issue-1997-05-22•Federal Register proposed rules — 1997-05-22
Federal Register proposed rules — 1997-05-22
issue-1997-05-22Federal Register proposed rules — 1997-05-22Proposed Regulation
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. 97-13510 Drawbridge Operation Regulations; Manistee River, MI
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 27990-27991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13510]
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DEPARTMENT OF TRANSPORTATION
Coast Guard
33 CFR Part 117
[CGD09-97-014]
RIN 2115-AE47
Drawbridge Operation Regulations; Manistee River, MI
AGENCY: Coast Guard, DOT.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Coast Guard proposes to revise the regulations governing
the operations of the Maple Street bridge, mile 1.1, and the U.S. Route
31 bridge, mile 1.4, both over the Manistee River in Manistee, MI. This
proposal would change the times that the bridges are required to open
on signal between May 1 and October 31. The current hours of 6 a.m. to
10 p.m. would be revised to 7 a.m. to 11 p.m. This revision was
requested for the convenience of recreational vessels using the
facilities above the bridges.
DATES: Comments must be received on or before July 21, 1997.
ADDRESSES: Comments may be mailed or delivered to Commander (obr),
Ninth Coast Guard District, 1240 E. Ninth St., Room 2019, Cleveland, OH
44199-2060, between 7 a.m. and 3 p.m., Monday through Friday, except
Federal holidays. The telephone number is (216) 902-6084.
FOR FURTHER INFORMATION CONTACT:
Mr. Scot M. Striffler, Project Manager, at (216) 902-6084.
SUPPLEMENTARY INFORMATION:
Drafting Information
The principal persons involved in drafting this document are Mr.
Scot Striffler, Project Manager, and Lieutenant Commander Kent Booher,
Project Counsel, Ninth Coast Guard District.
Request for Comments
The Coast Guard encourages interested persons to submit written
data, or arguments for or against this rule. Persons submitting
comments should include their name, address, identify this rulemaking
(CGD09-97-014), the specific section of this rule to which each comment
applies, and the reasons(s) for each comment. The Coast Guard requests
that all comments and attachments be submitted in an 8\1/2\'' x 11''
unbound format suitable for copying and electronic filing. If that is
not practical, a second copy of any bound material is requested.
Persons wanting acknowledgement of receipt of comments should enclose a
stamped self-addressed post card or envelope. Persons may submit
comment by writing to the Commander (obr), Ninth Coast Guard District
listed under ADDRESSES.
Background and Purpose
The City of Manistee, MI, on behalf of the marina owners in
Manistee, requested the Coast Guard approve a change to the operating
regulations pertaining to the Maple Street bridge and U.S. Route 31
bridge over the Manistee River. The City of Manistee owns and operates
the Maple Street bridge. The Michigan Department of Transportation
(MDOT) owns the U.S. Route 31 bridge and contracts the City of Manistee
to operate the bridge. The marina owners and operators on Manistee Lake
requested the hours during which the bridges open on signal be revised
to allow longer evening sailing times for the vessels using the marinas
above the bridges.
The City of Manistee conducted meetings with marina owners, along
with a written survey of boat owners using these facilities, in
January-
[[Page 27991]]
February 1997 to ascertain the most desirable time of operation for
the bridges. The meetings and survey concluded that the idea hours of
operation would be from 7 a.m. to 11 p.m., between May 1 and October 31
each year.
The City of Manistee and MDOT have stated no objections to this
change since the total number of operational hours remain the same and
there are no additional costs involved for the owners/operators of the
bridges. Coast Guard operations on Manistee Lake will not be affected
by this revision. The three commercial shipping companies who transit
the bridges have stated no objections to this change.
Commander, Ninth Coast Guard District, approved a temporary
deviation from the regulations for the bridges from May 31, 1997 to
August 31, 1997. The temporary deviation, published elsewhere in
today's Federal Register, was authorized to test the proposed schedule
before making a permanent change to the regulations.
Under the proposed schedule, from May 1 to October 31, the bridges
would only be required to open on signal between 7 a.m. and 11 p.m.
Between 11 p.m. and 7 a.m., the bridges would open if at least a 2-hour
advance notice is provided by vessels intending to transit the draws.
The operations of the bridges between November 1 and April 30 would
remain the same.
Regulatory Evaluation
This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866 and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that order. It has not been reviewed by the Office of Management and
Budget under that order. It is not significant under the regulatory
policies and procedures of the Department of Transportation (DOT) (44
FR 11040; February 26, 1979). The Coast Guard expects the economic
impact of this proposed rule to be so minimal that a full Regulatory
Evaluation under paragraph 10e of the regulatory policies and
procedures of DOT is unnecessary. This action was initiated by the City
of Manistee, on behalf of the marina operators on Manistee Lake, to
increase access to recreational facilities located above the bridge and
to enhance the economic potential of commerce in the area.
Small Entities
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Coast Guard must consider the economic impact on small entities of a
rule for which a general notice of proposed rulemaking is required.
``Small entities'' may include (1) small businesses and not-for-profit
organizations that are independently owned and operated and are not
dominant in their fields and (2) governmental jurisdictions with
populations of less than 50,000.
Because this rulemaking was initiated on behalf of the marina
operators on Manistee Lake in order to increase use of recreational
facilities, thereby enhancing potential economic commerce, no adverse
economic impact is anticipated on a substantial number of small
businesses. Any comments submitted in response to this finding will be
evaluated under the criteria described earlier in the preamble for
comments.
Collection of Information
This rule contains no collection-of-information requirements under
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Federalism
The Coast Guard has analyzed this rule under the principles and
criteria contained in Executive Order 12612 and has determined that
this rule does not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
Environment
The Coast Guard considered the environmental impact of this
proposed rule and concluded that, under paragraph 2.B.2 of Commandant
Instruction M16475.1B, (as revised by 59 FR 38654, July 29, 1994), this
rule is categorically excluded from further environmental
documentation. A ``Categorical Exclusion Determination'' is available
in the docket for inspection or copying where indicated under
ADDRESSES.
List of Subjects in 33 CFR Part 117
Bridges.
For reasons set out in the preamble, 33 CFR part 117 is revised as
follows:
PART 117--DRAWBRIDGE OPERATION REGULATIONS
1. The authority citation for part 117 continues to read as
follows.
Authority: 33 U.S.C. 499; 49 CFR 1.46; 33 CFR 1.05(g); section
117.255 also issued under the authority of Pub. L. 102-587, 106
Stat. 5039.
2. Section 117.637 is amended by revising paragraph (a)(1) to read
as follows:
Sec. 117.637 Manistee River.
(a) * * *
(1) From May 1 through October 31 from 7 a.m. to 11 p.m., the
bridges shall open on signal. From 11 p.m. to 7 a.m., the bridges need
not open unless notice is given at least two hours in advance of a
vessel's time of intended passage through the draws.
* * * * *
Dated: May 7, 1997.
G.F. Woolever,
Rear Admiral, U.S. Coast Guard Commander, Ninth Coast Guard District.
[FR Doc. 97-13510 Filed 5-21-97; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 97-13483 List of Regulated Substances and Thresholds for Accidental Release Prevention; Proposed Amendments
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 27992-27996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13483]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 68
[FRL-5828-9]
List of Regulated Substances and Thresholds for Accidental
Release Prevention; Proposed Amendments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing
modifications to the list of regulated substances and threshold
quantities the accidental release prevention regulations authorized by
section 112(r) of the Clean Air Act as amended. EPA is proposing to
vacate the listing and related threshold for hydrochloric acid
solutions with less than 37% concentrations of hydrogen chloride. The
current listing and threshold for all other regulated substances,
including hydrochloric acid solutions with 37% or greater
concentrations and the listing and threshold for anhydrous hydrogen
chloride, are unaffected by today's proposed amendment. Today's action
implements, in part, a settlement agreement between EPA and the General
Electric Company (GE) to resolve GE's petition for review of the
rulemaking listing regulated substances and establishing thresholds
under the accidental release prevention regulations.
DATES: Comments must be submitted on or before June 23, 1997, unless a
hearing
[[Page 27993]]
is requested by June 2, 1997. If a hearing is requested, written
comments must be received by July 7, 1997.
Public Hearing. Anyone requesting a public hearing must contact EPA
no later than June 2, 1997. If a hearing is held, it will take place on
June 6, 1997 at 9:30 a.m.
ADDRESSES: Comments should be mailed or submitted to: Environmental
Protection Agency, Air Docket (6102), Attn: Docket No. A-97-28,
Waterside Mall, 401 M St., SW, Washington, DC 20460. Comments must be
submitted in duplicate. Comments may be submitted on disk in
WordPerfect or Word formats. If a public hearing is held, written
testimony should be submitted in duplicate at the time of the hearing.
Public Hearing. If a public hearing is held, it will be held at
Waterside Mall, 401 M St., SW, Washington, DC 20460, in the Conference
Center in a room to be designated. Persons interested in attending the
hearing or wishing to present oral testimony should notify by telephone
Dorothy McManus (see For Further Information Contact).
Docket. The docket for this rulemaking is A-97-28. This proposed
rule would amend a final rule, the docket for which is A-91-74. The
docket may be inspected between 8 am and 5:30 pm, Monday through Friday
at EPA's Air Docket, Room M1500, Waterside Mall, 401 M St., SW,
Washington, DC 20460; telephone (202) 260-7548. A reasonable fee may be
charged for copying.
FOR FURTHER INFORMATION CONTACT: Prior to June 16, 1997, contact
Dorothy McManus, Program Analyst, Chemical Emergency Preparedness and
Prevention Office, Environmental Protection Agency, MC 5104, 401 M St.,
SW, Washington, DC 20460, (202) 260-8606. After June 16, 1997, contact
Vanessa Rodriguez, Chemical Engineer, Chemical Emergency Preparedness
and Prevention Office, Environmental Protection Agency, MC 5104, 401 M
St., SW, Washington, DC 20460, (202) 260-7913.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially affected by this action include the following
types of facilities if the facility has more than the 15,000 pound
threshold quantity of hydrochloric acid solutions with concentrations
of less than 37% hydrogen chloride.
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Example of regulated
Category entities
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Chemical manufacturers.................... Industrial inorganics.
Petrochemical............................. Plastics and resins.
Other manufacturers....................... Pulp and paper mills,
primary metal production,
fabricated metal products,
electronic and other
electric equipment,
transportation equipment,
industrial machinery and
equipment, food processors.
Wholesalers............................... Chemical distributors.
Federal sources........................... Defense and energy
installations.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists types of entities that the EPA is now aware
could potentially be affected by this action. Other types of entities
not listed in the table could be affected. To determine whether your
facility is affected by this action, you should carefully examine
today's notice. If you have questions regarding the applicability of
this action to a particular entity, consult the person listed in the
preceding For Further Information Contact section.
The following outline is provided to aid in reading this preamble
to the proposed rule:
Table of Contents
I. Introduction and Background
A. Statutory Authority
B. Regulatory History
C. List Rule Litigation
II. Discussion of Proposed Modifications
A. Rationale for Vacating 30% to 37% Solutions
B. Potential Future Actions Affecting Hydrochloric Acid
III. Discussion of the Proposed Rule
IV. Required Analyses
A. Executive Order 12866
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Unfunded Mandates Reform Act
I. Introduction and Background
A. Statutory Authority
This notice of proposed rulemaking (NPRM) is being issued under
sections 112(r) and 301 of the Clean Air Act (Act) as amended.
B. Regulatory History
The Clean Air Act (CAA or Act), section 112(r), contains
requirements related to prevention of accidental releases. The goal of
the accidental release provisions is to prevent accidental releases and
minimize the consequences of releases by focusing on those chemicals
and operations that pose the greatest risk. The CAA requires EPA to
promulgate an initial list of at least 100 substances (``regulated
substances'') that, in the event of an accidental release, are known to
cause or may be reasonably expected to cause death, injury, or serious
adverse effects to human health and the environment. The Act identifies
16 substances to be included in the initial list. Factors required to
be considered in listing substances are the severity of acute adverse
health effects associated with accidental releases of the substance,
the likelihood of accidental releases of the substance, and the
potential magnitude of human exposure to accidental releases of the
substance. The CAA also requires EPA to establish a threshold quantity
for each chemical at the time of listing. In developing these
thresholds, factors required to be considered include toxicity,
reactivity, volatility, dispersibility, combustibility, or flammability
of the substance and the amount of the substance which is known to
cause or can be reasonably anticipated to cause death, injury, or
serious adverse effects in case of a release. Stationary sources that
have more than a threshold quantity of a regulated substance are
subject to accident prevention regulations promulgated under CAA
section 112(r)(7), including the requirement to develop risk management
plans.
On January 31, 1994, EPA promulgated the list of regulated
substances and thresholds that identify stationary sources subject to
the accidental release prevention regulations (59 FR 4478) (the ``List
Rule''). EPA subsequently promulgated a rule requiring owners and
operators of these stationary sources to develop programs addressing
accidental releases and to make publicly available risk management
plans (``RMPs'') summarizing these programs. (61 FR 31668, June 20,
1996) (the ``RMP Rule''). On April 15, 1996, EPA proposed amendments to
the List Rule (61 FR 16598) and on June 20, 1996, stayed certain
provisions of the list and threshold regulations affected by the
proposed amendments (61 FR 31730). For further information on these
regulations, section 112(r), and related statutory provisions, see
these notices. These rules can be found in 40 CFR part 68, ``Chemical
Accident Prevention Provisions,'' and collectively are referred to as
the accidental release prevention regulations.
In the List Rule, EPA promulgated a list that includes 77 acutely
toxic substances, 63 flammable gases and volatile flammable liquids,
and Division 1.1 high explosive substances as listed by the United
States Department of Transportation (DOT) in 49 CFR 172.101. The final
rule established
[[Page 27994]]
threshold quantities for toxic substances ranging from 500 to 20,000
pounds, as well as thresholds for regulated flammable substances
(10,000 pounds) and explosive substances (5,000 pounds). The rule also
specified the requirements for any petitions to the Agency requesting
to add substances to, or delete substances from, the list.
In considering the statutory criteria for listing regulated
substances discussed above, EPA selected commercially produced acutely
toxic and volatile substances mostly from the list of extremely
hazardous substances (EHSs) under section 302 of the Emergency Planning
and Community Right-to-Know Act (EPCRA). EPA chose volatile substances
because they are more likely to become airborne and impact the public.
EPA also considered the accident history of substances. Because vapor
cloud explosions and blast waves from detonations of high explosives
have caused injuries to the public and damage to the environment, EPA
also included highly flammable gases and liquids and high explosives on
the list.
C. List Rule Litigation
The American Petroleum Institute (API), the Institute of Makers of
Explosives (IME), and the General Electric Company (GE) filed petitions
for judicial review of the List Rule (American Petroleum Institute v.
