issue-1996-10-03•Federal Register final rules — 1996-10-03
Federal Register final rules — 1996-10-03
issue-1996-10-03Federal Register final rules — 1996-10-03Regulation
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. 96-25405 Privacy Act Policy and Procedures
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51593-51596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25405]
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ARMS CONTROL AND DISARMAMENT AGENCY
22 CFR Part 603
Privacy Act Policy and Procedures
AGENCY: Arms Control and Disarmament Agency.
ACTION: Final rule.
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SUMMARY: The United States Arms Control and Disarmament Agency (ACDA)
is revising and restating in their entirety its rules that govern the
means by which individuals can examine and request correction of ACDA
records containing personal information. Clarifying these rules will
help the public interact better with ACDA and is part of ACDA's effort
to update and streamline its regulations.
EFFECTIVE DATE: October 3, 1996.
FOR FURTHER INFORMATION CONTACT:
Frederick Smith, Jr., United States Arms Control and Disarmament
Agency, Room 5635, 320 21st Street, NW., Washington, DC 20451,
telephone (202) 647-3596.
SUPPLEMENTARY INFORMATION: On June 13, 1996, ACDA published a notice of
proposed rulemaking (61 FR 30009-30012) with a 36-day comment period.
No comments were received during the comment period. Accordingly, the
rule is adopted as proposed.
List of Subjects in 22 CFR Part 603
Privacy Act.
Chapter VI of Title 22 of the Code of Federal Regulations is
amended by revising part 603 to read as follows:
PART 603--PRIVACY ACT POLICY AND PROCEDURES
Sec.
603.1 Purpose and scope.
603.2 Definitions.
603.3 Policy.
603.4 Requests for determination of existence of records.
603.5 Requests for disclosure to an individual of records
pertaining to the individual.
603.6 Requests for amendment of records.
603.7 Appeals from denials of requests.
603.8 Exemptions.
603.9 New and amended systems of records.
603.10 Fees.
Authority: 5 U.S.C. 552a; 22 U.S.C. 2581; and 31 U.S.C. 9701.
Sec. 603.1 Purpose and scope.
This part 603 contains the regulations of the U.S. Arms Control and
Disarmament Agency implementing the provisions of the Privacy Act of
1974, 5 U.S.C. 552a. In addition to containing internal policies and
procedures, these regulations set forth procedures whereby an
individual can determine if a system of records maintained by the
Agency contains records pertaining to the individual and can request
disclosure and amendment of such records. These regulations also set
forth the bases for denying amendment requests and the procedures for
appealing such denials.
Sec. 603.2 Definitions.
As used in this part:
(a) Act means the Privacy Act of 1974, 5 U.S.C. 552a.
(b) ACDA and Agency mean the U.S. Arms Control and Disarmament
Agency.
(c) Privacy Act Officer means the Agency official who receives and
acts
[[Page 51594]]
upon inquiries, requests for access and requests for amendment.
(d) Deputy Director means the Deputy Director of the Agency.
(e) Individual means a citizen of the United States or an alien
lawfully admitted for permanent residence;
(f) Maintain includes maintain, collect, use, or disseminate;
(g) Record means any item, collection, or grouping of information
about an individual that is maintained by an agency, including, but not
limited to, education, financial transactions, medical history, and
criminal or employment history and that contains the name of, or the
identifying number, symbol, or other identification particularly
assigned to, the individual, such as a finger or voice print or a
photograph;
(h) System of records means a group of any records under the
control of any agency from which information is retrieved by the name
of the individual or by some identifying number, symbol, or other
identification particularly assigned to the individual;
(i) Statistical record means a record in a system of records
maintained for statistical research or reporting purposes only and not
used in whole or in part in making any determination about an
identifiable individual, except as provided by section 8 of title 13
U.S.C.; and
(j) Routine use means, with respect to the disclosure of a record,
the use of such record for a purpose which is compatible with the
purpose for which it was collected.
Sec. 603.3 Policy.
(a) It is the policy of the Agency that only such information about
an individual as is relevant and necessary to accomplish a purpose of
the Agency required to be accomplished by statute or by executive order
of the President shall be maintained in an Agency record. No
information about the political or religious beliefs and activities of
an individual will be maintained within such records unless
specifically authorized by statute or by the subject individual, or
unless pertinent to and within the scope of a law enforcement activity.
(b) The Agency will not disclose any record that is contained in a
system of records to any person, or to another agency, except pursuant
to a written request by, or with the prior written consent of, the
individual to whom the record pertains, unless disclosure of the record
is:
(1) To those officers and employees of the Agency who have a need
for the record in the performance of their duties;
(2) Required under the Freedom of Information Act, as amended (5
U.S.C. 552);
(3) For a routine use, notice of which has been published in
accordance with the Act;
(4) To the Bureau of the Census for purposes of planning or
carrying out a census or survey or related activity pursuant to the
provisions of title 13 U.S.C.;
(5) To a recipient who has provided the Agency with advance
adequate written assurance that the record will be used solely as a
statistical research or reporting record, and the record is to be
transferred in a form that is not individually identifiable;
(6) To the National Archives of the United States as a record that
has sufficient historical or other value to warrant its continued
preservation by the United States Government, or for evaluation by the
Administrator of General Services or his/her designee to determine
whether the record has such value;
(7) To another agency or to an instrumentality of any governmental
jurisdiction within or under the control of the United States for a
civil or criminal law enforcement activity if the activity is
authorized by law, and if the head of the agency or instrumentality has
made a written request to the Agency that maintains the record
specifying the particular portion desired and the law enforcement
activity for which the record is sought;
(8) To a person pursuant to a showing of compelling circumstances
affecting the health or safety of an individual if upon such disclosure
notification is transmitted to the last known address of such
individual;
(9) To either House of Congress, or, to the extent of matter within
its jurisdiction, any committee or subcommittee thereof, any joint
committee of Congress or subcommittee of any such joint committee;
(10) To the Comptroller General, or any authorized representatives,
in the course of the performance of the duties of the General
Accounting Office; or
(11) Pursuant to the order of a court of competent jurisdiction.
(c) Except for disclosures of information to Agency employees
having need for the information in the official performance of their
duties or required under the provisions of the Freedom of Information
Act, an accurate accounting of each disclosure will be made and
retained for five years after the disclosure or for the life of the
record, whichever is longer. The accounting will include the date,
nature, and purpose of each disclosure and the name and address of the
person or agency to whom the disclosure is made. Each such disclosure,
unless made to agencies engaged in law enforcement activities in
accordance with paragraph (b)(7) of this section, will be made
available to the individual upon request.
(d) To the greatest extent practicable, information that may result
in an adverse determination about an individual shall be collected from
that individual, and the individual will be informed of the purposes
for which the information will be used and any rights, benefits, and
obligations with respect to supplying the data.
(e) The Agency shall ensure that all records that are used by the
Agency to make a determination about any individual are maintained with
such accuracy, relevance, timeliness and completeness as is reasonably
necessary to assure fairness to the individual. Whenever information
about an individual contained in an Agency record is used or disclosed,
the custodian of the system of records in which the record is located
will make every effort to ensure that it is accurate, relevant, timely
and complete.
(f) The Agency shall establish appropriate administrative,
technical, and physical safeguards to ensure that records are disclosed
only to those who are authorized to have access to them and to protect
against any anticipated threats or hazards to their security or
integrity that would result in substantial harm, embarrassment,
inconvenience, or unfairness to any individual on whom information is
maintained.
(g) Agency records pertaining to an individual shall be made
available to that individual to the greatest extent possible.
(h) No lists of names and addresses will be rented or sold unless
such action is specifically authorized by law, provided that names and
addresses otherwise permitted to be made public will not necessarily be
withheld when requested.
(i) All requests for information under the Privacy Act received by
the Agency will be acted upon as promptly as possible.
Sec. 603.4 Requests for determination of existence of records.
Any individual desiring to know whether any system of records
maintained by the Agency contains a record pertaining to the individual
shall send a written request to the Privacy Act Officer, U.S. Arms
Control and Disarmament Agency, 320 21st Street, NW., Washington, DC
20451. All
[[Page 51595]]
requests for determination of the existence of records should include
sufficient information to identify the system of records, such as its
name or Federal Register identifier number if known, in addition to
such identifying information as the individual's name and date of
birth.
Sec. 603.5 Requests for disclosure to an individual of records
pertaining to the individual.
(a) An individual desiring access to or copies of records
maintained by the Agency shall send a written request to the Privacy
Act Officer, U.S. Arms Control and Disarmament Agency, 320 21st Street,
NW., Washington, DC 20451. All requests for disclosure to an individual
of records pertaining to that individual should include sufficient
information to identify the record or system of records such as its
name or Federal Register identifier number if known, in addition to
such identifying information as the individual's name and date of
birth.
(b)(1) Except as provided in paragraph (b)(2) of this section:
(i) If the individual making a written request is not personally
known to the Privacy Act Officer or to other Agency personnel
processing the request, the written request must include satisfactory
evidence that the requester is in fact the individual to whom the
requested records pertain. For this purpose, the Agency normally will
be satisfied by the receipt of the requester's statement of identity
made under penalty of perjury.
(ii) If the individual making a request in person is not personally
known to the Privacy Act Officer or to other Agency personnel
processing the request, the requester must present two identification
documents (at least one of which must bear the requester's picture)
containing the individual's signature and other suitable evidence of
identity. Examples of acceptable evidence are a driver's license,
passport, employee identification card, or military identification
card.
(2) Evidence that the requester is in fact the individual to whom
the requested records pertain is not required for information that
would be required to be made available to a third party under the
Freedom of Information Act (5 U.S.C. 552).
(c)(1) Access to or copies of records requested pursuant to this
section shall be furnished except as provided in paragraph (c)(3) of
this section:
(i) To an individual making a request in person, upon verification
of personal identity as required in paragraph (b) of this section, to
that individual, and if the individual is accompanied by any other
person, upon the individual's request, to that person, except that the
Agency may require the individual to furnish a written statement
authorizing disclosure of the individual's record in the presence of
the accompanying person.
(ii) To an authorized representative or designee of an individual,
if the individual has provided verification of personal identity as
required in paragraph (b) of this section, and submits a signed,
notarized statement authorizing and consenting to access or disclosure
to the representative or designee.
(iii) To a physician authorized by a signed, notarized statement
made by the individual making the request, in the event that the
records requested are medical records of such a nature that the Privacy
Act Officer has determined that the release of such medical information
directly to the requester could have an adverse effect on the
requester. The individual making the request must also provide
verification of personal identity as required in paragraph (b) of this
section.
(2) Access to records or copies of records requested shall be
furnished as promptly as possible.
(3) Access to or copies of records requested pursuant to this
section shall not be granted if:
(i) The individual making the request does not comply with the
requirements for verification of personal identity as required in
paragraph (b) of this section; or
(ii) The records are exempt from disclosure pursuant to Sec. 603.8.
Sec. 603.6 Requests for amendment of records.
(a) An individual may request amendment of a record pertaining to
that individual by sending a written request to the Privacy Act
Officer, U.S. Arms Control and Disarmament Agency, 320 21st Street,
NW., Washington, DC 20451. The request should identify the record
sought to be amended, specify the precise nature of the requested
amendment, and state why the requester believes that the record is not
accurate, relevant, timely or complete.
(b) Not later than ten (10) days after receipt of such request
(excluding Saturdays, Sundays and legal holidays), the Privacy Act
Officer shall promptly:
(1) Make any correction of any portion of the record pertaining to
the individual which the Agency considers appropriate; and
(2) Inform the requester in writing of the action taken by the
Agency, of the reason for refusing to comply with any portion of the
request, and of the procedures established by the Agency to consider
requests for review of such refusals.
(c) The Privacy Act Officer will refuse to amend a record if the
information therein is deemed by the Agency:
(1) To be relevant and necessary to accomplish a purpose of the
Agency required to be accomplished by statute or by executive order of
the President; and
(2) To be maintained with such accuracy, relevance, timeliness and
completeness as is reasonably necessary to assure fairness to the
individual in making any determination about the individual; and
(3) Not to describe how the individual exercises rights guaranteed
by the First Amendment unless expressly authorized by statute or by the
individual about whom the record is maintained.
(d) When the Privacy Act Officer agrees to amend a record, written
notice that the record has been amended and the substance of the
amendment will be sent to the last known address of all previous
recipients of that record shown in Agency's Privacy Act Requests File.
Sec. 603.7 Appeals from denials of requests.
(a) An individual who disagrees with the refusal of the Privacy Act
Officer to disclose or amend a record may request a review of such
refusal within 30 days of receipt of notice of the refusal. Such
request should be addressed to the Deputy Director, U.S. Arms Control
and Disarmament Agency, 320 21st Street, NW., Washington, DC 20451, and
should include a copy of the written request that was refused, a copy
of the denial complained of, and reasons for appeal from the denial.
(b) Review shall be made by the Deputy Director on the submitted
record. No personal appearance, oral argument, or hearing shall be
permitted.
(c) Review will be completed and a final determination made not
later than 30 days (excluding Saturdays, Sundays and legal holidays)
from the date on which the request for such review is received. This
30-day limitation may be extended, at the discretion of the Agency for
good cause shown. The requester will be notified in writing of the
Agency's final determination.
(d) If, after completion of the review, the Deputy Director also
refuses to disclose or amend the record as requested, the notice to the
individual will advise the individual of the right to file with the
agency a concise statement setting forth the reasons for disagreement
with this refusal.
[[Page 51596]]
(e) When an individual has filed with the Agency a statement of
disagreement following a refusal to amend the record as requested, the
Agency will clearly note that portion of the record that is disputed
and will send copies of the statement of disagreement to the last known
address of all previous recipients of the disputed record shown in the
Agency's Privacy Act Requests File.
Sec. 603.8 Exemptions.
(a) As authorized by the Act, the following categories of records
are hereby exempted from the requirements of sections (c)(3), (d),
(e)(4) (G), (H) and (I), and (f) of 5 U.S.C. 552a, and will not be
disclosed to the individuals to which they pertain:
(1) System of Records of ACDA-4--Statements by Principals during
the Strategic Arms Limitation Talks, Mutual Balanced Force Reduction
negotiations, and the Standing Consultative Committee. This system
contains information classified pursuant to Executive Order 12958 that
is exempt from disclosure by the Act (5 U.S.C. 552a(k)(1)) in that
disclosure could damage national security.
(2) System of Records ACDA-3--Security Records. This system
contains investigatory material compiled for law enforcement purposes
which is exempt from disclosure by the Act (5 U.S.C. 552a(k)(2)):
Provided, however, that if any individual is denied any right,
privilege, or benefit to which the individual would otherwise be
entitled by Federal law, or for which the individual would otherwise be
eligible, as a result of the maintenance of such material, such
material will be provided to such individual, except to the extent that
disclosure of such material would reveal the identity of a source who
furnished information to the Government under an express promise that
the identity of the source would be held in confidence, or, if
furnished to the Government prior to September 27, 1975, under an
implied promise that the identity of the source would be held in
confidence.
(3) Systems of Records ACDA-3--Security Records. This system
contains investigatory materials compiled solely for the purpose of
determining suitability, eligibility, or qualifications for Federal
civilian employment, military service, Federal contracts, or access to
classified information which is exempt from disclosure by the Act (5
U.S.C. 552a(k)(5)), but only to the extent that disclosure of such
material would reveal the identity of a source who furnished
information to the Government under an express promise that the
identity of the source would be held in confidence, or, if furnished to
the Government prior to September 27, 1975, under an implied promise
that the identity of the source would be held in confidence.
(b) Nothing in these regulations shall be construed to allow an
individual access to:
(1) Any information compiled in reasonable anticipation of a civil
action or proceeding; or
(2) Testing or examination material used solely to determine
individual qualification for appointment or promotion in the Federal
Service, the disclosure of which would compromise the objectivity or
fairness of the testing or examination process.
Sec. 603.9 New and amended systems of records.
(a) The Agency shall provide adequate advance notice to Congress
and to the Office of Management and Budget of any proposal to establish
or alter any system of records. Such notice shall be in a form
consistent with guidance on content, format and timing issued by the
Office of Management and Budget.
(b) The Agency shall publish by August 31 of each year in the
Federal Register a notice of the existence and character of each system
of records maintained by the Agency. Such notice shall be consistent
with guidance on format contained in the Act and issued by the General
Services Administration. At least 30 days before any new or changed
routine use of records contained within a system of records can be
made, the Agency shall publish notice of such new or changed use in the
Federal Register.
Sec. 603.10 Fees.
Fees to be charged in responding to requests under the Privacy Act
shall be, to the extent permitted by paragraph (f)(5) of the Act, the
rates established in title 22 CFR 602.20 for responding to requests
under the Freedom of Information Act.
Dated: September 23, 1996.
Mary Elizabeth Hoinkes,
General Counsel.
[FR Doc. 96-25405 Filed 10-2-96; 8:45 am]
BILLING CODE 6820-32-M
Complete official Federal Register PDF
FR Doc. 96-25401 Displacement, Relocation Assistance, and Real Property Acquisition for HUD and HUD-Assisted Programs; Streamlining Rule
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51756-51760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25401]
[[Page 51755]]
_______________________________________________________________________
Part III
Department of Housing and Urban Development
_______________________________________________________________________
Office of the Secretary
_______________________________________________________________________
24 CFR Part 42, et al.
Displacement, Relocation Assistance, and Real Property Acquisition for
HUD and HUD-Assisted Programs: Streamlining; Final Rule
Federal Register / Vol. 61, No. 193 / Thursday, October 3, 1996 /
Rules and Regulations
[[Page 51756]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
Office of the Secretary
24 CFR Parts 42, 91, 92, 570
[Docket No. FR-3982-F-01]
RIN 2501-AC11
Displacement, Relocation Assistance, and Real Property
Acquisition for HUD and HUD-Assisted Programs; Streamlining Rule
AGENCY: Office of the Secretary, HUD.
ACTION: Final rule.
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SUMMARY: This final rule amends HUD's regulations implementing section
104(d) of the Housing and Community Development Act of 1974, including
residential antidisplacement and relocation assistance plans, one-for-
one replacement requirements, and relocation benefits. In an effort to
comply with the President's regulatory reform initiatives, this rule
will streamline those regulations by consolidating them into one part.
This final rule will make the regulations clearer and more concise.
EFFECTIVE DATE: November 4, 1996.
FOR FURTHER INFORMATION CONTACT: Janice Petty, Relocation Specialist,
Relocation and Real Estate Division, Room 7168, Department of Housing
and Urban Development, 451 Seventh Street, SW, Washington, DC 20410,
telephone number (202) 708-1367 (this is not a toll-free number). For
hearing- and speech-impaired persons, this number may be accessed via
TTY by calling the Federal Information Relay Service at 1-800-877-8339.
SUPPLEMENTARY INFORMATION: On March 4, 1995, President Clinton issued a
memorandum to all Federal departments and agencies regarding regulatory
reinvention. In response to this memorandum, HUD conducted a page-by-
page review of its regulations to determine which can be eliminated,
consolidated, or otherwise improved.
This revised part 42 implements section 104(d) of the Housing and
Community Development Act of 1974 (HCD Act of 1974) (42 U.S.C.
5304(d)(4)), which sets forth requirements governing conversion,
demolition, and one-for-one replacement of units removed from the
housing stock. Section 104(d) requires residential antidisplacement and
relocation assistance plans (RARAPs) for State and local governments
receiving funds under the Community Development Block Grant (CDBG) and
Urban Development Action Grant (UDAG) programs. This requirement was
extended to the HOME Investment Partnerships (HOME) program by section
105(b)(14) of the Cranston-Gonzalez National Affordable Housing Act
(NAHA) (42 U.S.C. 12705(b)(14)). In streamlining these requirements,
this final rule also implements the restrictions in 42 U.S.C. 3537c on
lump-sum payments for relocation assistance.
On July 1, 1994 (59 FR 34300), HUD published a proposed rule that
would have created a new part 43 to replace the current requirements in
Secs. 92.353(e) and 570.606(c) of title 24. Consistent with its
reinvention objectives, HUD is adding the section 104(d) requirements
to part 42, rather than creating a detailed new part 43. In doing so,
it is retaining some of the current language of part 570. As a result,
part 42 will make clear the distinction between the generally
applicable requirements of the Uniform Relocation Assistance and Real
Property Acquisition Policies Act of 1970 (42 U.S.C. 4601 et seq.)
(Uniform Relocation Act or URA) and the more targeted requirements of
section 104(d) of the HCD Act of 1974 (Section 104(d)).
Proposed Rule
Some existing section 104(d) requirements established for the CDBG
programs do not work well in the HOME Program. The July 1, 1994, rule
proposed section 104(d) policies that would be better tailored to both
HOME and CDBG Program policy needs, providing consistent and workable
policies for both programs in the same regulation. Such consistency is
essential because CDBG and HOME funds may be used in the same project.
Portions of the proposed rule necessary to achieve that objective have
been incorporated in this final rule. Other parts of the proposed rule,
however, are unnecessarily lengthy, complex, or prescriptive. Since
adoption of these portions would be inconsistent with HUD's
streamlining objectives, HUD has not included them in the final rule.
Two organizations and three other persons submitted comments in
response to the proposed rule. Commenters have asked why it is
necessary to have a RARAP when there would be no displacement resulting
from the project. Section 104(d) of the HCD Act of 1974 states that a
grant for a CDBG program ``may be made only if the grantee certifies
that it is following'' a RARAP. While HUD cannot bypass this statutory
requirement, an acceptable ``plan'' for such circumstances need not be
elaborate. Since the RARAP does not need to be revised or readopted
annually, but only when the recipient's program necessitates, this
requirement should not impose any major burden on program participants.
Overnight Homeless Shelters and Other Public Facilities
``Conversion'' (defined in the final rule) is one of the two
actions that triggers the requirements of section 104(d). In the past,
HUD had stated that a change of lower-income housing into an overnight
emergency shelter constituted ``conversion,'' even if the market rent
of the shelter housing, upon completion of the project, did not exceed
the Section 8 Fair Market Rent (FMR). Questions were raised about the
policy applicable to changing lower-income housing into nursing homes,
battered spouse shelters, halfway houses, group homes, and transitional
housing. The July 1, 1994, proposed rule stated, ``The Department has
concluded that such facilities and emergency overnight shelters may
contribute to the supply of available lower income housing, and
changing conventional housing into such a use does not necessarily
trigger a replacement requirement. * * * In other words, the Department
would consider the physical structure, rather than whether the tenants
are permitted to remain for only a temporary period of time and must
vacate to permit use by other tenants.''
In response to public comments, and upon further consideration of
the issue, HUD has revised its position. It is HUD's determination that
housing that is changed to an emergency shelter, whether it serves
homeless persons, battered spouses, or others, is indeed a
``conversion'' of lower-income housing. Changing lower-income housing
into nursing homes, halfway houses, group homes and transitional
housing, or other forms of permanent or transitional housing, does not
constitute a ``conversion'' and, thus, does not trigger a replacement
requirement. Accordingly, the final rule revises the definition of
conversion at Sec. 42.305(b)(2) to include alteration of a housing unit
to be used for an emergency shelter.
Removal of Dilapidated Housing
CDBG recipients had been required to replace vacant, dilapidated
housing that is not suitable for rehabilitation if the unit was
occupied at any time within the period beginning 1 year before the
execution of the contract covering the demolition. The proposed rule
reduced the 12-month period to 3 months. Two commenters agreed with the
proposal. One opposed it, stating that the change was an evasion of the
one-for-one housing replacement requirement.
[[Page 51757]]
HUD disagrees with the latter comment and remains concerned that
the old 1-year rule has had the effect of unduly delaying the
demolition of run-down vacant buildings that are a danger to public
health and safety. Moreover, the removal of vacant, dilapidated housing
that is clearly not occupiable does not effectively diminish the
available supply of lower-income housing. Therefore, the final rule
definition of ``vacant occupiable dwelling unit'' at Sec. 42.305 adopts
the 3-month policy set out in the proposed rule.
Other Matters
Executive Order 12866
The Office of Management and Budget reviewed this final rule under
Executive Order 12866, Regulatory Planning and Review. Any changes made
to the rule as a result of that review are clearly identified in the
docket file, which is available for public inspection at the Office of
the Rules Docket Clerk, Office of General Counsel, Room 10276,
Department of Housing and Urban Development, 451 Seventh Street, SW.,
Washington, DC 20410-0500.
Regulatory Flexibility Act
The Secretary, in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)), has reviewed and approved this final rule, and in so
doing certifies that this rule will not have a significant economic
impact on a substantial number of small entities. This rule merely
streamlines and consolidates existing requirements, thereby providing
consistency in affected programs. The rule will have no adverse or
disproportionate economic impact on small businesses.
Environmental Impact
A Finding of No Significant Impact with respect to the environment
was made in accordance with HUD regulations in 24 CFR part 50 that
implement section 102(2)(C) of the National Environmental Policy Act of
1969 (42 U.S.C. 4332). This Finding is available for public inspection
between 7:30 a.m. and 5:30 p.m. weekdays in the Office of the Rules
Docket Clerk, Office of General Counsel, Room 10276, Department of
Housing and Urban Development, 451 Seventh Street, SW., Washington, DC.
Executive Order 12612, Federalism
The General Counsel, as the Designated Official under section 6(a)
of Executive Order 12612, Federalism, has determined that this rule
will not have substantial direct effects on States or their political
subdivisions, or the relationship between the Federal government and
the States, or on the distribution of power and responsibilities among
the various levels of government. No programmatic or policy changes
will result from this rule that would affect the relationship between
the Federal Government and State and local governments.
Executive Order 12606, The Family
The General Counsel, as the Designated Official under Executive
Order 12606, The Family, has determined that this rule will not have
the potential for significant impact on family formation, maintenance,
or general well-being, and thus is not subject to review under the
Order. No significant change in existing HUD policies or programs will
result from promulgation of this rule.
List of Subjects
24 CFR Part 42
Administrative practice and procedure, Grant programs, Loan
programs, Manufactured homes, Real property acquisition, Relocation
assistance, Reporting and recordkeeping requirements.
24 CFR Part 91
Aged, Grant programs--housing and community development, Homeless,
Individuals with disabilities, Low and moderate income housing,
Reporting and recordkeeping requirements.
24 CFR Part 92
Administrative practice and procedure, Grant programs--housing and
community development, Grant programs--Indians, Indians, Low and
moderate income housing, Manufactured homes, Rent subsidies, Reporting
and recordkeeping requirements.
24 CFR Part 570
Administrative practice and procedure, American Samoa, Community
development block grants, Grant programs--education, Grant programs--
housing and community development, Guam, Indians, Lead poisoning, Loan
programs--housing and community development, Low and moderate income
housing, New communities, Northern Mariana Islands, Pacific Islands
Trust Territory, Pockets of poverty, Puerto Rico, Reporting and
recordkeeping requirements, Small cities, Student aid, Virgin Islands.
Accordingly, part 42 of title 24 of the Code of Federal Regulations
is revised in its entirety, and parts 91, 92, and 570 are amended as
follows:
PART 42--DISPLACEMENT, RELOCATION ASSISTANCE, AND REAL PROPERTY
ACQUISITION FOR HUD AND HUD-ASSISTED PROGRAMS
1. Part 42 is revised to read as follows:
Subpart A--General
Sec.
42.1 Applicable rules.
Subpart B--[Reserved]
Subpart C--Requirements Under Section 104(d) of Housing and Community
Development Act of 1974
42.301 Applicability.
42.305 Definitions.
42.325 Residential antidisplacement and relocation assistance plan.
42.350 Relocation assistance for displaced persons.
42.375 One-for-one replacement of lower-income dwelling units.
42.390 Appeals.
Authority: 42 U.S.C. 3535(d), 4601, 5304, and 12705(b).
Subpart A--General
Sec. 42.1 Applicable rules.
(a) URA. HUD-assisted programs and projects are subject to the
Uniform Relocation Assistance and Real Property Acquisition Policies
Act of 1970, 42 U.S.C. 4601 (URA) (42 U.S.C. 4601), and implementing
regulations issued by the Department of Transportation at 49 CFR part
24.
(b) Section 104(d). In addition to the URA, the Community
Development Block Grant (CDBG), Urban Development Action Grant (UDAG),
and HOME Investment Partnerships (HOME) programs are also subject to
section 104(d) of the Housing and Community Development Act of 1974 (42
U.S.C. 5304(d)). The provisions applicable to these programs are set
out in subpart C of this part.
(c) Additional requirements. Applicable program regulations may
contain additional relocation provisions.
Subpart B--[Reserved]
Subpart C--Requirements Under Section 104(d) of Housing and
Community Development Act of 1974
Sec. 42.301 Applicability.
This subpart applies only to CDBG grants under 24 CFR part 570,
subparts D, F, and I (Entitlement grants, HUD-Administered Small
Cities, and State programs); grants under 24 CFR part 570, subpart G
(Urban Development Action Grants), and Loan Guarantees under 24 CFR
part 570, subpart M; and assistance to State and local governments
under 24 CFR part 92 (HOME program).
[[Page 51758]]
Sec. 42.305 Definitions.
The terms Fair Market Rent (FMR), HUD, Section 8, and Uniform
Relocation Act (URA) are defined in part 5 of this title. Otherwise, as
used in this subpart:
Comparable replacement dwelling unit means a dwelling unit that:
(1) Meets the criteria of 49 CFR 24.2(d)(1) through (6); and
(2) Is available at a monthly cost for rent plus estimated average
monthly utility costs that does not exceed the ``Total Tenant Payment''
determined under Sec. 813.107 of this title, after taking into account
any rental assistance the household would receive.
Conversion. (1) This term means altering a housing unit so that it
is:
(i) Used for nonhousing purposes;
(ii) Used for housing purposes, but no longer meets the definition
of lower-income dwelling unit; or
(iii) Used as an emergency shelter.
(2) A housing unit that continues to be used for housing after
completion of the project is not considered a ``conversion'' if, upon
completion of the project, the unit is owned and occupied by a person
who owned and occupied the unit before the project.
Displaced person means a lower-income person who, in connection
with an activity assisted under any program subject to this subpart,
permanently moves from real property or permanently moves personal
property from real property as a direct result of the demolition or
conversion of a lower-income dwelling. For purposes of this definition,
a permanent move includes a move made permanently and:
(1) After notice by the grantee to move from the property following
initial submission to HUD of the consolidated plan required of
entitlement grantees pursuant to Sec. 570.302; of an application for
assistance pursuant to Secs. 570.426, 570.430, or 570.465 that is
thereafter approved; or an application for loan assistance under
Sec. 570.701 that is thereafter approved;
(2) After notice by the property owner to move from the property,
following the submission of a request for financial assistance by the
property owner (or other person in control of the site) that is
thereafter approved; or
(3) Before the dates described in this definition, if HUD or the
grantee determine that the displacement was a direct result of
conversion or demolition in connection with an activity subject to this
subpart for which financial assistance has been requested and is
thereafter approved.
HCD Act of 1974 means the Housing and Community Development Act of
1974 (42 U.S.C. 5301 et seq.).
Lower-income dwelling unit means a dwelling unit with a market rent
(including utility costs) that does not exceed the applicable Fair
Market Rent (FMR) for existing housing established under 24 CFR part
888.
Lower-income person means, as appropriate, a ``low and moderate
income person'' as that term is defined in Sec. 570.3 of this title, or
a ``low-income family'' as that term is defined in Sec. 92.2 of this
title.
Recipient means CDBG grantee, UDAG grantee, or the HOME
participating jurisdiction.
Standard condition and substandard condition suitable for
rehabilitation have the meaning the recipient has established for those
terms in its HUD-approved consolidated plan pursuant to 24 CFR part 91.
In the case of a unit of general local government funded by a State,
either the State's definitions for those terms or the definitions
adopted by the unit of general local government for this purpose shall
apply.
Vacant occupiable dwelling unit means a vacant dwelling unit that
is in a standard condition; a vacant dwelling unit that is in a
substandard condition, but is suitable for rehabilitation; or a
dwelling unit in any condition that has been occupied (except by a
squatter) at any time within the period beginning 3 months before the
date of execution of the agreement by the recipient covering the
rehabilitation or demolition.
