leak.... 7,500
--With leak allowing 15,000
the product (or fumes
or vapors) to contact
any human being).
Note: Contact with
fumes must be
substantial.
174.69......................... --Complete failure to 6,000
remove loaded
placards and replace
with RESIDUE placard
on tank cars.
--Partial failure. 1,000
(Unit of violation is
the placard; the
guideline is used for
each placard up to 3,
then the penalty
above is applicable.).
174.81......................... --Failure to obey 6,000
segregation
requirements for
materials forbidden
to be stored or
transported together.
(``X'' in the table).
--Failure to obey 4,000
segregation
requirements for
materials that must
be separated to
prevent commingling
in the event of a
leak. (``O'' in the
table).
174.83(a)...................... Improper switching of 5,000
placarded rail cars.
174.83(b)...................... Improper switching of 8,000
loaded rail car
containing Division
1.1/1.2, 2.3 PG I
Zone A, or Division
6.1 PG I Zone A, or
DOT 113 tank car
placarded for 2.1.
174.83(c)-(e).................. Improper switching of 5,000
placarded flatcar.
174.83(f)...................... Switching Division 1.1/ 8,000
1.2 without a buffer
car or placement of
Division 1.1/1.2 car
under a bridge or
alongside a passenger
train or platform.
174.84......................... Improper handling of 4,000
Division 1.1/1.2, 2.3
PG I Zone A, 6.1 PG I
Zone A in relation to
guard or escort cars.
174.85......................... Improper Train
Placement (The unit
of violation under
this section is the
car. Where more than
one placarded car is
involved, e.g., if 2
placarded cars are
too close to the
engine, both are
violations. Where
both have a similar
violation, e.g., a
Division 1.1 car next
to a loaded tank car
of a Class 3
material, each car
gets the appropriate
penalty as listed
below.)
RESIDUE car without at 3,000
least 1 buffer from
engine or occupied
caboose.
Placard Group 1--
Division 1.1/1.2
(Class A explosive)
materials
--Fewer than 6 cars 8,000
(where train length
permits) from engine
or occupied caboose.
--As above but with at 7,000
least 1 buffer.
--No buffer at all 8,000
(where train length
doesn't permit 5).
--Next to open top car 7,000
with lading beyond
car ends or, if
shifted, would be
beyond car ends.
--Next to loaded flat 6,000
car, except closed
TOFC/COFC equipment,
auto carriers,
specially equipped
car with tie-down
devices, or car with
permanent bulkhead.
--Next to operating 7,000
temperature-control
equipment or internal
combustion engine in
operation.
--Next to placarded 7,000
car, except one from
same placard group or
COMBUSTIBLE.
Placard Group 2--
Division 1.3/1.4/1.5
(Class B and C
explosives); Class 2
(compressed gas,
other than Division
2.3, PG 1 Zone A;
Class 3 (flammable
liquids); Class 4
(flammable solid);
Class 5 (oxidizing
materials); Class 6,
(poisonous liquids),
except 6.1 PG 1 Zone
A; Class 8 (corrosive
materials).
[[Page 38655]]
For tank cars:
--Fewer than 6 cars 6,000
(where train length
permits) from engine
or occupied caboose.
--As above but with at 5,000
least 1 buffer.
No buffer at all 6,000
(where train length
doesn't permit 5).
--Next to open top car 5,000
with lading beyond
car ends or, if
shifted, would be
beyond car ends.
--Next to loaded flat 4,000
car, except closed
TOFC/COFC equipment,
auto carriers,
specially equipped
car with tie-down
devices, or car with
permanent bulkhead.
--Next to operating 5,000
temperature-control
equipment or internal
combustion engine in
operation.
--Next to placarded 5,000
car, except one from
same placard group or
COMBUSTIBLE.
For other rail cars:
--Next to placarded 5,000
car, except one from
same placard group or
COMBUSTIBLE.
Placard Group 3--
Divisions 2.3 (PG 1
Zone A; poisonous
gases) and 6.1 (PG 1
Zone A; poisonous
materials)
For tank cars:
--Fewer than 6 cars 8,000
(where train length
permits) from engine
or occupied caboose.
--As above but with at 7,000
least 1 buffer.
No buffer at all 8,000
(where train length
doesn't permit 5).
--Next to open top car 7,000
with lading beyond
car ends or, if
shifted, would be
beyond car ends.
--Next to loaded flat 6,000
car, except closed
TOFC/COFC equipment,
auto carriers,
specially equipped
car with tie-down
devices, or car with
permanent bulkhead.
--Next to operating 7,000
temperature-control
equipment or internal
combustion engine in
operation.
--Next to placarded 7,000
car, except one from
same placard group or
COMBUSTIBLE.
For other rail cars:
--Next to placarded 5,000
car, except one from
same placard group or
COMBUSTIBLE.
Placard Group 4--Class
7 (radioactive)
materials.
For rail cars:
--Next to locomotive 8,000
or occupied caboose.
--Next to placarded 5,000
car, except one from
same placard group or
COMBUSTIBLE.
--Next to carload of 3,000
undeveloped film.
174.86......................... Exceeding maximum 3,000
allowable operating
speed (15 mph) while
transporting molten
metals or molten
glass.
174.101(o)(4).................. Failure to have proper
explosives placards
on flatcar carrying
trailers/containers
placarded for Class
1. (Except for a
complete failure to
placard, the unit of
violation is the
placard.).
--Complete failure to 7,500
placard.
--One placard missing 1,000
(add $1,000 per
missing placard up to
a total of three,
then use the
guideline above).
174.104(f)..................... Failure to retain car 1,000
certificates at
``forwarding
station''.
Failure to attach car 1,000
certificates to car.
(Unit of violation is
the certificate, 2
are required.).
174.204........................ Improper tank car 3,000
delivery of gases
(Class 2 materials).
174.304........................ Improper tank car 3,000
delivery of flammable
liquids (Class 3
materials).
174.600........................ Improper tank car 5,000
delivery of materials
extremely poisonous
by inhalation
(Division 2.3 Zone A
or 6.1 Zone A
materials).
------------------------------------------------------------------------
PART 178
------------------------------------------------------------------------
178.2(b)........................... Package not
constructed according
to specifications--
also cite section not
complied with.
--Bulk packages, 8,000
including portable
tanks.
--55-gallon drum...... 2,500
--Smaller package..... 1,000
------------------------------------------------------------------------
PART 179
------------------------------------------------------------------------
179.1(e)........................... Tank car not 8,000
constructed according
to specifications--
also cite section not
complied with. (Note:
Part 179 violations
are against the
builder or repairer.
Sections in this Part
are often cited in
conjunction with
violations of Secs.
172.330 and 173.31
(a)&(b) by shippers.
In such cases, the
Part 179 sections are
cited as references,
not as separate
alleged violations.).
179.6.............................. Repair procedures not 5,000
in compliance with
Appendix R of the
Tank Car Manual.
------------------------------------------------------------------------
\1\ See Sec. 172.334.
\2\ See Sec. 172.516.
\3\ Varies.
\4\ See specific section.
\5\ See penalties: 172.700-.704.
[[Page 38656]]
Donald M. Itzkoff,
Deputy Administrator.
[FR Doc. 96-18823 Filed 7-24-96; 8:45 am]
BILLING CODE 4910-06-P
Complete official Federal Register PDF
FR Doc. 96-18822 Transportation of Hazardous Materials by Rail; Miscellaneous Amendments; Response to Petitions for Reconsideration
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38642-38644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18822]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Part 172
[Docket HM-216; Amdt No. 172-148]
RIN 2137-AC66
Transportation of Hazardous Materials by Rail; Miscellaneous
Amendments; Response to Petitions for Reconsideration
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Final rule; Response to petitions for reconsideration.
-----------------------------------------------------------------------
SUMMARY: RSPA is publishing a June 28, 1996 letter in which it denied
petitions for reconsideration of a provision in the June 5, 1996 final
rule in this proceeding which allowed rail shippers and carriers to
discontinue use of the RESIDUE placard on June 30, 1996, three months
in advance of the effective date of the June 5 final rule.
DATES: Effective date: The effective date for the final rule published
under
[[Page 38643]]
Docket HM-216 on June 5, 1996 (61 FR 28666) remains October 1, 1996.
Compliance date: Voluntary compliance with the regulations, as
amended in the final rule under Docket HM-216 on June 5, 1996, remains
June 30, 1996.
FOR FURTHER INFORMATION CONTACT: Beth Romo, telephone (202) 366- 8553,
Office of Hazardous Materials Standards, Research and Special Programs
Administration, Washington, DC 20590-0001, or James H. Rader, telephone
(202) 366-0510, Office of Safety Assurance and Compliance, Federal
Railroad Administration, Washington, DC 20590-0001.
SUPPLEMENTARY INFORMATION: On June 6, 1996, RSPA published a final rule
which amended the Hazardous Materials Regulations to incorporate a
number of changes to rail requirements. The effective date of the rule
is October 1, 1996, but compliance with all of the changes made in the
rule was permitted beginning June 30, 1996. RSPA received several
petitions for reconsideration concerning one provision of the June 5,
1996 final rule allowing rail shippers and carriers to discontinue use
of the RESIDUE placard on June 30, 1996. On June 28, 1996, RSPA denied
the petitions for reconsideration in a letter which has been sent to
each petitioner, each party writing in support of the petitions for
reconsideration, and each party who submitted comments on the original
proposal to discontinue use of the RESIDUE placard. The letter of
denial included a statement of enforcement policy by the Federal
Railroad Administration (FRA). This document publishes verbatim the
letter of denial and FRA enforcement policy as follows:
June 28, 1996
By Facsimile
Mr. Charles Keller, Director, Bureau of Explosives, Association of
American Railroads, 80 F Street, NW., Washington, DC 20001-1564
Mr. Jean Ouellete, Chairman, Dangerous Goods Subcommittee, Railway
Association of Canada, 800 Rene-Levesque Blvd. West, Suite 1105,
Montreal, Quebec H3B 1X9, Canada.
Gentlemen: The Research and Special Programs Administration
(RSPA) denies your petitions for reconsideration--and similar
petitions submitted by the other parties identified below--of the
provision in RSPA's final rule in Docket HM-216 that allows rail
shippers and carriers to discontinue use of the ``RESIDUE'' placard
on June 30, 1996.
The final rule in Docket HM-216 eliminates use of a ``RESIDUE''
placard, currently required only for the transportation of the
residue of a hazardous material in a tank car. 49 C.F.R. 172.510,
172.526. See 61 FR 28666, 28667-68, 28676 (June 5, 1996). This
change is effective on October 1, 1996; however, voluntary
compliance with this change, and the other amendments made in HM-216
to the Hazardous Materials Regulations (HMR), 49 C.F.R. Parts 171-
180, is authorized on June 30, 1996. 61 Fed. Reg. 28666. In the
absence of this June 30 voluntary compliance date, rail shippers and
carriers would be required to continue use of the ``RESIDUE''
placard until September 30, 1996, and then begin using (on tank cars
holding only a residue of a hazardous material) the placard required
for a tank car containing a full load of the applicable hazardous
material with respect to shipments on and after October 1, 1996.
In a June 14, 1996 facsimile memorandum, the Association of
American Railroads (AAR) petitioned RSPA to postpone the June 30,
1996 voluntary compliance date for elimination of the ``RESIDUE''
placard until September 1, 1996. AAR stated that, with the June 30,
1996 voluntary compliance date, shippers could discontinue using the
``RESIDUE'' placard before rail carriers had sufficient time before
June 30 to issue instructions and train their personnel with regard
to this change. AAR cautioned that the lack of time to train rail
carrier personnel would create ``a very real chance that tank cars
will be delayed due to crew confusion, a situation that is not in
the interest of safety.''
Similar petitions for reconsideration were also submitted by the
Burlington Northern Santa Fe Railroad (BNSF), Consolidated Rail
Corporation, the Illinois Central Railroad, and the Norfolk Southern
Corporation (NS). In addition, CSX Transportation Company, the
Kansas City Southern Railway, the Soo Line Railroad, and the Union
Pacific Railroad expressed support for AAR's petition. BNSF and NS
also stated that the June 30 voluntary compliance date did not allow
sufficient time to make changes to their computer programming
systems.
In a June 18, 1996 letter, the Railway Association of Canada
(RAC) asked RSPA to postpone the elimination of the ``RESIDUE''
placard ``until a harmonization of all train marshaling rules in
both the United States and Canada can be achieved'' or, in the
alternative, until September 1, 1996, as requested by AAR. RAC
stated that the June 30 voluntary compliance date did not allow
sufficient time for training personnel and modifying computer
systems. RAC expressed concern that there would be ``delays to
hazardous materials traffic due to confusion by the train crews.''
Requests similar to that of RAC were submitted by the Canadian
National Railroad and the Canadian Fertilizer Institute. The
Canadian Chemical Producers'' Association (CCPA) wrote in support of
RAC's request.
In a June 24, 1996 letter, the Chemical Manufacturers
Association (CMA) expressed ``qualified support for the recent
petitions for reconsideration submitted by'' AAR and CCPA, but
suggested that RSPA not allow shippers to discontinue use of the
``RESIDUE'' placard before October 1, 1996. CMA stated that its
concerns about insufficient time for training rail carrier personnel
and ``confusion and safety concerns among the emergency response
community'' would also exist during a September 1-October 1
``voluntary compliance window.'' CMA also stated its assumption that
RSPA would ``address enforcement-related issues for empty tank cars
placarded as a residue which are in-transit at the time of the
effective date of the rule.''
RSPA does not believe the concerns expressed by these parties
justify postponement of the June 30, 1996 voluntary compliance date.
Between June 30 and October 1, 1996, a tank car containing the
residue of a hazardous material may bear ``RESIDUE'' placards or the
placards that were required to be affixed to the tank car when it
was full. On and after October 1, 1996, the ``RESIDUE'' placard may
no longer be used, and the ``loaded'' car placard is required for a
tank car containing a residue.
From the standpoint of rail operations, train placement of the
car is the only difference between treatment of a tank car fully
loaded with a hazardous material and one containing a residue. 49
C.F.R. Sec. 174.85. The discontinuance of the ``RESIDUE'' placard
simply means that train placement must be done based on the shipping
paper (or electronic data interchange, as discussed in comments
submitted in HM-216, see 61 FR at 28669). RSPA understands that this
is generally the present means of car placement (rather than relying
on the placard). Therefore, the major ``training'' needed is to
inform rail carrier employees that an apparently misplaced tank car
may in fact be properly placed and that the shipping papers will
resolve that fact. Because the HMR's underlying rules on train
placement have not changed, there is no reason to postpone
discontinuance of the ``RESIDUE'' placard until a later proceeding
to consider harmonization of the HMR with Canadian regulations in
this respect.
A fundamental reason for allowing voluntary compliance before
the effective date is to provide time for carriers to train their
employees about this change, during the three-month voluntary
compliance period, rather than requiring adherence to the ``old''
rules until the eve of the effective date. Allowing voluntary
compliance here is consistent with RSPA's past practice in amending
the HMR, including the extensive changes in packaging authorizations
and hazard communications made in Docket No. HM-181. See 55 FR 52402
(Dec. 21, 1990) (voluntary compliance allowed beginning January 1,
1991, eleven days after publication of the final rule).
Both RSPA and the Federal Railroad Administration (FRA) envision
the three-month voluntary compliance period as allowing rail
carriers to ``debug'' their systems, both with respect to operating
personnel and computer programs. Accordingly, FRA has developed a
policy that will consider this as a ``learning'' period. A copy is
attached. This policy should allow rail carriers to modify their
computer programming systems during the three-month transition
period.
For the above reasons, RSPA is denying these petitions for
reconsideration.
[[Page 38644]]
Sincerely,
[signed]
Kelley S. Coyner,
Deputy Administrator.
Attachment
cc: Mr. David E. Edington, Manager, Hazardous Materials, Burlington
Northern Santa Fe Railroad
Mr. J.R. McNally, General Manager, Hazardous Materials Systems,
Consolidated Rail Corporation
Mr. Steve H. Huff, Director Operating Practices, Hazardous
Materials/Special Services, CSX Transportation
Mr. Michael A. De Smedt, Manager Hazardous Materials Transportation,
Illinois Central Railroad
Mr. J.W. Talley, Superintendent of Hazardous Materials Control, The
Kansas City Southern Railway Company
Mr. D.L. Schoendorfer, Manager Hazardous Materials, Norfolk Southern
Corporation, Environmental Protection
Mr. Phillip Marbut, Field Manager Hazardous Materials & Emergency
Response, Soo Line Railroad Company
Pat Student, Manager, Technical Research, Chemical Transportation
Safety, Union Pacific Railroad Company
Mr. Achille P. Ferrusi, Assistant Vice President, Safety &
Regulatory Affairs, Canadian National
Mr. David M. Finlayson, Canadian Chemical Producers' Association
Mr. Jim Farrell, Manager, Technical Affairs, Canadian Fertilizer
Institute
Mr. Frank J. Principi, Associate Director, Distribution Safety &
Economic Programs, Chemical Manufacturers Association.
Explanation of FRA Enforcement Policy
Elimination of the ``Residue'' Placard, Placard Notation, and
Placard Endorsement
On June 5, 1996, the Research and Special Programs
Administration (RSPA) published a final rule in docket HM-216 (61 FR
28665). The final rule amended the Hazardous Materials Regulations
(HMR) to incorporate a number of changes based on petitions from the
railroad and shipping industries and on RSPA's own initiative. In
order to facilitate an early transition form the pre-HM-216
regulations to the new standards, FRA is making this statement of
enforcement policy with respect to the elimination of the placard
notation, endorsement, and RESIDUE placard. This policy statement
does not alter or add to the final rule, but offers guidance to
railroads and shippers concerning the voluntary compliance period.
First, FRA will continue to expect accurate shipping
descriptions during and after the transition period.
Second, FRA will continue to expect that the placard on a rail
shipment of a hazardous material will accurately reflect the class
of the commodity in the car and, if the identification numbers
appear on the placard, that they will be accurate.
Third, FRA will expect shippers to offer tank cars consistently
placarded, for example, if a RESIDUE placard is displayed at one
location, the other three locations will also display RESIDUE
placards.
Fourth, FRA will expect shippers to discontinue use of the
RESIDUE placard after September 30, 1996, although cars offered
before that date may continue their transportation cycle back to the
loading point with RESIDUE placards.
Fifth, FRA expects railroads and shippers to train their
employees about the new requirements to ensure an orderly transition
before October 1, 1996. FRA believes that this phase-in period will
help railroads and shippers ``de-bug'' automated systems such as
electronic data interchange programs before the mandatory deadline.
FRA is aware that some entities are concerned that, during the
voluntary compliance period, a shipping document may carry the
RESIDUE placard notation (e.g., Placarded: Flammable--RESIDUE) while
the car displays the traditional ``loaded'' placard. As noted above,
if the shipping description is accurate and the placards are for the
correct class (and carry the correct UN/NA number as appropriate),
FRA will take no exception. Further, the final rule in this docket
eliminates the requirement for the placard endorsement and notation,
but does not prohibit their use. Shippers and carriers may continue
to use this information, and to display it on shipping and movement
documents, as they wish.
FRA and RSPA are aware of the problems created when regulatory
changes require many companies in different industries to change
their procedures and processes. We intend to be flexible in
achieving full compliance and we urge the shipping and transporting
companies involved to work with each other towards the enhancements
in Docket HM-216. For example, shipping and transportation companies
may mutually agree on a date prior to October 1, 1996 by which they
will implement the changes recently published.
During the transition period for implementing requirements based
on the UN Recommendations (Docket HM-181), RSPA adopted regulations
in Sec. 171.14 (popularly called ``mix & match''), that recognized
the impossibility of bringing everything into phase at one instant.
FRA will enforce the rules promulgated in Docket HM-216 in the same
spirit.
For further information contact James H. Rader (Telephone 202-
366-0510), Hazardous Materials Division; Thomas A. Phemister
(Telephone 202-366-0635), Trial Attorney, Office of Chief Counsel,
FRA, Washington D.C. 20590-0001.
Office of Safety Assurance and Compliance
June 27, 1996
Issued in Washington, DC, on July 18, 1996, under authority
delegated in 49 CFR part 1.
Alan I. Roberts,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 96-18822 Filed 7-24-96; 8:45 am]
BILLING CODE 4910-60-P
Complete official Federal Register PDF
FR Doc. 96-18758 Approval and Promulgation of Air Quality Implementation Plans; Illinois: Motor Vehicle Inspection and Maintenance
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38582-38590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18758]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[IL102-2; FRL-5532-3]
Approval and Promulgation of Air Quality Implementation Plans;
Illinois: Motor Vehicle Inspection and Maintenance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is approving portions and conditionally approving other
portions of a vehicle inspection and maintenance (I/M) State
Implementation Plan (SIP) revision submitted by the State of Illinois
on June 29, 1995, based on the State's April 22, 1996, letter of
commitment to submit certain items within one year of the final
conditional approval. This revision provides for the adoption and
implementation of an enhanced I/M program in both the Chicago severe
ozone nonattainment area and the East St. Louis moderate ozone
nonattainment area. Both areas are required to attain the National
Ambient Air Quality Standards (NAAQS) as specified under the Clean Air
Act (Act) by 2007 and 1996 respectively. Illinois indicates that the
implementation of this important program in the two areas stated above,
will reduce vehicle emissions which contribute to the formation of
urban smog in Illinois by more than 38 tons per day. In support of the
conditional approval of the SIP revision, the State has submitted the
State's Request-For-Proposals as supplemental information to the SIP.
In addition, the State has committed in an April 22, 1996, letter to
submit to EPA as supplemental information in support of the SIP, the
State's final I/M contract and any rules necessary to address the
requirements identified in the analysis section of this document.
EFFECTIVE DATE: This final rule is effective July 25, 1996.
ADDRESSES: Materials relevant to this rulemaking are available for
inspection at the following address: (It is recommended that you
telephone Francisco J. Acevedo at (312) 886-6061, before visiting the
Region 5 office.) U.S. Environmental Protection Agency, Region 5, Air
and Radiation Division, Air Programs Branch, 77 West Jackson Boulevard
(AR-18J), Chicago, Illinois 60604.
FOR FURTHER INFORMATION CONTACT: Francisco J. Acevedo, Environmental
Engineer, Regulation Development Section, Air Programs Branch (AR-18J),
United States Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6061.
SUPPLEMENTARY INFORMATION:
I. Introduction
Motor vehicles are significant contributors of volatile organic
compounds (VOC), carbon monoxide (CO), and nitrogen oxide (NOX)
emissions. The motor vehicle inspection and maintenance program is an
effective means of reducing these emissions. Despite improvements in
emission control technology in past years, mobile sources in urban
areas continue to remain responsible for roughly half of the emissions
of VOC causing ozone, and most of the emissions of CO. They also emit
substantial amounts of nitrogen oxides and air toxics. This is because
the number of vehicle miles traveled has doubled in the last 20 years
to 2 trillion miles per year, offsetting much of the technological
progress in vehicle emission control over the same period. Projections
indicate that the steady growth in vehicle miles will continue.
Under the Act, the EPA is pursuing a three-point strategy to
achieve emission reductions from motor vehicles. The development and
commercialization of cleaner vehicles and cleaner fuels represent the
first two elements of the strategy. These developments will take many
years before cleaner vehicles and fuels dominate the fleet and
favorably impact the environment. This document deals with the third
element of the strategy, inspection and maintenance, which is aimed at
the reduction of emissions from the existing fleet by ensuring that
vehicles are maintained to meet the emission standards established by
EPA. Properly functioning emission controls are necessary to keep
pollution levels low. The driving public is often unable to detect a
malfunction of the emission control system. While some minor
malfunctions can increase emissions significantly, they do not affect
drivability and may go unnoticed for a long period of time. Effective
I/M programs can identify excessive emissions and assure repairs. The
EPA projects that sophisticated I/M programs such as the one being
approved in this rulemaking in Illinois will identify emission related
problems and prompt the vehicle owner to obtain timely repairs thus
reducing emissions.
The Act requires that polluted cities adopt either a ``basic'' or
``enhanced'' I/M program, depending on the severity of the pollution
and the population of the area. Moderate ozone nonattainment areas,
plus marginal ozone areas with existing or previously required I/M
[[Page 38583]]
programs in Census-defined urbanized areas, fall under the ``basic'' I/
M requirements. Basic and enhanced I/M programs both achieve their
objective by identifying vehicles that have high emissions as a result
of one or more malfunctions, and requiring them to be repaired. An
``enhanced'' I/M program covers more vehicles in operation in the
fleet, employs inspection methods which are better at finding high
emitting vehicles, and has additional features to better assure that
all vehicles are tested properly and effectively repaired. The Act
directed EPA to establish a minimum performance standard for enhanced
I/M programs. The standard is based on the performance achievable by
annual inspections in a centralized test program. States have
flexibility to design their own programs if they can show that their
program is as effective as the model program used in the performance
standard. Naturally, the more effective the program the more credit a
State will get towards the emission reduction requirement. An effective
program will help to offset emissions associated with growth in vehicle
use and allow for industrial and/or commercial growth.
The EPA and the States have learned a great deal about what makes
an I/M program effective since the Clean Air Act of 1977 first required
I/M programs for polluted areas. There are three major keys to an
effective program:
(1) Given the advanced state of current vehicle design and
anticipated technology changes, the ability to accurately fail problem
vehicles and pass clean ones requires improved test equipment and test
procedures;
(2) Comprehensive quality control and aggressive enforcement are
essential to assuring the testing is done properly;
(3) Skillful diagnostics and capable mechanics are important to
assure that failed cars are fixed properly.
These three factors are missing in most older I/M programs.
Specifically, the idle and 2500 RPM/idle short tests and anti-tamper
inspections used in current I/M programs are not as effective in
identifying and reducing in-use emissions from the types of vehicles in
the current and future fleet. Also, covert audits by EPA and State
agencies typically discover improper inspection and testing 50 percent
of the time in test-and-repair stations indicating poor quality
control. Experience has shown that quality control at high-volume test
only stations is usually much better. And, finally, diagnostics and
mechanics training are often poor or nonexistent.
On November 5, 1992 (57 FR 52950), EPA established a high-tech
emission test for high-tech cars. This I/M test, known as the IM240
test, is so effective that biennial test programs yield almost the same
emission reduction benefits as annual programs. The test can also
accurately measure NOX emissions where NOX is important to
address an ozone problem. The addition of the pressure and purge test
increases the benefit even more and results in lower testing costs and
consumer time demands. The pressure test is designed to find leaks in
the fuel system, and the purge test evaluates the functionality of the
vapor control system. In addition, EPA published changes to the I/M
rule in the Federal Register on October 18, 1995, (60 FR 48029) in
order to provide greater flexibility to States required to implement I/
M programs.
II. Background
The State of Illinois currently contains two ozone nonattainment
areas which are required to implement I/M programs in accordance with
the Act. The Chicago severe-17 ozone nonattainment area contains the
Chicago, Aurora, Crystal Lake, Elgin, Joliet, and Round Lake Beach-
McHenry urbanized areas. The Federal I/M rule requires the Chicago
urbanized area to implement an enhanced I/M program. Since the I/M rule
does not require enhanced I/M programs in severe urbanized areas with a
Census population of less than 200,000, the remaining five cities in
the Chicago nonattainment area will be required to implement only a
basic I/M program based on their 1990 Census-defined urbanized area
populations. The East St. Louis moderate ozone nonattainment area
contains the Illinois portion of the St. Louis and Alton urbanized
areas. Both areas are required to implement a Basic I/M program in the
nonattainment area. On June 29, 1995, IEPA submitted to EPA a SIP
revision for the implementation of an enhanced I/M program to cover
both the Chicago and the East St. Louis nonattainment areas. This
submittal includes the Vehicle Emissions Inspection Law of 1995 (625
ILCS 5/13B), P.A. 88-533, which became effective January 18, 1994. That
statute provides authority for IEPA to implement an enhanced I/M
program and meet EPA's requirements for such a program. P.A. 88-533
mandates enhanced I/M testing for the Metro-East area and certain
portions of the Chicago nonattainment area. In addition, the Illinois
submittal includes I/M regulations (R94-19 and R94-20) adopted on
December 1, 1994, by the Illinois Pollution Control Board (Board),
which include emissions standards based upon EPA's preferred IM240
loaded mode exhaust emissions standard. On December 23, 1994, the
amended rule for R94-20 was published in the Illinois State Register
and its effective date was December 12, 1994. On December 30, 1994, the
amended rule R94-19 was published in the Illinois Register and had an
effective date of December 14, 1994. On April 22, 1996, IEPA submitted
the State's I/M Request-For-Proposal as part of the Illinois SIP
submittal. Under the Environmental Protection Act [415 ILCS 5 (1992)],
the Board has the authority to adopt air pollution regulations for the
State of Illinois. The adopted regulations and the legislation
submitted by Illinois changes the existing program from a basic I/M
program to a fully enhanced I/M program in both of Illinois' ozone
nonattainment areas.
In a proposed rule published in the Federal Register on May 10,
1996 (61 FR 21405), EPA proposed to approve portions of the Illinois
enhanced I/M submittal and to conditionally approve other portions as
stated below in section III of this notice. The public comment period
for the May 10, 1996, notice of proposed rulemaking closed on June 10,
1996, and no comments were received.
III. EPA's Analysis of the Illinois, Enhanced I/M Program
As discussed above, section 182 of the Act requires that States
adopt and implement updated regulations for I/M programs in moderate
and above ozone nonattainment areas. The following sections of this
notice summarize the requirements of the Federal I/M regulations and
address whether the elements of the State's submittal comply with the
Federal rule.
Applicability--40 CFR 51.350
Section 182(c)(3) of the Act and 40 CFR 51.350(a) require States
which contain areas classified as serious or worse ozone nonattainment
and containing metropolitan statistical areas (MSAs) with a population
of 200,000 or more to implement an enhanced I/M program. As noted
above, the State of Illinois contains the Aurora, Chicago, Crystal
Lake, Elgin, Joliet, and Round Lake beach-McHenry urbanized areas in
its Chicago Severe-17 ozone nonattainment area, but the Chicago
urbanized area is the only area which contains a population of more
than 200,000, based on 1990 Census data. The remaining urbanized areas
in the Chicago nonattainment area with populations less than 200,000
are required to implement a basic I/M program. In addition, section
182(b)(4) of the Act and 40 CFR part 51.530(a) require States with
moderate ozone
[[Page 38584]]
nonattainment areas containing 1990 census defined urbanized areas to
implement a basic I/M program. The State of Illinois contains the East
St. Louis moderate nonattainment area where this requirement applies.
The Illinois submittal contains the legal authority and regulations
necessary for IEPA to establish the program boundaries and operate an
enhanced I/M program in ozone nonattainment areas stated above. P.A.
88-533 specifies the geographic boundaries of the program in both ozone
nonattainment areas. The program boundaries described in the Illinois
submittal meet the Federal I/M requirements under Sec. 51.350 and are
approvable. The Federal I/M regulation requires that the State I/M
program must operate until it is no longer necessary. EPA has
determined that a SIP which does not terminate prior to the attainment
deadline for each applicable area (i.e. 2007 for the Chicago severe-17
ozone nonattainment area, and 1996 for the Metro-East moderate ozone
nonattainment area) satisfies this requirement. The State I/M submittal
does not contain a termination provision and is therefore approvable.
EPA approves this section of the Illinois submittal in this notice.
Enhanced I/M Performance Standard 40 CFR 51.351
The enhanced I/M program must be designed and implemented to meet
or exceed a minimum performance standard, expressed in area-wide
average grams per mile (gpm), for emission levels of certain
pollutants. The performance standard shall be established using local
characteristics, such as vehicle mix and local fuel controls, and the
following model I/M program parameters: network type, start date, test
frequency, model year coverage, vehicle type coverage, exhaust emission
test type, emission standards, emission control device, evaporative
system function checks, stringency, waiver rate, compliance rate and
evaluation date. The emission levels achieved by the State's program
design shall be calculated using the most current version, at the time
of submittal, of the EPA mobile source emission factor model. At the
time of the Illinois submittal, the most current version was MOBILE5a.
Areas shall meet or exceed the performance standard for the pollutants
which cause them to be subject to I/M requirements. In the case of
ozone nonattainment areas, the performance standard must be met for
both nitrogen oxides (NOX) and volatile organic compounds (VOCs).
Urban Airshed Modeling (UAM) has been conducted in both the Chicago and
St. Louis regions. In the Chicago area, the UAM has demonstrated that
control of NOX within the nonattainment area is counterproductive
in controlling ambient ozone. IEPA has petitioned for, and has received
from EPA, a waiver from Clean Air Act NOX control requirements,
including the requirement to meet the NOX enhanced I/M performance
standard. EPA is currently in the process of evaluating the UAM data
and an IEPA NOX waiver request for the St. Louis region. NOX
testing will be restricted to tests conducted for program evaluation
purposes in accordance with 40 CFR Part 51.353(c).
The June 30, 1995, Illinois submittal includes three alternative
enhanced program options based on the use of either ASM5015, ASM2, or
IM240 networks. All three options use the following program design
parameters: centralized test only network; 1996 start date; biennial
frequency; 1968 and newer model year coverage; Vehicle type include
LDGV, LDGT1, LDGT2 and HDGV; IM240 for 1981 and newer vehicles, and
idle for 1968-1980 LDGV's and LDGT's and 1968 and later HDGV's; purge
test on 1981 and newer LDGV's and LDGT's undergoing either ASM or
IM240; pressure test of gas cap; stringency rate of 20 percent for 1980
and older vehicles; waiver rate of 3 percent and a 96 percent
compliance rate. In the February 29, 1996, Request-For-Proposal,
submitted to EPA on April 22, 1996, Illinois further specifies the
program to be implemented in the ozone nonattainment areas as one which
includes IM240 transient load testing for 1981 and newer vehicles, and
an evaporative system integrity test on all vehicles required to be
equipped with evaporative controls at the time of manufacture. Such
test shall consist of the identification of missing, defective gas
caps, and a gas cap leak test.
The Illinois program design parameters meet the Federal I/M
regulations and are approvable. The emission levels achieved by the
State, for each area, were modeled using MOBILE5a. The modeling
demonstration was performed correctly, using local characteristics
where available, and it demonstrated that the program design will meet
the enhanced I/M performance standard, expressed in grams per mile, for
VOCs and NOX for each milestone and for the attainment deadline.
The modeling demonstration submitted by the State is approvable. EPA
approves this section of the submittal in this notice.
Network Type and Program Evaluation 40 CFR 51.353
Enhanced I/M programs shall be operated in a centralized test-only
format, unless the State can demonstrate that a decentralized program
is equally effective in achieving the enhanced I/M performance
standard. The enhanced program shall include an ongoing evaluation to
quantify the emission reduction benefits of the program and to
determine if the program is meeting the requirements of the Act and the
Federal I/M regulations. The SIP shall include details on the program
evaluation and a schedule for submittal of biennial evaluation reports,
data from a State monitored or administered mass emission test of at
least 0.1 percent of the vehicles subject to inspection each year,
description of the sampling methodology, the data collection and
analysis system and the legal authority enabling the evaluation
program.
The State legislative authority and the State I/M regulations
provide for a centralized, test-only network. Illinois' centralized,
test only network type is approvable. The submittal does not, however,
include provisions for on-going program evaluation to satisfy all of
the requirements of 40 CFR part 51.353. Specifically, the State must
submit schedules for program evaluations and methodologies by which
this biennial program evaluation will be carried out, as required by 40
CFR part 51.353. EPA is conditionally approving this section of the
Illinois enhanced I/M SIP based on the April 22, 1996, letter and phone
conversation record committing to submit to EPA as supplemental
information in support of the SIP the necessary documentation within
one year of today's final conditional approval. In addition, the State
has committed to submit to EPA biennial program evaluation reports
meeting the requirements of 40 CFR part 51.353 starting at the end of
the program's first biennial cycle.
Adequate Tools and Resources 40 CFR 51.354
The Federal I/M regulation requires States to demonstrate that
adequate funding of the program is available. A portion of the test fee
or a separately assessed per year vehicle fee shall be collected,
placed in a dedicated fund and used to finance the program. Alternative
funding approaches are acceptable if it is demonstrated that the
funding can be maintained. Reliance on funding from a State or local
General Fund is not acceptable unless doing otherwise would be a
violation of the State's constitution. The SIP shall
[[Page 38585]]
include a detailed budget plan which describes the source of funds for
personnel, program administration, program enforcement and purchase of
equipment. The SIP shall also detail the number of personnel dedicated
to the quality assurance program, data analysis, program
administration, enforcement, public education and assistance and other
necessary functions. P.A. 88-533 prevents the IEPA from charging motor
vehicle owners for inspections required under this law. Instead, P.A.
88-533 states that the Vehicle Inspection Fund, which was a fund
created in the State treasury for the purpose of receiving money from
the Motor Fuel Tax and other sources, shall be used for the payment of
the cost of the program, including reimbursement of those agencies of
the State that incur expenses in the administration and enforcement of
the program. EPA approves this section of the Illinois submittal in
this notice.
Test Frequency and Convenience 40 CFR 51.355
The enhanced I/M performance standard assumes an annual test
frequency; however, other schedules may be approved if the performance
standard is achieved. The SIP shall describe the test year selection
scheme and shall include the legal authority, regulations or contract
provisions necessary to implement and enforce the test frequency
requirement. The program shall be designed to provide convenient
service to motorists by ensuring short waiting times, short driving
distances and regular testing hours. The Illinois enhanced I/M law of
1995 provides the legal authority to implement and enforce biennial
test frequency for all subject vehicles. New vehicles are exempt from
testing for two years, requiring the vehicle to be initially tested in
the second calendar year after the vehicle model year. Based on the
performance standard modeling provide by the State, the enhanced I/M
program meets the performance standard accounting for biennial test
frequency. P.A. 88-533 also requires that the program be designed so
that covered vehicle owners reside within 12 miles of an official
inspection station. In addition, the law requires the program to be
designed in such a way that sufficient inspection capacity at the
station is so that the usual wait before the start of an inspection
does not exceed twenty minutes. The test frequency and convenience
section is approvable and EPA approves this section of the Illinois
submittal in this notice.
Vehicle Coverage 40 CFR 51.356
The performance standard for enhanced I/M programs assumes coverage
of all 1968 and newer model year light duty vehicles and light duty
trucks up to 8,500 pounds gross vehicle weight rating (GVWR), and
includes vehicles operating on all fuel types. Other levels of coverage
may be approved if the necessary emission reductions are achieved.
Vehicles registered or required to be registered within the I/M program
area boundaries, and fleets primarily operated within the I/M program
area boundaries belonging to the covered model years and vehicle
classes comprise the subject vehicles. Fleets may be officially
inspected outside the normal I/M program test facilities, if such
alternatives are approved by the program administration, but shall be
subject to the same test requirements using the same quality control
standards as non-fleet vehicles and shall be inspected in independent,
test-only facilities, according to the requirements of 40 CFR part
51.353(a).
The Federal I/M regulation requires that the SIP shall include the
legal authority or rule necessary to implement and enforce the vehicle
coverage requirement, a detailed description of the number and types of
vehicles to be covered by the program and a plan for how those vehicles
are to be identified, including vehicles that are routinely operated in
the area but may not be registered in the area, and a description of
any special exemptions, including the percentage and number of vehicles
to be impacted by the exemption.
The Illinois Vehicle Inspection Law of 1995 requires coverage of
all 1968 and newer vehicles registered or required to be registered in
the I/M program area, except those vehicles which run on diesel or
exclusively by electricity. The modeling demonstration submitted with
the SIP includes vehicle coverage of LDGV, LDGT1, and LDGT2. The
Illinois legislation provides the legal authority to implement and
enforce the vehicle coverage. This level of coverage is approvable
because it provides the necessary emission reductions. The modeling
demonstration does contain estimates of the number of registered
vehicles in the area. However, the State's June 29, 1995, SIP submittal
does not adequately address fleet testing requirements. Existing
legislation allows for the self testing of fleets, but the submittal
fails to address the specific requirements involved in fleet testing.
The State also did not provide a description of the impact vehicle
exemptions will have on the subject fleet. The modeling demonstration
submitted by the State does not account for these exemptions in the
emission reduction analysis. The State must describe the extent of the
exemption's impact, in accordance with 40 CFR part 51.356, in order for
EPA to fully approve this section of the State submittal. EPA
conditionally approves this section based on the April 22, 1996, letter
to EPA committing to address the requirements of 40 CFR 51.356 with
regard to fleets, within one year of today's final conditional
approval.
Test Procedures and Standards 40 CFR 51.357
Written test procedures and pass/fail standards are required to be
established and followed for each model year and vehicle type included
in the program. Federal test procedures and standards are found in 40
CFR 51.357 and in the EPA document entitled ``High-Tech I/M Test
Procedures, Equipment Standards, Quality Control Requirements, and
Equipment Specifications'', EPA-AA-EPSD-IM-93-1, finalized in April,
1994. P.A. 88-533 provides the State the authority to establish test
procedures according to the needs of the program. The Illinois
submittal also includes I/M regulations (R94-19 and R94-20) adopted on
December 1, 1994, by the Illinois Pollution Control Board (Board) which
include emissions standards based upon EPA's preferred IM240 loaded
mode exhaust emissions standard. IEPA has asked I/M contract bidders to
address in detail the requirements of this section in its Request-For-
Proposal (RFP). EPA conditionally approves this section of the SIP
based on the State's commitment to submit to EPA as supplemental
information in support of the SIP its final signed I/M contract
addressing the requirements of 40 CFR part 51.357 within one year of
today's final conditional approval.
Test Equipment 40 CFR 51.358
The Federal regulation requires computerized test systems for
performing any measurement on subject vehicles. The Federal I/M
regulations requires that the State SIP submittal include written
technical specifications for all test equipment used in the program.
The specifications shall describe the emission analysis process, the
necessary test equipment, the required features and written acceptance
testing criteria and procedures.
P.A. 88-533 provides the general authority for the State to
establish the designation of official test equipment
[[Page 38586]]
and testing procedures. The Illinois submittal also includes I/M
regulations (R94-19 and R94-20) which include emissions standards based
upon EPA's preferred IM240 loaded mode exhaust emissions standard. IEPA
has addressed the requirements of this section in its RFP released
February 29, 1996. EPA conditionally approves this section of the SIP
based on the State's April 22, 1996, commitment to submit to EPA as
supplemental information in support of the SIP its final signed
contract addressing the requirements of 40 CFR part 51.358 within one
year of EPA's final conditional approval.
Quality Control 40 CFR 51.359
Quality control measures shall ensure that emission measurement
equipment are calibrated and maintained properly, and that inspection,
calibration records and control charts are accurately created, recorded
and maintained. The Illinois submittal contains general legal authority
in P.A. 88-533 which requires IEPA to establish an enhanced program
containing procedures to assure the correct operation, maintenance and
calibration of test equipment, and also procedures for certifying test
results and for reporting and maintaining relevant data and records.
Illinois' RFP requires bidders as part of their Technical proposal to
submit a Quality Assurance Plan which addresses the requirements of
this section. EPA conditionally approves this section of the SIP based
on the State's April 22, 1996 commitment to submit to EPA as
supplemental information in support of the SIP its final signed
contract and the contractor's Quality Assurance Plan addressing the
quality control requirements of 40 CFR part 51.359 within one year of
EPA's final conditional approval.
Waivers and Compliance Via Diagnostic Inspection 40 CFR 51.360
The Federal I/M regulation allows for the issuance of a waiver,
which is a form of compliance with the program requirements that allows
a motorist to comply without meeting the applicable test standards, as
long as prescribed criteria are met. For enhanced I/M programs, an
expenditure of at least $450 in repairs, adjusted annually to reflect
the change in the Consumer Price Index (CPI) as of 1989, is required in
order to qualify for a waiver. Waivers can only be issued after a
vehicle has failed a retest performed after all qualifying repairs have
been made. Any available warranty coverage must be used to obtain
repairs before expenditures can be counted toward the cost limit.
Tampering related repairs shall not be applied toward the cost limit.
Repairs must be appropriate to the cause of the failure. Repairs for
1980 and newer model year vehicles must be performed by a recognized
repair technician. The Federal regulation allows for compliance via a
diagnostic inspection after failing a retest on emissions and requires
quality control of waiver issuance. The SIP must set a maximum waiver
rate and must describe corrective action that must be taken if the
waiver rate exceeds that committed to in the SIP.
The Illinois SIP submittal contains the necessary authority in P.A.
88-533 to issue waivers, set and adjust cost limits, and administer and
enforce the waiver system. The Illinois law requires that IEPA certify
whether a vehicle that has failed a vehicle emission retest qualifies
for a waiver of the emission inspection standards if the following
criteria are met: The vehicle has received all repairs and adjustments
for which it is eligible under any emission performance warranty
provided under section 207 of the Act; IEPA determines by normal
inspection procedures that the vehicle's emission control devices are
present and appear to be properly connected and operating; consistent
with 40 CFR 51.360 for vehicles required to be tested under the
Illinois law, a minimum expenditure of $450 in emission-related repairs
exclusive of tampering-related repairs have been made; repairs for
vehicles of model year 1981 and later are conducted by a recognized
repair technician; evidence of repair is presented consisting of either
signed and dated receipts identifying the vehicle and describing the
work performed and amount charged for eligible emission-related
repairs, or an affidavit executed by the person performing the eligible
emission related repairs; and that the repairs have resulted in an
improvement in vehicle emissions as determined by comparison of initial
and final retest results.
The State of Illinois has chosen not to allow compliance via a
complete documented physical and functional diagnosis and inspection
which shows that no additional emission-related repairs are needed. The
State has set a maximum waiver rate of 3 percent for both pre-1981 and
for 1981 and later vehicles. Illinois used MOBILE5a and assumed a
maximum waiver rate of 3 percent for 1980 and older model year vehicles
and 3 percent for 1981 and newer vehicles. In the event the actual
waiver rate exceeds the planned maximum used for estimating the
emission reduction benefit, the State will need to remodel to assess
the emission reduction benefits based on the actual waiver rate. EPA is
approving this section of the Illinois submittal in this notice.
Motorist Compliance Enforcement 40 CFR 51.361
The Federal regulations require the use of registration denial to
ensure compliance with the requirements of the I/M program unless an
exception for use of an alternative is approved. Registration denial
enforcement consists of rejecting an application for initial
registration or registration for a used vehicle unless the vehicle has
complied with the I/M requirements prior to the granting of the
application. The SIP shall provide information concerning the
enforcement process, legal authority to implement and enforce the
program, a commitment to a compliance rate to be used for modeling
purposes and to be maintained in practice. The Illinois SIP contains an
alternative compliance system to that of registration denial. The
Illinois compliance approach uses computer matching of vehicle
registration records and inspection records to identify violations. The
Illinois Secretary of State (SOS) is required under P.A. 88-533 to
suspend either the driving privileges or the vehicle registration, or
both, of any vehicle owner who has not complied with the requirements
of P.A. 88-533. A suspension under this requirement would not be
terminated until proof of compliance has been submitted to the SOS. In
the I/M SIP, Illinois commits to the level of motorist enforcement
necessary to ensure a compliance rate of no less than 96 percent among
subject vehicles in the program area. If it is determined as part of
the required program evaluation that the I/M program is not meeting the
compliance rate, Illinois will need to investigate the problem and
institute changes to improve the compliance rates. EPA approves this
section of the Illinois SIP in this notice.
Motorist Compliance Enforcement Program Oversight 40 CFR 51.362
The Federal I/M regulation requires that the enforcement program
shall be audited regularly and shall follow effective program
management practices, including adjustments to improve operation when
necessary. The SIP shall include quality control and quality assurance
procedures to be used to insure the effective overall performance of
the enforcement system. An information management system shall be
established which will characterize, evaluate and enforce the program.
The legal authority for the implementation of an I/M program is
[[Page 38587]]
found in P.A. 88-53. This statute provides the authority necessary to
develop and implement the enforcement program oversight element of the
I/M program. EPA conditionally approves this portion of the State's
submittal based on the April 22, 1996, letter to EPA committing to
addressing the requirements of 40 CFR part 51.362 within one year of
today's final conditional approval.
Quality Assurance 40 CFR 51.363
An ongoing quality assurance program shall be implemented to
discover, correct and prevent fraud, waste, and abuse in the program.
The program shall include covert and overt performance audits of the
inspectors, audits of station and inspector records, equipment audits,
and formal training of all state I/M enforcement officials and
auditors. A description of the quality assurance program which includes
written procedure manuals on the above discussed items must be
submitted as part of the SIP. The Illinois submittal contains only a
general provision under P.A. 88-533 which requires that the State I/M
program provide for procedures to assure the correct operation,
maintenance, and calibration of test equipment. Illinois' RFP requires
bidders as part of their Technical proposal to submit a Quality
Assurance Plan which addresses the requirements of this section. EPA
conditionally approves this section of the SIP based on the State's
April 22, 1996 commitment to submit to EPA as supplemental information
in support of the SIP its final signed contract and the contractor's
Quality Assurance Plan addressing the quality assurance requirements of
40 CFR part 51.363 within one year of EPA's final conditional approval.
Enforcement Against Contractors, Stations and Inspectors 40 CFR 51.364
Enforcement against licensed stations or contractors and inspectors
shall include swift, sure, consistent penalties for violation of
program requirements. The Federal I/M regulation requires the
establishment of minimum penalties for violations of program rules and
procedures which can be imposed against stations, contractors and
inspectors. The legal authority for establishing and imposing
penalties, civil fines, licence suspensions and revocations must be
included in the SIP. State quality assurance officials shall have the
authority to temporarily suspend station and/or inspector licenses
immediately upon finding a violation that directly affects emission
reduction benefits. The SIP shall describe the administrative and
judicial procedures and responsibilities relevant to the enforcement
process. The Illinois submittal includes the legal authority to
establish and impose penalties against station, contractors, and
inspectors. In addition, the RFP contains detailed provisions
addressing the requirements of this section, including specific
monetary penalties established for violation of program rules and
procedures. The provisions found in the RFP will be enforceable once a
final I/M contract is developed and signed. EPA conditionally approves
this section of the SIP based on the State's April 22, 1996 commitment
to submit to EPA as supplemental information in support of the SIP its
final signed contract and any necessary administrative rules addressing
the requirements of 40 CFR part 51.364 within one year of EPA's final
conditional approval.
Data Collection 40 CFR 51.365
In order to manage, evaluate and enforce the program requirements
an effective I/M program requires accurate data collection. The Federal
I/M regulation requires data to be gathered on each individual test
conducted and on the results of the quality control checks of test
equipment required under 40 CFR part 51.359. The Illinois submittal
contains a general provision under P.A. 88-533 which requires that the
State I/M program provide for procedures for certifying test results
and for reporting and maintaining relevant data and records. In
addition, the RFP requires that the contractor submit to IEPA, on a
monthly basis, a file containing detailed data for each vehicle test
transaction conducted. The data collection requirements specified in
the RFP meet those specified in 40 CFR part 51.365. Once the final I/M
contract is submitted to EPA as supplemental information in support of
the SIP this section of the I/M SIP can be fully approved. At this
time, EPA conditionally approves this section of the SIP based on the
State's April 22, 1996 commitment to submit to EPA as supplemental
information in support of the SIP its final signed contract addressing
the data collection requirements of 40 CFR part 51.365 within one year
of EPA's final conditional approval.
Data Analysis and Reporting 40 CFR 51.366
Data analysis and reporting are required in order to monitor and
evaluate the program by the State and EPA. The Federal I/M rule
requires annual reports to be submitted to EPA that provide information
and statistics and summarize activities performed for each of the
following programs: testing, quality assurance, quality control and
enforcement. These reports are to be submitted by July of each year and
shall provide statistics for the period of January to December of the
previous year. A biennial report shall be submitted to EPA that
addresses changes in the program design, regulations, legal authority,
program procedures, any weaknesses in the program found during the
previous two year period and how these problems will be or were
corrected. The Illinois RFP contains the necessary provisions
addressing the requirements of this section. However, in order to
receive full approval, the State must submit its final, signed contract
as supplemental information in support of the SIP addressing the
requirements of 40 CFR part 51.366 to EPA within one year of EPA's
final conditional approval. EPA conditionally approves this section of
the SIP based on the State's April 22, 1996 commitment to submit to EPA
as supplemental information in support of the SIP its final signed
contract addressing the data analysis and reporting requirements of 40
CFR part 51.366 within the time frame specified above.
Inspector Training and Licensing or Certification 40 CFR 51.367
The Federal I/M regulation requires all inspectors to be formally
trained and licensed or certified to conduct inspections. The Illinois
P.A. 88-533 requires all inspectors to be certified by IEPA after
successfully completing a course of training and successfully passing a
written test. The RFP requires Bidders to include in their Technical
Proposal a detailed Management Plan for the implementation and
operation of the contracted elements of the Illinois enhanced I/M
program. The Management Plan must include as part of its elements, a
description of the Personnel Training and Certification Program as
described in the RFP. The RFP requires the Contractor to establish and
operate an on-going program to train and certify contractor and IEPA
personnel. EPA conditionally approves this section of the SIP based on
the State's April 22, 1996 commitment to submit to EPA as supplemental
information in support of the SIP its final signed contract and the
contractor's Management Plan addressing the requirements of 40 CFR part
51.367 within one year of EPA's final conditional approval.
[[Page 38588]]
Public Information and Consumer Protection 40 CFR 51.368
The Federal I/M regulation requires the SIP to include a public
information and consumer protection programs. The submittal needs to
include a public information program, which educates the public on I/M,
State, and Federal regulations, air quality, the contribution of motor
vehicles to the air pollution problem, and other items as described in
the Federal rule. A consumer protection program, which includes
provisions for a challenge mechanism, protection of whistle blowers and
assistance to motorists in obtaining warranty covered repair, will also
need to be addressed. The Illinois submittal contains the legal
authority establishing grievance procedures for consumers to use, but
it does not address the rest of the requirements stated above for this
section. In order to receive full approval, the State has committed in
IEPA's April 22, 1996, letter to submit the remaining provisions of the
public information program within one year from EPA's final conditional
approval. EPA conditionally approves this portion of the SIP based on
the State's commitment to address the requirements of this section
within the time frame stated above.
Improving Repair Effectiveness 40 CFR 51.369
Effective repairs are the key to achieving program goals. The
Federal regulation requires states to take steps to ensure that the
capability exists in the repair industry to repair vehicles. The SIP
must include a description of the technical assistance program to be
implemented, a description of the procedures and criteria to be used in
meeting the performance monitoring requirements required in the Federal
regulation and a description of the repair technician training
resources available in the community. The Illinois submittal does not
contain any provisions addressing the requirements of this section,
however the State has submitted a commitment to address the
requirements of this section, including the submittal of a description
of available technician training resources, within one year of EPA's
final conditional approval. EPA is conditionally approving this portion
of the State submittal based on the State's commitment to submit the
necessary documentation to EPA in the time frame stated above.
Compliance With Recall Notices 40 CFR 51.370
States are required to establish a method to ensure that vehicles
subject to enhanced I/M and that are included in either a voluntary
emissions recall as defined at 40 CFR 85.1902(d), or in a remedial plan
determination made pursuant to section 207(c ) of the Act, receive the
required repairs prior to completing the emission test or renewing the
vehicle registration. The Illinois P.A. 88-533 provides the legal
authority to require owners to comply with emission related recalls
before completing the emission test. The Illinois RFP requires that the
contractor provide and maintain as part of the data handling system a
means to identify vehicles with unresolved emissions recalls based upon
the data provided by EPA. At a minimum, the Contractor and IEPA will
have the capability to store, retrieve, and update recall data that
consists of the VIN, the numbers of the recall campaign, and the date
that the repairs were performed. The system is to be capable of
interactively updating vehicle and/or recall database records based
upon information supplied by vehicle owners indicating that required
repairs have been made. The system will also be capable of updating
appropriate records based upon updated data provided by EPA. EPA
conditionally approves this section of the SIP based on the State's
April 22, 1996 commitment to submit to EPA as supplemental information
in support of the SIP its final signed contract addressing the annual
reporting requirements of 40 CFR part 51.370 within one year of EPA's
final conditional approval.
On-Road Testing 40 CFR 51.371
On-road testing is required in enhanced I/M areas. The use of
either remote sensing devices (RSD) or roadside pullovers including
tailpipe emission testing can be used to meet the Federal regulations.
The program must include on-road testing of 0.5 percent of the subject
fleet or 20,000 vehicles, whichever is less, in the nonattainment area
or the I/M program area. Motorists that have passed an emission test
and are found to be high emitters as a result of a on-road test shall
be required to pass an out-of-cycle test. The Illinois P.A. 88-533
requires on-road testing through the use of remote sensing devices. The
SIP submittal requires the use of RSD to test at least 0.5 percent of
the subject fleet per year in the I/M program area. The RFP requires
that the Contractor develop and maintain written on-road inspection
procedures to be approved by IEPA. In addition, the Contractor is to
provide and maintain as part of the system on-road testing information
containing vehicle and test results obtained from the on-road testing
program. The Contractor will be responsible for evaluating all on-road
emission data, including linking emissions data with vehicle database
records. EPA conditionally approves this section of the SIP based on
the State's April 22, 1996 commitment to submit to EPA as supplemental
information in support of the SIP its final signed contract addressing
the on-road testing specifications of 40 CFR part 51.371 within one
year of EPA's final conditional approval.
Rulemaking Action
EPA is approving portions and conditionally approving other
portions of this revision to the Illinois SIP for an enhanced I/M
program, as cited above. The public comment period for the May 10,
1996, notice of proposed rulemaking closed on June 10, 1996, and no
comments were received. If Illinois fails to timely submit the
materials discussed above within one year of EPA's final conditional
approval, the final conditional approval will automatically convert to
a disapproval.
I. Basis for Conditional Approval
The EPA believes conditional approval is appropriate in this case
because the State has the necessary legal authority for an enhanced I/M
program and needs only to award the I/M contract and amend current
administrative rules to address a number of enhanced I/M program
requirements. As a condition of EPA's conditional approval, the State
must submit a final signed I/M contract as supplemental information in
support of the SIP and any additional material necessary to address the
deficiencies identified in this document to EPA no later than one year
after today's final conditional approval. On April 22, 1996, the IEPA
submitted a letter committing to this. In the letter IEPA commits to
provide EPA the signed enhanced I/M contract, in addition to provide
appropriate analyses, calculations, and rules as discussed in a
conference call on April 9, 1996 between IEPA and EPA. The telephone
conversation record of this call will be included as part of the
Illinois SIP.
II. Statement of Approvability
Under the authority of the Governor of Illinois, the IEPA submitted
a SIP revision to satisfy the requirements of the I/M regulation to the
EPA on June 29, 1995. EPA found the Illinois SIP
[[Page 38589]]
complete in a letter dated June 30, 1995. The EPA has reviewed this
submittal and is approving portions and conditionally approving other
portions of it pursuant to Section 110(k) of the Act, on the condition
that the portions of the I/M program noted above are adopted and/or
submitted on the schedules noted in this final rulemaking. Once EPA
takes final conditional approval on the commitment, the State must meet
its commitment to submit the final I/M contract and all other
supporting documentation within one year of the conditional approval.
Once the EPA has conditionally approved this committal, if the State
fails to submit any necessary rules and/or documentation to EPA, final
conditional approval will automatically convert to a disapproval. EPA
will notify the State by letter to this effect. Once the SIP has been
disapproved, these commitments will no longer be a part of the approved
nonattainment area SIPs. The EPA subsequently will publish a notice to
this effect in the notice section of the Federal Register indicating
that the commitment or commitments have been disapproved and removed
from the SIP. If the State adopts and submits the final rule amendments
and the final I/M contract, as supplemental information in support of
the SIP, to EPA within the applicable time frame, the conditionally
approved commitments will remain part of the SIP until the EPA takes
final action approving or disapproving the new submittal. If the EPA
approves the subsequent submittal, those newly approved rules and/or
documentation will become part of the SIP.
If after considering the comments on the subsequent submittal, the
EPA issues a final disapproval or if the conditional approval portions
are converted to a disapproval, the sanctions clock under section
179(a) will begin. If the State does not submit and EPA does not
approve the rule on which any disapproval is based within 18 months of
the disapproval, the EPA must impose one of the sanctions under section
179(b)-highway funding restrictions or the offset sanction. In
addition, any final disapproval would start the 24 month clock for the
imposition of a section 110(c) Federal Implementation Plan. Finally,
under section 110(m) the EPA has discretionary authority to impose
sanctions at any time after a final disapproval.
EPA finds that there is good cause for this final conditional
approval to become effective immediately upon publication because a
delayed effective date is unnecessary due to the nature of a
conditional approval, which requires that the State make certain
submittals within one year of the final conditional approval. Any delay
in the effective date of this conditional approval further delays the
compliance date by which the State has to submit the documentation
committed to in this notice. The immediate effective date for this SIP
approval is authorized under both 5 U.S.C. 553(d)(1), which provides
that rulemaking actions may become effective less than 30 days after
publication if the rule ``grants or recognizes an exemption or relieves
a restriction'' and section 553(d)(3), which allows an effective date
less than 30 days after publication ``as otherwise provided by the
agency for good cause found and published in the rule.'' Under the
Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA must prepare a
regulatory flexibility analysis assessing the impact of any proposed or
final rule on small entities. 5 U.S.C. 603 and 604. Alternatively, EPA
may certify that the rule will not have a significant impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and government entities
with jurisdiction over populations of less than 50,000.
SIP approvals under 110 and subchapter I, Part D of the CAA do not
create any new requirements, but simply approve requirements that the
State is already imposing. Therefore, because the Federal SIP approval
does not impose any new requirements, I certify that it does not have a
significant impact on any small entities affected. Moreover, due to the
nature of the Federal-state relationship under the CAA, preparation of
a regulatory flexibility analysis would constitute Federal inquiry into
the economic reasonableness of state action. The CAA forbids EPA to
base its actions concerning SIPs on such grounds. Union Electric Co. v.
U.S. E.P.A., 427 U.S. 246, 256-66 (S.Ct. 1976); 42 U.S.C. 7410(a)(2)
and 7410(k)(3).
Section 202 of the Unfunded Mandates Reform Act of 1995 (``Unfunded
Mandates Act'') (signed into law on March 22, 1995) requires that the
EPA prepare a budgetary impact statement before promulgating a rule
that includes a Federal mandate that may result in expenditure by
State, local, and tribal governments, in aggregate, or by the private
sector, of $100 million or more in any one year. Section 203 requires
the EPA to establish a plan for obtaining input from and informing,
educating, and advising any small governments that may be significantly
or uniquely affected by the rule.
Under section 205 of the Unfunded Mandates Act, the EPA must
identify and consider a reasonable number of regulatory alternatives
before promulgating a rule for which a budgetary impact statement must
be prepared. The EPA must select from those alternatives the least
costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule, unless the EPA explains why this
alternative is not selected or the selection of this alternative is
inconsistent with law.
Because this final rule is estimated to result in the expenditure
by State, local, and tribal governments or the private sector of less
then $100 million in any one year, the EPA has not prepared a budgetary
impact statement or specifically addressed the selection of the least
costly, most cost-effective, or least burdensome alternative. Because
small governments will not be significantly or uniquely affected by
this rule, the EPA is not required to develop a plan with regard to
small governments. It imposes no additional requirements. The Office of
Management and Budget has exempted this action rule from Executive
Order 12866 review.
Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of this rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Incorporation by
reference, Carbon monoxide, Nitrogen Oxide, Ozone, Volatile Organic
Compound.
Dated: June 17, 1996.
David A. Ullrich,
Acting Regional Administrator.
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
[[Page 38590]]
Authority: 42 U.S.C. 7401-7671q.
Subpart O--Illinois
2. Section 52.726 is amended by adding paragraph (m) to read as
follows:
Sec. 52.726 Control Strategy: Ozone.
* * * * *
(j) On June 29, 1995, and April 22, 1996, the Illinois
Environmental Protection Agency (IEPA) submitted enhanced inspection
and maintenance (I/M) legislation, rules, and a Request-For-Proposal
(RFP) as a revision to the State's ozone State Implementation Plan
(SIP). The EPA conditionally approved the SIP revision based on the
State's commitment to submit to EPA the signed enhanced I/M contract,
in addition to provide appropriate analyses, calculations, and rules
necessary to address deficiencies noted in the final conditional
approval. The final signed contract and any supporting documentation
needed to address the deficiencies must be submitted to EPA within one
year of the EPA's conditional approval.
3. Section 52.720 is amended by adding paragraphs (c)(130) to read
as follows:
Sec. 52.720 Identification of plan.
(c) * * *
(130) On June 29, 1995, the State of Illinois submitted a revision
to the State Implementation Plan (SIP) for the implementation of an
enhanced motor vehicle inspection and maintenance (I/M) program in the
Chicago and East St. Louis ozone nonattainment areas. This revision
included the Vehicle Emissions Inspection Law of 1995 (625 ILCS 5/13B),
P.A. 88-533, effective January 18, 1995; I/M regulations (R94-19 and
R94-20) adopted on December 1, 1994, by the Illinois Pollution Control
Board; February 29, 1996, Request-For-Proposals; April 22, 1996, letter
of commitment; plus additional support documentation including modeling
demonstration.
(i) Incorporation by reference.
(A) Vehicle Emissions Inspection Law of 1995 (625 ILCS 5/13B),
Public Act 88-533, signed into law by Governor Edgar on January 18,
1995 effective January 18, 1995.
(B) 35 Illinois Administrative Code 240; Sections 240.101, 240.102,
240.104, 240.105, 240.106, 240.107, 240.124, 240.125, 240.151, 240.152,
240.153, 240.161, 240.162, 240.163, 240.164, 240.171, 240.Table A,
240.Table B amended or added in R94-19 at 18 Ill. Reg. 18228, effective
December 14, 1994.
(C) 35 Illinois Administrative Code 240; Sections 240.172, 240.173
amended in R94-20 at 18 Ill. Reg. 18013, effective December 12, 1994.
(ii) Additional Materials.
(A) February 29, 1996, Request-For-Proposals submitted on April 22,
1996.
(B) April 22, 1996, letter of commitment and attachments from
IEPA's Bureau of Air Chief to the USEPA's Regional Air and Radiation
Division Director.
[FR Doc. 96-18758 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-18651 Clean Air Act Approval and Promulgation of Carbon Monoxide Implementation Plan for the State of Washington: Puget Sound Attainment Demonstration
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38597-38600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18651]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[WA47-7120a; FRL-5538-3]
Clean Air Act Approval and Promulgation of Carbon Monoxide
Implementation Plan for the State of Washington: Puget Sound Attainment
Demonstration
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is approving the attainment demonstration portion of the
Puget Sound carbon monoxide (CO) State implementation plan (SIP)
revision submitted on September 30, 1994, by the State of Washington
Department of Ecology (Washington) for the purpose of documenting
attainment of the national ambient air quality standards (NAAQS) for
CO. The implementation plan revision was submitted by the State to
satisfy certain federal requirements for an approvable nonattainment
area CO SIP for the Puget Sound nonattainment area in the State of
Washington. The rationale for the approval is set forth in this notice.
Additional information is available at the address indicated below.
Under the Clean Air Act (CAA), EPA must approve or disapprove SIPs or
portions of SIPs within time frames specified in the CAA; failure to do
so would render EPA liable to citizen suits to conduct rulemaking on
those SIPs and would delay making approvable rules federally
enforceable.
DATES: This action is effective on September 23, 1996 unless adverse or
critical comments are received by August 26, 1996. If the effective
date is delayed, timely notice will be published in the Federal
Register.
ADDRESSES: Written comments should be addressed to: Montel Livingston,
SIP Manager, Office of Air Quality (OAQ-107), EPA, 1200 Sixth Avenue,
Seattle, Washington 98101.
Documents which are incorporated by reference are available for
public inspection at the Air and Radiation Docket and Information
Center, Environmental Protection Agency, 401 M Street SW., Washington,
D.C. 20460.
[[Page 38598]]
Copies of material submitted to EPA may be examined during normal
business hours at the following locations: EPA Region 10, Office of Air
Quality, 1200 Sixth Avenue (OAQ-107), Seattle, Washington 98101;
Washington Department of Ecology, Attention Tami Dahlgren, Olympia,
Washington 98504-7600, telephone (360) 407-6830; and the Puget Sound
Air Pollution Control Authority, 110 Union Street, Suite 500, Seattle,
Washington 98101-2038.
FOR FURTHER INFORMATION CONTACT: William M. Hedgebeth, EPA Region 10,
Office of Air Quality, 1200 Sixth Avenue, M/S OAQ-107, Seattle,
Washington 98101, (206) 553-7369.
SUPPLEMENTARY INFORMATION:
I. Background
The air quality planning requirements for moderate CO nonattainment
areas are set out in sections 186-187 of the CAA Amendments of 1990
(CAAA) which pertain to the classification of CO nonattainment areas
and to the submission requirements of the SIPs for these areas,
respectively. The EPA has issued a ``General Preamble'' describing
EPA's preliminary views on how EPA intends to review SIPs and SIP
revisions submitted under Title I of the CAA, [see generally 57 FR
13498 (April 16, 1992) and 57 FR 18070 (April 28, 1992)]. Because EPA
is describing its interpretations here only in broad terms, the reader
should refer to the General Preamble for a more detailed discussion of
the interpretations of Title I advanced in today's proposal and the
supporting rationale.
Those States containing CO nonattainment areas with design values
greater than (>) 12.7 parts per million (ppm) were required to submit,
among other things, an attainment demonstration by November 15, 1992,
showing that the plan will provide for attainment by December 31, 1995,
for moderate CO nonattainment areas. The Puget Sound area, which
includes lands within the Puyallup, Tulalip, and Muckleshoot Indian
Reservations, had a design value of 14.8 ppm based on 1987 data, and
was classified as ``moderate > 12.7 ppm,'' under the provisions of
section 186 of the CAA (see 56 FR 56694, November 6, 1991, 40 CFR
Sec. 81.348).
The CO NAAQS are for 1-hour and 8-hour periods and are not to be
exceeded more than once per year. The 1-hour CO NAAQS is 35 ppm (40 mg/
m3) and the 8-hour CO NAAQS is 9 ppm (10 mg/m3). Washington's
attainment demonstration predicted that the highest 8-hour design
concentration as of the attainment date would be 9 ppm, thus
demonstrating attainment of the 8-hour CO NAAQS. No demonstration was
required to be carried out for the 1-hour NAAQS, as the Puget Sound
area has not violated this NAAQS since before the 1990 CAAA were
enacted. The same strategies which bring the area into attainment with
the 8-hour NAAQS will also contribute to reduced 1-hour concentrations.
The modeled attainment demonstration is discussed in greater detail
below.
II. Review of State Submittal
Section 110(k) of the CAA sets out provisions governing EPA's
review of SIP submittals (see 57 FR 13565-66). In this action, EPA is
granting approval of the attainment demonstration portion of the plan
revision submitted to EPA on September 30, 1994, because it meets all
of the applicable requirements of the CAA.
1. Procedural Background
The CAA requires States to observe certain procedural requirements
in developing implementation plans and plan revisions for submission to
EPA. Section 110(a)(2) of the CAA provides that each implementation
plan submitted by a State must be adopted after reasonable notice and
public hearing.1 Section 110(l) of the CAA similarly provides that
each revision to an implementation plan submitted by a State under the
CAA must be adopted by such State after reasonable notice and public
hearing.
---------------------------------------------------------------------------
\1\ Also Section 172(c)(7) of the Act requires that plan
provisions for nonattainment areas meet the applicable provisions of
section 110(a)(2).
---------------------------------------------------------------------------
The EPA also must determine whether a submittal is complete and
therefore warrants further EPA review and action [see section 110(k)(1)
and 57 FR 13565]. The EPA's completeness criteria for SIP submittals
are set out at 40 CFR Part 51, Appendix V (1991), as amended by 57 FR
42216 (August 26, 1991). The EPA attempts to make completeness
determinations within 60 days of receiving a submission. However, a
submittal is deemed complete by operation of law if a completeness
determination is not made by EPA six months after receipt of the
submission. In this instance, a completeness determination was made by
operation of law.
The State of Washington Department of Ecology held a public hearing
in Bellevue, Washington on September 8, 1994, to entertain public
comment on the implementation plan for the Puget Sound CO nonattainment
area. Following the public hearing the plan was adopted by the State
and submitted to EPA on September 30, 1994, as a proposed revision to
the SIP.
With respect to the portions of the tribal lands which lie within
the CO nonattainment area, EPA contacted the chairpersons of the
Puyallup and Muckleshoot Tribal Councils and the Chairman of the
Tulalip Board of Directors of the Tulalip Tribes of Washington to
provide them with the information EPA has regarding the CO levels in
the ambient air within the entire nonattainment area and to identify
the effects that redesignating the entire area as attainment would have
on those tribal lands. Mobile sources of CO are the primary sources of
concern on the tribal lands within the nonattainment area. No CO ``hot
spot'' problems have been identified on the tribal lands by EPA,
Washington, or PSAPCA, nor have any stationary CO sources of concern
been identified. EPA provided the three tribes the opportunity to
discuss any concerns that they had regarding the pending redesignation;
no concerns were identified.
In today's action EPA is approving the attainment demonstration
portion of Washington's CO SIP submittal for the Puget Sound area and
invites public comment on the action. EPA also finds that information
and requirements provided in the attainment demonstration portion of
the Department of Ecology SIP revision request for the Puget Sound
nonattainment area demonstrate that the section 187(a)(7) requirements
have been met for the entire Puget Sound area, including portions of
the Tulalip, Puyallup, and Muckleshoot Indian Reservations.
2. Attainment Demonstration
As noted, CO moderate nonattainment areas with design values
greater than 12.7 parts per million (ppm) were required to submit a
demonstration by November 15, 1992, showing that the plan will provide
for attainment by December 31, 1995. Washington conducted an attainment
demonstration using a ``rollback'' modeling approach for the Puget
Sound CO nonattainment area to show that emission reductions resulting
from implementation of control measures were sufficient to ``roll
back'' the design value to a concentration at or below the NAAQS for CO
of 9 ppm.
The CO NAAQS are for 1-hour and 8-hour periods and are not to be
exceeded more than once per year. The 8-hour CO NAAQS is 9 ppm (10 mg/
m\3\). As noted, no demonstration was required to be carried out for
the 1-hour NAAQS, as the Puget Sound nonattainment area has
[[Page 38599]]
not violated the 1-hour NAAQS since before the CAAA were enacted. In
the attainment demonstration portion of the SIP submittal, Washington
showed that the 8-hour design value concentration of 9.0, predicted for
1995, the attainment year, documents attainment of the 8-hour CO NAAQS
by the required date, December 31, 1995.
The rollback modelling used in the 1994 SIP submittal incorporated
the use of a 90/10 split for emission sources, specifically attributing
90% of the CO emissions to local traffic and 10% of the CO emissions to
regional CO sources. Because of questions about whether the use of this
split was adequately justified, Washington submitted additional
information on May 10, 1996, documenting that the Puget Sound Air
Pollution Control Agency (PSAPCA) had conducted additional rollback
modelling using a 75/25 split, specifically attributing 75% of the CO
emission sources to local traffic and 25% to regional CO sources. This
general approach had been approved by EPA in a letter dated October 16,
1992. Conservative assumptions used in the 1994 modelling were: (1) all
sources included in the regional emission inventory contribute to
ambient concentrations at monitoring sites uniformly (i.e., distant
point sources contribute just as much as motor vehicles two blocks
away); (2) the attainment demonstration for Tacoma (the site of the
highest design value in the nonattainment area) uses 1987 data, when
the CAA calls for the most recent two years of data (1988 and 1989) and
base year air quality data for all other monitoring sites are from 1988
and 1989; and (3) the rollback analysis is based on 1987, 1988, and
1989 air quality and a 1990 base year for emissions. A fundamental
assumption of the rollback approach is that there is a proportional
relationship between emissions and air quality during a base year and
emissions and air quality in a future year. Use of the same base year
for air quality and emissions is the norm.
Changes made by PSAPCA in the additional rollback modelling
included the following four factors. First, the additional modeling
used the same base year for emissions and air quality in Tacoma.
Second, it conservatively assumed that all emissions other than local
traffic emissions were the same in 1987 as in 1990, when in all
likelihood, these emissions were higher in 1987. Third, the MOBILE5a
model was run for 1987 and 1990 and, using the fleet average emission
factors for CO from these runs, developed a factor by which to multiply
the 1990 mobile source emissions to produce a reasonable approximation
of 1987 mobile source emissions. (No adjustment was made for traffic
volumes, which may have been lower in 1987). And fourth, as noted, the
estimated 1987 mobile source emissions were input into the rollback
model using a 75/25 split. Separate design values were calculated for
cold and warm weather since both cold and warm weather exceedances had
been recorded. The recalculation of the rollback modelling predicted
attainment for both cold and warm weather in 1995, with a predicted
cold weather design value of 8.6 ppm and a predicted warm weather
design value of 8.4 ppm, both in Tacoma, the site of the monitor with
the highest recorded CO measurements.
A review of 1995 air quality data entered into the Aerometric
Information Retrieval System (AIRS) data base indicated that the actual
1995 design value for the Tacoma CO monitor was 6.3. The 1995 design
value for the entire nonattainment area was 6.5, significantly below
the modeled 1995 design value of 9.0 using the 90/10 split or the cold
and warm weather predicted design values using the 75/25 split in the
modeling developed by PSAPCA in 1996.
Major control measures used by Washington during the winter season
to effect annual emission reductions were the State's Emission Check
Program, the expansion of the Program into new areas, and oxygenated
fuel. During the ``warm season,'' there was no oxygenated fuel. The
following summarizes the 1990 to 1995 emission inventory reductions.
1990 to 1995 Emission Inventory Reductions
------------------------------------------------------------------------
Percent reduction
-------------------
Category Cold Warm
weather weather
------------------------------------------------------------------------
King County:
On-Road Mobile Sources............................ 36.5 25.6
Total Emission Inventory.......................... 27.8 15.9
Pierce County:
On-Road Mobile Sources............................ 40.0 30.2
Total Emission Inventory.......................... 29.7 19.2
Snohomish County:
On-Road Mobile Sources............................ 37.5 27.0
Total Emission Inventory.......................... 28.5 16.7
------------------------------------------------------------------------
These are maximum estimates. MOBILE5a was used to develop these
figures and assumed a basic inspection and maintenance program rather
than Washington's specific program.
3. Enforceability Issues
All measures and other elements in the SIP must be enforceable by
the State and EPA (See CAA sections 172(c)(6), 110(a)(2)(A) and 57 FR
13556). The EPA criteria addressing the enforceability of SIP's and SIP
revisions were stated in a September 23, 1987, memorandum (with
attachments) from J. Craig Potter, Assistant Administrator for Air and
Radiation, et al. (see 57 FR 13541). Nonattainment area plan provisions
must also contain a program that provides for enforcement of the
control measures and other elements in the SIP [see section
110(a)(2)(C)]. There are no specific enforceability issues related to
EPA's approval of the Puget Sound CO attainment demonstration. General
enforceability issues related to EPA's proposed approval of
Washington's redesignation request and maintenance plan for the Puget
Sound CO nonattainment area are discussed in the Federal Register, 61
FR 29515, June 11, 1996.
III. Final Action
EPA is approving the attainment demonstration portion of the Puget
Sound CO attainment plan because it meets the requirements set forth in
section 187(a)(7) of the CAA. EPA is publishing this action without
prior proposal because the Agency views this as a noncontroversial
amendment and anticipates no adverse comments. However, in a separate
document in this Federal Register publication, EPA is proposing to
approve the SIP revision should adverse or critical comments be
received. This action will be effective September 23, 1996 unless, by
August 26, 1996, adverse or critical comments are received. If EPA
receives such comments, this action will be withdrawn before the
effective date by publishing a subsequent document that will withdraw
the final action. All public comments received will then be addressed
in a subsequent final rule based on this action serving as a proposed
rule. EPA will not institute a second comment period on this action.
Any parties interested in commenting on this action should do so at
this time. If no such comments are received, the public is advised that
this action will be effective on September 23, 1996.
IV. Administrative Review
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C.
[[Page 38600]]
Sec. Sec. 603 and 604. Alternatively, EPA may certify that the rule
will not have a significant impact on a substantial number of small
entities. Small entities include small businesses, small not-for-profit
enterprises, and government entities with jurisdiction over populations
of less than 50,000.
SIP approvals under section 110 and subchapter I, Part D of the CAA
do not create any new requirements, but simply approve requirements
that the state is already imposing. Therefore, because the federal SIP-
approval does not impose any new requirements, I certify that it does
not have a significant impact on any small entities affected. Moreover,
due to the nature of the federal-state relationship under the CAA,
preparation of a regulatory flexibility analysis would constitute
federal inquiry into the economic reasonableness of state action. The
CAA forbids EPA to base its actions concerning SIPs on such grounds.
Union Electric Co. v. U.S.E.P.A., 427 U.S. 246, 256-66 (S.Ct. 1976); 42
U.S.C. 7410(a)(2).
Nothing in this action should be construed as permitting or
allowing or establishing a precedent for any future request for
revision to any SIP. Each request for revision to any SIP shall be
considered separately in light of specific technical, economic, and
environmental factors and in relation to relevant statutory and
regulatory requirements.
V. Unfunded Mandates
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under Section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
EPA has determined that the approval action promulgated today does
not include a Federal mandate that may result in estimated costs of
$100 million or more to either State, local, or tribal governments in
the aggregate, or to the private sector. This Federal action approves
pre-existing requirements under State or local law, and imposes no new
Federal requirements. Accordingly, no additional costs to State, local,
or tribal governments, or to the private sector, result from this
action.
Under section 801(a)(1)(A) of the Administrative Procedures Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of the rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
The Office of Management and Budget has exempted this action from
review under Executive Order 12866.
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.
Note: Incorporation by reference of the Implementation Plan for
the State of Washington was approved by the Director of the Office
of Federal Register on July 1, 1982.
Dated: July 2, 1996.
Chuck Clarke,
Regional Administrator.
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows: Chapter I, title 40 of the Code of Federal
Regulations is amended as follows:
PART 52--[AMENDED]
1. The authority citation for Part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart WW--Washington
2. Section 52.2470 is amended by adding paragraph (c)(62) to read
as follows:
Sec. 52.2470 Identification of plan.
* * * * *
(c) * * *
(62) On September 30, 1994, the Director of WDOE submitted to the
Regional Administrator of EPA a revision to the carbon monoxide State
Implementation Plan for, among other things, the CO attainment
demonstration for the Puget Sound carbon monoxide nonattainment area.
This was submitted to satisfy federal requirements under section
187(a)(7) of the Clean Air Act, as amended in 1990, as a revision to
the carbon monoxide State Implementation Plan.
(i) Incorporation by reference.
(A) September 30, 1994, letter from WDOE to EPA submitting an
attainment demonstration revision for the Puget Sound CO nonattainment
area (adopted on September 30, 1994), and a supplement letter and
document from WDOE, ``Reexamination of Carbon Monoxide Attainment
Demonstration for the Tacoma Carbon Monoxide Monitoring Site for the
Supplement to the State Implementation Plan for Washington State, A
Plan for Attaining and Maintaining National Ambient Air Quality
Standards for Carbon Monoxide in the Puget Sound Nonattainment Area,''
dated May 10, 1996.
[FR Doc. 96-18651 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-18649 Approval and Promulgation of Implementation Plans; Illinois
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38577-38582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18649]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[IL114-1-6788a; FRL-5540-5]
Approval and Promulgation of Implementation Plans; Illinois
AGENCY: Environmental Protection Agency.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: On May 5, 1995, and May 31, 1995, the State of Illinois
submitted a State Implementation Plan (SIP) revision request to the
Environmental Protection Agency (EPA) establishing regulations for
motor vehicle refinishing operations in the Chicago and Metro-East
ozone nonattainment areas, as part of the State's 15 percent (%) Rate
of Progress (ROP) plan control measures for Volatile Organic Matter
(VOM) emissions. VOM, as defined by the State of Illinois, is identical
to ``volatile organic compounds'' (VOC), as defined by EPA. VOM
combines with oxides of nitrogen in the atmosphere to form ground-level
ozone, commonly known as smog. Exposure to ozone is associated with a
wide variety of human health effects, agricultural crop loss, and
damage to forests and ecosystems. ROP plans are intended to bring areas
which have been exceeding the public health based Federal ozone air
quality standard closer to attaining this standard. This SIP revision
contains rules which establish VOM content limits for certain coatings
and surface preparation products used in automobile and mobile
equipment refinishing operations in the Chicago and Metro-East areas,
as well as requires these operations to meet certain equipment and work
practice standards to further reduce VOM. Illinois expects that the
control measures specified in this SIP revision will reduce VOM
emissions by 16.30 tons per day (TPD) in the Chicago area and 1.2 TPD
in the Metro-East area. This rulemaking action approves, through direct
final, the Illinois motor vehicle refinishing rule SIP revision
request.
DATES: The ``direct final'' is effective on September 23, 1996, unless
EPA receives adverse or critical comments by August 26, 1996. If the
effective date is delayed, timely notice will be published in the
Federal Register.
ADDRESSES: Copies of the SIP revision request is available for
inspection at the following address: U.S. Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. (It is recommended that you
telephone Mark J. Palermo at (312) 886-6082 before visiting the Region
5 Office.)
Written comments should be sent to: J. Elmer Bortzer, Chief,
Regulation Development Section, Air Programs Branch (AR-18J), U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604.
FOR FURTHER INFORMATION CONTACT: Mark J. Palermo at (312) 886-6082.
SUPPLEMENTARY INFORMATION:
I. Background
Section 182(b)(1) of the Clean Air Act (the Act) requires all
moderate and above ozone nonattainment areas to achieve a 15% reduction
of 1990 emissions of VOC (VOM) by 1996. In Illinois, the Chicago area
(Cook, DuPage, Kane, Lake, McHenry, Will Counties and Aux Sable and
Goose Lake Townships in Grundy County and Oswego Township in Kendall
County) is classified as ``severe'' nonattainment for ozone, while the
Metro-East area (Madison, Monroe, and St. Clair Counties) is classified
as ``moderate'' nonattainment. As such, these areas are subject to the
15% ROP requirement.
The Act specifies under section 182(b)(1)(C) that the 15% emission
reduction claimed under the ROP plan must be achieved through the
implementation of control measures through revisions to the SIP, the
promulgation of federal rules, or through permits under Title V of the
Act, by November 15, 1996. Control measures implemented before November
15, 1990, are precluded from counting toward the 15% reduction.
Illinois has adopted and submitted motor vehicle refinishing rules
for the control of VOM as a revision to the SIP for the purpose of
meeting the 15% ROP plan control measure requirement for the Chicago
and Metro-East ozone nonattainment areas. A public hearing on the rule
was held on December 16, 1994, in Chicago, Illinois. The rule was
adopted by the Illinois Pollution Control Board on April 20, 1995. The
rule became effective on May 9, 1995; it was published in the Illinois
State Register on May 19, 1995. The Illinois Environmental Protection
Agency (IEPA) formally submitted the motor vehicle refinishing rule to
EPA on May 5, 1995, as a revision to the Illinois SIP for ozone;
supplemental documentation to this revision was submitted on May
[[Page 38578]]
31, 1995. EPA made a finding of completeness in a letter dated July 13,
1995.
The May 5, 1995, and May 31, 1995 submittals include the following
new or revised rules:
Part 211: Definitions and General Provisions
Subpart B: Definitions
211.240 Adhesion Promoter
211.495 Anti-Glare/Safety Coating
211.685 Basecoat/Clearcoat System
211.1875 Elastomeric Materials
211.3915 Mobile Equipment
211.3960 Motor Vehicles
211.3965 Motor Vehicle Refinishing
211.5010 Precoat
211.5061 Pretreatment Wash Primer
211.5080 Primer Sealer
211.5090 Primer Surfacer Coat
211.6145 Specialty Coatings for Motor Vehicles
211.6540 Surface Preparation Materials
211.6620 Three or Four Stage Coating System
211.6695 Topcoat System
211.6720 Touch-Up Coating
211.6860 Uniform Finish Blender
Part 218: Organic Material Emission Standards and Limitations for
the Chicago Area
Subpart HH: Motor Vehicle Refinishing
218.780 Emission Limitations
218.782 Alternative Control Requirements
218.784 Equipment Specifications
218.786 Surface Preparation Materials
218.787 Work Practices
218.788 Testing
218.789 Monitoring and Recordkeeping for Control Devices
218.790 General Recordkeeping and Reporting
218.791 Compliance Date
218.792 Registration
Part 219: Organic Material Emission Standards and Limitations for
the Metro-East St. Louis Area
Subpart HH: Motor Vehicle Refinishing
219.780 Emission Limitations
219.782 Alternative Control Requirements
219.784 Equipment Specifications
219.786 Surface Preparation Materials
219.787 Work Practices
219.788 Testing
219.789 Monitoring and Record keeping for Control Devices
219.790 General Record keeping and Reporting
219.791 Compliance Date
219.792 Registration
The motor vehicle refinishing regulations contained in part 218 are
identical to those in part 219 except for the areas of applicability.
Part 218 applies to the Chicago area, while part 219 applies to the
Metro-East area. EPA's evaluation of these rules are as follows.
II. Evaluation of Rules
As previously discussed, this SIP submittal is required by the Act
to the extent that the rule submitted is part of the Illinois 15% ROP
plan.
A review of what emission reduction this SIP achieves for purposes
of the Illinois 15% ROP plans will be addressed when rulemaking on the
Chicago 15% ROP SIP, and the Metro-East 15% ROP SIP is taken. (EPA will
take rulemaking on the overall 15% ROP in subsequent rulemaking
action(s).) It should also be noted that Illinois' motor vehicle
refinishing rules are not required to be reviewed for purposes of
Reasonably Available Control Technology (RACT) requirements under the
Act because no motor vehicle refinishing facility in Illinois has the
potential to emit at least 25 tons of VOC, which would qualify a major
source for RACT purposes.
In order to determine the approvability of the Illinois motor
refinishing SIP, the rule was reviewed for its consistency with section
110 and part D of the Act, and its enforceability. Used in this
analysis were EPA policy guidance documents, including the draft
Control Techniques Guidelines (CTG) for motor vehicle refinishing; the
Alternative Control Techniques (ACT) document for motor vehicle
refinishing; and the June 1992, model VOC rules as they pertain to add-
on control systems. A discussion of the rule and EPA's rule analysis is
as follows.
Definitions
The new definitions added to part 211, which are based upon similar
definitions in the ACT and draft CTG, accurately describe the subject
industry, the subject and exempt coating categories, and the applicable
control methods and equipment specified in the rule. These definitions
are, therefore, approvable.
Sections 218/219.780 Emission Limitations
The emission limitations specified in these sections apply to all
owners or operators of a motor vehicle refinishing operation located in
the Chicago and Metro-East ozone nonattainment areas. ``Motor vehicle
refinishing'' is defined in this rule as any application of coating to
motor vehicle, mobile equipment, or their parts and components, which
is subsequent to the original coating applied at an original equipment
manufacturing plant (211.3965). In turn, ``motor vehicles'' means
automobiles, trucks, vans, motorcycles, or buses (211.3960). Finally,
``mobile equipment'' is any equipment which may be drawn or is capable
of being driven on a roadway, other than motor vehicles, including, but
not limited to, truck or automobile trailers, farm machinery,
construction equipment, street cleaners, and golf carts (211.3915).
Sections 218/219.780 establish VOM content limitations for
specified categories of coatings applied at each coating applicator
used in motor vehicle refinishing operations. Touch-up coatings,
however, are exempt from VOM content limitations (218/219.780(a))
``Touch-up coatings'' are defined in the rule as coatings applied by
brush or hand held, non-refillable aerosol cans to repair minor surface
damage and imperfections (211.6720).
Likewise, sections 218/219.786 provide VOM content limits for
surface preparation products, which are used to remove foreign matter,
such as wax, tar, grease, and silicone from the surface to be coated.
The specific VOM content limitation for each coating and surface
preparation material category is as follows, expressed as units of VOM
per volume of coating or product applied at each coating or product
applicator, minus water and any compounds that are specifically
exempted from the definition of VOM:
------------------------------------------------------------------------
kg/l lb/gal
------------------------------------------------------------------------
(1) Pretreatment wash primer........................ 0.78 6.5
(2) Precoat......................................... 0.66 5.5
(3) Primer/primer surfacer coating.................. 0.58 4.8
(4) Primer sealer................................... 0.55 4.6
(5) Topcoat system or basecoat/clearcoat............ 0.60 5.0
(6) Three or four stage topcoat system.............. 0.63 5.2
(7) Specialty coatings.............................. 0.84 7.0
(8) Anti-glare/safety coating....................... 0.84 7.0
(9) Plastic parts preparation product............... 0.78 6.5
(10) Preparation Products for other substrates...... 0.17 1.4
------------------------------------------------------------------------
These emission limitations are generally based on ``option 1''
coating limits in the draft CTG. The Illinois rule requires that all
coatings must be used according to manufacturer's specifications and if
the coating is mixed with additives prior to application, this mixing
cannot create a violation of the VOM content limitations (218/
219.780(b)).
Further, specialty coatings must represent no more than 5 percent,
by volume, of all coatings applied by a source on a monthly basis (218/
219.780(c)). This requirement is based upon a draft CTG recommendation
to
[[Page 38579]]
assure that specialty coatings are not used as substitutes for coatings
which are subject to more stringent emission limits. Specialty coatings
for motor vehicles are defined as coatings used for unusual job
performance requirements, including, but not limited to, adhesion
promoters, uniform finish blenders, elastomeric materials, gloss
flatteners, and bright metal trim repair (211.6145).
The rule also contains equations based on those contained in the
draft CTG to determine the weighted average VOM content of topcoat
systems, which include clearcoat/basecoat and three or four stage
topcoat systems (218/219.780(d)). This average must be at or below the
limit to be in compliance.
Sections 218/219.782 Alternative Control Requirements
As an alternative to complying with the coating requirements of
this rule, sections 218/219.782 allow a subject motor vehicle
refinishing operation to operate control equipment that reduces VOM at
the source by at least 90 percent. Subsection (b) states that a
facility may operate either an afterburner or carbon adsorber, or use
an equivalent alternative control plan if approved by the IEPA and EPA
through federally enforceable permit conditions.
On December 17, 1992 (57 FR at 59928), EPA approved Illinois'
existing Operating Permit program as satisfying EPA's June 28, 1989 (57
FR at 27274), five criteria regarding Federal enforceability. One of
the criteria is that permits may not be issued that make less stringent
any SIP limitation or requirement. EPA's December 17, 1992, rulemaking
states that operating permits issued by Illinois in conformance with
the five criteria (including the prohibition against States issuing
operating permit limits less stringent than the regulations in the SIP)
discussed in the June 28, 1989, rulemaking will be considered federally
enforceable. The December 17, 1992, rulemaking also states Illinois'
operating permit program allows EPA to deem an operating permit not
``federally enforceable.''
On July 21, 1992, EPA promulgated a new part 70 of chapter 1 of
title 40 of the Code of Federal Regulations (CFR) (See 57 FR 32250).
This new part 70 contains regulations, required by Title V of the Act,
that require and specify the minimum elements of State operating permit
programs. Part 70 is therefore an appropriate basis for evaluating the
acceptability of Illinois' use of federally enforceable State operating
permits (FESOP) and Title V permits in its VOM rules.
If an applicable implementation plan allows a determination of an
alternative emission limit at a part 70 source, equivalent to that
contained in the plan, to be made in the permit issuance, renewal, or
significant modification process, and the State elects to use such
process, any permit containing such equivalency determination shall
contain provisions to ensure that any resulting emissions limit has
been demonstrated to be quantifiable, accountable, enforceable, and
based on replicable procedures.
EPA has therefore determined that section 218/219.782(b), is
approvable because it requires that any alternative must be equivalent
to the underlying SIP requirements (consistent with part 70) and EPA
can deem a permit containing an alternative control plan to be not
``federally enforceable'' if it determines that a permit is not
quantifiable or practically enforceable or a permit relaxes the SIP.
The underlying SIP, to which any equivalent alternative control plan
must be compared, has federally enforceable control requirements, test
methods, and record keeping and reporting requirements. The procedures
for EPA's approval of these alternative control plans are specified in
a September 13, 1995, letter from the IEPA to Region 5 of the EPA.
Sections 218/219.784 Equipment Specifications
Besides meeting VOM content limits for coatings and surface
preparation materials, motor vehicle refinishing operations in the
Chicago and Metro East nonattainment areas using 20 or more gallons of
coating per calendar year are required by sections 218/219.784 to coat
motor vehicles, mobile equipment, or their parts and components using
either electrostatic or high volume low pressure (HVLP) spray
equipment. Electrostatic spray is already defined in part 211 as a
spray coating method in which opposite electrical charges are applied
to the substrate and the coating; the coating is attracted to the
object due to the electrostatic potential between them (211.1890).
Likewise, HVLP spray is defined as equipment used to apply coatings by
means of a spray gun which operates between 0.1 and 10 pounds per
square inch gauge (psig) air pressure (211.2990). These two definitions
have already been approved in a prior rulemaking action on September 9,
1994 (See 59 FR at 46562). The spray guns are required by the Illinois
rule to be calibrated, operated, and maintained in accordance with the
manufacturer's specifications. Use of this equipment increases the
transfer efficiency of the coating from the applicator to the surface,
thereby reducing overspray and resultant VOM emissions.
Facilities which apply 20 or more gallons of coating per year are
also required under sections 218/219.784 to clean all coating
applicators with a device that recirculates solvent during the cleaning
process, collects spent solvent so it is available for disposal or
recycling, and minimizes evaporation of solvents during cleaning,
rinsing, draining, and storage.
Sections 218/219.786 Surface Preparation Materials
These sections are discussed in conjunction with sections 218/
219.780 above.
Sections 218/219.787 Work Practices
Sections 218/219.787 require that every motor vehicle refinishing
operation in the Chicago and Metro-East ozone nonattainment areas
ensures that fresh and spent solvent, cloth or paper used to apply
solvent for surface preparation or cleanup, waste paint, and sludge are
stored in closed containers. This is intended to reduce evaporation of
solvent and resultant VOM emissions. Further, facilities which are
exempt from equipment specifications because they use less than 20
gallons of coating per year must direct solvent used to clean coating
applicator equipment and paint lines into a container for proper
disposal or recycling.
Sections 218/219.788 Testing
Under sections 218/219.787, motor vehicle refinishing facilities
are required, upon the request of IEPA, to conduct tests in order to
demonstrate compliance with VOM limits or control device requirements.
These tests are to be done in accordance with the applicable test
methods and procedures specified in sections 218/219.105, which were
approved and incorporated into the Illinois SIP on September 9, 1994
(See 59 FR at 46562).
The facility shall notify IEPA 30 days prior to conducting such
tests, as well as submit all test results to IEPA within 45 days after
completion of the tests. In addition, sections 218/219.788 state that
nothing in these sections shall limit the authority to require testing
or inspect facilities under section 114 of the Act.
Sections Section 218/219.789 Monitoring and Record keeping for Control
Devices
Sources using add-on control devices to comply with this rule are
required under sections 218/219.789 to install and operate equipment to
continuously monitor each control device as specified
[[Page 38580]]
in sections 218/219.105(d)(2)(A), which was approved and incorporated
into the SIP on September 9, 1994 (See 59 FR at 46562). Facilities must
also keep and maintain for three consecutive years records of
parameters for control devices as monitored, as well as logs of
operating time and maintenance of the control device and monitoring
equipment, and make all such records available to IEPA immediately upon
request. These requirements are generally consistent with those
provided in the June 1992 VOC model rules for add-on control devices.
An alternative monitoring method, or monitoring of other parameters
than required, can be used if approved by the IEPA and EPA through
federally enforceable permit conditions. As discussed previously for
alternative control plans under section 218/219.782, EPA approved, on
December 17, 1992 (57 FR at 59928), Illinois' existing Operating Permit
program as satisfying EPA's June 28, 1989 (57 FR at 27274), five
criteria regarding Federal enforceability. Moreover, these federally
enforceable permit conditions are subject to the approvability criteria
outlined in the July 21, 1992, rulemaking establishing 40 CFR part 70
(57 FR 32250). The procedures for EPA's review and approval for these
alternative monitoring methods and parameters are specified in a
September 13, 1995, letter from IEPA to Region 5 of EPA. These sections
are, therefore, approvable.
Section 218.219 General Record keeping and Reporting
All motor vehicle refinishing operations in the Chicago and Metro-
East ozone nonattainment areas shall keep the following records on a
monthly basis for three consecutive years, and the records shall be
available to IEPA immediately upon request, as required by sections
218/219.790:
(a) the name and manufacturer of each coating and surface
preparation product used at the facility each month;
(b) the volume of each category of coating purchased (specified
according to emission limit categories) by the facility each month;
(c) the coating mixing instructions, as specified and supplied by
the manufacturer, for each coating purchased each month;
(d) the VOM content, expressed as weight of VOM per volume of
coating, minus water and any compounds that are specifically exempted
from the definition of VOM, recorded on a monthly basis for:
(1) each coating as purchased, if not to be mixed with additives
prior to application on the substrate; or,
(2) each coating after mixing according to the manufacturer's
instructions;
(e) the weighted average VOM content of each basecoat/clearcoat,
and three or four stage coating system purchased by the source,
recorded on a monthly basis;
(f) the total monthly volume of all specialty coatings purchased
and the percentage specialty coatings comprised in the aggregate of all
coatings purchased by the source each month;
(g) the volume of each category of surface preparation material, as
specified by the emission limit categories, purchased by the source
each month;
(h) the VOM content, expressed as weight of VOM per volume of
material, including water, of each surface preparation material
purchased by the source, recorded on a monthly basis.
Although the draft CTG for motor vehicle refinishing recommends
that rules require daily record keeping of coatings and additives to
determine compliance, Illinois indicates that the State rule's
requirements are adequate for the following reasons. On April 30, 1996,
EPA proposed a National rule requiring motor vehicle refinishing
manufacturers to meet coating emission limits that are as stringent as,
or tighter than, the coating limits required under the Illinois rule
(See 61 FR 19005). This rule is required to be made final by March,
1997, as established under the schedule for promulgating consumer and
commercial products, which was published on March 23, 1995 (See 56 FR
at 15264). The Federal rule for motor vehicle refinishing coating
manufacturers, once final, will assure that coating purchases made by
refinishing operations covered under the Illinois rule, will, when
prepared for application according to the manufacturer's mixing
instructions, meet the applicable VOM content limit. Illinois further
indicates that based on extensive outreach with the affected motor
vehicle refinishing industry, the State is assured that manufacturer's
mixing instructions are strictly followed because the industry is
dependent on using these instructions in conjunction with computerized
mixing equipment, in order to obtain customer satisfaction with the
color match of the finished job, and to properly adhere to the
conditions of the coating manufacturer's warranty.
Finally, although certain record keeping requirements are required
for touch-up coatings exemptions under rules for other coating source
categories to ensure the exempted coatings are being used as
substitutes for covered coatings, such record keeping does not need to
be kept for motor vehicle refinishing touch-up coatings exempted under
section 218/219.780, because these coatings are typically dispensed
from small containers and are not capable of being used as substitutes
for the subject coatings.
Based on the reasons outlined above, EPA finds that the Illinois
rule's record keeping is acceptable for determining compliance.
Section 218/219.791 Compliance Date
Sections 218/219.791 require that every motor vehicle refinishing
operation in the Chicago and Metro-East ozone nonattainment areas
comply with applicable requirements of this rule by March 15, 1996,
upon modification, or upon initial start-up.
Section 218/219 Registration
In accordance with sections 218/219.792, each motor vehicle
refinishing operation shall report to the IEPA before or on its
compliance date and annually thereafter the following information: a
description of all coating operations of all refinishing and associated
surface preparation operations at the source, along with a description
of all coating applicators, cleanup operations, and work practices at
the source; certification that the source uses less than 20 gallons of
coating per year (if applicable); a written declaration stating whether
the source is in compliance with coating VOM content limits or
compliance with control device requirements; and a description of any
control device used and when the device became operational. These
reporting requirements are acceptable.
IV. Final Rulemaking Action
The EPA approves, through direct final, the Illinois SIP revision
request governing the control of VOM from motor vehicle refinishing
facilities in the Chicago and Metro-East ozone nonattainment areas.
V. Procedural Background
A. Direct Final Action
The EPA is publishing this action without prior proposal because
EPA views this action as a noncontroversial revision and anticipates no
adverse comments. However, EPA is publishing a separate document in
this Federal Register publication, which constitutes a ``proposed
approval'' of the requested SIP revision and clarifies that the
rulemaking will not be deemed final if timely adverse or critical
comments are filed. The ``direct final'' approval shall be effective on
September 23, 1996,
[[Page 38581]]
unless EPA receives adverse or critical comments by August 26, 1996. If
EPA receives comments adverse to or critical of the approval discussed
above, EPA will withdraw this approval before its effective date by
publishing a subsequent Federal Register document which withdraws this
final action. All public comments received will then be addressed in a
subsequent rulemaking document. Any parties interested in commenting on
this action should do so at this time. If no such comments are
received, EPA hereby advises the public that this action will be
effective on September 23, 1996.
B. Executive Order 12866
This action has been classified as a Table 3 action for signature
by the Regional Administrator under the procedures published in the
Federal Register on January 19, 1989 (54 FR 2214-2225), as revised by a
July 10, 1995, memorandum from Mary D. Nichols, Assistant Administrator
for Air and Radiation. The Office of Management and Budget (OMB) has
exempted this regulatory action from Executive Order 12866 review.
C. Applicability to Future SIP Decisions
Nothing in this action should be construed as permitting, allowing
or establishing a precedent for any future request for revision to any
SIP. EPA shall consider each request for revision to the SIP in light
of specific technical, economic, and environmental factors and in
relation to relevant statutory and regulatory requirements.
D. Unfunded Mandates
Section 202 of the Unfunded Mandates Reform Act of 1995 (``Unfunded
Mandates Act'') (signed into law on March 22, 1995) requires that the
EPA prepare a budgetary impact statement before promulgating a rule
that includes a Federal mandate that may result in expenditure by
State, local, and tribal governments, in aggregate, or by the private
sector, of $100 million or more in any one year. Section 203 requires
the EPA to establish a plan for obtaining input from and informing,
educating, and advising any small governments that may be significantly
or uniquely affected by the rule.
Under section 205 of the Unfunded Mandates Act, the EPA must
identify and consider a reasonable number of regulatory alternatives
before promulgating a rule for which a budgetary impact statement must
be prepared. The EPA must select from those alternatives the least
costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule, unless the EPA explains why this
alternative is not selected or the selection of this alternative is
inconsistent with law.
This final rule only approves the incorporation of existing state
rules into the SIP and imposes no additional requirements. This rule is
estimated to result in the expenditure by State, local, and tribal
governments or the private sector of less than $100 million in any one
year. EPA, therefore, has not prepared a budgetary impact statement or
specifically addressed the selection of the least costly, most cost-
effective, or least burdensome alternative. Furthermore, because small
governments will not be significantly or uniquely affected by this
rule, the EPA is not required to develop a plan with regard to small
governments.
E. Regulatory Flexibility Analysis
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. (5 U.S.C. 603 and 604.)
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000.
SIP approvals under section 110 and subchapter I, part D of the
Clean Air Act do not create any new requirements, but simply approve
requirements a State has already imposed. Therefore, because the
Federal SIP-approval does not impose any new requirements, I certify
that it does not have a significant impact on any small entities
affected. Moreover, due to the nature of the Federal-State relationship
under the Act, preparation of a regulatory flexibility analysis would
constitute Federal inquiry into the economic reasonableness of the
State action. The Clean Air Act forbids EPA to base its actions
concerning SIPs on such grounds. Union Electric Co. v. EPA., 427 U.S.
246, 256-66 (S.Ct. 1976); 42 U.S.C. section 7410(a)(2).
F. Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of the rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
G. Petitions for Judicial Review
Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 23, 1996. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See Section 307(b)(2)).
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Volatile organic compounds.
Dated: July 3, 1996.
Valdas V. Adamkus,
Regional Administrator.
For the reasons stated in the preamble, part 52, chapter I, title
40 of the Code of Federal Regulations is amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart O--Illinois
2. Section 52.720 is amended by adding paragraph (c)(120) to read
as follows:
Sec. 52.720 Identification of plan.
* * * * *
(c) * * *
(120) On May 5, 1995, and May 31, 1995, the State of Illinois
submitted a rule for motor vehicle refinishing operations, which
consisted of new volatile organic material (VOM) emission limitations
to the Ozone Control Plan for the Chicago and Metro East St. Louis
areas. This State Implementation Plan revision contains rules which
establish VOM content limits for certain coatings and surface
preparation products used in automobile and mobile equipment
refinishing operations in the Chicago and Metro-East area, as well as
requires these operations to meet certain equipment and work practice
standards to further reduce VOM.
[[Page 38582]]
(i) Incorporation by reference. Illinois Administrative Code, Title
35: Environmental Protection, Subtitle B: Air Pollution, Chapter I:
Pollution Control Board, Subchapter c: Emissions Standards and
Limitations for Stationary Sources.
(A) Part 211: Definitions and General Provisions, Subpart B;
Definitions, Sections 211.240 Adhesion Promoter, 211.495 Anti-Glare/
Safety Coating, 211.685 Basecoat/Clearcoat System, 211.1875 Elastomeric
Materials, 211.3915 Mobile Equipment, 211.3960 Motor Vehicles, 211.3965
Motor Vehicle Refinishing, 211.5010 Precoat, 211.5061 Pretreatment Wash
Primer, 211.5080 Primer Sealer, 211.5090 Primer Surfacer Coat, 211.6145
Specialty Coatings for Motor Vehicles, 211.6540 Surface Preparation
Materials, 211.6620 Three or Four Stage Coating System, 211.6695
Topcoat System, 211.6720 Touch-Up Coating, 211.6860 Uniform Finish
Blender, amended at 19 Ill. 6823, effective May 9, 1995.
(B) Part 218: Organic Material Emission Standards and Limitations
for the Chicago Area, Subpart HH; Motor Vehicle Refinishing, Sections
218.780 Emission Limitations, 218.782 Alternative Control Requirements,
218.784 Equipment Specifications, 218.786 Surface Preparation
Materials, 218.787 Work Practices, 218.788 Testing, 218.789 Monitoring
and Record keeping for Control Devices, 218.790 General Record keeping
and Reporting, 218.791 Compliance Date, 218.792 Registration, amended
at 19 Ill. 6848, effective May 9, 1995.
(C) Part 219: Organic Material Emissions Standards and Limitations
for the Metro-East Area, Subpart HH; Motor Vehicle Refinishing,
Sections 219.780 Emission Limitations, 219.782 Alternative Control
Requirements, 219.784 Equipment Specifications, 219.786 Surface
Preparation Materials, 219.787 Work Practices, 219.788 Testing, 219.789
Monitoring and Record keeping for Control Devices, 219.790 General
Record keeping and Reporting, 219.791 Compliance Date 219.792
Registration, amended at 19 Ill. Reg. 6958, effective May 9, 1995.
* * * * *
[FR Doc. 96-18649 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-18644 Approval and Promulgation of Air Quality Implementation Plans; Approval of the Carbon Monoxide Implementation Plan Submitted by the State of Connecticut Pursuant to Sections 186-187 and 211(m)
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38574-38577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18644]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[CT26-1-7198; A-1-FRL-5523-2]
Approval and Promulgation of Air Quality Implementation Plans;
Approval of the Carbon Monoxide Implementation Plan Submitted by the
State of Connecticut Pursuant to Sections 186-187 and 211(m)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On September 15, 1995, EPA proposed to approve the State
implementation plans (SIP) submitted by the State of Connecticut for
the purpose of bringing about the attainment of the national ambient
air quality standard (NAAQS) for carbon monoxide (CO). The
implementation plans were submitted by the State to satisfy the
requirements of Sections 187(a)(2)(A), 187(a)(3), 187(a)(7) and 211(m)
of the Clean Air Act for an approvable nonattainment area CO SIP for
Connecticut's portion of the New York-New Jersey-Connecticut CO
nonattainment area. Public comments were solicited on Connecticut's SIP
submittals, which included the CO attainment demonstration, contingency
measures, vehicle miles travelled (VMT) forecasts and the oxygenated
fuels program for Connecticut's portion of the New York-New Jersey-
Connecticut CO nonattainment area, and on EPA's proposed action. No
public comments were received. In this action, EPA is finalizing the
approvals of these SIP revisions. This document also updates 40 CFR
52.372, 52.373, and 52.374.
EFFECTIVE DATE: August 26, 1996.
ADDRESSES: Copies of the SIP revision relevant to this action are
available for public inspection during normal business hours at the
following location: U.S. Environmental Protection Agency, Region I, Air
Quality Planning Unit, One Congress Street, 11th floor, Boston, MA
02203; and the Bureau of Air Management, Department of Environmental
Protection, 79 Elm Street, Hartford, CT 06106.
FOR FURTHER INFORMATION CONTACT: Wing H. Chau, Air Quality Planning
Unit (CAQ), Office of Ecosystem Protection, U.S. Environmental
Protection Agency, Region 1, J.F.K. Federal Building, Boston, MA 02203,
(617) 565-3570.
SUPPLEMENTARY INFORMATION: On January 12, 1993, January 14, 1993 April
7, 1994, and August 1, 1995, the Connecticut Department of
Environmental Protection (DEP) submitted revisions to its State
Implementation Plan (SIP) for air quality. The revisions are designed
to satisfy the requirements of Sections 187(a)(2)(A), 187(a)(3),
187(a)(7) and 211(m) of the Clean Air Act, as amended in 1990 (CAA).
Those States containing CO nonattainment areas with design values
greater than 12.7 parts per million (ppm) were required to submit,
among other things, a State Implementation Plan revision, by November
15, 1992, that contains a forecast of VMT in the nonattainment area for
each year before the year in which the SIP projects the NAAQS for CO to
be attained and an attainment demonstration such that the plan will
provide for attainment by December 31, 1995 for moderate CO
nonattainment areas. The SIP revision is also required to provide for
annual updates of the VMT forecasts along with annual reports regarding
the extent to which the forecasts proved to be accurate. In addition,
these annual reports must contain estimates of actual VMT in each year
for which a forecast was required. The attainment demonstration must
include a SIP control strategy, which is also due by
[[Page 38575]]
November 15, 1992. The SIP control strategy for a given nonattainment
area must be designed to ensure that the area meets the specific annual
emissions reductions necessary for reaching attainment by the deadline.
In addition, section 187(a)(3) requires these areas to implement
contingency measures if any estimate of actual VMT or any updated VMT
forecast for the area contained in an annual report for any year prior
to attainment exceeds the number predicted in the most recent VMT
forecast. Contingency measures are also triggered by failure to attain
the NAAQS for CO by the attainment deadline. Contingency measures must
be submitted with the CO SIP by November 15, 1992. Section 211(m) of
the Act requires states with CO nonattainment areas classified as
moderate or above to submit SIP revisions to implement oxygenated
gasoline programs by November 1, 1992. The oxygenated gasoline program
must require gasoline sold or dispensed in the CMSA encompassing the CO
nonattainment area to contain not less than 2.7 percent oxygen by
weight during the portion of the year in which the area is prone to
high ambient CO levels. This control period is to be determined by the
Administrator, but shall not be less than four months.
On September 15, 1995, (60 FR 47907) EPA proposed approval of the
SIP revisions designed to satisfy the requirements of Sections
187(a)(2)(A), 187(a)(3), 187(a)(7) and 211(m) of the Clean Air Act, as
amended in 1990 (CAA). Among the elements EPA proposed to approve was
Connecticut's oxygenated gasoline program as it applies to the
Southwestern Control Area and that portion of the definition of control
period that applies to the Southwestern Control Area. In a separate
action approving redesignation of the Hartford CO nonattainment area,
EPA approved Connecticut's oxygenated gasoline requirements as they
apply to the Hartford area. EPA is here approving the State's
oxygenated gasoline requirements as they apply to the Southwestern
Control Area, including the control period for this area. In final
action on the New York CO SIP published elsewhere in today's Federal
Register, EPA is determining that the length of the period prone to
high ambient concentrations of CO for the New York-New Jersey-
Connecticut CMSA extends from November 1 through the last day of
February. The scope of the Connecticut oxygenated gasoline program
corresponds with this required control period, thereby satisfying that
element of the section 211(m) requirements. Please refer to the
September 15, 1995, Federal Register (60 FR 47907), the August 31,
1995, technical support document and the New York CO SIP approval for
additional information on this final rule.
Public Comments
The public comment period for the September 15, 1995, (60 FR
47907), notice of proposed rulemaking to approve the SIP revisions
submitted by the State of Connecticut for the purpose of bringing about
the attainment of the National Ambient Air Quality Standard (NAAQS) for
carbon monoxide closed on October 16, 1995, and no comments were
received.
Final Rulemaking Action
The EPA is approving collectively the plan revisions submitted to
EPA for the Connecticut portion of the NY-NJ-CT CO nonattainment area
on January 12, 1993, January 14, 1993, April 7, 1994, and August 1,
1995. Among other things, Connecticut has demonstrated that the
Connecticut portion of the NY-NJ-CT CO nonattainment area will continue
to attain the CO NAAQS through December 31, 1995, the applicable
attainment date.
This action has been classified as a Table 3 action for signature
by the Regional Administrator under the procedures published in the
Federal Register on January 19, 1989 (54 FR 2214-2225), as revised by a
July 10, 1995 memorandum from Mary Nichols, Assistant Administrator for
Air and Radiation. The Office of Management and Budget (OMB) has
exempted this regulatory action from review under Executive Order
12866.
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et. seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000.
A SIP approval does not create any new requirements, but simply
approve requirements that the State is already imposing. Therefore,
because the federal SIP-approval does not impose any new requirements,
I certify that it does not have a significant impact on any small
entities affected. Moreover, due to the nature of the federal-state
relationship under the CAA, preparation of a regulatory flexibility
analysis would constitute federal inquiry into the economic
reasonableness of state action. The CAA forbids EPA to base its actions
concerning SIPs on such grounds. Union Electric Co. v. U.S. E.P.A., 427
U.S. 246, 256-66 (S.Ct. 1976); 42 U.S.C. 7410 (a)(2).
As noted, additional submittals for the CO nonattainment areas are
required under Section 186 and 187 of the Act. The EPA will determine
the adequacy of any such submittal as appropriate. Nothing in this
action should be construed as permitting or allowing or establishing a
precedent for any future request for revision to any State
implementation plan. Each request for revision to the State
implementation plan shall be considered separately in light of specific
technical, economic, and environmental factors and in relation to
relevant statutory and regulatory requirements.
The Administrator's decision to approve or disapprove the SIP
revision will be based on whether it meets the requirements of Section
110(a)(2)(A)-(K) and 110(a)(3) of the Clean Air Act, as amended, and
EPA regulations in 40 CFR Part 51.
Unfunded Mandates
Under Sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 25,
1995, EPA must undertake various actions in association with proposed
or final rules that include a Federal mandate that may result in
estimated costs of $100 million or more to the private sector, or to
State, local, or tribal governments in the aggregate.
Through submission of this state implementation plan or plan
revision, the State and any affected local or tribal governments have
elected to adopt the program provided for under section 175A and
section 187(a)(1) of the Clean Air Act. The rules and commitments
approved in this action may bind State, local and tribal governments to
perform certain actions and also may ultimately lead to the private
sector being required to certain duties. To the extent that the
imposition of any mandate upon the State, local or tribal governments
either as the owner or operator of a source or as mandate upon the
private sector, EPA's action will impose no new requirements under
State law; such sources are already subject to these requirements under
State law. Accordingly, no additional costs to State, local, or tribal
governments, or to the private sector, results from this action. EPA
has also determined that this final action does not include a mandate
that may result in estimated costs of $100 million or more to State,
[[Page 38576]]
local, or tribal governments in the aggregate or to the private sector.
Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of this rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
List of Subjects in 40 CFR Part 52
Incorporation by reference, Environmental protection, Air pollution
control, Carbon monoxide, Intergovernmental relations, Reporting and
recordkeeping requirements.
Dated: June 7, 1996.
John P. DeVillars,
Regional Administrator, EPA-Region 1.
Title 40 of the Code of Federal Regulations, chapter I, part 52 is
amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart H-Connecticut
2. Section 52.370 is amended by adding paragraph (c)(71) to read as
follows:
Sec. 52.370 Identification of plan.
* * * * *
(c) * * *
(71) Revisions to the Connecticut State Implementation Plan (SIP)
for carbon monoxide concerning the control of carbon monoxide from
mobile sources, dated January 12, 1993, January 14, 1993, April 7,
1994, and August 1, 1995 submitted by the Connecticut Department of
Environmental Protection (CT DEP).
(i) Incorporation by reference.
(A) Letter dated August 1, 1995 which included the amendments and
revisions to the Regulation of Connecticut State Agencies (RCSA),
Section 22a-174-28(a) regarding the definition for the Southwestern
Control Area and that portion of the definition of ``control period''
that applies to the Southwestern Control Area with an effective date of
July 26, 1995.
(ii) Additional materials.
(A) January 12, 1993 and April 7, 1994, VMT forecasts beginning
with the year 1993 and including all subsequent years up to the year of
attainment (1995).
(B) January 12, 1993 and April 7, 1994, Carbon Monoxide Attainment
Demonstration and Contingency Measures.
3. Section 52.372 is removed and reserved.
Sec. 52.372 [Removed and reserved]
4. Section 52.373 is revised to read as follows:
Sec. 52.373 Approval status.
(a) The Administrator approves the general procedures of the
state's sulfur control regulations (19-508-19) and accompanying
narrative submitted on October 23, 1981, and November 4, 1981 and
identified under Sec. 52.370(c)(18), provided that any individual
source approvals granted by the state under the Air Pollution Control/
Energy Trade Option and solid fuel burning permitting system are
submitted to EPA as SIP revisions.
(b) The Administrator approves the total suspended particulate
regulation for foundry sand processes as submitted and identified under
paragraph (c)(22) of this section. This includes only the requirement
to remove ninety percent of the particulate matter and not the
requirement to emit not more than 0.75 pounds of particulate per ton of
material cast, a provision which may be found in state regulation 19-
508-18(f)(3).
5. Section 52.374 is amended by revising the table to read as
follows:
Sec. 52.374 Attainment dates for national standards.
* * * * *
Attainment Dates Established By Clean Air Act of 1990
----------------------------------------------------------------------------------------------------------------
Pollutant
-----------------------------------------------------------------------------------
Air quality control region SO2
and nonattainment area ---------------------------- PM-10 NO2 CO O3
Primary Secondary
----------------------------------------------------------------------------------------------------------------
AQCR 41: Eastern Connecticut
Intrastate:
Middlesex County (part)
All portions except
cities and towns in
Hartford Area.......... (a) (b) (a) (a) (a) (a)
New London County....... (a) (b) (a) (a) (a) (a)
Tolland County (part)
All portions except
cities and towns in
Hartford Area.......... (a) (b) (a) (a) (a) (e)
Windham County.......... (a) (b) (a) (a) (a) (e)
AQCR 42: Hartford-New Haven-
Springfield Interstate:
Hartford-New Britian-
Middletown Area
Hartford County
(part) See 40 CFR
81.307............. (a) (b) (a) (a) (d) (e)
Litchfield County
(part) See 40 CFR
81.307............. (a) (b) (a) (a) (d) (e)
Middlesex County
(part) See 40 CFR
81.307............. (a) (b) (a) (a) (d) (e)
Tolland County
(part) See 40 CFR
81.307............. (a) (b) (a) (a) (d) (e)
New Haven-Meriden-
Waterbury Area
Fairfield County
(part) See 40 CFR
81.307............. (a) (b) (a) (a) (c) (e)
Litchfield County
(part) See 40 CFR
81.307............. (a) (b) (a) (a) (c) (e)
New Haven County
All portions
except City of
New Haven...... (a) (b) (a) (a) (c) (e)
City of New
Haven.......... (a) (b) (a) (a) (c) (e)
AQCR 43: NY-NJ-CT
Interstate:
New York-N. New Jersey-
Long Island Area
Fairfield County
(part) See 40 CFR
81.307............. (a) (b) (a) (a) (c) (e)
Litchfield County
(part) See 40 CFR
81.307............. (a) (b) (a) (a) (c) (e)
AQCR 44: Northwestern
Connecticut Intrastate
Hartford County (part)
Hartland Township...... (a) (b) (a) (a) (a)
[[Page 38577]]
Litchfield County (part)
All portions except
cities and towns in
Hartford, New Haven,
and New York Areas..... (a) (b) (a) (a) (a) (e)
----------------------------------------------------------------------------------------------------------------
(a) Air quality levels presently below primary standards or area is unclassifiable.
(b) Air quality levels presently below secondary standards or area is unclassifiable.
(c) November 15, 1995.
(d) December 31, 1995.
(e) November 15, 1999.
(f) November 15, 2007.
(g) December 31, 1995 (one-year extension granted).
6. Section 52.376 is amended by adding paragraph (c) to read as
follows:
Sec. 52.376 Control strategy: Carbon monoxide.
* * * * *
(c) Approval-On January 12, 1993 and April 7, 1994, the Connecticut
Department of Environmental Protection submitted revisions to the
carbon monoxide State Implementation Plan for VMT forecasts,
contingency measures, and attainment demonstration for CO. These VMT
forecasts, contingency measures, and attainment demonstration were
submitted by Connecticut to satisfy Federal requirements under sections
187(a)(2)(A), 187(a)(3) and 187(a)(7) of the Clean Air Act, as amended
in 1990, as revisions to the carbon monoxide State Implementation Plan.
[FR Doc. 96-18644 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-18643 Approval and Promulgation of Implementation Plans; Revision to the New York State Implementation Plan for Carbon Monoxide; Determination of Length of Control Period for New York-Northern New Jersey-Long Island Consolidated Metropolitan Statistical Area
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38594-38597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18643]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[Region II Docket No. 151; SIPTRAX NY12-2-6920, FRL-5524-5]
Approval and Promulgation of Implementation Plans; Revision to
the New York State Implementation Plan for Carbon Monoxide;
Determination of Length of Control Period for New York-Northern New
Jersey-Long Island Consolidated Metropolitan Statistical Area
AGENCY: Environmental Protection Agency.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
approval of portions of a request by the State of New York to revise
its State Implementation Plan for Carbon Monoxide. EPA is approving New
York's carbon monoxide plan which includes a vehicle miles travelled
forecast, carbon monoxide emission inventory, multi-state coordination
commitment, and Downtown Brooklyn Master Plan. EPA is also approving
the State's use of the wintertime gasoline volatility program as a
contingency measure. In addition, EPA is partially approving the
State's oxygenated fuels rule. EPA will be taking action on New York's
attainment demonstration, revised new source review program, conformity
rules, and enhanced vehicle inspection and maintenance program in a
separate Federal Register action.
These revisions were required by the Clean Air Act as amended in
1990 and will contribute towards attaining the carbon monoxide
standard. EPA is also determining that the period prone to high ambient
concentrations of carbon monoxide in the New York-Northern New Jersey-
Long Island Consolidated Metropolitan Statistical Area extends for the
four month period from November 1 through the last day of February.
This is the control period for carbon monoxide when State programs in
this area must require oxygenated gasoline.
EFFECTIVE DATE: This action is effective August 26, 1996.
ADDRESSES: Copies of New York's submittals are available at the
following addresses for inspection during normal business hours:
Environmental Protection Agency, Region II Office, Library, 16th Floor,
290 Broadway, New York, New York 10007-1866.
New York Department of Environmental Conservation, Division of Air
Resources, 50 Wolf Road, Albany, New York 12233.
Environmental Protection Agency, Air and Radiation Docket and
Information Center (Air Docket 6102), 401 M Street, S.W., Washington,
D.C. 20460.
FOR FURTHER INFORMATION CONTACT: Henry Feingersh, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, New York, New York
10007-1866, (212) 637-4249.
SUPPLEMENTARY INFORMATION:
Background
The Clean Air Act, as amended in 1990, sets forth in Title I a
number of requirements applicable to areas designated as moderate
nonattainment for carbon monoxide (CO). Among these is the requirement
that by November 15, 1992 the State Implementation Plans (SIP) for such
areas be revised to include the following: an attainment demonstration,
an enhanced vehicle emission inspection and maintenance (I/M) program,
an oxygenated fuels rule, a vehicle miles travelled forecast,
contingency measures, a CO emission inventory, a revised new source
review program, and a multi-state coordination letter.
EPA has issued a ``General Preamble'' describing its preliminary
views on how it intends to review SIPs and SIP revisions submitted in
order to meet Title I requirements [see generally 57 FR 13498 (April
16, 1992) and 57 FR 18070 (April 28, 1992)]. The reader should refer to
the General Preamble for a more detailed discussion of the Title I
requirements and what EPA views as necessary to comply adequately with
Title I provisions.
On November 13, 1992, New York submitted to EPA proposed revisions
to its CO SIP that addressed each of the aforementioned requirements
for its moderate CO nonattainment area. In addition, in a submittal
dated March 21, 1994, New York submitted additional information on the
subject.
The New York portion of the New York-Northern New Jersey-Long
Island CO nonattainment area is classified as a moderate 2 area (an
area that has a design value of 12.8-16.4 ppm). This area, which is
part of the New York-Northern New Jersey-Long Island Consolidated
Metropolitan Statistical Area (CMSA), includes the Counties of Bronx,
Kings, New York, Queens,
[[Page 38595]]
Richmond, Nassau, and Westchester. The remainder of New York State is
in attainment for CO.
EPA proposed approval of most provisions of the State's submission
on September 15, 1995 (60 FR 47911). The reader is referred to the
proposal for a detailed discussion of EPA's action. Comments were due
by October 15, 1995. The State of New York was the only commenter.
In its proposal to approve revisions to the New York SIP for CO,
EPA also proposed to determine that the period prone to high ambient
concentrations of CO, and thus the control period when oxygenated
gasoline is required for the New York-Northern New Jersey-Long Island
CMSA, extends from November 1 to the last day of February.
Consequently, EPA proposed to approve New York's oxygenated gasoline
requirement only for that four month period because anything beyond the
control period required by section 211(m) of the Clean Air Act is
preempted under 211(c)(4), due to the reformulated gasoline oxygen
content requirements applicable in this area.
On February 12, 1996, EPA published (61 FR 5363) a Solicitation of
Comment action regarding the proposed determination to set a four month
control period for the New York-Northern New Jersey-Long Island CMSA.
This action solicited comment on the limited issue of some additional
information with regard to emissions modeling and data for the New
Jersey portion of the area. The New York Mercantile Exchange was the
only commenter on this action.
Public Comment
New York's comments on the New York SIP Federal Register concerned
EPA's proposed action on the State's attainment demonstration, I/M
program, oxygenated fuels rule, and contingency measures. For a
detailed discussion of these comments, the reader is referred to the
``New York Carbon Monoxide State Implementation Plan Technical Support
Document (TSD), September 1, 1995 and amended February 28, 1996.'' The
comments are summarized as follows:
1. New York urges EPA to grant full approval to the State's CO
attainment demonstration because the State has devoted substantial
resources to developing it. The principle steps the State used include:
1. Ranking and selection of the ``worst case'' intersections
2. Selection of an air quality model
3. Selection of a background concentration
4. Selection of the temperature to use in the model
5. Modeling
6. Summary of modeling results
These steps are described in more detail in the TSD accompanying
this rule. In general, New York's model shows that the area reaches
attainment of the CO NAAQS when credit for implementing an enhanced I/M
program is considered. However, the State does not, at this time, have
a fully adopted and submitted I/M program. Accordingly, contrary to the
commenter's suggestion, EPA is precluded from granting a full approval
to the attainment demonstration.
EPA is not taking action at this time on the State's attainment
demonstration.
2. In its Federal Register action, EPA proposed not to approve
section 225-3.8 of New York's gasoline regulation. This section allows
the State to grant waivers to the regulation's summertime Reid Vapor
Pressure (RVP) limitations. In its comments, New York states that it
believes this section should be approved along with the rest of the
State's oxygenated gasoline rule, noting that the provision has no
bearing on New York's wintertime oxygenated gasoline program.
While EPA agrees that the summertime RVP controls are not a part of
the oxygenated gasoline requirements, New York is requesting EPA to
approve those RVP controls as part of its federally enforceable SIP.
This requires EPA to evaluate whether those provisions are approvable
as a revision to New York's SIP. For the reasons stated in its proposed
rulemaking, EPA continues to believe that it would be inappropriate to
approve the State's waiver provisions for the RVP requirement given
that the State controls are otherwise identical to the Federal
controls, which the State has no power to waive.
3. New York also commented on the fact that EPA did not propose to
approve section 225-3.9(a), which would allow the State to grant
waivers of the oxygenated gasoline requirements due to shortages in
supply. It believes that the discretion to grant variances should be
part of the State's responsibilities for administering the program, and
that it would take EPA too long to authorize these types of waivers
through the SIP process.
As discussed more fully in the proposal, EPA has identified
specific circumstances under which EPA may approve a narrow state
variance provision that would allow the State to grant waivers and
which would be consistent with the applicable statutory requirements.
Since the New York submission does not provide that any increased
emissions due to a waiver would subsequently be made up, EPA cannot
approve the submitted waiver provision because EPA would have no
assurance that such waivers would not violate the requirement of
section 110(l) by potentially exempting sources from the requirements
of the Clean Air Act.
Absent approval of the waiver provision, EPA would have to evaluate
in each individual case whether a waiver would be consistent with the
statutory requirements. EPA will attempt to address these issues in a
timely fashion. Furthermore, if the State elects to revise its waiver
provision to include the necessary assurance that emissions would be
made up, EPA would make every effort to revise the SIP quickly to
include the waiver provision.
4. New York commented that it believes that, although its employee
commute option program (ECO) submittal must meet certain specific
requirements as an ozone SIP element, the submittal should be approved
as an adequate CO contingency measure at this time.
EPA expects the ECO program to be subject to change by New York
State. It is expected that this will then be submitted to EPA as part
of the ozone SIP. EPA sees no need to reduce the flexibility available
to the State in revising its ECO plan by approving it now as a
contingency CO control measure.
EPA received no negative comments on its proposal to determine that
the period prone to high ambient concentrations of CO for the New York-
Northern New Jersey-Long Island CMSA extends from November 1 through
the last day of February, either on the proposed rulemaking for the New
York CO SIP or the additional Solicitation of Comment (61 FR 5363). The
New York Mercantile Exchange raised concerns on issues outside the
scope of this rulemaking, but strongly supported EPA finalizing the
proposed determination of the control period. Thus, EPA is hereby
determining that the period prone to high ambient concentrations of CO
extends from November 1 through the last day of February. EPA is also
approving New York's oxygenated fuel requirement for only those four of
the seven months provided in New York's submission.
This action of determining that the control period for the New
York-Northern New Jersey-Long Island CMSA is the four month period from
November through February has the effect of converting EPA's limited
approval of the four month portion of New Jersey's oxygenated gasoline
SIP submission
[[Page 38596]]
into a full approval of that part. The reader is referred to the New
Jersey notice (61 FR 5299) for further details.
Elements of the SIP Being Fully Approved
Vehicle Miles Travelled Forecast
The New York SIP is required under section 187(a)(2)(A) of the
Clean Air Act to include a forecast of vehicle miles travelled through
the year 1995. In addition, annual reports on the accuracy of the
forecast and estimates of actual vehicle miles travelled and annual
updates of the forecasts are required of the State; the first of these
was required by September 30, 1994. EPA finds that New York has
submitted documentation satisfying these requirements and, therefore,
is approving New York's vehicle miles travelled forecast SIP revision.
Carbon Monoxide Emission Inventory
The New York SIP is required under section 187(a)(1) and as
described in section 172(c)(3) of the Clean Air Act to include a
comprehensive, actual inventory of all CO emission sources in the
nonattainment areas. EPA proposed to approve the CO inventory, and no
comments on this proposal were received. For the reasons described more
fully in the TSD, EPA is approving New York's 1990 base year emission
inventory for CO.
Multi-State Coordination
The New York SIP is required under section 187(e) of the Clean Air
Act to include a joint workplan to demonstrate early cooperation and
integration of all states in the nonattainment area. This workplan
consisted of a letter signed by former Director Thomas M. Allen
containing a detailed schedule of milestones and a commitment to
coordinate with EPA and each of the states involved. EPA proposed to
approve the joint workplan, and no comments on this proposal were
received. EPA finds that New York has fulfilled this requirement and
approves New York's multi-state coordination commitment.
Contingency Measures
The New York SIP is required under section 187(a)(3) of the Clean
Air Act to include adopted contingency measures in the event the State
fails to attain the national ambient air quality standards by the
required date or if any estimate of vehicle miles travelled contained
in an annual report required by section 187(a)(2) exceeds the number
predicted in the most recent prior forecast. In a January 1992 guidance
document entitled ``Section 187 VMT Forecasting and Tracking
Guidance,'' EPA discussed what it considers to be the allowable limit
of an exceedance after which contingency measures must take effect
without further action by the State or EPA. EPA proposed to approve, as
a contingency measure, the State's wintertime gasoline volatility
program, and no comments on this proposal were received. Thus, EPA
approves, as a contingency measure, the State's wintertime gasoline
volatility program as an adequate contingency measure should New York
fail to attain the CO standard or exceed the vehicle miles travelled
forecast.
Downtown Brooklyn Master Plan
On September 21, 1990, New York submitted a revision to the New
York SIP to attain the carbon monoxide air quality standard in the
Brooklyn portion of the New York City metropolitan area. EPA is
approving this plan as a revision to the SIP.
Elements of the SIP Being Partially Approval
Oxygenated Fuels Rule
The New York SIP is required under section 211(m) of the Clean Air
Act to include an oxygenated gasoline program which requires gasoline
for the State's specified control areas to contain not less than 2.7
percent oxygen by weight during that portion of the year in which the
areas are prone to high ambient concentrations of CO. EPA is approving
that part of New York's Subpart 225-3, ``Fuel Composition and Use--
Gasoline (oxygenated gasoline program) which meets the requirements of
the Clean Air Act and which was part of its November 13, 1992, SIP
submittal. As discussed earlier and in its proposed rulemaking, EPA is
approving New York's program only for the four months when the area is
prone to higher ambient concentrations of CO, which is the control
period required by section 211(m) of the Clean Air Act. EPA is also not
approving sections 225-3.8 and 225-3.9(a), which deal with State
gasoline waiver provisions, as discussed earlier. Although EPA is not
approving a portion of the State's regulation, EPA has determined that
the approved provisions fully meet the requirements of section 211(m)
of the Clean Air Act.
Further Actions
EPA will be taking action on New York's I/M program, attainment
demonstration, revised new source review program, and conformity rules
in future Federal Register actions. New York is in the process of
revising its I/M program. Once this revision is submitted as a SIP
revision and approved by EPA, EPA will take action on the I/M program
and the attainment demonstration which relies on credit from the I/M
program.
Conclusion
EPA is fully approving New York's vehicle miles travelled forecast,
CO emission inventory, multi-state coordination commitment, and
Downtown Brooklyn Master Plan, as revisions to New York's CO SIP. In
addition, the State's wintertime gasoline volatility program is being
approved as a contingency measure. EPA is approving portions of New
York's Subpart 225-3, ``Fuel Composition and Use--Gasoline,''
regulation as fully meeting the oxygenated fuels requirement of section
211(m) of the Clean Air Act.
This action is issued as required by section 110 of the Clean Air
Act, as amended. The Administrator's decision regarding the approval of
this plan revision is based on its meeting the requirements of section
110 of the Clean Air Act, and 40 CFR Part 51.
Nothing in this rule should be construed as permitting or allowing
or establishing a precedent for any future request for revision to any
SIP. Each request for revision to any SIP shall be considered
separately in light of specific technical, economic, and environmental
factors and in relation to relevant statutory and regulatory
requirements.
Under sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 22,
1995, EPA must undertake various actions in association with proposed
or final rules that include a federal mandate that may result in
estimated annual costs of $100 million or more to the private sector,
or to state, local, or tribal governments in the aggregate.
Through submission of this SIP or plan revision, the State and any
affected local or tribal governments have elected to adopt the program
provided for under section 187 of the Clean Air Act. These rules may
bind state, local and tribal governments to perform certain actions and
also require the private sector to perform certain duties. To the
extent that the rules being approved by this action will impose any
mandate upon the State, local or tribal governments either as the owner
or operator of a source or as a regulator, or would impose any mandate
upon the private sector, EPA's action will impose no new requirements;
such sources are already subject to these regulations under State law.
Accordingly, no additional costs to State, local, or tribal
governments, or to
[[Page 38597]]
the private sector, result from this action. EPA has also determined
that this final action does not include a mandate that may result in
estimated annual costs of $100 million or more to State, local, or
tribal governments in the aggregate or to the private sector.
The Office of Management and Budget has exempted this action from
review under Executive Order 12866.
Under section 307(b)(l) of the Clean Air Act, petitions for
judicial review of this rule must be filed in the United States Court
of Appeals for the appropriate circuit within 60 days from date of
publication. Filing a petition for reconsideration by the Administrator
of this final rule does not affect the finality of this rule for the
purposes of judicial review nor does it extend the time within which a
petition for judicial review may be filed and shall not postpone the
effectiveness of such rule or action. This rule may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2)).
Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of this rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.
Dated: May 31, 1996.
William J. Muszynski,
Acting Regional Administrator.
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart HH--New York
2. Section 52.1670 is amended by adding new paragraph (c)(89) to
read as follows:
Sec. 52.1670 Identification of plan.
* * * * *
(c) * * *
* * * * *
(89) Revisions to the New York State Implementation Plan (SIP) for
carbon monoxide concerning the control of carbon monoxide from mobile
sources, dated November 13, 1992 and March 21, 1994 submitted by the
New York State Department of Environmental Conservation (NYSDEC).
(i) Incorporation by reference.
(A) Subpart 225-3 of Title 6 of the New York Code of Rules and
Regulations of the State of New York, entitled ``Fuel Composition and
Use--Gasoline,'' effective September 2, 1993 (as limited in section
1679).
(ii) Additional material.
(A) March 21, 1994, Update to the New York Carbon Monoxide SIP.
3. Section 52.1679 is amended by removing the existing entry for
Subpart 225-3 and adding a new entry for Subpart 225-3 in numerical
order to read as follows:
Sec. 52.1679 EPA--approved New York State regulations.
----------------------------------------------------------------------------------------------------------------
State effective Latest EPA approval
New York State regulation date date Comments
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Subpart 225-3, Fuel Composition and 9/2/93 [insert date of Section 225-3.4 applicable
Use-- Gasoline. publication and FR November 1 through last day
page citation]. of February. Variances
adopted by the State
pursuant to sections 225-
3.8 and 225-3.9(a) become
applicable only if approved
by EPA as SIP revisions.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
[FR Doc. 96-18643 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-18642 Approval and Promulgation of Implementation Plans; Revision to the New Jersey State Implementation Plan for Carbon Monoxide
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38591-38594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18642]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[Region II Docket No. 142; SIPTRAX NJ15-2-6920, FRL-5524-3]
Approval and Promulgation of Implementation Plans; Revision to
the New Jersey State Implementation Plan for Carbon Monoxide
AGENCY: Environmental Protection Agency (EPA).
[[Page 38592]]
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document takes final EPA action on certain elements of a
request by the State of New Jersey to revise its State Implementation
Plan (SIP) for carbon monoxide. EPA is approving New Jersey's vehicle
miles travelled forecast and multi-state coordination commitment and is
giving a limited approval to New Jersey's new source review regulation,
which covers all nonattainment pollutants. EPA will be taking future
action on New Jersey's attainment demonstration and enhanced inspection
and maintenance program in a separate Federal Register document. In a
December 7, 1995 document EPA approved New Jersey's contingency
measures and statewide emissions inventory. The contingency measures
include transportation control measures which cover traffic flow
improvements, park & ride lots, and increased ridesharing. In a
February 12, 1996 document EPA approved New Jersey's oxygenated fuels
rule. These revisions were required by the Clean Air Act as amended in
1990 and will contribute towards attaining the carbon monoxide
standard.
EFFECTIVE DATE: This action is effective August 26, 1996.
ADDRESSES: Copies of New Jersey's submittals are available at the
following addresses for inspection during normal business hours:
Environmental Protection Agency, Region II Office, Library, 16th Floor,
290 Broadway, New York, New York 10007-1866.
New Jersey Department of Environmental Protection, Bureau of Air
Quality Planning, 401 East State Street, CN027, Trenton, New Jersey
08625.
Environmental Protection Agency, Air and Radiation Docket and
Information Center (Air Docket 6102), 401 M Street, SW., Washington, DC
20460.
FOR FURTHER INFORMATION CONTACT: Henry Feingersh, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, New York, New York
10007-1866, (212) 637-4249.
SUPPLEMENTARY INFORMATION:
Background
The Clean Air Act, as amended in 1990, sets forth a number of
requirements that states had to submit as revisions to their State
Implementation Plans (SIPs) by November 15, 1992 for areas designated
as moderate nonattainment for carbon monoxide. These requirements are:
an attainment demonstration, an enhanced vehicle inspection and
maintenance (I/M) program, an oxygenated fuels rule, a vehicle miles
travelled forecast, contingency measures, a carbon monoxide emission
inventory, a revised new source review program, and a multi-state
coordination letter.
EPA has issued a ``General Preamble'' describing its preliminary
views on how it intends to review SIPs and SIP revisions submitted in
order to meet Title I requirements [see generally 57 FR 13498 (April
16, 1992) and 57 FR 18070 (April 28, 1992)]. The reader should refer to
the General Preamble for a more detailed discussion of the Title I
requirements and what EPA views as necessary to adequately comply with
Title I provisions.
On November 15, 1992, New Jersey submitted to EPA proposed
revisions to its carbon monoxide SIP that addressed each of the above
requirements for its two moderate carbon monoxide nonattainment areas.
In addition, in a submittal dated October 4, 1993, New Jersey submitted
to EPA information on transportation control measures which New Jersey
will use as a contingency measure.
The New Jersey portion of the New York-Northern New Jersey-Long
Island carbon monoxide nonattainment area is classified as a Moderate 2
area (an area that has a design value of 12.8-16.4 ppm). The New York-
Northern New Jersey-Long Island carbon monoxide nonattainment area is
part of the New York-Northern New Jersey-Long Island Consolidated
Metropolitan Statistical Area and includes the counties of Bergen,
Essex, Hudson, Union, and parts of Passaic County. The nonattainment
area in Passaic County includes the cities of Clifton, Paterson, and
Passaic. The remainder of the State is in attainment for carbon
monoxide.