EPA, No. 94-1273 (D.C. Cir.) and consolidated cases). The API and IME
petitions for review focused primarily on issues related to the
regulation of flammable and explosive substances. EPA, API, and IME
signed settlement agreements in March 1996 that, when fully
implemented, will resolve these two cases. Consistent with these
settlements, EPA proposed amendments to the List Rule on April 15, 1996
(61 FR 16598). Furthermore, on June 20, 1996, EPA promulgated a stay of
certain provisions of the List Rule that were affected by the proposed
amendments (61 FR 31730). The effect of the stay is to provide sources
affected by the proposed amendments the same amount of time to meet the
requirements of the accident prevention regulations as other sources
not affected by the proposal in the event that EPA ultimately decides
not to promulgate the amendments as proposed. EPA anticipates final
action on the API/IME related amendments by December 20, 1997, which is
the date on which the stay is scheduled to expire.
The GE petition for review raised issues regarding EPA's listing
criteria under the List Rule, the listing of certain substances in the
List Rule, the setting of threshold quantities for certain substances
in particular and all regulated toxic substances generally, and the
petition process for adding and deleting regulated substances to the
list. GE identified as ``[t]he crux of the dispute * * * the legality
and propriety of including solutions of hydrochloric acid at 30% or
greater on the list of regulated substances,'' and challenged the
adequacy of the administrative record support for both the listing and
the 15,000 pound threshold for such solutions (see GE Status Report of
January 27, 1997, page 2, and the settlement agreement between GE and
EPA, page 1, both of which are in the docket for today's proposed
rule). While neither GE nor EPA conceded the correctness of the
opposing party's position on any of the issues raised by GE, both
parties recognized that there were substantial and material issues
regarding the support in the administrative record for the listing of
concentrations of hydrochloric acid up to 37% hydrogen chloride.
Recognizing that the public's interest would best be served by
settlement of all issues raised in this litigation, GE and EPA agreed
to a settlement on April 7, 1997. Under the terms of the settlement
agreement, EPA would propose to vacate provisions of the accidental
release prevention regulations that specifically address hydrochloric
acid solutions with less than 37% hydrogen chloride. On April 24, 1997,
EPA made available for public comment under CAA section 113(g) the
proposed settlement agreement with GE (62 FR 20007).
II. Discussion of Proposed Modifications
A. Rationale for Vacating 30% to 37% Solutions
In the above-described litigation, GE raised substantial concerns
regarding whether the administrative record for the List Rule supports
the listing of Hydrochloric Acid solutions at 30% hydrogen chloride
concentrations. Among other issues, GE has questioned whether the
listing criteria EPA used to list such solutions appropriately
characterize these solutions' potential magnitude of human exposure and
has challenged the methodology used to assign such solutions a 15,000
pound threshold. As discussed below, EPA believes that the concerns
discussed above warrant vacating the listing of hydrochloric acid
solutions of less than 37% (i.e., from 30% inclusive, up to but not
including 37%).
It is unlikely that the GE challenge to hydrochloric acid and all
other chemicals and thresholds established in the List Rule would be
resolved much sooner than 1998 if the parties were to brief and
litigate this case. As with any litigation, there is uncertainty about
the outcome of this case. In the event that the litigation proceeded
and the Court required EPA to conduct further rulemaking concerning
aspects of the List Rule, additional time would lapse before EPA could
complete such actions. In that situation, the RMP Rule's June 21, 1999,
compliance date potentially could be impacted not only for the
solutions proposed to be delisted today, but also for other regulated
substances that are not affected by today's proposal.
Today's action addresses the essential element of the dispute
between EPA and GE while eliminating the collateral uncertainty that
would exist about the regulatory status of the remaining chemicals if
the litigation proceeded. EPA has vigorously advocated responsible
accident prevention efforts by industry even before enactment of
section 112(r). The Agency is concerned that prolonging this dispute
may encourage owners and operators of sources who are solely concerned
about regulatory compliance to defer engaging in responsible accident
prevention activities. By implementing the settlement agreement with GE
and by implementing the settlement agreements reached in the other two
challenges to the List Rule, EPA will be able to retain on the list of
regulated substances nearly all of the chemicals originally listed and
eliminate uncertainty about their regulatory status.
EPA believes today's proposed rule is protective of the public
health in several respects. First, the proposed rule would allow the
listing of hydrochloric acid solutions to remain in effect for
solutions with concentrations of 37% or greater. Relative to the
solutions proposed to be vacated, the solutions that will remain listed
have a higher partial pressure of hydrogen chloride, which may indicate
a greater capacity to release hydrogen chloride and have hydrogen
chloride affect offsite communities. Second, the types of solutions
that remain regulated are prevalent in commerce. Third, as has been
explained by EPA in rulemakings and other interpretations, the presence
or absence of a chemical on the list of regulated substances in no way
affects the applicability of section 112(r)(1), the general duty
clause, to substances that are extremely hazardous in fact (see, for
example, 59 FR at 4481; and Risk Management Program Rule: Summary and
Response to Comments, section 32, Docket A-91-73, entry IX-C-01). The
general duty clause creates a duty for the owner or operator of a
stationary
[[Page 27995]]
source ``in the same manner and to the same extent as'' the general
duty provision under the Occupational Safety and Health Act ``to
identify hazards which may result from [accidental] releases using
appropriate hazard assessment techniques, to design and maintain a safe
facility, and to minimize the consequences of accidental releases which
do occur'' (CAA section 112(r)(1)). The general duty clause provides an
important level of protection of the public health for substances that
are extremely hazardous in fact regardless of whether they are listed.
Finally, EPA wishes to clarify that this proposed rule would not
affect in any way the listing of anhydrous hydrogen chloride. Anhydrous
hydrogen chloride would retain its 5000 pound threshold. Threshold
determination provisions for regulated toxic substances would apply to
anhydrous hydrogen chloride. Anhydrous mixtures of Hydrogen Chloride
would be subject to the mixture provisions for regulated toxic
substances. Aqueous mixtures of hydrochloric acid would be affected to
the extent that the minimum concentration cutoff would be revised.
Based on the reasons discussed above, EPA is proposing to vacate
the listing in part 68 of hydrochloric acid solutions at concentrations
of less than 37% (from 30% up to 37%) hydrogen chloride. Solutions of
37% or greater would not be affected by today's proposal and remain on
the list. In addition, EPA is proposing to vacate other provisions of
the accidental release prevention regulations insofar as they apply to
hydrochloric acid solutions at concentrations less than 37% hydrogen
chloride. For example, the reference to ``hydrochloric acid (conc 30%
or greater)'' in the toxic endpoint table for 40 CFR part 68 would be
revised to refer to concentrations of 37% or greater.
EPA recognizes that there will be uncertainty for owners and
operators of stationary sources as to the regulatory status of 30% to
37% solutions until EPA takes final action on today's proposal. Such
uncertainty is likely to impact compliance planning for processes
subject to the accidental release prevention regulations. Therefore,
EPA is proposing that if EPA does not issue a final rule vacating the
listing of hydrochloric acid solutions with less than 37%
concentrations and related part 68 provisions, EPA will extend the June
21, 1999 RMP Rule compliance deadline for such solutions by no less
than the amount of time that elapses from April 7, 1997, to 180 days
following the publication of a final action that declines to vacate the
listing of hydrochloric acid solutions with less than 37%
concentrations and related portions of part 68. For example, if such a
notice were published on September 4, 1997, which is 150 days after
April 7, 1997, then the compliance deadline applicable to 30% to 37%
solutions would be extended 330 days from June 21, 1999, to May 16,
2000.
B. Potential Future Actions Affecting Hydrochloric Acid
EPA notes that it is required by statute to review its list at
least every five years (section 112(r)(3)). Therefore, EPA will need to
address the appropriate concentration for the hydrochloric acid listing
no later than the time it performs this review. A future rulemaking
will provide an opportunity to more fully explain the basis for the
listing, including any issues peculiar to hydrochloric acid solutions.
For example, EPA anticipates it would address matters such as any new
accident history data involving solutions in the 30% to 37% range as
well as any substance-specific technical issues regarding such a
listing.
EPA is not at this time reopening the rulemaking record on the
listing of hydrochloric acid solutions within the range of 30% to 37%.
Any subsequent action to list solutions at concentrations within the
30% to 37% range will be taken only after a new notice of proposed
rulemaking and an opportunity for interested parties to comment. In the
event that EPA proceeds to relist, stationary sources would have no
less than three years to comply with the RMP Rule following
promulgation of a final rule listing hydrochloric acid solutions at
concentrations within this range.
III. Discussion of the Proposed Rule
EPA is proposing to amend several sections of part 68 of title 40
of the Code of Federal Regulations.
In Sec. 68.130, tables 1 and 2, the listing for Hydrochloric Acid
would be revised to read ``Hydrochloric Acid (conc 37% or greater).''
In addition, note ``d'' from Table 1 would be added to Table 2, from
which it was inadvertently omitted when the list rule was promulgated.
Note ``d'' would apply to only hydrochloric acid with concentrations
37% or greater when this action is finalized.
In part 68, Appendix A, the table of toxic endpoints, the entry for
hydrochloric acid would be revised to read ``Hydrochloric Acid (conc
37% or greater).''
IV. Required Analyses
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must judge whether the regulatory action is ``significant,'' and
therefore subject to OMB review and the requirements of the Executive
Order. The Order defines ``significant regulatory action'' as one that
is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or state, local, or tribal government or communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
It has been determined that this proposed rule is not a
``significant regulatory action'' under the terms of Executive Order
12866 and, therefore, is not subject to OMB review.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
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 small governmental
jurisdictions. This proposed rule would not have a significant impact
on a substantial number of small entities because it would, if adopted
as a final rule, reduce the range of hydrochloric acid solutions listed
under part 68 and thus reduce the number of stationary sources subject
to part 68. Therefore, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
C. Paperwork Reduction Act
This proposed rule does not include any information collection
requirements for OMB to review under the provisions of the Paperwork
Reduction Act.
[[Page 27996]]
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation of why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
EPA has determined that this rule does not contain a Federal
mandate that may result in expenditures of $100 million or more for
State, local, and tribal governments, in the aggregate, or the private
sector in any one year. Today's proposed rule, if adopted, would reduce
the number of sources subject to part 68. Thus, today's rule is not
subject to the requirements of sections 202 and 205 of the UMRA. For
the same reason, EPA has determined that this rule contains no
regulatory requirements that might significantly or uniquely affect
small governments.
List of Subjects in 40 CFR Part 68
Environmental protection, Chemicals, Chemical accident prevention,
Extremely hazardous substances, Incorporation by reference,
Intergovernmental relations, Hazardous substances, Reporting and
recordkeeping requirements.
Dated: May 16, 1997.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, title 40, chapter I,
subchapter C, part 68 of the Code of Federal Regulations is proposed to
be amended as follows:
PART 68--CHEMICAL ACCIDENT PREVENTION PROVISIONS
1. The authority citation for part 68 continues to read as follows:
Authority: 42 U.S.C. 7412(r), 7601(a)(1), 7661-7661f.
Sec. 68.130 Tables 1 and 2 [Amended]
2. In Sec. 68.130 List of substances, Table 1 is proposed to be
amended by revising the listing in the column ``Chemical name'' from
``Hydrochloric acid (conc 30% or greater)'' to ``Hydrochloric acid
(conc 37% or greater).''
3. In Sec. 68.130 List of substances, Table 2 is proposed to be
amended by revising the listing in the column ``Chemical name'' from
``Hydrochloric acid (conc 30% or greater)'' to ``Hydrochloric acid
(conc 37% or greater),'' and by adding a note ``d'' between note ``c''
and ``e'' at the end of the table to read as follows:
d Toxicity of hydrogen chloride, potential to release hydrogen
chloride, and history of accidents.
Appendix A of Part 68 [Amended]
4. Appendix A of Part 68 is proposed to be amended by revising the
listing in the column ``Chemical name'' from ``Hydrochloric acid (conc
30% or greater)'' ``Hydrochloric acid (conc 37% or greater).''
[FR Doc. 97-13483 Filed 5-21-97; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 97-13482 Notification of Completeness of the Department of Energy's Compliance Certification Application for the Waste Isolation Pilot Plant
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 27996-27998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13482]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 194
[FRL-5829-1]
Notification of Completeness of the Department of Energy's
Compliance Certification Application for the Waste Isolation Pilot
Plant
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance notice of proposed rulemaking; notification of
completeness of compliance certification application.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) has determined that
the Department of Energy's (DOE) Compliance Certification Application
(CCA) for the Waste Isolation Pilot Plant (WIPP) is complete. The
Administrator of the EPA provided written notice of the completeness
decision to the Secretary of Energy on May 16, 1997. The text of the
letter is contained in the SUPPLEMENTARY INFORMATION.
EPA has determined that the CCA is complete in accordance with 40
CFR Part 194, ``Criteria for the Certification and Recertification of
the Waste Isolation Pilot Plant's Compliance with the 40 CFR Part 191
Disposal Regulations'' (Compliance Certification Criteria). The
completeness determination is an interim preliminary administrative
step in the certification rulemaking for WIPP that is required by
regulation, and does not imply in any way that the CCA demonstrates
compliance with the Compliance Criteria and/or the Disposal
Regulations.
ADDRESSES: Written comments should be submitted, in duplicate, to:
Docket No. A-93-02, Air Docket, Room M-1500 (LE-131), U.S.
Environmental Protection Agency, 401 M Street, S.W., Washington, D.C.,
20460.
FOR FURTHER INFORMATION CONTACT: Mary Kruger or Scott Monroe; telephone
number: (202)233-9310; address: Radiation Protection Division, Mail
Code 6602J, U.S. Environmental Protection Agency, Washington, DC 20460.
SUPPLEMENTARY INFORMATION:
Background
The Waste Isolation Pilot Plant (WIPP) was authorized in 1980,
under section 213 of the Department of Energy (DOE) National Security
and Military Applications of Nuclear Energy Authorization Act of 1980
(Pub. L. 96-164, 93 Stat. 1259, 1265). The WIPP is being constructed by
the DOE near Carlsbad, New Mexico, as a potential repository for the
safe disposal of transuranic radioactive waste.
The 1992 WIPP Land Withdrawal Act, as amended (Pub. L. 102-579)
requires EPA to evaluate and certify whether the WIPP will comply with
subparts B and C of 40 CFR part 191--known as the ``disposal
regulations''--and to issue or deny a certification of compliance. The
Department of Energy is required to submit an application to EPA that
will be the basis of EPA's evaluation of whether a certification of the
WIPP's compliance with the disposal
[[Page 27997]]
regulations should be issued. The disposal regulations limit releases
of radioactive materials from disposal systems for radioactive waste,
and require implementation of measures to provide confidence for
compliance with the radiation release limits. Additionally, the
disposal regulations limit radiation doses to members of the public,
and protect ground water resources by establishing maximum
concentrations for radionuclides in ground water. For more information
about 40 CFR part 191, refer to Federal Register notices published in
1985 (50 FR 38066-38089, Sep. 19, 1985) and 1993 (58 FR 66398-66416,
Dec. 20, 1993).