Sec. 42.325 Residential antidisplacement and relocation assistance
plan.
(a) Certification. (1) As part of its consolidated plan under 24
CFR part 91, the recipient must certify that it has in effect and is
following a residential antidisplacement and relocation assistance
plan.
(2) A unit of general local government receiving funds from the
State must certify to the State that it has in effect and is following
a residential antidisplacement and relocation assistance plan, and that
it will minimize displacement of persons as a result of assisted
activities. The State may require the unit of general local government
to follow the State's plan or permit it to develop its own plan. A unit
of general local government that develops its own plan must adopt the
plan and make it public.
(b) Plan contents. (1) The plan shall indicate the steps that will
be taken consistent with other goals and objectives of the program, as
provided in parts 92 and 570 of this title, to minimize the
displacement of families and individuals from their homes and
neighborhoods as a result of any assisted activities.
(2) The plan shall provide for relocation assistance in accordance
with Sec. 42.350.
(3) The plan shall provide one-for-one replacement units to the
extent required by Sec. 42.375.
Sec. 42.350 Relocation assistance for displaced persons.
A displaced person may choose to receive either assistance under
the URA and implementing regulations at 49 CFR part 24 or assistance
under section 104(d) of the HCD Act of 1974, including:
(a) Advisory services. Advisory services at the levels described in
49 CFR part 24. A displaced person must be advised of his or her rights
under the Fair Housing Act (42 U.S.C. 3601-19). If the comparable
replacement dwelling to be provided to a minority person is located in
an area of minority concentration, as defined in the recipient's
consolidated plan, if applicable, the minority person must also be
given, if possible, referrals to comparable and suitable decent, safe,
and sanitary replacement dwellings not located in such areas.
(b) Moving expenses. Payment for moving expenses at the levels
described in 49 CFR part 24.
(c) Security deposits and credit checks. The reasonable and
necessary cost of any security deposit required to rent the replacement
dwelling unit, and for credit checks required to rent or purchase the
replacement dwelling unit.
(d) Interim living costs. The recipient shall reimburse a person
for actual reasonable out-of-pocket costs incurred in connection with a
displacement, including moving expenses and increased housing costs,
if:
(1) The person must relocate temporarily because continued
occupancy of the dwelling unit constitutes a substantial danger to the
health or safety of the person or the public; or
(2) The person is displaced from a ``lower-income dwelling unit,''
none of the comparable replacement dwelling units to which the person
has been referred qualifies as a lower-income dwelling unit, and a
suitable lower-income dwelling unit is scheduled to become available in
accordance with Sec. 42.375.
(e) Replacement housing assistance. Persons are eligible to receive
one of the following two forms of replacement housing assistance:
(1) Each person must be offered rental assistance equal to 60 times
the amount necessary to reduce the monthly rent and estimated average
monthly cost of utilities for a replacement dwelling
[[Page 51759]]
(comparable replacement dwelling or decent, safe, and sanitary
replacement dwelling to which the person relocates, whichever costs
less) to the ``Total Tenant Payment,'' as determined under part 813 of
this title. All or a portion of this assistance may be offered through
a certificate or voucher for rental assistance (if available) provided
under Section 8. If a Section 8 certificate or voucher is provided to a
person, the recipient must provide referrals to comparable replacement
dwelling units where the owner is willing to participate in the Section
8 Tenant-Based Assistance Existing Housing Program (see part 982 of
this title). When provided, cash assistance will generally be in
installments, in accordance with 42 U.S.C. 3537c; or
(2) If the person purchases an interest in a housing cooperative or
mutual housing association and occupies a decent, safe, and sanitary
dwelling in the cooperative or association, the person may elect to
receive a payment equal to the capitalized value of 60 times the amount
that is obtained by subtracting the ``Total Tenant Payment,'' as
determined under part 813 of this title, from the monthly rent and
estimated average monthly cost of utilities at a comparable replacement
dwelling unit. To compute the capitalized value, the installments shall
be discounted at the rate of interest paid on passbook savings deposits
by a federally insured financial institution conducting business within
the recipient's jurisdiction. To the extent necessary to minimize
hardship to the household, the recipient shall, subject to appropriate
safeguards, issue a payment in advance of the purchase of the interest
in the housing cooperative or mutual housing association.
Sec. 42.375 One-for-one replacement of lower-income dwelling units.
(a) Units that must be replaced. All occupied and vacant occupiable
lower-income dwelling units that are demolished or converted to a use
other than as lower-income dwelling units in connection with an
assisted activity must be replaced with comparable lower-income
dwelling units.
(b) Acceptable replacement units. Replacement lower-income dwelling
units may be provided by any government agency or private developer and
must meet the following requirements:
(1) The units must be located within the recipient's jurisdiction.
To the extent feasible and consistent with other statutory priorities,
the units shall be located within the same neighborhood as the units
replaced.
(2) The units must be sufficient in number and size to house no
fewer than the number of occupants who could have been housed in the
units that are demolished or converted. The number of occupants who
could have been housed in units shall be determined in accordance with
applicable local housing occupancy codes. The recipient may not replace
those units with smaller units (e.g., a 2-bedroom unit with two 1-
bedroom units), unless the recipient has provided the information
required under paragraph (c)(7) of this section.
(3) The units must be provided in standard condition. Replacement
lower-income dwelling units may include units that have been raised to
standard from substandard condition if:
(i) No person was displaced from the unit (see definition of
``displaced person'' in Sec. 42.305); and
(ii) The unit was vacant for at least 3 months before execution of
the agreement between the recipient and the property owner.
(4) The units must initially be made available for occupancy at any
time during the period beginning 1 year before the recipient makes
public the information required under paragraph (d) of this section and
ending 3 years after the commencement of the demolition or
rehabilitation related to the conversion.
(5) The units must be designed to remain lower-income dwelling
units for at least 10 years from the date of initial occupancy.
Replacement lower-income dwelling units may include, but are not
limited to, public housing or existing housing receiving Section 8
project-based assistance.
(c) Preliminary information to be made public. Before the recipient
enters into a contract committing it to provide funds under programs
covered by this subpart for any activity that will directly result in
the demolition of lower-income dwelling units or the conversion of
lower-income dwelling units to another use, the recipient must make
public, and submit in writing to the HUD field office (or State, in the
case of a unit of general local government funded by the State), the
following information:
(1) A description of the proposed assisted activity;
(2) The location on a map and number of dwelling units by size
(number of bedrooms) that will be demolished or converted to a use
other than for lower-income dwelling units as a direct result of the
assisted activity;
(3) A time schedule for the commencement and completion of the
demolition or conversion;
(4) The location on a map and the number of dwelling units by size
(number of bedrooms) that will be provided as replacement dwelling
units. If such data are not available at the time of the general
submission, the submission shall identify the general location on an
area map and the approximate number of dwelling units by size, and
information identifying the specific location and number of dwelling
units by size shall be submitted and disclosed to the public as soon as
it is available;
(5) The source of funding and a time schedule for the provision of
replacement dwelling units;
(6) The basis for concluding that each replacement dwelling unit
will remain a lower-income dwelling unit for at least 10 years from the
date of initial occupancy; and
(7) Information demonstrating that any proposed replacement of
dwelling units with smaller dwelling units (e.g., a 2-bedroom unit with
two 1-bedroom units) is consistent with the needs assessment contained
in its HUD-approved consolidated plan. A unit of general local
government funded by the State that is not required to submit a
consolidated plan to HUD must make public information demonstrating
that the proposed replacement is consistent with the housing needs of
lower-income households in the jurisdiction.
(d) Replacement not required. (1) In accordance with 42 U.S.C.
5304(d)(3), the one-for-one replacement requirement of this section
does not apply to the extent the HUD field office determines, based
upon objective data, that there is an adequate supply of vacant lower-
income dwelling units in standard condition available on a
nondiscriminatory basis within the area.
(2) The recipient must submit directly to the HUD field office the
request for determination that the one-for-one replacement requirement
does not apply. Simultaneously with the submission of the request, the
recipient must make the submission public and inform interested persons
that they have 30 days from the date of submission to provide to HUD
additional information supporting or opposing the request.
(3) A unit of general local government funded by the State must
submit the request for determination under this paragraph to the State.
Simultaneously with the submission of the request, the unit of general
local government must make the submission public and inform interested
persons that they have 30 days from the date of submission to provide
to the State additional information supporting or opposing the request.
If the State, after considering
[[Page 51760]]
the submission and the additional data, agrees with the request, the
State must provide its recommendation with supporting information to
the field office.
Sec. 42.390 Appeals.
A person who disagrees with the recipient's determination
concerning whether the person qualifies as a ``displaced person,'' or
with the amount of relocation assistance for which the person is
eligible, may file a written appeal of that determination with the
recipient. A person who is dissatisfied with the recipient's
determination on his or her appeal may submit a written request for
review of that determination to the HUD field office (or to the State
in the case of a unit of general local government funded by the State).
If the full relief is not granted, the recipient shall advise the
person of his or her right to seek judicial review.
PART 91--CONSOLIDATED SUBMISSIONS FOR COMMUNITY PLANNING AND
DEVELOPMENT PROGRAMS
2. The authority citation for part 91 continues to read as follows:
Authority: 42 U.S.C. 3535(d), 3601-3619, 5301-5315, 11331-11388,
12701-12711, 12741-12756, and 12901-12912.
3. Section 91.205 is amended to add a new sentence at the end of
paragraph (b)(1):
Sec. 91.205 Housing and homeless needs assessment.
* * * * *
(b) * * *
(1) * * * (The jurisdiction must define in its consolidated plan
the terms ``standard condition'' and ``substandard condition but
suitable for rehabilitation.'')
* * * * *
4. Section 91.305 is amended to add a new sentence at the end of
paragraph (b)(1):
Sec. 91.305 Housing and homeless needs assessment.
* * * * *
(b) * * *
(1) * * * (The State must define in its consolidated plan the terms
``standard condition'' and ``substandard condition but suitable for
rehabilitation.'')
* * * * *
PART 92--HOME INVESTMENT PARTNERSHIPS PROGRAM
5. The authority citation for part 92 continues to read as follows:
Authority: 42 U.S.C. 3535(d), 12701-12839.
6. Section 92.353(e) is revised to read as follows:
Sec. 92.353 Displacement, relocation, and acquisition.
* * * * *
(e) Residential antidisplacement and relocation assistance plan.
The participating jurisdiction shall comply with the requirements of 24
CFR part 42, subpart B.
* * * * *
PART 570--COMMUNITY DEVELOPMENT BLOCK GRANTS
7. The authority citation for part 570 continues to read as
follows:
Authority: 42 U.S.C. 3535(d) and 5300-5320.
8. Section 570.606(c) is revised to read as follows:
Sec. 570.606 Displacement, relocation, acquisition, and replacement of
housing.
* * * * *
(c) Residential antidisplacement and relocation assistance plan.
The grantee shall comply with the requirements of 24 CFR part 42,
subpart B.
Dated: September 23, 1996.
Henry G. Cisneros,
Secretary.
[FR Doc. 96-25401 Filed 10-2-96; 8:45 am]
BILLING CODE 4210-32-P
Complete official Federal Register PDF
FR Doc. 96-25400 Approval and Promulgation of Implementation Plans; Arizona Maricopa Nonattainment Area; Carbon Monoxide
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51599-51611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25400]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[AZ033-0007 FRL-5628-6]
Approval and Promulgation of Implementation Plans; Arizona--
Maricopa Nonattainment Area; Carbon Monoxide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is approving contingency measures adopted pursuant to the
Clean Air Act (CAA) and submitted to EPA by the State of Arizona as
revisions to the Arizona State Implementation Plan (SIP) for the
Maricopa (Phoenix) carbon monoxide (CO) nonattainment area. Based on
the approval of these measures, EPA is withdrawing its federal
contingency process for the Maricopa area and its proposed list of
highway projects subject to delay.
EFFECTIVE DATE: December 2, 1996.
FOR FURTHER INFORMATION CONTACT: Frances Wicher, A-2-1, Air and Toxics
Division, U.S. Environmental Protection Agency, Region 9, 75 Hawthorne
Street, San Francisco, California 94105, (415) 744-1248.
SUPPLEMENTARY INFORMATION:
I. Background
A. Federal Contingency Process
On February 11, 1991, EPA disapproved elements of the Arizona CO
SIP and promulgated a limited federal implementation plan (FIP) for the
Maricopa County (Phoenix) CO nonattainment area in response to an order
of the Ninth Circuit Court of Appeals in Delaney v. EPA, 898 F.2d 687
(9th Cir. 1990).1 For a discussion of Delaney, the SIP
disapproval, and the FIP, see the notice of proposed rulemaking (NPRM)
for the FIP, 55 FR 41204 (October 10, 1990) and the notice of final
rulemaking (NFRM) for the FIP, 56 FR 5458 (February 11, 1991).
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\1\ While the FIP was promulgated after the enactment of the
1990 Clean Air Act Amendments, it was designed, pursuant to the
Delaney Court's order, to comply with the CAA and EPA guidance as
they existed prior to the 1990 Amendments.
---------------------------------------------------------------------------
As required by the Delaney order, the FIP contained a two-part
contingency process consistent with the Agency's 1982 ozone and CO SIP
guidance regarding contingency procedures.2 These two parts were a
list of transportation projects that would be delayed while an
inadequate plan was being revised and a procedure to adopt measures to
compensate for unanticipated emission reduction shortfalls. The FIP
contingency process is described in detail at 56 FR 5458, 5470-5472.
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\2\ ``State Implementation Plans; Approval of 1982 Ozone and
Carbon Monoxide Plan Revisions for Areas Needing an Attainment Date
Extension. Final Policy.'' 46 FR 7182 at 7187, 7192 (January 22,
1981) (hereafter referred to as ``1982 guidance'').
---------------------------------------------------------------------------
Implementation of the FIP contingency process was triggered by
violations of the CO standard in Phoenix in December 1992. On June 28,
1993 (58 FR 5458), EPA published a notice of proposed rulemaking
proposing to find that the implementation plan was inadequate
[[Page 51600]]
and that additional control measures were necessary to attain and
maintain the CO national ambient air quality standard (NAAQS) in the
Maricopa area. In the same notice, EPA also proposed an updated list of
highway projects subject to delay while the implementation plan was
being revised. On August 9, 1993, EPA issued a SIP call under section
110(k)(5) of the CAA requiring that Arizona submit a new plan by July
19, 1994. Arizona submitted SIP revisions to EPA in November 1993,
March 1994 and August 1995 that contained new control measures and a
demonstration that the area would attain the CO NAAQS by December 31,
1995, the attainment deadline under the 1990 Clean Air Act Amendments
for CO nonattainment areas classified as ``moderate'' such as
Phoenix.3 See CAA section 186(a). As a result, EPA took no final
action on the June 28, 1993 proposal and is today withdrawing that
proposal.
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\3\ At the time of the SIP submittals that are the subject of
today's document, Phoenix was classified as moderate and, because
its design value is under 12.7 ppm, was considered a low moderate
area. EPA has recently found that the Phoenix area failed to attain
the CO NAAQS by the statutory deadline. See 61 FR 39343 (July 29,
1996) As a consequence of this finding, the area has been
reclassified to ``serious'' under section 186(b)(2). As a result,
the area is now subject to the section 187(b) requirements for
serious CO areas. These requirements include those applicable to CO
areas with design values between 12.7 ppm and 16.4 ppm (high
moderate areas) in section 187(a). For the purpose of today's
action, however, the relevant CAA requirements are those that apply
to low moderate CO nonattainment areas. The serious area
requirements are referred to throughout this notice when they inform
individual discussions.
---------------------------------------------------------------------------
B. CAA Contingency Requirements and EPA Guidance
The Clean Air Act Amendments (CAAA) of 1990 completely revised the
nonattainment provisions of the Act, part D of title I, repealing the
generally applicable provisions of section 172 and adopting substantial
new requirements and planning and attainment deadlines applicable to CO
nonattainment SIPs. See sections 171-193. A number of these provisions
are discussed in detail in section III of this document.
Among the new requirements in the 1990 CAAA is section 172(c)(9)
which provides for contingency measures. Section 172(c)(9) requires
that plans for nonattainment areas ``shall provide for the
implementation of specific measures to be undertaken if the area fails
to make reasonable further progress, or to attain the national ambient
air quality standard by the attainment date applicable under this part
[D]. Such measures shall be included in the plan revision as
contingency measures to take effect in any such case without further
action by the State or the Administrator.''
EPA has issued several guidance documents related to the post-1990
requirements for CO SIPs. Among them is the ``General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990.''
See generally 57 FR 13498 (April 16, 1992) and 57 FR 18070 (April 28,
1992) (hereafter ``General Preamble'') and the ``Technical Support
Document to Aid the States with the Development of Carbon Monoxide
State Implementation Plans,'' July 1992 (hereafter ``1992 TSD'').
For CO, the General Preamble addresses specifically only the
contingency measures required under section 187(a)(3) of the Act for
moderate areas with design values above 12.7 ppm (high moderate areas).
See 57 FR 13498, 13532-13533. As a low moderate area, section 187(a)(3)
did not apply to Phoenix. In connection with the discussion of
requirements for moderate ozone areas, the General Preamble addresses
generally the section 172(c)(9) requirements which are also applicable
to low moderate CO nonattainment areas such as Phoenix. See 57 FR
13498, 13510-13511. In both discussions, EPA states that the
contingency measure provisions of the 1990 Amendments supersede the
contingency requirements contained in the 1982 guidance.
The 1992 TSD contains a discussion directly applicable to low
moderate CO areas. See pages 5-6. This guidance explains that the
trigger for implementation of the section 172(c)(9) measures is a
finding by EPA that such an area failed to attain the CO NAAQS by the
applicable attainment date and that states must show that their
contingency measures can be implemented with minimal further action on
their part and with no additional rulemaking actions upon such a
finding.
In the 1992 TSD, EPA notes that section 172(c)(9) does not specify
how many contingency measures are needed or the magnitude of emission
reductions they must provide if an area fails to attain the CO NAAQS.
EPA suggests that one appropriate choice would be to provide for the
implementation of sufficient reductions in vehicle miles traveled (VMT)
or emission reductions to counteract the effect of one year's growth in
VMT while the state revises its SIP to incorporate the new requirements
for a serious CO area. Thus, in suggesting a benchmark of one year's
growth in VMT, EPA concluded that the purpose of the Act's contingency
requirement is to maintain the actual attainment year emissions level
while the serious area attainment demonstration is being developed.
II. Summary of Proposed Action
On April 9, 1996 (61 FR 15745), EPA proposed to approve two
contingency measures submitted by the State of Arizona for the Phoenix
CO nonattainment area. These measures are enhancements to the State's
remote sensing program for vehicle emissions and a traffic diversion
measure. Both measures are described in detail in the proposal. See 61
FR 15745 at 15746-15747 and 15749-15750. In the proposal, EPA also
described in detail the SIP approval standards applicable to the
State's contingency measure submittals. EPA proposed to conclude that
the State's two contingency measures, when considered in conjunction
with emission reductions expected to be achieved in 1996 and 1997
through the continued implementation of the State's federally approved
Vehicle Emission Inspection program (enhanced I/M program), met the
requirements of section 172(c)(9) and other applicable provisions of
the CAA. The Agency's preliminary analysis reaching that conclusion is
set forth at 61 FR 15747-15750.
Based on its approval of the State's contingency measures, EPA also
proposed to withdraw the federal contingency process for the Maricopa
area from the State's applicable implementation plan and to withdraw
the list of highway projects subject to delay that was proposed on June
28, 1993 (58 FR 5458).
III. Response to Comments Received on Proposal
EPA received comments on its proposal from three groups: the
Arizona Center for Law in the Public Interest (ACLPI), the Maricopa
Association of Governments (MAG), and the Arizona Department of
Environmental Quality (ADEQ). A summary of the ACLPI and MAG comments
and EPA's responses to those comments follow. The comments submitted by
ADEQ were not substantive and are therefore only addressed in the TSD.
A. Comments by the Arizona Center for Law in the Public Interest, May
7, 1996
Comment: ACLPI states that it is strongly opposed to EPA's proposed
action and some of its reasons for this opposition are contained in its
January 4, 1994 letter commenting on the EPA's December 12, 1993
proposal (58 FR 64530). ACLPI requests that its previous comments of
January 4, 1994 be incorporated by reference into this
[[Page 51601]]
rulemaking along with the docket for the December 12, 1993 proposal.
Response: EPA has incorporated ACLPI's January 4, 1994 comment
letter into the docket for this rulemaking and, to the extent that the
comments are germane to this rulemaking, has responded to them below.
The vast majority of ACLPI's 1994 comments dealt with the specific
merits of EPA's proposed substitution of the Maricopa Association of
Governments (MAG) contingency process and the State's gasoline
volatility control measure for the FIP's contingency process and
highway delays. Because EPA is not acting in this rulemaking on either
the MAG process or the volatility control measure, most of ACLPI's 1994
comments are not relevant to this action. ACLPI did comment at that
time on the application of CAA section 193 to the FIP contingency
process and has made almost identical comments on this action. EPA has
responded to these comments below.
It should be noted that EPA has not finalized the December 12, 1993
proposal and has not done so for reasons unrelated to the comments
received on the proposal. Because it is acting on an entirely different
State submittal from the one it proposed to approve in December 1993,
EPA does not believe that the rulemaking docket for that proposal,
except for ACLPI's comment letter, is relevant to this document.
Therefore, EPA has included in the docket for today's rulemaking only
ACLPI's comment letter from the docket for the 1993 proposal.
Comment: ACLPI comments that EPA's proposed action violates the
CAA's antibacksliding clause. Under section 193 of the CAA, no control
requirement in effect, or required to be adopted by an order in effect
before the date of enactment of the 1990 CAAA in any nonattainment area
may be modified in any manner unless the modification insures
equivalent or greater emission reductions. The contingency provisions
of the existing CO FIP were ordered by the Ninth Circuit prior to
enactment of the 1990 CAAA (Delaney v. EPA, 898 F.2d 687, entered March
1, 1990) and, therefore, according to ACLPI, cannot be modified without
insuring equivalent or greater emission reductions. ACLPI asserts that
the proposal does not assure equivalent or greater emission reductions
and provides several grounds for this assertion.4
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\4\ In extensive comments on this issue, ACLPI argues that the
SIP contingency measures approved today cannot supplant the FIP
contingency process because they do not assure equivalent or greater
emission reductions as required by section 193. Because EPA does not
agree, as discussed below, with ACLPI's basic premise that the FIP
contingency process is a control requirement within the meaning of
section 193, for which equivalent emissions would otherwise be
required prior to substitution, the Agency is not addressing ACLPI's
equivalency arguments in today's notice.
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ACLPI also disagrees with the Agency's statement that section 193
does not apply to the FIP contingency provisions because those
provisions constitute ``procedures'' rather than ``control
requirements.'' ACLPI claims that the FIP provisions are not merely
procedural but are also substantive because they mandate EPA adoption
of specific control measures adequate to produce attainment and delay
of road projects. The FIP contingency provisions have already been
triggered.
Further, ACLPI does not agree that the control requirements
preserved by section 193 are limited to measures that have previously
been identified and defined in detail, or that the term ``control
requirement'' excludes mandated procedures. ACLPI argues that no such
limitation appears in the language of the statute and such limitation
would sharply conflict with the statutory purpose-namely to prevent
backsliding. ACLPI believes that EPA's construction also conflicts with
the Agency's own policies and guidelines and with the Act itself, all
of which require implementation plans to include both procedural and
substantive provisions, and which treat both as enforceable control
requirements.
Response: ACLPI made the same comments regarding the applicability
of section 193 to the FIP in its January 4, 1994 comment letter. The
following discussion is a response to both the 1994 and 1996 comments.
EPA addressed the relevancy of section 193 to its proposed action
in the April 9, 1996 notice (61 FR 15748-49). The Agency concluded that
the FIP contingency process does not constitute a ``control
requirement'' within the meaning of section 193 of the Act (see
footnote 10 for the text of section 193) and provided its reasoning.
EPA elaborates here on its section 193 discussion in the proposal.
The contingency process contained in the Maricopa CO FIP was
required by a March 1, 1990 order of the Ninth Circuit--before the
enactment of the CAAA on November 15, 1990. Having concluded that
Maricopa's pre-amendment CO plan did not contain contingency procedures
that met EPA's 1982 guidance, the Ninth Circuit ordered EPA to
promulgate a FIP that contained contingency procedures in accordance
with that guidance. Delaney, at 695. The Court, however, did not order
EPA to implement that process or to promulgate any specified control
requirements in that plan. Indeed, the inclusion of any specific
control requirements by EPA would have been inconsistent with the terms
and intent of EPA's 1982 guidance on contingency procedures. EPA's 1982
guidance required a two-part contingency plan:
``The first part * * * [is] a list of planned transportation
measures and projects that may adversely affect air quality and that
will be delayed, while the SIP is being revised, if expected
emission reductions or air quality improvements do not occur. The
second part * * * consists of a description of the process that will
be used to determine and implement additional transportation
measures beneficial to air quality that will compensate for the
unanticipated shortfalls in emission reductions. (45 FR 7187)
A list of highway projects that may be delayed and a description of
actions that may occur at some later date are not control requirements.
A list and a description have no air quality impacts and yield no
emission reductions. Nor do they have any potential for either air
quality impacts or emission reductions until and unless they are
triggered by ``unanticipated shortfalls in emission reductions.'' Even
triggered, the particular contingency process in the Maricopa FIP is
not a control requirement within the meaning of section 193.
The FIP contingency process, promulgated in accordance with the
Court's order, consists of an intricate series of actions by EPA
potentially spanning a minimum of 14 to 16 months. The federal process
may involve, among other things, various assessments and findings, air
quality modeling, and the review and the potential adoption of
additional control measures. The eventual length and scope of the
process is dependent upon the outcome of the assessments and findings
called for in the process and is, therefore, not predictable in
advance. See 56 FR 5471-5472.
Likewise, the highway delay provision in the FIP contingency
process involves the development of a new list of highway projects with
potentially adverse air quality impacts and triggering of project
delays only if certain findings are made as part of the overall
contingency process. Since it is not known in advance what projects, if
any, will be listed and whether any projects will be delayed, the scope
of highway delays is also not predictable. Additionally, because the
contingency process only requires the delay of highway project
construction and not elimination of the projects altogether,
[[Page 51602]]
the long-term direct impact on air quality and attainment--good or
bad--is also extremely uncertain.5
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\5\ ACLPI notes (repeating an EPA statement) that the highway
delay provision provides an important coercive benefit in inducing
the State to adopt control measures. However, if the primary impact
of the highway delay provision is to leverage State controls, then
the provision is best characterized, in this context, as a sanction
and not as a control requirement.
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While the term ``control requirement'' is not defined in the Act,
it is generally viewed as a discrete regulation directed at a specific
source of pollution; e.g., an emission limitation on a smoke stack at a
power plant. By contrast, a contingency process, as outlined by EPA's
1982 guidance, is much broader and more far-reaching than a simple,
quantifiable control limitation.6
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\6\ It is instructive to contrast the FIP contingency process,
and EPA's 1982 guidance on which it is based, with the new
contingency measure requirements in the 1990 CAAA. For example,
section 172(c)(9) requires all nonattainment area plans to provide
for the implementation of specific measures to be undertaken if the
area fails to attain the NAAQS by the applicable attainment date.
See also sections 187(a)(3) and 182(c)(9). The remainder of this
discussion refers primarily to section 172(c)(9) because, as stated
before, it is the only contingency measure requirement that applies
to Maricopa.
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It should also be noted that the use of the term ``control
requirement'' in the Act is unique to section 193. Its closest parallel
is the use of the term ``control measures'' in various provisions of
the statute. The term ``control measures'' in these provisions clearly
means direct, effective, enforceable controls on sources of air
pollution (such as reasonably available control technologies or
transportation control measures) and not procedures for the adoption of
such controls.7
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\7\ Wherever the statute mandates ``control measures'' it is
clear that it is speaking in terms of discrete means or techniques
of controlling emissions from particular sources. For instance,
section 110(a)(2)(A) requires state implementation plans to include
enforceable emission limitations ``and other control measures,
means, or techniques * * *'' as are necessary to attain the national
standards. All state plans for nonattainment areas must also provide
``for the implementation of all reasonably available control
measures * * * (including such reductions in emissions from existing
sources in the area as may be obtained through the adoption, at a
minimum, of reasonably available control technology).'' Section
172(c)(1). See also section 172(c)(6).
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EPA also disagrees with ACLPI that the failure to include the FIP
procedures or process within the meaning of section 193's ``control
requirement'' conflicts with the statutory purpose of preventing
backsliding by assuring that modifications will not occur without the
substitution of equivalent or greater emission reductions. This
argument would have some merit if section 193 were the sole savings
clause in the Act. The Act, however, has other savings clauses,
including section 110(n) which specifically applies to all plan
elements, procedural or otherwise. Moreover, a procedure per se does
not yield emission reductions. For example, the FIP contingency process
is just as likely to conclude with no additional emission
reductions.8 Similarly, as discussed above, highway delays may
result in no emission reductions.
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\8\ See, for example, the end of section (a) under Determination
of the Need for Additional Measures (56 FR 5471):
Should the Agency find that no additional measures are needed,
the [Notice of Final Rulemaking] shall contain this finding and
conclude the contingency process.
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EPA agrees with ACLPI that the Agency's own policies and guidelines
require implementation plans to include both procedural and substantive
provisions and that the Agency considers both as enforceable elements
of SIPs. The fact that a particular provision is enforceable, however,
does not automatically make it a control requirement. Under section
113(a), EPA can enforce ``any requirement or prohibition of an
applicable implementation plan.'' There is no requirement that such
provisions be considered to be ``control requirements'' in order to be
enforceable.9
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\9\ See also section 118(a) of the CAA which requires compliance
with all requirements whether substantive or procedural.
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In summary, under a straightforward reading, the savings clause is
best viewed as an anti-backsliding provision by which Congress intended
to prevent the relaxation of actual, existing control requirements on
specific pollution sources or controls required to be adopted for
specific pollution sources while states are proceeding with their new
planning obligations under the 1990 Amendments.
There is simply no evidence that Congress intended ``control
requirement'' to encompass a process as complex and broad as the FIP
contingency procedures. Indeed it is fundamental that the words of a
statute are to be given their ordinary, plain meaning unless it is
clear that some other meaning is intended. See Columbia Pictures
Indus., Inc. v. Professional Real Estate Investors, Inc., 866 F.2d 278,
280 n. 4 (9th Cir. 1989); Arizona Elec. Power Coop., Inc. v. United
States, 816 F.2d 1366, 1375 (9th Cir. 1987), cert. denied, 488 U.S. 818
(1988). EPA's interpretation of the savings clause is in full accord
with the plain language of section 193. Under the standard articulated
in Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837 (1984), where Congress has
spoken directly on an issue, that is the end of the matter.
Beyond the plain language, however, EPA's interpretation of section
193 is consistent with the structure of the 1990 Amendments as they
relate to the new planning requirements for nonattainment areas and the
failure of those areas to attain the NAAQS. Under the pre-1990 Act,
nonattainment areas were not classified according to the severity of
their air quality problems. An area found to have failed to attain by
the applicable attainment deadline was subject only to a SIP call under
pre-amended section 110. The pre-amended Act contained no provisions
for contingency procedures or measures. Therefore, EPA added
administratively in the 1982 guidance a SIP process that included,
among other things, a delay of highway projects that could adversely
affect air quality while the SIP was being revised in response to a SIP
call.
In contrast, under the 1990 CAAA, a finding of failure to attain by
the applicable attainment date for any area triggers the implementation
of discrete contingency measures under new section 172(c)(9) and also
results in the area being reclassified. The reclassification in turn
results in a new attainment deadline and more stringent planning
requirements to be submitted on a date certain. See e.g., sections
186(b)(2), 186(c) and 187(f). The eternal retention of the FIP
contingency process (or its equivalent) in the applicable plan would
forever overlay its outdated and inconsistent planning scenario on to
the new statutory scheme.