EPA published its proposed action on those parts of the New Jersey
submittal covered by this document on November 10, 1994 (59 FR 56019).
The reader is referred to that proposal for a detailed discussion of
EPA's action. Comments were due by December 10, 1994. The State of New
Jersey was the only commenter.
Public Comment
All of New Jersey's comments concerned EPA's proposed action on the
State's Subchapter 18, ``Control and Prohibition of Air Pollution From
New or Altered Sources Affecting Ambient Air Quality (Emission Offset
Rules)'' (new source review regulation). In its November 10, 1994
Federal Register document EPA noted that New Jersey's Subchapter 18
lacked certain elements which are summarized as follows:
1. A provision that requires changes in existing permits providing
offsets to be in effect by the time of permit issuance;
2. A process that provides information from nonattainment new
source review permits to EPA's control technology clearinghouse;
3. A definition of ``stationary source'' which excludes the new
category of ``nonroad engines;''
4. Provisions for modifications in serious and severe ozone
nonattainment areas required under sections 182(c)(6), (7) and (8) of
the Clean Air Act;
5. A net air quality benefit test;
6. A methodology for calculating net emissions increase that
adheres to EPA guidance and policy; and
7. Definitions for ``initiation of construction'' and ``initiation
of operation.''
The November 10, 1994 Federal Register proposal contains detailed
information on each of the aforementioned items.
The State commented that it will revise its regulations to address
Items 1, 2, 5, and 7 on an expedited schedule and is currently doing
so. However, the State has requested guidance from EPA on issues
associated with Items 3, 4 and 6. As a result, there are still
deficiencies in the rule that need to be corrected before it can be
fully approved. It is EPA's position that these deficiencies must be
addressed expeditiously. Until they are, the requirements related to
the afore-referenced elements are currently in effect under the
authority of the Clean Air Act, even in the absence of an applicable
implementation plan addressing these requirements.
In the interim, EPA is moving forward by finalizing its proposed
limited approval of New Jersey's new source review rule because it
strengthens the existing New Jersey SIP by incorporating Clean Air Act
requirements. Such requirements include, but are not limited to, new
offset ratios, new applicability thresholds, and the NOX
requirements of section 182(f) for most ozone nonattainment areas.
Vehicle Miles Travelled Forecast
The New Jersey SIP is required under section 187(a)(2)(A) of the
Clean Air Act to include a forecast of vehicle miles travelled through
the year 1995. In addition, annual reports and annual updates are
required of the State; the first of these was required by September 30,
1994. EPA finds that New Jersey has submitted documentation satisfying
these requirements, and therefore, is approving New Jersey's vehicle
miles travelled forecast SIP revision.
[[Page 38593]]
Multi-State Coordination
The New Jersey SIP is required under section 187(e) of the Clean
Air Act to include a joint workplan to demonstrate early cooperation
and integration of all states in the nonattainment area. This workplan
consisted of a letter signed by former Director Nancy Wittenberg
containing a detailed schedule of milestones and a commitment to
coordinate with EPA and each of the states involved. EPA finds that New
Jersey has fulfilled this requirement and approves the multi-state
coordination commitment.
Further Action
EPA will be taking action on New Jersey's Subchapter 18, enhanced
inspection and maintenance program, attainment demonstration, and
conformity rules in future Federal Register documents.
New Jersey is currently in the process of adopting an enhanced
inspection and maintenance program. Once this is submitted as a SIP
revision and approved by EPA, the attainment demonstration (which
relies on credit from the enhanced inspection and maintenance program)
would also be acted upon by EPA.
Conclusion
EPA is fully approving New Jersey's vehicle miles travelled
forecast and the multi-state coordination as revisions to New Jersey's
carbon monoxide SIP. In addition, EPA is giving limited approval to New
Jersey's Subchapter 18, ``Control and Prohibition of Air Pollution from
New or Altered Sources Affecting Ambient Air Quality (Emission Offset
Rules)'' effective March 15, 1993.
Once the remaining elements are approved, EPA can give a full
approval to the carbon monoxide SIP. Therefore, EPA can only give the
New Jersey carbon monoxide SIP a limited approval until action is taken
on the remaining elements.
This document is issued as required by section 110 of the Clean Air
Act, as amended. The Administrator's decision regarding the approval of
this plan revision is based on its meeting the requirements of section
110 of the Clean Air Act, and 40 CFR Part 51.
Nothing in this rule should be construed as permitting or allowing
or establishing a precedent for any future request for revision to any
SIP. Each request for revision to any SIP shall be considered
separately in light of specific technical, economic, and environmental
factors and in relation to relevant statutory and regulatory
requirements.
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000.
SIP approvals under section 110 and Subchapter I, Part D of the
Clean Air Act do not create any new requirements, but simply approve
requirements that the State is already imposing. Therefore, because the
federal SIP-approval does not impose any new requirements, I certify
that it does not have a significant impact on any small entities
affected. Moveover, due to the nature of the federal-state relationship
under the Clean Air Act, preparation of a regulatory flexibility
analysis would constitute federal inquiry into the economic
reasonableness of state action. The Clean Air Act forbids EPA to base
its actions concerning SIPs on such grounds. Union Electric Co. v. US
EPA, 427 US 246, 256-66 (S.Ct. 1976); 42 U.S.C. 7410(a)(2).
Under sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 22,
1995, EPA must undertake various actions in association with proposed
or final rules that include a federal mandate that may result in
estimated annual costs of $100 million or more to the private sector,
or to state, local, or tribal governments in the aggregate.
Through submission of this SIP or plan revision, the state and any
affected local or tribal governments have elected to adopt the program
provided for under section 187 of the Clean Air Act. These rules may
bind state, local and tribal governments to perform certain actions and
also require the private sector to perform certain duties. To the
extent that the rules being approved by this action will impose any
mandate upon the state, local or tribal governments either as the owner
or operator of a source or as a regulator, or would impose any mandate
upon the private sector, EPA's action will impose no new requirements;
such sources are already subject to these regulations under state law.
Accordingly, no additional costs to state, local, or tribal
governments, or to the private sector, result from this action. EPA has
also determined that this final action does not include a mandate that
may result in estimated annual costs of $100 million or more to state,
local, or tribal governments in the aggregate or to the private sector.
The Office of Management and Budget has exempted this action from
review under Executive Order 12866.
Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this rule must be filed in the United States Court
of Appeals for the appropriate circuit within 60 days from date of
publication. Filing a petition for reconsideration by the Administrator
of this final rule does not affect the finality of this rule for the
purposes of judicial review nor does it extend the time within which a
petition for judicial review may be filed and shall not postpone the
effectiveness of such rule or action. This rule may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2).)
Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of this rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.
Dated: May 31, 1996.
William J. Muszynski,
Acting Regional Administrator.
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart FF--New Jersey
2. Section 52.1570 is amended by adding new paragraph (c)(54) to
read as follows:
Sec. 52.1570 Identification of plan.
* * * * *
(c) * * *
* * * * *
(54) Revisions to the New Jersey State Implementation Plan (SIP)
for carbon monoxide concerning the control of
[[Page 38594]]
carbon monoxide from mobile sources, dated November 15, 1992 and
November 21, 1994 submitted by the New Jersey State Department of
Environmental Protection (NJDEP).
(i) Incorporation by reference.
(A) Chapter 27, Title 7 of the New Jersey Administrative Code
Subchapter 18, ``Control and Prohibition of Air Pollution from New or
Altered Sources Affecting Ambient Air Quality (Emission Offset
Rules),'' effective March 15, 1993.
(ii) Additional material.
(A) November 21, 1994, Technical update to the New Jersey Carbon
Monoxide SIP.
3. In Sec. 52.1605 the table is amended by removing the first entry
for Title 7, Chapter 27: Subchapter 18 and revising the second entry to
read as follows:
Sec. 52.1605 EPA-approved New Jersey State regulations.
----------------------------------------------------------------------------------------------------------------
State regulation State effective date EPA approved date Comments
----------------------------------------------------------------------------------------------------------------
* * * * * *
Title 7, Chapter 27
* * * * * *
*
Subchapter 18, ``Control and Mar. 15, 1993......... July 25, 1996......... See July 25, 1996 for items
Prohibition of Air Pollution from not included in this
New or Altered Sources Affecting limited approval.
Ambient Air Quality (Emission
Offset Rules).''.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
[FR Doc. 96-18642 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-18641 Approval and Promulgation of Implementation Plans; Louisiana State Implementation Plan Revision; Major Source Definition Corrections for Reasonably Available Control Technology (RACT) Rules; Volatile Organic Compounds (VOC) RACT Catch-Ups
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38590-38591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18641]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[LA-8-1-6391; FRL-5525-8]
Approval and Promulgation of Implementation Plans; Louisiana
State Implementation Plan Revision; Major Source Definition Corrections
for Reasonably Available Control Technology (RACT) Rules; Volatile
Organic Compounds (VOC) RACT Catch-Ups
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The EPA is approving revisions to the Louisiana State
Implementation Plan (SIP) adopted by the Louisiana Department of
Environmental Quality on October 20, 1992, and March 26, 1993. This SIP
revision contains regulations which require the implementation of RACT
for various types of VOC sources. The intended effect of this action is
to approve these revisions to the VOC regulations. This action is being
taken under section 110 and subchapter I, Part D, of the Clean Air Act
as amended in 1990 (the Act).
EFFECTIVE DATE: This final rule is effective on August 26, 1996.
ADDRESSES: Copies of the documents relevant to this action are
available for inspection during normal hours at the following
locations:
Environmental Protection Agency, Region 6, Air Planning Section (6PD-
L), 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733.
Air and Radiation Docket and Information Center, Environmental
Protection Agency, 401 M Street, SW., Washington, DC 20460.
Louisiana Department of Environmental Quality, Office of Air Quality,
7290 Bluebonnet Boulevard, Baton Rouge, Louisiana 70810.
Anyone wishing to review this petition at the EPA office is asked
to contact the person below to schedule an appointment 24 hours in
advance.
FOR FURTHER INFORMATION CONTACT: Lt. Mick Cote, Air Planning Section
(6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Dallas, Texas 75202-2733, telephone (214) 665-7219.
SUPPLEMENTARY INFORMATION:
Background
On April 11, 1994, the EPA published a notice of proposed
rulemaking (NPR) for the State of Louisiana in the Federal Register
(FR). See 59 FR 17078. The NPR proposed approval of RACT revisions to
the SIP regulations concerning the control of VOC emissions. The SIP
revision was submitted by the State of Louisiana on November 10, 1992,
with a subsequent submittal on March 26, 1993.
Specific requirements of the revised VOC regulations and the
rationale for the EPA's proposed action are explained in the NPR and
will not be restated here. No public comments were received on the NPR.
The EPA's approval of these revisions was contingent on the State's
submission to the EPA of a negative declaration stating that no non-
Control Techniques Guidelines sources exist in the Baton Rouge
nonattainment area which have a potential to emit of 50 tons per year
or more of VOCs, and that none are expected. The State of Louisiana
verified that no such sources exist and submitted a letter of negative
declaration to the EPA on March 29, 1994.
Final Action
The EPA has evaluated the State's submittal for consistency with
the Act. The EPA has determined that the revised rules meet the Act's
requirements and today is approving the SIP revision under section
110(k)(3) of the Act.
Regulatory Process
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., the EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. See 5 U.S.C. 603 and 604.
Alternatively, under 5 U.S.C. 605(b), the EPA may certify that the rule
will not have a significant impact on a substantial number of small
entities. See 46 FR 18709. Small entities include small businesses,
small not-for-profit enterprises, and governmental entities with
jurisdiction over populations of less than 50,000.
The SIP approvals under section 110 and subchapter I, part D of the
Act do not create any new requirements, but simply approve requirements
that the State is already imposing. Therefore, because the Federal SIP-
approval does
[[Page 38591]]
not impose any new requirements, I certify that it does not have a
significant impact on small entities. Moreover, due to the nature of
the Federal-State relationship under the Act, preparation of a
regulatory flexibility analysis would constitute Federal inquiry into
the economic reasonableness of State action. The Act forbids the EPA
from basing its actions concerning SIPs on such grounds. Union Electric
Co. v. U.S. E.P.A., 427 U.S. 246, 256-66 (S.Ct. 1976); 42 U.S.C.
section 7410(a)(2). The Office of Management and Budget (OMB) has
exempted this action from review under Executive Order 12866.
Under section 307(b)(1) of the Act, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 23, 1996. Filing a petition for
reconsideration of this final rule by the Regional Administrator does
not affect the finality of this rule for purposes of judicial review;
nor does it extend the time within which a petition for judicial review
may be filed, or postpone the effectiveness of this rule. This action
may not be challenged later in proceedings to enforce its requirements.
See section 307(b)(2) of the Act.
Nothing in this action shall be construed as permitting, allowing,
or establishing a precedent for any future request for a revision to
any SIP. Each request for revision to the SIP shall be considered
separately in light of specific technical, economic, and environmental
factors and in relation to relevant statutory and regulatory
requirements.
Unfunded Mandates
Under sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995, signed into law on March 22, 1995, the EPA must undertake
various actions in association with proposed or final rules that
include a Federal mandate that may result in estimated costs of $100
million or more to the private sector, or to State, local, or tribal
governments in the aggregate.
Through submission of this SIP or plan revision approved in this
action, the State and any affected local or tribal governments have
elected to adopt the program provided for under section 175A of the
Act. The rules and commitments approved in this action may bind State,
local, and tribal governments to perform certain actions and also
require the private sector to perform certain duties. To the extent
that the rules and commitments being approved by this action will
impose or lead to the imposition of any mandate upon the State, local,
or tribal governments, either as the owner or operator of a source or
as a regulator, or would impose or lead to the imposition of any
mandate upon the private sector, the EPA's action will impose no new
requirements; such sources are already subject to these requirements
under State law. Accordingly, no additional costs to State, local, or
tribal governments, or to the private sector, result from this action.
Therefore, the EPA has determined that this final action does not
include a mandate that may result in estimated costs of $100 million or
more to State, local, or tribal governments in the aggregate or to the
private sector.
Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedures Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, the EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of the rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
SIP Actions Exempt from OMB Review
This action has been classified for signature by the Regional
Administrator under the procedures published in the Federal Register on
January 19, 1989 (54 FR 2214-2225), as revised by a July 10, 1995,
memorandum from Mary Nichols, Assistant Administrator for Air and
Radiation. The OMB has exempted this regulatory action from Executive
Order 12866 review.
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Hydrocarbons,
Incorporation by reference, Intergovernmental regulations, Reporting
and recordkeeping, Ozone, Volatile organic compounds.
Dated: June 12, 1996.
Allyn M. Davis,
Acting Regional Administrator.
40 CFR part 52 is amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart T--Louisiana
2. Section 52.970 is amended by adding paragraph (c)(64) to read as
follows:
Sec. 52.970 Identification of plan.
* * * * *
(c) * * *
(64) Revisions to the Louisiana SIP addressing VOC RACT catch-up
requirements were submitted by the Governor of Louisiana by letters
dated December 21, 1992, and April 13, 1993.
(i) Incorporation by reference.
(A) Revisions to LAC, Title 33, Environmental Quality, Part III.
Air; Chapter 21. Control of Emissions of Organic Compounds, Subchapter
A. General; section 2103. Storage of Volatile Organic Compounds,
paragraphs G., G.1., G.4.; section 2109. Oil/Water Separation,
paragraph B.4.; section 2215. Waste Gas Disposal, introductory
paragraph, paragraph H., H.5.; Subchapter B. Organic Solvents; section
2123. Organic Solvents, paragraph D.6.; Subchapter C. Vapor Degreasers;
section 2125. Vapor Degreasers, paragraph D.; Subchapter F. Gasoline
Handling; section 2131. Filling of Gasoline Storage Vessels, paragraphs
D., D.1., D.3., G.; section 2135. Bulk Gasoline Terminals, paragraph
A.; Subchapter H. Graphic Arts; section 2143. Graphic Arts (Printing)
by Rotogravure and Flexographic Processes, paragraph B, as adopted by
LDEQ on October 20, 1992.
(B) Revisions to LAC, Title 33, Environmental Quality, Part III.
Air; Chapter 21. Control of Emissions of Organic Compounds, Subchapter
A. General; section 2115. Waste Gas Disposal, introductory paragraph,
paragraphs H.1., H.1.a. through H.1.d., H.2., H.2.a., H.2.b., H.3., L.,
as adopted by LDEQ on March 20, 1993.
(ii) Additional material.
(A) Letters dated November 10, 1992 and December 21, 1992, signed
by Edwin Edwards, Governor of Louisiana.
(B) Letter dated April 14, 1993, signed by Edwin Edwards, Governor
of Louisiana.
(C) Letter of negative declaration dated March 29, 1994, signed by
Gustave Von Boduungen, P.E., Assistant Secretary, LDEQ.
* * * * *
[FR Doc. 96-18641 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-18477 Telephone Number Portability
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38605-38642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18477]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Parts 20 and 52
[CC Docket No. 95-116; FCC 96-286]
Telephone Number Portability
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On June 13, 1995, The Commission adopted a notice of proposed
rulemaking (CC Docket No. 95-116) regarding telephone number
portability . The First Report and Order released July 2, 1996,
promulgates rules and regulations implementing the statutory
requirement that local exchange carriers (LECs) provide number
portability as set forth in section 251 of the Telecommunications Act
of 1996 (1996 Act). The Report and Order mandates the implementation of
number portability by LECs, consistent with the procompetitive goals of
the Telecommunications Act of 1996. Concurrently with the adoption of
the Report and Order, the Commission adopted a Further Notice of
Proposed Rulemaking which is published elsewhere in this issue.
EFFECTIVE DATE: August 26, 1996.
FOR FURTHER INFORMATION CONTACT: Jason Karp, Attorney, Common Carrier
Bureau, Policy and Program Planning Division, (202) 418-1517, or Mindy
Littell, Attorney, Common Carrier Bureau, Policy and Program Planning
Division, (202) 418-1394. For additional information concerning the
information collections contained in this Report and Order contact
Dorothy Conway at 202-418-0217, or via the Internet at [email protected].
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's First
Report and Order adopted June 27, 1996, and released July 2, 1996. The
full text of this First Report and Order is available for inspection
and copying during normal business hours in the FCC Reference Center
(Room 239), 1919 M St., NW., Washington, DC. The complete text also may
be obtained through the World Wide Web, at http://www.fcc.gov/Bureaus/
Common Carrier/Orders/fcc96286.wp, or may be purchased from the
Commission's copy contractor, International Transcription Service,
Inc., (202) 857-3800, 2100 M St., NW., Suite 140, Washington, DC 20037.
Pursuant to Section 251, the Report and Order establishes performance
criteria for acceptable long-term number portability methods and
requires all LECs to begin deploying number portability in the 100
largest Metropolitan Statistical Areas (MSAs) no later than October 1,
1997, and to complete deployment in those MSAs by December 31, 1998, in
accordance with a phased schedule. Number portability must be provided
in these areas by all LECs to all telecommunications carriers,
including commercial mobile radio services (CMRS) providers. In
addition, pursuant to the Commission's independent authority under
sections 1, 2, 4(i) and 332 of the Communications Act of 1934, as
amended, the Report and Order requires all cellular, broadband personal
communications services (PCS) and covered Specialized Mobile Radio
(SMR) service providers to be able to deliver calls from their networks
to ported numbers anywhere in the country by December 31, 1998, and
requires cellular, broadband PCS and covered SMR customers to be able
to move their own numbers to other carriers by June 30, 1999. In the
Report and Order, the Commission delegates responsibility to the North
American Numbering Council (NANC) to oversee the initial administration
of the system of regional databases which will be used by carriers to
provide number portability. Pursuant to the 1996 Act, the Commission
also requires LECs to provide currently available number portability
measures upon specific request from another carrier until long-term
number portability is available. However, the Report and Order
concludes that CMRS providers need not provide such measures due to
technical considerations specific to the CMRS industry. In addition,
consistent with section 251(e)(2) of the Telecommunications Act of
1996, the Report and Order sets forth principles that ensure that the
costs of currently available measures are borne by all
telecommunications carriers on a competitively neutral basis, and
permits states to utilize various cost recovery mechanisms, so long as
they are
[[Page 38606]]
consistent with these statutory requirements.
Regulatory Flexibility Analysis:
As required by the Regulatory Flexibility Act, the Report and Order
contains a Final Regulatory Flexibility Analysis which is set forth in
Appendix C to the Report and Order. A brief description of the analysis
follows.
The rules adopted in this Report and Order are necessary to
implement the provisions of the Telecommunications Act of 1996
requiring LECs to offer number portability, if technically feasible.
Although there were no comments submitted in response to the
Initial Regulatory Flexibility Analysis set forth in the Notice of
Proposed Rulemaking, the general comments of Chief Counsel for Advocacy
of the United States Small Business Administration (SBA) generally
supported the actions of the Commission in the Report and Order.
However, in their general comments filed prior to the passage of the
1996 Act, some LECs suggested that the Commission should neither adopt,
nor direct the adoption of, number portability without performing a
thorough cost/benefit analysis--a course of action which may result in
less of an impact on small entities. However, after passage of the 1996
Act, most parties agreed that the 1996 Act clearly directs the
Commission to implement long-term number portability.
The statutory meaning of the term ``small business'' is one which
(1) is independently owned and operated; (2) is not dominant in its
field of operation; and (3) satisfies any additional criteria
established by the Small Business Administration (SBA). According to
SBA's regulations, entities engaged in the provision of telephone
service may have a maximum of 1,500 employees in order to qualify as a
small business concern. 13 CFR 121.201. This standard also applies in
determining whether an entity is a small business for purposes of the
Regulatory Flexibility Act.
The rules adopted by the Commission governing long-term number
portability apply to all LECs, including incumbent LECs as well as new
LEC entrants, and also apply to cellular, broadband PCS, and covered
SMR providers. According to the SBA definition, incumbent LECs do not
qualify as small businesses because they are dominant in their field of
operation. However, the rules may have a significant economic impact on
a substantial number of small businesses insofar as they apply to
telecommunications carriers other than incumbent LECs, such as new
entrant LECs, as well as cellular, broadband PCS, and covered SMR
providers. Based upon data contained in the most recent census and a
report by the Commission's Common Carrier Bureau, the Commission
estimated that 2,100 carriers could be affected. This estimate was
derived based on an analysis using census data on the number of firms
with fewer than 1,000 employees and subtracting the number of incumbent
LECs (as established by an FCC report). For a detailed analysis, see
Appendix C of the Report and Order.
There are several reporting requirements imposed by the Report and
Order which will likely require the services of persons with technical
expertise to prepare the reports. First, carriers participating in a
field test in the Chicago, Illinois, area are required to file with the
Commission a report of their findings within 30 days after completion
of the test. Second, after December 31, 1998, long-term number
portability must be provided by LECs outside of the 100 largest MSAs
within six months after a specific request by another
telecommunications carrier in which the requesting carrier is operating
or plans to operate. The specific request must contain certain
information. Third, state regulatory commissions must file with the
Commission a notification if they opt to develop a state-specific
database in lieu of participating in a regional database system.
Carriers that object to a state decision to opt out of the regional
database system may file with the Commission a petition for relief.
Fourth, the item requires any administrator selected by a state prior
to the release of the Report and Order, that wishes to bid for
administration of one of the regional databases, must submit a new
proposal in accordance with the guidelines established by the NANC.
Fifth, the Report and Order requires carriers that are unable to meet
the deadlines for implementing a long-term number portability solution
to file with the Commission at least 60 days in advance of the deadline
a petition to extend the time by which implementation in its network
will be completed. Finally, we require an industry body known as the
Industry Numbering Committee (INC) to file a report with the Commission
on the portability of non-geographic numbers assigned to LECs within 12
months after the effective date of the Report and Order.
The Commission's actions in this Report and Order will benefit
small entities by facilitating their entry into the local exchange
market. The record in this proceeding indicates that the lack of number
portability would deter entry by competitive providers of local service
because of the value customers place on retaining their telephone
numbers. These competitive providers, many of which may be small
entities, may find it easier to enter the market as a result of number
portability which will eliminate this barrier to entry.
In general, the Commission has attempted to keep burdens on local
exchange carriers to a minimum. For example, the phased deployment
schedule requires long-term number portability to be implemented
initially in the 100 largest MSAs, and then elsewhere upon a carrier's
request. The provision of currently available measures is conditioned
upon request only. In addition, the Commission has attempted to
minimize the impact of our rules upon cellular, broadband PCS, and
covered SMR providers, which may be small businesses, by not requiring
such carriers to offer currently available number portability measures.
Similarly, paging and messaging service providers, which may be small
entities, are required to provide neither currently available measures
nor long-term number portability under our rules. The regulatory
burdens imposed are necessary to ensure that the public receives the
benefit of the expeditious provision of service provider number
portability in accordance with the statutory requirements.
Paperwork Reduction Act
Public reporting burden for the collections of information is
estimated as follows:
----------------------------------------------------------------------------------------------------------------
Estimated
number of
respondents
Information collections Estimated avg. hours per response (all are one-
time only
responses)
----------------------------------------------------------------------------------------------------------------
Field test report........................... 20 hours per respondent (joint response).......... 11
[[Page 38607]]
Requests for long-term number portability in 3 hours........................................... 80
areas outside the 100 largest MSAs.
State notification of intention to ``opt 3 hours........................................... 5
out'' of regional database system.
Carrier petitions challenging state decision 10 hours.......................................... 2
to ``opt out'' of regional database system.
Proposal to administer database(s).......... 160 hours......................................... 1
Petitions to extend implementation deadline. 10 hours.......................................... 8
----------------------------------------------------------------------------------------------------------------
Total Annual Burden: 735 hours.
Frequency of Response: All collections of information require one-
time only responses.
These estimates include the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collections of information.
Send comments regarding these burden estimates or any other aspects of
the collections of information, including suggestions for reducing the
burden, to the Federal Communications Commission, Records Management
Branch, Room 234, Paperwork Reduction Project, Washington, DC 20554 and
to the Office of Management and Budget, Paperwork Reduction Project,
Washington, DC 20503.
Synopsis of First Report and Order
I. Introduction
1. We initiated this proceeding on July 13, 1995, when we adopted a
Notice of Proposed Rulemaking seeking comment on a wide variety of
policy and technical issues related to telephone number portability (60
FR 39136 (August 1, 1995)). Since our adoption of the NPRM, the
Telecommunications Act of 1996 became law. Section 251, added by the
1996 Act, requires all local exchange carriers (LECs), both incumbents
and new entrants, to offer number portability in accordance with
requirements prescribed by the Commission. On March 14, 1996, the
Common Carrier Bureau released a Public Notice seeking comment on how
the passage of the 1996 Act may have affected the issues raised in the
NPRM (61 FR 11174 (March 19, 1996)). Comments in response to the Public
Notice were received on March 29, 1996, and reply comments were filed
on April 5, 1996. In addition, efforts to implement number portability
at the state level have progressed since adoption of the NPRM.
2. The Telecommunications Act of 1996 establishes ``a pro-
competitive, de-regulatory national policy framework'' that is intended
to ``promote competition and reduce regulation * * * to secure lower
prices and higher quality services for American telecommunications
consumers and encourage the rapid deployment of new telecommunications
technologies.'' The statute imposes obligations and responsibilities on
telecommunications carriers, particularly incumbent local exchange
carriers, that are designed to open monopoly telecommunications markets
to competitive entry and to promote competition in markets that already
are open to new competitors. In particular, section 251(b) imposes
specific obligations on all local exchange carriers to open their
networks to competitors. The Act envisions that removing legal and
regulatory barriers to entry and reducing economic impediments to entry
will enable competitors to enter markets freely, encourage
technological development, and ensure that a firm's prowess in
satisfying consumer demand will determine its success or failure in the
marketplace. In implementing the statute, the Commission has the
responsibility to adopt the rules that will implement most quickly and
effectively the national telecommunications policy embodied in the 1996
Act. Number portability is one of the obligations that Congress imposed
on all local exchange carriers, both incumbents and new entrants, in
order to promote the pro-competitive, deregulatory markets it
envisioned. Congress has recognized that number portability will lower
barriers to entry and promote competition in the local exchange
marketplace. In its report, the Senate Committee on Commerce, Science,
and Transportation concluded that the ``minimum requirements [for
interconnection set forth in new section 251(b), including number
portability,] are necessary for opening the local exchange market to
competition.'' Likewise, the House of Representatives Committee on
Commerce determined that ``the ability to change service providers is
only meaningful if a customer can retain his or her local telephone
number.''
3. In this Order, we promulgate rules and regulations implementing
this congressional directive. Although we decline to choose a
particular technology for providing number portability, we establish in
this Report and Order performance criteria that any long-term number
portability method selected by a LEC must meet. Pursuant to the
statutory requirement in section 251 to provide number portability, we
require all LECs to begin to implement a long-term service provider
portability solution that meets our performance criteria in the 100
largest Metropolitan Statistical Areas (MSAs) no later than October 1,
1997, and to complete deployment in those MSAs by December 31, 1998, in
accordance with a phased schedule set forth below. Number portability
must be provided in these areas by all LECs to all telecommunications
carriers, including commercial mobile radio services (CMRS) providers.
4. The statute explicitly excludes CMRS providers from the
definition of local exchange carriers, and therefore from the section
251(b) obligations to provide number portability, unless the Commission
concludes that they should be included in the definition of local
exchange carrier. Our recent Notice of Proposed Rulemaking on
interconnection issues raised by the 1996 Act sought comment generally
on whether, and to what extent, CMRS providers should be classified as
LECs. Because we conclude that we have independent authority under
sections 1, 2, 4(i), and 332 of the Communications Act of 1934, as
amended, to require cellular providers, broadband personal
communications services (PCS), and covered Specialized Mobile Radio
(SMR) providers to provide long-term service provider portability, we
need not decide here whether CMRS providers must provide number
portability as local exchange carriers under section 251(b). We require
all cellular, broadband PCS, and covered SMR providers to have the
capability of delivering calls from their networks to
[[Page 38608]]
ported numbers anywhere in the country by December 31, 1998, and to
offer service provider portability, including the ability to support
roaming, throughout their networks by June 30, 1999.
5. We conclude that a system of regional databases that are managed
by an independent administrator will serve the public interest. We
direct the North American Numbering Council (NANC) to provide initial
oversight of this regional database system. We direct the NANC to
determine the number and location of the regional databases and to
select one or more administrators responsible for deploying the
database system. Any state that prefers to develop its own statewide
database rather than participate in a regionally-deployed database,
however, may opt out of its designated regional database and implement
a state-specific database. We will retain authority to override a
state's decision to develop a statewide database if an affected carrier
can demonstrate that the state's proposal would significantly delay
deployment of a long-term method or impose unreasonable costs on
affected carriers.
6. Until long-term service provider portability is available, we
require LECs to provide currently available number portability
measures, such as Remote Call Forwarding (RCF) and Direct Inward
Dialing (DID), upon specific request from another carrier. We conclude,
however, that commercial mobile radio service providers need not
provide such measures due to technical considerations specific to the
CMRS industry. We enunciate principles that ensure that the costs of
currently available measures are borne by all telecommunications
carriers on a competitively neutral basis, and we conclude that states
may utilize various cost recovery mechanisms, so long as they are
consistent with these statutory requirements. We decline at this time
to require the provision of either service or location portability. We
conclude that, while the statute requires LECs to implement 500 and 900
number portability, there is insufficient record evidence to determine
whether LEC provision of portability for 500 and 900 numbers is
technically feasible. As a result, we refer the issue to the Industry
Numbering Committee (INC), which must report its findings to the
Commission within 12 months of the effective date of this Order.
Finally, we adopt a Further Notice of Proposed Rulemaking regarding
cost recovery for long-term number portability.
II. Background
A. Telecommunications Act of 1996
7. New section 251(b)(2) of the Communications Act of 1934, as
added by the 1996 Act, directs each local exchange carrier ``to
provide, to the extent technically feasible, number portability in
accordance with requirements prescribed by the Commission.'' The 1996
Act defines the term ``local exchange carrier'' as:
any person that is engaged in the provision of telephone exchange
service or exchange access. Such term does not include a [commercial
mobile service provider,] as defined under section 332(c), except to
the extent that the Commission finds that such provider should be
included in the definition of such term.
The 1996 Act defines ``number portability'' as ``the ability of
users of telecommunications services to retain, at the same location,
existing telecommunications numbers without impairment of quality,
reliability, or convenience when switching from one telecommunications
carrier to another.''
8. The 1996 Act defines the term ``telecommunications carrier'' as
``any provider of telecommunications services, except that such term
does not include aggregators of telecommunications services (as defined
in section 226).'' The term ``telecommunications service'' is defined
by the 1996 Act as ``the offering of telecommunications for a fee
directly to the public, or to such classes of users as to be
effectively available directly to the public, regardless of the
facilities used.'' Because the 1996 Act's definition of number
portability requires LECs to provide number portability when customers
switch from any telecommunications carrier to any other, the statutory
obligation of LECs to provide number portability runs to other
telecommunications carriers. Because CMRS falls within the statutory
definition of telecommunications service, CMRS carriers are
telecommunications carriers under the 1996 Act. As a result, LECs are
obligated under the statute to provide number portability to customers
seeking to switch to CMRS carriers.
9. In addition to the duties imposed by section 251(b) on all LECs,
section 251(c)(1) imposes upon incumbent LECs, inter alia, the ``duty
to negotiate in good faith * * * the terms and conditions of agreements
to fulfill'' the section 251(b) obligations, including the duty to
provide number portability. An incumbent LEC is defined as a carrier
that was providing exchange access service in a particular area on
February 8, 1996, and was a member of the National Exchange Carrier
Association (NECA) pursuant to Sec. 69.601(b) of the Commission's
regulations. The 1996 Act creates an exemption from the obligations of
section 251(c) for rural telephone companies, and allows LECs with
fewer than two percent of the nation's subscriber lines to petition a
state commission for suspension or modification of the application of
sections 251(b) and (c).
10. Section 251(e)(1) reinforces the Commission's authority over
matters relating to the administration of numbering resources by giving
the Commission exclusive jurisdiction over those portions of the North
American Numbering Plan (NANP) that pertain to the United States. This
subsection also requires the Commission to ``create or designate one or
more impartial entities to administer telecommunications numbering and
to make such numbers available on an equitable basis.'' Moreover,
section 251(e)(2) provides that the cost of ``number portability shall
be borne by all telecommunications carriers on a competitively neutral
basis as determined by the Commission.''
11. Finally, new section 271(c)(2)(B) establishes a ``competitive
checklist'' of requirements that the Bell Operating Companies (BOCs)
must meet to provide in-region interLATA services. One of the
requirements that the BOCs must satisfy is the provision of ``interim
number portability through remote call forwarding, direct inward
dialing trunks, or other comparable arrangements, with as little
impairment of functioning, quality, reliability, and convenience as
possible'' until the Commission issues regulations pursuant to section
251 to implement the statute's number portability requirements. Section
271(c)(2)(B)(xi) directs the BOCs to comply fully with the regulations
implemented by the Commission.
B. Proposed Number Portability Methods
12. Because most telephone numbers within the NANP are associated
with a particular switch operated by a particular service provider,
they currently cannot be transferred outside the service area of a
particular switch or between switches operated by different service
providers without technical changes to the switch or network. Several
methods exist, or are being developed, to provide telephone number
portability. These methods generally consist of two types: database and
non-database methods.
[[Page 38609]]
1. Database Methods
13. Several industry participants have proposed methods for
providing service provider portability that use databases containing
the customer routing information necessary to route telephone calls to
the proper terminating locations. All these methods depend on
Intelligent Network (IN) or Advanced Intelligent Network (AIN)
capabilities. Before the release of our NPRM, AT&T proposed a Location
Routing Number (LRN) method to the Industry Numbering Committee (INC),
an industry body that provides an open forum to address and resolve
industry-wide issues associated with the non-policy-related planning,
administration, allocation, assignment, and use of numbering resources
within the NANP area. Since it proposed LRN to the INC, AT&T has
continued to develop and refine this method. Essentially, LRN assigns a
unique 10-digit telephone number to each switch in a defined geographic
area. The location routing number serves as a network address. Carriers
routing telephone calls to customers that have transferred their
telephone numbers from one carrier to another perform a database query
to obtain the location routing number that corresponds to the dialed
telephone number. The database query is performed for all calls to
switches from which at least one number has been ported. The carrier
then would route the call to the new carrier based on the location
routing number.
14. MCI, DSC Communications, Nortel, Tandem Computers, and Siemens
Stromberg-Carlson have developed a method referred to as the Carrier
Portability Code (CPC) method. This method operates in a similar manner
to LRN. Under CPC, however, the database associates the dialed
telephone number with a 3-digit carrier portability code identifying
the particular carrier to whom the dialed number has been transferred,
rather than a particular switch. As described below, many of the
parties in this proceeding and staff of some state commissions consider
the CPC method to be an interim database solution.
15. Stratus Computer and US Intelco have developed another database
method commonly referred to as Local Area Number Portability (LANP).
This method uses two ``domains'' of 10-digit numbers to route telephone
calls to customers that have transferred their numbers to new carriers
or new geographic locations. Specifically, LANP assigns a ten-digit
customer number address (CNA) to each end user; this is the number that
callers would dial to place telephone calls to the particular end user.
It also assigns each customer a 10-digit network node address (NNA)
that identifies where in the telephone network to reach the particular
end user. Both the CNA and the NNA are stored in routing databases so
that carriers can determine from the dialed telephone number where in
the network to reach the called party.
16. GTE has proposed both on the record in this proceeding and
before the INC what it refers to as the Non-Geographic Number (NGN)
method. While this method uses a database, it operates in a
fundamentally different manner from CPC, LRN, and LANP. The NGN method
would provide service provider and location portability to end users by
assigning them non-geographic telephone numbers, such as an INPA
(interchangeable numbering plan area) code that has been assigned for
non-geographic numbers. Telephone calls to such end users would be
routed in much the same way as toll free calls are today, by performing
a database query to determine the geographic telephone number
corresponding to the dialed non-geographic telephone number, and
routing the call to the appropriate geographic number.
17. Pacific Bell has proposed a triggering mechanism which operates
in conjunction with the same addressing scheme utilized in AT&T's LRN
method. This mechanism, called Query on Release (QOR) or Look Ahead,
determines under what circumstances a database query is performed.
Under QOR, the signalling used to set up a telephone call is routed to
the end office switch to which the dialed telephone number was
originally assigned (the release switch), i.e., according to the NPA-
NXX of the dialed number. If the dialed number has been transferred to
another carrier's switch, the previous switch in the call path queries
the database to obtain the routing information. The call is then
completed to the new carrier's switch.
18. Another number portability method triggering mechanism that is
similar to QOR is Release-to-Pivot (RTP). RTP differs from QOR in that
when a number has been ported from the release switch, the release
switch--rather than the previous switch in the call path--returns the
address information necessary for routing the call. The information
regarding where to route the telephone call, if the number has been
transferred, may be contained either in the release switch or an
external database.
2. Non-Database Methods
19. In our NPRM, we discussed two currently available methods of
providing service provider portability that do not use databases:
Remote Call Forwarding and Flexible Direct Inward Dialing. These
methods are commonly referred to as ``interim measures.'' While most
LECs currently are able to port numbers to other service providers
using these methods, they suffer from certain limitations that make
them unsuitable for long-term number portability. RCF redirects calls
to telephone numbers that have been transferred by essentially placing
a second telephone call to the new network location. DID routes the
second call over a dedicated facility to the new service provider's
switch, instead of translating the dialed number to a new number.
20. In the NPRM, we also discussed three derivative methods of RCF
and DID (enhanced remote call forwarding, route index/portability hub,
and hub routing with AIN), all of which require routing incoming calls
to the terminating switch identified by the NPA-NXX code of the dialed
phone number. Unlike RCF and DID, they use LEC tandem switches to
aggregate calls to a particular competing service provider before those
calls are routed to that provider. In addition, LECs in several states
reportedly are providing Directory Number Route Indexing (DNRI), which
first routes incoming calls to the switch to which the NPA-NXX code was
originally assigned, then routes ported calls to the new service
provider either through a direct trunk or by attaching a pseudo NPA to
the number and using a tandem, depending on availability.
C. Current State Efforts
1. State Task Forces and Implementation
21. Parties to this proceeding report that several states have
established task forces of industry participants or are otherwise
beginning to investigate the development and implementation of long-
term number portability methods. Those states include: Alabama,
Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois,
Indiana, Kansas, Maryland, Michigan, Minnesota, New York, Ohio, Oregon,
Texas, Utah, Virginia, Washington, Wisconsin, and Wyoming. Of these
states, the task forces in Colorado, Florida, Georgia, Illinois,
Maryland, and New York have all selected AT&T's Location Routing Number
method for implementing service provider number portability in areas
within their states'
[[Page 38610]]
boundaries. In addition, the state commissions of Colorado, Georgia,
Illinois, Maryland, New York, and Ohio have adopted the recommendation
of their staff and task forces to implement LRN. Parties to this
proceeding assert, moreover, that state task forces or commissions in
other states, such as Indiana, Michigan, and Wisconsin, as well as in
Canada, are utilizing the results of the Illinois task force's efforts
in the area of number portability.
22. Several states have set implementation schedules for the
portability methods they have selected. Switch vendors have committed
to make available LRN software to carriers in Illinois in the second
quarter of 1997. Colorado, Illinois, and Georgia plan to begin
deploying LRN in mid-1997. New York also expects LRN to be generally
available for installation in that state in mid-1997, though deployment
in certain AT&T switches is expected to begin earlier. Maryland plans
to begin implementing LRN by no later than the third quarter of 1997.
According to NARUC, Colorado similarly expects LRN availability in the
second quarter of 1997 (but plans to monitor switch vendor progress and
reevaluate this time frame in the third quarter of 1996). Ohio will use
a LRN number portability workshop, to be established within 120 days of
the issuance of its June 12, 1996 Order, to establish the time frame
and manner of the implementation of LRN in Ohio. Michigan has ordered
that implementation of long-term number portability in Michigan start
at the same time that implementation begins in Illinois. The Illinois
and Maryland task forces are examining various implementation issues,
including a deployment schedule, cost recovery, billing and rating, and
service management system (SMS) administration. The Illinois task force
selected an SMS provider in April 1996. The Maryland and Colorado task
forces have been planning to release their requests for proposals for
their SMS administrators in the second quarter of 1996.
2. State Trials
23. Two states have conducted or are conducting number portability
trials. As we described in the NPRM, ten companies, working with the
New York Department of Public Service (NY DPS), jointly initiated two
number portability trials, one in Rochester and another in Manhattan.
The companies originally planned to test the LANP method of Stratus
Computers and US Intelco in Rochester, but that trial was canceled. The
Manhattan trial, testing the CPC method, began in early February of
this year. The New York DPS, however, now considers CPC to be, at best,
an interim method and has changed the trial's emphasis from the
technical aspects of the method to the operational and administrative
aspects of the intercompany procedures that are required to change a
customer from one local exchange provider to another. MCI, one of the
original proponents of CPC, no longer views CPC as a viable long-term
method.
24. A group of telecommunications service providers conducted a
technical trial of the LANP method in Seattle, Washington, during 1995.
That trial ended in December 1995. The objective of the technical trial
was to identify the technical, operational, and administrative issues
that arise when a telephone number is not associated with a specific
geographic location. Because the trial revealed certain technical and
operational difficulties with the LANP technology, the Washington task
force on number portability declined to adopt LANP. The Washington
Utilities and Transportation Commission has not adopted LANP, and the
companies involved in the trial have ceased advocating LANP.
3. State Interim Measures
25. Carriers are providing interim portability measures in a number
of states, either voluntarily or pursuant to state commission orders.
According to NARUC and other parties to the proceeding, LECs are
providing RCF, DID, and/or other comparable arrangements in Arizona,
California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana,
Iowa, Louisiana, Maryland, Massachusetts, Michigan, New York, Ohio,
Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington,
Wisconsin, and Wyoming. According to USTA, Alabama and Minnesota are
considering interim portability requirements, while North Carolina
requires carriers to negotiate interim portability as part of their
interconnection agreements.
III. Report and Order
A. Importance of Service Provider Number Portability
1. Background
26. In the NPRM, we tentatively concluded that number portability
benefits consumers of telecommunications services and would contribute
to the development of competition among alternative providers of local
telephone and other telecommunications services. With respect to
service provider portability, we sought comment on the effects that
local number portability, or lack thereof, would have on the local
exchange marketplace. Specifically, we sought comment on the value
consumers place on their telephone numbers, the deterrent effect that a
lack of number portability would have on consumer decisions to change
service providers, and any resultant effect on competition between
incumbent local service providers and new competitors in local markets.
2. Discussion
27. Since we adopted the NPRM, Congress passed the 1996 Act, which
requires all LECs to ``provide, to the extent technically feasible,
number portability in accordance with requirements prescribed by the
Commission.'' The 1996 Act defines number portability as ``the ability
of users of telecommunications services to retain, at the same
location, existing telecommunications numbers without impairment of
quality, reliability, or convenience when switching from one
telecommunications carrier to another.'' Accordingly, we hereby modify
our proposed definition of number portability to conform to the
statutory definition of number portability and note that the statutory
definition of this term is synonymous with the NPRM's definition of
``service provider portability.''
28. Although some incumbent LECs assert that local exchange market
competition will develop without number portability, the record
developed in this proceeding confirms the congressional findings that
number portability is essential to meaningful competition in the
provision of local exchange services. Several state commissions have
also recognized the significant role that number portability will play
in the development of local exchange competition. We, therefore, affirm
our tentative conclusion that number portability provides consumers
flexibility in the way they use their telecommunications services and
[[Page 38611]]
promotes the development of competition among alternative providers of
telephone and other telecommunications services.
29. We note that several studies described in the record
demonstrate the reluctance of both business and residential customers
to switch carriers if they must change numbers. For example, MCI has
stated that, based on a nationwide Gallup survey, 83 percent of
business customers and 80 percent of residential customers would be
unlikely to change local service providers if they had to change their
telephone numbers. Time Warner Holdings states that consumers are 40
percent less likely to change service providers if a number change is
required. Citizens Utilities notes that approximately 85 percent of the
discussions that its subsidiary, ELI, has with potential customers
about switching providers end when those potential customers learn that
they must change their telephone numbers. The study commissioned by
Pacific Bell concludes that, without portability, new entrants would be
forced to discount their local exchange service and other competing
offerings by at least 12 percent below the incumbent LECs' prices in
order to induce customers to switch carriers due to customers'
resistance to changing numbers.
30. The ability of end users to retain their telephone numbers when
changing service providers gives customers flexibility in the quality,
price, and variety of telecommunications services they can choose to
purchase. Number portability promotes competition between
telecommunications service providers by, among other things, allowing
customers to respond to price and service changes without changing
their telephone numbers. The resulting competition will benefit all
users of telecommunications services. Indeed, competition should foster
lower local telephone prices and, consequently, stimulate demand for
telecommunications services and increase economic growth.
31. Conversely, the record demonstrates that a lack of number
portability likely would deter entry by competitive providers of local
service because of the value customers place on retaining their
telephone numbers. Business customers, in particular, may be reluctant
to incur the administrative, marketing, and goodwill costs associated
with changing telephone numbers. As indicated above, several studies
show that customers are reluctant to switch carriers if they are
required to change telephone numbers. To the extent that customers are
reluctant to change service providers due to the absence of number
portability, demand for services provided by new entrants will be
depressed. This could well discourage entry by new service providers
and thereby frustrate the pro-competitive goals of the 1996 Act.
B. The Commission's Role
1. Background
32. In the NPRM, we tentatively concluded that the Commission has a
significant interest in promoting the nationwide availability of number
portability due to its impact on interstate telecommunications. We
based this interest on four grounds: (1) Our obligation to promote an
efficient and fair telecommunications system; (2) the inability to
separate the impact of number portability between intrastate and
interstate telecommunications; (3) the likely adverse impact deploying
different number portability solutions across the country would have on
the provision of interstate telecommunications services; and (4) the
impact that number portability could have on the use of the numbering
resource, that is, ensuring that the use of numbers is efficient and
does not contribute to area code exhaust.
33. In the 1996 Act, Congress expressly assigned to the Commission
exclusive jurisdiction over that portion of the NANP that pertains to
the United States. Moreover, Congress directed the Commission to
prescribe regulations for LEC provision of number portability: Section
251(b)(2) requires carriers ``to provide, to the extent technically
feasible, number portability in accordance with the requirements
prescribed by the Commission.''
2. Positions of the Parties
34. Prior to passage of the 1996 Act, some LECs asserted that the
Commission should neither adopt, nor direct the adoption of, number
portability without performing a thorough cost/benefit analysis. Most
parties, however, now agree that the 1996 Act clearly directs this
Commission to implement long-term number portability. Moreover, some
parties contend that this mandate reflects the fact that Congress has
weighed the costs and benefits of implementing number portability. USTA
adds, however, that the Commission may consider economic efficiencies
in determining what rules to implement.
34. Several commenters, while agreeing that the Commission should
take a leadership role, urge us to leave certain implementation issues
to the states. USTA advocates allowing the states to determine their
own deployment schedules. The California PUC asserts that the
Commission's jurisdiction over number portability is not exclusive, and
that states must be allowed to implement number portability methods
that are most compatible with local exchange competition in each state.
3. Discussion
36. We believe that Congress has determined that this Commission
should develop a national number portability policy and has
specifically directed us to prescribe the requirements that all local
exchange carriers, both incumbents and others, must meet to satisfy
their statutory obligations. Section 251(b)(2) requires LECs ``to
provide, to the extent technically feasible, number portability in
accordance with the requirements prescribed by the Commission.''
Moreover, section 251(e)(1)'s assignment to the Commission of exclusive
jurisdiction over that portion of the NANP that pertains to the United
States gives us authority over the implementation of number portability
to the extent that such implementation will affect the NANP. Consistent
with the role assigned to the Commission by the 1996 Act, the record
developed in this proceeding overwhelmingly indicates that the
Commission should take a leadership role with respect to number
portability. We, therefore, affirm our conclusion that we should take a
leadership role in developing a national number portability policy. We
further note that, in light of Congress's mandate to us to prescribe
requirements for number portability, it is not necessary to engage in a
cost/benefit analysis as to whether to adopt rules that require LECs to
provide number portability in the first instance. We may consider
economic and other factors, however, when determining the specific
requirements in such rules.
37. The 1996 Act directs this Commission to adopt regulations to
implement number portability, and we believe it is important that we
adopt uniform national rules regarding number portability
implementation and deployment to ensure efficient and consistent use of
number portability methods and numbering resources on a nationwide
basis. Implementation of number portability, and its effect on
numbering resources, will have an impact on interstate, as well as
local, telecommunications services. Ensuring the interoperability of
networks is essential for deployment of a national number portability
regime, and for the
[[Page 38612]]
prevention of adverse impacts on the provision of interstate
telecommunications services or on the use of the numbering resource. We
believe that allowing number portability to develop on a state-by-state
basis could potentially thwart the intentions of Congress in mandating
a national number portability policy, and could retard the development
of competition in the provision of telecommunications services.
C. Performance Criteria for Long-Term Number Portability
1. Background
38. In the NPRM, we sought comment on what long-term number
portability methods would be in the public interest. Specifically, we
sought comment on various number portability proposals offered by
different industry participants, including proposals by AT&T, MCI
Metro, Stratus Computer and US Intelco, and GTE. We also sought comment
on the extent to which these proposals would support certain services
that we deemed important. We tentatively concluded that any method
should support operator services and emergency services because they
are critical to public safety and are important features of the public
switched network. We also tentatively concluded that any number
portability proposal should efficiently use telephone numbers. In
addition, we discussed and sought comment on which of three call
processing scenarios (i.e., which carrier performs the database query
in a database method), or any alternative, would best serve the public
interest. We sought comment on whether telephone numbers should be
portable within local calling areas, throughout a particular area code,
state-wide, regionally, nationwide, or on some other basis, and how the
geographic scope of portability would impact different types of
carriers and their billing systems. We also asked whether number
portability could be provided nationwide without significant network
modifications.
2. Positions of the Parties
39. Performance criteria versus selection of architecture.
Commenting parties differ on whether the Commission should establish
performance criteria or guidelines that any number portability method
must meet, or require the implementation of one national portability
method. Many parties, including several state regulatory agencies,
cable interests, and LECs, favor establishment of broad guidelines and
interoperability criteria for implementing a long-term portability
method. NYNEX maintains that this approach would encourage cooperative
industry resolutions for a true number portability method and would
properly account for legitimate state interests in the deployment of
number portability. NYNEX further claims that guidelines would allow
the Commission to ensure the implementation of compatible methods, with
seamless call flows and service operation, without expending scarce
resources by focusing on the detailed implementation of every method in
each region of the country. The California Department of Consumer
Affairs contends that the 1996 Act's pro-competitive policies mandate
that the portability method adopted be flexible and allow for future
innovation. GTE urges the Commission to determine the type of routing
information to be employed, but leave selection of the triggering
mechanism to the individual carriers. SBC Communications asserts that
section 251(d)(1) only requires the Commission to outline principles
for a long-term method within six months of enactment of the 1996 Act,
not to adopt a specific method.
40. Conversely, some parties contend that requiring a single,
national method would avoid the implementation of numerous inconsistent
and inefficient approaches, and the need for carriers to adapt to
different requirements in different states. Jones Intercable argues
that allowing number portability to develop state-by-state would give
the incumbent LECs the opportunity to delay development of local
exchange competition. BellSouth and Nortel argue that a single long-
term method is necessary to minimize the costs of implementation,
operation, and maintenance; to protect billing systems against problems
created by use of differing SS7 parameters; and to foster network
integrity. PCIA claims that a state-regulated market would inhibit
development of a nationwide wireless network. Arch/AirTouch Paging adds
that deployment of different portability methods would adversely impact
interstate telecommunications. Bell Atlantic and PCIA argue that a
national method is more likely to conserve scarce numbering resources.
Bell Atlantic further claims, however, that each individual carrier
should be allowed the flexibility to utilize whatever architecture or
technology within its own network best enables that carrier to
implement whatever national method is selected. Moreover, some parties
urge the Commission to select a particular method to be implemented
nationwide, while others advocate allowing the industry to select the
specific method.
41. Commenting parties suggest numerous performance criteria with
which any long-term number portability method must comply. These
include: (1) The ability to support emergency services, i.e., 911 and
enhanced 911 (E911) services; (2) the ability to support existing
network services and capabilities, (e.g., operator and directory
services, vertical and advanced services, custom local area signaling
services (also known as ``CLASS''), toll free and pay-per-call
services, and intercept capabilities); (3) efficient use of numbering
resources; (4) no initial change of telephone numbers; (5) no reliance
on network facilities of, or services provided by, other service
providers (e.g., incumbent LECs) in order to route calls; (6) no
degradation in service quality or network reliability (e.g., no
significant increase in call set-up time); (7) reliance on existing
network infrastructure and functionalities to the extent possible; (8)
equal application to both incumbents and new entrants (i.e., carriers
who receive ported numbers must also provide portability); (9) no
proprietary interests or licensing fees; (10) the ability to migrate to
location and service portability; and (11) no adverse impact in areas
where portability has not been deployed.
42. Call processing scenarios. In the NPRM, we discussed three call
processing scenarios. They were: (1) The terminating ``access''
provider (TAP) scenario, under which the database query is performed by
the terminating access provider (usually the incumbent LEC, who
recovers interstate access charges from interexchange carriers (IXCs)
for terminating traffic under our existing access charge regime); (2)
the originating service provider (OSP) scenario, under which the
originating service provider performs the database query; and (3) the
``N minus 1'' (N-1) scenario, under which the carrier immediately prior
to the terminating service provider performs the database query or dip.
In addition, ITN suggests a ``first-switch-that-can'' approach, under
which the first switch that handles the call and has the capability to
do the database dip performs the query.
43. Pacific Bell and Bell Atlantic recommend that carriers should
be permitted to choose a call processing scenario to enable them to
implement the QOR triggering mechanism in addition to LRN. These
parties assert that QOR would eliminate unnecessary database queries,
thereby decreasing the number of databases necessary to
[[Page 38613]]
provide number portability and the transmission capacity between
switches and databases. In contrast, AT&T argues against allowing
carriers to choose a call processing scenario, such as QOR, because
doing so would delay deployment of a long-term number portability
method and would result in significant network interoperability issues.
MCI opposes implementation of QOR because it forces competitive LECs to
rely on the incumbent LEC's network and results in inefficient routing.
AT&T and MCI also argue against use of the RTP or QOR triggering
mechanisms because they treat transferred and non-transferred numbers
differently, and significantly increase post-dial delay and the
potential for call blocking.
44. Most of the parties that favor the Commission's selection of a
particular call processing scenario prefer the N-1 scenario because
they believe it allows database queries to be made at the most
efficient points in the process of routing telephone calls. In
contrast, ITN states that use of the N-1 scenario may hinder the
evolution from localized to national number portability environments.
BellSouth contends that the Commission need not select a particular
scenario because all four triggering mechanisms (OSP, TAP, N-1, and
Look-Ahead) could exist simultaneously through engineering and business
arrangements. Citizens Utilities and NCTA oppose the TAP scenario
because it requires routing most calls to the incumbent LEC networks,
thus denying terminating access charges to competitive providers.
45. Rating and billing. Several LECs, MCI, and MFS contend that any
long-term method should preserve existing rating and billing systems to
minimize costs and impact. Conversely, AT&T and Florida PSC argue that
any long-term method should permit flexible rating and billing schemes.
Pacific Bell, US West, and BellSouth also argue that the Commission
must in this proceeding address billing problems, including issues
relating to proper mileage, rating, calling cards, and billing format.
3. Discussion
46. Performance criteria versus selection of architecture. We
conclude that establishing performance criteria that a LEC's number
portability architecture must meet would better serve the public
interest than choosing a particular technology or specific
architecture. First, we believe that to date there appears to be
sufficient momentum to deploy compatible methods, if not an identical
method, nationwide. Every state that has selected a particular
architecture for implementation within its state boundaries has
selected the same method, LRN, and numerous states are reportedly
following suit. With the exception of some of the incumbent LECs, most
parties that advocate selection of a particular method at this time are
also supporting the LRN method. Under these circumstances, mandating
the implementation of a particular number portability architecture, or
mandating that the same architecture be deployed nationwide, appears
unnecessary. Second, such a mandate might actually delay the
implementation of number portability. We are reluctant, based on the
record in this proceeding, to select one of the proposed long-term
methods. According to a number of parties, none of the currently
supported methods, including LRN, has been tested or described in
sufficient detail to permit the Commission to select the particular
architecture without further consultation with the industry. If,
however, we were to direct an industry body to recommend a specific
number portability architecture, it would likely delay the
implementation of number portability that already is underway in
several states, and would create significant uncertainty for those
switch vendors currently modifying switch software to accommodate LRN.
Third, dictating implementation of a particular method could foreclose
the ability of carriers to improve on those methods already being
deployed or to implement hybrid (but compatible) methods.
47. We believe that our establishment of criteria for long-term
number portability methods, however, will ensure an appropriate level
of national uniformity, while maintaining flexibility to accommodate
innovation and improvement. The deployment of a uniform number
portability architecture nationwide will be important to the efficient
functioning of the public switched telephone network and will reduce
the costs of implementing number portability nationwide by allowing
switch vendors to spread the costs of development over more customers.
Moreover, a uniform deployment will allow switch manufacturers to work
toward a single standard, thus avoiding the situation where different
manufacturers partition the market among different methods.
48. Performance Criteria. We thus adopt the following minimum
criteria. Any long-term number portability method, including call
processing scenarios or triggering, must:
(1) Support existing network services, features, and capabilities;
(2) Efficiently use numbering resources;
(3) Not require end users to change their telecommunications
numbers;
(4) Not require telecommunications carriers to rely on databases,
other network facilities, or services provided by other
telecommunications carriers in order to route calls to the proper
termination point;
(5) Not result in unreasonable degradation in service quality or
network reliability when implemented;
(6) Not result in any degradation of service quality or network
reliability when customers switch carriers;
(7) Not result in a carrier having a proprietary interest;
(8) Be able to accommodate location and service portability in the
future; and
(9) Have no significant adverse impact outside the areas where
number portability is deployed.
We discuss each of these performance criteria in turn below.
49. First, we require that any long-term method support existing
network services, features, or capabilities, such as emergency
services, CLASS features, operator and directory assistance services,
and intercept capabilities. The 1996 Act requires that consumers be
able to retain their numbers ``without impairment of quality,
reliability, or convenience when switching from one telecommunications
carrier to another.'' Moreover, customers are not likely to switch
carriers and retain their telephone numbers if they are required to
forego services and features to which they have become accustomed.
Thus, any long-term method that precludes the provision of existing
services and features would place competing service providers at a
competitive disadvantage.
50. The public interest also requires that service provider
portability not impair the provision of network capabilities that are
important to public safety, such as emergency services and intercept
capabilities. In our proposal to ensure that PBXs and CMRS providers
support enhanced 911 services, we reaffirmed that 911 services enable
telephone users to receive fast response to emergency situations, and
that broad availability of 911 and E911 services best promotes ``safety
of life and property through the use of wire and radio communication.''
In addition, the Communications Assistance for Law Enforcement Act
requires telecommunications carriers generally to provide capabilities
that enable secure, reliable, and non-intrusive law enforcement
interception of call setup information and call content so that law
enforcement agencies can intercept and monitor calls when necessary.
[[Page 38614]]
51. Second, we require that any long-term method efficiently use
numbering resources. Telephone numbers are the means by which
commercial and residential consumers gain access to, and reap the
benefits of, the public switched telephone network. In recent years,
the explosive growth of wireless services has caused an equally
dramatic increase in the consumption of telephone numbers. Indeed, in
January 1995, carriers began to deploy interchangeable NPA (INPA) codes
because all NPA codes had been exhausted. The anticipated shortage of
numbers has prompted several BOCs to propose the use of area code
overlays. The increased use of overlays and area code splits has
resulted in both industry and consumer inconvenience and confusion. The
consumption rate of NANP resources is likely to accelerate with the
entry of new wireline and wireless carriers. Thus, we conclude that
deploying a long-term number portability method that rapidly depletes
numbering resources would undermine the efforts of the industry, the
states, and the Commission to ensure sufficient numbering resources.
52. Third, deployment of a long-term method should not require
customers to make any telecommunications number change. The 1996 Act
mandates that end users be able ``to retain * * * existing
telecommunications numbers * * * when switching from one
telecommunications carrier to another.'' Requiring any number change
would contravene this basic requirement. Congress noted that the
ability to switch service providers is only meaningful if customers can
retain their telephone numbers.
53. Fourth, we require that any long-term method ensure that
carriers have the ability to route telephone calls and provide services
to their customers independently from the networks of other carriers.
Requiring carriers to rely on the networks of their competitors in
order to route calls can have several undesirable effects. For example,
dependence on the original service provider's network to provide
services to a customer that has switched carriers contravenes the
choice made by that customer to change service providers. In addition,
such dependence creates the potential for call blocking by the original
service provider and may make available to the original service
provider proprietary customer information. Moreover, methods which
first route the call through the original service provider's network in
order to determine whether the call is to a ported number, and then
perform a query only if the call is to be ported, would treat ported
numbers differently than non-ported numbers, resulting in ported calls
taking longer to complete than unported calls. This differential in
efficiency would disadvantage the carrier to whom the call was ported
and impair that carrier's ability to compete effectively against the
original service provider. Finally, dependence on another carrier's
network also reduces the new service provider's ability to control the
routing of telephone calls to its customers, thus inhibiting its
ability to control the costs of such routing. For these reasons, a
long-term number portability method should not require dependency on
another carrier's network. We note that this criterion does not prevent
individual carriers from determining among themselves how to process
calls, including a method by which a carrier voluntarily agrees to use
the original service provider's network.
54. We recognize that this criterion will effectively preclude
carriers from implementing QOR. Those carriers that oppose QOR argue
that it would treat ported and non-ported numbers differently, force
reliance on the incumbent LEC's network, increase post-dial delay and
the potential for call blocking, result in inefficient routing, create
significant network interoperability issues, and delay deployment of a
long-term number portability method. There is little evidence in the
record to support the claim that allowing carriers to implement QOR
would result in significant cost savings. Pacific Bell submitted
summary figures indicating that it would save approximately $14.2
million per year assuming that 20 percent of subscribers port their
numbers if it implemented QOR. These savings, which represent less than
0.2 percent of Pacific Bell's total annual operating revenues, appear
insignificant in relation to the potential economic and non-economic
costs to competitors if QOR is used. According to AT&T, using QOR on
Lucent switches is more cost effective only if less than 12 percent of
subscribers have ported their numbers. Similarly, AT&T asserts that
using QOR on Siemens switches is more cost effective only if less than
23 percent of subscribers have ported their numbers. In addition,
because carriers using QOR may be required to send a QOR message to
another carrier's switch to determine if a customer has transferred the
number, the second carrier must have the ability to recognize and
respond to the QOR message, which also may increase its costs. Based on
the record before us, we conclude that the competitive benefits of
ensuring that calls are not routed through the original carrier's
network outweigh any cost savings that QOR may bring in the immediate
future.
55. Fifth, as a general matter, we require that the implementation
of any long-term method not unreasonably degrade existing service
quality or network reliability. Consumers, both business and
residential, rely on the public switched telephone network for their
livelihood, health and safety. Jeopardizing the reliability of the
network would stifle business growth and economic development, and
endanger individuals' personal safety and convenience. Consumers, both
business and residential, have also come to expect a certain level of
quality and convenience in using basic telecommunications services. We
note that this Commission has repeatedly affirmed its commitment to
maintaining service quality and network reliability. We, therefore,
require that any long-term method of providing number portability not
cause any unreasonable degradation to the network or the quality of
existing services. This requirement extends to degradation that affects
carriers operating, and end users obtaining services, outside as well
as within the area of portability.
56. Sixth, once long-term number portability is implemented, we
require that customers not experience any degradation of service
quality or network reliability when they port their numbers to other
carriers. We reiterate that the 1996 Act requires that consumers be
able to retain their numbers ``without impairment of quality,
reliability, or convenience when switching from one telecommunications
carrier to another.'' We interpret this mandate to mean, at a minimum,
that when a customer switches carriers, that customer must not
experience a greater dialing delay or call set up time, poorer
transmission quality, or a loss of services (such as CLASS features)
due to number portability compared to when the customer was with the
original carrier.
57. Seventh, we require that no carrier have a proprietary interest
in any long term method. A telecommunications carrier may not own
rights to, or have a proprietary interest in, number portability
technology. We believe that the requirement in the 1996 Act that the
costs of number portability be borne on a competitively neutral basis
precludes carrier ownership of the long-term method, and their
collection of licensing or other fees for use of the method. In
addition, it would be competitively unfair if a LEC providing
portability
[[Page 38615]]
were to benefit directly, through licensing fees or a proprietary
interest, from its competitors' use of portability. We note that one of
the first criteria required by the Illinois task force in selecting a
number portability method was that it be non-proprietary.
58. Eighth, we require that any long-term method be able to
accommodate service and location portability in the future. Although we
do not at this time mandate provision of service or location
portability, we recognize that service and location portability have
certain benefits, and we may take steps to implement them in the future
if demand for these services develops. As our society becomes
increasingly mobile, the importance that consumers attribute to the
geographic identity of their telephone numbers may change. It is,
therefore, in the public interest to take steps now to ensure that we
do not foreclose realization of future economies of scope.
59. Finally, we require that any long-term method not have a
significant adverse impact on carriers operating, and end users
obtaining services, outside the area of number portability. We believe
it is fundamentally unfair to impose any new or different obligations
on carriers and customers that do not benefit from service provider
portability. Indeed, we are adopting a phased approach to
implementation so that number portability is available only in the most
populous local markets where competition already has begun to develop
or is likely to develop in the near term.
60. We do not believe it is necessary to require that a long-term
method utilize existing network infrastructure and functionalities to
the extent possible, as some commenting parties have suggested.
Minimizing the costs of implementing a long-term method should be in
the best interests of all the parties involved in such implementation.
This conclusion is also consistent with our tentative conclusion that
the carrier-specific costs that are not directly related to number
portability must be borne by the individual carriers. Thus, existing
local service providers have an incentive to minimize the extent of the
necessary modifications and upgrades, as well as the costs of
implementing number portability-specific software. Moreover, while new
entrants may not need to modify existing networks, they must deploy and
build networks with at least the same capabilities as those of the
incumbents if they are to provide number portability.
61. We also decline to require carriers that receive ported numbers
also to provide portability because we believe the 1996 Act renders
such a requirement unnecessary. Specifically, section 251(b)(2) imposes
a duty to provide number portability on all LECs--incumbents as well as
new entrants. In light of the fact that the 1996 Act applies this duty
across all LECs, establishing a reciprocity performance criterion would
be needlessly redundant.
62. Call processing scenarios. We decline to specify the carrier
that must perform the database query in a database method, because we
recognize that individual carriers may wish to determine among
themselves how to process calls under alternative scenarios. We
therefore leave to local exchange carriers the flexibility to choose
and negotiate the scenario that best suits their networks and business
plans, as long as they act consistently with the requirements
established by this Order. While our criterion requiring carriers to be
able to route calls and provide service independently from other
carriers' networks may preclude unilateral use of the TAP scenario by a
particular carrier, there may be instances where carriers agree to use
the TAP scenario, or where the terminating provider is the only carrier
capable of performing the database query. In those instances, our
performance criterion would not preclude use of the TAP scenario.
63. Rating and billing. Finally, we decline to regulate the rating
and billing of local wireline calls to end users in connection with a
long-term number portability method. Traditionally, the billing and
rating of local wireline calls--including the establishment of mileage
standards, procedures for calling cards, and billing format--have been
left to the purview of the states and the carriers themselves. While
s
FR Doc. 96-18477 Telephone Number Portability
everal parties have raised rating and billing questions with regard to
number portability, we believe that such issues are more properly
addressed by the states.
D. Mandate of Number Portability
1. Background
64. In the NPRM, we sought comment on the estimated time to design,
build, and deploy a long-term service provider number portability
system. We also requested that parties address what network and other
modifications would be necessary to effect the transition to
portability. The 1996 Act mandates that all LECs ``provide, to the
extent technically feasible, number portability in accordance with
requirements prescribed by the Commission.''
2. Position of the Parties
65. Mandate Implementation By A Date Certain. The competitive local
exchange providers generally contend that the Commission should mandate
the availability of number portability by a date certain. The incumbent
LECs, however, caution the Commission not to act with undue haste by
mandating the implementation of number portability by a date certain.
Indeed, BellSouth claims that the 1996 Act's omission of a deadline for
implementation indicates Congress's intent not to require a date
certain at this time. It adds that the industry must first give careful
attention to developing an implementation checklist that will ensure
that the necessary tasks for the implementation are properly identified
and performed. Instead of establishing a mandatory implementation date,
some LECs contend that the Commission should direct an industry body,
such as the INC, to determine the most appropriate schedule for
deployment of a long-term solution. Other commenters argue that the
implementation schedule should be determined by state regulatory
bodies. Pacific Bell warns that a Commission-mandated solution at this
time would be premature and cites a late proposal introduced by ITN as
an illustration that the optimal solution may not yet have been
introduced.
66. The wireless industry offers various implementation plans. For
instance, PageNet urges the Commission to establish federal guidelines
for number portability, and at a specified time in the future, to
evaluate the industry's standards using the guidelines through a notice
and comment proceeding. However, Omnipoint believes the Commission
should act more aggressively in mandating service provider portability
by a date certain.
67. Time Estimates for Deployment. Parties differ on their
estimates for deployment. AT&T asserts that virtually all of the
equipment vendors participating in the Illinois number portability task
force indicate that they can provide most upgrades necessary to
implement LRN by the second quarter of 1997. As noted above, Illinois,
Georgia, and Colorado plan to deploy LRN in mid-1997. New York also
expects to deploy LRN in mid-1997, though deployment in certain AT&T
switches is expected to begin earlier. Michigan has ordered that
implementation of long-term number portability in Michigan start at the
same time that implementation begins in Illinois. BellSouth, however,
estimates that three to five years are required to deploy a
[[Page 38616]]
number portability system that addresses all the necessary issues.
68. Parties also differ on the interpretation of ``technically
feasible'' as that term is used in section 251(b)(2) of the 1996 Act.
GTE argues that the term should not be equated with ``technically
possible'' because cost and timing considerations cannot be separated
from the concept of technical feasibility. GTE also maintains that no
long-term solution proposed is currently technically feasible, since
they all require further information on costs, operation, and
reliability. Bell Atlantic contends that deploying a system that is
technically feasible, but inefficient, may not be consistent with
Congress's goal of a ``rapid, efficient'' telecommunications system.
Bell Atlantic and BellSouth also claim that LRN is merely a call
handling protocol, as opposed to a technical solution for number
portability.
69. In contrast, Time Warner Holdings and Cox argue that
``feasible'' must be given common dictionary meaning--``capable of
being done, executed or effected''--and does not mean ``commercially
available.'' Time Warner Holdings points out that equal access and 800
number portability proved to be technically feasible even when they
were not commercially available. Time Warner Holdings claims, moreover,
that LECs control commercial availability because vendors will not
develop and manufacture portability methods until LECs demand them.
Similarly, Sprint argues that technically feasible does not mean that
every operational and regulatory issue must be resolved before any
decision on national number portability can be made. Sprint further
claims that Congress's use of the phrase ``technically feasible''
precludes any consideration of economic feasibility. AT&T and MCI argue
that LRN is technically feasible, although they do not explicitly
address the precise meaning of the statutory language.
70. Phased Implementation. Most parties addressing the
implementation of number portability caution against a flash-cut
approach (i.e., deployment nationwide simultaneously). USTA argues that
because section 251(b)(2) only requires provision of number
portability, not deployment of the necessary software and network
upgrades, LECs need only deploy portability upon a bona fide request.
Most parties, however, recommend that service provider portability be
deployed on a per-market basis within a period of time specified by the
Commission. For example, Competitive Carriers proposes that service
provider portability be implemented in the 100 largest MSAs within 24
months of this Order. Similarly, Sprint proposes that the Commission
adopt a phased approach requiring local service providers to deploy a
long-term solution upon receipt of a bona fide request from a certified
carrier: (1) In the top 100 MSAs by the end of fourth quarter 1997; (2)
in the next 135 MSAs, within 3-4 years after this Order is issued; and
(3) within any remaining areas, beginning in the fifth year after this
Order is issued. Omnipoint maintains that service provider portability
should be made available in the top 100 MSAs between October of 1997
and October of 1998, while GO Communications proposes implementation of
service provider portability in the major metropolitan areas by early
1997. MFS supports a final cut-over in the 100 largest MSAs by October
1997, with an initial cut-over in the top 35 MSAs on March 31, 1997. It
adds that, in order to deploy this capability as competition develops
in specific markets, number portability should be implemented by LECs
within 18 months of activation of an NXX code in the Local Exchange
Routing Guide (LERG) and assignment to a competitor. AT&T has indicated
that LRN deployment could begin in the third quarter of 1997 in one MSA
in each of the seven BOC regions, followed by deployment in at least
three additional MSAs per region during both fourth quarter 1997 and
first quarter 1998. Once this initial phase is completed, AT&T suggests
that the Commission could require LRN to be deployed in at least four
additional MSAs during both second and third quarters 1998, or 105 MSAs
total. AT&T's proposed plan would result in deployment of LRN software
in a total of 7 MSAs in third quarter 1997, 21 additional MSAs in
fourth quarter 1997, 21 additional MSAs in first quarter 1998, 28
additional MSAs in second quarter 1998, and 28 additional MSAs in third
quarter 1998. AT&T further asserts that its proposed schedule would
require major switch manufacturers to update switch software at a rate
of 53 switches per week, and that one major switch manufacturer has
claimed that it alone can update 50 switches per week. MCI urges that
number portability be deployed in the top 100 MSAs, by population, over
a 10 month period beginning no later than June 30, 1997. After
implementation is complete in the initial 100 MSAs, MCI recommends that
the remaining MSAs be converted based on written requests from carriers
filed with the Commission, which may order implementation in a
particular MSA to be completed within six months of the request. MCI
and Time Warner Holdings also support the notion of requiring number
portability implementation within six months of a request of a
telecommunications carrier. Finally, Ameritech argues it is premature
to set a deployment schedule for LRN because there are several
operational issues yet to be resolved. It further argues that schedules
proposed by various carriers are too aggressive and exceed the
resources of the industry.
71. Switch vendors assert that LRN software will be generally
available for service providers to deploy in 1997. Lucent Technologies
plans general availability of LRN software for March 21, 1997, for its
1A ESS switch; March 31, 1997, for its 5ESS-2000 switch; and May 1,
1997, for its 4ESS switch. Lucent asserts that, after the new software
becomes generally available, it will be able to support up to 50
software release updates per week for the 5ESS and 1A ESS switches for
North America (each release update upgrades the software for one
switch). Nortel states that its LRN software will be available in the
second quarter of 1997 for its DMS-100, DMS-200, and DMS-500 switches,
and will be available in the third quarter of 1997 for its DMS-10 and
TOPS switches. Siemens Stromberg-Carlson asserts that its LRN software
will be available for testing on its EWSD switch in its Release 14.E
generic in October 1996, and will be generally available in the first
quarter of 1997. Siemens further claims that upgrades to EWSD switches
deployed within the top 100 MSAs can be completed within five months of
the date of general availability. Ericsson asserts that its LRN
software for Ericsson SCPs will be generally available in the second
quarter of 1997, and that its LRN software for Ericsson SSPs will be
generally available in the third quarter of 1997. Ericsson expects that
6-7 switch upgrades can be accomplished each week, with each upgrade
taking 3-4 days.
72. The Illinois Commerce Commission argues that a phased
approach--implementing number portability in those areas where local
competition is developing--may be more cost-effective and more feasible
technically than a nationwide uniform deadline. Similarly, US West
contends that a nationwide uniform deadline for service provider
portability is neither practical nor necessary due to differing levels
of competition. Sprint asserts that a phased implementation will
accommodate the concerns of the small LECs, arguing that a phased
approach best balances the need for rapid deployment with the capital
constraints facing individual carriers. Nextel asserts that a phased
approach is more efficient
[[Page 38617]]
because it results in the introduction of number portability where the
demand for service provider portability is greatest. Bell Atlantic and
US West contend that state agencies should determine when and where
service provider portability should be introduced within their
respective jurisdictions. Alternatively, US West suggests that the
Commission could use the same approach to implementing service provider
portability that it adopted in implementing equal access for
independent LECs.
73. Rural and Small LEC Exemption. In comments filed prior to
passage of the 1996 Act, GVNW, TDS Telecom, NECA, and OPASTCO argue
that, if the Commission mandates the implementation of number
portability, it should exempt small and rural LECs from such a mandate.
GNVW, NECA, and NTCA claim that the demand for service provider
portability is significantly less in areas served by rural and small
LECs because local exchange competition is not likely to develop there
soon, if at all.
3. Discussion
74. Section 251(b) requires that all local exchange carriers, as
defined by section 153(26), ``provide, to the extent technically
feasible, number portability in accordance with requirements prescribed
by the Commission.'' We believe that requiring implementation of long-
term number portability by a date certain is consistent with the 1996
Act's requirement that LECs provide number portability as soon as they
can do so and will advance the 1996 Act's goal of encouraging
competition in the local exchange market. The record indicates that at
least one long-term method will be available for deployment in mid-
1997.
75. We decline the suggestion of some parties that we direct an
industry body to determine an appropriate implementation plan. The INC
has been analyzing the issues surrounding number portability for over
two years. Delegating responsibility for number portability
implementation to an industry group such as the INC would unnecessarily
delay implementation of number portability. Similarly, we reject
BellSouth's arguments in favor of delaying implementation for three to
five years. We believe such a delay is inconsistent with the 1996 Act's
requirement that LECs make number portability available when doing so
is technically feasible, as well as with the pro-competitive goals of
the 1996 Act, and would not serve the public interest.
76. Carriers filing comments in this proceeding have suggested
various deployment schedules, with most suggesting deployment within
two years of a Commission order or sooner. According to current
schedules in Illinois, Georgia, Colorado, Maryland, and New York,
AT&T's LRN method is scheduled for deployment (most likely excluding
necessary field testing) beginning in mid-1997. Thus, the record
indicates that one method for providing number portability will be
available in mid-1997.
77. Pursuant to our statutory authority under the 1996 Act, we
require local exchange carriers operating in the 100 largest MSAs to
offer long-term service provider portability commencing on October 1,
1997, and concluding by December 31, 1998, according to the deployment
schedule set forth in Appendix F of the Report and Order. We require
deployment in one MSA in each of the seven BOC regions by the end of
fourth quarter 1997, 16 additional MSAs by the end of first quarter
1998, 22 additional MSAs by the end of second quarter 1998, 25
additional MSAs by the end of third quarter 1998, and 30 additional
MSAs by the end of fourth quarter 1998. As a practical matter, this
obligation requires LECs to provide number portability to other
telecommunications carriers providing local exchange or exchange access
service within the same MSA. This schedule is consistent with switch
vendor estimates that software for at least one long-term number
portability method will be generally available for deployment by
carriers around mid-1997, and with the schedule proposed by AT&T. One
major switch manufacturer has claimed that it alone can support the
deployment of number portability software in 50 switches per week. We
conclude that a schedule consistent with AT&T's proposed schedule,
which would require all of the major switch manufacturers collectively
to update switch software at a total rate of 53 switches per week,
appears workable.
78. We note that, in establishing this schedule, we have relied
upon representations of switch vendors concerning the dates by which
the necessary switching software will be generally available. As a
result, our deployment schedule depends directly upon the accuracy of
those estimates and the absence of any significant technical problems
in deployment. We delegate authority to the Chief, Common Carrier
Bureau, to monitor the progress of local exchange carriers implementing
number portability, and to direct such carriers to take any actions
necessary to ensure compliance with this deployment schedule. We expect
that the industry will work together to resolve any outstanding issues,
technical or otherwise, which are involved with providing long-term
number portability in accordance with our requirements and deployment
schedule. We note that while we prescribe the time constraints within
which LECs must implement number portability, we strongly encourage
carriers to provide such portability before the Commission-imposed
deadlines.
79. In addition, we direct the carriers that are members of the
Illinois Local Number Portability Workshop to conduct a field test of
LRN or another technically feasible long-term number portability method
that comports with our performance criteria concluding no later than
August 31, 1997. We select the Chicago area for the field test because
the record indicates that the Illinois workshop was responsible for
drafting requirements for switching software currently being developed
by switch manufacturers. Because of the significant work which has been
done on behalf of the Illinois workshop, we believe the Chicago area is
the best site within which to conduct a field test. The field test
should encompass both network capability and billing and ordering
systems, as well as maintenance arrangements. We delegate authority to
the Chief, Common Carrier Bureau, to monitor developments during the
field test. We further direct that the carriers participating in the
test jointly file with the Bureau a report of their findings within 30
days following completion of the test. While we do not routinely order
field testing of telecommunications technologies as part of rulemaking
proceedings, we have a significant interest in ensuring the integrity
of the public switched network as number portability is deployed
nationwide. We believe a field test will help to identify technical
problems in advance of widespread deployment, thereby safeguarding the
network.
80. After December 31, 1998, each LEC must make long-term number
portability available in smaller MSAs within six months after a
specific request by another telecommunications carrier in the areas in
which the requesting carrier is operating or plans to operate.
Telecommunications carriers may file requests for number portability
beginning January 1, 1999. Such requests should specifically request
long-term number portability, identify the discrete geographic area
covered by the request, and provide a tentative date six or more months
in the future when the carrier expects to need number
[[Page 38618]]
portability in order to port prospective customers.
81. We believe that this deployment schedule is consistent with the
requirements of sections 251(b)(2) and (d), which give the Commission
responsibility for establishing regulations regarding the provision of
number portability to the extent technically feasible. As the record
indicates, long-term number portability requires the use of one or more
databases. Such databases have yet to be deployed. As indicated above,
the methods for providing long-term number portability that would
satisfy our criteria require the development of new switching software
that is not currently available, but is under development. The record
indicates, however, that at least one method of long-term number
portability will be technically feasible by mid-1997. Requiring number
portability to be fully operational in the largest 100 MSAs by December
31, 1998, would allow a reasonable amount of time to install the
appropriate generic and application software in the relevant switches.
Moreover, such a phased deployment is preferable to implementing
nationwide number portability simultaneously in all markets (or
implementing this service in multiple large MSAs at the same time)
because a phased deployment would be less likely to impose a
significant burden on those carriers serving multiple regions of the
country. Specifically, our phased approach spreads the implementation
over 15 months, thus easing the burden on carriers serving multiple
regions by limiting the number of MSAs in which implementation is
required during a particular calendar quarter. In addition, the burden
on such carriers should be less than that upon carriers in smaller
markets because the latter may be required to undertake hardware
upgrades whereas larger carriers may already have upgraded their
switches. Our phased approach would also avoid the potential strain on
vendors caused by implementation in all the largest 100 MSAs on or
around a single date, as well as help to safeguard the integrity of the
public switched telephone network.
82. In addition, we believe that our phased implementation of long-
term number portability is in the public interest and supported by the
record. Our phased deployment schedule takes in account the differing
levels of local exchange competition that are likely to emerge in the
different geographic areas throughout the country. Thus, our deployment
schedule is designed to ensure that number portability will be made
available in those regions where competing service providers are likely
to offer alternative services. We believe that competitive local
service providers are likely to be providing service in the major
metropolitan areas soon. In those areas beyond the 100 largest MSAs,
however, the actual pace of competitive entry into local markets should
determine the need for service provider portability. We therefore agree
with those parties that argue that, in markets outside of the 100
largest MSAs, long-term number portability should be deployed within
six months of a specific request from another telecommunications
provider. We believe a six-month interval is appropriate given the more
significant network upgrades that may be necessary for carriers
operating in these smaller areas.
83. We note that the 1996 Act exempts rural telephone companies
from the ``duty to negotiate * * * the particular terms and conditions
of agreements to fulfill the (interconnection) duties'' created by the
1996 Act, including the provision of number portability, and that
carriers satisfying the statutory criteria contained in section 251(f)
may be exempt from the obligations to provide number portability as set
forth herein. In addition, section 251(f)(2) permits a LEC with fewer
than two percent of the country's total installed subscriber lines to
petition a state commission for suspension or modification of the
requirements of section 251. In our recent notice of proposed
rulemaking implementing sections 251 and 252 of the Communications Act,
we address the application of this statutory exemption, and we believe
that specific application of such provisions is best addressed in that
proceeding. We intend to establish regulations to implement these
provisions by early August 1996, consistent with the requirements of
section 251(d).
84. In our Second Further Notice of Proposed Rulemaking on Billed
Party Preference (BPP), we stated that the Commission would further
consider the feasibility of implementing BPP in the upcoming proceeding
to implement the 1996 Act's local number portability requirements in
section 251(b)(2). We recognize that our deployment schedule may have
implications for the provision of BPP, the ability of a customer to
designate in advance which Operator Service Provider (OSP) should be
billed when that customer makes a call from a pay telephone. This
capability may involve querying a database, similar to the proposed
long-term number portability methods. In the BPP Second Further Notice
(61 FR 30581 (June 17, 1996)), we noted that the record indicated that
the cost of BPP would likely be substantial, and we sought comment on
the costs of requiring OSPs to disclose their rates for 0+ calls in a
variety of circumstances. In that NPRM, we reaffirmed our belief that
BPP would generate significant benefits for consumers, but stated that,
at this time, unless local exchange providers were required to install
the facilities needed to perform database queries for number
portability purposes, the incremental cost to query the database for
the customer's preferred OSP would outweigh the potential incremental
benefits that BPP would provide. While we continue to recognize the
benefits that could be achieved through such an approach, we note that
creating the capability for all LECs to query OSP databases would
require a uniform deadline to nationwide number portability which, for
the reasons discussed above, is not in the public interest.
Nonetheless, as indicated by our deployment schedule, LECs in the 100
largest MSAs will be required to install the capability to query number
portability databases by December 31, 1998, which could then
potentially be utilized for BPP in those markets.
85. Finally, we delegate to the Chief, Common Carrier Bureau, the
authority to waive or stay any of the dates in the implementation
schedule, as the Chief determines is necessary to ensure the efficient
development of number portability, for a period not to exceed 9 months
(i.e., no later than September 30, 1999). In the event a carrier is
unable to meet our deadlines for implementing a long-term number
portability method, it may file with the Commission, at least 60 days
in advance of the deadline, a petition to extend the time by which
implementation in its network will be completed. We emphasize, however,
that carriers are expected to meet the prescribed deadlines, and a
carrier seeking relief must present extraordinary circumstances beyond
its control in order to obtain an extension of time. A carrier seeking
such relief must demonstrate through substantial, credible evidence the
basis for its contention that it is unable to comply with our
deployment schedule. Such requests must set forth: (1) The facts that
demonstrate why the carrier is unable to meet our deployment schedule;
(2) a detailed explanation of the activities that the carrier has
undertaken to meet the implementation schedule prior to requesting an
extension of time; (3) an identification of the particular switches for
which the extension is requested; (4) the time within which the carrier
will
[[Page 38619]]
complete deployment in the affected switches; and (5) a proposed
schedule with milestones for meeting the deployment date.
E. Database Architecture and Administration
1. Background
86. In the NPRM, we sought comment on the type of database
architecture that would best serve the public interest and the
technical feasibility of deploying a single national database or a
series of regionally distributed databases. We also sought comment on
the type of information that should be contained within such
database(s) and who should have access to such database(s). Finally, we
sought comment on administration of the number portability database(s),
i.e., who should administer and maintain the database(s), how should
they be funded, how should the administrator(s) be selected, and what
responsibilities should the administrator(s) be given.
2. Position of the Parties
Many parties assert that any long-term number portability solution
will require the use of one or more databases. Jones Intercable states
that use of a database solution: (1) Makes numbering information
available to numerous competing carriers; (2) provides the platform to
offer other types of number portability; and (3) permits the deployment
of other advanced services. ACTA, AT&T, and Citizens Utilities assert
that the database architecture of a long-term solution should resemble
the architecture used for the toll free database, but with databases
distributed on a regional basis. US Intelco and MCI note that multiple,
regional databases, rather than one national database, will be
necessary to process the data for all portable geographic numbers. Only
Scherers Communications claims that a single national database will be
able to accommodate all portable numbers, geographic and non-
geographic, and will ensure consistency and cost efficiency.
88. AT&T and several BOCs support the ability of individual
carriers to download information from the regional databases to routing
systems associated with their own networks, i.e., downstream databases.
Several other parties add that access to the regional databases must be
open, and carriers, individually or collectively, must be permitted to
develop routing databases that obtain information from the regional
databases. ITN contends that an architecture of regionally-deployed
SCPs which correspond to blocks of NPA-NXXs would give carriers the
option of maintaining their own customer records or having a third
party provider perform such functions. It adds that such openness in
data management will help ensure number portability to all service
providers, including providers of service to end users and various
other intelligent network service providers.
89. Almost all parties, incumbent LECs and new entrants, support
administration of the database(s) by a neutral third party. MFS adds
that the operator of a number portability database must not be able to
gain a competitive advantage by manipulating the data or controlling
access to the database. ACTA urges that the database administrator be a
non-profit organization selected through a competitive bidding process
that excludes LECs and IXCs, with responsibilities established by the
North American Numbering Plan Administrator (NANPA).
90. Competitive Carriers assert that the database(s) should include
only service provider portability-specific information, and that the
carriers using the database should be responsible for the integrity of
these data. Teleport claims that an industry group should determine the
contents of any distributed databases, subject to the Commission's
criteria. The Texas Advisory Commission also asserts that the
database(s) should easily integrate with 911 databases.
3. Discussion
91. Section 251(b) directs the Commission to establish requirements
governing the provision of number portability without specifically
addressing the appropriate database architecture necessary for long-
term number portability. We find that an architecture that uses
regionally-deployed databases best serves the public interest and is
supported by the record. The deployment of multiple regional databases
will facilitate the ability of LECs to provide number portability by
reducing the distance that such carriers will have to transmit carrier
routing information. This, in turn, should reduce the costs of routing
telephone calls based on such data. Moreover, a nationwide system of
regional databases would relieve individual carriers of the burden of
deploying multiple number portability databases over various geographic
areas. A regionally-deployed database system will ensure that carriers
have the number portability routing information necessary to route
telephone calls between carriers' networks, and will also promote
uniformity in the provision of such number portability data. We agree
with those parties arguing that one national number portability
database is not feasible. The potential amount of information that such
a database would be required to process would, according to parties in
this proceeding, likely become overwhelming as number portability is
deployed nationwide.
92. We also conclude that it is in the public interest for the
number portability databases to be administered by one or more neutral
third parties. Both the record and the Commission's recent decision to
reorganize the administration of telephone numbers under the NANP
support neutral third party administration of these facilities. We also
note that section 251(e)(1) requires the Commission to ``create or
designate one or more impartial entities to administer
telecommunications numbering and to make such numbers available on an
equitable basis.'' Neutral third party administration of the databases
containing carrier routing information will facilitate entry into the
communications marketplace by making numbering resources available to
new service providers on an efficient basis. It will also facilitate
the ability of local service providers to transfer new customers by
ensuring open and efficient access for purposes of updating customer
records. As we stated above, the ability to transfer customers from one
carrier to another, which includes access to the data necessary to
perform that transfer, is important to entities that wish to compete in
the local telecommunications market. Neutral third party administration
of the carrier routing information also ensures the equal treatment of
all carriers and avoids any appearance of impropriety or anti-
competitive conduct. Such administration facilitates consumers' access
to the public switched network by preventing any one carrier from
interfering with interconnection to the database(s) or the processing
of routing and customer information. Neutral third party administration
would thus ensure consistency of the data and interoperability of
number portability facilities, thereby minimizing any anti-competitive
impacts.
93. We hereby direct the NANC to select as a local number
portability administrator(s) (LNPA(s)) one or more independent, non-
governmental entities that are not aligned with any particular
telecommunications industry segment within seven months of the initial
meeting of the NANC. Selection of the LNPA(s) falls within the duties
we established for the NANC in the
[[Page 38620]]
Numbering Plan Order (60 FR 38737 (July 28, 1995)) and the NANC
Charter. The NANC charter describes the scope the NANC's activities:
The purpose of the (NANC) is to advise the (Commission) and to
make recommendations, reached through consensus, that foster
efficient and impartial number administration. The (NANC) will
develop policy on numbering issues, initially resolve disputes, and
select and provide guidance to the North American Numbering Plan
Administrator.
The fundamental purpose of the NANC is to act as an oversight committee
with the technical and operational expertise to advise the Commission
on numbering issues. The Commission has already directed the NANC to
select a NANPA. We believe the designation of a centralized entity to
select and oversee the LNPA(s) is preferable to ensure consistency and
to provide a national perspective on number portability issues, as well
as to reduce the costs of implementing a national number portability
plan.
94. We believe that the NANC is especially well-situated to handle
matters relating to local number portability administration because of
its similarity to the administration of central office codes. Both
functions rely heavily on the use of databases, and both involve
administration of NANP resources, only at different levels.
Administration of number portability data is essentially the
administration of telephone numbers (as opposed to NXX codes) between
different carriers.
95. We believe that the NANC should determine, in the first
instance, whether one or multiple administrators should be selected,
whether LNPA(s) can be the same entity selected to be the NANPA, how
the LNPA(s) should be selected, the specific duties of the LNPA(s), and
the geographic coverage of the regional databases. Once the NANC has
selected the LNPA(s) and determined the locations of the regional
databases, it must report its decisions to the Commission. The NANC
should also determine the technical interoperability and operational
standards, the user interface between telecommunications carriers and
the LNPA(s), and the network interface between the SMS and the
downstream databases. Finally, the NANC should develop the technical
specifications for the regional databases, e.g., whether a regional
database should consist of a service management system (SMS) or an SMS/
SCP pair. In reaching its decisions, the NANC should consider the most
cost-effective way of accomplishing number portability. We note that it
will be essential for the NANPA to keep track of information regarding
the porting of numbers between and among carriers. We thus believe it
necessary for the NANC to set guidelines and standards by which the
NANPA and LNPA(s) share numbering information so that both entities can
efficiently and effectively administer the assignment of the numbering
resource. For example, the NANC might require that the databases easily
integrate with 911 databases.
96. We recognize that authorizing the NANC to select a LNPA(s) may
have an impact on Illinois's April 1996 selection of Lockheed-Martin as
the administrator of the Illinois SMS, as well as the Maryland and
Colorado task forces' plans to release their RFPs for their SMS
administrators in the second quarter of 1996. Therefore, in light of
these and other ongoing efforts by state commissions, we conclude that
any state that prefers to develop its own statewide database rather
than participate in a regionally-deployed database may opt out of its
designated regional database and implement a state-specific database.
We direct the Chief, Common Carrier Bureau, to issue a Public Notice
that identifies the administrator selected by the NANC and the proposed
locations of the regional databases. A state will have 60 days from the
release date of the Public Notice to notify the Common Carrier Bureau
and NANC that the state does not wish to participate in the regional
database system for number portability. Carriers may challenge a
state's decision to opt out of the regional database system by filing a
petition with the Commission. Relief will be granted if the petitioner
can demonstrate that the state decision to opt out would significantly
delay deployment of permanent number portability or result in excessive
costs to carriers. We note that state databases would have to meet the
national requirements and operational standards recommended by the NANC
and adopted by this Commission. In addition, such state databases must
be technically compatible with the regional system of databases and
must not interfere with the scheduled implementation of the regional
databases.
97. We further note that any administrator selected by a state
prior to the release of this Order that wishes to bid for
administration of one of the regional databases must submit a new
proposal in accordance with the guidelines established by the NANC. We
emphasize that nothing in this section affects any other action that
the Commission may take regarding the delegation and transfer of
functions related to number administration. We delegate authority to
the Chief, Common Carrier Bureau, to monitor the progress of the NANC
in selecting the LNPA(s) and in developing and implementing the
database architecture described above.
98. We believe that telecommunications carriers should have open
access to all regional databases. Just as we conclude all carriers must
have equal access to any long-term number portability method, and that
no portion of a long-term number portability method should be
proprietary to any carrier, we further conclude that all carriers must
have equal and open access to all regionally-deployed databases
containing number portability-specific data. Allowing particular
carriers access to the databases over others would be inherently
discriminatory and anti-competitive. All carriers providing number
portability need to have access to all relevant information to be able
to provide customers with this important capability. We thus conclude
that the 1996 Act, in addition to general rules of equity and
competitive neutrality, requires equal and open access to all
regionally-deployed databases for all carriers wishing to interconnect.
99. We believe that, at this time, the information contained in the
number portability regional databases should be limited to the
information necessary to route telephone calls to the appropriate
service providers. The NANC should determine the specific information
necessary to provide number portability. To include, for example, the
information necessary to provide E911 services or proprietary customer-
specific information would complicate the functions of the number
portability databases and impose requirements that may have varied
impacts on different localities. For instance, because different
localities have adopted different emergency response systems, the
regional databases would have to be configured in such a fashion as to
provision the appropriate emergency information to each locality's
particular system. Similarly, special systems would need to be
developed to restrict access to proprietary customer-specific
information. In either instance, the necessary programming to add such
capabilities to the regional databases would complicate the
functionality of those databases.
100. Because we require open access to the regional databases, it
would be inequitable to require carriers to disseminate, by means of
those databases, proprietary or customer-specific information. We
therefore contemplate that the regional
[[Page 38621]]
deployment of databases will permit individual carriers to own and
operate their own downstream databases. These carrier-specific
databases will allow individual carriers to provide number portability
in conjunction with other functions and services. To the extent that
individual carriers wish to mix information, proprietary or otherwise,
necessary to provide other services or functions with the number
portability data, they are free to do so at their downstream databases.
We reiterate, however, that a carrier may not withhold any information
necessary to provide number portability on the grounds that such data
are combined with other information in its downstream database; it must
furnish all information necessary to provide number portability to the
regional databases as well as to its own downstream database.
101. Carriers that choose not to access directly the regional
databases or deploy their own downstream databases can seek access to
the carrier-specific databases deployed by other carriers. The
provision of access to network elements and facilities of incumbent
LECs is addressed in our proceeding implementing section 251 of the
Communications Act. We believe the issue of access to incumbent LECs'
carrier-specific databases by other carriers for purposes of number
portability is best addressed in that proceeding. Parties may negotiate
third-party access to non-incumbent LECs' carrier-specific databases on
an individual basis.
102. In the Numbering Plan Order, we concluded that the Commission
should invoke its statutory authority to recover its costs for
regulating numbering activities, including costs incurred from the
establishment, oversight of, and participation in the NANC. The
Commission is required to institute a rulemaking proceeding annually to
adjust the schedule of regulatory fees to reflect its performance of
activities relating to enforcement, policy and rulemaking, user
information services, and international activities, pursuant to the
relevant appropriations legislation. Therefore, we intend to include
the additional costs incurred by the Commission related to NANC and
regulating number portability in the fiscal 1997 adjustment of the
schedule of regulatory fees. In that proceeding, we will assess the
nature and amount of the additional burdens imposed by the activities
authorized here, and all interested parties will be afforded an
opportunity to comment.
F. Currently Available Number Portability Measures
1. Background
103. In the NPRM, we discussed certain currently available number
portability measures that LECs can use to provide service provider
number portability. We focused on RCF and DID and acknowledged that the
use of either method for number portability has significant
limitations. We sought comment on the costs of implementing these
measures, and on their limitations and disadvantages. We also requested
that parties discuss whether these currently available measures can be
improved so that they are workable, long-term solutions, and if so, at
what cost. Finally, we sought comment on how the costs of providing
service provider portability using RCF and DID should be recovered.
2. Implementation of Currently Available Number Portability Measures
a. Positions of the Parties
104. Commenting parties, with the exception of several of the
incumbent LECs, generally agree that the technical limitations
described in the NPRM render the interim measures unacceptable in the
long term. Indeed, many parties point out additional disadvantages of
RCF and DID, such as: Longer call set-up times, incumbent access to
competitors' proprietary information, complicated resolution of
customer complaints, increased potential for call blocking, and
substantial costs to new entrants. Bell Atlantic counters that calls
forwarded by RCF in its network can support CLASS features if the co-
carrier has modern digital switching equipment and common channel
signalling, and it adds that there is no limit on the number of calls
RCF can handle simultaneously.
105. Many of the new entrants, nevertheless, urge the Commission to
require incumbent LECs to provide interim measures until a long-term
solution is implemented. These carriers generally caution that use of
interim solutions should not delay implementation of a permanent
solution. While acknowledging that RCF and DID are already technically
feasible and generally available, several LECs argue that the
Commission need not take action on interim measures. They generally
focus, instead, on phasing in a long-term solution.
106. AT&T and MCI initially argued for using a medium-term database
solution, namely, the Carrier Portability Code (CPC) method, because of
its advantages over RCF or DID, but subsequently favored implementing
LRN as soon as possible. NYNEX and SBC Communications claim that
adopting CPC as an interim solution would result in wasted and
duplicative efforts. They note that CPC fails to support certain
services, such as ISDN calls, pay phone calls, and CLASS features when
customers place a call into an NXX from which a number has been
transferred to a different service provider, and that CPC may prevent
an operator from identifying the switch serving a ``ported'' number,
thereby interfering with busy line verification of that line.
107. Potential new entrants into the local exchange market
generally contend that requiring interim number portability is
consistent with the 1996 Act. Indeed, MFS maintains that the 1996 Act
requires immediate implementation of interim measures until long-term
portability is implemented. Teleport notes that the Bell Operating
Companies, at least, are required to provide interim number portability
as a condition of entry into the interLATA market. MCI agrees that
interim measures should be made available until long-term portability
is implemented, and argues that section 4(i) of the Communications Act
authorizes the Commission to perform any acts ``necessary and proper''
to execute section 251(b)(2), and that such authority is pre-existing
and remains in effect. ALTS contends that Congress clearly contemplated
that the Commission should require interim measures until long-term
portability is available because otherwise BOCs could satisfy the
competitive checklist of section 271(c)(2)(B)(xi) for entry in
interLATA services without providing any form of number portability.
AT&T argues that interim arrangements are incapable of preserving the
functionality for long-term number portability required by the 1996
Act, but should be provided until long-term number portability can be
deployed.
108. US West, in contrast, asserts that the Commission's
jurisdiction over interim measures is unclear because sections 153(30)
and 251(b)(2), giving the Commission jurisdiction over number
portability, appear to include only permanent portability. Cox and NCTA
claim that the interim measures do not satisfy the ``without impairment
of quality, reliability, or convenience'' standard in the definition of
number portability in 47 U.S.C. section 153(30).
109. Several of the cable interests argue that, although section
271(c)(2)(B)(xi) allows the BOCs initially to satisfy the competitive
[[Page 38622]]
checklist for entry into interLATA services by providing only interim
measures, the BOCs are also required to provide long-term portability
to fulfill the checklist requirements. Moreover, Cox and Time Warner
Holdings warn that the Commission will lose its leverage to encourage
prompt implementation of long-term portability once the BOCs are
permitted to provide in-region interLATA services pursuant to section
271. NCTA asserts that, since section 271(c)(2)(B)(xi) distinguishes
between ``interim'' measures and ``regulations pursuant to section 251
to require number portability,'' the portability required by section
251 is long-term number portability. CCTA urges the Commission to
review and require BOC progress toward deployment of a long-term method
when BOCs apply for in-region interLATA market entry, and to deny a BOC
application if the BOC tries to delay implementation of long-term
portability. Cox goes further and argues that, after the Commission
adopts number portability rules, BOCs must implement long-term service
provider portability, not just interim measures, before they can obtain
interexchange and manufacturing relief under section 271 because
interim measures do not satisfy section 251. In response, Ameritech
contends that provision of interim measures, and later compliance with
the Commission's portability rules, satisfies the BOC checklist and
notes that section 271(d)(4) directs the Commission not to limit or
extend the checklist terms.
b. Discussion
110. The 1996 Act requires that carriers ``provide, to the extent
technically feasible, number portability in accordance with the
requirements prescribed by the Commission.'' Number portability is
defined in the 1996 Act as ``the ability of users of telecommunications
services to retain, at the same location, existing telecommunications
numbers without impairment of quality, reliability, or convenience when
switching from one telecommunications carrier to another.'' The record
indicates that currently technically feasible methods of providing
number portability, such as RCF and DID, may impair to some degree
either the quality, reliability, or convenience of telecommunications
services when customers switch between carriers. Because of these
drawbacks, some may argue that the use of RCF and DID methods for
providing number portability would not satisfy the requirements of
sections 3(30) and 251(b)(2). We disagree. Section 251(b)(2)
specifically requires carriers to provide number portability, as
defined in section 3(30), ``to the extent technically feasible.'' Thus,
because currently RCF and DID are the only methods technically
feasible, we believe that use of these methods, in fact, comports with
the requirements of the statute. We believe that the 1996 Act
contemplates a dynamic, not static, definition of technically feasible
number portability methods. Under this view, LECs are required to offer
number portability through RCF, DID, and other comparable methods
because they are the only methods that currently are technically
feasible. LECs are required by this Order to begin the deployment of a
long-term number portability solution by October 1, 1997, because,
based on the evidence of record, such methods will be technically
feasible by that date. We believe that this conclusion is consistent
with Congress's goal of developing a national number portability
framework, as well as the general purpose of the Act to ``promote
competition * * * in order to secure lower prices and higher quality
services for American telecommunications consumers and encourage the
rapid deployment of new technologies.''
111. This interpretation finds further support in section
271(c)(2)(B)(xi), which sets forth the competitive checklist for BOC
entry into in-region interLATA services. That section requires the BOCs
wishing to enter the in-region interLATA market: (1) To provide interim
number portability through RCF, DID, and other comparable arrangements
``until the date by which the Commission issues regulations pursuant to
section 251 to require number portability,'' and then (2) to comply
with the Commission's regulations. There will necessarily be a
significant time period between the adoption date of these rules and
the availability of long-term number portability measures. Therefore,
were the Commission to promulgate rules providing only for the
provision of long-term number portability, during this time period the
BOCs could satisfy the competitive checklist without providing any form
of number portability. This could be true even if they had been
providing interim number portability pursuant to the checklist prior to
the effective date of the Commission's regulations. We do not believe
that Congress could have intended this result. We, therefore, agree
with MFS, ALTS, MCI, and AT&T that Congress intended that currently
available number portability measures be provided until a long-term
number portability method is technically feasible and available.
112. We conclude that we had authority to require the provision of
currently available methods of service provider portability prior to
passage of the 1996 Act. In the NPRM, we tentatively concluded that
sections 1 and 202 of the Communications Act establish a federal
interest in the provision of number portability. Specifically, we
concluded in the NPRM that such interest arises from: (1) Our
obligation to promote an efficient and fair telecommunications system;
(2) the inability to separate the impact of number portability between
intrastate and interstate telecommunications; (3) the potential adverse
impact deploying different number portability solutions across the
country would have on the provision of interstate telecommunications
services; and (4) the impact number portability could have on the use
of the numbering resource, that is, ensuring that the use of numbers is
efficient and does not contribute to area code exhaust. We now affirm
these tentative conclusions and conclude that we have jurisdiction to
require the provision of currently available number portability
methods, independent of the statutory changes adopted in the 1996 Act.
113. There are also substantial policy reasons that support our
requiring LECs to provide currently available number portability
measures. The ability of customers to keep their telephone numbers when
changing carriers, even with some impairment in call set-up time or
vertical service offerings, is critical to opening the local
marketplace to competition. By facilitating entry of new carriers into
the local market, currently available number portability measures will
increase competition in local markets which will result in lower prices
and higher service quality for telecommunications services consistent
with the goals of the 1996 Act. Several parties to this proceeding
likewise advocate that such measures are necessary for the development
of effective local exchange competition.
114. We note that sections 251(b)(2) and 251(d) give to the
Commission the authority to prescribe requirements for the provision of
number portability. Pursuant to that authority, we mandate the
provision of currently available number portability measures as soon as
reasonably possible upon receipt of a specific request from another
telecommunications carrier, including from wireless service providers.
By conditioning the obligation to provide currently available number
portability measures upon a specific request,
[[Page 38623]]
number portability will be offered only in those areas where a
competing local exchange carrier seeks to provide service. Thus, it
avoids the imposition of number portability implementation costs on
carriers (and end users) in areas where no competitor is operating.
115. We agree with the many parties who claim that the technical
limitations described in the NPRM that handicap all currently available
measures for providing number portability render them unacceptable as
long-term solutions. Despite Bell Atlantic's claims to the contrary for
its own network, the record indicates that currently available number
portability measures are inferior to LRN portability or any other
method that meets our performance criteria. The 1996 Act, and
particularly the BOC checklist in section 271, clearly contemplates
that these methods should serve as only temporary measures until long-
term number portability is implemented. As indicated above, the 1996
Act requires that number portability be provided, to the extent
technically feasible, without impairment of quality, reliability, and
convenience. Therefore, when a number portability method that better
satisfies the requirements of section 251(b)(2) than currently
available measures becomes technically feasible, LECs must provide
number portability by means of such method. In addition, we find that
the existing measures fail to satisfy our criteria set forth for any
long-term solution; for example, they depend on the original service
provider's network, may result in the degradation of service quality,
and are wasteful of the numbering resource. For these reasons, we do
not believe that long-term use of the currently available measures is
in the public interest. We emphasize that we encourage all LECs to
implement a long-term solution that meets our technical standards as
soon as possible. We also note that BOCs must comply with the
requirements set forth in this Order, including the requirement to
provide currently available measures, in order to satisfy the BOC
competitive checklist. Upon the date on which long-term portability
must be implemented according to our deployment schedule, BOCs must
provide long-term number portability and will be subject to an
enforcement action under section 271(d)(6) if they fail to do so.
116. We decline to require a ``medium-term'' or short-term database
solution such as CPC. The increased costs of implementing this approach
are unwarranted given the imminent implementation of a long-term
solution that meets our criteria. In addition, devoting resources to
implement a medium-term database solution, which is currently not
available, may delay implementation of a long-term database solution.
We note that the Colorado, Georgia, Illinois, and Ohio state
commissions have declined to adopt, and the California and Maryland
task forces have declined to recommend, CPC as an interim solution,
while the emphasis on New York's CPC trial has shifted in favor of
concentrating on the adoption of LRN. We also note that several parties
originally advocating CPC have since retreated from that view and now
instead support implementing a long-term database solution as soon as
possible. To the extent carriers wish to provide a medium-term database
solution, such as CPC, however, we do not prevent them from doing so.
3. Cost Recovery for Currently Available Number Portability Measures
a. Positions of the Parties
117. In comments filed before passage of the 1996 Act, Cablevision
Lightpath argues that all carriers should pay incremental, cost-based
rates for interim measures and suggests, as an example, an annual
surcharge based on the product of the incremental cost of switching and
minutes of traffic forwarded. AT&T and MCI agree with Cablevision
Lightpath and endorse the formula used by the New York Department of
Public Service, which allocates the costs of providing interim measures
across all carriers based on the product of switching and transport
costs, and minutes of forwarded traffic. Cablevision Lightpath urges,
however, the Commission to ban incumbent LECs from treating the costs
of currently available number portability as exogenous adjustments to
their interstate price cap indices. GSA, Jones Intercable, and the
Users Committee point out that the short-term incremental costs of
providing interim measures are low.
118. Many of the new entrants advocate placing much of the burden
of cost-recovery for interim measures on the incumbent LECs. Jones
Intercable, along with several other cable interests, argues that the
incumbent LECs and new LECs should recover the costs of interim
measures under a ``bill and keep'' system, under which incumbent LECs
and new entrants would not charge each other for interim number
portability arrangements that require them to forward calls of
customers who have changed service providers. In the alternative, Jones
Intercable contends that incumbent LECs' charges for interim number
portability services should be equal to or less than the LECs'
incremental cost of providing those services. Teleport also supports
the provision of interim portability measures with no intercarrier
usage charges.
119. Several commenters propose large discounts comparable to those
mandated for non-equal access during the transition to equal access.
Competitive Carriers assert that allowing LECs to charge retail prices
would discourage provision of long-term number portability. MCI argues
that portability is a network function, not a service, and proposes
that all local carriers share the costs or at least that incumbent LECs
not be allowed to recover more than the incremental costs. AT&T and MFS
argue that any interim measures should be provided at rates that
encourage incumbents to offer the most efficient routing available, or
reflect these measures' inferior quality and true costs. ALTS and MFS
further argue that competitive local exchange carriers should be
entitled to retain all terminating access charges. Similarly, MCI and
NCTA argue that the terminating access charges paid by IXCs should be
shared with the competitor that actually completes calls forwarded to
it.
120. AT&T and MCI argue that the 1996 Act requires that the costs
of providing interim number portability measures be borne by all
telecommunications carriers on a competitively neutral basis. MFS
argues that interim measures should be provided at no cost or in the
alternative, allocated on revenues net of payments to intermediaries.
Several LECs, in contrast, claim that the competitively neutral
standard prohibits requiring incumbent LECs to subsidize their
competitors by providing interim measures for free or at deeply
discounted rates. Ameritech asserts that section 251(e)(2)'s
``competitively neutral'' standard for cost recovery does not apply to
interim portability at all. It asserts that interim portability is
addressed in section 271(c)(2)(B)(xi), and therefore the Commission is
not authorized under the BOC checklist to eliminate or discount interim
portability rates below levels that state commissions have already
judged reasonable. Similarly, BellSouth argues that Congress's
endorsement of interim RCF and DID arrangements in the BOC checklist,
and the 1996 Act's structure of requiring state-approved carrier
negotiations for interconnection agreements, compel the conclusion that
RCF and DID cost recovery issues be left to the states.
[[Page 38624]]
b. Discussion
121. In light of our statutory mandate that local exchange carriers
provide number portability through RCF, DID, or other comparable
arrangements until a long-term number portability approach is
implemented, we must adopt cost recovery principles for currently
available number portability that satisfy the 1996 Act. We emphasize
that the cost recovery principles set forth below will apply only until
a long-term number portability method can be deployed. As we have
indicated, deployment of long-term number portability should begin no
later than October 1997, so currently available number portability
arrangements, and the associated cost recovery mechanism, should be in
place for a relatively short period.
122. It is also important to recognize that the costs of currently
available number portability are incurred in a substantially different
fashion than the costs of long-term number portability arrangements.
First, the capability to provide number portability through currently
available methods, such as RCF and DID, already exists in most of
today's networks, and no additional network upgrades are necessary. In
contrast, long-term, or database, number portability methods require
significant network upgrades, including installation of number
portability-specific switch software, implementation of SS7 and IN or
AIN capability, and the construction of multiple number portability
databases. Second, the costs of providing number portability in the
immediate term are incurred solely by the carrier providing the
forwarding service. Long-term number portability, in contrast, will
require all carriers to incur costs associated with the installation of
number portability-specific software and the construction of the number
portability databases. Those costs will have to be apportioned in some
fashion among all carriers. Finally, we note that, initially, the costs
of providing currently available number portability will be incurred
primarily by the incumbent LEC network because most customers will be
forwarding numbers from the incumbents to the new entrants.
123. Parties have advanced a wide range of methods for recovering
the costs of currently available number portability measures, including
arrangements whereby neither carrier charges the other for provision of
such measures and incremental, cost-based pricing schemes. In addition,
several states have adopted different cost recovery mechanisms. For
example, in Florida, carriers have negotiated appropriate rates for
currently available measures. The Louisiana PSC has adopted a two-
tiered approach to pricing of currently available measures. In the
first instance, carriers are permitted to negotiate an appropriate
rate. If the parties cannot agree upon a rate, the PSC will determine
the appropriate rate that can be charged by the forwarding carrier
based on cost studies filed by the carriers. These rates are not
required to be set at long-run incremental costs (LRIC) or total
service long-run incremental costs (TSLRIC), however.
124. In addition, incumbents and new entrants have voluntarily
negotiated a variety of cost recovery methods. Carriers in Rochester,
New York, for example, are voluntarily using a formula that allocates
the incremental costs of currently available number portability
measures, through an annual surcharge assessed by the carrier from
which the number is transferred. The charge assessed on each carrier is
the product of the total number of forwarded minutes and the
incremental per-minute costs of switching and transport, multiplied by
the ratio of a particular carrier's forwarded telephone numbers
relative to total working numbers in the area. In addition, Rochester
Telephone has agreed not to charge competitors for the first $1 million
of the cost of number portability. The New York DPS has adopted this
formula for the New York Metropolitan area as well. Ameritech and MFS
recently entered into an agreement for Ameritech's five-state region
under which MFS will pay Ameritech $3 per line per month for interim
measures. MFS plans to seek regulatory approval to allocate that cost
under a formula that would require MFS to pay a portion of the $3
charge equal to the ratio of MFS's gross telecommunications service
revenues, net of its payments to other carriers, to Ameritech's gross
telecommunications revenues, net of payments to other carriers.
125. Our cost recovery principles for currently available methods,
of course, must comply with the statutory requirements of the 1996 Act.
In addition, consistent with the pro-competitive objectives of the 1996
Act, we seek to create incentives for LECs, both incumbents and new
entrants, to implement long-term number portability at the earliest
possible date, since, as we have noted, long-term number portability is
clearly preferable to existing number portability methods. The
principles we adopt should also mitigate any anti-competitive effects
that may arise if a carrier falsely inflates the cost of currently
available number portability.
126. In our interconnection proceeding, we have sought comment on
our tentative conclusion that the 1996 Act authorizes us to set pricing
principles to ensure that rates for interconnection, unbundled network
elements, and collocation are just, reasonable, and nondiscriminatory.
We need not, however, reach in this proceeding the issue of whether
section 251 generally gives us authority over pricing for
interconnection because the statute sets forth the standard for the
recovery of number portability costs and grants the Commission the
express authority to implement this standard. Specifically, section
251(e)(2) requires that the costs of ``number portability be borne by
all telecommunications carriers on a competitively neutral basis as
determined by the Commission.'' We therefore conclude that section
251(e)(2) gives us specific authority to prescribe pricing principles
that ensure that the costs of number portability are allocated on a
``competitively neutral'' basis.
127. In exercising our authority under section 251(e)(2), we
conclude that we should adopt guidelines that the states must follow in
mandating cost recovery mechanisms for currently available number
portability methods. To date, the state commissions have adopted
different cost recovery methods. We seek to articulate general criteria
that conform to the statutory requirements, but give the states some
flexibility during this interim period to continue using a variety of
approaches that are consistent with the statutory mandate. The states
are also free, if they so choose, to require that tariffs for the
provision of currently available number portability measures be filed
by the carriers.
128. In establishing the standard for number portability cost
recovery, section 251(e)(2) sets forth three specific elements, which
we must interpret. First, we must determine the meaning of number
portability ``costs;'' second, we must interpret the phrase ``all
telecommunications carriers;'' and third, we must construe the meaning
of the phrase ``competitively neutral.''
129. The costs of currently available number portability are the
incremental costs incurred by a LEC to transfer numbers initially and
subsequently forward calls to new service providers using existing RCF,
DID, or other comparable measures. According to the record, the costs
of RCF differ depending on where the call originates in a carrier's
network. Calls that originate on the switch from which a number has
been forwarded (intraoffice
[[Page 38625]]
calls) result in fewer costs than calls that originate from other
switches (interoffice calls). This is because fewer transport and
switching costs are incurred in the forwarding of an intraoffice call.
The BOCs claim, for example, that there are essentially three costs
incurred in the provision of RCF for an intraoffice call: (1) Switching
costs incurred by the original switch in determining that the number is
no longer resident; (2) switching costs incurred in performing the RCF
translation, which identifies the address of the receiving switch; and
(3) switching costs incurred in redirecting the call from the original
switch to the switch to which the number has been forwarded. The BOCs
further assert that the additional costs incurred for an interoffice
call include: (1) The transport costs incurred in directing the call
from the tandem or end office to the office from which the number was
transferred and back to the tandem or end office; and (2) remote tandem
or end office switching costs. There is conflicting evidence in the
record on whether these costs are incurred on a per-minute, per-call,
or some fixed basis. State commissions in some states have set cost-
based rates for currently available number portability measures. In
order to do so, states have used different methods of identifying
costs, including LRIC, TSLRIC, and direct embedded cost studies. In
California and Illinois, the state commissions set cost-based fixed
monthly rates for RCF, while in New York and Maryland, the commissions
set cost-based rates for minutes of use. In addition, there is some
evidence in the record that carriers incur some non-recurring costs in
the provision of currently available methods of number portability.
Several states, such as California, Illinois, and Maryland, have
permitted the carrier forwarding a number to recover such non-recurring
costs as a one-time, non-recurring charge.
130. Section 251(e)(2) of the Communications Act requires that the
costs of providing number portability be borne by ``all
telecommunications carriers.'' No party commented on the meaning of the
term ``all telecommunications carriers.'' Read literally, the statutory
language ``all telecommunications carriers'' would appear to include
any provider of telecommunications services. Section 3 of the
Communications Act defines telecommunications services to mean ``the
offering of telecommunications for a fee directly to the public, or to
such classes of users as to be effectively available directly to the
public, regardless of facilities used.'' Under this reading, states may
require all telecommunications carriers--including incumbent LECs, new
LECs, CMRS providers, and IXCs--to share the costs incurred in the
provision of currently available number portability arrangements. As
discussed in greater detail below, states may apportion the incremental
costs of currently available measures among relevant carriers by using
competitively neutral allocators, such as gross telecommunications
revenues, number of lines, or number of active telephone numbers.
131. Section 251(e)(2) of the Act states that the costs of number
portability are to be ``borne by all telecommunications carriers on a
competitively neutral basis as determined by the Commission.'' We
interpret ``on a competitively neutral basis'' to mean that the cost of
number po
FR Doc. 96-18477 Telephone Number Portability
rtability borne by each carrier does not affect significantly
any carrier's ability to compete with other carriers for customers in
the marketplace. Congress mandated the use of number portability so
that customers could change carriers with as little difficulty as
possible. Our interpretation of ``borne * * * on a competitively
neutral basis'' reflects the belief that Congress's intent should not
be thwarted by a cost recovery mechanism that makes it economically
infeasible for some carriers to utilize number portability when
competing for customers served by other carriers. Ordinarily the
Commission follows cost causation principles, under which the purchaser
of a service would be required to pay at least the incremental cost
incurred in providing that service. With respect to number portability,
Congress has directed that we depart from cost causation principles if
necessary in order to adopt a ``competitively neutral'' standard,
because number portability is a network function that is required for a
carrier to compete with the carrier that is already serving a customer.
Depending on the technology used, to price number portability on a cost
causative basis could defeat the purpose for which it was mandated. We
emphasize, however, that this statutory mandate constitutes a rare
exception to the general principle, long recognized by the Commission,
that the cost-causer should pay for the costs that he or she incurs.
132. Our interpretation suggests that a ``competitively neutral''
cost recovery mechanism should satisfy the following two criteria.
First, a ``competitively neutral'' cost recovery mechanism should not
give one service provider an appreciable, incremental cost advantage
over another service provider, when competing for a specific
subscriber. In other words, the recovery mechanism should not have a
disparate effect on the incremental costs of competing carriers seeking
to serve the same customer. The cost of number portability borne by a
facilities-based new entrant that wins a customer away from an
incumbent LEC is the payment that the new entrant must make to the
incumbent LEC. The higher this payment, the higher the price the new
entrant must charge to a customer to serve that customer profitably,
which will put the new entrant at a competitive disadvantage. We thus
interpret our first criterion as meaning that the incremental payment
made by a new entrant for winning a customer that ports his number
cannot put the new entrant at an appreciable cost disadvantage relative
to any other carrier that could serve that customer.
133. An example illustrates the application of this criteria. When
a facilities-based carrier that competes against an incumbent LEC for a
customer, the incumbent LEC incurs no cost of number portability if it
retains the customer. If the facilities-based carrier wins the
customer, an incremental cost of number portability is generated. The
share of this incremental cost borne by the new entrant that wins the
customer cannot be so high as to put it at an appreciable cost
disadvantage relative to the cost the incumbent LEC would incur if it
retained the customer. Thus, the incremental payment by the new entrant
if it wins a customer would have to be close to zero, to approximate
the incremental number portability cost borne by the incumbent LEC if
it retains the customer.
134. A couple of additional examples may further clarify and
illustrate this criterion. On the one hand, a cost recovery mechanism
that imposes the entire incremental cost of currently available number
portability on a facilities-based new entrant would violate this
criterion. This cost recovery mechanism would impose an incremental
cost on a facilities-based entrant that neither the incumbent, nor an
entrant that merely resold the incumbent's service, would have to bear,
because neither the incumbent nor the reseller would have to use
currently available number portability measures in order for the
prospective customer to keep his or her existing number. On the other
hand, a cost recovery mechanism that recovers the cost of currently
available number portability through a uniform assessment on the
revenues of all telecommunications carriers, less any charges paid to
other carriers, would satisfy this criterion. This approach does not
disparately affect the
[[Page 38626]]
incremental cost of winning a specific customer or group of customers,
because a LEC with a small share of the market's revenue would pay a
percentage of the incremental cost of number portability that will be
small enough to have no appreciable affect on the new entrant's ability
to compete for that customer.
135. The second criterion for a ``competitively neutral'' cost
recovery mechanism is that it should not have a disparate effect on the
ability of competing service providers to earn normal returns on their
investment. If, for example, the total costs of currently available
number portability are to be divided equally among four competing local
exchange carriers, including both the incumbent LEC and three new
entrants, within a specific service area, the new entrant's share of
the cost may be so large, relative to its expected profits, that the
entrant would decide not to enter the market. In contrast, recovering
the costs of currently available number portability from all carriers
based on each local exchange carrier's relative number of active
telephone numbers would not violate this criterion, since the amount to
be recovered from each carrier would increase with the carrier's size,
measured in terms of active telephone numbers or some other measure of
carrier size. In addition, allocating currently available number
portability costs based on active telephone numbers results in
approximately equal per-customer costs to each carrier. We also believe
that assessing costs on a per-telephone number basis should give no
carrier an advantage, relative to its competitors. An alternative
mechanism that would also satisfy our competitive neutrality
requirement would be to recover currently available number portability
costs from all carriers, including local exchange, interexchange, and
CMRS carriers, based on their relative number of presubscribed
customers.
136. We conclude that a variety of approaches currently in use
today essentially comply with our competitive neutrality criteria. One
example is the formula voluntarily being used by carriers in Rochester,
NY, and adopted by the NY DPS in the New York metropolitan area.
Specifically, this mechanism allocates the incremental costs of
currently available number portability measures, through an annual
surcharge assessed by the incumbent LEC from which the number is
transferred. This surcharge is based on each carrier's number of ported
telephone numbers relative to the total number of active telephone
numbers in the local service area. Similarly, as noted above, a cost
recovery mechanism that allocates number portability costs based on a
carrier's number of active telephone numbers (or lines) relative to the
total number of active telephone numbers (or lines) in a service area
would also satisfy the two criteria for competitive neutrality. As
noted above, MFS in Illinois plans to seek regulatory approval for a
similar formula that would allocate the costs of currently available
measures between it and Ameritech based on each carrier's gross
telecommunications revenues net of charges to other carriers. A third
competitively neutral cost recovery mechanism would be to assess a
uniform percentage assessment on a carrier's gross revenues less
charges paid to other carriers. Finally, we believe that a mechanism
that requires each carrier to pay for its own costs of currently
available number portability measures would also be permissible.
137. The cost recovery mechanisms described in the preceding
paragraphs define payments made by new entrants to incumbent LECs for
providing number portability. We recognize that incumbent LECs must
make payments to new entrants if the incumbent LEC wins a customer of
the new entrant that wants to port its number. To be competitively
neutral, the incumbent LEC would have a reciprocal compensation
arrangement with each new entrant. That is, the incumbent LEC would pay
to the new entrant a rate for number portability that was equal to the
rate that the new entrant pays the incumbent LEC.
138. In contrast, requiring the new entrants to bear all of the
costs, measured on the basis of incremental costs of currently
available number portability methods, would not comply with the
statutory requirements of section 251(e)(2). Imposing the full
incremental cost of number portability solely on new entrants would
contravene the statutory mandate that all carriers share the cost of
number portability. Moreover, as discussed above, incremental cost-
based charges would not meet the first criterion for ``competitive
neutrality'' because a new facilities-based carrier would be placed at
an appreciable, incremental cost disadvantage relative to another
service provider, when competing for the same customer. Rates for
interim number portability would also not meet the second criterion if
they approximate the retail price of local service. New entrants may
effectively be precluded from entering the local exchange market if
they are required to bear all the costs of currently available number
portability measures. Retail rates for call forwarding, to the extent
they are set above incremental costs, would also not meet the
principles of competitive neutrality for the same reasons that
incremental cost-based rates would not. Finally, placing the full cost
burden of number portability on new entrants would also deter customers
of incumbent carriers from transferring to a new service provider to
the extent that the entrant passes on the cost of currently available
number portability, in the form of higher prices for customers. In
addition, if incumbent LECs were not required to bear a portion of the
incremental costs of currently available number portability measures,
they would have an incentive to delay implementation of a long-term
number portability method.
139. A carrier has a number of options for seeking relief if it
believes that the pricing provisions for number portability offered by
a LEC violate the statutory standard in section 251(e)(2), the rules we
set forth in this order, or state-mandated cost recovery mechanisms.
First, it may bring action against the carrier in federal district
court pursuant to section 207 for damages or file a section 208
complaint against another carrier alleging a violation of the Act or
the Commission's rules. Alternatively, the carrier may file a request
for declaratory ruling with the Commission, seeking our view on whether
the statute and our rules have been properly applied. Finally, carriers
in many instances will be able to pursue existing avenues before their
state commission if a dispute arises regarding recovery of currently
available number portability costs.
140. Finally, in response to questions concerning the appropriate
treatment of terminating access charges in the interim number
portability context, we conclude that the meet-point billing
arrangements between neighboring incumbent LECs provide the appropriate
model for the proper access billing arrangement for interim number
portability. We decline to require that all of the terminating
interstate access charges paid by IXCs on calls forwarded as a result
of RCF or other comparable number portability measures be paid to the
competing local service provider. On the other hand, we believe that to
permit incumbent LECs to retain all terminating access charges would be
equally inappropriate. Neither the forwarding carrier, nor the
terminating carrier, provides all the facilities when a call is ported
to the other carrier. Therefore, we direct forwarding carriers and
terminating carriers to assess on IXCs charges for terminating access
through meet-point billing
[[Page 38627]]
arrangements. The overarching principle is that the carriers are to
share in the access revenues received for a ported call. It is up to
the carriers whether they each issue a bill for access on a ported
call, or whether one of them issues a bill to the IXCs covering all of
the transferred calls and shares the correct portion of the revenues
with the other carriers involved. If the terminating carrier is unable
to identify the particular IXC carrying a forwarded call for purposes
of assessing access charges, the forwarding carrier shall provide the
terminating carrier with the necessary information to permit the
terminating carrier to issue a bill. This may include sharing
percentage interstate usage (PIU) data and may require the terminating
entity to issue a bill based on allocated interstate minutes per IXC as
derived from data provided by the forwarding carrier.
G. Number Portability by CMRS Providers
1. Background
141. In our NPRM, we sought comment and other information on the
competitive significance of service provider portability for the
development of competition between CMRS and wireline service providers.
We also sought comment on the current, and estimated future, demand of
commercial mobile radio service customers for portable wireless
telephone numbers when they change their service provider either to
another CMRS provider or to a wireline service provider. Finally, we
sought comment on whether the burdens of implementing service provider
portability (1) between CMRS carriers, and (2) between CMRS and
wireline carriers are similar to the burdens of implementing service
provider portability between wireline carriers.
2. Position of the Parties
142. Parties commenting on CMRS issues generally fall into three
groups. One group consists of the providers of Personal Communications
Services (PCS). The PCS providers are just beginning to build advanced
wireless networks to enter the market. Their successful market entry
depends largely upon convincing consumers of other commercial mobile
radio services, e.g., cellular, to switch to PCS. The PCS providers
therefore want number portability to be implemented as soon as
technically possible. A second group is composed primarily of cellular
providers, along with paging and messaging service providers. Parties
in this category are generally incumbent service providers with
relatively less sophisticated systems. These parties generally claim
that number portability is unnecessary in the CMRS marketplace and
oppose being required to upgrade their networks for such capabilities
at allegedly great expense. A third group includes parties, such as
Ameritech and AT&T Wireless, that support implementation of number
portability by CMRS providers, but on a later deployment schedule than
wireline portability so as to allow time for technical issues specific
to CMRS to be resolved.
143. Authority to Require CMRS Providers To Provide Number
Portability. SBC Communications argues that CMRS providers have no
obligation to provide number portability under the 1996 Act, since the
1996 Act imposes that duty only on LECs, and the definition of LEC
specifically excludes CMRS providers. As a result, SBC Communications
claims, the Commission should examine CMRS portability separately from
wireline portability. Similarly, Bell Atlantic NYNEX Mobile, Arch/
AirTouch Paging, and MobileMedia argue that the 1996 Act and its
legislative history demonstrate that the number portability obligation
of section 251(b)(2) was not intended to apply to CMRS providers.
BellSouth further argues that CMRS providers should not be required to
offer portability until they compete directly with a LEC. Moreover,
Bell Atlantic NYNEX Mobile asserts that section 332 of the
Communications Act only subjects CMRS providers to limited regulation,
where there is a ``clear cut need'' for doing so.
144. Importance of Number Portability to CMRS Providers. Most PCS
providers maintain that number portability is important in the CMRS
industry because it will promote competition between different types of
CMRS providers. PCIA supports long-term number portability solutions
for broadband PCS systems when they are technically feasible, and urges
the Commission to set a consistent long-term nationwide policy for
number portability. Omnipoint, a winner of several licenses in the
broadband PCS C Block auction, explains that the success of PCS entry
depends on whether PCS providers can attract a significant share of
embedded cellular customers.
145. PCIA maintains that number portability is of considerable
competitive importance to the broadband CMRS market because the
advantages of portability will be a significant factor in consumers'
decisions to change providers even though they must endure the
inconvenience of changing equipment to do so. PCS Primeco claims that
arguments made by incumbent cellular companies that downplay the
importance of CMRS number portability are based on the fact that
current cellular subscribers usually do not make their numbers widely
known because, under existing cellular pricing plans, subscribers
typically pay for both inbound and outbound calls. PCS Primeco contends
that, since cellular and other CMRS customers do not distribute their
numbers widely, such customers currently may not regard number
portability as an important factor in deciding whether to switch CMRS
providers. PCS Primeco asserts that in the future, as CMRS providers
compete to become a substitute for wireline service, they will not
assess charges on inbound calls, and CMRS customers will assign the
same importance to number portability as wireline subscribers do today.
PCIA argues similarly that portability will facilitate the convergence
of and competition between CMRS and wireline services, which will
likely result in cellular customers publishing their telephone numbers.
PCIA adds that the ability to transfer telephone numbers between
wireline and CMRS carriers ameliorates ``number exhaustion'' concerns.
The Illinois Commerce Commission also considers number portability
between wireline and CMRS providers important.
146. CTIA maintains that the CMRS industry supports the goal of
full number portability for all telecommunications providers, including
CMRS providers, but claims that the Commission should not delay
implementation of service provider portability in the wireline networks
while awaiting network solutions for CMRS carriers. Most of the
commenting cellular providers believe that number portability is not as
important to CMRS providers as it is to wireline service providers
because there is little current demand for CMRS number portability and
because of the unique technical problems involved. AT&T asserts that,
while number portability is more important in the wireline market than
the CMRS market, the Commission should not preclude such portability
for CMRS carriers. Parties opposing CMRS portability generally argue
that the benefits of CMRS portability are diminished by the following
factors: (1) Substantial competition already exists in the CMRS market
since CMRS customers already may choose from multiple competitive
carriers; (2) CMRS customers place less value on their
[[Page 38628]]
numbers, as indicated by the fact that they do not publish them, do not
often make them available through directory assistance, and more
frequently change their telephone numbers due to competition and a
variety of non-competitive reasons; (3) number portability would impair
the ability of a carrier to identify immediately the validity of a
customer's number and thereby prevent fraudulent use of numbers; (4)
customers will have a disincentive to switch carriers because broadband
PCS will require equipment that is not compatible with incumbent
cellular equipment; (5) number portability would adversely affect
roaming capabilities because cellular carriers rely on the ability to
identify a roaming cellular customer's ``home carrier'' by the NPA/NXX;
(6) service provider portability would require CMRS carriers to expand
significantly the capacity of their roaming databases to provide
additional information about each subscriber and his or her current
service provider; and (7) CMRS uses different signalling protocols than
wireline carriers, which will make implementation of number portability
more difficult.
147. Paging providers similarly oppose being required to provide
number portability. Arch/AirTouch Paging claims that the recent
proliferation of new area codes, the introduction of a variety of
competing services, and the availability of 800 and 888 numbers (and
possibly of portable 500 and 900 numbers) have reduced in general the
importance of number portability for all carriers. Arch/AirTouch Paging
further argues against the imposition of number portability on CMRS
providers because it believes competition will continue to develop
without number portability. It maintains that various factors, such as
price, service quality, coverage area, equipment functions, customer
service, and enhanced service options can overcome the reluctance of
customers to change carriers. PageNet argues that paging and messaging
service providers should not be required to provide number portability
because these services are already competitive, as no single carrier
controls more than 12 percent of any paging market, and that markets,
on average, have five competing carriers.
148. Deployment of Long-Term Solutions by CMRS Carriers. The PCS
providers generally assert that CMRS providers will face technical
burdens comparable to wireline carriers in updating their networks, and
argue that there is no reason to treat CMRS providers differently from
wireline carriers. Some CMRS parties indicate that it is technically
possible to update cellular and PCS networks to accommodate long-term
number portability. PCIA acknowledges that implementation of number
portability by CMRS providers presents technical difficulties specific
to CMRS, but argues that such difficulties can be overcome. PCIA
asserts that most broadband carriers already plan to deploy the
components necessary to implement LRN (i.e., SS7 signaling, AIN/IN to
do database queries and responses, and AIN triggers). Omnipoint
contends that implementation deadlines for number portability should
apply equally to wireless and wireline carriers, and proposes
implementation in the top 100 MSAs between October 1997 and October
1998. Competitive Carriers argues that the Commission's number
portability rules should be technology-neutral, and favors requiring
implementation of number portability within 24 months of the issuance
of our Order throughout the top 100 MSAs.
149. In contrast, several cellular interests claim that upgrading
cellular networks to handle number portability will require greater
time and effort than adapting wireline networks, primarily because
relatively few cellular networks have IN or AIN capabilities, and
because the current six-digit-based screening used to validate customer
information and handle billing will have to be adapted to ten-digit-
based screening. These parties claim that the necessary standards for
functions such as ten-digit-based screening have yet to be developed.
150. Several parties caution that implementing number portability
for CMRS providers will require more time than for wireline service
providers because to date industry efforts aimed at developing number
portability have focused on wireline carriers. For example, CMRS
carriers did not participate in the Illinois number portability
workshop and CMRS carriers generally have not participated in technical
trials of number portability. PCIA estimates that it will be four to
five years before CMRS networks are capable of implementing long-term
number portability. Similarly, AT&T Wireless argues that CMRS carriers
must follow a different implementation schedule than wireline.
151. Interim Number Portability Measures. Many of the CMRS carriers
oppose requiring CMRS carriers to provide measures such as RCF and DID.
PCIA and Arch/AirTouch Paging claim that requiring interim measures
would divert resources from, and thus delay implementation of, a long-
term method. The paging service providers, in particular, oppose
interim measures as not cost-justified and unnecessary for the already
competitive paging industry. According to PCIA, RCF and DID currently
cannot be provided by mobile telephone switching offices and would be
more problematic and expensive to deploy in a CMRS network than in a
wireline network. For example, PCIA claims that RCF requires carriers
to maintain a point of interconnection within each NPA in which it
intends to provide such service, and that, currently, many broadband
CMRS carriers' switches do not interconnect at all such points. In
addition, PCIA asserts that most new broadband carriers are already
planning to deploy the components necessary to implement a long-term
database method as part of their initial network designs. Consequently,
those new broadband carriers might have to spend as much or more to
upgrade their networks to support interim measures as they would to
upgrade to support a long-term database method. Because substantial
resources would have to be devoted to modifying CMRS networks to
support interim measures, and thus diverted away from modifying CMRS
networks to support long-term number portability, requiring
implementation of interim measures now might delay future
implementation of the long-term method. Other CMRS carriers make claims
of technical inefficiencies, but acknowledge that RCF and DID are
technically possible for CMRS providers today.
3. Discussion
152. Authority to Require CMRS Providers to Provide Number
Portability. Section 251(b) requires local exchange carriers to provide
number portability to all telecommunications carriers, and thus to CMRS
providers as well as wireline service providers. The statute, however,
explicitly excludes commercial mobile service providers from the
definition of local exchange carrier, and therefore from the section
251(b) obligation to provide number portability, unless the Commission
concludes that they should be included in the definition of local
exchange carrier. Our recent NPRM on interconnection issues raised by
the 1996 Act seeks comment on whether, and to what extent, CMRS
providers should be classified as LECs. Because we conclude that we
have independent bases of jurisdiction over commercial mobile service
providers, we need not decide here whether CMRS providers must provide
number portability as
[[Page 38629]]
local exchange carriers under section 251(b).
153. We possess independent authority under sections 1, 2, 4(i),
and 332 of the Communications Act of 1934, as amended, to require CMRS
providers to provide number portability as we deem appropriate.
Ensuring that the portability of telephone numbers within the United
States is handled efficiently and fairly is within our jurisdiction
under these other provisions of the Communications Act. Sections 2 and
332(c)(1) of the Act give the Commission authority to regulate
commercial mobile service providers as common carriers, except for the
provisions of Title II that we specify are inapplicable. Section 1 of
the Act requires the Commission to make available to all people of the
United States ``a rapid, efficient, Nation-wide, and world-wide wire
and radio communication service.'' The Commission's interest in number
portability is bolstered by the potential deployment of different
number portability solutions across the country, which would
significantly impact the provision of interstate telecommunications
services. Section 1 also creates a significant federal interest in the
efficient and uniform treatment of numbering because such a system is
essential to the efficient delivery of interstate and international
telecommunications. Implementation of long-term service provider
portability by CMRS carriers will have an impact on the efficient use
and uniform administration of the numbering resource. Section 4(i)
grants the Commission authority to ``perform any and all acts, make
such rules and regulations, and issue such orders, not inconsistent
with [the Communications Act of 1934, as amended], as may be necessary
in the execution of its functions.'' We conclude that the public
interest is served by requiring the provision of number portability by
CMRS providers because number portability will promote competition
between providers of local telephone services and thereby promote
competition between providers of interstate access services.
154. Bell Atlantic NYNEX Mobile cites the CT DPUC Petition in
support of its argument that the Commission can only regulate CMRS
providers under section 332 to the extent clearly necessary, and that
regulation of number portability is not clearly necessary in the CMRS
market. We conclude, however, that the CT DPUC Petition does not limit
our authority to require CMRS providers to provide number portability
to other CMRS or wireline carriers because that proceeding did not
address the Commission's authority to require CMRS providers to provide
number portability. That proceeding related solely to state authority
to regulate rates of CMRS providers. We believe that imposing number
portability obligations on CMRS providers will foster increased
competition in the CMRS marketplace, and furthers our CMRS regulatory
policy of establishing moderate, symmetrical regulation of all
services, and a preference for curing market imperfections by lowering
barriers to entry in order to encourage competition.
155. Importance of Number Portability to CMRS Providers. We require
cellular, broadband PCS, and covered specialized mobile radio (SMR)
providers (as defined in the First Report and Order in CC Docket 94-
54), which are the CMRS providers that are expected to compete in the
local exchange market, to offer number portability. This mandate is in
the public interest because it will promote competition among cellular,
broadband PCS, and covered SMR carriers, as well as among CMRS and
wireline providers. We therefore include those carriers in our mandate
to provide long-term service provider portability, under the
Commission-mandated performance criteria set forth above, pursuant to
our authority under sections 1, 2, 4(i), and 332 of the Communications
Act of 1934. This mandate applies when switching among wireline service
providers and broadband CMRS providers, as well as among broadband CMRS
providers, even if the broadband CMRS and wireline service providers or
the two broadband CMRS providers are affiliated. We base this
conclusion on our view, as discussed in the following paragraphs, that
cellular, broadband PCS, and covered SMR providers will compete
directly with one another, and potentially will compete in the future
with wireline carriers.