The WIPP Land Withdrawal Act also calls for EPA to establish
criteria by which to judge whether the WIPP will comply with the
disposal regulations. EPA published the Compliance Certification
Criteria (40 CFR Part 194) on February 9, 1996. See 61 FR 5224. Thus,
EPA will determine whether the WIPP complies with the Part 191 disposal
regulations by applying the Compliance Certification Criteria in its
evaluation of the CCA. For more information about 40 CFR part 194,
refer to Federal Register notices published in 1995 (60 FR 5766-5791,
Jan. 30, 1995), and 1996 (61 FR 5224-5245, Feb. 9, 1996).
Section 8(d)(2) of the WIPP Land Withdrawal Act, as amended,
requires EPA to determine whether the WIPP complies with the disposal
regulations by rulemaking pursuant to the Administrative Procedure Act
(5 U.S.C. 553) within 1 year of receipt of the application. The
Compliance Certification Criteria at 40 C.F.R. 194.11 provide that
EPA's evaluation for certification pursuant to Section 8(d) shall not
begin until the Administrator has informed the Secretary in writing
that EPA has received a complete application.
With today's document, the Agency announces that it has determined
that the compliance certification application (CCA) for the WIPP is
sufficiently complete to allow EPA to conduct the required technical
evaluation. This determination is solely an administrative measure and
does not reflect any conclusion regarding the WIPP's compliance with
the disposal regulations.
DOE submitted the CCA to EPA on October 29, 1996. Pursuant to
Section 8(d)(1) of the WIPP Land Withdrawal Act, as amended, EPA
identified additional information necessary for the CCA to constitute a
complete application in a letter transmitted to DOE on December 19,
1996. DOE submitted the requested information with letters dated
January 17, January 24, February 7, February 14, and February 26, 1997.
EPA announced its receipt of the CCA in an Advance Notice of
Proposed Rulemaking (ANPRM) for the compliance determination published
in the Federal Register on November 15, 1996 (61 FR 58499). A copy of
the submitted application, as well as the Agency's comments on draft
versions, is available for inspection in EPA's public dockets, as
described below. In addition, all correspondence between EPA and DOE
regarding the completeness of the compliance application is available
in the public dockets.
EPA received numerous public comments regarding the completeness
and technical sufficiency of the CCA during both a 120-day public
comment period provided for in the ANPRM (November 15, 1996, to March
17, 1997) and a series of public hearings held in New Mexico. All
significant public comments received during the first public comment
period will be considered and responded to as EPA develops the proposed
certification decision on whether the WIPP complies with the disposal
regulations. In response to public requests for an additional
opportunity to comment on the complete CCA, EPA will accept and
consider public comments submitted to the docket after publication of
this notice.
EPA will determine whether to certify that the WIPP complies with
the disposal regulations after several additional regulatory steps,
including technical evaluation of the application, issuance of a notice
of proposed rulemaking in the Federal Register, a second 120-day public
comment period, a second set of public hearings in New Mexico, analysis
of public comments, and issuance of a final notice in the Federal
Register. A ``response to comments'' document that summarizes and
addresses significant comments will accompany the final notice and will
be made available in the public dockets. Comments must be received
within the time frame specified by the Notice of Proposed Rulemaking.
Any contacts between EPA and any party occurring after the close of the
comment period will be strictly governed in accordance with the
Administrator's Statement of Policy on ex parte contacts in rulemaking
and the transparency requirements of Executive Order 12866.
Text of Letter
Dear Mr. Secretary: Pursuant to Section 8(d) of the Waste
Isolation Pilot Plant (WIPP) Land Withdrawal Act, as amended,(the
Act, or the LWA), and in accordance with the WIPP Compliance
Criteria at 40 CFR Sec. 194.11, I hereby notify you that the U.S.
Environmental Protection Agency (EPA) has determined that the U.S.
Department of Energy's (DOE) Compliance Certification Application
(CCA) for WIPP is complete. This completeness determination is a
preliminary, interim determination required under the WIPP
Compliance Criteria, which implement the Agency's Final Radioactive
Waste Disposal Regulations at Subparts B and C of 40 CFR Part 191
(Disposal Regulations). While the completeness determination
initiates the one-year evaluation period provided for in Section
8(d)(2) of the LWA, it does not have any generally applicable legal
effect. Further, this determination does not imply or indicate that
the CCA demonstrates compliance with the Compliance Criteria and/or
the Disposal Regulations.
Section 8(d)(2) of the LWA requires EPA to certify whether WIPP
complies with the Agency's Disposal Regulations. Section 8(d)(4) of
the Act requires that EPA only perform such certification after DOE
has submitted a ``full'' (or complete) application. Upon receipt of
the CCA on October 29, 1996, EPA immediately commenced its review to
determine whether the CCA was complete. Shortly thereafter, the
Agency began to identify areas of the CCA that required
supplementary information and analyses. In addition, EPA received
numerous public comments on the CCA that identified areas of
concern.
EPA identified completeness concerns in a December 19, 1996
letter from Mary Nichols, Assistant Administrator for the Office of
Air and Radiation, to Alvin Alm, Assistant Secretary for
Environmental Management. DOE responded with additional information,
records packages, and clarifications, as necessary.
To the extent possible, the Agency has also been conducting a
preliminary technical sufficiency review, and has provided the
Department with relevant technical comments on an ongoing basis. EPA
will continue to conduct its technical review of the CCA. The Agency
will issue its proposed compliance certification decision, in
accordance with 40 CFR Part 194 and Part 191 Subparts B and C, after
it has thoroughly evaluated the complete CCA and considered relevant
public comments. Thank you for your cooperation during our review
process. Should you have questions regarding this request, please
contact Ramona Trovato at (202) 233-9320.
Sincerely,
[signed]
Carol M. Browner,
Administrator.
Additional Docket Information
The CCA consists of the application received by EPA on October 29,
1996, plus all relevant supplementary information sent by DOE after
that date. Documents that constitute the CCA are filed in Category II-G
of Docket No. A-93-02. Correspondence between DOE
[[Page 27998]]
and EPA in reference to the CCA is filed in Category II-I.
EPA maintains the following public information dockets: (1) Docket
No. A-93-02, located in room 1500 (first floor in Waterside Mall near
the Washington Information Center), U.S. Environmental Protection
Agency, 401 M Street, S.W., Washington, D.C., 20460 (open from 8:00
a.m. to 4:00 p.m. on weekdays); (2) EPA's docket in the Government
Publications Department of the Zimmerman Library of the University of
New Mexico located in Albuquerque, New Mexico, (open from 8:00 a.m. to
9:00 p.m. on Monday through Thursday, 8:00 a.m. to 5:00 p.m. on Friday,
9:00 a.m. to 5:00 p.m. on Saturday, and 1:00 p.m. to 9:00 p.m. on
Sunday); (3) EPA's docket in the Fogelson Library of the College of
Santa Fe in Santa Fe, New Mexico, located at 1600 St. Michaels Drive
(open from 8:00 a.m. to 12:00 midnight on Monday through Thursday, 8:00
a.m. to 5:00 p.m. on Friday, 9:00 a.m. to 5:00 p.m. on Saturday, 1:00
p.m. to 9:00 p.m. on Sunday); and (4) EPA's docket in the Municipal
Library of Carlsbad, New Mexico, located at 101 S. Halegueno (open from
10:00 a.m. to 9:00 p.m. on Monday through Thursday, 10:00 a.m. to 6:00
p.m. on Friday and Saturday, and 1:00 p.m. to 5:00 p.m. on Sunday). As
provided in 40 CFR part 2, a reasonable fee may be charged for
photocopying docket materials.
Dated: May 16, 1997.
Carol M. Browner,
Administrator.
[FR Doc. 97-13482 Filed 5-21-97; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 97-13468 Airworthiness Directives; Saab Model SAAB 2000 Series Airplanes
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 27986-27987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13468]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 62, No. 99 / Thursday, May 22, 1997 /
Proposed Rules
[[Page 27986]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 96-NM-211-AD]
RIN 2120-AA64
Airworthiness Directives; Saab Model SAAB 2000 Series Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This document proposes the adoption of a new airworthiness
directive (AD) that is applicable to certain Saab Model SAAB 2000
series airplanes. This proposal would require performing a one-time
inspection of the dropout boxes of the passenger oxygen system to
detect discrepancies and determine whether the system operates
properly; correcting any discrepancy found; and reworking or installing
new components, if necessary. This proposal is prompted by a report
indicating that the oxygen system failed to operate correctly after
activation at a low cabin pressure due to the incorrect installation of
the oxygen masks or oxygen generators during manufacturing. The actions
specified by the proposed AD are intended to ensure that a sufficient
supply of oxygen is provided to airplane passengers in the event of
rapid decompression of the airplane.
DATES: Comments must be received by July 3, 1997.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 96-NM-211-AD, 1601 Lind Avenue, SW.,
Renton, Washington 98055-4056. Comments may be inspected at this
location between 9:00 a.m. and 3:00 p.m., Monday through Friday, except
Federal holidays.
The service information referenced in the proposed rule may be
obtained from Saab Aircraft AB, Saab Aircraft Product Support, S-
581.88, Linkping, Sweden. This information may be examined at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington.
FOR FURTHER INFORMATION CONTACT: Ruth Harder, Aerospace Engineer,
Standardization Branch, ANM-113, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425)
227-1721; fax (425) 227-1149.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall identify the Rules Docket number
and be submitted in triplicate to the address specified above. All
communications received on or before the closing date for comments,
specified above, will be considered before taking action on the
proposed rule. The proposals contained in this notice may be changed in
light of the comments received.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 96-NM-211-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 96-NM-211-AD, 1601 Lind Avenue, SW., Renton, Washington
98055-4056.
Discussion
The Luftfartsverket (LFV), which is the airworthiness authority for
Sweden, notified the FAA that an unsafe condition may exist on certain
Saab Model SAAB 2000 series airplanes. The LFV advises of reports
indicating that the passenger oxygen system failed to operate correctly
in an airplane after activation at a low cabin pressure due to the
improper packing of the mask assemblies or incorrect installation of
the oxygen generators or masks during manufacturing. The following
failures were noted for some of the oxygen system components:
1. Lids to the dropout boxes did not open.
2. Oxygen mask hoses became disconnected from the generator outlet
connections.
3. Oxygen masks were not released from the dropout boxes.
In addition, subsequent inspection of the passenger oxygen system
on one Model SAAB 2000 series airplane revealed that two oxygen
generators were released along with the oxygen masks, which indicates
that the oxygen mask assembly was incorrectly packed in the dropout
boxes.
Improper functioning of the passenger oxygen system, if not
corrected, could result in an insufficient supply of oxygen being
provided to airplane passengers in the event of rapid decompression of
the airplane.
Explanation of Relevant Service Information
Saab has issued Service Bulletin 2000-35-001, dated February 20,
1996, which describes procedures for performing a one-time inspection
of the dropout boxes of the passenger oxygen system to detect
discrepancies and determine whether the system operates properly;
correcting any discrepancy found; and reworking or installing new
components, if necessary.
The LFV classified this service bulletin as mandatory and issued
Swedish airworthiness directive (SAD) 1-091, dated February 20, 1996,
in order to assure the continued airworthiness of these airplanes in
Sweden.
FAA's Conclusions
This airplane model is manufactured in Sweden and is type
certificated for operation in the United States under the provisions of
section 21.29 of the
[[Page 27987]]
Federal Aviation Regulations (14 CFR 21.29) and the applicable
bilateral airworthiness agreement. Pursuant to this bilateral
airworthiness agreement, the LFV has kept the FAA informed of the
situation described above. The FAA has examined the findings of the
LFV, reviewed all available information, and determined that AD action
is necessary for products of this type design that are certificated for
operation in the United States.
Explanation of Requirements of Proposed Rule
Since an unsafe condition has been identified that is likely to
exist or develop on other airplanes of the same type design registered
in the United States, the proposed AD would require performing a one-
time inspection of the dropout boxes of the passenger oxygen system to
detect discrepancies and determine whether the system operates
properly; correcting any discrepancy found; and reworking or installing
new components, if necessary. These actions would be required to be
accomplished in accordance with the service bulletin described
previously.
Cost Impact
The FAA estimates that 3 Saab Model SAAB 2000 series airplanes of
U.S. registry would be affected by this proposed AD, that it would take
approximately 3 work hours per airplane to accomplish the proposed
actions, and that the average labor rate is $60 per work hour. Based on
these figures, the cost impact of the proposed AD on U.S. operators is
estimated to be $540, or $180 per airplane.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the proposed requirements of
this AD action, and that no operator would accomplish those actions in
the future if this AD were not adopted.
Regulatory Impact
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this
proposal would not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this proposed
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
SAAB Aircraft AB: Docket 96-NM-211-AD.
Applicability: Model SAAB 2000 series airplanes, having serial
numbers -003 through -039 inclusive; certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
otherwise modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (b) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent an insufficient supply of oxygen being provided to
airplane passengers in the event of rapid decompression of the
airplane, accomplish the following:
(a) Within 30 days after the effective date of this AD, perform
a one-time inspection of the dropout boxes of the passenger oxygen
system to detect discrepancies and determine whether the system
operates properly, in accordance with the Accomplishment
Instructions of Saab Service Bulletin 2000-35-001, dated February
20, 1996.
(1) If the passenger oxygen system operates properly and no
discrepancy is found in this system, no further action is required
by this AD.
(2) If any discrepancy is found in the passenger oxygen system,
prior to further flight, perform rework or install new components,
as applicable, in accordance with the service bulletin.
(b) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Standardization Branch, ANM-113,
FAA, Transport Airplane Directorate. Operators shall submit their
requests through an appropriate FAA Principal Maintenance Inspector,
who may add comments and then send it to the Manager,
Standardization Branch, ANM-113.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Standardization Branch, ANM-113.
(c) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
Issued in Renton, Washington, on May 16, 1997.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 97-13468 Filed 5-21-97; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 97-13466 Airworthiness Directives; Saab Model SAAB 2000 Series Airplanes
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 27987-27989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13466]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 96-NM-213-AD]
RIN 2120-AA64
Airworthiness Directives; Saab Model SAAB 2000 Series Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This document proposes the adoption of a new airworthiness
directive (AD) that is applicable to certain Saab Model SAAB 2000
series airplanes. This proposal would require the deactivation of
certain floormat heaters in the cabin area. In addition, this proposal
would provide for optional terminating action for that deactivation.