The FIP contingency process was never grounded in a statutory
requirement but was rather based on guidance designed to fill a
perceived gap in the absence of a statutory requirement. In 1990,
Congress remedied that omission by adding both section 172(c)(9) to
fill that gap and a new scheme for additional planning for areas
failing to attain the NAAQS. As discussed above and further below,
EPA's pre-amendment contingency guidance is inconsistent with this new
statutory scheme and thus became ineffective under section 193 upon
enactment of the CAAA.10 EPA affirmed
[[Page 51603]]
this position in the General Preamble. See General Preamble at 57 FR
13498, 13511 and 13532. It is axiomatic that two parts of a single
statutory section cannot be read to have opposite effects. Since the
first sentence of section 193 renders ineffective the 1982 guidance for
contingency processes, the second sentence cannot be read to retain a
requirement that is intimately based on that 1982 guidance.
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\10\ Section 193 states:
Each regulation, standard, rule, notice, order and guidance
promulgated or issued by the Administrator as in effect before
November 15, 1990 shall remain in effect according to its terms,
except to the extent otherwise provided under this chapter,
inconsistent with any provision of this chapter, or revised by the
Administrator. No control requirement in effect, or required to be
adopted by an order, settlement agreement, or plan in effect before
the date of enactment of the Clean Air Act Amendments of 1990 in any
area which is a nonattainment area for any air pollutant may be
modified after such enactment in any manner unless the modification
insures equivalent or greater emission reductions of such air
pollutant. (Emphasis added).
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Both the plain language of section 193 and the new statutory scheme
support EPA's interpretation that the FIP contingency process is not
saved. If, however, there is any ambiguity in the savings clause, EPA's
interpretation of section 193 is reasonable, consistent with the
language and revised structure of the Act, and serves to advance the
goals of the statute. Therefore, it is a permissible construction
entitled to considerable deference. Chevron, 467 U.S. at 844.
Comment: ACLPI disagrees with EPA's suggestion that the contingency
mandate in section 172(c)(9) supplants the FIP contingency provisions
and EPA's pre-amendment contingency guidance. ACLPI asserts that there
is nothing in the Act or its legislative history to suggest such a
result and such a result would be contrary to sections 110(n), 193, and
other provisions of the Act. Therefore, according to ACLPI, the section
172(c)(9) mandate is in addition to, and not in lieu of pre-existing
control requirements. ACLPI concludes that in enacting the 1990
Amendments, Congress made clear that it intended to strengthen the Act,
and preserve preexisting control requirements to ensure maximum
progress toward clean air.
Response: As discussed previously, the Agency's 1982 contingency
guidance was an effort by EPA to fill a gap in the statute as it
existed prior to the 1990 CAAA. The pre-amended Act contained no
requirement for contingency provisions in non-attainment area plans. In
amending the Act in 1990 to explicitly include a requirement for
specific contingency measures in section 172(c)(9), Congress clearly
anticipated that EPA would update its nonattainment area guidance to
reflect the new statutory scheme.11 There is nothing in the
language or structure of the 1990 Amendments or their legislative
history to suggest that Congress intended to reaffirm EPA's 1982
guidance regarding appropriate contingency procedures. On the contrary,
by providing explicit contingency measure requirements that differed
from that guidance, if anything, it can be concluded that Congress
intended to overrule the 1982 guidance in the 1990 Amendments.
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\11\ Additional contingency provisions for certain moderate CO
nonattainment areas are found in section 187(a)(3). See also
contingency provisions in section 182(c)(9) for certain ozone
nonattainment areas.
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Moreover, the amended Act and EPA's pre-amendment contingency
guidance are in fact both duplicative and inconsistent and thus made
ineffective by section 193 on enactment of the CAAA. See footnote 10.
EPA's 1982 contingency guidance required the State to invoke a new
planning process if the SIP was inadequate for attainment. In the 1990
Amendments, Congress established a different scheme for areas that
failed to attain.12 The new contingency measure provisions serve a
different purpose than EPA's pre-amendment guidance in that they call
for immediate implementation of already adopted control measures.
Consistent with the new scheme for implementation of contingency
measures and reclassification with new planning requirements for areas
that fail to attain, EPA stated that its pre-amendment guidance had
been superseded. See General Preamble at 13498, 13511, and 13532. Such
statements are reasonable in light of the 1990 Amendments and was
within EPA's discretion. See Ober v. EPA, 84 F.3d 304, 311-312 (9th
Cir. 1996).
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\12\ EPA's 1982 policy stated that ``the contingency provision
must be initiated when the EPA Administrator determines that a SIP
is inadequate to attain NAAQS and additional emission reductions are
necessary.'' 46 FR 7187. In the 1990 Amendments, Congress in section
186(b)(2)(A) required EPA to determine within 6 months of an area's
attainment date whether the area has attained the CO standard and,
should EPA find a failure to attain, the area is reclassified by
operation of law to serious, triggering new planning requirements
under section 187(f). Under section 172(c)(9), contingency measures
are also triggered if an area fails to attain.
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Furthermore, neither section 193 nor section 110(n) of the Act bars
revisions to EPA's 1982 contingency guidance as ACLPI suggests. Both
sections provide for revisions to EPA guidance and SIPs upon
affirmative action by the Administrator.13
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\13\ Section 110(n)(1) states that ``[a]ny provision of any
applicable implementation plan that was approved or promulgated by
the Administrator pursuant to this section as in effect before
November 15, 1990, shall remain in effect as part of such
implementation plan, except to the extent that a revision to such
provision is approved or promulgated by the Administrator pursuant
to this chapter.'' (Emphasis added). However, the FIP contingency
provisions were not promulgated as a part of the Arizona applicable
implementation plan until February 11, 1991, and therefore are
clearly not subject to section 110(n)(1). Further, even if this
section applied to the FIP contingency process, it would, by its
terms, present no impediment to EPA's withdrawal of the FIP process.
See footnote 10 for the text of section 193.
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Comment: ACLPI also disagrees with EPA's proposed interpretation of
section 172(c)(9) as requiring only such SIP contingency measures as
necessary to offset one year's growth in vehicle miles traveled (VMT).
ACLPI claims that the focus of section 172(c)(9), other provisions of
172, and section 110 is on timely attainment and achievement of
reasonable further progress (RFP)--not on VMT offsets. Thus ACLPI
states that contingency measures must be adequate to make up the
entirety of any potential emission reduction shortfall. ACLPI further
asserts that EPA's proposed approach would allow states to defer
attainment and RFP. It also allegedly allows states to defer attainment
to the deadline for the new classification, even if additional
contingency measures could produce attainment much sooner.
Response: First, it should be noted that there is nothing in the
plain language of section 172(c)(9) or any other provision of the Act
to support ACLPI's contention that contingency measures must be
adequate to make up the entirety of any potential emission reduction
shortfall. Indeed, such an interpretation makes no sense when
considered in the context of the new statutory scheme. Because section
172(c)(9) does not specify either the number or type of contingency
measures required, EPA's reasonable interpretation of the required
measures should receive deference. Chevron, 467 U.S. at 844.
As discussed before, section 172 and the pollutant-specific
requirements in sections 181 through 189 establish a basic
classification scheme and associated planning cycles. This scheme
started with the original classifications of nonattainment areas
following enactment. An area's initial classification established its
attainment deadline and the initial elements of its plan. Sections 181,
186, and 188 all require EPA to review an area's air quality after the
passage of its attainment date to determine if an area in fact attained
by its deadline. If the Agency finds that an area has not attained,
then the area is reclassified to the next higher classification by
operation of law.
This reclassification triggers new planning requirements that in
all cases lead to the development of new attainment and RFP
demonstrations. The role of the section 172(c)(9) measures in this
scheme is to assure areas do not lose ground during the period that
they are developing these new plans. It is not the role of these
[[Page 51604]]
measures to replace or accelerate the development of the new plans. To
require the section 172(c)(9) contingency measures to be adequate to
make up the entirety of any potential emission reduction shortfall
would in fact result in replacing the reclassification scheme in part D
with just section 172(c)(9).14 Such a result is clearly not what
Congress intended. Thus it is the basic statutory structure, and not
EPA's approach, that allows states to defer attainment to the deadline
for the new classification.15
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\14\ The fact that Congress did not intend section 172(c)(9)
contingency measures to entirely make up any shortfall needed for
attainment of the CO standard is made even clearer by section
187(g). Section 187(g) requires submittal, nine months after EPA
determines that a serious CO nonattainment area failed to attain by
December 31, 2000, of controls sufficient to demonstrate a five
percent per year reduction in CO emission until attainment occurs.
If section 172(c)(9) were intended to require immediate
implementation of measures sufficient to correct any attainment
shortfall, then section 187(g) would not be necessary.
\15\ Note, however, that the attainment deadline for the new
classification is not a fixed date providing a number of additional
years while attainment is reached; rather the deadline is ``as
expeditiously as practicable but not later than'' a fixed date. If
practicable controls can bring an area into attainment prior to the
fixed date, they must be implemented to achieve earlier attainment.
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Regarding ACLPI's disagreement with EPA's use of one year's growth
in VMT as a benchmark for the amount of emission reductions section
172(c)(9) measures should achieve,16 it should be noted that EPA
went beyond the suggested approach in the 1992 TSD. EPA showed in its
proposal that the State's contingency measures coupled with continuing
emission reductions from the State's enhanced inspection and
maintenance program (as well as other measures whose effectiveness was
built into the baseline) provided sufficient emission reductions to
offset on-road mobile source emissions growth during the period of time
that the Phoenix area would be developing its serious area attainment
plan (i.e., from early 1996 until late 1997).
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\16\ See section I.B. of this notice.
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EPA agrees with ACLPI that the primary thrust of sections 110 and
172 of the Act is for timely attainment and achievement of RFP and not
on VMT offsets. It, however, is an indisputable fact that the bulk of
CO emissions in Phoenix (as in the vast majority of CO nonattainment
areas) are from motor vehicles and the main culprit behind increases in
overall CO levels is growth in vehicle usage. It is, therefore,
reasonable to relate needed emission reductions from contingency
measures to the factor that most influences emissions growth, that is
vehicle miles traveled. Thus EPA's guidance on contingency measures in
the General Preamble and the 1992 TSD is reasonable.
On the other hand, as discussed above, EPA does not agree with
ACLPI that the purpose of section 172(c)(9) is to alone assure
attainment of the standard or RFP. To read that purpose into section
172(c)(9) is to ignore the broader reclassification and new planning
requirements scheme in part D of title I of the Act. For the foregoing
reasons, EPA believes that its interpretation of section 172(c)(9) is
reasonable and, as such, is entitled to considerable deference.
Chevron, 467 U.S. at 844.
Comment: ACLPI also comments that the State is not eligible to base
its contingency measures on EPA's VMT emission offset policy. According
to the General Preamble, that policy applies where failure to timely
attain or achieve RFP is due to ``exceedence of a VMT forecast'' and
the State has made no claim or showing that its failure to timely
attain or achieve RFP is due to exceedence of a VMT forecast. ACLPI
cites 57 FR 13532 for this policy.
Response: The section of the General Preamble cited by ACLPI
addresses the contingency requirement in section 187(a)(3) for high
moderate CO nonattainment areas. Section 187(a)(3) requires CO
nonattainment areas with design values of 12.7 ppm or higher (that is,
high moderate areas) to provide for the implementation of specific
measures to be undertaken if any estimate of VMT exceeds forecasts.
Section 187(a)(3) is a companion requirement to section 187(a)(2)(A)
which requires high moderate areas to forecast VMT for each year before
the attainment year and annually update those forecasts. Because
section 187(a)(3) contingency measures are triggered by higher than
expected VMT growth, it is reasonable to link its contingency measure
requirement to annual VMT growth. However, section 187(a)(3) and the
cited section of the General Preamble concern contingency requirements
applicable only to high moderate nonattainment areas whereas Phoenix is
a low moderate area. As stated previously, neither the statute nor the
General Preamble addresses how many contingency measures or emission
reductions from them are necessary in low moderate CO areas. EPA's
interpretation of the statute, which has been shown above to be
reasonable, for these areas is only in the 1992 TSD.
Comment: ACLPI comments that just offsetting one year's growth in
VMT does not even assure EPA's stated goal--namely, to prevent air
quality from worsening while the SIP is being revised. ACLPI points out
that on-road mobile sources in Phoenix contribute only about 70 percent
of the total emission inventory; therefore, there is no assurance
whatsoever that RFP will be maintained merely because VMT-related
emission increases are offset.17
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\17\ Although acknowledging that EPA's action is limited to CO,
ACLPI also comments on the Agency's section 172(c)(9) policy as it
relates to ozone. Because today's action concerns only CO
contingency measures, these comments are not germane and need not be
addressed here.
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Response: The 70 percent figure for on-road mobile sources is the
contribution of this source category to the 1990 base year annual daily
CO season emissions inventory (found on page 3.3 of the MAG 1993 CO
Plan for the Maricopa County Area, November 1993). EPA believes that
the purpose of section 172(c)(9) for contingency measures is to prevent
air quality from worsening while the SIP is being revised. EPA's
calculations indicate that during this period total CO emissions will
not increase and the State's contingency measures therefore are
sufficient to accomplish that purpose. See the TSD for this rulemaking.
As discussed below, EPA does not believe that section 172(c)(9)
measures are required to assure RFP.
Comment: ACLPI requests the entirety of the MAG 1993 Carbon
Monoxide Plan for the Maricopa County Area (November 1993) as well as
the March 1994 Addendum to that Plan be incorporated by reference into
the record for this rulemaking.
Response: EPA has not relied on substantial portions of the MAG
1993 CO Plan for its action in this rulemaking and declines to
incorporate the entire plan into its rulemaking docket.18 The
March 1994 Addendum and relevant excerpts from the MAG 1993 CO Plan are
already included in the docket for the proposal. EPA is also
incorporating by reference the rulemaking docket for its proposed
approval of the Phoenix area's CO inventory. This docket includes
additional portions of the MAG 1993 CO Plan. EPA has included all
applicable portions of the plan in the docket for today's rulemaking.
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\18\ Section 307(d)(3) requires the docket accompanying a
proposed Agency action to include all data, information, and
documents on which the proposed rule relies. Section 307(d)(4)(B)(i)
requires the final docket to include all comments received on the
proposed rulemaking, the transcript of any public hearings, as well
as any documents which become available after the proposed has been
published and which EPA determines are of central relevance to the
rulemaking.
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Comment: ACLPI comments that even if an offset of emissions from
one year's VMT growth were sufficient to assure RFP in that year, it
would not assure continued RFP during the entire period
[[Page 51605]]
that the SIP is being revised. EPA is apparently planning to give the
State 18 months to revise the SIP and the normal approval process will
protract this SIP revision period even further.
Response: ACLPI misinterprets the RFP requirements of the CAA.
Sections 172(c)(2) and 171(1) require ``such annual incremental
reductions in emissions * * * for the purpose of ensuring attainment of
the applicable national ambient air quality standard by the applicable
attainment date'' (Emphasis added). Thus the moderate area plan for
Phoenix was required to assure RFP through 1995, the moderate area
attainment deadline under section 186(a)(1).19 However, since the
area has now been reclassified, additional RFP requirements apply to
the serious area plan. In the interim, the section 172(c)(9)
contingency measures will ensure that air quality does not deteriorate
while the plan is being revised. There is nothing in the language of
that section to suggest that the contingency measures are expected to
assure RFP during this period.
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\19\ On August 9, 1993, EPA issued a SIP call under section
110(k)(5) of the CAA that required Arizona to submit a plan to EPA
that demonstrated attainment of the CO NAAQS by December 31, 1995.
As an area with a design value under 12.7 ppm, the State would not
otherwise have been required to submit an attainment plan, including
an RFP demonstration, for the Phoenix area. See section 187(a).
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EPA does not believe that EPA's approval process can be reasonably
interpreted to ``protract the SIP revision process'' as ACLPI suggests.
Revision of the SIP clearly relates to the State's actions to develop
and submit rather than EPA's actions to approve or disapprove.
Moreover, the vast majority of State control measures do not depend
upon EPA's approval of them into the SIP to be implemented and
effective.20 Therefore, it is appropriate to consider the
contingency period to run only until the date the State is required to
submit its serious area plan with its accompanying control measures. As
discussed above, EPA has concluded that there will be sufficient
emission reductions during 1996 and 1997 to offset all emissions growth
while the plan is being revised.
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\20\ Even the contingency measures that are the subject of this
rulemaking did not require EPA's formal approval into the SIP in
order to be triggered. EPA triggered their implementation when its
finding that the Phoenix area failed to attain the CO standard
became effective on August 28, 1996.
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Comment: ACLPI comments that the Arizona's contingency measures
also fail the Act's contingency requirements because there are no
contingency measures for the contingency measures and if the first
contingency measures do not achieve the emission reductions expected of
them then there is no assurance that an offset of emissions from VMT
growth will be achieved, even in the first year.
Response: It would be an absurd reading of the Act to conclude that
contingency measures need their own contingency measures. The only
reading of the Act for which such an interpretation would make any
sense is the one that EPA has already rejected for the reasons
explained above: that section 172(c)(9) requires sufficient measures to
immediately make up any potential shortfall in attainment or RFP. As
discussed earlier, the purpose of the section 172(c)(9) contingency
measures is to assure that air quality does not worsen during the
period a new plan is being developed. This new plan will necessarily
evaluate the existing situation, including any failure of contingency
measures to achieve emission reductions, and factor the effectiveness
of existing controls into determining the additional controls necessary
for attainment.
Comment: ACLPI comments that in proposing to find that the State's
contingency measures will offset emissions from one year's VMT growth,
EPA relies primarily on emission reductions from the State's enhanced
I/M program. ACLPI asserts that this reliance is misplaced for several
reasons. First, the enhanced I/M program is not a contingency measure,
rather it is one of the primary strategies included in the SIP and the
State has already claimed emission reductions from this strategy in the
SIP attainment and maintenance demonstration. ACLPI claims that EPA
cannot now convert the program to a contingency measure to create an
offset of VMT emission increases.
Response: EPA did not claim that the Arizona's enhanced I/M program
is a section 172(c)(9) contingency measure, just that it contributes to
reducing emissions during the contingency (SIP revision) period. In
establishing a benchmark of one year's growth in VMT for these
measures, EPA intended that the status quo, as represented by the
emissions level in the attainment deadline year, be maintained during
this period. EPA believes that this result can be achieved by
considering reductions from the section 172(c)(9) measures in
combination with new reductions scheduled to occur in the area during
the SIP revision period, as long as these offsetting reductions are
from measures approved into the SIP and are in excess of reductions
occurring in the attainment deadline year. As discussed above, the
emission reductions from the enhanced remote sensing program, the
traffic diversion measure, and the additional reductions from the I/M
program in 1996 and 1997 more than meet this test.
While the State explicitly identified in the proposal emission
reductions from its enhanced I/M program in determining that the
contingency measures are adequate to maintain the area at or below 1995
levels during the contingency period, it need not have done so. In
order to make this determination, the State calculated the baseline
emissions level, i.e., the emissions level expected in the year after
the attainment deadline prior to the implementation of the contingency
measures. Rather than incorporating emission reductions from the
enhanced I/M program into the baseline, the State chose to explicitly
account for reductions from the program.21 If the State had
incorporated the emission reductions from the enhanced I/M program into
the baseline emissions level, the determination that the contingency
measures are adequate would have been the same. The difference between
explicitly accounting for reductions from the program or implicitly
including them in the emission baseline is simply the method of
bookkeeping.
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\21\ In fact, there are emission reductions anticipated to occur
after the attainment deadline year from numerous measures whose
effects are assumed in the baseline emissions. These measures
include federal tailpipe standards, oxygenated gasoline, basic I/M,
RVP limitations, and transportation control measures.
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Comment: ACLPI comments that neither the state nor EPA has provided
viable technical justifications for the emission reductions claimed
from the enhanced I/M and enhanced remote sensing programs. There is no
explanation of how the State arrived at the estimated effectiveness
percentages for these programs. ACLPI asserts that under EPA guidelines
and rules, as well as general principles of administrative law, EPA
cannot credit these measures with emission reductions without a sound,
thoroughly justified technical basis for the level of reductions being
claimed. The State now has considerable experience with both remote
sensing and enhanced I/M in 1995 and should be required to provide
evidence of their actual performance as proof of their emission
reduction potential.
Response: EPA does not believe the State must submit evidence of
the actual performance of the enhanced I/M and remote sensing programs
to support their estimated emission reduction potential. For both the
enhanced I/M
[[Page 51606]]
and enhanced remote sensing programs, the State used EPA's MOBILE5A
model to calculate emission reductions. The MOBILE5A inputs used to
generate the reduction estimates for enhanced I/M and the methodology
and assumptions used to estimate the effectiveness of the enhanced
remote sensing program are also provided in the 1994 Addendum at pp. 3-
191 and 3-201, respectively. EPA requires the use of its latest mobile
sources emissions model (in this case,the MOBILE5A)to determine credits
for I/M programs. See 40 CFR 51.351(a) and 51.352(a).22 The MOBILE
models have been the standard methodology for this purpose for more
than a decade and EPA does not believe that it should or can require
States to independently validate the accuracy of the model.
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\22\ Remote sensing programs are components and are means of
increasing the effectiveness of I/M programs; therefore, emission
reduction estimates for these programs are also calculated using
MOBILE5a consistent with EPA guidance.
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Comment: ACLPI comments that a related and equally serious flaw is
the State's reliance on the air quality modeling in the 1994 Addendum
that has not been reviewed and approved by EPA as part of the SIP
review process. Stating that EPA has neither proposed to approve that
modeling nor has it evaluated that modeling in the context of this
rulemaking, ACLPI maintains that if EPA is going to rely on the State's
CO modeling, it must first specifically propose approval of that
modeling and allow public comment on it.
ACLPI also comments that the emission reductions from the control
measures are not adequate. ACLPI states that the State contends that
emission reductions from the contingency measures and enhanced I/M will
be sufficient to offset increased emissions from VMT growth and bases
this claim on its projections of on-road mobile source emissions and
its estimates of emission reductions from contingency and enhanced I/M
measures. ACLPI claims that aside from the lack of substantiation for
the latter, the projections of mobile source emissions are not
supported by EPA-approved emissions inventories and VMT projections.
The State is relying on the emission inventory and VMT projections in
the MAG 1993 CO Plan for Phoenix, but EPA has not yet even proposed
approval of those components of the Plan. ACLPI further states that the
Agency cannot simply assume that the State's inventory and VMT
projections are accurate, particularly when the State's attainment
projections (based on this inventory) have proven to be incorrect nor
can EPA simply approve these items at this stage of the rulemaking.
ACLPI concludes that because a current, accurate emissions inventory is
a mandated component of the SIP, EPA must first propose approval or
disapproval of the inventory and provide an opportunity for public
comment.
Response: EPA has relied on the base year and 1995 projected year
emission inventories in the 1993 CO plan and 1994 Addendum in this
rulemaking and has recently proposed to approve the base year inventory
as meeting the requirements of sections 172(c)(3) and 187(a)(1) and
EPA's guidelines. Because it is closely related to the base year
inventory, EPA has also fully evaluated the 1995 projected year
inventory against applicable guidelines as part of its rulemaking on
the base year inventory and has found that that inventory conforms to
these guidelines. EPA's evaluation of the projected inventory can be
found in the draft TSD available for public comment in the docket for
the proposed emission inventory approval. Should EPA ultimately
disapprove the base year inventory in response to public comments on
its proposed approval or re-evaluate its finding on the projected
inventory, the Agency will consider the effect, if any, of such an
action on this rulemaking and revise it if appropriate.
EPA, however, has not relied on the air quality modeling in either
the 1993 CO plan or the 1994 Addendum for this rulemaking. Since the
adequacy of contingency measures is based on their effect on emission
levels and not on ambient air quality levels, air quality modeling does
not factor into the adequacy determination. While contingency measures
are triggered by a failure to attain the NAAQS, that determination is
based solely on monitored air quality and not on modeled air quality.
Comment: ACLPI noted that the Arizona legislature had recently
repealed the funding for the State's I/M program. It also stated that
the State had not identified the financial and manpower resources
necessary to implement enhanced remote sensing, nor provide legal
commitments to adequately fund and staff that measure. Under EPA
guidelines and rules, as well as section 110 of the Act, EPA cannot
approve, or credit the State with emission reductions for the measures
without funding or commitments.
Response: On July 18, 1996 the Governor of Arizona signed Arizona
Senate Bill 1002 (42nd Legislature, 1st Special Session). Section 51 of
the bill provided $4.3 million to fund the State's Vehicle Emissions
Inspection Program (including its enhanced remote sensing component)
23 through June 30, 1997. See section 51 of the bill. The bill
also includes a statement of intent that the program become self-
funding from July 1, 1997 on.24 See section 52 of the bill. While
there is no longer an explicit funding source identified for the
program beyond the middle of 1997, EPA believes there are adequate
grounds, based on past practice and the contribution of test fees to
the administration of the program, to believe the program will continue
operating at its current level without interruption. Arizona's I/M
program has been in operation since 1976, is a key element of both the
State's ozone and CO control strategies, and is a model for the rest of
the Country.
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\23\ There is a tendency to refer to the components of Arizona's
Vehicle Emission Inspection Program (VEIP) as if they are separate
and distinct programs. This is done primarily to identify the
additional emission reduction benefits that each new component adds
to the overall VEIP. Arizona VEIP is operated and funded as a single
program with multiple components including enhanced I/M, basic I/M,
diesel I/M, and remote sensing. See EPA's approval of Arizona's
VEIP, 60 FR 22520 (May 8, 1995).
\24\ It should be noted that the program is already partially
funded by fees charged for vehicle emission inspections. The
legislative appropriation covers the shortfall between the fees and
the cost to run the program.
---------------------------------------------------------------------------
EPA approved Arizona's basic and enhanced I/M program on May 8,
1995 (60 FR 22518). As part of that approval, EPA evaluated the program
against the requirements in 40 CFR 51.354 which requires that the State
demonstrate that appropriate administrative, budgetary, personnel, and
equipment resources have been allocated to the program.25 At that
time, EPA concluded that the funding mechanism met EPA's requirements
for I/M programs. Despite the recent turbulence in the funding for the
program, EPA believes its evaluation is still correct. Should EPA in
the future find that funding is not forthcoming for the program, EPA
would issue a SIP call based on failure to implement the program under
section 110(k)(5).
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\25\ The requirements in 40 CFR 51.354 define for I/M programs
what states must submit to meet the section 110(a)(2)(E)(i)
requirement that SIPs provide necessary assurances that adequate
personnel, funding, and authority under state law are available to
implement the program.
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Finally EPA notes that under section 307(b)(1) of the CAA,
petitions for review of the Agency's 1995 final action approving the
basic and enhanced I/M program would need to have been properly filed
within 60 days of such action. Comments relating to EPA's approval were
required to have been raised during the comment period for that
rulemaking. Therefore, ACLPI's comments regarding financial and
[[Page 51607]]
manpower resources of the I/M program are not timely.
Comment: ACLPI comments that yet another flaw is the State's use of
513 tpd as the 1995 baseline figure for on-road mobile source
emissions. MAG's 1994 Addendum projected attainment in 1995 with a
mobile source CO emission budget of 513 tpd. ACLPI notes that there
were CO violations in 1995, so the 1995 design day emissions must have
been higher than 513 tpd. Yet MAG has used this 513 tpd figure as the
baseline for projecting actual emissions in 1995, 1996, and 1997. ACLPI
concludes that because actual emissions were almost certainly higher
than these projections, MAG's projections are flawed as well.
Response: The 513 tpd figure, like all emission inventory figures,
is an estimate subject to an unavoidable degree of uncertainty. It was
arrived at through a series of modeling steps including transportation
and motor vehicle emissions modeling. See, in general, Chapter 5 of
``1990 Base Year Carbon Monoxide Emission Inventory for the Maricopa
County, Arizona Nonattainment Area,'' (located in Appendix B, Exhibit 1
of the 1993 CO Plan). Each one of these models attempts to reproduce
highly complex processes with comparatively limited data sets and thus
introduces some natural range of error into the results.26 Given
that no absolute ton per day figure is likely to be entirely accurate,
the real question is whether the use of the 513 tpd figure is
acceptable for the purpose at hand.
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\26\ For example, EPA has discussed the potential sources of
errors in the MOBILE model and work underway to correct those errors
in Highway Vehicle Emission Estimates--II, U.S. EPA, May 1995.
---------------------------------------------------------------------------
As stated before, EPA's primary test for determining the adequacy
of contingency measures is to assure emissions do not increase during
the period the SIP is being revised. This is a comparative process: is
the emission level at the end of the SIP revision period, considering
the effect of the contingency measures, less than or equal to the
emission level at the beginning of that period? Comparisons tend to
mitigate errors between numbers that are derived in similar manners
because the errors tend to cancel themselves out. Therefore, even
though 513 tpd may not be the absolute attainment emission level for
on-road motor vehicles in Maricopa, EPA believes it is acceptable for
determining the adequacy of the contingency measures since it is used
as the baseline for calculating both emissions with the contingency
measures and emissions without such measures.
Comment: ACLPI also questions the State's projections regarding the
rate of emissions growth from on-road mobile sources. The State
predicts that VMT will increase at a rate of about 3.9 percent in 1995-
96, and about 3.7 percent between 1996-97. Yet the State also predicts
that, even without additional controls, on-road mobile sources will
only increase at a rate of about 1.8 percent per year in 1995-96 and at
a rate of 1.5 percent in 1996-97. ACLPI concludes that these figures
indicate that the State is substantially understating the emissions
growth likely from on-road mobile sources and therefore understating
the emission reductions needed to offset that growth.
Response: Actually, the State is not predicting that ``without
additional controls,'' on-road mobile sources will increase at a rate
less than VMT growth. Implicit in the State's baseline inventory is the
effect of ``additional controls,'' including the impact of the federal
tailpipe standards (which reduces the composite vehicle fleet emission
rate as newer cars replace older cars) and continuing reductions from
the State's non-enhanced I/M program, oxygenated gasoline, RVP limits,
and other required controls. All of these control programs serve to
dampen the growth in CO emissions compared to growth in VMT. Therefore,
the figures cited by ACLPI do not indicate that the State is
substantially underestimating the emissions growth from on-road mobile
sources. Historically, CO emission levels in Phoenix have not increased
at the rate of VMT growth and, for many years, actually decreased as
VMT has grown. Despite the fact that the Phoenix area has not yet
attained the CO standard, it has experienced substantial reductions in
ambient CO levels even in the face of its rapid population and VMT
growth.27
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\27\ See, for example, pages 2 and 3 in ``Conformity Analysis
Appendices, Volume 2'' for the MAG Long Range Transportation Plan,
Summary and 1996 Update and the 1997-2001 MAG Transportation
Improvement Program (MAG, July 1996) which juxtapose daily VMT
figures for each year from 1979 to 1993 and the 8-hour CO
concentrations and number of annual exceedences at the Indian School
monitor from 1981 to 1993. The VMT figures double between 1981 and
1993 while CO concentrations drop by half and the number of
exceedences decreases from more than 60 to less than 5 between the
same years.
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Comment: ACLPI states that EPA's proposal to approve the State's CO
SIP contingency measures without acting on the overall CO SIP itself is
contrary to the Act. The SIP contains an attainment demonstration and
other provisions proposed by the State to meet all of the SIP
requirements for moderate CO areas and to address EPA's 1993 CO SIP
call. ACLPI asserts that under applicable court precedent (Abramowitz
v. EPA, 832 F.2d 1071 (9th Cir. 1987)), EPA cannot select out a few
provisions of the plan for approval (i.e., the contingency measures)
while deferring action on the attainment demonstration and all other
provisions.