156. We specifically exclude at this time paging and other
messaging services, and the following CMRS providers as listed in part
20 of our rules: Private Paging, Business Radio Services, Land Mobile
Systems on 220-222 MHz, Public Coast Stations, Public Land Mobile
Service, 800 MHz Air-Ground Radio-Telephone Service, Offshore Radio
Service, Mobile Satellite Services, Narrowband PCS Services. We do so
because such services currently will have little competitive impact on
competition between providers of wireless telephony service or between
wireless and wireline carriers. Because local SMR licensees offering
mainly dispatch services to specialized customers in a non-cellular
system configuration do not compete substantially with cellular and
broadband PCS providers, we also exclude them from the number
portability requirements we adopt today. For similar reasons, we also
specifically exclude at this time Local Multipoint Distribution Service
(LMDS). If, however, any of these services begins to compete in the
local exchange market, or if there are other public interest reasons to
require them to provide number portability, we will reassess the
exclusion of these services from the requirement to provide number
portability.
157. Service provider portability between cellular, broadband PCS,
and covered SMR providers is important because customers of those
carriers, like customers of wireline providers, cannot now change
carriers without also changing their telephone numbers. While we
recognize that customers may need to purchase new equipment when
switching among such CMRS providers, the inability of customers to keep
their telephone numbers when switching carriers also hinders the
successful entrance of new service providers into the cellular,
broadband PCS, and SMR markets. We believe, therefore, that service
provider portability, by eliminating one major disincentive to switch
carriers, will ameliorate customers' disincentive to switch carriers if
they must purchase new equipment. We believe service provider
portability will promote competition between existing cellular
carriers, as well as facilitate the viable entry of new providers of
innovative service offerings, such as PCS and covered SMR providers.
158. With the recent and expected future entry of new PCS
providers, and the growth of existing CMRS generally, we believe it
important that service provider portability for cellular, broadband
PCS, and covered SMR providers be made available so as to remove
barriers to competition among such providers. Removing barriers, such
as the requirement of changing telephone numbers when changing
providers, will likely stimulate the development of new services and
technologies, and create incentives for carriers to lower prices and
costs. We find unpersuasive arguments that number portability is
unimportant because the CMRS market is already substantially
competitive since CMRS customers already may choose from multiple
competitive carriers. Most CMRS customers today subscribe to cellular
service because broadband PCS has been offered for a very short time,
[[Page 38630]]
SMR service has typically been used for communications among mobile
units of the same business subscriber (e.g., taxi dispatch), and mobile
satellite services have typically been used only in rural areas. The
possibility of entry by new competitors can constrain monopolistic, or
in this case, duopolistic, conduct by incumbent providers and thus
serve the public interest by potentially lowering prices, improving
service quality, and encouraging innovation. We note that while the
cellular industry, with two facilities-based carriers offering service
in each market area, is more competitive than traditional monopoly
telephone markets, it is far from perfectly competitive. The United
States Government Accounting Office, the Department of Justice, and the
Commission have determined that only limited competition currently
exists in the cellular market.
159. We conclude that number portability will facilitate the entry
of new service providers, such as PCS and covered SMR providers, into
CMRS markets currently dominated by cellular carriers, and thus provide
incentives for incumbent cellular carriers to lower prices and increase
service choice and quality. Indeed, we noted recently that competition
from PCS, alone, is expected to reduce cellular prices by as much as 40
percent over the next two years. We believe that such pro-competitive
effects will be enhanced by eliminating the need for customers to
change telephone numbers when switching providers of cellular services,
broadband PCS, and covered SMR services.
160. We further conclude that number portability will promote
competition between CMRS and wireline service providers as CMRS
providers offer comparable local exchange and fixed commercial mobile
radio services. The Commission has recognized on several occasions that
CMRS providers, such as broadband PCS and cellular, will compete in the
local exchange marketplace. For example, the Commission permitted
Southwestern Bell Mobile Systems, Inc. to own local exchange facilities
outside of Southwestern Bell's service area in order to ``promote
significant Commission objectives by encouraging local loop
competition. The development of CMRS is one of several potential
sources of competition that we have identified to bring market forces
to bear on the existing LECs.'' The Commission also adopted an auction
licensing mechanism to speed deployment of PCS and thereby ``create
competition for existing wireline and wireless services.'' In addition,
the Commission decided to permit foreign investment in Sprint
Corporation based, in part, on a finding that a portion of that
investment would be used to fund PCS competition with wireline local
exchange providers in the U.S. market. Finally, in the Fixed CMRS
Notice (61 FR 6189 (February 16, 1996)), the Commission tentatively
concluded that PCS and cellular providers will provide fixed CMRS local
loop services, and that such carriers will directly compete with
traditional wireline local exchange carriers. We believe, for the
reasons stated above, that service provider portability will encourage
CMRS-wireline competition, creating incentives for carriers to reduce
prices for telecommunications services and to invest in innovative
technologies, and enhancing flexibility for users of telecommunications
services.
161. We find unpersuasive commenters' arguments that number
portability is not a competitive issue for CMRS providers because
consumers are not interested in retaining their CMRS numbers. We
recognize that currently customers of cellular, broadband PCS, and
covered SMR providers may generally initiate more calls than they
receive, and are reluctant to distribute their CMRS telephone numbers.
We agree with the argument advanced by PCS Primeco that this reluctance
generally is caused by the current cellular carrier pricing structures,
under which customers pay for incoming calls, rather than lack of
attachment to CMRS telephone numbers. Several parties have indicated
that at least some CMRS providers intend to compete with wireline
carriers in the local exchange market. To do so effectively, CMRS
carriers are likely to change their pricing structures to resemble more
closely wireline pricing structures. As broadband CMRS pricing
structures are modified as a likely result of increased competition,
and cellular, broadband PCS, and covered SMR become integrated and less
functionally distinguishable from wireline services, customers may be
more likely to make their CMRS telephone numbers known, and utilize
numbering resources in a manner more comparable with that of the
current wireline market. We, therefore, conclude that requiring number
portability for cellular, broadband PCS, and covered SMR providers will
enhance the development of competition among those providers and among
CMRS and wireline service providers.
162. Deployment of Long-Term Solutions by CMRS Carriers. The record
of this proceeding suggests that cellular, broadband PCS, and covered
SMR providers will face burdens comparable to wireline carriers in
modifying their networks to implement number portability, and that any
technical issues that are unique to those carriers can be resolved.
While a number of parties have raised CMRS-specific issues that must be
resolved before CMRS carriers can effectively provide number
portability, we conclude that the record demonstrates that none of
these difficulties are insurmountable. Several parties claim that CMRS
networks can be updated to accommodate long-term number portability. In
addition, the report on number portability recently released by the INC
indicates that broadband CMRS roaming systems, including mobile station
registration and call delivery, switches, protocols, and wireline
interconnection arrangements can be updated to accommodate number
portability. PCIA asserts that most broadband carriers already plan to
deploy the components necessary to implement LRN (i.e., SS7 signaling,
IN/AIN to do database queries and responses, and AIN triggers).
Omnipoint argues that the cellular industry has failed to demonstrate
why CMRS-specific technical issues cannot be worked out within the same
time as wireline technical issues.
163. A number of commenters, however, also suggest that
implementation of service provider portability for broadband CMRS would
necessitate more time than deployment of wireline methods. For
instance, several cellular interests claim that upgrading cellular
networks to handle number portability will require greater time and
effort than adapting wireline networks, primarily because relatively
few cellular networks have IN or AIN capabilities, and because the
current six-digit-based screening used to provide roaming, validate
customer information, and handle billing will have to be adapted to
ten-digit-based screening. These parties claim that the necessary
standards for functions such as ten-digit-based screening have yet to
be developed.
164. It appears that while the wireline industry has already
developed many of the standards and protocols necessary for wireline
carriers to provide number portability, the CMRS industry is only
beginning to address the additional standards and protocols specific to
the provision of portability by CMRS carriers. The technical
requirements for broadband CMRS portability have been given
comparatively little attention compared to those for wireline. Initial
state efforts have generally not addressed CMRS issues; for example,
the Illinois Number Portability
[[Page 38631]]
Workshop, which began studying wireline portability in April 1995, only
plans to begin addressing CMRS portability in July 1996. Moreover,
cellular, broadband PCS, and covered SMR providers face technical
burdens unique to the provision of seamless roaming on their networks,
and standards and protocols will have to be developed to overcome these
difficulties. Therefore, based on the record, and the technical
evidence presented both by the parties in this proceeding and the INC
Report, we conclude that cellular, broadband PCS, and covered SMR
providers should implement long-term service provider portability based
on the following schedule.
165. We require all cellular, broadband PCS, and covered SMR
carriers to have the capability of querying appropriate number
portability database systems in order to deliver calls from their
networks to ported numbers anywhere in the country by December 31,
1998, the date by which wireline carriers must complete implementation
of number portability in the largest 100 MSAs. This schedule will
ensure that cellular, broadband PCS, and covered SMR providers will
have the ability to route calls from their customers to a wireline
customer who has ported his or her number, by the time a substantial
number of wireline customers have the ability to port their numbers
between wireline carriers. This capability to access a database for
routing information can be accomplished in either of two ways. First,
the carrier may implement hardware and software upgrades (e.g., IN/AIN
capabilities) similar to those needed in wireline networks. Since these
upgrades do not require development of the standards and protocols
necessary to support roaming, we believe that cellular, broadband PCS,
and covered SMR carriers should be able to complete these upgrades by
the date by which wireline carriers must complete implementation of
number portability in the largest 100 MSAs. Second, the carrier may
make arrangements with other carriers that are capable of performing
database queries. Cellular, broadband PCS, and covered SMR carriers
operating in areas outside the largest 100 MSAs thus would need to make
arrangements with other CMRS providers that have the capability to
query databases, or with wireline carriers in the largest 100 MSAs,
which will have completed deployment of number portability by December
31, 1998.
166. We require all cellular, broadband PCS, and covered SMR
carriers to offer service provider portability throughout their
networks, including the ability to support roaming, by June 30, 1999.
The record indicates that additional time is needed to develop
standards and protocols, such as ten-digit-based screening, to overcome
the technical burdens unique to the provision of seamless roaming on
cellular, broadband PCS, and covered SMR networks. Individual carriers,
of course, may implement number portability sooner, and we expect that
some carriers will do so based on individual technical, economic, and
marketing considerations. We believe a nationwide implementation date
for number portability for cellular, broadband PCS, and covered SMR
providers is necessary to ensure that validation necessary for roaming
can be maintained. We delegate authority to the Chief, Wireless
Telecommunications Bureau, to establish reporting requirements in order
to monitor the progress of cellular, broadband PCS, and covered SMR
providers implementing number portability, and to direct such carriers
to take any actions necessary to ensure compliance with this deployment
schedule. We believe it necessary to establish reporting requirements
for CMRS to ensure timely resolution of the standards issues unique to
CMRS number portability, particularly roaming.
167. We recognize, however, that additional technical issues may
arise as the industry begins to focus on provision of portability by
CMRS carriers. We therefore delegate authority to the Chief, Wireless
Telecommunications Bureau, to waive or stay any of the dates in the
implementation schedule, as the Chief determines is necessary to ensure
the efficient development of number portability, for a period not to
exceed 9 months (i.e., no later than September 30, 1999, for the first
deadline, and no later than March 31, 2000, for the second deadline).
168. In the event a carrier is unable to meet our deadlines for
implementing a long-term number portability solution, it may file with
the Commission at least 60 days in advance of the deadline a petition
to extend the time by which implementation in its network will be
completed. We emphasize, however, that carriers are expected to meet
the prescribed deadlines, and a carrier seeking relief must present
extraordinary circumstances beyond its control in order to obtain an
extension of time. Carriers seeking such relief must demonstrate
through substantial, credible evidence the basis for its contention
that it is unable to comply with our deployment schedule. Such requests
must set forth: (1) The facts that demonstrate why the carrier is
unable to meet our deployment schedule; (2) a detailed explanation of
the activities that the carrier has undertaken to meet the
implementation schedule prior to requesting an extension of time; (3)
an identification of the particular switches for which the extension is
requested; (4) the time within which the carrier will complete
deployment in the affected switches; and (5) a proposed schedule with
milestones for meeting the deployment date.
169. Interim Number Portability Measures. We do not require CMRS
providers to provide RCF, DID, or comparable measures. Different
treatment of CMRS and wireline carriers in this instance is justified
by their differing circumstances. According to the record, RCF and DID
currently cannot be provided by mobile telephone switching offices. Due
to the different nature of CMRS networks and wireline networks,
implementation of RCF or DID capability in a CMRS network appears far
more problematic and expensive than in a wireline network. For example,
PCIA claims that RCF requires carriers to maintain a point of
interconnection within each NPA in which it intends to provide such
service, and that currently, many broadband CMRS carriers' switches do
not interconnect at all such points. Moreover, cellular roaming systems
would have to be modified to account for the fact that, under RCF, a
number different than the one dialed is used to route the call. As a
result, alternative means will have to be developed to enable CMRS
carriers to validate mobile subscribers who have roamed out of their
service areas. Broadband carriers may also have to purchase new
switches in order to provide RCF and DID. Moreover, most new broadband
carriers are already planning to deploy the components necessary to
implement a long-term database method as part of their initial network
designs. Consequently, those new broadband carriers might have to spend
as much or more to upgrade their networks to support interim measures
as they would spend to upgrade to support a long-term database method,
and requiring implementation of both might delay implementation of the
long-term method. We also find it significant that, while the wireline
parties advocating full portability generally support interim measures,
the CMRS parties advocating full portability generally oppose interim
measures.
170. We therefore conclude that it would be counterproductive to
require
[[Page 38632]]
CMRS carriers to provide interim measures since they can provide long-
term portability comporting with our standards just as quickly and less
expensively. We believe that relieving cellular, broadband PCS, and
covered SMR carriers of the burden of providing interim measures will
allow them to devote their full resources toward implementing a long-
term method and thus enhance their ability to provide long-term
portability on the same schedule as wireline carriers. We note that
CMRS carriers are, of course, free to provide interim number
portability, if they choose to do so.
171. Number Transferability. A few parties raise the issue of
number transferability, the ability of a reseller to transfer telephone
numbers from one facilities-based carrier to another in order to permit
the reseller's end user customers to retain their existing telephone
numbers. Because the record does not establish any relationship between
number transferability and number portability, and does not identify
the technical issues involved in providing number transferability, we
decline to address the provision of number transferability in this
proceeding. We note that this issue has been raised in the Second CMRS
Interconnection NPRM (60 FR 20949 (April 28, 1996)), and will be
addressed in CC Docket No. 94-54.
H. Service and Location Portability
1. Background
172. While service provider portability refers to the ability of
end users to retain the same telephone numbers as they change from one
service provider to another, service portability refers to the ability
of users of telecommunications services to retain existing
telecommunications numbers without impairment of quality, reliability,
or convenience when switching from one telecommunications service to
another service provided by the same telecommunications carrier. We
regard switching among wireline service providers and broadband CMRS
providers, or among broadband CMRS providers, as changing service
providers, not changing services, even if the broadband CMRS and
wireline service providers or the two broadband CMRS providers are
affiliated. We base this conclusion on our view that CMRS providers,
such as cellular, broadband PCS, and covered SMR providers, compete
directly with one another, and broadband CMRS providers potentially
will compete in the future with wireline carriers.
173. Today, telephone subscribers must change their telephone
number when they change telephone service (e.g., from Plain Old
Telephone Services (POTS) to Integrated Services Digital Network
(ISDN)) because a particular service may be available only through a
particular switch. In our NPRM, we sought comment on the demand for
service portability and the extent to which a lack of service
portability inhibits the growth of new services, such as ISDN. We
requested information on the relative importance of service portability
to the decisions of end users when considering whether to switch from
one service to another. We also sought comment on what public interest
objectives would be served by encouraging (or possibly mandating)
implementation of service portability, and how the Commission could
encourage service portability.
174. Location portability refers to the ability of users of
telecommunications services to retain existing telecommunications
numbers without impairment of quality, reliability, or convenience when
moving from one physical location to another. Today, telephone
subscribers must change their telephone numbers when they move outside
the area served by their current central office. In our NPRM, we sought
comment on the demand for location portability and the geographic area
in which portability might be desired by consumers. We asked what
federal policy objectives would be served by encouraging (or possibly
mandating) implementation of location portability, and how such
objectives could be attained. We sought comment on the potential impact
that location portability for wireline telephone numbers and the
development of the 500 personal communications services market, which
permits customers to be reached through a single telephone number
regardless of their location, may have on each other.
2. Position of the Parties
175. Most parties agree that location portability and service
portability do not have the same potential impact on consumer choice
and on the development of local competition as service provider
portability. Pacific Bell and the Missouri PSC argue that the
availability of service portability will be driven by market forces,
and that product differentiation will stimulate customers to change
their telecommunications services. Ameritech and SBC Communications
note that since the 1996 Act addresses only service provider
portability, the Commission should not adopt rules mandating service
and location portability. OPASTCO claims that requiring service
portability would strain the limited abilities of small LECs, and thus
delay deployment of rural infrastructure. The Missouri PSC and New York
DPS argue that there currently is not enough demand for ISDN to warrant
requiring service portability. The Florida PSC, on the other hand,
maintains that, in many cases, service portability is already
available, as long as the switch has the needed functionality.
176. Most parties agree that implementation of location portability
poses many problems, including: (1) Loss of geographic identity of
one's telephone number; (2) lack of industry consensus as to the proper
geographic scope of location portability; (3) substantial modification
of billing systems and the consumer confusion regarding charges for
calls; (4) loss of the ability to use 7-digit dialing schemes; (5) the
need to restructure directory assistance and operator services; (6)
coordination of number assignments for both customer and network
identification; (7) network and switching modifications to handle a
two-tiered numbering system; (8) development and implementation of
systems to replace 1+ as toll identification; and (9) possible adverse
impact on E911 services.
177. Several BOCs maintain that the Commission should require
location portability immediately because currently new entrants can
serve larger geographic areas with a single switch. Some of these
parties maintain that the ability of competing carriers to serve larger
geographic areas from a single wire center may increase consumer demand
for location portability, thus giving competing carriers an advantage
over incumbent LECs. MCI, SBC Communications, Nextel, and Arch/AirTouch
Paging argue that, if location portability is implemented, it should be
limited to the local calling area of a wireline carrier. MCI further
maintains that allowing numbers to be transferred across NPA or state
boundaries would negatively affect the numbering resource because
individuals could remove numbers from the NPA by taking such numbers to
other areas of the country. In contrast, GSA believes that the greater
the geographic scope of location portability, the more meaningful the
consumer benefits.
178. While many parties believe location portability has some
value, most parties maintain that its implementation should not delay
implementation of service provider portability. At the same time,
numerous parties, including incumbents, new entrants, and state
commissions, argue
[[Page 38633]]
that any number portability method adopted by the Commission should be
capable of expanding to encompass location portability if such demand
arises. GSA, Nortel, and Bell Atlantic argue that a long-term
portability method should eventually encompass service and location
portability. The National Emergency Numbering Association (NENA)
contends the statutory definition of ``number portability'' in its
broadest interpretation would limit any requirement to provide location
portability to the area served by the same central office.
179. Pacific Bell and Time Warner Holdings argue that market forces
should drive the development of location portability. Florida PSC,
Missouri PSC, ACTA, Pacific Bell, BellSouth, and Sprint maintain that
current market demand for location portability is mixed, and depends on
such factors as the geographic scope of location portability and costs
of implementation. GSA, on the other hand, claims that demand for
location portability is reflected in the increase in demand for 800
services and by the demand for 500 services. A number of wireless
parties argue that wireless carriers already provide significant
location portability. Finally, the New York DPS maintains that location
portability, if limited to a rate center, will avoid the problems of
customer confusion, and that the 1996 Act does not prohibit provision
of location portability within that limitation.
180. OPASTCO, SBC Communications, and Nextel argue that location
portability should only be provided through use of non-geographic
numbers, such as 500 services. GTE argues that its survey illustrates
that customers are not adverse to a one-time number change to a non-
geographic number in order to have number portability. Florida PSC
maintains, however, that location portability and 500 services serve
different purposes, with location portability providing the ability to
take a phone number when a customer changes premises, and 500 services
providing the ability to take a telephone number to different locations
during the day, week, or month.
3. Discussion
181. We decline at this time to require LECs to provide either
service or location portability. This decision is not inconsistent with
the 1996 Act, which mandates the provision of service provider
portability, but does not address explicitly service or location
portability. The 1996 Act's requirement to provide number portability
is limited to situations when users remain ``at the same location,''
and ``switch[ ] from one telecommunications carrier to another,'' and
thus does not include service and location portability.
182. While the 1996 Act does not require LECs to offer service and
location portability, it does not preclude this Commission from
mandating provision of these features if it would be in the public
interest, nor does it prevent carriers from providing service and
location portability, consistent with this Order, if they so choose. We
believe, however, that requiring service or location portability now
would not be in the public interest. As the record indicates, service
provider portability is critical to the development of competition, but
service and location portability have not been demonstrated to be as
important to the development of competition.
183. Consistent with the result advocated by most parties
commenting on this issue, we believe that a mandate for service
portability is unnecessary for several reasons. First, and most
importantly, requiring carriers to make the necessary switch and
network modifications to accommodate service portability as well as
service provider portability may delay implementation of the latter.
Second, consumer demand for service portability is unclear. The record
indicates that the benefits of service portability are limited because
the current unavailability of this capability affects only customers
who wish to change their current service to Centrex and ISDN services
or vice versa. Since most non-basic services offered by incumbent LECs
are purchased in addition to (not in lieu of) basic services,
implementation of service portability may actually lower demand for the
alternate services if it raises their prices. Third, our requirement to
provide service provider portability does not preclude carriers from
offering service portability where they perceive a demand for it. In
fact, our mandate will likely facilitate carriers' ability to provide
service portability. Service provider portability will naturally drive
the provision of service portability because if a user can receive a
different service and keep the same number simply by switching
carriers, service providers will have an incentive to offer service
portability to keep those customers. Finally, carrier attempts to
differentiate their products from those of other carriers will
stimulate changes in services by customers, regardless of service
portability.
184. We also believe that, at this time, the disadvantages of
mandating location portability outweigh the benefits. Our chief concern
is that users currently associate area codes with geographic areas and
assume that the charges they incur will be in accordance with the
calling rates to that area. Location portability would create consumer
confusion and result in consumers inadvertently making, and being
billed for, toll calls. Consumers would be forced to dial ten, rather
than seven, digits to place local calls to locations beyond existing
rate centers. In order to avoid this customer confusion, carriers, and
ultimately consumers, would incur the additional costs of modifying
carriers' billing systems, replacing 1+ as a toll indicator, and
increasing the burden on directory, operator, and emergency services to
accommodate 10-digit dialing and the loss of geographic identity.
185. In addition to the disadvantages, the demand for location
portability is currently unclear. There is no consensus on the
preferred geographic scope of location portability. Also, users who
strongly desire location portability can use non-geographic numbers by
subscribing to a 500 or toll free number. Finally, whereas having to
change numbers deters users from switching service providers, we
believe that a customer's decision to move to a new residential or
business location generally would not be influenced significantly by
the availability of number portability. Therefore, location portability
will not foster the development of competition to the same extent as
service provider portability.
186. We recognize that new entrants will be able to offer a greater
range of location portability per switch due to their network
architecture and because they will generally have fewer customers in
the area covered by a switch. To avoid the consumer confusion and other
disadvantages inherent in requiring location portability, however, we
believe state regulatory bodies should determine, consistent with this
Order, whether to require carriers to provide location portability. We
believe the states should address this issue because we recognize that
``rate centers'' and local calling areas have been created by
individual state commissions, and may vary from state to state. To the
extent rate centers and/or local calling areas vary from state to
state, the degree of location portability possible without causing
consumer confusion may also vary. We therefore expect state regulatory
bodies to consider the particular circumstances in their respective
locales in determining whether to require carriers to implement
location portability.
[[Page 38634]]
187. We recognize that location portability would promote consumer
flexibility and mobility and potentially promote competition by
allowing carriers to offer different levels of location portability in
a competitive manner. Also, the importance that consumers attribute to
the geographic identity of their telephone numbers may change, and our
concerns regarding customer confusion may no longer hold true. For
these reasons, we require any long-term method to have the capability
of accommodating location and service portability if, in the future,
demand increases or the burdens decrease.
I. 500 and 900 Number Portability
1. Background
188. Currently, consumers can purchase 500 or 900 services from
either local exchange or interexchange carriers. A consumer subscribing
to 500 service receives a 500 ``area code'' number that can be
programmed to deliver calls wherever the consumer travels in the United
States and in many locations around the world. 900 service is a calling
service providing businesses with a method to deliver information,
advice, or consultations quickly and conveniently by telephone.
Individuals calling 500 or 900 subscribers dial 500 or 900 plus a 7-
digit number (NXX-XXXX). When a call is placed to a 500 or 900 service
telephone number, the originating LEC uses the NXX of the dialed number
to identify the carrier serving either the owner of the 500 number, or
the business operating the 900 number service. The LEC then routes the
call over the appropriate carrier's network.
189. In the NPRM, we tentatively concluded that service provider
portability for 500 and 900 numbers is beneficial for customers of
those services. We sought comment on this tentative conclusion and on
the costs (monetary and nonmonetary) of making such portability
available. With respect to 500 service provider portability, we sought
comment on the estimated costs of deploying and operating a database
solution, and whether it would be technically feasible to upgrade the
existing 800 database and associated software to accommodate PCS N00
numbers. We also sought comment on whether it is feasible (both
technically and economically) to provide PCS N00 service provider
portability in a switch-based translation environment. Further, we
sought comment on the following issues raised by the Industry Numbering
Committee's (INC's) PCS N00 report: (1) Who would be the owner/operator
of an SMS administering a PCS N00 database; (2) how would that
administrator be selected; (3) how would the costs of providing PCS N00
portability be recovered; and (4) by what date should PCS N00
portability be deployed. Finally, we sought comment on the ability of
900 number portability to lower prices and stimulate demand for 900
services, and on the costs of deploying and operating the necessary
database.
2. Positions of the Parties
190. In comments filed prior to passage of the 1996 Act, a majority
of parties argue that consideration of 500 and 900 number portability
is premature, as the current costs of implementation outweigh any
benefits. Indeed, several LECs maintain that the Commission should
establish a separate docket to address the unique issues raised by 500
and 900 service provider portability.
191. In contrast, MCI, Citizens Utilities, Competitive Carriers,
Florida Public Service Commission, and some CMRS providers contend that
500 and 900 number portability would benefit consumers, and that
service provider portability for 500 and 900 numbers should be
developed, as long as the costs are not prohibitive. The information
service providers generally agree that 900 portability should be
mandated by the Commission as soon as possible to increase competition
for information service provider traffic among IXCs, and to offer a
more efficient and broader range of information services.
192. Interactive Services, MCI, and Teleservices maintain that the
toll free database can be modified to include 900 numbers at relatively
modest cost, and that the implementation and administration of toll
free number portability would provide a model for 500 and 900 number
portability. Both Interactive Services and MCI note that parties have
failed to provide relevant cost and benefit data in the record of this
proceeding, and urge the Commission to require parties to submit data
concerning the total costs of implementation and operation.
193. Ameritech states that updating the existing toll free platform
to support 900 numbers is technically possible, but would require
extensive systems modifications. Ameritech also states that it would be
technically and economically infeasible to provide PCS N00 portability
in a switch-based translation environment due to the memory capacity
limitations and the operational issues associated with updating the
routing tables. Bell Atlantic states that it may be technically
feasible to upgrade the existing toll free database to accommodate 500
and 900 numbers, but this would require extensive system changes. NYNEX
supports implementation of service provider portability for 500 numbers
as proposed in the INC Report on PCS N00 Portability, which sets forth
a four-year implementation schedule. USTA argues that 500 number
portability can best be provided through a national, centralized
database, similar to the toll free database, and notes that a 900
number portability solution may not be able to utilize the same
platform as that contemplated for 500 number portability because of the
differing structures of the services associated with 900 number
services.
194. Only two parties addressed the issue of 500 or 900 portability
in comments filed after passage of the 1996 Act. Interactive Services
asserts that the 1996 Act requires LECs to provide service provider
portability for 900 numbers when technically feasible, and that the
record in this proceeding demonstrates that long-term service provider
portability for 900 numbers is technically feasible. Interactive
Services did not comment on whether service provider portability for
500 numbers is technically feasible. BellSouth states that the 1996 Act
is silent with respect to the portability of non-geographic numbers.
3. Discussion
195. Section 251(b)(2) of the 1996 Act requires all LECs ``to
provide, to the extent technically feasible, number portability in
accordance with requirements prescribed by the Commission.'' Section 3,
in turn, defines number portability as ``the ability of users of
telecommunications services to retain, at the same location, existing
telephone numbers * * * when switching from one telecommunications
carrier to another.''
196. While both LECs and interexchange carriers are able to provide
500 and 900 services, such services are more frequently provided by
IXCs. LECs, to date, have offered relatively few 500 and 900 services
because the Bell Operating Companies, which serve over 76 percent of
the nation's access lines, were precluded from offering interLATA
services under the Modification of Final Judgment, and therefore could
offer 500 and 900 services only on an intraLATA basis. Conversely, 500
and 900 interLATA services, which account for most of the 500 and 900
numbers, have, up until now, been exclusively provided by IXCs. Thus,
most users of 500 and 900
[[Page 38635]]
services obtain their numbers from IXCs, and not from LECs.
197. Although the statute does not define specifically the numbers
that must be portable, the statute on its face imposes an obligation to
provide number portability only on LECs. Because the statute's
directive to provide number portability applies only to LECs, IXCs are
not obligated under the 1996 Act to participate in making their numbers
portable when their customers wish to move their numbers to another IXC
or any other carrier offering 500 or 900 service. In the case of 900
service, the ``user'' of the telecommunications service that wants to
keep its number when switching carriers is the business that is
offering a 900 service, not the end user that is purchasing the
information service from the 900 service provider. A 900 service
provider typically purchases transport from an IXC and uses a 900
number assigned to that IXC to offer its service. As a consequence, if
a 900 service provider wishes to retain its number when switching from
one carrier to another, the IXC (and not the LEC that provides exchange
access to the IXC) is the party that would have to release the
management of the number in question. Likewise, 500 service today is
offered exclusively by IXCs, which have blocks of 500 numbers assigned
to them for this purpose. When a 500 customer wishes to switch from one
carrier to another, the IXC providing the 500 service (and not the LEC
that provides exchange access to the 500 service provider) would have
to relinquish the number in question to the competing carrier. Thus, as
a practical matter, portability for the vast majority of 500 and 900
numbers can occur only if the IXC releases to the new carrier
management of the assigned 500 or 900 number that is to be ported.
198. We recognize, however, that LECs increasingly may offer 500
and 900 services themselves in the future. To the extent they do, we
conclude that those LECs would be obligated under the 1996 Act to offer
number portability for their own 500 and 900 numbers to the extent
``technically feasible.'' We believe we have insufficient evidence in
this record to determine whether it is technically feasible for LECs to
provide portability for their own 500 and 900 numbers. Neither the INC
nor state number portability task forces have addressed the issue of
500 and 900 number portability. The record developed on this issue
largely predates passage of the 1996 Act, and as a consequence, few
parties have focused on this issue. No party to this proceeding has
suggested that any of the
FR Doc. 96-18477 Telephone Number Portability
currently available methods, such as RCF or
DID, or any of the long term methods currently under consideration,
such as LRN, could be used to provide portability for non-geographic
numbers. Instead, the parties that addressed this issue suggest that
the current toll free database potentially could be modified to
accommodate 500 and 900 numbers, but note that a host of major
technical issues would need to be resolved. The only party to this
proceeding that argues that the Commission is required under the 1996
Act to mandate service provider portability for 900 numbers,
Interactive Services, fails to address the fact that the statutory
obligation to offer number portability falls only on LECs, and not on
other carriers that offer 900 services. No party has addressed the
technical feasibility of modifying the existing toll free database to
make only those 500 and 900 numbers that are assigned to LECs portable.
We, therefore, direct the INC to examine this issue, and file a report
with this Commission within twelve months of the effective date of this
order addressing the technical feasibility of requiring LECs to make
their assigned 500 and 900 numbers portable, whether it be through
modifying the existing toll free database or through another system.
Upon receipt of this report, we will take appropriate action under the
1996 Act.
Regulatory Flexibility Act Analysis
Final Analysis of First Report and Order
199. As required by section 603 of the Regulatory Flexibility Act,
5 U.S.C. 603 (RFA), an Initial Regulatory Flexibility Analysis (IRFA)
was incorporated in the NPRM (60 FR 39136, August 1, 1995). The
Commission sought written public comments on the proposals in the NPRM,
including the Initial Regulatory Flexibility Analysis. Our final
analysis conforms to the RFA, as amended by the Contract With America
Advancement Act of 1996, Pub. L. No. 104-121, 110 Stat. 847 (1996)
(CWAAA). Subtitle II of CWAAA is ``The Small Business Regulatory
Enforcement Fairness Act of 1996'' (SBREFA). The Commission's Final
Regulatory Flexibility Analysis (FRFA) in this Report and Order is as
follows:
200. Need for and Objectives of Rules: The Commission, in
compliance with sections 251(b)(2) and 251(d)(1) of the Communications
Act of 1934, as amended by the Telecommunications Act of 1996 (the
Act), adopts rules and procedures intended to ensure the prompt
implementation of telephone number portability with the minimum
regulatory and administrative burden on telecommunications carriers.
These rules are necessary to implement the provision in the
Telecommunications Act of 1996 (1996 Act) requiring local exchange
carriers (LECs) to offer number portability, if technically feasible.
In implementing the statute, the Commission has the responsibility to
adopt rules that will implement most quickly and effectively the
national telecommunications policy embodied in the Act and to promote
the pro-competitive, deregulatory markets envisioned by Congress.
Congress has recognized that number portability will lower barriers to
entry and promote competition in the local exchange marketplace.
201. Summary of Significant Issues Raised by the Public in Response
to the IRFA: There were no comments submitted in response to the
Initial Regulatory Flexibility Analysis. The Chief Counsel for Advocacy
of the United States Small Business Administration filed comments on
the NPRM which generally support the actions we take in this Report and
Order. However, in their general comments, some commenters suggested a
course of action which may result in less of an impact on small
entities. Specifically, prior to passage of the 1996 Act, some LECs
asserted that the Commission should neither adopt, nor direct the
adoption of, number portability without performing a thorough cost/
benefit analysis. Most parties, however, now agree that the 1996 Act
clearly directs the Commission to implement long-term number
portability. In the Report and Order, we concluded that Congress has
determined that the Commission should develop a national number
portability policy and has specifically directed us to prescribe the
requirements that all local exchange carriers, both incumbents and
others, must meet to satisfy their statutory obligations. See 47 U.S.C.
251(b)(2), (d). Moreover, section 251(e)(1)'s assignment to the
Commission of exclusive jurisdiction over that portion of the North
American Numbering Plan (NANP) that pertains to the United States gives
us authority over the implementation of number portability to the
extent that such implementation will affect the NANP. See 47 U.S.C.
251(e)(1).
202. Description and Estimate of Number of Small Businesses to
Which Rules Will Apply: The Regulatory Flexibility Act generally
defines the term ``small business'' as having the same meaning as the
term ``small business concern'' under the Small Business Act, 15 U.S.C.
632. A small business concern is one which (1) is independently owned
and operated; (2) is not dominant in its field of operation;
[[Page 38636]]
and (3) satisfies any additional criteria established by the Small
Business Administration (SBA). Id. According to the SBA's regulations,
entities engaged in the provision of telephone service may have a
maximum of 1,500 employees in order to qualify as a small business
concern. 13 CFR 121.201. This standard also applies in determining
whether an entity is a small business for purposes of the Regulatory
Flexibility Act.
203. Our rules governing long-term number portability apply to all
LECs, including incumbent LECs as well as new LEC entrants, and also
apply to cellular, broadband PCS, and covered SMR providers. According
to the SBA definition, incumbent LECs do not qualify as small
businesses because they are dominant in their field of operation.
Accordingly, we will not address the impact of these rules on incumbent
LECs.
204. However, our rules may have a significant economic impact on a
substantial number of small businesses insofar as they apply to
telecommunications carriers other than incumbent LECs. The rules may
have such an impact upon new entrant LECs, as well as cellular,
broadband PCS, and covered SMR providers. Based upon data contained in
the most recent census and a report by the Commission's Common Carrier
Bureau, we estimate that 2,100 carriers could be affected. We have
derived this estimate based on the following analysis:
205. According to the 1992 Census of Transportation,
Communications, and Utilities, there were approximately 3,469 firms
with under 1,000 employees operating under the Standard Industrial
Classification (SIC) category 481--Telephone. See U.S. Dept. of
Commerce, Bureau of the Census, 1992 Census of Transportation,
Communications, and Utilities (issued May 1995). Many of these firms
are the incumbent LECs and, as noted above, would not satisfy the SBA
definition of a small business because of their market dominance. There
were approximately 1,350 LECs in 1995. Industry Analysis Division, FCC,
Carrier Locator: Interstate Service Providers at Table 1 (Number of
Carriers Reporting by Type of Carrier and Type of Revenue) (December
1995). Subtracting this number from the total number of firms leaves
approximately 2,119 entities which potentially are small businesses
which may be affected. This number contains various categories of
carriers, including competitive access providers, cellular carriers,
interexchange carriers, mobile service carriers, operator service
providers, pay telephone operators, PCS providers, covered SMR
providers, and resellers. Some of these carriers--although not
dominant--may not meet the other requirement of the definition of a
small business because they are not ``independently owned and
operated.'' See 15 U.S.C. 632. For example, a PCS provider which is
affiliated with a long distance company with more than 1,000 employees
would be disqualified from being considered a small business. Another
example would be if a cellular provider is affiliated with a dominant
LEC. Thus, a reasonable estimate of the number of ``small businesses''
affected by this Order would be approximately 2,100.
206. Description of Projected Reporting, Recordkeeping and Other
Compliance Requirements of the Rules: There are several reporting
requirements imposed by the Report and Order. It is likely that the
entities filing the reports will require the services of persons with
technical expertise to prepare the reports. First, carriers
participating in a field test in the Chicago, Illinois, area are
required to file with the Commission a report of their findings within
30 days after completion of the test. At this time, it is not clear how
many carriers will be participating, but it is likely to include
several new entrant LECs and the dominant incumbent LEC in the region.
Second, after December 31, 1998, long-term number portability must be
provided by LECs outside of the 100 largest MSAs within six months
after a specific request by another telecommunications carrier in which
the requesting carrier is operating or plans to operate. The request
specifically must request long-term number portability, identify the
discrete geographic area covered by the request, and provide a
tentative date six or more months in the future when the carrier
expects to need number portability in order to port prospective
customers. Third, state regulatory commissions must file with the
Commission a notification if they opt to develop a state-specific
database in lieu of participating in a regional database system.
Carriers that object to a state decision to opt out of the regional
database system may file with the Commission a petition for relief.
Fourth, the item requires any administrator selected by a state prior
to the release of the Report and Order, that wishes to bid for
administration of one of the regional databases, must submit a new
proposal in accordance with the guidelines established by the NANC. We
expect that only one entity, Lockheed Martin, will be subject to this
requirement since it is the only administrator which has been selected
by a state to date. Fifth, the Report and Order requires carriers that
are unable to meet the deadlines for implementing a long-term number
portability solution to file with the Commission at least 60 days in
advance of the deadline a petition to extend the time by which
implementation in its network will be completed. Finally, we require an
industry body known as the Industry Numbering Committee (INC) to file a
report with the Commission on the portability of non-geographic numbers
assigned to LECs within 12 months after the effective date of the
Report and Order.
207. Steps Taken to Minimize Impact on Small Entities Consistent
with Stated Objectives: The Commission's actions in this Report and
Order will benefit small entities by facilitating their entry into the
local exchange market. The record in this proceeding indicates that the
lack of number portability would deter entry by competitive providers
of local service because of the value customers place on retaining
their telephone numbers. These competitive providers, many of which may
be small entities, may find it easier to enter the market as a result
of number portability which will eliminate this barrier to entry.
208. In general, we have attempted to keep burdens on local
exchange carriers to a minimum. For example, we have adopted a phased
deployment schedule which requires long-term number portability to be
implemented initially in the 100 largest MSAs, and then elsewhere upon
a carrier's request. The provision of currently available measures is
conditioned upon request only. In addition, we have attempted to
minimize the impact of our rules upon cellular, broadband PCS, and
covered SMR providers, which may be small businesses, by not requiring
such carriers to offer currently available number portability measures.
Similarly, paging and messaging service providers, which may be small
entities, are required to provide neither currently available measures
nor long-term number portability under our rules. The regulatory
burdens we have imposed are necessary to ensure that the public
receives the benefit of the expeditious provision of service provider
number portability in accordance with the statutory requirements.
V. Ordering Clauses
209. Accordingly, it is ordered that, pursuant to the authority
contained in sections 1, 4(i), 4(j), 201-205, 218, 251, and 332 of the
Communications Act as amended, 47 U.S.C. 151, 154(i), 154(j), 201-205,
218, 251 and 332, Part 20 of
[[Page 38637]]
the Commission's rules, 47 CFR part 20, is amended, and part 52 of the
Commission's rules, 47 CFR part 52, is added as set forth below.
210. It is further ordered that the policies, rules, and
requirements set forth herein are adopted, effective August 26, 1996
except for collections of information subject to approval by the Office
of Management and Budget (OMB), which are effective December 23, 1996.
211. It is further ordered that, pursuant to the authority
contained in sections 1, 4(i), 4(j), 201-205, 218, 251, and 332 of the
Communications Act as amended, 47 U.S.C. 151, 154(i), 154(j), 201-205,
218, 251, and 332, a Further Notice of Proposed Rulemaking is hereby
adopted.
212. It is further ordered that BellSouth's Motion to Accept Late
Filed Comments is granted.
213. It is further ordered that authority is delegated to the
Chief, Common Carrier Bureau, as set forth supra in Paras. 78, 79, 85,
97, and to the Chief, Wireless Telecommunications Bureau, as set forth
supra in Paras. 166, 167.
List of Subjects
47 CFR Part 20
Federal Communications Commission, Local number portability, Radio,
Telecommunications.
47 CFR Part 52
Federal Communications Commission, Cost recovery, Database
architecture and administration, Local exchange carrier, Local number
portability, Long-term database methods, Numbering, Telecommunications,
Transitional methods.
Federal Communications Commission.
William F. Caton,
Acting Secretary.
Rule Changes
Parts 20 and 52 of Title 47 of the Code of Federal Regulations are
amended as follows:
PART 20--COMMERCIAL MOBILE RADIO SERVICES
1. The authority citation for part 20 continues to read as follows:
Authority: Secs. 4, 303, and 332, 48 Stat. 1066, 1082, as
amended; 47 U.S.C. 154, 303, and 332, unless otherwise noted.
2. Section 20.15 is amended by adding paragraph (e) to read as
follows:
Sec. 20.15 Requirements under Title II of the Communications Act.
* * * * *
(e) For obligations of commercial mobile radio service providers to
provide local number portability, see Sec. 52.1 of this chapter.
3. A new part 52 is added to read as follows:
PART 52--NUMBERING
Subpart A--[Reserved]
Subpart B--Local Number Portability
Sec.
52.1 Definitions.
52.3 Deployment of long-term database methods for number
portability by LECs.
52.5 Database architecture and administration.
52.7 Deployment of transitional measures for number portability.
52.9 Cost recovery for transitional measures for number
portability.
52.11 Deployment of long-term database methods for number
portability by CMRS providers.
52.12 through 52.99 [Reserved].
Appendix to Part 52--Deployment Sechdule for Long-Term Database Methods
for Local Number Portability
Authority: Sec. 4, 48 Stat. 1066, as amended; 47 U.S.C. 154,
unless otherwise noted. Interpret or apply sec. 153, 154, 201-04,
218, 225-7, 251-2, 271, 48 Stat. 1070, as amended, 1077; 47 U.S.C.
201-04, 218, 225-7, 251-2, 271 unless otherwise noted.
Subpart A--[Reserved]
Subpart B--Local Number Portability
Sec. 52.1 Definitions.
As used in this subpart:
(a) The term broadband PCS has the same meaning as that term is
defined in Sec. 24.5 of this chapter.
(b) The term cellular service has the same meaning as that term is
defined in Sec. 22.99 of this chapter.
(c) The term covered SMR means either 800 MHz and 900 MHz SMR
licensees that hold geographic area licenses or incumbent wide area SMR
licensees that offer real-time, two-way switched voice service that is
interconnected with the public switched network, either on a stand-
alone basis or packaged with other telecommunications services. This
term does not include local SMR licensees offering mainly dispatch
services to specialized customers in a non-cellular system
configuration, licensees offering only data, one-way, or stored voice
services on an interconnected basis, or any SMR provider that is not
interconnected to the public switched network.
(d) The term database method means a number portability method that
utilizes one or more external databases for providing called party
routing information.
(e) The term downstream database means a database owned and
operated by an individual carrier for the purpose of providing number
portability in conjunction with other functions and services.
(f) The term incumbent local exchange carrier means, with respect
to an area, the local exchange carrier that:
(1) On February 8, 1996, provided telephone exchange service in
such area; and
(2)(i) On February 8, 1996, was deemed to be a member of the
exchange carrier association pursuant to Sec. 69.601(b) of the
Commission's regulations (47 CFR 69.601(b)); or
(ii) Is a person or entity that, on or after February 8, 1996,
became a successor or assign of a member described in paragraph
(f)(2)(i) of this section.
(g) The term incumbent wide area SMR licensee has the same meaning
as that term is defined in Sec. 20.3 of this chapter.
(h) The term local exchange carrier means any person that is
engaged in the provision of telephone exchange service or exchange
access. For purposes of this subpart, such term does not include a
person insofar as such person is engaged in the provision of a
commercial mobile service under 47 U.S.C. 332(c).
(i) The term local number portability administrator (LNPA) means an
independent, non-governmental entity, not aligned with any particular
telecommunications industry segment, whose duties are determined by the
NANC.
(j) The term location portability means the ability of users of
telecommunications services to retain existing telecommunications
numbers without impairment of quality, reliability, or convenience when
moving from one physical location to another.
(k) The term long-term database method means a database method that
complies with the performance criteria set forth in Sec. 52.3(a).
(l) The term North American Numbering Council (NANC) means an
advisory committee created under the Federal Advisory Committee Act, 5
U.S.C., App (1988), to advise the Commission and to make
recommendations, reached through consensus, that foster efficient and
impartial number administration.
(m) The term number portability means the ability of users of
telecommunications services to retain, at the same location, existing
telecommunications numbers without impairment of quality, reliability,
or convenience when switching from one telecommunications carrier to
another.
[[Page 38638]]
(n) The term regional database means an SMS database or an SMS/SCP
pair that contains information necessary for carriers to provide number
portability in a region as determined by the NANC.
(o) The term service control point (SCP) means a database in the
public switched network which contains information and call processing
instructions needed to process and complete a telephone call. The
network switches access an SCP to obtain such information. Typically,
the information contained in an SCP is obtained from the SMS.
(p) The term service management system (SMS) means a database or
computer system not part of the public switched network that, among
other things:
(1) Interconnects to an SCP and sends to that SCP the information
and call processing instructions needed for a network switch to process
and complete a telephone call; and
(2) Provides telecommunications carriers with the capability of
entering and storing data regarding the processing and completing of a
telephone call.
(q) The term service portability means the ability of users of
telecommunications services to retain existing telecommunications
numbers without impairment of quality, reliability, or convenience when
switching from one telecommunications service to another, without
switching from one telecommunications carrier to another.
(r) The term service provider portability means the ability of
users of telecommunications services to retain, at the same location,
existing telecommunications numbers without impairment of quality,
reliability, or convenience when switching from one telecommunications
carrier to another.
(s) The term telecommunications means the transmission, between or
among points specified by the user, of information of the user's
choosing, without change in the form or content of the information as
sent and received.
(t) The term telecommunications carrier means any provider of
telecommunications services, except that such term does not include
aggregators of telecommunications services (as defined in 47 U.S.C.
226(a)(2)).
(u) The term telecommunications service means the offering of
telecommunications for a fee directly to the public, or to such classes
of users as to be effectively available directly to the public,
regardless of the facilities used.
(v) The term transitional measure means a method such as Remote
Call Forwarding (RCF), Flexible Direct Inward Dialing (DID), or other
comparable and technically feasible arrangement that allows one local
exchange carrier to transfer telephone numbers from its network to the
network of another telecommunications carrier, but does not comply with
the performance criteria set forth in Sec. 52.3(a).
Sec. 52.3 Deployment of long-term database methods for number
portability by LECs.
(a) Subject to paragraphs (b) and (c) of this section, all local
exchange carriers (LECs) must provide number portability in compliance
with the following performance criteria:
(1) Supports network services, features, and capabilities existing
at the time number portability is implemented, including but not
limited to emergency services, CLASS features, operator and directory
assistance services, and intercept capabilities;
(2) Efficiently uses numbering resources;
(3) Does not require end users to change their telecommunications
numbers;
(4) Does not require telecommunications carriers to rely on
databases, other network facilities, or services provided by other
telecommunications carriers in order to route calls to the proper
termination point;
(5) Does not result in unreasonable degradation in service quality
or network reliability when implemented;
(6) Does not result in any degradation in service quality or
network reliability when customers switch carriers;
(7) Does not result in a carrier having a proprietary interest;
(8) Is able to migrate to location and service portability; and
(9) Has no significant adverse impact outside the areas where
number portability is deployed.
(b) All LECs must provide a long-term database method for number
portability in the 100 largest Metropolitan Statistical Areas (MSAs) by
December 31, 1998, in accordance with the deployment schedule set forth
in the appendix to this part 52.
(c) Beginning January 1, 1999, all LECs must make a long-term
database method for number portability available within six months
after a specific request by another telecommunications carrier in areas
in which that telecommunications carrier is operating or plans to
operate.
(d) The Chief, Common Carrier Bureau, may waive or stay any of the
dates in the implementation schedule, as the Chief determines is
necessary to ensure the efficient development of number portability,
for a period not to exceed 9 months (i.e., no later than September 30,
1999).
(e) In the event a LEC is unable to meet the Commission's deadlines
for implementing a long-term database method for number portability, it
may file with the Commission at least 60 days in advance of the
deadline a petition to extend the time by which implementation in its
network will be completed. A LEC seeking such relief must demonstrate
through substantial, credible evidence the basis for its contention
that it is unable to comply with the deployment schedule set forth in
the appendix to this part 52. Such requests must set forth:
(1) The facts that demonstrate why the carrier is unable to meet
the Commission's deployment schedule;
(2) A detailed explanation of the activities that the carrier has
undertaken to meet the implementation schedule prior to requesting an
extension of time;
(3) An identification of the particular switches for which the
extension is requested;
(4) The time within which the carrier will complete deployment in
the affected switches; and
(5) A proposed schedule with milestones for meeting the deployment
date.
(f) The Chief, Common Carrier Bureau, shall monitor the progress of
local exchange carriers implementing number portability, and may direct
such carriers to take any actions necessary to ensure compliance with
the deployment schedule set forth in the appendix to this part 52.
(g) Carriers that are members of the Illinois Local Number
Portability Workshop must conduct a field test of any technically
feasible long-term database method for number portability in the
Chicago, Illinois, area concluding no later than August 31, 1997. The
carriers participating in the test must jointly file with the Common
Carrier Bureau a report of their findings within 30 days following
completion of the test. The Chief, Common Carrier Bureau, shall monitor
developments during the field test.
Sec. 52.5 Database architecture and administration.
(a) The North American Numbering Council (NANC) shall direct
establishment of a nationwide system of regional SMS databases for the
provision of long-term database methods for number portability.
(b) All telecommunications carriers shall have equal and open
access to the regional databases.
[[Page 38639]]
(c) The NANC shall select a local number portability
administrator(s) (LNPA(s)) to administer the regional databases within
seven months of the initial meeting of the NANC.
(d) The NANC shall determine whether one or multiple
administrator(s) should be selected, whether the LNPA(s) can be the
same entity selected to be the North American Numbering Plan
Administrator, how the LNPA(s) should be selected, the specific duties
of the LNPA(s), the geographic coverage of the regional databases, the
technical interoperability and operational standards, the user
interface between telecommunications carriers and the LNPA(s), the
network interface between the SMS and the downstream databases, and the
technical specifications for the regional databases.
(e) Once the NANC has selected the LNPA(s) and determined the
locations of the regional databases, it must report its decisions to
the Commission.
(f) The information contained in the regional databases shall be
limited to the information necessary to route telephone calls to the
appropriate telecommunications carriers. The NANC shall determine what
specific information is necessary.
(g) Any state may opt out of its designated regional database and
implement a state-specific database. A state must notify the Common
Carrier Bureau and NANC that it plans to implement a state-specific
database within 60 days from the release date of the Public Notice
issued by the Chief, Common Carrier Bureau, identifying the
administrator selected by the NANC and the proposed locations of the
regional databases. Carriers may challenge a state's decision to opt
out of the regional database system by filing a petition with the
Commission.
(h) Individual state databases must meet the national requirements
and operational standards recommended by the NANC and adopted by the
Commission. In addition, such state databases must be technically
compatible with the regional system of databases and must not interfere
with the scheduled implementation of the regional databases.
(i) Individual carriers may download information necessary to
provide number portability from the regional databases into their own
downstream databases. Individual carriers may mix information needed to
provide other services or functions with the information downloaded
from the regional databases at their own downstream databases. Carriers
may not withhold any information necessary to provide number
portability from the regional databases on the grounds that such data
has been combined with other information in its downstream database.
Sec. 52.7 Deployment of transitional measures for number portability.
All LECs shall provide transitional measures, which may consist of
Remote Call Forwarding (RCF), Flexible Direct Inward Dialing (DID), or
any other comparable and technically feasible method, as soon as
reasonably possible upon receipt of a specific request from another
telecommunications carrier, until such time as the LEC implements a
long-term database method for number portability in that area.
Sec. 52.9 Cost recovery for transitional measures for number
portability.
Any cost recovery mechanism for the provision of number portability
pursuant to Sec. 52.7(a), that is adopted by a state commission must
not:
(a) Give one telecommunications carrier an appreciable, incremental
cost advantage over another telecommunications carrier, when competing
for a specific subscriber (i.e., the recovery mechanism may not have a
disparate effect on the incremental costs of competing carriers seeking
to serve the same customer); or
(b) Have a disparate effect on the ability of competing
telecommunications carriers to earn a normal return on their
investment.
Sec. 52.11 Deployment of long-term database methods for number
portability by CMRS providers.
(a) By June 30, 1999, all cellular, broadband PCS, and covered SMR
providers must provide a long-term database method for number
portability, including the ability to support roaming, in compliance
with the performance criteria set forth in Sec. 52.3(a).
(b) By December 31, 1998, all cellular, broadband PCS, and covered
SMR providers must have the capability to obtain routing information,
either by querying the appropriate database themselves or by making
arrangements with other carriers that are capable of performing
database queries, so that they can deliver calls from their networks to
any party that has retained its number after switching from one
telecommunications carrier to another.
(c) The Chief, Wireless Telecommunications Bureau, may waive or
stay any of the dates in the implementation schedule, as the Chief
determines is necessary to ensure the efficient development of number
portability, for a period not to exceed 9 months (i.e., no later than
September 30, 1999, for the deadline in paragraph (b) of this section,
and no later than March 31, 2000, for the deadline in paragraph (a) of
this section).
(d) In the event a carrier subject to paragraphs (a) and (b) of
this section is unable to meet the Commission's deadlines for
implementing a long-term number portability method, it may file with
the Commission at least 60 days in advance of the deadline a petition
to extend the time by which implementation in its network will be
completed. A carrier seeking such relief must demonstrate through
substantial, credible evidence the basis for its contention that it is
unable to comply with paragraphs (a) and (b) of this section. Such
requests must set forth:
(1) The facts that demonstrate why the carrier is unable to meet
our deployment schedule;
(2) A detailed explanation of the activities that the carrier has
undertaken to meet the implementation schedule prior to requesting an
extension of time;
(3) An identification of the particular switches for which the
extension is requested;
(4) The time within which the carrier will complete deployment in
the affected switches; and
(5) A proposed schedule with milestones for meeting the deployment
date.
(e) The Chief, Wireless Telecommunications Bureau, may establish
reporting requirements in order to monitor the progress of cellular,
broadband PCS, and covered SMR providers implementing number
portability, and may direct such carriers to take any actions necessary
to ensure compliance with this deployment schedule.
Secs. 52.12 through 52.99 [Reserved]
Appendix to Part 52--Deployment Schedule for Long-Term Database Methods
for Local Number Portability
Implementation must be completed by the carriers in the relevant
MSAs during the periods specified below:
10/97-12/97
Chicago, IL........................................................ 3
Philadelphia, PA................................................... 4
Atlanta, GA........................................................ 8
New York, NY....................................................... 2
Los Angeles, CA.................................................... 1
Houston, TX........................................................ 7
Minneapolis, MN.................................................... 12
1/98-3/98
Detroit, MI........................................................ 6
Cleveland, OH...................................................... 20
Washington, DC..................................................... 5
Baltimore, MD...................................................... 18
Miami, FL.......................................................... 24
Fort Lauderdale, FL................................................ 39
Orlando, FL........................................................ 40
Cincinnati, OH..................................................... 30
[[Page 38640]]
Tampa, FL.......................................................... 23
Boston, MA......................................................... 9
Riverside, CA...................................................... 10
San Diego, CA...................................................... 14
Dallas, TX......................................................... 11
St. Louis, MO...................................................... 16
Phoenix, AZ........................................................ 17
Seattle, WA........................................................ 22
4/98-6/98
Indianapolis, IN................................................... 34
Milwaukee, WI...................................................... 35
Columbus, OH....................................................... 38
Pittsburgh, PA..................................................... 19
Newark, NJ......................................................... 25
Norfolk, VA........................................................ 32
New Orleans, LA.................................................... 41
Charlotte, NC...................................................... 43
Greensboro, NC..................................................... 48
Nashville, TN...................................................... 51
Las Vegas, NV...................................................... 50
Nassau, NY......................................................... 13
Buffalo, NY........................................................ 44
Orange Co, CA...................................................... 15
Oakland, CA........................................................ 21
San Francisco, CA.................................................. 29
Rochester, NY...................................................... 49
Kansas City, KS.................................................... 28
Fort Worth, TX..................................................... 33
Hartford, CT....................................................... 46
Denver, CO......................................................... 26
Portland, OR....................................................... 27
7/98-9/98
Grand Rapids, MI................................................... 56
Dayton, OH......................................................... 61
Akron, OH.......................................................... 73
Gary, IN........................................................... 80
Bergen, NJ......................................................... 42
Middlesex, NJ...................................................... 52
Monmouth, NJ....................................................... 54
Richmond, VA....................................................... 63
Memphis, TN........................................................ 53
Louisville, KY..................................................... 57
Jacksonville, FL................................................... 58
Raleigh, NC........................................................ 59
West Palm Beach, FL................................................ 62
Greenville, SC..................................................... 66
Honolulu, HI....................................................... 65
Providence, RI..................................................... 47
Albany, NY......................................................... 64
San Jose, CA....................................................... 31
Sacramento, CA..................................................... 36
Fresno, CA......................................................... 68
San Antonio, TX.................................................... 37
Oklahoma City, OK.................................................. 55
Austin, TX......................................................... 60
Salt Lake City, UT................................................. 45
Tucson, AZ......................................................... 71
10/98-12/98
Toledo, OH......................................................... 81
Youngstown, OH..................................................... 85
Ann Arbor, MI...................................................... 95
Fort Wayne, IN..................................................... 100
Scranton, PA....................................................... 78
Allentown, PA...................................................... 82
Harrisburg, PA..................................................... 83
Jersey City, NJ.................................................... 88
Wilmington, DE..................................................... 89
Birmingham, AL..................................................... 67
Knoxville, KY...................................................... 79
Baton Rouge, LA.................................................... 87
Charleston, SC..................................................... 92
Sarasota, FL....................................................... 93
Mobile, AL......................................................... 96
Columbia, SC....................................................... 98
Tulsa, OK.......................................................... 70
Syracuse, NY....................................................... 69
Springfield, MA.................................................... 86
Ventura, CA........................................................ 72
Bakersfield, CA.................................................... 84
Stockton, CA....................................................... 94
Vallejo, CA........................................................ 99
El Paso, TX........................................................ 74
Little Rock, AR.................................................... 90
Wichita, KS........................................................ 97
New Haven, CT...................................................... 91
Omaha, NE.......................................................... 75
Albuquerque, NM.................................................... 76
Tacoma, WA......................................................... 77
Note: This Appendix A will not be published in the Code of
Federal Regulations.
Appendix A--100 Largest Metropolitan Statistical Areas (MSAs) and Their
Populations
1. Los Angeles, CA........................................ 9,150,000
2. New York, NY........................................... 8,584,000
3. Chicago, IL............................................ 7,668,000
4. Philadelphia, PA....................................... 4,949,000
5. Washington, DC......................................... 4,474,000
6. Detroit, MI............................................ 4,307,000
7. Houston, TX............................................ 3,653,000
8. Atlanta, GA............................................ 3,331,000
9. Boston, MA*............................................ 3,211,000
10. Riverside, CA......................................... 2,907,000
11. Dallas, TX............................................ 2,898,000
12. Minneapolis, MN....................................... 2,688,000
13. Nassau, NY............................................ 2,651,000
14. San Diego, CA......................................... 2,621,000
15. Orange Co., CA........................................ 2,543,000
16. St. Louis, MO......................................... 2,536,000
17. Phoenix, AZ........................................... 2,473,000
18. Baltimore, MD......................................... 2,458,000
19. Pittsburgh, PA........................................ 2,402,000
20. Cleveland, OH......................................... 2,222,000
21. Oakland, CA........................................... 2,182,000
22. Seattle, WA........................................... 2,180,000
23. Tampa, FL............................................. 2,157,000
24. Miami, FL............................................. 2,025,000
25. Newark, NJ............................................ 1,934,000
26. Denver, CO............................................ 1,796,000
27. Portland, OR.......................................... 1,676,000
28. Kansas City, KS....................................... 1,647,000
29. San Francisco, CA..................................... 1,646,000
30. Cincinnati, OH........................................ 1,581,000
31. San Jose, CA.......................................... 1,557,000
32. Norfolk, VA........................................... 1,529,000
33. Fort Worth, TX........................................ 1,464,000
34. Indianapolis, IN...................................... 1,462,000
35. Milwaukee, WI......................................... 1,456,000
36. Sacramento, CA........................................ 1,441,000
37. San Antonio, TX....................................... 1,437,000
38. Columbus, OH.......................................... 1,423,000
39. Fort Lauderdale, FL................................... 1,383,000
40. Orlando, FL........................................... 1,361,000
41. New Orleans, LA....................................... 1,309,000
42. Bergen, NJ............................................ 1,304,000
43. Charlotte, NC......................................... 1,260,000
44. Buffalo, NY........................................... 1,189,000
45. Salt Lake City, UT.................................... 1,178,000
46. Hartford, CT*......................................... 1,156,000
47. Providence, RI*....................................... 1,131,000
48. Greensboro, NC........................................ 1,107,000
49. Rochester, NY......................................... 1,090,000
50. Las Vegas, NV......................................... 1,076,000
51. Nashville, TN......................................... 1,070,000
52. Middlesex, NJ......................................... 1,069,000
53. Memphis, TN........................................... 1,056,000
54. Monmouth, NJ.......................................... 1,035,000
55. Oklahoma City, OK..................................... 1,007,000
56. Grand Rapids, MI...................................... 985,000
57. Louisville, KY........................................ 981,000
58. Jacksonville, FL...................................... 972,000
59. Raleigh, NC........................................... 965,000
60. Austin, TX............................................ 964,000
61. Dayton, OH............................................ 956,000
62. West Palm Beach, FL................................... 955,000
63. Richmond, VA.......................................... 917,000
64. Albany, NY............................................ 875,000
65. Honolulu, HI.......................................... 874,000
66. Greenville, SC........................................ 873,000
67. Birmingham, AL........................................ 872,000
68. Fresno, CA............................................ 835,000
69. Syracuse, NY.......................................... 754,000
70. Tulsa, OK............................................. 743,000
71. Tucson, AZ............................................ 732,000
72. Ventura, CA........................................... 703,000
73. Akron, OH............................................. 677,000
74. El Paso, TX........................................... 665,000
75. Omaha, NE............................................. 663,000
76. Albuquerque, NM....................................... 646,000
77. Tacoma, WA............................................ 638,000
78. Scranton, PA.......................................... 637,000
79. Knoxville, TN......................................... 631,000
80. Gary, IN.............................................. 620,000
81. Toledo, OH............................................ 614,000
82. Allentown, PA......................................... 612,000
83. Harrisburg, PA........................................ 610,000
84. Bakersfield, CA....................................... 609,000
85. Youngstown, OH........................................ 604,000
86. Springfield, MA*...................................... 584,000
87. Baton Rouge, LA....................................... 558,000
88. Jersey City, NJ....................................... 552,000
89. Wilmington, DE........................................ 539,000
90. Little Rock, AR....................................... 538,000
91. New Haven, CT*........................................ 527,000
92. Charleston, SC........................................ 522,000
93. Sarasota, FL.......................................... 518,000
94. Stockton, CA.......................................... 518,000
95. Ann Arbor, MI......................................... 515,000
96. Mobile, AL............................................ 512,000
97. Wichita, KS........................................... 507,000
98. Columbia, SC.......................................... 486,000
99. Vallejo, CA........................................... 483,000
100. Fort Wayne, IN........................................ 469,000
*Population figures for New England's city and town based MSAs are for
1992, while others are for 1994.
Note: This Appendix B will not be published in the Code of
Federal Regulations.
Appendix B--Description of Number Portability Methods
I. Database methods
1. Location Routing Number (LRN). Under AT&T's LRN proposal, a
carrier seeking to route a call to a ported number queries or
``dips'' an external routing database, obtains a ten-digit location
routing number for the ported number, and uses that location routing
number to route the call to the end office switch which serves the
called party. The carrier dipping the database may be the
originating carrier, the terminating carrier, or the N-1 carrier
(the carrier prior to the terminating carrier). Under the LRN
method, a unique location routing number is assigned to each switch.
For example, a local service provider receiving a 7-digit local
call, such as 887-1234, would examine the dialed number to determine
if the NPA-NXX is a portable code. If so, the 7 digit dialed number
would be prefixed with the NPA and a 10-digit query (e.g., 679-887-
1234) would be launched to the routing database. The routing
database then would return the LRN (e.g.,
[[Page 38641]]
679-267-0000) associated with the dialed number which the local
service provider uses to route the call to the appropriate switch.
The local service provider then would formulate an SS7 call set up
message with a generic address parameter, along with the forward
call indicator set to indicate that the query has been performed,
and route the call to the local service provider's tandem for
forwarding.
2. LRN is a ``single-number solution'' because only one number
(i.e., the number dialed by the calling party) is used to identify
the customer in the serving switch. Each switch has one network
address--the location routing number. The record and the Industry
Numbering Committee (INC) indicate that LRN supports custom local
area signalling services (CLASS), emergency services, and operator
and directory services, but may result in some additional post-dial
delay. LRN can support location and service as well as service
provider portability. Finally, LRN supports wireless-wireline and
wireless-wireless service provider portability.
3. Carrier Portability Code (CPC). Under CPC, each local service
provider within a given area would be assigned a three-digit Carrier
Portability Code (CPC). The database serving that area would contain
all the telephone numbers that have been transferred from one
carrier to another and their corresponding CPCs. A carrier querying
the database for purposes of routing a call to a customer that has
transferred his or her telephone number would know from the NXX code
of the dialed number that the telephone number may have been
transferred to another local service provider. The carrier would
query a database serving that area, which would return to the
carrier a three-digit CPC corresponding to the service provider
serving the dialed number. The carrier then would route the call
according to the carrier portability code and the dialed NXX code.
For example, an IXC delivering a call to the 301 NPA would query the
database serving the 301 area code. In return, that database would
transmit back to the IXC a ten-digit number consisting of the three-
digit NPA replaced with the CPC for the LEC serving that customer,
plus the customer's seven-digit telephone number. The IXC then would
route the call to the location pre-designated by the terminating
carrier based on the six-digit CPC-NXX. Similarly, carriers
providing service within the area would query the same database to
identify the local service provider responsible for handling
specific local calls.
4. AT&T asserts that CPC is compatible with LRN by permitting
adoption of switch trigger mechanisms, switch interfaces, signalling
translations, and the development of an SMS to an LRN environment.
CPC supports an N-1 call processing scenario, avoids routing calls
through incumbent LEC networks, permits carriers to own or provide
for their own routing databases, and supports vertical features. On
the other hand, the CPC method essentially uses two NPA codes, and
therefore precludes use of the second NPA code for other purposes.
CPC supports location portability to a limited extent. It is not
clear how operator services, such as busy line verification, collect
calls, calling card calls, and third-party billing, would be handled
under this proposal. Routing telephone calls based on carrier
portability codes likely will require, among other things, that the
software be modified in each network switch located in the NPA
within which this system is deployed. It also would require
modification to the Local Exchange Routing Guide (LERG) on the same
NPA-basis so that the LERG contains routing data based on carrier
portability codes.
5. Release-to-Pivot (RTP). Carriers using RTP attempt to
complete all calls as they presently do to a switch that is assigned
a given NPA-NXX. If the dialed number has not been ported, the call
will be completed exactly as it is currently. If the dialed number
has been ported from the switch (the ``release'' switch), the call
will be released back to a previous switch (the ``pivot'' switch) in
the call path along with rerouting information (RI). The pivot
switch uses the RI to reroute the call to the new switch. For
example, a switch with pivot capabilities would determine whether a
particular call should proceed to a release capable switch. The
pivot switch would formulate an initial address message (IAM)
containing a capability indicator informing the release switch that
the call can be released back to the pivot switch. Once the release
switch receives the call, it would use a translation table to
determine whether the called number has been ported. If it has, the
switch then would formulate a release message containing a cause
value (RTP) and an LRN for delivery back to the pivot switch. The
LRN would be included in the release message as a redirection
number. The pivot switch then would access a translation table and
determine routing based on the first six digits of the LRN. A new
IAM then would be formulated and the call redirected to the
appropriate switch.
6. RTP must traverse the existing LEC network by means of
switches equipped with release and pivot functionality and an
internal database for call setup. RTP using the location routing
number to route calls is a single-number solution. RTP does not
involve the assignment of ``pseudo numbers,'' which minimizes number
exhaust. RTP should not interfere with emergency services or
operator and directory services, but may increase call setup time
and post-dial delay. RTP can support service as well as service
provider portability, but it is unclear to what extent RTP can
support location portability. Finally, RTP supports portability
between wireless carriers, but it is unclear whether it can support
wireless-wireline portability. Some parties believe that RTP is not
appropriate for long-term implementation of service provider
portability because of its reliance on the networks of incumbent
LECs, the potential for post-dial delay, and its inefficient use of
signaling links.
7. Query on Release (QOR). Also known as ``Look Ahead,'' QOR is
similar to RTP in that queries are performed only for calls to
ported numbers. However, QOR is different in several respects. Prior
to querying a routing database, the switch from which the call
originates reserves the appropriate call path through the SS7
network and attempts to complete a call to the switch where the NPA-
NXX of the dialed number resides. If the number is ported, the call
is released back to a previous switch in the call path, which
performs a query to determine the LRN of the new serving switch. The
call then is routed to the serving switch. This method differs from
RTP in that when a number has been ported from the Release switch,
the previous switch in the call path will query the database to
obtain the routing information instead of that information being
supplied by the Release switch. In other words, the switch that
redirects the call also performs the query, thus eliminating the
need for the carrier to which the number was originally assigned to
provide routing information. Pacific Bell indicates that QOR can
support both location and service portability, since any call can be
released back and routed through a non-incumbent provider's network.
8. Local Area Number Portability (LANP). Under this proposal,
each customer is assigned a ten-digit customer number address (CNA)
which is mapped to a unique ten-digit network node address (NNA),
both of which are stored in routing databases. A service provider
receives the called number (the CNA), queries a routing database,
translates the called number from its CNA to its associated NNA,
uses the NNA to route the call, and passes the NNA to the serving
end office which, based on the NNA, terminates the call to the
appropriate line or trunk. Unlike LRN, which assigns a unique
location routing number to each switch, LANP requires a separate NNA
for each CNA. The California Local Number Portability Task Force
indicates that LANP does not result in post-dial delay or require
changes in the wireless networks. In addition, LANP supports service
provider, service, and unrestricted location portability. Moreover,
the CNA can be disassociated from the switches and moved to a common
pool of numbers for reassignment. However, LANP may impact emergency
services, as the information displayed at the Public Safety
Answering Point (PSAP) will initially be the NNA rather than the
CNA. Some parties and state commissions believe that the LANP method
is not a viable option for long-term number portability because it
is too complicated to implement.
9. Non-Geographic Number (NGN). Under this approach, which
overlays the existing LEC network, a ported subscriber is assigned a
non-geographic number (NGN) and a geographic number (GN) that
indicates the customer's physical location and the serving central
office. If the customer moves or changes local service providers,
the GN--but not the NGN--changes, similar to 800 service. When the
NGN is dialed, the NGN is translated into the GN through a database
query, and the call is routed based on the GN as is done today. All
other calls are processed as they are currently. A database dip is
required only for calls to ported numbers. Ported calls will
experience longer call setup delay and post-dial delay. Emergency
and operator and directory services are not affected. This approach
supports service provider, service, and unlimited location
portability. On the other hand, NGN strains numbering resources by
forcing all ported
[[Page 38642]]
customers to limited non-geographic numbers, requires a nationwide
cut-over, and requires an initial change of telephone numbers to
obtain portability.
II. Non-database methods
1. Remote Call Forwarding (RCF). RCF is an existing LEC service
that redirects calls in the telephone network and can be adapted to
provide a semblance of service provider number portability. If a
customer transfers his or her existing telephone number from Carrier
A to Carrier B, any call to that customer is routed to the central
office switch operated by Carrier A that is designated by the NXX
code of the customer's telephone number. Carrier A's switch routes
that call to Carrier B, translating the dialed number into a number
with an NXX corresponding to a switch operated by Carrier B. Carrier
B then completes the routing of the call to its customer. The change
in terminating carriers is transparent to the calling party.
Disadvantages of RCF include the following: (1) It requires the use
of two, ten-digit telephone numbers and thus strains number plan
administration and contributes to area code exhaust; (2) it
generally does not support several custom local area signalling
services (CLASS), such as caller ID, and may degrade transmission
quality, because it actually places a second call to a transparent
telephone number; (3) it can handle only a limited number of calls
to customers of the same competing service provider at any one time;
(4) it may result in longer call set-up times; (5) it requires the
use of the incumbent LEC network for routing of calls; (6) it may
enable incumbents to access competitors' proprietary information;
(7) it may result in more complicated resolution of customer
complaints; (8) the potential for call blocking may be increased;
and (9) it may impose substantial costs upon new entrants.
2. Flexible Direct Inward Dialing (DID). DID works similarly to
RCF, except the original service provider routes calls to the dialed
number over a dedicated facility to the new service provider's
switch instead of translating the dialed number to a new number. DID
has many of the same limitations as RCF, although DID can process
more simultaneous calls to a competing service provider.
3. Other. We are aware of three derivatives of RCF and DID, all
of which require routing of all incoming calls to the terminating
switch identified by the NXX code of the dialed phone number, and
involve the loss of CLASS functionalities. Unlike RCF and DID, they
use LEC tandem switches to aggregate calls to a particular competing
service provider before those calls are routed to that provider. In
addition, Cablevision Lightpath advocates use of Trunk Route
Indexing (TRI), which it claims routes calls directly to the
competitor's interconnection facilities and supports CLASS features.
Finally, Directory Number Route Indexing (DNRI) is a method which
first routes incoming calls to the switch to which the NPA-NXX code
originally was assigned. DNRI then routes ported calls to the new
service either through a direct trunk or by attaching a temporary
``pseudo NPA'' to the number and using a tandem, depending on
availability.
Note: This Appendix C will not be published in the Code of
Federal Regulations.
Appendix C--Implementation Schedule
Implementation must be completed by the carriers in the relevant
MSAs during the periods specified below:
10/97-12/97
Chicago, IL........................................................ 3
Philadelphia, PA................................................... 4
Atlanta, GA........................................................ 8
New York, NY....................................................... 2
Los Angeles, CA.................................................... 1
Houston, TX........................................................ 7
Minneapolis, MN.................................................... 12
1/98-3/98
Detroit, MI........................................................ 6
Cleveland, OH...................................................... 20
Washington, DC..................................................... 5
Baltimore, MD...................................................... 18
Miami, FL.......................................................... 24
Fort Lauderdale, FL................................................ 39
Orlando, FL........................................................ 40
Cincinnati, OH..................................................... 30
Tampa, FL.......................................................... 23
Boston, MA......................................................... 9
Riverside, CA...................................................... 10
San Diego, CA...................................................... 14
Dallas, TX......................................................... 11
St. Louis, MO...................................................... 16
Phoenix, AZ........................................................ 17
Seattle, WA........................................................ 22
4/98-6/98
Indianapolis, IN................................................... 34
Milwaukee, WI...................................................... 35
Columbus, OH....................................................... 38
Pittsburgh, PA..................................................... 19
Newark, NJ......................................................... 25
Norfolk, VA........................................................ 32
New Orleans, LA.................................................... 41
Charlotte, NC...................................................... 43
Greensboro, NC..................................................... 48
Nashville, TN...................................................... 51
Las Vegas, NV...................................................... 50
Nassau, NY......................................................... 13
Buffalo, NY........................................................ 44
Orange Co, CA...................................................... 15
Oakland, CA........................................................ 21
San Francisco, CA.................................................. 29
Rochester, NY...................................................... 49
Kansas City, KS.................................................... 28
Fort Worth, TX..................................................... 33
Hartford, CT....................................................... 46
Denver, CO......................................................... 26
Portland, OR....................................................... 27
7/98-9/98
Grand Rapids, MI................................................... 56
Dayton, OH......................................................... 61
Akron, OH.......................................................... 73
Gary, IN........................................................... 80
Bergen, NJ......................................................... 42
Middlesex, NJ...................................................... 52
Monmouth, NJ....................................................... 54
Richmond, VA....................................................... 63
Memphis, TN........................................................ 53
Louisville, KY..................................................... 57
Jacksonville, FL................................................... 58
Raleigh, NC........................................................ 59
West Palm Beach, FL................................................ 62
Greenville, SC..................................................... 66
Honolulu, HI....................................................... 65
Providence, RI..................................................... 47
Albany, NY......................................................... 64
San Jose, CA....................................................... 31
Sacramento, CA..................................................... 36
Fresno, CA......................................................... 68
San Antonio, TX.................................................... 37
Oklahoma City, OK.................................................. 55
Austin, TX......................................................... 60
Salt Lake City, UT................................................. 45
Tucson, AZ......................................................... 71
10/98-12/98
Toledo, OH......................................................... 81
Youngstown, OH..................................................... 85
Ann Arbor, MI...................................................... 95
Fort Wayne, IN..................................................... 100
Scranton, PA....................................................... 78
Allentown, PA...................................................... 82
Harrisburg, PA..................................................... 83
Jersey City, NJ.................................................... 88
Wilmington, DE..................................................... 89
Birmingham, AL..................................................... 67
Knoxville, KY...................................................... 79
Baton Rouge, LA.................................................... 87
Charleston, SC..................................................... 92
Sarasota, FL....................................................... 93
Mobile, AL......................................................... 96
Columbia, SC....................................................... 98
Tulsa, OK.......................................................... 70
Syracuse, NY....................................................... 69
Springfield, MA.................................................... 86
Ventura, CA........................................................ 72
Bakersfield, CA.................................................... 84
Stockton, CA....................................................... 94
Vallejo, CA........................................................ 99
El Paso, TX........................................................ 74
Little Rock, AR.................................................... 90
Wichita, KS........................................................ 97
New Haven, CT...................................................... 91
Omaha, NE.......................................................... 75
Albuquerque, NM.................................................... 76
Tacoma, WA......................................................... 77
[FR Doc. 96-18477 Filed 7-24-96; 8:45 am]
BILLING CODE 6712-01-P
Complete official Federal Register PDF
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
[Federal Register Volume 61, Number 144 (Thursday, July 25, 1996)]
[Rules and Regulations]
[Pages 38806-38989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17837]
[[Page 38805]]
_______________________________________________________________________
Part II
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Part 304, et al.
Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP)
Systems; Final Rule
Federal Register / Vol. 61, No. 144 / Thursday, July 25, 1996 / Rules
and Regulations
[[Page 38806]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417
[Docket No. 93-016F]
RIN 0583-AB69
Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is establishing
requirements applicable to meat and poultry establishments designed to
reduce the occurrence and numbers of pathogenic microorganisms on meat
and poultry products, reduce the incidence of foodborne illness
associated with the consumption of those products and provide a new
framework for modernization of the current system of meat and poultry
inspection. The new regulations (1) require that each establishment
develop and implement written sanitation standard operating procedures
(Sanitation SOP's); (2) require regular microbial testing by slaughter
establishments to verify the adequacy of the establishments' process
controls for the prevention and removal of fecal contamination and
associated bacteria; (3) establish pathogen reduction performance
standards for Salmonella that slaughter establishments and
establishments producing raw ground products must meet; and (4) require
that all meat and poultry establishments develop and implement a system
of preventive controls designed to improve the safety of their
products, known as HACCP (Hazard Analysis and Critical Control Points).
DATES: Effective Date: July 25, 1996, however these rules are not
applicable until the dates listed below.
Applicability dates: (1) The HACCP regulations set forth in 9 CFR
Part 417 and related provisions set forth in 9 CFR 304, 327, and 381
parts will be applicable as follows:
In large establishments, defined as all establishments
with 500 or more employees, on January 26, 1998.
In smaller establishments, defined as all establishments
with 10 or more employees but fewer than 500, on January 25, 1999.
In very small establishments, defined as all
establishments with fewer than 10 employees or annual sales of less
than $2.5 million, on January 25, 2000.
(2) The Sanitation SOP's regulations set forth in 9 CFR 416 will be
applicable on January 27, 1997.
(3) The E. coli process control testing regulations set forth in 9
CFR 310.25(a) and 381.94(a) will be applicable on January 27, 1997.
(4) The Salmonella pathogen reduction performance standards
regulations set forth in 9 CFR 310.25(b) and 9 CFR 381.94(b) will be
applicable simultaneously with applicability dates for implementation
of HACCP.
Comments: Comments on specified technical aspects of the final
regulations must be received on or before September 23, 1996. With
respect to the HACCP final regulations, FSIS requests comments by
November 22, 1996.
ADDRESSES: Submit one original and two copies of written comments to:
FSIS Docket Clerk, DOCKET #93-016F, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 4352, 1400 Independence
Avenue, S.W., Washington, DC 20250-3700. All comments submitted on this
rule will be available for public inspection in the Docket Clerk's
Office between 8:30 a.m. and 1:00 p.m., and 2:00 p.m. and 4:30 p.m.,
Monday through Friday. The references and baseline surveys cited in
this document are available for inspection in the FSIS Docket Room.
FOR FURTHER INFORMATION CONTACT: (1) GENERAL: Dr. Judith A. Segal,
Director, Policy, Evaluation, and Planning Staff, (202) 720-7773; (2)
MICROBIAL TESTING: Patricia F. Stolfa, Acting Deputy Administrator,
Science and Technology, (202) 205-0699.
SUPPLEMENTARY INFORMATION:
Obtaining Copies of This Document:
An electronic version of this document is available on the Internet
from the Federal Register at www.access.gpo.gov/su__docs/aces/
aces140.html. Paper or diskette copies of this document may be ordered
from the National Technical Information Service (NTIS), U.S. Department
of Commerce, 5285 Port Royal Road, Springfield, VA 22161. For a
complete copy of this document orders must reference NTIS accession
number PB96-177613 (paper copy) and PB96-502166 (disk copy). For a copy
of the preamble and rule, the individual appendices, and the impact
assessment reference the following NTIS accession numbers: PB96-177621
(preamble and rule only), PB96-177639 (Appendix A), PB96-177647
(Appendix B), PB96-177654 (Appendix C), PB96-177662 (Appendix D), PB96-
177670 (Appendix E), PB96-177688 (Appendix F), PB96-177696 (Appendix
G), and PB96-177704 (impact assessment). For telephone orders or more
information on placing an order, call NTIS at (703) 487-4650 for
regular service or (800) 553-NTIS for rush service. Dial (703) 321-8020
with a modem or Telnet fedworld.gov to access this document
electronically for ordering and downloading via FedWorld. For technical
assistance to access FedWorld, call (703) 487-4608.
Table of Contents
I. Background
Overview of FSIS Food Safety Goal and Strategy
FSIS Regulatory Proposals
FSIS Regulatory and Inspection Reform Plans
Change Within FSIS
The FSIS Pathogen Reduction/HACCP Rulemaking Process
Seven Information Briefings
Three Scientific and Technical Conferences
Public Hearing
Federal-State Relations Conference
Scoping Session and Six Issue-Focused Meetings
Food Safety Forum
Farm-to-Table Strategy
General Overview of the Comments and the Final Rule
HACCP and Performance Standards
Sanitation SOP's, Antimicrobial Treatments, and Cooling
Requirements for Raw Meat and Poultry Products
Timetable for Implementation
Federally Inspected Establishments
State-inspected Establishments
Foreign-inspected Establishments
Implementation Conferences
Request for Comments
II. Hazard Analysis and Critical Control Point Systems
Overview of Final Rule
History and Background of HACCP
The Seven HACCP Principles
HACCP and the FSIS Food Safety Strategy
Preparing for HACCP Implementation
Inspection under HACCP
Implementation Schedule
Small Business Issues
Training Considerations
Mandatory versus Voluntary HACCP
HACCP from Farm-to-Table
Total Quality Control (TQC) Establishments and HACCP
Freedom of Information Act Concerns
FSIS Enforcement Authority and Whistleblower Protection
Enforcement and Due Process
The Final Rule
Reorganization of HACCP Regulatory Text
HACCP Systems as a Condition of Receiving Inspection
Definitions
Hazard Analysis and HACCP Plan
Corrective Actions
Validation, Verification, and Reassessment
Reassessment
FSIS Verification
Records
[[Page 38807]]
Training
Adequacy of HACCP Plans
III. Sanitation Standard Operating Procedures
The Proposed Rule
The Final Rule
Comments and Responses
General
Development of Sanitation SOP's
Maintaining Sanitation SOP's
Recordkeeping
``Layering''
Role of Inspectors
Relation to HACCP
Training
Pre-operation Sanitation Inspection
Implementation Date
IV. Microbiological Performance Criteria and Standards
Summary of Proposal
Role of Microbiological Performance Criteria and Standards in
FSIS Food Safety Strategy
Overview of Final Rule
Process Control Verification Performance Criteria
Pathogen Reduction Performance Standards
Process Control Verification: E. coli Performance Criteria and
Testing
Rationale for Using E. coli Tests to Verify Process Control
Use of Baseline Values to Establish E. coli Performance Criteria
Establishment of E. coli Performance Criteria to Verify Process
Control
Sampling Frequency for E. coli Testing
Sampling and Analytical Methodology
Recordkeeping
Use of E. coli Test Results by Establishments
Use of E. coli Test Results by FSIS
Implementation Timetable
Request for Comments
Pathogen Reduction Performance Standards
Rationale for Selecting Salmonella
Basis for Performance Standards and Plans for Future Adjustments
Determining Compliance with the Standard
FSIS Testing Strategy
FSIS Testing Methods
FSIS Enforcement Strategy
Implementation Timetable for Pathogen Reduction Performance
Standards
Response to Comments
The Indicator Organism
Frequency and Cost of Testing
Legal Authority for Testing Requirement
Performance Standards for Process Control
Basis for Target Levels
Methodology for Meeting Targets
Sample Size
Testing Methodology
Role of Inspectors
Laboratories
Alternative Sampling under HACCP
Relationship to HACCP
V. Other Issues and Initiatives
Antimicrobial Treatments
Cooling and Chilling Requirements for Raw Meat and Poultry
International Trade
Recordkeeping and Record Retention
Finished Product Standards for Poultry Carcasses
VI. Economic Impact Analysis and Executive Orders
Executive Order 12866
HACCP-based Regulatory Program Produces Net Benefit to Society
Market Failure Justifies Regulation of Pathogens
Regulatory Alternatives
Unfunded Mandates Reform Act
Regulatory Flexibility Act
Executive Order 12778
Paperwork Requirements
Sanitation Standard Operating Procedures (Sanitation SOP's)
Time and Temperature
Microbiological Testing
HACCP
VII. Final Rules
VIII. Appendix A--Guidelines for Developing a Standard Operating
Procedure for Sanitation (Sanitation SOP's) in Federally Inspected
Meat and Poultry Establishments
IX. Appendix B--Model of a Standard Operating Procedure for
Sanitation
X. Appendix C--Guidebook for the Preparation of HACCP Plans
XI. Appendix D--Hazards and Preventive Measures Guide
XII. Appendix E--FSIS Sample Collection Guidelines and Procedure for
Isolation and Identification of Salmonella from Raw Meat and Poultry
Products
XIII. Appendix F--Guidelines for Escherichia coli Testing for
Process Control Verification in Cattle and Swine Slaughter
Establishments
XIV. Appendix G--Guidelines for Escherichia coli Testing for Process
Control Verification in Poultry Slaughter Establishments
XV. Supplement--Final Regulatory Impact Assessment
I. Background
Overview of FSIS Food Safety Goal and Strategy
The mission of the FSIS is to ensure that meat, poultry, and egg
products are safe, wholesome, and properly marked, labeled, and
packaged. Regarding meat and poultry, FSIS currently carries out its
food safety responsibility primarily by managing an inspection program
within meat and poultry slaughter and processing establishments. This
program relies heavily on FSIS inspectors to detect and correct
establishment sanitation and food safety problems.
Recent outbreaks of foodborne illness and studies conducted over
the past decade by the National Academy of Sciences (NAS), the U.S.
General Accounting Office (GAO), and FSIS itself have established the
need for fundamental change in the FSIS meat and poultry inspection
program to improve food safety, reduce the risk of foodborne illness in
the United States, and make better use of the Agency's resources.
FSIS has embarked on a broad effort to bring about the necessary
changes in its program. In the preamble to the ``Pathogen Reduction;
Hazard Analysis Critical Control Point (HACCP) Systems'' proposed rule,
published in the Federal Register of February 3, 1995 (Docket #93-016P,
60 FR 6774; hereafter ``Pathogen Reduction/HACCP proposal''), FSIS
traced the origins of its current program, described today's food
safety challenges, and outlined a new food safety strategy for meat and
poultry products. In that document, FSIS proposed new regulations to
mandate adoption within meat and poultry establishments of HACCP, a
science-based process control system for food safety.
The HACCP requirement and other food safety measures proposed by
FSIS in the Pathogen Reduction/HACCP proposal were motivated by the
critical need to fill a gap in the current regulation and inspection
system and the lack of adequate measures to address the problem of
pathogenic microorganisms on raw meat and poultry products.
Such bacteria, including Salmonella, E. coli O157:H7, Campylobacter
and Listeria monocytogenes, are significant food safety hazards
associated with meat and poultry products. FSIS estimates that the
contamination of meat and poultry products with these bacteria results
annually in as many as 4,000 deaths and 5,000,000 illnesses.
FSIS stated the goal of its food safety strategy and proposed
Pathogen Reduction/HACCP regulations as follows: FSIS believes its
food safety goal should be to reduce the risk of foodborne illness
associated with the consumption of meat and poultry products to the
maximum extent possible by ensuring that appropriate and feasible
measures are taken at each step in the food production process where
hazards can enter and where procedures and technologies exist or can
be developed to prevent the hazard or reduce the likelihood it will
occur (60 FR 6785).
In establishing this goal, FSIS recognized that no single
technological or procedural solution exists for the problem of
foodborne illness and that the Agency's food safety goal would be
achieved only through continuous efforts to improve hazard
identification and prevention.
The food safety strategy FSIS outlined in the Pathogen Reduction/
HACCP proposal included the following major elements: (1) provisions
for systematic prevention of biological, chemical, and physical hazards
through adoption by meat and poultry establishments of science-based
process control systems;
[[Page 38808]]
(2) targeted efforts to control and reduce harmful bacteria on raw meat
and poultry products; (3) adoption of food safety performance standards
that provide incentives for innovation to improve food safety and to
provide a measure of accountability for achieving acceptable food
safety results; (4) removal of unnecessary regulatory obstacles to
innovation; and (5) efforts to address hazards that arise throughout
the food safety continuum from farm to table.
FSIS also stressed, as a central theme of its strategy, a need to
clarify and strengthen the responsibilities of establishments for
maintaining effective sanitation, following sound food safety
procedures, and achieving acceptable food safety results.
FSIS Regulatory Proposals
FSIS proposed HACCP as the organizing structure for its food safety
program because HACCP is the optimal framework for building science-
based process control to prevent food safety hazards into food
production systems. HACCP also focuses FSIS inspection on the most
significant hazards and controls.
To complement HACCP, FSIS proposed to establish, for the first
time, food safety performance standards for pathogenic microorganisms
on raw meat and poultry products, initially as ``interim'' targets for
the reduction of Salmonella contamination of raw carcasses and raw
ground meat and poultry products. These performance standards would
measure whether HACCP systems are working effectively to address food
safety hazards. FSIS proposed to require that establishments conduct
daily microbial testing for Salmonella to verify achievement of the
``targets.''
FSIS also proposed three near-term measures to speed progress on
controlling and reducing pathogenic microorganisms on raw products
during the proposed three year phase-in of HACCP. These proposed
measures were: (1) a requirement that all establishments adopt and
implement sanitation standard operating procedures (Sanitation SOP's);
(2) a requirement that all slaughter establishments use at least one
effective antimicrobial treatment to reduce harmful bacteria; and, (3)
standards for cooling red meat carcasses to prevent the growth of
harmful bacteria.
FSIS Regulatory and Inspection Reform Plans
In the Pathogen Reduction/HACCP proposal, FSIS acknowledged that it
must do more than mandate HACCP and other new regulatory requirements
in order to achieve its food safety goals. FSIS must also reform its
existing regulations, policies, and directives to be consistent with
HACCP principles and with the Agency's intention to rely more heavily
on performance standards. Current FSIS regulatory requirements and
procedures are generally highly detailed and prescriptive. They
specify, for example, precise cooking time-and-temperature combinations
for many products. Current regulations often assign to FSIS
responsibility for the means used by establishments to produce safe
food in a sanitary environment (e.g., FSIS requires that facility
blueprints and equipment receive Agency approval before use).
As part of its regulatory reform initiative, FSIS has undertaken
the conversion of current command-and-control regulations to
performance standards. Command-and-control regulations, and the
Inspection System Guide that FSIS inspectors use to enforce those
regulations, resulted from the perceived need to achieve uniformity
among federally inspected meat and poultry establishments.
Technological advances introduce a new imperative, however. If
establishments are to innovate, using new technologies to improve food
safety, they cannot be impeded by a one-size-fits-all regulatory
system. Under contemporary conditions, affording establishments the
flexibility to make establishment-specific decisions outweighs the
advantages of uniformly applicable rules. Recognizing this, FSIS is
changing inspection to meet the needs of the new regulatory system.
Under the command-and-control-based system, the inspector assumed
responsibility for ``approving'' production-associated decisions. Under
the new system, industry assumes full responsibility for production
decisions and execution. FSIS, having set food safety standards,
monitors establishments' compliance with those standards and related
requirements and under HACCP, verifies process control and pathogen
reduction and control. The number of inspection tasks will be reduced,
so that inspectors can focus more attention on areas of greatest risk
in the meat or poultry production system within each establishment.
With the shift to HACCP and greater reliance on performance
standards, establishments will be afforded greater autonomy in
decision-making affecting their own operations and, in return, be
expected to take responsibility for setting up site- and product
appropriate process control measures to achieve FSIS-established
performance standards. This approach, which is intended to increase
both the incentives and the flexibility establishments need to innovate
and improve food safety, requires a complete review and overhaul of the
``command-and-control'' requirements and procedures in current FSIS
regulations, policies, and directives.
HACCP-based food safety strategies and performance standards also
require important changes in FSIS's approach to inspection. FSIS
intends to clarify the respective responsibilities of FSIS inspectors
and establishment management.
In the Federal Register of December 29, 1995 (60 FR 67469), FSIS
published an advance notice of proposed rulemaking (ANPR) and
additional rulemaking proposals describing the Agency's strategy for
the regulatory and inspectional reform required to achieve the changes
required for consistency with HACCP. These changes will be accomplished
before establishments are required to implement HACCP.
Change Within FSIS
Finally, achieving the Agency's food safety goals will require
substantial change within FSIS itself, as the roles of establishments
and Federal inspectors are realigned to accord with the HACCP
philosophy. The scope of FSIS's food safety activities will also extend
beyond slaughter and processing establishments to include new
preventive approaches to hazards that occur during transportation,
distribution, and retail, restaurant or food service sale of meat and
poultry products.
This expansion of the Agency's roles will require substantial
training and redeployment of employees, and will place an enormous
strain on agency resources. To meet these challenges, FSIS has
conducted a top-to-bottom review of its regulatory roles, resource
allocation and organizational structure. Reports prepared by FSIS
employees containing analysis and recommendations on these topics were
described and made available for public comment in the Federal Register
of September 12, 1995 (60 FR 47346). FSIS will be making the
fundamental internal changes required to successfully carry out its
HACCP-based farm-to-table food safety strategy. These changes within
FSIS, which include a major reorganization of the Agency, will ensure
that FSIS is using its resources to improve food safety consistent with
its new regulatory framework.
[[Page 38809]]
The FSIS Pathogen Reduction/HACCP Rulemaking Process
Recognizing that HACCP and other regulatory requirements contained
in the Pathogen Reduction/HACCP proposal are part of a broad overhaul
of the FSIS regulatory program, and involve important changes in the
responsibilities of meat and poultry establishments, FSIS has conducted
a thorough and interactive rulemaking process. The Agency's goal has
been to provide many opportunities for submission by the public of both
written and oral comments and for interchange between FSIS and
interested parties on the many major policy and technical issues
involved in the reform of meat and poultry inspection.
The initial comment period was 120 days, which FSIS subsequently
extended for an additional 30 days and later reopened for another 95
days. During this period, FSIS held seven informational briefings,
three scientific and technical conferences, a two-day public hearing, a
scoping session and six issue-focused public meetings, a Federal-State
conference, and a Food Safety Forum. Extensive oral comments were
transcribed and included with written comments in the record of this
rulemaking. A brief summary of the various public meetings follows.
Seven Information Briefings
Initially, FSIS held informational briefings in seven cities across
the country to explain the Pathogen Reduction/HACCP proposal to the
public and to answer questions. A panel of FSIS officials and
scientists provided information on the proposed regulations and
answered questions. These briefings were not intended to solicit
comments, but to help interested parties prepare themselves to comment
on the Pathogen Reduction/HACCP proposal. These briefings were held:
March 7, 1995; Oakland, California
March 14, 1995; Dallas, Texas
March 16, 1995; Chicago, Illinois
March 21, 1995; Atlanta, Georgia
March 23, 1995; New York, New York
March 30, 1995; Washington, D.C.
May 22, 1995; Kansas City, Kansas
The Kansas City session included an informational briefing and
public meeting for owners and representatives of small meat and poultry
establishments and other affected small businesses to discuss the
Pathogen Reduction/HACCP proposal. At the meeting, many small business
owners said that the Pathogen Reduction/HACCP proposal might eventually
inhibit small businesses from competing with larger entities because
the resulting additional costs could be borne more easily by larger
companies. Three Directors of State Meat and Poultry Inspection
Programs stated their views that the Pathogen Reduction/HACCP proposal
might have a negative impact upon the small businesses for which they
provide inspection. Consumers requested that FSIS base its decisions on
the Pathogen Reduction/HACCP proposal not on industry impacts, but on
what will best protect the public.
Three Scientific and Technical Conferences
FSIS held three scientific and technical conferences to foster the
development of beneficial new food safety technologies, to fill gaps in
scientific knowledge, and to ensure that the Agency had the best
scientific information available for the rulemaking. Concerned that the
typical rulemaking process would not elicit this information, the
Agency invited experts on relevant subjects to the meetings, which were
open to all interested parties.
The first conference, titled ``New Technology to Improve Food
Safety,'' was held April 12-13, 1995, in Chicago, Illinois. This
conference explored the available technology that might be introduced
into the production and manufacturing of meat and poultry products to
control E. coli O157:H7 and other harmful pathogens in the food supply.
Participants included members of industry, academia, research
organizations, and consumers. Additionally, Government representatives
from non-food Federal regulatory agencies discussed technology
development and transfer in other industries. FSIS discussed how it
emphasized and encourages the approval and introduction of new
technologies.
The second conference, titled ``The Role of Microbiological Testing
in Verifying Food Safety,'' was held May 1-2, 1995, in Philadelphia,
Pennsylvania. This meeting explored scientific issues related to the
use of microbiological testing for verifying meat and poultry safety.
Six persons were invited to present discussions relating to the use and
limitations of microbiological testing in ensuring food safety. Twelve
representatives from academia, consumer groups, industry, and exporting
countries also presented talks on the concepts and methods for
microbiological testing that appeared in the proposed regulation.
During the comment period following the presentations, 15 people
commented on the subjects covered at the meeting and in the proposed
regulation.
The third conference, titled ``An Evaluation of the Role of
Microbiological Criteria in Establishing Food Safety Performance
Standards in Meat and Poultry Products,'' was held May 18-19, 1995, in
Washington, D.C. It explored the use of microbiological criteria to
establish food safety performance standards for meat and poultry
products. Participants generally agreed that HACCP is an effective
approach to controlling microbiological hazards in foods, and that
government and industry must work together to establish microbiological
criteria, sampling plans and training for food safety performance
standards. Most commenters agreed that the use of an indicator organism
is effective to facilitate and monitor the reduction of microbiological
contamination in meat and poultry products. Diverse opinions were
expressed on which indicator organisms should be chosen for each type
of product.
Public Hearing
On May 30 and 31, 1995, FSIS held a public hearing in Washington,
D.C., on the proposed rule.
Thirty-seven persons presented comments at the 2-day hearing.
Issues and viewpoints varied greatly. For instance, requests were made
to keep carcass-by-carcass inspection, but it was suggested that
organoleptic inspection is outdated. While there was support for a
HACCP system, many suggestions were made for changes in specific parts
of the proposal, particularly microbial testing and antimicrobial
treatments. Several commenters described their personal experiences
with foodborne illness. Small business owners and their representatives
commented on the potential financial burdens that might result from the
Pathogen Reduction/HACCP proposal.
Federal-State Relations Conference
As part of the annual meeting of Directors of State Meat and
Poultry Inspection Programs, FSIS held a ``Federal-State Relations
Conference,'' August 21-23, 1995, in Washington, D.C. This meeting, in
which the National Association of State Departments of Agriculture
participated, provided an opportunity for representatives from State
government to engage in an open exchange with senior USDA officials on
the Pathogen Reduction/HACCP proposal. In addition to State Directors,
the meeting included representatives from State Departments of
Agriculture, State Health Departments and local food safety enforcement
agencies; additionally, the Food and Drug Administration (FDA)
[[Page 38810]]
and the Association of Food and Drug Officials were participants. These
parties recognized a need to better protect the public by optimizing
the use of available resources. State agency representatives discussed
the need for better coordination within their own States and with the
Federal Government to prevent foodborne illness outbreaks. Improved
food handling education for industry and consumers was seen as one of
the primary ways to improve farm-to-table food safety.
Scoping Session and Six Issue-Focused Meetings
By late August, FSIS had received more than 6,800 comments on the
Federal Register notice, in addition to the input obtained at the
meetings and the hearing. All this information raised new issues and
modified Agency thinking in some areas. In order to share new
information and current thinking with its constituencies, FSIS held six
issue-focused public meetings on the proposed rule and accepted written
comments from those unable to attend. The meetings were announced in
the Federal Register (60 FR 45380; Thursday, August 31, 1995) and held
at USDA, Washington, D.C., on September 13, 14, 15, 27, 28, and 29,
1995.
FSIS framed an agenda for the meetings and provided issue papers
describing current Agency thinking on the proposed rule. Before the
issue-focused public meetings, FSIS held a public scoping session on
August 23, 1995, to ensure that all parties had an opportunity to
suggest issues for the agenda.
The issue papers provided at the six issue-focused public meetings
were published in the Federal Register (60 FR 54450; Tuesday, October
24, 1995).
Food Safety Forum
A Food Safety Forum chaired by Secretary Glickman was held on
November 8, 1995 to discuss food safety reform issues beyond the
specific issues raised by the proposed Pathogen Reduction/HACCP
proposal. The forum agenda included topics such as: (1) whether
legislative changes to the Federal Meat Inspection Act (FMIA) and the
Poultry Products Inspection Act (PPIA) were needed; (2) how FSIS could
improve food safety by organizational change, regulatory reform,
reliance on user fees, effective resource allocation and other means;
(3) cooperation between USDA and State inspection programs; and (4)
government and private sector roles in consumer education regarding
safe food handling practices. A transcript of the forum has been
included in the record for this rulemaking.
Farm-to-Table Strategy
In the preamble to its Pathogen Reduction/HACCP proposal, FSIS
presented a strategy for the control of food safety hazards throughout
the continuum of animal production and slaughter, and the processing,
distribution, and sale of meat and poultry products. FSIS has
historically focused on the manufacturing of meat and poultry products
through its inspection program, but the Agency's public health mandate
requires that the Agency also consider pre- and post-processing hazards
as part of a comprehensive strategy to prevent foodborne illness.
This farm-to-table food safety strategy is founded on three
principles:
Hazards that could result in foodborne illness arise at
each stage in the farm-to-table continuum: animal production and
slaughter, and the processing, transportation, storage and retail,
restaurant or food service sale of meat and poultry products. Each
stage presents hazards of pathogen and other contamination and each
provides opportunities for minimizing the effect of those hazards.
Those in control of each segment of the farm-to-table
continuum bear responsibility for identifying and preventing or
reducing food safety hazards that are under their operational control.
The Agency's public health mandate requires that it
address foodborne illness hazards within each segment of the food
production chain and implement or encourage preventative strategies
that improve the whole system.
FSIS remains committed to a farm-to-table food safety strategy
based on these principles. To address hazards arising within slaughter
and processing establishments, FSIS proposed and is adopting in this
rule significant new regulatory measures. Improving food safety before
the animals reach slaughter establishments will require a different
approach. The preamble to the Pathogen Reduction/HACCP proposal stated
that FSIS will be cooperating with animal producers, scientists in
academia, the Animal and Plant Health Inspection Service and other
government agencies to develop and foster food safety measures that can
be taken on the farm and through marketing channels to decrease public
health hazards in animals presented for slaughter. Within this context,
the voluntary application of food safety assurance programs based on
HACCP principles can be useful in establishing risk reduction practices
on the farm and through intermediate marketing stages to control and
reduce pathogen hazards at slaughter.
FSIS expects, within the limits of available resources, to serve as
a facilitator and coordinator of research and other activities designed
to encourage development and implementation of animal production
technologies and practices that can improve food safety. FSIS also
intends to offer its expertise to assist State health and agricultural
officials, when requested, during outbreak investigations of foodborne
illnesses to learn more about potential risk factors. FSIS does not
intend nor is FSIS authorized, to mandate production practices on the
farm, but does expect that continued public concern about foodborne
pathogens and adoption of HACCP and food safety performance standards
within slaughter and processing establishments will increase incentives
for improving food safety practices at the animal production level.
The post-processing transportation, storage, and retail, restaurant
or food service sectors are also important links in the chain of
responsibility for food safety. In these areas, FDA and State and local
governments share authority and responsibility for oversight of meat
and poultry products outside of official establishments. FSIS and FDA
are collaborating in the development of standards governing the safety
of potentially hazardous foods, including meat and poultry, eggs, and
seafood, during transportation and storage, with particular emphasis on
proper cooling to minimize the growth of pathogenic microorganisms, and
on disclosure of prior cargoes in transport vehicles. This effort will
be discussed in a forthcoming advance notice of proposed rulemaking.
In the retail, restaurant and food service areas, FSIS and FDA are
working in concert with State and local food regulatory officials to
foster adoption of updated, uniform, science-based standards, including
mandates for HACCP process controls for high-risk processing and
packaging operations. State and local authorities have assumed primary
responsibility for food safety oversight of retail, restaurant and food
service operations, but FSIS and FDA, working through the Conference on
Food Protection and other collaborative mechanisms, provide expertise
and leadership to support local authorities and foster development of
sound food safety standards and practices nationwide. FSIS is
cooperating with FDA to update the Food Code, a set of model ordinances
recommended for adoption by the
[[Page 38811]]
States, to ensure meat and poultry safety is adequately addressed in
retail, restaurant and food service settings.
Even as progress is made in reducing contamination of food by
harmful bacteria and other safety hazards at the production, processing
and subsequent commercial stages of the farm-to-table continuum, it
will remain critically important that individual consumers follow safe
food handling practices. Proper storage, preparation, and cooking of
meat and poultry products are essential to achieving the goal of
reducing the risk of foodborne illness to the maximum extent possible.
FSIS intends to augment its food handler and consumer education efforts
by expanding its collaboration with the meat and poultry industry,
other government agencies, consumer and public interest groups,
educators, and the media to effectively develop and deliver food safety
education and information to the public.
The HACCP requirements and other regulations FSIS is adopting in
this final rule will ensure that inspected establishments are taking
appropriate measures to reduce hazards at critical stages where the
risk of initial contamination is greatest. The public health benefits
of these measures, however, are only a part of a comprehensive food
safety strategy that seeks to minimize hazards throughout the farm-to-
table continuum.
General Overview of the Comments and the Final Rule
HACCP and Performance Standards
The FSIS proposal to require adoption of HACCP in meat and poultry
establishments was widely endorsed by comments from large and small
businesses, the scientific and public health communities, consumers,
and public interest organizations. Commenters strongly supported the
concept that meat and poultry establishments should systematically
build science-based food safety measures into their production
processes following the seven HACCP principles developed by the
National Advisory Committee on Microbiological Criteria for Food
(NACMCF). Although many commenters requested clarification of how FSIS
intends to implement HACCP and conduct inspection under HACCP, the
principal critical comments concerned costs and the practicality of
using HACCP in very small establishments. FSIS is adopting the HACCP
requirements, based on the NACMCF principles, essentially as proposed.
From a food safety standpoint, the most important objective of this
rulemaking is to build into food production processes, and into the
system of FSIS regulation and oversight, effective measures to reduce
and control harmful bacteria on raw meat and poultry products. This
will not by itself solve the problem of foodborne illness associated
with meat and poultry products. Effective measures are needed
throughout the farm-to-table continuum, but this rulemaking will fill
the most critical gap in the current system of meat and poultry
inspection. While products sold in cooked or otherwise ready-to-eat
forms are currently subject to controls and regulatory standards
designed to eliminate harmful bacteria, products sold raw are not
currently subject, as a general matter, to any such controls or
standards.
FSIS has concluded that HACCP-based process control, combined with
appropriate food safety performance standards, is the most effective
means available for controlling and reducing harmful bacteria on raw
meat and poultry products. HACCP provides the framework for industry to
set up science-based process controls that establishments can validate
as effective for controlling and reducing harmful bacteria. Performance
standards tell establishments what degree of effectiveness their HACCP
plans will be expected to achieve and provide a necessary tool of
accountability for achieving acceptable food safety performance.
Science-based process control, as embodied in HACCP, and appropriate
performance standards are inextricably intertwined in the Agency's
regulatory strategy for improving food safety. Neither is sufficient by
itself, but, when combined, they are the basis upon which FSIS expects
significant reductions in the incidence and levels of harmful bacteria
on raw meat and poultry products and, in turn, significant reductions
in foodborne illness.
The proposed interim targets for pathogen reduction based on
Salmonella generated widely diverse comments. Commenters supported the
goal of pathogen reduction, and many recognized some role for microbial
testing and the need for a microbial reduction target or performance
standard. Some commenters argued that the proposed testing regimen (a
single sample per species per day) was inadequate for its purpose in
large establishments, while others argued it was too burdensome in
small establishments. Some commenters specifically supported the
proposed Salmonella reduction targets and the daily testing
requirements. Many, however, criticized the proposed testing
requirements and considered Salmonella testing less useful than generic
E. coli testing as an indicator of whether process controls in
slaughter establishments are effectively preventing fecal
contamination, the primary pathway for pathogen contamination. At the
scientific conference on the role of microbial testing held in
Philadelphia, broad support also was expressed for using generic E.
coli rather than Salmonella as a process control indicator.
Based on public comments, FSIS has modified its approach to
establishing microbial performance standards. FSIS believes that
testing for generic E. coli is the appropriate and necessary means by
which meat and poultry slaughter establishments must verify their
process controls. FSIS reviewed written comments received on the
original proposal and comments made at the scientific conferences and
public meetings, as well as available scientific data, and has decided
to require slaughter establishments to conduct testing for generic E.
coli to verify process controls. Establishments will be required to
test for E. coli at a frequency that takes into account their volume of
production. FSIS is seeking additional scientific and economic data
that may help to further improve the E. coli testing protocols.
FSIS is also establishing performance criteria based on national
microbiological baseline surveys. The criteria are not regulatory
standards but rather provide a benchmark for use by slaughter
establishments in evaluating E. coli test results. Test results that do
not meet the performance criteria will be an indication that the
slaughter establishment may not be maintaining adequate process control
for fecal contamination and associated bacteria. Such results will be
used in conjunction with other information to evaluate and make
appropriate adjustments to ensure adequate process control for fecal
contamination and associated bacteria.
FSIS is also establishing pathogen reduction performance standards
for Salmonella that will require all slaughter establishments to reduce
the incidence of Salmonella contamination of finished meat and poultry
carcasses below the national baseline prevalence as established by the
most recent FSIS national microbiological baseline data for each major
species. FSIS will conduct Salmonella testing in slaughter
establishments to detect whether they are meeting the pathogen
reduction performance standards, and will require corrective action or
take regulatory
[[Page 38812]]
action, as appropriate, to ensure establishments are meeting the
pathogen reduction standards.
Pathogen-specific performance standards for raw products are an
essential component of the FSIS food safety strategy because they
provide a direct measure of progress in controlling and reducing the
most significant hazards associated with raw meat and poultry products.
The Salmonella standards being established in this final rule, which
are based on the current national baseline prevalence of Salmonella
(expressed as a percentage of contaminated carcasses), are a first step
in what FSIS expects to be a broader reliance in the future on
pathogen-specific performance standards. FSIS plans to repeat its
baseline surveys and collect substantial additional data through other
means and, on that basis, adjust the Salmonella performance standards
and possibly set standards for additional pathogens, as appropriate.
Also, FSIS will continue to explore establishing pathogen-specific
performance standards based on the levels of contamination (i.e., the
number of organisms) on a carcass. Future FSIS efforts on such
performance standards will reflect the fact that achieving the food
safety goal of reducing foodborne illness to the maximum extent
possible will require continuous efforts and improvement over a
substantial period.
Sanitation SOP's, Antimicrobial Treatments, and Cooling Requirements
for Raw Meat and Poultry Products
Comments generally supported the objectives of the three near-term
measures for raw meat and poultry products proposed by FSIS, Sanitation
SOP's, antimicrobial treatments, and carcass cooling standards, and
most commenters agreed that Sanitation SOP's should be a required
element of any meat and poultry establishment's food safety program.
Many commenters objected, however, to FSIS mandated antimicrobial
treatments in slaughter establishments and carcass cooling standards
for red meat prior to the implementation of HACCP. Although most
comments generally agreed that antimicrobial treatments would play an
important role in many slaughter establishments' HACCP plans, and that
proper carcass cooling would be an essential part of any HACCP plan for
raw meat and poultry products, these commenters argued that mandating a
particular approach to antimicrobial treatments or carcass cooling
would be inconsistent with the HACCP concept that establishment
management is responsible for designing a system of controls
appropriate for each establishment. They also argued that mandating
antimicrobial treatments was unnecessary if establishments were
required to meet pathogen reduction performance standards. Similarly,
with respect to the proposed requirement that establishments cool red
meat carcasses following specific cooling rate standards prescribed by
FSIS, commenters argued that HACCP, reinforced by performance
standards, would ensure proper carcass cooling. Many commenters said
that the specific time-and-temperature requirements proposed by FSIS
were often not feasible, posed worker safety concerns, and would divert
effort and resources that could be used more productively in preparing
for implementation of HACCP.
Based on the comments, FSIS has reconsidered its approach to the
proposed near-term measures. FSIS believes that its regulatory program
and the food safety efforts of the meat and poultry industry should be
focused on making a transition to HACCP as rapidly and effectively as
possible and that FSIS should not mandate any near-term measures that
would not be expected to continue as mandatory elements of a HACCP-
based system.
FSIS has decided to adopt final rules that mandate Sanitation
SOP's. Good sanitation is a critical foundation for HACCP, and
Sanitation SOP's are an essential element of the FSIS effort to more
clearly define establishment and inspector responsibilities, and better
focus both the establishment management and FSIS on those elements of
daily sanitation that relate most directly to the risk of product
contamination. Near-term implementation of Sanitation SOP's will
facilitate the transition to HACCP.
FSIS has decided not to mandate antimicrobial treatments in
slaughter establishments. The Agency expects that antimicrobial
treatments will play an important role in the design of slaughter HACCP
plans as establishments institute controls that are effective in
reducing pathogens and meeting FSIS performance standards. As a general
matter, however, FSIS does not intend to mandate the specific controls
that establishments must adopt in their HACCP plans. In the case of
antimicrobial treatments, FSIS believes that improvement in food safety
would be better served by providing establishments the incentive and
flexibility to incorporate antimicrobial treatments in any manner they
judge most effective for their operations to meet FSIS-established
performance standards for reducing bacterial contamination.
With respect to carcass cooling, FSIS continues to believe that, in
a HACCP environment, appropriate performance standards are needed for
the cooling of carcasses and raw meat and poultry products to prevent
the growth of harmful bacteria. After consideration of the comments,
FSIS has concluded, however, that the specific time-and-temperature
combinations proposed by FSIS were too restrictive and that a
scientifically sound and effective strategy for preventing the growth
of pathogens through proper cooling must apply not only within, but
also beyond, FSIS-inspected establishments. Thus, instead of including
requirements for carcass cooling in this final rule, FSIS intends to
extend this rulemaking to consider alternative approaches to
performance standards for cooling within establishments. Concurrently,
FSIS also intends to develop rulemaking covering the adoption of
standards for cooling of raw products during transportation, storage,
and retail, restaurant or food service sale. FSIS anticipates adopting
performance standards designed to minimize the growth of harmful
bacteria on raw products that establishments will be required to meet
through their HACCP plans. FSIS will announce in a future issue of the
Federal Register a three-day public conference to gather further
scientific information and public comment on these subjects.
Timetable for Implementation
Federally Inspected Establishments
FSIS proposed an implementation timetable that would have phased in
the near-term measures and HACCP over a period of time beginning 90
days and ending three years after publication of the final rule.
Sanitation SOP's and the other near-term measures, as well as the
proposed microbial sampling by establishments for Salmonella, were to
begin 90 days after publication. Slaughter establishments were to be
held accountable for meeting the Salmonella targets two years after
publication.
FSIS proposed to phase in HACCP over a one to three-year period,
primarily on a process-by-process basis. For example, raw ground
products would be subject to the HACCP requirements one year after
publication of the final rule, while all slaughter establishments would
be required to start HACCP thirty months (2\1/2\ years) after
publication of the final rule. However, FSIS proposed that
establishments with annual sales of less than $2.5 million be given
three years to
[[Page 38813]]
comply with the HACCP requirement, regardless of the processes they
run.
Some commenters said the proposed implementation timetable was too
slow, considering the seriousness of the food safety issues involved
and the familiarity with HACCP that already exists among many in the
industry. Other commenters pointed out that many larger establishments
have already adopted HACCP. Some said the Pathogen Reduction/HACCP
proposal placed excessive burdens on smaller establishments, which were
said to be less prepared technically and financially to carry out
HACCP. Wide support was voiced for implementing HACCP as promptly as
practicable, taking into account the diversity of businesses involved
and the different levels of readiness for HACCP.
FSIS has considered these comments and has also re-evaluated the
proposed timetable for implementation of all requirements discussed
above in light of preparations FSIS will itself have to make to
implement HACCP, including the training of inspection and other agency
employees. FSIS believes it is important to bring the meat and poultry
supply under HACCP-based process control and to implement other
elements of its food safety strategy as rapidly as possible. It is also
important to have a timetable that is realistic for implementing this
fundamental transformation in how FSIS regulates meat and poultry
establishments. FSIS is modifying the timetable for implementation in a
way that achieves both goals.
The Sanitation SOP's requirements will take effect 6 months after
publication of these final rules, rather than 90 days as originally
proposed.
Establishments slaughtering livestock or poultry will be required
to begin process control verification testing for generic E. coli 6
months after publication of this final rule.
FSIS will begin holding slaughter establishments and establishments
producing raw ground products accountable for achieving Salmonella
pathogen reduction performance standards at the time they will be
required to implement HACCP under the phase-in schedule described
below, rather than the single, two-year delayed effective date
originally proposed. Beginning approximately three months after
publication of this final rule, FSIS will initiate its pre-enforcement
Salmonella testing program. This establishment-by-establishment
Salmonella prevalence survey will provide critical data on the
performance of establishments; it will inform establishments of their
performance, and guide FSIS enforcement testing and compliance
strategies after establishments are required to meet the Salmonella
performance standards.
In response to comments, FSIS is modifying the proposed timetable
for implementing HACCP from one based primarily on production process
in an establishment to one based on establishment size. Under this
approach, the pace at which most of the Nation's meat and poultry
supply comes under HACCP-based process control will be accelerated.
Most important, slaughter establishments that account for 75% of the
annual meat and poultry production in the United States will be
required to implement HACCP 18 months after publication of these final
rules, rather than 30 months after publication as originally proposed.
At the same time, very small establishments (those with fewer than 10
employees or with annual sales of less than $2.5 million, together
accounting for less than 2% of meat and poultry production) will be
provided an additional six months beyond the proposed three years to
implement HACCP.
Under this timetable, FSIS gains needed time to develop and
sequence inspector training and other preparatory activities. Also,
establishments that carry out multiple processes (such as the so-called
``combo'' establishments that both slaughter animals and grind raw
products) will be able to implement HACCP on a more coherent
establishment-wide basis, rather than on a process-by-process basis. A
detailed description of the implementation timetable and its rationale
is provided in section II of this preamble.
State-Inspected Establishments
Both the FMIA and PPIA direct Federal cooperation with States in
developing and administering intrastate inspection programs that
include mandatory antemortem and postmortem inspection, reinspection,
and sanitation requirements which are ``at least equal to'' Federal
requirements. Consequently, each State receiving matching Federal funds
for the administration of its intrastate meat and poultry inspection
program must implement Pathogen Reduction/HACCP programs that are at
least equal to provisions set forth in this final rule. FSIS will
coordinate closely with States that maintain federally supported meat
and poultry inspection programs to ensure that Pathogen Reduction/HACCP
is implemented in all intrastate establishments.
Foreign-Inspected Establishments
In order to export meat or poultry to the United States, foreign
countries must establish a system of inspection that is equivalent to
the system in this country. Determinations of equivalency made by U.S.
reviewers of foreign meat and poultry inspection systems are currently
based upon (1) the presence or lack of specific regulatory requirements
and (2) how those requirements are enforced. As Pathogen Reduction/
HACCP regulatory provisions are implemented in the U.S. domestic
market, foreign countries will concurrently be evaluated to ascertain
whether their inspection systems provide equivalent regulatory
provisions with adequate levels of enforcement.
Implementation Conferences
FSIS plans to convene a three-day HACCP implementation conference
in Washington, DC, about 60 days after publication of this final rule.
Similar sessions will follow in various cities around the country.
The purpose of the implementation conferences is to continue, and
build upon, the dialogue among interested parties that occurred during
the six days of public meetings FSIS conducted in September 1995 on the
proposed rule. FSIS anticipates that the following topics will be
discussed at the implementation conferences: (1) status of FSIS efforts
to develop generic model HACCP plans and conduct small establishment
HACCP demonstration projects; (2) the draft guidance materials
published as Appendices; (3) the revised HACCP implementation schedule
and certain technical aspects of the regulations being promulgated in
this final rule; (4) other implementation issues identified by the
public; (5) methods to achieve the goal of consistent training for FSIS
and industry employees; and (6) due process and enforcement issues.
In addition, FSIS plans to conduct two public conferences on
technical issues related to E. coli testing. The first conference is
planned to be held approximately 45 days into the 60-day comment period
following publication of this rule. The public conference will be led
by a panel of scientists from FSIS and other government agencies who
will listen to testimony and review comments received on these
technical issues and share their observations and opinions. FSIS will
consider their input as well as all comments received as the basis for
any necessary technical amendments which will be completed at least 30
days before the
[[Page 38814]]
implementation date. The second conference is tentatively planned for
approximately 9 months following publication of this rule. This
conference would be an opportunity for the industry and others to
discuss with FSIS new information based on about 3 months of testing
experience that may bear on these same issues and might allow for
further adjustments of protocols before FSIS inspectors are tasked,
about three months later, with comparing test results to the national
criteria as part of their inspection routine. FSIS will publish
further, more detailed notice of these conferences in future issues of
the Federal Register.
Request for Comments
These final rules have benefitted from substantial public comment
and the dialogue that took place during extensive public meetings with
interested groups and individuals. Following the close of the comment
period on November 13, 1995, several industry associations requested
that these regulations be issued as ``interim'' final rules with a 30-
day opportunity for further public comment prior to the rules becoming
final. FSIS is denying this request because the HACCP principles and
other major elements of these final regulations have already been the
subject of unusually extensive public comment and dialogue, and it is
important to proceed toward implementation of these new food safety
measures as promptly as possible.
FSIS seeks comments, however, on certain technical aspects of these
final regulations and on the guidelines (published here as Appendices)
that will play a role in implementation of sanitation SOP's, microbial
testing, and HACCP. FSIS requests comments no later than September 23,
1996 on (1) technical issues that are associated with E. coli testing;
(2) the E. coli performance criteria, and (3) the Sanitation SOP's
Guideline and Model Sanitation SOP's, published at Appendices A and B,
respectively.
Based on comments it receives, FSIS will make any necessary
revisions in the draft guidelines and technical aspects of the E. coli
testing regulation prior to the effective date of the affected
regulatory requirements.
With respect to the HACCP final regulations, FSIS requests comments
by November 22, 1996 on (1) the revised HACCP implementation timetable,
including any factual information that commenters believe would justify
any adjustments in the announced effective dates; (2) the Hazards and
Preventive Measures Guide (published at Appendix D) and (3) the
Guidebook for the Preparation of HACCP Plans (published at Appendix C).
II. Hazard Analysis and Critical Control Point Systems
Overview of Final Rule
This final rule requires that federally inspected establishments
implement HACCP systems to address hazards that are reasonably likely
to occur in their operations. The HACCP systems mandated by this final
rule focus on attributes affecting product safety, not those affecting
economic adulteration or quality. On the effective dates of this final
rule, FSIS will begin verifying HACCP system operations as part of its
inspection program. Establishments will be required to maintain a HACCP
plan covering every meat or poultry product produced for human food.
Processes for which HACCP plans must be developed include slaughter for
all species; raw ground meat or poultry products; raw product, not
ground (e.g., meat cuts or whole or cut-up birds); shelf-stable
nonheat-treated products (e.g., jerky); shelf-stable heat-treated
products (e.g., edible fats); thermally processed/commercially sterile
products (e.g., canned soup); fully cooked nonshelf-stable products
(e.g., canned hams that must be refrigerated); not fully cooked/heat-
treated products (e.g., char-marked beef patties); and nonshelf-stable
products with secondary inhibitors (e.g., fermented sausage). It should
be noted that the category of raw, not ground product can include
products with certain additional processing steps beyond carcass
dressing, such as cutting up whole carcasses or marinating meat or
poultry products.
History and Background of HACCP
HACCP is a conceptually simple system whereby meat and poultry
establishments can identify and evaluate the food safety hazards that
can affect the safety of their products, institute controls necessary
to prevent those hazards from occurring or keeping them within
acceptable limits, monitor the performance of controls, and maintain
records routinely. HACCP is the best system currently available for
maximizing the safety of the nation's food supply.
HACCP systems have been recommended for use in the food industry
for more than a quarter century. The HACCP concept has been promoted by
government and scientific groups and incorporated for many years in
FSIS's and FDA's regulations on canned foods. Committees of the NAS
have recommended that government agencies with responsibility for
controlling microbiological hazards in foods, including FSIS,
promulgate regulations requiring industry to utilize the HACCP system
for food protection purposes.
The NACMCF, which was established in accordance with a NAS
committee recommendation, endorsed the HACCP system as an effective and
rational approach to the assurance of food safety. In its March 20,
1992, publication ``Hazard Analysis and Critical Control Point
System,'' NACMCF advocated the standardization of the HACCP principles
and their application by industry and regulatory authorities, with each
food-producing establishment developing a HACCP system tailored to its
individual product, processing, and distribution conditions.
The U.S. General Accounting Office, in a series of reports between
1992 and 1994, endorsed HACCP as an effective, scientific, risk-based
system for protecting the public from foodborne illness. On December
18, 1995, the FDA published final rules requiring the adoption of HACCP
systems in seafood processing plants (60 FR 65096).
International and foreign government bodies have also advocated the
adoption of HACCP systems. The International Commission on
Microbiological Specifications for Foods (ICMSF), in its 1988 report,
``HACCP in Microbiological Safety and Quality,'' endorsed the use of
HACCP systems in food production, processing, and handling. In 1993,
the Food and Agriculture Organization/World Health Organization Codex
Alimentarius Commission adopted a HACCP document that now serves as a
guide for countries to incorporate HACCP principles into their food
industries. The seven HACCP principles adopted by the Codex
Alimentarius Commission are identical to those adopted by the NACMCF
and on which this final rule is based. HACCP principles have been
embodied in recent European Union regulatory directives and in food
protection programs conducted by the governments of Canada, New
Zealand, and Australia.
The Seven HACCP Principles
The seven HACCP principles recommended by NACMCF in 1992 provide
the framework for this final rule. While the seven principles are not
explicitly listed as such in the codified regulatory text, they are
embodied in the regulatory requirements for a hazard analysis in
Sec. 417.2(a); the elements of a HACCP plan in Sec. 417.2 (b) and (c);
the corrective action requirements in Sec. 417.3; the validation,
verification, and reassessment requirements in Sec. 417.4; and the
record review and maintenance
[[Page 38815]]
requirements in Sec. 417.5. The seven HACCP principles are discussed
below.
Principle No. 1: A hazard analysis of each process must be carried
out. The purpose of the analysis is to identify and list the food
safety hazards reasonably likely to occur in the production process for
a particular product and the preventive measures necessary to control
the hazards. A food safety hazard is any biological, chemical, or
physical property that may cause a food to be adulterated or otherwise
unsafe for human consumption. A listed hazard must be of such a nature
that its prevention, elimination, or reduction to acceptable levels is
essential to the production of a safe food.
Examples of questions to be considered in a hazard analysis
include: (1) What potential hazards may be present in the animals to be
slaughtered or the raw materials to be processed? (2) What are the
avenues that might lead to contamination of finished product with
pathogenic microorganisms, hazardous chemicals, or other potentially
hazardous contaminants? (3) What is the likelihood of such
contamination and what are the means for preventing it? (4) Does the
food contain any ingredient historically associated with a known
microbiological hazard? (5) Does the food permit survival or
multiplication of pathogens or toxin formation during processing? (6)
Does the process include a controllable processing step that destroys
pathogens? (7) Is it likely that the food will contain pathogens and
are they likely to increase during the times and conditions under which
the food is normally stored before being consumed? (8) What product
safety devices are used to enhance consumer safety (e.g., metal
detectors, filters, thermocouples)? (9) Does the method of packaging
affect the multiplication of pathogenic microorganisms and/or the
formation of toxins? (10) Is the product epidemiologically linked to a
foodborne disease?
Principle No. 2: The critical control points (CCP) of each process
must be identified. A CCP is a point, step, or procedure at which
control can be applied and a food safety hazard can be prevented,
eliminated, or reduced to an acceptable level. All hazards identified
during the hazard analysis must be addressed. The information developed
during the hazard analysis should enable the establishment to identify
which steps in their processes are CCP's.
Identification of CCP's for controlling microbial hazards
throughout the production process is particularly important because
these hazards are the primary cause of foodborne illness. The
establishment may find the CCP decision tree developed by the NACMCF
useful in the CCP identification process (see Figure 1). However, the
use of this technique in identifying CCP's is not required by this
final rule.
Principle No. 3: The critical limits for preventive measures
associated with each identified CCP must be established.
BILLING CODE 3410-DM-P
[[Page 38816]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.000
BILLING CODE 3410-DM-C
A critical limit is the maximum or minimum value to which a process
parameter must be controlled at a CCP to prevent, eliminate, or reduce
to an acceptable level the identified physical, biological, or chemical
food safety hazard. Critical limits are most often based on process
parameters such as temperature, time, physical dimensions, humidity,
moisture level, water activity, pH, titratable acidity, salt
concentration, available chlorine, viscosity, preservatives, or
survival of target pathogens. Critical limits should be based on
applicable FSIS regulations or guidelines, FDA tolerances and action
levels, scientific and technical literature, surveys, experimental
studies, or the recommendations of recognized experts in the industry,
academia, or trade associations.
Establishments are encouraged to establish critical limits more
stringent than those now required by FSIS regulations or suggested by
scientific data to ensure that regulatory requirements are routinely
met, even when minor deviations occur.
Principle No. 4: The monitoring requirements for CCP's must be
established. Monitoring is an integral part of HACCP and consists of
observations or measurements taken to assess whether a CCP is within
the established critical limit. Continuous monitoring is preferred, but
when it is not feasible, monitoring frequencies must be sufficient to
ensure that the CCP is under control.
Assignment of the responsibility for monitoring is an important
consideration for each CCP. Personnel assigned the monitoring
activities should be properly trained to accurately record all results,
including any deviations, so that immediate corrective actions may be
taken.
Principle No. 5: The HACCP plan must include corrective action to
be taken when monitoring indicates that there is a deviation from a
critical limit at a critical control point. Although the process of
developing a HACCP plan emphasizes organized and preventive thinking
about what is occurring as the meat or poultry product is being
manufactured, the existence of a HACCP plan does not guarantee that
problems will not arise. For this reason, the identification of a
planned set of activities to address deviations is an important part of
a HACCP plan. In such instances, corrective action plans must be in
place to determine the disposition of the potentially unsafe or
noncompliant product and to identify and correct the cause of the
deviation. The HACCP plan itself might require modification, perhaps in
the form of a new critical limit, or of an additional CCP.
[[Page 38817]]
Principle No. 6: Effective recordkeeping procedures that document
the entire HACCP system must be developed and maintained. A HACCP
system will not work unless consistent, reliable records are generated
during the operation of the plan, and those records are maintained and
available for review. One of the principal benefits of a HACCP process
control system to both industry and regulatory officials is the
availability of objective, relevant data.
Principle No. 7: HACCP systems must be systematically verified.
After initial validation that the HACCP system can work correctly and
effectively with respect to the hazards, the system must be verified
periodically. Periodic verification involves the use of methods,
procedures, or tests in addition to those used for monitoring, to
determine whether the HACCP system is in compliance with the HACCP plan
and/or whether the HACCP plan needs modification and revalidation to
achieve its food safety objective.
In the NACMCF explanation of the verification principle, which FSIS
is following, four processes are involved in the verification of the
establishment's HACCP system. The establishment is responsible for the
first three; FSIS is responsible for the fourth. The first is the
scientific and technical process, known as ``validation,'' for
determining that the CCP's and associated critical limits are adequate
and sufficient to control likely hazards. The second process is to
ensure, initially and on an ongoing basis, that the entire HACCP system
functions properly. The third consists of documented, periodic,
reassessment of the HACCP plan. The fourth process defines FSIS's
responsibility for certain actions (Government verification) to ensure
that the establishment's HACCP system is functioning adequately.
HACCP and the FSIS Food Safety Strategy
The food safety goal of FSIS's Pathogen Reduction/HACCP rulemaking
proposal is to reduce the risk of foodborne illness from meat and
poultry products to the maximum extent possible by ensuring that
appropriate and feasible preventive and corrective measures are taken
at each stage of the food production process where food safety hazards
occur. There is no single technological or regulatory solution to the
problem of foodborne illness. Continuous efforts are required by
industry and government to improve methods for identifying and
preventing hazards and to minimize the risk of illness.
FSIS proposed HACCP as the framework for carrying out its
comprehensive strategy to improve food safety. HACCP, combined with the
other measures required by this rulemaking, will substantially improve
the ability of meat and poultry establishments and FSIS to target and
systematically prevent and reduce food safety hazards and, working
together, to continuously improve food safety as science and technology
improve. These measures fill a critical gap in the current system with
respect to the control and reduction of harmful bacteria on raw meat
and poultry products and will, over time, significantly reduce the risk
of foodborne illness.
FSIS's meat and poultry inspection program currently a
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
ddresses and
will continue to address many matters of importance to the safety and
quality of the food supply, including supervision of industry
compliance with sanitation standards, exclusion of diseased animals
from the food supply, examination of carcasses for other visible
defects that can affect safety and quality, and inspecting for economic
adulteration. These activities respond to some of the public's most
basic expectations regarding the safety and quality of the food supply
and reflect the standards and requirements established by Congress in
the laws FSIS administers. FSIS is strongly committed to the most
effective and efficient implementation of these statutory requirements.
This final rule initiates a fundamental change in the inspection
program to better meet FSIS's paramount obligation to protect the
public health. Specifically, it addresses in a substantive way the
public health problem of foodborne illness associated with the
consumption of meat and poultry products. It does so in large part by
better delineating and clarifying the respective roles of industry and
FSIS to ensure that meat and poultry products are produced in
accordance with sanitation and safety standards and are not adulterated
or misbranded within the meaning of the FMIA and PPIA. This rule makes
clear that the industry is responsible for producing and marketing
products that are safe, unadulterated, and properly labeled and
packaged. FSIS is responsible for inspecting products and facilities to
verify that the statutory requirements are being met and for taking
appropriate compliance and enforcement actions when the requirements
are not being met.
The line between the responsibilities of FSIS and those of the
industry has often been blurred. This is because of the prescriptive
nature of the current FSIS inspection program and the tendency for some
establishments to rely on FSIS inspectors to do what is necessary to
direct the correction of deficiencies and to ensure that outgoing
products are safe, and not adulterated or misbranded. Some
establishments operate on the assumption that if the inspector
identifies no problem, their meat or poultry products may be entered
into commerce. This is even more problematic because the current
inspection system is based primarily on organoleptic methods that
cannot detect the hazards of pathogenic microorganisms. The line has
also been blurred because of the excessive reliance of the FSIS
inspection program on the detection and correction of problems after
the fact, rather than assurance that problems will be prevented,
systematically by design, in the first place.
The changes FSIS will effect with this final rule will eliminate
this confusion and delineate clearly the respective responsibilities of
FSIS and industry. The changes constitute a fundamental shift in the
FSIS regulatory program, which FSIS is convinced will significantly
enhance the effectiveness of the program and substantially reduce the
risk of foodborne illness.
Preparing for HACCP Implementation
For the new FSIS food safety strategy, particularly HACCP, to be
successful, FSIS must reconsider its current reliance on prescriptive
command-and-control regulations and instead rely more on performance
standards. Not only do command-and-control regulations prescribe the
means by which establishments are to achieve a particular food safety
objective, but they are susceptible of being enforced in a manner that
leads to the inspector's substantial involvement in management
decisionmaking. Performance standards, on the other hand, prescribe the
objectives or levels of performance (such as pathogen reduction
standards for raw product) establishments must achieve, but afford
establishments flexibility in determining how to achieve those
performance objectives. The shift to performance standards and the
concomitant increase in flexibility for meat and poultry establishments
reflect FSIS's commitment to stimulating the innovative capacity of the
meat and poultry and allied industries to improve the safety of their
products.
Command-and-control regulations are generally incompatible with
HACCP and the FSIS food safety strategy, and conflict with the goal of
reducing the
[[Page 38818]]
risk of foodborne illness on a continuing basis. They deprive
establishments of the flexibility to innovate, one of the primary
advantages of HACCP, and undercut the clear delineation of food safety
responsibilities between industry and FSIS, on which the FSIS strategy
is based. Therefore, to prepare for HACCP implementation, FSIS is
conducting a thorough review of its current regulations and will, to
the maximum extent possible, convert its command-and-control
regulations to performance standards. (For a discussion of this
regulatory reform initiative, see advance notice of proposed rulemaking
published on December 29, 1995; Docket No. 95-008A; 60 FR 67469).
Inspection Under HACCP
HACCP-oriented food safety inspection changes FSIS's approach to
overseeing the safety of meat and poultry products. Under this new
approach, FSIS will rely less on after-the-fact detection of product
and process defects and more on verifying the effectiveness of
processes and process controls designed to ensure food safety. FSIS
will restructure its inspection tasks and rely on review techniques
aimed at systems designed for preventing problems that could lead to
the production of unsafe meat or poultry products. FSIS will carry out
various activities to ensure that industry HACCP systems meet the
requirements of this rule, and are functioning as designed.
Beginning on the effective date of the regulation for a particular
establishment, FSIS personnel will carry out a general review of an
establishment's HACCP plan to determine its conformance with the seven
HACCP principles. This evaluation will take place at the time of start-
up or initial implementation of the HACCP plan for new establishments.
Subsequently, special teams of FSIS personnel will work in conjunction
with assigned inspectors to conduct in-depth reviews, on a regular
basis, of the establishment's current HACCP plan to verify their
scientific validity and ongoing adequacy for preventing food safety
hazards. Further, at any time that the HACCP plan is revised or
amended, FSIS personnel assigned to the establishment will review the
plan to determine if it is in conformance with regulatory requirements.
FSIS will also carry out its verification activities by focusing on
an establishment's ongoing compliance with HACCP-related requirements.
Inspectors will be assigned to carry out the verification activities
under HACCP-oriented inspection in much the same way as they receive
their assignment schedules under the current system. A verification
activity might include reviewing all establishment monitoring records
for a process, reviewing establishment records for a production lot,
direct observation of CCP controls as conducted by establishment
employees, collecting samples for FSIS laboratory analysis, or
verifying establishment verification activities for a process.
As HACCP-based process control is established in meat and poultry
establishments, with its continuous monitoring by the establishment and
oversight by FSIS, opportunities to incorporate new technologies and
continuously improve food safety will be more readily identified. The
continuous monitoring and verification of production processes and
controls by the establishment and FSIS, which is an essential feature
of the HACCP system, will set the stage for further food safety
improvements.
Many commenters on the proposal expressed concern that the number
of inspectors would decline and the quality of Federal inspection would
diminish with HACCP implementation. FSIS expects HACCP to enhance the
effectiveness of its meat and poultry inspection, not diminish it.
Implementation of this final rule will clarify that the meat and
poultry industries and FSIS have separate responsibilities for safety
of the food supply. Industry will be required to establish process
control systems for all forms of meat and poultry slaughter and
processing and meet appropriate regulatory performance standards. By
vigorous inspectional oversight of HACCP and reliance on objective test
results and other observations to verify compliance with performance
standards, FSIS inspectors will be better able to ensure that products
leaving FSIS establishments are safe. Also, FSIS will be better able to
allocate its resources to areas of greatest risk. HACCP implementation
will move both industry and FSIS toward a more preventive approach to
ensuring the safety of meat and poultry.
A cross-section of consumer groups, FSIS employees, and meat and
poultry establishments stated that each livestock and bird carcass must
continue to be examined by trained, experienced FSIS inspectors and
veterinarians, even under a HACCP system. They stated that carcass-by-
carcass inspection is essential to identifying animals with diseases
that are transmissible to humans and other disease conditions causing
animals to be unacceptable for human food. About 2,000 commenters
maintained that HACCP is not, nor should it be, a substitute for
carcass-by-carcass inspection by Federal inspectors.
Carcass-by-carcass inspection is a legal requirement that binds
both FSIS and the industry. It also addresses nonsafety considerations
that are not addressed by HACCP. Therefore, HACCP cannot substitute for
carcass-by-carcass examination. However, in light of HACCP, which will
improve process control in slaughter establishments, FSIS plans to
examine current tasks related to carcass-by-carcass inspection and
determine what changes, if any, could improve the effectiveness of
inspection or result in a more productive use of resources.
Many commenters representing the meat and poultry industries argued
that proposed pathogen reduction and HACCP system requirements layer an
additional set of regulations and an additional program of inspection
onto the current meat and poultry inspection system. These commenters
recommended that FSIS review and revise or eliminate current
regulations, directives and other FSIS guidance prior to finalizing the
proposal as a means for ensuring they are compatible with pathogen
reduction and HACCP requirements. Commenters stated that this review
would not only mitigate inspection burdens imposed on industry by the
proposal, but would facilitate the smooth implementation of pathogen
reduction and HACCP requirements, as well.
FSIS agrees that regulations, directives, and guidelines should be
consistent with HACCP and is currently reviewing regulations,
directives, and other guidance materials governing meat and poultry
inspection. Those regulations, directives, and guidance documents that
are inconsistent or incompatible with HACCP principles and procedures
will be amended or revoked. This task will not only ensure consistency
throughout the regulations, directives, and other documents, but will
reduce duplication and help focus inspection on the most serious risks
to food safety.
Implementation Schedule
FSIS proposed to phase in implementation of HACCP during a 12 to
36-month period primarily on a process-by-process basis, except that
all ``small'' establishments (defined as establishments with annual
sales of less than $2.5 million) would be allowed the full 36 months to
implement their HACCP plans.