This proposal is prompted by a report indicating that a flight
attendant's floormat heater became overheated as a result of a short
circuit between a floormat heater and a floor
[[Page 27988]]
panel that was made of conductive material; this condition resulted in
smoke in the cabin area. The actions specified by the proposed AD are
intended to prevent such short circuiting, which could cause
overheating of the floormat heater and lead to smoke or fire in the
airplane cabin.
DATES: Comments must be received by July 3, 1997.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 96-NM-213-AD, 1601 Lind Avenue, SW.,
Renton, Washington 98055-4056. Comments may be inspected at this
location between 9:00 a.m. and 3:00 p.m., Monday through Friday, except
Federal holidays.
The service information referenced in the proposed rule may be
obtained from SAAB Aircraft AB, SAAB Aircraft Product Support, S-
581.88, Linkoping, Sweden. This information may be examined at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington.
FOR FURTHER INFORMATION CONTACT: Ruth Harder, Aerospace Engineer,
Standardization Branch, ANM-113, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425)
227-1721; fax (425) 227-1149.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall identify the Rules Docket number
and be submitted in triplicate to the address specified above. All
communications received on or before the closing date for comments,
specified above, will be considered before taking action on the
proposed rule. The proposals contained in this notice may be changed in
light of the comments received.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 96-NM-213-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 96-NM-213-AD, 1601 Lind Avenue, SW., Renton, Washington
98055-4056.
Discussion
The Luftfartsverket (LFV), which is the airworthiness authority for
Sweden, notified the FAA that an unsafe condition may exist on certain
Saab Model SAAB 2000 series airplanes. The LFV advises of a report
indicating that during flight of a Model SAAB 2000 series airplane, a
flight attendant's floormat heater in the cabin area overheated as a
result of a short circuit between the heater and the floor. A possible
cause was attributed to an object being placed inadvertently between a
floormat heater and a floor panel that was made with a conductive
carbon fiber skin. Such short circuiting, if not corrected, could cause
overheating of the floormat heater, and lead to smoke or fire in the
airplane cabin.
Explanation of Relevant Service Information
Saab has issued Service Bulletin 2000-A25-022, Revision 01, dated
January 23, 1996, which describes procedures for deactivating the
flight attendant's floormat heater in the cabin area, either by
disconnecting, isolating, and storing electrical cable HW71-20, or by
removing fuse 17HW (1) from panel 306VU. Accomplishment of this
deactivation will prevent a short circuit between the floormat heater
and floor panel. The LFV classified this service bulletin as mandatory
and issued Swedish airworthiness directive (SAD) 1-086, dated January
19, 1996, in order to assure the continued airworthiness of these
airplanes in Sweden.
In addition, Saab has issued Service Bulletin 2000-53-020, Revision
02, dated October 18, 1996, which describes procedures for replacing
the floor panel under the flight attendant's seat in the fuselage with
a new floor panel. These procedures include removing the existing floor
covering in the entrance area, floormat heater, and floor panel; and
installing a floormat heater, floor covering, and a new floor panel.
The existing floor panel, which is made of conductive carbon fiber skin
material, will be replaced by a new floor panel made of non-conductive
material. Accomplishment of these actions will eliminate the need for
deactivating the flight attendant's floormat heater, as described in
Saab Service Bulletin 2000-A25-022. The LFV classified Saab Service
Bulletin 2000-53-020 as optional.
FAA's Conclusions
This airplane model is manufactured in Sweden and is type
certificated for operation in the United States under the provisions of
section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and
the applicable bilateral airworthiness agreement. Pursuant to this
bilateral airworthiness agreement, the LFV has kept the FAA informed of
the situation described above. The FAA has examined the findings of the
LFV, reviewed all available information, and determined that AD action
is necessary for products of this type design that are certificated for
operation in the United States.
Explanation of Requirements of Proposed Rule
Since an unsafe condition has been identified that is likely to
exist or develop on other airplanes of the same type design registered
in the United States, the proposed AD would require the deactivation of
certain floormat heaters in the cabin area. In addition, this proposed
AD would also provide for optional terminating action for that
deactivation. These actions would be required to be accomplished in
accordance with the Saab service bulletins described previously.
Cost Impact
The FAA estimates that 3 Saab Model SAAB 2000 series airplanes of
U.S. registry would be affected by this proposed AD, that it would take
approximately 1 work hour per airplane to accomplish the proposed
deactivation, and that the average labor rate is $60 per work hour.
Based on these figures, the cost impact of the proposed AD on U.S.
operators is estimated to be $180, or $60 per airplane.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the proposed requirements of
this AD action, and that no operator would accomplish those actions in
the future if this AD were not adopted.
Should an operator elect to accomplish the optional terminating
action that would be provided by this AD action, it would take
approximately 2 work hours to accomplish it, at an
[[Page 27989]]
average labor rate of $60 per work hour. Required parts would be
supplied by the manufacturer to the operators at no cost. Based on
these figures, the cost impact of this optional terminating action is
estimated to be $120 per airplane.
Regulatory Impact
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this
proposal would not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this proposed
regulation: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
SAAB Aircraft AB: Docket 96-NM-213-AD.
Applicability: Model SAAB 2000 series airplanes, serial numbers
-004 through -039 inclusive, on which Saab Modification No. 5780, as
specified in Saab Service Bulletin 2000-53-020, Revision 02, dated
October 18, 1996, has not been accomplished; certificated in any
category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
otherwise modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (c) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent short circuiting between the floormat heater and the
floor panel, which could cause overheating of the floormat heater
and lead to smoke or fire in the airplane cabin, accomplish the
following:
(a) Within 14 days after the effective date of the AD,
deactivate the flight attendant's floormat heater by either
disconnecting electrical cable HW71-20 between the floormat heater
and the floor panel, or by removing fuse 17HW (1) on panel 306VU, in
accordance with Saab Service Bulletin 2000-A25-022, Revision 01,
dated January 23, 1996.
(b) Installation of a floormat heater, floor covering, and a new
floor panel made of non-conductive material, in accordance with Saab
Service Bulletin 2000-53-020, Revision 02, dated October 18, 1996,
constitutes terminating action for the deactivation required by
paragraph (a) of this AD.
(c) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Standardization Branch, ANM-113.
Operators shall submit their requests through an appropriate FAA
Principal Maintenance Inspector, who may add comments and then send
it to the Manager, Standardization Branch, ANM-113.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Standardization Branch, ANM-113.
(d) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
Issued in Renton, Washington, on May 16, 1997.
S.R. Miller,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 97-13466 Filed 5-21-97; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 97-13395 Family Relationships; Social Security Overall Minimum Guarantee
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 27989-27990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13395]
=======================================================================
-----------------------------------------------------------------------
RAILROAD RETIREMENT BOARD
20 CFR Parts 222 and 229
RIN 3220-AB28
Family Relationships; Social Security Overall Minimum Guarantee
AGENCY: Railroad Retirement Board.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In accord with amendments to the Social Security Act made by
section 104 of Public Law 104-121, the Railroad Retirement Board hereby
proposes to amend its regulations to eliminate the ``living with''
requirement as an alternative to actual dependency as a basis for
eligibility for an annuity as the stepchild of a railroad employee, and
to provide for termination of the inclusion of a stepchild in the
computation of the social security overall minimum guarantee provision
when the stepparent's marriage to the natural parent is terminated.
DATES: Comments must be received on or before July 21, 1997.
ADDRESSES: Secretary of the Board, Railroad Retirement Board, 844 North
Rush Street, Chicago, Illinois 60611.
FOR FURTHER INFORMATION CONTACT: Michael C. Litt, General Attorney,
Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois
60611, telephone (312) 751-4929, TTD (312) 751-4701.
SUPPLEMENTARY INFORMATION: Section 2(d)(4) of the Railroad Retirement
Act provides in pertinent part that a child is deemed dependent if the
conditions set forth in sections 202(d) (3), (4), and (9) of the Social
Security Act are met. Since section 202(d)(4), as amended by Public Law
104-121, requires as a condition of dependency that the child have
received one-half his or her support from the stepparent, and
eliminates the alternative of the child having lived with the
stepparent as a means of establishing dependency, this change in the
definition of dependency in regard to stepchildren applies to benefits
paid under the Railroad Retirement Act. Specifically, it will impact
upon the entitlement of a spouse or survivor of an employee whose
entitlement is based upon having a stepchild of the employee in care,
or on an individual seeking a child's annuity as a stepchild of an
employee. In these instances, actual dependency on the employee will
have to be established for purposes of entitlement. The amendment is
effective with respect to the benefits of individuals who become
entitled to benefits for July 1996 and later.
[[Page 27990]]
The change will also affect the inclusion of auxiliary
beneficiaries in the computation of the employee annuity under the
Social Security overall minimum guarantee provision of the Railroad
Retirement Act. The Social Security overall minimum guarantee provision
guarantees that a railroad retirement annuitant will receive, in a
combined benefits under the Railroad Retirement and Social Security
Acts, not less than the amount which would have been paid to the
employee and members of his family under the Social Security Act if the
employee's railroad service had been creditable under that Act.
Public Law 104-121 also amends section 202(d)(1) of the Social
Security Act to provide that a child's benefits based on the earnings
record of a stepparent will terminate the month after the month in
which the stepparent and the natural parent are divorced. The Railroad
Retirement Act contains its own termination provisions: Section 5(c)(7)
of that Act specifies when a child's annuity paid under the Railroad
Retirement Act terminates. Therefore, this amendment to section
202(d)(1) does not directly apply to benefits paid under the Railroad
Retirement Act. However, it will affect the inclusion of auxiliary
beneficiaries in the computation of the Social Security overall minimum
guarantee provision.
Consequently, under section 202(d)(1), as amended, if the marriage
of a railroad employee stepparent and natural parent is terminated,
then the stepchild would no longer be included in the computation under
the Social Security overall minimum guarantee provision. Therefore, the
Board is proposing to amend its regulations to provide that the
inclusion of the stepchild in the computation under the Social Security
overall minimum guarantee provision will terminate when the marriage of
the stepparent and the natural parent is terminated.
The Office of Management and Budget has determined that this is not
a significant regulatory action under Executive Order 12866. There are
no new information collections associated with this rule.
List of Subjects in 20 CFR Parts 222 and 229
Railroad employees, Railroad retirement.
For the reasons set out in the preamble, title 20, chapter II,
parts 222 and 229 of the Code of Federal Regulations are proposed to be
amended as follows:
PART 222--FAMILY RELATIONSHIPS
1. The authority citation for part 222 continues to read as
follows:
Authority: 45 U.S.C. 231f.
Sec. 222.55 [Amended]
2. Section 222.55 is amended by removing the words ``is living with
or''.
PART 229--SOCIAL SECURITY OVERALL MINIMUM GUARANTEE
3. The authority citation for part 229 continues to read as
follows:
Authority: 45 U.S.C. 231f(b)(5).
4. Section 229.42 is amended by removing the period at the end of
paragraph (f), by adding ``; or'' to the end of paragraph (f), and by
adding a new paragraph (g) to read as follows:
Sec. 229.42 When a child can no longer be included in computing an
annuity rate under the overall minimum.
* * * * *
(g) In the case of a stepchild of the employees, the month after
the month in which the divorce between the stepparent and the natural
parent becomes final.
Dated: May 9, 1997.
Beatrice Ezerski,
Secretary of the Board.
[FR Doc. 97-13395 Filed 5-21-97; 8:45 am]
BILLING CODE 7905-01-M
Complete official Federal Register PDF
FR Doc. 97-13379 Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Coronary Heart Disease
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 28234-28245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13379]
Federal Register / Vol. 62, No. 99 / Thursday, May 22, 1997 /
Proposed Rules
[[Page 28234]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 96P-0338]
Food Labeling: Health Claims; Soluble Fiber from Certain Foods
and Coronary Heart Disease
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to
authorize the use, on food labels and in food labeling, of health
claims on the association between soluble fiber from psyllium husks and
reduced risk of coronary heart disease (CHD). FDA is proposing this
action in response to a petition filed by the Kellogg Co. (the
petitioner). The agency has tentatively concluded that, based on the
totality of publicly available scientific evidence, soluble fiber from
psyllium husk, similar to beta ()-glucan soluble fiber from
whole oats, when included as part of a diet low in saturated fat and
cholesterol, may reduce the risk of CHD by lowering blood cholesterol
levels. Therefore, the agency is proposing to amend the regulation that
authorized a health claim on soluble fiber from whole oats and the risk
of CHD to include soluble fiber from psyllium husks.
DATES: Written comments by August 5, 1997. The agency is proposing that
any final rule that may issue based upon this proposal become effective
upon its publication.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5916.
SUPPLEMENTARY INFORMATION:
I. Background
The Nutrition Labeling and Education Act of 1990
On November 8, 1990, the President signed into law the Nutrition
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). This new law amended the Federal Food, Drug, and Cosmetic Act
(the act) in a number of important ways. One of the most notable
aspects of the 1990 amendments was that they confirmed FDA's authority
to regulate health claims on food labels and in food labeling.
In the Federal Register of January 6, 1993 (58 FR 2478), FDA
adopted a final rule that implemented the health claim provisions of
the act (hereinafter referred to as the 1993 health claims final rule).
In that final rule, FDA adopted Sec. 101.14 (21 CFR 101.14), which sets
out the rules for the authorization and use of health claims. The
agency also adopted Sec. 101.70 (21 CFR 101.70), which establishes a
process for petitioning the agency to authorize health claims about a
substance-disease relationship (Sec. 101.70(a)) and sets out the types
of information that any such petition must include (Sec. 101.70(d)).
These regulations became effective on May 8, 1993.
In addition, FDA conducted an extensive review of the evidence on
the 10 substance-disease relationships listed in the 1990 amendments.
As a result of its review, FDA has authorized claims that relate to 8
of these 10 relationships.
In its review of the relationship between dietary fiber and
cardiovascular disease (CVD), the agency reviewed all relevant
scientific evidence on dietary fiber and its effects on serum
cholesterol. The agency started by examining the conclusions and
recommendations of the pertinent Federal Government reviews on this
topic area: the 1988 ``Surgeon General's Report on Nutrition and
Health'' (the Surgeon General's report) (Ref. 3) and the 1989 Food and
Nutrition Board, National Academy of Sciences' (FNB/NAS) ``Diet and
Health'' (Ref. 4). These two reports (Refs. 3 and 4) provided a
comprehensive review of the role of a broad range of nutrients,
including dietary fiber, in the development of a number of chronic
diseases, including heart disease. Because the FNB/NAS and Surgeon
General's report were done independently but concurrently, taken
together, they provide an authoritative picture of the state of
scientific opinion at the time that they were published in 1988 and
1989. Therefore, the agency began its review of the dietary fiber
evidence with studies that had been published since 1988. This evidence
included studies on all fibers and did not focus on any particular
individual fibers. While the agency denied the use in food labeling of
health claims relating total dietary fiber to reduced risk of CVD (58
FR 2552), it authorized a health claim relating diets low in saturated
fat and cholesterol and high in fruits, vegetables, and grain products
that contain dietary fiber (particularly soluble fiber) to a reduced
risk of CHD, one of the most common, most frequently reported, and most
serious forms of CVD.