Response: The Ninth Circuit in Abramowitz reviewed the Agency's
action to approve certain control measures in the California carbon
monoxide and ozone SIPs and to withhold action on the attainment
demonstrations in those plans. The Court concluded that EPA could not
approve the control measures without requiring any demonstration that
those measures would achieve attainment by the statutory deadline. The
control measures at issue were adopted by the State as an integral part
of the attainment and RFP demonstrations and were intended to be
implemented before the passage of the applicable attainment date. Those
control measures were not contingency measures whose implementation was
to be triggered by the failure of an area to actually make RFP or
attain, as is the case for the measures under consideration in this
rulemaking.
In addition, the Abramowitz case was decided prior to the 1990
Amendments to the Act. As noted before, the pre-amended Act had no
contingency provisions. Congress added specific contingency provisions
in 1990, including the section 172(c)(9) requirement of interest here.
This section refers to ``implementation of specific measures to be
undertaken if the area fails to make reasonable further progress, or to
attain the [NAAQS] by the attainment date applicable under this part.''
(Emphasis added)
These specific contingency measures are clearly outside the set of
control measures that make up a State's attainment and RFP
demonstrations required under sections 172(c) (1) and (2).28 They
are not triggered until or unless an area fails to make RFP or attain
by the applicable attainment date. For the foregoing reasons, EPA does
not
[[Page 51608]]
believe the Court's finding in Abramowitz applies to this rulemaking.
---------------------------------------------------------------------------
\28\ The fact that contingency measures are a distinct and
separate requirement from and unrelated to prospective attainment
and RFP demonstrations is clearly demonstrated by the Act's planning
requirements for low moderate CO nonattainment areas. While these
areas are required to submit section 172(c)(9) contingency measures,
they are specifically exempt from the requirement to submit an
attainment (and by extension, an RFP) demonstration by section
187(a). Note that even where contingency measures and attainment
demonstrations are required, section 172(b) authorizes EPA to set
separate SIP submittal deadlines for them which shows these can (and
sometimes must) be acted on separately.
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It should also be noted that EPA routinely receives SIP submittals
that include rules, regulations, and other elements responding to
various SIP requirements such as I/M programs, new source review
programs, and reasonably available control technology rules. EPA has
traditionally acted on these elements independently.
Comment: ACLPI claims that approving contingency measures while
deferring action on the attainment and other provisions of the 1993 CO
SIP as amended stands the process on its head. ACLPI asserts that if
the CO SIP is inadequate to produce timely attainment, or fails to meet
other requirements of the Act, then EPA is obligated to disapprove the
plan and require additional control measures as part of the plan. ACLPI
concludes that EPA cannot evade this responsibility via the alleged
artifice of treating essential measures as ``contingency'' measures and
avoiding action on the attainment demonstration in the SIP itself.
Response: As discussed above, EPA believes that the section
172(c)(9) contingency measure requirement is separate and distinct from
the attainment demonstration requirement and, thus, may be acted on
independently. EPA agrees that if it finds that a SIP is inadequate to
achieve timely attainment, then EPA is obligated to disapprove the plan
and require additional control measures as necessary for timely
attainment. However, in developing its new attainment demonstration, a
state would not be compelled to choose its section 172(c)(9)
contingency measures to contribute to that demonstration. While the
Clean Air Act explicitly requires certain controls in SIP attainment
demonstrations (e.g., oxygenated gasoline, I/M programs, RACT), it also
allows states broad discretion to identify the exact controls that make
up the remaining portion of such demonstrations.29
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\29\ See, for example, section 172(c)(6) which states: Such
plan provisions shall include enforceable emission limitations, and
such other control measures, means or techniques * * * as may be
necessary or appropriate to provide for attainment of the [NAAQS] by
the applicable attainment date * * *. (Emphasis added).
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Under the circumstances posited by ACLPI, EPA could approve a
state's contingency measures as meeting the requirements of section
172(c)(9) while at the same time disapproving the plan's attainment
demonstration, assuming such an action were warranted. See section
110(k)(3). The state would then be required to develop and submit a new
attainment demonstration. In so doing, the state could choose to
include its pre-existing contingency measures as part of the attainment
demonstration, in which case it would also be required to submit new
contingency measures. On the other hand, the state would be free to
choose entirely different measures as long as they resulted in
expeditious attainment. In that event, the approved contingency
measures would remain as such.
Therefore, acting on a state's chosen contingency measures prior to
acting on the attainment demon
FR Doc. 96-25400 Approval and Promulgation of Implementation Plans; Arizona Maricopa Nonattainment Area; Carbon Monoxide
stration does not ``stand the process on
its head;'' it merely acknowledges the state's right under the Act to
select what measures will and will not make up its control strategy and
what measures will and will not make up its section 172(c)(9)
contingency measures.
Comment: ACLPI states that the proposal violates section 110(l) of
the Act because under that section, EPA cannot approve a revision to a
plan if the revision would interfere with any applicable requirement
concerning attainment and RFP. Contrary to EPA's assertion, ACLPI
claims that the Agency's proposed action would most definitely
interfere with applicable requirements for attainment and RFP--namely,
those set forth in the FIP and, because the FIP contingency provisions
explicitly require adoption of federal measures to provide for
attainment of the CO NAAQS, these provisions are most assuredly
``applicable requirements.'' ACLPI additionally asserts that EPA's
action would interfere with those requirements by repealing them and
that EPA's action further interferes with the Act's requirement that
the state produce, and EPA approve or disapprove, a CO SIP that
provides for attainment and RFP. ACLPI also comments that EPA's
assertion that its approval of the State's contingency measures will
not interfere with RFP because the measures are only triggered if there
is a failure to make RFP is truly disingenuous. ACLPI objects to EPA's
proposing to replace a FIP which mandates RFP and timely attainment
with a plan that requires neither, and that will allegedly allow air
quality to worsen.30
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\30\ Contrary to ACLPI's comments, the FIP contingency process
does not mandate RFP. See the FIP contingency process at 56 FR 5472.
Therefore the discussion below does not address this aspect of
ACLPI's comments.
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Response: EPA refers the reader to the discussion of the
application of section 110(l) to today's action in its proposal. See 61
FR 15647. That analysis shows why the proposed action meets the
requirements of section 110(l). That discussion is expanded here.
Section 110(l), added to the CAA in the 1990 Amendments, states
that the ``Administrator shall not approve a revision of a plan if the
revision would interfere with any applicable requirement concerning
attainment and reasonable further progress * * * or any other
applicable requirement of this Act.'' As addressed below, EPA believes
that the purpose of this provision is to assure that in changing one
substantive aspect of its SIP, a state does not simultaneously impair
its compliance with another aspect of the SIP or with the statutory
mandates applicable to the aspect under revision.
In making its arguments regarding section 110(l), ACLPI attempts to
re-write the section to serve its own purposes. It is clear, however,
from the plain language of section 110(l) that that provision is
referring to noninterference with the requirements of the statute, and
not to the requirements of a FIP as ACLPI contends. The term
``applicable implementation plan,'' which includes FIPs as well as
SIPs, is specifically defined in the Act and used throughout title I.
See section 302(q); see also, e.g., section 110(c) and (n). Therefore,
had Congress intended section 110(l) to have the meaning ACLPI
suggests, it could easily have included at the end of the section the
clause ``or requirements of any applicable implementation plan.''
It is consistent with the Act as a whole for Congress to have
limited section 110(l) to statutory rather than SIP requirements.
States are at liberty to include such provisions as they see fit in
their attainment demonstrations, provided attainment is demonstrated.
They are also free to change those measures at any time, subject to
certain savings clauses, provided expeditious attainment is still
demonstrated. Congress did not in section 110(l) intend to override
this general scheme by forbidding revisions (including revocations and
replacements) of any SIP measure because it would by definition
interfere with the pre-existing requirement of that very SIP measure.
This analysis applies even more so to FIPs. In a FIP, EPA promulgates
measures for a state which may be very different from the measures that
the state would choose to implement in its own SIP. In keeping with the
overriding statutory goal of federalism in the Act, when a state does
adopt measures to replace FIP measures it should be able to select
those measures it deems most suited to the state needs, provided they
comply with the statutory requirements applicable to the element at
issue. A state should not be subject forever to the
[[Page 51609]]
identical measures in the FIP, notwithstanding its initial failure to
meet the statutory requirement giving rise to the FIP.
In contrast, ACLPI, without any textual support, attempts to turn
section 110(l) into a savings clause. In so doing, ACLPI's
interpretation would render the Act's actual savings clauses virtually
meaningless. For example, the section 110(n) savings clause keeps in
effect pre-amendment provisions of any approved or promulgated
applicable implementation plan, including a FIP, except to the extent
that EPA approves a revision.31 Using ACLPI's interpretation of
section 110(l), virtually any change to a pre-amendment SIP approved by
EPA to conform to new 1990 statutory provisions would be prohibited.
Clearly, Congress would not in one section of the statute effectively
outlaw all SIP revisions to meet the new Act's many requirements
wherever a prior SIP had addressed a similar requirement while allowing
those revisions in another section.
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\31\ See footnote 13 for the text of section 110(n). As a
savings clause, section 110(n) works in tandem with section 193, the
Act's general savings clause. Pre-amendment SIP (or FIP) provisions
remain in effect until a revision is approved by EPA, except that
discrete controls on specific sources cannot be modified unless
equivalent or greater emission reductions are assured.
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One example should suffice to demonstrate the untenability of
ACLPI's position: pre-amendment SIPs were required under pre-amended
section 110(a)(2)(B) to provide for maintenance as well as attainment
of the NAAQS. Under the 1990 Amendments, maintenance plans for
nonattainment areas are only required in connection with a
nonattainment area's redesignation to attainment. See sections
107(d)(3)(E) and 175A. Under ACLPI's interpretation, a state could
never revise its SIP to eliminate or modify its pre-amendment
maintenance plan because such an action would interfere with a
requirement of the applicable implementation plan. Clearly this result
is not what Congress intended in section 110(l).
Likewise, if ACLPI's all-encompassing interpretation of section
110(l) were to prevail, the section 193 control requirement savings
provision would make no sense. For example, if any emission limitation
for a specific source in a pre-amendment SIP (approved by EPA) were
considered an ``applicable requirement'' within the meaning of section
110(l), then any change in such a limitation would constitute
interference. If that were the case, there would be no point in
Congress' requiring that modifications to such requirements assure
equivalent or greater emission reductions. Obviously Congress intended
to allow substitution of control measures provided emissions reductions
were equivalent in such cases.
The section 110(l) admonishment that a SIP revision cannot
``interfere with any applicable requirement concerning attainment and
reasonable further progress'' or with any other ``applicable
requirement of the Act'' must be read within the broad context of the
Act rather than the narrow context of the SIP. As ACLPI has pointed
out, the primary purpose of the nonattainment provisions of the Act is
to assure attainment of the NAAQS and RFP towards attainment. Congress
in 1990 explicitly established provisions in pursuit of these goals
including contingency measures, reclassification and additional
planning requirements for attainment and RFP that are triggered by an
area's failure to attain by its attainment deadline. For CO, these
provisions lie in sections 172, 186, and 187. These statutory
requirements have been discussed extensively above and the FIP
contingency process, including the highway delay provision, serves
essentially the same purpose.32 Withdrawal of the FIP contingency
process leaves these statutory provisions fully operable and,
therefore, does not interfere with ``an applicable requirement
concerning attainment and RFP;'' to wit, the area still remains under
an applicable requirement to attain the standard and demonstrate RFP.
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\32\ This is true except for RFP. As noted before, the FIP
contingency process did not require RFP; therefore, in this regard,
the FIP contingency process does not go as far as the new statutory
scheme.
---------------------------------------------------------------------------
As stated previously, for low moderate CO areas, section 172(c)(9)
establishes the only requirement for contingency measures. As discussed
elsewhere in this notice, EPA has concluded that the State's submittals
meet the requirements of section 172(c)(9). Neither the statute nor
current EPA policy requires contingency procedures (as distinguished
from actual contingency measures) in SIPs. As noted above, the 1982 SIP
guidance, which required contingency procedures and under which the FIP
was promulgated are inconsistent with the new statutory scheme and are
no longer in effect. Therefore, withdrawal of the FIP contingency
process, in conjunction with the approval of contingency measures
consistent with the requirements of the CAA, does not conflict with
current law or EPA policy regarding contingency requirements.
To summarize, EPA believes that ACLPI's contention that section
110(l) precludes EPA from approving the State's section 172(c)(9)
contingency measures and withdrawing the FIP contingency process is
supported neither by the plain language of section 110(l) nor by the
structure of the 1990 Amendments.
Finally, even if EPA believed, which it does not, that section
110(l) encompasses purely procedural statutory requirements, EPA does
not understand how its approval of the State's contingency measures and
withdrawal of the FIP contingency process could be deemed to interfere
with the Act's requirement that the State produce, and EPA approve or
disapprove, a CO SIP that provides for attainment and RFP. EPA's action
in this notice does not in any way affect the State's obligation under
the Act to produce a CO SIP that provides for attainment and RFP, nor
does it preclude in any way EPA's action on that or any other SIP the
State has submitted or will submit.
Comment: ACLPI requests that its December 22, 1995 and March 29,
1996 notices of intent to sue EPA for failing to comply with the FIP
contingency provisions be incorporated into the record of this matter.
Response: ACLPI's two notices have been incorporated into the
docket as comments on EPA's action.
Comment: ACLPI states that rather than moving forward with adoption
of additional measures to produce attainment, the Agency is proposing
to ignore the bulk of the State's CO SIP and its SIP call and only act
on the State's contingency procedures.
Response: Approval of the State's contingency measures does not
indicate what future action EPA will or will not take on the State's
1993 CO plan, which was submitted in response to EPA's August 9, 1993
SIP call, nor does it preclude any future actions on that plan. EPA's
SIP call did not require that the State submit section 172(c)(9)
contingency measures. As discussed above, the section 179(c)(9)
requirement for specific contingency measures is a separate and
distinct provision of the Act that may be approved separately from
other elements of the CO plan.
Comment: ACLPI claims that the extension and reclassification
procedures in the 1990 Amendments assume that EPA will first review,
and approve or disapprove moderate area CO SIPs before considering
reclassification and attainment deadline extensions, and that EPA has
flouted those requirements here.
[[Page 51610]]
Response: EPA does not agree that reclassification of an area to
serious under the Act requires prior review and approval or disapproval
of a moderate area plan.33 Once an attainment date has passed, EPA
must determine, based solely on ambient air quality data, whether an
area has failed to attain without regard to whether EPA has approved a
plan for the area. Once the Agency makes this finding, the area is
reclassified to serious by operation of law. See section 186(b)(2). As
a result of its recent reclassification to serious, the Maricopa area
is now required to submit a new serious area CO plan by February 28,
1998. See footnote 3. Because the Phoenix area experienced violations
of the CO standard in 1995, it did not qualify for an extension of its
attainment date; therefore, CAA requirements for extension of the
attainment date are not relevant.
---------------------------------------------------------------------------
\33\ Note that for low moderate areas the only plan submittals
required by the CAA are section 172(c)(9) contingency measures and a
section 187(a) emissions inventory. Therefore Congress could not
have intended that EPA act on attainment plans for these areas
before considering an attainment deadline extension or
reclassification.
---------------------------------------------------------------------------
B. Comments by the Maricopa Association of Governments, May 9, 1996
Comment: MAG made three technical comments correcting certain
references in the proposal:
Page 15747, second column, first partial paragraph: The
appropriate reference is ``See 1993 CO Plan Addendum, Appendix, Exhibit
4, memo re: Re-calculation of Carbon Monoxide Emission Reductions for
the Committed Measures.''
Page 15750, first column, first full paragraph, third
sentence: The phrase ``1996 and 1997'' is inconsistent with the data
provided and should be replaced with ``1995 through 1997.''
Page 15750, first column, second full paragraph, third
sentence: The phrase ``1996 and 1997'' is inconsistent with the data
provided and should be replaced with ``1995 through 1997.''
Response: EPA notes the first correction.
EPA states in the proposal that ``data indicat[e] that emission
increases of 17 tpd from VMT growth are expected to occur in 1996 and
1997.'' EPA arrived at this number by subtracting the expected CO 1997
emissions level (without post 1995 I/M 240), 530 tpd, from the expected
CO 1995 emission level (without post 1995 I/M 240), 513 tpd. Both the
530 tpd figure and the 513 tpd figure are calculated for December 1997
and 1995, respectively. EPA's statement in the proposal is, therefore,
correct: an emission increase of 17 tpd is expected in the two year
period (characterized as 1996 and 1997 in the proposal) from December
1995 through December 1997. The same reasoning applies to MAG's third
correction.
III. Final Actions
EPA is approving into the Arizona SIP for the Phoenix CO
nonattainment area the State's enhanced remote sensing program and
traffic diversion measure as meeting the requirements of sections 110
and 172(c)(9) of the CAA.
Based on the approval of the State's contingency measures, EPA is
withdrawing the federal contingency process for the Phoenix CO
nonattainment area. Specifically, the Agency is deleting the phrase
``After December 31, 1991 for the Maricopa CO nonattainment area or''
from the contingency provisions at 56 FR 5470, column 2 (February 11,
1991). This deletion leaves the federal contingency process in place
for the Pima County CO nonattainment area. EPA also is withdrawing the
list of highway projects potentially subject to delay that was proposed
on June 28, 1993 during the partial implementation of the FIP
contingency process at that time. 58 FR 34547.
EPA is taking these actions because, with its final approval of the
State's section 172(c)(9) measures, the federal process will become
unnecessary for attainment and maintenance of the CO NAAQS in the
Phoenix area. To leave the federal process in place would complicate
air quality planning within Maricopa County and would be unnecessarily
redundant. In addition, giving preference to the State's measures is
consistent with the Clean Air Act's intent that states have primary
responsibility for the control of air pollution within their borders.
See CAA sections 101(a)(3) and 107(a).
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 a 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.
IV. Administrative Requirements
A. Executive Order 12866
The Office of Management and Budget has exempted this regulatory
action from Executive Order 12866 review.
B. Regulatory Flexibility Act
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 business, small not-for-profit enterprises and
government entities with jurisdiction over populations of less than
50,000.
SIP approvals under sections 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. Similarly, withdrawal
of the FIP contingency process does not impose any new requirements.
Therefore, because the federal SIP approval and FIP withdrawal does not
impose any new requirements, the Administrator certifies that they do
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 state action. The
Act 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).
C. Unfunded Mandates
Under sections 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), 2 U.S.C. 1501-1571, 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 that 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 this rule.
EPA has determined that the approval action promulgated does not
include a federal mandate that may result in estimate costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector.
[[Page 51611]]
Through submission of these SIP revisions, the State and any
affected local or tribal governments have elected to adopt the program
provided for under sections 110 and 182 of the CAA. 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 today 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 requirements under State law.
Similarly, EPA's withdrawal of the FIP contingency process will not
impose any new requirements. 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 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. This federal action approves pre-existing requirements under
State or local law, imposes no new Federal requirements, and withdraws
other federal requirements applicable only to EPA. Accordingly, no
additional costs to State, local or tribal governments, or to the
private sector, result from this action.
D. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) added 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 5 U.S.C.
804(2).
E. 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 December 2, 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations.
Dated: September 26, 1996.
Carol M. Browner,
Administrator.
For the reasons set forth in this preamble, 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 D--Arizona
2. Section 52.120 is amended by adding paragraphs (c)(83) and
(c)(85) to read as follows:
Sec. 52.120 Identification of plan.
* * * * *
(83) Plan revisions were submitted on December 11, 1992, by the
Governor's designee.
(i) Incorporation by reference.
(A) State Transportation Board of Arizona.
(1) Resolution to Implement a Measure in the Maricopa Association
of Governments 1992 Carbon Monoxide Contingency Plan, adopted on
November 20, 1992.
(85) Plan revisions were submitted on April 4, 1994, by the
Governor's designee.
(i) Incorporation by reference.
(A) Arizona Revised Statutes.
(1) House Bill 2001, Section 27: ARS 49-542.01(E) approved by the
Governor on November 12, 1993.
[FR Doc. 96-25400 Filed 10-2-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-25396 Approval and Promulgation of Air Quality Implementation Plans; Commonwealth of Pennsylvania; Interim Final Determination of the Pennsylvania Enhanced I/M SIP Revision
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51598-51599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25396]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[PA 091-4029a; FRL-5613-1]
Approval and Promulgation of Air Quality Implementation Plans;
Commonwealth of Pennsylvania; Interim Final Determination of the
Pennsylvania Enhanced I/M SIP Revision
AGENCY: Environmental Protection Agency (EPA).
ACTION: Interim final rule.
-----------------------------------------------------------------------
SUMMARY: Elsewhere in today's Federal Register, EPA has published a
rulemaking notice proposing conditional interim approval of the
Commonwealth of Pennsylvania's enhanced motor vehicle inspection and
maintenance (I/M) program under Section 348 of the National Highway
System Designation Act of 1995 (NHSDA) and Section 110 of the Clean Air
Act (CAA). Based on the proposed conditional interim approval, EPA is
making an interim final determination by this action that the
Commonwealth has corrected the deficiency prompting the original
disapproval of the Pennsylvania enhanced I/M SIP revision. This action
will defer the application of the offset sanction which would have been
implemented on October 13, 1996 and defers the future application of
the highway sanction. Although this action is effective upon
publication, EPA will take comment on this interim final determination
as well as EPA's proposed conditional interim approval of the
Commonwealth's submittal. EPA will publish a final rule taking into
consideration any comments received on EPA's proposed action and this
interim final action.
DATES: This interim rule is effective on October 3, 1996.
Comments must be received by November 4, 1996.
ADDRESSES: Comments should be sent to Marcia L. Spink, Associate
Director, Air Programs, (3AT00), Air, Radiation and Toxics Division,
U.S. EPA Region III, 841 Chestnut Building, Philadelphia, Pennsylvania
19103. The state submittal and EPA's analysis for that submittal, which
are the basis for this action, are available for public review at the
above address.
FOR FURTHER INFORMATION CONTACT: Brian Rehn (215) 566-2176, at the EPA
Region III address above or via e-mail at [email protected].
While information may be requested via e-mail, comments must be
submitted in writing to the EPA Region III address above.
SUPPLEMENTARY INFORMATION:
I. Background
In an April 13, 1995 letter EPA notified Pennsylvania that the
conditional approval of the Pennsylvania enhanced I/M SIP revision had
been converted to a disapproval (60 FR 47084). The letter triggered the
18 month time clock for the mandatory application of sanctions under
section 179(a) of the CAA. This 18 month sanction clock will expire on
October 13, 1996 at which time 2:1 offset sanctions would be
automatically imposed to new or modified sources seeking permits under
section 173 of the CAA.
On March 22, 1996, the Commonwealth of Pennsylvania submitted an
enhanced I/M SIP revision to EPA, requesting action under the NHSDA of
1995 and the CAA. On June 27, 1996 and July 29, 1996, supplements to
the March 22, 1996 SIP revision were officially submitted to EPA. In
the Proposed Rules section of today's Federal Register, EPA has
proposed conditional interim approval of the Pennsylvania enhanced I/M
program. EPA had determined that it is more likely than not that the
March 22, 1996 enhanced I/M SIP revision, as supplemented (hereinafter,
the ``March 22, 1996 I/M SIP revision''), has cured the SIP deficiency
triggering the sanctions clock for the duration of EPA's rulemaking
process on this I/M SIP revision. This interim determination will not
stop the sanctions clock but will defer the implementation of sanctions
until either the conditional interim approval is converted to a
disapproval, the interim approval lapses, the full SIP is approved or
the full SIP is disapproved.
Today EPA is also providing the public with an opportunity to
comment on this interim final determination. If, based on any comments
on this action and any comments on EPA's proposed conditional interim
approval of the March 22, 1996 I/M SIP revision, EPA determines that
the March 22, 1996 I/M SIP revision is not approvable and this final
action was inappropriate, EPA will take further action to disapprove
the March 22, 1996 I/M SIP revision. If EPA's proposed conditional
interim approval of the Pennsylvania I/M SIP revision is reversed, then
sanctions would be applied as required under Section 179(a) of the CAA
and 40 CFR Section 52.31.
II. EPA Action
Based on the proposed conditional interim approval set forth in
today's Federal Register, EPA believes that it is more likely than not
that the Commonwealth has corrected the deficiency that prompted the
original disapproval of the Pennsylvania enhanced I/M SIP for which the
April 13, 1995 finding of failure to submit was issued.
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 the SIP shall be
considered separately in light of specific technical, economic, and
environmental factors and in relation to relevant statutory and
regulatory requirements.
III. Administrative Requirements
Because EPA has preliminarily determined that the March 22, 1996
Pennsylvania I/M SIP revision is conditionally approvable, relief from
future sanctions should be provided as quickly as possible. Therefore,
EPA is invoking the good cause exception under the Administrative
Procedure Act (APA) in not providing an opportunity for comment before
this action takes effect.1 5 U.S.C. 553(b)(B). The EPA believes
that notice-and-comment rulemaking before the effective date of this
action is impracticable and contrary to the public interest. The EPA
has reviewed the March 22, 1996 I/M SIP revision and, through its
proposed interim action, is indicating that it is more likely than not
that the Commonwealth has corrected the disapproval that started the
sanctions clock. Therefore, it is not in the public interest to
initially apply sanctions
[[Page 51599]]
when the Commonwealth has most likely corrected the deficiency that
triggered the sanctions clock. Moreover, it would be impracticable to
go through notice-and-comment rulemaking on a finding that the
Commonwealth has corrected the deficiency prior to the rulemaking
approving the March 22, 1996 I/M SIP revision. Therefore, EPA believes
that it is necessary to use the interim final rulemaking process to
defer sanctions while EPA completes its rulemaking process on the
approvability of the March 22, 1996 I/M SIP revision. In addition, EPA
is invoking the good cause exception to the 30-day notice requirement
of the APA because the purpose of this notice is to relieve a
restriction. See 5 U.S.C. 553(d)(1).
---------------------------------------------------------------------------
\1\ As previously noted, however, by this action EPA is
providing the public with a chance to comment on EPA's determination
after the effective date and EPA will consider any comments received
in determining whether to reverse such action.
---------------------------------------------------------------------------
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 Nichols, Assistant Administrator for
Air and Radiation. The Office of Management and Budget (OMB) has
exempted this regulatory action from E.O. 12866 review.
Regulatory Flexibility Act
Under the Regulatory Flexibility Act, (RFA) 5 U.S.C. 600 et. seq.,
EPA must prepare a regulatory flexibility analysis assessing the impact
on small entities of any rule subject to prior notice and comment
rulemaking requirements. 5 U.S.C. 603 and 604. Alternatively, EPA may
certify that the rule will not have a significant economic 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.
Because this action is not subject to prior notice and comment
requirements (see above), it is not subject to RFA. In any even,
today's action temporarily relieves sources of an additional burden
potentially placed on them by the sanction provisions of the Act.
Therefore, the action will not have a significant impact on a
substantial number of small entities.
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 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 proposed/promulgated
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 imposes
no new Federal requirements. Accordingly, no additional costs to State,
local, or tribal governments, or to the private sector, result from
this action.
Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) as added 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 interim final determination regarding the
Pennsylvania I/M SIP is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Hydrocarbons,
Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements.
Authority: 42 U.S.C. 7401-7671q.
Dated: September 12, 1996.
William T. Wisniewski,
Acting Regional Administrator, Region III.
[FR Doc. 96-25396 Filed 10-2-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-25358 Guides for Select Leather and Imitation Leather Products
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51577-51584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25358]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
16 CFR Part 24
Guides for Select Leather and Imitation Leather Products
AGENCY: Federal Trade Commission.
ACTION: Final rule; Final Guides for Select Leather and Imitation
Leather Products.
-----------------------------------------------------------------------
SUMMARY: The Federal Trade Commission (the ``Commission''), as part of
its periodic review of its rules and guides, announces that it has
concluded a review of its proposed Guides for Select Leather and
Imitation Leather Products (``proposed Guides''), which combined and
amended the provisions of Guides for the Luggage and Related Products
Industry, the Guides for Shoe Content Labeling and Advertising, the
Guides for the Ladies' Handbag Industry and the Commission's Trade
Regulation Rule Concerning Misbranding and Deception as to Leather
Content of Waist Belts. The Commission has decided to adopt the
proposed Guides, modified as discussed below.
EFFECTIVE DATE: The effective date of this rule is December 2, 1996.
FOR FURTHER INFORMATION CONTACT: Susan E. Arthur, Attorney, (214) 767-
[[Page 51578]]
5503, Federal Trade Commission, Dallas Regional Office, 100 N. Central
Expressway, Suite 500, Dallas, Texas 75201.
SUPPLEMENTARY INFORMATION:
I. Background
On September 18, 1995, the Commission rescinded the Guides for the
Luggage and Related Products Industry (``Luggage Guides''), the Guides
for Shoe Content Labeling and Advertising (``Shoe Content Guides''),
and the Guides for the Ladies' Handbag Industry (``Handbag Guides'').
60 FR 48027 (September 18, 1995). On the same day, the Commission
sought public comment on proposed Guides for Select Leather and
Imitation Leather Products. 60 FR 48056 (September 18, 1995). The
proposed Guides combined relevant portions of the three Guides, updated
certain language used in the Guides, and made other modifications to
clarify and streamline the provisions of the Guides. The Commission
included within the coverage of the proposed combined Guides certain
provisions of the Commission's Trade Regulation Rule Concerning
Misbranding and Deception as to Leather Content of Waist Belts, 16 CFR
Part 405 (``Waist Belt Rule'').1
---------------------------------------------------------------------------
\1\ The Commission recently repealed the Waist Belt Rule. 61 FR
25560 (May 22, 1996).
---------------------------------------------------------------------------
The request for public comment contained questions designed to
assist the Commission in determining whether the proposed Guides should
be expanded in scope and to allow interested parties to apprise the
Commission of any special considerations for their industries. The
questions were as follows:
1. Should the proposed Guides for Select Leather and Imitation
Leather Products be expanded in scope to include other products made of
leather or imitation leather? Such products might include, but are not
limited to, clothing, furniture, watchbands, and equestrian items.
2. Are there special considerations for these or other leather or
imitation leather goods which are not addressed by the proposed Guides?
How could any such special considerations be addressed by the Guides?
II. Comments Received
Nine comments were received in response to this request for public
comment. Additionally, the Commission received two Waist Belt Rule
comments in response to an advance notice of proposed rulemaking
published on September 18, 1995. Previously, the Commission had
received 12 comments in response to its March 27, 1995 Federal Register
notice on the three individual Guides and 10 comments on the Waist Belt
Rule (all but three of the Waist Belt Rule comments were also submitted
in response to the request for comment on the three Guides). Because
the Waist Belt Rule comments concern the same or similar issues as
those under consideration in this proceeding, they have been considered
in this review.
In its September 18, 1995 Federal Register notice, the Commission
addressed the first set of comments on the three Guides and the Waist
Belt Rule, which had been received in response to its March 27, 1995
Federal Register notice. The Commission now addresses the comments
received in response to the September 18, 1995 Federal Register notice
and will refer to the first set of comments where appropriate or
necessary to the discussion.2
---------------------------------------------------------------------------
\2\ Comments Received in Response to the March 27, 1995 Federal
Register Notice.
Concerning the Three Guides:
1. Rose E. Kettering (``REK''). Same comment sent regarding
Waist Belt Rule
2. Matt Anderson (``MA''). Same comment sent regarding Waist
Belt Rule.
3. Marilyn Raeth (``MR''). Same comment sent regarding Waist
Belt Rule.
4. James A. McGarry (``JAM''). Same comment sent regarding Waist
Belt Rule.
5. Lenna Mae Gara (``LMG''). Same comment sent regarding Waist
Belt Rule.
6. Linda D. Lipinski (``LDL'').
7. Footwear Industries of America (``FIA'').
8. Leather Industries of America, Inc. (``LIA''). Same comment
sent regarding Waist Belt Rule.
9. Luggage and Leather Goods Manufacturers of America, Inc.
(``LLGMA'').
10. Cromwell Leather Company, Inc. (``CL''). Same comment sent
regarding Waist Belt Rule.