FSIS received numerous comments on the proposed implementation
schedule. Many commenters from meat and
[[Page 38819]]
poultry establishments said the proposed period for implementing HACCP
was too short. These commenters requested more time to develop HACCP
plans, train employees, and purchase or upgrade equipment. Many
commenters requested that small businesses be granted more time to
implement HACCP so they could amortize the costs of hazard analysis and
plan development, equipment purchases, personnel training and records
maintenance. A number of commenters suggested alternative timetables
for implementation, ranging from three to fifteen years.
Several consumer groups argued that the proposed implementation
schedule was too slow and would compromise public health because
serious outbreaks of foodborne illness would continue to occur while
establishments prepare for HACCP implementation. Some industry
commenters said they were ready to implement HACCP immediately and
expressed concern about whether and when the FSIS inspection force
would be prepared to oversee HACCP implementation.
Also, several commenters requested a tiered implementation based on
product risk. These commenters suggested that establishments which
produce high-risk products, such as slaughter establishments or ground
beef processors, be required to implement HACCP first and that
establishments which produce low-risk products, such as canning
establishments, be required to implement HACCP last.
Also, some commenters were concerned about the proposed phase-in
period based on different types of product categories and processes
because contaminated meat and poultry are known to come from a variety
of sources. Commenters said that requiring establishments to implement
HACCP at different times for different processes within an
establishment would confuse establishment employees, inspection
personnel and consumers. Consequently, these commenters suggested that
HACCP be implemented simultaneously by all establishments.
Other commenters disputed the definition of small business used in
the proposal. Recommendations for defining a small business included
using fewer-than-500-employees definition developed by the Small
Business Administration (SBA), using a definition reflecting volume of
product or number of animals slaughtered, or using a definition based
on the level of sales.
In response to concerns expressed by commenters, FSIS is modifying
the implementation schedule for HACCP. The revised implementation
schedule is based on the size of an establishment, that is, a business
entity producing meat or poultry products at a location. Each
establishment is required to implement HACCP simultaneously for all
processes, rather than on a process-by- process basis. Large
establishments (those having 500 or more employees) are required to
implement HACCP 18 months after publication of this final rule.
``Small'' establishments are required to implement HACCP 30 months
after publication. The definition of ``small'' establishment has been
changed to correspond with SBA's size standards for business entities,
and is now an establishment having 10 or more but fewer than 500
employees. A new category of ``very small'' establishments (those
having fewer than 10 employees or less than $2.5 million in annual
sales) will have 42 months to implement HACCP. All individuals employed
on a full-time, part-time, temporary, or other basis at a given
establishment must be counted as employees. This requirement
corresponds with the SBA definition of employee set forth in 13 CFR
121.404.
FSIS is committed to bringing the Nation's meat and poultry supply
under HACCP systems as rapidly as possible. Phasing in HACCP
implementation is essential due to the logistical effort required to
manage a fundamental change in work processes, roles, and
responsibilities for both establishments and FSIS. The revised
implementation schedule reflects the readiness of establishments of
varying sizes to implement HACCP, the time needed by industry to
develop HACCP plans and train employees, and the time needed by FSIS to
train its employees.
The principal advantages of the revised implementation schedule are
as follows:
1. Large slaughter establishments account for 75 percent of
slaughter production and thus, most of the Nation's meat and poultry
supply will come under HACCP-based process control one year earlier
than originally proposed. Because the greatest risk of contamination
with pathogenic microorganisms occurs during this initial stage of
production, FSIS considers this a significant improvement over the
original schedule in terms of expediting progress on improving the
safety of meat and poultry products. The revised implementation
schedule also ensures that approximately 45 percent of processed
products will be produced under a HACCP system within 18 months. In
comparison, only 25 percent of processed products would have been
produced under HACCP systems at the 18-month mark based on the proposed
implementation schedule.
2. By shifting initial implementation of HACCP from 12 months to 18
months after publication of the final rule, FSIS will have sufficient
time to manage the transition to sanitation SOP's in all
establishments, which will begin six months after publication of this
final rule, and to train FSIS employees to implement HACCP. FSIS does
not believe it could manage this transition and successfully implement
HACCP in 12 months.
3. Eighteen months will provide ample time for the large
establishments to comply. In fact, it is reasonable to assume that many
of these establishments may implement HACCP before the deadline.
4. Implementing HACCP on the basis of establishment size will be
simpler for both FSIS and establishments and much less disruptive for
establishments with multiple processes. Under the proposal, these
establishments would have faced multiple implementation dates (e.g.,
establishments that both slaughter cattle and grind beef).
5. The ``very small'' establishments will have an additional six
months to implement HACCP. This will enable FSIS to complete the
demonstration projects planned for ``small'' and ``very small''
establishments. The extra time will also ensure the availability of
``off-the-shelf'' HACCP training programs prepared by private or
industry-sponsored consultants. Other FSIS implementation aids, such as
model HACCP plans, audio, video, or computer training aids, and various
publications such as guidelines, notices and pamphlets will have
undergone extensive development as well.
Small Business Issues
FSIS recognizes that many smaller establishments lack the
familiarity with HACCP that exists already in many larger
establishments. Therefore, FSIS is planning an array of assistance
activities that will facilitate implementation of HACCP in ``small''
and ``very small'' establishments.
FSIS is developing 13 generic HACCP models for the major process
categories, which will be available in draft form for public comment,
and in final form, at least six months before HACCP implementation. The
generic models are being developed especially to assist ``small'' and
``very small'' establishments in preparing their HACCP plans. Because
each HACCP system is developed by an individual establishment for its
specific process and practices, the generic models will serve only as
illustrations, rather than as
[[Page 38820]]
prescriptive blueprints for a specific HACCP plan. They should,
however, remove much of the guesswork and reduce the costs associated
with developing HACCP plans.
FSIS will also conduct HACCP demonstration projects for ``small''
and ``very small'' establishments during the two-year period following
promulgation of this final rule. These projects will be conducted at
various sites to show how HACCP systems can work for various products
under actual operating conditions. Some of these demonstrations will
involve ``very small'' establishments and will address issues unique to
those establishments. For instance, how does a HACCP system function in
an establishment with only a single employee? Through these
demonstration projects, FSIS, State inspection authorities,
participating establishments, and the industry at large will gain added
understanding of the problems and techniques of HACCP implementation
and operation in ``small'' and ``very small'' establishments.
FSIS is making available to ``small'' and ``very small''
establishments various HACCP materials that should assist these
establishments in conducting their hazard analyses and developing their
HACCP plans. These guidance materials include a ``Guidebook for the
Preparation of HACCP Plans'' (Appendix C) and a ``Hazards and
Preventive Measures Guide'' (Appendix D). These materials should be
particularly useful to ``small'' and ``very small'' establishments that
may lack the expertise for conducting hazard analyses and designing
establishment-specific HACCP plans.
The ``Guidebook for the Preparation of HACCP Plans'' has been
designed to provide ``small'' and ``very small'' establishments with a
step-by-step approach for developing a HACCP plan and includes examples
and sample forms at each step. The Guidebook can be used alone or in
combination with the ``Hazards and Preventive Measures Guide.''
Because the development of an adequate HACCP plan depends on a good
hazard analysis, the ``Hazards and Preventive Measures Guide'' develops
HACCP Principle No. 1 in much greater detail than does the ``Guidebook
for the Preparation of HACCP Plans.'' The hazards guide identifies
potential biological, chemical, and physical hazards associated with a
variety of raw materials and common ingredients, as well as major
processes used in the meat and poultry industry. In addition, the
hazards guide contains examples of preventive measures for common
hazards and associated critical limits for those measures. Also
provided are examples to illustrate approaches to implementing the
remaining HACCP principles (e.g., monitoring, corrective actions,
records, and verification procedures) for various hazards and critical
control points.
FSIS invites comments and suggestions on how it may further ease
the transition of ``small'' and ``very small'' establishments to HACCP-
based operations.
Training Considerations
Many commenters, including consumer groups, FSIS employees, meat
and poultry establishments, and State governments, agreed that proper
training in HACCP procedures and plan development is vital for
successful HACCP implementation. A number of commenters suggested that
joint training sessions be held for FSIS and establishment employees to
ensure uniform understanding between inspection personnel and industry.
Others suggested that FSIS certify acceptable training sites and
courses of study for establishment employees to coincide with
government employee training. However, some commenters argued that FSIS
should not accredit training programs because to do so would limit the
development of training programs.
FSIS agrees that effective training of both FSIS and industry
employees is critical to HACCP's success. FSIS also agrees that
alternatives are needed to make training practical for various kinds of
establishments. With these objectives in mind, FSIS is cooperating with
the private sector to ensure that a wide variety of training options
are available to industry and FSIS employees. For instance, FSIS is
encouraging the International Meat and Poultry HACCP Alliance, national
and local trade associations, State and local officials, the State
agricultural extension services, and local colleges and universities to
help establishments incorporate HACCP into their operations. The
implementation conferences, discussed elsewhere in this preamble, will
address how to achieve the goal of consistent training for FSIS and
industry employees.
Other plans include offering HACCP briefings to industry at many
locations nationwide. Each session will be led by FSIS HACCP trainers,
will be held during the evening, be open to industry and other
interested persons, and include a question-and-answer period. FSIS
training sessions will be limited to FSIS and State employees because
of complex logistical and cost considerations.
USDA's National Agricultural Library has developed and maintains
the HACCP Training Programs and Resources Database. It is accessible
via the Internet at ``http://www.nalusda.gov/fnic/foodborne/
foodborn.htm'' or ``gopher://gopher.nalusda.gov/11/infocntr/fnic/
foodborne/haccp'' and provides listings of available training programs
(workshops, satellite conferences, etc.), resources (videotapes,
software, manuals, textbooks, etc.), and consultants (individuals and
companies). Other Internet servers with HACCP-related information are
operated by various firms, governments, organizations, and academic
institutions.
Several meat and poultry establishments also commented on funding
for HACCP training, suggesting that FSIS or State inspection programs
fund establishment employee HACCP training. FSIS is making every effort
to assist establishments in making the transition to HACCP. However,
each establishment will be responsible for training its employees.
Mandatory Versus Voluntary HACCP
Most commenters supported the FSIS proposal to make HACCP mandatory
in all meat and poultry establishments. However, some commenters
requested that HACCP be voluntary rather than mandatory to alleviate
economic burdens, especially on small businesses. Commenters further
suggested that, at such time as a voluntary HACCP program proved
successful, FSIS could mandate HACCP or, alternatively, market forces
and advancing technology could be relied on to ensure its broad
acceptance in all parts of the meat and poultry industry.
FSIS has determined that a mandatory HACCP program is the only
viable option that will effect adequate processing improvements in all
establishments throughout the meat and poultry industries. Mandatory
HACCP systems are supported by several prominent organizations,
including the International Meat and Poultry HACCP Alliance and the
American Meat Institute, which petitioned FSIS to initiate rulemaking
to mandate HACCP. HACCP is now and has been voluntary; some
establishments have it, most do not. The preamble to the proposed rule
explained FSIS's conclusion, affirmed by most commenters, that HACCP is
the optimal framework for targeting and reducing the many potential,
but largely preventable, hazards associated with meat and poultry
products. The risks of
[[Page 38821]]
foodborne illness associated with meat and poultry products will be
minimized to the greatest extent possible only if HACCP systems are
implemented in every establishment.
HACCP From Farm-to-Table
A large number of commenters requested that HACCP be required
throughout all phases of food production, from the farm to the
consumer. These commenters asserted that HACCP plans could be developed
by producers, slaughterers, processors, retailers, food service
operators, and restaurants to assess and mitigate food safety risks.
Furthermore, many commenters claimed that the majority of foodborne
illness cases can be attributed to mishandling at the consumer level
and FSIS should therefore strengthen consumer education as well as
require HACCP.
There is widespread agreement that ensuring food safety requires
taking steps throughout the farm-to-consumer continuum to prevent
hazards and reduce the risk of foodborne illness. FSIS is encouraging
the active development of food safety measures to minimize public
health hazards in animals presented for slaughter. A description of
these farm-to-table efforts is discussed earlier in this document.
Total Quality Control (TQC) Establishments and HACCP
One commenter requested that establishments currently operating
under the TQC provisions (9 CFR 318.4(c) and, 381.145(c)) be allowed to
continue to operate under modified hours. If this is not the case,
establishments currently under TQC will incur considerable overtime
costs. The commenter asked why, if HACCP represents an improvement over
TQC, the establishment operating under HACCP should require more
inspection coverage than one operating under current TQC provisions.
This final rule does not alter current policies and practices
regarding inspectional coverage and overtime charges in establishments
operating under FSIS-approved TQC systems. HACCP is a safety-oriented
system of process control that addresses food safety hazards
differently than any current FSIS inspection systems, including TQC.
Because TQC systems address considerations unrelated to safety,
inspection practices developed by FSIS in connection with TQC may or
may not be applicable to the implementation of HACCP.
Freedom of Information Act Concerns
Most commenters stated that HACCP records should not be available
to requestors through the Freedom of Information Act (FOIA). Some said
HACCP records should be used for verification only and should not be
included in government files. Others also suggested that access to
records by FSIS inspection personnel be restricted to records that are
necessary for HACCP compliance monitoring, such as hazard analyses,
HACCP plans, CCP monitoring records and corrective action
documentation. Other commenters wanted to prohibit FSIS personnel from
copying or removing any records from the establishment. Some commenters
requested that HACCP records be generally available to the public.
In the preamble to the proposed regulation, FSIS stated that, as a
preliminary matter, at least some elements of HACCP plans and
monitoring records could be classified as trade secrets or commercial
confidential information and may be protected from public disclosure
under exemptions provided by FOIA and USDA and FSIS regulations
promulgated pursuant to FOIA. FSIS specifically invited comment on the
issue of public disclosure of HACCP records and on whether FSIS has any
discretion about the releasability of HACCP records that it has in its
possession.
Recordkeeping is critical to the successful functioning of HACCP
systems in meat and poultry establishments. FSIS will have access to
HACCP records and any other records FSIS regulations require. While the
records required by this final rule are clearly within the
establishment's domain and ownership, FSIS will have access to them.
These records, and FSIS access to them, are necessary to effectuate a
mandatory system of preventive controls to achieve food safety.
FSIS will continue to make use of documentation to which it has
access when necessary to evaluate the operations of official
establishments. Inspection personnel will normally review the records
at establishments as part of routine HACCP oversight activities. When
inspection personnel suspect that an establishment's HACCP system is
not operating correctly, they will copy appropriate portions of
establishment records, as needed, for further evaluation and possible
enforcement action.
An establishment will not ordinarily be required to submit copies
of HACCP plans, verification documents, or day-to-day operating records
to FSIS. Consequently, FSIS will not normally possess establishment
records that may be of a proprietary nature and the issue of whether
they are releasable under FOIA should not arise.
Copies of establishment HACCP records may, however, be acquired by
inspection personnel to document enforcement actions or otherwise
assist FSIS in carrying out its responsibilities. The release by FSIS
of information about establishments and their operations is governed by
the FOIA. This statute requires Federal agencies to make available to
the public agency rules, opinions, orders, records, proceedings, and
information concerning agency organization and operations. FOIA
provides exemptions from public disclosure for various kinds of
information, including information concerning trade secrets and
confidential commercial or financial information, and information
compiled for law enforcement purposes, the release of which would be
prejudicial or harmful to law enforcement or to the privacy rights or
safety of individuals.
The FOIA disclosure exemption that is most likely to be relevant is
that covering trade secret and confidential, commercially valuable
information. FSIS's experience in meat and poultry inspection, its
experience with HACCP, and its understanding from the cost-benefit
modeling and other studies undertaken in the preparation of these
regulations is that HACCP plans will take each establishment some time
and money to develop, and will be considered by the establishment to be
confidential. It follows that some HACCP plans will include
confidential, commercially valuable information, meeting the definition
of ``trade secret.'' Plans that incorporate unique time-and-temperature
regimens to achieve product safety, or other parameters that are
processor-specific and that are the result of considerable research and
effort, will ordinarily meet this definition.
Moreover, a plan is valuable to the establishment that produces it
for no other reason than that it took work to write. The equity in such
a product is not readily given away to competitors. FSIS also knows
from its own experience that establishment configurations tend to be
unique to individual establishments, or at least have unique features.
While generic plans will have great utility in many circumstances, they
serve primarily as models for establishments to develop their own
plans. Establishments will still have to expend time and money to
tailor HACCP to their individual
[[Page 38822]]
circumstances. Thus, at least some HACCP plans or other records will
include information to which FSIS has access but which FSIS will not be
required to disclose publicly under FOIA.
It should be noted, in this regard, that FOIA is not a
confidentiality statute, but has as its primary purpose the assurance
of the public's right of access to Government information. Agencies
must grant requests that ``reasonably describe'' information sought in
agency files that is not exempt from mandatory disclosure. For this
reason, FSIS understands that it cannot make promises of
confidentiality that exceed the permissible boundaries established
under FOIA.
FSIS Enforcement Authority and Whistleblower Protection
A large number of commenters requested that FSIS endorse
enforcement tools contained in the proposed Family Food Protection Act
(H.R. 1423, S. 515), including strengthened authority to refuse or
withdraw inspection from official establishments, assessment by the
Secretary of civil penalties for violations of the inspection laws, and
protection of ``whistleblowers'' from harassment, discrimination,
prosecution, and liability. Within the meaning of the proposed
legislation, whistleblowers are employees or other persons who assist
or demonstrate an intent to assist USDA in achieving compliance with
the laws and regulations, refuse to violate or assist in violating the
law, or are involved in commencing or testifying in a legal proceeding
conducted by USDA.
FSIS has determined that, while additional legislative authority
would be helpful in certain areas, it is not needed to implement HACCP
and the other requirements established in this final rule.
As to whistleblower protection, many comments urged that these
regulations include such protection for employees of meat and poultry
slaughtering or processing establishments. Whistleblower protection is
designed to protect workers from being fired or otherwise discriminated
against for revealing wrongdoing by their employers. The wrongdoing in
this case would presumably involve the forced falsification of HACCP
records or other interference with proper operation of the HACCP
system.
One concern raised by these commenters and others about the
credibility of a HACCP system is that important records can be
falsified. It is alleged that, without whistleblower protection, it is
much less likely that FSIS will know about falsifications. It was also
suggested that there is a need to encourage and protect employees who
report food safety problems or other violations of the inspection laws.
While FSIS is confident that it can detect falsification in the
course of its routine reviews of establishment records, coupled with
in-plant observations, FSIS also expects that, as is now the case, it
will be alerted by establishment employees to possible wrongdoing even
in the absence of whistleblower protection. FSIS has relied on
information provided by employees of the regulated industries for many
years. From time to time, information is provided with an expectation
that the identity of the informant will be kept confidential. FSIS
provides this protection, to the extent possible. This policy has been
effective.
As a legal matter, FSIS is not empowered by the FMIA and PPIA to
build explicit whistleblower protection into the regulations. In
contrast to the explicit statutory whistleblower protection accorded
Government employees, the FMIA and PPIA do not provide for
whistleblower protection for industry employees of the kind suggested
by some commenters, and no such explicit protection is included in the
final rule.
FSIS believes, however, that certain features of the HACCP
regulations being adopted and the manner in which FSIS will inspect
meat and poultry establishments compensate for the lack of formal
whistleblower protection, for purposes of ensuring food safety. Most
importantly, each establishment will be required to document, through
records kept by establishment employees, that the critical limits
required to ensure food safety are being met and when a failure occurs,
proper corrective action is taken. The failure to document safety-
related failures and to take necessary corrective action violates HACCP
regulations and the establishment will be subject to appropriate
regulatory action. Moreover, the falsification of required HACCP
records is a serious violation of Federal criminal law and will be
investigated and pursued aggressively by FSIS.
Establishments that conscientiously implement HACCP will, in the
course of normal operations, support employee reports of HACCP
deviations or other potential hazardous processing conditions and take
immediate corrective action. HACCP systems in which employees with
HACCP responsibilities are prevented or deterred from carrying out
their responsibilities will be considered inadequate, and FSIS will
pursue appropriate enforcement action.
By virtue of the extensive presence of FSIS inspectors in meat and
poultry establishments and the daily access of FSIS inspectors to HACCP
records, FSIS will be able to verify whether problems are being
properly documented and addressed and will be able to observe potential
food safety problems that establishments have not found or are not
confronting in an appropriate manner. FSIS emphasizes that undetected
or uncorrected conditions which are likely to cause foodborne illness
or injury should be reported immediately to FSIS by any person with
knowledge of their existence.
Enforcement and Due Process
A significant number of commenters raised concerns about the level
of discretion inspection personnel will have in suspending
establishment operations due to alleged deficiencies in either the
design or the operation of a HACCP plan. Some urged FSIS to make clear
to inspection personnel that such extreme actions are to be reserved
only for situations in which continued operation of the establishment
presents an imminent public health risk. Others strongly argued that
operations should be suspended or inspection withdrawn when an
establishment fails to comply with any HACCP requirements.
Clarification was requested regarding the imposition of penalties and,
specifically, what circumstances would warrant suspension of operations
or withdrawal of inspection.
Generally, the nature of the enforcement action taken will vary,
depending on the seriousness of the alleged violation. Minor violations
of the HACCP requirements may be recorded by Agency personnel to
determine establishment compliance trends. Minor violations may also
result in intensified inspection to ensure that there is no pattern of
noncompliance and that there is no underlying food safety concern.
Conversely, serious, repeated, or flagrant violations will result
in immediate regulatory action, such as stopping production lines;
applying ``U.S. Rejected'' tags to involved equipment, lines, or
facilities; retention of product, and suspension or withdrawal of
inspection. Because of the importance of recordkeeping to the
functioning of HACCP systems and the production of foods that are safe
for human consumption, FSIS views recordkeeping as a serious matter
with potentially grave implications if records are not properly
maintained or are falsified.
[[Page 38823]]
Many commenters were troubled by what they perceived to be limited
procedural due process afforded to establishments when faced with the
suspension of inspection due to a finding that the HACCP plan is
inadequate. FSIS agrees that all findings of inadequacy should be sound
scientifically and legally, and that suspensions should not be invoked
in an arbitrary manner. The optimal system would provide an appropriate
level of protection to establishments without unnecessary delay,
especially where no factual dispute is likely.
Based on the comments received on this issue, FSIS has decided not
to finalize the proposed Rules of Practice at this time. FSIS is
interested in receiving comments and suggestions on enforcement,
alternative dispute resolution, and due process issues, and has
included these topics for discussion at the implementation conferences.
On the basis of the conference discussions, FSIS will complete any
required rulemaking covering these issues prior to the first
implementation date for HACCP.
The Final Rule
Reorganization of HACCP Regulatory Text
FSIS has reorganized the codified regulatory text proposed in the
Pathogen Reduction/HACCP proposal and reworded a number of the
provisions. These changes have been made in response to comments
received on the proposal, for the sake of greater clarity and ease of
use, and to conform with FSIS's planned reorganization and
consolidation of all its meat and poultry inspection regulations. In
general, the final HACCP regulations are more streamlined than the
proposed provisions, organized in a more logical form, and less
prescriptive than the proposed regulations. Also, as part of the FSIS
and FDA effort to adopt a common approach to food safety (described in
the January 1996 National Performance Review document ``Reinventing
Food Regulations''), FSIS has made changes to the proposed regulatory
text, where applicable, to be consistent with FDA's final rule on HACCP
systems for seafood (60 FR 65096; December 18, 1995).
To the extent possible, the HACCP requirements for both meat and
poultry products have been consolidated in a new part 417.
Requirements affecting grants or refusals of inspection have been
moved to a new Sec. 304.3 and a new Sec. 381.22.
FSIS received approximately 7,500 written and many oral comments on
the proposed rule from meat and poultry slaughter operations,
processors, retailers, trade and other associations, consumer
advocates, the scientific and public health community, Federal and
State government agencies and foreign governments, employees, and other
interested parties. While a majority of these commenters supported the
proposal to require adoption of HACCP by meat and poultry
establishments, they differed widely regarding plan development,
implementation, and related issues. Comments on the specific proposed
regulatory requirements and FSIS's responses, follow.
HACCP Systems as a Condition of Receiving Inspection
Proposed Sec. 326.7(a)(2) and Sec. 381.602(a)(2) would have
permitted the issuance of a grant of inspection concurrent with a new
establishment's development and validation of its HACCP plan. This
provision is confusing because it is unclear how an establishment can
develop and validate its HACCP plan ``concurrent'' with the granting of
inspection when the HACCP plan can only be validated on the basis of
commercial operations and the establishment can operate commercially
only under inspection. Therefore, it would be impossible for an
establishment to validate a HACCP plan prior to receiving a grant of
inspection, as proposed. A number of commenters noticed this difficulty
and requested that establishments be allowed a reasonable amount of
time under commercial production to validate their HACCP plans.
Commenters also disagreed with the proposed HACCP plan development
timetable for new establishments or establishments producing new
products or those conducting product test production runs. Some said
that new establishments and establishments producing new products or
conducting test runs subsequent to the applicable HACCP effective date
should have at least six months or up to two years to finalize HACCP
plans. Others said that all HACCP plans should be developed before
start-up with revisions allowed within a reasonable period.
FSIS is in basic agreement with these comments and is revising the
basic procedures for granting inspection to allow establishments time
to validate their HACCP plans. The provisions in Secs. 304.3(b) and
381.22(b) require that any new establishment conduct a hazard analysis
and develop a HACCP plan prior to being issued a conditional grant of
inspection. The establishment must validate its HACCP plan within 90
days after the conditional grant of inspection is issued. After FSIS
has determined that the establishment has validated its HACCP plan, a
permanent grant of inspection will be issued. An establishment already
receiving inspection may produce a new product for distribution only if
it has developed a HACCP plan applicable to the product and validates
the plan within 90 days after beginning production of the product.
FSIS is requiring that new facilities and products be covered by a
HACCP plan at the time commercial production begins. Establishment
management is expected to consider development of HACCP systems as part
of essential pre-production decisions for new operations.
Establishments are also expected to modify their HACCP plans as needed
based upon experience and reported results. FSIS has determined that no
start-up time is needed in these instances since the establishment will
not be experiencing any transition from an old system to a new
processing system.
FSIS is considering what further changes may be necessary in the
procedures for granting and inaugurating inspection at official
establishments to better accommodate HACCP-oriented inspection. FSIS
plans to publish a notice of proposed rulemaking on this matter in the
near future.
Definitions
Proposed Secs. 326.1 and 381.601 have been combined, streamlined,
and redesignated as Sec. 417.1. Thirteen proposed definitions were
determined to be commonly understood or unnecessary and have been
removed. Of the seven definitions remaining, the definitions for
``critical control point,'' ``critical limit,'' ``HACCP system,'' and
``responsible establishment official'' have been clarified. For
example, the definition of ``critical control point'' includes the
phrase ``as a result'' to indicate that the prevention, reduction, or
elimination of a food safety hazard occurs because of action taken at
the critical control point. The definition of ``responsible
establishment official'' has been expanded to include the individual
with overall authority or a higher level official of the establishment.
The revised definitions are consistent with those promulgated in
FDA's final rule on HACCP systems for seafood. For example, FSIS has
added a new definition to Sec. 417.1 for the term ``process-monitoring
instrument.'' This term is defined as ``an instrument or device used to
indicate conditions during processing at a critical control
[[Page 38824]]
point.'' FSIS determined that this definition would be helpful to
establishments developing HACCP plans.
Hazard Analysis and HACCP Plan
The proposal required each establishment to develop and implement a
HACCP plan which incorporated the seven HACCP principles. A hazard
analysis was to be conducted to identify biological, chemical and
physical hazards and a list of steps in the process where potentially
significant hazards could occur and the preventive measures to be taken
were to be identified.
Provisions relating to the hazard analysis and development of the
HACCP plan were proposed as Secs. 326.2 and 381.602, ``Development of
HACCP Plan,'' Secs. 326.3 and 381.603, ``HACCP Principles,'' and
Secs. 326.4 and 381.604, ``Implementation of the HACCP Plan.'' These
provisions have been modified and incorporated into Sec. 417.2.
Several commenters argued that in the event the hazard analysis
identified no significant hazards, the establishment should be exempt
from developing HACCP plans and operating under a HACCP system.
Commenters identified lard and meat flavoring manufacturers and canning
operations as examples of establishments that may identify no hazards.
To clarify the concept of potentially significant hazards, and to
be consistent with the FDA final rule on HACCP systems for seafood, the
final rule requires each establishment to conduct, or have conducted
for it, a hazard analysis to determine the food safety hazards
reasonably likely to occur in the production process. A food safety
hazard that is reasonably likely to occur is defined as one for which a
prudent establishment would establish controls because it historically
has occurred, or because there is a reasonable possibility that it will
occur in the particular type of product being processed, in the absence
of those controls.
FSIS agrees that if an establishment's hazard analysis reveals no
hazards, then no HACCP plan would be required. However, FSIS is
currently unaware of any meat or poultry production process that can be
deemed categorically to pose no likely hazards. With regard to the lard
and meat flavoring examples, FSIS believes that reasonably likely
biological and physical hazards requiring control measures exist in
establishments manufacturing these products and that, therefore, HACCP
plans are required.
FSIS agrees that the microbial hazards associated with canned meat
and poultry products are eliminated by complying with the regulations
in 9 CFR Secs. 318.300-311 and 381.300-311. These regulations are based
on HACCP concepts and provide for the analysis of thermal processing
systems and controls to exclude microbial hazards. Accordingly, the
final rule provides that HACCP plans for thermally processed/
commercially sterile products do not have to address the food safety
hazards associated with microbiological contamination if the product is
produced in accordance with the canning regulations. However, because
the current regulations exclusively address microbial hazards,
processors of canned meat, meat food and poultry products must develop
and implement HACCP plans to address chemical and physical hazards that
are reasonably likely to occur.
The current canning regulations contain numerous prescriptive
features, including extensive FSIS involvement in the decisionmaking
process, that are inconsistent with the philosophy underlying HACCP. In
the advance notice of proposed rulemaking ``FSIS Agenda for Change:
Regulatory Review'' (60 FR 67469; December 29, 1995), FSIS stated its
intention to convert the canning regulations to performance standards,
which are more consistent with HACCP. Until changes in the canning
regulations are finalized, canning establishments do not have to
address microbial hazards in their HACCP plans.
The provisions of proposed Sec. 326.3(a), (a)(1), and (a)(2), and
Sec. 381.603(a), (a)(1), and (a)(2) relating to process flow charting
and the identification of intended uses and consumers of the product
have been combined in the final rule into Sec. 417.2(a)(2).
Proposed Secs. 326.2(b) and 381.602(b) would have required that any
HACCP plan be developed with assistance of a HACCP-trained individual
employed by the establishment, that the individual's name and resume be
on file, and that the individual meet other prescriptive requirements.
These requirements have been removed in response to criticism expressed
in comments received and for reasons given below in the discussion of
Sec. 417.7. The new Sec. 417.2(a)(1) permits someone other than an
establishment employee to conduct the hazard analysis.
Proposed Secs. 326.3(a) and 381.603(a) would have required a hazard
analysis to identify any biological (including microbiological),
physical, or chemical hazards. In Sec. 417.2(a)(3), FSIS lists ten
areas that should be considered by an establishment when performing its
hazard analysis. These ten areas are: natural toxins; microbiological
contamination; chemical contamination; pesticides; drug residues;
zoonotic diseases; decomposition; parasites; unapproved use of direct
or indirect food or color additives; and physical hazards. This list of
possible hazards provides more complete guidance to establishments
conducting a hazard analysis; it responds to industry comments
criticizing as ``vague'' the proposed definition of hazard; and it is
also consistent with the list of hazards in FDA's final rule on HACCP
systems for seafood.
Proposed Secs. 326.2(a) and 381.602(a) would have required that
establishments develop, implement, and operate a HACCP plan for each
process conducted by the establishment, and provided a list of process
categories subject to this requirement. Section 417.2(b) provides that
each establishment develop and implement a HACCP plan covering each
product produced, whenever its hazard analysis reveals one or more food
safety hazards that are likely to occur. This requirement is
substantively the same as the proposal.
Section 417.2(b)(1) provides a revised list of process categories,
while Sec. 417.2(b)(2) states that a single HACCP plan may encompass
multiple products within a single processing category, if the hazards,
CCP's, and critical limits are essentially the same, and as long as any
plan features that are unique to a specific product be clearly set out
in the HACCP plan and observed in practice. For example, an
establishment's HACCP plan for the processing of cooked sausage might
cover bologna, knockwurst, and frankfurters that the establishment
produces.
Proposed Secs. 326.2(d) and 381.602(d) would have required that the
HACCP plan be developed in two stages, both to be completed six months
prior to the phase-in date of the applicable process category or upon
application for inspection or when a new process is ready for
implementation. FSIS has eliminated these requirements because they are
impractical.
Proposed Secs. 326.2(d)(1) and 381.602(d)(1) would have required
that every HACCP plan be in a format similar to the NACMCF and FSIS
generic models. FSIS agrees with those commenters who found this
proposed requirement to be unnecessary and too prescriptive, and has
not included this requirement in the final rule.
Proposed Secs. 326.3 and 381.603 set forth the seven HACCP
principles accompanied by the corresponding requirements establishments
must meet when developing HACCP plans. In response to comments that the
detailed
[[Page 38825]]
provisions were unnecessary, FSIS has set forth in Sec. 417.2(c) a
simplified list of requirements, based on the seven HACCP principles,
to be met by establishments when developing HACCP plans. The proposed
requirements remain, except for the following additions, unchanged.
Two subparagraphs have been added to new Sec. 417.2(c)(2),
clarifying the requirements for the identification of CCP's within a
HACCP plan. This new section requires that establishments list in their
HACCP plan the CCP's for each of the identified food safety hazards,
including, as appropriate: (1) CCP's designed to control food safety
hazards that could be introduced in the establishment, and, (2) CCP's
designed to control food safety hazards that may have been introduced
into the product before, during and after its entry into the
establishment. In response to comments objecting to the proposed
requirement for establishments to use a decision tree in identifying
CCP's (proposed Sec. 326.3(b) and 381.603(b)), this requirement has
been removed from the final rule.
Proposed Secs. 326.4 and 381.604 would have required that a
responsible establishment official, formerly defined as ``the
management official located on-site at the establishment who is
responsible for the establishment's compliance with this part,''
review, approve, and sign the HACCP plan. Section 417.2(d)(1) requires
that the HACCP plan be signed by the responsible establishment
official, defined as the individual with overall authority on-site or a
higher level official of the establishment, possibly off-site. Further,
in Sec. 417.2(d)(2), FSIS is correcting an oversight in the proposal by
requiring that the HACCP plan must be signed and dated upon initial
acceptance by the establishment and at any time the plan is modified.
The proposal required that the responsible establishment official sign
the plan upon completion of the hazard analysis and the development of
the HACCP plan. The HACCP plan must also be signed and dated at least
once each year after the required reassessment.
Finally, FSIS explicitly states its statutory authority to enforce
the HACCP regulations under Sec. 417.2(e), providing that if an
establishment fails to develop and implement a HACCP plan or to operate
in accordance with the requirements of this part, the products produced
by the establishment may be deemed adulterated.
Corrective Actions
Proposed Secs. 326.3(e) and 381.603(e) would have required that
each establishment develop corrective actions to be taken when there is
a deviation from an established critical limit. Under the proposed
provisions, if a deviation were found, the establishment would describe
the steps taken to identify and correct the deviation, determine how
noncompliant product would be handled, ensure that no safety hazards
exist after the corrective actions are taken, and define measures to
prevent recurrence. Further, this section required that the
establishment determine whether its HACCP plan required modification
and, if so, to modify the plan.
Many commenters stated that establishments should be empowered to
make decisions on product safety. Commenters generally maintained that
the establishment should have primary responsibility for setting the
CCP's and critical limits and for taking corrective action when there
is a deviation. Inspectors should verify the overall effectiveness of
the HACCP plans, including the corrective actions taken by
establishments. A number of commenters were concerned about the
possibility that FSIS might take action on a product if a critical
limit in the establishment's HACCP plan was not met, even if the
establishment were taking corrective action under the plan. Commenters
felt that this action by FSIS would be unwarranted. An additional
concern was that the potential for this type of problem would be
compounded if the establishment set a critical limit more restrictive
than necessary for food safety to meet quality standards, for example,
a higher cooking temperature than necessary to produce a pathogen-free
product.
The establishment must take corrective action for any deviation
from a set critical limit. FSIS will verify that the establishment has
taken appropriate corrective action as specified in their HACCP plan.
If an establishment fails to take corrective action as specified in its
HACCP plan, FSIS may find that the HACCP system is inadequate pursuant
to Sec. 417.6(c). FSIS agrees that establishments should be empowered
to make decisions regarding product disposition in accordance with
corrective actions specified in their HACCP plans. FSIS is requiring
(Secs. 417.2(c)(5) and 417.3) that establishments describe in their
HACCP plans the corrective actions that will be taken if a critical
limit is not met and assign responsibility for taking corrective
action. Corrective actions must ensure that no product that is
injurious to health or is otherwise adulterated as a result of the
deviation enters commerce, that the cause of the deviation is
identified and eliminated, that the CCP will be under control after the
corrective action is taken, and that measures to prevent recurrence are
established.
FSIS recognizes that preestablished corrective actions may not
cover every contingency and that unforeseen hazards or deviations may
occur. Thus, Sec. 417.3 of the regulations provides a series of steps
to be taken in such situations. These steps include segregating and
holding affected product and conducting a review to determine the
acceptability of the product for distribution, ensuring that any
adulterated product or product otherwise injurious to health does not
enter commerce, and reassessing HACCP plans to determine if any
modification is needed.
Validation, Verification, and Reassessment
Proposed Secs. 326.3(g) and 381.602(g) would have required that
establishments develop procedures for HACCP plan validation by an
adequately trained individual, and set forth the related requirements.
Proposed Secs. 326.4 and 381.604 further detailed the validation
requirements, stating that during the validation period, establishments
shall conduct repeated verifications of the plan, hold frequent
meetings with Program employees, and review records generated by the
HACCP system. Under the proposal, establishments were to modify their
HACCP plan following any ingredient change, product reformulation,
manufacturing process or procedure modification, equipment change, or
any other such change. Revalidation of an establishment's HACCP plan
would have been required whenever significant product, process,
deviations, or packaging changes required modification of the plan.
Many commenters expressed confusion about the meaning of the terms
``validation'' and ``verification'' as used in the proposed rule. The
question of who will be responsible for validating HACCP plans was
raised by a number of commenters. Some requested a clearer definition
of the term ``validation'' as well as clarification of who will approve
and verify a HACCP program. Particular concern was expressed about what
role local inspection personnel will have in the HACCP plan development
and approval process. Some said that FSIS should assume more
responsibility for approving HACCP plans through a prior approval
system; others argued that no formal acceptance or prior approval of
[[Page 38826]]
HACCP plans by FSIS should be required.
In the final rule, FSIS has clarified the concepts of
``validation'' and ``verification'' by delineating the responsibilities
of FSIS and establishments in separate codified sections. The initial
validation, ongoing verification, and reassessment procedures to be
followed by establishments are presented in Sec. 417.4 and FSIS's
verification procedures are presented in Sec. 417.8.
Because prior approval of HACCP plans by FSIS would be contrary to
redefined roles and responsibilities inherent in the HACCP philosophy,
FSIS will not approve or validate HACCP plans before an establishment
implements its HACCP system. Each establishment will be responsible for
developing its HACCP plan and ensuring its adequacy.
Commenters opposed to FSIS involvement in plan validation offered
two suggestions: (1) establishments could use an independent third
party, such as a processing authority or consultant with HACCP
expertise to validate HACCP plans or (2) HACCP-trained establishment
employees could validate plans.
FSIS concurs. Establishments will be required to have validated
plans and may use independent consultants, process authorities, or
establishment employees trained in accordance with Sec. 417.7 for plan
development and validation. FSIS is not prescribing that any particular
validation method be used.
Some establishments may choose to use the services of laboratories
or processing authorities to validate their CCP's, especially if there
are questions about the effectiveness of traditional controls, or if
they are considering use of controls which have not been previously
validated, such as cooking time/temperature combinations. However, many
establishments will choose to rely on CCP's that have been
scientifically validated and reported in the literature. In either
case, FSIS believes that requiring individual establishments to
validate their HACCP plan ensures that the CCP's and the overall HACCP
plan work as intended in the establishment to reduce or eliminate
hazards and prevent the production of unsafe food.
One industry member observed that his company defines validation as
documenting that a critical control point eliminates or effectively
addresses microbiological hazards.
FSIS agrees that validation includes documenting that critical
control points effectively address relevant hazards, including such
microbiological hazards as E. coli O157:H7, Salmonella, and
Campylobacter, but emphasizes that validation is more than just the
accumulation of microbiological data verifying each CCP. It involves
scientifically demonstrating that a HACCP system as designed is
effective in controlling the food safety hazards identified through the
hazard analysis.
One academic commenter advocated inoculation studies using
pathogens as the best way to assure that a HACCP plan will effectively
control microbiological hazards. Such studies would be conducted before
HACCP implementation and should be aimed at demonstrating that selected
CCP's are appropriately monitored to control specific pathogens. The
studies would be performed under controlled conditions in off-site
laboratories or pilot establishments. One advantage of this approach,
according to the commenter, would be to permit validation studies to be
conducted by trade associations and other industry groups on a
collective basis in a way that could benefit both large and small
establishments.
FSIS agrees that validation of CCP's is an important part of HACCP
plan validation, and that laboratory inoculation studies as suggested
by the commenter can make an important contribution in appropriate
cases. Inoculation studies can demonstrate the effectiveness of
particular controls in addressing particular hazards under experimental
conditions, and can produce data that can be relied upon by many
establishments to support plan validation. In no case, however, would a
laboratory inoculation study or any laboratory study be sufficient by
itself to validate a HACCP plan. An important element of validation is
the identification or development of data which show that the
establishment can apply the process or control to get the anticipated
effect under actual in-plant operational conditions. For some well-
established, widely used processes or technologies, in-plant validation
can be accomplished by combining existing scientific data from
laboratory studies, the scientific literature, or other sources, with
the results of commercial trials using recognized protocols. Where
processes are well-documented in the scientific literature, it is not
necessary to require inoculation studies or any other research effort
as part of the validation process. However, an establishment
introducing a new technology, applying standard technology in an
unusual way, or lacking experience with a technology, would have to
undertake more extensive scientific and in-plant validation of its
HACCP plan under commercial operating conditions.
Data assembled to validate a HACCP plan are usually of two types:
(1) theoretical principles, expert advice from processing authorities,
scientific data, or other information demonstrating that particular
process control measures can adequately address specified hazards, such
as studies establishing the temperatures necessary to kill organisms of
concern; and (2) in-plant observations, measurements, test results, or
other information demonstrating that the control measures, as written
into a HACCP plan, can be operated within a particular establishment to
achieve the intended food safety objective. This means that the data
used to validate a HACCP plan may be derived from various sources,
including the scientific literature, product testing results,
experimental research results, scientifically based regulatory
requirements, FSIS guidelines, computer-modeling programs, and data
developed by process authorities. The nature and quantity of
information required to validate a HACCP plan will vary depending on
factors such as the nature of the hazard and the control measures
chosen to address it.
FSIS believes that validation data for any HACCP plan must include
some practical data or information reflecting an establishment's actual
early experience in implementing the HACCP plan. This is because
validation must demonstrate not only that the HACCP plan is
theoretically sound, but also that this establishment can implement it
and make it work. For example, steam vacuuming has been scientifically
demonstrated to be effective in removing visible contamination and
associated bacteria from carcass surfaces. A slaughtering establishment
using the technology as a control measure at a CCP, however, would
still have to demonstrate its ability to use the technology effectively
at the CCP.
Establishment verification is intended to show that the HACCP
system is actually working effectively on a day-to-day basis.
Verification also includes repeatedly reviewing and evaluating the
various components of the system. Verification activities include
checking the adequacy of the critical limits; reviewing monitoring and
recordkeeping procedures (as distinguished from monitoring the CCP's),
and evaluating the adequacy of corrective actions.
One consumer group stated that FSIS should require that
establishments identify the specific microbiological hazards that their
HACCP plans are
[[Page 38827]]
designed to address, and validate and verify the plans using pathogen-
specific testing to ensure that establishments control these hazards.
FSIS agrees that establishments must identify the specific
microbiological hazards their HACCP plans are designed to address and
that the plan must be initially validated and continually verified as
effective in addressing those hazards. FSIS also agrees that pathogen-
specific testing can play an important role in both initial validation
and verification.
For example, in validating the adequacy of a beef slaughter HACCP
plan addressing the hazard posed by E. coli O157:H7, laboratory
inoculation studies involving pathogen-specific testing could be used
to validate the effectiveness of the specific control measures that an
establishment is considering for incorporation in its HACCP plan. As
discussed above, to complete the validation of the control measures for
E. coli O157:H7, the establishment would also be required to
demonstrate that the experimentally validated measures can be
successfully carried out under actual operating conditions, but, for E.
coli O157:H7 on going verification is unlikely to include in-plant
testing for the pathogen due to its relatively infrequent occurrence.
In-plant testing to verify a control measure may be appropriate
with other pathogens, however. For example, a poultry slaughter
establishments would be required to validate and verify the
effectiveness of its HACCP plan in addressing the hazards posed by
Salmonella and Camplylobactor. Depending on the nature of the control
measures the establishment selects, in-plant pathogen testing could be
a necessary and practical component of an on-going verification for
these pathogens as they are present in sufficient numbers to make in-
plant testing feasible and informative. FSIS intends to work closely
with industry at large and with specific establishments in particular
to ensure that HACCP plans are adequately validated and verified for
microbial pathogens of public health concern.
Verification of HACCP plans by establishments is designed to
demonstrate that the HACCP plan is accomplishing process control and
resulting in the production of safe food on a continuing basis.
Verification is distinct from ongoing establishment monitoring, which
is designed to provide a record showing that the written HACCP plan is
being followed. Establishment verification activities should provide
practical results specific to the operation of its HACCP plan, and can
include review of CCP-monitoring records; review of corrective action
records; calibration of process-monitoring instruments; collection of
either in-line or finished product samples for microbiological,
chemical, or physical analysis; and direct observations of monitoring
activities and corrective actions. Frequencies for conducting
verification activities will vary, depending on various factors, such
as the type of process and volume of products, the results of prior
verification activities, consistency of conformance with the HACCP
plan, how deviations are handled, and the results of any sampling
activities.
The record-verification could include determining whether the
critical limit for the CCP, as called for in the HACCP plan, matches
the critical limit indicated in the records. The verification could
also involve checking to assure that the critical limit as set in the
establishment's HACCP plan is adequate to prevent a hazard. For
example, this check might involve determining whether the random
variations inherent in any process are within the limits (temperature
ranges, physical contamination) set for the process, and that the
critical limit is never exceeded or, further, that the probability that
the critical limit might ever be exceeded is extremely low.
The visual observations and records verification could include, in
addition to seeing that the records are being properly maintained,
assuring that cor
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
rective actions have been taken whenever any
deviations have occurred and that, when taken, the corrective actions
were sufficient to solve the problem.
FSIS has made two minor changes from the proposed validation and
verification requirements. First, FSIS has removed the proposed
requirement that during validation an establishment hold frequent
meetings with Program employees. FSIS recognizes that frequent meetings
may not be necessary or appropriate. Also, Sec. 417.4(a)(2) provides
that the establishment's ongoing verification activities include direct
observation of monitoring activities and corrective actions, review of
records, and calibration of process-monitoring instruments. An
establishment calibrates its monitoring instruments to determine
whether they are functioning properly.
Reassessment
The proposed rule would have required that establishments
revalidate the HACCP plan whenever significant product, process,
deviations, or packaging changes required modification of the plan.
A consumer group stated that establishments should be required to
examine their plans on a regular basis, whenever any new equipment is
introduced, new employee training is implemented, or for any other
significant change in the processing environment. The commenter further
stated that revalidation should be required of establishments every
three years even if there has been no significant change in operations.
Most commenters generally agreed that the industry has the primary
responsibility to review and modify HACCP plans when necessary and that
the review and modification process should be flexible.
FSIS agrees that HACCP plans should be reexamined periodically and
that the review and modification process should be flexible. The final
rule requires that each establishment reassess the adequacy of its
HACCP plan at least annually, and whenever any changes occur that could
affect the hazard analysis or alter the HACCP plan (Sec. 417.4(a)(3)).
These changes may include, but are not limited to, changes in: raw
materials or source of raw materials; product formulation; slaughter or
processing methods or systems; production volume; personnel; packaging;
finished product distribution systems; or the intended use or consumers
of the finished product. The reassessment must be completed by an
individual trained in accordance with Sec. 417.7. Immediate
modification of the plan is required if the reassessment reveals that
the plan is no longer adequate to meet the requirements of part 417.
FSIS is also requiring that an establishment that does not have a HACCP
plan reassess its hazard analysis whenever a change occurs that could
reasonably affect whether a food safety hazard exists.
FSIS considers annual reassessment appropriate because, as
commenters have noted, HACCP plans are dynamic and evolving. HACCP
plans may be modified several times during the months after they are
first implemented. Further, repeating the entire validation process may
not be necessary to ensure that the HACCP system is functioning
correctly after modification.
The intent of this provision is to provide for periodic
modification of the HACCP plan to ensure that it is continuously
effective in controlling and preventing food safety hazards. This
intent is supported by comments received from various sectors of the
public. The commenters tended to see periodic review and modification
of HACCP plans as both desirable and
[[Page 38828]]
expected and that periodic review and modification would allow the
establishment to apply its experience to continually improve process
controls.
FSIS believes that ``reassessment'' encompasses the different types
of evaluation, from reanalyzing the verification procedures for an
updated CCP to repeating the validation procedures set forth in
Sec. 417.4, that may be necessary.
FSIS Verification
Verification of HACCP plans is also a regulatory responsibility.
FSIS will verify that HACCP plans comply with the requirements of Part
417 and have been validated by the establishment. Potential
verification activities by FSIS may include, but are not limited to,
sampling activities (targeted and non-targeted, marketplace, rapid
screening tests for chemical residues); hands-on verification
(organoleptic inspection, use of temperature or other monitoring
devices); and review of establishment monitoring records. The frequency
of FSIS verification activities will vary, depending on a number of
factors such as the establishment's past performance, risk inherent in
the processes or products, quantity of product, and likely uses.
A consumer group stated that as part of its verification
activities, FSIS should review all pathogen data generated by the
establishment to determine the adequacy of the establishment's
conclusions regarding pathogen control. FSIS plans to undertake
extensive and varied activities to verify that a HACCP plan is working
as intended, including review of data generated or relied on by the
establishment to validate its HACCP plan.
Proposed Secs. 326.7(b) and 381.607(b) set forth FSIS's
responsibilities with respect to verification activities. These
provisions have been slightly revised for clarity and are consolidated
in Sec. 417.8.
Records
Proposed Secs. 326.6(b) and 381.606(b) listed the types of records
every establishment would have been required to maintain regarding
their operations under HACCP. The list included the written HACCP plan,
hazard analysis, records associated with CCP monitoring, corrective
actions, verification procedures and results, product codes, identity,
and slaughter production lot, the dates of the records, and supporting
documentation for the various features of the HACCP plan. FSIS also
proposed to require a preshipment review of processing and production
records associated with the HACCP plan to ensure that the records were
complete, that all critical limits were met, and, if applicable, that
corrective actions were taken. The review was to be performed by
someone other than the person who created the records, preferably by a
HACCP-trained individual, or by the responsible establishment official.
FSIS considers the preshipment record review a routine verification
function under HACCP principle No. 7.
FSIS also proposed that establishments retain all required records
on site at all times, except those records concerning monitoring CCP's,
corrective actions, and verification procedures were to be retained at
the establishment for no less than one year, and for an additional two
years at the establishment or other location from which the records
could be made available to Program employees.
Regarding the preshipment review of records, several small
establishments commented that there may not be a person other than the
person who created the record available to conduct the preshipment
review. Several large establishments were concerned that a HACCP-
trained individual may not be available to conduct the preshipment
review. FSIS has modified this requirement by stating that the
preshipment review shall be conducted by someone other than the person
who produced the records where practicable. Also, FSIS has retained the
provision that the review be conducted preferably by an individual
trained in accordance with Sec. 417.7 or the responsible establishment
official.
Some commenters recommended that FSIS allow the use of electronic
or computerized recordkeeping systems to ease the burden of the
proposed recordkeeping requirements. In response to these comments,
FSIS has added a new Sec. 417.5(d) which provides for the maintenance
of data and information on computers, as long as controls are
implemented by the establishment to ensure the integrity of the data
and signatures.
Commenters also raised concerns regarding proposed record retention
requirements, maintaining that keeping HACCP records for a minimum of
three years would be excessive. Commenters requested flexibility in
deciding how long to retain records; many stated that retention should
be based on product shelf-life. In response to these commenters, FSIS
has modified this requirement to provide that records required by
Sec. 417.5(a)(3) be retained at the establishment for one year if they
pertain to slaughter activities or refrigerated products, and for two
years if they pertain to frozen, preserved, or shelf-stable products.
To further ease the recordkeeping provisions for establishments,
FSIS will permit the off-site storage of records required by
Sec. 417.5(a)(3) that are over 6 months old if the records can be made
available to Program employees within 24 hours of the request. The
records required by Sec. 417.5 (a)(1) and (a)(2), however, are not
eligible for off-site storage.
Proposed Secs. 326.6 and 381.606 would have provided that records
be made available to Program employees. Section 417.5(f) clarifies that
all records required by part 417 be available to Program employees for
review and copying.
For clarity, FSIS has reworded the recordkeeping provisions to
require that the establishment maintain the written hazard analysis and
all supporting documentation, the written HACCP and all decisionmaking
documents associated with the selection and development of CCP's and
critical limits, and documents supporting both the monitoring and
verification procedures selected and the frequency of those procedures.
Records documenting the monitoring of CCP's and critical limits,
corrective actions, verification procedures and results, product
code(s), product name or identity, or slaughter production lot must
also be maintained. Each record must include the date the record was
made. To be consistent with FDA's final rule on HACCP systems for
seafood, FSIS has also added a requirement that records relating to the
calibration of process-monitoring instruments be maintained.
Training
FSIS proposed two definitions related to training: ``HACCP-trained
individual'' and ``recognized HACCP course.'' ``HACCP-trained
individual'' was defined as ``a person who has successfully completed a
recognized HACCP course in the application of HACCP principles to meat
or poultry processing operations, and who is employed by the
establishment. A HACCP-trained individual must have sufficient
experience and training in the technical aspects of food processing and
the principles of HACCP to determine whether a specific HACCP plan is
appropriate to the process in question.'' A ``recognized HACCP course''
was defined as ``a HACCP course available to meat and poultry industry
employees which satisfies the following: consists of at least 3 days, 1
day devoted to understanding the seven principles of HACCP, 1 day
devoted to applying these concepts to this and other regulatory
requirements of FSIS, and 1 day devoted
[[Page 38829]]
to beginning development of a HACCP plan for a specific process.''
Some commenters thought that defining a HACCP-trained individual
was unnecessary, that the role of such a person in operating HACCP
systems should be analogous to the role of the processing authority in
canning operations.
A few commenters questioned the effectiveness of the proposed
three-day training requirement stating it would not sufficiently
qualify a person to implement or operate a HACCP system. Some
commenters asserted that the detailed course composition with no FSIS
certification of courses was inadequate and too rigid. Others insisted
that what is needed is a common understanding of the basic principles
of HACCP and of how HACCP can be applied to specific processes and
establishments, with no FSIS certification of courses.
FSIS has revised the regulations, which are now codified in
Sec. 417.7, to simplify the proposed training requirements. The
proposed definition and requirements for a HACCP-trained individual
have been removed. Section 417.7 requires that individuals performing
certain functions must have successfully completed a course in the
application of the seven HACCP principles to meat and poultry product
processing, including a segment on the development of a HACCP plan for
a specific product. Only those individuals who meet the training
requirements may perform the following functions:
Development of the HACCP plan as required by
Sec. 417.2(b);
Reassessment and modification of the HACCP plan as
required by Sec. 417.3 and/or Sec. 417.4(a)(3).
The rule has been modified to set a basic standard for HACCP
training while preserving the flexibility needed by industry to
implement HACCP systems effectively. The provisions of Sec. 417.7 are
consistent with FSIS's view that training is central to the success of
HACCP, that there are many avenues for HACCP training needs, and that
responsible establishment officials are in the best position to
determine the training needs for each establishment.
Adequacy of HACCP Plans
The proposed rule stated that a HACCP plan could be found invalid
if it does not meet the regulatory requirements, if HACCP records are
not being maintained to validate the plan or verify process control
under the plan, or if a processing failure results in production of
adulterated product.
The provisions of the final rule relating to the criteria for
finding a HACCP plan inadequate are essentially the same as in the
proposal, except that the term ``invalid'' has been replaced with
``inadequate'' for clarity. Also, the final rule states that a HACCP
plan may be found to be inadequate if establishment personnel are not
performing tasks specified in the HACCP plan. One change from the
proposal concerns the correction of HACCP systems found inadequate
because of product adulteration. Under the proposed
Secs. 326.7(c)(3)(ii) and 381.607(c)(3)(ii), the establishment would
have been required to submit to FSIS, among other things, a written
plan for chemical or microbiological testing by an external laboratory
of finished product produced under the modified HACCP plan to show that
the modified plan corrected the problem. The final rule is more
flexible because decisions regarding the appropriateness of the HACCP
system modifications are made by the establishment.
FSIS will verify that HACCP plans are adequate. The procedure for
determining the adequacy of the HACCP plan will not be a one-step
process. Instead, FSIS will take a variety of actions including
reviewing the HACCP plan and associated records, directly observing the
HACCP system in operation, and assessing the adequacy of corrective
actions. After a thorough review is conducted, FSIS will determine
whether a HACCP plan is adequate. If a plan is found to be inadequate,
FSIS will take appropriate regulatory action.
III. Sanitation Standard Operating Procedures
The Proposed Rule
FSIS proposed that all meat and poultry establishments be required
to develop, maintain, and adhere to written sanitation standard
operating procedures (Sanitation SOP's). The proposal was based on
FSIS's belief that effective establishment sanitation is essential for
food safety and to successful implementation of HACCP. Insanitary
facilities or equipment, poor food handling practices, improper
personal hygiene, and similar insanitary practices create an
environment conducive to contamination of products. There are direct
and substantial links between inadequate sanitation and the
contamination of meat and poultry products by pathogenic bacteria. FSIS
tentatively concluded that Sanitation SOP's were necessary because they
would clearly define each establishment's responsibility to
consistently follow effective sanitation procedures and would
substantially minimize the risk of direct product contamination and
adulteration.
FSIS also had determined that Sanitation SOP's would improve the
utilization of FSIS Inspection Program resources by refocusing FSIS
sanitation inspection on the oversight of establishment prevention and
correction of conditions that cause direct product contamination or
adulteration. After Sanitation SOP's were in place, Agency inspection
personnel would spend less time enforcing detailed sanitation
requirements and directing the correction of problems after they occur.
Instead, FSIS inspectors would focus on oversight of an establishment's
implementation of Sanitation SOP's and on taking appropriate regulatory
action when an establishment's Sanitation SOP's were not properly
executed or when product contamination or adulteration was imminent,
directly observed, or probably had occurred.
The concepts underlying the proposed requirements for Sanitation
SOP's are important and new. In the past, FSIS has not clearly
articulated the responsibility every establishment has to ensure that
sanitation requirements are met every day, both before and during
operations. Although the majority of meat and poultry establishments
maintain adequate sanitary conditions, some establishments have
significant sanitation problems that can be resolved only through more
clearly defining establishment responsibility and accountability for
the daily observance of sound sanitation practices.
The proposed requirements for Sanitation SOP's were the result of
many years of observations by FSIS of establishment sanitation and
management practices. The persistence of insanitary conditions within
some meat and poultry establishments was documented in the ``1,000
Plant Review,'' conducted by FSIS between September 1993 and February
1995. This project involved unannounced visits to 1,014 inspected
establishments during which operations were observed and deficiencies
noted. More than 60 percent of all deficiencies documented by the
review involved establishment sanitation. The distribution of
sanitation problems was not, however, uniform in the establishments
sampled. Fewer than half those establishments visited accounted for 90
percent of the sanitation deficiencies. Data collected through FSIS's
Performance Based Inspection System similarly documents that sanitation
is the most frequent deficiency noted by inspection personnel in
routine establishment visits.
[[Page 38830]]
Through analysis of this information, FSIS determined that the
difference between establishments with consistently sanitary conditions
and those with chronic sanitation deficiencies is often that the better
performing establishments have effective quality control and sanitation
programs, including written Sanitation SOP's, while the marginal
establishments do not. As a means of bringing all establishments to a
consistently acceptable level of sanitation, as well as to clarify the
respective roles of establishments and FSIS in achieving that goal in
each establishment, FSIS proposed that every meat and poultry
establishment develop, maintain, and adhere to written Sanitation
SOP's.
FSIS proposed that Sanitation SOP's cover the daily preoperational
and operational sanitation procedures that the establishment would
implement to prevent direct product contamination or adulteration.
Additionally, establishments would be required to identify the
establishment officials who would monitor daily sanitation activities,
evaluate whether the Sanitation SOP's are effective, and take
appropriate corrective action when needed. Also, each establishment
would be required to make daily records showing completion of the
procedures in the Sanitation SOP's, any deviations and corrective
actions taken, and maintain those records for a minimum of six months.
Further, an establishment's Sanitation SOP's and records were to be
made available to FSIS for verification and monitoring. Finally, the
proposal provided that any equipment, utensil, room or compartment
found by an inspection program official to be not in compliance with
the Sanitation SOP's or insanitary would be tagged ``U.S. Rejected,''
and could not be used until it had been reinspected and passed.
FSIS solicited comments on the proposed regulatory requirements for
Sanitation SOP's. FSIS also requested comments on how Sanitation SOP's
should clarify the responsibilities of establishments and what role
inspection personnel should play in authorizing daily startup of
operations. Comments also were requested on whether certain Good
Manufacturing Practices (GMP's) or other sanitation practices should be
mandatory elements of the Sanitation SOP's.
The majority of the comments addressing the proposed Sanitation
SOP's provisions expressed support. Many commenters, however, expressed
concern about the lack of detail in the proposal regarding the required
contents of an establishment's Sanitation SOP's and about how
Sanitation SOP's would be enforced by inspectors. The comments, both
written and oral, and FSIS's responses are discussed in the
``Comments'' section, which follows the description of the final rule.
The Final Rule
After careful consideration of the comments, FSIS is promulgating
requirements for Sanitation SOP's, essentially the same as proposed,
though with several changes and additions for both clarity and to grant
establishments greater flexibility in meeting the Sanitation SOP's
requirements.
As proposed, all inspected establishments shall develop, implement,
and maintain written Sanitation SOP's. The Sanitation SOP's shall
describe all procedures and establishment conducts daily to prevent
direct contamination or adulteration of product(s). FSIS has clarified
that Sanitation SOP's also shall specify the frequency with which each
procedure in the Sanitation SOP's is to be conducted and identify the
establishment employee(s) responsible for the implementation and
maintenance of such procedure(s). While the employee responsible for
implementation and maintenance of procedures in the Sanitation SOP's
may be the employee who actually performs such activities, he or she
instead may be the employee in charge of ensuring that the sanitation
procedures are carried out. All that is required is that the Sanitation
SOP's identify the employee(s) responsible for implementation and
maintenance of the procedures in the Sanitation SOP's. The
establishment does not need to necessarily identify the employee(s) who
will actually perform the sanitation procedures. Also, an
establishment's Sanitation SOP's may have more than one employee
responsible for implementation and maintenance of sanitation
procedures. For example, one employee may be responsible for pre-
operational procedures and another may be responsible for operational
procedures. The rule provides such flexibility.
Further, FSIS is clarifying in this final rule that establishments
must explicitly identify pre-operational sanitation procedures in their
written Sanitation SOP's, distinguishing them from sanitation
activities to be carried out during operations. This will assist both
the establishment and FSIS in identifying which sanitation procedures
are to be carried out each day prior to start-up of operations.
FSIS is also requiring that Sanitation SOP's be signed and dated by
``the individual with overall authority on-site or a higher level
official of the establishment,'' and that the signature shall signify
that the establishment will implement the Sanitation SOP's. This new
language grants establishments greater flexibility than did the
proposed requirement that ``the establishment owner or operator'' be
responsible for implementation of Sanitation SOP's. Additionally, this
final rule specifies that Sanitation SOP's must be signed upon
initiation and upon any modification.
As in the proposal, the format and content of Sanitation SOP's are
not specified in the final regulations. Because there are many types of
inspected establishments that will achieve the required sanitary
conditions in different ways, this rule gives establishments
flexibility to customize their sanitation plans. Each meat and poultry
establishment must analyze its own operations and identify possible
sources of direct contamination that must be addressed in its
Sanitation SOP's.
As proposed, each establishment is required to conduct the pre-
operational and operational procedures as specified in the Sanitation
SOP's, monitor the conduct of the procedures, and routinely evaluate
the content and effectiveness of the SOP's and modify the Sanitation
SOP's accordingly. The Sanitation SOP's must be kept current. The
establishment must evaluate and modify Sanitation SOP's as needed in
light of changes to establishment facilities, personnel, or operations
to ensure they remain effective in preventing direct product
contamination and adulteration. As upon initial implementation,
Sanitation SOP's must be dated and signed by the individual with
overall authority on-site or a higher level official of the
establishment following any modification.
Also as in the proposal, FSIS is requiring that each establishment
initiate corrective action when either the establishment or FSIS
determines that Sanitation SOP's or their implementation may have
failed to prevent direct product contamination or adulteration. The
requirements regarding corrective actions have been more thoroughly
explained, however, and now specify that corrective actions shall
include ``procedures to ensure appropriate disposition of product(s)
that may be contaminated, restore sanitary conditions, and prevent the
recurrence of direct contamination or adulteration of product(s),
including
[[Page 38831]]
appropriate reevaluation and modification of the Sanitation SOP's and
the procedures specified therein.''
This final rule also adopts the provision in the proposal requiring
establishments to keep daily records documenting that sanitation and
monitoring procedures listed in the Sanitation SOP's are performed.
Establishments also must maintain records documenting any corrective
actions taken to prevent direct contamination or adulteration of
products, or when the establishment determines or FSIS notifies the
establishment that its Sanitation SOP's are inadequate. FSIS has
clarified that such records must be initialed and dated by the
designated establishment employee(s) responsible for the implementation
and monitoring of the Sanitation SOP's procedures.
In response to comments, FSIS has revised the recordkeeping
requirements to allow for computer maintenance of records, as long as
establishments implement controls to ensure the integrity of the
electronic data. FSIS recognizes that many establishments currently use
computers for maintaining a variety of types of information, including
sanitation data. It would be impractical and burdensome to prohibit
these establishments, or others wishing to use computers, from using
computers to record and store required sanitation data.
FSIS proposed that establishments must maintain sanitation records
for a minimum of six months, but did not specify whether these records
had to be stored on-site. Several commenters expressed concern about
the physical location of establishment sanitation records and
questioned whether sanitation records must be maintained in the
establishment.
FSIS requires unimpeded access to all establishment sanitation
records for oversight and enforcement purposes; these records are to be
an integral part of the Agency's inspection activities. FSIS
anticipates that, for most establishments, these records will not be
voluminous and will not create a significant storage problem. However,
the Agency recognizes that space may be limited at certain inspected
facilities and has revised this requirement to allow establishments to
retain records off-site, provided they are not removed from the
establishment for at least 48 hours following completion and they can
be provided to FSIS personnel within 24 hours of being requested.
In this final rule, FSIS is clarifying that it will verify that the
Sanitation SOP's are being implemented and maintained, and that they
are effective. FSIS inspectors will ensure not only that an
establishment is complying with the requirement to develop, implement,
and maintain Sanitation SOP's, and to maintain daily records for them,
but also that the Sanitation SOP's are in fact working. Inspectors will
review the Sanitation SOP's, the daily records, the conduct of
procedures specified in the Sanitation SOP's, and the sanitary
conditions themselves.
The failure by an establishment to comply with the Sanitation SOP's
regulations may initiate regulatory action. The full array of
compliance tools includes process deficiency reports, tagging of
equipment or areas, retention of product, letters of warning, and
suspension and withdrawal of inspection. The nature of FSIS's response
will depend on the circumstances. Minor omissions or errors in
Sanitation SOP's documentation, not symptomatic of larger ``system''
problems, will result in regulatory action commensurate with the
severity of the violation. For example, process deficiency reports
might be issued to direct corrective action. However, a pattern of
violations of the Sanitation SOP's provisions would lead to additional
responses, with persistent and serious failures resulting in suspension
or withdrawal of inspection from the establishment. Suspensions and
withdrawals would be made in accordance with applicable rules of
practice for those proceedings.
If FSIS determines that an establishment's Sanitation SOP's fail to
include procedures to prevent direct product contamination or
adulteration or that required records are not being kept, the Agency
may tag affected facilities and equipment and suspend inspection until
the failure is remedied. Because the tagging of insanitary facilities
and equipment is based on current statutory authority, the specific
regulatory provisions for tagging in the proposal are not retained in
this final rule.
Verification and compliance activities under the Sanitation SOP's
provisions are distinguishable from actions taken as a consequence of a
finding of product adulteration under the sanitation requirements
elsewhere in the regulations. As a practical matter, however, such
findings are likely to be connected. A finding of deficient Sanitation
SOP's or Sanitation SOP's records may prompt additional inspection
activity directed at determining whether or not product contamination
or adulteration has occurred. If it has, FSIS will take appropriate
action to prevent adulterated product from entering commerce and, where
necessary, seek recall of product that has already entered commerce.
Finally, the Sanitation SOP's requirements of this final rule are
set out in a new Part 416, Sanitation. These provisions are formatted
differently from the proposal to comport with FSIS's announced project
to reform, reorganize, and recodify the meat and poultry regulations.
This regulatory reform project is well underway, and will, among other
things, eliminate unneeded regulations by combining, to the extent
possible, the currently separate meat and poultry regulations. New Part
416, like new part 417 on HACCP, covers both meat and poultry products.
Part 416 will be expanded and supplemented as the Agency proceeds with
its initiative to review, reform, and reorganize existing FSIS
regulations concerning sanitation.
Comments and Responses
General
Support for the proposed requirements for Sanitation SOP's was
expressed by a wide range of commenters. Most supporters agreed that
establishment sanitation is essential to product safety and that every
meat and poultry establishment should be required to have a written
sanitation plan. Those who opposed mandatory Sanitation SOP's argued
that current sanitation regulations would be adequate if they were
better enforced, that Sanitation SOP's would be no more than a
paperwork exercise, and that they would be an additional burden on
establishments. FSIS strongly disagrees with the notion that Sanitation
SOP's will be a mere ``paperwork exercise,'' and believes this
regulation will, in fact, result in improved sanitation and provide for
more effective enforcement of the sanitation requirements.
Substantial evidence exists that insanitary facilities or
equipment, poor food handling, improper personal hygiene, and similar
insanitary conditions create an environment in which products become
contaminated with microorganisms, including pathogens. While sanitation
has improved greatly throughout the industry over the years, some
individual establishments still have difficulty getting their
facilities and equipment ready to start operations each day and keeping
conditions sanitary during establishment operations. FSIS affirms that
proper sanitation is an important and integral part of every food
process and a fundamental requirement of the inspection laws that the
Agency enforces.
[[Page 38832]]
In the past, FSIS has enforced the sanitation requirements
primarily through a combination of prescriptive sanitation regulations,
detailed guidance materials, and direct, hands-on involvement by
inspectors in day-to-day pre-operational and operational sanitation
procedures in inspected establishments. This system achieved sanitation
goals on a daily basis in individual establishments, but at a
relatively large public cost because it encouraged establishments to
shift accountability for sanitation to the FSIS inspector. For example,
in the past, FSIS inspectors have taken responsibility for checking
sanitation in every slaughter establishment before it begins daily
processing. In extreme cases, inspectors have led daily ``bucket
brigades'' of slaughter establishment employees through pre-operational
establishment cleanup. In these circumstances, FSIS has, in effect,
taken responsibility for establishment sanitation conditions. The
Sanitation SOP's requirement is intended to end this practice.
Sanitation SOP's make it clear that responsibility for identifying and
conducting procedures needed to maintain sanitary conditions rests with
the establishment, not with FSIS.
Sanitation SOP's are an inspection tool. They will help individual
inspectors focus their oversight in an establishment on those
conditions that pose a risk of direct product contamination or
adulteration, that is, on conditions which pose the greatest
adulteration hazards to products subject to inspection in that
establishment. The effectiveness of each establishment's Sanitation
SOP's in achieving acceptable sanitation will be subject to continuing
verification by FSIS inspectors through direct observation of
conditions in the establishment. It is expected that, over time,
inspectors in most establishments will increasingly be able to rely on
a review of daily Sanitation SOP's records to determine whether
establishments are complying with sanitation requirements. However,
FSIS inspectors will continue to have a full array of regulatory tools
to ensure the maintenance of sanitary conditions. For instance, FSIS
inspectors will continue tagging equipment, utensils, rooms, or
compartments in instances where there is physical evidence of
insanitary conditions in the production areas of the establishment.
FSIS anticipates that the development, implementation, and
maintenance of Sanitation SOP's, as well as the recordkeeping
provisions, will impose a minimal burden on establishments. Some
establishments already utilize written Sanitation SOP's. For other
establishments, compliance with the Sanitation SOP's requirements will
consist of recording their current sanitation practices. A complete
discussion of the anticipated costs of implementing the SOP's
requirements is contained in the Final Regulatory Impact Analysis.
Sanitation SOP's are an integral part of the Agency's strategy for
making inspection more effective and more risk-based in its focus. For
these reasons, FSIS is adopting the proposed requirements for
Sanitation SOP's and is clarifying that developing, implementing, and
maintaining Sanitation SOP's and keeping daily Sanitation SOP's
records, is a condition of inspection.
Development of Sanitation SOP's
As noted previously, a number of commenters raised concerns about
the content of the Sanitation SOP's and asked for more specificity.
Some commenters recommended that FSIS be more specific about what
procedures must be in the Sanitation SOP's. Other commenters suggested
that such procedures be fully described and be made mandatory. The
Agency recognizes these commenters' concerns and therefore is providing
guidance on how individual establishments may develop their Sanitation
SOP's in Appendix A and Appendix B to this final rule. Appendix A is a
guideline on Sanitation SOP's that establishments can use in developing
their own Sanitation SOP's; Appendix B is a model of an establishment's
Sanitation SOP's that demonstrates what a completed Sanitation SOP's
might include. Together, these guidance documents will assist
establishments to develop Sanitation SOP's that address conditions
unique to individual establishments and processes and that prevent
direct product contamination or adulteration. As with all FSIS guidance
materials, the Agency welcomes comments on how these two documents
might be improved.
However, the final rule itself remains nonprescriptive in that it
requires each establishment to determine for itself what procedures are
necessary to prevent insanitary conditions that will cause direct
product contamination or adulteration. Overall, the comments confirmed
that, while proper sanitation is a common need in every food production
facility, the means to achieve it are diverse and establishment-
specific. Establishments that now have good sanitation and effective
process controls are expected to continue using techniques that work in
their establishment. Other establishments will need to analyze and
select effective abatement procedures among various alternatives for
attaining a sanitary processing environment. What works in one
establishment may or may not work in another.
The proposed rule also solicited comments as to whether FSIS should
mandate Good Manufacturing Practices (GMP's) for all or certain
Sanitation SOP's. FSIS listed illustrations in the proposal of elements
that might be mandatory elements of Sanitation SOP's. Although some
commenters expressed support for making GMP's or other practices
mandatory, many objected to such specific requirements on the basis
that they would be infeasible. FSIS agrees with those commenters who
stated that detailed GMP regulations are infeasible because of the
difficulty in making them specific enough to be useful. FSIS also was
concerned that such specificity could result in lost flexibility.
For these reasons, this final rule will not prescribe a single
format for individual establishment Sanitation SOP's or mandate
specific GMP's. It will be the responsibility of each establishment to
consider existing FSIS regulations and guidelines; evaluate its
facilities, processes, and sanitation conditions; determine what
sanitation procedures must be implemented to prevent direct product
contamination or adulteration; and describe these procedures in
Sanitation SOP's.
Maintaining Sanitation SOP's
FSIS received several comments regarding the maintenance of
Sanitation SOP's. Some commenters wanted to know whether if an
establishment will be able to update its Sanitation SOP's to
incorporate new technologies. Other commenters wanted to know what type
of system, if any, FSIS will use to review changes to Sanitation SOP's
and if a formal request for FSIS review or approval would be required.
As has been discussed previously, the final rule requires that each
establishment develop, implement, and maintain its Sanitation SOP's and
incorporate new sanitation technologies as appropriate. FSIS encourages
the adoption of new technologies that can improve sanitation and food
safety. This is an establishment responsibility. Although FSIS will not
approve Sanitation SOP's, it will provide advice and guidance to
establishments as they develop and begin to implement Sanitation SOP's.
Recordkeeping
Commenters also expressed concerns about what was to be in daily
sanitation
[[Page 38833]]
records and how long and where such records were to be retained. As the
proposal explained, and this final rule requires, Sanitation SOP's
records must document the implementation and maintenance of Sanitation
SOP's, as well as any deviations from Sanitation SOP's procedures, and
corrective actions taken. As with the development of Sanitation SOP's
themselves, FSIS will allow each establishment to determine the form
and format of its daily sanitation records. In many establishments, a
simple, daily checklist, showing that specific Sanitation SOP's
procedures were implemented, initialed by the responsible establishment
employee, is likely to suffice. Other establishments may find a more
detailed format for its records is more useful. Some establishments may
wish to use a computer-based system. This final rule provides such
flexibility.
Some commenters stated that the proposed six-month retention of
daily sanitation records was too long. FSIS disagrees and is adopting
the proposed requirement that establishments retain Sanitation SOP's
records for six months. Increased product shelf-life and the potential
need for FSIS personnel to review Sanitation SOP's records many months
after production make it necessary that establishments retain records
for six months. Furthermore, sanitation records provide both FSIS and
establishment management near-term trend data to evaluate how
establishment sanitation is being carried out under the Sanitation
SOP's. This feedback should be very useful to establishments in
determining whether and how their Sanitation SOP's need revision.
Inspectors will benefit, too, from knowing how the establishment has
complied with these requirements. Establishment sanitation records will
also need to be reviewed by the Agency as part of any compliance
investigation.
In a related matter, several commenters expressed concern about the
physical location of establishment sanitation records and questioned
whether sanitation records must be maintained in the establishment. As
explained above, FSIS requires unimpeded access to all establishment
sanitation records for oversight and enforcement purposes. FSIS
anticipates that, for most establishments, these records will not be
voluminous and will not create a significant storage problem. However,
in response to these comments, this final rule will allow
establishments to retain Sanitation SOP's records off-site provided
they are not removed from the establishment for at least 48 hours
following completion and they can be provided to FSIS personnel within
24 hours of request.
Some commenters also expressed concern about public accessibility
to an establishment's Sanitation SOP's records. Like establishment
HACCP records, these records are kept and maintained by the
establishment and generally are not Agency records. Occasionally,
however, such records will be copied and incorporated into Agency
records for some official purpose. These records will be disclosed to
third parties only to the extent disclosure is required by the Freedom
of Information Act and the Privacy Act or other applicable law.
Proprietary information, personal information, and other information
exempt from disclosure would be protected.
``Layering''
Many commenters were concerned that FSIS was layering requirements
for Sanitation SOP's over existing regulations governing establishment
sanitation practices, thereby increasing rather than decreasing
intrusive, command-and-control oversight of all inspected
establishments. Concern was also expressed that the new requirements
might conflict with current sanitation regulations.
FSIS does not consider the Sanitation SOP's requirement to be
layered over or in conflict with existing regulations. Existing
regulations establish substantive sanitation-related requirements,
while the new Sanitation SOP's provisions establish a means by which
establishments will take responsibility for achieving sanitary
conditions and preventing direct product contamination or adulteration.
Sanitation SOP's also will better focus inspection oversight by FSIS
inspectors on those sanitation measures required to prevent direct
product contamination or adulteration. As discussed, one of the
Agency's goals is to reduce inspectors' personal involvement in the
conduct of routine, day-to-day sanitation procedures.
FSIS emphasizes that it does not intend or require that an
establishment's Sanitation SOP's incorporate all elements of the
existing FSIS sanitation regulations. These regulations contain many
detailed provisions that do not relate to the prevention of direct
product contamination. As the text of the Sanitation SOP's regulations
and the guidance materials at Appendices A and B makes clear, FSIS
intends and requires only that the Sanitation SOP contain a description
of the procedures an establishment will follow to address the elements
of pre-operational and operational sanitation that relate to the
prevention of direct product contamination.
For example, under paragraph (a) of Sec. 308.4 of the regulations,
FSIS requires that ``Dressing rooms, toilet rooms, and urinals shall be
sufficient in number, ample in size, and conveniently located.''
Although compliance with this requirement is important for the
maintenance of establishment sanitation, and employee hygiene must be
part of Sanitation SOP's, Sec. 308.4(a) does not concern direct product
contamination and would not need to be addressed in an establishment's
Sanitation SOP's. On the other hand, the rule requires that Sanitation
SOP's specifically address the pre-operational ``cleaning of food
contact surfaces of facilities, equipment, and utensils'' because these
procedures are necessary to prevent the direct contamination of
product. Additionally, the guidance materials in Appendices A and B
give examples of other procedures necessary to prevent direct product
contamination that Sanitation SOP's should include, such as
``Descriptions of equipment disassembly, reassembly after cleaning, use
of acceptable chemicals according to label directions, and cleaning
techniques.'' FSIS emphasizes, however, that an establishment does not
need to reproduce in its written Sanitation SOP's the existing
regulatory requirements concerning the prevention of direct
contamination or adulteration of product.
FSIS also realizes that its existing sanitation regulations contain
some detailed and prescriptive provisions and that some of those
regulations may be outmoded and no longer needed in light of the
Agency's effort to clarify that good sanitation is the responsibility
of each establishment. FSIS will continue to review, reevaluate, and
revise, as necessary, all current sanitation regulations, along with
related issuances and sanitation inspection procedures, to simplify and
streamline them and make them more compatible with Sanitation SOP's
requirements. This process was announced and initiated in the advance
notice of proposed rulemaking published on December 29, 1995 (60 FR
67469). The review of sanitation regulations is a high priority for the
Agency. The elements of sanitation that are required to be addressed in
the Sanitation SOP's will remain as central elements of the FSIS
sanitation regulations. Establishments will not need to revise their
Sanitation SOP's because of the simplification and streamlining of
existing FSIS sanitation regulations.
[[Page 38834]]
Role of Inspectors
A related concern of many commenters was the role FSIS inspectors
will play in the development and enforcement of Sanitation SOP's. Some
commenters expressed concern that during inspection inspectors would
rely solely on record reviews instead of actually observing
establishment conditions. Other commenters expressed concerns that
Sanitation SOP's would merely provide FSIS inspectors with more
latitude to make intrusive and arbitrary decisions.
FSIS strongly disagrees with this characterization of Sanitation
SOP's and the role of the Agency's inspection personnel. Industry's
responsibility for producing safe meat and poultry and FSIS's
responsibility for regulatory oversight are fundamentally different.
Sanitation SOP's are the establishment's commitment to FSIS that they
will consistently provide a sanitary environment for food production.
FSIS inspectors will not be tasked with directing an establishment's
sanitation procedures, nor with ``approving'' the establishment's
Sanitation SOP's. They will, however, verify that the Sanitation SOP's
are being implemented and that they are effective in preventing direct
product contamination and adulteration.
Oversight of Sanitation SOP's will become an increasingly important
part of daily inspection activity, while the directing of sanitation
activities will occur less frequently. Periodic inspection tasks will
include verifying that Sanitation SOP's meet the regulation's
requirements, are being implemented and maintained, and are effective
in producing sanitary conditions. FSIS inspectors' oversight will
include review of the Sanitation SOP's and required records, direct
observation of the implementation and monitoring of the Sanitation
SOP's, and visual observation of sanitary conditions in the production
areas of the establishment.
FSIS expects that establishments will rely less on inspectors to
direct them in maintaining sanitary conditions as establishments rely
more on adherence to their own Sanitation SOP's. The mix of inspector
tasks that comprise sanitation inspection also will change. As
establishments adopt and successfully implement Sanitation SOP's, and
consistently achieve good sanitation results, FSIS inspectors can spend
less time ensuring that basic sanitation requirements are being met.
Conversely, to the extent some establishments do not implement
effective Sanitation SOP's and consistently achieve good sanitation,
FSIS inspectors will be obliged to intensify their focus on actual
establishment conditions and initiate appropriate enforcement actions.
Ensuring establishments operate under sanitary conditions should be
made easier for inspectors, and ultimately permit inspectors to spend
more time on other tasks. One purpose of the Sanitation SOP's
regulations is to help inspectors, as well as establishments, focus
their attention on those aspects of establishment sanitation that pose
the most risk of causing product contamination or adulteration. Under
the current inspection system, inspectors look at all aspects of
establishment sanitation, including many that have a relatively low
probability of causing product contamination. In the future, normal
oversight activities will focus more on whether an establishment is
following its Sanitation SOP's and thereby consistently preventing, or
as appropriate, correcting, conditions that cause direct product
contamination or adulteration. Some commenters were concerned about the
effect on establishment operations if inspection personnel, when
enforcing the Sanitation SOP's requirements, reject one piece of
equipment, utensil, room or compartment as insanitary. As previously
stated, inspectors will take prompt action in cases where there is a
finding of insanitation or the likelihood of product contamination or
adulteration. The type and intensity of this response will vary. For
example, establishment operations may be allowed to continue if
inspection personnel determine that a rejected item, compartment or
room is not related to other processes or products being produced.
However, inspection would be withheld in rooms, departments, or
facilities associated with the production of contaminated or
adulterated products where the establishment can not show FSIS that
they have isolated the cause of the contamination or adulteration and
have taken appropriate action to prevent further contamination or
adulteration. In a similar vein, commenters also stated that
establishments should not be penalized for the occurrence of a
sanitation problem that is effectively abated. These commenters
suggested that ``U.S. Rejected'' tags should be used only if an
establishment fails to identify and correct insanitary conditions. If
the establishment takes proper corrective action, they argued, it
should be viewed as evidence that the Sanitation SOP's is being
adequately implemented. FSIS agrees. Establishments that identify and
correct insanitary conditions in a timely manner and make proper
disposition of any affected product will be considered to be in
compliance with the Sanitation SOP's regulations.
Although FSIS fully expects that the clarification of
establishments' sanitation responsibilities will lead to better and
more consistent compliance with sanitation requirements, the Agency
recognizes that this will not be the case in all establishments.
Establishments that fail to comply with the requirements in this final
rule for Sanitation SOP's will be subject to appropriate compliance and
regulatory action that will, when necessary, include suspension or
withdrawal of inspection. Further, as noted in the proposal, anyone who
intentionally falsifies records will be subject to criminal
prosecution.
FSIS also recognizes commenters' concerns about its rules of
practice and due process procedures. FSIS expects that these concerns
will be addressed through changes to these procedural requirements
initiated as a result of the Agency's regulatory reform project. These
subjects are also on the agenda for discussion at FSIS's upcoming
implementation conferences.
Relation to HACCP
Another important topic raised by commenters was the link between
an establishment's Sanitation SOP's and its HACCP plan. This link was
unclear to some who stated the two were redundant. HACCP plans aim at
ensuring safety at specific critical control points within specific
processes, while Sanitation SOP's typically transcend specific
processes. Sanitation SOP's are important tools for meeting existing
statutory sanitation responsibilities and preventing direct product
contamination or adulteration. As such, it is appropriate that they be
developed and implemented in the near-term prior to implementation of
HACCP. In a sense, the Sanitation SOP's are a prerequisite for HACCP.
It is anticipated that some procedures addressed in an establishment's
Sanitation SOP's might eventually be incorporated into an
establishment's HACCP plan. Other procedures in an establishment's
Sanitation SOP's, including those addressing pre-operational sanitation
procedures for cleaning facilities, equipment, and utensils, will most
likely remain in the Sanitation SOP's. A sanitation procedure that is
incorporated into a validated HACCP plan need not be duplicated in the
Sanitation SOP's.
[[Page 38835]]
Training
A number of comments expressed concern about the content of
inspector training, suggesting that inadequate training would result in
inconsistent enforcement of the rule. Assurance was requested that
inspectors would be trained to consistently monitor Sanitation SOP's.
FSIS recognizes that inspectors must be trained to react as regulators
rather than as quality control consultants or establishment sanitarians
when a sanitation or other health and safety problem is discovered in
an establishment. A primary focus of agency training sessions will be
to attain this goal.
Also, some commenters asked whether joint FSIS and industry
training would be offered. FSIS does not plan to allow industry to
attend Agency training sessions. However, FSIS does plan to hold
informational briefings for industry personnel. These will be the
subject of future notices in the Federal Register.
Pre-Operation Sanitation Inspection
Some commenters asserted that establishments with good Sanitation
SOP's should be permitted to start daily operations on their own,
instead of having to wait for an inspector to conduct a pre-operational
sanitation inspection and allow operations to start. FSIS agrees with
these commenters. Accordingly, upon the effective date of this rule and
implementation of Sanitation SOP's, establishments not otherwise
notified by FSIS may begin daily processing upon completion of pre-
operational sanitation activities without the prior approval of an
inspector.
Extending the implementation date for Sanitation SOP's will also
give FSIS additional time to provide needed training, instruction and
management support to FSIS inspection personnel tasked with enforcing
the Sanitation SOP's requirements.
Implementation Date
Finally, many commenters expressed concern about the amount of time
they said it would take to prepare and implement effective Sanitation
SOP's. These commenters requested more lead time to implement these
requirements. FSIS agrees that some establishments may need more time
than the 90 days the proposed rule provided for implementing Sanitation
SOP's requirements. Consequently, FSIS is modifying this aspect of the
proposal. This final rule will provide establishments six months from
the effective date of this regulation to develop and implement written
Sanitation SOP's. This additional time will allow these establishments
to initially develop and refine their Sanitation SOP's to best meet
operational needs before the effective date of the Sanitation SOP's
requirements. Extending the implementation date for Sanitation SOP's
will also give FSIS additional time to provide needed training,
instruction, and management support to personnel tasked with enforcing
the Sanitation requirements.
IV. Microbiological Performance Criteria and Standards
Summary of Proposal
As part of the Pathogen Reduction/HACCP proposal, FSIS proposed
interim targets for the reduction of Salmonella for the major species
and for ground meat and poultry. Further, FSIS proposed to require
daily testing by slaughter establishments and establishments producing
raw ground product in order to verify achievement of the Salmonella
targets on an ongoing basis. The proposal reflected a central tenet of
the FSIS food safety strategy: to be effective in improving food safety
and reducing the risk of foodborne illness, HACCP-based process control
must be combined with objective means of verifying that meat and
poultry establishments are achieving acceptable levels of food safety
performance.
FSIS explained in the preamble to the proposal that food safety
performance standards, in the form of tolerances or other limits, have
been an important feature of the food safety regulatory system for
chemical residues (such as those resulting from the use of animal drugs
and pesticides) and for pathogenic microorganisms in ready-to-eat meat
and poultry products (such as Listeria monocytogenes in ready-to-eat
products and Salmonella in cooked beef). However, performance standards
have not in the past been incorporated into the regulatory system for
pathogens on raw meat and poultry products.
FSIS recognizes that establishing performance standards for
pathogens on raw products raises different and difficult issues. The
microbiological safety of a meat or poultry product at the point of
final sale or consumption is affected by many factors. Most
significantly, unlike other kinds of contaminants, microbiological
pathogens can be introduced at many points on the farm-to-table
continuum, and once in the product, under certain conditions, the
bacteria can multiply. Some pathogens, such as E. coli O157:H7, are so
virulent that a small number of organisms can pose a significant
hazard. Indeed, on that basis the Agency has determined that any amount
of E. coli O157:H7 will adulterate a meat or poultry product. On the
other hand, some pathogens, such as Salmonella, ordinarily must
multiply to relatively large numbers to cause illness, although the
susceptibility of individuals to illness varies widely. Certain
segments of the population, such as the very young, the elderly, and
persons with compromised immune systems, are particularly vulnerable to
illnesses caused by Salmonella and other foodborne pathogens.
Therefore, FSIS has not taken the position in this rulemaking that
some amount of a pathogen necessarily renders a raw meat or poultry
product unsafe and legally adulterated; the proposed targets for
pathogen reduction would not have served as a standard for determining
whether any particular lot of raw product could be released into
commerce. The proposed targets were intended instead as an initial step
toward defining levels of food safety performance that establishments
would be required to achieve consistently over time. The interim
targets and the required testing by establishments were also intended
as a first step toward the eventual incorporation of microbial testing
as an integral part of process-control validation and verification in
facilities operating under HACCP.
Salmonella was selected as the target organism because it is the
most common cause of foodborne illness associated with meat and poultry
products. It is present to varying degrees in all major species. And,
interventions targeted at reducing Salmonella may be beneficial in
reducing contamination by other enteric pathogens.
As interim targets for pathogen reduction, FSIS proposed that the
prevalence of Salmonella contamination in each of the major species and
in raw ground products be reduced by each establishment to a level
below the current national baseline prevalence as measured by the FSIS
Nationwide Microbiological Baseline Data Collection Programs and
Nationwide Microbiological surveys (collectively referred to below as
the FSIS baseline surveys) or other available data.
Role of Microbiological Performance Criteria and Standards in FSIS Food
Safety Strategy
As explained in the ``Background'' section of this preamble, the
most important objective of this rulemaking is to build into food
production processes and the FSIS system of regulation and oversight,
effective measures to reduce and control pathogenic microorganisms
[[Page 38836]]
on raw meat and poultry products. FSIS has concluded that HACCP-based
process control combined with appropriate microbiological performance
criteria and standards will achieve this objective.
Because the current regulatory system lacks any performance
criteria or standards for harmful bacteria on raw products (other than
with respect to E. coli O157:H7 on raw ground beef), FSIS inspectors
have no adequate basis for judging whether establishments producing raw
meat and poultry products are dealing effectively with the food safety
hazard posed by harmful bacteria.
The HACCP requirements discussed in the preceding section of this
preamble will ensure that all meat and poultry establishments implement
science-based process controls designed to prevent and reduce the
significant food safety hazards that arise in their particular
production processes and products. For slaughter establishments and
other establishments producing raw meat and poultry products, this will
mean developing controls that address the hazards posed by pathogenic
microorganisms as well as other biological, chemical and physical
hazards. HACCP principles provide the framework by which establishments
target and reduce harmful bacteria on raw meat and poultry products.
To be successful in ensuring food safety, however, HACCP must be
coupled with appropriate performance criteria and standards against
which the effectiveness of the controls developed by each establishment
can be validated and verified. For example, controls designed to
prevent the contamination of processed, ready-to-eat meat and poultry
products with harmful bacteria would have to be validated as effective
in meeting the already-existing requirement that such products be free
of harmful bacteria. Without such performance criteria and standards,
there would be no objective basis for determining whether a particular
HACCP plan is adequate for its food safety purpose. Additionally, there
would be no way to determine whether industry or FSIS had met their
respective food safety responsibilities.
In this rulemaking, FSIS for the first time proposed
microbiological performance standards for raw products. The need for
some measure of performance in the area of microbiological
contamination was generally supported by the comments FSIS received on
its proposal. In response to the comments, FSIS has refined and
improved its proposed approach, and is establishing microbiological
performance standards for reduction of Salmonella in raw products,
coupled with performance criteria for use with E. coli testing to
verify the effectiveness of process controls in slaughter
establishments.
These new provisions are the first steps in what FSIS expects to be
a long-term effort to ensure that appropriate microbial testing is
conducted, and appropriate criteria and standards exist, to reduce the
food safety hazards posed by harmful bacteria on raw meat and poultry
products. The numerical targets for both the performance criteria and
the pathogen reduction performance standards are likely to be changed
as new data become available. The targets currently are set at the
national baseline prevalence of contamination and reflect what is
achievable using available technology. FSIS intends to repeat
periodically its baseline surveys, on which the criteria and standards
are based. FSIS will collect additional data on Salmonella by testing
products in establishments pursuant to the performance standards and on
E. coli through close monitoring of establishments' experience and test
results associated with that mode of process control verification.
These new data, together with relevant epidemiologic data, scientific
research, and new technologies, will be considered by FSIS when
proposing future revisions to the performance criteria and testing
requirements for E. coli and the pathogen reduction performance
standards for Salmonella. New information and data also may support
different standards and different approaches to microbial testing.
FSIS is committed to the development and implementation of future
performance standards, as needed, to achieve the FSIS's public health
goal of reducing the incidence of foodborne illness associated with
harmful bacteria on raw meat and poultry products. FSIS is also
concerned that standards achieve this public health goal in a manner
that encourages industry innovation and minimizes regulatory burdens on
the regulated industry. The pathogen reduction performance standards
promulgated in this regulation will be implemented on the basis of a
statistical evaluation of the prevalence of bacteria in each
establishment's products, measured against the nationwide prevalence of
the bacteria in the same products. These standards will not be used to
judge whether specific lots of product are adulterated under the law.
As more research is done and more data become available, and as more
sophisticated techniques are developed for quantitative risk assessment
for microbiological agents, it may be possible and appropriate to
develop performance standards that use a different approach.
Consideration may also be given to the possibility of establishing
similar standards for other pathogenic microorganisms. FSIS will
continue to work with the scientific community in this area.
The microbiological performance standards set out in this
rulemaking are part of a fundamental shift in FSIS regulatory
philosophy and strategy. The current inspection system relies heavily
on intensive ``command-and-control'' prescription of the means by which
meat and poultry establishments must achieve statutory objectives
concerning food safety, sanitation, product wholesomeness, and
prevention of economic adulteration and misbranding. As explained in
the ``Background'' section of this preamble, in FSIS's ANPR ``FSIS
Agenda for Change: Regulatory Review,'' and in the January, 1996,
National Performance Review report ``Reinvention of Food Regulations,''
FSIS plans to shift from this reliance on command and control
regulations to much greater reliance on performance standards. FSIS
believes that public health and consumer protection goals can be
achieved more effectively, in most cases, by converting command-and-
control regulations to performance standards, which provide industry
with the flexibility to devise the optimal means of achieving food
safety objectives. FSIS would verify compliance with such performance
standards through inspection and other forms of oversight.
Overview of Final Rule
Comments on the proposed rule's microbial testing provisions have
resulted in a number of changes to those provisions. As discussed in
the ``Response to Comments'' section, below, FSIS received numerous
comments supporting the concept of microbiological performance criteria
or standards, but also received many comments urging alternatives to
the specific approach proposed by FSIS, including testing for organisms
other than Salmonella.
The Agency actively sought out comment and information on the issue
of target organism(s) to be selected for process control verification
and pathogen reduction purposes in this regulation. In the proposal,
FSIS stated that ``the Agency recognizes that there are other foodborne
human pathogens of public health concern that can be isolated from raw
meat and poultry product. The Agency would welcome
[[Page 38837]]
comments on the targeting of other pathogens in addition to or in lieu
of Salmonella'' (60 FR 6800). As noted earlier in this preamble, during
the comment period FSIS held many meetings to solicit comment on
various issues, including microbiological criteria and standards.
Microbiological criteria and standards were discussed in detail at the
FSIS-sponsored scientific conference held in Philadelphia,
Pennsylvania, on May 1 and 2, 1995, titled ``The Role of
Microbiological Testing in Verifying Food Safety.'' This conference was
open to the public and was announced in the Federal Register on March
24, 1995 (60 FR 15533). An expert panel at that conference endorsed the
role of microbiological testing in accordance with appropriate criteria
or standards, but suggested that mandatory establishment testing focus
on a quantitative assay for generic E. coli rather than the proposed
qualitative assay for Salmonella. The panel stated that a quantitative
assay for the more commonly occurring generic E. coli is a more
effective process control indicator with respect to the prevention of
contamination of meat and poultry by feces and associated bacteria.
FSIS also held a series of six issue-focused public meetings in
September, 1995. During a preliminary public meeting on August 23,
1995, at which issues were identified and the meeting agenda was
established, participants decided that a full day should be devoted to
further public discussion of pathogen reduction standards and microbial
testing. The agenda for the six meetings appeared in the Federal
Register on August 31, 1995 (60 FR 45381). The issues discussed on
September 27 included: (1) the scientific and policy basis for
establishing targets; (2) whether Salmonella is the appropriate
organism for some or all species; (3) whether other pathogens would be
preferable for some or all animal species; (4) the utility of targets
for E. coli or other non-pathogenic indicator organisms as a means of
controlling and reducing pathogenic microorganisms; (5) the advantages
and disadvantages of targets based on the prevalence of detectable
contamination vs. targets based on the number of organisms present; and
(6) the need for pathogen reduction targets for raw ground products in
general and in establishments that both slaughter animals and produce
ground product.
At the September 27, 1995, issue-focused meeting, there was
additional comment in favor of testing for an organism other than
Salmonella, such as generic E. coli, that has a strong track record in
the industry as a good organism to use for process control verification
testing. There was, however, continued strong support for raw product
testing targeted at pathogens, such as Salmonella, and support for
pathogen reduction as the primary goal of such testing.
At the meetings, FSIS distributed issue papers on the various
issues being addressed, based in large part on comments already
received. The issue paper on Pathogen Reduction Performance Standards
and Microbial Testing stated that the two most common concerns in the
comments received to that date were the proposed selection of
Salmonella as the indicator organism and the frequency of proposed
testing. It stated that although some commenters recommended finalizing
Salmonella testing, others recommended using E. coli instead of or in
addition to Salmonella. The issue paper stated the Agency's current
thinking on the organism to be selected, the need for daily testing at
every establishment, and the necessity of testing each species
slaughtered and each ground product produced. In the issue paper FSIS
stated, among other things, that it was ``seriously considering generic
E. coli as the process control indicator organism and the adoption of a
quantitative E. coli standard as a measure of process control with
respect to the prevention and reduction of fecal contamination in
slaughter plants.'' FSIS also stated that it was considering setting
forth pathogen-specific performance standards as a direct measure of
accountability for controlling and reducing harmful bacteria in raw
meat and poultry products and that Salmonella targets might be adopted
as performance standards and enforced by FSIS through its own
compliance monitoring. The Agency published the issue papers in the
Federal Register on October 24, 1995 (60 FR 54450).
Based on the large body of written and oral comments FSIS has
received on this issue,
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
the Agency has decided not to use Salmonella
both as a target for pathogen reduction and as an indicator of process
control. FSIS has decided to adopt pathogen reduction performance
standards targeting Salmonella, as proposed, except that FSIS, not the
establishments, will conduct testing for the pathogen to verify
compliance. FSIS also has decided to require establishments
slaughtering livestock and poultry to conduct routine testing for
generic E. coli (instead of the proposed use of Salmonella tests) as an
ongoing, objective process control indicator for fecal contamination,
and to establish performance criteria by which results can be
evaluated.
Process Control Verification Performance Criteria
Under the FMIA and the PPIA, meat and poultry establishments
inspected by FSIS are required to maintain sanitary conditions
sufficient to prevent contamination of products with filth and to
prevent meat and poultry products from being rendered injurious to
health (21 U.S.C. 601(m) and 608 (FMIA); 21 U.S.C. 453 (g) and 456
(PPIA)). A grant of inspection by FSIS is contingent upon an
establishment meeting this responsibility. FSIS is authorized by law to
issue regulations establishing appropriate sanitation requirements.
Meat and poultry products are deemed legally adulterated, whether or
not they are shown to be contaminated, if prepared, packed, or held
under insanitary conditions whereby they may have become contaminated
with filth or may have been rendered injurious to health.
In slaughter establishments, fecal contamination of carcasses is
the primary avenue for contamination by pathogens. Pathogens may reside
in fecal material and ingesta, both within the gastrointestinal tract
and on the exterior surfaces of animals going to slaughter. Therefore,
without care being taken in handling and dressing procedures during
slaughter and processing, the edible portions of the carcass can become
contaminated with bacteria capable of causing illness in humans.
Additionally, once introduced into the establishment environment, the
organisms may be spread from carcass to carcass.
Because the microbial pathogens associated with fecal contamination
are the single most likely source of potential food safety hazard in
slaughter establishments, preventing and removing fecal contamination
and associated bacteria are vital responsibilities of slaughter
establishments. Further, because such contamination is largely
preventable, controls to address it will be a critical part of any
slaughter establishment's HACCP plan. Most slaughter establishments
already have in place procedures designed to prevent and remove visible
fecal contamination.
There is general agreement within the scientific community that
generic E. coli is the best single microbial indicator for fecal
contamination. FSIS, therefore, is requiring that establishments
slaughtering livestock or poultry begin testing for E. coli (E. coli,
biotype I, nonspecific as to species, hereinafter referred to simply as
E. coli) at the
[[Page 38838]]
frequency and following the procedures described in ``Process Control
Verification; E. coli Performance Criteria and Testing'' section,
below, 6 months after publication of the final rule. FSIS considers the
required testing to be essential for meeting current statutory
requirements for sanitation and the prevention of adulteration. This
testing also will play an integral role in the successful
implementation of HACCP in slaughter establishments. In addition, FSIS
is establishing process control performance criteria for fecal
contamination based on the frequency and levels of contamination of
carcasses with E. coli.
As explained below, FSIS is establishing performance criteria to
reflect the prevalence and levels of contamination of E. coli on
carcasses produced nationwide, as determined by FSIS baseline surveys.
The performance criteria and required testing will provide each
slaughter establishment and FSIS with an objective means of verifying
that the establishment is achieving this level of performance and
maintaining it consistently over time. Test results that show an
establishment is meeting or exceeding the criteria provide evidence
that the establishment is maintaining adequate process control for
fecal contamination.
FSIS is purposely using the term performance ``criteria'' rather
than performance ``standard'' in this context because no single set of
test results can demonstrate conclusively that adequate process control
for fecal contamination is or is not being maintained. As explained
below, if test results do not meet the applicable criterion, it raises
questions about the adequacy of the process control. FSIS intends to
consider the establishment's results and corrective actions, together
with other information and inspectional observations, in evaluating
whether a problem exists that requires regulatory action or other
measures to protect consumers and ensure compliance with the law.
Also, as discussed below, although FSIS is proceeding with the
final rule at this time, it is inviting comment on technical aspects of
the process control performance criteria and the required testing. FSIS
requests that comments on the E. coli performance criteria and testing
requirement be focused on the technical aspects of the rule, i.e., the
manner in which the criteria are articulated, the sampling frequency,
and the sampling and testing methodologies.
FSIS intends to update the criteria periodically to ensure that the
criteria adequately reflect an appropriate level of performance with
respect to prevention and removal of fecal contamination and associated
bacteria from livestock and poultry carcasses.
Pathogen Reduction Performance Standards
As proposed, FSIS is adopting pathogen reduction performance
standards using Salmonella as the target organism. The most significant
difference between the proposal and this final rule is that, as
explained above, FSIS is not relying on Salmonella to be a process
control indicator, as well as the target organism for the pathogen
reduction performance standard. Establishments will not be required by
this final rule to test for Salmonella, as had been proposed. Instead,
FSIS will obtain samples from slaughter establishments and
establishments producing raw ground product or fresh pork sausage and
test those samples for Salmonella to ensure that the pathogen reduction
performance standards are being met.
As proposed, FSIS will require that no establishment can have a
prevalence of Salmonella contamination, as a percentage of positive
samples from carcasses and percentage of positive samples from raw
ground product, greater than the baseline prevalence for each raw
product as reflected in the FSIS baseline survey for each species or
other category of raw product. These targets constitute performance
``standards'' rather than performance ``criteria'' because, following
an establishment's implementation of HACCP, FSIS will require that the
establishment meet the standard consistently over time as a condition
of maintaining inspection.
The Salmonella pathogen reduction performance standards are not,
however, lot release standards, and the detection of Salmonella in a
specific lot of raw product will not by itself result in the
condemnation of that lot. The performance standards and FSIS's
enforcement approach, as discussed below, are intended to ensure that
each establishment is consistently achieving an acceptable level of
performance with regard to controlling and reducing harmful bacteria on
raw meat and poultry products.
FSIS considers systematic reduction of pathogenic microorganisms in
raw product to be an essential responsibility of meat and poultry
establishments under the current statutes. As a condition of inspection
and to avoid the production of product that would be deemed legally
adulterated, establishments must utilize available process control
methods and technologies as necessary to achieve applicable pathogen
reduction standards.
Process Control Verification; E. coli Performance Criteria and Testing
Establishments that slaughter livestock and poultry currently have
an obligation to control the slaughter and sanitary dressing process so
that contamination with fecal material and other intestinal contents is
prevented. This means that establishments must maintain sanitary
conditions and use good manufacturing practices to avoid contamination
with visible feces and ingesta and associated bacteria. When such
visible contamination occurs, establishments are expected to detect it
and physically remove it through knife trimming or other approved
removal procedures. The present FSIS verification activity to
demonstrate that this has been accomplished is organoleptic inspection.
FSIS inspectors apply a zero tolerance performance standard for visible
feces and ingesta on dressed carcasses. As a practical matter, however,
additional measures must be taken if inspectors are to assess the
extent to which the invisible bacteria associated with feces and
ingesta may be present on the carcass.
FSIS has concluded, based on its proposal and the comments
received, that the current practice of organoleptic examination by
inspectors and the physical removal of visible contamination by
establishments needs to be supplemented with an establishment-conducted
microbial verification activity. This microbial testing is designed to
verify, for the establishment and FSIS, that the establishment has
controlled its slaughter process with respect to prevention and removal
of fecal material and ingesta and associated bacteria.
Rationale for Using E. coli Tests to Verify Process Control
E. coli testing is more useful than the originally proposed
Salmonella testing in verifying that a slaughter process is under
control. This was expressed in numerous comments on the proposal,
comments generated in FSIS public hearings, and the results of the
scientific and technical conference on the Role of Microbiological
Testing in Verifying Food Safety. The expert panel at that conference
stated:
Microbial testing is an essential element for verifying process
control of raw meat and poultry. A variety of indicators exists, but
the panel concluded that quantitative measurement of Escherichia
coli would be more effective than qualitative Salmonella testing.
When processes are under control for
[[Page 38839]]
E. coli, the potential presence of enteric pathogens will be
minimized.1
\1\ Expert Panel's Summary Report and Recommendations,
Scientific and Technical Conference on Role of Microbiological
Testing in Verifying Food Safety, May 1-2, 1995.
---------------------------------------------------------------------------
The panel compared selection criteria for the choice of an
indicator organism and considered alternative microbial targets such as
E. coli, Enterobacteriaceae, and aerobic plate count, to be used alone
or in combination with Salmonella testing. In reaching its conclusion
that E. coli would be the most effective measure of process control for
enteric pathogens, the panel considered the ideal characteristics of
microbial indicators for the stated purpose. Important characteristics
of E. coli are:
There is a strong association of E. coli with the
presence of enteric pathogens and, in the case of slaughtering, the
presence of fecal contamination.
E. coli occurs at a higher frequency than Salmonella,
and quantitative E. coli testing permits more rapid and more
frequent adjustment of process control.
E. coli has survival and growth characteristics similar
to enteric pathogens, such as E. coli O157:H7 and Salmonella.
Analysis for E. coli poses fewer laboratory safety
issues and testing at the establishment site is more feasible than
such testing with Salmonella.
There is wide acceptance in the international
scientific community of its use as an indicator of the potential
presence of enteric pathogens.
In the panel's view, microbial testing should be used to
demonstrate process control; they concluded that a proximate indicator
for enteric pathogens is needed for demonstrating process control with
respect to fecal contamination. The panel concluded that E. coli would
be the single most effective indicator for this purpose. The panel's
conclusion reinforces previous statements by the NAS that ``at present,
E. coli testing is the best indicator of fecal contamination among the
commonly used fecal-indicator organisms.'' 2 FSIS agrees with
these conclusions.
---------------------------------------------------------------------------
\2\ Subcommittee on Microbiological Criteria, Committee on Food
Protection, Food and Nutrition Board, National Research Council.
1985. ``An Evaluation of the Role of Microbiological Criteria for
Foods and Food Ingredients.'' National Academy Press, Washington,
D.C.
---------------------------------------------------------------------------
If future scientific research identifies another organism or group
of organisms which would prove as effective in measuring process
control for fecal contamination, FSIS would consider appropriate
revisions to the regulations.
Use of Baseline Values to Establish E. coli Performance Criteria
The presence of some microorganisms on raw meat and poultry is
unavoidable and highly variable. The goal of process control in a
slaughter establishment is to minimize initial microbial contamination
of the carcasses, remove harmful microorganisms that nonetheless may be
present, control the proliferation of any remaining microorganisms, and
prevent re-contamination. Process control criteria based on data from
FSIS's nationwide baseline surveys will aid establishments in achieving
this goal and complement the transition to HACCP.
FSIS collects data to develop and maintain a general, ongoing
microbiological profile of carcasses for selected microorganisms of
varying degrees of public health concern, and organisms or groups of
organisms of value as indicators of general hygiene or process control,
and to document changes in the profiles over time. FSIS's Nationwide
Microbiological Baseline Data Collection Programs provide for sampling
over a year's time to account for possible seasonal variations. This
was the approach taken in collecting data from carcasses for all
slaughter classes: steer/heifer, cow/bull, broilers, market hogs, and
turkey. Sampling is designed to represent the vast majority of raw meat
and poultry products produced, in most cases approximately 99% of the
product produced. These programs are nationwide in scope. Enough
samples are taken to enable the Agency to describe the annual
distribution of test results. The number of samples collected also
allows for control of sampling variation and non-sampling errors (such
as missing samples, incomplete data, and inconsistent data). By
contrast, FSIS's Nationwide Surveys provide a snapshot over a specified
period of time less than a year. They involve a large enough number of
samples to ensure a reasonable level of precision for estimates, given
the prevalence of the microorganisms included in the surveys. This was
the approach taken in developing baseline data for other raw meat and
poultry products: ground beef (at inspected establishments and at
retail), ground chicken, ground turkey, and fresh pork sausage.
For the current baselines, carcass samples were taken from fresh,
whole chilled carcasses after slaughter and dressing but before any
further processing took place. Samples were analyzed fresh, not frozen,
to gather more accurate data on numbers of microorganisms, especially
those that are more susceptible to freezing, such as Campylobacter
jejuni/coli. FSIS personnel collected the samples tested in the surveys
using standard Agency procedures for taking aseptic samples from animal
tissues and for ensuring random sample selection.3,4
---------------------------------------------------------------------------
\3\ Food Safety and Inspection Service. 1994. Nationwide Broiler
Chickens Microbiological Baseline Data Collection Program: Broiler
Chicken Sample Collection Procedures, 2/18/94. U.S. Department of
Agriculture, Washington, D.C.
\4\ Food Safety and Inspection Service. 1993. Nationwide Beef
Microbiological Baseline Data Collection Program: Cow/Bull Sample
Collection Procedures, 8/1/93. U.S. Department of Agriculture,
Washington, D.C.
---------------------------------------------------------------------------
Reports of FSIS baseline programs and surveys are issued after
testing results have been compiled and analyzed. Reports have been
completed for cattle, broiler chickens, hogs, ground beef, ground
chicken, and ground turkey. The collection and analysis of samples for
the turkey baseline program and the fresh pork sausage survey will be
underway soon; criteria for turkeys and fresh pork sausage will be
determined upon completion of the sampling and analysis of results.
Establishment of E. coli Performance Criteria to Verify Process Control
Using data from the baseline surveys described in the preceding
section, FSIS has developed animal species-specific, minimum
performance benchmarks, or performance criteria, for E. coli on
carcasses.
As explained above, these criteria are not enforceable regulatory
standards. The E. coli performance criteria are intended to assist
slaughter establishments and FSIS in ensuring that establishments are
meeting their current statutory obligation to prevent and reduce
contamination of carcasses by fecal material, ingesta, and associated
bacteria. The criteria are flexible and are subject to amendment as
FSIS and the industry gain experience with them and accumulate more
data on establishment performance. The criteria are intended
specifically to provide an initial basis upon which slaughter
establishments and FSIS can begin to use microbial testing to evaluate
the adequacy of establishment process controls to prevent feces,
ingesta, and other animal-derived contaminants from contaminating the
tissues intended for use as food.
FSIS has designed the criteria so that establishments meeting them
are achieving results, in terms of E. coli levels, consistent with
those being achieved by a large majority of the slaughter production in
the United States, as reflected in the FSIS baseline
[[Page 38840]]
surveys for each species of livestock and poultry.
The E. coli performance criteria are expressed in terms of a
statistical procedure known as a ``3-class attributes sampling plan''
applied in a moving window. This procedure specifies cutoffs (denoted m
and M, with m m
Marginal--result > m and M
Unacceptable--result > M
Under this approach, m and M are defined in relation to the
distribution of E. coli results for each slaughter class. The Agency
has used as the starting point for establishing the cutoff for m the
80th percentile of current industry wide performance, in terms of E.
coli levels, for each slaughter class. The starting point for
establishing M is the 98th percentile of industry performance. Thus, if
the criterion for any species were set precisely at those percentiles,
a set of test results indicating performance in the 80th to 98th
percentile range, according to FSIS's Nationwide Microbiological
Baseline Data Collection Program results, would be deemed ``marginal,''
and, as discussed below, would raise a question about the adequacy of
the establishment's process control. Expressed in another way,
``marginal'' results would be within the worst 20% of overall industry
performance in terms of E. coli counts. Similarly, results worse than
the 98th percentile (M) are within the worst 2% of overall industry
performance. Any single result exceeding M is, therefore, deemed
``unacceptable.''
Table 1.--Distribution of E. coli by Slaughter Class
----------------------------------------------------------------------------------------------------------------
Percentile Steer/heifer Cow/bull Broilers Hogs
----------------------------------------------------------------------------------------------------------------
50th (median)................... Negative*......... Negative*......... 29 cfu/ml......... Negative*
80th (m)........................ Negative*......... Negative*......... 80................ 10 cfu/cm \2\
90th............................ Negative*......... 10 cfu/cm \2\..... 180............... 150
95th............................ 10 cfu/cm \2\..... 40................ 360............... 880
98th (M)........................ 80................ 300............... 1100.............. 6,800
99th............................ 290............... 2200.............. 3300.............. 33,000
----------------------------------------------------------------------------------------------------------------
* Negative by the method used in the baselines which had a minimum detectable level of 5 cfu/cm \2\ of carcass
surface area.
Table 1 shows the level at which E. coli has been found on
carcasses, by slaughter class as a percent of all such product. For
example, the data show that 80% of broilers tested at or below 80
colony forming units per milliliter (cfu/ml), while 90% tested at or
below 180 cfu/ml. More detailed descriptions of the distribution of
numbers of E. coli found per carcass species are provided in FSIS's
baseline reports.
To make the criteria as simple and easy to use as possible,
consistent with the accepted laboratory practice of diluting samples
successively by factors of 10 to obtain bacteria counts, FSIS has
elected to express the criteria in terms of powers of 10 (i.e., 10,
100, 1000, etc.). As shown in Table 2, this results in m and M being
the closest power of 10 to the actual numbers estimated for the 80th
and 98th percentiles from the baseline data.
Because the Agency's baseline survey work on turkeys is still
underway, no E. coli criterion is being established at this time for
that slaughter class.
Table 2.--m and M Values for E. coli Performance Criteria
------------------------------------------------------------------------
Slaughter class m M
------------------------------------------------------------------------
Steer/Heifer........................ (1).................. 100
Cow/Bull............................ (1).................. 100
Broiler............................. 100.................. 1000
Hogs................................ 10................... 10,000
------------------------------------------------------------------------
\1\ Negative.
It should be noted that ``negative,'' in this context, is defined
by the sensitivity of the method used in the Baseline Surveys, which
was 5 cfu/cm2 of carcass surface area for cattle and hogs.
FSIS is requiring the use of an analytic method approved by the
Association of Official Analytic Chemists or any method validated by a
scientific body in collaborative trials against the three tube Most
Probable Number (MPN) method and agreeing with the 95 percent upper and
lower confidence limit of the appropriate MPN index.
FSIS has concluded that, at some point, the number of samples
testing in the marginal range raises a significant question about the
adequacy of an establishment's process control, and has defined that
point for purposes of these criteria as more than 3 results above m
within any consecutive 13 samples tested. This point was established
based on the following analysis.
There occasionally will be test results that exceed the acceptable
level, m, because of variations or aberrations in establishment
performance, sampling, etc., that do not reflect the state of overall
process control. FSIS believes that the performance criteria and
approach to evaluating test results should avoid raising a significant
process control question on the basis of chance results, but should be
sensitive enough to provide a reasonably high likelihood of detecting
performance that falls significantly short of the national baseline
levels. FSIS has decided that it is appropriate to evaluate test
results in a manner that ensures that there is an 80% probability that
establishments actually operating at the acceptable performance level
will achieve results that are deemed to satisfy the criteria. This is
the same statistical approach FSIS took in its proposed approach to
evaluating an establishment's Salmonella test results, using the moving
window approach to evaluating process control verification tests (see
pages 6798-6805 of the Pathogen Reduction/HACCP proposal).
Using this approach, it can be predicted statistically that
slaughter establishments that are operating at the acceptable
performance level reflected by m will, with an 80% probability, have
three or fewer results above m (denoted as c) within every 13 samples
tested (denoted as n). FSIS will require slaughter establishments to
record and evaluate E. coli results in a ``moving window'' of 13
consecutive results. A moving window provides a continuous picture of
establishment performance and is the preferred statistical approach for
assessing ongoing processes (as opposed to sampling specific lots of
product for contaminants). Thus, the presence of more than three
marginal results within any 13 consecutive samples, or the ``window,''
will be indicative of an operation failing to meet the criteria.
Use of a different probability level, such as a 70% or 90%
probability of getting acceptable test results if establishments are
operating at the specified level would result in different values for c
and n (namely, c=3 and
[[Page 38841]]
n=15 using the 70% probability level, and c=3 and n=10 using the 90%
probability level). Using 70% as the statistical criterion for setting
c and n would result in too many chance failures of the criteria, while
using 90% would make it too difficult to detect potential process
control problems. It is the judgment of the Agency that use of the 80%
probability level strikes a reasonable balance.
In summary, if the results of one test are above M, or if more than
3 of 13 test results are above m, a significant question is raised as
to whether the establishment is maintaining adequate process control
and will trigger further review of establishment process control. FSIS
stresses again that these E. coli criteria are guidelines, not
regulatory standards. Ideally, each establishment will develop its own
equally or more effective criteria for process control based on its own
data and/or industry-developed benchmarks. FSIS encourages
establishments, in the context of their HACCP plans, to apply their
own, establishment-specific criteria to ensure process control.
FSIS also is inviting comment on the approach it has taken to
expressing its E. coli performance criteria for verifying process
control. FSIS recognizes that there is more than one possible approach
and welcomes comments and suggestions.
Sampling Frequency for E. coli Testing
FSIS has chosen to use production volume as the basis for
determining the frequency at which establishments will conduct testing
for E. coli. In the proposed rule, FSIS proposed to require all
slaughter establishments and establishments producing ground meat and
poultry, regardless of size or volume, to conduct one test for
Salmonella each day. This was based on the premise that verifying that
a process is ``in control'' is more a function of specific
establishment characteristics than the amount of product being
produced. However, commenters suggested and FSIS recognizes that there
may be striking differences in the ways in which high and low volume
establishments operate, which can influence the ability of the
establishment to keep processes in control. High volume establishments
may receive animals for slaughter from a number of different sources
for each day's production; there may be several shifts, and production
personnel are often more transient; there may be multiple supervisors;
and there may be much greater complexity in the overall slaughter
process. In contrast, a low volume establishment will have a smaller
and possibly more stable work-force, often supervised by an owner-
operator, and may employ relatively simple procedures that are
performed consistently over time. This does not negate the need in low
volume establishments for microbial verification of a HACCP plan;
however, under these circumstances it may not be as essential for very
low volume establishments to undertake daily microbial testing, as
initially proposed. By adopting a volume-based system, the testing
frequency will, by definition, be highest in large establishments
producing the most product, while the number of tests will be minimized
in smaller establishments.
The majority of commenters who opposed daily testing stated that
such a testing requirement would place an unfair cost burden and have a
negative financial impact on small establishments, as it would require
the same expenditure for testing by establishments that slaughtered one
or two animals per day as those slaughtering several thousand daily. It
was also noted that there is a public health consequence to the
proposed approach. If a process control problem detectable by microbial
testing existed in a high volume establishment that tested only once a
day, a great deal more potentially contaminated product would be
produced and distributed before enough microbial tests were performed
to show the problem existed than would be the case in a small volume
establishment. These issues are addressed by the switch to a volume-
based testing system.
There is no single method for determining the frequency of
microbial testing within a volume-based testing system that will be
equally effective in all establishments. Testing frequencies are
ideally determined on an establishment-by-establishment basis, taking
into account a number of variables, including differences in sources of
raw materials, the type and nature of the process, and the consistency
of microbial test results over time. Nonetheless, for both public
health and process control verification reasons, FSIS considers it
necessary and reasonable to require a minimum frequency of testing
sufficient to result in completion of at least one E. coli test window
(13 samples) per day in the highest volume establishments for each
species. This will provide a daily set of results adequate to verify
process control in the highest volume establishments. Accumulation of
results over a longer period of time will be an acceptable basis for
verifying process control in lower volume establishments.
Based on these principles and conclusions, the required minimum
frequencies for E. coli testing for each slaughter species are as shown
in Table 3.
Table 3.--E. coli Testing Frequencies
------------------------------------------------------------------------
------------------------------------------------------------------------
Cattle............................ 1 test per 300 carcasses.
Swine............................. 1 test per 1,000 carcasses.
Chicken........................... 1 test per 22,000 carcasses.
Turkey............................ 1 test per 3,000 carcasses.
------------------------------------------------------------------------
The frequencies were derived by first rank-ordering all slaughter
establishments by species based on total annual production. This
ranking, which was based on data from FY 1993 and FY 1994, revealed
that establishment production volumes vary widely and that there are
appreciable differences in the concentration of business among the
industries. In cattle slaughter, 12 of 912 establishments accounted for
over 42% of production, with the smallest of these slaughtering about
one million head annually. On the small volume end, 620 establishments
slaughtered fewer than 1000 head annually and together accounted for
about one-half of one percent (0.5%) of national slaughter production.
By contrast, there are ten or fewer very low volume establishments
slaughtering chickens, and production is spread more evenly over the
240 establishments on the FSIS FY 1994 inventory of establishments. 42
of 240 slaughter establishments accounted for 40% of production.
FSIS has selected sampling frequencies so that in the subgroup of
establishments accounting for 99% of total production for each species,
the 5% of establishments with the highest production volume would each
have to conduct a minimum of 13 E. coli tests, or at least one complete
test window, each day. In addition, with these frequencies, 90% of all
cattle, 94% of all swine, 99% of all chicken, and 99% of all turkeys
will be slaughtered in establishments conducting a minimum of one E.
coli test per day.
The above frequencies notwithstanding, FSIS has concluded that all
establishments must conduct sampling at a frequency of at least once
per week to provide a minimum, adequate basis for process control
verification using E. coli testing. However, establishments with very
low volumes, annually slaughtering no more than 6,000 cattle, 20,000
swine, or a combination of such livestock not to exceed a total of
20,000 with a maximum of 6,000 cattle, or 440,000 chickens or 60,000
turkeys (or a combination of such poultry not to
[[Page 38842]]
exceed a total of 440,000, with a maximum of 60,000 turkeys), will be
required to sample once per week only until a sampling window that
verifies process control has been completed and the results indicate
that the slaughter process is under control. Establishments
slaughtering more than one species would sample the species slaughtered
in greater number. Once these criteria have been met, these
establishments will be required to complete a new sampling window that
verifies process control only once each year, in the 3-month period of
June through August, or when a change has been made in the slaughter
process or personnel.
The Agency is permitting these very low volume establishments to
conduct as few as 13 tests per year, in part because of their
relatively simple and stable production environments. The slaughtering
equipment in many cases may consist merely of a skinning bed, hoist,
bonesaw (for poultry establishments, a small scalding tank, small
defeathering device), and/or several types of knives. There are fewer
personnel and there is less turnover in general. Of course, these
establishments do change. Should there be any substantial changes in
installed equipment or personnel, a new sampling window must be
completed. These establishments must also complete a successful
sampling window annually, regardless of whether there have been any
substantial changes, in order to verify that the performance criteria
continue to be met. Many small, nonsubstantial changes, in aggregate,
may have an impact on process control. This annual testing must be
conducted during the summer months of June through August, when there
is a seasonal peak in the occurrence of foodborne diseases attributable
to the major bacteria pathogens. Published and summary reports of
Centers for Disease Control and Prevention (CDC) outbreak and sporadic
disease surveillance have documented this seasonal trend for Salmonella
spp.5,6 and for Campylobacter jejuni/coli.7 Although national
surveillance for E. coli O157:H7 is relatively new and data are not
available, Washington State surveillance has documented a similar
seasonal trend for that pathogen.8 The proposed requirement of one
Salmonella sample per day would have assured testing during this
period.
---------------------------------------------------------------------------
\5\ Bean, N.H. and P.M. Griffin. 1990. Foodborne Disease
Outbreaks in the United States, 1973-1987. J. Food Protection.
53:804-817.
\6\ Centers for Disease Control and Prevention. 1995. Salmonella
Surveillance, Annual Tabulation Summary, 1993-1994. U.S. Department
of Health and Human Services, Public Health Service, Atlanta, GA.
\7\ Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K.
Wachsmuth. 1988. Campylobacter Isolates in the United States, 1982-
1986. MMWR. 37 (SS-2):1-13.
\8\ Ostroff, S.M., J.M. Kobayshi, and J.H. Lewis. 1989.
Infections with Escherichia coli O157:H7 in Washington State. JAMA
262(3):355-359.
---------------------------------------------------------------------------
Therefore, the regulation specifies that when sampling and testing
is done annually, instead of continually, it be conducted within a 13-
sample window between June and August each year. This annual sampling
must occur during this period, regardless of when other sampling
windows may have occurred. Completing a successful sampling window
annually will verify that the slaughter process continues to meet the
performance criteria or will point to the need to reassess and revise
the HACCP plan.
Another reason for this approach to very low volume establishment
testing is that the total risk of exposure to enteric pathogens from
product produced at such establishments is assumed to be small and
roughly proportional to the amount of product produced. Eighty-one
percent of establishments slaughtering cattle would meet this low
volume criteria; however, these establishments together supply only
1.5% of the total national production. Further, establishments meeting
these low volume criteria constitute 86% of all swine establishments,
accounting for 1.3% of overall production. Thirteen percent of all
establishments slaughtering chicken would meet this low volume
requirement; however, these establishments together supply only 0.05%
of total national production. Similarly, 42% of all turkey
establishments are low volume establishments accounting for only 0.1%
of production.
FSIS intends that establishments operating under a validated HACCP
system use microbial testing in their process control verification
activities, and is requiring that slaughter establishments under HACCP
use E. coli testing for that purpose. As noted above, however, the
Agency acknowledges that there may be other, perhaps equally effective
alternative approaches for determining sampling frequencies for E. coli
testing for process control verification in slaughter establishments
with a carefully designed HACCP system. The Agency is aware that
comparable models have been developed in the context of quality
assurance programs. These models, however, are part of programs that,
like HACCP, involve more than mere statistical sampling, and usually
are much more oriented to specific establishment/process/product
combinations. Such models cannot easily be transferred to a nationwide
collection of producers of a product, each with unique characteristics.
The frequency rule established in this regulation recognizes the
relevance of establishment characteristics in the area of verification,
as in other facets of the HACCP plan, and therefore allows slaughter
establishments to alter frequencies as appropriate for their
circumstances when they institute HACCP. That is, slaughter
establishments under HACCP may use a sampling frequency other than that
provided for in the regulation, if the alternative sampling frequency
is an integral part of the establishment's HACCP verification
procedures and if FSIS does not determine, and notify the establishment
in writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's processing controls.
Establishments electing to institute HACCP prior to the dates required
may use an alternative sampling frequency upon presentation to FSIS of
data demonstrating the adequacy of that sampling frequency for
verification of process controls to prevent fecal contamination.
Establishments currently using an alternative E. coli sampling
frequency for process control purposes, but not yet under a HACCP plan,
will have to test at the frequencies specified in the regulation unless
they have been granted an exemption by FSIS. However, after
consideration of comments received on this rule that may result in
protocol changes affecting all establishments, and publication of a
Federal Register document addressing the comments, FSIS will consider
requests for such exemptions on a case-by-case basis, upon the timely
submission to FSIS of data demonstrating the adequacy of the
alternative frequency for verification of process controls to prevent
fecal contamination.
Sampling and Analytical Methodology
Carcasses within the same establishment and in different
establishments must be sampled and analyzed in the same manner if the
results are to provide a useful measure of process control. Such
consistency also will facilitate FSIS verification activities. As
discussed below, the performance criteria are applicable to each type
of carcass, industry-wide, based on FSIS's national baseline survey
data. Because each establishment's performance is measured against the
[[Page 38843]]
performance of all surveyed establishments producing the same kind of
product, it is essential that all like establishments adhere to the
same basic sampling and analysis requirements.
Each establishment is responsible for having written sampling
procedures that are to be followed by a designated employee or agent.
Samples are to be taken randomly at the required frequency. If an
establishment runs more than one line, the lines from which samples are
to be taken also are to be selected randomly. Samples from livestock
carcasses are to be collected by a nondestructive method that requires
a commercially available sampling sponge to be rubbed on the carcass
surface after the carcass has been chilled in the cooler for 12 hours
or more after slaughter. Establishments are required to take samples
from three sites on each carcass. These three sites are the same ones
that were used by FSIS when conducting the baseline studies for cattle
and swine. On cattle carcasses, establishments will take samples from
the flank, brisket, and rump areas; on swine carcasses, samples will be
taken from the ham, ``belly,'' and jowl areas. The sponge is to be
placed afterwards in an amount of buffer to transfer any E. coli to a
solution, which then is analyzed for E. coli. Samples from poultry
carcasses will be collected by taking whole birds from the end of the
chilling process, after the drip line, and rinsing them in an amount of
buffer appropriate for the type of bird being tested.
The sponge sampling technique to be used on swine and cattle
carcasses has been subject to many studies. A sponge technique has been
reported by Dorsa et al.9 and others, including Gill et
al.10, as an acceptable means of in-plant sampling to detect fecal
contamination.
---------------------------------------------------------------------------
\9\ Dorsa, W.J., C.N. Cutter, G.R. Siragusa. 1996. Evaluation of
Six Sampling Methods for Recovery of Bacteria from Beef Carcass
Surfaces. Letters in Applied Microbial. 22:39-41.
\10\ Gill, C.O. J.C. McGinnis, M. Badoni. 1996. Assessment of
the Hygienic Characteristics of a Beef Carcass Dressing Process. J.
Food Protection 59(2):136-140.
---------------------------------------------------------------------------
The excision method for sample collection would not be acceptable
for routine sampling to verify process control because this defaces the
carcass, and some establishments would be required to sample 13
carcasses per day. Instead, for both cattle and swine carcasses, the
sponge method requires that 100 cm2 at each of the three sites be
sampled by swabbing, for a total area of 300 cm2 compared to the
60 cm2 area of excised tissue analyzed in the baseline studies for
cattle and swine. The results would still be reported on a square
centimeter basis. The larger sampling area for the swabbing method is
expected to provide results comparable to the excision technique.
The exact correlation between the sponging technique and the
excision technique used during the baseline surveys is being assessed
by ARS. Currently available results indicate a high degree of
correlation between the two. These studies and any other new microbial
sampling data will be made available to the public. This sponging
technique will also be used in the FSIS Salmonella program. FSIS is
continuing to improve the sponging technique and welcomes comments.
FSIS considered providing that samples be taken from only one site
on livestock carcasses: from the brisket on cattle and the belly area
on swine. Sampling from one site has advantages. It would be less labor
intensive. Further, sampling from one site might pose fewer worker
safety problems than sampling from three sites because, for the latter
option, a ladder generally is needed to reach the rumps of the
suspended carcasses. Nonetheless, FSIS has determined that slaughter
establishments must take samples from the three sites from which
samples were drawn during the baseline studies or programs in the
absence of data demonstrating that one-site sampling also will provide
results comparable to the baseline survey data. The Agency invites
comments on its requirement that establishments collect samples from
the specified three sites on swine and cattle carcasses and the
adequacy of alternative sampling approaches.
Samples may be analyzed in either the establishment's own
laboratory or a commercial laboratory. Samples must be analyzed by a
quantitative method of analysis for E. coli. The method must be
approved by the Association of Official Analytic Chemists or validated
by a scientific body in collaborative trials against the three tube
most probable number (MPN) method and agreeing with the 95 percent
upper and lower confidence limit of the appropriate MPN index.
FSIS has developed and is publishing as an appendix to the document
guidelines that provide additional, detailed information on how best to
sample, test, record, and interpret results for E. coli under this
regulation. FSIS invites comment on these guidelines.
Recordkeeping
Results of each test must be recorded, in terms of colony forming
units per milliliter (cfu/ml) for poultry carcasses or per square
centimeter (cfu/cm2) for livestock carcasses, on a process control
chart or table that permits evaluation of the test results in relation
to preceding tests in accordance with the applicable criteria. These
records must be maintained at the establishment for 12 months and must
be made available to Inspection Program employees on request.
Inspectors will monitor results over time, to verify effective and
consistent process control.
Use of E. Coli Test Results by Establishments
As discussed in preceding sections, establishments slaughtering
livestock or poultry are required to use E. coli testing and evaluation
of the results to verify the adequacy of their process controls for
fecal contamination. Any test result in the marginal range (above m)
indicates to the establishment that there is a potential problem in its
processing control that may require attention. If the number of test
results above m exceeds the specific number allowed, c (3, for all
species), in the specific number of consecutive tests in the moving
window, n (13 for all species), the establishment has failed to meet
the performance criteria, and a significant question has been raised
about the adequacy of the establishment's process controls for fecal
contamination. Review of the process by the establishment and necessary
corrective actions are strongly suggested.
Results above the upper value M are unacceptable and should trigger
immediate establishment review of slaughter process controls to
discover the cause of the failure and to prevent recurrence, and, if a
product has been affected, to consider the status and proper
disposition of the product as the circumstances dictate.
Use of E. coli Test Results by FSIS
FSIS personnel, like establishment personnel, will use the E. coli
test results to help assess how well the establishment is controlling
its slaughter and dressing processes. FSIS will compare establishment
test results to the applicable E. coli performance criterion. A single
failure to meet the criterion does not by itself demonstrate a lack of
process control or product adulteration, but it will trigger greater
inspection activity to establish that all applicable sanitation and
process control requirements are being met and product is not being
adulterated. Inspectors may make additional visual inspections of
products and/or equipment and facilities, collect samples for FSIS
laboratory analysis, and retain or condemn product, as appropriate. In
addition, Sanitation
[[Page 38844]]
SOP's and HACCP records will be reviewed, as appropriate. Failure to
meet the criterion may also result in the establishment being selected
for intensified Agency testing for Salmonella under the pathogen
reduction performance standard sampling program; and, if the
establishment produced ground beef, its product could be targeted in
the E. coli. O157:H7 ground beef testing program.
The E. coli test results will be used by FSIS, along with all other
relevant data and observations, including past establishment
performance, to determine whether a slaughter establishment is meeting
its process control responsibilities. Repeated failures to meet the
criterion would lend support to a finding that the establishment's
process controls are inadequate. Failure to maintain adequate process
control will result in suspension and withdrawal of inspection, as
appropriate. Such actions will be made in accordance with rules of
practice that will be adopted for those proceedings.
After a slaughter establishment implements HACCP, the E. coli
testing program will continue as a HACCP verification activity.
Isolated or occasional failures to meet the E. coli performance
criterion may indicate that establishment personnel need to take
corrective actions spelled out in their HACCP plan. Repeated failures
to meet the criterion will result in FSIS focusing its verification
oversight on relevant CCP's, which could lead to the need for HACCP
plan reassessment by the establishment, as well as other inspection and
compliance related activities that may be appropriate, as discussed
above.
Implementation Timetable
Six months from this publication date, establishments that
slaughter livestock or poultry will be required to begin sampling and
testing for E. coli at the volume-based rates described above. From
that time, those establishments that do not test or fail to keep
records of results as prescribed by the regulation will be subject to
withdrawal of inspection in accord with the procedures set forth in 9
CFR 335.13 or 381.234. After another six months, i.e., 12 months after
publication of this final rule, after establishments have had an
opportunity to gain experience in conducting this testing, recording
the results, and using the data to verify and improve process control,
FSIS personnel will incorporate the review of establishment E. coli
test results into its inspection routine.
In considering the timeframe for implementing the E. coli testing
requirement, FSIS has taken into account the practicality of initiating
such testing in a large number of establishments, the potential utility
of the resulting data to establishments as they prepare for HACCP
implementation, and the added consumer protection of having
establishments, particularly those scheduled to implement HACCP towards
the end of the implementation timetable, initiating testing and
evaluating results against the process control performance criteria.
FSIS is aware that many establishments, especially large ones, already
use microbial testing as a means of verifying their process control
systems; many may already be testing for generic E. coli. Some of those
establishments may already have HACCP plans in place as well.
Establishments performing microbiological testing and already working
under HACCP plans have found that such testing is an important element
in conducting a hazard analysis, validating HACCP plans, and verifying
the ongoing effectiveness of HACCP systems.
For establishments that are not already performing microbiological
testing and not operating under HACCP plans, the data will be valuable
in revealing how well or poorly their slaughter process is performing
in microbiological terms, when compared against the microbial
characteristics of a large portion of national production, and will
provide an indication of whether immediate actions are required to
prevent product adulteration and protect food safety. In addition, such
data, when accumulated over a period of time, will contribute to the
conduct of hazard analyses and selection of process control measures.
Collection of these data will provide benchmarks for each establishment
as it begins to understand the food safety implications of its
processes and how to improve them.
In the meantime, FSIS personnel, using the performance criteria as
benchmarks for overall industry performance in terms of the number of
E. coli organisms found on carcasses at a specific point in the
slaughter process, will be able to review establishment data and other
evidence to determine if each establishment is achieving an acceptable
level of performance.
Request for Comments
The Agency is soliciting additional comment and information on a
number of technical issues concerning the protocols for E. coli
testing, and on that basis will consider adjusting those protocols
prior to the effective date. In particular, two concerns have been
raised on the issue of the rule's statistical framework: 1) the
representativeness of the proposed sample collection, and 2) the levels
and distribution of E. coli on carcasses and the ways in which these
levels affect the utility of the proposed testing protocol.
Because poultry slaughter establishments must collect samples with
a whole bird rinse, the representativeness of the sampling site is not
an issue; the entire bird is being sampled. FSIS used this technique
when collecting baseline data and therefore, establishment data should
be comparable to baseline survey data. Further, greater than 99 percent
of broiler carcasses in the national baseline survey had detectable E.
coli. Generic E. coli testing data therefore clearly will be useful to
poultry slaughter establishments as they initiate HACCP and begin to
verify the associated process control procedures. E. coli testing
procedures for poultry required by this rule comport well with the
available scientific data and discussions held as part of the public
comment process.
More difficult issues arose in developing E. coli sampling
procedures for cattle and swine carcasses. Part of the concern, as
discussed, stems from the fact that a whole carcass rinse is impossible
with a large carcass, and thus it is necessary to select specific
sampling sites. Selections of sites, in turn, may influence results,
particularly if generic E. coli is not randomly distributed on the
carcass. Site selection may also influence the usefulness of resultant
data. For example, the appropriate response to an elevated generic E.
coli level on the rump of a beef carcass may be different from the
appropriate response to an elevated generic E. coli level at the site
of the midline incision. The Agency wants comments on the relative
merits of a one-site versus three-site sampling approach.
Another concern revolves around the correlation between non-
destructive and destructive sampling. The baseline surveys used
destructive sampling, that is, culturing of tissue excised from the
carcass. FSIS agrees with commenters that reasonable results can be
obtained with a non-destructive swabbing technique for sampling.
Preliminary data indicate that results obtained with a destructive and
non-destructive sampling are comparable, although studies continue.
Another concern arises from the statistical basis for E. coli
testing. In
[[Page 38845]]
particular, the levels of generic E. coli on cattle carcasses in the
national baseline survey were low, with the majority of carcasses
having no detectable E. coli. This could raise questions about the
utility of the E. coli test results in evaluating process controls in
establishments slaughtering cattle.
The principal utility of process control testing stems from the
availability to a establishment of results over time from that
establishment. The tracking of trends and identification of anomalous
results permits isolation and correction of problem areas that might
otherwise go unnoticed. FSIS has concluded that testing for generic E.
coli is the appropriate and necessary means by which meat and poultry
slaughter establishments must evaluate and verify the adequacy of their
process controls. FSIS considers systematic measures to prevent and
remove fecal contamination and associated bacteria, coupled with
microbial testing to verify effectiveness, to be the state of the art
in slaughter establishment sanitation. Microbial testing for bacteria
that are good indicators of fecal contamination and the regular
availability of test results will help to focus establishments on the
effectiveness of their measures for preventing and removing fecal
contamination and will provide information establishments can use in
maintaining adequate process control. FSIS reached this conclusion upon
its review of written comments received on the proposal and comments
made at the scientific conferences and public meetings, as well as
available scientific data, and has retabulated and reassessed its
baseline data as it applies to the E. coli testing in the rule.
In the first reassessment, it was determined that the lower levels
and more frequent negative test results of E. coli found on livestock,
particularly steers and heifers, as compared to poultry in the baseline
survey data does not undercut the utility of the E. coli criteria which
are also based on the baseline survey data. FSIS tested the performance
criteria in this rule by applying it to plant-specific test results
obtained during the baseline surveys. FSIS looked at data from
establishments for which at least 20 test results were available, and
listed the results by collection date much as would be done by the
establishments under the rule. The Agency found that about half of the
establishments in each of the livestock slaughter categories fully met
the criteria, which suggests that those establishments have good
process controls for prevention of fecal contamination. The Agency also
found that many establishments failed to meet the applicable E. coli
criterion (any result above M, or more than 3 results above m out of
the most recent 13 test results): 2 out of 30 steer/heifer
establishments, 10 out of 34 cow/bull establishments, and 11 out of 31
market hog establishments failed to meet the criterion at least 20% of
the time, suggesting that a significant number of livestock slaughter
establishments should review and make adjustments to their process
controls.