In denying the dietary fiber and CVD health claim, the agency
stated that it is difficult to determine the relationship between
dietary fiber and heart disease because dietary fiber is a diverse
group of chemical substances that may be associated with different
physiological functions (58 FR 2552 at 2572). Chemically and
physiologically, cellulose, lignin, hemicellulose, pectin, and alginate
(all relatively purified fiber types) behave differently. Likewise,
wheat bran, oat bran, and rice bran (all heterogeneous mixtures of
fibers) are not similar in composition. The agency also noted that it
is very difficult to chemically analyze dietary fiber components, and
that, consequently, it is hard to correlate the role of specific fiber
components to health effects.
Based on its review of numerous authoritative documents, including
Federal Government reports and recent research on dietary fiber and
CHD, and on its consideration of comments received in response to the
proposed rule entitled ``Health Claims; Dietary Fiber and
Cardiovascular Disease'' (56 FR 60582, November 27, 1991) (hereinafter
referred to as the 1991 dietary fiber and CVD proposal), FDA concluded
that the publicly available scientific evidence supported an
association between diets low in saturated fat and cholesterol and high
in fruits, vegetables, and grain products (i.e., foods that are low in
saturated fat and cholesterol and that are good sources of dietary
fiber) and reduced risk of heart disease (58 FR 2552 at 2572). The
agency further stated that, although the specific roles of the numerous
potentially protective substances in such plant foods were not yet
understood, populations with diets rich in these foods experience many
health advantages, including lower rates of heart disease. The agency
noted, however, that there was no scientific agreement as to whether
the observed protective effects against heart disease were the result
of the combination of nutrient components of the foods, including
soluble fiber; of the other components of soluble fiber-rich diets (for
example, potassium and magnesium); of the displacement of saturated fat
and cholesterol from the diet; or of nonnutritive substances in these
foods.
For all these reasons, the agency stated that the fact that these
foods contain dietary fiber, particularly soluble fiber, could serve as
a useful marker for identifying those fruits, vegetables, and grain
products that,
[[Page 28235]]
when added to diets low in saturated fat and cholesterol, may help in
reducing blood low density lipoprotein (LDL)-cholesterol levels (58 FR
2552 at 2572). Thus, the agency authorized a health claim in
Sec. 101.77 (21 CFR 101.77) on the association between diets low in
saturated fat and cholesterol and high in vegetables, fruit, and grain
products that contain soluble fiber and a reduced risk of heart
disease.
In the 1993 dietary fiber and CVD final rule, in response to a
comment regarding the apparent hypocholesterolemic properties of
specific food fibers, e.g., oats, FDA agreed that the effectiveness of
naturally occurring fibers in foods may be documented for specific food
products (e.g., oat brans meeting specified parameters) (58 FR 2552 at
2567). Further, the agency stated that if manufacturers could document,
through appropriate studies, that dietary consumption of the soluble
fiber in their particular food has the effect of lowering LDL-
cholesterol, and has no adverse effects on other heart disease risk
factors (e.g., high density lipoprotein (HDL)-cholesterol), they should
petition for a health claim for their particular product.
In the Federal Register of January 23, 1997, FDA published a final
rule on the relationship between soluble fiber from whole oats and
reduced risk of coronary heart disease (the soluble fiber from whole
oats final rule), Sec. 101.81 (21 CFR 101.81) (62 FR 3584 and modified
at 62 FR 15343, March 31, 1997). In that document, the agency concluded
that the type of soluble fiber in whole oats, -glucan soluble
fiber, is the primary component responsible for the hypocholesterolemic
properties associated with consumption of whole oat products as part of
a diet that is low in saturated fat and cholesterol (62 FR 3584 at
3585). The agency based its conclusions on the totality of publicly
available evidence, taking into account evidence showing that
consumption of -glucan soluble fiber from whole oats has the
effect of lowering blood total- and LDL-cholesterol in both humans and
animals (62 FR 3584 at 3586).
The agency also acknowledged the likelihood that consumption of
-glucan soluble fiber from sources other than whole oats, as
well as that from certain other non -glucan soluble fibers,
will affect, as part of an appropriate diet, blood lipid levels (62 FR
3584 at 3587). Although the agency considered structuring the final
rule as one on ``soluble fiber from certain foods'' and the risk of CHD
to allow flexibility in expanding the claim to other sources of soluble
fiber, it stated that it was premature to do so inasmuch as the agency
had not reviewed the totality of evidence on other, non-whole oat
sources of soluble fiber. However, FDA structured Sec. 101.81 in a way
that, while the regulation covered -glucan soluble fiber from
whole oats, would allow it to be amended as evidence becomes available
to support the use of the claim for other sources of soluble fiber.
The present rulemaking is in response to a manufacturer's health
claim petition on the relationship between soluble fiber from psyllium
and the risk of heart disease.
II. Petition for Health Claim on Psyllium and Reduced Risk of CHD
A. Background
On June 12, 1996, the Kellogg Co. submitted a petition to FDA
requesting that the agency authorize a health claim on the relationship
between consumption of soluble fiber from psyllium (specifically from
psyllium husks) and the risk of CHD (Ref. 1). On September 18, 1996,
the agency sent the petitioner a letter stating that it had completed
its initial review of the petition, and that the petition would be
filed in accordance with section 403(r)(4) of the act (21 U.S.C.
343(r)(4)) (Ref. 2). In this document, the agency will consider whether
a health claim on this nutrient-disease relationship is justified under
the standard in section 403(r)(3)(B)(i) of the act and in
Sec. 101.14(c) of FDA's regulations. The following is a review of the
health claim petition.
B. Preliminary Requirements
1. The Substance Is Associated With a Disease for Which the U.S.
Population Is at Risk
The regulations authorizing claims on dietary saturated fat and
cholesterol and risk of CHD (Sec. 101.75 (21 CFR 101.75)); fruits,
vegetables, and grain products that contain soluble fiber and risk of
CHD (Sec. 101.77); and soluble fiber from whole oats and risk of CHD
(Sec. 101.81) establish that CHD is a disease for which the U.S.
population is at risk. In adopting those regulations, FDA stated that
CHD remains a major public health problem, the number one cause of
death in the United States. Despite the decline in deaths from CHD over
the past 30 years, this disease is still exacting a tremendous toll in
morbidity and mortality (Refs. 3 through 5). There are more than
500,000 deaths each year for which CHD is an underlying cause, and
another 250,000 deaths for which CHD is a contributing cause. About 20
percent of American adults ages 20 to 74 years have blood total
cholesterol levels in the ``high'' category (total cholesterol greater
than or equal to () 240 milligrams (mg) per (/) deciliter
(dL) or LDL-cholesterol 160 mg/dL) (Ref. 6). Another 31
percent have ``borderline'' cholesterol levels (total cholesterol
between 200 to 239 mg/dL). Therefore, based on these facts as presented
in Secs. 101.75, 101.77, and 101.81, FDA tentatively concludes that the
requirement in Sec. 101.14(b)(1) has been met.
2. The Substance is a Food
Psyllium is a harvestable grain from plants of the Plantago genus
(Ref. 1, p. 5-6). Different types of psyllium are available, depending
on the growing region. It is primarily cultivated in France, Spain, and
India, with some small quantities grown in the American Southwest.
Psyllium husk (also known as psyllium seed husk), which comes from the
dried coat of the psyllium seed, is used as a food or food component in
a number of foods in the United States (Ref. 1, p. 9-11) and is the
source of psyllium soluble fiber that is the subject of the petition.
Psyllium husk is a concentrated source of soluble fiber and contributes
certain technical effects (e.g., as a stabilizer) that are retained
when it is consumed at levels necessary to justify the petitioned
claim.
Therefore, FDA tentatively concludes that the substance satisfies
the preliminary requirements of Sec. 101.14(b)(3)(i).
3. The Substance Is Safe and Lawful
The petitioner has also submitted a petition requesting that FDA
affirm that the use of psyllium husk in grain-based foods is generally
recognized as safe (GRAS) (55 FR 4481, February 8, 1990). The agency
notes that this GRAS affirmation petition (GRASP 0G0357) is still under
review, and that authorization of a health claim should not be
interpreted as affirmation that the petitioned uses of psyllium are
GRAS. Such a determination can be made only after the agency has
completed its review of the GRAS petition. A preliminary review of the
GRAS affirmation petition, however, reveals that it contains
significant evidence supporting the safety of the use of this substance
at the levels necessary to justify a health claim.
In its GRAS affirmation petition, the petitioner relied heavily on
the conclusions about the safety of psyllium by the Life Sciences
Research Office (LSRO) of the Federation of American Societies for
Experimental Biology (FASEB) (Ref. 1, pp. 12-17). In its 1993 report
entitled ``The Evaluation of the Safety of Using Psyllium Husk as a
Food Ingredient,'' LSRO reviewed and
[[Page 28236]]
evaluated published data, unpublished studies that were in press at
that time, and other information and data. Based on this review, LSRO
concluded that:
There is no evidence in the available information on psyllium
that demonstrates or suggests reasonable grounds to suspect a hazard
to the public when it is used in a number of food categories and at
levels of addition that would result in total consumption of as much
as 25 g/day of psyllium. However, it is not possible to determine
without additional data whether a significant increase in
consumption above 20 to 25 g/day would constitute a dietary hazard.
(Ref. 31, p. 57.) The agency is not prepared to disagree with LSRO's
conclusions on the safety of psyllium husk.
The agency points out, however, that some concerns about the safety
of psyllium do exist. For example, available information suggests that
long-term exposure to high levels of psyllium husk may enhance
epithelial cell proliferation in the gastrointestinal tract. Rats
consuming an elemental diet containing 30 percent fiber supplement, of
which 10 percent was Ispaghula (psyllium), had increased cell
proliferation in the stomach, distal small intestine, and colon when
compared to rats consuming an elemental diet with no fiber supplement
(Ref. 36). There is no agreement in the scientific community, however,
whether such an increase in cell proliferation is related to an adverse
health effect (Ref. 37). FDA requests comments on whether enhanced
proliferation of gastrointestinal tract epithelial cells as a result of
long-term exposure to psyllium husk is of concern, and whether it would
provide a basis for not authorizing a claim.
The agency is also aware that psyllium husk can cause allergic
reactions in some people, such as health care professionals, who
regularly dispense psyllium containing products in the course of their
work. Information provided by the petitioner (Ref. 32) shows that there
are at least 13 protein fractions present in psyllium husk
preparations. Some of these protein fractions cross react with sera
obtained from individuals who experienced allergic reactions to
psyllium-containing foods. The information also shows that refinement
of psyllium husk preparations, i.e., increasing the purity of psyllium
husk, by mechanical sieving can reduce the level of antigenic protein
fractions (Ref. 32).
Because of concerns regarding the allergenic potential of products
derived from psyllium seed, FDA is proposing specifications for the
purity of the psyllium husk that is the subject of this health claim
proposal to reduce the potential for allergic reactions to foods
containing added psyllium. These specifications are based on
information provided in the petition (Ref. 32) and on the
specifications used by the petitioner (Ref. 1). FDA requests comments
on the adequacy of these proposed specifications to reduce the
allergenic potential of psyllium husk consumed as a component of food.
Are other steps, such as requiring that a psyllium-containing product
that bears a health claim declare on its prinicipal display panel that
psyllium is present in the food, necessary?
Additionally, the agency is aware of the potential for
gastrointestinal obstruction to occur following consumption of psyllium
husk in the absence of sufficient liquid to ensure thorough hydration.
However, the 1993 report by LSRO noted that reports of gastrointestinal
obstruction have been associated almost exclusively with consumption of
bulk laxatives without proper hydration (Ref. 31). Moreover, LSRO
stated that there have been no such reports associated with the
consumption of psyllium-containing cereals consumed with milk. It also
noted that there are no data regarding possible alimentary tract
obstruction that could be associated with consumption of psyllium-
containing products such as poptarts, waffles, breads, and other foods
that may be consumed without a liquid (Ref. 31). LSRO stated that the
moderate amount of psyllium in these products would not be expected to
cause gastrointestinal obstruction, and that any such possibility would
be reduced by a suitable suggestion that these products be consumed
with fluids (Ref. 31). The agency is asking for comments on whether
psyllium-containing foods should carry a statement advising that the
product be consumed with liquids, or whether the potential for blockage
is not an issue of concern for psyllium-containing food.
Based on the totality of the evidence, the agency is not prepared,
at this time, to take issue with the petitioner's view that the use of
psyllium husk is safe and lawful. Although FDA tentatively concludes
that the petitioner has provided evidence that satisfies the
requirement in Sec. 101.14(b)(3)(ii) that use of psyllium husk at the
levels necessary to justify a claim is safe and lawful, the agency
requests comment on this tentative conclusion. The agency recognizes
that, should this proposed health claim be authorized, there may be an
increase in the consumption of psyllium. Therefore, the agency also
requests comments on actions, if any, that may be necessary to ensure
that longterm consumption of psyllium will be at safe levels, such as
establishing a maximum psyllium content that foods may contain to bear
the health claim or limiting the kinds of foods that can contain
psyllium and bear a claim.
III. Review of Scientific Evidence
A. Basis for Evaluating the Relationship Between Soluble Fiber from
Psyllium and CHD
In the 1991 dietary fiber and CVD proposal, the agency set forth
the basis for the relationship between dietary fiber and CVD (56 FR
60582 at 60583). In that document, the agency stated that there are
many risk factors that contribute to the development of CVD, and
specifically CHD, one of the most serious forms of CVD and the leading
cause of disability. The agency also stated that there is general
agreement that elevated blood cholesterol levels are one of the major
``modifiable'' risk factors in the development of CVD and, more
specifically, CHD.
The Federal Government and others who have reviewed the matter have
concluded that there is substantial epidemiologic evidence that high
blood levels of total cholesterol and LDL-cholesterol are a cause of
atherosclerosis (inadequate circulation of blood to the heart due to
narrowing of the arteries) and represent major contributors to CHD (56
FR 60582 at 60583, Refs. 3 through 5). Factors that decrease total
cholesterol and LDL-cholesterol will also tend to decrease the risk of
CHD. High intakes of saturated fat and, to a lesser degree, of dietary
cholesterol are associated with elevated blood total and LDL-
cholesterol levels (56 FR 60727 at 60728, November 27, 1991). Thus, it
is generally accepted that blood total cholesterol and LDL-cholesterol
levels can influence the risk of developing CHD, and, therefore, that
dietary factors affecting blood total cholesterol levels affect the
risk of CHD (Refs. 3 through 5).