11. Enger Kress (``EK'').
12. Footwear Distributors and Retailers of America (``FDRA'').
Concerning the Waist Belt Rule:
13. Stephen Toso (``ST'').
14. Humphreys, Inc. (``HI'').
15. Enger Kress (``EK2'').
Comments Received in Response to the September 18, 1995 Federal
Register Notice.
Concerning the Proposed Guides:
16. Ecological Fibers, Inc. (``EFI'').
17. Leather Industries of America (``LIA2''). Addendum dated
January 11, 1996 (``LIA3''). Addendum dated January 18, 1996
(``LIA4'').
18. Fried, Frank, Harris, Shriver & Jacobson (``FFHSJ'').
19. Footwear Industries of America (``FIA2''). Addendum dated
January 25, 1996, to Susan Arthur (``FIA3''). Addendum dated January
25, 1996, to Secretary's Office (``FIA4''). Addendum dated January
30, 1996 (``FIA5'').
20. Footwear Distributors and Retailers of America (``FDRA2'').
21. Cromwell Leather Company, Inc. (``CL2'').
22. People for the Ethical Treatment of Animals (``PETA'').
23. Hong Kong Government Industry Department (``HK'').
24. Luggage and Leather Goods Manufacturers of America
(``LLGMA2'').
Concerning the Waist Belt Rule:
24. Humphreys, Inc. (``HI2'').
25. Larry Gundersen (``LG'').
---------------------------------------------------------------------------
In conducting this review, the Commission also examined the
European Union Directive 94/11/EC, which applies to footwear. The
Directive has as its objective informing consumers of the contents of
their shoes, which is different from the Guides' aim of preventing
misrepresentation caused by the appearance of leather. However, to
enhance global harmonization, the Commission has, where appropriate,
incorporated some of the concepts of the Directive into the Guides.
A. Comments Concerning the Usefulness of the Guides
The proposed Guides are premised on the Commission's long-standing
position that a product that looks like leather makes an implied
representation that the product is made of leather. The Commission
received a number of comments which indicated a need for the Guides.
One comment, however, stated that the proposed Guides are at odds with
current Commission law and policy and urged the Commission to abandon
the Guides as they apply to shoes and boots.3 This comment also
said that the proposed Guides convert silence about shoe content into
an ``appearance of leather'' misrepresentation and then require
disclosure to cure that misrepresentation.
---------------------------------------------------------------------------
\3\ FDRA2, #20 at 2.
---------------------------------------------------------------------------
Specifically, the Footwear Distributors and Retailers of America
argues that the proposed Guides deal with conduct that is not
prohibited under modern FTC deception law. The association cites
International Harvester Co., 104 F.T.C. 949 (1984), as setting forth
the circumstances under which the Commission will apply deception
theory to omissions: (1) where the seller fails to disclose information
necessary to prevent an affirmative statement from creating a
misleading impression, and (2) where the seller remains silent under
circumstances which constitute an implied but false representation.
International Harvester, however, also states that a deceptive omission
can arise from the physical appearance of a product, and cites as
authority a case in which the Commission upheld charges against a
seller who failed to disclose that a simulated wood product was
actually paper. Haskelite Mfg. Corp., 33 F.T.C. 1212, 1216 (1941),
aff'd, 127 F.2d 765 (7th Cir. 1942). The proposed
[[Page 51579]]
Guides are designed to correct the same type of omission as that in
Haskelite. Both cases provide support for the underlying premise of the
Guides.
The Footwear Distributors and Retailers of America also cites
Thompson Medical, 104 F.T.C. 648, (1984), aff'd, 791 F.2d 189 (D.C.
Cir. 1986), cert. denied, 479 U.S. 1086 (1987) and Leonard Porter, 88
F.T.C. 546, (1976), as support for the proposition that a product
appearing to be leather does not make an implied representation
concerning the material from which the product is made. In Thompson
Medical, the Commission said that if an initial review does not permit
it to conclude with confidence that an implied message exists, it will
not find the implied claim unless extrinsic evidence (consumer surveys,
expert testimony) allows it to conclude that such a reading is
reasonable. In Leonard Porter, the Commission found that consumers
would not generally assume that certain souvenirs were handmade in
Alaska by natives. The Commission said that, simply from the appearance
of the items, it could not conclude that the items possessed the
capacity to deceive as to their origin and method of manufacture.4
With regard to the appearance of leather and the potential resulting
content representation created by that appearance, however, a visual
examination of the item is sufficient to determine whether a
representation is made. Extrinsic evidence is unnecessary to determine
the existence of the claim.
---------------------------------------------------------------------------
\4\ The Commission also said that complaint counsel's extrinsic
consumer evidence did not appear to be representative either of
current conditions or of any substantial segment of consumers and
did not support a need for disclosures.
---------------------------------------------------------------------------
The Footwear Distributors and Retailers of America comment also
expresses a belief that new high-tech synthetics are far superior to
the synthetics used in the early 1960's, ``offering the appearance,
comfort, breathability, durability, and other qualities that are
comparable or superior to leather.'' The organization believes that the
performance and value of the shoe, not the materials used, drive
consumer choice. Further, Footwear Distributors and Retailers of
America states that consumers do not assume that footwear is made of
leather nor do they care about the exact materials used in shoes.
The Commission believes that leather content representations likely
are material to consumers. Two consumers who responded to the first
request for comment indicated a belief that imitation leather, when
used in shoes, may cause feet to sweat excessively.5 Another
stated that animal lovers, vegetarians and others who do not wish to
wear leather need to know what they are buying.6 Two other
comments from the first set of comments indicated that the requirements
of the Guides assist consumers in making purchasing decisions.7
Although the Footwear Distributors and Retailers of America comment
contends that these consumer comments are anecdotal evidence which
should be rejected, the Commission believes that they demonstrate a
desire on the part of consumers to be informed of the nature of a
product and that this desire is common to a substantial number of
consumers.
---------------------------------------------------------------------------
\5\ REK, #1; MA, #2 at 2.
\6\ LMG, #5.
\7\ MR, #3 and JAM, #4.
---------------------------------------------------------------------------
It seems likely that the appearance of leather in a synthetic
material may be a representation that the product is leather. Further,
price or other factors are unlikely to signal to consumers that a
product which appears to be leather is not.8 Products made from
synthetics that look like leather, especially synthetic athletic shoes,
are often priced the same as similar products made of leather.
---------------------------------------------------------------------------
\8\ In contrast, consumers are unlikely to confuse a gold-toned
product with real gold when the ``pretender'' sells for a fraction
of the amount that gold items typically cost.
---------------------------------------------------------------------------
In addition, the Guides trigger disclosures for non-leather
materials only when a product appears to be leather and is not. Many
synthetics are intentionally made to simulate the look of leather,
apparently because many consumers prefer leather. Other synthetic
products, however, are clearly and visibly synthetic, and for such
products disclosure requirements would not be triggered. Thus, the
application of the Guides is properly limited to situations where
consumers are likely to be misled about a product's true composition.
In sum, it seems likely that that the appearance of leather in a
non-leather product constitutes a representation that a product is
leather. Consumers have come to rely upon the information provided
pursuant to the Guides, and if the Commission did not adopt the
proposed Guides, it is likely that confusion in the marketplace would
result.
B. Comments Concerning Products Covered by the Guides
The request for comment on the proposed Guides contained questions
related to (1) expansion of the Guides to include other types of
products made of leather or imitation leather and (2) any special
considerations for such products not addressed by the proposed Guides.
For the reasons discussed below, the Commission has decided not to
expand the Guides to cover additional types of products.
A number of comments received in response to the first Federal
Register notice concerning the three individual Guides addressed the
expansion issue. One comment said that a single set of guides should
cover all leather-using industries.9 Another stated that the
Guides could be generalized to many, if not all, industries.10
Leather Industries of America suggested that a set of leather
definitions be developed to apply to all finished goods.11 The
Luggage and Leather Goods Manufacturers of America stated, however,
that it did not endorse combining the Guides because of the special
circumstances in other industries.12 None of the second set of
comments concerning the proposed Guides expressed any views on whether
the Guides should be expanded to include additional products.
---------------------------------------------------------------------------
\9\ CL, #10 at 1.
\10\ EK, #11 at 2.
\11\ LIA, #8 at 4-5.
\12\ LLGMA, #9 at 2.
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Other than the request for special consideration of footwear
contained in the Footwear Distributors and Retailers of America comment
discussed above, only one comment from the second set of comments
requested any special consideration for certain products. This comment
came from a company which supplies paper and cover products to the
bookbinding and looseleaf industry. The comment requested an exclusion
for material thinner than 10/1000th of an inch, provided that the
material is identified by some name which indicates the presence of
non-leather ingredients (the company suggests the term ``reinforced
bonded leather'') and that the material is used as covering
material.13 No such exclusion has been incorporated into the
Guides as adopted. The leather appearance of the product, rather than
its thickness, makes a representation to consumers. Further, as
addressed below, use of the term ``bonded leather'' is sanctioned by
the proposed Guides, provided that appropriate disclosures are made.
---------------------------------------------------------------------------
\13\ EFI, #16 at 2.
---------------------------------------------------------------------------
While there are some arguments for broadening the Guides, they are
not compelling. The record developed during this review does not
provide sufficient support to justify expansion of the Guides. There
are still many unanswered questions regarding the extent to which
misrepresentations are made in other industries, how
[[Page 51580]]
consumers would interpret the appearance of leather for products in
other industries, and whether there are special considerations for
other industries. Thus, the Commission has decided that the Guides
should not be expanded to cover additional products.14
Nevertheless, all industries which utilize leather and imitation
leather can obtain valuable guidance from the Guides. Because the
Guides are interpretive of laws enforced by the Commission, these
industries may obtain useful information from the Guides even though
they are not specifically covered. Further, although other industries
may not be within the coverage of the Guides, the Commission is in no
way prevented from otherwise taking action against a company engaged in
deceptive omissions.
---------------------------------------------------------------------------
\14\ The provision concerning the scope of the Guides is
modified in that the term ``footwear'' is substituted for the
enumeration of footwear items.
---------------------------------------------------------------------------
C. Suggested Changes to the Guides
A number of the comments received in response to the second request
for comment suggested that certain changes be made to the proposed
Guides. Generally, these suggestions fall into the following
categories: (1) Use of the term ``Leather,'' (2) Multi-material Shoes,
(3) Disclosure Requirements, (4) Concealed Innersoles, (5) Use of the
term ``Bonded Leather,'' (6) Use of the term ``Waterproof,'' and (7)
Deletion of Unnecessary Provisions.
1. Use of the Term ``Leather''
Split leather is the leather which results from the splitting of
hides or skins into two or more thicknesses, other than the grain or
hair side. Top grain leather is the grain or hair side. As published
for comment, the proposed Guides provided for use of the term
``leather'' only when the material is top grain leather. Originally,
the distinction was retained because of apparent differences between
the performance and appearance of top grain leather and that of split
leather, as well as possible consumer expectations with regard to these
materials. Upon further consideration, the Commission has decided that
the term ``leather'' would also be appropriate for split leather
products.
The European Union Directive 94/11/EC, which applies to footwear,
allows split leather to be called ``leather'' without
qualification.15 For this reason, two comments from the first set
of comments urged that the Guides be amended to allow split leather to
be called ``leather.'' 16 The comments suggested that
technological advances have resulted in a split leather which is
superior to that produced years ago. In support of preservation of the
Guides' distinction between top grain and split leather, however, one
of the first set of comments stated that split grain is less expensive,
less attractive, and less durable than top grain leather, and that
split leather is subject to ``crocking.'' 17 Another of that set
of comments stated that the Guides should continue to permit only top
grain leather to be called ``leather'' or ``genuine leather'' and that
other forms of leather should include qualifying words.18
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\15\ Under the European Union directive, leather which has a
surface coating thicker than 0.15 mm cannot be called ``leather.''
Leather with a surface coating which does not exceed one third of
the thickness of the material but is greater than 0.15 mm must be
referred to as ``coated leather.'' The proposed Guides do not
address coating materials because such materials were not addressed
in the original Guides, and there is insufficient record evidence
regarding practices in the United States upon which to base guidance
about coatings.
\16\ LIA, #8 at 4; FDRA, #12 at 3. FDRA restated this position
in its second comment.
\17\ FIA, #7 at 2. The comment stated that crocking is the
transfer of color from the surface of a colored material to an
adjacent area of the same material or to another surface,
principally by rubbing. In its second comment, Footwear Industries
of America again supported qualification of split leather because of
differences in the performance and appearance of split leather and
top grain leather.
\18\ CL, #10 at 1.
---------------------------------------------------------------------------
One of the second set of comments reasoned that top grain leather
is in fact a split--albeit the top grain split--of a cowhide or sheep-
skin.19 Further, the comment stated that top grain leathers are
noted for their exceptionally low tear strength and structural
weakness. The comment also said that it could be argued that there is
no application where splits could not visually and physically replace
or substitute top grain leathers, but that the reverse would not apply.
The commenter stated that for use on the products its client
manufactures, appointment books and diaries, splits are preferable for
their strength characteristics and their blemish-free surface. Since
these products are enhanced by use of split leather, the comment states
that it would not be unfair or deceptive to represent that the products
are leather, but that it would detract from the marketing of the
products to refer to them as anything other than leather.20
---------------------------------------------------------------------------
\19\ FFHSJ, #18 at 1.
\20\ Alternatively, the comment requested a clarification of the
scope of the Guides to make clear that the Guides do not apply to
the company's products.
---------------------------------------------------------------------------
Rather than relying upon the performance characteristics of split
leather and top grain leather, the Commission believes that consumer
understanding and the messages conveyed to consumers should be the
focus in deciding whether to permit use of the term ``leather'' to
describe split leather. Footwear Distributors and Retailers of America
commented that there is no reason to assume that consumers distinguish
between top grain and split leather.21 Another comment requested
modification of the proposed Guides to accurately reflect consumer
acceptance of split leather.22 The Commission believes that it is
reasonable to assume that consumers do not perceive a distinction
between ``leather'' and ``split leather'' and that consumers do not
assume that ``leather'' means only ``top grain leather.'' Indeed, the
relevant definition of leather is the ``dressed or tanned hide of any
animal, usually with the hair removed.'' 23 If the Guides are
modified to allow split leather to be called ``leather,'' manufacturers
of top grain leather would be free to label their products as ``top
grain leather'' if they so choose. It is likely that a number of top
grain leather product manufacturers already label their products in
this manner. If consumers are aware of any difference in the quality of
various types of leather, the term ``top grain'' will likely convey
more useful information to consumers than will the term ``split.''
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\21\ FDRA2, #20 at 3.
\22\ FFHSJ, #18 at 1.
\23\ The American Heritage Dictionary, Houghton Mifflin Company,
Third Edition (1992).
---------------------------------------------------------------------------
Based on the European Union position on split leather and the
representation that the Commission believes is made to consumers by use
of the term ``leather,'' the Commission deletes from the Guides the
provision stating that only top grain leather can be called leather
without qualification. Furthermore, the provision requiring disclosure
of the presence of split leather and other references to the term
``split leather'' are deleted.
2. Multi-Material Shoes
Footwear Distributors and Retailers of America suggested that the
proposed Guides should be more flexible with regard to multi-material
footwear.24 The proposed Guides stated that if all or part of a
shoe is non-leather with the appearance of leather, the general nature
of the material or the fact that the material is not leather should be
disclosed.25 The proposed Guides also stated that a product which
is made principally of leather but which has
[[Page 51581]]
non-leather parts with the appearance of leather may be described as
leather as long as there is a disclosure of the non-leather parts.
Given the current design of footwear, it may have been necessary in
order to comply with the proposed Guides to disclose the composition of
a number of different parts of a shoe. Such a lengthy disclosure may
have been cumbersome to manufacturers and confusing to consumers.
---------------------------------------------------------------------------
\24\ FDRA2, #20 at 4.
\25\ Under the proposed Guides as published for comment, the
composition of heels, stiffenings, and ornamentation was not
considered when making the determination of whether a shoe, boot, or
slipper may be called ``leather.''
---------------------------------------------------------------------------
The EU Directive on Footwear states that labels shall provide
information on only three parts of a shoe: the upper, the lining and
sock, and the outersole.26 The Commission believes that such a
limitation is appropriate to prevent costly and cumbersome disclosures.
Consequently, a footnote has been added to the Guides indicating that
footwear is considered to be composed of these three parts.
---------------------------------------------------------------------------
\26\ The European Union Directive defines these three parts of a
shoe as follows: (1) the upper is the outer face of the structural
element which is attached to the outersole; (2) the lining and sock
are the lining of the upper and the insole, constituting the inside
of the footwear article; and (3) the outersole is the bottom part of
the footwear article subjected to abrasive wear and attached to the
upper.
According to the Directive, labels must disclose the material
which constitutes at least 80% of the surface area of the upper, 80%
of the surface area of the lining and sock, and at least 80% of the
volume of the outersoles. The Guides have not been modified to
conform with the European Union Directive with respect to the 80%
figure.
---------------------------------------------------------------------------
Footwear Distributors and Retailers of America suggest allowing use
of a more flexible disclosure if a footwear part is composed of both
leather and non-leather materials. For example, if the majority of the
upper is leather, the following term would be used: ``leather and
manmade upper.'' If leather is not the majority of the material:
``upper of manmade and leather materials.'' Because such disclosures
would inform consumers that the upper of a shoe is not entirely leather
and would prevent deception, a footnote has been added to the Guides
which states that, with regard to footwear, it is sufficient to
disclose the presence of non-leather materials in the upper, the lining
and sock, or the outersole, provided that the disclosure is made
according to the predominance of materials. An example similar to the
one mentioned above has also been added.
3. Disclosure Requirements
People for the Ethical Treatment of Animals stated that its
members, because of their ethical concerns, need labels affixed to
products which accurately identify the material from which the product
is made. The organization suggests that all leather products be labeled
``Animals Suffered to Make This Product'' and that all non-leather
products be labeled ``Cruelty-free Product.'' The aim of the Guides is
to prevent misrepresentation of leather content. The disclosures
provided in the proposed Guides accomplish this goal. The disclosures
suggested by People for the Ethical Treatment of Animals are not
appropriate in the context of the Guides.
4. Concealed Innersoles
The proposed Guides currently state that shoes with visible parts
having the appearance of leather but containing non-leather concealed
innersoles should bear a disclosure of the composition of the
innersoles.27 Initially, the Commission believed that insufficient
evidence of consumer beliefs had been presented to warrant removal of
this provision. On further consideration, however, the Commission now
has decided that disclosure of the composition of concealed innersoles
is not needed.
---------------------------------------------------------------------------
\27\ Concealed innersoles are the portion of a shoe hidden
between the liner and the outersole of a shoe.
---------------------------------------------------------------------------
Comments from two trade associations addressed this issue. Footwear
Industries of America objected to the Guides' not being limited to
uppers and outersoles, the two main components of a shoe upon which the
association believes consumers base their purchasing decisions.28
The comment said that innersoles are typically covered with a sock
lining or insole sock which conceals the innersole and separates it
from the foot, so consumers are not deceived into thinking it is
leather. Footwear Distributors and Retailers of America argued that the
concealed innersole disclosure should be deleted given the absence of
any empirical evidence that consumers care about concealed
innersoles.29 The comment also said that consumers should not have
any expectations at all about a part of the shoe which is not seen.
---------------------------------------------------------------------------
\28\ FIA2, #19 at 1. Footwear Industries of America also made
this argument in its first comment.
\29\ FDRA2, # 20 at 3. In its first comment, the organization
stated that the Guides should not apply to concealed innersoles
because consumers expect that the concealed portions of footwear
bottoms, particularly innersoles, are made of synthetic material.
---------------------------------------------------------------------------
Footwear Industries of America stated that leather innersoles do
not guarantee better performance, and that leather is no longer being
used in this manner.30 The comment states that leather innersoles
crack and break during flexing movements due to the effects of
perspiration acids and humidity. The comment also estimates that less
than 1% of the 1.6 billion pairs of shoes sold annually in the U.S.
have a leather innersole, and that most are cellulose board. The
association also provided information to indicate that cellulose board
can outperform leather in a number of respects, including dimensional
stability, porosity, and thermal conductivity.31 The information
provided also indicates that the material is lighter in weight than
leather and has a lower Ph factor than leather.
---------------------------------------------------------------------------
\30\ FIA2, #19 at 2.
\31\ FIA5, #19 at 1.
---------------------------------------------------------------------------
As discussed above, with regard to footwear, the coverage of the
Guides has been limited to the three main parts of footwear. Therefore,
the provision regarding concealed innersoles has been deleted. A
concealed innersole does not make any implied representation to
consumers and, therefore, no disclosure of the content of concealed
innersoles is necessary.32
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\32\ As indicated above, the European Union Directive does not
apply to concealed innersoles.
---------------------------------------------------------------------------
5. Use of the Term ``Bonded Leather''
In drafting the proposed Guides, the Commission considered a number
of comments concerning use of the term ``bonded leather,'' which
generally refers to material made of leather fibers held together with
a bonding agent. Although the original three Guides did not mention the
term ``bonded leather,'' they addressed this type of material, which is
also called ``ground leather,'' ``pulverized leather,'' or ``shredded
leather.'' The Shoe Content Guides and the Ladies' Handbag Guides
allowed either a disclosure stating that the material is simulated or
imitation leather or that the material is ground, pulverized, or
shredded leather. The Luggage Guides stated that an accurate
representation as to the ground, pulverized or shredded leather content
of the material could be made, but that if the material had the
appearance of being leather a disclosure must be made in accordance
with the imitation leather provision of the Luggage Guides. The example
given in the Luggage Guides contains a disclosure that shredded leather
fibers are contained in the material, but that rubber adhesive and
vinyl are also contained in the material. The Luggage Guides provide
that consumers should be made aware of the different components in this
type of material. The history of this issue was considered in drafting
the proposed Guides, which state that if the term ``bonded leather'' is
used (or if similar terms such as ``ground leather,'' ``pulverized
leather,'' or ``shredded leather'' are used), a disclosure of the
percentage of leather fiber and of the
[[Page 51582]]
percentage of non-leather substances contained in the product should be
made.
One of the comments expressed support for the proposed Guides'
treatment of this issue.33 Another comment suggested that this
material should be called ``reinforced bonded leather'' rather than
simply ``bonded leather'' in order to put the public on notice that
there are other ingredients in the material.34 A comment regarding
the Waist Belt Rule suggested that the term ``bonded leather'' should
be permitted to be used unconditionally.35 The Commission
concludes, however, that use of the terms ``bonded leather'' or
``reinforced bonded leather'' without further information is likely to
confuse consumers as to leather content, and the best way to avoid such
confusion is to include the disclosures as provided by the Guides.
---------------------------------------------------------------------------
\33\ FIA2, #19 at 1.
\34\ EFI, #16 at 2.
\35\ HI2, #24 at 1.
---------------------------------------------------------------------------
Another commenter supported using the term ``bonded leather'' but
did not think the additional content information as provided by the
Guides was the best solution.36 Cromwell Leather believed that a
qualifying word before the term ``leather'' (such as ``bonded'' or
``split'') will keep the Guides simple, yet effective, and suggests
that ongoing education will increase consumer understanding of the
qualifying terms. The comment stated that the proposed Guides'
disclosure requirement for bonded leather will create additional costs
and cause confusion because some manufacturers get bonded leather from
more than one supplier. The company believes there should be a 75%
leather fiber minimum for use of the term ``bonded leather'' (without
further qualification). The comment states that there is widespread
industry agreement on the 75% figure.
---------------------------------------------------------------------------
\36\ CL2, #21 at 1.
---------------------------------------------------------------------------
As discussed in response to the first set of comments, however,
even if the 75% figure were an industry practice or standard, it would
not prevent deception. In one of the original comments regarding the
Waist Belt Rule, consumer survey evidence was provided in support of
use of the term ``bonded leather.'' 37 The data provided indicates
that some consumers may be misled by use of the term. Further, the term
may be interpreted to mean that the material is of greater quality than
leather,38 or is strengthened or reinforced leather. Without the
qualifying information contained in the Guides, the term ``bonded
leather'' may not inform consumers that non-leather fibers are
contained in the material.
---------------------------------------------------------------------------
\37\ HI, #14, part 6.
\38\ EK, #11 at 3 and letter dated February 3, 1964, to the
Commission from counsel for the Tanners' Council of America at 10-
11.
---------------------------------------------------------------------------
The ecological benefits of using the term ``bonded leather''
(namely, encouraging the use of leather scrap or recycled leather
fiber) are also addressed in the second set of comments. One of the
comments urges the Commission to reconsider the decision not to require
a minimum leather content for use of the term ``bonded leather''
because ecological benefits are subverted.39 Another comment
urging a minimum threshold for use of the term stated that permitting
any amount of leather fibers to be called ``bonded leather'' may
diminish the use of recycled leather fibers and reverse the ecological
progress the industry has made.40 Whether recycling goals are
affected by use of the term ``bonded leather'' or not, consumers should
be made aware of the contents of such material.
---------------------------------------------------------------------------
\39\ LIA2, # 17 at 1.
\40\ CL2, #21 at 2.
---------------------------------------------------------------------------
One of the second set of comments urged the Commission to require a
minimum leather content for use of the term ``bonded leather'' since
consumers may not read fine print.41 The Guides already contain a
provision regarding the form of disclosures which should prevent any
``fine print'' from being used to mislead consumers. This provision
states that the disclosures affixed to products and made in advertising
should be conspicuous and clear and should be in close conjunction with
the representation necessitating the disclosure.
---------------------------------------------------------------------------
\41\ LIA2, #17 at 1.
---------------------------------------------------------------------------
In summary, the Commission believes that consumers should be made
aware of the contents of bonded leather and similar materials. The
Guides' treatment of this issue accomplishes this objective. One change
has been made to the ``bonded leather'' provision. The term
``reconstituted leather'' has been added to the section concerning use
of the terms ground, pulverized, shredded, and bonded leather.
Apparently, this term is often used interchangeably with ``bonded
leather.''
6. Use of the Term ``Waterproof''
A number of comments expressed concern about the provision in the
proposed Guides which relates to the term ``waterproof'' because the
Guides provide for use of the term only if an item is impermeable to
water.42 The comments argue that a product can be waterproof
without being totally impermeable to water. New technology waterproofs
leather by chemically modifying the leather fibers. Use of this
material in footwear allows air molecules to pass through while
preventing larger water molecules from reaching the foot. Total
impermeability is not desirable since the ability of leather to breathe
is a form of permeability. Leather Industries of America proposed the
following modification:
---------------------------------------------------------------------------
\42\ LLGMA2, #24 at 1, LIA3, #17 at 1, LIA4, #17 at 1, FIA4, #19
at 1.
---------------------------------------------------------------------------
It is unfair or deceptive to:
(a) Use the term ``Waterproof'' to describe all or part of an
industry product unless the designated product or material prevents
water from contact with its contents under normal conditions of
intended use during the anticipated life of the product or
material.43
---------------------------------------------------------------------------
\43\ LIA3, #17 at 1. Footwear Industries of America and Luggage
and Leather Goods Manufacturers of America each submitted a somewhat
similar proposal, without reference to the anticipated life of the
product.
---------------------------------------------------------------------------
Due to changes in technology and consumer acceptance of the modern
waterproofing methods, the waterproof provision has been modified as
contained in Leather Industries of America's suggestion.
7. Deletion of Unnecessary Provisions
The proposed Guides stated that it is unfair or deceptive to
misrepresent that a product is colored, finished, or dyed with aniline
dye. One of the comments expressed concern about this provision.44
Leather Industries of America stated that ``aniline leather'' is
universally used in the industry in a non-chemical sense to describe
leather that is finished without pigment coverage. The association
believes that the term does not imply that the leather has been dyed
with an aniline dye, only that the finish is clear and contains no
pigment. Because the term ``aniline'' now refers to a clear finish
which allows the surface to be seen, the Commission has removed the
provision in the proposed Guides relating to aniline dye.
---------------------------------------------------------------------------
\44\ LIA2 at 1.
---------------------------------------------------------------------------
The same provision also deals with misrepresentations that a
product is dyed, embossed, grained, processed, finished, or stitched in
a certain manner. Such misrepresentations would fall within the general
deception provision and do not need to be contained in a specific
provision.
Although no comments were received regarding the ``fictitious
animal'' provision in the proposed Guides, this provision has also been
deleted. Any representation that a product is made from the skin or
hide of an animal that
[[Page 51583]]
does not exist would clearly fall within the general deception
provision of the Guides.
III. Conclusion
A number of changes to the Guides have been made based upon the
second set of comments. The final Guides incorporate the following
modifications:
--The scope of the Guides has been modified to use the term
``footwear'' instead of a list of footwear items, and the term
``footwear'' is used as appropriate throughout the Guides.
--The provision stating that only top grain leather can be called
leather without qualification is modified. The provision requiring
disclosure of the presence of split leather and other references to the
term ``split leather'' have been deleted.
--The provision regarding concealed innersoles has been deleted.
--With regard to footwear, the Guides have been modified to state that
for purposes of the Guides, footwear is composed of three parts: the
upper, the lining and sock, and the outersole. A footnote has been
added which says that with regard to footwear, it is sufficient to
disclose the presence of non-leather materials in the upper, the lining
and sock, or the outersole, provided that the disclosure is made
according to predominance of materials.
--The term ``reconstituted leather'' has been added to the provision
dealing with use of the terms ground, pulverized, shredded, or bonded
leather.
--The provision concerning use of the term ``waterproof'' has been
modified to allow the term to be used if a product or material prevents
water from contact with its contents under normal conditions of
intended use during the anticipated life of the product or material.
--The provision relating to misrepresentation that a product has been
dyed with aniline dye and other specific misrepresentations has been
deleted.
--The ``fictitious animal'' provision has been deleted as unnecessary.
List of Subjects in 16 CFR Part 24
Advertising, Clothing, Distribution, Footwear, Imitation-leather
products, Labeling, Ladies' handbags, Leather and leather products
industry, Luggage and related products, Shoes, Trade practices, Waist
belts.
Accordingly, 16 CFR Part 24 is added to read as follows:
PART 24--GUIDES FOR SELECT LEATHER AND IMITATION LEATHER PRODUCTS
Sec.
24.0 Scope and purpose of guides.
24.1 Deception (general).
24.2 Deception as to composition.
24.3 Misuse of the terms ``waterproof,'' ``dustproof,''
``warpproof,'' ``scuffproof,'' ``scratchproof,'' ``scuff
resistant,'' or ``scratch resistant.''
Authority: 15 U.S.C. 45, 46.
Sec. 24.0 Scope and purpose of guides.
(a) The Guides in this part apply to the manufacture, sale,
distribution, marketing, or advertising of all kinds or types of
leather or simulated-leather trunks, suitcases, traveling bags, sample
cases, instrument cases, brief cases, ring binders, billfolds, wallets,
key cases, coin purses, card cases, French purses, dressing cases, stud
boxes, tie cases, jewel boxes, travel kits, gadget bags, camera bags,
ladies' handbags, shoulder bags, purses, pocketbooks, footwear, belts
(when not sold as part of a garment) and similar articles (hereinafter,
``industry products'').
(b) These Guides represent administrative interpretations of laws
administered by the Federal Trade Commission for the guidance of the
public in conducting its affairs in conformity with legal requirements.
These Guides specifically address the application of section 5 of the
FTC Act (15 U.S.C. 45) to the manufacture, sale, distribution,
marketing, and advertising of industry products listed in paragraph (a)
of this section. They provide the basis for voluntary compliance with
such laws by members of industry. Conduct inconsistent with the
positions articulated in these Guides may result in corrective action
by the Commission under section 5 if, after investigation, the
Commission has reason to believe that the behavior falls within the
scope of conduct declared unlawful by the statute.
Sec. 24.1 Deception (general).
It is unfair or deceptive to misrepresent, directly or by
implication, the kind, grade, quality, quantity, material content,
thickness, finish, serviceability, durability, price, origin, size,
weight, ease of cleaning, construction, manufacture, processing,
distribution, or any other material aspect of an industry product.
Sec. 24.2 Deception as to composition.
It is unfair or deceptive to misrepresent, directly or by
implication, the composition of any industry product or part thereof.