The Agency also made an assessment of whether the baselines show
true differences in E. coli results among establishments that slaughter
the same categories of livestock. The Agency did a statistical analysis
of a hypothesis: percents positive are equal among establishments
slaughtering the same category of livestock. The analysis involved
comparing E. coli test results of pairs of establishments. This
comparison showed wide ranges in the percents positive between
establishments albeit smaller differences among steer/heifer
establishments. The percents positive ranged between 0.0 to 27.1 for
steer/heifer establishments, 0.0 to 45.2 for cow/bull establishments,
and 2.2 to 97.1 for market hog establishments. The hypothesis,
therefore, was rejected because the data showed significant differences
in the prevalence of E. coli on carcasses of animals found in
establishments slaughtering the same categories of livestock.
The retabulated data developed for these two analyses are available
for viewing in the FSIS Docket Room (See ADDRESSES) as part of the
administrative record of this rulemaking.
FSIS invites comments on the statistical frameworks it has used for
E. coli testing and performance criteria. The Agency is open to the
possibility that it might further improve its testing protocols prior
to the implementation date, and is seeking additional relevant
scientific and economic data. In particular, in light of the concerns
noted above, FSIS is seeking additional data relating to the
distribution of generic E. coli on cattle and swine carcasses,
differences in E. coli levels within and between establishments, and
the appropriateness of various data sets for establishing the proposed
80th and 98th percentile national criteria for generic E. coli levels
on cattle and swine carcasses.
FSIS also requests comments and information addressing the
following questions:
Are there alternative, equally or more effective risk based
microbial sampling protocols that could be used for process control
verification by establishments that slaughter cattle or swine?
Are there more appropriate anatomical sites for microbial
testing than those adopted?
Are there alternative sampling frequencies that would elicit
results more indicative of process control performance?
How could the proposed testing protocol be revised to better
account for differing establishment characteristics and how can FSIS
minimize the cost to establishments of E. coli testing without
sacrificing testing effectiveness?
Are there worker safety concerns regarding sampling from
difficult to reach carcass sites and, if so, how might they be
mitigated?
Given that testing is based on production volume, are there
effective approaches other than requiring very small establishments
to conduct a minimal amount of testing during certain months of the
year?
FSIS is aware that some individuals, companies, and trade groups
have conducted research and have data on the various carcass sampling
sites and associated levels of bacteria at these sites (carcass
mapping). FSIS welcomes any information concerning E. coli and other
microorganisms at various sites on carcasses.
FSIS has opted to establish performance criteria based on the
levels and distribution of E. coli for the various slaughter classes.
Some individuals and companies may have established their own criteria
for process control verification. FSIS welcomes information on the
rationales, sampling plans and protocols on which any such criteria are
based, as well as data (or data summaries) collected under such
protocols.
FSIS welcomes any new or unpublished research results or
information that exists concerning the relationship between the
presence of generic E. coli and the presence of other pathogenic
microorganisms on cattle and swine carcasses.
FSIS specifically invites establishments currently conducting
generic E. coli testing for process control verification to submit data
regarding their costs, including labor and training costs, as well as
testing costs per unit. FSIS will use this data to assess the merits of
alternative testing protocols.
FSIS invites comments on how, and the extent to which, it should
summarize and make available to the industry and public E. coli testing
data made available to it under these regulations. Reports on the
collective experiences of establishments with various characteristics
could be useful to the industry, the Agency, and the public at large.
In light of these issues, in particular those reflecting continuing
concerns
[[Page 38846]]
about the applicability of the national criteria to all affected
establishments, the frequency and other parts of the testing protocols,
and the statistical utility of the establishment's test results as a
measure of process control, FSIS plans to conduct two public
conferences. The first conference is planned to be held approximately
45 days into the 60 day comment period following publication of this
rule. This public conference will be led by a panel of scientists from
FSIS and other government agencies who will listen to testimony and
review comments received on these technical issues and share their
observations and opinions. FSIS will consider their input along with
all comments received as the basis for any necessary technical
amendments, which will be completed at least 30 days before the
implementation date. The second public conference is tentatively
planned for approximately 9 months following publication of this final
rule. This conference would be an opportunity for the industry and
others to discuss with FSIS new information based on about 3 months of
testing experience that may bear on these same issues and might allow
for further adjustments of protocols before FSIS inspectors are tasked,
about three months later, with comparing test results to the national
criteria as part of their inspection routine. FSIS will publish
further, more detailed notice of these conferences in future issues of
the Federal Register.
Pathogen Reduction Performance Standards
The pathogen reduction performance standards for Salmonella FSIS is
establishing in this final rule complement the process control
performance criteria for fecal contamination and E. coli testing.
The likelihood of product contamination by Salmonella is affected
by factors in addition to the incidence or degree of fecal
contamination, including the condition of incoming animals and cross
contamination among carcasses during the slaughter process and further
processing. Under HACCP, establishments will be expected to establish
controls wherever practicable to address and reduce the risk of
contamination with harmful bacteria. The pathogen reduction performance
standards FSIS is establishing for Salmonella are an important step
toward enabling FSIS and the establishment to verify the aggregate
effectiveness of an establishment's HACCP controls in reducing harmful
bacteria.
Rationale for Selecting Salmonella
In the future, FSIS may develop pathogen reduction performance
standards targeting a number of pathogens. Initially, however, FSIS has
developed pathogen reduction performance standards only for one--
Salmonella. Salmonella is an enteric pathogen, which as a group cause
most preventable illnesses associated with meat and poultry.
FSIS has selected Salmonella because: (1) it is the most common
bacterial cause of foodborne illness; (2) FSIS baseline data show that
Salmonella colonizes a variety of mammals and birds, and occurs at
frequencies which permit changes to be detected and monitored; (3)
current methodologies can recover Salmonella from a variety of meat and
poultry products; and (4) intervention strategies aimed at reducing
fecal contamination and other sources of Salmonella on raw product
should be effective against other pathogens.
Basis for Performance Standards and Plans for Future Adjustments
The pathogen reduction performance standards for Salmonella are
based on the current prevalence of Salmonella, as determined from
FSIS's baseline surveys. Current prevalence percentages based on the
data from these surveys are listed in Table 4 and in the regulations
(new Secs. 310.25(c)(3)(ii) and 381.94(c)(3)(ii)) under the column
headed ``Performance Standard.'' This is the performance standard that
establishments must achieve, not on a lot-by-lot basis, but
consistently over a period of time through appropriate and well-
executed process control.
This is the same approach to setting the ``interim targets for
pathogen reduction'' that FSIS proposed in its Pathogen Reduction/HACCP
proposal. As explained in the preamble to that proposal, basing the
performance standard on the national baseline prevalence means that
some establishments are already meeting or exceeding the standard,
while other establishments are not. FSIS believes that it is feasible
for all establishments to meet or exceed the current baseline
prevalence of contamination with Salmonella, through careful process
control to prevent contamination and incorporation of readily available
food safety technologies and procedures to remove contamination. The
feasibility of achieving this standard is demonstrated by the fact that
many establishments are already doing so.
The Agency believes that most establishments maintaining sanitary
conditions under their Sanitation SOP's and operating under validated
HACCP plans, as provided for elsewhere in this regulation, will be able
to meet the pathogen reduction performance standards without major new
costs. For example, HACCP plans for slaughter establishments are
expected to address the condition of incoming animals, and may provide
for more systematic control of relevant processes or interventions,
such as the cleaning of animals or carcasses before evisceration. HACCP
systems should, therefore, result in many establishments improving the
microbial profile of their finished raw products.
Slaughter establishments concerned that they might not meet the
pathogen reduction performance standard have available a wide range of
technologies shown to reduce the levels of pathogens that may be on the
surface of carcasses. As discussed in some detail in the proposed rule,
antimicrobial treatments normally include washes or sprays that use
either hot water or a solution of water and a substance approved by
FSIS for that use. Such substances include acids (lactic, acetic, and
citric), trisodium phosphate (TSP), and chlorine. In addition, FSIS has
recently established that spray-vacuum devices that apply pressurized
steam or hot water to beef carcasses and immediately vacuum it up also
are effective in reducing bacteria on carcasses.
Establishments producing raw ground product from raw meat or
poultry supplied by other establishments cannot use technologies for
reducing pathogens that are designed for use on the surfaces of whole
carcasses at the time of slaughter. Such establishments may require
more control over incoming raw product, including contractual
specifications to ensure that they begin their process with product
that meets the standard, as well as careful adherence to their
Sanitation SOP's and HACCP plan.
By basing its Salmonella performance standards on the current
national baseline prevalence for each major species and product class,
FSIS is applying a uniform policy principle: all establishments must
achieve at least the current baseline level of performance with respect
to Salmonella for the product classes they produce. This policy is
based on the public health judgment that reducing the percentage of
carcasses with Salmonella will reduce the risk of foodborne illness,
and on the regulatory policy judgment that establishing for the first
time a clear standard for Salmonella, in conjunction with the
implementation of HACCP, will lead to significant reductions in
[[Page 38847]]
contamination rates. This policy is not based on a quantitative
assessment of the risk posed by any particular incidence of Salmonella
contamination or the determination of a ``safe'' incidence or level.
There is not currently a scientific basis for making such assessments
or determinations.
FSIS recognizes that this approach results in a range of
performance standards among the various product classes (see Table 4).
For example, the current Salmonella prevalence for broilers is 20
percent, while the current prevalence for steers and heifers is 1
percent. This range reflects the current level of performance for each
class of product, as reflected in the FSIS baseline surveys.
FSIS intends to revise its Salmonella performance standards
periodically as new baseline prevalence data become available and in
furtherance of the Agency's goal of reducing the risk of foodborne
illness. FSIS will periodically repeat its baseline studies to assess
the overall progress of the pathogen reduction effort. Also, as
indicated below in the discussion of the FSIS testing strategy, FSIS
will be conducting extensive Salmonella testing to ensure compliance
with the pathogen reduction performance standards. If the data from
this testing or future baseline surveys justify revision of the
performance standards, FSIS will promptly publish such revisions for
public comment in the Federal Register. FSIS anticipates revision of
these performance standards downward as justified by progress in
pathogen reduction and demonstrated reductions in the national baseline
prevalence of Salmonella. In making such adjustments, FSIS will take
into account the state of scientific knowledge, available technology,
feasibility, and public health benefits to be achieved. FSIS will also
consider the current level of industry performance with respect to
Salmonella prevalence in particular classes of livestock and poultry.
It is anticipated that such adjustments would more likely occur in
classes with the highest prevalence. FSIS originally proposed to call
these performance ``interim'' standards or targets. The final rule
removes that language.
Approximately 15 months after the publication of this final rule,
FSIS will convene a public conference to review available Salmonella
data and discuss whether they warrant refining the S
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
almonella
performance standards. Prior to the conference, FSIS will make
available the data resulting from the pre- implementation phase of the
FSIS Salmonella testing program. FSIS also will take advantage of this
conference to receive public input on the E. coli testing program. FSIS
will extend an invitation to all interested parties.
Additionally, FSIS intends to work closely with other Federal
agencies and the scientific community to improve the scientific basis
for establishing food safety performance standards for microbial
pathogens. In particular, the Executive Office of the President, Office
of Science and Technology Policy, will oversee a task force to
determine what research and data collection are needed to develop a
workable approach to quantitative risk assessment for foodborne
pathogens and determine the most cost-effective way of conducting the
necessary research. FSIS and other USDA agencies will participate in
this government-wide task force.
Determining Compliance With the Standard
The pathogen reduction performance standards specify for each
species and category of raw product a maximum number of positive test
results (c) permitted to be found in a specified number of samples (n)
for each class of raw product before the establishment will be deemed
to be exceeding the performance standard. The standards were determined
by first calculating for each category of product tested in the FSIS
national baseline programs and surveys the percentage of Salmonella
positives nationwide. This is, in effect, the performance standard that
must be achieved consistently by each establishment over time. Then the
number of samples to test (n) and the number of positives to allow from
among those samples (c) were calculated to provide approximately an 80%
probability of passing when the establishment is operating at the
national baseline prevalence of Salmonella positive results, i.e., just
within the performance standard. As discussed in the preamble to the
Pathogen Reduction/HACCP proposal and above with respect to E. coli
testing, the statistical criteria for evaluating Salmonella test
results balance the need to prevent establishments from failing to meet
the standard, based on chance results, and the need to ensure both that
violations are readily detected and that establishments have an
incentive to improve their performance beyond what is minimally
required by the standard. The resulting values for the pathogen
reduction performance standards are shown in Table 4.
Table 4.--Pathogen Reduction Performance Standards
----------------------------------------------------------------------------------------------------------------
Performance
standard Maximum number
(percent Number of of positives
Class of product positive for samples to achieve
Salmonella) tested (n) standard (c)
(%)
----------------------------------------------------------------------------------------------------------------
Steers/Heifers.................................................. 1.0 82 1
Cows/Bulls...................................................... 2.7 58 2
Ground Beef..................................................... 7.5 53 5
Fresh Pork Sausage.............................................. *NA *NA *NA
Broilers........................................................ 20.0 51 12
Hogs............................................................ 8.7 55 6
Ground Turkey................................................... 49.9 53 29
Ground Chicken.................................................. 44.6 53 26
Turkeys......................................................... *NA *NA *NA
----------------------------------------------------------------------------------------------------------------
* Not available at this time.
FSIS has concluded that, for purposes of this rulemaking, it should
rely only on FSIS baseline data for determinations of the prevalence of
bacteria on which it is establishing standards. The proposal discussed
the possibility of relying on other data sources, such as industry
surveys or other reports in the scientific literature. No such data
were
[[Page 38848]]
submitted to FSIS in response to the proposal, and FSIS has concluded
that those alternative data sources are not likely to provide the
nationwide, objective data that are needed for the Agency's regulatory
purpose of establishing performance standards. FSIS will consider
modifications of the scope and approach to these surveys and additional
data sources, as the needs of public health dictate, but will continue
to rely only on data that are gathered with appropriate scientific
rigor.
FSIS has completed its baseline survey work and has issued reports
on its findings for Steers/Heifers, Cows/Bulls, Broiler Chickens,
Market Hogs, Ground Beef, Ground Chicken, and Ground Turkey. Copies of
these reports are available for inspection in the FSIS Docket Room (see
ADDRESSES).
FSIS is currently conducting the fresh pork sausage survey and will
begin the Baseline Program for turkeys soon. Therefore, performance
standards for fresh pork sausage and turkeys cannot be established at
this time. The performance standards for these two classes of products
will be published for public comment once FSIS's reports on the data
are available.
FSIS will determine an establishment's compliance with the
applicable pathogen reduction performance standard by taking the
indicated number of samples, generally at the rate of one or more per
day, testing each sample for Salmonella, and determining whether the
number of positive results is above the maximum permitted for that
product in the regulation.
FSIS has established performance standards for Salmonella on
carcasses and on raw products derived from meat and poultry. Because
Salmonella is more likely to be present on raw, ground, or comminuted
products than on the carcasses from which they are derived, raw,
ground, or comminuted product ordinarily will be the focus of FSIS
compliance testing in those establishments that both slaughter and
produce raw ground product.
The pathogen reduction performance standard applies to
establishments, not to individual products. As discussed,
microbiological testing of raw products for purposes of routinely
separating adulterated from unadulterated products is impractical at
this time. The pathogen reduction standard for Salmonella requires
testing of products not for purposes of determining product disposition
(although in some circumstances it may contribute to additional
inspection or compliance activities that do), but rather as a measure
of the effectiveness of the process in limiting contamination with this
particular pathogen. If an establishment fails to meet the standard, it
must institute corrective actions to lower the incidence of Salmonella
on all such product it produces as measured by subsequent testing, or,
ultimately, it must cease producing that product. The FSIS enforcement
strategy is further discussed below.
FSIS Testing Strategy
FSIS's Salmonella testing program will be implemented in two
phases, a pre-implementation phase and a compliance phase. The pre-
implementation phase will begin approximately three months after
publication of the final rule and initially will consist of an
establishment-by-establishment survey of the slaughter establishments
represented in the National Microbiological Baseline Data Collection
Programs. These establishments account for approximately 99 percent of
the total production volume for each of the major species slaughtered
nationwide. The testing in each slaughter establishment will be
conducted in a manner designed to provide a reliable picture of the
establishment's performance throughout a 12-month period, in relation
to the pathogen performance standard applicable to the species being
slaughtered. It is anticipated that initially FSIS will take
approximately 250 samples per establishment over a one-year period,
with testing to be completed before the implementation date for the
standard in each establishment.
FSIS will also conduct pre-implementation testing in ground product
establishments and in establishments that account for the remaining one
percent of production and that were not included in the FSIS baseline
surveys. This testing will be conducted in a manner and at a level that
takes into account the size and nature of the establishments involved.
FSIS will provide more detail on this testing soon in a separate
notice.
This pre-implementation testing will inform both the establishments
and FSIS, prior to the actual enforcement of the performance standards,
whether each establishment is already meeting the standard, is close to
meeting the standard, or requires substantial improvement to meet the
standard. As with all FSIS testing done to check compliance with the
pathogen reduction standards, the testing results will be provided to
the establishment by FSIS. These testing results will assist
establishments in designing and validating their HACCP plans as needed
to ensure that products meet pathogen reduction performance standards.
This information also will assist FSIS to more effectively target its
compliance testing after the standards go into effect, as discussed
below. This FSIS-generated data on the prevalence of Salmonella on
inspected products will be available to the public.
Upon the implementation of HACCP, and upon publication of Federal
Register documents concerning the pathogen reduction performance
standards for which baseline survey reports have not yet been
published, FSIS will initiate phase 2, the compliance phase, of its
Salmonella testing program in affected establishments. As an integral
part of its overall responsibility for food safety, FSIS will conduct
an ongoing testing program to determine compliance with the Salmonella
performance standard for all classes of livestock and poultry. In
addition, FSIS will conduct a program of targeted testing where
warranted. The frequency and intensity of this testing will be
determined based on past establishment performance, the establishment's
own generic E. coli test results, FSIS inspectional observations,
reports of illness associated with product produced at an
establishment, the results of Salmonella testing during the pre-
implementation phase, previous failures to meet the performance
standards, and other factors.
The costs to FSIS of this testing for Salmonella, estimated to be
approximately 2 million dollars annually, are addressed in the Final
Regulatory Impact Analysis of this rule.
FSIS Testing Methods
Details of the sample collection and testing procedures the Agency
will be using are in Appendix E, ``FSIS Sample Collection Guidelines
and Procedure for Isolation and Identification of Salmonella from Raw
Meat and Poultry Products.''
FSIS Enforcement Strategy
The objective of FSIS's enforcement policy with respect to
microbial testing is to achieve compliance with the regulations. With
respect to Salmonella, the Agency's goal is to achieve pathogen
reduction by ensuring that all slaughter and ground product
establishments meet the performance standards established by FSIS. FSIS
intends to achieve this goal through an enforcement strategy based on
the two-part testing program mentioned above: the ongoing testing,
which will include all establishments at some fixed interval,
irrespective of performance;
[[Page 38849]]
and targeted testing focusing on establishments unable to meet the
Salmonella performance standard when tested by FSIS or for the other
reasons discussed above.
The Salmonella enforcement strategy will embody an objective,
uniform systems approach to ensure that it is administered and applied
in a fair, equitable, and common-sense manner. The Agency will
carefully monitor and adjust its enforcement program on an ongoing
basis to ensure that its enforcement activities reflect these
principles while ensuring food safety.
If ongoing or targeted testing in an establishment indicates the
performance standard is not being met, FSIS will decide whether to
conduct follow-up testing on the basis of several factors. If an
establishment with Salmonella test results marginally above the limit
takes corrective action, FSIS could judge, based on the establishment's
actions and other factors relevant to ensuring food safety, that
immediate follow-up testing is not necessary. If, however, that
establishment were to take inadequate corrective action after failing
to meet the Salmonella performance standard, or if it simply ignored
that failure, FSIS will conduct a second series of tests. FSIS will
invariably conduct further testing at all establishments whose test
results significantly exceed the standard.
If an establishment fails the second, targeted series of FSIS-
conducted tests, the establishment will be required to reassess its
HACCP plan for the tested product, modifying the plan as necessary to
achieve the Salmonella performance standard. If the establishment fails
to modify its HACCP plan as necessary, or if it fails the third series
of targeted tests, FSIS will suspend inspection services. The
suspension will remain in effect until the establishment demonstrates
its ability to meet the performance standard.
The probability of an establishment failing the Agency's pathogen
reduction standard three consecutive times is less than 1% when the
establishment prevalence is at the limit of the standard.
Implementation Timetable for Pathogen Reduction Performance Standards
Slaughter establishments and establishments producing raw, ground,
and comminuted product subject to these pathogen reduction performance
standards must meet the Salmonella standard at the time the
establishment is required to implement HACCP. As explained in section
II above, HACCP implementation will be phased in based on establishment
size over a period of 18 to 42 months following the date of publication
of this final rule. FSIS originally proposed a single two-year delayed
effective date for its Salmonella performance standards. Many
commenters argued that it was not reasonable to hold all establishments
to the same effective date, and, furthermore, that it was more logical
to hold establishments to compliance with the standard after, rather
than before, HACCP was in place. This proposition also was strongly
endorsed by many people who attended an information briefing and public
meeting held by FSIS in Kansas City, Missouri, on May 22, 1995,
expressly for small meat and poultry establishments and small
businesses (60 FR 25869, May 15, 1995). They questioned, among other
things, the need for and wisdom of a common implementation date for
large and small establishments.
Harmonizing the effective dates with implementation of HACCP is
more consistent with the nature of the pathogen reduction standards as
measures of what establishments can and should achieve through HACCP-
based process control. It will bring 74% of the nation's slaughter
production of meat and poultry (by weight) under the performance
standard 18 months following publication of this final rule. It will
also facilitate the transition to HACCP, for both the FSIS workforce
and affected establishments, by requiring all establishments to meet
the performance standards as they implement HACCP.
Response to Comments
FSIS proposed to require that all meat and poultry slaughtering
establishments and establishments producing raw ground product conduct
daily microbial testing to determine compliance with interim targets
for the reduction of Salmonella. FSIS proposed to require a single
qualitative test per day, with daily results to be accumulated over
time to provide information regarding the performance of an
establishment's process and to collect data sufficient for process
control verification. Daily testing was considered the minimal sampling
necessary to detect process deviations within a realistic time frame.
The three issues most commonly raised by commenters concerning the
proposed microbial testing requirements were the proposed selection of
Salmonella as the indicator organism, the frequency of proposed
testing, and the disproportionate costs to small establishments. Some
commenters also argued that the regulatory approach was not justified
and exceeded FSIS's legal authority.
The Indicator Organism
Many commenters opposed the use of Salmonella as the indicator
organism, arguing that its low incidence in beef makes it a poor
indicator of pathogen reduction in the species, the positive/negative
test result is a weak measure of process control, and, compared to some
nonpathogenic alternatives such as generic E. coli, Salmonella tests
are more difficult, time-consuming, and costly. Others commented that
testing for Salmonella alone is unacceptable, as there is no direct
correlation between the presence of this organism and other pathogens
such as E. coli O157:H7, Listeria, and Campylobacter.
Various alternative indicator organisms were suggested, including
generic E. coli (biotype I), total plate counts, Enterobacteriaceae,
Total Viable Counts (TVC), and Aerobic Plate Counts (APC). Commenters
who recommended alternatives stated that tests for these organisms
would be better indicators for process control and fecal contamination
levels than tests for Salmonella. Still others requested that more
studies be conducted to determine which type of indicator organism
would be most useful for verifying process control.
Some commenters recommended retaining Salmonella as the target for
pathogen reduction, but suggested adding a requirement for generic E.
coli testing because it serves effectively as an indicator of fecal
contamination in all species. A minority of commenters supported the
proposed use of Salmonella as the indicator organism because of its
significance as a cause of foodborne illness and because there are
relatively simple tests available for detecting Salmonella. Some
commenters recommended requiring testing for Salmonella and additional
pathogens in selected species or products based on the degree of public
health risk posed by the pathogen. A number of consumer groups
requested a pathogen goal of zero for E. coli O157:H7.
These comments are generally addressed by the FSIS decisions to
require slaughter establishments to test for generic E. coli as a means
to verify process control for fecal contamination, and to have FSIS
conduct testing for Salmonella for pathogen reduction.
FSIS considers systematic measures to prevent and remove fecal
contamination and associated bacteria, coupled with microbial testing
to verify effectiveness, to be the state of the art in slaughter
establishment sanitation. Further, FSIS believes that testing for
generic E. coli is the appropriate and necessary means by which meat
and poultry slaughter
[[Page 38850]]
establishments must verify their process controls. FSIS reviewed
written comments received on the original proposal and comments made at
the scientific conferences and public meetings, as well as available
scientific data, and has decided to require slaughter establishments to
conduct testing for generic E. coli to verify process controls.
The Agency has concluded that each kind of testing serves an
important function. Both play a major part in the Agency's pathogen
reduction efforts, and working in unison will permit the Agency to use
its inspection resources more effectively, and efficiently, thereby
enhancing inspection.
E. coli testing for process control verification and Salmonella
testing to enforce the pathogen reduction performance standard both are
aimed at FSIS's objective to reduce the incidence of disease caused by
foodborne pathogens. However, E. coli testing and Salmonella testing
aim at the objective from different directions.
An ongoing screen for generic E. coli serves both the establishment
and FSIS as a means of verifying that a slaughter facility's process is
``in control'' with regard to prevention of fecal contamination of the
carcasses being produced. In other words, it becomes a marker for
verifying a slaughter establishment's adherence to the zero tolerance
for fecal contamination. Such testing provides a standard measure for
verification of process control at the critical slaughter stage of
production. Without such a standard measure, there is no objective
basis upon which either the establishment or FSIS can determine the
adequacy of process controls, from one establishment to another, in
preventing fecal contamination. It will permit establishments to make
ongoing adjustments or changes to their slaughter process when
necessary to meet the performance criteria. The test results will also
guide FSIS's ongoing inspection, permitting adjustments in intensity
and focus as appropriate.
Generic E. coli testing to verify process control alone, however,
does not adequately address legitimate public health concerns about
pathogenic bacteria in and on raw product. E. coli (except for certain
pathogenic subgroups) is not itself a cause of foodborne disease. It is
a ``surrogate marker'' or ``indicator'' for fecal contamination, which
in turn is a source of many pathogens that may contaminate products.
Fecal contamination, however, does not always correlate with the
presence of pathogens; high levels of E. coli may be present without
pathogens, and pathogens may be present without high E. coli levels.
Because testing for E. coli cannot serve as a surrogate for the
presence of Salmonella, FSIS's specific public health objective of
reducing nationwide Salmonella levels on raw meat and poultry products,
including raw ground products, requires a standard and a testing regime
that are directed at that pathogen.
The pathogen reduction performance standard for Salmonella must be
met by all inspected establishments producing raw meat and poultry
products. Agency testing for Salmonella is necessary for enforcement of
that requirement. Slaughter establishments' E. coli testing, a means
for verifying process control for fecal contamination, should promote
improved process controls which should, in turn, result in reductions
of Salmonella and other pathogens. But, E. coli testing cannot measure
actual reductions and control of Salmonella nor be the basis for Agency
enforcement of the pathogen reduction standards.
The test results from both kinds of testing are valuable to the
Agency in the shift to a HACCP-based regulatory regime, but their value
comes from the way they work together to verify the effectiveness of an
overall system of preventive process control. The Agency continues to
believe that pathogen reduction in inspected establishments requires
that establishments build into their operations preventive measures and
systems to reduce the potential for pathogens to be on products to
begin with, and that such systems must be establishment-produced and
establishment-specific. The Agency's HACCP and Sanitation SOP's
regulations are intended to do that. However, these regulations are not
self-enforcing. The Agency's inspection mandate does not permit it to
simply assume that an establishment's systems are in fact producing
uniformly safe and unadulterated products. Pathogen reduction will be
achieved instead by the combination of HACCP plans validated as
effective for pathogens of concern, E. coli testing by the
establishment to provide on-going verification of process control for
fecal contamination, and Salmonella testing by FSIS to enforce
compliance with the pathogen reduction performance standards.
Frequency and Cost of Testing
Many commenters questioned the proposed frequency of daily testing
for each species and for raw, ground products. The majority of
commenters who opposed daily testing stated that this testing
requirement would place an unfair cost burden and have a negative
economic impact on some establishments, especially small volume
establishments and establishments producing multiple species and
multiple ground products that would require multiple tests. These
commenters stated that under the proposed sampling methodology, a small
establishment could conceivably conduct more tests per day than a very
large establishment with a much higher production volume. Also
mentioned was the fact that many of these establishments do not have
on-site testing facilities and would have an additional cost of
shipping samples for testing.
To minimize the economic impact on establishments, especially small
establishments, some commenters suggested that FSIS should pay for
microbial testing. Others recommended less than daily testing or other
changes to the proposed sampling frequency. Various alternatives to the
proposed sampling protocol were mentioned, but the sampling scheme
recommended most often as the most equitable, and the one FSIS is
requiring, is one based on production volume.
Although many commenters requested less frequent testing than that
proposed, others supported the one sample per day testing requirement
as an efficient means of verifying process control. Still others
recommended testing even more frequently than once per day. These
commenters asserted that testing once a day is inadequate to verify
process control or to screen out product with pathogens. Their main
concern was that the proposed sampling frequency and moving sum
statistical procedure would allow inadequate process control to go
undetected, resulting in large quantities of suspect product being
produced; recommendations were made for a testing frequency more
proportional to an establishment's production volume.
Some commenters requested that exemptions from the proposed daily
microbial testing be made for small establishments and establishments
that have consistently complied with their HACCP programs. Others
requested exemptions for specific products including: raw ground meat
products; cured products; thermally processed canned foods; frozen
foods; boxed meat and beef and pork carcasses from other inspected
establishments; minor species (i.e., sheep, lamb, goats, equines,
guineas); and raw ground products to be further processed as fully
cooked, ready-to-eat items, while others stated that exemptions for
these items would be inappropriate.
[[Page 38851]]
FSIS has modified the proposal in response to these comments. As
explained above, FSIS is requiring E. coli testing in slaughter
establishments where the initial and primary opportunity for fecal
contamination occurs. FSIS is not requiring E. coli testing of
processed products. A more limited testing requirement is possible
because oversight of slaughter establishment verification testing for
E. coli is not the sole means relied upon by FSIS to detect or prevent
lack of process control. It is only one of many aspects of
establishment operations FSIS will inspect in assessing the adequacy of
an establishment's process controls. In particular, FSIS will
increasingly rely on its verification that HACCP systems are working as
intended. HACCP principles require establishments to identify CCP's,
monitor them to see that they are in control, and take appropriate
corrective action when monitoring detects a deviation. This is where
control must be exercised by the establishment and where any lack of
control will be detected in a establishment operating under a validated
HACCP system.
FSIS has reconsidered the proposed requirement of daily testing in
all slaughter establishments, in part because of the unnecessary and
disproportionate economic impact that would occur for some small
establishments. Instead, FSIS is requiring slaughter establishments to
test carcasses for generic E. coli at frequencies corresponding to
production volume. In addition, slaughter establishments will have 6
months, not just 3 months as proposed, after publication of the final
rule to begin testing carcasses for generic E. coli. Further, very low
volume establishments may not need to do more than one set of 13 E.
coli tests annually, and such establishments slaughtering more than one
species need not test both. These changes will significantly reduce the
cost impact of mandatory testing for small establishments, while
providing adequate and useful information to verify process control.
In addition to requiring testing for generic E. coli by slaughter
establishments at a frequency relative to the establishment's
production volume, Salmonella testing will be conducted by FSIS.
``Minor species,'' such as sheep, goats, equines, ducks, geese, and
guineas, are not being addressed at this time because the Agency is
addressing first the most commonly consumed foods under its
jurisdiction. FSIS intends to address how best to gather data on and
develop testing requirements and performance criteria and standards for
these other food animals at a future date.
Legal Authority for Testing Requirement
Several commenters have questioned FSIS's legal authority for the
proposed microbiological testing program. These comments are still
relevant despite the differences between the proposed and final rules
for microbiological testing.
The major change in the final rule is that FSIS is not adopting the
proposed Salmonella testing regimen. As proposed, results of a series
of establishment-conducted Salmonella tests would have been used to
accomplish two goals: to verify process control and to enforce the
prevalence targets for pathogens in raw products. Instead, FSIS is
promulgating separate provisions to address these two regulatory goals.
The first provision requires that slaughter establishments test
carcasses for E. coli so that the effectiveness of the establishment's
sanitation and process control measures can be assessed in an
objective, uniform manner. The second provision sets a pathogen
reduction performance standard to bring about reductions in the
prevalence of Salmonella on raw meat and poultry products. This
standard will be enforced by an FSIS-conducted testing program, and
will require establishments with prevalence of Salmonella above the
standard to change their operations to meet that standard. Failure by
an establishment to achieve the standard could result in Agency
sanctions, as discussed above. This standard will also encourage
innovation to reduce pathogens throughout the industry.
One commenter argues that, because this regulatory strategy is
precedent-setting, FSIS has a greater than usual burden of articulating
the legal basis for it. This commenter notes that the testing
regulation does not rely on a finding that the presence of the targeted
organisms causes specific lots of product to become adulterated, as is
the case with E. coli O157:H7 in ground beef. This commenter then
argues that FSIS is relying upon a vague ``sanitation theory'' as its
legal basis, and that the Agency has a greater duty to articulate its
legal basis when new regulations impose new kinds of costs, like
mandatory E. coli testing, or when the Agency is establishing a new
regulatory policy.
This commenter believes that FSIS reliance on a ``sanitation
theory'' is legally flawed because, if the Agency is unable to tell
establishments how to correct a failure to meet the established
targets, it cannot legally require microorganism testing, or impose
sanctions for failure to meet established standards.
FSIS has ample statutory authority under the FMIA and PPIA to
promulgate these microbiological testing provisions. The meat and
poultry inspection statutes mandate Federal regulatory oversight of
unusual intensity and comprehensiveness, and they provide the Secretary
broad rulemaking authorities to implement them. The primary goal of the
statutes is to prevent adulterated or misbranded meat and poultry
products from entering into commerce by inspecting meat and poultry
products and the establishments that produce them before the products
are introduced into commerce. Such inspections are supplemented by
compliance actions to remove adulterated or misbranded products from
commerce and to apply appropriate sanctions against violators of the
law. FSIS regulations under the FMIA and PPIA may be divided into two
categories: (1) regulations prescribing the conditions under which, and
the manner in which, mandatory inspections are conducted; and (2)
regulations directed more broadly at preventing adulteration or
misbranding of products, preparation of products in violation of the
law, and sale of such products in commerce.
These two regulatory categories are interrelated. The broader
category is similar to regulations imposed on foods generally by the
FDA under the Federal Food, Drug, and Cosmetic Act. However, FSIS
authorities also require compliance with the inspection provisions of
the acts and regulations by anyone slaughtering poultry or livestock,
or preparing poultry products, or meat or meat food products for use as
human food. Thus, the requirements that establishments must meet to
obtain inspection and to have products marked ``inspected and passed''
comprise a unique statutory scheme which provides the Secretary with
broad rulemaking authorities.
From their inception, the meat and poultry inspection laws have
recognized that sanitary conditions in establishments are critical to
the safety and wholesomeness of the products being produced. Any
product found to have been ``prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health'' is adulterated.
No product will be granted inspection or marked ``inspected and
passed'' unless the sanitary conditions and practices required by the
Secretary are maintained.
[[Page 38852]]
It is important to distinguish the statutorily required finding
that a product is not adulterated from the absence of a finding that it
is adulterated. Only products found not to be adulterated may be marked
``inspected and passed.'' Even if the evidence does not compel an
inspector to find that a product is adulterated, it, nonetheless, may
be enough to prevent him from finding that it is not adulterated. This
means that products may not be distributed for food use without the
affirmative determination that they are not adulterated. Products as to
which such an affirmative determination has not been made must be
retained at the establishment pending such determination. They are
being detained because they have not been inspected and passed, not
because they have been found to be adulterated.
Thus, FSIS clearly has the authority to require that establishments
slaughtering livestock or poultry conduct and record tests for E. coli
on carcasses to measure how well contamination is being avoided. These
tests provide information by which establishments may evaluate and
ensure the effectiveness of their sanitary procedures and related
process controls in preventing product contamination during slaughter
and dressing.
Although E. coli testing will not be used to determine the
disposition of inspected products, it will be an effective indicator of
the presence of fecal contamination that is not visible and therefore
not detectable by traditional inspection methods. It will also provide
FSIS with information necessary to determine how best to conduct
inspection to ensure that product is not being adulterated.
Similarly, FSIS has clear authority to establish a Salmonella
standard for producers of raw meat and poultry to reduce the public's
exposure to Salmonella and associated pathogens from inspected meat and
poultry products. The Salmonella standard, like the criteria for E.
coli on carcasses, is based on the national baseline prevalence of the
bacteria for the product of concern. However, unlike the E. coli
criteria, which are, in essence, guidelines, the Salmonella standard
must be met. Compliance will be determined by Agency testing.
FSIS is continuing its policy of permitting raw meat and poultry
products to be marked and labeled ``inspected and passed,'' despite the
known or suspected presence of some pathogenic bacteria. FSIS
recognizes that currently there is no available technology (with the
possible exception of irradiation) to ensure that raw product bears no
pathogenic microorganisms.
However, there is overwhelming evidence that raw meat and poultry
products are frequently contaminated with pathogens and expose
consumers to avoidable and unacceptable risks of foodborne illness.
FSIS's statutory mandate to protect consumers from adulterated product
is not limited to actions associated with inspection. The Secretary may
also regulate how meat and poultry products are stored and handled by
anyone who buys, sells, freezes, stores, transports, or imports them,
to ensure they are not misbranded or adulterated when delivered to the
consumer.
The new pathogen reduction standards for Salmonella are necessary
to establish that raw product is being produced under sanitary
conditions, has not been prepared, packed or held under insanitary
conditions, and is not for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food.
The fact that the new performance standards and guidelines do not
specify how the E. coli process control verification performance
criteria or the Salmonella pathogen reduction standard must be met does
not undercut the reasonableness or the legal basis of either testing
program. Process control and the production of product that is not
adulterated is the responsibility of the establishment, not the
government. The Agency is responsible for establishing and enforcing
reasonable standards; it intends to give the industry the maximum
flexibility to decide how best to meet such standards. It does not
intend to regulate or prescribe how the standards are to be met. FSIS
will provide guidance and assistance to the industry, especially small
businesses. But it is not legally obliged to provide technical services
to establishments in finding the most efficient and effective way to
operate within the E. coli criteria and to meet the Salmonella
reduction standard.
In summary, FSIS has concluded that the E. coli testing program and
the Salmonella reduction standard are fully supported by the FMIA and
PPIA.
Performance Standards for Process Control
A related comment asserted that FSIS's proposed Salmonella standard
was not a standard at all, but instead was merely an unenforceable
criterion because its violation would not alone support seizure or
condemnation of products. FSIS agrees with the principle that a
regulatory standard should be enforceable, but does not agree that a
regulatory ``standard'' must be limited to product-specific
requirements, or to enforcement by seizure or condemnation of products.
The Agency acknowledges that historically it has used the term
``standard'' normally to refer to regulations concerning particular
products, e.g., standards of identity regulations, but notes that
current government-wide regulatory reform efforts stress the use of
``performance standards'' to describe the desired focus of government
regulations generally. FSIS intends now to issue regulations consistent
with the notion behind ``performance standards,'' that to the extent
possible regulations should tell regulated entities what they must
achieve to comply with the law, while providing maximum flexibility
regarding how to achieve the standard. Thus, FSIS agrees that one test
of a ``standard'' might be that violation of that requirement alone
supports some sort of regulatory sanction, but does not agree that
``standards'' should be limited to product-specific regulations or to
enforcement actions directed at specific products. The FMIA and PPIA do
not limit the Agency to product-specific regulations and enforcement
activities, and for reasons fully discussed earlier in this preamble,
the Agency has concluded that standards directed at processes are, at
this time, the only practical way in which to effectively address the
hazard presented by microbiological pathogens on raw meat and poultry
products.
Basis for Target Levels
Some commenters questioned the validity of microbial target levels
established by FSIS, while others supported FSIS national baseline
studies as an effective way to evaluate industry performance. After
careful review, the Agency considers it reasonable and appropriate to
use the distribution of results observed for each animal species in the
FSIS baseline surveys as the basis for both the E. coli criteria and
the pathogen reduction performance standard for Salmonella. These are
currently the best available data on the nationwide prevalence and
level of microbial contamination of raw meat and poultry products. The
data demonstrate that the E. coli process control verification criteria
and the Salmonella pathogen reduction standard are being achieved by
many establishments with today's technology and therefore are
achievable by all establishments.
FSIS Nationwide Microbiological Baseline Data Collection Programs
and its Nationwide Microbiological Surveys provide similar data, but
the
[[Page 38853]]
``Programs'' generally involve more extensive sampling over a longer
period, generally 12 months, than the ``Surveys'', which are generally
limited to 6 months of data collection. They both have provided data
for an ongoing microbial profile of carcasses and other raw meat and
poultry products for selected microorganisms or groups of
microorganisms of various degrees of public health concern of value as
indicators of general hygiene or process control.
As explained above, FSIS plans to revise the performance criteria
and standards as more current baseline data become available from
future baseline surveys, through establishment E. coli testing, through
FSIS Salmonella testing, or from other FSIS testing that may be
appropriate for establishing criteria and standards.
Although the majority of commenters focused on the issues mentioned
above, a number of others addressed various aspects of the proposed
rule such as microbial testing methodology, the concept of end product
testing, the role of FSIS personnel in test verification, enforcement
actions for non-compliance, and laboratory qualifications.
Methodology for Meeting Targets
Some commenters raised objections to use of the ``moving sum''
statistical procedure for determining when microbial testing results
are within the process control. Moving sum procedures are recognized in
the field of statistical quality control. The American National
Standard ``Guide for Quality Control Charts'' 11 identifies two
principal uses of such charts: assisting judgment as to whether a state
of control exists and attaining and maintaining control. In order to
judge whether a state of control exists, operators must analyze
``collectively an accumulation of quality data.'' In the proposed
regulation FSIS took this view of the purpose of the moving sum
procedure: establishments would need to verify that a state of control
exists with respect to the interim target set by the Agency. FSIS did
not claim, however, that the procedure would be useful for the second
purpose, attaining and maintaining control. That requires more timely
and probably more intense monitoring of process parameters at CCP's.
---------------------------------------------------------------------------
11 American National Standard ANSI Z1.1-1985. ``Guide for
Quality Control Charts.'' American Society for Quality Control.
Milwaukee, WI.
---------------------------------------------------------------------------
The proposed approach to use testing to measure process control was
designed to inform establishments how they are currently operating with
respect to the relevant target, and to help them track progress toward
meeting that target. A simple plot of the moving sum chart would give
them sufficient feedback for this purpose.
Some commenters recommended that the moving window verification
program should use a 90% probability criteria, rather than 80%, to
reduce the possibility of the testing procedure erroneously identifying
an establishment as not meeting the pathogen target. The Agency notes
that the moving sum procedure was designed to measure effectiveness of
process control with respect to an interim performance standard (called
a target in the proposal) based on current industry performance (as
determined by a baseline study). This measure was intended to be the
first step in holding establishments accountable for meeting acceptable
levels of performance. As such, the Agency wanted to be able to readily
identify establishments operating above the target and wanted to
provide an incentive for establishments to produce at levels better
than (below) the target. Giving establishments producing at the target
only an 80% chance of passing was expected to promote this. Giving
establishments producing at the target a higher chance of passing
(e.g., 95%) would reduce both the incentive to do better and the
ability to detect establishments above the target.
Sample Size
Others specifically addressed the proposed sample size,
recommending that the same number of samples be used for all species.
Not all species have the same risks of failure, in part because of the
varied incidence of pathogens, as was determined in FSIS's baseline
surveys. The proposed sampling rate was the same for all
establishments, one per day. Thus the sampling was the same for all
establishments, only the rules for interpreting results were different.
The number of results included in the window differed by product class
because the target percents positive differed by product class. It was
necessary to employ different-sized windows to maintain a fixed
probability of passing (80%) at the target for all product classes
while choosing as short a window as possible and allowing at least one
positive in the window.
Testing Methodology
Other commenters asked for clarification on testing methodology.
Some remarked that using a sponge or swab method to sample carcasses is
preferable to the proposed excision method because the proposed method
is time consuming, cumbersome, and expensive, and it may mutilate and
contaminate the carcass. The Agency agrees and has elected to use non-
destructive sampling methods.
Others asked for clarification of enforcement actions that would
result from an establishment not meeting its microbial targets. How the
rule will be enforced is addressed above.
Role of Inspectors
Still others asked about the role of inspection personnel in
verification testing and expressed concern about the amount and type of
training inspection personnel would receive to analyze test results.
The final rule makes slaughter process control verification testing
(E. coli) the responsibility of establishments slaughtering livestock
or poultry, although FSIS inspectors may also collect samples for E.
coli testing as needed to carry out their oversight responsibilities.
FSIS personnel sampling carcasses for Salmonella to ensure that
establishments are meeting the pathogen reduction performance standard
will send the samples to an Agency laboratory for analysis. FSIS
personnel have been involved in collection of samples for FSIS's
baseline surveys, and have been trained and are highly qualified to
collect samples for this regulatory program. Inspectors will work with
other program officials, including scientifically trained experts, in
analyzing test results and making appropriate regulatory decisions.
Inspectors will receive training to prepare them for their role in this
process.
Laboratories
Some commenters asked for clarification regarding qualifications
for in-house and outside laboratories. They stated that laboratories
should be required to use standardized techniques for analyzing test
results.
The microbiological test method used by the establishments must be
AOAC validated techniques, or other methods validated by a scientific
body in collaborated trials against the three tube most probable number
(MPN) method and agreeing with the 95 percent upper and lower
confidence interval, as discussed in the E. coli Methods Section.
Establishments are responsible for the accuracy of the tests of their
samples. If the samples are not analyzed by the establishment, the
establishment, perhaps in concert with a trade association, should
ensure that the laboratory it chooses is reputable and
[[Page 38854]]
adheres to a Quality Control/Quality Assurance Program.
Alternative Sampling Under HACCP
Other commenters stated that the proposed microbial testing system
does not reward very clean establishments by granting reasonable
reductions in testing when significant periods are pathogen free. They
recommended that once a facility has implemented its HACCP program, the
required frequency for mandatory microbial testing should be reduced or
eliminated altogether.
In this final rule, a slaughter establishment successfully
operating under a validated HACCP plan may reduce the specified
sampling frequency as long as the alternative sampling plan is an
integral part of the establishment's verification procedures for its
HACCP system. FSIS does, however, reserve the right to determine that
the alternative frequency is inadequate to verify the effectiveness of
the establishment's process controls. In that case, FSIS would notify
the establishment in writing of its finding, advise that the frequency
specified in the regulation must be maintained, and specify any
conditions an acceptable alternative frequency would have to meet to be
found acceptable to the Agency.
Relationship to HACCP
Finally, some commenters stated that the proposed end-product
testing is inconsistent with HACCP principles and that establishments
should decide for themselves through hazard analysis whether testing is
needed and at what frequency. Others objected to the concept of end-
product testing because it only measures effectiveness over a small
percentage of a production lot and has limited value in measuring the
overall success of a HACCP plan. Still others concluded that placing an
emphasis on end-product testing gives consumers a false sense of
confidence about the safety of meat and poultry products. A few
commenters were concerned about product liability due to product
recalls stemming from test results.
The objective of the generic E. coli testing is to verify that
process control has been maintained by the establishment throughout the
slaughter and dressing process and that resultant carcasses are
produced hygienically. If processes are under control for E. coli, the
potential presence of enteric pathogens will be reduced. End-product
verification testing of this kind is a well recognized component of
HACCP-based process control.12 The goal of FSIS's Salmonella
testing program is to verify that pathogen reduction performance meets
current standards in each establishment and thereby effect a nationwide
reduction in the incidence of that organism and other enteric pathogens
on raw meat and poultry products. The end of production is the only
point that reflects all steps in the production process and,
ultimately, all elements of the HACCP system. The seventh HACCP
principle is verification that the HACCP system is working; one cannot
verify that HACCP is working in slaughter establishments (controlling
fecal contamination/pathogens) without some end-product testing, so
end-product testing is not inconsistent with HACCP principles. The two
different kinds of testing programs: (1) E. coli testing by
establishments to verify control of fecal contamination; and (2)
Salmonella testing by FSIS to hold establishments accountable for
meeting pathogen performance standards, are both forms of end-product
testing that FSIS considers consistent with HACCP.
---------------------------------------------------------------------------
\12\ National Advisory Committee on Microbiological Criteria for
Foods. 1994. ``Hazard Analysis and Critical Control Point Systems.''
FSIS, USDA.
---------------------------------------------------------------------------
End-product testing as part of an overall system of HACCP-based
process control and performance standards should not give consumers a
false sense of confidence about the safety of meat and poultry
products. FSIS recognizes that limited end-product testing alone
provides little assurance of safety, but, as part of a process control
system, appropriate end-product testing brings rigor and accountability
to the system and should appropriately increase consumer confidence in
the safety of products. By requiring HACCP, FSIS is in fact moving away
from sole reliance on end-product assessments for lot acceptance, an
approach that is the opposite of the HACCP system approach to food
safety. FSIS recognizes that producing safe food requires preventing
hazards throughout the process rather than relying solely on end-
product testing to ensure safety. Establishments' liability to civil
lawsuits should not be adversely affected by this rule precisely
because it is an establishment's process, not individual lots of
product, that is being assessed, for inspection purposes, on the basis
of this testing.
V. Other Issues and Initiatives
Antimicrobial Treatments
FSIS proposed that all slaughter establishments apply at least one
antimicrobial treatment or other approved intervention to livestock and
poultry carcasses prior to the chilling or cooling operation. Proposed
treatment methods included chlorine compounds, hot water, and any
antimicrobial compound previously approved by FSIS and listed in the
meat or poultry regulations. Product prepared for export to countries
that restrict or prohibit the use of antimicrobial treatments would
have been exempted from this requirement upon application to the
Administrator.
While most commenters generally agreed that antimicrobial
treatments could play an important role in reducing contamination with
pathogenic microorganisms in slaughter establishments, many commenters
opposed mandating such treatments. The commenters argued that mandating
the use of antimicrobial treatments in slaughter operations would not
be consistent with the HACCP philosophy and the overall shift by FSIS
to greater reliance on performance standards.
FSIS agrees with these commenters and has decided not to mandate
the use of antimicrobial treatments in slaughter establishments. FSIS
continues to believe that slaughter establishments will find that these
treatments can play a useful role in reducing pathogens and improving
the safety of meat and poultry products. Rather than mandating specific
antimicrobial treatments, FSIS will rely on other requirements in this
final rule to ensure that slaughter establishments are achieving an
acceptable level of performance in controlling and reducing harmful
bacteria on raw product.
The principle of using antimicrobial treatments as an intervention
to control pathogens on meat and poultry carcasses was strongly
endorsed by most commenters. However, few agreed that the treatments
should be mandatory. A majority of commenters recommended that
antimicrobial treatments be voluntary interventions. Establishments
would decide if antimicrobial interventions were needed to control
specific hazards at one or more critical control points in the
slaughter process.
Similarly, a number of commenters tied antimicrobial treatments to
microbial testing. They argued that carcass treatments should not be
required in establishments that consistently meet or exceed performance
standards for microbial contamination.
Commenters said FSIS should focus its regulatory efforts on
measurable, attainable goals and not on prescriptive requirements for
particular processing steps. Several commenters emphasized the need for
``whole system'' interventions instead of single
[[Page 38855]]
techniques such as antimicrobial treatments. They said these
interventions work best when they are tailored to species and product
hazards, individual establishment configurations, and processing
methods. Furthermore, some commenters cited a danger that
establishments and inspection personnel would focus on the treatment
function itself instead of broader food safety goals.
FSIS generally agrees with these comments. FSIS has concluded that
its food safety goals can be achieved more effectively and more
efficiently by requiring HACCP-based process control combined with
appropriate performance criteria and standards than by mandating
specific interventions, such as antimicrobial treatments. New
technological interventions will play a significant role in reducing
the risk of foodborne illness and should be adopted as part of an
overall system of HACCP-based process control. FSIS expects that such
treatments may be used by establishments to meet the process control
performance criteria and pathogen reduction performance standards FSIS
is adopting in this final rule.
A few commenters opposed mandating antimicrobial treatments because
they believed their use would allow for correction of sloppy carcass
dressing procedures. These commenters argued that antimicrobial
treatments, whether mandatory or voluntary, emphasize post-
contamination clean-up rather than prevention.
FSIS also received many comments which addressed the four proposed
antimicrobial treatment methods. Many commenters stated that FSIS
should not restrict establishments to these particular antimicrobial
interventions.
A variety of commenters addressed technology issues concerning the
proposed treatment methods themselves. Many said that too few studies
have been conducted to show which interventions are most effective and
efficient for specific pathogens associated with particular species in
individual slaughter establishment configurations. Some argued that the
studies FSIS cited in its proposal were too narrow and did not
adequately demonstrate effectiveness. They said additional studies were
needed to determine the practicality, efficacy, and expense of various
antimicrobial treatments in commercial settings. In addition, some
commenters were concerned that insufficient research was available on
whether the elimination of competitive micro flora would allow
uninhibited growth of pathogenic bacteria.
Individual antimicrobial techniques were also criticized. For
example, hot water sprays were said to pose dangers to establishment
personnel applying the treatments at temperatures necessary for
effectiveness. Hot water sprays raise carcass temperatures with
consequent melting of surface fat in some species, contribute to
quality defects such as change in product color and partial cooking,
and result in higher energy costs. Commenters recognized, however, that
hot water was the only currently available nonchemical intervention
that could be implemented at comparatively low cost. Other commenters
criticized lactic, acetic, and citric acid solution sprays because they
have low effectiveness as a treatment against E. coli O157:H7. The
possible carcinogenic effects of chlorine were also mentioned, as were
concerns about water reuse and possible environmental effects from
spray effluents.
Commenters also suggested a variety of alternative antimicrobial
interventions that could be used by establishments. These interventions
included irradiation and radiation-emitting electronic devices such as
x-rays and linear accelerators; high-energy ultraviolet light; pulsed
light, sonic, infrasonic, and ultrasonic emitters; chemicals such as
copper sulfate in the pentahydrate form, chlorine dioxide, and hydrogen
peroxide; procedures such as pre-evisceration washes, water curtains,
counter current or counter flow scalders, the Peroxi bicarb process,
automatic warm fresh water rinses, ozonated water, steam
pasteurization, steam vacuuming, hot wax dipping, and singeing.
A number of commenters also suggested that FSIS establish protocols
to evaluate various forms of antimicrobial procedures and treatments.
FSIS could then publish a regularly updated list of acceptable
treatments and provide guidelines for their use in a commercial
setting. It was argued that this process would give establishments the
flexibility to implement any interventions they deem necessary. Others
said FSIS should set up a predetermined protocol for antimicrobial
agents or an expedited review process for new technologies.
FSIS agrees that issues of effectiveness, product and worker
safety, product quality, interference with inspection, and
environmental impact can be raised about most food safety
interventions, including antimicrobial treatments. Therefore, to
facilitate industry development of new technologies, FSIS has
established a process that will facilitate this development.
On May 25, 1995, FSIS published a notice in the Federal Register
(60 FR 27714) that presented guidelines for preparing and submitting
experimental protocols to FSIS for use by establishments wishing to
conduct trials of new technologies and procedures. In that notice, FSIS
confirmed its long-standing commitment to foster innovative
technologies and procedures that more effectively protect meat and
poultry products from microbiological and other hazards. Specifically,
FSIS encouraged the development of efficacious, practical and
manageable technologies and procedures by establishments.
FSIS also published guidelines (FSIS Directive 10,700.1) for
establishments to use for submitting written proposals and protocols to
FSIS for approval to conduct experiments. Agency approval is required
in cases where the intended technology, procedure or process may affect
(1) product safety or lead to economic adulteration, (2) worker safety,
(3) environmental safety, or (4) inspection procedures.
Similarly, FSIS published a proposed rule in the Federal Register
(60 FR 67459; December 29, 1995) that will facilitate the review and
approval of substances intended for use in or on meat and poultry
products. Under the proposed procedures, FSIS would no longer issue its
own regulations listing substances it finds suitable for use in meat
and poultry products. Instead, FDA's regulations would specify whether
a substance approved for use in foods under the Federal Food, Drug, and
Cosmetic Act may be used in or on meat or poultry products.
Many commenters stated that antimicrobial interventions should be
permitted at any stage in the slaughter process: live animal, pre-hide
removal, pre- or post-carcass wash, pre- or post-chill, or just prior
to fabrication.
Some commenters argued that the proposed treatments would seriously
compromise the Kosher ritual salting process, while others said the
interventions would conflict with Confucian and Buddhist-style poultry
prepared for religious rites.
A number of commenters questioned the relationship between FSIS's
policy on zero tolerance for fecal contamination and its antimicrobial
treatment proposal. In particular, they were concerned about where in
the process zero tolerance would be measured.
Finally, several commenters requested a practical definition of
``feces'' as a means to resolve disagreements between inspectors and
establishment personnel about trimming contamination.
[[Page 38856]]
Cooling and Chilling Requirements for Raw Meat and Poultry
FSIS proposed that establishments slaughtering livestock be
required to chill carcass surfaces and hot-boned meat to 50 deg.F
(10 deg.C) within 5 hours and then to 40 deg.F (4.4 deg.C) within 24
hours of slaughter or meat and bone separation. Chilling of meat
products such as liver and cheek meat would have been required to begin
within one hour of removal from a carcass. The proposed rule also would
have changed existing poultry chilling requirements (Sec. 381.66) to be
comparable with those proposed for meat. Chilling would have been
required unless the raw product was going directly from slaughter to
heat processing.
The proposal also would have required that establishments maintain
raw meat and poultry products at an internal temperature of 40 deg.F or
below while in the establishment and before release into commerce. Raw
products not chilled in accordance with the requirements would have
required further processing to kill pathogens or would be condemned.
Lastly, the proposal would have required each establishment
handling raw product to have a written plan for temperature controls
and monitoring and make monitoring records available to FSIS upon
request.
The proposed rule was based on good manufacturing practices
generally prevalent in the industry. FSIS's position was that
temperature controls, which are known to prevent bacterial growth, are
an accepted part of current industry practices, are already required by
regulation for poultry carcasses, and should be mandated for all raw
product to minimize the possibility that raw products leaving official
establishments bear significant levels of pathogenic microorganisms.
Commenters generally supported the concept that establishments
should be required to chill raw product as a means of minimizing the
growth of harmful bacteria. Some commenters supported the time and
temperature requirements as proposed. Others argued that the specific
time and temperature combinations in the proposed rule were unduly
restrictive and unworkable. A number of commenters advocated ``more
realistic'' cooling requirements that take into consideration
establishment and product variety, different processing operations, and
diverse shipping and receiving operations. These commenters supported
the use of independent ``process authorities'' to advise establishments
on cooling carcasses and other raw products. Some suggested that the
proposed chilling requirements should be recast as guidelines.
Many commenters questioned the need for any regulatory requirements
for chilling and asserted that it was conceptually at odds with the
proposed HACCP provisions. They recommended that FSIS defer any
regulation on chilling because establishments would have to address
chilling as part of their HACCP plans.
Some commenters raised concerns about the scientific basis of the
proposed time and temperature requirements. They asserted that the
cooling requirements would not result in any demonstrable improvement
in food safety because they were not based on scientifically valid
data. A number of commenters said that the proposed time and
temperature requirements were simply not achievable by the beef
industry due to the large size of beef carcasses. Also, they said that
these carcass cooling requirements might change meat quality attributes
such as product texture and palatability.
Many commenters asserted that FSIS's regulatory focus and the
economic burdens are placed entirely on establishments when, these
commenters argue, a large proportion of foodborne illnesses are caused
by temperature abuse and other mishandling of raw products after they
leave the establishment.
Many commenters expressed concern about risks to employees' health
that could result from employees working continuously in a colder
environment. They cited worker safety studies showing many human
physical ailments are created or aggravated by cold ambient
temperatures. Worker safety was also cited as an issue on the grounds
that the difficulty of handling and cutting meat at such cold
temperatures increases the potential for accidents and injuries.
Some commenters noted that FSIS did not specify how the equivalence
of alternative procedures could be established. In addition, some
suggested specific alternative methodologies they thought would provide
equivalent procedures, such as cooling with dry ice, CO2, or
nitrogen. Others either did not approve of using any alternative
chilling process or wanted them to be included in the final rule.
Some commenters questioned the rationale for proposing identical
requirements for meat and poultry. They said that using the same set of
requirements for all species fails to take into account the variation
in carcass size.
Commenters from small businesses said they did not have the cooling
capacity to comply with the proposed requirements, and that the cost of
expanding facilities, obtaining the necessary refrigeration equipment,
and retaining quantities of carcasses long enough to chill them to
40 deg.F before shipping was prohibitive.
Other commenters said the time and temperature requirements
conflicted with religious, cultural, and ethnic practices. For example,
there are ethnic markets for ``hot pork,'' whereby hogs are slaughtered
and delivered directly to customers for preparation and consumption
with little or no intervening chilling. A similar process is used with
lamb, goat, and beef for Moslem customers. Some commenters asserted
that the proposed requirements also conflict with and preclude the
Kosher process of ritual salting of poultry.
Commenters also were concerned that carcasses that are processed in
one establishment and shipped to another establishment for immediate
further processing or directly to an off-site cooling facility would
have to meet carcass cooling requirements.
Questions were raised about the disposition of products that did
not meet temperature requirements. Concern was expressed about the
possible condemnation of large quantities of product based on slight
deviations from temperature requirements that would not by themselves
jeopardize food safety.
A number of commenters addressed the proposed shipping temperature
requirements. Many asserted that temperature variation during shipping
is a significant problem. Several commenters asked about their
liability for product after it has left their custody and is found
later, e.g., at a warehouse or retail establishment, to have been
subjected to temperature abuse or other mishandling. Related comments
stated that time and temperature controls were important at all stages
of food production, especially at retail, and should be more of a focus
of FSIS's regulatory oversight.
A few commenters expressed concern about the burden of preparing a
written plan and the proposed recordkeeping requirements.
After reviewing the comments, FSIS agrees that the proposed
regulations on this issue should not be promulgated at this time. FSIS
is persuaded that the complexity and variety of acceptable chilling
practices now in use make the proposed prescriptive time and
temperature requirements unduly burdensome and impractical. FSIS
[[Page 38857]]
intends to seek an alternative that will not conflict with Kosher or
other religious, cultural, or ethnic practices that do not present food
safety hazards to consumers. FSIS has concluded that its food safety
objectives may be achieved more effectively by regulatory means other
than those proposed.
Nevertheless, FSIS continues to believe that prompt, thorough
chilling of carcasses and raw meat and poultry products by slaughtering
establishments is necessary to minimize consumers' exposure to
pathogenic microorganisms. Cooling of carcasses is generally
acknowledged to be an essential component of any establishment's
processing controls for safe food production.
FSIS agrees with those commenters who stated that keeping raw
products cooled after they leave the establishment, during
transportation, storage, distribution, and sale to consumers, is
essential if growth of pathogenic microorganisms on raw products is to
be prevented. This is consistent with FSIS's farm-to-table food safety
strategy.
Instead, FSIS believes that the best way to regulate in this area
would be by having as a performance standard a maximum temperature for
products being shipped into commerce, and at which raw products in
commerce must be maintained. This standard would be applicable to all
persons who handle such product before the product reaches the
consumer. FSIS believes that there are at least two possible
temperatures for this purpose.
A mandatory temperature of 41 deg.F would provide a large margin of
safety against the multiplication of pathogenic bacteria, which
generally will not multiply at temperatures below 50 deg.F. It is
similar to the maximum temperature of 40 deg.F originally proposed by
FSIS and recommended in Agriculture Handbook No. 412. It is also the
same temperature as that specified in the Food and Drug
Administration's current model Food Code which is offered for adoption
by States and other government entities with jurisdiction over food
service, retail food stores and food vending machine operations.
Alternatively, a temperature of 45 deg.F would still provide a
margin of safety and also is that required in FDA's current Good
Manufacturing Regulations for refrigerated foods generally. It also
would comport with the temperature establis
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
hed for raw product in
commerce by the European Union. That temperature is increasingly
accepted as a standard for raw product storage and transportation by
other countries and appears to be an emerging standard for
international trade.
FSIS could supplement the shipping/storage temperature regulations
with guidelines, including recommended criteria for microorganisms,
that would provide purchasers and vendors in commerce additional means
by which to determine whether products bear a level of bacteria
indicative of temperature abuse and, therefore, are likely to bear
levels of pathogenic microorganisms that could be associated with
foodborne illnesses.
FSIS has concluded that development of such a performance standard
requires that it obtain additional information and engage in further
rulemaking. Therefore, FSIS will extend and expand this rulemaking
proceeding on the issue of cooling raw meat and poultry products. FSIS
will consider alternatives to the specific time and temperature
requirements it proposed, including performance standards governing
cooling during transportation and storage of raw meat and poultry,
probably in the form of a maximum temperature for transporting and
holding such product.
As the next step in its proceedings on this topic, FSIS plans to
hold a public conference to gather further information on the many
technical and practical issues raised in the comments as well as on
possible alternatives to the proposal which will be outlined in the
Agency's announcement of the conference.
International Trade
The inspection statutes require that meat and poultry products
imported into the United States be produced under an inspection system
equivalent to the U.S. inspection system.
A large number of commenters requested that FSIS clarify how it
will determine the ``equivalence'' of foreign inspection systems
following HACCP implementation. Commenters questioned exactly how FSIS
will determine foreign system equivalency regarding HACCP systems.
Further, some commenters asserted that requiring foreign equivalency
with the U.S. HACCP system could create problems in foreign trade if
HACCP implementation in the United States causes some foreign
inspection programs previously designated ``equivalent'' to lose that
designation.
Foreign countries with establishments exporting to the United
States must establish inspection system requirements ``equivalent to''
U.S. requirements. This means that all foreign meat and poultry
establishments that export meat to the United States must operate HACCP
systems or process control systems ``equivalent to'' HACCP. They must
also adopt equivalent performance standards.
The components of FSIS's current import inspection system will not
change. As part of the evaluation of the laws, policies, and
administration of the inspection system of any foreign country eligible
to export meat or poultry products into the United States, FSIS will
assess the status of HACCP-- or equivalent process control system-
implementation in that country. This assessment will include on-site
reviews of individual establishments, laboratories, and other
facilities within the foreign system. The ``equivalency'' of foreign
inspection will be determined at this stage.
Further, when these regulations are implemented, the import
inspection system will continue to include port-of-entry inspection by
FSIS inspectors to verify the effectiveness of foreign inspection
systems. All countries exporting raw products to the United States must
develop and implement performance standards that are equivalent to the
pathogen reduction performance standards for Salmonella. They must also
be able to demonstrate that they have systems in place to assure
compliance with the standards.
As of January 1, 1995, 1,395 establishments in 36 countries were
certified to export meat or poultry products to the United States.
Canada, with 599 establishments; Denmark, with 125; Australia, with 111
establishments; and New Zealand, with 94 establishments, accounted for
two-thirds of those, which were collectively the source of 85 percent
of the 2.6 billion pounds of product imported into the United States
during 1994. Canada, Denmark, Australia, and New Zealand are currently
developing HACCP systems.
Most of the comments concerning the impact on exports dealt with
the proposed requirement for antimicrobial treatment of U.S. product
and the proposed exemption for exported product. That proposed
requirement raised particular concerns because the European Union
member states and Canada restrict the use of certain antimicrobials on
meat and poultry carcasses.
A number of commenters cited the fact that a proposed exemption
would be ineffective because establishments cannot segregate treated
product from untreated product. Commenters said this occurs because
antimicrobial treatments are performed on whole carcasses, while most
meat and poultry is exported in parts. This condition, the commenters
argued, would cause
[[Page 38858]]
significant operational difficulty to establishments that were required
to separate product that had and had not been treated, as well as
inventory management problems. This requirement might also result in an
artificial trade barrier with countries such as Canada, which restrict
use of certain antimicrobial treatments. Suggestions were made that
FSIS should obtain Codex support and acceptance for the proposed
antimicrobial interventions as a means to overcome international
objections to their use. The Agency's decision not to mandate
antimicrobial treatments largely negates these concerns. FSIS will
continue to work within Codex and in its bilateral relations with major
trading partners to ensure that the scientific basis for food safety
practices in the U.S. are understood and accepted.
The final rule will affect U.S. exports only if an establishment
has difficulty meeting the new microbial performance standards without
using an antimicrobial treatment. FSIS is aware that alternative
technologies now available can facilitate international trade. For
example, public comments indicated that trisodium phosphate is approved
for use in Canada and the United Kingdom, and is being considered by
the European Union, Australia, and New Zealand. Steam vacuum systems
constitute an improved technology for establishments exporting beef and
pork products.
Recordkeeping and Record Retention
FSIS notes that recordkeeping requirements and record retention
periods for sanitation SOP's, microbiological testing, and HACCP are
found in 416.12, 310.25(b)(4), and 381.94(b)(4), and 417.5,
respectively. The proposed amendments to sections 320.1, 320.3,
381.175, and 381.177 were intended to continue FSIS' practice of cross-
referencing recordkeeping requirements in Secs. 320.1, 320.3, 381.175,
and 381.177. FSIS has determined that it is unnecessary to amend these
sections at this time, especially in view of its ongoing efforts to
simplify, consolidate, and streamline the meat and poultry inspection
regulations.
Finished Product Standards for Poultry Carcasses
FSIS proposed to remove the feces nonconformance specification from
the poultry finished product standards regulations (Sec. 381.76, Table
1). That change in the poultry products inspection regulations is being
effected not in this final rule but in the forthcoming final rule,
``Enhanced Poultry Inspection; Revision of Finished Product Standards
with Respect to Fecal Contamination,'' Docket No. 94-016F.
VI. Economic Impact Analysis and Executive Orders
Executive Order 12866
This rule has been determined to be economically significant and
was reviewed by OMB under Executive Order 12866.
HACCP-based Regulatory Program Produces Net Benefit to Society
FSIS has prepared a Final Regulatory Impact Assessment (FRIA) that
evaluates the costs and benefits of a mandatory HACCP-based program for
all meat and poultry establishments under inspection. The FRIA
concludes that mandating HACCP systems will lead to potential benefits
that far exceed industry implementation and operating costs.
The 20-year industry costs of implementing the HACCP-based
regulatory program are estimated to be $968 to $1,156 million. The 20-
year costs to the government are estimated at $56.5 million. FSIS
estimated that the proposed rule would have 20-year costs of $2.2
billion dollars. The costs from the Preliminary Regulatory Impact
Analysis (PRIA) are not directly comparable to costs estimated for the
final rule. The proposed rule had a larger number of explicit
regulatory requirements. The PRIA focused on estimating the predictable
costs of meeting those requirements and included an implicit assumption
that compliance with the proposed requirements would assure compliance
with pathogen reduction objectives. In contrast, the final rule allows
for greater flexibility in meeting the pathogen reduction standards,
but also outlines a more rigorous enforcement strategy. Thus for the
FRIA, it was necessary to develop separate cost estimates for the
potential costs of meeting the new pathogen reduction performance
standards for Salmonella. Modifications incorporated into the final
rule have both reduced the total estimated costs and redistributed
costs in a way that reduces the relative burden on smaller
establishments.
Both the preliminary and final analysis identify a potential public
health benefit of $7.13 to $26.59 billion, tied to eliminating the
contamination by four pathogens that now occurs in meat and poultry
establishments. These four pathogens include the three most common
enteric pathogens of animal origin: Campylobacter jejuni/coli, E. coli
O157:H7, Salmonella and one environmental pathogen Listeria
monocytogenes. The potential benefit estimate is tied to the
minimization of risk from the 90 percent of these pathogens that are
estimated to contaminate meat and poultry during slaughter and dressing
procedures. The remaining 10 percent of contamination is estimated to
occur after the product leaves the manufacturing sector. The link
between regulatory effectiveness, where effectiveness refers to the
percentage of pathogens eliminated at the manufacturing stage, and
health benefits is the assumption that a reduction in pathogens leads
to a proportional reduction in foodborne illness. The high and low
range for potential benefits occurs because of the current uncertainty
in the estimates of the number of cases of foodborne illness and death
attributable to pathogens that enter the meat and poultry supply at the
manufacturing stage.
The benefits analysis in the FRIA concludes that there is
insufficient knowledge to predict with certainty the effectiveness of
the rule, where effectiveness refers to the percentage of pathogens
eliminated at the manufacturing stage. Without specific predictions of
effectiveness, FSIS has calculated projected health benefits for a
range of effectiveness levels. For example, if the HACCP-based program
can reduce the four pathogens by 50 percent and that reduction leads to
a proportionate reduction in foodborne illness, the projected benefits
range from $3.6 to $13.3 billion, which is half the potential benefit
estimate of $7.13 to $26.59 billion.
If the low potential benefit estimate is correct, the analysis
shows that the new HACCP-based program must reduce pathogens by 15 to
17 percent before benefits outweigh projected costs. If the high
estimate is the correct estimate, the new program needs to reduce
pathogens by only 4 to 5 percent to generate net societal benefits.
While there were a large number of comments relating to the
effectiveness estimates in the PRIA, there were no comments that
claimed or implied that HACCP would not reduce pathogens at levels
necessary to produce net societal benefits. The requirements of the
final rule are organized around the following three components:
The requirement that all inspected establishments
develop and implement HACCP programs based on the seven recognized
principles of HACCP.
The requirement that all inspected establishments
develop and implement Sanitation SOP's.
The requirements that all establishments that slaughter
cattle, swine, chickens or turkeys implement a microbial sampling
[[Page 38859]]
program using E. coli (generic) as a measure of control of slaughter
and sanitary dressing procedures and that all establishments that
slaughter cattle, swine, chickens or turkeys or produce raw ground
product from these animals or birds meet new pathogen reduction
performance standards for Salmonella.
The proposal and final rule can be viewed as two scenarios for
implementing a mandatory HACCP-based regulatory program. While it's not
possible to compare the benefits of these two options, the FRIA does
present a comparison of the costs.
Table 5 summarizes the estimated costs for both the proposal and
final rule by individual regulatory component. As mentioned above, the
costs are not directly comparable because the regulatory components
have changed. Table 5 shows that all costs have been eliminated for the
components of time-and-temperature requirements and antimicrobial
treatments. However, the discussion of potential costs in the FRIA
recognizes that some establishments may use antimicrobial treatments to
help meet the pathogen reduction performance standards for Salmonella.
Other establishments may impose temperature limits to help control
Salmonella growth.
Table 5 includes the final cost estimate for generic E. coli
sampling in slaughter establishments under the regulatory component for
microbial testing. The costs for required microbial sampling have
decreased substantially from the proposal.
In the FRIA, FSIS increased or added a cost estimate for four
regulatory components. First, based on comments, FSIS added costs for
recurring training to account for the fact that employee turnover will
sometimes require establishments to train additional employees. Second,
FSIS also added a minimal cost for annual reassessment of HACCP plans,
although the Agency believes that reassessment will be negligible for
establishments successfully operating HACCP systems. Third, FSIS has
increased the estimated cost for HACCP plan development. The estimate
for this cost was increased after reviewing public comments and
assessing the overall impact on plan development costs of decisions to
eliminate time-and-temperature and antimicrobial treatment requirements
prior to HACCP implementation. Finally, the Agency recognizes that some
establishments will have difficulty meeting the new performance
standards for Salmonella and that implementing sanitation SOP's and
HACCP plans will not always assure sufficient pathogen reduction. The
FRIA has developed two scenarios that lead to low and high cost
estimates related to potential actions that establishments might
undertake. Such actions include both process modifications to reduce
pathogens and the implementation of Salmonella testing programs to
assure compliance with the new performance standards.
As shown in Table 5, the two scenarios developed in the FRIA lead
to a range in cost estimates of $55.5 to $243.5 million to comply with
the new pathogen reduction standards for Salmonella. The FRIA
recognizes that the performance criteria for generic E. coli also
create a set of potential costs for slaughter establishments. A line
for these costs is shown in Table 5 along with the entry that these
costs were not separately quantified.
As discussed in the FRIA, the anticipated actions to comply with
the generic E. coli criteria are the same as the anticipated actions to
comply with the standards for Salmonella. FSIS has concluded that if
the low cost scenario for Salmonella compliance proves to be more
accurate, than the Agency would expect to see some compliance costs for
the generic E. coli performance criteria. If the high cost scenario is
correct, then the compliance actions taken to assure compliance with
the Salmonella standards should also assure compliance with the generic
E. coli criteria.
Table 5.--Comparison of Costs--Proposal to Final
[$ Millions--Present value of 20-year costs]
----------------------------------------------------------------------------------------------------------------
Regulatory component Proposal Final
----------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's.............. 175.9a................................ 171.9
II. Time/Temperature Requirements 45.5.................................. 0.0
III. Antimicrobial Treatments.... 51.7.................................. 0.0
IV. Micro Testing................ 1,396.3b.............................. 174.1
V. Compliance With Salmonella Not Separately Estimatedc............. 55.5-243.5
Standards.
Compliance with generic E. Not Applicable........................ Not Separately Estimated
coli criteria.
VI. HACCP
Plan Development............. 35.7.................................. 54.8
Annual Plan Reassessment..... 0.0................................... 8.9
Recordkeeping (Recording, 456.4................................. 440.5d
Reviewing and Storing Data).
Initial Training............. 24.2.................................. 22.7d
Recurring Training........... 0.0................................... 22.1e
VII. Additional Overtime......... 20.9.................................. 17.5d
==============================================================================
Subtotal--Industry Costs... 2,206.6............................... 968.0-1,156.0
VIII. FSIS Costs................. 28.6f................................. 56.5
------------------------------------------------------------------------------
Total...................... 2,235.2............................... 1,024.5-1,212.5
----------------------------------------------------------------------------------------------------------------
a The preliminary analysis included a higher cost estimate for sanitation SOP's ($267.8 million) that resulted
because of a programming error. The cost estimate of $175.9 million is based on an effective date of 90 days
after publication.
b The preliminary analysis was based on the premise that microbial testing would be expanded to cover all meat
and poultry processing after HACCP implementation. The proposed rule only required sampling for carcasses and
raw ground product. Thus, the cost estimate of $1,396.3 million was higher than the actual cost of the
proposed sampling requirements.
c The preliminary analysis accounted for some of the cost of complying with the new standards under the
regulatory components of micro testing, antimicrobial treatments, and time and temperature requirements.
d These costs are slightly different from the proposal because of changes in the implementation schedule.
e FSIS added costs for recurring training based on the review of public comments.
f Based on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP
verification testing.
[[Page 38860]]
Market Failure Justifies Regulation of Pathogens
Since all raw meat and poultry products contain microorganisms that
may be pathogens, raw food unavoidably entails some risk to consumers
of pathogen-exposure and foodborne illness. The presence and level of
this risk cannot be determined by a consumer since pathogens are not
visible to the naked eye. The societal impact of this food safety
information deficit is a lack of accountability for foodborne illnesses
caused by pathogenic microorganisms. Consumers often cannot trace a
transitory illness to any particular food or even be certain it was
caused by food. Thus, food retailers and restaurateurs are generally
not held accountable by their customers for selling pathogen-
contaminated products and they, in turn, do not hold their wholesale
suppliers accountable either.
This lack of marketplace accountability for foodborne illness means
that meat and poultry producers and processors have little incentive to
incur extra costs for more than minimal pathogen controls. The
widespread lack of information about pathogen sources means that
business at every level from farm to final sale can market unsafe
products and not suffer legal consequences or a reduced demand for
their product.
The science and technology required to reduce meat and poultry
pathogens is well established, readily available, and commercially
practical. FSIS has concluded that the lack of consumer information
about meat and poultry product safety and the absence of adequate
incentives for industry to provide more than minimal levels of
processing safety represents a market failure requiring Federal
regulatory intervention. The present combination of market regulation
and industry self-policing has not resolved increasingly apparent
problems with meat and poultry pathogens. Documented cases of foodborne
illness each year, some of which have resulted in death, represent a
public health risk that FSIS has determined to be unacceptable. A
comprehensive Federal regulatory program is the only means available to
society for lowering foodborne pathogen risks to an acceptable level.
FSIS further concludes that a mandatory HACCP regulatory program is the
only means to attain this goal.
Regulatory Alternatives
After considering broader regulatory approaches including market
incentives and voluntary industry standards, FSIS has determined that
effective process control is needed throughout the meat and poultry
industry in order to minimize pathogen contamination of food products
and lower the risk of subsequent foodborne illness.
FSIS examined the following seven process control approaches before
determining that mandatory HACCP was the most effective means for
industry to eliminate pathogens in meat and poultry:
Status quo
Intensify present inspection
Voluntary HACCP regulatory program
Mandatory HACCP regulation with exemption for small
businesses
Mandatory HACCP regulation only for ready-to-eat products
Modified HACCP--negative records only
Mandatory HACCP for all establishments
Each of these seven alternatives was assessed using the following
five effectiveness factors for process control:
Controls production safety hazards
Reduces foodborne illness
Makes inspection more effective
Increases consumer confidence
Provides the opportunity for increased productivity
Only mandatory HACCP for all establishments was determined to meet
all five criteria; all of the others were found to be flawed in meeting
one or more of the target factors.
The full text of the Final Regulatory Impact Analysis is published
as a supplement to this document.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act (P.L. 104-4) requires (in Section
202) that agencies prepare an assessment of anticipated costs and
benefits before proposing any rule that may result in annual
expenditures by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000, (adjusted annually for
inflation). The preliminary and final RIA's fulfill this requirement of
the Unfunded Mandates Reform Act. FSIS has treated both the proposed
rule and this final rule as an economically significant regulatory
action, i.e., annual cost to the private sector of more than
$100,000,000, under Executive Order 12866 and has prepared a final
Regulatory Impact Analysis (RIA) in compliance with the provisions of
Executive Order 12866. The final RIA identifies annual recurring
private sector costs of from $99.6 to $119.8 million and potential
annual public health benefits of $.99 to $3.69 billion.
The Act also requires (in Section 205) that the Agency identify and
consider a reasonable number of regulatory alternatives and, from these
alternatives, select the least costly, most cost-effective, or least
burdensome alternative that achieves the objective of the rule. In the
final RIA, FSIS considered several broad regulatory alternatives and
selected the one that is both cost-effective and also the least
burdensome alternative that achieves the food safety objectives of the
rule. FSIS concluded that market incentives will not address the public
health risk resulting from microbial pathogens in meat and poultry,
primarily because there is rarely feedback to consumers that allows
more informed purchase decisions nor is there feedback which would
permit consumers who experience a foodborne illness to routinely, and
at low cost, seek compensation from responsible parties for losses
arising from their foodborne illness. Thus, market solutions would not
adequately address the food safety objectives on the rule. FSIS
concluded that an industry administered system of voluntary standards
is likely to be more expensive and less effective than a governmental
one. Finally, FSIS has recognized that public education is essential
for assuring food safety, but experience has shown that education alone
has limited effectiveness in reducing foodborne illness. Thus, while
consumer education may be cost-effective it would not meet the
objective of substantially reducing foodborne illness.
Based on a qualitative analysis of broad regulatory strategies, the
final RIA concluded that mandatory government standards were needed to
achieve a solution that is both cost-effective and meets the objective
of reducing the risk of foodborne illness from meat and poultry. Within
the framework of a mandatory regulatory program, the final RIA
discusses several alternatives to a mandatory HACCP-based program for
all inspected establishments including intensified inspection,
mandatory HACCP with a small business exemption and mandatory HACCP for
only ready-to-eat products. These alternatives were evaluated using
several criteria incorporating the goals of effectiveness, efficiency
and increased consumer confidence. Using these criteria FSIS concluded
that HACCP systems designed to meet microbial performance standards
will be both cost-effective and the least burdensome alternative for
meeting the foodborne illness reduction objectives of the rule. As the
final RIA points out, requiring mandatory process control without
microbial performance
[[Page 38861]]
standards could lead to processes that are well controlled at
unacceptable pathogen levels. FSIS believes that microbial performance
standards are necessary to achieve substantial pathogen reduction,
encourage industry innovation, and provide the impetus for continuing
improvement and increasing effectiveness.
Consistent with the requirements in Section 204 to provide
opportunity for input from State, local and tribal government
officials, FSIS held a ``Federal-State-Relations Conference,'' August
21-23, 1995, in Washington, D.C. This meeting, in which the National
Association of State Departments of Agriculture participated, provided
an opportunity for representatives from State government to engage in
an open exchange with senior USDA officials on the Pathogen Reduction/
HACCP proposal. In addition to Directors of State meat and poultry
inspection programs, the meeting included representatives from State
Departments of Agriculture, State Health Departments and local food
safety enforcement agencies.
Also related to the Section 204 requirements, on May 22, 1995 the
Agency held a public meeting for owners and representatives of small
meat and poultry establishments and other affected small businesses to
discuss the pathogen Reduction/HACCP proposal. Three Directors of State
meat and poultry inspection programs provided comments at the meeting.
Section 202 of the Act also requires a summary and evaluation of
comments received from State, local, or tribal governments. There were
a large number of comments from State and local governments, elected
members of State legislatures and associations representing State
programs or businesses within States. Collectively, these comments
covered most, if not all, of the issues addressed as part of this final
rule. This preamble and the final RIA represent a summary and
evaluation of these comments.
Most of the comments from State, local, or tribal governments
addressed the potential economic impact on small businesses. The Kansas
City meeting was intentionally focused on the small business issues.
Comments from the State program Directors included recommendations for
various forms of exemptions, voluntary programs or financial assistance
for small State inspected establishments. The Federal-State-Relations-
Conference included a more focused discussion on the cost to the State
programs. Attendees stated that FSIS failed to adequately consider the
cost of the changes to State programs and that FSIS was increasing the
resource demands for State programs without providing adequate funding.
There were also written comments stating that the proposed rule was
an unfunded Federal mandate because of the cost to small establishments
and the potential impact on State inspection programs. The preliminary
RIA did not address the impact on State programs. However, FSIS
recognizes that the 27 States operating their own meat and poultry
inspection programs will likely have to substantially modify their
programs after the HACCP/Pathogen Reduction regulation is finalized to
remain ``at least equal to'' Federal inspection programs as required by
the FMIA and PPIA. During the regulation's implementation period, FSIS
will be using the Agency's State-Federal Program resources to assist
the States in bringing the necessary changes to the State inspection
programs. Although FSIS has requested some additional funds to
implement this rule, FSIS has also acknowledged that implementation of
this rule will require eliminating some tasks, conducting other tasks
differently and streamlining the organization in order to free up
resources to fully address the new requirements. FSIS believes that the
same type of restructuring or reprogramming will take place within the
State programs. This does guarantee, however, that all States with
inspection programs will be able to implement the necessary program
changes without additional funds. FSIS believes, however, that with
FSIS assistance and with the flexibility provided under the ``equal
to'' provisions, most of the States should be able to modify their
programs with minimal additional costs. To the extent that there are
any additional costs, the State inspection programs are eligible to
receive up to 50 percent Federal matching funds.
Regulatory Flexibility Act
The Administrator, FSIS, has determined that this rule will have a
significant economic impact on a substantial number of small entities.
This final rule uses two size criteria for providing regulatory
flexibility for small entities. For livestock and poultry slaughter
facilities, the microbial sampling requirements vary depending on the
number of animals or birds slaughtered annually. This will
significantly reduce the microbial testing costs for smaller
establishments which, under the proposed rule, would have been required
to test each species they slaughter every day on which slaughter of
that species occurred. Under the final rule, establishments that
annually slaughter fewer than 6,000 cattle, 20,000 swine (or a
combination of such livestock not to exceed a total of 20,000, with a
maximum of 6,000 cattle), 60,000 turkeys or 440,000 chickens (or a
combination of chickens and turkeys not to exceed 60,000 turkeys or
440,000 birds total) will not be required to operate microbial sampling
programs on a continuous basis. Over 78 percent (2,098) of the total
2,682 slaughter establishments meet these criteria. These
establishments will be required to annually verify that their slaughter
and sanitary dressing processes are under control. However, after an
initial period of sampling in each year, these establishments will be
required to conduct further sampling in that year only if they make
major changes to facilities, equipment, and personnel whereby the
slaughter and dressing process is significantly changed.
These low-volume establishments will be required to analyze one
sample per week until they have demonstrated compliance with
established criteria. At a minimum, low-volume slaughter establishments
will be required to collect and analyze one sample per week until they
complete a sampling window (13 samples) annually in order to assess
whether the performance criteria continue to be met.
Small slaughter establishments that process only minor species
(e.g., goats, sheep, ducks, pheasants, etc.) will not be required to
conduct any sampling. Small slaughter establishments will also face
less burden because the final rule no longer requires that both cattle
and swine or chickens and turkeys be sampled in the same establishment,
i.e., if a low-volume establishment slaughters both cattle and swine or
turkeys and chickens, it will be required to analyze one sample per
week from the predominant species until it has demonstrated compliance
with established criteria. The costs of small slaughter establishments
are also reduced because the carcass cooling and antimicrobial near-
term requirements have been eliminated from the final rule. Sampling
frequencies for even the larger slaughter establishments will be based
on production-volume, thus spreading the cost per pound relatively
equally among establishments.
For the purpose of sequencing HACCP implementation FSIS has defined
a small entity using the Small Business Administration size standard
for a small meat or poultry manufacturing establishment. That is, all
establishments with fewer than 500 employees will have additional time
to implement HACCP. In addition, in
[[Page 38862]]
response to comments that there are hundreds of ``very small'' or
``micro'' establishments, the Agency will classify an establishment as
``very small'' if it has either fewer than 10 employees or annual sales
of less than $2.5 million. This sequencing of HACCP responds to a large
number of comments requesting that small businesses be given a longer
period of time to implement HACCP requirements. Many small businesses
stated they did not want to be exempt, but asked for more flexibility
in implementing HACCP.
The FRIA is based on 353 large firms implementing HACCP at 18
months, 2,941 small firms implementing HACCP at 30 months and 5,785
very small (2,892 Federal plus 2,893 State) firms implementing HACCP at
42 months.
Table 6 illustrates the costs for a small, single-shift, processing
establishment (no TQC or sanitation PQC program) with two distinct
production operations other than raw ground product (overall average
estimated at 2.29 operations per establishment).
Table 6.--Costs for Typical Single-Shift Processing Establishment
[Dollars]
------------------------------------------------------------------------
Development
and Recurring
Requirement implementation annual
costs costs
------------------------------------------------------------------------
Sanitation SOP's........................... 190 1,242
HACCP Plan Development..................... 6,958 0
Annual Plan Reassessment................... 0 102
Training................................... 2,514 251
Recordkeeping.............................. 0 6,480
----------------------------
Total................................ 9,662 8,075
------------------------------------------------------------------------
If one of the two production operations produced a raw ground
product, the establishment would have to meet the pathogen reduction
performance standard for that product. The FRIA points out that raw
ground operations do not have the same opportunities to reduce
Salmonella levels as do slaughter establishments. They can control
growth by avoiding temperature abuse and can limit cross-contamination,
but basically they must depend on the Salmonella levels of their
incoming product in order to meet the performance standards. These
establishments may choose to test incoming product in order to
eliminate suppliers whose product is found to be positive. The FRIA has
assumed that the low volume producers would not test incoming
ingredients.
Table 7 illustrates the costs for a small, single-shift,
combination (slaughter and further processing) establishment that
slaughters cattle or swine, but not both, and has a single further
processing operation other than ground product. The establishment is
not under TQC inspection.
The cost of meeting the pathogen reduction performance standards
assumes that the establishment will use a hot water antimicrobial rinse
and have one sample per month analyzed at an outside laboratory ($33.35
per sample-$400 per year). The average number of head slaughtered in a
low volume establishment is approximately 5,000 annually. The annual
cost for the rinse is $400.
Table 7.--Costs for Typical Single-Shift Combination Establishment
[Dollars]
------------------------------------------------------------------------
Development
and Recurring
Requirement implementation annual
costs costs
------------------------------------------------------------------------
Sanitation SOP's........................... 190 1,242
Compliance with Salmonella Standards....... 0 800
E. coli Sampling........................... 1,043 653
HACCP Plan Development..................... 6,958 0
Annual Plan Reassessment................... 0 102
Training................................... 5,028 503
Recordkeeping.............................. 0 5,434
----------------------------
Total................................ 13,219 8,734
------------------------------------------------------------------------
The development costs for E. coli sampling in the small
establishment includes $640 for developing a sampling plan and $403 to
train an individual to conduct aseptic sampling. The recurring costs
are based on the assumption that an average low volume slaughter
establishment will have to complete two sampling windows (26 samples)
before they demonstrate compliance with established criteria.
The cost of HACCP training has doubled for the combination
establishment because the FRIA assumed that slaughter and processing
operations are significantly different, so that the establishment must
either train two employees or send one employee to two separate
training courses.
The HACCP recordkeeping costs (monitoring CCPs and recording
findings, reviewing records and storing records) in the above two
examples assume that the establishments are operating each process
continuously over a standard 52-week, 260-day, 2,080-hour work year.
Data collected during the preliminary analysis indicates that many low-
volume establishments frequently have only a single production line
operating at a given time. The final analysis estimates an average
annual cost for HACCP monitoring and recording of $4,030 for low-volume
establishments.
Executive Order 12778
This rule has been reviewed pursuant to Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the FMIA and PPIA from imposing any requirements with respect to
federally inspected premises and facilities, and operations of such
establishments, that are in addition to, or different from, those
imposed under the FMIA and PPIA. States and local jurisdictions may,
however, exercise concurrent jurisdiction over meat and poultry
products that are outside official establishments for the purpose of
preventing the distribution of meat or poultry products that are
misbranded or adulterated under the FMIA or PPIA, or, in the case of
imported articles, which are not at such an establishment, after their
entry into the United States. Under the FMIA and PPIA, States that
maintain meat and poultry inspection programs must impose requirements
on State-inspected products and establishments that are at least equal
to those required under the FMIA and the PPIA. These States may,
however, impose more stringent requirements on such State-inspected
products and establishments.
Paperwork Requirements
The paperwork and recordkeeping for this rule are approved under
OMB number 0583-0103, ``Pathogen Reduction, Hazard Analysis and
Critical Control Points (HACCP) Systems.'' OMB approved 14,371,901
annual reporting hours. Overall, the burden hours associated with the
rule decreased. FSIS determined that the new burden is 8,053,319 hours,
a 6,318,582-hour reduction. This reduction resulted from the
elimination of proposed requirements and the adjustment of certain
burden hour estimations. The following discusses the finalized
paperwork and recordkeeping requirements and the changes in the burden
estimations.
Sanitation Standard Operating Procedures (Sanitation SOP's)
As part of establishments' sanitation requirements, each
establishment must develop and maintain Sanitation SOP's that must, at
a minimum, address core
[[Page 38863]]
sanitation procedures. As part of the Sanitation SOP's, establishment
employees(s) must record results of daily sanitation checks on a
checklist at the frequencies stated in the Sanitation SOP's. The
checklist must include both preoperational sanitation checks and
operational sanitation checks. This checklist must be made available to
FSIS upon request.
Agency subject matter experts and private consultants estimate that
it will take an average of 5, 10, and 25 hours to develop a sanitation
program for low, medium, and high volume establishments, respectively.
The burden of documenting the adherence to Sanitation SOP's is based on
three factors; recording, reviewing, and storage. Recording encompasses
conducting and inscribing the finding from an observation and filing of
the document produced. This action is assumed to take 15, 25, and 45
minutes per day in a low-, medium-, and high- volume establishment,
respectively. Review of the records generated is estimated to take 5,
10, and 20 minutes per day for a low-, medium-, and high-volume
establishment, respectively.
OMB approved 1,243,622 burden hours for Sanitation SOP's plan
development, recording and filing, and record review. FSIS determined
that the burden estimate for these activities was too high. Based on
more accurate data, FSIS reevaluated the burden estimate and calculated
the new burden hours to be 1,231,986 hours. This is a 11,636 burden
hour decrease.
Time and Temperature
As discussed earlier, the proposed time-and-temperature
requirements are eliminated. OMB approved 869,156 burden hours for
time-and-temperature requirements. Therefore, elimination of the time-
and-temperature requirements, results in a 869,156 burden hour
decrease.
Microbiological Testing
As part of microbiological testing, each slaughter establishment
must develop written procedures outlining specimen collection and
handling. The slaughter establishments will be responsible for entering
the results into a statistical process control chart or table. The data
and chart will be available for review by FSIS upon request.
Agency subject matter experts estimate that it will take 25 hours
for establishments to develop a microbial sampling and analysis plan.
It will take an estimated 17.5 minutes to collect samples and 5 minutes
per sample to enter data into the chart, review, and file the
information.
OMB has approved 1,177,924 burden hours for microbial testing plan
development, sample collection, and data entry by meat and poultry
establishments. As discussed earlier, the number of meat and poultry
establishments required by the Pathogen Reduction/HACCP proposal to
perform microbial testing and the number of tests required decreased.
FSIS reevaluated this burden estimate and concluded that the burden for
microbial testing by meat and poultry establishments is 468,061 burden
hours. Therefore, the burden hour decrease associated with microbial
testing is 709,863 hours.
HACCP
Establishments will develop written HACCP plans that include:
identification of the food safety hazards reasonably likely to occur;
identification and description of the critical control point for each
identified hazard; specification of the critical limit that may not be
exceeded at the CCP; description of the monitoring procedure or device
to be used; description of the corrective action to be taken if the
limit is exceeded; description of the records that will be generated
and maintained regarding this CCP; and description of the establishment
verification activities and the frequency at which they are to be
conducted. Performance standards or limits specified in related FSIS
regulations must be accounted for in the critical limits.
Establishments will keep records of measurements taken during
slaughter and processing, corrective actions, verification check
results, and related activities that contain the identity of the
product, the product code or slaughter production lot, and the date the
record was made. The record will be signed by the operator or observer.
The HACCP records will be reviewed by an establishment employee
other than the one who produced the record, if practicable, before the
product is distributed in commerce. If a HACCP-trained individual is
on-site, that person should be the second reviewer. The reviewer will
sign the records.
Although the amount of time to develop a plan for each process
varies based on its difficulty, Agency subject matter experts estimate
that low, medium, high volume and state establishments will need an
average of 136, 126, 113, and 78 hours to develop each plan. There are
an estimated 7.4 CCP's for each processing plan in Federal
establishments, 5 CCP's for each slaughter plan in Federal
establishments, and 5 CCP's for both types of plans in State slaughter
establishments. The recording and filing is assessed to take 5 minutes
per CCP and the review should take 2 minutes per CCP.
OMB approved 11,081,199 burden hours for the maintenance of the
HACCP-trained individual's resume, plan development, recording, and
record review. As discussed earlier, FSIS will not require personnel
resumes to be maintained, thus the burden reported for this activity is
eliminated. Also, FSIS determined that the burden estimate for plan
development, recording, and record review was too high. Based on more
accurate data, FSIS reevaluated the burden estimate and calculated the
new burden hours to be 6,353,272. This is a 4,727,927 burden hour
decrease.
To better illuminate the burden hour changes, the following table
is provided.
Table 8.--Changes in Burden Hours
----------------------------------------------------------------------------------------------------------------
Burden hours
Requirement approved by New burden Reduction in
OMB hours burden hours
----------------------------------------------------------------------------------------------------------------
SOP's for Sanitation............................................ 1,243,622 1,231,986 11,636
Time and Temperature............................................ 869,156 0.00 869,156
Microbiological Testing......................................... 1,177,924 468,061 709,863
HACCP........................................................... 11,081,199 6,353,272 4,727,927
-----------------------------------------------
Total (Hours)............................................. 14,371,901 8,053,319 6,318,582
----------------------------------------------------------------------------------------------------------------
[[Page 38864]]
The changes in the paperwork and recordkeeping requirements
contained in this rule have been submitted to the Office of Management
and Budget for approval under the Paperwork Reduction Act (44 U.S.C.
3501 et seq.).
VII. Final Rules
List of Subjects
9 CFR Part 304
Meat inspection.
9 CFR Part 308
Meat inspection.
9 CFR Part 310
Meat inspection, Microbial testing.
9 CFR Part 320
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 327
Imports.
9 CFR Part 381
Poultry and Poultry products, Microbial testing.
9 CFR Part 416
Sanitation.
9 CFR Part 417
Hazard Analysis and Critical Control Point (HACCP) Systems.
For reasons set forth in the preamble, 9 CFR chapter III is amended
as follows:
PART 304--APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF
INSPECTION
1. The authority citation for part 304 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. Section 304.3 is added to read as follows:
Sec. 304.3 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an establishment shall
have developed written sanitation Standard Operating Procedures, as
required by part 416 of this chapter.
(b) Before being granted Federal inspection, an establishment shall
have conducted a hazard analysis and developed and validated a HACCP
plan, as required by Secs. 417.2 and 417.4 of this chapter. A
conditional grant of inspection shall be issued for a period not to
exceed 90 days, during which period the establishment must validate its
HACCP plan.
(c) Before producing new product for distribution in commerce, an
establishment shall have conducted a hazard analysis and developed a
HACCP plan applicable to that product in accordance with Sec. 417.2 of
this chapter. During a period not to exceed 90 days after the date the
new product is produced for distribution in commerce, the establishment
shall validate its HACCP plan, in accordance with Sec. 417.4 of this
chapter.
PART 308--SANITATION
3. The authority citation for part 308 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
4. Section 308.3 is amended by adding a sentence to the end of
paragraph (a) to read as follows:
Sec. 308.3 Establishments; sanitary condition; requirements.
(a) * * *. The provisions of part 416 of this chapter also apply.
* * * * *
PART 310--POST MORTEM INSPECTION
5. The authority citation for part 310 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
6. Part 310 is amended by adding a new Sec. 310.25 to read as
follows:
Sec. 310.25 Contamination with microorganisms; pathogen reduction
performance standards for Salmonella.
(a) Criteria for verifying process control; E. coli testing.
(1) Each official establishment that slaughters cattle and/or hogs
shall test for Escherichia coli Biotype I (E. coli) and shall:
(i) Collect samples in accordance with the sampling techniques,
methodology, and frequency requirements in paragraph (a)(2) of this
section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of
this section; and
(iii) Maintain records of such analytic results in accordance with
paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written
specimen collection procedures which shall identify employees
designated to collect samples, and shall address location(s) of
sampling, how sampling randomness is achieved, and handling of the
sample to ensure sample integrity. The written procedure shall be made
available to FSIS upon request.
(ii) Sample collection. The establishment shall collect random
samples from carcasses in the cooler. Samples shall be collected by
sponging three sites on the selected carcass. On cattle carcasses,
establishments shall take samples from the flank, brisket, and rump; on
swine carcasses, establishments shall take samples from the ham, belly,
and jowl areas. 1
---------------------------------------------------------------------------
\1\ A copy of FSIS's ``Guidelines for E. coli Testing for
Process Control verification in Cattle and Swine Slaughter
Establishments'' is available for inspection in the FSIS Docket
Room.
---------------------------------------------------------------------------
(iii) Sampling frequency. Samples shall be taken at a frequency
proportional to a slaughter establishment's volume of production, at
the following rates:
Bovines: 1 test per 300 carcasses
Swine: 1 test per 1,000 carcasses
(iv) Sampling frequency alternatives. An establishment operating
under a validated HACCP plan in accordance with Sec. 417.2(b) of this
chapter may substitute an alternative frequency for the frequency of
sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in
writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's processing controls.
(v) Sampling in very low volume establishments.
(A) An establishment annually slaughtering no more than 6,000
bovines, 20,000 swine, or a combination of bovines and swine not
exceeding 6,000 bovines and 20,000 animals total, shall collect one
sample per week starting the first full week of June and continuing
through August of each year. An establishment slaughtering both species
shall collect samples from the species it slaughters in larger numbers.
Weekly samples shall be collected and tested until the establishment
has completed and recorded one series of 13 tests that meets the
criteria shown in Table 1 of paragraph (a)(5) of this section.
(B) Upon the establishment's meeting requirements of paragraph
(a)(2)(v)(A) of this section, weekly sampling and testing is optional,
unless changes are made in establishment facilities, equipment,
personnel or procedures that may affect the adequacy of existing
process control measures, as determined by the establishment or FSIS.
FSIS determinations that changes have been made requiring resumption of
weekly testing shall be provided to the establishment in writing.
(3) Analysis of samples. Laboratories may use any quantitative
method for
[[Page 38865]]
analysis of E. coli that is approved by the Association of Official
Analytic Chemists International 2 or approved by a scientific body
in collaborative trials against the three tube Most Probable Number
(MPN) method and agreeing with the 95 percent upper and lower
confidence limit of the appropriate MPN index.
---------------------------------------------------------------------------
\2\ A copy of the ``Official Methods of Analysis of the
Association of Official Analytical Chemists International,'' 16th
edition, 1995, is on file with the Director, Office of the Federal
Register, and may be purchased from the Association of Official
Analytical Chemists International, Inc., 481 North Frederick Ave.,
Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------
(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of cfu/cm\2\ of surface
area sponged. Results shall be recorded onto a process control chart or
table showing at least the most recent 13 test results, by class of
livestock slaughtered, permitting evaluation of the laboratory results
in accordance with the criteria set forth in paragraph (a)(5) of this
section. Records shall be retained at the establishment for a period of
12 months and shall be made available to FSIS upon request.
(5) Criteria for Evaluation of test results. An establishment is
operating within the criteria when the most recent E. coli test result
does not exceed the upper limit (M), and the number of samples, if any,
testing positive at levels above (m) is three or fewer out of the most
recent 13 samples (n) taken, as follows:
Table 1.--Evaluation of E. coli Test Results
Maximum
Number of number
Slaughter class Lower limit of marginal Upper limit of marginal samples permitted
range range tested in marginal
range
(m)........................ (M)....................... (n) (c)
----------------------------------------------------------------------------------------------------------------
Steers/heifers............... Negative a................. 100 cfu/cm\2\............. 13 3
Cows/bulls................... Negative a................. 100 cfu/cm\2\............. 13 3
Market hogs.................. 10 cfu/cm\2\............... 10,000 cfu/cm\2\.......... 13 3
a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of
at least 5 cfu/cm\2\ carcass surface area.
(6) Failure to meet criteria. Test results that do not meet the
criteria described in paragraph (a)(5) of this section are an
indication that the establishment may not be maintaining process
controls sufficient to prevent fecal contamination. FSIS shall take
further action as appropriate to ensure that all applicable provisions
of the law are being met.
(7) Failure to test and record. Inspection shall be suspended in
accordance with rules of practice that will be adopted for such
proceedings upon a finding by FSIS that one or more provisions of
paragraphs (a) (1)-(4) of this section have not been complied with and
written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standard; Salmonella.
(1) Raw meat product performance standards for Salmonella. An
establishment's raw meat products, when sampled and tested by FSIS for
Salmonella, as set forth in this section, may not test positive for
Salmonella at a rate exceeding the applicable national pathogen
reduction performance standard, as provided in Table 2:
Table 2.--Salmonella Performance Standards
------------------------------------------------------------------------
Maximum
Performance number of
Standard Number of positives
Class of product (percent samples to achieve
positive for tested (n) Standard
Salmonella)a (c)
------------------------------------------------------------------------
Steers/heifers.................. 1.0% 82 1
Cows/bulls...................... 2.7% 58 2
Ground beef..................... 7.5% 53 5
Hogs............................ 8.7% 55 6
Fresh pork sausages............. bN.A. N.A. N.A.
------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national
prevalence of Salmonella on the indicated raw product based on data
developed by FSIS in its nationwide microbiological data collection
programs and surveys. Copies of Reports on FSIS's Nationwide
Microbiological Data Collection Programs and Nationwide
Microbiological Surveys used in determining the prevalence of
Salmonella on raw products are available in the FSIS Docket Room.
b Not available; values for fresh pork sausage will be added upon
completion data collection programs for those products.
(2) Enforcement. FSIS will sample and test raw meat products in an
individual establishment on an unannounced basis to determine
prevalence of Salmonella in such products to determine compliance with
the standard. The frequency and timing of such testing will be based on
the establishment's previous test results and other information
concerning the establishment's performance. In an establishment
producing more than one class of product subject to the pathogen
reduction standard, FSIS may sample any or all such classes of
products.3
---------------------------------------------------------------------------
\3\ A copy of FSIS's ``Sample Collection Guidelines and
Procedure for Isolation and Identification of Salmonella from Meat
and Poultry Products'' is available for inspection in the FSIS
Docket Room.
---------------------------------------------------------------------------
(3) Noncompliance and establishment response. When FSIS determines
that an
[[Page 38866]]
establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the
standard.
(ii) If the establishment fails to meet the standard on the next
series of compliance tests for that product, the establishment shall
reassess its HACCP plan for that product and take appropriate
corrective actions.
(iii) Failure by the establishment to act in accordance with
paragraph (b)(3)(ii) of this section, or failure to meet the standard
on the third consecutive series of FSIS-conducted tests for that
product, constitutes failure to maintain sanitary conditions and
failure to maintain an adequate HACCP plan, in accordance with part 417
of this chapter, for that product, and will cause FSIS to suspend
inspection services. Such suspension will remain in effect until the
establishment submits to the FSIS Administrator or his/her designee
satisfactory written assurances detailing the action taken to correct
the HACCP system and, as appropriate, other measures taken by the
establishment to reduce the prevalence of pathogens.
7. The authority citation for part 320 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
8. Section 320.6 is amended by revising paragraph (a) to read as
follows:
Sec. 320.6 Information and reports required from official
establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, mandatory
microbiological testing, and other aspects of the operations of the
establishment and the conduct of inspection, as may be required by the
Administrator in special cases.
* * * * *
PART 327--IMPORTED PRODUCTS
9. The authority citation for Part 327 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
10. Section 327.2 is amended by redesignating paragraphs (a)(2)(i)
(a)-(g) as (a)(2)(i) (A)-(G), redesignating paragraphs (a)(2)(ii) (a)-
(g) to (a)(2)(ii) (A)-(G), redesignating paragraph (a)(2)(ii)(h) as
(a)(2)(ii)(I), and by adding a new paragraph (a)(2)(ii)(H) to read as
set forth below, and by redesignating paragraphs (a)(2)(iv) (a)-(c) as
(a)(2)(iv) (A)-(C).
Sec. 327.2 Eligibility of foreign countries for importation of
products into the United States.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as
set forth in part 417 of this chapter.
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
11. The authority citation for part 381 is revised to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
Subpart D--Application for Inspection; Grant or Refusal of
Inspection
12. A new Sec. 381.22 is added to subpart D to read as follows:
Sec. 381.22 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an establishment shall
have developed written sanitation Standard Operating Procedures, in
accordance with Part 416 of this chapter.
(b) Before being granted Federal inspection, an establishment shall
have conducted a hazard analysis and developed and validated a HACCP
plan, in accordance with Secs. 417.2 and 417.4 of this chapter. A
conditional grant of inspection shall be issued for a period not to
exceed 90 days, during which period the establishment must validate its
HACCP plan.
(c) Before producing new product for distribution in commerce, an
establishment shall have conducted a hazard analysis and developed a
HACCP plan applicable to that product in accordance with Sec. 417.2 of
this chapter. During a period not to exceed 90 days after the date the
new product is produced for distribution in commerce, the establishment
shall validate its HACCP plan, in accordance with Sec. 417.4 of this
chapter.
Subpart H--Sanitation
13. Section 381.45 is amended to read as follows:
Sec. 381.45 Minimum standards for sanitation, facilities, and
operating procedures in official establishments.
The provisions of Secs. 381.46 and 381.61, inclusive, and part 416
of this chapter shall apply with respect to all official
establishments.
Subpart K--Post Mortem Inspection: Disposition of Carcasses and
Parts
14. Section 381.94 is added to subpart K to read as follows:
Sec. 381.94 Contamination with Microorganisms; process control
verification criteria and testing; pathogen reduction standards.
(a) Criteria for verifying process control; E. coli testing.
(1) Each official establishment that slaughters poultry shall test
for Escherichia coli Biotype I (E. coli) and shall:
(i) Collect samples in accordance with the sampling techniques,
methodology, and frequency requirements in paragraph (a)(2) of this
section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of
this section; and
(iii) Maintain records of such analytic results in accordance with
paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written
specimen collection procedures which shall identify employees
designated to collect samples, and shall address location(s) of
sampling, how sampling randomness is achieved, and handling of the
sample to ensure sample integrity. The written procedure shall be made
available to FSIS upon request.
(ii) Sample collection. The establishment shall collect random
samples from carcasses. Carcasses to be sampled will be selected
randomly. Samples shall be collected by taking a whole bird from the
end of the chilling process, after the drip line, and rinsing it in an
amount of buffer appropriate for the type of bird being tested. 1
---------------------------------------------------------------------------
\1\ A copy of FSIS's guideline, ``Sampling Technique for E. coli
in Raw Meat and Poultry for Process Control Verification,'' is
available in the FSIS Docket Room for inspection.
---------------------------------------------------------------------------
(iii) Sampling frequency. Samples will be taken at a frequency
proportional to a slaughter establishment's volume of production, at
the following rates:
Chickens: 1 sample per 22,000 carcasses
Turkeys: 1 sample per 3,000 carcasses
(iv) Sampling frequency alternatives. An establishment operating
under a validated HACCP plan in accordance with Sec. 417.2(b) of this
chapter may substitute an alternative frequency for the frequency of
sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in
writing, that
[[Page 38867]]
the alternative frequency is inadequate to verify the effectiveness of
the establishment's processing controls.
(v) Sampling in very low volume establishments.
(A) An establishment annually slaughtering no more than 440,000
chickens, 60,000 turkeys, or a combination of chickens and turkeys not
exceeding 60,000 turkeys and 440,000 birds total, shall collect one
sample per week starting the first full week of June through August of
each year. An establishment slaughtering both chickens and turkeys
shall collect samples from the species it slaughters in larger numbers.
Weekly samples shall be collected and tested until the establishment
has completed and recorded one series of 13 tests that meets the
criteria shown in Table 1 of paragraph (a)(5) of this section.
(B) Upon the establishment's meeting the requirements of paragraph
(a)(2)(v)(A) of this section, weekly sampling and testing is optional,
unless changes are made in establishment facilities, equipment,
personnel or procedures that may affect the adequacy of existing
process control measures, as determined by the establishment or by
FSIS. FSIS determinations that changes have been made requiring
resumption of weekly testing shall be provided to the establishment in
writing.
(3) Analysis of samples. Laboratories may use any quantitative
method for analysis of E. coli that is sensitive to 5 or fewer cfu/ml
of rinse fluid and is approved by the Association of Official Analytic
Chemists International 2 or approved by a scientific body in
collaborative trials against the three tube Most Probable Number (MPN)
method and agreeing with the 95 percent upper and lower confidence
limit of the appropriate MPN index.
---------------------------------------------------------------------------
\2\ A copy of the ``Official Methods of Analysis of the
Association of Official Analytical Chemists International,'' 16th
edition, 1995, is on file with the Director, Office of the Federal
Register, and may be purchased from the Association of Official
Analytical Chemists International, Inc., 481 North Frederick Ave.,
Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------
(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of cfu/ml of rinse
fluid. Results shall be recorded onto a process control chart or table
showing at least the most recent 13 test results, by kind of poultry
slaughtered, permitting evaluation of the laboratory results in
accordance with the criteria set forth in paragraph (a)(5) of this
section. Records shall be retained at the establishment for a period of
12 months and shall be made available to FSIS upon request.
(5) Criteria for Evaluation of test results. An establishment is
operating within the criteria when the most recent E. coli test result
does not exceed the upper limit (M), and the number of samples, if any,
testing positive at levels ab
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
ove (m) is three or fewer out of the most
recent 13 samples (n) taken, as follows:
Table 1.--Evaluation of E. coli Test Results
----------------------------------------------------------------------------------------------------------------
Maximum number
Lower limit of Upper limit of Number of sample permitted in
Slaughter class marginal range marginal range tested (n) marginal range
(m) (M) (c)
----------------------------------------------------------------------------------------------------------------
Broilers............................ 100 cfu/ml 1,000 cfu/ml 13 3
Turkeys............................. a N.A. N.A. N.A. N.A.
----------------------------------------------------------------------------------------------------------------
a Not available; values for turkeys will be added upon completion of data collection program for turkeys.
(6) Failure to meet criteria. Test results that do not meet the
criteria described in paragraph (a)(5) of this section are an
indication that the establishment may not be maintaining process
controls sufficient to prevent fecal contamination. FSIS shall take
further action as appropriate to ensure that all applicable provisions
of the law are being met.
(7) Failure to test and record. Inspection will be suspended in
accordance with rules of practice that will be adopted for such
proceeding, upon a finding by FSIS that one or more provisions of
paragraphs (a) (1)-(4) of this section have not been complied with and
written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standards; Salmonella.
(1) Raw poultry product performance standards for Salmonella. (i)
An establishment's raw poultry products, when sampled and tested by
FSIS for Salmonella as set forth in this section, may not test positive
for Salmonella at a rate exceeding the applicable national pathogen
reduction performance standard, as provided in Table 2:
Table 2.--Salmonella Performance Standards
----------------------------------------------------------------------------------------------------------------
Performance Maximum number of
Standard (percent Number of samples positives to
Class of product positive for tested (n) achieve Standard
Salmonella) a (c)
----------------------------------------------------------------------------------------------------------------
Broilers............................................... b 20.0% 51 12
Ground chicken......................................... 44.6 53 26
Ground turkey.......................................... 49.9 53 29
Turkeys................................................ b N.A. N.A. N.A.
----------------------------------------------------------------------------------------------------------------
a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw
products based on data developed by FSIS in its nationwide microbiological baseline data collection programs
and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide
Microbiological Surveys used in determining the prevalence of Salmonella on raw products are avialable in the
FSIS Docket Room.)
b Standard is based on partial analysis of baseline survey data; subject to confirmation upon publication of
baseline survey report.
d Not available; baseline targets for turkeys will be added upon completion of the data collection programs for
that product.
[[Page 38868]]
(2) Enforcement. FSIS will sample and test raw poultry products in
an individual establishment on an unannounced basis to determine
prevalence of Salmonella in such products to determine compliance with
the standard. The frequency and timing of such testing will be based on
the establishment's previous test results and other information
concerning the establishment's performance. In an establishment
producing more than one class of product subject to the pathogen
reduction standard, FSIS may sample any or all such classes of
products.3
---------------------------------------------------------------------------
\3\ A copy of FSIS's ``Sample Collection Guidelines and
Procedure for Isolation and Identification of Salmonella from Raw
Meat and Poultry Products'' is available for inspection in the FSIS
Docket Room.
---------------------------------------------------------------------------
(3) Noncompliance and establishment response. When FSIS determines
that an establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the
standard.
(ii) If the establishment fails to meet the standard on the next
series of compliance tests for that product, the establishment shall
reassess its HACCP plan for that product.
(iii) Failure by the establishment to act in accordance with
paragraph (b)(3)(ii) of this section, or failure to meet the standard
on the third consecutive series of FSIS-conducted tests for that
product, constitutes failure to maintain sanitary conditions and
failure to maintain an adequate HACCP plan, in accordance with part 417
of this chapter, for that product, and will cause FSIS to suspend
inspection services. Such suspension will remain in effect until the
establishment submits to the FSIS Administrator or his/her designee
satisfactory written assurances detailing the action taken to correct
the HACCP system and, as appropriate, other measures taken by the
establishment to reduce the prevalence of pathogens.
Subpart Q--Records, Registration, and Reports
15. Section 381.180 is amended by revising paragraph (a) to read as
follows:
Sec. 381.180 Information and reports required from official
establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, mandatory
microbiological testing, and other aspects of the operations of the
establishment and the conduct of inspection thereat, as may be required
by the Administrator in special cases.
* * * * *
Subpart T--Imported Poultry Products
16. Section 381.196 is amended by redesignating paragraphs
(a)(2)(i) (a)-(g) as paragraphs (a)(2)(i) (A)-(G), redesignating
paragraphs (a)(2)(ii) (a)-(g) to (a)(2)(ii) (A)-(G), redesignating
paragraph (a)(2)(ii)(h) as (a)(2)(ii)(I), and by adding a new paragraph
(a)(2)(ii)(H) to read as set forth below, and redesignating paragraphs
(a)(2)(iv) (a)-(c) as (a)(2)(iv)(A)-(c).
Sec. 381.196 Eligibility of foreign countries for importation of
products into the United States.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as
set forth in part 417 of this chapter.
* * * * *
17. A new subchapter E, consisting of Parts 416 and 417 is added to
chapter III--Food Safety and Inspection Service, Meat and Poultry
Inspection, Department of Agriculture to read as follows:
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION
ACT AND THE POULTRY PRODUCTS INSPECTION ACT
Part
416 Sanitation
417 Hazard Analysis and Critical Control Point (HACCP) Systems
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT
INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT
PART 416--SANITATION
Sec.
416.11 General rules.
416.12 Development of sanitation SOP's.
416.13 Implementation of SOP's.
416.14 Maintenance of Sanitation SOP's.
416.15 Corrective Actions.
416.16 Recordkeeping Requirements.
416.17 Agency verification.
Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906;
7 CFR 2.18, 2.53.
Sec. 416.11 General rules.
Each official establishment shall develop, implement, and maintain
written standard operating procedures for sanitation (Sanitation SOP's)
in accordance with the requirements of this part.
Sec. 416.12 Development of Sanitation SOP's.
(a) The Sanitation SOP's shall describe all procedures an official
establishment will conduct daily, before and during operations,
sufficient to prevent direct contamination or adulteration of
product(s).
(b) The Sanitation SOP's shall be signed and dated by the
individual with overall authority on-site or a higher level official of
the establishment. This signature shall signify that the establishment
will implement the Sanitation SOP's as specified and will maintain the
Sanitation SOP's in accordance with the requirements of this part. The
Sanitation SOP's shall be signed and dated upon initially implementing
the Sanitation SOP's and upon any modification to the Sanitation SOP's.
(c) Procedures in the Sanitation SOP's that are to be conducted
prior to operations shall be identified as such, and shall address, at
a minimum, the cleaning of food contact surfaces of facilities,
equipment, and utensils.
(d) The Sanitation SOP's shall specify the frequency with which
each procedure in the Sanitation SOP's is to be conducted and identify
the establishment employee(s) responsible for the implementation and
maintenance of such procedure(s).
Sec. 416.13 Implementation of SOP's.
(a) Each official establishment shall conduct the pre-operational
procedures in the Sanitation SOP's before the start of operations.
(b) Each official establishment shall conduct all other procedures
in the Sanitation SOP's at the frequencies specified.
(c) Each official establishment shall monitor daily the
implementation of the procedures in the Sanitation SOP's.
Sec. 416.14 Maintenance of Sanitation SOP's.
Each official establishment shall routinely evaluate the
effectiveness of the Sanitation SOP's and the procedures therein in
preventing direct contamination or adulteration of product(s) and shall
revise both as necessary to keep them effective and current with
respect to changes in facilities, equipment, utensils, operations, or
personnel.
Sec. 416.15 Corrective Actions.
(a) Each official establishment shall take appropriate corrective
action(s) when either the establishment or FSIS determines that the
establishment's Sanitation SOP's or the procedures specified therein,
or the implementation or maintenance of the Sanitation SOP's, may have
failed to prevent direct
[[Page 38869]]
contamination or adulteration of product(s).
(b) Corrective actions include procedures to ensure appropriate
disposition of product(s) that may be contaminated, restore sanitary
conditions, and prevent the recurrence of direct contamination or
adulteration of product(s), including appropriate reevaluation and
modification of the Sanitation SOP's and the procedures specified
therein.
Sec. 416.16 Recordkeeping requirements.
(a) Each official establishment shall maintain daily records
sufficient to document the implementation and monitoring of the
Sanitation SOP's and any corrective actions taken. The establishment
employee(s) specified in the Sanitation SOP's as being responsible for
the implementation and monitoring of the procedure(s) specified in the
Sanitation SOP's shall authenticate these records with his or her
initials and the date.
(b) Records required by this part may be maintained on computers
provided the establishment implements appropriate controls to ensure
the integrity of the electronic data.
(c) Records required by this part shall be maintained for at least
6 months and made accesable available to FSIS. All such records shall
be maintained at the official establishment for 48 hours following
completion, after which they may be maintained off-site provided such
records can be made available to FSIS within 24 hours of request.
Sec. 416.17 Agency verification.
FSIS shall verify the adequacy and effectiveness of the Sanitation
SOP's and the procedures specified therein by determining that they
meet the requirements of this part. Such verification may include:
(a) Reviewing the Sanitation SOP's;
(b) Reviewing the daily records documenting the implementation of
the Sanitation SOP's and the procedures specified therein and any
corrective actions taken or required to be taken;
(c) Direct observation of the implementation of the Sanitation
SOP's and the procedures specified therein and any corrective actions
taken or required to be taken; and
(d) Direct observation or testing to assess the sanitary conditions
in the establishment.
PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)
SYSTEMS
Sec.
417.1 Definitions.
417.2 Hazard analysis and HACCP plan.
417.3 Corrective actions.
417.4 Validation, verification, reassessment.
417.5 Records.
417.6 Inadequate HACCP Systems.
417.7 Training.
417.8 Agency verification.
Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C.
1901-1906; 7 CFR 2.18, 2.53.
Sec. 417.1 Definitions.
For purposes of this part, the following definitions shall apply:
Corrective action. Procedures to be followed when a deviation
occurs.
Critical control point. A point, step, or procedure in a food
process at which control can be applied and, as a result, a food safety
hazard can be prevented, eliminated, or reduced to acceptable levels.
Critical limit. The maximum or minimum value to which a physical,
biological, or chemical hazard must be controlled at a critical control
point to prevent, eliminate, or reduce to an acceptable level the
occurrence of the identified food safety hazard.
Food safety hazard. Any biological, chemical, or physical property
that may cause a food to be unsafe for human consumption.
HACCP System. The HACCP plan in operation, including the HACCP
plan itself.
Hazard. SEE Food Safety Hazard.
Preventive measure. Physical, chemical, or other means that can be
used to control an identified food safety hazard.
Process-monitoring instrument. An instrument or device used to
indicate conditions during processing at a critical control point.
Responsible establishment official. The individual with overall
authority on-site or a higher level official of the establishment.
Sec. 417.2 Hazard Analysis and HACCP Plan.
(a) Hazard analysis. (1) Every official establishment shall
conduct, or have conducted for it, a hazard analysis to determine the
food safety hazards reasonably likely to occur in the production
process and identify the preventive measures the establishment can
apply to control those hazards. The hazard analysis shall include food
safety hazards that can occur before, during, and after entry into the
establishment. A food safety hazard that is reasonably likely to occur
is one for which a prudent establishment would establish controls
because it historically has occurred, or because there is a reasonable
possibility that it will occur in the particular type of product being
processed, in the absence of those controls.
(2) A flow chart describing the steps of each process and product
flow in the establishment shall be prepared, and the intended use or
consumers of the finished product shall be identified.
(3) Food safety hazards might be expected to arise from the
following:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Zoonotic diseases;
(vii) Decomposition;
(viii) Parasites;
(ix) Unapproved use of direct or indirect food or color additives;
and
(x) Physical hazards.
(b) The HACCP plan. (1) Every establishment shall develop and
implement a written HACCP plan covering each product produced by that
establishment whenever a hazard analysis reveals one or more food
safety hazards that are reasonably likely to occur, based on the hazard
analysis conducted in accordance with paragraph (a) of this section,
including products in the following processing categories:
(i) Slaughter--all species.
(ii) Raw product--ground.
(iii) Raw product--not ground.
(iv) Thermally processed--commercially sterile.
(v) Not heat treated--shelf stable.
(vi) Heat treated--shelf stable.
(vii) Fully cooked--not shelf stable.
(viii) Heat treated but not fully cooked--not shelf stable.
(ix) Product with secondary inhibitors--not shelf stable.
(2) A single HACCP plan may encompass multiple products within a
single processing category identified in this paragraph, if the food
safety hazards, critical control points, critical limits, and
procedures required to be identified and performed in paragraph (c) of
this section are essentially the same, provided that any required
features of the plan that are unique to a specific product are clearly
delineated in the plan and are observed in practice.
(3) HACCP plans for thermally processed/commercially sterile
products do not have to address the food safety hazards associated with
microbiological contamination if the product is produced in accordance
with the requirements of part 318, subpart G, or part 381, subpart X,
of this chapter.
(c) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List the food safety hazards identified in accordance with
paragraph (a) of this section, which must be controlled for each
process.
[[Page 38870]]
(2) List the critical control points for each of the identified
food safety hazards, including, as appropriate:
(i) Critical control points designed to control food safety hazards
that could be introduced in the establishment, and
(ii) Critical control points designed to control food safety
hazards introduced outside the establishment, including food safety
hazards that occur before, during, and after entry into the
establishment;
(3) List the critical limits that must be met at each of the
critical control points. Critical limits shall, at a minimum, be
designed to ensure that applicable targets or performance standards
established by FSIS, and any other requirement set forth in this
chapter pertaining to the specific process or product, are met;
(4) List the procedures, and the frequency with which those
procedures will be performed, that will be used to monitor each of the
critical control points to ensure compliance with the critical limits;
(5) Include all corrective actions that have been developed in
accordance with Sec. 417.3(a) of this part, to be followed in response
to any deviation from a critical limit at a critical control point; and
(6) Provide for a recordkeeping system that documents the
monitoring of the critical control points. The records shall contain
the actual values and observations obtained during monitoring.
(7) List the verification procedures, and the frequency with which
those procedures will be performed, that the establishment will use in
accordance with Sec. 417.4 of this part.
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be
signed and dated by the responsible establishment individual. This
signature shall signify that the establishment accepts and will
implement the HACCP plan.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) At least annually, upon reassessment, as required under
Sec. 417.4(a)(3) of this part.
(e) Pursuant to 21 U.S.C. 608 and 621, the failure of an
establishment to develop and implement a HACCP plan that complies with
this section, or to operate in accordance with the requirements of this
part, may render the products produced under those conditions
adulterated.
Sec. 417.3 Corrective actions.
(a) The written HACCP plan shall identify the corrective action to
be followed in response to a deviation from a critical limit. The HACCP
plan shall describe the corrective action to be taken, and assign
responsibility for taking corrective action, to ensure:
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is
taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated
as a result of the deviation enters commerce.
(b) If a deviation not covered by a specified corrective action
occurs, or if another unforeseen hazard arises, the establishment
shall:
(1) Segregate and hold the affected product, at least until the
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
(2) Perform a review to determine the acceptability of the affected
product for distribution;
(3) Take action, when necessary, with respect to the affected
product to ensure that no product that is injurious to health or
otherwise adulterated, as a result of the deviation, enters commerce;
(4) Perform or obtain reassessment by an individual trained in
accordance with Sec. 417.7 of this part, to determine whether the newly
identified deviation or other unforeseen hazard should be incorporated
into the HACCP plan.
(c) All corrective actions taken in accordance with this section
shall be documented in records that are subject to verification in
accordance with Sec. 417.4(a)(2)(iii) and the recordkeeping
requirements of Sec. 417.5 of this part.
Sec. 417.4 Validation, Verification, Reassessment.
(a) Every establishment shall validate the HACCP plan's adequacy in
controlling the food safety hazards identified during the hazard
analysis, and shall verify that the plan is being effectively
implemented.
(1) Initial validation. Upon completion of the hazard analysis and
development of the HACCP plan, the establishment shall conduct
activities designed to determine that the HACCP plan is functioning as
intended. During this HACCP plan validation period, the establishment
shall repeatedly test the adequacy of the CCP's, critical limits,
monitoring and recordkeeping procedures, and corrective actions set
forth in the HACCP plan. Validation also encompasses reviews of the
records themselves, routinely generated by the HACCP system, in the
context of other validation activities.
(2) Ongoing verification activities. Ongoing verification
activities include, but are not limited to:
(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective
actions; and
(iii) The review of records generated and maintained in accordance
with Sec. 417.5(a)(3) of this part.
(3) Reassessment of the HACCP plan. Every establishment shall
reassess the adequacy of the HACCP plan at least annually and whenever
any changes occur that could affect the hazard analysis or alter the
HACCP plan. Such changes may include, but are not limited to, changes
in: raw materials or source of raw materials; product formulation;
slaughter or processing methods or systems; production volume;
personnel; packaging; finished product distribution systems; or, the
intended use or consumers of the finished product. The reassessment
shall be performed by an individual trained in accordance with
Sec. 417.7 of this part. The HACCP plan shall be modified immediately
whenever a reassessment reveals that the plan no longer meets the
requirements of Sec. 417.2(c) of this part.
(b) Reassessment of the hazard analysis. Any establishment that
does not have a HACCP plan because a hazard analysis has revealed no
food safety hazards that are reasonably likely to occur shall reassess
the adequacy of the hazard analysis whenever a change occurs that could
reasonably affect whether a food safety hazard exists. Such changes may
include, but are not limited to, changes in: raw materials or source of
raw materials; product formulation; slaughter or processing methods or
systems; production volume; packaging; finished product distribution
systems; or, the intended use or consumers of the finished product.
Sec. 417.5 Records.
(a) The establishment shall maintain the following records
documenting the establishment's HACCP plan:
(1) The written hazard analysis prescribed in Sec. 417.2(a) of this
part, including all supporting documentation;
(2) The written HACCP plan, including decisionmaking documents
associated with the selection and development of CCP's and critical
limits, and documents supporting both the monitoring and verification
procedures selected and the frequency of those procedures.
(3) Records documenting the monitoring of CCP's and their critical
limits, including the recording of actual
[[Page 38871]]
times, temperatures, or other quantifiable values, as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring
instruments; corrective actions, including all actions taken in
response to a deviation; verification procedures and results; product
code(s), product name or identity, or slaughter production lot. Each of
these records shall include the date the record was made.
(b) Each entry on a record maintained under the HACCP plan shall be
made at the time the specific event occurs and include the date and
time recorded, and shall be signed or initialed by the establishment
employee making the entry.
(c) Prior to shipping product, the establishment shall review the
records associated with the production of that product, documented in
accordance with this section, to ensure completeness, including the
determination that all critical limits were met and, if appropriate,
corrective actions were taken, including the proper disposition of
product. Where practicable, this review shall be conducted, dated, and
signed by an individual who did not produce the record(s), preferably
by someone trained in accordance with Sec. 417.7 of this part, or the
responsible establishment official.
(d) Records maintained on computers. The use of records maintained
on computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and
signatures.
(e) Record retention. (1) Establishments shall retain all records
required by paragraph (a)(3) of this section as follows: for slaughter
activities for at least one year; for refrigerated product, for at
least one year; for frozen, preserved, or shelf-stable products, for at
least two years.
(2) Off-site storage of records required by paragraph (a)(3) of
this section is permitted after six months, if such records can be
retrieved and provided, on-site, within 24 hours of an FSIS employee's
request.
(f) Official review. All records required by this part and all
plans and procedures required by this part shall be available for
official review and copying.
Sec. 417.6 Inadequate HACCP Systems.
A HACCP system may be found to be inadequate if:
(a) The HACCP plan in operation does not meet the requirements set
forth in this part;
(b) Establishment personnel are not performing tasks specified in
the HACCP plan;
(c) The establishment fails to take corrective actions, as required
by Sec. 417.3 of this part;
(d) HACCP records are not being maintained as required in
Sec. 417.5 of this part; or
(e) Adulterated product is produced or shipped.
Sec. 417.7 Training.
(a) Only an individual who has met the requirements of paragraph
(b) of this section, but who need not be an employee of the
establishment, shall be permitted to perform the following functions:
(1) Development of the HACCP plan, in accordance with Sec. 417.2(b)
of this part, which could include adapting a generic model that is
appropriate for the specific product; and
(2) Reassessment and modification of the HACCP plan, in accordance
with Sec. 417.3 of this part.
(b) The individual performing the functions listed in paragraph (a)
of this section shall have successfully completed a course of
instruction in the application of the seven HACCP principles to meat or
poultry product processing, including a segment on the development of a
HACCP plan for a specific product and on record review.
Sec. 417.8 Agency verification.
FSIS will verify the adequacy of the HACCP plan(s) by determining
that each HACCP plan meets the requirements of this part and all other
applicable regulations. Such verification may include:
(a) Reviewing the HACCP plan;
(b) Reviewing the CCP records;
(c) Reviewing and determining the adequacy of corrective actions
taken when a deviation occurs;
(d) Reviewing the critical limits;
(e) Reviewing other records pertaining to the HACCP plan or system;
(f) Direct observation or measurement at a CCP;
(g) Sample collection and analysis to determine the product meets
all safety standards; and
(h) On-site observations and record review.
Done at Washington, DC, on: July 5, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
The following are appendices to the preamble of the Final Rule.
Note: The following appendices will not appear in the Code of
Federal Regulations.
Appendix A--Guidelines for Developing a Standard Operating Procedure
for Sanitation (Sanitation SOP's) in Federally Inspected Meat and
Poultry Establishments
I. Introduction
Foodborne illness is a significant public health problem in the
United States. While data on illness associated with meat and poultry
products are limited, data from various sources suggest that foodborne
microbial pathogens may cause up to 7 million cases of illness each
year, and 7,000 deaths. Of these, nearly 5 million cases of illness and
more than 4,000 deaths may be associated with meat and poultry
products.
FSIS is pursuing a broad and long-term science-based strategy to
improve the safety of meat and poultry products to better protect
public health. FSIS is undertaking steps to improve the safety of meat
and poultry throughout the food production, processing, distribution,
and marketing chain. The Agency's goal is to reduce the risk to public
health of consuming meat and poultry products by reducing pathogenic
microbial contamination. The FSIS strategy relies heavily on building
the principle of prevention into production processes.
Sections 308.7, 381.57 and 381.58 of the Meat and Poultry
Inspection Regulations require that rooms, compartments, equipment, and
utensils used for processing or handling meat or poultry in a federally
inspected establishment must be kept clean and in a sanitary condition.
Establishments are responsible for sanitation of facilities, equipment
and utensils.
Sanitation maintains or restores a state of cleanliness, and
promotes hygiene for the prevention of foodborne illness. Sanitation
encompasses many areas and functions of an establishment, even when not
in production. However, there are certain sanitary procedures that must
be addressed and maintained on a daily basis to prevent direct product
contamination or adulteration. Good sanitation is essential in these
areas to maintaining a safe food production process.
FSIS is requiring meat and poultry establishments to develop and
implement a written Standard Operating Procedure for sanitation
(Sanitation SOP's) which addresses these areas. An establishment's
adherence to its written Sanitation SOP will demonstrate knowledge of
and commitment to sanitation and production of safe meat and poultry
products.
New part 416 to the Meat and Poultry Inspection Regulations
requires that a written Sanitation SOP contain
[[Page 38872]]
established procedures to be followed routinely to maintain a sanitary
environment for producing safe and unadulterated food products. Plant
management must develop a Sanitation SOP that describes daily
sanitation procedures to be performed by the establishment. A
designated establishment employee(s) must monitor the Sanitation SOP
and document adherence to the SOP and any corrective actions taken to
prevent direct product contamination or adulteration. This written
documentation must be available to FSIS program employees.
These FSIS guidelines should help federally inspected meat or
poultry establishments develop, implement and monitor written
Sanitation SOPs.
The Sanitation SOP developed by the establishment must detail daily
sanitation procedures it will use before (pre-operational sanitation)
and during (operational sanitation) operation to prevent direct product
contamination or adulteration. FSIS program employees will verify an
establishment's adherence to its Sanitation SOP and will take
appropriate action when there is noncompliance.
These guidelines, where applicable, are for:
Livestock Slaughter and/or Processing Establishments
Poultry Slaughter and/or Processing Establishments
Import Inspection Establishments
Identification Warehouses
The establishment should update the Sanitation SOP to reflect
changes in equipment and facilities, processes, new technology, or
designated establishment employees.
II. Pre-operational Sanitation
Established procedures of pre-operational sanitation must result in
clean facilities, equipment and utensils prior to starting production.
Clean facilities, equipment, and utensils are free of any soil, tissue
debris, chemical or other injurious substance that could contaminate a
meat or poultry food product. Pre-operational sanitation established
procedures shall describe the daily, routine sanitary procedures to
prevent direct product contamination or adulteration. The sanitary
procedures must include the cleaning of product contact surfaces of
facilities, equipment and utensils to prevent direct product
contamination or adulteration. The following additional sanitary
procedures for pre-operational sanitation might include:
Descriptions of equipment disassembly, reassembly after
cleaning, use of acceptable chemicals according to label directions,
and cleaning techniques.
The application of sanitizers to product contact surfaces
after cleaning. Sanitizers are used to reduce or destroy bacteria that
may have survived the cleaning process.
III. Operational Sanitation
All federally inspected establishments must describe daily, routine
sanitary procedures that the establishment will conduct during
operations to prevent direct product contamination or adulteration.
Established procedures for operational sanitation must result in a
sanitary environment for preparing, storing, or handling any meat or
poultry food product in accordance with sections 308/381 of the Meat
and Poultry Inspection Regulations. Established procedures during
operations might include, where applicable:
Equipment and utensil cleaning--sanitizing--disinfecting
during production, as appropriate, at breaks, between shifts, and at
midshift cleanup.
Employee hygiene: includes personal hygiene, cleanliness
of outer garments and gloves, hair restraints, hand washing, health,
etc.
Product handling in raw and in cooked product areas.
The established sanitary procedures for operational sanitation will
vary with the establishment. Establishments with complex processing
need additional sanitary procedures to ensure a sanitary environment
and to prevent cross contamination. Establishments that do not
slaughter or process (such as an Import Inspection facility) should
develop established sanitary procedures specific to that facility.
IV. Implementing and Monitoring of the Sanitation SOP
The Sanitation SOP shall identify establishment employee(s)
(positions rather than specific names of employees) responsible for the
implementation and maintenance of the Sanitation SOP. Employee(s) are
to be identified to monitor and evaluate the effectiveness of the
Sanitation SOP and make corrections when needed. The evaluation can be
performed by using one or more of the following methods: (1)
organoleptic (sensory--e.g., sight, feel, smell); (2) chemical (e.g.,
checking the chlorine level); (3) microbiological (e.g., microbial
swabbing and culturing of product contact surfaces of equipment or
utensils).
Establishments might specify the method, frequency, and
recordkeeping processes associated with monitoring. Pre-operational
sanitation monitoring should, at a minimum, evaluate and document the
effective cleaning of all direct product contact facilities, equipment,
and/or utensils that are to be used at the start of production.
Operational sanitation monitoring should, at a minimum, document
adherence to the SOP, including actions that identify and correct
instances or circumstances of direct product contamination which occur
from environmental sources (facilities, equipment, pests, etc.) or
employee practices (personal hygiene, product handling, etc.). All
establishment records of pre-operational and operational sanitation
monitoring, including corrective actions to prevent direct product
contamination or adulteration, must be maintained by the establishment
for at least six months, and be made available to FSIS program
employees. After 48 hours, they may be maintained off-site.
V. Corrective Actions
When deviations occur from the established sanitary procedures
within the Sanitation SOP, the establishment must take corrective
actions to prevent direct product contamination or adulteration.
Instructions should be provided to employees and management officials
for documenting corrective actions. The actions must be recorded.
Appendix B--Model of a Standard Operating Procedure for Sanitation
Hill-Top Meats has prepared a written Standard Operating Procedure
(SOP) for Sanitation. Let's look at the Sanitation SOP and discuss its
attributes (guidance and advice are inside the boxes).
Hill-Top Meats, Est. 38, Anytown, U.S.A. is a slaughter and medium
processing establishment. This plant receives live cattle for slaughter
and dressing and processes the carcasses into chubs of ground beef,
roast beef, and ready to eat beef products.
------------------------------------------------------------------------
-------------------------------------------------------------------------
This introductory information is not a regulatory requirement but
identifies the type of establishment and its production. The
information will help FSIS personnel, who are not familiar with the
establishment, review the Sanitation SOP.
------------------------------------------------------------------------
Management structure is as follows:
President--Joe Doe
Slaughter Manager--Ken Smith
Processing Manager--Susan Jones
Quality Control (QC) Manager--Gwen Summers
Sanitation Manager--Carl Anderson
The QC Manager is responsible for implementing and daily monitoring
of the Sanitation SOP and recording the findings and any corrective
actions. The
[[Page 38873]]
Slaughter, Processing and Sanitation Managers are responsible for
training and assigning specific duties to other employees and
monitoring their performance within the Sanitation SOP.
All records, data, checklists and other information pertaining to
the Sanitation SOP will be maintained on file and made available to
FSIS program employees.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The identification of establishment personnel (positions rather than
specific names of employees) responsible for implementing, maintaining,
monitoring and records associated with the Sanitation SOP is a
regulatory requirement. All records pertaining to the Sanitation SOP
must be kept on file and made available to FSIS personnel, but it is
not necessary to make that statement.
------------------------------------------------------------------------
Sanitation SOP for EST. 38
I. Preoperational Sanitation--Equipment and Facility Cleaning Objective
All equipment will be cleaned and sanitized prior to starting
production.
A. General Equipment Cleaning. (Simple equipment and hand tools are
cleaned and sanitized in the same manner but they do not require
disassembly and reassembly.)
1. Established Sanitary Procedures for Cleaning and Sanitizing
Equipment:
a. The equipment is disassembled. Parts are placed in the
designated tubs, racks, etc.
b. Product debris is removed.
c. Equipment parts are rinsed with water to remove remaining
debris.
d. An approved cleaner is applied to parts and they are cleaned
according to manufacturers' directions.
e. Equipment parts are rinsed with potable water.
f. Equipment is sanitized with an approved sanitizer, and rinsed
with potable water if required.
g. The equipment is reassembled.
h. The equipment is resanitized with an approved sanitizer, and
rinsed with potable water if required.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The established sanitary procedures are daily routine sanitary
procedures to prevent direct product contamination or adulteration.
Daily routine sanitary procedures to prevent direct product
contamination or adulteration are required in the Sanitation SOP; FSIS
personnel use them to verify compliance with the Sanitation SOP. The
procedures shall be specific for each establishment; however, they can
be as detailed as the establishment wants to make them.