When considering the effect that the diet or components of the diet
have on blood (or serum) lipids, it is also important to consider the
effect that these factors may have on blood levels of high density
lipoprotein-cholesterol (HDL-cholesterol). HDL-cholesterol is involved
in the regulation of cholesterol transport out of cells and to the
liver, from which it is ultimately excreted (Refs. 3 and 33).
Therefore, HDL-cholesterol has a protective effect in the body by
helping to reduce the risk of CHD.
[[Page 28237]]
For these reasons, FDA limited its review of the relationship
between soluble fiber from the psyllium husk, hereinafter referred to
as ``psyllium,'' and CHD to effects of dietary intake of this substance
on blood lipid levels and on the risk of developing CHD. The agency
based its evaluation of the relationship between consumption of this
substance and CHD on changes in blood total cholesterol, LDL-
cholesterol, and HDL-cholesterol, resulting from dietary intervention
with soluble fiber from psyllium and with psyllium-containing products.
This focus is consistent with that used by the agency in response to
the 1990 amendments in deciding on the dietary saturated fat and
cholesterol and CHD health claim, Sec. 101.75 (56 FR 60727 and 58 FR
2739); the fruits, vegetables, and grain products and CHD claim,
Sec. 101.77 (56 FR 60582 and 58 FR 2552); and the soluble fiber from
whole oats and CHD claim, Sec. 101.81 (61 FR 296 and 62 FR 3584).
B. Review of Scientific Evidence
1. Evidence Considered in Reaching the Decision
The petitioner submitted scientific studies evaluating the
relationship between soluble fiber from psyllium, consumed as a food
and as an ingredient in foods, and serum lipid levels (Ref. 1). These
studies were conducted between 1965 and 1996. The petition included
tables that summarized the outcome of those studies and a summary of
the evidence. Consistent with the approach taken in the dietary fiber/
CVD proposed rules, the agency began its review by considering those
psyllium studies that were published since 1988 (date of publication of
the Surgeon General's report). In addition, in its review of the
petition, the agency considered the conclusions of two LSRO reports
(Refs. 7 and 8) relative to studies involving psyllium.
2. Criteria for Selection of Human Studies
The criteria that the agency used to select pertinent studies were
that the studies: (1) Present data and adequate descriptions of the
study design and methods; (2) be available in English; (3) include
estimates of, or enough information to estimate, soluble dietary fiber
intakes; (4) include direct measurement of blood total cholesterol and
other blood lipids related to CHD; and (5) be conducted in persons who
represent the general U.S. population (adults with blood total
cholesterol levels less than (<) 300 mg/dL).
In selecting human studies for review, the agency excluded studies
that were published in abstract form because they lacked sufficient
detail on study design and methodologies, and because they lacked
necessary primary data. Studies using special population groups, such
as insulin-dependent diabetics, individuals with very high serum
cholesterol (mean greater than 300 mg/dL), individuals taking lipid-
lowering medication during treatment periods, children with
hypercholesterolemia, and persons who had already experienced a
myocardial infarction, were excluded because of questions about their
relevance to the general healthy U.S. population. Studies in which
psyllium was tested as part of a mixture of other soluble fibers, e.g.,
oat bran, were also excluded from review because it was not possible to
evaluate the influence of psyllium alone on risk factors for heart
disease. These criteria are consistent with those that the agency used
to evaluate the relationship between other substances and CHD.
3. Criteria for Evaluating the Relationship Between Soluble Fiber from
Psyllium and CHD
FDA generally applied the same criteria in evaluating studies on
the relationship between soluble fiber from psyllium and CHD that it
used in evaluating studies on the relationship between dietary fiber
and CVD in the 1991 proposed rule (56 FR 60582 at 60587) and in the
January 1996 proposed rule on whole oats and CHD (61 FR 296). The
criteria that the agency used in evaluating the studies for this
rulemaking include: (1) Reliability and accuracy of the methods used in
nutrient intake analysis, including measurements of total dietary
soluble fiber and total dietary fiber; (2) estimates of intake of
saturated fat and cholesterol; (3) available information on the soluble
fiber content of the psyllium test products and control food; (4)
measurement of study endpoints (i.e., total cholesterol, LDL-
cholesterol, and HDL-cholesterol); and (5) general study design
characteristics.
The general study design characteristics for which the agency
looked included randomization of subjects, appropriateness of controls,
selection criteria for subjects, attrition rates (including reasons for
attrition), potential for misclassification of individuals with regard
to dietary intakes, presence of recall bias and interviewer bias,
recognition and control of confounding factors (for example, monitoring
body weight and control of weight loss), appropriateness of statistical
tests and comparisons, and statistical power of the studies. The agency
considered whether the intervention studies that it evaluated had been
of long enough duration to reasonably ensure stabilization of blood
lipids (greater than or equal to 3 weeks duration). Finally, the agency
considered it highly desirable if the available information on a study
included information on total dietary soluble fiber content of
baseline, treatment, and control diets and on the nutrient intakes of
the subjects during the course of the study.
C. Review of Human Studies
FDA has done a comprehensive review of 21 human studies on psyllium
(Refs. 9 through 28 and 30) that were submitted with the petition and
met the forementioned criteria for selection (Ref. 35). Of these, the
agency gave particular weight to seven studies (Table 1 of this
document) (Refs. 14, 15, 16, 19, 23, 24, and 30) that were well
controlled, reported intakes of saturated fat and cholesterol, and
avoided problems associated with small sample size, lack of placebo
control, lack of blinding, and other design problems. The studies
listed in Table 1 also had run-in periods of 4 or more weeks duration
before the treatment period. During the run-in period, subjects
consumed a low saturated fat and cholesterol diet without psyllium or
placebo to allow time for serum lipid levels to stabilize to the change
in dietary intake. Three of the studies in Table 1 were randomized,
double blind, placebo-controlled, parallel trials (Refs. 14, 15, and
19). One study was a randomized, double blind, placebo-controlled,
crossover trial (Ref. 16), and three studies were randomized, single
blind, placebo-controlled, crossover trials (Refs. 23, 24, and 30).
Five of the studies (Refs. 14, 15, 19, 23, and 24) in Table 1
evaluated the effect of psyllium on serum lipid levels in subjects
consuming a Step 1 diet (Ref. 5) (i.e., a diet with no more than 30
percent of calories from total fat, less than 10 percent calories from
saturated fat, and less than 300 mg cholesterol daily,) and one study
(Ref. 30) included psyllium as part of a Step 2 diet (i.e., a diet with
no more than 30 percent of calories from total fat, <7 percent of
calories from saturated fat, and <200 mg/day (d) cholesterol). One
study (Ref. 16) evaluated the effects of psyllium in subjects consuming
their usual diets. The source of psyllium in three studies (Refs. 14,
16, and 19) was a bulk laxative. Subjects mixed the psyllium with a
liquid (usually water) and consumed it before meals. The placebo in
these studies was cellulose.
Four studies (Refs. 15, 23, 24, and 30) incorporated psyllium into
breakfast cereals or a variety of foods (e.g., breads,
[[Page 28238]]
cereal, pasta). In these studies, the placebo controls were the same or
similar foods that did not contain psyllium (e.g., breads, cereal,
pasta).
The level of psyllium consumed in the 7 studies ranged from 3.4
grams (g)/d (about 2.6 g/d soluble fiber) (Ref. 15) to about 11.6 g/d
(an estimated 8 g/d soluble fiber) (Refs. 23 and 24). The duration of
the treatment periods ranged from 4 weeks (Ref. 30) up to 24 weeks
(Ref. 15). The male and female subjects in the 7 studies were
moderately hypercholesterolemic and ranged in age from 20 to 80 years.
The results of the studies that evaluated psyllium as a supplement
to the diet (Refs. 14, 16, and 19) demonstrated that the subjects
consuming psyllium daily experienced significant decreases in blood
total cholesterol of about 4 percent (Refs. 14 and 16) and 5 percent
(Ref. 19) compared to the control group, which consumed a placebo. LDL-
cholesterol decreased significantly, from about 5 percent (Ref. 16) to
about 7 percent (Ref. 14), compared to the placebo control. In these
three studies, the psyllium group consumed 10.2 g/d psyllium (about 7
g/d soluble fiber) (Refs. 14 and 19) or 15.3 g/d (about 10 g/d soluble
fiber) (Ref. 16).
One study evaluated the effect of 3 levels of psyllium intake from
foods on lipid levels in hypercholesterolemic men and women (Ref. 15).
Three groups (Group 1, 2, and 3) consumed a variety of foods (cereal,
bread, pasta, and snack bars) that provided 3.4 g, 6.8 g, or 10.2 g/d
psyllium (Groups 1, 2, and 3, respectively) as part of a Step 1 diet
for 24 weeks. A control group consumed the same foods with no psyllium.
Blood total cholesterol was significantly lowered only in Group 3 from
2 to 4 percent compared to the control group. LDL-cholesterol decreased
significantly in Groups 1 and 3 (i.e., about 5 percent) compared to the
control group. The total soluble fiber intakes for the control and
Groups 1, 2, and 3 were 7 g, 10 g, 10.6 g, and 12.4 g/d, respectively.
The authors stated that the difference in soluble fiber intake among
the psyllium groups was less than expected and suggested that the
subjects may have partially substituted psyllium-containing foods for
other foods containing soluble fiber. The results of this study suggest
that there is a dose-response relationship between psyllium intake and
significant reductions in CHD risk factors, but no specific level can
be determined from these data because of possible problems with subject
compliance in Groups 1 and 2.
The results of three other studies that tested psyllium-containing
cereals (Refs. 23, 24, and 30) showed significant reductions in both
blood total cholesterol (about 4 to 8 percent) and LDL-cholesterol
(about 5 to 10 percent) compared to the placebo control. The subjects
in these studies consumed 9.3 g/d psyllium (about 6.8 g soluble fiber)
(Ref. 30) and 11 g/d psyllium (about 8 g soluble fiber) (Refs. 23 and
24).
There were no statistically significant differences between the
psyllium and placebo groups in HDL-cholesterol in all but one of the
studies in Table 1. In the one study (Ref. 19), post-treatment HDL-
cholesterol was significantly higher in the placebo group compared to
the psyllium group.
In summary, based on the totality of the evidence presented in
randomized studies, consumption of psyllium helped to reduce the levels
of blood total and LDL-cholesterol, and thus the risk of CHD, in
subjects with moderately elevated to high blood total cholesterol who
consumed either a Step 1 or Step 2 diet (low saturated fat and
cholesterol) or their usual diets. Psyllium did not adversely affect
HDL-cholesterol levels.
IV. Decision to Propose a Health Claim Relating Soluble Fiber from
Psyllium to Reduction in Risk of CHD
The results of 7 clinical trials with psyllium that were published
between 1988 and 1996 (Table 1), as discussed in section III.C, above,
consistently supported that there is a relationship between consumption
of soluble fiber from psyllium, as part of a diet that is low in
saturated fat and cholesterol, and reduced blood cholesterol levels,
which in turn may reduce the risk of heart disease. Based on this
evidence, FDA has tentatively concluded that there is significant
scientific agreement that the available evidence supports that this
nutrient/disease relationship is valid. Thus, the agency is proposing
to authorize health claims on the relationship between soluble fiber
from psyllium and reduced risk of CHD.
FDA points out, however, that in preparing this document, as is its
regular practice in health claim proceedings, the agency conferred with
other Public Health Service (PHS) agencies with relevant expertise.
These agencies have raised issues that merit consideration in this
rulemaking.
First, in the seven studies that met the criteria for evaluation,
three involved administration of psyllium in the form of a bulk
laxative (Refs. 14, 16, and 19), and in only four of the studies was
psyllium incorporated into foods (Refs. 15, 23, 24, and 30). One PHS
agency raised an issue about the appropriateness of reliance on the
former studies, in which psyllium was not consumed as an ingredient of
conventional food.
The agency has tentatively decided that reliance on References 14,
16, and 19, in which psyllium was administered in the form of a bulk
laxative, is appropriate because in these studies the psyllium was fed
at mealtimes, much in the manner of a dietary supplement, and in
concentrations similar to those at which psyllium was incorporated into
conventional foods in References 15, 23, 24, and 30. Moreover, the
effect of consuming psyllium on the risk of heart disease (i.e., about
3 to 5 percent reductions in blood total and LDL-cholesterol) observed
in the studies in which this substance was consumed in conventional
food, e.g., in cereal (Refs. 15, 23, 24, and 30), was similar to that
seen in the studies (Refs. 14, 16, and 19) in which it was consumed as
a bulk laxative. These results suggest that the form in which psyllium
is consumed is not significant. However, the agency is asking for
comments on whether it is appropriate to consider studies in which
psyllium was fed in bulk form as evidence in evaluating this substance/
disease relationship.
Second, the subject populations in the studies listed in Table 1
had borderline to high blood cholesterol levels. One PHS agency
questioned the relevance of these studies to the general population,
which includes individuals with normal as well as elevated blood
cholesterol levels. The agency has tentatively concluded that the
hypercholesterolemic study populations in the studies listed in Table 1
are relevant to the general population because, based on data from the
National Health and Nutrition Examination Surveys (NHANES) III, the
prevalence of individuals with elevated blood cholesterol (i.e., 200
mg/dL or greater) is high (approximately 51 percent of adults) (Ref.
6). The proportion of adults having moderately elevated blood
cholesterol levels (i.e., between 200 and 239 mg/dL) was estimated to
be approximately 31 percent, and the proportion of adults with high
blood cholesterol levels (240 mg/dL or greater) was estimated to be
approximately 20 percent (Ref. 6). It is also estimated that 52 million
Americans 20 years of age and older would be candidates for dietary
intervention to lower blood cholesterol (Ref. 6). The agency considers
the high proportion of Americans that have elevated blood cholesterol
levels (i.e., 51 percent) to make up a significant portion of the
general population, thus making the subject population in the studies
listed in Table 1 relevant to the general population. However, the
[[Page 28239]]
agency is asking for comments on this issue.
V. Decision to Propose to Amend Sec. 101.81
As discussed in section I.B of this document, FDA authorized a
claim for soluble fiber from whole oats and CHD on January 23, 1997 (62
FR 3584). In that document, the agency stated that it is very likely
that soluble fiber from certain foods, in addition to -glucan
soluble fiber from whole oats, may affect serum lipid levels and thus
help to reduce the risk of CHD (62 FR 3584 at 3587). The agency further
stated that if a manufacturer can document, through appropriate human
and laboratory studies, that a soluble fiber has an effect on blood
total- and LDL-cholesterol levels, and thereby can be useful in
reducing the risk of CHD, the manufacturer may petition to amend
Sec. 101.81 to include that source of soluble fiber among the food
sources about which claims are authorized (62 FR 3584 at 3587 and
3588). The agency explained that it was necessary to evaluate each
source of soluble fiber individually because soluble fiber is a family
of very heterogeneous substances that vary greatly in their effect on
the risk of CHD.