It is unfair or deceptive to use the unqualified term ``leather'' or
other unqualified terms suggestive of leather to describe industry
products unless the industry product so described is composed in all
substantial parts of leather.1 This section includes, but is not
limited to, the following:
---------------------------------------------------------------------------
\1\ For purposes of these Guides, footwear is composed of three
parts: the upper, the lining and sock, and the outersole. These
three parts are defined as follows: (1) The upper is the outer face
of the structural element which is attached to the outersole; (2)
the lining and sock are the lining of the upper and the insole,
constituting the inside of the footwear article; and (3) the
outersole is the bottom part of the footwear article subjected to
abrasive wear and attached to the upper.
---------------------------------------------------------------------------
(a) Imitation or simulated leather. If all or part of an industry
product is made of non-leather material that appears to be leather, the
fact that the material is not leather, or the general nature of the
material as something other than leather, should be disclosed. For
example: Not leather; Imitation leather; Simulated leather; Vinyl;
Vinyl coated fabric; or Plastic.
(b) Embossed or processed leather. The kind and type of leather
from which an industry product is made should be disclosed when all or
part of the product has been embossed, dyed, or otherwise processed so
as to simulate the appearance of a different kind or type of leather.
For example:
(1) An industry product made wholly of top grain cowhide that has
been processed so as to imitate pigskin may be represented as being
made of Top Grain Cowhide.
(2) Any additional representation concerning the simulated
appearance of an industry product composed of leather should be
immediately accompanied by a disclosure of the kind and type of leather
in the product. For example: Top Grain Cowhide With Simulated Pigskin
Grain.
(c) Backing material. (1) The backing of any material in an
industry product with another kind of material should be disclosed when
the backing is not apparent upon casual inspection of the product, or
when a representation is made which, absent such disclosure, would be
misleading as to the product's composition. For example: Top Grain
Cowhide Backed With Vinyl.
(2) The composition of the different backing material should be
disclosed if it is visible and consists of non-leather material with
the appearance of leather, or leather processed so as to simulate a
different kind of leather.
(d) Misuse of trade names, etc. A trade name, coined name,
trademark, or other word or term, or any depiction or device should not
be used if it misrepresents, directly or by implication, that an
industry product is made in whole or in part from animal skin or hide,
or that
[[Page 51584]]
material in an industry product is leather or other material. This
includes, among other practices, the use of a stamp, tag, label, card,
or other device in the shape of a tanned hide or skin or in the shape
of a silhouette of an animal, in connection with any industry product
that has the appearance of leather but that is not made wholly or in
substantial part from animal skin or hide.
(e) Misrepresentation that product is wholly of a particular
composition. A misrepresentation should not be made, directly or by
implication, that an industry product is made wholly of a particular
composition. A representation as to the composition of a particular
part of a product should clearly indicate the part to which the
representation applies.2 Where a product is made principally of
leather but has certain non-leather parts that appear to be leather,
the product may be described as made of leather so long as accompanied
by clear disclosure of the non-leather parts. For example:
---------------------------------------------------------------------------
\2\ With regard to footwear, it is sufficient to disclose the
presence of non-leather materials in the upper, the lining and sock,
or the outersole, provided that the disclosure is made according to
predominance of materials. For example, if the majority of the upper
is composed of manmade material: Upper of manmade materials and
leather.
---------------------------------------------------------------------------
(1) An industry product made of top grain cowhide except for frame
covering, gussets, and partitions that are made of plastic but have the
appearance of leather may be described as: Top Grain Cowhide With
Plastic Frame Covering, Gussets and Partitions; or Top Grain Cowhide
With Gussets, Frame Covering and Partitions Made of Non-Leather
Material.
(2) An industry product made throughout, except for hardware, of
vinyl backed with cowhide may be described as: Vinyl Backed With
Cowhide (See also disclosure provision concerning use of backing
material in paragraph (c) of this section).
(3) An industry product made of top grain cowhide except for
partitions and stay, which are made of plastic-coated fabric but have
the appearance of leather, may be described as: Top Grain Cowhide With
Partitions and Stay Made of Non-leather Material; or Top Grain Cowhide
With Partitions and Stay Made of Plastic-Coated Fabric.
(f) Ground, pulverized, shredded, reconstituted, or bonded leather.
A material in an industry product that contains ground, pulverized,
shredded, reconstituted, or bonded leather and thus is not wholly the
hide of an animal should not be represented, directly or by
implication, as being leather. This provision does not preclude an
accurate representation as to the ground, pulverized, shredded,
reconstituted, or bonded leather content of the material. However, if
the material appears to be leather, it should be accompanied by either:
(1) An adequate disclosure as described by paragraph (a) of this
section; or
(2) If the terms ``ground leather,'' ``pulverized leather,''
``shredded leather,'' ``reconstituted leather,'' or ``bonded leather''
are used, a disclosure of the percentage of leather fibers and the
percentage of non-leather substances contained in the material. For
example: An industry product made of a composition material consisting
of 60% shredded leather fibers may be described as: Bonded Leather
Containing 60% Leather Fibers and 40% Non-leather Substances.
(g) Form of disclosures under this section. All disclosures
described in this section should appear in the form of a stamping on
the product, or on a tag, label, or card attached to the product, and
should be affixed so as to remain on or attached to the product until
received by the consumer purchaser. All such disclosures should also
appear in all advertising of such products irrespective of the media
used whenever statements, representations, or depictions appear in such
advertising which, absent such disclosures, serve to create a false
impression that the products, or parts thereof, are of a certain kind
of composition. The disclosures affixed to products and made in
advertising should be of such conspicuousness and clarity as to be
noted by purchasers and prospective purchasers casually inspecting the
products or casually reading, or listening to, such advertising. A
disclosure necessitated by a particular representation should be in
close conjunction with the representation.
Sec. 24.3 Misuse of the terms ``waterproof,'' ``dustproof,''
``warpproof,'' ``scuffproof,'' ``scratchproof,'' ``scuff resistant,''
and ``scratch resistant.''
It is unfair or deceptive to:
(a) Use the term ``Waterproof'' to describe all or part of an
industry product unless the designated product or material prevents
water from contact with its contents under normal conditions of
intended use during the anticipated life of the product or material.
(b) Use the term ``Dustproof'' to describe an industry product
unless the product is so constructed that when it is closed dust cannot
enter it.
(c) Use the term ``Warpproof'' to describe all or part of an
industry product unless the designated product or part is such that it
cannot warp.
(d) Use the term ``Scuffproof,'' ``Scratchproof,'' or other terms
indicating that the product is not subject to wear in any other
respect, to describe an industry product unless the outside surface of
the product is immune to scratches or scuff marks, or is not subject to
wear as represented.
(e) Use the term ``Scuff Resistant,'' ``Scratch Resistant,'' or
other terms indicating that the product is resistant to wear in any
other respect, unless there is a basis for the representation and the
outside surface of the product is meaningfully and significantly
resistant to scuffing, scratches, or to wear as represented.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 96-25358 Filed 10-2-96; 8:45 am]
BILLING CODE 6750-01-P
Complete official Federal Register PDF
FR Doc. 96-25282 Medicare and Medicaid Programs; New Payment Methodology for Routine Extended Care Services Provided in a Swing-Bed Hospital
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51611-51617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25282]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 413
[BPD-805-F]
RIN 0938-AG68
Medicare and Medicaid Programs; New Payment Methodology for
Routine Extended Care Services Provided in a Swing-Bed Hospital
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule revises the regulations governing the
methodology for payment of routine extended care services furnished in
a swing-bed hospital. Medicare payment for these services is determined
based on the average rate per patient day paid by Medicare for these
same services provided in freestanding skilled nursing facilities
(SNFs) in the region in which the hospital is located. The reasonable
cost for these services is the higher of the reasonable cost rates in
effect for the current calendar year or for the previous calendar year.
In addition, this final rule revises the regulations concerning the
method used to allocate hospital general routine inpatient service
costs for purposes of determining payments to swing-bed hospitals.
These changes are necessary to conform the regulations to section 1883
of the Social Security Act (the Act), and section 4008(j) of the
Omnibus Budget Reconciliation Act of 1990.
EFFECTIVE DATE: These regulations are effective on November 4, 1996.
FOR FURTHER INFORMATION CONTACT: John Davis (410) 786-0008.
SUPPLEMENTARY INFORMATION:
I. Background
Before the enactment of the Omnibus Budget Reconciliation Act of
1980 (Public Law 96-499), small rural hospitals had difficulty in
establishing separately identifiable units for Medicare and Medicaid
long-term care because of limitations in their physical plant and
accounting capabilities. These hospitals often had an excess of
hospital beds, while their communities had a scarcity of long-term care
beds in Medicare and Medicaid participating facilities. To alleviate
this problem, Congress enacted section 904 of Public Law 96-499, known
as the ``swing-bed provision,'' which authorized a cost-efficient means
of providing nursing home care in rural communities. This provision
added sections 1883 and 1913 of the Social Security Act (the Act),
under which certain rural hospitals with fewer than 50 beds could use
their inpatient facilities to furnish long-term care services to
Medicare and Medicaid patients. These hospitals were paid at rates that
were deemed appropriate for those services and were generally lower
than hospital rates. Medicare payment for routine SNF services was made
at the average Statewide Medicaid rate for the previous calendar year.
Payment for ancillary services was made based on reasonable cost.
[[Page 51612]]
On December 22, 1987, the Omnibus Budget Reconciliation Act of 1987
(OBRA 1987) (Public Law 100-203) was enacted. Section 4005(b) of OBRA
1987 amended section 1883(b)(1) of the Act to provide for an expansion
of the existing Medicare swing-bed program to include rural hospitals
with more than 49 but fewer than 100 beds, effective for swing-bed
agreements entered into after March 31, 1988. Although rural hospitals
having more than 49 beds but fewer than 100 beds can be swing-bed
hospitals, they are subject to additional payment limitations that do
not apply to the smaller swing-bed hospitals.
Also, sections 4201(a)(3), 4204, 4211(h)(9), and 4214 of OBRA 1987
provide that effective with services furnished on or after October 1,
1990, the terms ``skilled nursing facilities'' (SNFs) and
``intermediate care facilities'' (ICFs) are no longer to be used for
the purpose of certifying a facility for the Medicaid program. Instead,
they are replaced by the term ``nursing facility'' (NF). Thus, for
purposes of the Medicaid program, facilities are no longer certified as
ICFs but instead are certified only as NFs, and can provide services as
defined in section 1919(a)(1) of the Act. Effective October 1, 1990,
these long-term care services furnished by swing-bed hospitals to
Medicaid and to other non-Medicare patients have been referred to as
NF-type services.
On November 5, 1990, the Omnibus Budget Reconciliation Act of 1990
(OBRA 1990) (Public Law 101-508) was enacted. Section 4008(j) of OBRA
1990 amended section 1883(a)(2)(B)(ii)(II) of the Act to provide for a
new methodology to pay for routine SNF services provided in a swing-bed
hospital. Effective for services furnished on or after October 1, 1990,
Medicare payment for routine SNF services in a swing-bed hospital is
based on the average rate per patient day paid by Medicare for routine
services provided in freestanding SNFs in the region in which the
hospital is located. The rates are calculated using the regions as
defined in section 1886(d)(2)(D) of the Act.
Section 4008(j)(2) of OBRA 1990 also provides for a ``hold-harmless
harmless'' provision. Under this provision, if the reasonable cost of
routine SNF services furnished by a hospital during a calendar year is
less than the reasonable cost of these services determined for the
prior calendar year, payment is to be based on the reasonable cost
determination for the prior calendar year.
II. Provisions of the Proposed Rule
On April 22, 1996, we published a proposed rule in the Federal
Register (61 FR 17677), in which we included the following provisions.
New Payment Rate Methodology
We proposed to implement in regulations a revised methodology for
Medicare payment of routine SNF services provided in a swing-bed
hospital. Under the proposed rule, Medicare payment to a swing-bed
hospital for routine SNF services would be based on the average rate
per patient day paid by Medicare for routine SNF services provided in a
freestanding SNF in the region in which the hospital is located. These
rates would be determined prospectively based on the most current SNF
settled cost reporting data available (increased in a compounded
manner, using the increase applicable to the SNF routine cost limits,
up to and including the calendar year for which the rates are in
effect). Rates would be calculated using the regions as defined in
section 1886(d)(2)(D) of the Act (that is, one of the nine census
divisions established by the Bureau of the Census). Payment for
ancillary services furnished as SNF services in swing-bed hospitals
would continue to be paid on a reasonable cost basis.
We published the rates applicable to calendar years 1990 through
1994 (see below), which had been published in section 2231 of the
Provider Reimbursement Manual (HCFA Pub. 15-1). We stated our intent to
continue to publish annual updates in that manual.
We described the methodology for calculating the Medicare swing-bed
rates, and provided the rates for services furnished on or after
October 1, 1990, and before December 31, 1990, as well as for services
furnished in calendar years 1991, 1992, 1993, 1994, and 1995.
In accordance with section 4008(j)(2) of OBRA 1990, we also
proposed a hold-harmless provision for Medicare swing-bed payments. As
noted above, this provision would allow for payment of the higher of
the payment rate in effect for the current calendar year or the payment
rate received by the swing-bed hospital for the prior calendar year.
Development of Medicare Swing Bed Rates Effective for Services
Furnished on or after October 1, 1990 and before January 1, 1995
--Data--In developing the Medicare payment rates for swing-bed care, we
used the actual freestanding SNF inpatient routine service payments
obtained from settled Medicare cost reports. For fiscal years 1990-
1993, cost reports used were for periods ending on or after June 30,
1989 and through May 31, 1990; for 1994, cost reports used were for
periods ending on or after September 30, 1990 through August 31, 1991;
and for 1995, cost reports used were for periods ending on or after
October 31, 1992 through September 30, 1993. The data consist of
routine service payments that were adjusted for utilization review,
primary payor amounts, and application of lower of cost or charges. For
proprietary providers, the return on equity portion of the swing-bed
rate was adjusted to include only the routine portion (that is, the
return on equity component related to ancillary services costs was
removed).
HCFA adjusts these data, using the SNF market basket index (the
annual percent increase in SNF expenditures, considering inflation plus
an allowance for new technology) to inflate costs from the cost
reporting periods in the data base to the midpoint of the applicable
year to which the rates apply.
--Group Means--HCFA calculated the means of adjusted routine service
payments and the routine portion of return on equity for each census
region as shown in Tables A through D.
(We noted that effective October 1, 1993, section 13503(c) of the
Omnibus Budget Reconciliation Act of 1993 amended sections
1861(v)(1)(B) and 1878(f)(2) of the Act to eliminate return on equity
capital for SNF services furnished in a proprietary hospital. The
return on equity capital component was not added to the routine payment
rate for the months of October, November, and December of 1993 (Table
D) nor for any subsequent years.)
[[Page 51613]]
Table A.--Medicare Swing Bed Rates--for Services Furnished on or After
October 1, 1990 and Before December 31, 1990
------------------------------------------------------------------------
Routine Return on
Region payment equity \1\
------------------------------------------------------------------------
1. New England (CT, ME, MA, NH, RI, VT)....... $86.51 $1.42
2. Middle Atlantic (PA, NJ, NY)............... 86.39 1.27
3. South Atlantic (DE, DC, FL, GA, MD, NC, SC,
VA, WV)...................................... 75.28 1.48
4. East North Central (IL, IN, MI, OH, WI).... 75.03 1.18
5. East South Central (AL, KY, MS, TN)........ 65.79 1.21
6. West North Central (IA, KS, MN, MO, NB, ND,
SD).......................................... 74.09 1.34
7. West South Central (AR, LA, OK, TX)........ 67.85 1.87
8. Mountain (AZ, CO, ID, MT, NV, NM, UT, WY).. 81.32 1.47
9. Pacific (AK, CA, HI, OR, WA)............... 86.73 1.07
------------------------------------------------------------------------
\1\ The return of equity component is included only in the rate paid to
proprietary hospitals.
Table B.--Medicare Swing Bed Rates--for Services Furnished on or After
January 1, 1991 and Before December 31, 1991
------------------------------------------------------------------------
Routine Return on
Region payment equity \2\
------------------------------------------------------------------------
1. New England (CT, ME, MA, NH, RI, VT)....... $90.92 $1.42
2. Middle Atlantic (PA, NJ, NY)............... 90.73 1.27
3. South Atlantic (DE, DC, FL, GA, MD, NC, SC,
VA, WV)...................................... 79.03 1.28
4. East North Central (IL, IN, MI, OH, WI).... 78.78 1.18
5. East South Central (AL, KY, MS, TN)........ 69.14 1.21
6. West North Central (IA, KS, MN, MO, NB, ND,
SD).......................................... 77.83 1.34
7. West South Central (AR, LA, OK, TX)........ 71.22 1.87
8. Mountain (AZ, CO, ID, MT, NV, NM, UT, WY).. 85.34 1.47
9. Pacific (AK, CA, HI, OR, WA)............... 91.10 1.07
------------------------------------------------------------------------
\2\ The reutrn on equity component is included in the rate paid to
propriety hospitals.
Table C.--Medicare Swing Bed Rates--for Services Furnished on or After
January 1, 1992 and Before December 31, 1992
------------------------------------------------------------------------
Routine Return on
Region payment equity \3\
------------------------------------------------------------------------
1. New England (CT, ME, MA, NH, RI, VT)....... $95.10 $1.42
2. Middle Atlantic (PA, NJ, NY)............... 94.91 1.27
3. South Atlantic (DE, DC, FL, GA, MD, NC, SC,
VA, WV)...................................... 82.67 1.48
4. East North Central (IL, IN, MI, OH, WI).... 82.40 1.18
5. East South Central (AL, KY, MS, TN)........ 72.32 1.21
6. West North Central (IA, KS, MN, MO, NB, ND,
SD).......................................... 81.41 1.34
7. West South Central (AR, LA, OK, TX)........ 74.50 1.87
8. Mountain (AZ, CO, ID, MT, NV, NM, UT, WY).. 89.27 1.47
9. Pacific (AK, CA, HI, OR, WA)............... 95.29 1.07
------------------------------------------------------------------------
\3\ The return on equity component is included only in the rate paid to
proprietary hospitals.
Table D.--Medicare Swing Bed Rates--for Services Furnished on or After
January 1, 1993 and Before December 31, 1993
------------------------------------------------------------------------
Routine Return on
Region payment equity \4\
------------------------------------------------------------------------
1. New England (CT, ME, MA, NH, RI, VT)....... $100.05 $1.42
2. Middle Atlantic (PA, NJ, NY)............... 99.84 1.27
3. South Atlantic (DE, DC, FL, GA, MD, NC, SC,
VA, WV)...................................... 86.97 1.48
4. East North Central (IL, IN, MI, OH, WI).... 86.69 1.18
5. East South Central (AL, KY, MS, TN)........ 76.08 1.21
6. West North Central (IA, KS, MN, MO, NB, ND,
SD).......................................... 85.64 1.34
7. West South Central (AR, LA, OK, TX)........ 78.37 1.87
8. Mountain (AZ, CO, ID, MT, NV, NM, UT, WY).. 93.91 1.47
9. Pacific (AK, CA, HI, OR, WA)............... 100.24 1.07
------------------------------------------------------------------------
\4\ The return on equity component should be included in the rate paid
to proprietary hospitals only for the months of January through
September of this calendar year.
[[Page 51614]]
Table E.--Medicare Swing Bed Rates--for Services Furnished on or After
January 1, 1994 and Before December 31, 1994
------------------------------------------------------------------------
Routine
Region payment
------------------------------------------------------------------------
1. New England (CT, ME, MA, NH, RI, VT).................... $108.48
2. Middle Atlantic (PA, NJ, NY)............................ 104.33
3. South Atlantic (DE, DC, FL, GA, MD, NC, SC, VA, WV)..... 89.47
4. East North Central (IL, IN, MI, OH, WI)................. 88.76
5. East South Central (AL, KY, MS, TN)..................... 79.44
6. West North Central (IA, KS, MN, MO, NB, ND, SD)......... 83.84
7. West South Central (AR, LA, OK, TX)..................... 84.97
8. Mountain (AZ, CO, ID, MT, NV, NM, UT, WY)............... 100.11
9. Pacific (AK, CA, HI, OR, WA)............................ 104.58
------------------------------------------------------------------------
Table F.--Medicare Swing Bed Rates--for Services Furnished on or After
January 1, 1995 and Before December 31, 1995
------------------------------------------------------------------------
Routine
Region payment
------------------------------------------------------------------------
1. New England (CT, ME, MA, NH, RI, VT).................... $121.71
2. Middle Atlantic (PA, NJ, NY)............................ 117.28
3. South Atlantic (DE, DC, FL, GA, MD, NC, SC, VA, WV)..... 105.22
4. East North Central (IL, IN, MI, OH, WI)................. 105.73
5. East South Central (AL, KY, MS, TN)..................... 94.61
6. West North Central (IA, KS, MN, MO, NB, ND, SD)......... 99.75
7. West South Central (AR, LA, OK, TX)..................... 99.63
8. Mountain (AZ, CO, ID, MT, NV, NM, UT, WY)............... 117.21
9. Pacific (AK, CA, HI, OR, WA)............................ 125.80
------------------------------------------------------------------------
Table G.--Medicare Swing Bed Rates--for Services Furnished on or After
January 1, 1996 and Before December 31, 1996
------------------------------------------------------------------------
Routine
Region payment
------------------------------------------------------------------------
1. New England (CT, ME, MA, NH, RI, VT).................... $126.65
2. Middle Atlantic (PA, NJ, NY)............................ 121.74
3. South Atlantic (DE, DC, FL, GA, MD, NC, SC, VA, WV)..... 109.04
4. East North Central (IL, IN, MI, OH, WI)................. 109.51
5. East South Central (AL, KY, MS, TN)..................... 99.11
6. West North Central (IA, KS, MN, MO, NB, ND, SD)......... 103.38
7. West South Central (AR, LA, OK, TX)..................... 102.89
8. Mountain (AZ, CO, ID, MT, NV, NM, UT, WY)............... 121.31
9. Pacific (AK, CA, HI, OR, WA)............................ 130.62
------------------------------------------------------------------------
The Carve-Out Method
In a swing-bed hospital, acute care services and long-term care
services are furnished interchangeably. To determine payment for
inpatient hospital services in a swing-bed hospital, section 1883(e) of
the Act provides that the costs attributable to routine long-term care
(SNF-type and ICF-type) services for all classes of patients are to be
subtracted (``carved out'') from the total allowable inpatient cost for
general inpatient routine services. The resulting amount represents the
general inpatient routine costs applicable to hospital routine care.
Once amounts attributable to SNF-type and ICF-type services have been
carved out, the average per diem cost of general routine hospital
services for swing-bed hospitals not subject to the prospective payment
system is then determined by dividing the remaining amount by the total
number of inpatient general routine hospital days (excluding SNF days
and ICF days). This method was chosen to avoid imposing a burdensome
cost finding process to allocate general routine service costs between
hospital and long-term care.
Swing-bed hospitals subject to the prospective payment system (PPS)
are paid for SNF-type services in the same manner as any other swing-
bed hospital. The carve-out method would be used primarily to determine
proper payment of pass-through costs. The prospective payment rates
based on diagnosis related groups (DRGs) for inpatient hospital
services under PPS are unaffected by the carve-out method.
As stated above, with the enactment of OBRA 1987, effective October
1, 1990, the distinction between SNFs and ICFs was eliminated under the
Medicaid program and the two types of facility were combined under the
term ``nursing facility'' (NF). This presented a problem in attempting
to determine the amount of the carve-out. Since Medicaid payment is now
determined based on a NF rate, the carve-out method could not be used
as previously defined.
The proposed rule revised Sec. 413.53(a)(2) to set forth our
current policy regarding the carve-out method (presently explained in
section 2230.5B of the Provider Reimbursement Manual) for SNF and NF
services furnished on or after October 1, 1990. Under the revised
carve-out method, the reasonable cost of hospital routine services is
determined
[[Page 51615]]
by subtracting the reasonable costs attributable to routine SNF-type
and NF-type services from total inpatient routine service costs. For
swing-bed SNF days covered by Medicare, the amount subtracted, or
carved out, is based on the regional Medicare swing-bed SNF rate. If,
under the hold-harmless provision explained above, a swing-bed hospital
is paid based on the swing-bed SNF rate that was in effect during the
prior calendar year, that higher rate would also be used for purposes
of calculating the reasonable cost of routine Medicare SNF days, to be
subtracted from total routine costs under the carve-out method. For all
non-Medicare swing-bed days, the amount subtracted is based on the
average statewide rate paid for routine services in NFs under the State
Medicaid plan during the prior calendar year, adjusted to approximate
the average NF rate for the current calendar year. (The NF rate is used
for non-Medicare covered swing-bed days because such services may
encompass services that were formerly known as ICF and SNF-type
services.)
Definitions
As discussed above, effective for services furnished on or after
October 1, 1990, the terms SNFs and ICFs were no longer to be used for
the purpose of certifying a facility for the Medicaid program, in
accordance with the provisions of OBRA 1987. Instead, they were
replaced by the term ``nursing facility'' (NF). Effective October 1,
1990, extended care services furnished by swing-bed hospitals to
Medicaid and to other non-Medicare patients have been referred to as
NF-type services.
To reflect the above provisions, we are making changes to the
definitions in Sec. 413.53(b) by (1) Revising the definition of
``average cost per diem for general routine services''; (2) removing
the definition of ``ICF-type services;'' (3) adding a definition of
``nursing facility (NF)-type services;'' and (4) revising the
definition of ``SNF-type services.''
III. Analysis of and Responses to Public Comments
In response to the April 22, 1996 proposed rule, we received one
item of correspondence from the American Health Care Association. The
Association essentially supports the proposed rule in that it modifies
the regulations to conform with policies that have been in existence
since 1990, and that are contained in the Provider Reimbursement
Manual. However, the commenter points out that rural hospitals with
more than 49 beds but less than 100 beds are subject to an additional
payment limitation. The Medicare payment for SNF services by the
hospital may not be made for more than five days (excluding weekends
and holidays), after a bed in a SNF becomes available in the geographic
region, unless the patient's physician certifies within the five-day
period that the transfer is not medically appropriate. The commenter is
concerned that hospitals are not strictly adhering to the five-day
rule.
Response: We are not currently aware of any hospital that is
violating the five-day rule. However, the hospital is subject to a
periodic certification survey. It is during this survey that a sampling
of the records for swing-bed patients is examined to ensure that the
five-day rule is being followed correctly. Violators would endanger
their continued certification as a swing-bed facility.
In addition to this periodic certification survey, if someone is
aware that a hospital is violating the five-day rule, he or she can
contact the State Department of Licensure and Certification and request
that a complaint survey be done. A complaint survey is done within a
matter of weeks or months, which is much faster than the three to six
years that a periodic one takes.
IV. Provisions of the Final Regulations
This final rule incorporates the provisions of the proposed rule.
The rates applicable to calendar year 1996 were not published in the
proposed rule, but have been published in the Provider Reimbursement
Manual. For the convenience of the reader, we are including them as
Table G above in this final rule. Subsequent updates will be provided
in the Provider Reimbursement Manual.
V. Impact Statement
For final rules such as this, we generally prepare a regulatory
flexibility analysis that is consistent with the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 through 612). For purposes of a RFA, States and
individuals are not considered small entities. However, providers are
considered to be small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory flexibility analysis for any final rule that may have a
significant impact on the operations of a substantial number of small
rural hospitals. Such an analysis must conform to the provisions of
section 604 of the RFA. With the exception of hospitals located in
certain rural counties adjacent to urban ares, for purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area and has fewer
than 50 beds.
In accordance with the provisions of section 1883 of the Act, as
amended by section 4008(j) of OBRA 1990, this final rule revises the
regulations to incorporate a new methodology for payment of routine
extended care services provided in a swing-bed hospital. As the statute
specifies, Medicare payment for these services is determined based on
the average rate per patient day paid by Medicare for these same
services provided in freestanding skilled nursing facilities (SNFs) in
the region in which the hospital is located, during the most recent
year for which cost reporting data are available. This final rule also
provides that the reasonable cost for these services is the higher of
the reasonable cost rates in effect for the current calendar year or
for the previous calendar year.
In addition to the changes mandated by section 4008(j) of OBRA 1990
regarding payment for routine extended care services, we are changing
to the out method of determining routine inpatient hospital costs of
swing-bed hospitals. As discussed above, with the enactment of OBRA
1987, the distinction between SNFs and ICFs was eliminated under the
Medicaid program. Thus, the carve-out out method as described in
Sec. 413.53(a)(2) for computing costs associated with routine SNF and
ICF-type services cannot be used. This final rule codifies in
regulations existing policy concerning the carve-out out method as set
forth in section 2230.5B of the Provider Reimbursement Manual.
As noted above, the major provisions of this final rule are
required by section 1883 of the Act, as amended by section 4008(j) of
OBRA 1990. Thus, a majority of the costs associated with these final
rules are the result of legislation, and this rule, in and of itself,
has little or no independent effect or burden. Although we are unable
to provide a quantifiable estimate of impact, we note that the only
discretionary aspect of this rule is to set forth in regulations our
current policy concerning the carve-out out method. Codifying this
existing policy would have no economic impact.
Thus, we have determined, and we certify, that this final rule does
not have a significant impact on the operations of a substantial number
of small entities or on small rural hospitals. Therefore, we have not
prepared a regulatory flexibility analysis or an analysis of the
effects of this rule on small rural hospitals.
[[Page 51616]]
In accordance with the provisions of Executive Order 12866, this
final rule was not reviewed by the Office of Management and Budget.
This is not a major rule as defined by U.S.C. 804(2).
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
List of Subjects in 42 CFR Part 413
Health facilities, Kidney diseases, Medicare, Puerto Rico,
Reporting and recordkeeping requirements.
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES
1. The authority citation for part 413 continues to read as
follows:
Authority: Secs. 1102, 1861(v)(1)(A), and 1871 of the Social
Security Act (42 U.S.C. 1302, 1395x(v)(1)(A), and 1395hh).
Subpart D--Apportionment
2. Section 413.53 is amended by revising paragraph (a)(1)(ii)(C)
and (a)(2); under paragraph (b), definition of ``average cost per diem
for general routine services'', paragraph (2) is revised; the
definition of ``ICF-type services'' is removed; a new definition of
``nursing facility (NF) type services'' is added; and the definition of
``SNF-type services'' is revised, to read as follows:
Sec. 413.53 Determination of cost of services to beneficiaries.
(a) Principle. * * *
(1) Departmental method
* * * * *
(ii) Exception: Indirect cost of private rooms. For cost reporting
periods starting on or after October 1, 1982, except with respect to a
hospital receiving payment under part 412 of this chapter (relating to
the prospective payment system), the additional cost of furnishing
services in private room accommodations is apportioned to Medicare only
if these accommodations are furnished to program beneficiaries, and are
medically necessary. To determine routine service cost applicable to
beneficiaries--
* * * * *
(C) Effective October 1, 1990, do not include private rooms
furnished for SNF-type and NF-type services under the swing-bed
provision in the number of days in paragraphs (a)(1)(ii)(A) and (B) of
this section.
(2) Carve-out out method--(i) The carve-out out method is used to
allocate hospital inpatient general routine service costs in a
participating swing-bed hospital, as defined in Sec. 413.114(b). Under
this method, effective for services furnished on or after October 1,
1990, the reasonable costs attributable to the inpatient routine SNF-
type and NF-type services furnished to all classes of patients are
subtracted from total inpatient routine service costs before computing
the average cost per diem for inpatient routine hospital care.
(ii) The cost per diem attributable to the routine SNF-type
services covered by Medicare is based on the regional Medicare swing-
bed SNF rate in effect for a given calendar year, as described in
Sec. 413.114(c). The Medicare SNF rate applies only to days covered and
paid as Medicare days. When Medicare coverage runs out, the Medicare
rate no longer applies.
(iii) The cost per diem attributable to all non-Medicare swing-bed
days is based on the average statewide Medicaid NF rate for the prior
calendar year, adjusted to approximate the average NF rate for the
current calendar year.