------------------------------------------------------------------------
2. Implementing, Monitoring and Recordkeeping. The QC Manager
performs daily organoleptic sanitation inspection after preoperational
equipment cleaning and sanitizing. The results of the inspection are
recorded on Establishment Form E-1. If everything is acceptable, the
appropriate box is initialed. If corrective actions are needed, such
actions are to be documented (see below).
The QC Manager performs daily microbial monitoring for Total Plate
Counts (TPCs) after preoperational equipment cleaning and sanitizing.
The QC Manager swabs one square inch of a food contact surface on a
piece of equipment or hand tool within one hour prior to production.
The samples are plated and incubated at 35 deg. C. for 48 hours.
Colonies are counted and recorded as number of colony forming units
(CFU) per square inch of surface swabbed. Daily microbial counts are
documented on Establishment Form M-1.
3. Corrective Actions.
a. When the QC Manager determines that the equipment or hand tools
do not pass organoleptic examination, the cleaning procedure and
reinspection are repeated. The Sanitation Manager monitors the cleaning
of the equipment or hand tools and retrains sanitation crew employees,
if necessary. Corrective actions are recorded on Establishment Form E-
1.
b. If microbial counts exceed ____ CFUs/sq. in., the QC Manager
notifies the Sanitation Manager and attempts to determine the cause of
the high count (for example, cleaning procedures varied, new people
cleaned the equipment, sanitizer not applied). If microbial counts
remain high for several days, the QC Manager will confer with the
Sanitation Manager. The Sanitation Manager notifies sanitation crew
employees and reviews all cleaning and sanitizing procedures and
personal hygiene. Microbial counts are recorded on Establishment Form
M-1. Corrective actions to prevent direct product contamination or
adulteration are documented on Establishment Form E-1.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The establishment is required to monitor daily routine sanitation
activities as described in the Sanitation SOP, the establishment
determines the methods and frequency of monitoring. Microbiological
sampling is not required, but Hill-Top Meats wants to monitor the
effectiveness of the cleaning by daily microbial sampling, in addition
to organoleptic monitoring, and has set limits to enable them to take
appropriate action when those limits are exceeded. Establishment Forms
E-1 and M-1 are used only as examples; no specific forms or form
numbers are required. However, establishments must record the daily
completion or adherence to the established procedures in the Sanitation
SOP, any deviations from regulatory requirements, and corrective
actions.
------------------------------------------------------------------------
B. Cleaning of Facilities--including floors, walls and ceilings.
1. Cleaning Procedures.
a. Debris is swept up and discarded.
b. Facilities are rinsed with potable water.
c. Facilities are cleaned with an approved cleaner, according to
manufacturer's directions.
d. Facilities are rinsed with potable water.
2. Cleaning Frequency.
Floors and walls are cleaned at the end of each production day.
Ceilings are cleaned as needed, but at least once a week.
------------------------------------------------------------------------
-------------------------------------------------------------------------
There is no specific requirement to include facility cleaning in the
Sanitation SOP, unless part of the facility could directly contaminate
or adulterate product.
------------------------------------------------------------------------
3. Establishment Monitoring.
The QC Manager performs daily organoleptic inspection prior to the
start of operations. Results are recorded on Establishment Form E-1.
4. Corrective Actions.
When the QC Manager determines that the facilities do not pass
organoleptic inspection, the cleaning procedure and reinspection are
repeated. The Sanitation Manager monitors the cleaning of facilities
and retrains sanitation crew employees if necessary. Corrective actions
to prevent direct product contamination or adulteration are recorded on
Establishment Form E-1.
II. Operational Sanitation
Objective: Carcass dressing will be performed under sanitary
conditions and in a manner to prevent contamination of the carcass.
A. Slaughter Operations.
1. Established Methods for Carcass Dressing--
a. Employees will clean hands, arms, gloves, aprons, boots, etc.,
as often as
[[Page 38874]]
necessary during the dressing procedures.
b. Employees will clean and then sanitize with 180 deg. F. water,
knives and other hand tools, saws and other equipment, as often as
necessary during the dressing procedures to prevent contamination of
the skinned carcass.
c. The brisket saw is sanitized between carcasses using 180 deg. F.
water.
d. Eviscerating employees will maintain clean hands, arms, clothes,
aprons, boots and knives during the evisceration process. If
contamination occurs, the employee is required to step away from the
evisceration table onto a side platform to clean and sanitize apron,
boots and knives. It may be necessary to clean hands and arms with soap
and water. In cases of contamination from an abscess or other extensive
contamination, the employee may need to shower and change clothes
before resuming work.
e. The carcass splitting saw is sanitized with 180 deg. F. water
after each carcass.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The above methods for carcass dressing are specific for Hill-Top Meats.
The establishment considers them to be Good Manufacturing Practices for
their type of operation, to prevent direct contamination or
adulteration of carcasses. Each establishment determines the sanitary
procedures and any requirements they want to detail in their Sanitation
SOP.
------------------------------------------------------------------------
2. Monitoring and Recordkeeping.
a. The Slaughter Manager is responsible for ensuring that employee
hygiene practices, sanitary conditions and cleaning procedures are
maintained during a production shift. The QC Manager monitors the
sanitation procedures twice during a production shift. Results are
recorded on Establishment Form E-1.
b. A Microbiological Control and Monitoring Program is used to
determine the level of bacteria on product contact surfaces of
equipment (e.g., knives, hand tools, evisceration table, etc.) and
outer garments (such as aprons and gloves) during production. The QC
Manager performs daily microbial monitoring for Total Plate Counts
(TPCs). The samples are plated and incubated at 35 deg.C. for 48 hours.
Colonies are counted and recorded as number of colony forming units
(CFU) per square inch of surface swabbed. Daily microbial counts are
documented on Establishment Form M-1.
3. Corrective Actions.
a. When equipment is visibly contaminated, contaminants are removed
by cleaning and sanitizing equipment prior to resuming production. The
Slaughter Manager attempts to determine the cause of the contamination
and takes corrective action. This may require adjusting equipment,
retraining employees, temporarily stopping or slowing the line speed,
etc. Corrective actions are recorded on Establishment Form E-1.
b. If microbial counts from equipment swabbing exceed the action
level set, the QC Manager notifies the Slaughter Manager. The Slaughter
Manager attempts to determine the cause (for example, new people not
adequately trained, equipment not adjusted properly) and takes
corrective action. If microbial counts remain above established limits
for several days, the QC Manager confers with the Slaughter Manager and
all slaughter operations are reviewed. The Slaughter Manager notifies
the slaughter employees and reviews personal hygiene, equipment
adjustment, and sanitary handling procedures. Corrective actions to
prevent direct product contamination or adulteration are recorded on
Establishment Form E-1.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The establishment is required to monitor the regulatory daily sanitation
activities as described in its Sanitation SOP, but each establishment
determines its own methods for monitoring, the frequency of monitoring,
and the corrective actions to include in the Sanitation SOP. Records
must be kept on daily completion of the established procedures,
deviations, and corrective actions.
------------------------------------------------------------------------
B. Processing Operations.
Objective: Processing is performed under sanitary conditions to
prevent direct and cross contamination of food products.
1. Established Sanitary Procedures for Processing--
a. Employees clean and sanitize hands, gloves, knives, wizard
knives, other hand tools, cutting boards, etc., as necessary during
processing to prevent contamination of food products.
b. All equipment, belt conveyors, tables, and other product contact
surfaces are cleaned and sanitized throughout the day as needed.
c. Employees take appropriate precautions when going from a raw
product area to a cooked product area, to prevent cross contamination
of cooked products. Employees change outer garments, wash hands and
sanitize hands with an approved hand sanitizer (sanitizer is equivalent
to 50 ppm chlorine), put on clean gloves for that room and step into a
boot sanitizing bath on leaving and entering the respective rooms.
d. Raw and cooked processing areas are separate. There is no cross
utilization of equipment between raw and cooked products.
e. Outer garments, such as aprons, smocks and gloves, are
identified and designated specifically for either the raw processing
rooms or the cooked processing rooms. Blue is designated for raw
processing rooms and orange for cooked processing rooms. The outer
garments are hung in designated locations when an employee leaves each
room. Outer garments are maintained in a clean and sanitary manner and
are changed at least daily and, if necessary, more often.
------------------------------------------------------------------------
-------------------------------------------------------------------------
Establishments with processing will determine their own established
sanitary procedures in the Sanitation SOP and any establishment
requirements. Hill-Top Meats considers its established procedures for
processing to be Good Manufacturing Practices.
------------------------------------------------------------------------
2. Monitoring and Recordkeeping.
a. The Processing Manager is responsible for ensuring that employee
hygiene practices, employee and product traffic patterns, sanitary
product handling procedures, and cleaning procedures are maintained
during a production shift. The QC Manager monitors the sanitation
procedures twice during a production shift. Results are recorded on
Establishment Form P-1.
b. A Microbiological Control and Monitoring Program is used to
determine and control the level of bacteria on both raw and cooked
product contact surfaces during production. Once a day, the QC Manager
performs Microbial Monitoring for Total Plate Counts (TPCs). The QC
Manager swabs one square inch on a product contact surface from each of
three randomly selected pieces of equipment in each raw product room
and cooked product room.
Note: The samples are taken from the cooked product rooms first
and then from the raw product rooms. The samples are plated and
incubated at 35 deg. C. for 48 hours. Colonies are counted and
recorded as number of colony forming units (CFU) per square inch of
surface swabbed. Microbial counts are documented on Establishment
Form M-1.
3. Corrective Actions.
a. When the QC Manager identifies sanitation problems, the QC
Manager notifies the Processing Manager. The Processing Manager stops
production, if necessary, and notifies processing employees to take
appropriate action to correct the sanitation problems. If necessary,
processing employees are retrained. Corrective actions are recorded on
Establishment Form P-1.
[[Page 38875]]
If microbial counts exceed the action level set for each piece of
equipment for the specific product in that production line, the QC
Manager notifies the Processing Manager. The Processing Manager
attempts to determine the cause (for example, new people going back and
forth between the raw and cooked rooms, gloves not being changed
regularly) and takes corrective action. Additional daily microbial
sampling is done on any equipment that showed high microbial counts,
until the counts fall below the action level. If microbial counts
remain high for several days, the QC Manager confers with the
Processing Manager and Sanitation Manager to review all operations that
impact that equipment. The Processing Manager notifies the processing
employees and reviews personal hygiene and sanitary product handling
procedures. Corrective actions are recorded on Establishment Form P-1.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The monitoring and corrective actions are specific for Hill-Top Meats
only. Microbial sampling and monitoring are not required for product
contact surfaces. Each establishment determines its own procedures for
monitoring and the frequency of monitoring to include in its Sanitation
SOP.
------------------------------------------------------------------------
Appendix C--Guidebook for the Preparation of HACCP Plans
Preface
The Hazard Analysis Critical Control Points (HACCP) system is a
logical, scientific system that can control safety problems in food
production. HACCP is now being adopted worldwide. It works with any
type of food production system and with any food. It works by
controlling food safety hazards throughout the process. The hazards can
be biological, chemical, or physical.
This guidebook was developed to help meat and poultry
establishments prepare HACCP plans. The steps to developing a HACCP
plan can be used by all establishments, large or small, complex or
simple. The guidebook identifies additional sources of information, so
that small operators won't have to ``go it alone.''
The forms shown in this guidebook are examples only. Think of this
as a self-help guide or a do-it-yourself manual. There are many ways to
get to the final product--a good HACCP plan. So, choose the examples
that work best in your establishment.
The guidebook can be used to complement HACCP training. You may
also wish to use it in conjunction with a video about HACCP. The
guidebook will provide the basics. When you are ready to move on, there
are more specialized documents. FSIS is also publishing the Meat and
Poultry Products Hazards and Controls Guide. It explains in detail the
biological, chemical, and physical hazards that can occur at different
steps of meat and poultry slaughter and processing and provides some
examples of controls for those hazards. In addition, there will be a
series of Generic Models for different meat and poultry processes, to
be used as examples. You will probably want to look at the models for
processes that you use in your establishment. There will be model plans
for the following 13 processes:
Raw, Ground
Raw, Other
All Other Shelf-Stable, Heat Treated
Fully Cooked, Non-Shelf Stable
All Other Shelf-Stable, Not Heat Treated
All Non-Shelf Stable, Heat Treated, Not Fully Cooked
Non-Shelf Stable with Secondary Inhibitors
Thermally Processed/Commercially Sterile
Swine Slaughter
Poultry Slaughter
Beef Slaughter
Irradiation
Mechanically Separated Species
Developing a HACCP Plan
The Hazard Analysis and Critical Control Points (HACCP) System is a
logical, scientific approach to controlling safety problems in food
production. When a company adopts HACCP, it puts controls in place at
each point in the production system where safety problems could occur
from biological, chemical, or physical hazards. To start a HACCP
system, a company must first write a HACCP plan. This guidebook
explains how to write a HACCP plan in five preparatory steps and then
the seven HACCP principles.
The five ``pre-HACCP'' steps in this guidebook are:
1. Bring together your HACCP resources.
2. Describe the product and its method of distribution.
3. Develop a complete list of ingredients and raw materials used in
the product.
4. Develop a process flow diagram.
5. Meet the regulatory requirements for Sanitation Standard
Operating Procedures (SOPs).
Applying the seven HACCP principles makes up the major steps to
writing a HACCP plan. They are:
1. Conduct a hazard analysis.
2. Identify critical control points.
3. Establish critical limits for each critical control point.
4. Establish monitoring procedures.
5. Establish corrective actions.
6. Establish recordkeeping procedures.
7. Establish verification procedures.
As you read this guidebook and look at the examples, the process
for writing a HACCP plan should become clearer. This first section of
the guidebook explains the five ``pre-HACCP'' steps. The next seven
sections cover each of the HACCP principles that you will need to
follow to develop a HACCP plan.
Pre-HACCP Step 1--Bring Together Your HACCP Resources
The first step is to assemble your HACCP resources. When a company
develops a HACCP plan, it is important to bring as much knowledge to
the table as possible. Actually, you probably have access to more HACCP
resources than you think! With a small establishment, this might mean
bringing together one or two employees, one of whom has had HACCP
training. Your HACCP resources may include outside expertise. You can
get this expertise through your local Extension Office, a trade or
professional association, or a contractor of your choice. A larger
plant may wish to bring in employees from a number of departments, such
as production, sanitation, quality control, and engineering, as well as
employees directly involved in daily processing activities. There is no
magic number of employees needed to write a HACCP plan. It could be one
employee or, in a very large company, it could be seven or eight
people.
Your employee or employees writing the HACCP plan should understand
some basic things about your establishment: The technology and
equipment used in your processing lines; the practical aspects of food
operations; and the flow of the process in your plant. It will be a
bonus for your HACCP plan if those employees have some knowledge of the
applied aspects of food microbiology and of HACCP principles and
techniques, although this knowledge can be supplemented by outside
experts.
Pre-HACCP Step 2--Describe the Product and Its Method of Distribution
The second step is to describe completely each food product that
your plant makes. This will help identify hazards that may exist either
in the ingredients or in the packaging materials.
To describe your product, you might ask the following questions
about the product:
1. Common name?
[[Page 38876]]
For example, a cooked sausage could be called franks/hot dogs/
wieners.
2. How is it to be used?
Categories might include: Ready-to-eat, to be heated prior to
consumption, or for further processing.
3. The type of package?
For example, is it modified atmosphere packaging?
4. Length of shelf life?
In the cooked sausage example, the length of shelf life might be 30
to 50 days for modified atmospheric packaging.
5. Where will it be sold?
For example, will it be sold to wholesale, retail or institutions?
6. Labeling instructions?
``Keep Refrigerated'' would be a common labeling instruction for
meat and poultry products.
7. Is special distribution control needed?
For instance, should the product be kept refrigerated at or below
40 deg.F? Below is a blank Product Description Form. It is an example.
You may take it and tailor it to your own establishment.
Below is an example of a Product Description Form filled in for
cooked sausage. The HACCP Generic Models developed for 13 different
processes will give you more samples of product descriptions.
Pre-HACCP Step 3--Develop a Complete List of Ingredients and Raw
Materials
The third step is to develop a written list of ingredients and raw
materials for each process/product. You can write this on a very simple
form, as shown below. You may wish to divide the ingredients into just
two categories: Meat (meat such as boneless beef or chicken parts with
skin) and Other Ingredients (such as spices and preservatives). Below
is a sample Product and Ingredients Form for chunked and formed,
breaded chicken patties. Again, these forms are only examples to get
you started. You may wish to have more elaborate forms for your
establishment. The important thing is to list all ingredients that go
into each product!
Pre-HACCP Step 4--Develop a Process Flow Diagram
The next step is to construct a process flow diagram that
identifies all the steps used to prepare the product, from receiving
through final shipment. The diagram should not be so complex that it is
difficult to follow and understand, but must be complete from the
beginning of your process to the end.
You will want to verify the process flow diagram. You do this by
actually walking through the plant to make sure that the steps listed
on the diagram describe what really occurs in producing the product.
A blank process flow diagram is shown below. It is a very simple
form on which you may want to draw the flow freehand. If you have a
computer, you can make a fancier form, with arrows leading from step to
step.
BILLING CODE 3410-DM-P
[[Page 38877]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.001
[[Page 38878]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.002
[[Page 38879]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.003
[[Page 38880]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.004
[[Page 38881]]
An example of a Process Flow Diagram for cooked sausage is shown
below. The employees in this case chose to construct a flow diagram for
the meat and poultry ingredients, another one for the non-meat
ingredients, and a third flow diagram for supplies such as packaging
materials. You will find more examples of process flow diagrams for
specific products in the HACCP Generic Models.
Remember, the purpose of this diagram is to find any places in your
specific establishment where hazards could occur. As with all HACCP
planning forms, the approving employee should sign and date the form,
for your records.
Pre-HACCP Step 5--Meet the Regulatory Requirements for Sanitation
Standard Operating Procedures
Good sanitation is one of the most basic ways to ensure that you
produce safe products. Maintaining good sanitation serves as an
excellent and necessary foundation for building your HACCP plan. It
also demonstrates that you have the commitment and resources to
successfully implement your HACCP plan. Because it is so important,
meeting the regulatory requirements for Sanitation Standard Operating
Procedures (SOPs) is a pre-HACCP requirement that must be carried out
in all establishments. A separate guide and a model Sanitation SOP have
been prepared and are available to help you with this activity.
Now you are ready to apply the seven principles that will produce a
HACCP plan suited to your plant and your products. Those principles and
how to carry them out will be discussed in detail in the next seven
sections of this guidebook.
[[Page 38882]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.005
[[Page 38883]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.006
BILLING CODE 3410-DM-C
[[Page 38884]]
Principle 1--Conduct a Hazard Analysis
HACCP Principle No. 1 states:
``Conduct a hazard analysis. Prepare a list of steps in the process
where significant hazards occur and describe the preventive measures.''
The regulation defines a food safety hazard as ``Any biological,
chemical, or physical property that may cause a food to be unsafe for
human consumption.''
This section will define the hazards and discuss in general where
they may occur in meat and poultry production. It will then talk about
identifying hazards in your establishment.
Finally, this section will explain how you can apply preventive
measures to the hazards you have identified, to ensure that the
products are safe for consumers. A preventive measure is defined, in
the regulation, as ``Physical, chemical, or other means that can be
used to control an identified food safety hazard.''
You will find a far more detailed listing of and discussion of
hazards in the Meat and Poultry Products Hazards and Controls Guide.
The generic HACCP models discuss the hazards specific to various meat
and poultry processes, such as raw, ground product or swine slaughter.
In addition, the References section of this guidebook lists
publications which can help you identify hazards.
To identify biological, chemical, or physical hazards likely to
occur, you need to know about the chemical, physical, and
microbiological characteristics of meat, poultry, and other
ingredients, as well as how various processes affect those
characteristics. You also need to understand the interactions among
ingredients.
You need to evaluate each step in the process flow diagram to
determine whether a biological, chemical and/or physical hazard may be
introduced at that step and whether preventive measures are available.
Biological Hazards
Biological hazards are living organisms, including microorganisms,
that can put human health at risk. Biological hazards include bacteria,
parasites, protozoa, viruses, and the like.
Agricultural products and food animals carry a wide range of
bacteria. From a public health standpoint, most bacteria are harmless.
Others--the pathogenic microorganisms--can cause illness or even death
in humans. The numbers and types of bacteria vary from one food or
animal species to another, from one geographic region to another, and
with production and slaughter or harvesting methods. During production,
processing, packaging, transportation, preparation, storage and
service, any food may be exposed to bacterial contamination. The most
common biological hazards in meat and poultry are microbiological.
Some of the major pathogenic bacterial organisms that can cause
foodborne illness from eating meat or poultry are: Salmonella,
Clostridium perfringens, Listeria monocytogenes, Staphylococcus aureus,
Campylobacter jejuni, Yersinia enterocolitica, Bacillus cereus,
Clostridium botulinum, and Escherichia coli O157:H7.
In the Meat and Poultry Products Hazards and Controls Guide, you
will find a brief description of the major microorganisms of concern in
meat and poultry. Table 1 in that guide describes the temperature and
pH ranges and the minimum water activity needed for each organism to
grow. Table 4 lists some preventive measures for biological hazards. To
thoroughly identify significant biological hazards in your
establishment, you need to evaluate each specific ingredient and
processing step in your operation.
Chemical Hazards
Chemical hazards may also cause foodborne illnesses.
Chemical hazards fall into two categories:
1. Naturally occurring poisons or deleterious substances are those
that are natural constituents of foods and are not the result of
environmental, agricultural, industrial, or other contamination.
Examples include aflatoxins, mycotoxins, and shellfish toxins.
2. Added poisonous or deleterious substances are those which are
intentionally or unintentionally added to foods at some point in
growing, harvesting, storage, processing, packing, or distribution.
This group of chemicals can include pesticides, fungicides,
insecticides, fertilizers, and antibiotics, as well as direct and
indirect food additives. This group can also include chemicals such as
lubricants, cleaners, paints, and coatings.
To identify any chemical hazards, you first need to identify any
chemical residues that might be in the animal. To do this, think about
the following:
The types of drugs and pesticides routinely used in
raising the animals which are the source of your meat and poultry
ingredients.
Feeds and supplements fed to the animals.
Environmental contaminants the animals may have come into
contact with. This includes both naturally occurring contaminants and
added contaminants.
Pesticides used on plants that may end up as residues in
the animal.
The source of the water the animals were allowed to drink.
You can use the following preventive measures to help ensure that
animals entering your establishment are free of harmful residues:
Require that the animals have been raised in conjunction
with the January 1994 FDA Compliance Policy Guidelines.
Require written assurances from suppliers for each lot of
animals, stating that the animals are free of illegal residues.
Set your own maximum allowable residue limits for specific
drugs, pesticides, and environmental contaminants in animal urine or
tissues as targets to ensure that FDA and EPA tolerances are met.
Ensure that trucks used to ship the animals do not have
chemical hazards that could contaminate the animals.
Most establishments use chemicals during processing and to keep
their operations sanitary. Yet you need to be aware that chemical
hazards can occur at any of the following points:
Prior to receiving chemicals at your establishment.
Upon receiving chemicals.
At any point where a chemical is used during processing.
During storage of chemicals.
During the use of any cleaning agents, sanitizers,
lubricants, or other maintenance chemicals.
Prior to shipment of the finished product.
In trucks used to ship finished product.
Some of the
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
measures you can use to prevent chemical hazards are:
Use only approved chemicals.
Have detailed product specifications for chemicals
entering your plant.
Maintain letters of guarantee from suppliers.
Inspect trucks used to ship finished product.
Properly label and store all chemicals.
Properly train employees who handle chemicals.
In the Meat and Poultry Products Hazards and Controls Guide, Table
5 lists some preventive measures for chemical hazards. For still more
information, see the publication HACCP--Establishing Hazard Analysis
Critical Control Point Program, Food Processors Institute, 1993.
[[Page 38885]]
Physical Hazards
A physical hazard is any physical material not normally found in a
food which causes illness or injury to the individual using the
product. Physical hazards include a variety of foreign materials or
objects, such as glass, metal, and plastic. However, foreign objects
which cannot cause illness or injury are not hazards, even though they
may not be aesthetically pleasing to your customers.
A number of situations can result in physical hazards in finished
products. They include, but are not limited to:
Contaminated raw materials.
Poorly designed or poorly maintained facilities and
equipment. An example would be rust particles and paint chips falling
from overhead structures onto exposed product.
Improper procedures or improper employee training and
practices. For example, by using the wrong cutting technique during the
cut-up/prefabrication process, employees could cut off and leave pieces
of their rubber gloves in the product.
Measures you can take to prevent physical hazards include, but are
not limited to:
Make sure your plant specifications for building design
and operation are accurate and updated regularly.
Make sure your letters of guarantee for ingredients and
product supplies are accurate and updated regularly.
Perform random visual examinations of incoming product and
materials.
Use magnets and metal detectors to help find metal
fragments that would be a physical hazard.
Use stone traps and bone separators to remove these
potential physical hazards.
Keep equipment well maintained.
Train employees to identify potential problems.
To identify some preventive measures for physical hazards, see
Table 6 in the Meat and Poultry Products Hazards and Controls Guide.
Conducting a Hazard Analysis
Now that you have some understanding of the types of hazards that
can occur and how to identify and prevent them, you are ready to
conduct a hazard analysis for each process or product covered in your
HACCP plan.
A hazard analysis is the identification of any hazardous
biological, chemical, or physical properties in raw materials and
processing steps, and an assessment of their likely occurrence and
potential to cause food to be unsafe for consumption.
Your hazard analysis needs to be very specific to your
establishment and how you make your product, since hazards may vary
greatly from one establishment to another. This is due to differences
in: sources of ingredients, product formulations, processing equipment,
processing methods, duration of the processes and storage, and employee
experiences, knowledge, and attitudes.
You also need to review--and perhaps revise--your hazard analysis
whenever you make any changes in: raw materials suppliers, product
formulation, preparation procedures, processing steps, packaging
materials or procedures, distribution or intended use of the product.
Below is a blank Hazard Identification/Preventive Measures form
that you may wish to use for your hazard analysis. Below is an example
of that form filled in for hazards that might exist in a specific
establishment's ground beef process. The form contains space for the
process step in which the hazards could occur, the specific hazards,
and preventive measures to keep that hazard from occurring. Remember,
HACCP is a preventive system.
Steps in Conducting a Hazard Analysis
To conduct a hazard analysis, you need to do the following:
First--Evaluate Your Operation for Hazards
1. Review the product description developed in Pre-HACCP Step 2 and
determine how this information could influence your hazard analysis.
2. Look at all product ingredients and incoming materials for the
product. You developed this list in Pre-HACCP Step 3.
3. For each processing step identified in the process flow diagram,
determine if a biological, chemical or physical hazard(s) could exist
at that step.
BILLING CODE 3410-DM-P
[[Page 38886]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.007
[[Page 38887]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.008
BILLING CODE 3410-DM-C
[[Page 38888]]
4. To help identify hazards, you can ask the following questions at
each processing step:
Could contaminants reach the product during this processing step?
Possibilities include: worker handling, contaminated equipment or
materials, cross-contamination from raw materials, leaking valves or
pipes, dead ends, splashing, etc.
Could any pathogens multiply during this process step to the point
where they became a hazard? Consider product temperature, hold time,
etc.
Could this step create a situation where an ingredient, work in
process, or finished product became contaminated with pathogens?
Could this step introduce a chemical hazard into the product?
Could this step introduce a physical hazard into the product?
5. Fully describe the hazards identified for each step.
6. For each incoming ingredient and material, indicate if a
biological, chemical and/or physical hazard exists.
7. To help identify hazards, you can ask the following questions
about each ingredient:
Could this ingredient contain any pathogenic microorganisms,
toxins, chemicals or physical objects?
If it became contaminated or were mishandled, could this ingredient
support the growth of pathogenic microorganisms?
Are any hazardous chemicals used in growing, harvesting, processing
or packaging the ingredient?
Is this ingredient hazardous if used in excessive amounts?
If this ingredient were left out or used in amounts lower than
recommended, could it result in microbial growth?
Are any chemical or physical hazards associated with this
ingredient?
8. You can ask the following questions about the product in
general:
Have any livestock entering the slaughter establishment been
subjected to hazardous chemicals?
Are any returned/reworked products used as ingredients?
If so, could they cause a hazard?
Are preservatives or additives used in the product formulation to
kill or inhibit the growth of microorganisms?
Do the amount and type of acid ingredients, and the resulting
product pH, affect the growth/survival of microorganisms?
Does the water activity of the finished product affect microbial
growth?
Should refrigeration be maintained for products during transit or
in storage?
Are any chemical or physical hazards associated with any packaging
materials?
9. Fully describe the hazards identified.
Second--Observe the Actual Operating Practices in Your Operation
After describing the hazards you've identified with each step, you
should:
1. Observe the actual operation in your establishment and be sure
that it is the usual process or practice.
2. Observe employee practices where raw or contaminated product
could cross-contaminate workers' hands, gloves or equipment used for
finished/post-process products.
3. Observe product handling past any kill step for potential cross-
contamination.
For additional information about potential biological, chemical,
and physical hazards, you may wish to consult tables 8 through 12 in
the Meat and Poultry Products Hazards and Controls Guide. They can
serve as a guide for identifying potential hazards in ingredients and
at various steps in slaughter and processing. However, they do not
address every ingredient and every processing step used in the meat and
poultry industry.
Preventive Measures
You have identified all significant biological, chemical and
physical hazards for each processing step and each ingredient. Now, it
is time to identify measures to prevent hazards from compromising the
safety of your finished product. Remember, you may not be able to
identify a preventive measure for every hazard that you identified. You
are ready to fill in the preventive measure(s) column of the Hazard
Identification/Preventive Measures Form.
Remember, HACCP defines a preventive measure as ``Physical,
chemical, or other means that can be used to control an identified food
safety hazard.''
Some examples of preventive measures are:
In beef slaughter, a chemical hazard could result from animals
having high levels of drug residues. As a preventive measure, you could
test the animals or require letters of guarantee from producers that
the animals are free of harmful residues.
In poultry slaughter, the venting, opening and evisceration process
could result in a biological hazard from cross contamination by
pathogenic microorganisms. Preventive measures for this hazard would
be: use Good Manufacturing Practices (GMP's) at all times; properly
maintain and operate equipment used to perform these tasks; and rinse
food contact surfaces on equipment with chlorinated water between each
carcass.
In the grinding step for cooked sausage, a physical hazard could be
metal fragments from the grinding equipment. There could be three
different preventive measures for this hazard. You could inspect the
grinding equipment daily to ensure that it is assembled and operated
correctly, is functioning properly, and is not worn or damaged. You
could have an employee visually examine the product at the packaging
step. Or you could use a metal detector at the packaging step.
In many operations, the packaging step could pose chemical hazards
from the packaging materials. A preventive measure could be a letter of
guarantee from the supplier that the packaging materials are all food
grade.
Once you have identified your preventive measures and written them
on your form, you are ready to go on to the next step in developing
your HACCP plan. See blank and filled-in forms for preventive measures
below.
Principle 2--Identify Critical Control Points
HACCP Principle No. 2 states:
``Identify the Critical Control Points (CCPs) in the process.''
A critical control point (CCP) is defined as ``A point, step, or
procedure in a food process at which control can be applied and, as a
result, a food safety hazard can be prevented, eliminated, or reduced
to acceptable levels.''
So far, in developing your HACCP plan, you have identified
biological, chemical, and physical hazards in the raw materials and
ingredients you use and in the steps of your process. You've also
identified preventive measures, if they exist, for each hazard that you
identified. With this information, your next step is to identify the
points in the process at which the preventive measures can be applied
to prevent, eliminate, or reduce the hazard. Then you can use the CCP
Decision Tree to assess each step in the process to determine whether
it is a critical control point. (Many control points may not be
critical; often, companies starting out in HACCP identify too many
control points.)
Fortunately, a great deal of work has already been done for you in
identifying CCPs. Many CCPs are already recognized in various food
processing and production systems. Some common CCPs are:
Chilling.
Cooking that must occur for a specific time and
temperature in order to destroy microbiological pathogens.
[[Page 38889]]
Product formulation controls, such as mixing ground beef
and spices to form a meatball.
Certain processing procedures, such as filling and sealing
cans.
Prevention of cross contamination between raw and cooked
product.
Certain slaughter procedures, such as evisceration.
These are just a few examples of measures that may be CCPs.
There are many more possibilities. Different facilities, preparing
the same food, can differ in the number and location of hazards and the
points, steps or procedures which are critical control points. This is
due, in part, to differences in plant layouts, equipment used,
selection and sources of raw materials and ingredients, or the process
that is used.
Steps in Identifying Critical Control Points
A good tool for identifying Critical Control Points is the CCP
Decision Tree, shown below. The CCP Decision Tree was developed to help
companies separate CCPs from other controls. You will get the best
results if you use the Decision Tree very methodically and use simple,
descriptive, and familiar wording. You should apply the Decision Tree
at each step in the process where you have identified a hazard.
You can use the blank Critical Control Point Determination Form, to
record the results from your CCP Decision Tree work. Or, you may wish
to design your own form. An example of a filled-in Critical Control
Point Determination Form for poultry slaughter at one establishment is
shown below.
Determining whether a process step is a CCP is really a basic
exercise of answering four questions. To use the form and the Decision
Tree, follow the next six steps:
1. In Column 1 of the Critical Control Point Determination Form,
write in each step in the process where you have identified a hazard.
2. In Column 2, write in the identified hazard(s), indicating
whether it is biological, chemical or physical. Then take the
information you wrote on your Hazard Identification/Preventive Measures
form and answer the following questions for each hazard you identified.
3. Question #1--Do preventive measures exist for the identified
hazard?
Note: From a regulatory standpoint, no further action is
necessary if the hazard is not reasonably likely to occur.
If the answer is yes, write YES and proceed to the next question.
If the answer is no, ask the question ``Is control at this step
necessary for safety?''
If control is not necessary at this step in the process, this
process step is not a CCP. Write NO in Column 3 and write how and where
this hazard will be controlled. Proceed to the next process step and
identified hazard you have entered in Columns 1 and 2.
If control is necessary, in Column 3 explain how the step, process
or product will be modified to ensure safety.
BILLING CODE 3410-DM-P
[[Page 38890]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.009
[[Page 38891]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.010
[[Page 38892]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.011
BILLING CODE 3410-DM-C
[[Page 38893]]
Once the step, process, or product has been modified, return to
Question #1.
4. Question #2--Does this step eliminate or reduce the likely
occurrence of the hazard(s) to an acceptable level?
If the answer is yes, write YES in Column 4 and identify the step
as a CCP in Column 7.
If the answer is no, write NO in Column 4 and proceed to the next
question.
5. Question #3--Could contamination with identified hazard(s) occur
in excess of acceptable levels or could these increase to unacceptable
levels?
If the answer is yes, write YES in Column 5 and proceed to the next
question.
If the answer is no, write NO in Column 5, indicating that the step
is not a CCP. Then proceed to the next process step and hazard.
6. Question #4--Will a subsequent step eliminate identified
hazard(s) or reduce the likely occurrence to an acceptable level?
If the answer is yes, write YES in Column 6, indicating that the
step is not a CCP. Then write down which processing step, which occurs
later, will reduce the hazard to acceptable levels. Then proceed to the
next process step and hazard.
If the answer is no, write NO in Column 6 and identify the step as
a CCP in Column 7.
Principle 3--Establish Critical Limits for Each Critical Control Point
HACCP Principle No. 3 states:
``Establish critical limits for preventive measures associated with
each identified CCP.''
The regulation defines critical limit as ``The maximum or minimum
value to which a physical, biological, or chemical hazard must be
controlled at a critical control point to prevent, eliminate, or reduce
to an acceptable level the occurrence of the identified food safety
hazard.''
Critical limits are expressed as numbers, such as:
Time/temperature
Humidity
Water activity
pH
Salt concentration
Chlorine level
You will find that many critical limits for your identified CCPs
have already been established. You can find these limits in sources
such as regulatory requirements, scientific literature, experimental
studies, and through consultation with experts. Some examples of
regulatory critical limits for CCPs in meat and poultry production are
shown in Table 7 of the Meat and Poultry Products Hazards and Controls
Guide.
You may wish to establish critical limits that are stricter than
regulatory requirements. However, your critical limits must never be
less stringent than the requirements.
In some cases, you will need more than one critical limit to
control a particular hazard. For example, the critical limits for
cooked beef patties are time/temperature, pattie thickness, and
conveyor speed.
Below you will find an example of a Critical Limits, Monitoring and
Corrective Actions Form. You can use that form, or develop your own, to
use in this and the following two sections. You will find an example of
that form filled in for swine slaughter in one establishment below. You
can find examples of critical limits for specific processes in the
HACCP Generic Models.
Steps in Establishing Critical Limits
1. For each identified CCP, determine if there is a regulatory
critical limit. If so, write that critical limit--or a more stringent
one--into the critical limit column of your form.
For example, the regulatory critical limit for chilled poultry is
40 degrees F. So, for the chilling CCP in poultry slaughter, you would
write, in the Critical Limit column of your form: ``Deep breast muscle
temperature of 40 degrees F. as the carcasses exit the
chiller.''
2. If there are no regulatory critical limits for a CCP, you need
to establish critical limits for the CCP that are adequate to maintain
control and prevent a food safety hazard. That is the responsibility of
each establishment. You may wish to obtain the assistance of outside
HACCP experts to help you determine critical limits for your CCPs. Once
you have identified critical limits, enter them into the critical limit
column of your form.
3. You should also file, for future reference, any documentation
such as letters from outside HACCP experts or scientific reports
supporting the critical limits you have identified. This documentation
will help validate that the limits have been properly established. In
addition, you should keep on file any test results that show your early
experience in implementing the HACCP plan, to demonstrate you can
implement what is written and make it work.
BILLING CODE 3410-DM-P
[[Page 38894]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.012
[[Page 38895]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.013
BILLING CODE 3410-DM-C
[[Page 38896]]
Principle 4--Establish Monitoring Procedures
HACCP Principle No. 4 states:
``Establish CCP monitoring requirements. Establish procedures for
using the results of monitoring to adjust the process and maintain
control.''
Monitoring is a planned sequence of observations or measurements to
assess whether a CCP is under control and to produce an accurate record
for future use in verification.
Monitoring is essential to a HACCP system. Monitoring can warn you
if there is a trend towards loss of control, so that you can take
action to bring your process back into control before a critical limit
is exceeded. For example, say that an establishment tests the pH of a
batch of product at 6 a.m., 7 a.m., and 8 a.m. Each time, the pH is
within acceptable limits, but it is steadily climbing towards the high
end of the range. This information is showing a trend and the
establishment should take action to prevent the pH from exceeding the
critical limits.
The monitoring procedures you will establish at CCPs will generally
relate to on-line processes. Monitoring may be continuous or non-
continuous. Continuous monitoring at a CCP usually is done with
measuring equipment, such as automatic time-temperature equipment used
at a cooking step. Continuous monitoring is better because it results
in a permanent record that you can review and evaluate to ensure that
the CCP is under control. However, you should regularly check
continuous monitoring equipment for accuracy.
You should use non-continuous monitoring procedures when continuous
monitoring is not feasible. Non-continuous monitoring can include:
visual examinations; monitoring of ingredient specifications;
measurements of pH, water activity (Aw), and product temperatures;
attribute sampling; and the like. When you use non-continuous
monitoring, you need to ensure that the frequency of monitoring is
enough to ensure that the hazard is under control and that the
monitoring is performed at random times. For instance, each plant needs
to set its own times and frequency for checking the cooking time/
temperature of products. This may vary from one establishment to
another because of differences in plant size, plant layout, the type of
product, the length of time for processing, and the product flow.
Each establishment has the responsibility to establish a frequency
that ensures that the CCP is under control. In some cases, you may have
to perform tests at a CCP or use statistically based sampling.
Monitoring will go much more smoothly if you:
Clearly identify the employee(s) responsible for
monitoring.
Train the employee(s) monitoring the CCPs in the testing
procedures, the critical limits established, the methods of recording
test results, and actions to be taken when critical limits are
exceeded.
Ensure that the employee(s) understand the purpose and
importance of monitoring.
You can use the Critical Limits, Monitoring and Corrective Actions
Form shown below, or you can develop your own form. Below is an example
of a form filled in for swine slaughter in one establishment.
Steps in Establishing Monitoring Procedures
You can identify monitoring procedures for your HACCP plan by doing
the following:
1. For each CCP, identify the best monitoring procedure.
2. Determine the frequency of monitoring for each CCP.
3. Determine if the monitoring activity needs to be done randomly
to get a good representation of the product throughout the day's
production. If it does, decide how the random monitoring will be done.
4. Determine what testing procedures need to be done for each
monitoring function. For example, will you need to do a chlorine check
or a temperature measurement?
5. Identify and train the employee(s) responsible for monitoring.
6. Make sure that the employee doing the monitoring signs all
records and documents associated with CCP monitoring. Also make sure
that the monitoring results are documented or recorded at the time the
monitoring takes place.
7. Enter the above information in the monitoring column of your
form.
Principle 5--Establish Corrective Actions
HACCP Principle No. 5 states:
``Establish corrective action to be taken when monitoring indicates
that there is a deviation from an established critical limit.''
The regulation defines corrective action as ``Procedures to be
followed when a deviation occurs.''
A deviation is a failure to meet a critical limit.
Since HACCP is a preventive system to correct problems before they
affect the safety of the food, you have to plan in advance to correct
potential deviations from established critical limits. Once your HACCP
plan is in place, any time a critical limit is not met, you will need
to take corrective actions. Those corrective actions should include:
1. Determining the disposition of non-complying product;
2. Correcting the cause of the non-compliance to prevent a
recurrence;
3. Demonstrating that the CCP is once again under control (this
means examining the process or product again at that CCP and getting
results that are within the critical limits);
4. Maintaining records of the corrective actions.
Under HACCP, you determine in advance what you will do when a
critical limit is not met at a CCP. The employee(s) monitoring CCPs
should understand this process and be trained to perform the
appropriate corrective actions. It is important that an establishment
record all corrective actions and that the employee responsible for
taking the corrective actions sign all the documentation.
In some cases, the product in question will be held for further
investigation of the deviation. This investigation may require a
thorough record review, product testing, or consultation with a
processing authority.
Some examples of corrective actions are:
Immediately adjust the process and hold product for
further evaluation and disposition.
Empower employees to stop the line when a deviation
occurs, hold all product not in compliance, and call in the plant's
quality control manager.
Rely on an approved alternate process that can be
substituted for the one that is out of control at the specific critical
control point. For example, if the in-line eviscerators in a poultry
slaughter plant are malfunctioning, evisceration can be done by hand as
long as Good Manufacturing Practices (GMPs) are followed.
Regardless of the corrective actions you take, you need to keep
records that include:
The deviation that was identified.
The reason for holding the product; the time and date of
the hold; the amount of product involved; the disposition and/or
release of product; and the individual who made the disposition
decision.
Actions to prevent the deviation from recurring.
You can use the Critical Limits, Monitoring and Corrective Actions
form below or you can develop your own
[[Page 38897]]
form. A sample form, filled in for swine slaughter, appears below.
Steps in Establishing Corrective Actions
1. For each CCP, determine the corrective action to take if the
critical limits are exceeded. Determine what should be done with the
product if a deviation occurs at this step. You may need more than one
corrective action for a CCP.
2. Develop the record form to capture all the necessary information
on the deviation, and identify the employee responsible for maintaining
and signing the record.
3. Ensure that employees conducting the monitoring at each CCP are
fully trained and know the corrective actions to take if a deviation
occurs.
4. Enter the appropriate corrective action(s) for each CCP in the
corrective action column of the Critical Limits, Monitoring and
Corrective Actions form and identify the record that will be
maintained.
Principle 6--Establish Recordkeeping Procedures
HACCP Principle No. 6 states:
``Establish effective recordkeeping procedures that document the
HACCP system.''
Maintaining proper HACCP records is an essential part of the HACCP
system. Good HACCP records--meaning that they are accurate and
complete--can be very helpful to you for the following reasons:
Records serve as written documentation of your
establishment's compliance with its HACCP plan.
Records allow you to trace the history of an ingredient,
in-process operations, or a finished product, should problems arise.
Records help you identify trends in a particular operation
that could result in a deviation if not corrected.
If you were ever faced with a product recall, HACCP
records could help you identify and narrow the scope of such a recall.
Well-maintained records are good evidence in potential
legal actions against an establishment.
In accordance with the HACCP principles, your HACCP system should
include records for CCPs, establishment of critical limits, handling of
deviations, and your HACCP plan. Examples of these and other HACCP
forms that may be useful in assembling the HACCP plan are located in
the appropriate sections of this guidebook. For your review, these
forms are:
Product(s) Description Form
Product and Ingredients Form
Process Flow Diagram Form
Hazard Identification/Preventive Measures Form
CCP Determination Form
Critical Limits, Monitoring and Corrective Actions Form
Recordkeeping and Verification Form (Verification will be explained in
the next section of this guidebook)
HACCP Plan Form
In many cases, the records you currently maintain may be sufficient
to document your HACCP system. Records must contain at least the
following information: title and date of record; product
identification; critical criteria or limits; a line for the monitor's
signature; a place for the reviewer's signature; and, an orderly manner
for entering the required data.
An example of a blank Recordkeeping and Verification Form is found
below. Also below is an example of the form filled in for cooked
sausage in one establishment.
Steps in Establishing Recordkeeping Procedures
1. Review the records you currently maintain and determine which
ones adequately address the monitoring of the CCPs you have identified,
or develop forms for this information.
2. Develop any forms necessary to fully record corrective actions
taken when deviations occur.
3. Develop forms to document your HACCP system. (This will be
explained in the next section, on verification).
4. Identify the monitoring employees responsible for entering data
into the records and ensure that they understand their roles and
responsibilities.
5. Enter the record form name(s) on the Recordkeeping and
Verification Form under the records column adjacent to the appropriate
CCP. (Verification will be explained in the next section).
6. Enter the appropriate record form name(s) on the Recordkeeping
and Verification Form under the verification procedures column adjacent
to the appropriate CCP. (Verification will be explained in the next
section).
Principle 7--Establish Verification Procedures
HACCP Principle No. 7 states:
``Establish procedures to verify that the HACCP system is working
correctly.''
After a HACCP plan has been put into place, verification activities
occur on an ongoing basis. Verification entails the use of methods,
procedures, or tests in addition to those used in monitoring, to
determine whether the HACCP system is operating as intended.
Simply stated, you need to verify that your HACCP system is working
the way you expected it to work. There are several areas that warrant
checking. You will probably first want to review your HACCP plan to
determine whether the CCPs and critical limits that you established are
really the right ones and that you are controlling and monitoring them
adequately. You should also make sure that employees are following your
procedures for taking corrective actions when a critical limit is
exceeded. Finally, you should check to see that your employees are
keeping good HACCP records.
By doing these things, you will evaluate the day-to-day operation
of your HACCP system. Don't be surprised if you find that you need to
fine-tune your HACCP plan.
Some things you can do to verify your HACCP system are:
Analytically test or audit your monitoring procedures;
Calibrate your temperature equipment;
Sample your product, including microbiological sampling;
Review your monitoring records;
Review your records of deviations and product
dispositions;
Inspect and audit your establishment's operations;
Sample for environmental and other concerns.
BILLING CODE 3410-DM-P
[[Page 38898]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.014
[[Page 38899]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.015
BILLING CODE 3410-DM-C
[[Page 38900]]
You can use the Recordkeeping and Verification Form to record your
verification procedures. A sample blank form appears below. An example
filled in for cooked sausage in one establishment appears below.
Steps in Establishing Verification Procedures
1. Determine the appropriate verification procedure to ensure that
each CCP and critical limit is adequately controlled and monitored.
2. For each CCP, determine procedures to ensure that employees are
following your established procedures for handling product deviations
and for recordkeeping.
3. Identify the frequencies for conducting any verification checks
and the records where the results will be recorded.
4. Enter the appropriate details on the Recordkeeping and
Verification Form for future reference.
Validate Your HACCP Plan
It is very important to validate your HACCP plan. The regulation
defines validation as ``the scientific and technical process for
determining that the CCPs and associated critical limits are adequate
and sufficient to control likely hazards.''
Simply put, when you validate your HACCP plan, you demonstrate that
what you have written and put into place can actually prevent,
eliminate, or reduce the levels of hazards that you have identified.
To validate your HACCP plan, you need to assemble information to
show that your HACCP plan will work to control the process and to
prevent food safety hazards. There are two types of information that
you will probably collect. First, you will likely gather supporting
scientific information, such as studies that establish the time and
temperatures necessary to kill certain harmful bacteria. Second, you
may wish to gather practical information, such as test results from
products produced under your HACCP plan. An example of a test might be
microbiological analysis of your finished, ready-to-eat products. There
are many sources of information to validate your HACCP plan, including:
the scientific literature, product testing results, experimental
research results, scientifically-based regulatory requirements,
official FSIS guidelines, or information developed by process
authorities.
You have a great deal of flexibility in assembling the information
to validate your plan, in terms of both source and quantity of
information. For example, a slaughter plant should validate that its
plan ensures residue control, to prevent violative levels of chemicals,
animal drugs or pesticides in carcasses. A slaughter plant might choose
to purchase animals only from suppliers who provide veterinary
certifications that the animals have been raised under a program that
assures that all animal drugs, pesticides, and other chemicals are
properly used. In this situation, the establishment could validate this
critical control point with the following information: a copy of the
residue prevention program under which the producer is certified; a
report of an on-site visit to the feedlot; and results of analyses of
carcasses for compounds of concern.
Validation is simpler for HACCP plans for products such as cooked
beef, roast beef, or cooked corned beef. Current regulatory
requirements for these products include scientifically-based processing
times, temperatures, and handling requirements. Your HACCP plan would
need only to reflect these regulatory requirements; additional
information would be unnecessary. In this case, you could do a minimal
number of product analyses to demonstrate that hazards of concern, such
as Salmonella, were not found in the products produced under the HACCP
plan.
It is important that you reassess your HACCP plan at least once a
year and whenever any of the following occurs:
1. Potential new hazards are identified that may be introduced into
the process for the product.
2. You add new ingredients.
3. You change the process steps or procedures.
4. You introduce new or different processing equipment.
Finishing Your HACCP Plan
Now you are ready to assemble all your information into one HACCP
Plan. A sample HACCP Plan blank form is provided below. An example of a
form filled in for one establishment's canned beef stew process is
shown below. It is important for your records that you assemble all
your information into a final HACCP plan. To make sure that your HACCP
Plan is complete, you may want to check it against the checklist
provided in the next section of this guidebook.
Now you are ready to put your HACCP Plan into action and make HACCP
a reality in your establishment.
BILLING CODE 3410-DM-P
[[Page 38901]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.016
[[Page 38902]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.017
BILLING CODE 3410-DM-C
[[Page 38903]]
HACCP Plan Checklist
You can use the HACCP Plan Checklist provided in this section to
ensure that your HACCP plan adequately addresses all seven HACCP
principles.
When completing the checklist, if you answer ``NO'' to any
question, you reevaluate that section of the HACCP plan and make
whatever modifications are necessary. Some modifications may require
the assistance of recognized HACCP experts.
Any time you make major changes to the HACCP plan based upon
product or process modifications, it would be advisable to review the
checklist to ensure that the revisions are acceptable.
You can keep the HACCP Plan Checklist as part of your HACCP plan
for future reference and to provide documented evidence that your HACCP
plan addresses all seven HACCP principles.
ESTABLISHMENT NO.------------------------------------------------------
PRODUCT/PROCESS--------------------------------------------------------
DATE-------------------------------------------------------------------
HACCP Plan Checklist
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
A. DESCRIBE THE PRODUCT YES NO
1. Does the HACCP plan include:
a. The producer/establishment and the product name?
b. The ingredients and raw materials used along with the product receipt or formulation?
c. The packaging used?
d. The temperature at which the product is intended to be held, distributed and sold?
e. The manner in which the product will be prepared for consumption?
2. Has a flow diagram for the production of the product been developed that is clear,
simple, and descriptive of the steps in the process?
3. Has the flow diagram been verified for accuracy and completeness against the actual
operating process?
B. CONDUCT A HAZARD ANALYSIS YES NO
1. Have all steps in the process been identified and listed where hazards of potential
significance occur?
2. Have all hazards associated with each identified step been listed?
3. Have safety concerns been differentiated from quality concerns?
4. Have preventive measures to control the identified hazard been identified, if they exist,
and listed?
C. IDENTIFY CRITICAL CONTROL POINTS YES NO
1. Has the CCP Decision Tree been used to help determine if a particular step is a CCP for a
previously identified hazard?
2. Have the CCPs been entered on the forms?
3. Have all significant hazards identified during the hazard analysis been addressed?
D. ESTABLISH CRITICAL LIMITS YES NO
1. Have critical limits been established for each preventive measure at each CCP?
2. Has the validity of the critical limits to control the identified hazard been
established?
3. Were critical limits obtained from the regulations, processing authority, etc?
4. Is documentation attesting to the adequacy of the critical limits maintained on file at
the establishment?
E. ESTABLISH MONITORING PROCEDURES YES NO
1. Have monitoring procedures been developed to assure that preventive measures necessary
for control at each CCP are maintained within the established critical limits?
2. Are the monitoring procedures continuous or, where continuous monitoring is not possible,
is the frequency of monitoring sufficiently reliable to indicate that the hazard is under
control?
3. Have procedures been developed for systematically recording the monitoring data?
4. Have employees responsible for monitoring been identified and trained?
5. Have employees responsible for reviewing monitoring records been identified and trained?
6. Have signatures of responsible individuals been required on the monitoring records?
7. Have procedures been developed for using the results of monitoring to adjust the process
and maintain control?
F. ESTABLISH CORRECTIVE ACTIONS YES NO
1. Have specific corrective actions been developed for each CCP?
2. Do the corrective actions address:
a. Reestablishment of process control?
b. Disposition of affected product?
c. Procedures to correct the cause of non-compliance and to prevent the deviation from
recurring?
3. Have procedures been established to record the corrective actions?
4. Have procedures been established for reviewing the corrective action records?
G. ESTABLISH RECORDKEEPING PROCEDURES YES NO
1. Have procedures been established to maintain the HACCP plan on file at the establishment?
2. Do the HACCP records include:
Description of the product and its intended use?
Flow diagram for the process, indicating CCPs?
Preventive measures?
Critical limits?
Monitoring system:
Corrective action plans for deviations from critical limits?
Recordkeeping procedures for monitoring?
Procedures for verification of the HACCP system?
H. ESTABLISH VERIFICATION PROCEDURES YES NO
1. Have procedures been included to verify that all significant hazards were identified in
the HACCP plan when it was developed?
2. Have procedures been included to verify that the critical limits are adequate to control
the identified hazards?
3. Are procedures in place to verify that the HACCP system is functioning properly?
[[Page 38904]]
4. Are procedures in place to reassess the HACCP plan and system on a regular basis or
whenever significant product, process or packaging changes occur?
----------------------------------------------------------------------------------------------------------------
References
Agriculture Canada. Food Safety Enhancement Program--
Implementation Manual. Camelot Drive, Nepean, Ontario, Canada.
American Meat Institute Foundation. HACCP: The Hazard Analysis and
Critical Control Point System in the Meat and Poultry Industry.
1994. Washington, D.C.
Bean, N. H. and Griffin, P. M. 1990. ``Foodborne disease
outbreaks in the United States, 1973-1987: Pathogens, vehicles, and
trends.'' J. Food Protect. 53: 804-817.
Bean, N. H. and Griffin, P. M. 1990. ``Foodborne disease
outbreaks, 5-year summary, 1983-1987.'' J. Food Protect. 53: 711.
Corlett, D.A., Jr. and R.F. Steir. 1991. ``Risk assessment
within the HACCP system.'' Food Control 2:71-72.
Council for Agricultural Science and Technology. Risks
Associated with Foodborne Pathogens. February 1993.
Environmental Protection Agency. 1992. Tolerances for Pesticides
in Foods. Title 40, Code of Federal Regulations, Part 185. U.S.
Government Printing Office, Washington, DC.
FDA. 1989. The Food Defect Action Levels. FDA/CFSAN. Washington,
DC.
FDA. 1994. Fish and Fishery Products Hazards and Control Guide--
Get Hooked on Seafood Safety. Office of Seafood. Washington, DC.
International Commission on Microbiological Specification for
Foods. 1989. Microorganisms in Foods 4. Application of hazard
analysis and critical control point (HACCP) system to ensure
microbiological safety and quality. Blackwell Scientific
Publications, Boston.
National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). March 20, 1992--Hazard Analysis and Critical Control
Point System. Int. J. Food Micr. 16: 1-23.
National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). June 1993--Report on Generic HACCP for Raw Beef.
Food Micr. 10: 449-488.
Oblinger, J. L., ed. 1988. ``Bacteria Associated with Foodborne
Illnesses, A Scientific Status Summary by the Institute of Food
Technologists Expert Panel on Food Safety and Nutrition.'' Food
Technol. 42(4).
Padhye, N. V.; Doyle, M. P. 1992. ``E. Coli 0157:H7
Epidemiology, pathogenesis, and methods for detection in food.'' J.
Food Prot. 55:55-565.
Pierson, M. D. and Corlett, D. A., Jr. ed. 1992. HACCP/
Principles and Applications. Van Nostrand Reinhold.
Schuchat, A., Swaminathan, B. And Broome, C.V. 1991.
``Epidemiology of human listeriosis.'' Clin. Microbiol. Rev. 4: 169-
183.
Stevenson, K. E. ed. 1993. HACCP-Establishing Hazard analysis
Critical Control Point Programs. A Workshop Manual. The Food
Processors Institute. Washington, D.C.
Tauxe, R.V., Hargett-Bean, N., Patton, C.M. and Wachsmuth. I.K.
1988. ``Campylobacter isolates in the United States, 1982-1986.''
In, CDC Surveillance Summaries, June 1988. MMWR 37 (No. SS- 2) : 1-
13.
Tauxe, R. V., Epidemiology of Camplyobacter jejuni infections in
the United States and other Industrialized Nations. In Nachamkin,
Blaser, Tompkins, ed. Camplyobacter jejuni: Current Status and
Future Trends, 1994, chapter 2, pages 9-19.
Todd, E. 1990. ``Epidemiology of Foodborne Illness: North
America.'' The Lancet 336:788.
Tompkin, R. B. 1990. ``The Use of HACCP in the Production of
Meat and Poultry Products. J. of Food Protect.'' 53(9): 795-803.
Tompkin, R. B. 1995. The Use of HACCP for Producing and
Distributing Processed Meat and Poultry Products. In Advances in
Meat Research. Volume 10. Hazard Analysis Critical Control Point
(HACCP) in Meat, Poultry and Seafoods. Chapman & Hall (In Press).
USDA, 1994. List of Propriety Substances and Nonfood Compounds
Authorized for Use under USDA Inspection and Grading Programs. USDA,
FSIS, Washington, DC.
Internet Home Pages
Agriculture Canada
http://aceis.agr.ca
Center for Disease Control
http://fftp.cdc.gov/pub/mmwr/MMWRweekly
Food Law Sites
http://www.fsci.umn.edu/FoodLaw/foodlaw.html
HACCP95
http://www.cvm.uiuc.edu/announcements/haccp95/haccp95.html
International Meat and Poultry HACCP Alliance
http://ifse.tamv.edu./haccpall.html
Material Safety Data Sheets
http://listeria.nwfsc.noaa.gov/msds.html
U.S. Department of Agriculture
http://www.usda.gov
U.S. Food and Drug Administration/Bad Bug Book
http://vm.cfsan.fda.gov/list.html
Appendix D--Hazards and Preventive Measures Guide
Preface
This Guide is designed to help a plant's HACCP team conduct a
hazard analysis (HACCP Principle 1) by providing both general and
detailed information on hazards associated with meat and poultry
products and by listing some of the controls that can be used to
prevent or manage those hazards. When using this Guide it is very
important to remember that it is not all-inclusive: There may be other
hazards associated with ingredients or processes; there may be other
control measures. The examples assembled here are to help plant HACCP
teams think through all the hazards that could affect their product and
know about various controls that can be used.
Section I describes some of the biological (including
microbiological), chemical, and physical hazards generally recognized
and associated with meat and poultry products. This section can serve
as a resource when the HACCP team begins the hazard analysis. It is
probably useful to read through this general information early in the
process of developing the HACCP plan. This will help the team form an
idea of what is meant by a given hazard.
Section II provides information on generally recognized preventive
measures used in the meat and poultry industry to control biological,
chemical, and physical hazards. This section also has examples of
regulatory critical limits associated with some preventive measures.
Sections III, IV, and V list processing steps, hazards, and
controls for beef, poultry, and swine slaughter. This section should be
used with the process flow diagram developed by the HACCP team.
Section VI presents hazards and controls organized according to
ingredients, including both meat and poultry ingredients and other
ingredients used in meat and poultry production. This section should be
used with the list of ingredients developed by the HACCP team.
Section VII contains a set of tables identifying potential hazards
at various processing steps used to produce meat and poultry products.
This section should be used with the process flow diagram developed by
the plant's HACCP team.
Section VIII contains a list of valuable references that will help
the plant's HACCP team further develop the HACCP plan.
Section I
Overview of Biological, Chemical, and Physical Hazards
In a HACCP system, a hazard is defined as a biological, chemical,
or physical property that may cause a food
[[Page 38905]]
to be unsafe for human consumption. This guide is a reference for plant
HACCP teams to use in their hazard identification and analysis. It is
not intended to be totally inclusive; the team may have other
information or may rely on additional references.
Biological Hazards
Biological hazards, which are mainly bacterial, can cause either
foodborne infections or intoxications. A foodborne infection is caused
by a person ingesting a number of pathogenic microorganisms sufficient
to cause infection as a result of their multiplication, e.g.,
salmonellosis. A foodborne intoxication is caused by the ingestion of
already formed toxins produced by some bacteria when they multiply in
food, e.g., staphylococcal enterotoxin.
When assessing bacterial hazards to human health in meat and
poultry products, nine pathogenic bacteria must be considered. The
following identifies and discusses the nine pathogenic microorganisms
of concern.
Bacillus cereus
B. cereus foodborne intoxication includes two recognized types of
illness--diarrheal and emetic (vomiting).
Foods associated with illness include: Boiled and fried rice,
custards, cecal products meats, vegetables, and fish; food mixtures
such as sauces, puddings, soups, casseroles, pastries, and salads.
Campylobacter jejuni
Campylobacteriosis is the illness caused by C. jejuni. It is also
often known as campylobacter enteritis or gastroenteritis.
Food associated with illness include: raw and undercooked chicken,
raw milk, non-chlorinated water.
Clostridium botulinum
Foodborne botulism (as distinct from wound botulism and infant
botulism) is a severe foodborne disease caused by the ingestion of
foods containing the potent neurotoxin formed during growth of the
organism. Botulism has a high mortality rate if not treated immediately
and properly.
Foods associated with disease include: sausages, meat products, and
seafood products, improperly canned foods, vegetable products.
Clostridium perfringens
Perfringens foodborne illness is the term used to describe the
common foodborne disease caused by the release of enterotoxin during
sporulation of C. perfringens in the gut.
Foods associated with illness include: meat and poultry products
and gravy.
Escherichia coli O157:H7
Hemorrhagic colitis is the name of the acute disease caused by E.
coli O157:H7.
Foods associated with illness: undercooked or raw hamburger (ground
beef) has been implicated in many documented outbreaks and in other
sporadic cases; other meat products, raw milk, untreated water.
Listeria monocytogenes
Listeriosis is the name of the general group of disorders caused by
L. monocytogenes.
Foods associated with illness: cole slaw, cooked poultry, cooked
meat, and raw milk, supposedly pasteurized fluid milk, cheeses
(particularly soft-ripened varieties). Its ability to grow at
temperatures as low as 3 deg.C permits multiplication in refrigerated
foods.
Salmonella spp
S. typhi and the paratyphoid bacteria are normally septicemic and
produce typhoid or typhoid-like fever in humans and are pathogenic only
for humans. Other forms of salmonellosis generally produce milder
symptoms. The organism is found in the intestinal tracts of warm
blooded animals.
Foods associated with illness: raw and cooked meats, poultry, eggs
(and exterior of egg shells), untreated water, raw milk and dairy
products, fish, shrimp, frog legs, yeast, sauces and salad dressing,
etc.
Staphylococcus aureus
Staphylococcal food poisoning (staphylococcal enterotoxicosis;
staphylococcal enterotoxemia) is the name of the condition caused by
the enterotoxins that some strains of S. aureus produce.
Foods associated with illness: meat and meat products; poultry and
egg products; egg, tuna, ham, chicken, potato, and macaroni salads;
sandwich fillings; milk and dairy products; etc.
Yersinia enterocolitica
Yersiniosis is the name of the disease caused by pathogenic species
in the genus Yersinia. The disease is a gastroenteritis with diarrhea
and/or vomiting, and fever and abdominal pain.
Foods associated with illness: meats, oysters, fish, milk, and
chitterlings.
Table 1.--Characteristics of Growth for Nine Pathogens Associated With Meat and Poultry Products
----------------------------------------------------------------------------------------------------------------
Temperature of
Pathogens growth pH Minimum Aw
----------------------------------------------------------------------------------------------------------------
Bacillus cereus................................................. 10-48 deg.C 4.9-9.3 0.95
Campylobacter jejuni............................................ 30-47 deg.C 6.5-7.5 ..............
Clostridium botulinum........................................... 3.3-46 deg.C >4.6 0.94
(Types A,B,E)................................................... .............. .............. ..............
Clostridium perfringens......................................... 15-50 deg.C 5.5-8.0 0.95
Escherichia coli O157:H7........................................ 10-42 deg.C 4.5-9.0 ..............
Listeria monocytogenes.......................................... 2.5-44 deg.C 5.2-9.6 ..............
Salmonella...................................................... 5-46 deg.C .............. 4-9 0.94
Staphylococcus aureus........................................... 6.5-46 deg.C 5.2-9 0.86
Yersinis enterocolitica......................................... 2-45 deg.C 4.6-9.6 ..............
----------------------------------------------------------------------------------------------------------------
Zoonotic agents are biological hazards that cause disease in
animals and can be transmitted and cause disease in humans. The
following lists some zoonotic hazards:
Trichinella spiralis is a nematode parasite whose larval from
encysts primarily in the striated muscle of pigs, horses, rats, bears
and other mammals. Infection in humans results in ``flu-like symptoms''
(diarrhea, fever, stiffness, muscle pain, respiratory distress, etc.)
And heavy infection may lead to death.
Foods associated with illness include: raw and undercooked pork,
bear and equine meat.
Taenia saginata is a human tapeworm whose larval form (Cysticercus
bovis) encysts in the tissues of cattle.
Foods associated with illness include: raw or undercooked beef.
Taenia solium is a human tapeworm whose larval form (Cystricercus
cellulosae) encysts in the tissues of pigs,
[[Page 38906]]
dogs, and humans. Cysts in humans are most common in the subcutaneous
tissues, eye and the brain.
Foods associated with illness include: raw or undercooked pork.
Toxoplasma gondii is a protozoan parasite that encysts in the
tissues of a variety of mammalian hosts including pigs. Human infection
may result in ``flu like'' symptoms in adults, late term abortions in
pregnant women or serious congenial infections in children.
Foods associated with illness include: raw or undercooked pork.
Balantidium coli is a protozoal organism.
Foods associated with illness include: raw, undercooked pork (fecal
contamination)
Cryptosporidium spp.
Foods associated with illness include: inadequately treated water,
raw or undercooked veal or beef.
Chemical Hazards
While biological hazards are of great concern because contaminated
foods can cause widespread illness outbreaks, chemical hazards may also
cause foodborne illnesses, although generally affecting fewer people.
Chemical hazards can originate from four general sources:
(1) Agriculture chemicals: pesticides, herbicides, animal drugs,
fertilizers, etc.
(2) Plant chemicals: cleaners, sanitizers, oils, lubricants,
paints, pesticides, etc.
(3) Naturally-occurring toxicants: products of plant, animal, or
microbial metabolisms such as aflatoxins, etc.
(4) Food chemicals: preservatives, acids, food additives, sulfiting
agents, processing aids, etc.
(5) Environmental contaminants: lead, cadmium, mercury, arsenic,
PCBs.
For many years the Food Safety and Inspection Service has conducted
a National Residue Program to monitor the occurrence of residues from
hazardous chemicals in meat and poultry products. Under a HACCP regime,
frontline responsibility for control of residues from animal drugs or
environmental contaminants will move from the government to the
industry, although the agency will continue to verify that these
controls and preventive measures are effective. Companies that
slaughter livestock and poultry will probably find the FSIS National
Residue Program Plan to be a useful document. The plan contains lists
of compounds that might leave residues in the tissues of animals or
birds, and provides some information on their relative risk through the
rankings in the Compound Evaluation System. It provides information on
which compounds FSIS has included in its annual testing program. It
also provides information on the methods that are used to test for the
compounds. Another FSIS document, the Domestic Residue Data Book,
presents the results of FSIS testing. These data can help a HACCP team
understand the overall hazard presented by various residues, although
each company should gather information about the residue control
performance of its own suppliers.
Another useful reference about hazardous chemicals is the FSIS List
of Proprietary Substances and Nonfood Compounds. This publication lists
substances used in the preparation of product and nonfood compounds
used in the plant environment that have been authorized by FSIS.
Table 2 identifies some additional sources of chemical hazards.
References listed in Section VIII can be used by the HACCP team in
evaluating the potential chemical hazards associated with their product
or process.
Table 2.--Types of Chemical Hazards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Location Hazard
--------------------------------------------------------------------------------------------------------------------------------------------------------
Raw Materials....................... Pesticides, antibiotics, hormones, toxins, fertilizers, fungicides, heavy metals, PCBs.
Color additives, inks, indirect additives, packaging materials.
Processing.......................... Direct food additives--preservatives (nitrite), flavor enhancers, color additives.
Indirect food additives--boiler water additives, peeling aids, defoaming agents.
Building and Equipment Maintenance.. Lubricants, paints, coatings.
Sanitation.......................... Pesticides, cleaners, sanitizers.
Storage and Shipping................ All types of chemicals, cross contamination.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical Hazards
Physical hazards include a variety of materials referred to as
extraneous materials or foreign particles or objects. A physical hazard
can be defined as any physical material not normally found in a food
that can cause illness or injury to a person consuming the product.
Physical hazards in finished products can arise from several
sources, such as contaminated raw materials, poorly designed or
maintained facilities and equipment, faulty procedures during
processing, and improper employee training and practices. Table 3
identifies some common physical hazards and their causes or sources.
Table 3.--Types of Physical Hazards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hazard Source or cause
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glass............................... Bottles, jars, light fixtures, utensils, gauge covers, thermometers.
Metal............................... Nuts, bolts, screws, steel wool, wire, meat hooks.
Stones.............................. Raw materials.
Plastics............................ Packaging materials, raw materials.
Bone................................ Raw material, improper plant processing.
Bullet/BB Shot/Needles.............. Animals shot in field, hypodermic needles used for infections.
Jewelry............................. Pens/pencils, buttons, careless employee practices.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 38907]]
Section II
Controls and Critical Limits for Biological, Chemical, and Physical
Hazards
When all significant biological, chemical, and physical hazards are
identified along with their points of occurrence, the next task is to
identify measures to prevent the hazards from compromising the safety
of the finished product.
Preventive measures or controls can be defined as physical,
chemical, or other factors that can be used to remove or limit an
identified hazard. When considering preventive measures or controls, a
limit must be established--this is the criterion that must be met to
ensure safety. For example, proper heat treatment will control some
pathogenic bacteria, and it is thus crucial to know what time/
temperature combinations constitute proper heat treatment for various
products; these time/temperature combinations are the critical limits.
Another example of a preventive measure for a biological hazard is the
chlorination of poultry chiller water to prevent cross contamination of
carcasses with Salmonella.
With identified physical hazards, the most common preventive
measures may be visual examinations of product or the use of a metal
detector. Chemical hazards associated with raw materials may be
controlled through detailed product specifications, letters of
guarantee, or purchase specifications.
Tables 4, 5, and 6 identify preventive measures that may be
considered by the HACCP team. Table 7 gives some examples of regulatory
limits.
Table 4.--Examples of Preventive Measures for Biological Hazards
------------------------------------------------------------------------
Pathogen Preventive measure or control
------------------------------------------------------------------------
Bacillus cereus........................ Proper holding and cooling
temperatures of foods; thermal
processing of shelf-stable
canned food.
Campylobacter jejuni................... Proper pasteurization or
cooking; avoiding cross-
contamination of utensils,
equipment; freezing;
atmospheric packaging.
Clostridium botulinum.................. Thermal processing of shelf-
stable canned food; addition
of nitrite and salt to cured
processed meats; refrigeration
of perishable vacuum packaged
meats; acidification below pH
4.6; reduction of moisture
below water activity of 0.93.
Clostridium perfringens................ Proper holding and cooling
temperatures of foods; proper
cooking times and
temperatures; adequate cooking
and avoidance of cross-
contamination by unsanitary
equipment or infected food
handlers.
Listeria monocytogenes................. Proper heat treatments; rigid
environmental sanitation
program; separation of raw and
ready-to-eat production areas
and product.
Salmonella spp......................... Proper heat treatment;
separation of raw and cooked
product; proper employee
hygiene; fermentation
controls; decreased water
activity; withdrawing feed
from animals before slaughter;
avoiding exterior of hide from
contacting carcass during
skinning; antimicrobial
rinses; scalding procedures;
disinfecting knives.
Staphylococcus aureus.................. Employee hygiene; proper
fermentation and pH control;
proper heat treatment and post-
process product handling
practices; reduced water
activity.
Yersinia enterocolitica................ Proper refrigeration; heat
treatments; control of salt
and acidity; prevention of
cross-contamination.
------------------------------------------------------------------------
Table 5.--Examples of Preventive Measures for Chemical Hazards
------------------------------------------------------------------------
Hazard Preventive measure
------------------------------------------------------------------------
Naturally-Occurring Substances......... Supplier warranty or guarantee;
verification program to test
each supplier's compliance
with the warranty or
guarantee.
Added Hazardous Chemicals.............. Detailed specifications for
each raw material and
ingredient; warranty or letter
of guarantee from the
supplier; visiting
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
suppliers;
requirement that supplier
operates with a HACCP plan;
testing program to verify that
carcasses do not have
residues.
In-Process Chemicals................... Identify and list all direct
and indirect food additives
and color additives; check
that each chemical is
approved; check that each
chemical is properly used;
record the use of any
restricted ingredients.
------------------------------------------------------------------------
Table 6.--Examples of Preventive Measures for Physical Hazards
------------------------------------------------------------------------
Hazard Preventive measure
------------------------------------------------------------------------
Foreign objects in raw materials....... Supplier's HACCP plan; use of
specifications, letters of
guarantee; vendor inspections
and certification; in-line
magnets; screens, traps, and
filters; in-house inspections
of raw materials.
Foreign objects in packaging materials, Supplier's HACCP plan; use of
cleaning compounds, etc. specifications, letters of
guarantee; vendor inspections
and certification; in-house
inspections of materials.
Foreign objects introduced by In-line metal detectors; visual
processing operations or employee product examinations; proper
practices. maintenance of equipment;
frequent equipment
inspections.
------------------------------------------------------------------------
[[Page 38908]]
Table 7.--Some Examples of Regulatory Limits
------------------------------------------------------------------------
Regulatory
Hazard Regulatory limit citation
------------------------------------------------------------------------
biological: Microbial growth due All poultry must be Sec. 381.6
to temperature abuse-Poultry chilled immediately 6
Chilling. after processing to a
temperature of 40
deg.F or less.
chemical: Excess chemicals Chemicals used are Sec. 318.7
contact product. approved for the
intended use and at
appropriate amounts.
chemical: Chemical hazard from Edible products must be Sec. 317.2
packaging materials. packaged in container 4
that will not
adulterate product or
be injurious to health.
Packaging materials
must be covered by a
letter of guaranty.
biological: Trichinae in pork.... Products containing pork Sec. 318.1
muscle tissue must be 0
effectively heated,
refrigerated, or cured
to destroy any possible
live trichinae.
biological: Pathogens in ready to For destruction of Sec. 318.1
eat products. pathogens that may 7
survive a dry heat
process. One of the
time/temperature
combinations for cooked
beef, roast beef, and
cooked corned beef;
e.g., 143 deg.F\61.7
deg.C minimum
temperature at minimum
time of 6 minutes.
physical: Extraneous material Sampled carcasses Sec. 381.7
found on post chill examination observed for 6
of poultry carcasses. conformance with post
chill criteria,
including unidentified
foreign material.
------------------------------------------------------------------------
Section III
Table 8.--Red Meat (Beef) Slaughter Hazards and Controls Use of
Information
This section contains examples of common process steps in beef
slaughter. With each processing step, shown in the first column, you
will find an ``X'' in the next three columns to tell you if there is a
Biological hazard in column 2, a Chemical hazard in column 3, or a
Physical hazard in column 4. Column 5 describes the hazard(s), and the
last column lists some relevant controls or preventive measures. This
table should be used in conjunction with the process flow diagram
developed by your HACCP team for your plant's beef slaughter process.
Table 8.--Red Meat Slaughter: Beef
----------------------------------------------------------------------------------------------------------------
Description of biological,
Red meat slaughter-beef: examples of chemical, or physical Controls or preventive
processing steps B C P hazards for the process measures
steps
----------------------------------------------------------------------------------------------------------------
Receiving & Holding.................. X --Residues present in edible --Residue certification
tissues above tolerances. presented for live
animal(s).
Skinning............................. X --Micro contamination of --Skinning procedures are
carcass surface due to accomplished without hair
contaminated outside hide or visible fecal
surface--contamination of contamination of the
carcass from floor--cross- carcass.--Careful employee
contamination. practices.--Udder and
puzzle removal are
accomplished without
contamination of edible
product.
Evisceration......................... X --cross-contamination from --Esophagus is tied to
broken viscera. prevent escape of stomach
contents--Bung is dropped
with sanitized knife and
bagged to prevent escape of
feces--Viscera are removed
intact.
Final Wash........................... X --growth of pathogens --Final wash: Temperature:
through insufficient wash. 90-100 deg.F Pressure: 345-
2070 kpa (50-300 psi)--
Steam Pasteurization:
Temperature: 195 deg.F or
greater at surface Dwell
time: 5-15 seconds in
cabinet.
Chilling............................. X --growth of pathogens....... --Surface temperature 40 deg.F as soon as
possible--Carcasses spaced
a minimum of 1 inch apart.
Receiving-Packaging Materials and Non X --contamination from Letters of guarantee on file
Beef Supplies. deletious chemicals present for all packaging materials/
in the packaging materials. non-poultry supplies used
by the establishment.
Storage-Non Beef Supplies............ X --contamination of stored Examine to ensure no visible
packing materials/supplies foreign material on/in non-
from foreign material. poultry supplies or
packaging materials.
----------------------------------------------------------------------------------------------------------------
Section IV
Table 9.--Poultry Slaughter Hazards and Controls
Use of Information
This section contains examples of common process steps in poultry
slaughter. With each processing step, shown in the first column, you
will find an ``X'' in the next three columns to tell you if there is a
Biological hazard in column 2, a Chemical hazard in column 3, or a
Physical hazard in column 4. Column 5 describes the hazard(s), and the
last column lists some relevant controls or preventive measures. This
table should be used in conjunction with the process flow diagram
developed by your HACCP team for your plant's poultry slaughter
process.
[[Page 38909]]
Table 9.--Poultry Slaughter
----------------------------------------------------------------------------------------------------------------
Description of biological,
Poultry slaughter: examples of chemical, or physical Controls or preventive
processing steps B C P hazards for the process measures
steps
----------------------------------------------------------------------------------------------------------------
Scalding............................. X --contamination from --Fresh water input to
scalding medium. achieve a minimum of 1
quart per bird
--Temperature of the scald
water maintained at
appropriate levels (e.g.,
126 deg.F)
--Maintain counterflow
scalding unit function
--Post scald wash has
sufficient pressure and
volume to cover carcass
with fresh (potable) water
spray
--Overflow volumes are at
required amounts
Offline Procedures................... X --cross contamination from Follow approved offline
intestinal contents/exudate. plant procedures for
handling airsacculitis
salvage and reprocessing
for contamination (e.g., an
airsac salvage program that
transfers the carcasses to
another station where the
thigh, drumstick, wing tip,
and first wing section are
salvaged and washed with
chlorinated water).
Final Wash........................... X --growth of pathogens....... --A final water wash with
appropriate levels of
chlorinated water (e.g. 20-
50 ppm residual chlorine in
the water).
--Sufficient water volume
and pressure for equipment
operation and sufficient
dwell time in the final
washer to remove visible
contamination on internal
and external surfaces of
the carcass.
Chilling-Carcass..................... X --growth of pathogens....... Deep breast muscle
temperature of carcass is
40 deg.F within
the specified time from
slaughter for the class of
poultry.
--Maintain an adequate
chlorine level in the
overflow water of in-line
immersion chillers (e.g.,
20-50 ppm residual chlorine
in the incoming water).
--Maintain proper water flow
rates (input/overflow) for
continuous chillers per
USDA requirements (not less
than \1/2\ gallon of fresh
water per frying chicken
with continuous overflow).
X --contamination from foreign Product entering (prechill)
material. and exiting (postchill) the
chiller system meets the
criteria for defects per
USDA requirements (e.g. the
limits are not exceed for
the number and size of
extraneous materials found
during the postchill
examination-9 CFR Sec.
381.76).
Chilling-Giblet/Neck................. X --growth of pathogens....... --Temperature and fresh
water input sufficient to
meet USDA requirements for
giblets and necks.
--Chlorination of giblet
chiller water at
appropriate levels for
giblets and necks [e.g.,
giblets must be chilled to
40 deg.F within 2 hours
from removal from other
viscera/fresh water intake
not less than 1 gallon per
40 frying chickens
processed-9 CFR Sec.
381.66 (c)(5)].
X --contamination from foreign --Visually free of hazardous
material. foreign material.
--Defects on poultry giblet
and necks meet USDA
requirements (e.g., each
carcass must be observed
for conformance against pre
and post chill criteria,
including unidentified
foreign materials-MPI
Regulations 381.76).
[[Page 38910]]
Cut-Up/Boning/Packaging/ Labeling.... X --growth of pathogens....... Temperature of product does
not exceed 55 deg.F during
further or second
processing.
--Movement of product
through these areas and
into the cooler is timely
and efficient.
--A mid-shift cleanup of the
area(s) is performed if the
room temperature is not
maintained at or below 50
deg.F.
--Packaging/labeling
materials that come into
direct contact with product
are intact.
Receiving-Packaging Materials and Non X --contamination from Letters of guarantee are on
Poultry Supplies. deleterious chemicals file for all packaging
present in the packaging materials/non-poultry
materials. supplies used by the
establishment.
Storage-Non Poultry Supplies......... X --contamination of stored Examine to ensure no visible
packing materials/supplies foreign material on/in non-
from foreign material. poultry supplies or
packaging materials.
----------------------------------------------------------------------------------------------------------------
Section V
Table 10.--Red Meat (Swine) Slaughter Hazards and Controls
Use of Information
This section contains examples of common process steps in swine
slaughter. With each processing step, shown in the first column, you
will find an ``X'' in the next three columns to tell you if there is a
Biological hazard in column 2, a Chemical hazard in column 3, or a
Physical hazard in column 4. Column 5 describes the hazard(s), and the
last column lists some relevant controls or preventive measures. This
table should be used in conjunction with the process flow diagram
developed by your HACCP team for your plant's swine slaughter process.
Table 10.--Red Meat Slaughter: Swine
----------------------------------------------------------------------------------------------------------------
Description of biological,
Red meat slaughter-swine: Examples of chemical, or physical Controls or preventive
processing steps B C P hazards for the process measures
steps
----------------------------------------------------------------------------------------------------------------
Scalding............................. X X --contamination from Plant time/temperature
scalding medium. limits for scalding (e.g.,
although it may vary with
facilities, a temperature
of 138 to 140 deg.F is
usually satisfactory).
--Carcasses should remain in
scalding tanks long enough
to loosen hair (excessive
time or temperature results
in carcass cooking).
X ... --contamination with --USDA-FDA approved chemical
chemicals.. concentration not to exceed
manufacturer's
recommendations.
Dehairing............................ X ... ... --contamination and growth --Time/temperature
of microorganisms due to determined by plant-
breaking of the skin from specific testing results to
overexposure to the remove visible hair to an
dehairer. acceptable level without
breaking skin.
Evisceration......................... X ... ... --cross contamination from --Remove all viscera intact.
equipment/utensils. --Contaminated equipment
--contamination from will be clean and sanitized
stomach, intestines, and/or before being used again.
bladder contents. --Training program for all
--contamination from employees, to include
employee handling. personal hygiene, product
handling procedures, and
sanitary dressing
procedures.
Trimming............................. X ... ... Stick wound has not been Remove all visible stick-
removed.. wound related defects.
Chilling............................. X ... ... --growth of pathogens....... --Cool surface temperature
to 40 deg. as soon as
possible.
Receiving-Packaging Materials and Non ... X ... --contamination from Letters of guarantee are on
Swine Supplies. deleterious chemicals file for all packaging
present in the packaging materials/non-poultry
materials. supplies used by the
establishment.
Storage-Non Swine Supplies........... ... X --contamination of stored Examine to ensure no visible
packing materials/supplies foreign material on/in non-
from foreign material. poultry supplies or
packaging materials.
----------------------------------------------------------------------------------------------------------------
[[Page 38911]]
Section VI
Table 11.--Ingredient Hazards and Ingredient-Related Hazards
Use of Information
This section contains an alphabetical list of ingredients commonly
used in making meat and poultry products. For each entry you will find
the name of the ingredient in the first column, and an ``X'' in the
next three columns to tell you if there is a Biological hazard in
column 2, Chemical hazard in column 3, or Physical hazard in column 4.
Column 5 describes the hazard(s), and the last column lists some
relevant controls or preventive measures. This table should be used in
conjunction with the list of ingredients developed by your HACCP team
for the products produced by the process under consideration.
The HACCP team may find that a particular ingredient does not
present the hazard identified in these tables. The presence or absence
of a hazard can be influenced by the ingredient source and company.
Also, Ingredient Specifications, provided by the supplier to the
establishment, may give details on the material/ingredient being sold,
including statements that the materials/ingredients are food grade and
are free of harmful components. For example, the ingredient
specifications for dried legumes might state that there will be fewer
than 5 small rocks or stones per 10 pound bag and that no harmful
pesticides were used in the growing process.
Table 11.--Ingredient Hazards
----------------------------------------------------------------------------------------------------------------
Description of biological,
Examples of ingredient B C P chemical, or physical hazard Controls or preventive
for the ingredient measures
----------------------------------------------------------------------------------------------------------------
Acidifiers........................... ... X ... --toxicological effects if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Anticoagulants....................... ... X ... --toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Antifoaming agents................... ... X ... --toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/ provider
ingredient specifications.
Antioxidants......................... ... X ... --toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Batter/Breading...................... X ... X --growth of pathogens due to --Temperature controls for
improper storage and use
handling. --Ingredient specification
--foreign material sheet identifying the
required parameters the
ingredient must meet.
--Where applicable,
ingredients must be
pathogen-free.
Beef (fresh, frozen)................. X ... ... --growth of pathogens due to --Product temperature must
improper storage and be 40 degrees F or less at
handling. receiving.
--Product must meet
establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Binders/Extenders.................... ... X X --foreign material.......... --Ingredients purchased
under a Letter of
Guarantee.
--Ingredients purchased
based on producer/ provider
ingredient specifications.
Bleaching agents..................... ... X ... --toxicological effect if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/ provider
ingredient specifications.
Blood................................ X ... ... --growth of pathogens from --Ingredient specification
improper handling and sheet identifying the
storage. required parameters the
ingredient must meet.
--Where applicable,
ingredients must be
pathogen-free.
--Meet appropriate temp.
Boneless beef........................ X ... X --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--foreign particle --Product must meet
contamination, e.g., metal establishment purchase
fragments or bone. specifications.
--Product must be produced
under a HACCP plan.
--Visual examination of
product for foreign
materials.
[[Page 38912]]
Cooked beef.......................... X ... X --growth of pathogens due to --Receiving temperature of
improper handling and product must be frozen or
storage. refrigerated at 40 degrees
--foreign particle F or below.
contamination, e.g., metal --Product must be received
fragments or bone particles from an approved supplier
in boneless beef. who produces the product
under a HACCP plan.
--Visual examination of
product for foreign
materials upon receipt.
Cooked poultry....................... X ... X --growth of pathogens due to --Receiving temperature of
improper handling and product must be frozen or
storage. refrigerated at 40 degrees
--foreign particle F or below.
contamination, e.g., bone --Product must be received
particles in boneless from an approved supplier
poultry. who produces the product
under a HACCP plan.
--Product must be
organoleptically acceptable
at receipt.
Cooked pork.......................... X ... X --growth of pathogens due to --Receiving temperature of
improper handling and product must be frozen or
storage. refrigerated at 40 degrees
--foreign particle F or below.
contamination, e.g., bone --Product must be received
particles in boneless pork. from an approved supplier
who produces the product
under a HACCP plan.
--Product must be
organoleptically acceptable
at receipt.
Coloring agents (natural)............ ... X ... --Toxicological effect if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Coloring agents (artificial)......... ... X ... --Toxicological effect if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Curing agents........................ ... X ... --Toxico logical effect if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Curing accelerators.................. ... X ... ---toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Dairy products....................... X ... X --growth of pathogens due to --Temperature control.
improper handling and --Ingredient specification
storage. sheet identifying the
--foreign material required parameters the
ingredient must meet.
--Where applicable,
ingredients must be
pathogen-free.
Eggs or egg products................. X ... X --growth of pathogens due to --Temperature control.
improper handling and --Ingredient specification
storage. sheet identifying the
--foreign particle required parameters the
contamination, e.g., shell ingredient must meet.
particles in broken eggs. --Where applicable,
ingredients must be
pathogen-free.
Emulsifying agents................... ... X ... --toxicological effects if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Flavoring agents..................... ... X ... --toxicological effects if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Fruits............................... ... X X --contamination from --Ingredient specification
agricultural chemicals. sheet identifying the
--foreign material required parameters the
ingredient must meet.
Honey................................ X ... X --contamination from --Ingredient specification
inherent microorganisms. sheet identifying the
--foreign particle required parameters the
contamination, e.g., dirt, ingredient must meet.
insect parts.
Legumes (dry)........................ ... ... X --foreign particle --Ingredient specification
contamination, e.g., rocks. sheet identifying the
required parameters the
ingredient must meet.
[[Page 38913]]
Mechanically deboned product......... X ... X --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--foreign particle --Product must meet
contamination, e.g., bone establishment purchase
particles. specifications.
--Product must be produced
under a HACCP plan.
Mold inhibitors...................... ... X ... --toxicological effect if --Ingredient specification
improper amounts used. sheet identifying the
required parameters the
ingredient must meet.
Mushrooms............................ X X X --contamination from --Ingredient specification
inherent microorganisms. sheet identifying the
--contamination from required parameters the
agricultural chemicals. ingredient must meet.
--foreign material --Where applicable,
ingredients must be
pathogen-free.
Nuts................................. X X X --contamination from --Ingredient specification
inherent microorganisms. sheet identifying the
--contamination from required parameters the
agricultural chemicals. ingredient must meet.
--foreign particle
contamination, e.g., broken
shells.
Packaging materials.................. ... ... X --toxicological effects..... --Use only FDA approved
packaging materials.
-- Each lot of packaging
material must be
accompanied by a Letter of
Guarantee in which the
manufacturer attests to
compliance with FDA
requirements.
Phosphates........................... ... X ... --toxicological effect if --Ingredients purchased
limits are exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Poultry (fresh, frozen).............. X ... ... --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--Product must meet
establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Pork (fresh, frozen)................. X ... ... --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--Product must meet
establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Proteolytic enzymes--Aspergillus ... ... ... --toxicological effects if --Ingredients purchased
oryzae, Aspergillus, Flavusoryzae limits exceeded. under a Letter of
group, Bromelin, Ficin, Papain. Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Partially defatted products.......... X ... X --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--foreign particle --Product must meet
contamination, e.g., metal, establishment purchase
plastic. specifications.
--Product must be produced
under a HACCP plan.
Seafood (fresh, frozen).............. X X ... --growth of pathogens due to --Product temperature must
improper handling and be 40 degrees F or less at
storage. receiving.
--environmental --Product must meet
contamination. establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Spices/herbs--Sterilized, X ... ... --contamination from --Ingredient specification
Unsterilized. microorganisms inherent to sheet identifying the
the ingredient. required parameters the
--contamination from ingredient must meet.
agricultural chemicals.
--foreign material
Sweeteners--Saccharin, Citric acid, ... ... ... --toxicological effects if --Ingredients purchased
Malic acid, Monoisopropyl citrate, limits exceeded. under a Letter of
Phosphoric acid, Monoglyceride Guarantee.
citrate. --Ingredients purchased
based on producer/provider
ingredient specifications.
[[Page 38914]]
Tenderizing agents................... ... X ... --toxicological effects if --Ingredients purchased
limits exceeded. under a Letter of
Guarantee.
--Ingredients purchased
based on producer/provider
ingredient specifications.
Variety meats........................ X ... ... --growth of pathogens due to --Product temperature must
improper handling, storage, be 40 degrees F or less at
or cleaning. receiving.
--Product must meet
establishment purchase
specifications.
--Product must be produced
under a HACCP plan.
Vegetables........................... X X X --growth of pathogens due to --Ingredient specification
improper handling and sheet identifying the
storage. required parameters the
--contamination from ingredient must meet.
agricultural chemicals.
--foreign material
----------------------------------------------------------------------------------------------------------------
Section VII
Table 12.--Processing Hazards and Controls
Use of Information
This section contains a list of processing hazards and controls
commonly used in making meat and poultry products. They are listed in
alphabetical order. For each processing step, shown in the 1st column,
you will find an ``X'' in the next three columns to tell you if there
is a Biological hazard in column 2, Chemical hazard in column 3, or
Physical hazard in column 4. Column 5 describes the hazard(s), and the
last column lists some relevant controls or preventive measures. This
table should be used in conjunction with the process flow diagram
developed by your HACCP team for the products produced during the
process under consideration.
Table 12.--Processing Step Hazards
----------------------------------------------------------------------------------------------------------------
Description of biological,
chemical, or physical Controls or preventive
Processing steps B C P hazards for the process measures
steps
----------------------------------------------------------------------------------------------------------------
Acidifying (also see Pickling, X ... ... --survival of pathogens due --Shelf-stable non-heat
Brining). to final pH>4.6. treated acidified product
must obtain a pH of 4.6 or
lower.
Aging (Meats)........................ X ... ... --growth/survival of --The temperature of the
pathogens from aging room will not exceed
inappropriate storage 40 degrees Fahrenheit.
temperatures and humidity --Product temperature does
(inadequate product water not exceed 40 degrees
activity (aw)). Fahrenheit throughout the
--growth of pathogens due to aging process.
rise in the pH due to --The aging process will not
development of surface exceed seven days.
molds.
Boning............................... X ... ... --contamination by pathogens --Careful employee practices
in product accumulations to make sure that there is
(e.g., cutting boards, no contamination of the
conveyor belts, utensils product.
and other equipment). --Equipment and utensils are
--cross-contamination of washed and sanitized
product by equipment/ immediately when
utensils contaminated with contaminated and each time
pathogens when cutting the employee leaves the
through a non-apparent working station.
lesion (e.g., abscesses). --All hot water sanitizers
are maintained at 180
degrees Fahrenheit.
--Processing room
temperature is maintained
at 50 degrees Fahrenheit,
or a midshift cleanup is
performed within five hours
after operations begin.
--contamination from bones, --A boneless beef re-
cartilage/extraneous inspection procedure will
material. be established using
specifications outlined by
FSIS.
Cooling.............................. X ... ... --growth of pathogens due to Cooked product will be
improper temperatures. cooled according to
--germination of spore- established procedures.
forming pathogens due to
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
slow chilling (e.g., C.
perfringens).
Cooking.............................. X ... ... --survival of pathogens due --Time/Temperature
to improper procedures. combinations are adequate
to destroy the pathogens of
concern.
[[Page 38915]]
Drying (Meat)........................ X ... ... --bacterial growth due to --A water activity will be
inadequate control over specified that in
time, temperature and conjunction with other
humidity. barriers will inhibit
growth of pathogenic
microorganisms (e.g., for
shelf stable sausage Aw of
0.91 and a pH of 4.6).
Filling.............................. X ... ... --recontamination by --Product will be protected
pathogens in product from contamination during
accumulations. the filling process, and
--growth of pathogens due to product temperature/ time
temperature abuse. will be maintained at or
below the maximum
determined to inhibit
growth of pathogenic
microorganisms.
... X ... --contamination from --No lubricants or other
lubricants. chemical contaminants will
be allowed in or on the
product.
Formulation.......................... X ... ... --contamination by employee --Careful employee practices
handling. used at all times to make
--incorrect formulation sure that there is no
--contamination through contamination of product.
damaged packages. --Ingredient packages will
be clean and intact.
--Ingredients will be added
to product according to
requirements outlined 9CR
Sec. 318.7.
... X ... --excessive addition of --Restricted ingredients
restricted ingredients/ will be added to product
additives could be toxic to according to requirements
the consumer. outlined in the 9CFR Sec.
317.8.
Freezing (Meats)..................... X ... ... --survival of parasites due --Rapid cooling and
to improper time/ freezing.
temperature application.
--growth of pathogens due to
temperature abuse.
Grinding............................. X ... ... --contamination by employee --Careful employee practices
handling. to make sure that there is
--recontamination by no contamination of
pathogens in product product.
accumulations. --Product will not be
allowed to accumulate at
the end of the grinder.
--The temperature of the
grinding room will be
maintained at 50 degrees
Fahrenheit.
Grinding............................. ... X ... --contamination from --Food grade lubricants will
lubricants. be used on areas of the
machinery where a potential
for product contamination
exists.
... ... X --contamination from --All boneless product will
extraneous material. be re-inspected before
being loaded into the
grinder.
Handling and Inspecting of Empty X X X --recontamination through --Packaging materials and
Containers and Packaging Materials. damaged or soiled empty containers will be
containers/packaging protected from
material. contamination during their
storage and handling.
--No materials or containers
that appear to be
contaminated with hazardous
foreign material will be
used.
Mechanical Separating................ X ... ... --growth of pathogens....... --Product holding and
cooling requirements
outlined in 9CFR 318.18
will be followed.
X --contamination from bone, --The finished product will
cartilage fragments. meet the standards outlined
--contamination from in 9CFR 319.5 for bone
extraneous material. particles and calcium.
Packaging (also see Modified X X X --contamination from --Closure and/or machine
Atmosphere Packaging, Vacuum packaging material. specifications sufficient
Packaging Seaming, Sealing). --contamination through to ensure adequate barrier
damaged containers. formation.
... ... X ............................ --No detectable foreign
material will be allowed in
or on the product or
immediate product
containers.
Peeling.............................. X ... ... --contamination by pathogens --Careful employee practices
in product accumulations. to make sure that there is
--contamination from no contamination of
employee handling. product.
--Product will not be
allowed to accumulate in/on
peeling equipment.
... ... X --contamination from harmful --Peeling equipment will be
extraneous material. maintained in a proper
operating condition. No
foreign material in the
finished product.
[[Page 38916]]
Receiving............................ X ... ... --contamination through --Product must be received
damaged containers. in sound containers and at
--growth of pathogens due to temperatures appropriate
inappropriate storage for the type of product.
conditions (temperature,
humidity).
--growth of pathogens due to
temperature abuse.
--contamination from
receiving equipment (pumps,
hoses).
... X ... --cross-contamination from --Product must be received
non-food chemicals. in sound containers and be
accompanied by a letter of
guarantee from the supplier
if such letter is not on
file.
... X ... --contamination from --Product must be received
hazardous extraneous in sound containers and be
material (wood, nails from accompanied by a letter of
pallets, plastic pieces). guarantee from the supplier
if such letter is not on
file.
Retorting............................ X ... ... --inadequate application of --A thermal process specific
scheduled process. to the product, container
type and size, and
retorting system must be in
use. The initial product
temperature and any
critical factors specified
for the thermal process
must also be controlled.
Specified retort come up
procedures will be
followed.
Reworking............................ X ... ... --contamination by employee --Careful employee practices
handling. to make sure that there is
--contamination by pathogens no contamination of
in product accumulations. product.
--Room temperature of
storage coolers will not
exceed 40 degrees
Fahrenheit.
... ... X --contamination foreign --Careful employee practices
material. to make sure that there is
no contamination of
product.
Shipping............................. X ... ... --growth due to improper --Product will not be
temperatures. shipped unless it is 40
degrees Fahrenheit or less.
--Product will not be loaded
into transport vehicles if
the trailer temperature
exceeds 40 degrees
Fahrenheit.
... ... X --contamination from --All product packages will
hazardous extraneous be intact before shipping.
material through damaged --All transport vehicles
packages. will be cleaned after each
use and before loading of
product.
Thawing.............................. X ... ... --growth of pathogens due to --Thawing Room temperature
improper temperatures. will not exceed 50 degrees
Fahrenheit.
----------------------------------------------------------------------------------------------------------------
Section VIII
REFERENCES
Hazard Analysis Critical Control Point Systems
Agriculture Canada. Food Safety Enhancement Program--Implementation
Manual. Nepean, Ontario, Canada.
HACCP: The Hazard Analysis and Critical Control Point System in the
Meat and Poultry Industry. 1994. American Meat Institute Foundation.
Washington, D.C.
International Commission on Microbiological Specification for Foods.
1989. ``Microorganisms in Foods 4. Application of hazard analysis
and critical control point (HACCP) system to ensure microbiological
safety and quality.'' Blackwell Scientific Publications, Boston.
National Advisory Committee on Microbiological Criteria for Foods
(NACMCF).
March 20, 1992--Hazard Analysis and Critical Control Point System.
Int. J. Food Micr. 16: 1-23.
National Advisory Committee on Microbiological Criteria for Foods
(NACMCF). June 1993--Report on Generic HACCP for Raw Beef. Food
Micr. 10: 449-488.
Pierson, M.D. and Corlett, D.A., Jr. ed. 1992. ``HACCP/Principles
and Applications.'' Van Nostrand Reinhold.
Stevenson, K.E. ed. 1993. ``HACCP-Establishing Hazard Analysis
Critical Control Point Programs.'' A Workshop Manual. The Food
Processors Institute. Washington, D.C.
Tompkin, R.B. 1990. The Use of HACCP in the Production of Meat and
Poultry Products. J. of Food Protect. 53(9): 795-803.
Tompkin, R.B. 1995. The use of HACCP for producing and distributing
processed meat and poultry products. In Advances in Meat Research.
Volume 10. Hazard Analysis Critical Control Point (HACCP) in Meat,
Poultry and Seafoods. Chapman & Hall (In Press).
Foodborne Illnesses
Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks in
the United States, 1973-1987: Pathogens, vehicles, and trends. J.
Food Protect. 53: 804-817.
Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks, 5-
year summary, 1983-1987. J. Food Protect. 53: 711.
Council for Agricultural Science and Technology. ``Risks Associated
with Foodborne Pathogens.'' February 1993.
[[Page 38917]]
Oblinger, J.L., ed. 1988. Bacteria Associated with Foodborne
Illnesses, A Scientific Status Summary by the Institute of Food
Technologists Expert Panel on Food Safety and Nutrition. Food
Technol. 42(4).
Padhye, N.V.; Doyle, M.P. 1992. E. Coli O157:H7 Epidemiology,
pathogenesis, and methods for detection in food. J. Food Prot.
55:55-565.
Schuchat, A., Swaminathan, B. and Broome, C.V. 1991. Epidemiology of
human listeriosis. Clin. Microbiol. Rev. 4: 169-183.
Tauxe, R.V., ``Epidemiology of Camplyobacter jejuni infections in
the United States and other Industrialized Nations,'' In Nachamkin,
Blaser, Tompkins, ed. Camplyobacter jejuni: Current Status and
Future Trends, 1994, chapter 2, pages 9-19.
Tauxe, R.V., Hargett-Bean, N., Patton, C.M. and Wachsmuth, I.K.
1988. Campylobacter isolates in the United States, 1982-1986. In,
CDC Surveillance Summaries, June 1988. MMWR 37 (No. SS-2) : 1-13.
Todd, E. 1990. Epidemiology of Foodborne Illness: North America. The
Lancet 336:788.
Microbiological, Chemical, and Physical Hazards
Corlett, D.A., Jr. and R.F. Steir. 1991. Risk assessment within the
HACCP system. Food Control 2:71-72.
Environmental Protection Agency. 1992. Tolerances for Pesticides in
Foods. Title 40, Code of Federal Regulations, Part 185. U.S.
Government Printing Office, Washington, DC.
FDA. 1989. The Food Defect Action Levels. FDA/CFSAN. Washington, DC.
FDA. 1994. Fish and Fishery Products Hazards and Control Guide--Get
Hooked on Seafood Safety. Office of Seafood, Washington, DC.
HACCP: The Hazard Analysis and Critical Control Point System in the
Meat and Poultry Industry. 1994. American Meat Institute Foundation,
Washington, DC.
International Commission on Microbiological Specification for Foods.
1989. ``Microorganisms in Foods 4. Application of hazard analysis
and critical control point (HACCP) system to ensure microbiological
safety and quality.'' Blackwell Scientific Publications, Boston.
Pierson, M.D. and Corlett, D.A., Jr. ed. 1992. ``HACCP/Principles
and Applications.'' Van Nostrand Reinhold.
Stevenson, K.E. ed. 1993. ``HACCP-Establishing Hazard Analysis
Critical Control Point Programs.'' A Workshop Manual. The Food
Processors Institute. Washington, DC.
USDA, 1994. Domestic Residue Data Book: 1993. USDA, FSIS,
Washington, DC.
USDA, 1994. List of Propriety Substances and Nonfood Compounds
Authorized for Use under USDA Inspection and Grading Programs. USDA,
FSIS, Washington, DC.
USDA, 1995. National Residue Program Plan: 1995. USDA, FSIS,
Washington, DC.
Internet Home Pages
Agriculture Canada/http://aceis.agr.ca
Food Law Sites/http://www.fsci.umn.edu/FoodLaw/foodlaw.html
HACCP95/http://www.cvm.uiuc.edu/announcements/haccp95/haccp95.html
Center for Disease Control/http://fftp.cdc.gov/pub/mmwr/MMWRweekly
Material Safety Data Sheets/http://listeria.nwfsc.noaa.gov/msds.html
U.S. Food and Drug Administration/http://vm.cfsan.fda.gov/list.html
Bad Bug Book
U.S. Department of Agriculture/http://www.usda.gov
Appendix E--FSIS Sample Collection Guidelines and Procedure for
Isolation and Identification of Salmonella from Raw Meat and Poultry
Products
Introduction
This sampling protocol has been prepared to support the Pathogen
Reduction/HACCP Regulation. FSIS will be conducting a Salmonella
testing program in support of this regulation. The regulation does not
require establishments to conduct their own testing for Salmonella.
However, for those who choose to conduct their own Salmonella testing
program, the protocol outlined in this document provides detailed
instruction for sample collection and analysis that are the same as
those used in the FSIS Salmonella testing program for raw meat and
poultry products.
This protocol incorporates the use of a non-destructive sampling
technique for sample collection of raw beef and swine carcasses. These
techniques have been evaluated by the Agricultural Research Service and
have been designed to give comparable results to the FSIS Nationwide
Microbiological Baseline Data Collection Programs' excised tissue
samples. We are continuing to improve the sponging techniques and
welcome comments. This technique will be closely monitored during the
first year of prevalence phase Salmonella testing. Carcass sampling for
broiler and turkey carcasses remain the nondestructive whole bird rinse
which was used in the Baseline Programs. Ground product sampling
involves collecting approximately \1/2\ pound of the product.
The analytical methods section of this protocol details the
cultural procedures currently in use by FSIS/USDA for the examination
of raw meat and poultry products for Salmonella. Any screening method
under consideration for Salmonella testing must meet or exceed the
following performance characteristics: sensitivity = 97%,
specificity 96%, false-negative rate = 3%, false-positive
rate 4%.
Guidelines for Sample Collectors/Microbiologists
Pre-Sampling Preparation
Prior to collecting samples, the individual designated for sample
collection should compile a written establishment-specific sample
collection protocol for microbiological analysis. This protocol should
include a check list for tasks to be performed prior to sample
collection, materials needed for sample collection, random selection
procedures, where the samples will be analyzed (on-site versus off-
site), and other information that will aid the sample collector.
Sampling supplies, such as sterile gloves, sterile sampling solutions,
hand soap, sanitizing solution, etc., as well as specific materials
needed for sampling different carcass types (i.e., specimen sponges in
bags, if sampling cattle or swine carcasses), will need to be
assembled.
For cattle and hog carcass sampling, a template will be needed to
mark off the area to sample (Figure 1). The template can be made of
metal or aluminum foil, brown paper, etc. From a sheet larger than the
area to be sampled, cut out a 10 cm (3.94 inches) x 10 cm square for
sampling cattle or a 6 cm x 10 cm rectangle for swine carcass sampling.
If a reusable metal template is used, it will need to be sanitized with
an approved sanitizing solution (e.g. hypochlorite (bleach) solution or
alcohol). However, the template needs to be dry before placing it on
the carcass. Aluminum foil or paper templates can be used once and
discarded. The foil for the template should be stored in a manner to
prevent contamination. Since the area enclosed by the template will be
sampled, take care not to touch this area with anything other than the
sampling sponge. Using dirty or contaminated material may lead to
erroneous results. If an autoclave is available, paper or aluminum foil
templates can be wrapped in autoclavable paper and sterilized.
The sterile sampling solution, Buffered Peptone Water (BPW), can be
stored at room temperature. However, at least one day prior to sample
collection, check solutions for absence of cloudiness and/or turbidity
and place the number of containers of sampling solution (BPW) that will
be needed for the next day's sampling in the refrigerator. DO NOT use
solutions that are cloudy, turbid, or contain particulate matter.
To obtain the most accurate results, samples should be analyzed as
soon after collection as possible. However, if samples must be
transported to an off-site laboratory, the samples need to be
[[Page 38918]]
maintained at refrigeration temperatures until transport, then shipped
refrigerated via an overnight delivery service to the laboratory
performing the analysis. Samples analyzed off-site must be picked up by
the overnight courier the SAME calendar day the sample is collected.
The sample must arrive at the laboratory no later than the day after
the sample is collected. Samples shipped to an outside laboratory must
be analyzed no later than the day after collection. The following
section gives information on shipping containers and transporting
samples to off-site facilities.
Shipping Containers and Coolant Packs
It is important that samples fit easily into the shipping so that
the sample bags do not break.
Correct use of the refrigerant gel-ice packs and proper packing of
the shipping container are necessary so that samples arrive at the
laboratory at an acceptable temperature. Frozen samples or samples
which are too warm are not considered valid and must not be analyzed.
Some bacteria may be damaged by temperatures that are too cold.
Temperatures that are too warm can allow bacteria to reproduce.
Maintaining samples at improper temperatures may cause inaccurate
sample results.
The sample should be kept refrigerated, NOT FROZEN, in the shipping
container prior to pickup by the courier. The shipping container,
itself, should not be used as a refrigerator. However, multiple samples
(if needed) for that day may be stored in the open shipping container
in the cooler or refrigerator.
Random Selection of Carcasses or Ground Product for Sampling
Samples are to be taken randomly. There are different methods of
selecting the specific carcass for sampling that could be used but all
require the use of random numbers. Methods could include: using random
number tables, drawing cards, using calculator- or computer-generated
random numbers, etc. When selecting the random numbers, use the
method(s) currently in use at the establishment for other sampling
programs, if other programs are currently underway.
The carcass or ground product for sampling must be selected at
random from all eligible carcasses. If multiple lines exist, randomly
select the line for sample collection for that interval. Repeat the
random selection process for the next sampling interval. Each line
should have an equal chance of being selected at each sampling
interval.
Cattle Carcass Selection
The half-carcasses eligible for sampling should be selected from
those in the cooler 12 or more hours after slaughter. Both the
``leading'' and ``trailing'' sides of a carcass should have an equal
chance of being selected. NOTE: If more than one shift is operating at
the plant, the sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Determine the times that carcasses chilled for
12 or more hours will be on hand. Then randomly select a time for
collecting samples. If samples are shipped off-site, then take into
account that the delivery service may have limitations on pickup times.
Selection of COOLER SITE: Select a safe and accessible site in the
cooler for random selection of the half-carcass. This site may be
located at the transfer chain, grading chain, or a rail that contains
carcasses that have been chilled 12 hours or more.
Selection of HALF-CARCASS: At the random time selected, identify a
half-carcass (selected by your random number method) from the
predetermined point along the chain (selected cooler site) and then
count back five (5) half-carcasses and select the next half-carcass
(carcass) for sampling. The reason for counting back five half-
carcasses is to avoid any possible bias during selection.
Swine Carcass Selection
The carcasses eligible for sampling should be selected from those
in the cooler 12 or more hours after slaughter. Every carcass should
have an equal chance of being selected.
Note: If more than one shift is operating at the plant, the
sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Determine the times that carcasses chilled for
12 or more hours will be on hand. Then randomly select a time for
collecting samples. If samples are shipped off-site, then take into
account that the delivery service may have limitations on pickup times.
Selection of COOLER SITE: Select a safe and accessible site in the
cooler for random selection of the carcass. This site may be located at
the transfer chain, or a rail that contains carcasses that have been
chilled 12 hours or more. If there are multiple sites of the same kind,
select one at random.
Selection of CARCASS: At the random time selected, identify a
carcass (selected by your random number method) from the predetermined
point along the chain and then count back five (5) carcasses and select
the next carcass for sampling. The reason for counting back five
carcasses is to avoid any possible bias during selection.
Poultry Carcass Selection
The poultry carcasses will be selected at random after chilling, at
the end of the drip line or last readily accessible point prior to
packing/cut-up. A WHOLE carcass is required, that is, one that has not
been trimmed.
Note: If more than one shift is operating at the plant, the
sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Determine the times that chilled carcasses will
be on hand, then randomly select a time for collecting samples. If
samples are shipped off-site, then take into account that the delivery
service may have limitations on pickup times.
Selection of CHILLER: If more than one chiller system is in
operation at the time of sample collection, the chill tank from which
the sample is selected must be randomly selected.
Selection of POULTRY CARCASS: At the random time, identify a
carcass (selected by your random number method) from the predetermined
point, and then count back five (5) carcasses and select the next
carcass for sampling. Exception: If the fifth carcass is not a WHOLE
(untrimmed) bird, count back an additional five carcasses for sample
selection. Remember: Each carcass must have an equal chance of being
selected. The reason for counting back five carcasses is to avoid any
possible bias during selection.
Raw Ground Product Selection (Beef, Pork, Chicken, Turkey)
Raw ground product samples will be randomly selected and collected
after the grinding process and, if possible before any addition of
spices or seasonings, but prior to final packaging.
Note: If more than one shift is operating at the plant, the
sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Determine the times that raw ground product will
be produced, then randomly select a time for collecting samples. Take
into account that the overnight delivery service may have limitations
on pickup times, for determining sample collection time.
Selection of GRINDER: If more than one grinder is in operation at
the time of sample collection, the grinder from which the sample is
selected must be randomly selected.
[[Page 38919]]
Aseptic Techniques/Sampling
Extraneous organisms from the environment, hands, clothing, sample
containers, sampling devices, etc., may lead to erroneous analytical
results. Stringent requirements for microbiological analysis are
necessary, therefore, use of aseptic sampling techniques and clean
sanitized equipment and supplies are of utmost importance. The
following information gives general techniques for aseptic techniques
that are routinely used during sample collection for microbiological
analysis.
There should be an area designated for preparing samples, etc. A
stainless steel, wheeled cart or table would be useful during sampling.
A small tote or caddy could be could be easily transported to the
location of sampling and used for carrying supplies, supporting sample
bags when adding sterile solutions to sample bags, etc.
Sterile gloves should be used for collecting samples. The only
items which may contact the external surface of the glove are the
exposed sample being collected and/or the sterile sample utensil
(specimen sponge). Keep in mind that the outside surfaces of the sample
container are not sterile. Do not handle the inside surface of the
sterile sample containers. Do not touch anything else. The following
procedure for putting on sterile gloves can be followed when collecting
samples:
(a) Peel open the package of sterile gloves from the top without
contaminating (touching, breathing on, contacting, etc.) the exterior
of the gloves.
(b) Remove a glove by grasping it from the wrist-side opening inner
surface which is folded. Avoid any contact with the outer surface of
the glove. Insert the washed and sanitized hand into the glove, taking
care not to puncture the glove or touch the outside surface of the
glove.
(c) Next, follow the same procedure for the hand you will use to
physically handle the sample, using care not to contaminate the outer
surface of the glove.
(d) If at any time you are concerned that a glove may be
contaminated, discard it and begin again with Step (a) above.
Preparation for Sample Collection
Prior to collecting samples, review steps for sample collection,
random selection procedure, etc.
At least one or more days prior to sample collection, check
sampling solution (BPW) for cloudiness/turbidity and refrigerate if not
cloudy or turbid. If shipping samples to off-site facility, place
coolant packs in freezer then pre-chill open shipping in cooler/
refrigerator.
On the day of sampling, gather all sample collection bags, sterile
gloves, sanitizer, hand soap, sterile solutions for sampling, and
specific materials listed under the Materials section of the sample
collection section for the type of carcass to be sampled.
Label the sample bags before starting sampling procedure. Use
permanent ink. If you are using paper labels, it is important that the
label be applied to the bag at normal room temperature; it will not
stick if applied in the cooler.
Outer clothing (frocks, gloves, head gear, etc.) worn in other
areas of the plant should be removed before entering the sampling area
or preparing to collect samples. Replace outer clothing removed earlier
with clean garments (i.e. laboratory coat) that have not been directly
exposed to areas of the plant outside of the sampling area.
Sanitize the sample work area surfaces by wiping with a clean
disposable cloth or paper towel dipped in a freshly prepared 500 ppm
sodium hypochlorite solution (0.05% sodium hypochlorite) or other
approved sanitizer which provides an equivalent available chlorine
concentration. The sample work area surfaces must be free of standing
liquid before sample supplies and/or product containers are placed on
them.
Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands
using disposable paper towels.
Specific Sample Collection Procedures
Raw Ground Product
Materials
1. 2 sterile ziplock-type or stomacher bags or equivalent.
2. Sterile gloves.
3. Plastic cable-tie-wrap or thick rubber band for securing bag.
Collection
Ensure that all supplies are on hand and readily available. Use the
predetermined random selection procedure to select sample. Samples of
raw ground product will be collected after the grinding process, and,
if possible, before the addition of any spices or seasonings, but prior
to final packaging.
1. Put on sterile gloves.
2. Aseptically collect approximately \1/2\ pound of ground product,
if possible, before the addition of any spices or seasonings, but just
prior to final packaging. (Sample will be about the size of an orange.)
Use the sterile sampling bag, taking care not to contaminate the inside
of the bag with your gloved hand.
3. Close the bag tightly by twisting the top and securing it with
the plastic cable-tie-wrap or rubber band or securely closing the
ziplock-type bag.
4. Place bagged sample inside a second bag and close the outer bag
tightly.
5. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for analysis.
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
Cattle Surface Sample Collection Procedure
Materials
1. Sterile specimen sponge in sterile Whirl-Pak bag or
equivalent
2. 10 ml sterile Buffered Peptone Water (BPW)
3. Sterile ziplock-type or stomacher bag
4. Template for a 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies
Collection
A sterile, moistened sampling sponge (which usually come pre-
packaged in a sterile bag) will be used to sample all three sites on
the swine carcass (ham, belly, and jowls--see Figure 3). It is
important to swab the sampling areas in the order of least to most
contaminated to avoid spreading any contamination on the carcass.
Therefore, swab sampling areas in the sequence indicated in this
protocol. Use predetermined random selection procedures for selecting
carcass to be sampled. Remember: samples will be collected from
carcasses in the cooler 12 hours or more after slaughter.
Nondestructive surface sampling will be conducted as follows:
1. Ensure that all bags have been pre-labeled and all supplies are
on hand, including the sampling template. (An assistant may be helpful
during the sampling process.)
2. Position the wheeled ladder, sampling platform, or step ladder
near the carcass so the rump sample area (Figure 2) is within easy
reach from the ladder.
3. IF a reusable template is used, have the assistant immerse the
sampling
[[Page 38920]]
template in a sanitizing solution for at least 1-2 minutes. Just prior
to taking the first sample on the carcass, have the assistant put on a
pair of gloves (taking care not to contaminate the outer surface of the
glove with fingers) and retrieve the sampling template from the
sanitizing solution. Shake excess solution from utensil, then protect
the portion of the template that will contact the carcass from
contamination.
4. Locate the flank, rump, and brisket sampling sites using
illustrations and directions in Figure 2 (cattle carcass sampling
locations).
5. To hydrate the sponge, open the sponge bag. Remove cap from
sterile BPW bottle, being careful not to touch the bottle opening.
Carefully pour the contents of the sterile BPW bottle (10 ml) into the
sponge bag to moisten the sponge.
6. Close the top of the bag. Use hand pressure from the outside of
the bag and carefully massage the sponge until it is FULLY HYDRATED
(moistened).
7. With the bag still closed, carefully push the moistened sponge
to the upper portion of the bag orienting one narrow end of the sponge
up toward the opening of the bag. Do NOT open the bag or touch the
sponge with your fingers.
8. Open the bag containing the sponge, being careful not to touch
the inner surface of the bag with your fingers. The wire closure at the
top of the bag should keep the bag open. Set bag aside.
9. Put on sterile gloves.
10. Carefully remove the moistened sponge from the bag with your
sampling hand. Take care to avoid touching the surfaces of the sampling
sponge.
11. With the other hand, retrieve the template by the outer edge
taking care to avoid contaminating the inner edges of the sampling area
of the template.
12. Locate the flank sampling area (Figure 2) and place template
over this
location.
13. Hold the template in place with one gloved hand. Take care not
to contaminate the enclosed sampling area with your hands.
14. With the other hand, wipe the sponge over the entire enclosed
area (10 cm x 10 cm) for the sample for a total of approximately 10
times in the vertical and 10 times in the horizontal directions. The
pressure for swabbing would be as if you were removing dried blood from
the carcass. However, the pressure should not be too hard as to crumble
or destroy the sponge. (Note: The template may need to be ``rolled''
from side to side during swabbing since the surface of the carcass is
not flat. This ensures that the 100 cm\2\ area is enclosed while
swabbing.)
15. Repeat steps 13-15 for the brisket area, using the SAME side or
surface of the sponge used to swab the flank sampling area.
16. After swabbing the brisket area, transfer the template to the
same hand holding the sponge. Do not contaminate the inner edges of the
sampling area of the template.
17. Climb the ladder or platform, holding onto the handrail with
the hand NOT used to perform swabbing. Once at a convenient and safe
height for sampling the rump, transfer template back to ``climbing''
hand (hand used to hold onto the rail while climbing the ladder),
taking care not to contaminate the inner edges of the sampling area of
the template. Avoid contaminating your sampling hand.
18. Repeat steps 13-15 for the rump area, using the ``clean''
surface or side (the side that was NOT previously used to swab the
flank/brisket areas).
19. After swabbing the rump area, carefully place the sponge back
in the sample bag, taking care not to touch the outside of the sponge
to the outside of the sample bag.
20. While holding the handrail, climb down from the ladder.
21. Expel excess air and fold the top edge of the bag containing
the sponge 3 or 4 times to close. Secure the bag by folding the
attached wire tie back against the bag.
22. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation (ANALYTICAL METHODS section)
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow procedure in the Sample Shipment section.
Swine Surface Sample Collection Procedure
Materials
1. Sterile specimen sponge in sterile Whirl-Pak bag or
equivalent
2. 10 ml sterile Buffered Peptone Water (BPW)
3. Sterile Ziplock-type or stomacher bag
4. Template for a 100 cm2 sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. A
sterile, moistened sampling sponge (which usually come pre-packaged in
a sterile bag) will be used to sample all three sites on the swine
carcass (ham, belly, and jowls--see Figure 3). It is important to swab
the sampling areas in the order of least to most contaminated to avoid
spreading any contamination on the carcass. Therefore, swab sampling
areas in the sequence indicated in this protocol. Use predetermined
random selection procedures for selecting carcass to be sampled.
Remember: samples will be collected from carcasses in the cooler 12
hours or more after slaughter.
Nondestructive surface sampling will be conducted as follows:
1. Ensure that all supplies are on hand. (An assistant may be
helpful during the sampling process.)
2. Position the wheeled ladder, sampling platform, or step ladder
near the carcass so the ham sample area (Figure 3) is within easy reach
from the ladder.
3. Immerse the sampling template in a sanitizing solution for at
least 1-2 minutes. Just prior to swabbing the first sampling site on
the carcass (step 1), retrieve the sampling template from the
hypochlorite sanitizing solution. Shake excess solution from utensil,
then protect the portion of the template (especially the inner edges of
the sampling area) that will contact the carcass from contamination.
4. Locate the ``belly'', ham, and jowl sampling sites using
illustrations and directions in Figure 3 (swine carcass sampling
locations).
5. Open the sponge bag by holding the bag at one corner by the wire
closure (which is usually colored yellow) then tear off the clear,
perforated strip at the top of the bag. (Do not remove or tear off the
wire closures). Next, pull apart the two small white tabs on either
side of the bag to open the mouth of the bag.
6. Remove cap from sterile BPW tube, being careful not to touch the
bottle opening. Carefully pour the entire contents of the BPW bottle
(10 ml) into the sponge bag to moisten the sponge.
7. Close the top of the bag by pressing the wire closures together.
Use hand pressure from the outside of the bag and carefully massage the
sponge until it is FULLY HYDRATED (moistened).
8. With the bag still closed, carefully push the moistened sponge
to the upper portion of the bag positioning one narrow end of the
sponge up toward the opening of the bag. The whole sponge should still
be inside the bag.
9. Open the top of the bag containing the sponge, being careful not
to touch the inner surface of the bag with your fingers. The wire
closure at the top of
[[Page 38921]]
the bag should keep the bag open. Set bag aside.
10. Put on a pair of sterile gloves.
11. Carefully remove the moistened sponge from the bag with your
sampling hand. Take care not to touch the surfaces of the sampling
sponge intended for sampling with sterile glove.
12. With the other hand, retrieve the template by the outer edge,
taking care not to contaminate the inner edges of the sampling area of
the template.
13. Locate the ``belly'' sampling area (Figure 2) and place the
template over this location.
14. Hold the template in place with one gloved hand (Remember, only
the sponge should touch the sampling area. Take care not to contaminate
this area with your hands).
15. With the other hand, wipe the sponge over the entire enclosed
area (10 cm x 10 cm) for the sample for a total of approximately 10
times in the vertical and 10 times in the horizontal directions. The
pressure for swabbing would be as if you were removing dried blood from
the carcass. However, the pressure should not be too hard as to crumble
or destroy the sponge. (Note: The template may need to be ``rolled''
from side to side during swabbing since the surface of the carcass is
not flat. This ensures that the 100 cm2 area is enclosed while
swabbing.)
16. After swabbing the ``belly'' area, transfer the template to the
same hand that is holding the sponge. Do not contaminate the inner
edges of the sampling area of the template.
17. Climb the ladder or platform, holding onto the handrail with
the hand not used for sampling. Once at a convenient and safe height
for sampling the ham, transfer template back to the ``climbing'' hand
(hand used to hold onto the rail while climbing the ladder), taking
care not to contaminate the inner edges of the template. Avoid
contaminating your sampling hand.
18. Repeat steps 13-15 for the ham sampling area, using the SAME
surface of the sponge used to swab the ``belly'' area.
19. After swabbing the ham area, carefully place the template back
to the same hand that is holding the sponge. Do not contaminate the
inner edges of the sampling area of the template.
20. While holding the handrail with the hand not used for sampling,
climb down from the ladder.
21. Transfer the template back to the ``climbing'' hand (hand used
to hold onto the rail while descending the ladder), taking care not to
contaminate the inner edges of the template.
22. Repeat steps 13-15 for the the jowl area, using the ``clean''
surface or side (the side that was NOT previously used to swab the
``belly''/ham areas).
23. After swabbing the jowl area, carefully place the sponge back
into the sponge bag. Do not touch the surface of the sponge to the
outside of the sponge bag.
24. Press wire closures on the sponge bag together, expel the
excess air, then fold over the top of the bag 3 or 4 times. Close the
bag with attached wire by bending the wire tie back against the bag to
secure it.
25. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation (ANALYTICAL METHODS section).
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow procedure in the Sample Shipment section.
Whole Chicken Carcass Rinse Sampling Procedure
Materials
1. 2 Sterile 3500 ml stomacher-type bags or equivalent
2. 400 ml sterile Buffered Peptone Water (BPW)
3. Plastic cable-tie wraps or thick rubber bands or equivalent
4. Sterile gloves
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Ensure
all sampling supplies are present and have been properly labeled. Use
predetermined random selection procedure to select a carcass. Birds
will be collected after the chiller, at the end of the drip line as
follows:
1. Gather all supplies for sampling. An assistant may be helpful
during the sampling process when pouring the rinse solution (BPW) into
the bag containing the carcass.
2. Put on sterile gloves. Open a stomacher-type 3500 bag without
touching the sterile interior of the bag. Rubbing the top edges between
the thumb and forefinger will cause the opening to gap for easy
opening.
3. With one hand, push up through the bottom of the sampling bag to
form a `glove' over one hand with which to grab the bird, while using
your other hand to pull the bag back over the hand that will grab the
bird. This should be done aseptically without touching the exposed
interior of the bag.
4. Using the hand with the bag reversed over it, pick up the bird
by the legs (hocks) through the stomacher bag. (The bag functions as a
``glove'' for grabbing the bird's legs.) Take care not to contaminate
the exposed interior of the bag. Allow any excess fluid to drain before
reversing the bag back over the bird. (Alternately, have an assistant
hold open the bag. Using your gloved hand, pick up the bird by the
legs, allow any fluid to drain, and place the bird vent side up into
the sampling bag.)
5. Rest the bottom of the bag on a flat surface. While still
holding the top of the bag slightly open, add the 400 ml of sterile BPW
to the sterile plastic bag. (Alternately, with the aid of an assistant
holding the bag open, add the 400 ml of sterile BPW to the bag, pouring
the solution into the carcass cavity.)
6. Close the bag and while securely holding the bag, rinse bird
inside and out using a rocking motion for 30 shakes (approximately one
minute). This is done by holding the bird through the bottom of the bag
with one hand and the closed top of the bag with the other hand. Hold
the bird securely and rock it in an arcing motion, alternating the
weight of the bird from one hand to the other (motion like drawing an
invisible rainbow or arch), assuring that all surfaces (interior and
exterior of the carcass) are rinsed.
7. Put the bird in the bag on a flat surface. Open the bag.
8. With a gloved hand, remove the carcass from the bag. Since the
carcass was rinsed with a sterile solution, it should be returned to
the chill tank. Be sure not to touch the interior of the bag with your
gloved hand.
9. Twist the top of the bag several times (about 4 or 5 turns).
Fold the twisted portion of the bag to form a loop. Secure the twisted
loop with the supplied plastic tie-wrap. The tie-wrap should be very
tight so that the rinse fluid will not spill out. Place the sample bag
into another bag and secure the opening of the outer bag. [Alternately,
at least 30 ml of the rinse fluid can be poured into a sterile, leak-
proof sampling container and the container then can be placed in a
sampling bag for transport to the lab. NOTE: It is important to send at
least the minimum volume of rinse fluid, since 30 ml of rinse fluid
will be used for sample analysis. The solution remaining after
decanting the 30 ml can be poured down the drain]
10. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for the selected method of analysis.
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
[[Page 38922]]
Turkey Carcass Rinse Sampling Procedure
Materials
1. 1 large sterile 3500 ml stomacher-type or ziplock-type bags or
equivalent, at least 8'' x 24''
2. 600 ml sterile, Buffered Peptone Water (BPW)
3. Plastic cable-tie wraps or thick rubber bands or equivalent
4. Sterile gloves
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Ensure
that all supplies are on hand, labeled, and readily available. An
assistant will be needed to hold the bag for collecting the bird. Use
the predetermined random selection procedure to select the turkey
carcass to be sampled. The randomly selected birds will be collected
after the chiller, at the end of the drip line as follows:
1. Have an assistant open the large stomacher-type bag (18'' x
24''). (Rubbing the top edges of the stomacher-type bag between the
thumb and index finger will cause the opening to gap.) The assistant
should be ready to receive the turkey carcass.
2. Put on sterile gloves.
3. Remove the selected turkey from the drip line by grasping it by
the legs and allowing any fluid to drain from the cavity.
4. Place the turkey carcass, vent side up, into a sterile
Stomacher-type 3500 bag (or equivalent). Large turkeys should be placed
in a plain, clear polypropylene autoclave bag (ca. 24'' x 30-36'').
Only the carcass should come in contact with the inside of the bag.
5. While still supporting the carcass with one hand on the bottom
of the bag, have the assistant open the bag with the other hand.
Alternately, the assistant can rest the bottom of the bag on a
sanitized table and while still supporting the carcass, open the bag
with the other hand.
6. Add the 600 ml of sterile BPW to the sterile plastic bag,
pouring the solution into the carcass cavity of the BPW over the
exterior of the carcass. Close the bag.
7. Manipulate the loose neck skin on the carcass through the bag
and position it over the neck bone area to act as a cushion and prevent
puncturing of the bag. The assistant will need to support the carcass
with one hand on the bottom of the bag. Close bag.
8. Squeeze air from the bag and close top. Take the bag from the
assistant. Close the bag and while securely holding the bag, rinse bird
inside and out using a rocking motion for 30 shakes (approximately one
minute). This is done by holding the carcass through the bag with one
hand and the closed top of the bag with the other hand. Holding the
bird securely with both hands, rock in an arcing motion alternating the
weight of the bird from one hand to the other (motion like drawing an
invisible rainbow or arch), assuring that all surfaces (interior and
exterior of the carcass) are rinsed.
9. Hand the bag back to the assistant.
10. With a gloved hand, remove the carcass from the bag first
letting any excess fluid drain back into the bag. Since the carcass was
rinsed with a sterile solution, it should returned to the chill tank.
Be sure not to touch the interior of the bag with your gloved hand.
11. Expel excess air, taking care not to expel any rinse fluid.
Twist the top of the bag several times (about 4 or 5 turns). Fold the
twisted portion of the bag to form a loop. Secure the twisted loop with
the supplied plastic tie-wrap. The tie-wrap should be very tight so
that the rinse fluid will not spill out.
12. Place the sample bag into another bag and secure the opening of
the outer bag. [Alternately, no less than 30 ml of the rinse fluid can
be poured into a sterile, leak-proof sampling container and placed in a
sampling bag for transport to the lab. Thirty ml of rinse fluid will be
used for sample analysis. The solution remaining after decanting the 30
ml can be poured down the drain]
13. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for the selected method of analysis. (See
Analytical Methods section.)
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
Sample Shipment
It is recommended that samples be analyzed on-site (not in the
plant itself, but in a suitable laboratory). Those samples analyzed on-
site must be analyzed as soon after collection as possible. If no on-
site facilities are available, the samples must be shipped the same
calendar day as collected, to an outside laboratory. The samples must
be analyzed the day after collection.
1. Prechill shipping container by placing the open shipping
container in the refrigerator at least the day before sampling.
2. Place the appropriately-labeled double-bagged sample in the
prechilled shipper in an upright position to prevent spillage.
Newspaper may be used for cushioning the sample and holding it in the
upright position. Ensure that the sample is maintained at refrigeration
temperature to prevent multiplication of any microorganisms present and
to provide the most accurate results.
3. Place a corrugated cardboard pad on top of the sample. Next,
place the frozen gel pack(s) on top of the corrugated pad to prevent
direct contact of frozen gel packs with the sample. Use sufficient
frozen coolant to keep the sample refrigerated during shipment to the
designated laboratory. Insert a foam plug and press it down to minimize
shipper head space.
4. Ship sample (via overnight delivery or courier) to the assigned
laboratory.
Analytical Methods
Equipment, Reagents, and Media Equipment
1. Sterile scalpels, scissors, forceps, knives, spatulas, spoons, ruler
or template, pipettes, petri dishes, test tubes
2. Sterile Stomacher 3500 bags (or equivalent) or plain, clear
polypropylene autoclave bags (ca. 24'' x 30-36'')
3. Incubator, 36 1 deg.C
4. Incubator/Water bath, 42 0.5 deg.C
5. A mechanical homogenization device. A Stomacher, used with sterile
plastic bags, is acceptable. Some laboratories prefer to use a sterile
Osterizer-type blender with sterilized cutting assemblies and adapters
for use with sterile Mason jars.
6. Water bath, 48-50 deg.C
7. Glass slides, glass plate marked off in one-inch squares or
agglutination ring slides
8. Balance, 2000 gram capacity, sensitivity of 0.1 gram
9. Inoculating needles and loops
10. Vortex mixer
11. Sterile sampling sponge and sponge bag
Reagents
1. Iodine solution for TT broth (Hajna)
2. Buffered Peptone Water (BPW) diluent
3. Methyl red reagent
4. O'Meara's V-P reagent, modified
5. Kovac's reagent
6. Ferric chloride, 10% aqueous solution
7. Sterile mineral oil
8. Saline, 0.85%
9. Saline, 0.85% with 0.6% formalin
10. Salmonella polyvalent O antiserum
11. Salmonella polyvalent H antiserum
12. Salmonella individual O grouping sera for groups A-I
[[Page 38923]]
Media
1. Buffered peptone water (BPW)
2. Tetrathionate broth (TT-Hajna)
3. Rappaport-Vassiliadis (RV) broth (4)--Merck Chemical Co., Cat. #7700
or equivalent
4. Brilliant green sulfa agar (BGS; contains 0.1% sodium sulfapyridine)
5. Double modified lysine iron agar (DMLIA; 2)
6. Triple sugar iron agar (TSI)
7. Lysine iron agar (LIA)
8. MR-VP Medium
9. Tryptone broth
10. Simmons citrate agar
11. Phenol red tartrate agar
12. Motility Medium
13. Christensen's urea agar
14. Carbohydrate fermentation media with Andrade's indicator
15. Decarboxylase test media (Moeller)
16. Malonate broth
17. KCN broth
18. Phenylalanine agar
19. Nutrient gelatin
20. Trypticase soy broth
21. Tryptose broth
Analytical Procedures
Sample Preparation for Analysis
The diverse nature of the samples which may require analysis (e.g.,
ground product versus a poultry carcass rinse sample) requires separate
preparation procedures for each sample type.
Raw Ground Product Sample Preparation
a. Use a sterile spoon or spatula to take portions of product from
several areas of the sample to prepare a 25 g composite sample in a
sterile plastic stomacher-type bag or blender jar. Use of a stomacher
filter bag may facilitate pipetting after pre-enrichment.
b. Add 225 ml BPW. Homogenize for two minutes in a Stomacher or
blender.
Beef or Pork Carcass Sponge Sample Preparation
a. Add 50 ml of BPW to the sample bag containing the sponge to
bring the total volume to 50 ml. Mix well.
Whole Chicken Carcass Rinse-Fluid Sample Preparation
a. Remove 30 ml of carcass-rinse fluid and place it in a sterile
plastic bag or other sterile container.
b. Add 30 ml of BPW to the sample. Mix well.
Turkey Carcass Rinse-Fluid Sample Preparation
a. Remove 30 ml of carcass-rinse fluid and place it in a sterile
plastic bag or other sterile container.
b. Add 30 ml of BPW to the sample. Mix well.
Detection Procedure
Sample/BPW suspensions prepared as directed in Sample preparation
for analysis section (above) are the starting point for this step in
the protocol. From this point on, sample suspensions of various types
(e.g., whole bird rinse sample vs. raw ground product) can be treated
in the same manner.
Note: If using a screening test, follow manufacturer's
instruction for enrichment procedures. If an alternate enrichment
scheme is to be used, verification of the effectiveness of this
alternate enrichment protocol with the screening test should be
received from the manufacturer of the screening test or by in-
laboratory testing.
1. Incubate sample/BPW suspension at 36 1 deg.C for
20-24 hours.
2. a. Transfer 0.5 ml of the BPW sample pre-enrichment culture into
10 ml TT broth.
b. Transfer 0.1 ml of the BPW sample pre-enrichment culture into 10
ml RV broth.
3. a. Incubate the TT enrichment culture at 42
0.5 deg.C for 22-24 hours.
b. Incubate the RV enrichment culture at 42 0.5 deg.C
for 22-24 hours.
4. Streak each enrichment culture onto both DMLIA and BGS agar
plates. Do not subdivide plates for streaking multiple samples; streak
the entire agar plate with a single sample enrichment.
5. Incubate plates at 36 1 deg.C.
6. Examine plates after 22-24 hours of incubation. Reincubate
negative plates and reexamine them the following day.
7. Select and confirm suspect colonies as described in the sections
for Isolation procedure through Biochemical testing procedures (below).
Isolation Procedure
1. Pick typical well-isolated colonies.
a. BGS. Select colonies that are pink and opaque with a smooth
appearance and an entire edge surrounded by a red color in the medium.
On very crowded plates, look for colonies that appear tan against a
green background.
b. DMLIA. Select purple colonies with or without black centers.
Since salmonellae typically decarboxylate lysine and ferment neither
lactose nor sucrose, the color of the medium reverts to purple.
2. Select three suspect colonies from each plate. Pick only from
the surface and center of the colony. Avoid touching the agar because
these selective media may suppress growth of organisms which are viable
but not visible; such ``sleeper'' organisms can be picked up from the
agar surface and carried forward onto media used for confirmation
tests. If a plate is crowded and there are no well-isolated colonies
available, restreak from this plate directly onto fresh selective agar
plates.
Initial Isolate Screening Procedure
1. Inoculate TSI and LIA slants consecutively with a single pick
from a colony by stabbing the butts and streaking the slants in one
operation. If screw-cap tubes are used, the caps must be loosened
before incubation. Incubate at 36 1 deg.C for
242 hours.
2. Examine TSI and LIA slants as sets. Note the colors of butts and
slants, blackening of the media and presence of gas as indicated by gas
pockets or cracking of the agar. Note also the appearance of the growth
on the slants along the line of streak. Discard sets that show
``swarming'' from the original site of inoculation. Discard sets that
show a reddish slant in LIA. Isolates giving typical Salmonella spp.
reactions should be confirmed by serological tests. Examine isolates
which are suggestive, but not typical of Salmonella spp. by a
combination of biochemical and serological procedures. Confirm by
biochemical tests ONLY those isolates that appear typical of
salmonellae, but do not react serologically. Refer to the following
chart for assistance in making these determinations.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Triple sugar iron agar Lysine iron agar Polyvalent sera
---------------------------------------------------------------------------------------------------------------------- Disposition
Butt Slant H 2S Butt H2S O H
--------------------------------------------------------------------------------------------------------------------------------------------------------
Y.............. R + P + + + Salmonella spp.
Y.............. R + P + + - B. & M. T.
Y.............. R - P - ............... ............... B. & M. T.
Y.............. R - Y - + + B. & M. T.\1\
Y.............. R - Y - - ............... Discard.
Y.............. R + Y ............... ............... Discard.
Y.............. Y - Y/P - ............... ............... Discard.
[[Page 38924]]
Y.............. Y + P + ............... ............... B. & M. T.\2\
NC............. NC ............... ............... ............... ............... ............... Discard.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Y = Yellow; R = Red; P = Purple; B. & M. T. = Biochemical and motility tests; NC = No change in color from uninoculated medium.
\1\ Salmonella choleraesuis (rarely found in swine in U.S.).
\2\ Salmonella arizonae.
Serological Tests
All isolates giving TSI and LIA reactions which could be considered
suggestive of Salmonella should be tested serologically. If the TSI and
LIA reactions, together with the serological reactions, are indicative
of Salmonella, confirmation may cease at this point. If, however,
atypical TSI or LIA results and/or negative serological tests are
encountered, biochemical testing is mandatory (see Biochemical testing
procedure, below).
1. O Agglutination Tests
At a minimum, isolates should be tested with polyvalent O antiserum
reactive with serogroups A through I. Following a positive reaction
with polyvalent O antiserum, it is necessary to type the isolate using
individual Salmonella antisera for O groups A through I. Testing for O
groups A through I should encompass the majority of the Salmonella
serotypes commonly recovered from meat and poultry products.
Occasionally, however, an isolate which is typical of Salmonella
(biochemically and Poly H serologically) but non-reactive with antisera
to groups A through I will be recovered; such an isolate should be
reported as ``Salmonella non A-I'' or ``Salmonella O group beyond I''.
Follow the manufacturer's instructions enclosed with the antisera.
Use growth from either the TSI or LIA slant. Test the isolate first
using polyvalent O antiserum. Do not read agglutination tests with a
hand lens. If there is agglutination with the saline control alone
(autoagglutination), identify such an isolate by biochemical reactions.
If the saline control does not agglutinate and the polyvalent serum
does, identify the individual O group using the individual Salmonella O
grouping antisera for groups A through I. Record positive results and
proceed to H agglutination tests.
2. H Agglutination Tests
Inoculate Trypticase soy broth or Tryptose broth. Incubate at 36
1 deg.C overnight or until growth has an approximate
density of three on McFarland's scale. Add an equal amount of saline
containing 0.6% formalin and let set one hou
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
r. Remove one ml to each of
two 13 x 100 mm test tubes. To one of the tubes, add Salmonella
polyvalent H serum in an amount indicated by the serum titer or
according to the manufacturer's instructions. The other tube serves as
an autoagglutination control. Incubate both tubes at 48-50 deg.C in a
water bath for up to one hour. Record presence or absence of
agglutination. Alternatively, any other poly H agglutination test may
be used as long as it gives results equivalent to the conventional tube
agglutination procedure described above.
Biochemical Testing Procedures
Biochemical confirmation is only necessary with those isolates
giving atypical TSI or LIA results and/or negative serological tests.
Do the minimum number of tests needed to establish that an isolate can
be discarded or that it is a member of the genus Salmonella. Exhaustive
testing of any isolate from a sample that has already yielded a
typical, easily identifiable Salmonella is unnecessary.