The agency tentatively concludes that the soluble fiber in
psyllium, like -glucan soluble fiber from whole oats, when
consumed as part of a diet low in saturated fat and cholesterol, may
help to reduce the risk of heart disease, and that a health claim
describing this relationship is warranted. To this end, the agency is
proposing to amend Sec. 101.81, as discussed below, to include soluble
fiber from psyllium and to broaden the subject of the claim to
``soluble fiber from certain foods'' and risk of CHD.
As discussed in the preamble to the soluble fiber from whole oats
final rule, an umbrella regulation for ``soluble fiber from certain
foods'' and CHD will provide flexibility for the inclusion of other
food sources of soluble fiber when adequate data are provided to
demonstrate that consumption of those foods may help to reduce the risk
of heart disease (62 FR 3584 at 3588). Moreover, such an umbrella
regulation has the advantage of minimizing consumer confusion in that
the claim could not be used on the label of all foods that contain
soluble fiber. Rather, the claim will be limited to those soluble fiber
sources whose consumption has been demonstrated to have a relationship
to the risk of CHD.
VI. Description of Modifications to Sec. 101.81
A. Eligible Sources of Soluble Fiber
Section 101.81(c)(2)(ii) (``Nature of the substance. Eligible
sources of soluble fiber'') lists the types and sources of soluble
fiber that have been demonstrated to the satisfaction of FDA to have a
relationship to the risk of CHD. In Sec. 101.81(c)(2)(ii)(A), FDA lists
-glucan soluble fiber from the whole oat sources, along with
the method of analysis for -glucan soluble fiber by the
Association of Official Analytical Chemists. Section
101.81(c)(2)(ii)(A)(1) through (c)(2)(ii)(A)(3) identify the whole oat
sources that are eligible to bear the claim. FDA reserved
Sec. 101.81(c)(2)(ii)(B) for future use.
In this document, FDA is proposing to add new
Sec. 101.81(c)(2)(ii)(B) to specify psyllium husk as a source of
soluble fiber eligible to be the subject of this claim. As discussed in
section II.B.3 of this document, the agency is aware that psyllium has
been associated with allergic reactions in some people, especially in
health care professionals who dispense psyllium containing products in
the course of their work. The petitioner stated that using psyllium
with a purity of 95 percent in cereal significantly reduced the
potential for allergenic responses following consumption of psyllium-
containing food (Ref. 1, pp. 85-86). Information provided by the
petitioner showed that psyllium husk that has a purity of 95 percent
has a maximum protein content of 3 percent and total extraneous matter
not to exceed 4.9 percent (i.e., 4.5 percent or less of light
extraneous matter and 0.5 percent or less of heavy extraneous matter,
as determined by USP methods (Ref. 34)).
In this document, the agency is proposing to adopt these
specifications for psyllium husk that may be the subject of a claim.
Therefore, proposed Sec. 101.81(c)(2)(ii)(B)(1) states that ``to
qualify for this claim, psyllium husk shall have a purity of no less
than 95 percent, such that it has a 3 percent or less protein content,
4.5 percent or less of light extraneous matter, and 0.5 percent or less
of heavy extraneous matter, but in no case may the combined extraneous
matter exceed 4.9 percent, as determined by U.S. Pharmacopeia (USP)
methods'' that are incorporated by reference (Ref. 1, pp. 5-6, and Ref.
34). The agency requests comments on whether the requirements proposed
in Sec. 101.81(c)(2)(ii)(B)(1) are sufficient to reduce the potential
for allergenic responses in individuals sensitive to psyllium.
Proposed Sec. 101.81(c)(2)(ii)(B)(1) identifies psyllium husk as
the dried seed coat (epidermis) of the seed of Plantago (P) ovata,
known as blond psyllium or Indian psyllium; P. indica; or P. psyllium.
This information is consistent with that provided by the petitioner
(Ref. 1, pp. 5 and 6) and the description of psyllium husk given in the
U.S. Pharmacopeia's (USP) ``The National Formulary'' (Ref. 34).
In proposed Sec. 101.81(c)(2)(ii)(B)(2), FDA identifies the
analytical method that it intends to use to determine the amount of
soluble fiber that is provided by psyllium. Because psyllium-containing
food products are highly viscous in aqueous solutions and may not be
easily filtered, a method for analyzing for soluble and insoluble
dietary fiber from psyllium was developed by Lee et al. (Ref. 29). The
assay, a modification of method No. 991.31 from ``Official Methods of
Analysis of the Association of Official Analytical Chemists'' (AOAC),
appeared in the Journal of the AOAC International, volume 78, page 724,
1995, and FDA is proposing to incorporate it by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51 in this document.
B. Nature of the Food Eligible to Bear the Claim
Section 101.81(c)(2)(iii)(A) (as modified at 62 FR 15342) states
that ``the food product shall include one or more of the whole oat
foods from paragraph (c)(2)(ii) of this section, and the whole oat
foods shall contain at least 0.75 gram (g) of soluble fiber per
reference amount customarily consumed of the food'' (RACC). FDA arrived
at this amount of soluble fiber by dividing an intake of 3 g/d soluble
fiber from whole oats by 4 eating occasions per day (62 FR 3584 at
3592). The daily intake of 3 g soluble fiber was based on an analysis
of data from a dose-response study that showed that an intake of 3 g/d
-glucan soluble fiber from whole oats was associated with a
significant reduction (5 percent) in blood total- and LDL-cholesterol
levels, and the results of a meta-analysis and other oat studies (61 FR
296 at 308). Based on four eating occasions per day, each serving of
the eligible whole oat product would have to provide a minimum of 0.75
g per RACC as part of the requirements to qualify to bear the CHD
claim.
The petitioner for the psyllium claim stated that ``the
hypocholesterolemic dose-responsiveness of soluble fiber from psyllium
(i.e., psyllium husk) has not been extensively studied, but there is
evidence to suggest that the greater
[[Page 28240]]
the dose, the more pronounced the cholesterol-lowering effects will
be'' (Ref. 1, p. 100). The petitioner noted LSRO's (Ref. 7)
recommendations for soluble fiber intake for the general U.S.
population. LSRO stated that soluble fiber should account for 25 to 30
percent of the total dietary fiber intake and recommended a daily
intake of total dietary fiber intake of between 20 to 35 g/d (Ref. 7).
Based on these values, an optimal intake of soluble fiber intake would
range from 5 g/d to about 10.5 g/d.
The petitioner also reviewed the results of studies that evaluated
the effects of different intake levels of psyllium and considered the
conclusions of reviews of the literature on psyllium (Ref. 1, pp. 100
through 102). It noted that some overviews of the literature on
psyllium and serum cholesterol levels have suggested intake ranges of
10 to 30 g/d of psyllium (Ref. 1, p. 100). The petitioner also noted
that the results of the dose-response study by Davidson et al. (Ref.
15) showed that the group consuming 10.2 g/d of psyllium had
differences of approximately 4.6 percent for LDL-cholesterol and 3.3
percent for total cholesterol when compared to controls (Ref. 1, p.
101). Based on all of the evidence, the petitioner asserted that an
intake of about 7 g/d soluble fiber from 10.2 g/d psyllium may help to
reduce the risk of CHD (Ref. 1, p. 102).
The petitioner suggested that, based on a daily intake level of
10.2 g of psyllium, which provides about 7 g soluble fiber, the level
in a food to qualify to bear the CHD claim should be 2.5 g of psyllium
per RACC (10.2 g/d divided by 4 eating occasions per day), which
provides 1.7 g soluble fiber (7 g/d of soluble fiber divided by 4) per
RACC. The petitioner noted that the agency has usually assumed that
food consumption patterns generally reflect three meals and a snack (58
FR 2302 at 2379, January 3, 1993).
After review of data from studies submitted with the petition, the
agency notes that, with the exception of the dose-response study by
Davidson et al. (Ref. 15), psyllium was consumed in these studies at
levels of 10 or more g/d (soluble fiber was approximately 7 g/10 g of
psyllium) (see Table 1 and Ref. 35). In those placebo-controlled
studies that tested an intake of psyllium of 10.2 g, the effect on
serum blood lipids was consistent, i.e., blood total and LDL-
cholesterol levels were significantly lowered, and HDL-cholesterol
levels were not affected (Refs. 10, 11, 13 through 15, 18, 19, 22, and
26).
As noted earlier, Davidson et al. (Ref. 15) evaluated the effect of
psyllium at levels of 3.4 g (Group 1), 6.8 g (Group 2), and 10.2 g
(Group 3) per day from foods consumed as part of a Step 1 diet. The
results of the study showed significant lowering of serum lipids in
subjects consuming 10.2 g/d psyllium in food. The authors stated,
however, that the subjects in the first two groups may not have
complied with study protocol, thus confounding the results for them.
Because of the potential for confounding in this study, the agency
finds that the results of the Davidson study do not provide the
information needed to determine a dose-response between the level of
psyllium intake, and therefore the level of soluble fiber from
psyllium, and the degree of change in blood lipid levels.
In this document, the agency is proposing to amend Sec. 101.81 to
add soluble fiber from psyllium, but it does not have the data that
were available for -glucan soluble fiber from whole oats on
which to establish a dose-response based qualifying level for the
amount of soluble fiber from psyllium necessary for a food to be
eligible to bear the claim. As discussed above, relative to whole oat
soluble fiber qualifying levels, analysis of data from a dose-response
study showed that an intake of 3 g/d whole oat soluble fiber was
associated with a 5 percent reduction in blood lipids (61 FR 296 at
308). In the whole oat proposal, the agency explained that a
significant reduction in serum lipids of 5 percent is associated with
the level that was achieved as a result of a dietary fat and
cholesterol-focused intervention in the Multiple Risk Factor
Intervention Trial and Lipid Research Council clinical trials (61 FR
296 at 308). The agency does not have similar data from which to
determine the amount of soluble fiber from psyllium that is associated
with a 5 percent reduction in serum lipids.
In the absence of such data, the agency is tentatively proposing to
base the qualifying level of soluble fiber from psyllium on a total
daily intake of 10.2 g (about 7 g of soluble fiber), as suggested by
the petitioner. This level of intake was shown in the clinical studies
to be consistently associated with significant reductions in serum
lipids.
Therefore, FDA is proposing that the qualifying level of soluble
fiber for foods to bear this claim be 1.7 g soluble fiber from psyllium
per RACC (7 g divided by 4 eating occasions per day). The agency does
not consider it necessary to propose a qualifying amount of psyllium as
suggested in the petition (2.5 g) because the qualifying level of
soluble fiber will determine the amount of psyllium that is required.
Based on estimates from figures provided in the petition and in the
studies, psyllium is about 68 percent or more soluble fiber. Therefore,
1.7 g/RACC of soluble fiber from psyllium would relate to about 2.5 g/
RACC of psyllium husk. The agency is asking for comments on whether
this approach for establishing a qualifying soluble fiber level for
psyllium-containing products is appropriate or for data to support
another qualifying level for psyllium.
Health claims help consumers to identify those products that will
help them achieve a healthy diet (see, e.g., section 403(r)(3)(B)(iii)
of the act). Expanding Sec. 101.81 to include psyllium-containing foods
will give consumers an opportunity to select from a wider variety of
foods containing those soluble fibers that have been shown to help
reduce the risk of CHD. The availability of a variety of foods, in
turn, should help consumers increase their daily intake of soluble
fiber.
To reflect the agency's tentative decision to propose a qualifying
level of soluble fiber from psyllium that is different from that
required for whole oats, the agency is proposing to amend
Sec. 101.81(c)(2)(iii)(A) (as modified at 62 FR 15342) to set out the
qualifying level of soluble fiber from whole oat and psyllium foods.
Therefore, in this document, proposed Sec. 101.81(c)(2)(iii)(A) is
modified to state ``[T]he food product shall include:'' followed by
paragraphs (1) and (2). Paragraph (c)(2)(iii)(A)(1) is modified to
state ``one or more of the whole oat foods from paragraph (c)(2)(ii)(A)
of this section, and the whole oat foods shall contain at least 0.75
gram (g) of soluble fiber per reference amount customarily consumed of
the food product.'' FDA is proposing to state in
Sec. 101.81(c)(2)(iii)(A)(2): ``psyllium that complies with paragraph
(c)(2)(ii)(B) of this section, and the psyllium food shall contain at
least 1.7 g of soluble fiber per reference amount customarily consumed
of the food product.''
The agency recognizes that foods could be produced with a blend of
the eligible soluble fibers listed in paragraph (c)(2)(ii) and would be
willing to consider whether such foods should be eligible to bear the
health claim. An example of a product that contains a blend of the
eligible soluble fibers might be one that contains 75 percent of the
qualifying level of -glucan soluble fiber from whole oats and
25 percent of the qualifying level of soluble fiber from psyllium.
However, the agency does not have the data on which to evaluate the
relationship between consumption of foods containing both psyllium and
whole oats and risk of heart disease. Although
[[Page 28241]]
both soluble fiber sources affect the same CHD risk factor (i.e., blood
lipid levels), the agency cannot assume that foods containing a blend
of these grains would have the same ability to affect blood total and
LDL-cholesterol levels that a product containing either whole oats or
psyllium apparently has. Therefore, if a manufacturer can demonstrate
that a diet that is low in saturated fat and cholesterol that includes
a blend of the eligible soluble fibers listed in
Sec. 101.81(c)(2)(ii)(A) and (c)(2)(ii)(B) has an effect on the risk of
heart disease, the manufacturer should petition to amend Sec. 101.81
further. In addition, because the qualifying level that FDA is
proposing for soluble fiber from psyllium differs from that which it
adopted for -glucan soluble fiber from whole oats, the issue
of an appropriate qualifying level for a blended product should be
addressed in any petition.
In the preamble to the final rule in which it adopted Sec. 101.81,
the agency explained that the approach it used to derive the qualifying
level of 0.75 g per RACC for whole oat products is somewhat different
from the one that it used in authorizing other health claims (62 FR
3584 at 3592). The agency explained that the guiding principle for
other health claims was to use the established definition for ``good
source'' or ``high in,'' which characterize the amount of a nutrient
based on a percentage of the Daily Reference Value (DRV) for the
nutrient, in a serving of food as the qualifying level. In this way,
products that qualify to bear the claim contain a meaningful level of
the substance per serving compared to the recommended intake of the
substance from all food sources. However, there is no DRV for soluble
fiber. While the agency concluded that the approach it took to
establish the qualifying level in Sec. 101.81 was appropriate, it
stated that it intends to propose to establish a DRV for soluble fiber,
and, once that rulemaking is completed, assuming it results in a DRV,
it would revisit the requirements in Sec. 101.81 and propose any
changes in its provisions that are necessary. For the purposes of any
final rule that results from this rulemaking, the agency will also
revisit the requirements of Sec. 101.81(c)(2)(iii) if a DRV is
established for soluble fiber.