(iv) The sum of total Medicare SNF-type days multiplied by the cost
per diem attributable to Medicare SNF-type services and the total NF-
type days multiplied by the cost per diem attributable to all non-
Medicare days is subtracted from total inpatient general routine
service costs. The cost per diem for inpatient routine hospital care is
computed based on the remaining inpatient routine service costs.
* * * * *
(b) Definitions. As used in this section--
* * * * *
Average cost per diem for general routine services means the
following:
* * * * *
(2) For swing-bed hospitals, the amount computed by--(i)
Subtracting the routine costs associated with Medicare SNF-type days
and non-Medicare NF-type days from the total allowable inpatient cost
for routine services (excluding the cost of services provided in
intensive care units, coronary care units, and other intensive care
type inpatient hospital units and nursery costs); and
(ii) Dividing the remainder (excluding the total private room cost
differential) by the total number of inpatient hospital days of care
(excluding Medicare SNF-type days and non-Medicare NF-type days of
care, days of care in intensive care units, coronary care units, and
other intensive care type inpatient hospital units; and newborn days;
but including total private room days).
* * * * *
Nursing facility (NF)-type services, formerly known as ICF and SNF-
type services, are routine services furnished by a swing-bed hospital
to Medicaid and other non-Medicare patients. Under the Medicaid
program, effective October 1, 1990, facilities are no longer certified
as SNFs or ICFs but instead are certified only as NFs and can provide
services as defined in section 1919(a)(1) of the Act.
* * * * *
Skilled nursing facility (SNF)-type services are routine services
furnished by a swing-bed hospital that would constitute extended care
services if furnished by an SNF. SNF-type services include routine SNF
services furnished in the distinct part SNF of a hospital complex that
is combined with the hospital general routine service area cost center
under Sec. 413.24(d)(5). Effective October 1, 1990, only Medicare
covered services are included in the definition of SNF-type services.
* * * * *
Subpart F--Specific Categories of Costs
3. In Sec. 413.114, paragraphs (c)(1) and (2) are removed,
paragraph (c)(3) is redesignated as paragraph (c)(2), and a new
paragraph (c)(1) is added to read as follows:
Sec. 413.114 Payment for posthospital SNF care furnished by a swing-
bed hospital.
* * * * *
(c) Principle. The reasonable cost of posthospital SNF care
furnished by a swing-bed hospital is determined as follows:
(1) The reasonable cost of routine SNF services is based on the
average Medicare rate per patient day for routine services provided in
freestanding SNFs in the region where the swing-bed hospital is
located. The rates are calculated using the regions as defined in
section 1886(d)(2)(D) of the Social Security Act. The rates are based
on the most recent year for which settled cost reporting period data
are available, increased in a compounded manner, using the increase
applicable to the SNF routine cost limits, up to and including the
calendar year for which the rates are in effect. If the current
Medicare swing-bed rate for routine extended care services furnished by
a swing-bed
[[Page 51617]]
hospital during a calendar year is less than the rate for the prior
calendar year, payment is made based on the prior calendar year's rate.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance;) Catalog of Federal Domestic
Assistance Program No. 93.778, Medical Assistance Program)
Dated: September 3, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 96-25282 Filed 10-2-96; 8:45 am]
BILLING CODE 4120-01-P
Complete official Federal Register PDF
FR Doc. 96-25280 Kiwifruit Grown in California; Reduction of Reporting Requirements
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51575-51577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25280]
========================================================================
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. 193 / Thursday, October 3, 1996 /
Rules and Regulations
[[Page 51575]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 920
[Docket No. FV96-920-3 IFR]
Kiwifruit Grown in California; Reduction of Reporting
Requirements
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Interim final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: This interim final rule reduces the reporting requirements for
California kiwifruit handlers who ship less than 10,000 trays or tray
equivalents per fiscal year. The changes in reporting requirements were
unanimously recommended by the Kiwifruit Administrative Committee
(Committee), the agency responsible for the local administration of the
Federal marketing order for kiwifruit grown in California. This interim
final rule decreases the reporting burden on such handlers while
maintaining the information collection necessary for the efficient
operation of the program.
DATES: Effective October 4, 1996; comments received by November 4, 1996
will be considered prior to issuance of a final rule.
ADDRESSES: Interested persons are invited to submit written comments
concerning this rule. Comments must be sent in triplicate to the Docket
Clerk, Fruit and Vegetable Division, AMS, USDA, room 2525-S, P.O. Box
96456, Washington, DC 20090-6456, Fax # (202) 720-5698. All comments
should reference the docket number and the date and page number of this
issue of the Federal Register and will be made available for public
inspection in the Office of the Docket Clerk during regular business
hours. Small businesses may request information on compliance with this
regulation by contacting: Jay Guerber, Marketing Order Administration
Branch, Fruit and Vegetable Division, AMS, USDA, P.O. Box 96456, room
2523-S, Washington, DC 20090-6456; telephone (202) 720-2491, Fax #
(202) 720-5698.
FOR FURTHER INFORMATION CONTACT: Kurt J. Kimmel, California Marketing
Field Office, Marketing Order Administration Branch, F&V, AMS, USDA,
2202 Monterey Street, suite 102B, Fresno, California 93721; telephone:
(209) 487-5901, Fax # (209) 487-5906; or Charles L. Rush, Marketing
Specialist, Marketing Order Administration Branch, F&V, AMS, USDA, room
2522-S, P.O. Box 96456, Washington, DC 20090-6456; telephone: (202)
720-5127, Fax # (202) 720-5698.
SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Order
No. 920 (7 CFR part 920), as amended, regulating the handling of
kiwifruit grown in California, hereinafter referred to as the
``order.'' This order is effective under the Agricultural Marketing
Agreement Act of 1937, as amended (7 U.S.C 601-674), hereinafter
referred to as the ``Act.''
The Department of Agriculture (Department) is issuing this rule in
conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule is not intended to have retroactive effect.
This rule will not preempt any State or local laws, regulations, or
policies, unless they present an irreconcilable conflict with this
rule.
The Act provides that administrative proceedings must be exhausted
before parties may file suit in court. Under section 608c(15)(A) of the
Act, any handler subject to an order may file with the Secretary a
petition stating that the order, any provision of the order, or any
obligation imposed in connection with the order is not in accordance
with law and request a modification of the order or to be exempted
therefrom. A handler is afforded the opportunity for a hearing on the
petition. After the hearing the Secretary would rule on the petition.
The Act provides that the district court of the United States in any
district in which the handler is an inhabitant, or has his or her
principal place of business, has jurisdiction to review the Secretary's
ruling on the petition, provided an action is filed not later than 20
days after date of the entry of the ruling.
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA), the Agricultural Marketing Service (AMS) has considered the
economic impact of this action on small entities.
The purpose of the RFA is to fit regulatory actions to the scale of
business subject to such actions in order that small businesses will
not be unduly or disproportionately burdened. Marketing orders issued
pursuant to the Act, and rules issued thereunder, are unique in that
they are brought about through group action of essentially small
entities acting on their own behalf. Thus, both statutes have small
entity orientation and compatibility.
There are approximately 65 handlers of kiwifruit who are subject to
regulation under the marketing order and approximately 500 producers of
kiwifruit in the regulated area. Small agricultural service firms have
been defined by the Small Business Administration (13 CFR 121.601) as
those having annual receipts of less than $5,000,000, and small
agricultural producers are defined as those whose annual receipts are
less than $500,000. The majority of kiwifruit handlers and producers
may be classified as small entities. Interested persons are invited to
submit information on the regulatory and informational impacts of this
action on small businesses.
This rule reduces the number of reports required to be filed by
small kiwifruit handlers (those who handle less than 10,000 tray
equivalents per year). The decrease in the number of reports required
to be filed does not inhibit the effective operation of the order. It
is estimated that less than 100,000 tray equivalents would be shipped
by those eligible for the reduced reporting requirement, or
approximately one percent of California kiwifruit production. A
majority of these small volume handlers, eligible for the reduced
reporting requirement, sell fruit for two to five growers. Generally,
kiwifruit shipments are small and may consist of less than 50 trays at
a time. Shipment information from these small volume handlers will be
added into the total shipments at the end of each fiscal year. The lack
of shipment information that will be provided by these handlers on a
monthly basis is insignificant. The Committee is still able to levy
[[Page 51576]]
assessments on those handlers eligible for the reduced reporting
requirement based on the information in the shipment reports that is
still required twice per season.
This rule directly benefits small kiwifruit handlers. It is
anticipated that approximately 20 of the 65 handlers are eligible for
the reduced reporting burden authorized by this rule. The range of
volume of kiwifruit handled by kiwifruit handlers is extremely broad
with some handlers handling as few as 50 tray equivalents and others
over 1 million tray equivalents. The majority of handlers fall in the
middle and on average ship between 100,000 and 800,000 tray
equivalents.
Based on available information, the AMS has determined that this
action will not have a significant economic impact on a substantial
number of small entities.
Under the terms of the order, fresh market shipments of California
kiwifruit are required to be inspected and are subject to grade, size,
maturity, and pack and container requirements. In addition, the order
authorizes the Committee to collect information from kiwifruit handlers
in order to efficiently operate the program.
The Committee met on June 12, 1996, and unanimously recommended
reducing the reporting burden for handlers who ship less than 10,000
tray equivalents per season. Such handlers, if they qualified with the
committee, will no longer be required to complete biweekly inventory
reports and will only be required to fill out a monthly shipment report
twice per year.
Section 920.60 of the order authorizes the Committee, subject to
the approval of the Secretary, to request information from handlers
necessary to perform its duties under the order. Section 920.160(a) of
the order's rules and regulations requires a report of shipments to be
filed with the Committee by the fifth day of the month following such
shipment, or such other later time established by the Committee. This
report is used to compile statistical information on shipments and to
calculate assessments owed under the marketing order. Pursuant to
Sec. 920.160(b) each handler must file a Kiwifruit Inventory Shipment
System (KISS) report on the fifth and twentieth day of each month. The
information collected in the KISS report is used to track inventories
of California kiwifruit and provide inventory statistics, in aggregate,
to the industry. Both of these reports are also required under the
authority of the California Kiwifruit Commission (State Commission),
which administers a State program.
Prior to the 1995-96 season, the State Commission determined that
the reporting burden of the KISS report and the shipment report was
disproportionately impacting small volume handlers. As a result, the
State Commission created an alternate reporting system, known as
``Reporting EZ.'' It allows handlers who ship less than 10,000 tray
equivalents per season to file the shipment report twice per season
instead of monthly and exempts handlers from filing the KISS report.
Similarly, this rule reduces the frequency that the shipment report
is filed and eliminates the filing of a KISS report for those handlers
that ship less than 10,000 trays or tray equivalents per fiscal year so
that the ``Reporting EZ'' program is authorized under both the State
program and the Federal order. Handlers shipping under 10,000 trays or
tray equivalents per season will only have to fill out the shipment
report twice per year. The first report is due January 5 or such other
later time established by the Committee and includes information on
fresh shipments from the beginning of the fiscal year (August 1 through
December 31). The second shipment report is due the fifth day of the
month following each handler's last shipment for the season and
includes shipments from January 1 until the end of shipping season.
In order for a handler to qualify for the ``Reporting EZ'' program,
the Committee must make a determination prior to October 31 (near the
beginning of the shipping season). The information that the Committee
will use to determine whether a handler is qualified is available from
the State Commission. The State Commission already requires handlers to
submit information in order to determine whether a handler intends to
ship under 10,000 tray equivalents per year. Thus, the Committee will
not need to place any additional reporting burden on kiwifruit handlers
in order to determine handler eligibility for the ``Reporting EZ''
program. The State Commission and the Committee have a written
memorandum of understanding that provides for the sharing of
information while keeping proprietary information confidential. Once
the handler has qualified, the Committee will then notify handlers that
they are eligible for the ``Reporting EZ'' program.
The information collection requirements contained in the referenced
sections have been previously approved by the Office of Management and
Budget (OMB) under the provisions of the Paperwork Reduction Act (Pub.
L. 104-13) and have been assigned OMB number 0581-0149.
This rule reduces the reporting burden on approximately 20 handlers
of kiwifruit who have been spending approximately 240 hours completing
the shipment reports and the KISS reports.
This rule invites comments on a reduction in the reporting
requirements currently prescribed under the California kiwifruit
marketing order. Any comments received will be considered prior to
finalization of this rule.
After consideration of all relevant material presented, the
information and recommendation submitted by the Committee, and other
information, it is found that this interim final rule will tend to
effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined upon good
cause that it is impracticable, unnecessary, and contrary to the public
interest to give preliminary notice prior to putting this rule into
effect and that good cause exists for not postponing the effective date
of this rule until 30 days after publication in the Federal Register
because: (1) This rule relaxes the reporting requirements under the
marketing order and should be implemented prior to the shipping season
which begins October 1; (2) the Committee unanimously recommended these
changes at a public meeting and interested parties had an opportunity
to provide input; and (3) this rule provides a 30-day comment period
and any comments received will be considered prior to finalization of
this rule.
List of Subjects in 7 CFR Part 920
Kiwifruit, Marketing agreements, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, 7 CFR part 920 is
amended as follows:
PART 920--KIWIFRUIT GROWN IN CALIFORNIA
1. The authority citation for 7 CFR part 920 continues to read as
follows:
Authority: 7 U.S.C. 601-674.
2. In Sec. 920.160 paragraphs (a) and (b) introductory text are
revised to read as follows:
Sec. 920.160 Reports.
(a) When requested by the Kiwifruit Administrative Committee, each
shipper who ships kiwifruit, shall furnish a report of shipment and
inventory data to the committee no later than the fifth day of the
month following such shipment, or such other later time established by
[[Page 51577]]
the committee: Provided, That each shipper who ships less than 10,000
trays, or the equivalent thereof, per fiscal year and has qualified
with the committee shall furnish such report of shipment and inventory
data to the committee twice per fiscal year. The first report shall be
due no later than January 5 and the final report no later than the
fifth day of the following month after such shipment is completed for
the season, or such other later times established by the committee.
Such report shall show:
(1) The reporting period;
(2) the name and other identification of the shipper;
(3) the number of containers by type and weight by shipment
destination category;
(4) inventory at the end of the reporting period by container, and
with respect to flats, the size of the kiwifruit;
(5) the amount of kiwifruit lost in repack; and
(6) the amount of fruit set aside for processing.
(b) Kiwifruit Inventory Shipping System (KISS) form. Each handler,
except such handlers that ship less than 10,000 trays, or the
equivalent thereof, per season and have qualified with the committee,
shall file with the committee the initial Kiwifruit Inventory Shipment
System (KISS) form, which consists of three sections ``KISS/Add
Inventory,'' ``KISS/Deduct Inventory,'' and ``KISS/Shipment,'' on or
before December 5th, or such other later time as the committee may
establish.
* * * * *
Dated: September 27, 1996.
Sharon Bomer Lauritsen,
Acting Director, Fruit and Vegetable Division.
[FR Doc. 96-25280 Filed 10-2-96; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-25276 Permanent Replacement of Lawfully Striking Employees by Federal Contractors
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51596-51597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25276]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Office of Labor-Management Programs
29 CFR Part 270
RIN 1294-AA15
Permanent Replacement of Lawfully Striking Employees by Federal
Contractors
AGENCY: Office of Labor-Management Programs, Labor.
ACTION: Final rule; removal of regulations.
-----------------------------------------------------------------------
SUMMARY: This final rule removes the regulations found at 29 CFR Part
270. Those regulations implemented Executive Order 12954, which was
signed by President Clinton on March 8, 1995 (60 FR 13023, March 10,
1995). Executive Order 12954 provided that federal contracting agencies
may not contract with employers that permanently replace lawfully
striking employees in some situations. The regulations are being
removed as a result of a ruling by the Court of Appeals for the
District of Columbia Circuit voiding Executive Order 12954.
EFFECTIVE DATE: October 3, 1996.
FOR FURTHER INFORMATION CONTACT: Kay H. Oshel, Chief, Division of
Interpretations and Standards, Office of Labor-Management Standards,
U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5605,
Washington, DC 20210, (202) 219-7373. This is not a toll-free number.
SUPPLEMENTARY INFORMATION: On March 8, 1995, President Clinton signed
Executive Order 12954, ``Ensuring the Economical and Efficient
Administration and Completion of Federal Government Contracts'' (60 FR
13023, March 10, 1995). The Order set forth the finding that economy
and efficiency in procurement are generally advanced by contracting
with employers that do not permanently replace lawfully striking
employees, and provided that federal contracting agencies may not
contract with employers that permanently replace lawfully striking
employees in some situations.
The Secretary of Labor was assigned the authority and
responsibility for administering the Order and for issuing implementing
regulations. The Secretary delegated that authority and responsibility
to the Assistant Secretary for the American Workplace on March 8, 1995
(60 FR 13602, March 13, 1995) and to Acting Deputy Assistant Secretary
John Kotch on June 16, 1996 (61 FR 31164, June 19, 1996).
[[Page 51597]]
On March 29, 1995, proposed regulations implementing Executive
Order 12954 were published in the Federal Register (60 FR 16354). A
final rule was issued on May 25, 1995 (60 FR 27856).
On February 2, 1996, the Court of Appeals for the District of
Columbia Circuit issued a decision voiding Executive Order 12954,
Chamber of Commerce of the United States, et al, v. Reich, 74 F.3d 1322
(D.C. Cir. 1996). A rehearing was denied on May 10, 1996, 83 F.3d 442
(D.C. Cir. 1996). A petition for review on writ of certiorari was not
filed with the Supreme Court. Consequently, the Department is removing
the regulations implementing Executive Order 12954, 29 CFR Part 270.
Publication in Final
The Department has determined that the removal of these regulations
need not be published as a proposed rule, as generally required by the
Administrative Procedure Act (APA), 5 U.S.C. 553. The agency finds that
good cause exists for dispensing with notice and public comment as
unnecessary since Executive Order 12954, which gave rise to Part 270,
has been held to be void by the Court of Appeals for the District of
Columbia Circuit. The removal of the implementing regulations is thus
exempt from notice and comment by virtue of section 553(b)(B) of the
APA (5 U.S.C. 553(b)(B)).
Effective Date
This document will become effective upon publication pursuant to 5
U.S.C. 553(d). The Department has determined that good cause exists for
waiving the customary requirement to delay the effective date of a
final rule for 30 days following its publication. This determination is
based upon the fact that Executive Order 12954, which gave rise to Part
270, has been held to be void by the Court of Appeals for the District
of Columbia Circuit.
Executive Order 12866
This document removes regulations for which there is now no
authority and, therefore, is not a regulation or a rule as defined in
section 2(d) of Executive Order 12866, 58 FR 51735 (October 4, 1993).
Regulatory Flexibility Act
This rule was not preceded by a general notice of proposed
rulemaking and is not a rule as defined in the Regulatory Flexibility
Act (5 U.S.C. 601(2) and 604(a)).
Paperwork Reduction Act
This rule contains no information collection requirements which are
subject to review and approval by the Office of Management and Budget
under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501-3520).
Small Business Regulatory Enforcement Fairness Act
The Department has determined that this final rule is not a ``major
rule'' requiring prior approval by the Congress and the President
pursuant to the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 804), because it is not likely to result in (1) an
annual effect on the economy of $100 million or more, (2) a major
increase in costs or prices for consumers, individual industries,
Federal, State, or local government agencies, or geographic regions, or
(3) significant adverse effects on competition, employment, investment,
productivity, innovation, or the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic and
export markets.
Further, since the Department has determined, for good cause, that
publication of a proposed rule and solicitation of comments on this
rule removing 29 CFR Part 270 is not necessary, under 5 U.S.C. 808(2),
this final rule is effective immediately upon publication as stated
previously in this notice.
Unfunded Mandates Reform Act
For purposes of Section 2 of the Unfunded Mandates Reform Act of
1995, 2 U.S.C. 1532, as well as Executive Order 12875, (58 FR 58093,
October 28, 1993), this rule does not include any federal mandate that
may result in increased expenditures by State, local and tribal
governments, or increased expenditures by the private sector of more
than $100 million.
List of Subjects in 29 CFR Part 270
Administrative practice and procedure; Government contracts;
Federal contractors and subcontractors.
Accordingly, Chapter II of Title 29 of the Code of Federal
Regulations is amended by removing Part 270.
Signed at Washington, DC, this 27th day of September, 1996.
John Kotch,
Acting Deputy Assistant Secretary.
[FR Doc. 96-25276 Filed 10-2-96; 8:45 am]
BILLING CODE 4510-86-P
Complete official Federal Register PDF
FR Doc. 96-25261 Listing of Color Additives for Coloring Contact Lenses; 1,4- Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51584-51587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25261]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. 91C-0189]
Listing of Color Additives for Coloring Contact Lenses; 1,4-
Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester
copolymers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the color
additive regulations to provide for the safe use of the colored
reaction products formed by copolymerizing 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester either
with glyceryl methacrylate/methyl methacrylate/ethylene glycol
dimethacrylate monomers or with N, N-dimethyl acrylamide/methyl
methacrylate/ethylene glycol dimethacrylate monomers to form contact
lenses. This action is in response to a petition filed by Sola/Barnes-
Hind.
DATES: Effective November 5, 1996, except as to any provisions that may
be stayed by the filing of proper objections; written objections and
requests for a hearing by November 4, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration,
[[Page 51585]]
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Helen R. Thorsheim, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3092.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notice published in the Federal Register of June 14, 1991 (56
FR 27518), FDA announced that a color additive petition (CAP 0C0226)
had been filed by Sola/Barnes-Hind (now Pilkington Barnes Hind), 810
Kifer Rd., Sunnyvale, CA 94086-5200. The petition proposed that the
color additive regulations be amended in 21 CFR part 73 to provide for
the safe use of 1,4-bis[(2-methacryloxyethylamino)-9,10-anthraquinone
to color contact lenses prepared with glyceryl methacrylate/methyl
methacrylate/ethylene glycol dimethacrylate copolymer and N, N-dimethyl
acrylamide/methyl methacrylate/ethylene glycol dimethacrylate
copolymer. The petition was filed under section 706(d)(1) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 376(d)(1)),
presently section 721(d)(1) of the act (21 U.S.C. 379e(d)(1)). The
agency has subsequently determined that 1,4-bis[(2-
methacryloxyethylamino)-9,10-anthraquinone is more appropriately
identified as 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione
bis(2-propenoic)ester and that the color additives are the colored
reaction products formed by copolymerizing 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester either
with glyceryl methacrylate, methyl methacrylate, and ethylene glycol
dimethacrylate monomers, or with N, N-dimethyl acrylamide, methyl
methacrylate, and ethylene glycol dimethacrylate monomers.
II. Applicability of the Act
With the passage of the Medical Device Amendments of 1976 (Pub. L.
94-295), Congress mandated the listing of color additives for use in
medical devices when the color additive comes in direct contact with
the body for a significant period of time (21 U.S.C. 379e(a)). The use
of the reaction products of 1,4-bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester either with glyceryl
methacrylate, methyl methacrylate, and ethylene glycol dimethacrylate
monomers, or with N, N-dimethyl acrylamide, methyl methacrylate, and
ethylene glycol dimethacrylate monomers as color additives in
manufacturing contact lenses is subject to this listing requirement.
The color additives are formed into contact lenses in such a way that
at least some of the color additives will come in contact with the eye
when the lenses are worn. In addition, the lenses are intended to be
placed on the eye for several hours a day, each day, for 1 year or
more. Thus, the color additives will be in direct contact with the body
for a significant period of time. Consequently, the use of the color
additives currently before the agency is subject to the statutory
listing requirement.
III. Identity
The color additives are produced by copolymerizing 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester (CAS
Reg. No. 109561-07-1) either with glyceryl methacrylate, methyl
methacrylate, and ethylene glycol dimethacrylate monomers, or with N,
N-dimethyl acrylamide, methyl methacrylate, ethylene glycol
dimethacrylate monomers. The resulting copolymeric product is formed
into a contact lens.
IV. Safety Evaluation
The agency believes that because 1,4-bis[(2-hydroxyethyl)amino]-
9,10-anthracenedione bis(2-propenoic)ester has a significantly lower
molecular weight than the subject copolymer, it would be the compound
most likely to migrate out of the lens into the ocular fluid and would
also be more readily absorbed into the body than the subject copolymer
and would thus be expected to show a greater toxic effect. Therefore,
the safety evaluation of the subject color additives focused on
exposure to unreacted 1,4-bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester.
FDA concludes, from the data submitted in the petition and from
other relevant information, that the average daily exposure to 1,4-
bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester
from these petitioned uses in contact lenses would be no greater than
0.61 nanograms per person per day (ng/p/d). The agency-calculated upper
limit was based on two factors. First, the maximum use level
anticipated by the petitioner is 140 parts per million (ppm) of the
lens material or 11 micrograms (g) of 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester per
contact lens (Ref. 1). Second, the agency made two assumptions: (1) The
user will replace these lenses once each year with a new pair of
identical lenses; and (2) one percent of the 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester will
migrate from the lenses into the eyes over the 1-year period (Ref. 2).
Because these assumptions are conservative estimates, exposure to 1,4-
bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester
from these uses is likely to be less than 0.61 ng/p/d (Ref. 2).
To establish the safety of the subject additive, the petitioner
conducted toxicity studies with 1,4-bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester, colored lenses, and colored lens
extracts. Studies submitted included 27 in vitro cytotoxicity studies:
4 by the inhibition of cell growth method (with lens extracts and 1,4-
bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester),
4 by the agar overlay method (with lens), and 19 by the direct-contact
method using mouse fibroblast cells (with lens, lens extracts and neat
1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-
propenoic)ester). Both the lenses and lens extracts were found to be
noncytotoxic to mouse fibroblast cells. In addition, two guinea pig
maximization studies (Magnusson and Kligman) with lens extracts, two
72-hour ocular irritation studies with lens extracts in rabbits, one
intracutaneous skin reaction test with lens extracts in rabbits, two
acute systemic toxicity tests with lens extracts in mice, and four
ocular irritation studies with lenses in rabbits were submitted. The
most relevant tests for a color that is bound covalently to a contact
lens are those that compare colored to noncolored lenses in the rabbit
ocular irritation tests. These studies demonstrated no evidence of
ocular irritation or an allergic response in the test animals. The
maximum nontoxic concentration for 1,4-bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester was determined to be 140
g/milliliter (mL) by the ocular irritation tests.
To relate the 140 g/mL nontoxic level, established in the
ocular irritation tests, to the 0.61 ng/p/d exposure from wearing the
colored lenses, the agency calculated the maximum concentration level
of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-
propenoic)ester in each eye that would result from the use of the
contact lens. The agency estimated that the daily exposure to 1,4-
bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester
in each eye would be 0.30 ng and that
[[Page 51586]]
this would be diluted by the average daily tear film of 1.2 mL produced
in each eye. This concentration is equal to a maximum daily
concentration in the tear flow of the eye of 0.25 ng/mL, and represents
a more than a 55,000 fold safety factor for this proposed use of 1,4-
bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester,
when compared to the non-toxic level established in the ocular
irritation test.
Based upon the available toxicity data, the small amount of 1,4-
bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester
used to form the color additive in the contact lenses, and the agency's
exposure calculation for 1,4-bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester, FDA finds that the reaction
products formed by copolymerizing 1,4-bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester either with glyceryl
methacrylate, methyl methacrylate, and ethylene glycol dimethacrylate
monomers, or with N, N-dimethyl acrylamide, methyl methacrylate, and
ethylene glycol dimethacrylate monomers are safe for use as color
additives in contact lenses. FDA further concludes that the safety
margin is sufficiently large that no limitation is required beyond the
usual limitation that reactants may be used in amounts not to exceed
the minimum reasonably required to accomplish the intended technical
effect. Batch certification is not required to ensure safety.
V. Conclusions
Based on data contained in the petition and other relevant
material, FDA concludes that there is a reasonable certainty that no
harm will result from the petitioned use of the reaction products
formed by copolymerizing 1,4-bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester either with glyceryl
methacrylate, methyl methacrylate, and ethylene glycol dimethacrylate
monomers, or with N, N-dimethyl acrylamide, methyl methacrylate,
ethylene glycol dimethacrylate monomers to form colored contact lenses,
and that the color additives are safe and suitable for their intended
use.
VI. Inspection of Documents
In accordance with Sec. 71.15 (21 CFR 71.15), the petition and the
documents that FDA considered and relied upon in reaching its decision
to approve the petition are available for inspection at the Center for
Food Safety and Applied Nutrition (address above) by appointment with
the information contact person under the ``For Further Information
Contact'' section of this document. As provided in Sec. 71.15, the
agency will delete from the documents any materials that are not
available for public disclosure before making the documents available
for inspection.
VII. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
VIII. Objections
Any person who will be adversely affected by this regulation may at
any time on or before November 4, 1996, file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered, and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection on which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for which a hearing is requested shall include
a detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish
notice of the objections that the agency has received or lack thereof
in the Federal Register.
IX. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum from the Chemistry Review Branch to the Indirect
Additives Branch, ``CAP 0C0226 (MATS# 494, M2.3, 2.4, and 2.5): Sola
Barnes Hind submissions dated 8-19-92, 10-5-92, and 1-25-93. BMAQ as
a colorant in contact lenses,'' dated June 28, 1993.
2. Memorandum of meeting dated August 19, 1994.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
73 is amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
1. The authority citation for 21 CFR part 73 continues to read as
follows:
Authority: Secs. 201, 401, 402, 403, 409, 501, 502, 505, 601,
602, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e).
2. Section 73.3100 is added to subpart D to read as follows:
Sec. 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione
bis(2-propenoic)ester copolymers.
(a) Identity. The color additives are 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester (CAS
Reg. No. 109561-07-1) copolymerized either with glyceryl methacrylate,
methyl methacrylate, and ethylene glycol dimethacrylate monomers, or
with N, N-dimethyl acrylamide, methyl methacrylate, and ethylene glycol
dimethacrylate monomers to form the contact lens material.
(b) Uses and restrictions. (1) The substances listed in paragraph
(a) of this section may be used in amounts not to exceed the minimum
reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with these uses shall not be
construed as waiving any of the requirements of sections 510(k), 515,
and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with
respect to the contact lens made from the color additives.
(c) Labeling. The label of the color additives shall conform to the
requirements of Sec. 70.25 of this chapter.
(d) Exemption from certification. Certification of these color
additives is not necessary for the protection of the public health and
therefore the color
[[Page 51587]]
additives are exempt from the certification requirements of section
721(c) of the act.
Dated: September 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-25261 Filed 10-2-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-25258 Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51587-51588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25258]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 95F-0175]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to expand the safe use of sodium 2,2'-methylenebis
(4,6-di-tert-butylphenyl) phosphate as a clarifying agent in
polypropylene articles intended for contact with food. This action is
in response to a petition filed by Asahi Denka Kogyo K.K.
DATES: Effective October 3, 1996; written objections and requests for a
hearing by November 4, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John R. Bryce, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3023.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 13, 1995 (60 FR 36149), FDA announced that a food
additive petition (FAP 5B4458) had been filed by Asahi Denka Kogyo
K.K., c/o Japan Technical Information Center, Inc., 775 South 23d St.,
Arlington, VA 22202. The petition proposed to amend Sec. 178.3295
Clarifying agents for polymers (21 CFR 178.3295) of the food additive
regulations to provide for the safe use of sodium 2,2'-methylenebis
(4,6-di-tert-butylphenyl) phosphate as a clarifying agent in
polypropylene articles intended for contact with food under conditions
of use A and B as described in Table 2 of 21 CFR 176.170(c).
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that the proposed use
of the additive is safe, and the additive will achieve its intended
technical effect; therefore the regulations in Sec. 178.3295 should be
amended as set forth below.