If further testing is necessary, inoculate the following media
first: Tryptone broth, MR-VP medium, Simmons citrate agar,
Christensen's urea agar, motility test medium, phenol red tartrate
agar, and glucose, lactose, sucrose, salicin and dulcitol fermentation
broths. Incubate at 36 1 deg.C and record reactions the
following day. Test Tryptone broth with Kovac's reagent for indole
production in 24 hours and, if negative, again in 48 hours. Do not
perform the MR-VP test until 48 hours have elapsed. If results are
ambiguous, repeat MR test after five days of incubation. Hold negative
carbohydrate fermentation tests for 14 days.
Refer to ``Edwards and Ewing's Identification of
Enterobacteriaceae'', 4th Edition (3), for biochemical reactions of
Enterobacteriaceae and for fermentation media and test procedures.
Discard all isolates that give positive urea or VP reactions.
Discard any isolate that has the following combination of
characteristics: produces gas in glucose, produces indole but not
H2S, is MR positive, VP negative and citrate negative; such
organisms are E. coli regardless of ability to ferment lactose in 48
hours.
Inoculate additional biochemical tests as necessary to eliminate
other Enterobacteriaceae. Refer to Edwards and Ewing for details.
Eliminate Providencia spp. by a positive phenylalanine reaction.
Eliminate Hafnia alvei on the basis of the following biochemical
pattern: indole negative; MR negative, and VP and citrate positive
based on four days of incubation at 25 deg.C; fermentation of
arabinose and rhamnose; failure to ferment adonitol, inositol,
sorbitol, and raffinose.
Alternatively, any other biochemical test system may be used as
long as it gives results equivalent to the conventional tests.
Quality Control Procedures
It is recommended that a minimum of three method controls be
analyzed whenever meat or poultry products are being examined for the
presence of salmonellae. These controls should include a S. typhimurium
(H2S positive), S. senftenberg (H2S negative), and an
uninoculated media control. The inoculum level for the positive
controls should approximate 30-300 CFU per container of enrichment
medium. Inoculate positive controls at the end of each day's run.
Incubate the three controls along with the samples, and analyze them in
the same manner as the samples. Confirm at least one isolate recovered
from each positive control sample.
Storage of Isolates
Do not store isolates on TSI agar because this tends to cause
roughness of O antigens. For short-term (2-3 months) storage, inoculate
a nutrient agar slant, incubate at 36 1 deg.C overnight,
and then store at 4-8 deg.C.
For long-term storage of isolates, subculture Salmonella isolates
by stabbing nutrient agar (0.75% agar). Incubate at 36 1
deg.C overnight, and then seal with hot paraffin-soaked corks.
Household wax is better than embedding paraffin because it stays
relatively soft at room temperature making the corks easy to remove.
Store isolates in the dark at room
[[Page 38925]]
temperature. Such isolates will remain viable for several years.
Store ``working'' Salmonella stock cultures on nutrient agar
slants. Transfer stocks monthly, incubate overnight at 36
1 deg.C, and then store them at 4-8 deg.C.
References
1. AOAC International. 1995. Official Methods of Analysis of
AOAC International. P.A. Cunniff, ed. 16th Edition. Gaithersburg,
MD.
2. Bailey, J. S., J. Y. Chiu, N.A. Cox, and R.W. Johnston. 1988.
Improved selective procedure for detection of salmonellae from
poultry and sausage products. J. Food Protect. 51(5):391-396.
3. Ewing, W. H. 1986. ``Edwards and Ewing's Identification of
Enterobacteriaceae'', 4th Edition. Elsevier Science Publishing Co.,
Inc., New York, NY.
4. Vassiliadis, P. 1983. The Rappaport-Vassiliadis (RV)
enrichment medium for the isolation of salmonellas: An overview. J.
Appl. Bacteriol. 54:69-76.
BILLING CODE 3410-DM-P
[[Page 38926]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.018
[[Page 38927]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.019
[[Page 38928]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.020
BILLING CODE 3410-DM-C
[[Page 38929]]
Appendix F--Guidelines for Escherichia coli Testing for Process Control
Verification in Cattle and Swine Slaughter Establishments
Introduction
Under the Pathogen Reduction/HACCP Regulation, all slaughter
establishments will be required to test carcasses for generic E. coli
as a tool to verify process control. This document outlines the
sampling and microbial testing that should be followed to meet this
requirement. It also gives guidance to interpreting your results. This
document is a supplement to the Regulation, but not a substitute for
it. Further in-depth details of the program may be found in the
Regulation. Please provide these guidelines to your company
microbiologist or testing laboratory in order to help you meet the
regulatory requirements for generic E. coli testing.
Guidelines for Sample Collectors/Microbiologists
Background
This sampling protocol has been prepared to support the Pathogen
Reduction/HACCP Regulation. This protocol incorporates the use of a
nondestructive sampling technique for sample collection from raw beef
and swine carcasses. These techniques have been evaluated by the
Agricultural Research Service and have been designed to give comparable
results to the FSIS Nationwide Microbiological Baseline Data Collection
Programs' excised tissue samples. We are continuing to improve the
sponging techniques and welcome comments. This technique will also be
used in the FSIS Salmonella testing programs and will be closely
monitored during the first year of prevalence phase testing.
Carcasses within the same establishment and in different
establishments must be sampled and analyzed in the same manner if the
results are to provide a useful measure of process control across the
nation. It is imperative that all like establishments adhere to the
same sampling and analysis requirements detailed here, without
deviation. These sampling and analytical procedures may be directly
written into your establishment's individual HACCP plan.
Cattle and swine carcasses must be sampled at the end of the
slaughter process in the cooler. These sample collection locations are
the same as those in the FSIS baseline studies, making samples taken
here comparable to the nationwide baseline performance criteria.
Pre-sampling Preparation
Sample collection will be carried out by the individual designated
in the establishment's written protocol for microbiological sampling.
This protocol should include a check list of tasks to be performed
prior to sample collection, materials needed for sample collection,
random selection procedures, where the samples will be analyzed (on-
site versus off-site), and other information that will aid the sample
collector. As stated previously, this guideline can be a part of the
plant's sample collection guidelines, but plant specific details and
procedures will need to be included. Sampling supplies, such as sterile
gloves, sterile sampling solutions, hand soap, sanitizing solution,
etc., as well as specific materials needed for sampling different
carcass types (i.e., specimen sponges in bags and template for sampling
cattle or swine carcasses), will need to be assembled prior to
beginning sample collection.
For cattle and swine carcass sampling, a template will be needed to
mark off the area to sample. The template can be made of metal or
aluminum foil, brown paper, flexible plastic, etc. Some disposable
templates may come sterilized and individually prepackaged. To make a
reusable template, cut out a 10 centimeters (cm) x 10 cm (3.94 inches x
3.94 inches) square from a sheet larger than the area to be sampled.
(See Figure 1). If a reusable template is used, it will need to be
sanitized with an approved sanitizing solution [e.g., hypochlorite
(bleach) solution or alcohol]. However, the template needs to be dry
before placing it on the carcass. Aluminum foil or paper templates can
be used once and discarded. The foil for the template should be stored
in a manner to prevent contamination. Since the area enclosed by the
template will be sampled, take care not to touch this area with
anything other than the sampling sponge. Using dirty or contaminated
material may lead to erroneous results. If an autoclave is available,
paper or aluminum foil templates can be wrapped in autoclavable paper
and sterilized.
Sterile sampling solutions, Butterfield's phosphate diluent (BPD),
can be stored at room temperature. However, at least on the day prior
to sample collection, check solutions for cloudiness. DO NOT use
solutions that are cloudy, turbid or contain particulate matter. Place
the number of containers of sampling solution (BPD) that will be needed
for the next day's sampling in the refrigerator.
To obtain the most accurate results, samples should be analyzed as
soon after collection as possible. However, if samples must be
transported to an off-site laboratory, the samples need to be
maintained at refrigeration temperatures until transport, then shipped
refrigerated via an overnight delivery service to the laboratory
performing the analysis. Samples analyzed off-site must be picked up by
the overnight courier the SAME calendar day the sample is collected.
The sample must arrive at the laboratory the day after the sample is
collected. Samples shipped to an outside laboratory must be analyzed no
later than the day after collection. The following section gives
information on shipping containers and transporting samples to off-site
facilities.
Shipping Containers and Coolant Packs
It is important that samples fit easily into the shipping
containers so that the sample bags do not break. Correct use of the
refrigerant gel-ice packs and proper packing of the shipping container
are necessary so that samples arrive at the laboratory at an acceptable
temperature. Frozen samples or samples which are too warm are not
considered valid and must not be analyzed. Some bacteria may be damaged
by temperatures that are too cold, while temperatures that are too warm
can allow bacteria to reproduce. Maintaining samples at improper
temperatures may cause inaccurate sample results. The sample should be
kept refrigerated, NOT FROZEN, in the shipping container prior to
pickup by the courier service. The shipping container, itself, should
not be used as a refrigerator. However, multiple samples (if needed)
for that day may be stored in the open shipping container in the cooler
or refrigerator.
Sampling frequency
Sampling frequency for E. coli testing is determined by production
volume. The required minimum testing frequencies for all but very low
production volume establishments are shown in Table 1 by slaughter
species.
Table 1.--E. coli Testing Frequencies a
------------------------------------------------------------------------
Cattle.................................... 1 test per 300 carcasses.
Swine..................................... 1 test per 1,000 carcasses.
------------------------------------------------------------------------
a Note: These testing frequencies do not apply to very low volume
establishments. See Table 2.
Very Low Volume Establishments
Some establishments may be classified as very low volume
establishments. The maximum yearly
[[Page 38930]]
slaughter volumes for very low volume establishments are described in
Table 2.
Table 2.--Maximum Yearly Livestock Slaughter Volumes for Very Low Volume
Establishments
------------------------------------------------------------------------
Criteria (yearly slaughter
Slaughter species volume)
------------------------------------------------------------------------
Cattle................................ Not more than 6,000 head.
Swine................................. Not more than 20,000 head.
Cattle and Swine...................... Not more than 20,000 total, with
not more than 6,000 cattle.
------------------------------------------------------------------------
Establishments with very low volumes are to sample the predominant
species at an initial rate of once per week until at least 13 test
results have been obtained. Once the initial criteria have been met for
very low volume establishments (see APPLYING PERFORMANCE CRITERIA TO
TEST RESULTS), the establishment will repeat the same sampling regime
once per year, in the 3 month period of June through August, or
whenever a change is made in the slaughter process or personnel.
Random Selection of Carcasses
Samples are to be taken randomly at the required frequency (See
section on Sampling Frequency). For example, given the frequency of
testing for cattle is 1 (one) test per every 300 cattle slaughtered,
then if a plant slaughters 150 head of cattle an hour, 1 (one) sample
will be taken every 2 hours.
Different methods of selecting the specific carcass for sampling
could be used, but all require the use of random numbers. Methods could
include: using random number tables, using calculator- or computer-
generated random numbers, drawing cards, etc. When selecting the random
numbers, use the method(s) currently in use at the establishment for
other sampling programs, if other programs are currently underway.
The carcass for sampling must be selected at random from all
eligible carcasses. If multiple lines exist, randomly select the line
for sample collection for that interval. Repeat the random selection
process for the next sampling interval. Each line should have an equal
chance of being selected at each sampling interval.
Cattle Carcass Selection
The half-carcasses eligible for sampling should be selected from
those in the cooler 12 or more hours after slaughter. Both the
``leading'' and ``trailing'' sides of a carcass should have an equal
chance of being selected within the designated time frame (based on the
sampling frequency for the plant). NOTE: If more than one shift is
operating at the plant, the sample can be taken on any shift, provided
the following requirements are met:
Selection of TIME: Select the time, based on the appropriate
sampling frequency, for collecting the sample.
Selection of COOLER SITE: Select a safe and accessible site in the
cooler for random selection of the half-carcass. This site may be
located at the transfer chain, grading chain, or a rail that contains
carcasses that have been chilled 12 hours or more. If there are
multiple sites of the same kind, select one at random.
Selection of HALF-CARCASS: Based on the sampling frequency for the
plant, identify a half-carcass (selected by your random number method)
from the predetermined point along the chain (cooler site) and then
count back five (5) half-carcasses and select the next half-carcass
(carcass) for sampling. The reason for counting back five half-
carcasses is to avoid any possible bias during selection. (See Sampling
Frequency section to determine the rate of sampling.)
Swine Carcass Selection
The carcasses eligible for sampling should be selected from those
in the cooler 12 or more hours after slaughter. Every carcass should
have an equal chance of being selected within the designated time frame
(based on the sampling frequency for the plant). NOTE: If more than one
shift is operating at the plant, the sample can be taken on any shift,
provided the following requirements are met:
Selection of TIME: Select the time, based on the appropriate
sampling frequency, for collecting the sample.
Selection of COOLER SITE: Select a safe and accessible site in the
cooler for random selection of the carcass. This site may be located at
the transfer chain, grading chain, or a rail that contains carcasses
that have been chilled 12 hours or more. If there are multiple sites of
the same kind, select one at random.
Selection of CARCASS: Based on the sampling frequency for the
plant, identify a whole carcass from the predetermined point along the
chain and then count back five (5) carcasses and select the next
carcass for sampling. The reason for counting back five carcasses is to
avoid any possible bias during selection. (See Sampling Frequency
section to determine the rate of sampling.)
Aseptic Techniques/Sampling
Extraneous organisms from the environment, hands, clothing, sample
containers, sampling devices, etc., may lead to erroneous analytical
results. More stringent requirements for microbiological analysis are
necessary, therefore, use of aseptic sampling techniques and clean,
sanitized equipment and supplies are of utmost importance.
There should be an area designated for preparing sampling supplies,
etc. A stainless steel, wheeled cart or table would be useful during
sampling. A small tote or caddy could be moved to the location of
sampling and could be used for carrying supplies, supporting sample
bags when adding sterile solutions to sample bags, etc.
Sterile gloves should be used for collecting samples. The only
items which may contact the external surface of the glove are the
exposed sample being collected and/or the sterile sample utensil
(specimen sponge). Keep in mind that the outside surfaces of the sample
container are not sterile. Do not handle the inside surface of the
sterile sample containers. Do not touch anything else. The following
procedure for putting on sterile gloves can be followed when collecting
samples:
(a) Peel open the package of sterile gloves from the top without
contaminating (touching, breathing on, contacting, etc.) the exterior
of the gloves.
(b) Remove a glove by holding it from the wrist-side opening inner
surface. Avoid any contact with the outer surface of the glove. Insert
the washed and sanitized hand into the glove, taking care not to
puncture the glove.
(c) Taking care not to contaminate the exterior surface of the
glove, repeat the above step for the hand you will use to physically
handle the sample.
(d) If at any time you are concerned that a glove may be
Preparation for Sample Collection
Prior to collecting samples, review appropriate sampling steps,
random selection procedures, and other information that will aid in
sample collection.
On the day prior to sample collection, after checking for
cloudiness/turbidity, place the number of BPD containers that will be
needed for the next day's sampling in the refrigerator/cooler. If
samples are to be shipped to an off-site facility, pre-chill shipping
container and refrigerator packs.
On the day of sampling, gather all sample collection bags, sterile
gloves, sanitizer, hand soap, sterile solutions for
[[Page 38931]]
sampling, and specific materials listed under the Materials section of
the sample collection section for the type of carcass to be sampled.
Ensure that all sampling supplies are on hand and readily available
before beginning sample collection.
Label the sample bags before starting the sampling procedure. Use
permanent ink. If you are using paper labels, it is important that the
label be applied to the bag at normal room temperature; it will not
stick if applied in the cooler.
Outer clothing (frocks, gloves, head gear, etc.) worn in other
areas of the plant should be removed before entering the sampling area
or preparing to collect samples. Replace outer clothing removed earlier
with clean garments (i.e., laboratory coat) that have not been directly
exposed to areas of the plant outside of the sampling area.
Sanitize the sample work area surfaces by wiping with a clean
disposable cloth or paper towel dipped in a freshly prepared 500 ppm
(parts per million) sodium hypochlorite solution (0.05% sodium
hypochlorite) or other approved sanitizer which provides an equivalent
available chlorine concentration. The sample work area surfaces must be
free of standing liquid before sample supplies and/or product
containers are placed on them.
Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands
using disposable paper towels.
Specific Sample Collection Procedures
Cattle Sample Collection Procedure
Materials
1. Sterile specimen sponge in sterile Whirl-pack-type bag or
equivalent
2. 25 ml sterile Butterfield's phosphate diluent (BPD)
3. Sterile ziplock-type or stomacher bag
4. Template for 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Use
predetermined random selection procedures for selecting the half-
carcass to be sampled. Remember, samples will be collected from half-
carcasses in the cooler 12 hours or more after slaughter.
A sampling sponge (which usually comes dehydrated and prepackaged
in a sterile bag) will be used to sample all three sites on the carcass
(flank, brisket, and rump--see Figure 2). It is important to swab the
areas in the order of least to most contamination in order to avoid
spreading any contamination.
Therefore, swab the areas in the sequence indicated in this
sampling protocol. Nondestructive surface sampling will be conducted as
follows:
1. Ensure that all bags have been pre-labeled and all supplies are
on hand, including the sampling template. (An assistant may be helpful
during the sampling process.)
2. IF a reusable template is used, immerse the sampling template in
an approved sanitizing solution for at least 1-2 minutes. Just prior to
swabbing the first sample site on the carcass (step 13), retrieve the
sampling template from the sanitizing solution. Shake excess solution
from the utensil, then protect the portion of the template that will
contact the carcass from contamination.
3. Locate the flank, brisket, and rump sampling sites using
illustrations and directions in Figure 2 (cattle carcass sampling
locations).
4. Position the wheeled ladder, sampling platform, or step ladder
near the carcass so the rump sample area (Figure 2) is within easy
reach from the ladder.
5. While holding the sponge bag at the top corner by the wire
closure, tear off the clear, perforated strip at the top of the bag.
6. Remove the cap from sterile BPD bottle, being careful not to
touch the bottle opening.
7. Carefully pour about half the contents of the sterile BPD bottle
(approximately 10 ml) into the sponge bag to moisten the sponge.
8. Close the top of the bag by pressing the wire closures together.
Use hand pressure from the outside of the bag and carefully massage the
sponge until it is FULLY HYDRATED (moistened).
9. With the bag still closed, carefully push the moistened sponge
to the upper portion of the bag orienting one narrow end of the sponge
up toward the opening of the bag. Do NOT open the bag or touch the
sponge with your fingers. While holding the bag, gently squeeze any
excess fluid from the sponge using hand pressure from the outside. The
whole sponge should still be in the bag.
10. Open the bag containing the sponge, being careful not to touch
the inner surface of the bag with your fingers. The wire closure at the
top of the bag should keep the bag open. Set bag aside.
11. Put on a pair of sterile gloves.
12. Carefully remove the moistened sponge from the bag with the
thumb and fingers (index and middle) of your sampling hand.
13. With the other hand, retrieve the template by the outer edge,
taking care not to contaminate the inner edges of the sampling area of
the template.
14. Locate the flank sampling area (Figure 2). Place the template
over this location.
15. Hold the template in place with one gloved hand (Remember, only
the sponge should touch the sampling area. Take care not to contaminate
this area with your hands)
16. With the other hand, wipe the sponge over the enclosed sampling
area (10 cm x 10 cm) for a total of approximately 10 times in the
vertical and 10 times in the horizontal directions. The pressure for
swabbing would be as if you were removing dried blood from the carcass.
However, the pressure should not be too hard as to crumble or destroy
the sponge. (Note: The template may need to be ``rolled'' from side to
side during swabbing since the surface of the carcass is not flat. This
ensures that the 100 cm\2\ area is enclosed while swabbing.)
17. Repeat steps 14-16 for the brisket area, using the SAME side or
surface of the sponge used to swab the flank area.
18. After swabbing the brisket area, transfer the template to the
same hand holding the sponge. Do not contaminate the sponge or inner
edges of the sampling area of the template.
19. Climb the ladder or platform, holding onto the handrail with
the hand used to hold the template. Once at a convenient and safe
height for sampling the rump, transfer template back to ``climbing''
hand (hand used to hold onto the rail while climbing the ladder),
taking care not to contaminate the inner edges of the template.
20. Repeat steps 14-16 for the rump area, using the ``clean''
surface or side (the side that was NOT previously used to swab the
flank/brisket areas) of the sponge.
21. After swabbing the rump area, carefully place the sponge back
in the sponge sample bag, taking care not to touch the sponge to the
outside of the sample bag.
22. While holding the handrail, climb down from the ladder.
23. Add the additional BPD (about 15 ml) to the sample bag to bring
the total volume to approximately 25 ml.
24. Expel excess air from the bag containing the sponge and fold
down the top edge of the bag 3 or 4 times to close. Secure the bag by
folding the attached wire tie back against the bag.
[[Page 38932]]
Place closed sponge bag into second bag and close the second bag
securely.
25. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation (ANALYTICAL METHODS section)
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow procedure in the Sample Shipment section.
Swine surface sample collection procedure:
Materials
1. Sterile specimen sponge in sterile Whirl-Pak-type bag or
equivalent
2. 25 ml sterile Butterfield's phosphate diluent (BPD)
3. Sterile ziplock-type or stomacher-type bag
4. Template for a 100 cm\2\ sampling area
5. Sterile gloves
6. Wheeled ladder, sampling platform, or step ladder
7. Sanitizing solution
8. Small tote or caddy for carrying supplies
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Use
predetermined random selection procedures for selecting carcass to be
sampled. Remember: samples will be collected from carcasses in the
cooler 12 hours or more after slaughter. A sampling sponge (which
usually comes dehydrated and prepackaged in a sterile bag) will be used
to sample all three sites on the swine carcass (belly, ham, and jowl--
see Figure 3). It is important to swab the areas in the order of least
to most contamination in order to avoid spreading any contamination.
Therefore, swab the areas in the sequence indicated in this sampling
protocol. Nondestructive surface sampling will be conducted as follows:
1. Ensure that all supplies are on hand. (An assistant may be
helpful during the sampling process.)
2. If a reusable template is used, immerse the sampling template in
a sanitizing solution for at least 1-2 minutes. Just prior to swabbing
the first sample site on the swine carcass (step 12), retrieve the
sampling template from the sanitizing solution. Shake excess solution
from the utensil, then protect the portion of the template that will
contact the carcass from contamination.
3. Locate the belly, ham, and jowl sampling sites using
illustrations and directions in Figure 3 (swine carcass sampling
locations).
4. Position the wheeled ladder, sampling platform, or step ladder
near the carcass so the ham sample area (Figure 3) is within easy reach
from the ladder.
5. Hold the sponge bag at the top corner by the wire closure, then
tear off the clear perforated strip at the top of the bag. Open the
bag.
6. Remove the cap from sterile BPD bottle, being careful not to
touch the bottle opening. Do not contaminate the lid.
7. Carefully pour about half of the contents of the sterile BPD
bottle (10 ml) into the sponge bag to moisten the sponge. Put the lid
back on the BPD bottle.
8. Close the top of the bag by pressing the wire closures together.
Use hand pressure from the outside of the bag and carefully massage the
sponge until it is FULLY HYDRATED (moistened).
9. With the bag still closed, carefully push the moistened sponge
to the upper portion of the bag orienting one narrow end of the sponge
up toward the opening of the bag. Do NOT open the bag or touch the
sponge with your fingers. While holding the bag, gently squeeze any
excess fluid from the sponge using hand pressure from outside. The
whole sponge should still be inside the bag.
10. Open the bag containing the sponge, being careful not to touch
the inner surface of the bag with your fingers. The wire closure at the
top of the bag should keep the bag open.
11. Put on a pair of sterile gloves.
12. Carefully remove the moistened sponge from the bag with the
thumb and fingers (index and middle) of your sampling hand.
13. With the other hand, retrieve the template by the outer edge,
taking care not to contaminate the inner edges of the sampling area of
the template.
14. Locate the belly sampling area (Figure 2). Place the template
over this location.
15. Hold the template in place with one gloved hand. Remember, only
the sponge should touch the sampling area. Take care not to contaminate
this area with your hands.
16. With the other hand, wipe the sponge over the enclosed sampling
area (10 cm x 10 cm) for a total of approximately 10 times in the
vertical and 10 times in the horizontal directions. The pressure for
swabbing would be as if you were removing dried blood from the carcass.
However, the pressure should not be too hard as to crumble or destroy
the sponge.
Note: The template may need to be ``rolled'' from side to side
during swabbing since the surface of the carcass is not flat. This
ensures that the 100 cm2 area is enclosed while swabbing.
17. After swabbing the belly area, transfer the template to the
same hand that is holding the sponge. Do not contaminate the sponge or
the inner edges of the sampling area of the template.
18. Climb the ladder or platform, holding onto the handrail with
the hand used to hold the sampling template in place. Once at a
convenient and safe height for sampling the ham, transfer template back
to the ``climbing'' hand (hand used to hold onto the rail while
climbing the ladder), taking care not to contaminate the sponge or the
inner edges of the template.
19. Repeat steps 14-16 for the ham sampling area, using the SAME
surface of the sponge used to swab the belly area.
20. After swabbing the ham area, carefully place the template back
to the same hand that is holding the sponge. Do not contaminate the
sponge or the inner edges of the sampling area of the template.
21. While holding the handrail, climb down from the ladder.
22. Transfer the template back to the ``climbing'' hand (hand used
to hold onto the rail while descending the ladder), taking care not to
contaminate the sponge or the inner edges of the template.
23. Repeat steps 14-16 for the jowl area, using the ``clean''
surface or side (the side that was not previously used to swab the
belly/ham areas).
24. After swabbing the jowl area, carefully place the sponge back
into the sponge bag. Do not touch the surface of the sponge to the
outside of the sponge bag.
25. Add the additional BPD (about 15 ml) to the bag to bring the
total volume to approximately 25 ml.
26. Press wire closures of the sponge bag together, expel excess
air, then fold down the top edge of the bag 3 or 4 times. Secure the
bag by folding the attached wire tie back against the bag. Place the
closed sponge bag into the second bag and close the second bag
securely.
27. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation (ANALYTICAL METHODS section).
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow procedure in the Sample Shipment section.
Sample Shipment
Samples analyzed on-site must be analyzed as soon after collection
as possible. If no on-site facilities are available, the samples must
be shipped the same calendar day as collected, to
[[Page 38933]]
an outside laboratory. The samples must be analyzed no later than the
day after collection.
1. Prechill shipping container by placing the open shipping
container in the refrigerator at least the day before sampling.
2. Place the appropriately-labeled, double-bagged sample(s) in the
prechilled shipping container in an upright position to prevent
spillage. Newspaper may be used for cushioning the sample and holding
it in the upright position. If more than one sample is collected during
the day, take steps to ensure that samples are maintained at
refrigeration temperature. Refrigeration temperatures help limit
multiplication of any microorganisms present which ensures the most
accurate results.
3. Place a corrugated cardboard pad on top of samples. This
corrugated cardboard pad prevents direct contact of frozen gel packs
with the samples. Next place the frozen gel pack(s) on top of the
corrugated pad. Use sufficient frozen coolant to keep the sample
refrigerated during shipment to the designated laboratory. Insert foam
plug and press it down to minimize shipper head space.
4. Ship samples (via overnight delivery or courier) to the assigned
laboratory.
Analytical Methods
Samples must be analyzed using one of the E. coli (Biotype I)
quantitation methods found in the Official Methods of Analysis of the
Association of Official Analytical Chemists (AOAC), International, 16th
edition, or by any method which is validated by a scientific body in
collaborative trials against the three tube Most Probable Number (MPN)
method and agreeing with the 95% upper and lower confidence limits of
the appropriate MPN index.
Suggested Quantitation Schemes
If a generic one ml plating technique is used for E. coli
quantitation for cattle or swine carcass sponging sample analysis, the
plate count would be divided by 12 to equal the count per cm\2\. To
cover the marginal and unacceptable range for E. coli levels (described
in later section), the undiluted sample extract, a 1:10, a 1:100, a
1:1,000 and a 1:10,000 dilution should be plated, preferably in
duplicate. Higher or lower dilutions may need to be plated based on the
specific product.
If a hydrophobic grid membrane filtration method were used, the
only difference would be filtration of one ml of the undiluted sample
extract, 1:10, 1:100, 1:1,000 and 1:10,000 dilutions.
Additional dilutions of the original extract may need to be used if
a three tube MPN protocol is used. The three highest dilutions that
were positive for E. coli are used to calculate the MPN. MPN values
from the appropriate MPN Table represent the count per ml of original
extract and therefore must be divided by 12 to obtain the count per
cm\2\ of carcass surface area.
Record Keeping
Each test result must by recorded in terms of colony forming units
per square centimeter (cfu/cm\2\). A process control table or chart can
be used to record the results and facilitate evaluation. Results should
be recorded in the order of sample collection and include information
useful for determining appropriate corrective actions when problems
occur. The information needed for each sample includes date and time of
sample collection, and, if more than one slaughter line exists, the
slaughter line from which the sample was collected. These records are
to be maintained at the establishment for twelve months and must be
made available to Inspection Program employees on request. Inspection
personnel review results over time, to verify effective and consistent
process control.
For E. coli testing to be the most useful for verifying process
control, timeliness is important and the record should be updated with
the receipt of each new result. Detailed records should also be kept of
any corrective actions taken if process control deviations are detected
through microbiological testing.
Applying Performance Criteria to Test Results
Categorizing Test Results
E. coli test levels have been separated into 3 categories for the
purpose of process control verification: acceptable, marginal, and
unacceptable. (In the Pathogen Reduction/HACCP Regulation, the upper
limits for the acceptable and marginal ranges were denoted by m and M.)
These categories are described by slaughter species in Table 3.
Table 3.--Values for Marginal and Unacceptable Results for E. Coli Performance Criteria
----------------------------------------------------------------------------------------------------------------
Slaughter class Acceptable range Marginal range Unacceptable range
----------------------------------------------------------------------------------------------------------------
Cattle............................... Negative*.............. Positive but not above Above 100 cfu/cm\2\.
100 cfu/cm\2\.
Swine................................ 10 cfu/cm\2\........... Above 10 cfu/cm\2\ but Above 10,000 cfu/cm\2\.
not above 10,000 cfu/
cm\2\.
----------------------------------------------------------------------------------------------------------------
* It should be noted that negative here is defined by the sensitivity of the sampling and test method used in
the Baseline survey (5 cfu/cm\2\ carcass surface area).
To illustrate the use of Table 3, consider a steer/heifer slaughter
establishment. E. coli test results for this establishment will be
acceptable if negative, marginal if positive but not above 100 cfu/
cm\2\, and unacceptable if above 100 cfu/cm\2\.
Verification Criteria
The verification criteria are applied to test results in the order
that samples are collected. The criteria consist of limits on
occurrences of marginal and unacceptable results.
As each new test result is obtained, the verification criteria are
applied anew to evaluate the status of process control with respect to
fecal contamination.
1. An unacceptable result should trigger immediate action to review
process controls, discover the cause if possible, and prevent
recurrence.
2. A total of more than three marginal or unacceptable results in
the last 13 consecutive results also signals a need to review process
controls.
This way of looking at the number of marginal and unacceptable
results is described as a ``moving window'' approach in the regulation.
With this approach, results are accumulated until 13 have been accrued.
After this, only the most recent 13 results--those in the ``moving
window''--are considered.
An example of a record of results for Steer/Heifer testing is shown
(in table form) below for an establishment performing two tests per
day.
[[Page 38934]]
----------------------------------------------------------------------------------------------------------------
Number
Time Test result Result Result marginal or
Test # Date collected (cfu/cm\2\) unacceptable? marginal? unacceptable Pass/fail?
in last 13
----------------------------------------------------------------------------------------------------------------
1...... 10-07 08:50 10............. No............. Yes............ 1 Pass
2...... ......... 14:00 Negative....... No............. No............. 1 Pass
3...... 10-08 07:10 50............. No............. Yes............ 2 Pass
4...... ......... 13:00 Negative....... No............. No............. 2 Pass
5...... 10-09 10:00 Negative....... No............. No............. 2 Pass
6...... ......... 12:20 Negative....... No............. No............. 2 Pass
7...... 10-10 09:20 80............. No............. Yes............ 3 Pass
8...... ......... 13:30 Negative....... No............. No............. 3 Pass
9...... 10-11 10:50 Negative....... No............. No............. 3 Pass
10..... ......... 14:50 Negative....... No............. No............. 3 Pass
11..... 10-14 08:40 50............. No............. Yes............ 4 Fail
12..... ......... 12:00 Nonegative..... No............. No............. 4 Fail
13..... 10-15 09:30 Negative....... No............. No............. 4 Fail
14..... ......... 15:20 Negative....... No............. No............. 3 Pass
15..... 10-16 07:30 Negative....... No............. No............. 3 Pass
16..... ......... 11:40 Negative....... No............. No............. 2 Pass
17..... 10-17 10:20 120............ Yes............ No............. 3 Fail
----------------------------------------------------------------------------------------------------------------
The following observations can be made on this example:
1. As of 10-14 at 08:40, there are four marginal or unacceptable
results in the last 11 results, which exceeds the limit of 3 in 13
consecutive tests.
2. The limit of 3 in 13 also is exceeded for the next two tests,
but since no new marginal or unacceptable result has occurred, these
failures should not be treated as evidence of a new problem. The log or
documentation of corrective action taken for the first failure should
be adequate to verify that the deviation or problem was addressed.
3. On 10-15 at 15:20 the number of marginal or unacceptable results
in the last 13 tests goes down to 3 because the marginal result for 10-
07 at 08:50 is dropped and replaced by an acceptable result as the 13-
test window moves ahead 1 test.
4. The result for 10-17 at 10:20 exceeds 100 and is unacceptable.
Figure 4 shows the same results as the above example but the
results are displayed in chart form. The numbers along the horizontal
axis of the graph (x-axis), refers to the test number in the chart
above. The information for each test result, such as the time and date
the sample was collected could also be recorded on the chart.
BILLING CODE 3410-DM-P
[[Page 38935]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.021
[[Page 38936]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.022
[[Page 38937]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.023
[[Page 38938]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.024
BILLING CODE 3410-DM-C
[[Page 38939]]
Appendix G--Guidelines for Escherichia coli Testing for Process Control
Verification in Poultry Slaughter Establishments
Introduction
Under the Pathogen Reduction/HACCP Regulation, all poultry
slaughter establishments will be required to test carcasses for generic
E. coli as a tool to verify process control. This document outlines the
sampling and microbial testing that should be followed to meet this
requirement. It also gives guidance to interpreting your results. This
document is a supplement to the Regulation, but not a substitute for
it. Further in-depth details of the program may be found in the
Regulation. Please provide these guidelines to your company
microbiologist or testing laboratory in order to help you meet the
regulatory requirements for generic E. coli testing.
Guidelines for Sample Collectors/Microbiologists
Background
This sampling protocol has been prepared to support the Pathogen
Reduction/HACCP Regulation. Carcass sampling for broiler and turkey
carcasses remain the nondestructive whole bird rinse which was used in
the FSIS Nationwide Microbiological Baseline Data Collection Programs.
Carcasses within the same establishment and in different
establishments must be sampled and analyzed in the same manner if the
results are to provide a useful measure of process control across the
nation. It is imperative that all like establishments adhere to the
same sampling and analysis requirements detailed here, without
deviation. These sampling and analytical procedures may be directly
written into your establishment's individual HACCP plan.
Poultry carcasses must be sampled after the chill tank at the end
of the drip line or last readily accessible point prior to packing/cut-
up. This sample collection location is the same as that in the FSIS
baseline studies, making samples taken here comparable to the
nationwide baseline performance criteria.
Pre-sampling Preparation
Sample collection will be carried out by the individual designated
in the establishment's written protocol for microbiological sampling.
The protocol should include a check list of tasks to be performed prior
to sample collection, materials needed for sample collection, random
selection procedures, where the samples will be analyzed (on-site
versus off-site), and other information that will aid the sample
collector. As stated previously, this guideline can be a part of the
plant's sample collection guidelines, but plant specific details and
procedures will need to be included. Sampling supplies, such as sterile
gloves, sterile sampling solutions, hand soap, sanitizing solution,
etc., need to be assembled prior to beginning sample collection.
Sterile sampling solutions, Butterfield's phosphate diluent (BPD),
can be stored at room temperature. However, at least on the day prior
to sample collection, check solutions for cloudiness (DO NOT use
solutions that are cloudy, turbid or contain particulate matter) and
place the number of containers of sampling solution (BPD) that will be
needed for the next day's sampling in the refrigerator.
To obtain the most accurate results, samples should be analyzed as
soon after collection as possible. However, if samples must be
transported to an off-site laboratory, the samples need to be
maintained at refrigeration temperatures until transport, then shipped
refrigerated via an overnight delivery service to the laboratory
performing the analysis. Samples analyzed off-site must be picked up by
the overnight courier the SAME calendar day the sample is collected.
The sample must arrive at the laboratory no later than the day after
the sample is collected. Samples shipped to an outside laboratory must
be analyzed no later than the day after collection. The following
section gives information on shipping containers and transporting
samples to off-site facilities.
Shipping Containers and Coolant Packs
It is important that samples fit easily into the shipping
containers so that the sample bags do not break.
Correct use of the refrigerant gel-ice packs and proper packing of
the shipping container are necessary so that samples arrive at the
laboratory at an acceptable temperature. Frozen samples or samples
which are too warm are not considered valid and must not be analyzed.
Some bacteria may be damaged by temperatures that are too cold, while
temperatures that are too warm can allow bacteria to reproduce.
Maintaining samples at improper temperatures may cause inaccurate
sample results.
The sample should be kept refrigerated, NOT FROZEN, in the shipping
container prior to pickup by the courier service. The shipping
container, itself, should not be used as a refrigerator. However,
multiple samples (if needed) for that day may be stored in the open
shipping container in the cooler or refrigerator.
Sampling Frequency
Sampling frequency for E. coli testing is determined by production
volume. The required minimum testing frequencies for all but very low
production volume establishments are shown in Table 1 by slaughter
species.
Table 1.--E. coli Testing Frequencies a
------------------------------------------------------------------------
------------------------------------------------------------------------
Chickens............................ 1 test per 22,000
carcasses.
Turkeys............................. 1 test per 3,000
carcasses.
------------------------------------------------------------------------
a Note: These testing frequencies do not apply to very low volume
establishments. See Table 2.
Very Low Volume Establishments
Some establishments may be classified as very low volume
establishments based on their annual production volume. The maximum
yearly slaughter volumes for very low volume establishments are
described in Table 2.
Table 2.--Maximum Yearly Poultry Slaughter Volumes for Very Low Volume
Establishments
------------------------------------------------------------------------
Criteria (yearly slaughter
Slaughter species volume)
------------------------------------------------------------------------
Chickens.................................. Not more than 440,000 birds.
Turkeys................................... Not more than 60,000 birds.
Chickens and turkeys...................... Not more than 440,000 total,
with not more than 60,000
turkeys.
------------------------------------------------------------------------
Establishments with very low volumes are to sample the predominant
species once per week, initially, until at least 13 test results have
been obtained.
Once the initial criteria have been met for very low volume
establishments (see APPLYING PERFORMANCE CRITERIA TO TEST RESULTS), the
establishment will repeat the same sampling regime once per year, in
the 3 month period of June through August, or whenever a change is made
in the slaughter process or personnel.
Random Selection of Carcasses
Samples are to be taken randomly at the required frequency (See
section on Sampling Frequency). For example, given the frequency of
testing for turkeys is 1 (one) test per every 3,000 turkeys
slaughtered, then if a plant slaughters 1,500 turkeys an hour, 1 (one)
sample will be taken every 2 hours.
Different methods of selecting the specific carcass for sampling
could be used, but all require the use of random
[[Page 38940]]
numbers. Methods could include: using random number tables, using
calculator- or computer-generated random numbers, drawing cards, etc.
When selecting the random numbers, use the method(s) currently in use
at the establishment for other sampling programs, if other programs are
currently underway.
The carcass for sampling must be selected at random from all
eligible carcasses. If multiple lines exist, randomly select the line
for sample collection for that interval. Repeat the random selection
process for the next sampling interval. Each line should have an equal
chance of being selected at each sampling interval.
Poultry Carcass Selection
The poultry carcasses will be selected at random after chilling, at
the end of the drip line or last readily accessible point prior to
packing/cut-up. A WHOLE carcass is required, that is, one that has not
been trimmed.
Note: If more than one shift is operating at the plant, the
sample can be taken on any shift, provided the following
requirements are met:
Selection of TIME: Select the time, based on the appropriate
sampling frequency, for collecting the sample.
Selection of CHILLER: If more than one chiller system is in
operation at the time of sample collection, the chill tank from
which the sample is selected must be randomly selected.
Selection of POULTRY CARCASS: Based on the frequency of sampling
for your establishment, identify a carcass (selected by your random
number method) from the predetermined point, and then count back
five (5) carcasses and select the next carcass for sampling.
Exception: If the fifth carcass is not a WHOLE (untrimmed) bird,
count back an additional five carcasses for sample selection. Each
carcass must have an equal chance of being selected. The reason for
counting back five carcasses is to avoid any possible bias during
selection.
Aseptic Techniques/Sampling
Extraneous organisms from the environment, hands, clothing, sample
containers, sampling devices, etc., may lead to erroneous analytical
results. Stringent requirements for microbiological analysis are
necessary, therefore, use of aseptic sampling techniques and clean
sanitized equipment and supplies are of utmost importance.
There should be an area designated for preparing sampling supplies,
etc. A stainless steel, wheeled cart or table would be useful during
sampling. A small tote or caddy could be easily moved to the location
of sampling and could be used for carrying supplies, supporting sample
bags when adding sterile solutions to sample bags, etc.
Sterile gloves should be used for collecting samples. The only item
which may contact the external surface of the glove is the exposed
sample being collected. Keep in mind that the outside surfaces of the
sample container are not sterile. Do not handle the inside surface of
the sterile sample containers. Do not touch anything else. The
following procedure for putting on sterile gloves can be followed when
collecting samples:
(a) Peel open the package of sterile gloves from the top without
contaminating (touching, breathing on, contacting, etc.) the exterior
of the gloves.
(b) Remove a glove by holding it from the wrist-side opening inner
surface. Avoid any contact with the outer surface of the glove. Insert
the washed and sanitized hand into the glove, taking care not to
puncture the glove.
(c) Next, taking care not to contaminate the outer surface of the
glove, repeat the step above for the hand you will use to physically
handle the sample.
(d) If at any time you are concerned that a glove may be
contaminated, discard it and begin again with Step (a) above.
Preparation for Sample Collection
Prior to collecting samples, review appropriate sampling steps,
random selection procedures, and other information that will aid in
sample collection.
On the day prior to sample collection, after checking for
cloudiness/turbidity, place the number of Butterfield's phosphate
diluent (BPD) containers that will be needed for the next day's
sampling in the refrigerator/cooler. If samples will be shipped to an
off-site facility, pre-chill shipping container and refrigerator packs
(follow manufacturer's directions for gel-packs).
On the day of sampling, gather all sample collection bags, sterile
gloves, sanitizer, hand soap, sterile solutions for sampling (BPD), and
specific materials listed under the Materials section of the sample
collection section for the type of carcass to be sampled. Ensure that
all sampling supplies are on hand and readily available before
beginning sample collection.
Label the sample bags before starting the sampling procedure. Use
permanent ink. If you are using paper labels, it is important that the
label be applied to the bag at normal room temperature; it will not
stick if applied in the cooler.
Outer clothing (frocks, gloves, head gear, etc.) worn in other
areas of the plant should be removed before entering the sampling area
or preparing to collect samples. Replace outer clothing removed earlier
with clean garments (i.e., laboratory coat) that have not been directly
exposed to areas of the plant outside of the sampling area.
Sanitize the sample work area surfaces by wiping with a clean
disposable cloth or paper towel dipped in a freshly prepared 500 ppm
sodium hypochlorite solution (0.05% sodium hypochlorite) or other
approved sanitizer which provides an equivalent available chlorine
concentration. The sample work area surfaces must be free of standing
liquid before sample supplies and/or product containers are placed on
them.
Before sampling, thoroughly wash and scrub hands to the mid-
forearm. Use antibacterial hand soap. If available, this should include
a sanitizer at 50 ppm equivalence available chlorine. Dry the hands
using disposable paper towels.
Specific Sample Collection Procedures
Chicken Carcass Rinse Sampling Procedure
Materials
1. 2 Sterile 3500 milliliter (ml) stomacher-type or ziplock-type
bags or equivalent. (The bag must be sterile and should be large enough
to hold the carcass while rinsing.)
2. 400 ml sterile, Butterfield's phosphate diluent (BPD).
3. Plastic tie wraps or equivalent (if needed to secure the bag).
4. Sterile gloves.
5. Optional--(See alternate sampling--step 10)--Sterile leak-proof
container.
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Use the
predetermined random selection procedure to select the carcass to
sample. The randomly selected bird will be collected after the chiller,
at the end of the drip line as follows:
1. Ensure all sampling supplies are present and have been properly
labeled. An assistant may be helpful during sampling.
2. Open a large stomacher-type bag without touching the sterile
interior of the bag. (Rubbing the top edges of the bag between the
thumb and forefinger will cause the opening to gap for easy opening.)
3. Put on sterile gloves.
4. With one hand, push up through the bottom of the sampling bag to
form
[[Page 38941]]
a ``glove'' over one hand with which to grab the bird, while using your
other hand to pull the bag back over the hand that will grab the bird.
This should be done aseptically without touching the exposed interior
of the bag.
5. Using the hand with the bag reversed over it, pick up the bird
by the legs (hocks) through the stomacher bag. (The bag functions as a
`glove' for grabbing the bird's legs.) Take care not to contaminate the
exposed interior of the bag. Allow any excess fluid to drain before
reversing the bag back over the bird. (Alternately, have an assistant
hold open the bag. Using your gloved hand, pick up the bird by the
legs, allow any fluid to drain, and place the bird in the sampling
bag.)
6. Rest the bottom of the bag on a flat surface. While still
holding the top of the bag slightly open, add the sterile BPD (400 ml)
to the bag containing the carcass, pouring the solution over the
carcass.
(Alternately, with the aid of an assistant holding the bag open, add
the sterile BPD (400 ml) to the bag containing the carcass, pouring the
solution over the carcass.)
7. Expel most of the air from the bag, then close the top of the
bag. While securely holding the bag, rinse the bird inside and out
using a rocking motion for 30 shakes (approximately one minute). This
is done by holding the bird through the bottom of the bag with one hand
and the closed top of the bag with the other hand. Hold the bird
securely and rock it in an arcing motion, alternating the weight of the
bird from one hand to the other (motion like drawing an invisible
rainbow or arch), assuring that all surfaces (interior and exterior of
the carcass) are rinsed.
8. Rest the bag with the bird on a flat surface and, while still
supporting the bird, open the bag.
9. With a gloved hand, remove the carcass from the bag. Since the
carcass was rinsed with a sterile solution, it can be returned to the
chill tank. Be sure not to touch the interior of the bag with your
gloved hand.
10. Secure the top of the bag so that the rinse fluid will not
spill out or become contaminated.
(Alternately, at least 30 milliliters of rinse fluid can be poured into
a sterile leak-proof container to be sent to the lab for analysis.)
11. Place the sample bag (or leak-proof container) into another bag
and secure the opening of the outer bag.
12. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for the selected method of analysis.
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
Turkey Carcass Rinse Sampling Procedure
Materials
1. 2 Sterile 3500 ml stomacher-type or ziplock-type bags or
equivalent. (The bag must be sterile and should be large enough to hold
the carcass while rinsing, the bags FSIS will be using for the
Salmonella sampling program measure approximately 18'' x 24''. Large
turkeys should be placed in a plain, clear polypropylene autoclave bag
, about 24'' x 30'' to 36'').
2. 600 ml sterile, Butterfield's phosphate diluent (BPD)
3. Plastic tie wraps or thick rubber bands or equivalent, if needed
to secure sample bag
4. Sterile gloves
5. Optional--sterile, leak-proof container (see step 12 Alternate
procedure)
Collection
Read the sections under Pre-sampling Preparation and Preparation
for Sample Collection before beginning the sampling procedure. Use a
predetermined random selection procedure to select the carcass to be
sampled. The randomly selected bird will be collected after the
chiller, at the end of the drip line as follows:
1. Ensure that all supplies are on hand and readily available. An
assistant will be needed to hold the bag for collecting the bird.
2. Have an assistant open the large sterile stomacher-type bag
(designated for rinsing the carcass) and be ready to receive the turkey
carcass. (Rubbing the top edges of the bag between the thumb and index
finger will cause the opening to gap open).
(Alternately: If no assistant is available, place the closed large
sampling bag into a bucket or pail (e.g., use the bag to ``line'' a
bucket like a trash-can liner), then open the bag. The bucket will be
used as a holder or stand to support the bag. Do not contaminate the
inner surfaces of the sampling bag.)
3. Put on sterile gloves.
4. Remove the selected turkey from the drip line by grasping it by
the legs and allowing any fluid to drain from the cavity.
5. Place the turkey carcass, vent side up, into a sterile sampling
bag. Only the carcass should come in contact with the inside of the
bag.
6. Manipulate the loose neck skin on the carcass through the bag
and position it over the neck bone area to act as a cushion and prevent
puncturing of the bag. The assistant will need to support the carcass
with one hand on the bottom of the bag.
7. While still supporting the bottom of the bag, have the assistant
open the bag with the other hand. Alternately, rest the bottom of the
bag on a pre-sanitized surface (i.e. a table), and while still
supporting the carcass in the bag, open the bag with the other hand.
8. Add the sterile BPD (600 ml) to the bag containing the carcass,
pouring the diluent over the carcass.
9. Take the bag from the assistant and expel excess air from the
bag and close the top. While securely holding the bag, rinse the bird
inside and out using a rocking motion for 30 shakes (approximately one
minute). This is done by holding the carcass through the bag with one
hand and the closed top of the bag with the other hand. Holding the
bird securely with both hands, rock in an arcing motion alternating the
weight of the bird from one hand to the other (motion like drawing an
invisible rainbow or arch), assuring that all surfaces (interior and
exterior of the carcass) are rinsed.
10. Hand the bag back to the assistant.
11. With a gloved hand, remove the carcass from the bag letting
excess fluid drain back into the bag. Since the carcass was rinsed with
a sterile solution, it can be returned to the chill tank. Be sure not
to touch the interior of the bag with your gloved hand.
12. Expel excess air, taking care not to expel any rinse fluid.
Secure the top of the bag so that the rinse fluid will not spill out or
become contaminated.
(Alternately, at least 30 milliliters of rinse fluid can be poured into
a sterile, leak-proof container and sent to the lab for analysis.)
13. Place the sample bag (or container) into another bag and secure
the opening of the outer bag.
14. (a) If samples are to be analyzed at an ON-SITE LABORATORY,
begin sample preparation for the selected method of analysis. (See
Analytical Methods section.)
(b) If samples are to be analyzed at an OUTSIDE (OFF-SITE)
LABORATORY, follow the procedure in the Sample Shipment section.
Sample Shipment
Samples analyzed on-site must be analyzed as soon after collection
as possible. If no on-site facilities are available, the samples must
be shipped the same calendar day as collected, to an outside
laboratory. The samples must be analyzed no later than the day after
collection.
[[Page 38942]]
1. Prechill shipping container by placing the open shipping
container in the refrigerator at least the day before sampling.
2. Place the appropriately-labeled, double-bagged sample in the
prechilled shipping container in an upright position to prevent
spillage. Newspaper may be used for cushioning the sample and holding
it in the upright position. Ensure that samples are maintained at
refrigeration temperature. Refrigeration temperatures limit
multiplication of any microorganisms present.
3. Place a corrugated cardboard pad on top of samples. The
corrugated pad prevents direct contact of frozen gel packs with the
samples. Next, place the frozen gel pack(s) on top of the corrugated
pad. Use sufficient frozen coolant to keep the sample refrigerated
during shipment to the designated laboratory. Insert foam plug and
press it down to minimize shipper head space.
4. Ship samples (via overnight delivery or courier) to the assigned
laboratory.
Analytical Methods
Samples must be analyzed using one of the E. coli (Biotype I)
quantitation methods found in the Official Methods of Analysis of the
Association of Official Analytical Chemists (AOAC), International, 16th
edition, or by any method which is validated by a scientific body in
collaborative trials against the three tube Most Probable Number (MPN)
method and agreeing with the 95% upper and lower confidence limits of
the appropriate MPN index.
Suggested Quantitation Schemes
For poultry rinse fluid samples, if a generic one ml plating
technique is used for E. coli quantitation, the plate count would not
have to be divided to get the count per ml of rinse fluid. To cover the
marginal and unacceptable range for E. coli levels (described in later
section), the undiluted extract (optional), a 1:10, a 1:100, a 1:1,000
and a 1:10,000 dilution should be plated, preferably in duplicate.
Higher or lower dilutions may need to be plated based on the specific
product.
If a hydrophobic grid membrane filtration method were used, the
only difference would be filtration of one ml of the undiluted extract
(optional), 1:10, 1:100, 1:1,000 and 1:10,000 dilutions.
Additional dilutions of the original extract may need to be used if
a three tube MPN protocol is used. The three highest dilutions that
were positive for E. coli are used to calculate the MPN.
Record Keeping
Results of each test must by recorded, in terms of colony forming
units per milliliter rinse fluid (cfu/ml) for chicken and turkeys. A
process control table or chart can be used to record the results and
facilitate evaluation. Results should be recorded in the order of
sample collection and include information useful for determining
appropriate corrective actions when problems occur. The information
needed for each sample includes date and time of sample collection,
and, if more than one slaughter line exists, the slaughter line from
which the sample was collected. These records are to be maintained at
the establishment for twelve months and must be made available to
Inspection Program employees on request. Inspection personnel review
results over time, to verify effective and consistent process control.
For E. coli testing to be the most useful for verifying process
control, timeliness is important and the record should be updated with
the receipt of each new result. Detailed records should also be kept of
any corrective actions taken if process control deviations are detected
through microbiological testing.
Applying Performance Criteria to Test Results
Categorizing Test Results
E. coli test levels have been separated into 3 categories for the
purpose of process control verification: acceptable, marginal, and
unacceptable. (In the Pathogen Reduction/HACCP Regulation, the upper
limits for the acceptable and marginal ranges were denoted by m and M.)
These categories are described by slaughter species in Table 3.
Table 3.--Values for Marginal and Unacceptable Results for E. coli Performance Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
Slaughter class Acceptable range Marginal range Unacceptable range
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chicken............................... 100 cfu/ml or less......................... Over 100 cfu/ml but not over Above 1,000 cfu/ml.
1,000 cfu/ml.
Turkey................................ NA *....................................... NA *.......................... NA *.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The FSIS Baseline study has not been completed for this slaughter class. Levels will be set upon completion of this baseline.
To illustrate the use of Table 3, consider a chicken slaughter
establishment. E. coli test results for this establishment will be
acceptable if not above 100 cfu/ml, marginal if above 100 cfu/ml but
not above 1,000 cfu/ml, and unacceptable if above 1,000 cfu/ml.
Verification Criteria
The verification criteria are applied to test results in the order
that samples are collected. The criteria consist of limits on
occurrences of marginal and unacceptable results.
As each new test result is obtained, the verification criteria are
applied anew to evaluate the status of process control with respect to
fecal contamination.
1. An unacceptable result should trigger immediate action to review
process controls, discover the cause if possible, and prevent
recurrence.
2. A total of more than three marginal or unacceptable results in
the last 13 consecutive results also signals a need to review process
controls.
This way of looking at the number of marginal and unacceptable
results is described as a ``moving window'' approach in the regulation.
With this approach, results are accumulated until 13 have been accrued.
After this, only the most recent 13 results--those in the ``moving
window''--are considered
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
.
An example of a record of results for Chicken testing is shown (in
table form) below for an establishment performing two tests per day.
[[Page 38943]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number
Time Test result marginal or
Test No. Date collected (cfu/ml) Result unacceptable? Result marginal? unacceptable Pass/Fail?
in last 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................. 10-07 08:50 120 No.................. Yes................ 1 Pass.
2.................................. ........... 14:00 10 No.................. No................. 1 Pass.
3.................................. 10-08 07:10 150 No.................. Yes................ 2 Pass.
4.................................. ........... 13:00 50 No.................. No................. 2 Pass.
5.................................. 10-09 10:00 (\1\) No.................. No................. 2 Pass.
6.................................. ........... 12:20 10 No.................. No................. 2 Pass.
7.................................. 10-10 09:20 800 No.................. Yes................ 3 Pass.
8.................................. ........... 13:30 10 No.................. No................. 3 Pass.
9.................................. 10-11 10:50 10 No.................. No................. 3 Pass.
10................................. ........... 14:50 10 No.................. No................. 3 Pass.
11................................. 10-14 08:40 500 No.................. Yes................ 4 Fail.
12................................. ........... 12:00 30 No.................. No................. 4 Fail.
13................................. 10-15 09:30 10 No.................. No................. 4 Fail.
14................................. ........... 15:20 10 No.................. No................. 3 Pass.
15................................. 10-16 07:30 10 No.................. No................. 3 Pass.
16................................. ........... 11:40 10 No.................. No................. 3 Pass.
17................................. 10-17 10:20 1,200 Yes................. No................. 3 Fail.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Negative.
The following observations can be made on this example:
1. As of 10-14 at 08:40, there are four marginal or unacceptable
results in the last 11 results, which exceeds the limit of 3 in 13
consecutive tests.
2. The limit of 3 in 13 also is exceeded for the next two tests,
but since no new marginal or unacceptable result has occurred, these
failures should not be treated as evidence of a new problem. The log or
documentation of corrective action taken for the first failure should
be adequate to verify that the deviation or problem, if any, was
addressed.
3. On 10-15 at 15:20 the number of marginal or unacceptable results
in the last 13 tests goes down to 3 because the marginal result for 10-
07 at 08:50 is dropped replaced by an acceptable result as the 13-test
window moves ahead 1 test.
4. The result for 10-17 at 10:20 exceeds 1,000 and is unacceptable.
The Figure 1 shows the same results as above displayed in chart
form. The numbers along the horizontal axis of the graph (x-axis) refer
to the test number in the chart above. The information for each test
result, such as the time and date the sample was collected could also
be recorded on the chart.
BILLING CODE 3410-DM-P
[[Page 38944]]
[GRAPHIC] [TIFF OMITTED] TR25JY96.025
BILLING CODE 3410-DM-C
[[Page 38945]]
Note: The following Supplement will not appear in the Code of
Federal Regulations.
Supplement--Final Regulatory Impact Assessment for Docket No. 93-
016F, ``Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems.''
Table of Contents
I. Introduction
A. Purpose
B. Methodology
C. Summary Comparison of Costs and Benefits--Proposal to Final
II. Regulatory Alternatives
A. Market Failure
B. General Regulatory Approaches
C. Need For Improved Process Control
D. Regulatory Alternatives for Process Control
1. Mandatory HACCP
2. Alternatives to Mandatory HACCP
E. Comments on Analysis of Regulatory Alternatives
III. Summary of Impacts
A. Introduction
B. Net Benefit Analysis
C. Impact on ``Smaller'' Businesses
D. Effect on Retail Price
E. Impact on International Trade
F. Impact on Agency Costs
G. Impact on State Programs
H. Consumer Welfare Analysis
IV. Analysis of Public Health Benefits
A. Introduction
B. FSIS Risk Assessment
C. Risk Assessment Framework
D. FSIS Data Initiatives
E. ARS Food Safety Research Program
F. Analysis of Comments on Public Health Benefits
1. Incidence of Foodborne Illness
2. Cost of Foodborne Illness
3. Percentage of Foodborne Illness and Cost of Foodborne Illness
Attributable to Meat and Poultry
4. Pathogens Addressed by the Rule
5. Effectiveness of the Rule in Reducing Pathogens
6. Estimated Reduction in Cost of Foodborne Illness
G. Summary
V. Cost Analysis
A. Introduction
B. Methodology for Cost Analysis
C. Regulatory Flexibility
D. Final Cost Estimates
1. Sanitation Standard Operating Procedures
2. Costs of Meeting Pathogen Reduction and Microbial Sampling
3. HACCP Programs--Plan Development and Annual Reassessment
Costs
4. HACCP Programs--Recordkeeping Costs
5. HACCP Programs--Training Costs
6. HACCP Programs--Impact on Total Quality Control/Overtime
Issues
E. Summary of Costs for Low Volume Producers
Appendix A to Final Regulatory Impact Assessment
I. Introduction
A. Purpose
In docket No. 93-016F, the Food Safety and Inspection Service
(FSIS) is promulgating new regulations that require an estimated 9,079
inspected meat and poultry establishments to adopt a Hazard Analysis
and Critical Control Points (HACCP) processing control system covering
all production operations within 3\1/2\ years of final rule
publication. The regulation also requires that all 9,079 establishments
adopt and implement standard operating procedures (SOP's) for
sanitation and establishes, for the first time, food safety performance
standards for microorganisms on raw meat and poultry products. This
final rule establishes pathogen reduction performance standards for
Salmonella that are established using the current pathogen prevalence
as determined by the national baseline studies. These standards are not
directed at judging whether specific lots of a product are adulterated
under the law. Rather, compliance with the standards will be determined
by a statistical evaluation of the prevalence of bacteria in each
establishment's products. FSIS will implement sampling programs to
determine compliance with the Salmonella standard. The rule does not
require inspected establishments to test for Salmonella. The pathogen
reduction performance standards apply to 2,682 slaughter establishments
and another estimated 2,840 establishments that produce raw ground
product but do not have slaughter operations.
The final rule also requires that all slaughter establishments test
for generic E. coli to verify process control for fecal contamination
during slaughter and sanitary dressing. Results will be measured
against performance criteria established from the national baseline
surveys. Under this final rule, the 2,682 inspected slaughter
establishments will be required to verify by microbial testing that
they are controlling their slaughter and sanitary dressing processes in
accordance with the performance criteria. The rule establishes testing
frequencies based on production levels, but does not establish the
performance criteria as enforceable regulatory standards. As the
preamble points out, the criteria will be flexible and subject to
change as FSIS and the industry gain experience with them and
accumulate more data on establishment performance. The criteria are
intended specifically to provide an initial basis upon which slaughter
establishments and FSIS can begin to use microbial testing to evaluate
the adequacy of establishment controls for slaughter and sanitary
dressing procedures.
The objective of this regulation is to reduce the risk of foodborne
illness from meat and poultry. The focus is on reducing and eventually
minimizing the risk from the following four pathogens:
Campylobacter jejuni/coli.
Escherichia coli O157:H7.
Listeria monocytogenes.
Salmonella.
This document is the final Regulatory Impact Analysis (RIA)
prepared in compliance with the provisions of Executive Order 12866 and
analyses requirements of the Regulatory Flexibility Act (P.L. 96-354)
and the Unfunded Mandates Reform Act (P.L. 104-4). The purpose of this
final RIA is to evaluate alternatives to and costs and benefits
associated with a mandatory HACCP-based regulatory program for all meat
and poultry establishments under inspection.
B. Methodology
The methodology used to develop cost estimates for this final RIA
is relatively straightforward. The costs estimates are based on data
for average wages, the cost of specific processing equipment or the
cost of conducting specific laboratory analyses.
The benefits analysis is less straightforward. The analysis has
defined regulatory effectiveness as the percentage of pathogens
eliminated at the manufacturing stage. The benefits analysis concludes
that there is insufficient knowledge to predict with certainty the
effectiveness of the proposed rule. Without specific predictions of
effectiveness, FSIS has calculated projected health benefits for a
range of effectiveness levels.
The link between regulatory effectiveness and health benefits is
the assumption that a reduction in pathogens leads to a proportional
reduction in foodborne illness. FSIS has presented the proportional
reduction calculation as a mathematical expression that facilitates the
calculation of a quantified benefit estimate for the purposes of this
final RIA. FSIS has not viewed proportional reduction as a risk model
that would have important underlying assumptions that merit discussion
or explanation. For a mathematical expression to be a risk model, it
must have some basis or credence in the scientific community. That is
not the case here. FSIS has acknowledged that very little is known
about the relationship between pathogen levels at the manufacturing
[[Page 38946]]
stage and dose, i.e., the level of pathogens consumed.
There are many factors that play important roles in the actual link
between pathogen levels at the manufacturing stage and frequency of
foodborne illness. First, the effectiveness definition of ``percentage
of pathogens reduced'' can refer to the percentage of packages that
contain pathogens or the level of pathogens within packages. The
pathogens-to-illness relationship is further complicated because cross-
contamination in kitchens is believed to play a major role. It can not
be assumed that a reduction in the number of pathogens present in a
package of meat or poultry will prevent a cross-contamination related
illness. On the other hand, given that the number of consumed pathogens
necessary to cause illness (threshold) can be different for every
possible pathogen or individual combination, a reduction in pathogen
levels at the time of packaging may prevent illness for many cross-
contamination scenarios.
These types of unknowns illustrate why the relationship between
pathogen levels and foodborne illness levels remains unknown. As stated
above, without a known relationship, FSIS has used the proportional
reduction assumption to provide a quantified estimate, recognizing that
the real relationship is probably different for each pathogen and
category of meat and poultry product.
Risk minimization as the objective of this rule means the
elimination of most foodborne illness caused by the contamination of
meat and poultry products in inspected establishments by any of the
four pathogens listed above. The reduction in pathogens needed to do
this is unknown and would vary for individual pathogens and products.
This final RIA includes a discussion of the status of risk
assessment for foodborne pathogens that responds to the new
Departmental guidelines for preparing risk assessments contained in
Departmental Regulation 1521-1, December 21, 1995. Although the
statutory requirements for risk analysis included in the Federal Crop
Insurance Reform and Department of Agriculture Reorganization Act of
1994 (P.L. 103-354) do not apply to this final rule, there were public
comments on the need for additional risk assessment or risk analysis.
This final RIA includes the Agency's response to those comments.
On February 3, 1995, FSIS published a preliminary RIA as part of
the proposed Pathogen Reduction HACCP rule (60 F.R. 6871). The
preliminary RIA announced the availability of a detailed supplemental
cost analysis, titled ``Costs of Controlling Pathogenic Organisms on
Meat and Poultry,'' which was available from the FSIS Docket Clerk
during the comment period. This final RIA will refer to the analysis
published with the proposed rule and the supplemental cost analysis
collectively as the ``preliminary analysis.''
During the public comment period the Department conducted a number
of public hearings, technical conferences and information briefings. On
May 22, 1995, the Agency conducted a special hearing in Kansas City
dealing with the impacts of the proposed rule on small businesses. In
July 1995, FSIS conducted a survey of the State inspection programs to
collect additional information to assess the impact on State
establishments.
This final RIA is based on the preliminary RIA, the supplemental
cost analysis, all written public comments, the records from public
hearings including the meeting on small business impacts, the survey of
State programs, and any new information or data that have become
available during the comment period. The analysis also refers
specifically to cost estimates developed by the Research Triangle
Institute (RTI) during personal interviews with nine establishments
that previously participated in the FSIS HACCP Pilot Program. The RTI
report, HACCP Pilot Program Cost Findings, August 31, 1994, which was
referred to in both written and public hearing comments were developed
under contract to FSIS in 1994.
C. Summary Comparison of Costs and Benefits--Proposal to Final
FSIS estimated that the proposed rule would have 20-year industry
costs of $2.2 billion. Those costs are presented in Table 1, organized
by the regulatory components identified in the proposal.
The estimated costs for the final rule are also presented in Table
1. For some of the regulatory components, it is easy to track the costs
from the proposal to the final rule. For example, the costs for
Sanitation SOP's remain essentially the same. The reduction from $175.9
to $171.9 million reflects the change in implementation period from 90
days to six months.
The costs for developing and implementing HACCP plans are also
directly comparable. The estimated cost has increased for the HACCP
component of plan development. FSIS has increased its estimate for this
cost after reviewing the public comments and assessing the overall
impact on plan development costs of the decisions to eliminate the
requirements for implementing time/temperature and antimicrobial
treatment requirements prior to HACCP implementation. In the
preliminary analysis, the cost for developing HACCP plans was reduced
because of the experience that establishments would have gained in
developing their plans for implementing time/temperature and
antimicrobial treatment requirements.
Table 1.--Comparison of Costs--Proposal to Final
[$ Millions--Present Value of 20-year Costs]
----------------------------------------------------------------------------------------------------------------
Regulatory component Proposal Final
----------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's.......... 175.9a........................................ 171.9
II. Time/Temperature 45.5.......................................... 0.0
Requirements.
III. Antimicrobial Treatments 51.7.......................................... 0.0
IV. Micro Testing............ 1,396.3b...................................... 174.1
V.
Compliance with Not Separately Estimatedc..................... 55.5-243.5
Salmonella standards.
Compliance with generic Not Applicable................................ Not Separately Estimated
E. coli criteria.
VI. HACCP:
Plan Development......... 35.7.......................................... 54.8
Annual Plan Reassessment. 0.0........................................... 8.9
Recordkeeping (Recording, 456.4......................................... 440.5d
Reviewing and Storing
Data).
Initial Training......... 24.2.......................................... 22.7d
Recurring Training....... 0.0........................................... 22.1e
VII. Additional Overtime..... 20.9.......................................... 17.5d
----------------------------------------------------------------------------------
[[Page 38947]]
Subtotal--Industry 2,206.6....................................... 968.0-1,156.0
Costs.
VIII. FSIS Costs............. 28.6f......................................... 56.5
----------------------------------------------------------------------------------
Total.................. 2,235.2....................................... 1,024.5-1,212.5
----------------------------------------------------------------------------------------------------------------
a The preliminary analysis included a higher cost estimate for sanitation SOP's ($267.8 million) that resulted
because of a programming error. The cost estimate of $175.9 million is based on an effective date of 90 days
after publication.
b The preliminary analysis was based on the premise that microbial testing would be expanded to cover all meat
and poultry processing after HACCP implementation. The proposed rule only required sampling for carcasses and
raw ground product. Thus, the cost estimate of $1,396.3 million was higher than the actual cost of the
proposed sampling requirements.
c The preliminary analysis accounted for some of the cost of complying with the new standards under the
regulatory components of micro testing, antimicrobial treatments, and time and temperature requirements.
d These costs are slightly different from the proposal because of changes in the implementation schedule.
e FSIS added costs for recurring training based on the review of public comments.
f Based on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP
verification testing.
Table 1 shows that FSIS has added two categories of HACCP costs
that were not included in the preliminary cost analysis. A cost for
recurring annual HACCP training was added in response to comments that
there would be recurring costs because of employee turnover. FSIS also
added a minimal cost for annual reassessment of HACCP plans, although
the Agency believes that reassessment will be negligible for
establishments successfully operating under a HACCP plan.
Table 1 shows that the proposed requirements for time and
temperature specifications and antimicrobial treatments have not been
included in the final rule. The preliminary analysis treated these
items as interim costs that were incurred prior to HACCP
implementation. For the time and temperature requirements, the
preliminary analysis identified both one-time capital equipment costs
and recurring recordkeeping costs. The time and temperature
recordkeeping costs were assumed to become part of the HACCP
recordkeeping costs. The recurring costs for antimicrobials were
assumed to end with HACCP implementation. The preliminary analysis
indicated that at the time of HACCP implementation, the slaughter
establishments would make a decision on whether to continue the
antimicrobial treatments and employ other methods to reduce the
microbial load on carcasses. The preliminary analysis did not, however,
include a cost component for either continuing the antimicrobial
treatments or adding alternative pathogen reduction methods.
Under the micro testing component, the final rule requires that all
2,682 slaughter establishments implement microbial sampling programs
using generic E. coli. The 20-year cost of this requirement is $174.1
million. After HACCP implementation including validation that the E.
coli performance criteria are being met, establishments may use
alternate testing programs unless FSIS specifically objects. In
addition, in the period prior to mandatory HACCP, FSIS will consider
exemptions on a case-by-case basis for establishments that are
currently using an alternative E. coli sampling frequency if the
establishment can provide data demonstrating the adequacy of its
existing program. The cost estimate of $174.1 million assumes that all
slaughter establishments continue to test at the frequencies outlined
in the final rule.
Up to this point, all the costs discussed have been predictable in
the sense that they refer to a specific requirement directing all
establishments or a specific category of establishments to take a well-
defined action. FSIS has developed point estimates for all predictable
costs. In contrast, the pathogen reduction performance standards for
Salmonella do not prescribe a set of actions that establishments must
take. Because the standards are set using the national prevalence
estimates from the baseline studies, the Agency is also not able to
predict how many establishments are already meeting the standards or
how many will have to modify their current operations to comply.
The cost analysis in Section V recognizes that the performance
standards create a set of potential costs for 5,522 establishments,
2,682 slaughter establishments and another estimated 2,840
establishments that produce raw ground product but do not have
slaughter operations. The analysis estimates potential costs by
developing two scenarios that lead to a range of possible costs
depending on how the different industry sectors will respond to the new
standards and depending on how many establishments will need to modify
their production processes in order to comply.
Reducing pathogens for slaughter establishments involves either
modifying the incoming animals or birds, improving the dressing
procedures so as to reduce contamination during procedures such as hide
removal and evisceration, or using interventions such as antimicrobial
treatments to kill or remove the pathogens following contamination. For
many establishments, the process of implementing HACCP programs may, by
itself, improve the dressing procedures sufficiently to meet the new
standards. Other establishments may have to choose between slowing
production lines, modifying some attribute of their incoming live
animals or birds, or adding post-dressing interventions such as the new
steam vacuum process or antimicrobial rinses.
The 2,840 raw ground processing operations will have to control
their incoming ingredients either by conducting their own testing or by
requiring that suppliers meet purchase specifications. The cost
analysis also recognizes that even though the rule does not require the
2,682 slaughter establishments to test for Salmonella, some
establishments may conduct their own Salmonella testing programs to
avoid failing a series of tests conducted by the Agency. Thus, it can
be argued that the Agency's intent to implement establishment specific
testing for Salmonella is indirectly requiring the industry to
routinely monitor their Salmonella levels to assure they will be in
compliance.
As shown in Table 1, the two scenarios developed in the cost
analysis lead to a range in cost estimates of $55.5 to $243.5 million
to comply with the new pathogen reduction standards. Some of these
costs are contained in the
[[Page 38948]]
Table 1 proposal costs of $51.7 for antimicrobial treatments and the
$1,396.3 for micro testing that included the cost of having 5,522
establishments conduct daily Salmonella testing for each species
slaughtered and each variety of raw ground product produced.
The two cost scenarios were developed to illustrate potential costs
for compliance with standards established using the current pathogen
prevalence as determined by the national baseline studies. These
standards move the Agency's regulatory program in the direction of
meeting the food safety objective of minimizing the risk of foodborne
illness from pathogens that contaminate meat and poultry products. The
Agency has stated its intent to establish tighter standards over time.
The Agency recognizes that future tighter standards could impose a new
set of compliance costs. To illustrate, where the use of hot water
rinses may be adequate to assure compliance with the Salmonella
standards as established for this rule, such rinses may not be adequate
to assure compliance with future standards. Any change in the standards
will, however, be implemented through additional rulemaking. At that
time the Agency will have extensive data on the distribution of
pathogens by establishment and better data on the cost and
effectiveness of different interventions. These data enhancements will
allow for improved cost analysis of future standard setting activities.
Inspected establishments need to consider the Agency's overall food
safety objectives when making decisions on capital investments designed
to assure compliance with the food safety standards established by this
rulemaking.
The cost analysis in Section V also recognizes that the performance
criteria for generic E. coli create a set of potential costs for 2,682
slaughter establishments. A line for these costs is shown in Table 1
along with the entry that these costs were not separately quantified.
As discussed in Section V, the anticipated actions to comply with
the generic E. coli criteria are the same as the anticipated actions to
comply with the standards for Salmonella. FSIS has concluded that if
the low cost scenario for Salmonella compliance proves to be more
accurate, then the Agency would expect to see some compliance costs for
the generic E. coli performance criteria. If the high cost scenario is
correct, then the compliance actions taken to assure compliance with
the Salmonella standards should also assure compliance with the generic
E. coli criteria.
Finally, Table 1 includes a cost of $17.5 million associated with
additional overtime charges for inspection. While it is recognized that
final decisions on the future of the Agency's Total Quality Control
(TQC) program have not been made, this analysis includes a conservative
impact assumption that the existing TQC regulations will be withdrawn.
Both the preliminary and final analysis identify a maximum
potential 20-year public health benefit from $7.13 to $26.59 billion
that is tied to eliminating establishment-related contamination from
four pathogens on meat and poultry. The contamination from these four
pathogens at the manufacturing stage leads to an estimated annual cost
of foodborne illness ranging from $0.99 billion to $3.69 billion. The
maximum 20-year benefit results from eliminating this annual cost of
foodborne illness beginning in the fifth year after publication.
Although there is reason to believe significant benefits will be
generated during the first four years, for analytical purposes FSIS
used the conservative estimate that benefits do not begin until all
establishments have HACCP systems in place and pathogen reduction
standards for Salmonella apply to all establishments that slaughter or
produce raw ground product.
There are two principle reasons why benefits will begin to accrue
before the fifth year. First, the HACCP requirements and Salmonella
standards apply to large establishments at 18 months and small
establishments at 30 months. The large slaughter establishments account
for over 74 percent of total carcass weight. Second, the generic E.
coli testing requirements are effective six months after publication.
The generic E. coli results will provide both establishment management
and inspection program personnel a tool by which to assess
establishments' control over slaughter and sanitary dressing
procedures. Although the generic E. coli criteria are not being
established as regulatory standards, FSIS believes their use will lead
to improved control over slaughter and sanitary dressing procedures
which will, in turn, lead to reductions in fecal contamination and
corresponding reductions in contamination by enteric pathogens. Rather
than attempt to estimate the benefits associated with reduced
contamination resulting from use of generic E. coli testing, this
analysis has assumed public health benefits begin in the fifth year. By
that time all establishments have had an opportunity to adjust their E.
coli sampling programs based on their HACCP programs.
The low and high estimates for potential benefits are due to the
current uncertainty in estimates for incidence of foodborne illness and
death. If the low potential benefit estimate is correct, the analysis
shows that the new HACCP-based program must reduce pathogens by 15 to
17 percent for benefits to outweigh projected costs. If the high
estimate is the correct estimate, the new program needs to reduce
pathogens by only 4 to 5 percent to generate net societal benefits.
As discussed in Section III, there are other benefits to this rule
that have not been quantified. Examples include increased public
protection from physical hazards and the increased production
efficiency that accompanies improved process control.
In the preliminary analysis FSIS took the position that quantified
pathogen reduction benefits were related to the overall proposed HACCP-
based regulatory program and that there was no way to distribute
benefits among the five different components that made up the proposed
rule. Under the proposed rule it was essentially impossible to
determine the proportion of pathogen reduction benefits that could be
attributable to the proposed pathogen reduction standards versus the
proposed antimicrobial treatments or time-temperature requirements or
the proposed mandatory HACCP programs. Given the revised structure of
the final rule, this analysis attributes pathogen reduction benefits to
the requirements that all establishments implement HACCP systems and
that if those systems are implemented in slaughter establishments or
establishments shipping raw ground product, they must have critical
limits set to assure compliance with the new pathogen reduction
standards for Salmonella. However, as discussed above, FSIS believes
that pathogen reduction benefits will begin to occur when
establishments start using the generic E. coli results to assess their
control over slaughter and sanitary dressing procedures.
FSIS believes that the Sanitation SOP's component of this final
rule has significant benefits in terms of increased productivity for
inspection resources. The HACCP component also has productivity
benefits in addition to public health benefits. One of the reasons FSIS
has not yet achieved a program that can focus appropriate resources on
the risks of microbial pathogens is that in recent years
[[Page 38949]]
national budget problems have provided limited increases in Agency
resources compared to the increase in its responsibilities generated by
industry growth, the Federal takeover of more State programs, and new
food production technologies and products. For most of its history, the
inspection program was able to obtain additional resources when it took
on new responsibilities. Now FSIS is faced with taking on new
responsibilities with the same resources.
The final rule is a necessary component of an FSIS management
strategy that will raise the productivity of current resources so that
the program can maintain all its consumer protection objectives.
Raising productivity requires raising outputs, reducing inputs or any
combination of the two that gets more done for less. Productivity can
be increased in today's inspection program by: (1) focusing resource
use on the basis of risk, giving the highest priority to safety
objectives; (2) clarifying the respective responsibilities of
government and industry to assure the best use of government resources;
and (3) designing new methods of inspection that are more efficient
than existing inspection but which maintain or improve consumer
protection.
The Sanitation SOP's and HACCP requirements are designed to
accomplish objectives in all three of the above areas. With SOP's FSIS
can monitor sanitation plans with fewer resources than it takes to
conduct comprehensive sanitation reviews. The benefit of the SOP's is,
therefore, the capacity to reallocate inspection resources to other
activities where the payoff in terms of reducing the risk of foodborne
illness may be greater. With SOP's there is less likelihood that
establishments will be able to substitute the inspector's sanitation
review for their own sanitation program. Similarly, with HACCP there is
less likelihood that firms can use inspection as a substitute for their
own control programs. In both cases productivity is enhanced by
clarifying responsibilities. The benefits associated with increased
productivity are difficult to quantify because the precise reallocation
of inspection resources is not yet clear.
Finally, with the implementation of this rule, FSIS intends to
introduce new methods of inspection that are more efficient than those
currently in place. As noted above, more efficient methods is the third
way in which productivity can be increased in the inspection system.
II. Regulatory Alternatives
A. Market Failure
Consumers make choices about the food they purchase based upon
factors such as price, appearance, convenience, texture, smell, and
perceived quality. In an ideal world, people would be able to make
these decisions with full information about product attributes and
choose those foods which maximize their satisfaction. In the real
world, however, information deficits about food safety complicate
consumer buying decisions.
Since all raw meat and poultry products contain microorganisms that
may include pathogens, raw food unavoidably entails some risk of
pathogen exposure and foodborne illness to consumers. However, the
presence and level of this risk cannot be determined by a consumer,
since pathogens are not visible to the naked eye. Although they may
detect unwholesomeness from obvious indications such as unpleasant odor
or discoloration caused by spoilage microorganisms, consumers cannot
assume products are safe in the absence of spoilage. They simply have
no clear-cut way to determine whether the food they buy is safe to
handle and eat.
When foodborne illness does occur, consumers often cannot correlate
the symptoms they experience with a specific food because some
pathogens do not cause illness until several days, weeks or even months
after exposure. Thus, food safety attributes are often not apparent to
consumers either before purchase or immediately after consumption of
the food. This information deficit also applies to wholesalers and
retailers who generally use the same sensory tests--sight and smell--to
determine whether a food is safe to sell or serve.
The societal impact of this food safety information deficit is a
lack of accountability for foodborne illnesses caused by preventable
pathogenic microorganisms. Consumers often cannot trace a transitory
illness to any particular food or even be certain it was caused by
food. Thus, food retailers and restaurateurs are generally not held
accountable by their customers for selling pathogen-contaminated
products and they, in turn, do not hold their wholesale suppliers
accountable.
This lack of information applies equally to small businesses. Some
small businesses have argued for exemption from the rule because they
sell most of their product to family, friends and neighbors, but they
are overlooking the fact that perhaps the majority of foodborne illness
victims may believe they had some type of flu virus or other illness
and have no idea that their illness was foodborne and, if they do, they
have no idea as to the source. Without feedback, (i.e., without a
connection of product to illness), there is no market where buyers and
sellers have sufficient information upon which to judge purchase
decisions. Without feedback there is insufficient incentive to make
substantial improvements in process control.
This lack of marketplace accountability for foodborne illness means
that meat and poultry producers and processors have little incentive to
incur extra costs for more than minimal pathogen controls. The
widespread lack of information about pathogen sources means that
businesses at every level from farm to final sale can market unsafe
products and not suffer legal consequences or a reduced demand for
their product. An additional complication is that raw product is often
fungible at early stages of the marketing chain. For example, beef from
several slaughterhouses may be combined in a batch of hamburger
delivered to a fast food chain. Painstaking investigation by public
health officials in cases of widespread disease often fails to identity
foodborne illness causes; in half the outbreaks the etiology is
unknown.
Most markets in industrialized economies operate without close
regulation of production processes in spite of consumers having limited
technical or scientific knowledge about goods in commerce. Branded
products and producer reputations often substitute for technical or
scientific information and result in repeat purchases. Thus, brand
names and product reputations become valuable capital for producers.
In the U.S. food industry, nationally recognized brand names have
historically provided significant motivation for manufacturers to
ensure safe products. In recent years, more and more raw meat and
poultry have come to be marketed under brand names. Nevertheless, not
even all brand name producers produce their products under the best
available safety controls. Further, a significant part of meat and
poultry, particularly raw products, are not brand name products and are
not produced under conditions that assure the lowest practical risk of
pathogens.
The failure of meat and poultry industry manufacturers to produce
products with the lowest risk of pathogens and other hazards cannot be
attributed to a lack of knowledge or appropriate technologies. The
science and technology required to significantly
[[Page 38950]]
reduce meat and poultry pathogens and other hazards is well
established, readily available and commercially practical.
Explanations for why a large portion of the meat and poultry
industry has not taken full advantage of available science and
technology to effectively control manufacturing processes include the
following:
1. Meat and poultry processing businesses are relatively easy to
enter; there are no training or certification requirements for
establishment operators. Consequently, the level of scientific and
technical knowledge of management in many establishments is minimal.
2. The industry is very competitive and largely composed of small
and medium-sized firms that have limited capital and small profits.
3. Management in many of these establishments has little incentive
to make capital improvements for product safety because results from
that investment are not distinguishable by customers and therefore
yield no income.
In spite of these barriers, many industry establishments do produce
meat or poultry products using process controls that assure the lowest
practical risk of pathogens and other hazards.
FSIS has concluded that the lack of consumer information about meat
and poultry product safety and the absence of adequate incentives for
industry to provide more than minimal levels of processing safety
represents a market failure requiring Federal regulatory intervention
to protect public health.
B. General Regulatory Approaches
The problem of microbial pathogens in meat and poultry has become
increasingly apparent. Documented cases of foodborne illness each year,
some of which have resulted in death, represent a public health risk
that FSIS judges to be unacceptable. Within existing authorities there
are four broad regulatory approaches the Department could use to
address this unacceptable public health risk.
Market Incentives.
Information and Education.
Voluntary Industry Standards.
Government Standards.
The final rule represents the fourth approach.
The above discussion on market failure summarizes why FSIS has
concluded that the market will not address the public health risk
resulting from microbial pathogens in meat and poultry.
The role and effectiveness of consumer and food service worker
education in assuring food safety was raised in public comments. For
example, comments suggested that since most foodborne illness involves
temperature abuse or consumer/food handler mishandling, consumer
education offers the most cost-effective approach. FSIS sees a clear
role for education and agrees that education is essential for assuring
food safety. However, experience has shown that education alone has
limited effectiveness in reducing foodborne illness. The effectiveness
of education for food safety, and, indeed, for improving diets and
other food related behavior, has not been demonstrated. FSIS views
education as a valuable adjunct to other regulatory approaches, but it
has no evidence that a major increase in education expenditures will
produce the behaviors required to reduce foodborne illness.
A voluntary industry standard would call for the formation of a
standards setting group, such as the American National Standards
Institute (ANSI) to develop and publish a voluntary standard.
Compliance with such a voluntary standard would be determined by third-
party testing and certification. For example, Underwriter's Laboratory
(UL) tests and certifies electronic components for industry-wide
standards. FSIS has not seen any evidence that the industry is prepared
to undertake, or even desires a voluntary standards approach. This is
understandable. Because the principles underlying the safe production
of meat and poultry are the same regardless of who administers the
standards, an industry administered system is likely to be more
expensive and less effective than a government one. The lack of power
to mandate participation reduces the value of standard setting to
participants, since foodborne illness episodes attributable to non-
participants tend to raise suspicion of all similar products. Further,
the industry would be called upon to pay the enforcement cost which
under the present rule would be paid by the government.
For these reasons, the Department concludes that mandatory process
control regulations offer the best approach for addressing this
unacceptable public health risk.
C. Need For Improved Process Control
FSIS has determined that effective process control is needed
throughout the meat and poultry industry in order to minimize pathogen
contamination and control other health hazards. Accordingly, a
regulatory strategy has been formulated to mandate process control
improvements to achieve immediate reductions and an eventual
minimization of the risk of meat and poultry pathogens, chemical, and
physical hazards in the nation's food supply. This strategy is
supported by consumers, scientists, and the majority of meat and
poultry industry processors who already recognize the benefits of good
process control.
Process control is a proactive strategy that all segments of
industry can undertake to anticipate manufacturing problems in advance
and prevent unsafe foods from being produced. In practice, process
control is a systematic means to:
Identify and control production hazards.
Determine control points in the processing system.
Establish standard measures for each control point.
Set procedures for establishment workers to monitor
requirements.
Provide clear instructions for appropriate corrective
actions when a control point goes out of control.
Establish record-keeping to document control point
measurements.
Provide procedures for verification tests to ensure that
the system continues to operate as planned.
The process control strategy summarized in this paper is founded on
three principles:
1. USDA regulatory policy should be focused on providing a solution
to meat and poultry biological, chemical, and physical hazards that
present the highest public health risks.
2. It is essential that the Nation's food safety system address
pathogenic microorganisms which present the greatest foodborne risk to
human health.
3. These pathogens and resulting risks of foodborne illness can be
largely avoided by uniform meat and poultry industry efforts to attain
and maintain more effective methods of control during the manufacturing
process.
The focus of this strategy is explicitly on prevention; it is
designed to prevent the production of defective product as opposed to
more costly and less effective detect-and-condemn methods.
Process control is not a substitute for inspection any more than
inspection could be a substitute for process control. This distinction
is important because Federal inspection was never intended to be--and
cannot be--the front-line control for food safety in meat and poultry
processing establishments. Safety controls must be built into the
manufacturing process and be administered continuously by industry. The
objective of inspection in a process control environment is to assure
that those controls are present, adequate, and properly used.
[[Page 38951]]
To summarize, the process control regulatory strategy promulgated
by this rule will among its other well established attributes, correct
two important deficiencies in the nation's current food safety effort.
It will: (1) provide industry the tools and incentive to reduce meat
and poultry pathogens as a means to improve food safety, and (2) help
focus Federal inspection on the highest product, process and
establishment risks, and, at the same time, clarify that the industry
is responsible for producing safe meat and poultry, while the
Government's role is oversight.
Factors Considered in Evaluating a Process Control Strategy
The process control regulatory strategy was evaluated using five
factors for effectiveness. A processing control program is effective if
it:
1. Controls production safety hazards.
2. Reduces foodborne illness.
3. Makes inspection more effective.
4. Increases consumer confidence.
5. Provides the opportunity for increased productivity.
The following sections discuss these five effectiveness factors
that have been applied to evaluate process control alternatives.
Controls Production Safety Hazards
Process control is a system for identifying food hazards and
reducing or eliminating the risks they present. In operation, control
points are established in a food production line where potential health
hazards exist; management of these points has proven to be effective in
reducing the probability that unsafe product will be produced. Ongoing
records of each process control will enable establishment managers and
quality control personnel to spot trends that could lead to problems
and devise a strategy that prevents them before they occur.
Detection by end product testing is not a viable alternative to
process control because it only sorts good product from bad and does
not address the root cause of unacceptable foods. Additionally, keeping
``bad'' foods out of commerce through sorting end product is possible
only when tests and standards for sampling are well established and it
is practical only where the ``test'' is not expensive because sorting
requires a huge number of samples for reliability.
Reduces Foodborne Illness
As industry improves its control over the safety aspects of meat
and poultry production, foodborne illness will begin to decline. This
is the principal non-negotiable goal for both USDA and industry.
The precise occurrence of human health problems attributed to
pathogenic microorganisms or other potential foodborne hazards, such as
chemical contaminants, animal drug residues, pesticides, extraneous
materials, or other physical contaminants is not known. Foodborne
illness is nevertheless recognized by both domestic and international
scientists as a significant public health problem and there is wide
agreement that pathogenic microorganisms are the major cause of food-
related disease. The estimated annual (not discounted) cost of
foodborne illness attributable to meat and poultry products from the
four pathogens that are the focus of this regulation is from $1.1 to
$4.1 billion. FSIS estimates that 90 percent of this annual cost, $0.99
to $3.69 billion, is attributable to contamination that occurs in
establishments.
Makes Inspection More Effective
Currently, the FSIS inspectors in meat and poultry establishments
that are not assigned to slaughter line positions perform selected
inspection tasks that generate independent data about an
establishment's production processes and environment. This activity
produces ``snapshots'' of establishment operations at a particular
moment. In contrast, process control generates records of establishment
performance over time. These records and periodic verification
inspections will enable FSIS inspectors to see how an establishment
operates at all times, i.e., whether and where processing problems have
occurred, and how problems were addressed.
The availability of more and better processing data will establish
trends that set benchmarks from which deviations can be more quickly
and accurately assessed. USDA inspectors will be trained to spot these
deviations and take action when needed to ensure establishments bring a
faulty process back into control. This type of Federal oversight is
substantially more effective than a regulatory program that merely
detects and condemns faulty end products. In the words of the National
Advisory Committee on Microbiological Criteria for Foods,
``Controlling, monitoring, and verifying processing systems are more
effective than relying upon end-product testing to assure a safe
product.''
Increases Consumer Confidence
The number of foodborne illness outbreaks and incidents
attributable to pathogens in meat or poultry raise questions about
whether Federal inspection is as effective as it should be. Highly
visible public controversies about meat and poultry inspection indicate
an erosion of public confidence in the safety of meat and poultry
products. There are growing demands that USDA improve its regulation of
pathogens. The process control regulatory strategy described in this
paper is USDA's response to those demands.
Many outbreaks of foodborne illness have been determined to be
caused by mishandling of meat and poultry products after federally
inspected processing. USDA believes that additional efforts to reduce
pathogens during manufacturing will reduce these risks as well. This
coupled with the improved retail regulatory controls from state
adoption and enforcement of the Food Code should reduce this cause of
illness. The Food Code is an FDA publication, a reference that provides
guidance to retail outlets such as restaurants and grocery stores and
institutions such as nursing homes on how to prepare food to prevent
foodborne illness. State and local regulatory bodies use the FDA Food
Code as a model to help develop or update their food safety rules and
to be consistent with national food regulatory policy.
A significant portion of the meat and poultry industry do not take
advantage of readily available methods to control their manufacturing
processes. The Department has concluded that further regulation will
bring industry standards up to what can practically be achieved in the
manufacture of meat and poultry products through current scientific
knowledge and available process control techniques. Raising the safety
floor through regulations that mandate better process control will
demonstrate to the public that USDA and industry are making a concerted
effort to reduce the risk of foodborne illness from meat and poultry.
The economic benefits of increased consumer confidence can be
conceptually realized as the amount consumers would be willing to pay
for safer food. This ``willingness to pay'' reflects consumer desires
to avoid foodborne illness and the expected medical and other costs
associated with it. However, the data are not available to make
quantitative estimates of this benefit.
Provides the Opportunity for Increased Productivity
Better process control is a sound and rational investment in the
future of our
[[Page 38952]]
nation's meat and poultry industry. USDA's process control strategy
will educate industry management about the need and methodology for
development of a consistent, preventive, problem-solving approach to
safety hazards, which can be expanded to other business objectives such
as product quality and production efficiency. There is considerable
evidence of how process control has improved worldwide industrial
productivity in the past 40 years. This proposal will extend process
control principles to parts of the meat and poultry industry that have
not formerly used them.
Some important non-safety benefits that will accrue from industry
use of better process control methods are:
First, better production controls will result in more
efficient processing operations overall with fewer product defects.
Fewer defects mean less reworking, waste and give-away, resulting in
increased yields and more profit opportunities.
Second, better controls will significantly reduce the risk
to processors that product with food safety defects will slip into
commerce. Expensive and embarrassing product recalls can be, for the
most part, avoided or greatly reduced with proper process controls.
Third, better control of pathogens will impact all
microorganisms, including those responsible for decomposition,
resulting in quality improvement and longer shelf life for products.
Fourth, better production controls improve establishment
employee productivity which improves profit opportunities.
D. Regulatory Alternatives for Process Control
1. Mandatory HACCP
Considering the five effectiveness criteria of process control
discussed above, the most effective means for generating the benefits
reflected in these criteria is a mandatory HACCP regulatory program.
This alternative clearly meets all five criteria described above. In
fact, a mandatory HACCP program was judged to be the only option that
will effect adequate processing improvements in all establishments
throughout the industry. Only through mandatory HACCP can pathogen
risks be minimized to the fullest extent possible; thereby
significantly reducing foodborne illness, improving effectiveness of
inspection, increasing consumer confidence, and ensuring a more viable
industry. No other alternative accomplishes as much in these five areas
as mandatory HACCP.
HACCP is a process control strategy that has been scientifically
proven effective in food manufacturing establishments. HACCP is widely
recognized by scientific authorities such as the National Academy of
Sciences and international organizations such as the Codex
Alimentarius. It is used today by a number of establishments in the
food industry to produce consistently safe products. This approach has
been supported for years by numerous groups that have studied USDA meat
and poultry regulatory activities.
In 1983 FSIS asked the National Academy of Sciences (NAS) to
evaluate the scientific basis of its inspection system and recommend a
modernization agenda. The resulting report, ``Meat and Poultry
Inspection, The Scientific Basis of the Nation's Program,'' National
Academy Press, 1985 was the first comprehensive evaluation of a
scientific basis for inspection. The 1985 NAS report provided a
blueprint for change: it recommended that FSIS focus on pathogenic
microorganisms and require that all official establishments operate
under a HACCP system to control pathogens and other safety hazards.
After urging (NAS Recommendations, Page 4) the intensification of
``current efforts to control and eliminate contamination with micro-
organisms that cause disease in humans,'' NAS encouraged (Page 135)
USDA to ``move as vigorously as possible in the application of the
HACCP concept to each and every step in establishment operations, in
all types of enterprises involved in the production, processing, and
storage of meat and poultry products.''
The General Accounting Office (GAO) has also identified needed
improvements in USDA's present inspection system. In its reports and
congressional testimony, and in numerous publications, GAO has endorsed
HACCP as the most scientific system available to protect consumers from
foodborne illness. This sentiment is most clearly expressed in a May
1994 report, ``Food Safety: Risk-Based Inspections and Microbial
Monitoring Needed for Meat and Poultry,'' in which GAO recommended
development of a mandatory HACCP program that includes microbial
testing guidelines. GAO urged USDA to assist meat and poultry
establishments in the development of their microbial testing programs
by, among other things, disseminating information on the programs
already in operation.
A third major proponent of HACCP is the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF), which was established
in 1988 by the Secretary of Agriculture to advise and provide
recommendations to the Secretaries of Agriculture and Health and Human
Services on developing microbiological criteria to assess food safety
and wholesomeness. Since 1989, NACMCF has prepared a series of reports
on the development and implementation of HACCP. As one of its first
tasks, the Committee developed ``HACCP Principles for Food Production''
in November 1989. In this report, the Committee endorsed HACCP as a
rational approach to ensure food safety and set forth principles to
standardize the technique. In 1992, the Committee issued an updated
guide, ``Hazard Analysis and Critical Control Point System.''
In 1993 NACMCF defined the roles of regulatory agencies and
industry in implementing HACCP. ``The Role of Regulatory Agencies and
Industry in HACCP'' proposed responsibilities for FDA, USDA, and other
agencies and industry during various phases of HACCP implementation.
Similar suggestions for program change have been voiced by consumers,
industry, state and local government representatives, as well as other
constituent groups. For example, consumers at recent public hearings
and the HACCP Round Table supported implementation of mandatory HACCP
throughout the meat and poultry industry.
The meat and poultry industry has itself provided broad support for
HACCP as a means to control pathogens, emphasizing that HACCP-based
food production, distribution, and preparation can do more to protect
public health than any Federal inspection program. They have
recommended that HACCP be used to anticipate microbiological hazards in
food systems and to identify risks in new and traditional products.
State departments of health and agriculture have also endorsed the
HACCP approach.
2. Alternatives to Mandatory HACCP
FSIS examined six other approaches before determining that
mandatory HACCP was the most effective means for assuring process
control in the meat and poultry industries.
1. Status quo
2. Intensify present inspection
3. Voluntary HACCP regulatory program
4. Mandatory HACCP regulation with exemption for small businesses
5. Mandatory HACCP regulation only for ready-to-eat products
[[Page 38953]]
6. Modified HACCP--recording deviations and responses only
These alternatives were assessed using the five effectiveness
criteria presented in the previous section. The following six sections
summarize the appraisal of each alternative.
Status Quo
This option would essentially continue establishment processing
controls and Federal inspection as they are now. Good establishments
with adequate methods for managing process lines would probably remain
under control. The Agency, under its present authority, cannot shift
resources out of good establishments so the situation of poor
performing establishments is unlikely to change. This situation raises
immediate questions about the first factor--controls production safety
hazards--being met. Experience has proven that Federal inspection
cannot substitute for management in establishments which have
difficulty producing safe product consistently. Also, inspection cannot
be as effective in the current establishment environment as in a
process control establishment environment.
The status quo does not target industry and inspection resources on
those hazards that lead to the greatest reduction in foodborne illness
(factor two). In addition, food safety experts, consumers, and other
observers have told USDA they are not satisfied with pathogen control
by organoleptic methods as practiced in the present inspection program.
Doing nothing new would perpetuate consumer doubts about the ability of
Federal inspection to regulate pathogens which is counter to factor
four. Consequently, the Department has concluded that business as usual
is not an acceptable response to pathogens associated with meat and
poultry products. Agency public health responsibilities alone require
that more positive actions be taken.
Intensify Present Inspection
As one alternative to the proposed mandatory HACCP regulation, FSIS
could intensify its present inspection system, i.e., focus new
resources on suspected areas of risk in each establishment. This
approach would assign to FSIS responsibility for designing, testing and
mandating by specific regulation, process control systems for all meat
and poultry products with potential safety hazards. A major flaw with
this approach is that the burden of ensuring a safe product would be
placed largely on FSIS instead of industry establishments where it
belongs. Establishment management would have little motivation to
become knowledgeable about process control or to implement process
control systems.
The mandating of specific process controls has sometimes succeeded,
as a regulatory strategy, for example, in correcting food safety
problems in certain ready-to-eat products. However, these controls
largely consisted of lethal heat treatments applied during final
product processing. This approach is obviously inappropriate for
product that is marketed raw which is most frequently associated with
meat and poultry foodborne illness. The identification of processes
that can be applied to raw product in every establishment would be much
more difficult, if not impossible. Thus, intensified command-and-
control regulation fails to meet the primary criterion for process
control, i.e., control production safety hazards at all stages of meat
and poultry slaughter and processing. Related to this failing,
inspection would be ineffective without all establishments maintaining
process control systems (factor three.) This option would not only
require significant resource increases, it represents government taking
on more, not less, responsibility for the production process, making it
more difficult to focus on the highest risks of foodborne illness. With
the burden of control and monitoring on USDA's inspection force rather
than on establishment managers, industry performance in reducing
foodborne illness would be unlikely to improve (factor two).
Voluntary HACCP Regulatory Program
A voluntary HACCP program would not provide reduction of pathogens
uniformly across the processing spectrum because many in industry would
choose not to participate. Therefore voluntary HACCP would not be
sufficient to attain the necessary reduction in foodborne illness
(factor two).
Voluntary HACCP would be implemented most frequently in
establishments with good processing controls already, while
establishments with unsophisticated controls would be less likely to
participate. The explanation for this flaw is to be found in simple
economics and, to a large degree, the attitudes of establishment
management. Establishments with good processing controls now are most
likely to adopt HACCP voluntarily because their management understands
the linkage between how a product is handled during preparation and its
finished quality and safety.
Conversely, establishments without good processing controls today
are much less likely to participate in a voluntary HACCP program. These
establishments are more often operated by management that lacks the
knowledge or motivation to institute better processing controls.
Nevertheless, it is precisely this group of low performing
establishments that FSIS must reach to attain its public health goal.
Nothing short of a mandatory HACCP regulatory program will be effective
in bringing processing improvements to these marginal performers.
The Agency's regulation permitting the use of voluntary Total
Quality Control (TQC) Systems provides a useful analogy to how
effective a voluntary HACCP program would be. TQC focuses on
establishment responsibility for meeting or exceeding the standards set
by FSIS for all operations that are conducted in an establishment,
including incoming raw materials, processing procedures, critical
limits for product standards, and action limits for establishment
quality control personnel. These systems operate under Agency oversight
with an emphasis on timely and accurate recordkeeping and the necessity
for appropriate action to be taken by an establishment when a limit set
forth in an approved system is met or exceeded. However, over the last
10 years the number of establishments with active TQC Systems has
declined from a high of around 500 (approximately 8% of all
establishments) to the present 351 participating establishments
(approximately 5% of all establishments). USDA experience has shown
that a voluntary approach to HACCP would provide little assurance that
a major portion of meat and poultry products had been produced under
controls designed to minimize food safety hazards.0
Mandatory HACCP Regulation With Exemption for Small Businesses
Under this alternative, FSIS would mandate HACCP, but also provide
an exemption for some category of small businesses as was done with
nutrition labeling. While this final regulatory impact analysis does
develop very specific definitions for small and very small
establishments, the following discussion of comments uses the term
``small'' in a generic sense because many of the comments address small
establishments or small businesses without defining these terms. There
was a mix of public comments on whether or not HACCP should be
mandatory for small businesses.
[[Page 38954]]
Comments supporting an exemption from HACCP for small
establishments noted that many owner-operators of small establishments
oversee the entire operation on a daily basis and can pay closer
attention to procedures than can a large establishment. Similar
comments pointed out that small establishments pose a minimal potential
public health hazard because of the simplicity of their operations, the
slow pace of operations, and the small number of potentially affected
customers. Other comments pointed out that they sell their product to
family, friends and neighbors and that type of market provides the
greatest incentive for producing safe product.
Some commenters opposing an exemption did not want to create a two-
tiered system. Others opposing an exemption for small establishments
would require HACCP for everyone while easing the burden through
flexibility of implementation. Several of the commenters opposing any
type of exemption from HACCP identified themselves as owners of small
establishments. One commenter noted that just because small businesses
produce only 2 percent of the product does not mean they are
responsible for only 2 percent of the foodborne illness attributable to
meat and poultry.
The Agency used the evaluative factors presented above to consider
the application of the rule to small establishments. Since major goals
in implementing HACCP are to improve processing controls and
establishment performance across all of industry (factor one) as a
means to achieve foodborne illness reduction (factor two), the option
to exempt establishments that perform the least process control is
inherently flawed. USDA inspection experience shows that some of the
small establishments which would be exempted under this option have
particular difficulties maintaining control over their processing
system.
While it is true that small establishments produce a minimal amount
of the total meat and poultry supply, they do produce a full range of
products, including those most frequently associated with foodborne
illness from the meat and poultry supply.
This option also fails on factor three--provide more effective
inspection. Two different inspection systems would be needed: one risk-
based system to inspect HACCP establishments with good processing
controls; the other to provide resource intensive coverage for
establishments that largely do not. If the number of small
establishments were to increase, more inspection resources would be
required.
For these reasons, the final rule does not include an exemption for
small businesses. However, the Agency has made significant changes to
ease the burden on small business, including basing microbial sampling
programs on production volume and deferring implementation of mandatory
HACCP for small and very small businesses as defined in Section V.
Mandatory HACCP Regulation Only for Ready-to-Eat Products
This option wou
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
ld mandate HACCP only for establishments that
prepare ready-to-eat meat and poultry products, but not for
establishments that produce raw products. However, this decision would
leave the public without adequate protection from pathogenic
microorganisms clearly associated with product marketed in raw form.
Very little reduction in the most frequent causes of foodborne illness
(factor two) could be anticipated from this approach.
Government inspection costs would continue to increase to provide
traditional resource-intensive inspection for slaughtering and allied
processing establishments that would not be subject to mandatory HACCP.
Since most of the unsolved problems with pathogenic microorganisms are
associated with raw product and not with those products that would be
the subject of this HACCP option, this is an especially inappropriate
regulatory approach.
Modified HACCP--Recording Deviations and Responses Only
A final alternative considered would be to mandate HACCP, modified
to eliminate the record keeping burden to the inspected industry,
especially small establishments. Specifically, this option would modify
the HACCP record-keeping principles so that instead of demanding
continuous records at critical control points, companies would need to
record only deviations from critical limits and the response to them.
This would mean that HACCP-controlled operations would not generate
continuous monitoring data to reflect the operation at critical control
points, but would only record data when deviations occurred. This
arrangement eliminates the continuous picture of establishment
operations which is the underpinning of factor three--make inspection
more effective.
Such an approach would substantially reduce the paperwork burdens
associated with mandatory HACCP as recommended by NACMCF and recognized
by CODEX. However, it would also seriously compromise the usefulness of
HACCP as a means to make inspection more effective and avoid program
cost increases. Regulatory officials need to have a system which can be
reviewed in its entirety, so that a comprehensive picture of the
process is available, not just the truncated version which grows out of
recording deviations.
E. Comments on Analysis of Regulatory Alternatives
There were several general comments related to either the
alternatives discussed in the proposed rule or the level of analysis
conducted. There were comments noting that FSIS did not quantify the
costs and benefits of the regulatory alternatives. Similar comments
suggested that FSIS should have determined cost-benefit ratios for the
processed food industry or for ready-to-eat products or for small
businesses.
Generating quantitative benefit estimates for different types of
products or different industry sectors would be very difficult. The
estimates for foodborne illness attributable to meat and poultry have
not been broken down by industry sector or type of product. There are
no existing estimates for the portion of foodborne illness attributable
to meat versus poultry or raw product versus cooked or partially cooked
product.
Production volume can not be used as an indicator of potential
benefits. Foodborne illness is not proportionally related to production
volume because pathogen levels vary significantly by type of product.
As noted above, a commenter also pointed out that just because small
businesses account for only 2 percent of production does not mean that
small businesses account for only 2 percent of foodborne illness.
On the cost side, the estimates are, for the most part, based on
industry averages. In reality, costs will vary by industry sector based
on the hazards presented and the existing presence of process control.
Thus, in response to a comment that suggests that few benefits are
available from changing the process for the manufacture of processed
foods which are now produced under a zero pathogen standard, the
Department would suggest that the costs for implementing HACCP for
these products will also be low. Many ready-to-eat products such as
cooked patties and roast beef are presently produced under
comprehensive process control regulations.
One comment suggested that FSIS consider mandatory HACCP for only
firms that produce raw meat and poultry products because that sector of
the industry generates most of the problems
[[Page 38955]]
and would provide the greatest pathogen reduction benefits per dollar
of cost expended. The same commenter found it odd that the Agency did
include an alternative for mandatory HACCP for only ready-to-eat
products after acknowledging that most of the unsolved problems with
pathogenic microorganisms are associated with raw meat and poultry
products, rather than ready-to-eat products. In the above discussion of
regulatory alternatives, it was noted that mandatory HACCP for only
ready-to-eat products is an especially inappropriate regulatory
approach. In contrast, a raw product option appears attractive since
most of the unsolved problems with pathogenic microorganisms are
associated with raw product. Most establishments handle raw product
ingredients or prepare a finished raw product. Most of the cost of this
rule is associated with controlling the safety hazards of raw product
production. Extending the rule to cover all production adds little cost
while allowing a single inspection approach, avoiding confusion where
raw product production ends and ready-to-eat production begins, and
assuring that the potential hazard of recontaminating ready-to-eat
product by contact with raw ingredients is always covered by
comprehensive HACCP programs.
Other comments noted that FSIS did not analyze an option that
accounted for the savings associated with streamlining and modernizing
the inspection system or that FSIS should revise the cost-benefit
analysis to consider the savings from eliminating the current
inspection program. The savings referred to will be used to focus on
food safety risks that need more coverage.
III. Summary of Impacts
A. Introduction
This section provides a summary of the costs and benefits that will
be discussed in detail in Sections IV and V. The benefits analysis in
Section IV and this summary discuss benefits in terms of the reduction
in the cost of foodborne illness that results from reductions in
pathogen levels. There are other public health benefits beyond the
reduction of foodborne illness due to pathogenic bacteria. HACCP
systems will also provide increased public protection from risks posed
by chemical and physical hazards. There are also benefits beyond public
health benefits. As discussed in Section I, the SOP and HACCP
requirements have social benefits that derive from the capacity to
reallocate inspection resources to other activities where the payoff in
terms of reducing the risk of foodborne illness may be greater.
The February 1995 proposal and the subsequent public comment
recognized that the HACCP/Pathogen Reduction regulations would also
generate benefits for meat and poultry processors. For example, a
commenter at a public hearing provided confirmation that the insurance
industry is aware of HACCP and has offered reduced liability insurance
for firms with improved food safety controls. Other comments noted that
improved production efficiency has always been associated with improved
process control. Increased customer confidence can also be a benefit to
the extent that it has a positive influence on demand.
The benefits analysis in the preliminary RIA noted that benefits
also accrue through the reduction of operating costs like the cost of
product recalls or the cost of settling product liability claims. Other
operating costs include the loss of establishment production due to
suspensions for sanitation problems that could be reduced by improved
process control, premiums for product liability insurance, loss of
product reputation, and reduced demand when a foodborne illness
outbreak is publicized identifying a product or company.
The cost analysis in Section V addresses two types of costs
associated with this rule. There are the predictable costs associated
with requirements directing all establishments or a specific category
of establishments to take a well-defined action. Examples include the
requirements to develop SOP's and HACCP plans or the requirement to
have access to a HACCP-trained individual. This final RIA provides
point estimates for all predictable costs. There are also potential
costs that may impact some establishments because of current
establishment-specific situations. This analysis provides a range of
potential costs developed from two different scenarios of possible
establishment responses to new pathogen standards.
This summary compares both types of costs with the potential public
health benefits related to pathogen reduction, recognizing that there
are other potential benefits. The discussion in Section V notes how
this rule will set new requirements and also improve compliance with
existing requirements. Some of the potential costs discussed in Section
V are costs associated with improved compliance with existing standards
and should not necessarily be considered costs of this rulemaking.
Public comments demonstrate that the controversy in this rulemaking
derives not from the benefit cost ratio itself, which is very
favorable, but from the fact that the processors will bear most of the
costs while the public, in general, will experience the benefits. The
public includes both the consumers of meat and poultry and those who do
not consume meat or poultry but who bear the costs of illness in the
society. Another area of controversy arises from the lack of proof that
the estimated benefits will result from the promulgation of the rule.
These doubts are particularly troublesome to those who would have to
make resource investments under the rule while benefits largely accrue
to others. This is, of course, the standard controversy facing
government regulators. The essence of government regulation is that
there is a situation where the public undergoes unacceptable risk
because the current distribution of costs and benefits is unlikely to
change without government intervention. This rule represents the
Department's belief that the food safety risks being borne by the
public are unacceptable, that they can be reduced through the use of
readily available current technologies, and that the uncertainties
involved in just how much risks can be reduced should not prevent the
Department from making its best effort to reduce the risks.
B. Net Benefit Analysis
Because costs and benefits accrue at different rates over different
time periods, to compare costs and benefits it is necessary to examine
present value estimates for both cost and benefit streams. To make
these comparisons, both the preliminary analysis and this final RIA use
a 20-year time period. The present values for costs and benefits are
based on a discount rate of 7 percent, the current standard recommended
by the Office of Management and Budget.
As discussed above, the cost analysis (Section V) addresses two
types of costs. FSIS was able to develop point estimates for the direct
costs of complying with the requirements outlined in the rule that all
establishments must meet. These predictable costs include the costs of
developing and operating HACCP plans and SOP's and the costs of
required recordkeeping. There are also potential costs for
establishments that may have to purchase new equipment, or modify their
production practices to meet the pathogen reduction performance
standards for Salmonella, or actually implement Salmonella testing
programs to assure compliance with the new standards. The cost analysis
develops a range of cost estimates for these potential costs.
[[Page 38956]]
The estimated annual industry costs (not discounted) are summarized
in Table 2. These annual costs vary over the first four years as the
new HACCP-based program is undergoing its implementation phase. After
the initial four years, the recurring costs are estimated at a constant
$99.6 to $119.8 million per year. The present value of all industry
costs summarized in Table 2 for the 20-year time period is $968 to
$1,156 million as shown earlier in Table 1. This total of $968 to
$1,156 million ($0.97 to $1.16 billion) is the total industry cost for
the rule as shown in Table 3.
TABLE 2.--Summary of Annual Industry Costs--All Requirements
[$ Thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost Category Year 1 Year 2 Year 3 Year 4 Year 5+
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's:
Plans and Training................................... 2,992
Observation and Recording............................ 8,345 16,691 16,691 16,691 16,691
II. E. coli Sampling:
Plans and Training................................... 2,627
Collection and Analysis.............................. 8,716 16,122 16,122 16,122 16,122
Record Review........................................ 406 752 752 752 752
III. Compliance with Salmonella Standards................ ................. 5,472-16,899 5,353-25,753 5,811-25,956 5,811-26,079
Compliance with Generic E. coli Criteria............. ................. (\1\) (\1\) (\1\) (\1\)
IV. HACCP:
Plan Development..................................... ................. 3,769 27,755 35,464 .................
Annual Plan Reassessment............................. ................. ................. 69 448 1,179
Initial Training..................................... ................. 1,270 8,284 18,435 .................
Recurring Training................................... ................. 64 542 1,877 2,799
Recordkeeping (Recording, Reviewing and Storing Data) ................. 3,050 18,479 42,478 54,097
V. Additional Overtime................................... ................. 189 837 1,711 2,125
----------------------------------------------------------------------------------------------
Total.............................................. 23,086 47,379-58,806 94,884-115,284 139,789-159,934 99,576-119,844
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Not Separately Estimated.
Table 3.-- Present Value of 20-Year Costs and Benefits
[$ Billions]
------------------------------------------------------------------------
Public health
Effectiveness in reducing pathogens in the benefits Industry
manufacturing sector (percent) ---------------- costs
Low High
------------------------------------------------------------------------
10.......................................... 0.71 2.66 0.97-1.16
20.......................................... 1.43 5.32 0.97-1.16
30.......................................... 2.14 7.98 0.97-1.16
40.......................................... 2.85 10.64 0.97-1.16
50.......................................... 3.57 13.30 0.97-1.16
60.......................................... 4.28 15.96 0.97-1.16
70.......................................... 4.99 18.61 0.97-1.16
80.......................................... 5.71 21.27 0.97-1.16
90.......................................... 6.42 23.93 0.97-1.16
100......................................... 7.13 26.59 0.97-1.16
------------------------------------------------------------------------
Note: Analysis assumes zero benefits until year 5. All elements
of the HACCP-based program will be in place 42 months after
publication of the final rule.
The public health benefits of this rule are discussed in detail in
Section IV. The benefits are based on reducing the risk of foodborne
illness due to Campylobacter jejuni/coli, Escherichia coli 0157:H7,
Listeria monocytogenes and Salmonella. Section IV concludes that these
four pathogens are the cause of 1.4 to 4.2 million cases of foodborne
illness per year. FSIS has estimated that 90 percent of these cases are
caused by contamination occurring at the manufacturing stage that can
be addressed by improved process control. This addressable foodborne
illness costs society from $0.99 to $3.69 billion, annually. The high
and low range occurs because of the current uncertainty in the
estimates of the number of cases of foodborne illness and death
attributable to the four pathogens. Being without the knowledge to
predict the effectiveness of the requirements in the rule to reduce
foodborne illness, the Department has calculated projected health
benefits for a range of effectiveness levels, where effectiveness
refers to the percentage of pathogens eliminated at the manufacturing
stage. The link between effectiveness and health benefits is the
proportionate reduction assumption which is explained in Section IV.
Because of the wide range in estimates for the cost of foodborne
illness, each effectiveness level will have a low and high estimate for
public health benefits. These estimates of public health benefits are
shown in Table 2, as the present value of a 20-year benefit stream.
The analysis assumes that benefits will begin to accrue in year
five. The five year lag leads to conservative benefit estimates since
the new HACCP-based inspection program will be fully implemented in 42
months, and benefits should accrue during those 42 months as well as in
the 1\1/2\ years that follow. Limiting the benefit estimates to four
pathogens also leads to conservative cost estimates. To the extent that
the proportionate reduction estimate may overestimate benefits, these
other factors provide conservative balance.
Net benefits exist for every cost and benefit combination
illustrated in Table 2 except for the case of 10 percent effectiveness
using the low benefit estimate. If the low benefit estimate is correct,
the new HACCP-based regulatory program would have to reduce pathogens
by 14 to 17 percent to cover the projected 20-year industry costs of
$968 to $1,156 million. For the high benefit estimate net benefits
begin to occur at an effectiveness level of 4 to 5 percent.
The costs summarized in Tables 1 and 2 have not been reduced to
account for firms that already have existing HACCP programs. FSIS does
not have a good estimate of the number of such firms.
C. Impact on ``Smaller'' Businesses
The final rule provides regulatory flexibility for smaller firms
consistent with the Regulatory Flexibility Act. For the slaughter
facilities, the generic E. coli sampling requirements vary depending on
the number of birds or animals slaughtered annually. This will
significantly reduce the microbial
[[Page 38957]]
testing costs for smaller establishments which, under the proposed
rule, would have been required to test every species or kind they
slaughter every day on which slaughter of that species or kind occurs.
Under the final rule, the impact on smaller establishments is mitigated
by the change to base generic E. coli sampling requirements on annual
production and by a change to no longer require that every species or
kind be sampled. The costs to small establishments are also reduced
because the proposed carcass cooling and antimicrobial near term
requirements have been eliminated from the final rule and training
requirements are more flexible. The requirement to sample each variety
of raw ground product, which caused a heavier burden on small
establishments, has also been eliminated.
The regulatory burden on small establishments is eased by the
provisions which extend the time small establishments have to meet the
HACCP system requirements. The detailed cost analysis in Section V
outlines the methodology used in developing cost estimates and varying
regulatory requirements for the purpose of regulatory flexibility for
small establishments.
D. Effect on Retail Price
The preliminary analysis included an estimate that the total four-
year implementation costs represented only $0.0024 per pound of fresh
meat and poultry. This type of estimate helps put overall cost figures
into perspective in terms of the potential increase in food prices. A
large number of smaller processors responded very emotionally to the
low figure of $0.0024 per pound on the basis that the lack of economies
of scale in their businesses means their potential unit cost increases
would be far higher. This ``cost-per-pound'' analysis was not meant to
imply that the cost impact on all business would be the same. In a
competitive industry, the impact on overall retail price is, however,
an important indicator of net societal benefits. The four-year
implementation costs for the final rule represent $0.0011 to $0.0013
per pound based on 1993 production of 67.15 billion pounds (66.4
billion pounds federally inspected and 748 million state inspected) of
meat and poultry on a carcass weight basis. The annual recurring cost
of $99.6 to $119.8 million represents $0.0015 to $0.0018 per pound
based on 1993 production.
E. Impact on International Trade
The final rule will have an impact on countries and the
establishments in those countries that export meat and poultry products
to the United States. The inspection statutes require that imported
product be produced under an inspection system that is equivalent to
the U.S. inspection system. The equivalence of a country's system must
be established by the United States before product can be exported to
the United States. The notion of equivalence has been clarified under
the World Trade Organization (WTO) Agreement on Sanitary and
Phytosanitary measures. Under the WTO, all members have an obligation
to apply the principle of equivalence on importing countries.
Equivalence determinations are based on scientific evidence and risk
assessment methodologies.
In light of the WTO emphasis on the use of science to determine
equivalence, a number of countries are moving toward implementation of
HACCP systems. The preliminary analysis noted that a large portion of
the eligible exporting establishments are in countries that are
themselves in the process of implementing HACCP and complying with
their own country's HACCP requirements may achieve equivalence with the
requirements of this rule.
As of January 1, 1995 there were 1,395 establishments in 36
different countries certified to export meat or poultry products to the
United States. Canada (599 establishments), Denmark (125
establishments), Australia (111 establishments) and New Zealand (94
establishments) accounted for two-thirds of the 1,395 establishments.
These four countries were the source of 85 percent of the 2.6 billion
pounds of product imported during 1994. These four countries are
currently developing HACCP systems for their respective inspection
programs.
Half (18) of the 36 countries have fewer than 10 establishments
approved to export products to the U.S. These 18 countries represent a
total of 77 establishments, 5 percent of the total. Meeting the
equivalency requirements may present a problem for some of these
countries in the near term. Their inspection programs will have to meet
equivalency requirements for HACCP according to the implementation
schedule for domestic establishments, i.e., 18 months for large
establishments, 30 months for small establishments and 42 months for
very small establishments. This schedule should lessen the burden on
smaller establishments.
There are other factors that will affect the burden on foreign
establishments. As HACCP becomes the international norm, these
establishments will be required to implement changes to meet the
requirements of other countries implementing HACCP. Thus, their costs
may not be solely associated with U.S. requirements. Establishing
impact is further complicated because the U.S. requirements apply only
when they are preparing product that is to be exported to the U.S. This
product may represent only a small portion of total establishment
production.
Upon implementation of these regulations, FSIS will review other
countries' meat and poultry systems to ensure that exporting countries
have adopted comparable measures, which would entitle them to continue
exporting product to the United States. As other countries improve
their regulations by adopting provisions comparable to those contained
in this rule, it is expected that U.S. exports will similarly be
affected, i.e., the receiving countries will be closely reviewing
domestic exporting establishments to assure that they are meeting the
requirements of the importing country.
FSIS will continue to carry out its import inspection
responsibilities with a two-stage approach. The first stage is system
review, which consists of an evaluation of the laws, policies, and
administration of the inspection system in each eligible country. This
overall evaluation will include an assessment of the implementation of
HACCP supplemented by on-site reviews of individual establishments,
laboratories, and other facilities within the foreign system. The
``equivalency'' of foreign requirements will be determined at this
stage.
The second level of review involves port-of-entry inspection by
FSIS inspectors to verify the effectiveness of foreign inspection
systems. Using statistical sampling plans based on the foreign
establishment's history and the nature of the product, FSIS will
continue to give greater scrutiny to shipments posing the highest risk.
Products that do not meet U.S. requirements, which includes having been
produced under a HACCP or HACCP-equivalent system, will be refused
entry. FSIS has concluded that requiring HACCP systems in combination
with the two-stage inspection approach will better ensure the safety of
imported meat and poultry products.
All countries exporting raw products to the U.S. must develop and
implement performance standards that are equivalent to the pathogen
reduction performance standards for Salmonella. They must also be able
to demonstrate that they have systems in place to assure
[[Page 38958]]
compliance with the standards. As with any other type of standard, FSIS
could choose to test imported product for Salmonella at port-of-entry
to verify the effectiveness of the foreign inspection system.
With respect to the specific requirements for sampling generic E.
coli to validate control of slaughter and sanitary dressing procedures,
it will be necessary for all foreign countries to demonstrate that they
have an equivalent procedure to verify that they are controlling their
slaughter and sanitary dressing processes.
There were several comments related to trade issues. Most of the
comments concerning the impact on exports dealt with the proposed
requirement for antimicrobial treatment of U.S. product. That proposed
requirement raised particular concerns because the European Union
member states and Canada restrict the use of certain antimicrobials on
meat and poultry carcasses. The concerns raised in the comments are no
longer an issue because the final rule does not require the use of
antimicrobials. The final rule will affect exports only if a company
has difficulty meeting the microbial performance criteria without using
an antimicrobial. One option discussed in the proposed rule was that
hot water would be considered to be an acceptable antimicrobial
treatment, and that would be acceptable to Canada and the members of
the European Union. The public comments also indicated that Trisodium
Phosphate (TSP) is approved for use in Canada and the United Kingdom
and is being considered by the European Union, Australia, and New
Zealand.
Comments related to imports were concerned about the procedures
FSIS would use to determine equivalence with the new U.S. requirements.
As a condition of the NAFTA Treaty and the GATT Treaty, the United
States has agreed to allow imports from countries that have systems of
inspection equivalent to that of the United States. FSIS is considering
alternative methods for determining that a foreign country's system of
inspection can assure that the establishments within that system are
using a process control system equivalent to the HACCP-based inspection
system outlined in the final rule.
F. Impact on Agency Costs
Implementation of this rule will lead to both one-time nonrecurring
costs and recurring costs for FSIS. There are three categories of one-
time nonrecurring costs: (1) Training, (2) in-establishment
demonstration projects, and (3) laboratory renovation. In order to
implement the rule, FSIS will provide training to in-establishment
personnel in two segments. The first training segment will cover issues
related to sanitation standard operating procedures and generic E. coli
sampling and testing requirements. The estimated costs for this
activity is $3.6 million in the first year of implementation. The
second training segment will cover issues related to the implementation
of HACCP and is estimated the cost $3.6 million spread over the second
and third year of implementation. FSIS will utilize the train-the-
trainer approach to minimize the costs of these initiatives. FSIS is
also committed to working with States and industry to sponsor HACCP
demonstration projects for small businesses. Pursuant to implementation
of the HACCP rule, microbiological sampling and testing will increase
dramatically. In the period from 1990 to 1995, FSIS averaged
approximately 33,000 analyses for microbiology per year. This is
estimated to increase to 125,000 analyses per year after HACCP
implementation. In order to accommodate this increase, FSIS will
renovate its field laboratory facilities to expand their capacity,
improve ability to test for a broader range of pathogens, and purchase
new equipment. FSIS estimates that the planned renovation will cost
$1.5 million.
By implementing this rule, FSIS will incur recurring costs
associated with increased microbiological testing and upgraded
inspector salaries. FSIS estimates that microtesting costs will
increase approximately $3.0 million annually. Of this amount $2.0
million is needed for equipment, supplies, and shipping costs to
conduct Salmonella testing, $0.5 million for microtesting conducted to
verify HACCP systems, and $0.5 million for personnel necessary to
handle the increased workload. Under HACCP-based inspection, FSIS
personnel will be required to assume greater responsbility for more
complex food inspection tasks. Slaughter inspectors will be required to
perform health and safety tasks, such as taking microbiological
samples, and verifying HACCP systems. Processing inspectors' roles will
take them out of the establishment and put them into retail and market
place settings to take microbiological samples, and to ensure meat and
poultry products are handled in a manner to that minimizes the growth
of pathogenic organisms. FSIS estimates that compensating inspectors
for assuming more complex food safety tasks will cost $1.6 million per
year.
G. Impact on State Programs
Comments stated that FSIS failed to adequately consider the cost of
the changes to State programs and that FSIS was increasing the resource
demands for State programs without providing adequate funding. The
preliminary analysis did not address the impact on State programs.
However, FSIS recognizes that the 26 States operating their own meat
and poultry inspection programs will likely have to substantially
modify their programs after the HACCP/Pathogen Reduction regulation is
finalized to remain ``at least equal to'' Federal inspection programs
as required by the FMIA and PPIA. During the regulation's
implementation period, FSIS will be using the Agency's State-Federal
Program staff to assist the States in bringing the necessary changes to
the State inspection programs. Although FSIS has requested some
additional funds to implement this rule, FSIS has also acknowledged
that implementation of this rule will require eliminating some tasks,
conducting other tasks differently and streamlining the organization in
order to free up resources to fully address the new requirements. FSIS
believes that the same type of restructuring or reprogramming will take
place within the State programs. This does guarantee, however, that all
States with inspection programs will be able to implement the necessary
program changes without additional funds. FSIS believes, however, that
with FSIS assistance and with the flexibility provided under the
``equal to'' provisions, most of the States should be able to modify
their programs with minimal additional funding. To the extent that
there are any additional costs, the State inspection programs are
eligible to receive up to 50 percent Federal matching funds.
H. Consumer Welfare Analysis
It is likely that at least some of the costs of the new HACCP-based
regulatory program will be passed on to consumers in the form of higher
prices. Even if costs are fully reflected in retail prices, the impact
on consumers and consumption will be small. Retail costs are not
expected to increase more than 0.02 percent. Retail demand for meat and
poultry is inelastic. A likely range is -0.25 to -0.75. This suggests
changes in quantity demanded of less than 0.02 percent. Given that
annual per capita meat and poultry consumption is about 211 pounds,
retail weight, the impact on individual consumption will be less than
\1/10\th of a pound per year. In aggregate, with a high impact
[[Page 38959]]
scenario, consumption would decrease by about 50 million pounds. These
impacts may be overstated if meat and poultry producers pass some costs
back to livestock and poultry producers. Improved consumer confidence
in the safety of meat and poultry could offset price driven decreases
in consumption.
IV. Analysis of Public Health Benefits
A. Introduction
This section addresses the methodology used to develop the
estimates for public health benefits that, for the purpose of this
final Regulatory Impact Assessment, have been defined as the reduction
in the cost of foodborne illness attributable to pathogens that
contaminate meat and poultry products at the manufacturing stage. This
section is organized around the Agency's responses to the public
comments related to benefits. The first part of this section addresses
the general comments related to risk assessment. The Agency has
responded to these general requirements by providing an overall summary
of the current state-of-the-art with respect to risk assessment for
foodborne pathogens. The second part of the discussion (see subsection
titled ``Analysis of Comments on Public Health Benefits'') addresses
the more specific comments on the methodology used to estimate benefits
in the preliminary analysis.
Several comments suggested that FSIS has not conducted an adequate
risk assessment and/or should conduct a thorough risk assessment before
proceeding with the current rulemaking. More focused comments assert
that the relationship between pathogen reduction at the manufacturing
stage and foodborne illness reduction is unknown. Those comments
suggest that establishing that relationship requires a quantitative
risk assessment, i.e., an estimate of the probability of adverse health
effects (foodborne illness) given a particular level of a hazard
(pathogens at manufacturing stage).
The preliminary analysis and this final RIA recognize that the
relationship is unknown and acknowledge that there are significant data
gaps regarding both likelihood and magnitude of illness and numbers of
foodborne pathogens. These data gaps mean that multiple assumptions
must be made in order to calculate the probabilities of risk, and FSIS
is concerned with this tremendous uncertainty. However, the agency is
developing quantitative assessments and believes that these will become
the basis on which to make future regulatory decisions. In this
rulemaking, FSIS estimates of the risk of foodborne disease linked to
specific pathogens are based upon the best judgement of nationally
recognized experts in infectious disease, epidemiology, microbiology,
and veterinary medicine. FSIS is also relying on a qualitative
estimation of risk as expressed in publications and summary reports
from the CDC, other public health agencies, and special panels, such as
the National Advisory Committee on Microbiological Criteria in Foods
and those established by the NAS. Based on this sizable body of
information and scientific judgement, FSIS is proceeding to develop
benefit estimates using the assumption that a reduction in pathogens
leads to a proportionate reduction in illness and death. The benefits
analysis could have used a more conservative relationship estimate,
e.g., a reduction in pathogens leads to a reduction in illness that is
less than proportional. However, given the current level of knowledge,
FSIS views the proportional assumption as most appropriate at present.
The Department has initiatives in place that will begin to relate
pathogen levels at inspected establishments to incidence of human
illness and support quantitative risk assessment (see Section IV-D on
FSIS Data Initiatives). The present paucity of data to support a risk
model for the major foodborne pathogens causing human disease limits
the usefulness of quantitative risk assessment in the regulatory arena
of meat and poultry inspection. It is unlikely that any single
numerical constant will adequately describe the dose-response
relationships for all pathogens associated with all of the products
that FSIS regulates, given the complexity of possible interactions of
factors associated with the host, the pathogenic strain, the diet, and
the environment (CAST, 1994).
The Federal Crop Insurance Reform and Department of Agriculture
Reorganization Act of 1994 (P.L. 103-354) now requires that for each
proposed major regulation (i.e. economic effects of at least $100
million a year and effects on human health, safety, or the environment)
the Department publish an analysis of the risks addressed by the
regulation. While this statute does not apply to this final rule, FSIS
is providing a qualitative estimation of risk (Tables 4 and 5) and a
recommendation to manage risk using HACCP in meat and poultry
inspection programs. Concurrently, scientists from FSIS and USDA's
Agricultural Research Service (ARS), Economic Research Service (ERS),
and modelers from academia and industry continue to develop risk models
which blend failure analysis, predictive microbiology, and other models
into the framework described by the NAS (NRC, 1983). FSIS believes this
approach is flexible and responsive to new data necessary to fully
document risks of foodborne diseases.
B. FSIS Risk Assessment
Following the publication of the 1985 National Academy of Sciences
(NAS) study on the scientific basis for meat and poultry inspection,
FSIS requested that the National Research Council of NAS conduct a
follow-up study that included the objective of developing a risk
assessment model for the poultry production system. The subsequent
report, ``Poultry Inspection: The Basis for a Risk-Assessment
Approach'' was published by the National Academy Press in 1987. The
1987 study concluded that the present system of inspection provides
little opportunity to detect or control the most significant health
risks presented by microbial agents that are pathogenic to humans. The
study also concluded that current databases can serve as the basis for
a comprehensive, quantitative risk assessment only for certain well-
characterized chemical residues.
The committee conducting the study also concluded that their report
did constitute a qualitative risk assessment that could be useful for
many purposes, including the evaluation of inspection strategies. That
assessment found: ``There is evidence linking disease in humans to the
presence of pathogens on chickens. For example, epidemiological studies
indicate that approximately 48% of Campylobacter infections are
attributable to chicken. Data also suggest that chicken is probably an
important source of salmonellosis in the United States.'' Based on
these and other findings, the committee recommended that FSIS ``modify
the existing system so that it more directly addresses public health
concerns.'' FSIS believes that the implementation of HACCP programs at
slaughter for meat and poultry is such a ``modification'' of the food
safety system which will address human health hazards, particularly
foodborne diseases.
C. Risk Assessment Framework
The National Research Council (1983) presented a framework for risk
assessment that has become a standard paradigm to organize risk
assessments for chemical and microbial hazards. The framework,
consisting of hazard identification, dose-response assessment, exposure
assessment, and risk characterization, is flexible and can accommodate
many different modeling strategies. The major distinction
[[Page 38960]]
between foodborne microbial risk assessments and chemical risk
assessments may be the additional uncertainties of microbial growth and
survival in food prior to consumption. Survival of pathogens present in
a raw food and after cooking can be modeled using predictive
microbiology methods. These models can also address the growth of
pathogens with time and temperature abuse of raw and cooked foods.
One of the first U.S. publications on the application of predictive
microbiology to microbial risk assessment (Buchanan & Whiting, 1996)
included estimations of risk of salmonellosis for several ``what-if
scenarios'' as examples of potential time and temperature abuses of
partially cooked food. The predictive microbiology model was linked to
a published dose-response model for salmonellosis (Haas, 1983) to
calculate a risk estimate. The dose-response model was developed by
empirically fitting data from human feeding studies conducted at high-
dose challenges with a number of pathogenic strains of Salmonella to
the ``beta poisson'' model (Haas, 1983). The authors generated risk
estimates for selected cooking and abuse scenarios, but recognized that
the risk of illness is zero when the pathogen is not present in the
sample even with unsafe food handling. HACCP programs at slaughter are
expected to affect pathogen presence and levels before potential time
and temperature abuses can occur. Therefore, changes at slaughter, in
the duration of cooking, and final storage conditions of the food exert
a tremendous impact upon the model outcomes.
An unpublished draft risk model is in development as a research
endeavor by Agriculture and Agri-Food Canada and Health Canada. A
variety of modeling approaches were organized within the 1983 NRC
framework to estimate risk of human illness from E. coli 0157:H7 in
ground beef. The draft risk model includes many stochastic variables to
account for the variability and uncertainty associated with the inputs
and assumptions of the model. The authors are developing the model to
identify current limitations to the construction of quantitative models
which accurately describe the risk of foodborne disease along the farm
to fork continuum.
These recent quantitative risk assessment efforts are an
encouraging beginning and serve to illustrate the tremendous
uncertainties created by insufficient data describing processes
throughout the farm to table continuum that contribute to risk.
Additional uncertainties surround assumptions based on epidemiologic
data for human illness. For example, recent data in the U.S. indicates
a growing number of outbreaks of E. coli 0157:H7 disease linked to
sources other than ground beef. The ecology of the organism on the
farm, in the bovine gastrointestinal tract, and in irrigation,
recreational, and drinking waters is largely unknown. Additionally, the
primary sources of E. coli 0157:H7 causing sporadic disease may remain
undercooked hamburger and may differ from vehicles causing outbreaks,
as has been documented for Campylobacter (CDC, 1988). Outbreaks of
campylobacteriosis have been caused primarily by unpasteurized milk and
contaminated water, yet the overwhelming majority of infections are
sporadic and have been linked to undercooked chicken. Control
strategies to reduce both outbreak and sporadic case numbers for both
of these pathogens may require greater understanding of vehicles of
disease and more information than is currently available.
FSIS concludes that risk models for foodborne illnesses are
necessarily based largely on assumptions because scientific data
describing key foodborne disease processes have not been developed. The
models are extremely useful to identify basic research needs that might
reduce the uncertainty associated with the inputs and assumptions of
the models. The agency is proposing initiatives to generate data which
may reduce uncertainties associated with modeling the risk of foodborne
diseases. However, application of microbial risk assessment models to
regulatory decision-making appears premature at this time. The
following is a summary of the availability and limitations of data
supporting risk assessment for foodborne pathogens:
1. Hazard Identification
The Agency selected from the pathogens listed in Tables 4 and 5 the
three most common enteric pathogens of animal origin: Campylobacter
jejuni/coli, E. coli 0157:H7, Salmonella and one environmental pathogen
Listeria monocytogenes for consideration in risk assessment. FSIS
believes that these four pathogens may contaminate meat and poultry
food vehicles at slaughter and can be reduced through improved process
control in the manufacturing sector. Available data on estimated human
disease incidence are summarized in Table 4. Data on human disease
attributable to proven as well as epidemiologically linked pathogens
and food vehicles are presented in Table 5. Additional and more precise
information for this section regarding estimated national disease
incidence and disease severity and duration is expected on these
pathogens from the sentinel site surveillance initiative.
2. Exposure Assessment
Rarely can actual exposure to a specific strain of foodborne
pathogen be quantified with certainty in foodborne disease outbreaks.
Microbes in food are known to be non-homogeneously distributed,
imposing additional uncertainty due to sampling error upon the
analytical variability of the methods for detection and quantification
of microbes in foods. The outbreak strain may or may not be detected in
the feces of diarrheal cases or in leftovers or companion samples from
suspected lots. The levels detected in leftovers or companion samples
from the same lot of food may or may not be representative of the
serving that was prepared and consumed since the microbial numbers vary
with time and temperature conditions and the initial microbial
populations. The amount of the serving consumed may not be known.
The FSIS baseline studies provide data on occurrence of pathogens
(likelihood) and levels (magnitude) in uncooked meat and poultry
products at slaughter and raw ground processing. Data for likelihood
and magnitude of pathogens in the distribution, preparation, and
consumption phases of the farm-to-fork continuum of food production are
sparse. Predictive microbiology models may be the most cost-effective
method to deduce possible exposure scenarios in meat and poultry beyond
the slaughter phase that may result in foodborne illness. The
likelihood that the selected scenarios of improper cooking and abuse
actually occur among U.S. consumers may not be measurable, but the
scenarios may be useful in modification of behaviors that pose
increased risk to consumers.
3. Dose-Response Assessment
The relationship between the dose of a pathogen and response in the
host, when known, can vary greatly for foodborne pathogens. Human
feeding studies with foodborne pathogens were largely conducted several
decades ago with small numbers of healthy adult males. One study
reported both ill and asymptomatic volunteers who had consumed up to
1,000,000,000 pathogenic Salmonella. Outbreak data for other Salmonella
serotypes in food vehicles suggest a range of infective doses from one
cell to 1,000,000,000,000 cells (Blaser & Newman, 1982). Fatty food
vehicles, including some meat and
[[Page 38961]]
poultry products, are thought to protect enteropathogens from stomach
acids and digestive enzymes that might otherwise reduce the dose to the
intestinal tract and reduce the likelihood of disease. The effects of
competition of the pathogen with the large indigenous microbial
populations in food (ICMSF, 1980) and in the human gastrointestinal
tract (Rolfe, 1991) may reduce the likelihood and/or the severity of
foodborne disease.
Even carefully controlled volunteer feeding experiments at doses up
to one billion organisms per volunteer have shown variability in the
infectious dose of one pathogen for individuals within a group of
seemingly healthy, young adults. Extrapolation of empirical models of
effects at high doses to low doses typical of properly handled food may
or may not be appropriate. The dose-response curve for healthy adult
males may not be useful in estimating dose-response relationships for
the general population or sensitive sub-populations. The data available
from human feeding studies were generated from very few species and
strains of bacterial pathogens, excluding E. coli 0157:H7. Dose-
response modeling is crucial to microbial and chemical risk
assessments. FSIS believes that application of dose-response models in
food safety regulation requires careful examination of the validity of
the assumptions and inputs of the model and of the plausibility of the
model as a descriptor of foodborne disease processes.
4. Risk Characterization
The integration of exposure and dose-response models is expected in
risk characterization, along with sensitivity and uncertainty analyses
(Burmaster & Anderson, 1995) for the risk model. Perhaps of greater
significance than the numerical estimate of risk is the uncertainty
associated with the estimate. A fully developed risk characterization
would include risk estimates and sensitivity/uncertainty analyses for
alternative models and assumptions. FSIS is collaborating with
scientists in academia, the Agricultural Research Service, the Animal &
Plant Health Inspection Service, the Economic Research Service, and the
Office of Risk Assessment and Cost Benefit Analysis to develop and
validate a risk assessment model for a single pathogen in a single meat
product. This model may be modified for other specific pathogens of
concern. The expectation of a generic model for all foodborne disease
agents in all products does not appear promising based on differences
in pathogenesis of bacterial species and strains and in human
sensitivity and pathology.
FSIS continues to evaluate new information on foodborne pathogens
and on risk assessment methods and tools in accordance with the FSIS
public health mission. The NAS Report, the CAST Report and the 1995
Conference recognize HACCP as a system to reduce the likelihood of
foodborne illness. The CAST Task Force also concluded that ``the
efficacy of a HACCP system depends on the rigor and consistency with
which it is designed and implemented and the use of (a) critical
control point(s) that will control pathogens.''
D. FSIS Data Initiatives
The 1994 report, ``Foodborne Pathogens: Risks and Consequences,
CAST Task Force Report No. 122, September 1994'' concluded that ``a
comprehensive system of assessing the risks of human illness from
microbial pathogens in the food supply has yet to be devised.'' They
cited the limitations of the current food safety information database
and the difficulty in accumulating dose response and minimum infective
dose data. A recent multidisciplinary conference, ``Tracking Foodborne
Pathogens from Farm-to-Table, Data Needs to Evaluate Control Options'',
carefully reviewed current databases and confirmed limitations outlined
in the CAST Task Force report.
FSIS has established initiatives to improve the quality and
quantity of data in two major areas. First, FSIS is working with the
Food and Drug Administration (FDA) and the Centers for Disease Control
and Prevention (CDC) to establish an active sentinel site surveillance
system for the major causes of foodborne illness. This project is
designed to accumulate data on the incidence of foodborne illness by
pathogen and by food.
Second, the Agency has been developing baseline data for pathogen
levels on major food animal species at the time of slaughter. The
baseline data will allow the Agency to detect changes in the overall
nation-wide pathogen levels. The National Baseline program was
initiated in 1992 to provide information on the type and level of
microbiological contamination on raw products under Federal inspection.
Each sample collected is analyzed for nine microorganisms or groups of
organisms. Microbiological baseline data are now available for steers
and heifers, cows and bulls, and broiler chickens.
If sufficient data on both pathogen levels and foodborne disease
epidemiology result from current and future initiatives, FSIS should be
able to develop models showing how these two variables are related for
different pathogens. These models should then permit/facilitate a
quantitative estimate of risk. Such data are essential for FSIS to
evaluate the effect of control measures on both pathogens levels and on
foodborne illness.
E. ARS Food Safety Research Program
The Agricultural Research Service (ARS) administers a food safety
research program that is currently funded at approximately $45 million
per year. This program addresses problems in four different areas;
pathogen reduction, mycotoxins, residues, and natural toxins. The
reduction of microbial pathogens in food products of animal origin is
the most pressing food safety problem today. Consequently, the pathogen
reduction component is the largest of the four areas and is currently
funded at $18.2 million annually. The ARS research in pathogen
reduction addresses both preharvest and animal production, and post
harvest problem areas, with approximately equal funding for each.
Ongoing ARS research will help FSIS improve its capability for
performing quantitative risk assessment in the area of foodborne
pathogens or improve the ability to predict the effectiveness of new
pathogen reduction technologies. Ongoing projects include the modeling
of bacterial growth or thermal death times which will help set
standards for meat and poultry products. Ongoing projects will also
provide new laboratory screening or confirmatory methods. Other
projects provide and/or evaluate technology and management methods
which can help producers achieve lower contamination levels in animals
presented for slaughter, such as vaccines or competitive bacterial
cultures to prevent pathogens in live animals. There are also
technology and management methods for use in slaughter and processing
establishments, such as, organic acids for use in carcass sanitation,
improvements to the feather picking operation for poultry, washing of
trailers to reduce microbiological contamination, and establishment of
guidelines on the microbiological safety of recycling cooling solutions
for ready-to-cook meat and poultry products. In many cases the research
may provide the scientific basis for developing and improving
technology, for example, the nature of bacterial attachment to various
meat surfaces.
FSIS can and does forward very specific research requests to ARS.
In preparation for this final rule, FSIS requested that ARS compare the
results
[[Page 38962]]
from different microbial sample collection techniques, sponging versus
excision at one versus three carcass sites. These studies are currently
being conducted on both cow/bull and market hog carcasses. There are
other specific ARS projects that will help provide the scientific basis
for HACCP through risk assessment, predictive microbiology, and
pathogen reduction interventions for several different bacterial
pathogens which must be controlled to assure the safety of meat and
poultry.
These projects include: (1) Development of models to predict the
growth rates, survival times, and thermal death rates for microbial
pathogens potentially present in foods, including meat and meat
products. (Microbiological modeling is time consuming and expensive
because it requires that the data be quantified, that is, that numbers
of bacteria are obtained, rather just the knowledge of the presence or
absence of a pathogen under the conditions of the test.) The
microorganisms being studied include E. coli O157:H7, Listeria
monocytogenes, and Salmonella. These models are written into personal
computer software that gives FSIS a readily useable tool to help
evaluate proposed meat processes and assess out-of-process events.
Refining predictive models has the goal of linking an entire process
from raw ingredients to distribution of finished product. A specific
project is to model the survival of E. coli O157:H7 during the
manufacture of uncooked, fermented meat products. Using the information
obtained, ARS will closely collaborate with other USDA agencies to
develop strategies for risk reduction using the various processing
techniques, and to create risk assessment models.
(2) Modeling studies to predict the thermal inactivation of spore-
forming and non-spore-forming bacterial pathogens of both cooked and
ready-to-eat products. These studies will be extended to the cooling of
these products to ensure that there is no potential for growth of
Clostridium botulinum and C. perfringens.
(3) Determination of the long-term effects (21 days of storage at
refrigerated temperatures) of organic acid treatment of red meat on
some key pathogens (E. coli O157:H7, Listeria, and Clostridium), as
well as on spoilage bacteria (mesophilic aerobes, lactic acid bacteria,
and pseudomonads).
(4) Delineation of the parameters affecting the antibacterial
activity of organic acids. These include tissue type (pre-rigor, post-
rigor, frozen post rigor), inoculum type (pure culture or inoculated
feces), inoculum level and the temperature of spray wash at meat
surface. These results should clarify inconsistent reports on
antibacterial activity of organic acids and also define optimum
conditions to maximize the antibacterial activity of organic acids.
(5) The correlation of the Campylobacter levels in broilers from
the chill tank with their Campylobacter levels during production.
F. Analysis of Comments on Public Health Benefits
There were many comments on the methodology used to estimate public
health benefits in the preliminary analysis. This methodology used a
series of estimates or assumptions based on incomplete data related to
the six following areas:
Incidence of foodborne illness
Cost of foodborne illness
Percentage of foodborne illness and cost of foodborne
illness attributable to meat and poultry products
Pathogens addressed by the rule
Effectiveness of rule in reducing pathogens
Estimated reduction in cost of foodborne illness related
to reduction of pathogens
To facilitate discussion of the issues raised in comments, the
issues are addressed organized by these six areas.
1. Incidence of Foodborne Illness
Table 4 presents the most recent estimates on the incidence of
illness and death for selected pathogens along with the latest
estimates on the percentage of illness and death which is foodborne. As
discussed in the preliminary RIA, Table 4 includes the ``best
estimates'' when precise data are not available. Many of these
estimates are based on the landmark CDC study by Bennett, Holmberg,
Rogers, and Solomon, published in 1987, which used CDC surveillance and
outbreak data, published reports, and expert opinion to estimate the
overall incidence and case- fatality ratio for all infectious and
parasitic diseases. Estimates on the foodborne percentage of illness
and death for bacteria in Table 4 are all based on CDC data. The
resulting estimates for the number of foodborne cases and deaths are
presented in the second and third columns of Table 5.
The benefits for the preliminary analysis and this final RIA are
calculated for the three most common enteric pathogens of animal
origin: Campylobacter jejuni/coli, E. coli O157:H7, Salmonella and one
environmental pathogen Listeria monocytogenes. FSIS believes that these
four pathogens can be reduced through improved process control in the
manufacturing sector.
Although Clostridium perfringens and Staphylococcus aureus also
cause a significant number of foodborne illnesses, they are not
included in the benefits analysis because it is not clear that the
HACCP-based regulatory program, which focuses on federally inspected
processing, will significantly affect the incidence of disease caused
by these organisms. Staphylococcus aureus usually enters the food chain
through food handlers in restaurants and other commercial kitchens.
Although C. perfringens may enter the food chain through the slaughter
process, it is so ubiquitous in the environment that FSIS will not
assume that controls at slaughter will be effective against this
pathogen.
One commenter questioned why the Agency has not addressed the
public health problem of toxoplasmosis given the Table 5 estimate of
$2.7 billion in annual costs. FSIS believes that while process control
may help decrease the spread of cysts during boning and cutting
operations, most of the Toxoplasma gondi cysts are internal to
infective muscle tissues and are not addressable by process control.
Therefore, FSIS is making the more conservative assumption to exclude
this pathogen in the benefits estimate of disease averted.
Many comments suggested that the large range in the illness
incidence estimates demonstrates that there are insufficient data on
which to base a new regulatory program. Historically, the lack of
quantitative data on benefits and specific health risks have meant that
health and safety regulations have required decisionmaking under
uncertainty and have required the decisionmaker to balance the need to
act with the need for additional or improved data. Compared to such
issues as whether a chemical is a potential human carcinogen or whether
low levels of air pollutants cause adverse health effects, the health
effects of enteric pathogens are relatively well documented. If the
pathogens enter the food supply, they do, under certain conditions,
cause foodborne illness. If their presence can be prevented, no amount
of temperature abuse, mishandling or undercooking can lead to foodborne
illness.
The Agency believes that the existing estimates on foodborne
illness are adequate to conclude that a substantial and intolerable
public health problem exists. Furthermore, existing estimates are
appropriate for developing estimates on the cost of foodborne illness
attributable to meat and poultry. The
[[Page 38963]]
Agency notes that similar estimates on the incidence of foodborne
illness have been published by scientists from ERS in peer-reviewed
journal articles (see footnotes to Table 5) and by the 1994 CAST Task
Force.
The above statement that Table 4 includes the most recent estimates
of the incidence of illness and death requires further explanation in
the case of Listeria monocytogenes. The estimates of 1,795-1,860 cases
of listeriosis and 445-510 deaths are the ones used in the latest cost
of illness study conducted by ERS. ERS is in the process of publishing
a comprehensive documentation for the estimates of cost of illness for
1993. In their draft document they acknowledge that the estimate for
listeriosis cases originates from an extrapolation to the U.S.
population of incidence data from a CDC-conducted surveillance study of
six geographic regions in 1986 and 1987 (Gellin et al. 1987). They also
note that (Tappero et al. 1995) found that the incidence of listeriosis
has decreased since the 1960's and that projections from the
surveillance data suggest that there were 1,092 listeriosis cases and
248 deaths in 1993. ERS did not modify their cost of illness estimates
because Tappero et al., was published after their analysis was
concluded.
FSIS considered modifying the cost of illness estimates for this
final analysis but decided to use the estimates in Tables 4 and 5
because (1) They are the figures that will appear in the upcoming ERS
publication and, (2) updating the listeriosis estimates would have
minimal impact on the overall cost of illness estimates. Considering
the overall range and uncertainties involved in the cost of illness
estimates, the change in listeriosis estimates has negligible impact on
the regulatory analysis information conveyed through the potential
benefits estimate.
The Agency also recognizes that in using the 1993 estimates for
incidence of foodborne illness, the benefits analysis has not accounted
for possible reductions in foodborne illness attributable to the rule
that mandated safe handling statements on labeling of raw meat and
poultry products. The rule mandating safe handling instructions became
effective on May 27, 1994. Thus, it can be argued that the incidence of
foodborne illness for 1994 through the present should reflect the
effectiveness of the 1994 labeling requirement in reducing the
incidence of illness.
FSIS is not aware of any quantitative evaluation of the
effectiveness of safe handling labeling. Two recent surveys indicate a
high level of awareness, but these surveys do not contain findings that
can be translated into changes in consumer behavior. A recent
Associated Press poll found that 9 in 10 Americans say they follow the
safe-handling instructions. This poll, conducted in April 1996,
included 1,019 randomly selected adults. This was a telephone survey
conducted by ICR Survey Research Group. A November 1995 survey
conducted by Wegman Food Markets in Buffalo, Rochester, and Syracuse
found that 67.9 percent of respondents indicated they had read the safe
handling information. The Wegman's survey found that most household
meat preparers rely on color of meat or clarity of juices rather than
temperature to determine when meat has been cooked thoroughly.
In this analysis, FSIS has not attempted to adjust the 1993
baseline to account for safe handling labeling. The potential effect of
the 1994 regulation is one of many factors that could be affecting the
current incidence or cost of illness. A May 1996 GAO study on foodborne
illness notes that food safety and public health officials believe that
the risk of foodborne illness is increasing. If they are correct, the
1994 labeling rule may be slowing the growth rather than reducing the
absolute level.
There are many other factors that could have been incorporated into
the baseline for the analysis such as population growth and increases
in the cost of medical care. FSIS believes that attempts to adjust the
cost of illness baseline to account for factors such as inflation,
possible increases in foodborne illness due to behavior change or
population increases, and possible decreases due to inventions such as
safe handling labels are more likely to be misleading than informative
given the level of uncertainly and wide range in existing estimates.
2. Cost of Foodborne Illness
The fourth column of Table 5 shows that the 1993 estimated cost of
foodborne illness by pathogen or parasite was between $5.6 and $9.4
billion. These cost of illness estimates have been developed by ERS in
conjunction with CDC over the past 15 years. As indicated in footnotes
to Table 5, the results of that work have been frequently published in
peer-reviewed journals.
There were only a few public comments on the proposed rule which
addressed the methodology used for estimating the cost of foodborne
illness. Some comments argued that the public health benefit estimates
are low because of the low value-of-life factor used in the estimates
for the cost of foodborne illness.
ERS intentionally used a conservative method to estimate the value
of a statistical life (VOSL) acknowledging the controversy over valuing
lives. ERS used Landefeld and Seskin's VOSL estimates and recognizes
that the cost of illness estimates would be substantially higher if
they used alternative methods. For example, Viscusi (1993) summarized
the results of 24 principal labor market studies and found that the
majority of the VOSL estimates lie between $3 million and $7 million
per life. A survey of the wage-risk premium literature on the
willingness to pay to prevent death concluded that reasonably
consistent estimates of the value of a statistical life range from $1.6
million to $6.5 million dollars (1986 dollars) (Fisher et al. 1989).
Updated to 1993 dollars using the change in average weekly earnings,
Viscusi's range becomes $3.2 million to $7.6 million per VOSL and
Fisher's range becomes $2.0 million to $10.4 million dollars for each
statistical-life lost. Viscusi and the Fisher estimates are greater
than the highest Landefeld-Seskin (LS) VOSL estimate of $1,584,605 in
1993 dollars (estimate for a 22 year old).
Table 4.--Sources of Data for Selected Pathogens, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
Pathogen Estimated number of number of Source(s) for case and death Percent Source
cases deaths estimates foodborne
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli.. 2,500,000 200-730 Tauxe............................... 55-70 Tauxe et al.
Clostridium perfringens....... 10,000 100 Bennett et al....................... 100 Bennett et al.
Escherichia coli O157:H7...... 10,000-20,000 200-500 AGA Conference...................... 80 AGA Conf./CDC.
Listeria monocytogenes........ 1,795-1,860 445-510 Roberts and Pinner.................. 85-95 Schuchat.
[[Page 38964]]
Salmonella.................... 800,000-4,000,000 800-4,000 Helmick et al./Bennett et al. 87-96 Bennett et al./Tauxe & Blake.
Staphylococcus aureus......... 8,900,000 7,120 Bennett et al....................... 17 Bennett et al
Parasite:
Toxoplasma gondii............. 4,111 82 Roberts et al....................... 50 Roberts et al.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources: American Gastroenterological Associa
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
tion Consensus Conference on E. coli O157:H7, Washington, DC, July 11-13, 1994. Bennett, J.V., S.D.
Holmberg, M.F. Rogers, and S.L. Solomon. 1987. ``Infectious and Parasitic Diseases,'' In R.W. Amler and H.B. Dull (Eds.) Closing the Gap: The Burden
of Unnecessary Illness. Oxford University Press, New York. Helmick, C.G., P.M. Griffin, D.G. Addiss, R.V. Tauxe, and D.D. Juranek. 1994. ``Infectious
Diarrheas.'' In: Everheart, JE, ed. Digestive Diseases in the United States: Epidemiology and Impact. USDHHS, NIH, NIDDKD, NIH Pub. No. 94-1447, pp.
85-123, Wash, DC: USGPO.
Roberts, T., K.D. Murrell, and S. Marks. 1994. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423.
Schuchat, Anne, CDC, personal communication with T. Roberts at the FDA Science Forum on Regulatory Sciences, Washington, DC, September 29, 1994.
Tauxe, R.V., ``Epidemiology of Campylobacter jejuni infections in the United States and other Industrialized Nations.'' In Nachamkin, Blaser, Tompkins,
ed. Campylobacter jejuni: Current Status and Future Trends, 1994, chapter 2, pages 9-19. Tauxe, R.V. and P.A. Blake, 1992. ``Salmonellosis'' Chap. 12.
In: Public Health & Preventative Medicine, 13th ed. (Eds: Last JM: Wallace RB; Barrett-Conner E) Appleton & Lange, Norwalk, Connecticut, 266-268.
Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K. Wachsmuth. 1988. ``Campylobacter Isolates in the United States, 1982-1986,'' Morbidity and
Mortality Weekly Report, vol 31, no. SS-2: pages 1-14.
Table 5.--Medical Costs and Productivity Losses Estimated for Selected Foodborne Pathogens, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foodborne illness Percent Meat/poultry related Total
------------------------------ Foodborne from ------------------------------ costs *
Pathogen * costs meat/ meat/
Est. No. of Est. No. (bil $) poultry Est. No. of Est. No. poultry
cases deaths (%) cases deaths (bil $)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli............................. 1,375,000-1,75
0,000 110-511 0.6-1.0 75 1,031,250-1,31
2,500 83-383 0.5-0.8
Clostridium perfringens **............................... 10,000 100 0.1 50 5,000 50 0.1
Escherichia coli 0157:H7................................. 8,000-16,000 160-400 0.2-0.6 75 6,000-12,000 120-300 0.2-0.5
Listeria monocytogenes................................... 1,526-1,767 378-485 0.2-0.3 50 763-884 189-243 0.1-0.2
Salmonella............................................... 696,000-3,840,
000 696-3,840 0.6-3.5 50-75 348,000-2,880,
000 348-2,880 0.3-2.6
Staphylococcus aureus **................................. 1,513,000 1,210 1.2 50 756,500 605 0.6
------------------------------------------------------------------------------------------
Subtotal............................................. 3,603,526-7,13
0,767 2,654-6,546 2.9-6.7 N/A 2,147,513-4,96
6,884 1,395-4,461 1.8-4.8
------------------------------------------------------------------------------------------
Parasite:
Toxoplasma gondii........................................ 2,056 41 2.7 100 2,056 41 2.7
------------------------------------------------------------------------------------------
Total................................................ 3,605,582-7,13
2,823 2,695-6,587 5.6-9.4 N/A 2,149,569-4,96
8,940 1,436-4,502 4.5-7.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: ERS, 1993
* Column rounded to one decimal place.
** Roberts' rough approximation of costs in ``Human Illness Costs of Foodborne Bacteria'', Amer. J. of Agricultural Economics, vol. 71, no. 2 (May 1989)
pp. 468-474 were updated to 1993 dollars using the Consumer Price Index (all items, annual average). Cost estimates for other pathogens are more
detailed, see the following for a discussion of the methodology:
listeriosis--Roberts, Tanya and Robert Pinner, ``Economic Impact of Disease Caused by Listeria monocytogenes'' in Foodborne Listeriosis ed. by A.J.
Miller, J.L. Smith, and G.A. Somkuti. Elsevier Science: Amsterdam, The Netherlands, 1990, pp. 137-149,
E. coli O157:H7--Roberts, T. and Marks, S., ``E. coli O157:H7 Ranks as the Fourth Most Costly Foodborne Disease,'' FoodReview, USDA/ERS, Sept-Dec 1993,
pp. 51-59.
salmonellosis--Roberts, Tanya, ``Salmonellosis Control: Estimated Economic Costs,'' Poultry Science. Vol. 67 (June 1988) pp. 936-943,
campylobacteriosis--Morrison, Rosanna Mentzer, Tanya Roberts, and Lawrence Witucki, ``Irradiation of U.S. Poultry--Benefits, Costs, and Export
Potential, FoodReview, Vol. 15, No. 3, October-December 1992, pp. 16-21, congenital toxoplasmosis--Roberts, T., K.D. Murrell, and S. Marks. 1944.
``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423; and Roberts, Tanya and J.K. Frenkel,
``Estimating Income Losses and Other Preventable Costs Caused by Congenital Toxoplasmosis in People in the United States,'' J. of the Amer. Veterinary
Medical Assoc., vol. 196, no. 2 (January 15, 1990) pages 249-256.
N/A indicates item is not-applicable.
ERS is currently working on a sensitivity analysis for their cost
of illness estimates for foodborne illness. The sensitivity analysis
replaces the LS VOSL estimates with estimates found in the literature
on wage-risk studies. Preliminary findings show that the estimates of
the total cost of foodborne illness will increase greatly when these
higher VOSL estimates are used.
FSIS considers that the existing conservative estimates are
appropriate considering the controversy and uncertainty. The
conservative estimates are more than sufficient to justify the
[[Page 38965]]
final rule implementing a new HACCP-based regulatory program for meat
and poultry. This final RIA uses the cost of illness estimates shown in
Table 5.
Another comment stated that the cost of illness estimates are low
because they do not account for increases in productivity. In response,
the Agency notes that ERS used Landefeld and Seskin's estimates for the
value of a statistical life, and those estimates do include an
estimated 1% annual increase in productivity.
One commenter suggested that a methodology based on earning power
may overestimate the value of life where many deaths from foodborne
illness are the very elderly, the immunocompromised and the terminally
ill. This commenter also noted that while all deaths are tragic, from a
strictly economic standpoint many of these tragic cases have little or
no productivity left and in fact are utilizing resources at the rate of
$3,000 to $12,000 or more dollars per month of maintenance.
The cost of illness methodology used by ERS does account for the
fact that older individuals have lower remaining earning power than
younger individuals. This difference was taken into account when
estimating the costs of lost productivity for salmonellosis patients.
Different Landefeld and Seskin estimates of the values of statistical
life were used for the different age categories. The methodology used
U.S. death certificate data to estimate that the average age for
patients who die from salmonellosis is over 65 years. The concept of a
statistical value of life accounts for the fact that older individuals
may continue to work or be retired or be patients under long term
health care.
3. Percentage of Foodborne Illness and Cost of Foodborne Illness
Attributable to Meat and Poultry
The fifth column of Table 5 includes estimates on the percentage of
foodborne illness attributable to meat and poultry products. A separate
estimate has been developed for each pathogen. These estimates are
based on outbreak data reported under the CDC Foodborne Disease
Outbreak Surveillance System and on data from community-based and other
epidemiologic studies. Major data sources are cited in the preamble to
the final rule. An assumption is made in this analysis that the source
of foodborne pathogens, i.e., meat and poultry versus dairy products,
seafood, vegetable, etc., has no effect on the cost of illness. The
Department is not aware of any data indicating that the severity of
foodborne illness cases varies by source of pathogens.
Comments noted that the Department had increased the percentage of
foodborne illness attributable to meat and poultry from the earlier
rulemaking for safe handling labels. One commenter stated that the
Department has not revealed any new information which would support
such an increase.
At this time, data on incidence of foodborne illnesses and the
percentage of cases attributable to different food items are limited.
Estimates by pathogen have been made by experts at CDC and USDA, based
on a variety of studies. However, these are, indeed, estimates: FSIS
does not have exact numbers. The estimates in the 1993 Federal Register
document were relatively crude, assuming that 100% of Campylobacter and
E. coli O157:H7 cases, 96% of Salmonella cases, and 85% of Listeria
cases were foodborne, and that, for all bacterial pathogens, a flat 50%
of foodborne cases were attributable to meat and poultry. The 1995
document looked at the numbers in a somewhat more sophisticated way,
evaluating each pathogen individually and, where appropriate, giving
ranges for, first, percentage of cases which were foodborne, and,
secondly, percentage of cases which were attributable to meat and
poultry. Nonetheless, when all of the various percentages are
multiplied out, estimates of total cases attributable to meat and
poultry were remarkably similar, as shown below in Table 6.
Table 6.--Percentage of Foodborne Illness Attributable to Meat and Poultry
----------------------------------------------------------------------------------------------------------------
Percentage Percentage
of total of total
cases cases
attributed attributed Estimated total Estimated total
Pathogen to meat and to meat and cases, 1993 cases, 1995
poultry a poultry,
1993 1995
(percent) (percent)
----------------------------------------------------------------------------------------------------------------
Campylobacter............................... 50 41-53 1,050,000 1,031,250-1,312,500
Salmonella.................................. 48 43-72 921,600 348,000-2,880,000
E. coli O157:H7............................. 50 60 3,834-10,22 46,000-12,000
Listeria.................................... 43 43-48 649-672 763-884
----------------------------------------------------------------------------------------------------------------
a Reflects percentage of foodborne multiplied by percentage attributable to meat and poultry.
Most other comments related to the estimates on the percentage of
foodborne illness attributable to poultry. Comments questioned the high
incidence of poultry-related foodborne illness when even, as a
commenter asserted, public health authorities tell consumers that the
problem with poultry meat is not due to consumption because poultry is
cooked. Comments questioned whether cross-contamination in the kitchens
could possibly generate such high levels of foodborne illness. Related
comments suggested that if cross-contamination was such a serious
problem, the data would show more outbreaks and fewer single cases.
Other comments suggested that the cost of salmonellosis attributed to
poultry was high because of the high incidence of Salmonella
enteritidis in eggs and requested that the Agency exclude any foodborne
illness costs associated with eggs, because those issues are outside
the scope of this rulemaking. Another comment cited an Australian
finding that the Campylobacter strains that infect chickens are not the
strains that primarily infect humans.
The Department agrees that undercooked poultry is not a primary
cause of foodborne illness. The preamble to the proposal stated that
the majority of salmonellosis results from cross-contamination. The
best available estimates for foodborne illness do suggest that a high
incidence of illness is attributable to cross-contamination in
kitchens--both household kitchens and food-service establishments.
The comment suggesting that cross-contamination would have led to
more outbreaks makes sense, if the available estimates on incidence
were heavily
[[Page 38966]]
based on outbreak data. However, as mentioned in the proposal, it is
widely recognized that CDC outbreak data do not provide accurate
estimates of foodborne disease incidence. The outbreak data are more
useful in identifying factors that lead to illness and have been used
to estimate proportions of illness attributable to specific food
groups. They do not play a major role in the overall incidence
estimates. The existing incidence estimates are for total cases
including both individual cases and multiple cases. The methodology
used does not distinguish between outbreaks and single cases. Just as
there are unreported individual cases of foodborne illness, there are
unreported cases where entire households or portions of households
experience foodborne illness due to cross-contamination in household
kitchens. As discussed above, the estimates of foodborne illness were
derived from both CDC outbreak data and community-based epidemiologic
studies.
The outbreak data (two or more individuals ill from the same
source) are compiled by CDC from reports that are voluntarily submitted
from state and local health authorities. The laboratory reporting
system for Salmonella only captures information on those cases where a
patient sees a doctor, the doctor collects a stool culture and sends
the culture to a participating laboratory and the laboratory can
perform the specific diagnostic test. The estimates for overall disease
incidence are derived using both databases plus data collected from
population-based studies in specific geographic areas. The current
(initiative) collaborative surveillance project should improve the
estimates in the future.
The comment referring to the Australian finding is referring to an
article by Korolik, et al, published in the May 1995 issue of the
Journal of Clinical Microbiology, entitled, ``Differentiation of
Campylobacter jejuni and Campylobacter coli strains by Using
Restriction Endonuclease DNA Profiles and DNA Fragment Polymorphisms.''
The study was undertaken to determine if DNA fingerprinting
technologies could identify strains of Campylobacter in chickens that
cause disease in humans.
FSIS reviewed the article and concluded that the study did not
refute U.S. epidemiologic studies showing that approximately 50% of
human Campylobacter infections are due to poultry. To confirm FSIS's
interpretation of the study, a staff member contacted the author, Dr.
Victoria Korolik, in Australia. She confirmed that her study does not
shed doubt on the role of poultry in human Campylobacter infections.
4. Pathogens Addressed by the Rule
While the proposed rule indicated that HACCP systems will be
designed to control all public health hazards, the preliminary benefits
analysis assumed that the primary benefits will come from controlling
the three most common enteric pathogens of animal origin: Campylobacter
jejuni/coli, E. coli O157:H7, Salmonella and one environmental pathogen
Listeria monocytogenes. Two other pathogens--Clostridium perfringens
and Staphylococcus aureus primarily become or create hazards in meat
and poultry products as prepared in restaurants, other commercial
kitchens, and in homes. Consequently, the proposed regulatory program,
which focuses on the manufacturing sector, will not significantly
affect the presence of these organisms on meat and poultry products.
The public comments did not address the assumption that the
proposed rule would have the most impact on the four pathogens
identified above and that benefits would be most appropriately
discussed in terms of reducing the level of these pathogens. This final
RIA will continue to assume that the HACCP-based regulatory program
will have the most impact on the four pathogens identified in the
preliminary analysis.
The preliminary benefits analysis also included an assumption
concerning the percentage of the four pathogens that contaminate the
meat and poultry supply at inspected establishments or grow from
contamination that occurs at inspected locations. Based on the expert
judgment of FSIS microbiologists, the preliminary benefit analysis
assumed that 90 percent of the four pathogens result from contamination
that occurs at inspected establishments.
The public comments did not directly address the estimate that
slaughter and processing establishments are the source of 90 percent of
enteric pathogen contamination. There were, however, a large number of
comments that cited studies or estimates that show or indicate that the
majority of foodborne illness can be attributed to improper cooking,
recontamination and other mishandling and abuse in the food service and
home environment. Many comments cited data presented in the 1994 CAST
Report which ``demonstrated'' that only 6.9 percent of outbreaks were
``attributable'' to the food processing establishments. Other comments
referred to ``a well-recognized fact that 97 percent of the problems
with foodborne illness occur outside the realm of state and federal
inspection.'' Other comments attributed the 97 percent figure to a
Special Report by the American Association of Meat Processors. These
types of comments were presented in a manner indicating that the
commenters believe that the data attributing ``cause'' to the food
service or home environment directly contradicts the Agency's estimate
that inspected establishments are the source of 90 percent of the four
pathogens addressed by this rule.
In response, the Agency points out that the studies cited by
commenters concluding that high percentages of foodborne illness are
attributable to factors such as temperature abuse and mishandling do
not conflict with either the assumption that slaughter and processing
establishments are the source of 90 percent of enteric pathogen
contamination or the assumption discussed later concerning the
effectiveness of HACCP in reducing that contamination. Occurrence of
foodborne disease is a multi-step process. The first, and critical,
step is the introduction of a pathogen into or onto the raw product. If
a pathogen is present, then subsequent temperature abuse or mishandling
may permit bacterial counts to increase to levels which increase the
likelihood that illness will occur; mishandling may result in cross-
contamination of other foods which are not cooked before being eaten;
or improper cooking may not kill all pathogenic bacteria present in the
product. In these instances, it may be said that the illness was
``caused'' by improper handling. However, disease would not have
occurred if the pathogen had not been present on the raw product in the
first place.
The CAST study included a table showing factors contributing to the
occurrence of 1,080 outbreaks occurring from 1973 to 1982. That table
consisted of data from the CDC national foodborne disease surveillance
system that was published in an article in the Journal of Food
Protection by Frank L. Bryan in 1988. The CAST study and journal
articles use terminology like ``factors that contribute'' and address
the location or type of employee/consumer where any mishandling or
mistreatment of food occurred. The focus of these studies is to enhance
our understanding of the sequences of events and behaviors that lead to
foodborne illness since behavioral modification for the food preparer
and consumer at the end of the food chain may have the greatest impact
on the incidence of foodborne disease. Many of the comments are written
in a manner that blurs the distinction
[[Page 38967]]
between factors in the kitchen that may permit an outbreak to occur
from slaughter-origin contamination and those that would have caused an
outbreak despite the absence of contamination of the raw ingredients.
The comments referring to the CAST study or directly to CDC
estimates have not interpreted the Foodborne Disease Outbreak
Surveillance Data correctly. The standard CDC foodborne disease
outbreak report form does not include a question about whether the food
processing industry was involved, and while many foodborne outbreaks
have a chain of causation, investigators may differ in their assessment
of the point or points in the chain to which primary responsibility for
occurrence of the outbreak should be assigned.
The Bryan article used for the CAST study had the following summary
concerning the role of food processing establishments: ``Many of the
animals that enter abattoirs are either infected or contaminated with
foodborne pathogens and further spread occurs during processing. Hence,
abattoirs and raw-product processing establishments must accept some of
the blame of spreading salmonellae and other pathogens to many
carcasses and pieces of meat. These products are major sources of
pathogens for food-service establishments and homes where further abuse
(e.g., inadequate cooking or cross contamination) leads to outbreaks of
foodborne illness.''
The comments have not provided any basis for changing the expert
judgment of FSIS microbiologists that inspected establishments are the
source of 90 percent of the four pathogens addressed by the final rule.
This final benefits analysis is based on this assumption.
5. Effectiveness of the Rule in Reducing Pathogens
In accordance with the assumption that meat and poultry
establishments are the source of 90 percent of the four pathogens
addressed by the rule, the preliminary analysis calculated the benefits
under a scenario where the proposed rule would eliminate essentially
100 percent of those pathogens that enter the meat and poultry supply
at inspected processing establishments. In other words, for the
preliminary analysis, FSIS calculated an estimate of maximum benefits
by assuming the rule would eliminate 100 percent of the 90 percent.
By assuming this scenario, FSIS was not predicting that it believed
that the rule would result in elimination of 100 percent of those
pathogens in the manufacturing sector. Rather, the Agency was
acknowledging that it has responsibility for having a food safety
objective that recognizes the scope of the problem and attempts to
reduce pathogens in that sector as much as possible, since without
pathogens, no amount of subsequent abuse would result in foodborne
illness.
By presenting a sensitivity analysis in the proposal, FSIS intended
to clarify that the benefit estimates were a maximum and not a
prediction of what is likely to happen. The distinction was unclear to
many commenters who expressed doubt that the proposed HACCP program
would result in a 90 percent reduction in pathogens. A large number of
comments on the potential effectiveness of HACCP programs contrasted
the FSIS estimates with those contained in the recent study by the
Institute of Food Science and Engineering, Texas A&M University, titled
``Reforming Meat and Poultry Inspection: Impacts of Policy Options,''
(hereafter referred to as the IFSE study). Both FSIS and IFSE estimates
are useful as assumptions rather than as quantitative predictions of
potential effectiveness of HACCP.
The ISFE study examined four policy options for addressing
pathogens in the meat and poultry supply. One option called for
mandatory HACCP for inspected slaughter and processing establishments
and estimated that mandatory HACCP in inspected establishments would
produce a 20 percent reduction in pathogens. The difference in the FSIS
and IFSE estimates is not based on data but on assumptions for
different ``HACCP'' scenarios.
The HACCP program scenario considered in the IFSE study did not
assume a mandatory pathogen reduction performance standard. Requiring
process control without a standard could lead to processes that are
well controlled at unacceptable pathogen levels. The Agency would agree
that such a situation would result in less pathogen reduction. FSIS
believes that a standard is necessary to encourage innovation and
provide the impetus for continuing improvement and increasing
effectiveness. In estimating effectiveness, the IFSE study noted that
``with experience and additional research, it is possible that higher
levels of reduction in pathogens could be achieved * * *''.
Another major difference between the two program scenarios is that
the IFSE program does not include a prerequisite requirement for SOP's.
SOP's could cover potential sources of enteric and environmental
pathogens that are not be covered under a HACCP plan. However, as
discussed in Section I, this analysis discusses benefits of SOP's in
terms of increased productivity for inspection resources and clarity of
responsibilities.
Several comments refer to the IFSE estimates as being more
objective or ``scientific'' than those in the Agency's analysis. The
IFSE authors characterize their own effectiveness estimates as ``the
consensus judgment of the task force'' or ``the most reasonable
expectation.'' The IFSE estimates are judgments, as are the Agency's
estimates.
A general comment related to the effectiveness issue stated that
while HACCP remains an interesting theoretical concept, it is still
only a concept that has never been tested on a meaningful scale under
actual meat establishment conditions, and never proven to significantly
improve the microbial quality of the finished product. Although HACCP
has been tested in food processing establishments to the satisfaction
of scientists, food technologists, and industry management to produce
safe food, the Agency recognizes that the potential effectiveness of
HACCP in reducing pathogens within a regulatory framework is unknown at
the present time. FSIS conducted a pilot HACCP study in nine
establishments from 1991 to 1993. Findings regarding pathogen reduction
effectiveness were inconclusive. FSIS did not receive any data during
the comment period from establishments currently operating HACCP
systems. Rather than select an arbitrary effectiveness estimate, or use
the maximum potential 100 percent estimate from the preliminary
analysis, this RIA will present a range of effectiveness estimates and
show the minimum level necessary to generate net benefits.
6. Estimated Reduction in Cost of Foodborne Illness
Several comments focused on the issue that the relationship between
pathogen reductions at the manufacturing stage and foodborne illness
reductions is unknown. The comments recognize that the proposal did
acknowledge that little data exist on the relationship between pathogen
levels and incidence of illness. One comment pointed out that FSIS
recognized that the pathogen testing requirements that are part of the
proposal will help to elucidate the relationship between pathogen
contamination and foodborne disease. The commenter concluded that it
did not seem reasonable for the Agency to rely on an assumption, whose
very validity can only be tested by the implementation of the proposal
under examination, to justify the proposal.
[[Page 38968]]
Other commenters concluded that the Agency needed to develop better
data or complete a thorough risk assessment that would establish the
public health benefits of pathogen reduction before proceeding.
The comments asking for better data or requesting a thorough risk
assessment are not comments on the cost-benefits analysis. These
comments imply there is insufficient evidence to support new pathogen
reduction efforts. This issue is addressed in the preamble to the final
rule. The comments have made a policy judgment with which the
Department does not agree.
For the benefits analysis included with the proposed rule, FSIS
assumed that a reduction in pathogens will lead to a corresponding
proportional reduction in foodborne illness. The Department notes that
the IFSE study referred to favorably by many commenters used the same
method for estimating public health benefits as did FSIS, i.e., a
reduction in pathogens leads to a proportionate reduction in illness
and death. The Agency is aware that the proportionate reduction method
is an assumption that has not been tested or validated. However, the
Agency also recognizes that research methodology for relating pathogen
levels at establishments to incidence of illness is in its early
developmental stages. Risk models for foodborne pathogens are likely to
develop as the basis for regulatory decision-making in the future. The
Agency believes the implementation of mandatory HACCP will improve food
safety and protect public health while research in modeling risk
associated with foodborne pathogens continues.
The Agency has and continues to support any effort to improve the
quality of data and methodology available for risk assessment of
illness caused by foodborne biological agents. FSIS, FDA, CDC, and
local public health departments are collaborating with state health
departments and local investigators at five locations nationwide to
identify more accurately the incidence of foodborne illness, especially
illness caused by Salmonella and E. coli O157:H7.
G. Summary
The final rule addresses four pathogens that are estimated to cause
from $1.1 to $4.1 billion in annual illness and death costs
attributable to meat and poultry products. The rule addresses 90
percent of that cost of illness or from $0.99 to $3.69 billion
annually. FSIS recognizes that the actual effectiveness of the final
requirements in reducing pathogens is unknown, and presents a range of
benefits based on reducing varying percentages of the $0.99 to $3.69
billion in annual cost of foodborne illness addressed by this rule.
References
International Commission on Microbiological Specifications for
Foods (ICMSF). 1980. Microbial Ecology of Foods: Factors Affecting
Life and Death of Microorganisms. Volume I. Academic Press, New
York. Pp. 215-231.
Rolfe, R.D. 1991. Population dynamics of the intestinal tract.
In: Colonization Control of Human Bacterial Enteropathogens in
Poultry. Ed. L.C. Blankenshipp, J.S. Bailey, N.A. Cox, S.E. Craven,
R.J. Meinersmann, N.J. Stern. Academic Press, Inc., New York. Pp.
59-76.
Centers for Disease Control (CDC). 1988. Campylobacter isolates
in the United States, 1982-1986. In: CDC Surveillance Summaries.
June 1988. MMWR 1988; 37 (No. SS-2:1-13).
Blaser, M.J. & L.S. Newman. 1982. A review of human
salmonellosis: I. Infective dose. Reviews of Infectious Disease.
4(6):1096-1106.
Buchanan, R.L. & R.C. Whiting. 1996. Risk assessment and
predictive microbiology. J. Food Protection. 31-36.
Burmaster, D.E. & P.D. Anderson. 1994. Principles of good
practice for the use of Monte Carlo techniques in human health and
ecological risk assessments. Risk Analysis. 14(4):477-481.
Council for Agricultural Science and Technology (CAST). 1994.
Foodborne pathogens: Risks and consequences, Report No. 122, p. 87.
Haas, C.N. 1983. Estimation of risk due to low doses of
microorganisms: A comparison of alternative methodologies. Am. J.
Epidemiol. 118:573-582.
National Research Council. 1983. Committee on Institutional
Means for Assessment of Risks to Public Health. Risk Assessment in
the Federal Government: Managing the Process. National Academy
Press, Washington, DC p. 191.
Tappero, J.W. et al. 1995. Reduction in the Incidence of Human
Listeriosis in the United States; Effectiveness of Prevention
Efforts? Journal of the American Medical Association. 273(14):1118-
1122.
Gellin, B., C.V. Broome, R. Weaver and A.W. Hightower.
[Listeriosis Study Group.] Geographic Differences in Listeriosis in
the U.S. (Abstract). In Program and Abstracts of the twenty-seventh
International Conference on Antimicrobial Agents and Chemotherapy.
p. 155. Washington, DC: American Society for Microbiology, 1987.
V. Cost Analysis
A. Introduction
The final HACCP rule includes several regulatory components all
directed at improving process control in meat and poultry operations in
order to reduce the risk of foodborne illness associated with meat and
poultry products. The requirements of the final rule are organized
around the following three sections:
Requirements that all inspected establishments develop and
implement sanitation Standard Operating Procedures (SOP's) within 6
months.
Requirements that all inspected establishments develop and
implement HACCP programs within the 18 to 42 month time period
following publication. Scheduling will be based on establishment size.
Requirements that (1) all establishments slaughtering
cattle, swine, chickens, or turkeys, or producing a raw ground product
from beef, pork, chicken or turkey comply with new pathogen reduction
performance standards for Salmonella and (2) all establishments
slaughtering cattle, swine, chicken or turkeys implement microbial
testing programs using generic E. coli within 6 months. Compliance with
the pathogen reduction performance standards for Salmonella will be
required at the time the establishment is required to implement HACCP.
This cost analysis is presented in three sections. The first
section describes the methodology used in generating cost estimates.
The next section addresses the regulatory flexibility designed to
reduce the burden on small business. The last section presents the cost
estimates for each regulatory requirement. For each broad requirement,
the discussion of the cost estimates is organized using the following
five topics:
Summary of the requirements in the final rule identifying
any changes from the proposal.
Review of the cost estimates from the preliminary RIA.
Summary of the comments related to the preliminary cost
estimates.
Response to the comments.
Final cost estimates.
B. Methodology for Cost Analysis
The final pathogen reduction/HACCP rule includes regulatory
requirements that are directed at improving the control over food
processing operations. In general, compliance with these requirements
requires expenditures of time, i.e., employee hours to develop plans,
monitor critical control points, record findings and collect and
analyze samples. This final RIA is based on time required by four
categories of employees that were defined in the supplemental cost
analysis. These include the following:
Quality Control manager earning $25.60 per hour.
Supervisors or QC technicians that review findings and
records at $18.13 per hour.
[[Page 38969]]
Laboratory technicians earning $18.13 per hour.
Establishment employees/production workers that would
monitor sanitation and HACCP programs or collect samples at $12.87 per
hour.
The four categories of wages are based on 1993 data adjusted for
1994 dollar inflation from the Bureau of Labor Statistics and Meat and
Poultry Magazine and include a 33 percent overhead requirement for
benefits such as health insurance and retirement contributions. Unless
otherwise noted, the analysis assumes that all establishments and
employees work a standard 52 week, 260 day, 2080 hour work year.
This final cost discussion is based on retracing the steps and/or
calculations of the preliminary analysis and discussing related public
comments in the appropriate sections. Other comments that are related
to the analysis but do not reflect directly on the methodology are
summarized at the end of the analysis in Appendix A.
This analysis makes frequent references to the Enhanced Economic
Database. In 1994, the Research Triangle Institute (RTI) took a
compilation of existing FSIS databases containing establishment
production or inspection data and added data on annual sales and
employment from sources that included Dun and Bradstreet and American
Business List databases. Actual estimates for annual sales and number
of employees were available for approximately 80 percent of the
establishments. In other cases, estimates for sales and number of
employees were developed using the employment/sales data for
establishments producing the same type and volume of product.
The enhanced database includes production data (number of head
slaughtered, pounds of product produced) from 1993 for all federally-
inspected establishments in operation as of August 1994. The
preliminary analysis and this final RIA combine 1993 production data
with the population of federally and state- inspected establishments
that were in operation as of August 1994. As of August 1994, there were
6,186 federally inspected and 2,893 state inspected establishments.
These 9,079 establishments include a total of 11,719 ``operations''--
2,597 red meat slaughter operations, 364 poultry slaughter operations
and 8,758 further processing operations.
This final analysis assumes a constant level of 9,079 inspected
establishments. The analysis does not attempt to account for costs
associated with exits from or entries into the marketplace. For
operations that are entirely new, or include a new processing
operation, the requirements for HACCP plans and sanitation SOPs will
increase the one-time, up-front cost of entering the market. If
marketplace entry involves the purchase of an existing business, the
business will already have an existing HACCP plan and sanitation SOP.
In these cases, the acquisition cost of the business would include the
value of the existing HACCP plan and SOP.
There should be minimal additional cost for HACCP and SOP plan
development for new construction that expands a firm by replicating an
existing operation in a new location. This type of new establishment
can apply HACCP and SOP plans that have been developed for a similar
existing establishment. This analysis has assumed that each
establishment is independent and has not reduced cost estimates to
account for firms that operate several similar establishments.
The preliminary analysis developed cost estimates for three sizes
of manufacturing establishments. Most of the costs that involve
employee time are influenced by a number of factors including the
physical size of the establishment, the volume of production, the type
of production practices and the number or production lines. The
preliminary analysis used the data on annual sales developed by RTI
because the sales data correlated reasonably well with size and
production volume data and the Agency had an estimate of sales for
6,186 federally inspected establishments.
For the preliminary analysis the Agency defined a large
establishment as one with over $50 million in annual sales, a medium
establishment as one with between $2.5 and $50 million and a small
establishment as one with less than $2.5 million in annual sales. For
calculating costs, the Agency collected data from the field based on
these three size categories. Public comments provided good reason to
change size definitions for implementation (regulatory flexibility)
purposes and the Agency has done so for the final rule. This does not
affect the accuracy of proposed or current cost estimates based on
previously collected data. The final analysis uses the old categories
for presenting cost data to facilitate comparisons and minimize
confusion. To summarize, this cost analysis uses the terms high, medium
and low volume producers for cost presentation that involves average
establishment costs and uses the terms large, small and very small
business for discussing regulatory flexibility. The cost and
flexibility principles do not overlap in this analysis.
Commenters pointed out that in comparing total costs with the value
of current production, the preliminary analysis did not address impacts
on producers, i.e., the costs that would be passed back to livestock
producers. FSIS recognizes that some costs will be passed back to
producers in terms of lower prices for live animals and other costs
will be passed forward in terms of higher consumer prices. Other costs
may have to be absorbed by slaughter and processing establishments.
Because the necessary knowledge of empirical cost structures and supply
and demand elasticities is inadequate, FSIS does not offer any
quantitative estimates of the distribution of costs of this rule on
various sectors of the production and marketing chain. The aggregate
cost estimate establishes an upper bound on the costs any sector might
ultimately bear.
There are two types of potential costs that were not addressed in
the preliminary cost analysis. The first type of cost is the cost of
taking corrective action when routine monitoring of a CCP finds a
deviation from a critical limit. The critical limit could be associated
with assuring compliance with existing regulatory requirements or it
could be a limit set to assure compliance with the new pathogen
reduction standards for Salmonella or the criteria established for
generic E. coli. Corrective action would also occur when FSIS would
find a problem with either a HACCP plan or a sanitation SOP.
The second type of potential cost is related to the question of
whether existing processing methods are adequate to meet the pathogen
reduction performance standards for Salmonella and the criteria for
generic E. coli. It is expected that some establishments will have to
make permanent changes to their existing production practices to have a
HACCP-based program that assures compliance with the new standards and
criteria. The final rule raises a third type of potential cost when it
outlines the Agency's plans for using the results of its own Salmonella
testing program for regulatory purposes. Whether or not this testing
leads to industry testing costs depends on whether the government
testing indirectly forces an establishment to regularly conduct its own
testing.
The preliminary analysis did address a fourth category of potential
costs that includes the cost of necessary materials, such as
thermometers and test kits, that establishments will need to
[[Page 38970]]
systematically monitor their processes. Recognizing that the rule does
not make any equipment obsolete, the preliminary analysis suggested
costs of from $10 to $20 per establishment. These costs were not
included in the overall cost summary.
Potential costs are addressed in this final analysis under Section
V.D.2., Costs of Meeting Pathogen Reduction and Microbial Sampling
Requirements.
C. Regulatory Flexibility
The Regulatory Flexibility Act (P.L. 96-354) requires analyzing
options for regulatory relief for small businesses. This section
reviews the regulatory relief provided in the proposal, responds to
comments related to the definition of small business used in the
proposal and summarizes the regulatory relief for small business
provided for in the final rule. In Section II, this analysis addressed
the option of providing an exemption for small business noting that
comments on an exemption were mixed with a substantial number of
comments from small businesses strongly opposing an exemption.
The proposed rule intended to spread the implementation of HACCP
over a three year period. To minimize the burden on small
establishments, they would be given a maximum time of 36 months to
develop and implement their HACCP plans. A small establishment was
defined as one with annual sales of less than $2.5 million.
The decision to use the above definition generated a large number
of comments. ``Very small'' establishments commented that they could
not compete with a relatively ``large'' business with annual sales of
$2.5 million. For example one commenter stated that: ``calling an
establishment, small, that produces $2,500,000 worth of product
annually is not fair to those establishments producing far less.''
Other comments suggested that by defining small at the $2.5 million
level, the Agency demonstrated that it does not understand what a small
business is. Comments from businesses with annual sales of $2.5 to
$10.0 million or even $25.0 million stated that they should also be
considered small businesses. Commenters also pointed out that other
Federal agencies use different definitions. For example, one commenter
noted that OSHA uses 50 employees as their criterion for a ``small
business.'' Others commented that FSIS should or must use the existing
definition of fewer than 500 employees published by the Small Business
Administration (SBA).
Several comments promoted a set of requirements distinguishing
``small'' from ``very small'' establishments. ``Very small''
establishments would only be required to implement the proposed
provisions on sanitation standard operating procedures, antimicrobial
treatment of carcasses, and time and temperature provisions. They would
be exempt from routine microbial testing and long-term provisions of
HACCP as long as annual sales do not exceed $1 million (not counting
``pass through''). The establishments would still be subject to
incidental sampling for microbial testing as determined by the
Administrator. Required implementation of the three near-term
initiatives would be 12 months after publication of the final rule.
The ``small'' establishments (between $1.0 and $2.5 million) would
be required to implement SOPs, antimicrobial treatment, time and
temperature provisions, and limited routine sampling, in proportion to
the number of slaughtered animals and/or poundage of processed
products. The establishments would still be subject to incidental
sampling for microbial testing as determined by the Administrator. They
would be exempt from long-term provisions of HACCP as long as annual
sales, as defined above, do not exceed $2.5 million. The required
implementation of all near-term initiatives would be six months.
There were other comments that suggested variations on the above
definitions and requirements for ``small'' and ``very small''
establishments. For example, one State department of agriculture
recommended the same requirements for ``small'' and ``very small''
establishments but suggested that size criteria based on head
slaughtered or pounds produced would be more practical. Another State
department of agriculture recommended that a ``every small'' plant be
defined based on the number of employees (no more than 20 full-time),
slaughter volume (no more than 2,500 animals per year), or processing
volume (100,000 pounds of meat and/or poultry products per year). The
recommendation suggested that a plant in this category would be
required to implement the provisions of the proposed rule pertaining to
sanitation SOP's and time-temperature requirements. Antimicrobial
treatment of carcasses would be voluntary, and such a plant would be
exempted from microbial testing as proposed. Implementation of a HACCP
program would be initially voluntary, and phased in with considerations
in the areas of documentation and record-keeping for the limited work
force.
FSIS has considered the above regulatory framework for ``small''
and ``very small'' establishments. Some of the suggestions are no
longer applicable because major provisions of the proposed rule have
been dropped. FSIS believes it has addressed the other concerns in more
appropriate ways.
FSIS was aware of SBA Size Standards during the development of the
proposed rule. If FSIS used the size standard for meat and poultry
``manufacturing'' firms, over 94 percent of the federally inspected
establishments would meet the criterion of having fewer than 500
employees. FSIS is also aware that there are six different SBA size
standards that apply to the 6,415 FSIS official establishments. FSIS
determined the SBA size standards by themselves are not appropriate for
meeting FSIS's need to sequence HACCP implementation.
Table 7 shows the distribution of 6,415 official establishments by
Standard Industrial Classification (SIC) code. The SIC codes were
developed to promote the comparability of statistics describing various
facets of the Nation's economy. The SIC codes were used as part of the
Enhanced Economic Analysis Database developed by Research Triangle
Institute to represent all FSIS inspected establishments. As can be
seen from Table 7, a significant portion of official establishments are
not in an SIC Code for manufacturing. Food manufacturing establishments
have a 4-digit SIC Code beginning with 20. The Census of Manufacturers
published by the Department of Commerce characterizes the meat and
poultry manufacturing industry by summarizing data for SIC Code 2011--
Meat Packing Establishments, SIC Code 2013--Sausages and Other Prepared
Meats, and SIC Code 2015--Poultry Slaughtering and Processing. The SBA
Size Standards in Table 7 are published in the Code of Federal
Regulations--13 CFR, Chapter 1, Section 121.601.
In a written comment, the Office of Advocacy, Small Business
Administration claimed that FSIS was wrong in concluding that one-third
of federally inspected establishments would have the maximum time for
compliance with HACCP requirements using the criterion of $2.5 million
in annual sales. In supporting their claim, they cited U.S. Census
Bureau data. However, Census data do not accurately describe the
federally inspected meat and poultry industry. As shown in Table 7, the
problem is that less than half of the firms are classified in the three
4-digit SIC Codes identified above that define meat and poultry
manufacturing. FSIS addressed this data
[[Page 38971]]
problem by contracting with RTI to develop a more accurate economic
profile of federally inspected meat and poultry establishments.
Table 7.--Establishments Standard Industrial Classification
----------------------------------------------------------------------------------------------------------------
Cumulative
SIC code Standard industrial Number of number of SBA size standard
classification establishments establishments
----------------------------------------------------------------------------------------------------------------
2011.............. Meat packing 1,503 1,503 500 employees.
establishments.
5147.............. Meats and meat products. 1,312 2,815 100 employees.
2013.............. Sausages and other 939 3,754 500 employees.
prepared meats.
2015.............. Poultry slaughtering and 438 4,192 500 employees.
processing.
4222.............. Refrigerated warehousing 356 4,548 $18,500,000.
and storage.
5421.............. Meat and fish markets... 309 4,857 $5,000,000.
5144.............. Poultry and poultry 268 5,125 100 employees.
products.
5141.............. Groceries, general line. 238 5,363 100 employees.
5812.............. Eating places........... 156 5,519 $5,000,000.
2038.............. Frozen specialities, nec 139 5,658 500 employees.
5142.............. Packaged frozen foods... 130 5,788 100 employees.
5411.............. Grocery stores.......... 95 5,883 $20,000,000.
5149.............. Groceries and related 65 5,948 100 employees.
products, nec.
9999.............. Not applicable.......... 63 6,011
2032.............. Canned specialities..... 61 6,072 1,000 employees.
2099.............. Food preparations, nec.. 55 6,127 500 employees.
Other............. All other SIC codes..... 288 6,415
----------------------------------------------------------------------------------------------------------------
Note: The Enhanced Economic Analysis Database uses the number of active establishments as of August, 1994 and
identified 6,415 establishments as active official establishments. Of these 6,415, a total of 229 were
identified as cold storage/ID warehouses, universities or churches. From the 6,415 total, 6,186 federal
establishments were classified as processing, slaughter or combination operations. nec--(Not Elsewhere
Classified).
The final rule provides for sequencing HACCP implementation by
establishment size, using the SBA definition of a small manufacturing
business, i.e., a small business is an establishment with fewer than
500 employees. Those establishments with 500 or more employees will be
referred to as large establishments. In addition, in response to
comments that there are hundreds of ``very small'' or ``micro''
establishments, the Agency will classify an establishment as ``very
small'' if it has either fewer than 10 employees or annual sales of
less than $2.5 million.
This sequencing of HACCP responds to a large number of comments
requesting that small businesses be given a longer period of time to
implement HACCP requirements. Many small businesses stated they did not
want to be exempt, but asked for more flexibility in implementing
HACCP. Some commenters specifically requested five, eight or 10 years
to implement HACCP.
While the final rule does not provide for longer periods of five,
eight or 10 years, it does substantially extend the implementation
period for hundreds of small and very small establishments.
To illustrate, the proposed rule would have required HACCP plans
in over 2,100 establishments producing raw ground product within 12
months. Under the final rule, over 1,800 of those establishments will
have either 30 or 42 months to implement HACCP. The smallest 5,127
establishments (2,893 state and 2,234 federal) will have an additional
six months. The proposed rule called for implementation of a HACCP
system in all ``small'' establishments by 36 months; the final rule
allows 42 months for the newly defined ``very small'' category.
Table 8 illustrates the distribution of 6,186 federally-inspected
slaughter, processing, and combination establishments used for the
sequencing of HACCP implementation in the proposed rule and in the
final rule. There are 496 more establishments in the two smaller
categories than there were in the proposal. As shown in Table 8, there
are 353 large, 2,941 small and 2,892 very small federally-inspected
establishments.
Table 8.--Size Categories for Federally Inspected Establishments
------------------------------------------------------------------------
No. of
Establishment category Definition establishments
------------------------------------------------------------------------
Proposed Rule
------------------------------------------------------------------------
High volume....................... >$50 million........ 849
Medium volume..................... $2.5-$50 million.... 3,103
Low volume........................ <$2.5 million....... 2,234
Total........................... .................... 6,186
------------------------------------------------------------------------
Final Rule (Sequencing of HACCP)
------------------------------------------------------------------------
Large............................. 500 353
Employees.
Small a........................... 10-499 Employees.... 2,941
Very small b...................... <10 Employees or 2,892
<$2.5 Million.
Total........................... .................... 6,186
------------------------------------------------------------------------
a New definition of small includes 2,445 establishments that were medium
volume establishments plus 496 that were high volume for the
preliminary analysis.
b New definition of very small includes the 2,234 establishments that
were low volume establishments plus 658 that were medium volume
establishments for the preliminary analysis.
D. Final Cost Estimates
1. Sanitation Standard Operating Procedures
a. Summary of Requirements. The final rule requires that all
inspected establishments develop and implement Sanitation SOP's within
6 months after publication of the final rule. The proposed rule would
have required the implementation of SOP's within 90
[[Page 38972]]
days. To facilitate the development of SOP's and to provide maximum
flexibility, the Agency will not prescribe any specific format or
content but will provide guidelines to assist inspected establishments
in developing written SOP's. There will not be any FSIS approval of the
written documents. With the exception of the implementation schedule,
the requirements for SOP's in the final rule are the same as those in
the proposed rule.
b. Review of Preliminary Cost Estimates. The preliminary cost
analysis identified separate costs for SOP plan development and SOP
recordkeeping where recordkeeping was defined as observing or verifying
procedures, recording findings, reviewing records and maintaining
files. FSIS assumed that the Sanitation SOP's would be developed by a
quality control manager at a cost of $25.60 per hour. FSIS estimated
that it would cost an average of $128, $256 and $640 for low, medium
and high volume establishments to develop Sanitation SOP's.
The preliminary cost analysis assumed that Sanitation SOP's
observation and recording for low, medium and high volume
establishments would take 15, 25 and 45 minutes per day by an employee
earning $12.87 per hour and that supervisory review of records would
take 5, 10, and 20 minutes by an employee earning $18.13 per hour. In
developing these time estimates for recording and reviewing records,
FSIS recognized that the time required would be influenced by a number
of factors including the physical size of the establishment, the volume
of production, the type of production practices and the number of
production lines. The estimates are based on program judgement of the
time required to conduct two sets of sanitation observations per day,
one for preoperational sanitation procedures and one for operational
sanitation.
Using the above inputs, the annual costs for recording and
reviewing Sanitation SOP's records for low, medium and high volume
establishments would be approximately $1,230, $2,180 and $4,080,
respectively, based on a 260-day, 2,080 hour work year. These costs
were adjusted upward to approximately $1,242, $2,204 and $4,104 to
account for the cost of maintaining records.
The preliminary analysis also included training costs of $62, $155
and $372 for low, medium and high volume establishments. Instructing an
employee in verification and recording procedures was assumed to take
2, 5 and 12 hours, respectively involving both a QC technician ($18.13
per hour) and a production worker ($12.87 per hour). Total training
cost was, therefore, $31 per hour. Total per establishment Sanitation
SOP's costs, as estimated in the preliminary analysis, are summarized
in Table 9.
Table 9.--Summary of Sanitation SOP Costs Per Establishment
[Dollars]
----------------------------------------------------------------------------------------------------------------
Total
Plan Annual Training first Recurring
Establishment category development recordkeeping cost year annual
cost cost cost cost
----------------------------------------------------------------------------------------------------------------
Low.............................................. 128 1,242 62 1,432 1,242
Medium........................................... 256 2,204 155 2,615 2,204
High............................................. 640 4,104 372 5,116 4,104
----------------------------------------------------------------------------------------------------------------
Using the per establishment costs from Table 9, total aggregate
costs were calculated for all inspected establishments as shown in
Table 10. Establishments with an existing written sanitation program
were assumed to have only 50 percent of the plan development costs
because these establishments would have to modify an existing plan
rather than start from the beginning. Establishments with existing
sanitation plans include the 287 establishments with TQC programs and
46 slaughter establishments with PQC sanitation programs. It was also
assumed that these 333 establishments would not require training to
implement a sanitation SOP.
Table 10.--Costs of Sanitation SOP's
[Dollars in thousands]
------------------------------------------------------------------------
First
Establishment category No. of year Recurring
establishments costs costs
------------------------------------------------------------------------
High................................ 849 $4,276 $3,484
Medium.............................. 3,103 8,079 6,839
Low................................. 2,234 3,185 2,775
-----------------------------------
Subtotal.......................... 6,186 15,540 13,098
===================================
State............................... 2,893 4,143 3,593
-----------------------------------
Total............................. 9,079 19,683 16,691
------------------------------------------------------------------------
Note: For preliminary RIA, all State establishments were assumed to be
low volume establishments.
c. Comments on Preliminary RIA. Comments on proposed requirements
for sanitation Standard Operating Procedures (Sanitation SOP's) focused
on the cost of recordkeeping. In the preliminary cost analysis,
recordkeeping included observation (i.e., verifying the procedures),
recording findings, supervisory review of records and maintenance of
files. One commenter stated that the cost of recordkeeping for their
company would be approximately $10,000 annually.
A state inspected establishment, currently participating as a pilot
establishment for HACCP/sanitation plans in their state program,
indicated that they spend several hours each week verifying procedures
and have weekly costs of at least $50 to keep the paperwork for their
sanitation plan current. Their annual cost for keeping paperwork
current would, therefore, be at least $2,600. This state establishment
also stated that they had used an estimated $3,000 to $4,000 designing
an SOP and that was with the assistance of two universities, several
suppliers and their state inspection program. It took nine months to
put the plan together.
Comments at public hearings indicate that there is a lot of
uncertainty as to what FSIS expects in Sanitation SOP's. At one of the
public hearings the owner of a ``small'' establishment stressed the
importance of guidance and training with respect to what is expected in
terms of recordkeeping.
d. Response to Comments.
[[Page 38973]]
The Agency recognizes that the costs reported by the state
establishment participating in a pilot program are substantially higher
than the costs used in the preliminary analysis. The reported
development time of nine months is also longer than the allowed
implementation period. FSIS believes that the reported pilot project
involving two universities, several suppliers and a state program has
far exceeded the expectations of the rule. The same is true for the
comment suggesting recordkeeping costs of $10,000 per year.
FSIS has now developed model Sanitation SOP's and a guideline for
developing Sanitation SOP's. These documents should clarify FSIS
expectations. FSIS believes that these documents are consistent with
the cost estimates used in the preliminary analysis.
There is some reason to believe that the estimated cost for
Sanitation SOP's in the preliminary analysis is conservative, that is,
a possible overstatement of costs. Whether the costs associated with
Sanitation SOP's are totally new or just how they may be modified over
time can only be determined in individual establishment situations. For
example, task verification and recordkeeping are costs that can be
reduced through efficient management and allocation of resources and
should decrease with experience. In many cases the tasks can be
integrated with current duties.
For many establishments, the cost of Sanitation SOP's should be
offset by changes in the approach to sanitation. Under current
procedures, slaughter operations can not begin until inspection
personnel have given their approval. Under the new procedures all
establishments will be able to commence daily operations without USDA
approval upon successful completion of the preoperational portion of
their Sanitation SOP. When operational sanitation problems are
identified, corrected and documented as they occur by the
establishment, establishment officials will spend less time interacting
with inspectors or responding to inspection findings. For example,
federally inspected establishments currently provide written responses
to approximately 700,000 to 800,000 Processing Deficiency Records
(PDRs) per year. Over 70 percent of these PDRs are for sanitation
deficiencies.
Finally, while FSIS recognizes that keeping sanitation records will
be a new task, FSIS does not necessarily view the time spent verifying
sanitation procedures as a new regulatory cost. FSIS is not changing
any sanitation requirements. It is also true that FSIS has had an
ongoing problem getting all establishments to comply with existing
sanitation requirements. It can, therefore, be argued that some
establishments have not conducted the necessary verification to assure
compliance with existing regulations or have used FSIS employees to
conduct sanitation verification.
e. Final Cost Estimates. After considering the comments, FSIS does
not see a need to adjust the cost estimates shown in Tables 9 and 10.
The final aggregate cost estimates for SOP's are those shown in Table
10. The costs in Table 10 assume that the requirement for SOP's does
not lead to new compliance costs associated with new regulatory
obligations apart from paperwork and recordkeeping. The analysis
assumes that satisfactory sanitation is achieved one way or another
under current procedures and that the changes that will occur with
SOP's have more to do with issues of responsibility and efficient use
of inspection resources. It follows that, for the most part, this
provision of the rule will have no direct effect on the rate, extent or
severity of pathogenic contamination, and thus will also have no effect
on the rate, extent, or severity of foodborne illness. This is not
saying there will be no change in establishment or employee conduct. In
fact, FSIS expects to see more sanitation activities conducted at the
firm's initiative rather than following inspection findings.
2. Costs of Meeting Pathogen Reduction a
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
nd Microbial Sampling
Requirements
a. Summary of Requirements. The final rule implementing HACCP-based
programs establishes pathogen reduction performance standards for
Salmonella. The rule both establishes the standards and defines the
procedures the Agency will use to measure and assure compliance with
the standards. The rule does not specify a minimum testing requirement
for Salmonella. The pathogen reduction performance standards apply to
an estimated 5,522 inspected establishments, 2,682 establishments that
slaughter cattle, hogs, chicken or turkeys and another 2,840
establishments that do not slaughter, but produce raw ground product
from beef, pork, chicken or turkey. If an establishment slaughters two
species, e.g. cattle and hogs, the establishment would be subject to
the standards for both cattle and hogs. The Agency's testing program
would, however, be directed at the predominant species. If an
establishment both slaughters and processes a raw ground product from
that same species, the Agency will test the ground product. If an
establishment produces more than one variety of ground product, the
Agency intends to sample each.
The proposed rule included the same standards but contained a
different approach for enforcement. The proposed rule included the
requirement that each of the 5,522 affected establishments would
collect and analyze one sample for each species or variety of raw
ground product for Salmonella on a daily basis. The establishments
would maintain records from these tests that would be reviewed by
inspection program personnel to determine compliance. The proposed rule
did not include a discussion of how the Agency would use the test
results in a program for regulatory enforcement.
Under the proposal, the results from each establishment's
Salmonella testing program were also to be used as a measure of process
control. This final rule requires that all 2,682 slaughter
establishments implement sampling programs using generic E. coli as a
measure of process control for slaughter and sanitary dressing
procedures.
b. Review of Preliminary Cost Estimates. As discussed earlier under
methodology, the preliminary RIA did not attempt to analyze the overall
impact of complying with the new pathogen reduction standards. The
preliminary RIA did include a detailed analysis of the costs associated
with the requirement that slaughter and raw ground processing
establishments collect and analyze samples for Salmonella on a daily
basis. The laboratory analysis required only a positive-negative
finding, i.e., the proposed rule did not require the analysis necessary
to determine the number of bacteria present in the sample. The cost of
meeting the proposed requirement would vary depending on whether or not
the establishment had an inhouse laboratory. It was assumed that
approximately 20 percent of samples would be collected in
establishments with in-house laboratories. For an establishment without
a laboratory the total cost for each sample was estimated as shown in
Table 11.
Table 11.--Cost of a Salmonella Sample Analysis for Establishments With
No In-House Laboratory
(Dollars)
------------------------------------------------------------------------
Component Cost
------------------------------------------------------------------------
Average Private Laboratory Cost................................. 22.60
Shipping........................................................ 7.00
[[Page 38974]]
Collecting and Packaging........................................ 3.75
-------
Total......................................................... 33.35
------------------------------------------------------------------------
The establishment without an in-house laboratory would also be
required to train an individual to perform aseptic sampling. The cost
components for a Salmonella test at an in-house laboratory were
estimated for the preliminary RIA as shown in Table 12.
Table 12.--Cost of a Salmonella Sample Analysis For Establishments with
An In-House Laboratory
[Dollars]
------------------------------------------------------------------------
Component Cost
------------------------------------------------------------------------
Laboratory Supplies............................................. 5.90
Collecting and Preparing Sample................................. 5.28
Laboratory Analysis (0.5 hours at $18.13 per hour).............. 9.07
-------
Total..................................................... 20.25
------------------------------------------------------------------------
Since the requirements in the final rule have changed
substantially, this section will present only a brief summary of what
was a relatively complex analysis to estimate the total industry
sampling costs associated with the proposed requirements. The costs
associated with the proposed Salmonella testing requirement are
summarized in Tables 13 and 14. Table 13 shows the different cost
components.
Table 13.--Component Costs for Microbial Sampling as Proposed
[$ Thousands]
----------------------------------------------------------------------------------------------------------------
Sample
Training Sampling collection Recording
Establishment category for aseptic plan and and review
sampling development analysis time
----------------------------------------------------------------------------------------------------------------
High........................................................ 10 508 5,267 242
Medium...................................................... 514 1,473 20,555 887
Low......................................................... 604 959 18,624 606
---------------------------------------------------
Subtotal.............................................. 1,128 2,939 44,446 1,735
===================================================
State....................................................... 998 1,588 21,150 688
---------------------------------------------------
Total................................................. 2,126 4,527 65,597 2,423
----------------------------------------------------------------------------------------------------------------
Table 14.--Aggregate Costs of Microbial Sampling as Proposed
[$ Thousands]
----------------------------------------------------------------------------------------------------------------
Number of raw
Establishment category product First year Recurring
operations costs costs
----------------------------------------------------------------------------------------------------------------
High............................................................ 793 6,027 5,509
Medium.......................................................... 2,301 23,429 21,443
Low............................................................. 1,498 20,792 19,230
-----------------------------------------------
Subtotal.................................................. 4,592 50,248 46,181
===============================================
State........................................................... 2,481 24,424 21,838
-----------------------------------------------
Total..................................................... 7,073 74,672 68,020
----------------------------------------------------------------------------------------------------------------
Note: All state establishments were assumed to be low volume producers. Columns may not add to totals due to
rounding.
Table 14 summarizes the first year and annual recurring costs.
Training and sampling plan development costs are one-time first year
costs. Sample analysis and recording costs are both recurring annual
costs. The following notations help characterize the estimated costs
from the preliminary analysis:
Training and plan development costs were based on a total
of 7,073 raw product operations. This total is based on a count of meat
slaughter, poultry slaughter and raw ground processing operations.
Sample collection and analysis and recording and record review costs
were based on a count of 8,329 species-specific operations, i.e., the
total of beef slaughter, pork slaughter, raw ground processing, etc.
Thus, an establishment with beef slaughter, pork slaughter and raw
ground processing would count as two operations for training and plan
development, but three operations for sampling and recordkeeping.
The proposed requirement of one sample per day per species
resulted in low volume federal establishments and state establishments
accounting for over 60 percent of the estimated first year costs (See
Table 14).
The analysis underestimated costs in that with existing
data it was necessary to assume that the 3,029 establishments with raw
ground product operations produced only one product. The proposal would
have required 2 samples per day if an establishment produced both raw
ground beef and raw ground pork on a daily basis.
The analysis overestimated costs in that it counted
operations for minor species or kind ( e.g. sheep and goats). The
proposal did not cover sheep, goats, equine, ducks, geese, etc.
The analysis overestimated costs in that it assumed that
every establishment
[[Page 38975]]
with multiple operations was running each operation every day (260 days
per year).
Each of the 7,073 operations would require a sampling
plan--25 hours for a QC manager at $25.60 per hour for a total of $640
per plan. At $640 per plan, 7,073 plans totaled $4.53 million as shown
in Table 13.
The analysis assumed that 5,275 (approximately 75 percent)
of the 7,073 operations would have to train an individual to perform
aseptic sampling. The total of 5,275 includes all 1,498 low volume raw
operations, 1,275 (55.4%) of the 2,301 medium volume raw operations, 25
(3.2%) of the 793 high volume operations and 2,477 (99.8%) of the State
inspected raw product operations. Training was estimated at $403 per
operation--8 hours with a trainer at $37.50 per hour and a trainee at
$12.87 per hour. Training for 5,275 operations at $403 per operation
would cost $2.13 million as shown in Table 13.
Recording and review time was estimated at 5 minutes per
day for each of the 8,329 species-specific operations. Five minutes per
day equals approximately 21.7 hours per year or an average of
approximately $291 per year per operation based on wages of $18.13 and
$12.87 per year (average of $13.43). The total is $2.42 million as
shown in Table 13. Since the requirement was one sample per day per
species, the cost estimates could also be viewed as 5 minutes per
sample.
c. Comments on the Preliminary RIA. Similar to the preliminary
analysis, the public comments focused on the cost of required
Salmonella sampling and did not address the overall impact of meeting
the proposed pathogen reduction performance standards for Salmonella.
The proposed regulation would have required daily sampling for each
species or kind slaughtered and each type (meat or poultry) of raw
ground product per establishment per day. Comments from individual
establishments indicated that some small establishments could be
required to take 5 or more samples per day. A ``small'' establishment
currently slaughtering three different species (beef, swine and lamb)
and producing multiple raw ground products estimated they would need
approximately 2,200 samples per year at a cost of approximately $77,000
per year. That is over eight per day based on a 260 day work year. A
``small'' ground meat processing establishment estimated they would
need over 500 samples from approximately 350,000 pounds of annual
production.
Several comments from ``small'' establishments pointed out that the
proposed sampling program placed a disproportionate burden on small
establishments from two perspectives. First, ``small'' establishments
have less production over which to spread the cost of sampling. Second,
smaller establishments tend to be the ones that slaughter more species
or kind and produce more varieties of raw ground product. Other
comments pointed out that the proposed Salmonella testing would not
provide a good procedure to validate process control.
There were also comments that referred to the cost of the product
that is lost or damaged during sample collection. A turkey processor
noted that the value of a 40 pound tom is $63.60 at wholesale price.
The same comment pointed out that shipping costs could be very high,
especially if next day service is required.
Several comments noted that the IFSE study estimated costs for
microbiological testing that were far higher than the cost estimates
provided by FSIS. Another commenter noted that microbiological testing
is being proposed to correct a deficiency of an inspection system that
is currently unable to detect microbial contamination of meat. If
mandatory inspection is a federally funded program, why not the
``correction'' of the system?
Most of the comments referred to the cost of the proposed
requirement and were not comments on the methodology used to determine
costs in the preliminary analysis. One comment that did address the
cost methodology had calculated the cost of a Salmonella test at $38.00
to $44.50 per test where FSIS used a cost of approximately $33.00 to
$34.00. There was some confusion concerning the proposed requirements.
Some comments indicated the establishments believed that they would
have to test every product line. Other comments based estimates on a
far costlier test for Salmonella indicating they assumed the test would
require information concerning the number of bacteria present, not just
a positive-negative result.
There were also comments that suggested that FSIS has overestimated
the cost of microbial sampling because, as the amount of laboratory
analysis increases, the cost per sample will probably decrease. Other
commenters pointed out that demand will lead to simpler and less costly
new methods development.
d. Response to Comments. The changes in the final rule eliminate
the issues raised by most of the comments. The comments concerning the
burden on ``small'' establishments made a convincing argument that
``small'' establishments could not afford to implement the microbial
sampling program as proposed. The final rule does not include a minimum
testing requirement for Salmonella. Each individual establishment can
conduct the level of testing they deem necessary to provide assurance
that they are meeting the pathogen reduction performance standards for
Salmonella.
The Agency agrees with public comments and conclusions reached at
technical conferences that the proposed Salmonella testing would not
have provided a good measure of process control. The final rule
requires that all slaughter establishments implement testing programs
using generic E. coli to validate control of slaughter and sanitary
dressing procedures. After reviewing all public comments and other
materials made available during the comment period, FSIS concluded that
using generic E. coli is more practical. Generic E. coli is generally
present in the feces of mammals and birds and is, therefore, an
excellent indicator of fecal contamination. It has a higher frequency
than Salmonella and can be tested and quantified relatively less
expensively and, therefore, provides a more efficient measure of
control of slaughter and sanitary dressing procedures. Testing for
generic E. coli is also easier for in-house establishment laboratories.
By basing E. coli sampling programs on production volume, the
Agency is responding to small establishment concerns over equity of the
regulatory burden. In addition, establishments with very low production
will be required to conduct sampling for only a limited time period
each year. Sampling will only be required for slaughter establishments.
Establishments slaughtering more than one kind of poultry or species of
livestock will be required to sample only the kind or species
representing the most production. There will also be provisions for
decreasing the number of samples after implementation of HACCP plans
and provisions for using alternative generic E. coli sampling programs
in cases where the establishment can present data demonstrating control
of slaughter and sanitary dressing procedures.
The comments referring to the value of lost product identified a
cost that was not addressed in the preliminary analysis. Such costs
will not be a factor for the final rule because beef and pork samples
collected by FSIS will use the wet sponge swab technique and poultry
samples will be collected using a whole
[[Page 38976]]
bird rinse. In both cases, no product will be damaged or lost.
With respect to comments referring to high microbial sampling costs
identified by the IFSE study, FSIS notes that the Agency's preliminary
cost estimates were based on the proposed regulatory requirement of one
test per species (carcass or raw ground product) per day for
Salmonella. The IFSE study based their per establishment costs on a
microbiological testing program currently being used in a beef
slaughter establishment. The cost estimates generated by the IFSE study
were not related to the testing program outlined in the proposed rule.
The comments were correct that FSIS based the preliminary cost
analysis on existing laboratory methods and on current laboratory cost
estimates. The comments suggesting less expensive methods are only
speculative. There is no way to estimate potential new methods. While
there is no way to predict the effect of increased demand on costs, it
seems reasonable to expect that, in the long run, laboratory analysis
costs per sample will go down as more firms implement microbial
sampling programs. FSIS notes that short run costs could actually
increase as demand goes up faster than the supply of laboratory
capability. In the long run, however, establishments should benefit
from quantity discounts and lower fixed costs per sample as the total
number of analyses increases.
e. Final Cost Estimates. The final rule requires that all
establishments slaughtering cattle, hogs, chickens or turkeys or
producing a raw ground product from these species or kind meet a new
pathogen reduction performance standard for Salmonella. This
requirement applies to an estimated 5,522 establishments as shown in
Table 15. Because the standard has been established using the baseline
studies that estimate a national prevalence by carcass, the Agency does
not have an estimate for the number of establishments that are
currently meeting the standard. The baseline studies do not provide
data on how pathogen levels vary between establishments and include
data from only the larger establishments that represent most of the
production.
Table 15.--Establishments Affected by the Pathogen Reduction Performance
Standard
------------------------------------------------------------------------
Very
Category small Small Large Total
------------------------------------------------------------------------
Cattle and hog slaughter............ 1,876 376 66 2,318
Poultry slaughter................... 100 121 143 364
Raw ground processing............... 1,413 1,358 69 2,840
-----------------------------------
Total......................... 3,389 1,855 278 5,522
------------------------------------------------------------------------
This analysis of how the Salmonella standards will impact the 5,522
establishments will, by necessity, be primarily a qualitative
discussion. The analysis will, however, develop two scenarios that can
be used to present a range of potential impacts.
Since the focus of this rule is about reducing pathogens in or on
raw meat and poultry products, it is anticipated that the potential
costs are greatest for those slaughter establishments that are
currently not meeting the new pathogen reduction performance standards.
For slaughter establishments, the potential costs take one of two
forms.
First, even though the rule does not require establishments to test
for Salmonella, the Agency recognizes that some establishments may
conduct their own Salmonella testing programs to avoid failing a series
of tests conducted by the Agency. Thus, it can be argued that the
Agency's intent to implement establishment specific testing for
Salmonella is indirectly requiring the industry to routinely monitor
their Salmonella levels to assure they will be in compliance.
The manner in which FSIS will implement its Salmonella testing
program should help keep establishment costs down. During the first
phase, referred to as pre-implementation testing, FSIS will test
product from each slaughter or raw ground operation and share those
results with the establishment. Thus, before FSIS begins the actual
enforcement of the Salmonella performance standards, the Agency will
provide each establishment with a status report on Salmonella
incidence. This pre-implementation testing will precede HACCP
implementation, which occurs from 18 to 42 months after publication of
the final rule. The pre-implementation results will assist the
establishments in preparing for implementation of HACCP and the
pathogen reduction performance standards. Establishments with low
incidence of Salmonella will have some level of assurance that they are
already meeting the new Salmonella standards.
The second type of potential cost relates to the question of
whether firms will have to make permanent changes in their processing
or production practices in order to comply with the pathogen reduction
performance standards for Salmonella. Reducing pathogens for slaughter
establishments involves either modifying the incoming animals or birds,
improving the dressing procedures so as to reduce contamination during
procedures such as hide removal and evisceration, or using
interventions such as antimicrobial treatments to kill or remove the
pathogens following contamination. For many establishments, the process
of implementing HACCP programs may, by itself, improve the dressing
procedures sufficiently to meet the new standard. Other establishments
may have to choose between slowing production lines, modifying some
attribute of their incoming live animals or birds, or adding post-
dressing interventions such as the new steam vacuum process or
antimicrobial rinses.
This analysis will examine the two types of costs for the three
industry segments of poultry slaughter, meat slaughter and raw ground
processing. The analysis develops two cost scenarios to estimate the
impact of the new pathogen reduction standards for Salmonella. As
discussed earlier, the Agency does not have an estimate for the number
of establishments that are currently meeting the standards.
The two cost scenarios are based on three general premises. The
first premise is that a certain portion of large establishments will
take whatever action is necessary to provide assurance that they are
meeting all regulatory requirements. The second premise is that the
establishments that are typically having problems controlling
operations today will also have problems meeting the Salmonella
standards. The low cost scenario is based on these first two premises.
FSIS has historically found serious control problems in from 5 to 10
[[Page 38977]]
percent of establishments. The recent 1,000 establishment review found
serious control problems in 8.9 percent of 358 randomly selected
establishments. The 1993 review of establishments with the New Turkey
Inspection System found 3 of 26 establishments with problems with
product ready for shipment. A 1991-1992 survey of poultry reprocessing
found that while only 2 percent of poultry is reprocessed off-line,
from 5 to 10 percent of the establishments had very high reprocessing
rates.
The high cost scenario is based on a third premise that (1)
approximately half of the affected establishments are currently not
meeting the standards and that (2) most large establishments and the
majority of smaller establishments will take some action to assure
compliance with the Salmonella standards.
As shown in Table 15, there are 2,318 cattle or swine slaughter
establishments that must meet the pathogen reduction performance
standards for Salmonella. The Agency does not have information that
would indicate that Salmonella testing is routinely conducted by a
major segment of the beef or pork industry. The baseline studies have
shown a one percent positive rate for steers and heifers and a 2.7
percent positive rate for cows and bulls. In addition, the Agency does
not know how, or if, beef and pork establishments would respond to the
Agency's Salmonella testing initiative. Given the relatively low levels
of Salmonella, most establishments will probably choose to depend on
the assurance provided by a validated, well functioning HACCP program.
To develop a low cost scenario, the Agency assumes that the 66
large establishments would initiate daily testing using in-house
laboratories ($20.25 per analysis--$347,490 per year) and that half of
the 376 small establishments would conduct weekly testing at outside
laboratories ($33.35 per analysis--$326,030 per year). Under a high
cost scenario, the large establishments would conduct 8 tests per day
($2.78 million per year), the small establishments would all conduct
one test per week ($652,059 per year) and half (938) of the very small
establishments would conduct a test each month ($375,388 per year). The
low and high Salmonella sampling costs for cattle and hog slaughter
operations are summarized in Tables 16 and 17, respectively.
Beyond testing, there is the issue of whether the required actions
of developing and implementing process control procedures will, by
themselves, be sufficient to meet the Salmonella standards or whether
changes in processing methods will also be required. FSIS recognizes
that beef and pork dressing procedures involve a lot of manual steps
and, therefore, it is reasonable to assume that substantial pathogen
reduction can be accomplished through training and careful monitoring
of the dressing procedures. This is especially true for the low volume
establishments that do not have automated lines and use what is known
as the ``bed kill'' dressing process.
For slaughter establishments that do have to make process
modifications, there are several options available. First, FSIS is
aware of establishments that are testing live animal washing systems.
Second, the preliminary analysis included estimates for the cost of
using different antimicrobial treatments for varying sizes of cattle or
hog slaughter establishments. The lowest cost option was a hot water
spray system with no cabinet. The cost for that system was estimated at
$.08 per carcass or approximately $8.78 million annually for all cattle
and hog establishments. In contrast, a pre-evisceration acid spray
system with both a pre-wash spray cabinet and a sanitizing cabinet was
estimated at $.79 per carcass for a low volume establishment. A TSP
system for cattle was estimated at $.85 per carcass for a low volume
establishment.
The preliminary analysis noted that 23 establishments were already
using acetic or lactic acid sprays on carcasses either before or after
evisceration. Other establishments had requested approval for citric
acid, TSP, or hot water.
Third, FSIS has now approved the new steam vacuum systems for beef
and pork operations. The installation of a steam vacuum system is
estimated at $10,000 per establishment, with expectations that
increased use will result in lower prices. Annual increased utility
costs to run a steam vacuum system are estimated at $4,000. Maintenance
cost is estimated at 5 percent or $500 per year.
For a low cost option, it is assumed that 10 percent of the large
establishments must install a steam vacuum system to meet the new
requirements and that half of 376 small establishments must use a hot
water rinse at $.08 per carcass. The initial costs for the steam
systems would be $70,000. Annual operating costs would be $31,500.
Annual operating costs for hot water rinses on half the small
establishment production would be $915,000.
Under a high cost option, it is assumed that half (33) of the large
establishments would have to install steam systems and that all small
and very small establishments would use hot water rinses. The initial
cost for steam systems would be $330,000. Annual operating costs would
be $148,500. Annual costs for hot water rinses would be $2,075,387. The
low and high process modification costs for cattle and hog slaughter
operations are summarized in Tables 16 and 17, respectively.
As shown in Table 15, there are an estimated 2,840 establishments
that produce raw ground products using ingredients from other
establishments. These establishments do not have the same opportunities
to reduce Salmonella levels as do slaughter establishments. They can
control growth by avoiding temperature abuse and can limit cross-
contamination, but basically they must depend on the Salmonella levels
of their incoming product in order to meet the performance standards.
These establishments may choose to test incoming product in order to
eliminate suppliers whose product is found to be positive. Larger
establishments that are important customers of other suppliers may
choose to include pathogen requirements in their purchase
specifications.
For a low cost scenario, this analysis assumes that the 69 large
firms would analyze one sample per day using in-house laboratories
($20.25 per analysis) and that 10 percent (136) of the small firms
would test one sample per week using an outside laboratory ($33.35 per
analysis). Under a high cost scenario, this analysis assumes that half
(679) of the small firms would test one sample per week and that the
large firms would double their sampling. Under each scenario, it is
assumed that the large establishments would begin testing 12 months
after publication and the small establishments 24 months after
publication. These starting dates correspond with the end of the
Agency's pre-implementation testing. The low and high Salmonella
sampling costs for raw ground processors are summarized in Tables 16
and 17, respectively.
As shown in Table 15, there are 364 poultry slaughter operations
that will be required to meet the new pathogen reduction performance
standards for Salmonella. FSIS believes that almost all of the larger
establishments in the poultry industry currently conduct routine or
periodic analyses for Salmonella and will use their ongoing testing
programs to (1) establish and validate their HACCP controls to assure
they will initially comply with the new pathogen reduction performance
[[Page 38978]]
standard, and (2) periodically verify continuing compliance. Therefore,
the costs for additional Salmonella testing in the poultry industry
will be minimal.
For cattle and hog operations, this analysis used the cost of
antimicrobials from the preliminary analysis in estimating possible
process modification costs. In contrast, for the poultry industry,
meeting the pathogen reduction performance standards is clearly not
analogous to meeting the proposed antimicrobial requirement. The
preliminary analysis assumed that 90 percent of all high volume poultry
processors and 70 percent of all low or medium volume processors
already meet that proposed requirement.
FSIS recognizes that many poultry establishments may have to modify
existing procedures to meet the new standards for Salmonella. Where
cattle and hog dressing operations still include many manual procedures
that can be easily controlled by improved training and monitoring, the
poultry slaughter industry is highly automated, increasing the
probability that process control may require modifications of
equipment, facilities, or incoming product. However, because there is
extensive vertical integration in the poultry industry, many firms have
the added option of controlling Salmonella in the live birds. There is
evidence that controlling Salmonella in feed and controlling rodents in
poultry houses can have a substantial impact on the level of Salmonella
in birds entering the slaughter facility.
In the late 1980's, FSIS tested some alternative processing methods
at an establishment in Puerto Rico. Two methods included a counterflow
scalder and a hot rinse immediately following the scald tank. At the
time, FSIS recognized that it may be expensive to retrofit an existing
establishment with a counterflow scalder because of the physical space
and plumbing required.
Recognizing that other options are available, this analysis
develops potential cost estimates based on the addition of TSP rinses.
TSP rinse systems for the poultry industry are relatively expensive. It
is currently estimated that a TSP installation would cost $40,000 per
line with an operating cost of $0.003 per broiler or $0.014 per turkey.
As a low cost option, FSIS assumes that 36 large poultry
establishments (27 broiler and 9 turkey establishments) will add TSP
systems. Average broiler production is estimated at 35 million and
average turkey production at 6 million. Annual average operating cost
are, therefore, $105,000 for a chicken slaughter operation and $84,000
for a turkey slaughter operation. Each large poultry establishment is
assumed to have 2 lines. Small establishments were assumed to average
1.5 lines.
As a high cost option, FSIS assumes that 182 (100 large and 82
small) poultry establishments will have to add TSP systems to meet the
new requirements. The 182 establishments include 136 chicken and 46
turkey slaughter establishments. The total low cost scenario for
poultry slaughter operations is summarized in Table 16. The high cost
scenario is summarized in Table 17.
Table 16.--Salmonella Testing and Process Modification Costs
[Low Cost Scenario--$000]
----------------------------------------------------------------------------------------------------------------
Industry sector cost category Year 1 Year 2 Year 3 Year 4 Year 5+
----------------------------------------------------------------------------------------------------------------
Sampling by Raw Ground Processors............................. 0 363 599 599 599
Process Changes for Cattle and Hog Slaughter Operations....... 0 86 489 947 947
Sampling by Cattle and Hog Slaughter Operations............... 0 347 674 674 674
Process changes for poultry slaughter operations.............. 0 4,676 3,591 3,591 3,591
-------------------------------------------------
Total................................................... 0 5,472 5,353 5,811 5,811
----------------------------------------------------------------------------------------------------------------
Table 17.-- Salmonella Testing and Process Modification Costs
[High Cost Scenario--$000]
----------------------------------------------------------------------------------------------------------------
Industry sector cost category Year 1 Year 2 Year 3 Year 4 Year 5+
----------------------------------------------------------------------------------------------------------------
Sampling by raw ground processors............................. 0 $727 $1,904 $1,904 $1,904
Process changes for cattle and hog slaughter operations....... 0 404 1,063 2,101 2,224
Sampling by cattle and hog slaughter operations............... 0 2,780 3,807 3,807 3,807
Process Changes for Poultry Slaughter Operations.............. 0 12,988 18,979 18,144 18,144
-------------------------------------------------
Total................................................... 0 16,899 25,753 25,956 26,079
----------------------------------------------------------------------------------------------------------------
After the initial implementation years, the annual cost for all
three industry sectors is approximately $5.8 million for the low cost
scenario. Under the high cost scenario, the total recurring industry
cost of meeting the new performance standards is $26.1 million per
year.
The high and low cost scenarios have addressed the potential costs
of process modification when establishments find they are not meeting
critical limits set to assure compliance with the new pathogen
reduction standards for Salmonella. While the scenarios have addressed
permanent process modifications, it is also reasonable to assume that
meeting the Salmonella standards would involve some day-to-day process
adjustments, i.e., corrective actions that do not involve adding new
procedures or new equipment. One example would be the decision to
reduce line speeds on a day when the incoming live animals are
particularly dirty. The Agency believes that many establishments
already take this type of precautionary action.
Under HACCP, there will presumably also be some costs associated
with corrective actions related to critical limits set for the purpose
of meeting existing regulatory limits. As discussed earlier under
methodology, the preliminary analysis did not include any costs for
taking corrective actions when such deviations from critical limits
occur. If this rulemaking were implementing a new regulatory program
where none had previously existed, one might expect to see
establishments experiencing considerable additional costs due to
temporary production down-time, the need to rework or condemn product
or the need to
[[Page 38979]]
investigate the causes of deviations and develop corrective action
plans. Meat and poultry inspection is, however, an existing regulatory
program with a broad range of requirements that are well understood by
the regulated industry and enforced by the daily presence of an
inspector. The system already includes procedures whereby
establishments are (1) implementing corrective actions for almost a
million written Processing Deficiency Records (PDRs) annually, (2)
developing written Establishment Improvement Programs (PIPs) when
continuing problems with facility maintenance are observed, and (3)
developing Corrective Action Plans when establishments experience
serious ongoing problems in complying with existing sanitation or other
regulatory requirements. In addition, the regulations already include a
wide array of time and/or temperature requirements for cooking and
chilling processed products. Many of the existing regulations have been
developed with the standards of food safety in mind that are
represented by critical limits under HACCP.
Within this existing regulatory framework establishments already
experience down-time and expend considerable resources discussing
causes of problems and plans for preventing future occurrences. Thus,
from the perspective of looking at the existing system, FSIS does not
envision that establishments will experience a significant increase in
the costs of corrective action and believes the new system can help
establishments avoid situations that currently cost them resources to
correct. FSIS views the new program as a more effective way of assuring
that establishments meet already established health and safety related
requirements. For example, the requirement that establishments develop
and implement sanitation SOPs does not include any change in existing
sanitation standards. Under the existing system, FSIS takes
responsibility for determining when establishments meet the standard
and when they can operate. Under the new program, establishments will
have to document their procedures and take responsibility for
implementing those procedures before they begin operations. FSIS
recognizes that some establishments will have to spend more time
cleaning facilities and equipment. Today, many establishments conduct
sanitation procedures only after inspection has identified a problem.
FSIS does not, however, view such increased costs of sanitation as a
cost of this rulemaking. If this rule imposes such additional costs, it
is because the HACCP-based program will inherently provide improved
enforcement procedures in situations where firms have been substituting
the inspector's sanitation review for their own production control.
In summary, under the broader cost category of process modification
and corrective action, FSIS has concluded that the cost of this rule is
most appropriately addressed under the subject of potential costs
associated with meeting the new pathogen reduction standards. The low
and high cost scenarios provide the estimates for these potential
costs. As will be discussed under the next topic of generic E. coli
testing, these low and high cost scenarios include the types of actions
establishments would take if they were also experiencing continuing
difficulty in meeting criteria established for generic E. coli.
The final rule also requires that all establishments that slaughter
cattle, swine, chickens or turkeys implement testing programs for
generic E. coli to validate control of slaughter and sanitary dressing
procedures. All samples will be analyzed for quantity, i.e., number of
bacteria present. These testing programs will use production volume as
the basis for determining the frequency at which establishments will
conduct testing for generic E. coli. The frequencies for E. coli
testing for each slaughter species are as follows:
cattle--1 test per 300 carcasses
swine--1 test per 1,000 carcasses
chickens--1 test per 22,000 carcasses
turkeys--1 test per 3,000 carcasses
These frequencies were selected so that, in the subgroup of
establishments accounting for 99 percent of total production for each
species, the 5 percent of establishments with the highest production
volume would each have to conduct a minimum of 13 E. coli tests, or one
test window, each day. With these frequencies, 90 percent of all
cattle, 94 percent of all swine, 99 percent of all chicken, and 99
percent of all turkeys will be slaughtered in establishments conducting
a minimum of one E. coli test per day.
The above frequencies notwithstanding, all slaughter establishments
must conduct sampling at a minimum frequency of once per week.
Establishments with very low volumes, slaughtering at or below 6,000
cattle, 20,000 swine (or a combination of such livestock not to exceed
a total of 20,000, with a minimum of 6,000 cattle), 440,000 chickens,
or 60,000 turkeys annually, will only be required to sample once per
week until a sampling window has been completed where the results
indicate that the slaughter and dressing process is under control. Once
these criteria have been met, these establishments will be required to
complete a new sampling window once each year, or when a change has
been made in the slaughter process or personnel. This cost analysis
assumes that the average low volume establishment will have to complete
two windows (26 samples) each year before they meet the established
criteria, recognizing that some establishments will meet the criteria
on their first window and others may require three or more.
The final rule also provides that slaughter establishments
operating under a validated HACCP system may use a sampling frequency
other than that provided for in the regulation if the alternative
sampling frequency is an integral part of the establishment's HACCP
verification procedures and if FSIS does not determine, and notify the
establishment in writing, that the alternative frequency is inadequate
to verify the effectiveness of the establishmen's slaughter and
sanitary dressing controls. In addition, the final rule allows an
establishment to use an existing generic E. coli sampling program if it
can provide the data necessary to show that the existing plan is
assuring adequate control. This analysis has not attempted to account
for alternative sampling frequencies. It is likely that any reduction
in generic E. coli sampling would be offset by alternative verification
procedures.
The estimated component costs for collecting, shipping and
analyzing a generic E. coli sample at a commercial laboratory are shown
in Table 18.
Table 18.--Cost of a Generic E. coli Sample Analysis Commercial
Laboratory
[Dollars]
------------------------------------------------------------------------
Component Cost
------------------------------------------------------------------------
Average private laboratory cost................................. 13.00
Shipping........................................................ 7.00
Collecting and packaging........................................ 3.75
-------
Total..................................................... 23.75
------------------------------------------------------------------------
The component costs for collecting and analyzing a generic E. coli
sample at an FSIS field laboratory are shown in Table 19.
[[Page 38980]]
Table 19.-- Cost of a Generic E. coli Sample Analysis FSIS Field
Laboratory
[Dollars]
------------------------------------------------------------------------
Component Cost
------------------------------------------------------------------------
Sample collection supplies...................................... 1.45
Sample collection (0.5 hrs/$18.60 per hr)....................... 9.30
Laboratory supplies............................................. 2.90
Laboratory analysis (0.5 hrs/$18.60 per hr)..................... 9.30
-------
Total..................................................... 22.95
------------------------------------------------------------------------
Based on the above average cost estimates, this final RIA uses a
per sample cost of $24 per analysis, recognizing that establishments
with in-house laboratories will be able to conduct sample analysis at
lower costs. In using the average cost of $24 per sample, FSIS is
providing an upper bound estimate. The corresponding cost per sample
for Salmonella was $33.35 at a commercial laboratory. Thus, using
generic E. coli instead of Salmonella for process control validation
has reduced the per sample cost by approximately 30 percent.
Aggregate annual sampling costs were estimated by applying the
sampling frequencies to annual production data recorded by the Animal
Disposition Reporting System (ADRS), an existing Agency database. The
ADRS includes the total annual production in terms of number of
livestock or poultry slaughtered for each federally inspected
establishment. Table 20 summarizes estimates for the number of samples
that will need to be collected and analyzed each year by the 364
inspected poultry slaughter operations. As shown in Table 20, the 364
establishments will be required to analyze 419,123 samples annually.
Table 21 summarizes estimates for the number of samples that will need
to be collected and analyzed each year by the 2,318 inspected cattle
and swine slaughter operations. As shown in Table 21, the 2,318
establishments will be required to analyze 252,640 samples annually.
The smallest 2,098 slaughter operations (less than 6,000 cattle,
20,000 swine, 60,000 turkeys and 440,000 chickens) will be required to
analyze one sample per week until they demonstrate compliance with
established criteria. This analysis assumes an average of 26 samples
per establishment per year, recognizing that some may need more and
others less. These 2,098 smaller slaughter operations (over 78 percent
of the total 2,682) will not be required to conduct any further
analyses within a given year unless major changes to facilities,
equipment or personnel occur.
Tables 20 and 21 were constructed assuming that all establishments
operate on a 52 week, 260 day, 40 hours per week, 2,080-hour work-year.
As discussed above, this final RIA does not attempt to account for
possible reductions in sampling frequency in establishments where the
establishment can demonstrate an existing acceptable alternative
program or where alternative frequencies are an integral part of
successful HACCP verification procedures.
Tables 20 and 21 incorporate data from the preliminary analysis
showing that there are 1,328 state-inspected slaughter establishments,
with an estimated 1,270 slaughtering cattle or swine and 58
slaughtering poultry. Based on additional data collected in July 1995,
FSIS anticipates that 50 of the state-inspected cattle or swine
slaughtering establishments will exceed the limits of 6,000 cattle or
20,000 hogs and will be required to conduct a minimum of one sample per
week on an ongoing basis. It is further assumed that none of these
establishments will have to conduct more than one per week, i.e.,
cattle slaughter is under 15,600 (300 x 52) and swine slaughter is
under 52,000 (52 x 1,000). The other 1,220 state-inspected cattle or
swine establishments would average 26 samples per year (2 windows). The
July 1995 data indicate that all 58 state-inspected establishments
slaughtering poultry process fewer than 60,000 turkeys and 440,000
chickens annually.
Table 20.--Required E. Coli Sampling for Poultry Slaughter Establishments
----------------------------------------------------------------------------------------------------------------
Annual slaughter production Number Average sampling rate Annual
category establishments Sampling range per day per establishment samples
----------------------------------------------------------------------------------------------------------------
Chickens over 45.8 million......... 60 Over 8 per day........ 10.9 Per Day.......... 170,300
Chickens 5.72 to 45.8 million...... 125 1-8 per day........... 4.7 per day........... 152,230
Chickens 440,000 to 5,720,000...... 23 1 per week-1 per day.. 1.9 per week.......... 2,215
Turkeys over 6.24 million.......... 18 Over 8 per day........ 12.7 per day.......... 59,540
Turkeys 780,000 to 6,240,000....... 25 1-8 per day........... 4.8 per day........... 31,330
Turkeys 60,000 to 780,000.......... 5 1 per week-1 per day.. 2.7 per week.......... 700
Chickens under 440,000 and Turkeys 108 NA.................... One per week (26 2,808
under 60,000. weeks).
----------------------------------------------------------------------------
Total........................ 364 NA.................... NA.................... 419,123
----------------------------------------------------------------------------------------------------------------
NA--Not applicable.
Table 21.-- Required Generic E. coli Sampling for Swine and Cattle Slaughter Establishments
----------------------------------------------------------------------------------------------------------------
Annual slaughter production Number of Average sampling rate Annual
category establishments Sampling range per establishment samples
----------------------------------------------------------------------------------------------------------------
Cattle over 780,000................ 16 10 or more per day.... 14.8 per day.......... 61,750
Cattle between 78,000 and 780,000.. 50 1-10 per day.......... 3.2 Per Day........... 41,340
Hogs over 2,080,000................ 17 8 or more per day..... 11.6 per day.......... 51,090
Hogs between 260,000 and 2,080,000. 29 1-8 per day........... 4.0 Per Day........... 30,290
Cattle between 6,000 and 78,000 and/ 216 One per week--one per 1.5 per week.......... 16,430
or hogs between 20,000 and 260,000. day.
Under 6,000 cattle and under 20,000 1,990 NA.................... One per week (26 51,740
Hogs. weeks).
----------------------------------------------------------------------------
Total........................ 2,318 NA.................... NA.................... 252,640
----------------------------------------------------------------------------------------------------------------
NA--Not applicable.
[[Page 38981]]
The total costs for meeting the final requirements for generic E.
coli sampling in poultry and livestock slaughter establishments are
summarized in Tables 22 and 23. These tables use the same cost
estimates as the preliminary analysis for requirements such as plan
development, training and recording and reviewing analytical results.
Plan development is $640 per plan. The preliminary analysis assumed
that 75 percent of operations will require training for aseptic
sampling at $403 per operation. Recording and reviewing laboratory
results averages 5 minutes per sample at an average wage of $13.43.
As shown in Table 22, implementation costs (training and sampling
plan development) for generic E. coli sampling in poultry
establishments will be $286 thousand. For cattle and swine
establishments, the implementation costs are $2.34 million as shown in
Table 23. Annual recurring costs total $10.5 million for for the 364
poultry establishments and $6.35 million for the 2,318 cattle and swine
establishments. The total implementation costs for all 2,682 slaughter
establishments are $2.63 million. The total recurring costs are $16.85
million.
In addition to the required sampling costs, there is the question
of whether there will be additional compliance costs for establishments
where test results indicate the performance criteria generic E. coli
are not being met. In addressing this question, FSIS considered several
factors. First, FSIS acknowledges that some establishments will find
they are in compliance with the pathogen reduction standards for
Salmonella, but are not meeting the performance criteria for generic E.
coli. Second, the fact that the performance criteria are not
established as enforceable regulatory standards does not mean that
there will not be compliance costs. Third, the compliance actions
identified for meeting the Salmonella standards (steam vacuum system,
TSP systems and hot water rinses), are the same actions establishments
would likely employ to achieve compliance with the performance
criteria.
Table 22.--Costs for Implementing Generic E. coli Sampling Programs in Poultry Slaughter Establishments
[Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
Number of Samples
establishments Training Sampling collection Recording
Production Category (number of for aseptic plan and and review
annual sampling development analysis (recurring)
samples) (recurring)
----------------------------------------------------------------------------------------------------------------
Turkeys Under 60,000; Chickens Under 440,000 108
(2,808) 44 69 67 3
Turkeys Between 60,000 and 780,000; Chickens
Between 440,000 and 5,720,000.............. 28
(2,915) 6 18 70 3
Turkeys over 780,000; Chickens over
5,720,000.................................. 228
(413,400) 3 146 9,992 463
-------------------------------------------------------------------
Total................................. 364
(419,123) 53 233 10,059 469
----------------------------------------------------------------------------------------------------------------
Table 23.--Costs for Implementing Generic E. coli Sampling Programs for Cattle and Swine Slaughter
Establishments
[Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
Number of Samples
establishments Training Sampling collection Recording
Production category (number of for aseptic plan and and review
annual sampling development analysis (recurring)
samples) (recurring)
----------------------------------------------------------------------------------------------------------------
Cattle Under 6,000; Hogs Under 20,000....... 1,990
(51,740) 802 1,274 1,242 58
Cattle Between 6,000 and 78,000; Hogs
Between 20,000 and 260,000................. 216
(16,430) 54 138 394 18
Cattle over 78,000; Hogs over 260,000....... 112
(184,470) 1 72 4,427 206
-------------------------------------------------------------------
Total................................. 2,318
(252,640) 857 1,484 6,063 283
----------------------------------------------------------------------------------------------------------------
After considering the above factors, FSIS concluded that if the low
cost scenario for compliance with Salmonella standards proves to be
more accurate, there will likely be more separate compliance costs for
generic E. coli. As the costs for Salmonella compliance go up, the
likelihood of separate generic E. coli costs goes down. It is important
to note that under the high cost scenario, all cattle and swine
slaughter establishments are using the steam vacuum system or a hot
water rinse and half of all poultry slaughter establishments are using
TSP systems. Under this scenario, it is difficult to imagine that any
establishments would
[[Page 38982]]
still be failing to meet the performance criteria for generic E. coli.
FSIS considered the possibility that the smaller establishments
conducting only seasonal testing would increase testing to cover the
whole year to provide better assurance of control over sanitary
dressing procedures. However, FSIS rejected this possibility after
considering the cost pressures on small businesses. FSIS would
certainly not expect to see these establishments use both expanded
testing and hot water rinses.
3. HACCP Programs--Plan Development and Annual Reassessment Costs
a. Summary of Requirements. The proposed rule included a
requirement that each inspected establishment develop a written HACCP
plan for each distinct ``process'' conducted on the premises. The
proposed rule identified nine process categories that would require
separate HACCP plans. Each plan would include: identification of the
processing steps which present hazards; identification and description
of the CCP for each identified hazard; specification of the critical
limit which may not be exceeded at the CCP (and if appropriate a target
limit); a description of the establishment monitoring procedures; a
description of the corrective action to be taken if the limit is
exceeded; a description of the records which would be generated and
maintained regarding this CCP; and a description of the establishment
verification activities and the frequency at which they are to be
conducted.
The requirements in the final rule for HACCP plans are essentially
the same. The final rule requires that each establishment conduct a
hazard analysis and then develop a comprehensive HACCP plan that covers
each hazard identified. The final rule has eliminated the nine process
categories because the sequencing of HACCP implementation will be based
on establishment size and not on process categories. The final rule
also includes the provision that each plan be reassessed on an annual
basis.
b. Review of Preliminary Cost Estimates. Using existing databases
(PBIS and ADRS) FSIS estimated that the 6,186 federally inspected
establishments would require 16,899 HACCP plans, an average of 2.73
plans per establishment. It was assumed that each of the 2,893 state
inspected establishments would have 2.1 plans per establishment for a
total of 6,120 plans. The total number of plans for all establishments
is, therefore, 23,019. The Agency requested specific comments on the
assumptions used to estimate the number of state plans, but received
none. In estimating the cost of HACCP plan development for federally
inspected establishments, FSIS used the following cost estimates as
shown in Table 24.
Table 24.--HACCP Plan Development Costs
------------------------------------------------------------------------
Plan sequence
Plan difficulty --------------------------
First Second Third
------------------------------------------------------------------------
Easy......................................... 4,000 2,000 1,000
Moderate..................................... 8,000 4,000 2,000
Difficult.................................... 12,500 6,250 3,125
------------------------------------------------------------------------
Table 24 accounts for both the complexity or difficulty of the plan
and the experience gained by developing previous plans. The table was
developed from several sources including discussions with a number of
private sector food consultants and the results of the HACCP Pilot
Program Cost Findings study which was conducted by RTI and completed in
August 1994. The RTI Study found that the nine pilot establishments
reported plan development costs ranging from $607 to $15,750.
For state establishments, FSIS assumed an average cost of $2,000
for 6,120 plans. For the federally-inspected establishments, the above
table generated an average cost of approximately $2,020 per plan. The
resulting average cost is relatively low because the preliminary
analysis credited each establishment with having developed one plan
prior to HACCP because of the need to develop plans for sanitation
SOPs, microbial sampling and time-temperature controls. It was assumed
that the experience gained in developing plans for these three near-
term interventions could be applied to their first HACCP plan.
The total cost for developing 23,019 plans was estimated
at approximated $46.4 million ($34.14 million federal and $12.24
million state) spread over a 3 year implementation period.
c. Comments on the Preliminary RIA. There were several specific
comments on the cost of developing a HACCP plan. Examples include:
To write each plan would cost around $9,000.
Average time to draft a plan is 300 hours.
Average time of 300 hours at $125 per hour ($37,500).
An average of $5,000 per establishment.
Approximately $1,000 to $1,500 per establishment.
More general comments stated that FSIS had underestimated or
overestimated the cost of plan development or that FSIS should develop
or pay for the cost of developing plans. There were also comments that
indicate that some establishments believed that they would be required
to have a separate plan for each product they produce.
d. Response to Comments. The comments that suggested FSIS had
overestimated costs or had developed an upper limit on implementation
costs, pointed out that a market driven response to the rule would
likely cut costs. The market would increase the number of consultants
which would be available at reduced costs, especially for small
establishments that are most likely to employ outside consultants.
While FSIS agrees that the number of available consultants will
increase and that the hourly cost for outside assistance will likely
decrease, the Agency notes that Table 24 was developed with those
factors in mind. The discussions with private sector food consultants
focused on projected costs, recognizing that costs would decrease as
more consultants became available and the overall level of industry
expertise and experience increased.
The comments included a wide range of estimates for the cost of
developing a HACCP plan. Most of the specific cost estimates contained
in the comments were within the ranges presented in Table 24. The
comments do not provide a compelling reason to modify Table 24,
especially since FSIS has an ongoing effort to develop implementation
aids for establishments that will help keep plan development costs
down. In addition to generic models that will be available at least six
months before any mandatory requirement, FSIS is developing or
considering: (1) Information publications, such as a HACCP Handbook
that explains how a establishment can effectively and economically
incorporate the seven principles into its operations; (2) training
videos and computer programs that present HACCP implementation guidance
in alternative formats; (3) models for onsite HACCP training of
establishment employees; and (4) a catalog of hazards with examples of
control measures and generic plans for each slaughter and processing
category described in the proposed rule. FSIS is also planning to
sponsor in-establishment demonstration projects to generate real-world
information and guidance about near-term and HACCP implementation
issues in small businesses.
FSIS will also continue its technical assistance to state programs
by including states' training officials in
[[Page 38983]]
Federal training efforts, by facilitating state access to and use of
federal computer support systems, and by expansion of state/federal
cooperative efforts through the Conference for Food Protection, the
National Association of State Departments of Agriculture, the
Association of Food and Drug officials, and the Meat and Poultry
Inspection Advisory Committee. Also, FSIS' plans for in-establishment
demonstration projects referenced above will focus on small
establishments under State regulation as well as those under Federal
regulation.
The findings from the nine pilot establishments reported in the RTI
study were based on conditions existing in the 1991-1992 time period.
Many factors have changed since then including the number of available
HACCP consultants, the number of trained individuals, the number of
courses available and the general level of knowledge concerning the
implementation of HACCP principles in food processing establishments.
These factors should help drive plan development cost down.
The 1994 RTI study noted that: ``Several participants commented
that there is a lot more discussion and information about HACCP in the
trade press and elsewhere today than there was even three years ago.
Without exception, participants felt that USDA could reduce the costs
of HACCP--especially training and HACCP plan development costs--by
making as much information about HACCP available as possible.''
In response to comments that FSIS should develop or pay for the
development of plans, FSIS believes that these suggestions would
diminish the principle of having industry take ownership and
responsibility for the production process. This principle is a key
factor in HACCP. If FSIS developed or paid for the plans, it would
detract from the establishment's assuming ownership and responsibility
for the HACCP plans. FSIS also believes that government funding of the
plans would set a bad precedent. If the government assumes the cost of
compliance with regulatory actions which ultimately benefit the
regulated industry, establishments will campaign for additional actions
leading to greater government outlays. Government funded plans would
also require an increase in the FSIS budget requiring a corresponding
increase in taxes and also likely lead to more expensive plans. By
bearing the costs, establishments will have a stronger incentive to
control plan development costs than FSIS. Finally, FSIS expects that
market forces will permit establishments to shift some of the costs to
producers and consumers which is a more equitable allocation of costs
than placing the burden on
FR Doc. 96-17837 Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems
taxpayers in general.
In response to comments expressing concern that each product would
require a HACCP plan, FSIS notes that there is a major distinction
between requiring that ``each product must be covered by the
establishment's HACCP plan'' and requiring that ``each product have a
unique HACCP plan.'' The final complexity of an establishment's HACCP
plan is related to the number of distinct processes used by the
establishment and not the number of products produced.
e. Final Cost Estimates. Although the final rule has eliminated the
process categories and requires a single, comprehensive HACCP plan for
each establishment with hazards, the final cost estimates are based on
the earlier estimates of 16,889 plans for federally inspected
establishments and 6,120 plans for state inspected establishments.
Since final cost is still a function of the number and complexity of
processes, FSIS sees no reason to change the methodology for estimating
HACCP plan development costs. Furthermore, it is reasonable to assume
that establishments may develop their plans in segments beginning with
relatively simple processes and then proceeding to more complex
processes.
The final cost estimates for 23,019 HACCP plans are shown in Table
25. The final cost estimate for federally inspected establishments is
based on Table 24 which presents different costs, depending on the
sequence, for easy, moderate and difficult plans. The final cost
estimate does not, however, assume that the first HACCP plan is
actually the second plan because of experience gained in developing
sanitation SOP plans and microbial sampling plans. The result is that
the average cost for the 16,899 plans for federally inspected
establishments is now $3,240, up from the preliminary analysis average
of $2,020 per plan. The average cost for 6,120 plans in state inspected
establishments is $2,000, the same per plan cost used in the
preliminary analysis.
It is assumed that HACCP validation is an integral part of HACCP
plan development and that the requirement for annual reassessment will
be a minimal cost for establishments that do not modify their products
or processes and are not experiencing difficulty in meeting all
critical limits. The analysis assumes that the average annual
reassessment will take two hours per plan at a quality control
manager's salary of $25.60 per hour. Thus, the average annual
reassessment will cost $51.20 per plan.
Table 25.--Cost Of HACCP Plan Development and Annual Reassessment
----------------------------------------------------------------------------------------------------------------
Average
Number Number Total cost per Annual
Establishment category establishments plans cost plan reassessment
($000) (dollars) ($000)
----------------------------------------------------------------------------------------------------------------
Low.................................................. 2,234 5,106 17,762 3,479 261
Medium............................................... 3,103 8,712 28,075 3,223 446
High................................................. 849 3,081 8,911 2,892 158
==========================================================
Subtotal....................................... 6,186 16,899 54,748 3,240 865
State................................................ 2,893 6,120 12,240 2,000 313
----------------------------------------------------------
Total.......................................... 9,079 23,019 66,988 2,910 1,179
----------------------------------------------------------------------------------------------------------------
As discussed above under methodology, this cost analysis assumes a
static number of establishments and processes while recognizing that
the rule will add to the cost of new establishments or processes. One
such
[[Page 38984]]
cost would be the annual reassessment for establishments that add new
processes or substantially modify existing production practices.
4. HACCP Programs--Recordkeeping Costs
a. Summary of Requirements. The final rule requires that all
establishments record observations when monitoring critical control
points and document any deviations and corrective actions taken. The
rule also requires a certification review of records by an employee not
involved in recording observations. Such recording and certification
review of observations at critical control points is a fundamental
HACCP principle.
FSIS is requiring that the records involving measurements during
slaughter and processing, corrective actions, verification check
results, and related activities contain the identity of the product,
the product code or slaughter production lot, and the date the record
was made. The purpose of this requirement is to assure that both the
company and the regulator can readily link a record to a product and
the timeframe in which it was processed. FSIS is also requiring that
the information be recorded at the time that it is observed and that
the record be signed by the operator or observer.
FSIS is also requiring that the HACCP records be certified by a
company employee other than the one who produced the record, before the
product is distributed in commerce. The purpose of this review is to
verify that the HACCP system has been in operation during the
production of the product, that it has functioned as designed and that
the company is taking full responsibility for the product's meeting
applicable regulatory requirements. The employee conducting the
certification review must sign the records.
FSIS is also requiring that HACCP plans and records be available
for review by program personnel. Records access is necessary to permit
verification of all aspects of a HACCP system.
b. Review of Preliminary Cost Estimates. In the preliminary cost
analysis, recordkeeping cost was defined to include the time it takes
to make observations and record the results of those observations plus
the cost of certifying and maintaining records. Several key variables
were involved in the estimates for HACCP recordkeeping costs for the
preliminary RIA. First, it was established that recordkeeping costs are
related to the number of processing lines operating simultaneously and
not the number of HACCP plans. That is, an establishment may have
several HACCP plans but never have more than one operating at any given
time. To estimate recordkeeping costs it was necessary to collect data
on the average number of production lines operating per shift. To
estimate product lines, data was collected for a sample of low, medium
and high volume establishments from each of the FSIS Regional Offices.
The data on average number of simultaneous operating lines was
collected for processing operations, red meat slaughter operations and
poultry slaughter operations for both first and second shifts. Costs
were then estimated based on 7,639 federal and 4,080 state inspected
operations as shown in Table 26.
Table 26.--Operations in Federal and State Inspected Establishments
------------------------------------------------------------------------
Federal State
Manufacturing operation inspected inspected Total
establishments establishments
------------------------------------------------------------------------
Processing................... 6,006 2,752 8,758
Meat slaughter............... 1,327 1,270 2,597
Poultry slaughter............ 306 58 364
------------------------------------------
Total.................... 7,639 4,080 11,719
------------------------------------------------------------------------
It was further assumed that each State establishment was a single
shift establishment and that State establishments would have the same
number of production lines as the first shift of a low volume federal
establishment.
Other variables included the average number of CCP's per plan and
the average amount of time for recording and reviewing records per CCP.
For federally inspected establishments, the analysis assumed that
processing HACCP plans have an average of 7.4 CCP's and slaughter plans
have an average of 5 CCP's. It was assumed that State inspected
establishments will average 5 CCP's per HACCP plan. Recording time was
estimated at an average of 5 minutes per CCP per shift. Review time for
certification was estimated at an average of 2 minutes per CCP per
shift. Recording cost was estimated based on an employee earning $12.87
per hour. Certification cost was based on a supervisor or QC technician
earning $18.13 per hour. All storage costs were based on a national
survey of storage costs showing an average annual cost of $8.40 per
square foot.
Total recordkeeping costs are the sum of the costs for three
components: Monitoring CCP's and recording findings, certifying
records, and storing records. The following calculation for the annual
costs of recording the findings from monitoring CCP's in State
processing operations illustrates how the above estimates were used in
estimating total recordkeeping costs:
Recording Costs For State Processing Operations =
(2,752 operations) x (1.1 average production lines)
x (5 minutes per CCP per day 60 minutes per hour)
x (5 CCP's per line)
x ($12.87 per hour) x (260 days per year)
= Sec. 4.22 million
The total costs per establishment for recordkeeping, as estimated in
the preliminary analysis, are summarized in Table 27. The total
aggregate costs are shown in Table 28. The average cost per
establishment and the total aggregate costs were reduced to account for
the recordkeeping that already occurs in TQC, NELS and SIS
establishments.
Table 27.--Summary of Recordkeeping Costs per Establishment
[Dollars]
----------------------------------------------------------------------------------------------------------------
Recurring
Establishment category Recording Certifying Maintaining annual
observations records records cost
----------------------------------------------------------------------------------------------------------------
Low........................................................... 2,560 1,442 28 4,030
Medium........................................................ 4,202 2,368 52 6,621
High.......................................................... 10,994 6,195 90 17,279
State......................................................... 2,163 1,219 33 3,415
----------------------------------------------------------------------------------------------------------------
Table 28.--HACCP Recordkeeping Costs
[$ Thousands]
------------------------------------------------------------------------
Number of Annual
Establishment category establishments costs
------------------------------------------------------------------------
Low.......................................... 2,234 9,003
Medium....................................... 3,103 20,545
High......................................... 849 14,669
==========================
Subtotal............................... 6,186 44,217
State........................................ 2,893 9,880
Total.................................. 9,079 54,097
------------------------------------------------------------------------
With the methodology used for estimating recordkeeping costs, it is
also possible to look at annual recording and certification cost per
operating line. Assuming a line runs 52 weeks, 40 hours per week, 2,080
hours per year,
[[Page 38985]]
the average annual recordkeeping cost (excluding any storage costs) for
a processing line in a federally inspected establishment would be
$3,226.23 ($2,063.40 recording plus $1,162.74 certification). The
average annual cost for a federally inspected slaughter line would be
$2,179.88 ($1,394.25 recording plus $785.63 certification). All lines
in State inspected establishments were assumed to have an annual cost
of $2,179.88.
c. Comments on the Preliminary RIA. Most of the comments referring
to HACCP recordkeeping costs were general comments that the costs would
be extremely burdensome. The comments did not question the methodology
used in the preliminary analysis to estimate either recording,
reviewing or storage costs. The comments included at least two proposed
modifications that would substantially reduce costs. One comment
suggested that small establishments record only deviations from the
HACCP plan and responses to them. At one of the public hearings a
representative from a consumer organization suggested that inspectors
could conduct the recordkeeping in small establishments.
d. Response to Comments. FSIS believes that while both of the above
suggestions would reduce cost, they both do damage to the concept of
HACCP. Having the industry take ownership and responsibility of the
production process is a key component of HACCP. Having inspectors
conduct the recordkeeping would severely detract from ownership.
Furthermore, a fundamental HACCP principle requires that observations
be recorded and reviewed at critical points in the manufacturing
process on an ongoing basis. Recording only deviations does not meet
this principle.
The discussion of sanitation SOP recordkeeping costs identified
three factors that affect how one views such costs. At least two of
those factors apply here. HACCP recordkeeping is a cost that can be
reduced through good management and efficiency and should also decrease
with experience. If recordkeeping can be conducted by employees working
at a CCP location, the additional cost should be minimal. HACCP should
also substantially reduce the time establishment officials currently
spend interacting with or responding to inspection findings. In
addition to responding to the approximately 700,000 to 800,000
Processing Deficiency Records (PDRs) per year, establishments have
thousands of meetings with program officials following reviews
conducted by area and regional officials or reviewers from the Program
Review Division in Lawrence, Kansas. FSIS believes strongly that
establishment officials will find some recordkeeping time from reducing
inspection interaction time.
e. Final Cost Estimates. After considering the comments, FSIS does
not see a need to adjust the costs estimates shown in Tables 27 and 28.
The final aggregate cost estimates for recordkeeping are those shown in
Table 28.
5. HACCP Programs-Training Costs
a. Summary of Requirements. The final rule requiring that each
establishment have access to a HACCP-trained individual remains
identical to the training requirement as proposed. The final rule does
not, however, include the proposed requirement that the name and resume
of the HACCP-trained individual be on file at the establishment.
b. Review of Preliminary Cost Estimates. The proposed rule included
the requirement that each establishment have access to a HACCP-trained
individual. In the preliminary cost analysis FSIS pointed out that
establishments would have options for meeting that requirement. For
example, establishments could train an existing employee or use a
consultant on an as-needed basis. To provide a cost estimate, FSIS
assumed that each slaughter or processing operation would send one
employee to a recognized HACCP course for approximately three days.
The preliminary analysis assumed a combination establishment would
require training for both slaughter and processing operations. The
preliminary analysis identified 11,719 separate meat slaughter, poultry
slaughter and processing operations. The analysis assumed that 5
percent of these operations currently have a trained individual and
11,133 would require training.
Training would be a one-time, up-front expense. The cost of
training 11,133 establishment employees at $2,514 each would be
approximately $28 million. The $2,514 included tuition for a three-day
course, travel expenses and wages. In estimating these costs, FSIS used
a listing of 1994 HACCP courses compiled by the USDA Extension Service.
c. Comments on the Preliminary RIA. Most of the comments relating
to the cost of training industry personnel were of a general nature
(e.g., FSIS underestimated the cost of training) or suggested that all
training be funded by USDA. Many small processors lumped training with
other requirements and indicated that the cost of implementing HACCP
would force them to close. A couple of comments indicated that the
commenter believed they would have to hire an additional HACCP-trained
employee. Several comments noted that the training costs estimated in
the IFSE study were far higher than the costs estimated by FSIS.
d. Response to Comments. With respect to the comments that referred
to the higher training costs estimated in the IFSE study, FSIS notes
that the IFSE study assumed that training was both an up-front and a
continuing annual expense. They also assumed that HACCP training was
necessary for top management, supervisors and relevant hourly
employees. Since the IFSE study was written with a beef slaughter
establishment in mind, it is assumed that the authors believed it is
necessary to train some or all of the employees working the dressing
line. Under their assumptions, a high turnover would require
substantial recurring annual costs.
The FSIS cost estimate was tied to meeting the proposed regulatory
requirements. The IFSE estimates are the authors' judgment of what
would be required to ``successfully'' implement an effective HACCP
program. The IFSE study did not provide any rationale for the cost
estimates used. For example, the authors assumed that annual training
costs for 5,127 small businesses would be $10,000 each for a total
annual cost of $50 million. That estimate would appear high considering
the large number of establishments with fewer than five employees.
The IFSE study does raise the issue of whether a single three-day
course for one employee is adequate to ensure an effective HACCP
program. A low cost ongoing training program may be better. FSIS now
plans on having training videos and/or correspondence courses available
for each establishment. This will present an easier burden for very
small establishments because it will not require having an employee
leave on travel to receive training. As the number of available courses
and locations increases, travel costs will also decrease. Trade
associations can help provide local training for all establishments
near large metropolitan areas.
FSIS also recognizes that employee turnover will require some level
of recurring cost. The necessity of training new hires should, however,
decrease over time as the available pool of HACCP-trained individuals
increases. FSIS will, however, include a 10 percent recurring cost in
the final cost estimate.
[[Page 38986]]
e. Final Cost Estimates. The final training cost estimates are
shown in Table 29. The one-time cost of $27,988 thousand is the same
cost as estimated for the preliminary analysis. In response to
comments, an annual recurring cost of $2.8 million has been added.
Table 29.--HACCP--Training Costs
[$ Thousands]
------------------------------------------------------------------------
Recurring
Establishment category Number of One-time costs
employees cost (10%)
------------------------------------------------------------------------
Low.................................... 2,610 6,562 656
Medium................................. 3,593 9,033 903
High................................... 1,054 2,650 265
--------------------------------
Subtotal............................... 7,257 18,244 1,824
State.................................. 3,876 9,744 974
--------------------------------
Total.................................. 11,133 27,988 2,799
------------------------------------------------------------------------
6. HACCP Programs--Impact on Total Quality Control/Overtime Issues
a. Summary of Requirements. The proposed rule did not include
proposed revisions to existing Total Quality Control (TQC) regulations.
However, the preamble stated that FSIS is considering having HACCP be
the only Agency recognized health and safety related process control
system. The preliminary RIA published with the proposed rule stated
that: ``With the publication of the rule, TQC establishments could lose
their authority to produce and ship product after their normal shift
production time. As a result, 287 active TQC establishments could begin
to incur annual overtime charges.''
The final decisions on TQC regulations have not been made. This
final analysis uses the impact on overtime as a conservative estimate
of the potential impact of pending decisions.
b. Review of Preliminary Cost Estimates. The Agency's supplemental
cost analysis recognized that there are 287 TQC establishments that
would incur overtime costs to continue their current operating
schedules if the TQC regulations were eliminated. The total cost for
these 287 establishments was estimated at $2.1 million per year. The
preliminary analysis estimated that the total of 287 included 112 low,
124 medium and 51 high volume producers.
c. Comments on the Preliminary RIA. A TQC establishment commented
that under the proposed rule they would have to pay an additional
$32,308.80 per year in overtime charges. The establishment commented
that these additional overtime charges would equate to a substantial
portion of their annual net profit.
d. Response to Comments. The comment from the TQC establishment is
consistent with the preliminary analysis that was based on the premise
that TQC establishments would lose their authority to produce and ship
products after their normal shift production time. If such authority is
withdrawn establishments would have to incur overtime charges if they
want to continue their present operating schedules.
The establishment estimated its potential overtime cost based on an
assumption of 100 percent coverage. If the establishment's overtime
hours were covered by a patrol assignment, they would be subject to the
provisions of proportional coverage and the actual level of overtime
charges could be substantially lower.
Inspection assignments cover 8 hours of regular time and may also
include scheduled overtime inspection. An assignment may specify 8
hours in one establishment or direct the inspector to cover multiple
establishments, i.e., a patrol assignment where the inspector would
spend a portion of each day in each establishment. In cases where an
inspector spends 8 hours in a single establishment and that
establishment decides to operate for 2 hours of overtime on a routine
basis, inspection coverage may be provided by having the assigned
inspector work 2 hours of overtime. This type of coverage would be
likely if the establishment was located in an isolated area. In this
type of case, the establishment would be charged for 2 hours of
overtime inspection each day. This type of overtime situation would
lead to maximum costs as suggested by the commenter.
If the establishment was part of a patrol assignment and there were
two establishments working 2 hours of overtime, the overtime production
could be covered by having the inspector work 2 hours of patrol
overtime, but each establishment would only be billed for one hour,
i.e., proportional overtime coverage.
Because the majority of establishments are covered by patrol
assignments, proportional coverage is employed frequently. Thus, the
establishments' estimate of $32,308.80 is a maximum level. The actual
level of charges could probably be substantially lower.
e. Final Cost Estimates. This final analysis has included a cost of
$2.1 million for annual overtime charge. The analysis has assumed that
the additional overtime charges will occur on the same timeframe as the
sequencing of HACCP implementation.
E. Summary of Costs for Low Volume Producers
Because there has been particular interest in the impact of this
rule on small business, this final section summarizes the overall costs
for low volume producers. Table 30 illustrates the costs faced by a
typical low volume producer over the four-year implementation period.
Because there are less than 100 low volume poultry slaughter
establishments, the costs for generic E. coli sampling was not included
in Table 30. The costs illustrated in Table 30 apply to the majority of
inspected establishments, an estimated 2,234 federally inspected
establishments and all but a few of the 2,893 state inspected
establishments. These 5,000-plus establishments all meet the regulatory
flexibility definition for a very small establishment and have the full
42 months to implement mandatory HACCP systems. There are another 658
establishments (medium volume production) that will have slightly
higher costs, but will also have 42 months to implement HACCP because
they meet the regulatory flexibility criteria for a very small
establishment. All establishments meeting the regulatory flexibility
criteria for small establishments will have 30 months to implement
HACCP. The 353 large establishments (more than 500 employees) will be
required to implement HACCP 18 months after publication.
Table 30.--Summary of Costs for a Typical Low Volume Establishment
[Dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost category Year 1 Year 2 Year 3 Year 4 Year 5+
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Sanitation SOPs Plans and Training......................... a 190 ................ ................ ................
Observation and Recording................................. 1,242 1,242 1,242 1,242 1,242
II. Compliance With Salmonella Standards...................... ................ ................ ................ b 0-1,200 b 0-1,200
[[Page 38987]]
III. HACCP Plan Development................................... ................ ................ ................ 4,231-7,952
Annual Plan Reassessment.................................. ................ ................ ................ ................ 177
Initial Training.......................................... ................ ................ ................ d 2,937-3,368
Recurring Training........................................ ................ ................ ................ ................ 294-337
Recordkeeping............................................. ................ ................ ................ 2,015 4,030
IV. Additional Overtime....................................... ................ ................ ................ e 0-3,702 e 0-7,404
-----------------------------------------------------------------------------------------
Total................................................. 1,432 1,242 1,242 10,425-11,625 5,743-6,986
--------------------------------------------------------------------------------------------------------------------------------------------------------
a This cost for the 112 low volume TQC establishments would be $64.
b The estimate of $1,200 is based on monthly testing for two products and an antimicrobial rinse for one.
c The Cost Analysis is based on estimates that low volume federally inspected establishments will require an average of 2.29 plans each, at a cost of
$3,479 per plan (see Table 25) for a total average plan development cost of $7,952. The number of plans for federally inspected establishments is
based on data from existing FSIS data bases. It was assumed that state plans have an average of 2.12 plans each for a total cost of $4,231 per
establishment ($2,000 per plan).
d Average training costs for state establishments ($3,368 per establishment) were estimated to be slightly higher than the average federally inspected
low volume establishments ($2,937 per establishment) because the state programs have a higher percentage of combination slaughter and processing
establishments. The cost analysis assumed that plans would train one individual for each processing, red meat slaughter and poultry slaughter
operation.
e The preliminary analysis estimated that 112 of 287 active TQC establishments are low volume producers. The average TQC establishment avoids an annual
overtime charge of $7,404. The cost estimates in Table 30 for additional overtime costs apply only to those 112 establishments and assume that TQC
provisions will be phased out as HACCP is phased in--42 months after publication for the low volume establishments. Because the overtime costs apply
to only 112 establishments, they are not included in the Table 30 totals.
The average costs shown in Table 30 will be a burden for many of
the low volume producers. However, there are factors that should help
diminish the burden. Most of the costs and essentially all of the
recurring costs are labor costs for monitoring sanitation procedures,
monitoring HACCP critical control points and keeping both HACCP and
sanitation records. As the above analysis points out, these are costs
that can be reduced through efficient management and allocation of
resources and should decrease with experience. The Agency also views a
portion of these costs as a shift in resources, i.e., establishment
management should spend more resources monitoring establishment
operations and less time interacting with program personnel.
Another way of illustrating costs to small businesses is to look at
the costs for one or more specific examples. Table 31 illustrates the
costs for a small, single-shift, processing establishment (no TQC or
sanitation PQC program) with two distinct production operations other
than raw ground product (overall average was estimated at 2.29 based on
data shown in Table 25).
Table 31.--Costs for Typical Single-Shift Processing Establishment
[Dollars]
------------------------------------------------------------------------
Development
and Recurring
Requirement Implementation Annual
costs Costs
------------------------------------------------------------------------
Sanitation SOP's............................ 190 1,242
HACCP Plan Development...................... 6,958 0
Annual Plan Reassessment.................... 0 102
Training.................................... 2,514 251
Recordkeeping............................... 0 6,480
---------------------------
Total................................... 9,662 8,075
------------------------------------------------------------------------
If one of the two production operations produced a raw ground
product, the establishment would have to meet the pathogen reduction
performance standard for that product. As noted earlier in the
development of the low and high cost scenarios for meeting the new
Salmonella standards, raw ground operations do not have the same
opportunities to reduce Salmonella levels as do slaughter
establishments. They can control growth by avoiding temperature abuse
and can limit cross-contamination, but basically they must depend on
the Salmonella levels of their incoming product in order to meet the
performance standards. These establishments may choose to test incoming
product in order to eliminate suppliers whose product is found to be
positive. The final analysis has assumed that the low volume producers
would not test incoming ingredients.
Table 32 illustrates the costs for a small, single-shift,
combination (slaughter and further processing) establishment that
slaughters cattle or swine, but not both, and has a single further
processing operation other than raw ground product. The establishment
is not under TQC inspection.
Table 32.--Costs for Typical Single-Shift Combination Establishment
[Dollars]
------------------------------------------------------------------------
Development
and Recurring
Requirement implementation annual
costs costs
------------------------------------------------------------------------
Sanitation SOP's............................ 190 1,242
Compliance with Salmonella Standards........ 0 800
E. coli Sampling............................ 1,043 653
HACCP Plan Development...................... 6,958 0
Annual Plan Reassessment.................... 0 102
Training.................................... 5,028 503
Recordkeeping............................... 0 5,434
---------------------------
Total................................... 13,219 8,734
------------------------------------------------------------------------
The cost of meeting the pathogen reduction performance standards
assumes that the establishment will use a hot water antimicrobial rinse
and have one sample per month analyzed at an outside laboratory ($33.35
per sample-$400 per year). The average number of head slaughtered in a
low volume establishment is approximately 5,000
[[Page 38988]]
annually. The annual cost for the rinse is $400.
The development costs for E. coli sampling in the small
establishment includes $640 for developing a sampling plan and $403 to
train an individual to conduct aseptic sampling. The recurring costs
are based on the assumption that an average low volume slaughter
establishment will have to complete two sampling windows (26 samples)
before they demonstrate compliance with established criteria.
The cost of HACCP training has doubled for the combination
establishment because the FRIA assumed that slaughter and processing
operations are significantly different, so that the establishment must
either train two employees or send one employee to two separate
training courses.
The HACCP recordkeeping costs (monitoring CCP's and recording
findings, reviewing records and storing records) in the above two
examples assume that the establishments are operating each process
continuously over a standard 52-week, 260-day, 2,080-hour work year.
Data collected during the preliminary analysis indicates that many low
volume establishments frequently have only a single production line
operating at a given time. As shown in Tables 27 and 30, the final
analysis estimates an average annual cost for HACCP recordkeeping of
$4,030 for low volume establishments.
Appendix A to Final Regulatory Impact Assessment
Response to Comments Related to the Preliminary Regulatory Impact
Analysis But Not Addressed Directly in the Text of the Final Analysis
1. A comment noting that the ``data in Tables 1 and 2, (60 FR 6781)
for Toxoplasma gondii are confusing or in error'' is correct. The
tables as published contained typographical errors that have been
corrected for this analysis. The number of cases of foodborne illness
from toxoplasmosis should be 2,056 cases, not 3,056 cases. The total
number of cases from the foodborne illnesses considered also needs to
be adjusted to correct for the above typographical error. Specifically,
the total number of cases should be 3,605,582 to 7,132,823, and not
3,606,582 to 7,133,823.
2. The same comment questioned whether it is true that the
``estimated medical costs for the 2,056 cases (toxoplasmosis) and 41
deaths is $2,7000,000,000?'' This estimate is correct but these costs
include the estimated costs of lost productivity and costs of
residential care as well as the estimated medical costs of
toxoplasmosis.
3. There were several comments that indicated that while attempting
to reduce the overall public health risk, the Agency could be
increasing the risk to farmers and small producers that now have
livestock custom-slaughtered at inspected establishments. If a large
number of these small diverse businesses go under, the comments
predicted an increase in at- home slaughter under very marginal
conditions. These comments imply at-home slaughter is a high risk
practice using terms such as barn yard butchering or shade tree
butchering or back shed butchering.
Changes in the final rule should allow most small businesses to
continue to operate successfully under inspection. There are some small
businesses that are currently primarily custom-exempt/retail exempt
operations that may choose to withdraw from inspection. These types of
facilities will still be available for their custom slaughtering
services.
4. A comment referred to the FSIS assertion that consideration of
the costs of the various alternatives under examination is not relevant
because the alternatives do not meet the Agency's goal of achieving the
maximum pathogen reduction possible. The commenter concluded that this
is an entirely inappropriate analytical framework for the examination
of regulatory alternatives. By starting from the assumption that only
the maximum benefit attainable will suffice, FSIS effectively renders
its consideration of available regulatory alternatives a complete sham.
The purpose of a regulatory impact assessment should be to examine both
the benefits and the costs attributable to each available alternative,
and to consider whether there is an alternative to the Agency proposal
that is a more cost-effective means of addressing the problem at hand.
5. One commenter stated that the Agency must include the costs
attributable to the retained requirements as well. These retained costs
will significantly increase the operational costs of the combined,
layered system. FSIS does not agree that the RIA needs to include the
cost of existing requirements.
6. Comments expressed concern that the proposed rule was an
experiment to collect the data needed to determine whether it was a
good idea. These comments stated that industry should not bear the cost
of a government research project. FSIS has clearly stated the public
health objective of this rule.
7. There are several comments that referred to a study conducted by
the Research Triangle Institute for FSIS. In that study, HACCP Pilot
Programs Cost Findings, August 31, 1994, RTI collected cost information
during personal interviews at all nine establishments that had
participated in USDA's HACCP Model Pilot Program.
One comment noted that the pilot establishments used for the study
are establishments that are larger than most of the establishments that
are going to be affected. The RTI study noted that none of the
voluntary participants have annual sales under $3 million. The RTI
study was one source of information for the FSIS cost analysis. The
Agency did not use the information in a way that suggested it was
representative of all establishments or in any way imply that it was.
Another comment stated that USDA relied very heavily on the nine
pilot establishment studies. The data collected by RTI was one source
of information used for the preliminary cost analysis. The analysis
clearly cites the RTI study as one of several data sources.
A comment during the public hearing attributed a cost of $23,000 or
$27,000 to the RTI study for a hazard analysis, plan development and
validation for a small business that doesn't need any equipment or
establishment upgrade. The RTI study reported costs for plan
development ranging from $607 to $15,750. FSIS assumes that the hazard
analysis is part of plan development. The RTI study did not address a
separate cost component for validation.
8. One comment indicated that the source of the estimates for total
cases and deaths for E. coli O157:H7 does not support the number used
in the benefit estimates. The preliminary analysis was based on 10,000-
20,000 total cases and an estimate of from 200-500 total deaths.
Sources identified were the AGA conference and CDC communications. The
``CDC comm.'' citation mentioned in the FSIS proposal refers to both
the Ostroff et al. (1989) and the McDonald et al. (1988) articles as
described in the comment. These references provide an incidence rate
for E. coli O157:H7 of 2.1/100,000 to 8/100,000. The AGA conference
suggests there are 10,000 to 20,000 cases of E. coli O157:H7 each year
in the United States. This translates to a rate of approximately 4/
100,000 to 8/100,000, which is higher on the lower estimate. ERS chose
to use the consensus numbers because they reflect the current thinking
of a nonadvocate panel of experts. FSIS agrees with the commenter that
better data on
[[Page 38989]]
foodborne disease incidence is needed but believe that the preliminary
analysis used the best estimates available.
9. Commenter stated FSIS relied on faulty data. FSIS responds that
there is a difference between saying data are limited and saying data
are faulty. Existing food safety data are limited and more thorough
data may not be available for a long time.
10. A commenter noted that FSIS did not address the ``cost'' of the
development of a highly susceptible population because some exposure is
necessary to establish immunity. The same commenter suggested there
might be a ``nutritional health'' cost penalty, i.e., the rule would
increase the cost of food so much that consumers would not be able to
afford nutritional food. FSIS notes that the commenter did not provide
support for these ``costs.''
11. A commenter noted that their low annual insurance premium of
$150 strongly suggests that the insurance industry considers their
existing safety record commendable and worthy of a low liability rate.
FSIS notes that another comment has suggested that lower rates are
being offered in conjunction with improved process control systems.
[FR Doc. 96-17837 Filed 7-18-96; 8:45 am]
BILLING CODE 3410-DM-P
Continue your research in ChatGPT or Claude
Connect Omnilex to search the legal corpus from your AI assistant.