FDA's review of the subject petition indicates that the additive
may contain trace amounts of formaldehyde as an impurity. The potential
carcinogenicity of formaldehyde was reviewed by the Cancer Assessment
Committee (the Committee) of FDA's Center for Food Safety and Applied
Nutrition. The Committee noted that for many years formaldehyde has
been known to be a carcinogen by the inhalation route, but it concluded
that these inhalation studies are not appropriate for assessing the
potential carcinogenicity of formaldehyde in food. The Committee's
conclusion was based on the fact that the route of administration
(inhalation) is not relevant to the safety of formaldehyde residues in
food and the fact that tumors were observed only locally at the portal
of entry (nasal turbinates). In addition, the agency has received
literature reports of two drinking water studies on formaldehyde: (1) A
preliminary report of a carcinogenicity study purported to be positive
by Soffritti et al. (1989), conducted in Bologna, Italy (Ref. 1); and
(2) a negative study by Til, et al. (1989), conducted in The
Netherlands (Ref. 2). The Committee reviewed both studies and
concluded, concerning the Soffritti study,
``* * * that the data reported were unreliable and could not be used in
the assessment of the oral carcinogenicity of formaldehyde'' (Ref. 3).
This conclusion is based on a lack of critical detail in the study,
questionable histopathologic conclusions, and the use of unusual
nomenclature to describe the tumors. Based on the Committee's
evaluation, the agency has determined that there is no basis to
conclude that formaldehyde is a carcinogen when ingested.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person listed above. As provided in Sec. 171.1(h),
the agency will delete from the documents any materials that are not
available for public disclosure before making the documents available
for inspection.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Any person who will be adversely affected by this regulation may at
any time on or before November 4, 1996, file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered, and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection on which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for which a hearing is requested shall include
a detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Soffritti, M., C. Maltoni, F. Maffei, and R. Biagi,
``Formaldehyde: An Experimental Multipotential Carcinogen,''
Toxicology and Industrial Health, Vol. 5, No. 5:699-730, 1989.
2. Til, H. P., R. A. Woutersen, V. J. Feron, V. H. M.
Hollanders, H. E. Falke, and J. J. Clary, ``Two-Year Drinking Water
Study of Formaldehyde in Rats,'' Food Chemical Toxicology, Vol. 27,
No. 2, pp. 77-87, 1989.
3. Memorandum of Conference concerning ``Formaldehyde,'' Meeting
of the Cancer Assessment Committee, FDA, April 24, 1991, and March
4, 1993.
List of Subjects in 21 CFR Part 178
Food additives, Food packaging.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
178 is amended as follows:
[[Page 51588]]
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
1. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
2. Section 178.3295 is amended in the table by revising the entry
for ``Sodium 2,2'-methylenebis (4,6-di-tert-butylphenyl) phosphate'' to
read as follows:
Sec. 178.3295 Clarifying agents for polymers.
* * * * *
----------------------------------------------------------------------------------------------------------------
Substances Limitations
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Sodium 2,2'-methylenebis (4,6-di-tert-butylphenyl) For use only:
phosphate (CAS Reg. No. 85209-91-2).
1. As a clarifying agent at a level not exceeding 0.30
percent by weight of olefin polymers complying with
Sec. 177.1520(c) of this chapter, items 1.1, 3.1, or
3.2 (where the copolymers complying with items 3.1 and
3.2 contain not less than 85 weight percent of polymer
units derived from polypropylene). The finished
polymers contact foods only of types I, II, IV-B, VI-
B, VII-B, and VIII as identified in Table 1 of Sec.
176.170(c) of this chapter and limited to conditions
of use B through H, described in Table 2 of Sec.
176.170(c), or foods of all types, limited to
conditions of use C through H described in Table 2 of
Sec. 176.170(c).
2. As a clarifying agent at a level not exceeding 0.10
percent by weight of polypropylene complying with Sec.
177.1520(c) of this chapter, item 1.1. The finished
polypropylene may be used in contact with foods of all
types under conditions of use A through H described in
Table 2 of Sec. 176.170(c) of this chapter.
----------------------------------------------------------------------------------------------------------------
Dated: September 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-25258 Filed 10-2-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-25257 New Animal Drugs for Use in Animal Feeds; Oxytetracycline Type A Medicated Articles
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51588-51593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25257]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Oxytetracycline Type A
Medicated Articles
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides
revised labeling for Pfizer's pioneer, Type A, oxytetracycline-
containing, medicated articles which brings the products into
compliance with the findings of the National Academy of Sciences/
National Research Council (NAS/NRC), Drug Efficacy Study Group's (DESI)
effectiveness evaluation and subsequent FDA conclusions. In addition,
the regulations are further amended to reflect approval, based on FDA's
DESI ``me-too'' policy, of one original NADA each filed by Pfizer and
PennField Oil Co. for Type A medicated articles that are copies of the
Pfizer pioneer products.
EFFECTIVE DATE: October 3, 1996.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed a supplement to its approved NADA 8-804 which covers the
Type A medicated articles bearing the Terramycin
(oxytetracycline (OTC)) trade name on their labels. The articles
contain OTC quaternary salt expressed in terms of an equivalent amount
of OTC hydrochloride (HCl) (i.e., Terramycin 10, 20, 50, 50D,
100, 100D, 100SS, and 200). Pfizer also filed original NADA 95-143
which covers the Type A medicated articles OXTC 10, 30, 50,
50-S, 100, 100-S, 100MR, and 200. These articles contain OTC dihydrate
base expressed in terms of an equivalent amount of OTC HCl. PennField
Oil Co., 14040 Industrial Rd., Omaha, NE 68137, filed original NADA
138-938 which covers the Type A medicated articles Oxytetracycline 50,
100, and 100 MR (formulated for use in calf milk replacers or starter
feeds). These articles also contain OTC quaternary salt expressed in
terms of an equivalent amount of OTC HCl.
Pfizer Type A medicated articles covered by NADA 8-804 were the
subject of a NAS/NRC DESI evaluation of effectiveness (DESI 8622V). The
findings were published in the Federal Register of May 5, 1970 (35 FR
7089). NAS/NRC evaluated the articles as probably effective when used
for the control and treatment of specific diseases of livestock (swine,
cattle, sheep, rabbits, and mink) and poultry (broiler chickens, laying
chickens, and turkeys), and concluded that use may result in faster
gains and improved feed efficiency under appropriate conditions. NAS/
NRC stated that:
1. Labels and package inserts require extensive revision. There is
inadequate documentation of claims, excessive claims are made, and bold
conclusions are reached in the absence of sufficient controlled
experimental evidence.
2. Claims for growth promotion or stimulation are not allowed and
claims for faster gains and/or feed efficiency should be stated as
``may result in faster gains and/or improved feed efficiency under
appropriate conditions.''
3. Each disease claim should be properly qualified as ``appropriate
for use in (name of disease) caused by pathogens sensitive to (name of
drug) and if the disease cannot be so qualified the claim must be
dropped.''
4. The label claims ``for prevention of'' or ``to prevent'' should
be replaced with ``as an aid in the control of'' or ``to aid in the
control of.''
5. The label claim pertaining to egg production and hatchability
should be modified to read, ``May aid in maintaining egg production and
[[Page 51589]]
hatchability, under appropriate conditions, by controlling pathogenic
organisms.''
6. The labels should carry a warning that treated animals under the
conditions that prevail must actually consume sufficient medicated
water, or medicated feed, to constitute a therapeutic dose. As a
precaution, the labels should state what the desired oral dose is in
terms of animal weight per day for each species to serve as a guide to
effective use of the preparations in drinking water or feed.
7. The labels should declare the dosage for the treatment of
individual animals in terms of the amount of drug which should be given
per unit of animal weight.
The ``probably effective'' finding of NAS/NRC was subsequently
reviewed by FDA, resulting in an upgrade to ``effective'' status for
the control and treatment of bacterial diseases susceptible to OTC in
poultry, cattle, swine, sheep, and bees. FDA also made the following
conclusions:
1. The claims for hexamitiasis should be included under the
susceptible host.
2. Appropriate claims regarding faster weight gains and improved
feed efficiency should be stated as ``For increased rate of weight gain
and improved feed efficiency (under appropriate conditions of use).''
Pfizer filed a supplement to NADA 8-804 that revised the labeling
of its products to comply with the findings of the NAS/NRC review and
FDA's conclusions concerning those findings. Pfizer's supplement to
NADA 8-804 also provides for transfer to 8-804 of its proprietary
claims previously approved, under NADA 38-439, for use of OTC in
lobster, catfish, Pacific salmon, and salmonids. The supplemental NADA
is approved as of March 14, 1996.
The Type A medicated articles covered by Pfizer's NADA 95-143
(containing OTC dihydrate base) and those covered by PennField's NADA
138-938 (containing OTC quaternary salt) have demonstrated
comparability to Pfizer's pioneer products (NADA 8-804,
Terramycin Premixes containing OTC quaternary salt equivalent
in activity to a concentration of OTC HCl declared in grams per pound
of premix) which were subject to the NAS/NRC evaluation of May 5, 1970.
Based on that comparability, original NADA's 95-143 and 138-938 are
approved as of May 30, 1996, and March 15, 1996, respectively, under
FDA's DESI ``me-too'' policy.
FDA has now completed the NAS/NRC DESI evaluation for OTC Type A
articles. Accordingly, FDA is revising Sec. 558.450 Oxytetracycline (21
CFR 558.450) to set out the NAS/NRC and FDA-approved conditions of use
for OTC articles. FDA also has replaced the claims for OTC articles
listed in Sec. 558.15(g)(1) (21 CFR 558.15(g)(1)) with a cross-
reference to Sec. 558.450. This change makes the Sec. 558.15(g)(1)
reference to OTC Type A articles the same as that for chlortetracycline
(CTC) which cross-refers to Sec. 558.128 (21 CFR 558.128), the DESI-
finalized claims for that product (see the Federal Register of July 9,
1996, 61 FR 35949).
The NAS/NRC DESI evaluation is concerned only with the drugs'
effectiveness and safety to the treated animals. Nothing herein will
constitute a bar to further proceedings with respect to questions of
safety of the drugs or their metabolites in food products derived from
treated animals.
Products that comply with the NAS/NRC findings and FDA's
conclusions regarding those findings are eligible for copying under the
Generic Animal Drug and Patent Term Restoration Act (GADPTRA) (see the
eighth in a series of policy letters issued to facilitate
implementation of GADPTRA that published in the Federal Register of
August 21, 1991 (56 FR 41561)). Accordingly, sponsors may now obtain
approval of abbreviated new animal drug applications (ANADA's) for
these OTC Type A medicated articles.
Also, the agency is revising Sec. 558.515(d)(2) (21 CFR
558.515(d)(2)) to make the claim language for the robenidine/OTC
combination consistent with the NAS/NRC DESI findings.
In the Federal Register of October 21, 1977 (42 FR 56264), the then
Bureau of Veterinary Medicine issued a notice of opportunity for a
hearing (NOOH) on a proposal to withdraw approval of certain NADA's
listed in Sec. 558.15, for most subtherapeutic uses of tetracycline
(CTC and OTC) in animal feed. The NOOH was issued in response to
scientific research suggesting that subtherapeutic use of such drugs
has contributed to the pool of antibiotic-resistant pathogenic
microorganisms in food animals. Furthermore, research indicated that
the drug resistance could be transferred to pathogenic organisms in
humans. The NOOH is still pending and approval of these supplements to
finalize the DESI review process for OTC Type A medicated articles does
not constitute a bar to subsequent action to withdraw approval on the
grounds cited in the outstanding NOOH.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a
summary of safety and effectiveness data and information submitted to
support approval of these applications may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(ii) and (c)(2)(F)(iii) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii) and
(c)(2)(F)(iii)), these approvals for food-producing animals do not
qualify for marketing exclusivity because the original and supplemental
applications do not contain reports of new clinical or field
investigations (other than bioequivalence or residue studies) and new
human food safety studies (other than bioequivalence or residue
studies) essential to the approvals and conducted or sponsored by the
applicants.
The agency has carefully considered the potential environmental
effects of approving supplemental NADA 8-804. FDA has concluded that
the action will not have a significant impact on the human environment,
and that an environmental impact statement is not required. The
agency's finding of no significant impact and the evidence supporting
that finding, contained in an environmental assessment, may be seen in
the Dockets Management Branch (address above) between 9 a.m. and 4
p.m., Monday through Friday.
The agency has determined under 21 CFR 25.24(d)(1)(i) that approval
of original NADA's 95-143 and 138-938 is the type of action that does
not individually or cumulatively have a significant effect on the human
environment. Therefore, neither environmental assessments nor
environmental impact statements are required.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.15 [Amended]
2. Section 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in
the feed of animals is amended in the
[[Page 51590]]
table, in paragraph (g)(1) to read as follows:
a. In the entry for ``Pfizer, Inc., PennField Oil Co., VPO, Inc.,
and Purina Mills, Inc.'', by removing ``, VPO, Inc., and Purina Mills,
Inc.'';
b. Under the ``Species'' column of this entry, by removing
``Chickens and turkeys.'' and adding in its place ``Sec. 558.450.'';
c. All of the subentries for Pfizer, Inc., PennField Oil Co.,
represented by ``Do.'' are removed;
d. The ``Pfizer, Inc.'' entry for oxytetracycline for sheep,
including the three subentries represented by ``Do.'' are removed;
e. The ``Pfizer, Inc.'' entry for oxytetracycline for chickens,
including the first subentry represented by ``Do.'' is removed.
3. Section 558.450 is revised to read as follows:
Sec. 558.450 Oxytetracycline.
(a) Approvals. Type A medicated articles:
(1) 10, 20, 30, 50, 100, and 200 grams per pound to 000069 in
Sec. 510.600(c) of this chapter.
(2) 50 and 100 grams per pound to 053389 in Sec. 510.600(c) of this
chapter.
(b) Special considerations. (1) In accordance with Sec. 558.5
labeling shall bear the statement: ``FOR USE IN DRY ANIMAL FEED ONLY.
NOT FOR USE IN LIQUID FEED SUPPLEMENTS.''
(2) The articles in paragraph (a)(1) of this section contain an
amount of mono-alkyl (C8-C18) trimethylammonium
oxytetracycline expressed in terms of an equivalent amount of
oxytetracycline hydrochloride or an amount of oxytetracycline dihydrate
base expressed in terms of an equivalent amount of oxytetracycline
hydrochloride.
(3) The articles in paragraph (a)(2) of this section contain an
amount of mono-alkyl (C8-C18) trimethylammonium
oxytetracycline expressed in terms of an equivalent amount of
oxytetracycline hydrochloride.
(c) Related tolerances. See Sec. 556.500 of this chapter.
(d)(1) Conditions of use. It is used in feed as follows:
Table 1
----------------------------------------------------------------------------------------------------------------
Oxytetracycline amount Combination Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 20 grams per Sheep; increased rate 000069,
ton (g/ton) of weight gain and 053389
improved feed
efficiency.
(ii) 10 to 50 g/ton 1. Chickens; increased Do not feed to chickens do
rate of weight gain producing eggs for
and improved feed human consumption.
efficiency.
2. Growing turkeys; Do not feed to turkeys do
increased rate of producing eggs for
weight and improved human consumption.
feed efficiency.
3. Swine; increased do
rate of weight and
improved feed
efficiency.
(iii) 100 g/ton Turkeys; control of Feed continuously for 7 do
hexamitiasis caused by to 14 days (d); do not
Hexamita meleagridis feed to turkeys
susceptible to producing eggs for
oxytetracycline. human consumption.
(iv) 100 to 200 g/ton Chickens; control of Feed continuously for 7 do
infectious synovitis to 14 d; do not feed
caused by Mycoplasma to chickens producing
synoviae; control of eggs for human
fowl cholera caused by consumption; in low
Pasteurella multocida calcium feed, withdraw
susceptible to 3 d before slaughter.
oxytetracycline.
Nequinate 18.16 g/ton Chickens; control of do 000069
(0.002%) infectious synovitis
caused by M. synoviae;
control of fowl
cholera caused by P.
multocida susceptible
to oxytetracycline; as
an aid in the control
of coccidiosis caused
by Eimeria tenella, E.
necatrix, E.
acervulina, E. maxima,
E. brunetti, and E.
mivati.
(v) 200 g/ton Turkeys; control of Feed continuously for 7 000069,
infectious synovitis to 14 d; withdraw 5 d 053389
caused by M. synoviae before slaughter; do
susceptible to not feed to turkeys
oxytetracycline. producing eggs for
human consumption.
(vi) 400 g/ton Chickens; control of Feed continuously for 7 do
chronic respiratory to 14 d; do not feed
disease (CRD) and air to chickens producing
sac infection caused eggs for human
by M. gallisepticum consumption; in low
and Escherichia coli calcium feeds,
susceptible to withdraw 3 d before
oxytetracycline. slaughter.
[[Page 51591]]
Monensin 90 to 110 g/ Chickens; control of do 000069
ton CRD and air sac
infection caused by M.
gallisepticum and E.
coli susceptible to
oxytetracycline; and
as an aid in the
prevention of
coccidiosis caused by
E. necatrix, E.
tenella, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
Nequinate 18.16 g/ton Chickens; control of do do
(0.002%) CRD and air sac
infection caused by M.
gallisepticum and E.
coli susceptible to
oxytetracycline; as an
aid in prevention of
coccidiosis caused by
E. tenella, E.
necatrix, E.
acervulina, E. maxima,
E. brunetti, and E.
mivati.
(vii) 500 g/ton Chickens; reduction of Feed continuously for 5 000069,
mortality due to air d; do not feed to 053389
sacculitis (air-sac- chickens producing
infection) caused by eggs for human
E. coli susceptible to consumption; withdraw
oxytetracycline. 24 hours before
slaughter; in low
calcium feeds withdraw
3 d before slaughter.
Monensin 90 to 110 g/ Chickens; reduction of do 000069
ton mortality due to air
sacculitis (air-sac-
infection) caused by
E. coli susceptible to
oxytetracycline; as an
aid in the prevention
of coccidiosis caused
by E. necatrix, E.
tenella, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
Salinomycin 40 to 60 g/ Chickens; reduction of do 000069,
ton mortality due to air 012799
sacculitis (air-sac-
infection) caused by
E. coli susceptible to
oxytetracycline;
prevention of
coccidiosis caused by
E. necatrix, E.
tenella, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
(viii) 0.05 to 0.1 Calves (up to 250 lb); Feed continuously; in 000069,
milligram/pound (mg/lb) for increased rate of milk replacers or 053389
of body weight daily. weight gain and starter feed.
improved feed
efficiency.
(ix) 10 mg/lb of body 1.Calves and beef and Feed continuously for 7 do
weight daily. nonlactating dairy to 14 d; in feed or
cattle; treatment of milk replacers;
bacterial enteritis withdraw 5 d before
caused by E. coli and slaughter.
bacterial pneumonia
(shipping fever
complex) caused by P.
multocida susceptible
to oxytetracycline.
2. Calves (up to 250 Feed continuously for 7 do
lb); treatment of to 14 d; in milk
bacterial enteritis replacers or starter
caused by E. coli feed; withdraw 5 d
susceptible to before slaughter.
oxytetracycline.
3. Sheep; treatment of Feed continuously for 7 do
bacterial enteritis to 14 d; withdraw 5 d
caused by E. coli and before slaughter.
bacterial pneumonia
caused by P. multocida
susceptible to
oxytetracycline.
[[Page 51592]]
4. Swine; treatment of Feed continuously for 7 do
bacterial enteritis to 14 d; withdraw 5 d
caused by E. coli and before slaughter.
Salmonella
choleraesuis
susceptible to
oxytetracycline and
treatment of bacterial
pneumonia caused by P.
multocida susceptible
to oxytetracycline.
5. Breeding swine; Feed continuously for do
control and treatment not more than 14 d;
of leptospirosis withdraw 5 d before
(reducing the slaughter.
incidence of abortion
and shedding of
leptospirae) caused by
Leptospira pomona
susceptible to
oxytetracycline.
(x) 25 mg/lb of body Turkeys; control of Feed continuously for 7 do
weight complicating bacterial to 14 d; withdraw 5 d
organisms associated before slaughter; do
with bluecomb not feed to turkeys
(transmissible producing eggs for
enteritis; coronaviral human consumption.
enteritis) susceptible
to oxytetracycline.
(xi) 25 mg/head/day Calves (250 to 400 lb); do
increased rate of
weight gain and
improved feed
efficiency.
(xii) 75 mg/head/day Growing cattle (over do
400 lb); increased
rate of weight gain;
improved feed
efficiency, and
reduction of liver
condemnation due to
liver abscesses.
(xiii) 0.5 to 2.0 g/head/ Cattle; prevention and Feed 3 to 5 d before do
day treatment of the early and after arrival in
stages of shipping feedlots.
fever complex.
(xiv) 200 mg/colony Honey bees; control of Remove at least 6 weeks do
American foulbrood prior to main honey
caused by Bacillus flow.
larvae and European
foulbrood caused by
Streptococcus pluton
susceptible to
oxytetracycline.
----------------------------------------------------------------------------------------------------------------
(2) It is used in fish feed as follows:
Table 2
----------------------------------------------------------------------------------------------------------------
Oxytetracycline amount Combination Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 250 mg/kilogram of Pacific salmon for For salmon not over 30 000069
fish/d (11.35 g/100 lb marking of skeletal g body weight;
of fish/d). tissue. administer as sole
ration for 4
consecutive days in
feed containing
oxytetracycline
hydrochloride or mono-
alkyl (C8-C18)
trimethyl ammonium
oxytetracycline; fish
not to be liberated
for at least 7 d
following the last
administration of
medicated feed.
(ii) 2.5 to 3.75 g/100 1. Salmonids; control Administer as mono- 000069
lb of fish/d. of ulcer disease alkyl (C8-C18)
caused by Hemophilus trimethyl ammonium
piscium, furunculosis oxytetracycline in
caused by Aeromonas mixed ration for 10 d;
salmonicida, bacterial do not liberate fish
hemorrhagic septicemia or slaughter fish for
caused by A. food for 21 d
liquefaciens, and following the last
pseudomonas disease. administration of
medicated feed; do not
administer when water
temperature is below 9
C (48.2 F).
[[Page 51593]]
2. Catfish; control of Administer as mono- 000069
bacterial hemorrhagic alkyl (C8-C18)
septicemia caused by trimethyl ammonium
A. liquefaciens and oxytetracycline in
pseudomonas disease. mixed ration for 10 d;
do not liberate fish
or slaughter fish for
food for 21 d
following the last
administration of
medicated feed; do not
administer when water
temperature is below
16.7 C (62 F)
(iii) 1 g/lb of Lobsters; control of Administer as sole 000069
medicated feed. gaffkemia caused by ration for 5
Aerococcus viridans. consecutive days in
feed containing
monoalkyl (C8-C18)
trimethyl ammonium
oxytetracycline;
withdraw medicated
feed 30 d before
harvesting lobsters.
----------------------------------------------------------------------------------------------------------------
(3) Oxytetracycline may be used in accordance with the provisions
of this section in the combinations provided as follows:
(i) Robenidine hydrochloride in accordance with Sec. 558.515.
(ii) Lasalocid as in Sec. 558.311.
4. Section 558.515 is amended by revising paragraph (d)(2) to read
as follows:
Sec. 558.515 Robenidine hydrochloride.
* * * * *
(d) * * *
(2) For broiler chickens--(i) Amount per ton. Robenidine
hydrochloride, 30 grams (0.0033 percent) plus oxytetracycline, 400
grams.
(ii) Indications for use. As an aid in the prevention of
coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E.
acervulina, E. maxima, and E. necatrix; control of CRD and air sac
infection caused by Mycoplasma gallisepticum and Escherichia coli
susceptible to oxytetracycline.
(iii) Limitations. Feed continuously for 7 to 14 days; do not feed
to chickens producing eggs for human consumption; withdraw 5 days
before slaughter; do not use in feeds containing bentonite; feed must
be used within 50 days of manufacture; oxytetracycline as provided by
No. 000069 of this chapter.
Dated: September 16, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-25257 Filed 10-2-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-25152 Boundaries of the Cordell Bank National Marine Sanctuary; Correction
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Page 51577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25152]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
15 CFR Part 922
Boundaries of the Cordell Bank National Marine Sanctuary;
Correction
AGENCY: Sanctuaries and Reserves Division (SRD), Office of Ocean and
Coastal Resource Management (OCRM), National Ocean Service (NOS),
National Oceanic and Atmospheric Administration (NOAA), Commerce.
ACTION: Correcting amendment.
-----------------------------------------------------------------------
SUMMARY: The National Oceanic and Atmospheric Administration (NOAA) is
correcting a discrepancy in the coordinates of the Cordell Bank
National Marine Sanctuary, California.
EFFECTIVE DATE: October 3, 1996.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Moore at (301) 713-3141.
SUPPLEMENTARY INFORMATION: The Cordell Bank National Marine Sanctuary
(CBNMS or Sanctuary) was designated in 1989. SRD issued final
regulations, effective August 9, 1989, that included the coordinates of
the boundary of the CBNMS (15 CFR part 922, subpart K, Appendix A).
NOAA recently became aware of a minor discrepancy in the boundary
coordinates of the Sanctuary: one boundary coordinate was erroneously
duplicated at Points No. 27 and No. 29. This notice corrects that
discrepancy by deleting Point No. 27 and re-numbering the boundary
points that follow. Neither the actual boundary nor the area of the
Sanctuary are affected by this correction.
NOAA has decided to make this document effective immediately
because public comment and delayed effective date are not necessary due
to the minimal nature of the correcting amendment.
(Federal Domestic Assistance Catalog Number 11.429 Marine Sanctuary
Program)
Dated: September 23, 1996.
David L. Evans,
Acting Deputy Assistant Administrator for Ocean Services and Coastal
Zone Management.
Accordingly, for the reasons set forth above, 15 CFR part 922 is
amended as follows:
PART 922--[AMENDED]
1. The authority citation for part 922 continues to read as
follows:
Authority: 16 U.S.C. 1431 et seq.
2. Appendix A to subpart K of part 922 is revised to read as
follows:
Appendix A to Subpart K of Part 922--Cordell Bank National Marine
Sanctuary Boundary Coordinates
------------------------------------------------------------------------
Point No. Latitude Longitude
------------------------------------------------------------------------
1........................... 38 deg.15'51.72'' 123 deg.10'52.44''
2........................... 38 deg.07'55.88'' 123 deg.38'33.53''
3........................... 38 deg.06'45.21'' 123 deg.38'00.40''
4........................... 38 deg.04'58.41'' 123 deg.37'14.34''
5........................... 38 deg.04'28.22'' 123 deg.37'17.83''
6........................... 38 deg.03'42.75'' 123 deg.36'55.66''
7........................... 38 deg.03'11.10'' 123 deg.36'19.78''
8........................... 38 deg.02'46.12'' 123 deg.36'21.98''
9........................... 38 deg.02'02.74'' 123 deg.35'56.56''
10.......................... 38 deg.01'27.10'' 123 deg.35'55.12''
11.......................... 38 deg.01'22.28'' 123 deg.36'55.13''
12.......................... 38 deg.01'11.54'' 123 deg.37'28.21''
13.......................... 38 deg.00'49.16'' 123 deg.37'29.77''
14.......................... 37 deg.59'54.49'' 123 deg.36'47.90''
15.......................... 37 deg.59'12.39'' 123 deg.35'59.55''
16.......................... 37 deg.58'39.40'' 123 deg.35'14.85''
17.......................... 37 deg.58'00.57'' 123 deg.34'42.93''
18.......................... 37 deg.57'18.99'' 123 deg.33'43.15''
19.......................... 37 deg.56'56.42'' 123 deg.32'51.97''
20.......................... 37 deg.56'18.90'' 123 deg.32'49.24''
21.......................... 37 deg.55'22.37'' 123 deg.32'36.96''
22.......................... 37 deg.54'26.10'' 123 deg.32'21.73''
23.......................... 37 deg.53'07.46'' 123 deg.31'46.81''
24.......................... 37 deg.52'34.93'' 123 deg.31'18.90''
25.......................... 37 deg.51'42.81'' 123 deg.31'19.10''
26.......................... 37 deg.50'59.58'' 123 deg.31'02.96''
27.......................... 37 deg.49'22.64'' 123 deg.29'34.07''
28.......................... 37 deg.48'49.14'' 123 deg.28'44.61''
29.......................... 37 deg.48'36.95'' 123 deg.28'08.29''
30.......................... 37 deg.48'03.37'' 123 deg.28'23.27''
31.......................... 37 deg.47'41.54'' 123 deg.28'01.97''
32.......................... 37 deg.47'01.78'' 123 deg.27'16.78''
33.......................... 37 deg.46'51.92'' 123 deg.26'48.98''
34.......................... 37 deg.46'13.20'' 123 deg.26'04.79''
35.......................... 37 deg.46'00.73'' 123 deg.25'36.99''
36.......................... 37 deg.50'25.31'' 123 deg.25'26.53''
37.......................... 37 deg.54'32.28'' 123 deg.23'16.49''
38.......................... 37 deg.57'45.71'' 123 deg.19'17.72''
39.......................... 37 deg.59'29.27'' 123 deg.14'12.16''
40.......................... 37 deg.59'43.71'' 123 deg.08'27.55''
41.......................... 38 deg.03'10.20'' 123 deg.07'44.35''
42.......................... 38 deg.04'01.64'' 123 deg.06'58.92''
43.......................... 38 deg.08'33.32'' 123 deg.04'56.24''
44.......................... 38 deg.12'42.06'' 123 deg.07'10.21''
------------------------------------------------------------------------
[FR Doc. 96-25152 Filed 10-2-96; 8:45 am]
BILLING CODE 3510-08-M
Complete official Federal Register PDF
FR Doc. 96-25150 Security for Passenger Vessels and Passenger Terminals
[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Rules and Regulations]
[Pages 51597-51598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25150]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Coast Guard
33 CFR Parts 120 and 128
[CGD 91-012]
RIN 2115-AD75
Security for Passenger Vessels and Passenger Terminals
AGENCY: Coast Guard, DOT.
ACTION: Notice of policy clarification.
-----------------------------------------------------------------------
SUMMARY: On July 18, 1996, an Interim Rule was published (61 FR 139)
entitled ``Security for Passenger Vessels and Passenger Terminals''.
Since that time the Coast Guard has discovered two areas in need of
clarification to ensure that those affected by the Interim Rule can
meet compliance dates. The areas of clarification are tonnage
limitations and submission of terminal security plans.
FOR FURTHER INFORMATION CONTACT:
CDR Dennis J. Haise, Office of Compliance (G-MOC), Room 1116, (202)
267-1934, between 7:00 a.m. and 3:30 p.m., Monday through Friday,
except Federal holidays.
SUPPLEMENTARY INFORMATION:
Policy Clarification:
Tonnage
The tonnage measurement to be used in the application of this rule
is U.S. registered tonnage, not International Tonnage Convention (ITC)
measurements. Therefore, the rule applies to those vessels over 100
U.S. registered gross tons.
Submission of Terminal Security Plans
Terminal Security Plans should be submitted by the owner or
operator of the vessel in the following situations:
a. When there is an agreement with the owner or operator of the
passenger terminal that the owner or operator of the vessel will submit
the required security plan.
b. When the owner or operator of the vessel has exclusive use of
the pier and terminal building immediately adjacent to the pier and has
complete control of that area.
c. When there is no terminal.
d. When passengers embark and or disembark and no baggage or stores
are loaded or offloaded.
In situations c and d, an annex to the vessel's security plan may
be used instead of a terminal security plan with the permission of the
cognizant Coast Guard Captain of the Port.
Terminal Security Plans should be submitted by the owner or
operator of
[[Page 51598]]
the passenger terminal in the following situations:
a. When there is an agreement with the owner or operator of the
passenger vessel that the owner or operator of the terminal will submit
the required security plan.
b. When the terminal is multi-user or used by more that one cruise
line, and baggage and or stores are loaded or offloaded, and no
security agreement exists
Dated: September 24, 1996.
G.N. Naccara,
Captain, U.S. Coast Guard, Acting Chief, Marine Safety and
Environmental Protection.
[FR Doc. 96-25150 Filed 10-2-96; 8:45 am]
BILLING CODE 4910-14-M
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