C. Soluble Fiber From Certain Foods and From Eligible Food Sources
In light of the agency's tentative decision to broaden Sec. 101.81
to include soluble fiber from psyllium, the agency is proposing to
modify the section heading of Sec. 101.81 from ``Soluble fiber from
whole oats and risk of coronary heart disease'' to ``Health claims:
soluble fiber from certain foods and risk of coronary heart disease.''
The statement ``soluble fiber from certain foods'' reflects the fact
that the subject of the claim is no longer a specific source of soluble
fiber, i.e., -glucan from whole oats, but rather a broader
class of substances that includes those sources of soluble fiber for
which there is significant scientific agreement that they may help to
reduce the risk of heart disease.
The statement ``soluble fiber from whole oats'' also appears in
several paragraphs of Sec. 101.81. The agency is proposing to revise
this statement where it appears to state ``soluble fiber from certain
foods.'' The paragraphs of Sec. 101.81 that will be affected by this
change, if it is adopted, include: (a), (a)(3), (b), (b)(2), (c)(2)(i),
(c)(2)(i)(A), (d)(3), and (e).
The agency is proposing to revise the statement ``soluble fiber
from whole oats'' in three paragraphs of Sec. 101.81, paragraphs
(c)(2)(i)(E), (c)(2)(i)(F), and (d)(2), to read ``soluble fiber from
the eligible food sources from paragraph (c)(2)(ii) of this section.''
The agency tentatively finds that the statement ``soluble fiber from
the eligible food sources * * *'' more accurately identifies the
particular sources of soluble fibers that may be the subject of the
claim. For example, Sec. 101.81(c)(2)(i)(E) now specifies that the
claim must not attribute any degree of risk reduction for coronary
heart disease to diets low in saturated fat and cholesterol that
include soluble fiber from whole oats. The eligible food sources in
this proposed rule include whole oats and psyllium, so FDA is proposing
to revise Sec. 101.81(c)(2)(i)(E) to reflect the broader coverage of
the claim.
The agency notes, however, that it is not proposing changes to the
model claims in Sec. 101.81(e) (modified at 62 FR 15342). In both
example claims, the name of the soluble fiber source from
Sec. 101.81(c)(2)(ii) (Eligible source of soluble fiber) is provided,
and, if desired, the name of the food product may be provided. For
example, Sec. 101.81(e)(1) states ``Soluble fiber from foods such as
[name of soluble fiber source from section (c)(2)(ii) of this section
and, if desired, the name of the food product], as part of a diet low
in saturated fat and cholesterol, may reduce the risk of heart
disease.'' Therefore, a claim for a psyllium-containing food may state
``Soluble fiber from foods such as psyllium, as part of a diet low in
saturated fat and cholesterol, may reduce the risk of heart disease,''
and thus no change in Sec. 101.81(e)(1) or (e)(2) is necessary to
reflect the addition of psyllium to the list of substances eligible to
bear the claim.
The agency is proposing to make some minor editorial changes in
Sec. 101.81, which have no substantive effect on this regulation.
VII. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required. This finding is based on information submitted by the
petitioner in an environmental assessment prepared using the format
described in 21 CFR 25.31a(b)(5).
VIII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 12866
classifies a rule as significant if it meets any one of a number of
specified conditions, including having an annual effect on the economy
of $100 million or adversely affecting in a material way a sector of
the economy, competition, or jobs, or if it raises novel legal or
policy issues. If a rule has a significant economic impact on a
substantial number of small entities, the Regulatory Flexibility Act
requires agencies to analyze regulatory options that would minimize the
economic impact of that rule on small entities. FDA finds that this
proposed rule is not a significant rule as defined by Executive Order
12866 and finds under the Regulatory Flexibility Act that the proposed
rule will not have a significant impact on a substantial number of
small entities.
The establishment of this health claim results in benefits and in
costs only to the extent that food manufacturers elect to take
advantage of the opportunity to use the claim. This rule will not
require that any labels be redesigned or that any product be
reformulated.
Some manufacturers are currently using FDA's approved health claim
regarding the benefits of fruits, vegetables, and grain products. This
proposed health claim will allow them to specifically highlight the
role of
[[Page 28242]]
soluble fiber from psyllium. The benefit of establishing this health
claim is to provide for new information in the market regarding the
relationship of soluble fiber from psyllium and CHD.
Costs will be incurred by small entities only if they opt to take
advantage of the marketing opportunity presented by this regulation.
FDA cannot predict the number of small entities that will choose to use
the claim. However, no firm, including small entities, will choose to
bear the cost of redesigning labels unless they believe that the claim
will result in increased sales of their product. Therefore, this rule
will not result in either a decrease in revenues or a significant
increase in costs to any small entity. Accordingly, under the
Regulatory Flexibility Act, 5 U.S.C. 605(b), the Commissioner of Food
and Drugs certifies that the proposed rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
IX. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling, or other third party disclosure
requirement. Thus, there is no ``information collection'' necessitating
clearance by the Office of Management and Budget. However, to ensure
the accuracy of this tentative conclusion, FDA is seeking comment on
whether this proposed rule to permit health claims on the association
between soluble fiber from psyllium and reduced risk of CHD imposes any
paperwork burden.
X. Effective Date
FDA is proposing to make these regulations effective upon
publication of a final rule based on this proposal.
XI. Comments
Interested persons may, on or before August 5, 1997, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
XII. 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. Kellogg Co., ``Petition for Health Claim--Soluble Fiber from
Psyllium and Coronary Heart Disease,'' June 12, 1996 [CP1].
2. Scarbrough, F. Edward, Center for Food Safety and Applied
Nutrition, FDA, Letter to Richard M. Clark, Kellogg Co., September
18, 1996.
3. DHHS, PHS, ``The Surgeon General's Report on Nutrition and
Health,'' U.S. Government Printing Office, Washington, DC, pp. 83-
137, 1988.
4. Food and Nutrition Board, National Academy of Sciences,
``Diet and Health: Implications for Reducing Chronic Disease Risk,''
National Academy Press, Washington, DC, pp. 291-309 and 529-547,
1989.
5. DHHS, PHS and the National Institutes of Health, ``National
Cholesterol Education Program: Population Panel Report,'' Bethesda,
MD, pp. 1-40, 1990.
6. Sempos, C. T., J. I. Cleeman, M. D. Carroll, C. L. Johnson,
P. S. Bachorik, D. J. Gordon, V. L. Burt, R. R. Briefel, C. D.
Brown, K. Lippel, and B. M. Rifkind, ``Prevalence of High Blood
Cholesterol Among U.S. Adults. An Update Based on Guidelines From
the Second Report of the National Cholesterol Education Program
Adult Treatment Panel,'' Journal of the American Medical
Association, 269:3009-3014, 1993.
7. LSRO, FASEB, ``Physiological Effects and Health Consequences
of Dietary Fiber,'' Bethesda, MD, 1987.
8. LSRO, FASEB, ``Evaluation of Publicly Available Scientific
Evidence Regarding Certain Nutrient-Disease Relationships: 6.
Dietary Fiber and Cardiovascular Disease,'' Bethesda, MD, 1991.
9. Abraham, Z. D. and T. Mehta, ``Three-week Psyllium-husk
Supplementation: Effect on Plasma Cholesterol Concentrations, Fecal
Steroid Excretion, and Carbohydrate Absorption in Men,'' American
Journal of Clinical Nutrition, 47:67-74, 1988.
10. Anderson, J. W., N. Zettwoch, T. Feldman, J. Tietyen-Clark,
P. Oeltgen, and C. W. Bishop, ``Cholesterol-lowering Effects of
Psyllium Hydrophilic Mucilloid for Hypercholesterolemic Men,''
Archives of Internal Medicine, 148:292-296, 1988.
11. Anderson, J. W, T. L. Floore, P. B. Geil, D. Spencer, and T.
K. Balm, ``Hypercholesterolemic Effects of Different Bulk--Forming
Hydrophilic Fibers as Adjuncts to Dietary Therapy in Mild to
Moderate Hypercholesterolemia,'' Archives of Internal Medicine,
151:1597-1602, 1991.
12. Anderson, J. W., S. Riddell-Mason, N. J. Gustafson, S. F.
Smith, and M. Mackey, ``Cholesterol Lowering Effects of Psyllium-
Enriched Cereal as an Adjunct to a Prudent Diet in the Treatment of
Mild to Moderate Hypercholesterolemia,'' American Journal of
Clinical Nutrition, 56:93-98, 1992.
13. Anderson, J. W., M. H. Davidson, L. Blonde, W. V. Brown, W.
J. Howard, H. Ginsberg, L. D. Allgood, and K. W. Weingand, ``Long-
term Cholesterol-lowering Effects of Psyllium as an Adjunct to Diet
Therapy in the Treatment of Hypercholesterolemia,'' Unpublished,
1994.
14. Bell, L. P., K. Hectorne, H. Reynolds, T. K. Balm, and D. B.
Hunninghake, ``Cholesterol-lowering Effects of Psyllium Hydrophilic
Mucilloid--adjunct Therapy to a Prudent Diet for Patients with Mild
to Moderate Hypocholesterolemia,'' Journal of the American Medical
Association, 261:3419-3423, 1989.
15. Davidson, M. H., ``Long-term Influence of Psyllium-enriched
Foods on Serum Lipids among Subjects with Hypercholesterolemia
Consuming a Low Fat Diet,'' Unpublished study, 1996.
16. Everson, G. T., B. P. Daggy, C. McKinley, and J. A. Story,
``Effects of Psyllium Hydrophilic Mucilloid on LDL-synthesis and
Bile Acid Synthesis in Hypercholesterolemic Men,'' Journal of Lipid
Research, 33:1183-1192, 1992.
17. Gelissen, I. C., B. Brodie, and M. A. Eastwood, ``Effect of
Plantago Ovata (Psyllium) Husk and Seeds on Sterol Metabolism:
Studies in Normal and Ileostomy Subjects,'' American Journal of
Clinical Nutrition, 59:395-400, 1994.
18. Keane, W. F., V. T. Miller, L. P. Bell, C. E. Halstenson, L.
D. Allgood, H. Tully, J. C. LaRosa, ``Effect of Psyllium in
Conjunction with a Low-fat Diet on Plasma Lipids in Elderly Patients
with Mild-to-moderate Hypercholesterolemia,'' Unpublished, 1996.
19. Levin, E. G., V. T. Miller, R. A. Muesing, D. B. Stoy, T. K.
Balm, and J. C. LaRosa, ``Comparison of Psyllium Hydrophilic
Mucilloid and Cellulose as Adjuncts to a Prudent Diet in the
Treatment of Mild to Moderate Hypercholesterolemia,'' Archives of
Internal Medicine, 150:1822-1827, 1990.
20. Neal, G. W. and T. K. Balm, ``Synergistic Effects of
Psyllium in the Dietary Treatment of Hypercholesterolemia,''
Southern Medical Journal, 83:1131-1137, 1990.
21. Schectman, G., J. Hiatt, A. Hartz, ``Evaluation of the
Effectiveness of Lipid-lowering Therapy (Bile Acid Sequestrants,
Niacin, Psyllium, and Lovastatin) for Treating Hypercholesterolemia
in Veterans,'' American Journal of Cardiology, 71:759-765, 1993.
22. Sprecher, D. L., B. V. Harris, A. C. Goldberg, E. C.
Anderson, L. M. Bayuk, B. S. Russell, D. S. Crone, C. Quinn, J.
Bateman, B. R. Kuzmak, and L. D. Allgood, ``Efficacy of Psyllium in
Reducing Serum Cholesterol Levels in Hypercholesterolemic Patients
on High- or Low-fat Diets,'' Annals of Internal Medicine, 119:545-
554, 1993.
23. Stoy, D. B., J. C. LaRosa, B. K. Brewer, M. Mackey, R. A.
Muesing, ``Cholesterol-lowering Effects of Ready-to-eat Cereal
Containing Psyllium,'' Journal of the American Dietetic Association,
93:910-912, 1993.
24. Stoy, D. B., J. C. LaRosa, B. K. Brewer, L. G. Saldhanda, R.
A. Muesing, ``Lipid Lowering Effects of Ready-to-eat Cereal
Containing Psyllium: a Randomized Crossover Trial,'' Unpublished,
1993.
25. Summerbell, C. D., P. Manley, D. Barnes, and A. Leeds, ``The
Effects of Psyllium on Blood Lipids in Hypercholesterolemic
Subjects,'' Journal of Human Nutrition and Dietetics, 7:147-151,
1994.
26. Weingand, K. W., N-A. Le, B. R. Kuzmak, W. V. Brown, B. P.
Daggy, T. A.
[[Page 28243]]
Miettinen, B. V. Howard, and W. J. Howard, ``Effects of Psyllium on
Cholesterol and Low-density Lipoprotein Metabolism in Subjects with
Hypercholesterolemia,'' Unpublished, no date.
27. Gupta, R. R., C. G. Agrawal, G. P. Singh, and A. Ghatak,
``Lipid-lowering Efficacy of Psyllium Hydrophilic Mucilloid in Non-
insulin Dependent Diabetes Mellitus with Hyperlipidaemia,'' Indian
Journal of Medical Research, 100:237-241, 1994.
28. Stewart, R. B., W. E. Hale, M. T. Moore, F. E. May, and R.
G. Marks, ``Effect of Psyllium Hydrophilic Mucilloid on Serum
Cholesterol in the Elderly,'' Digestive Diseases and Sciences,
36:329-334, 1991.
29. Lee, S. C., E. Farmakalidis, and L. Prosky, ``Determination
of Soluble and Insoluble Dietary Fiber in Psyllium-containing Cereal
Products,'' Journal of the AOAC International, 78:724-729, 1995.
30. Jenkins, D. J. A., S. Mueller, T. M. S. Wolever, V. Rao, T.
Ransom, D. Boctor, P. Spadafor, C. Mehling, L. K. Relle, E. Chow, K.
MacMillan, and V. Fulgoni, ``High Soluble Fiber Foods Reduce Serum
Lipids Even When Diets Are Already Low in Saturated Fat and
Cholesterol,'' Unpublished study, 1992.
31. LSRO, ``The Evaluation of the Safety of Using Psyllium Seed
Husk as a Food Ingredient,'' Bethesda, MD, December 1993.
32. James, J. M., S. K. Cooke, A. Barnett, and H. A. Sampson,
``Anaphylactic Reactions to a Psyllium-containing Cereal,'' Journal
of Allergy and Clinical Immunology, 88:402-408, 1991.
33. Ross, R., ``Atherosclerosis,'' in Cecil - Textbook of
Medicine, J. B. Wyngaarden, L. H. Smith, and J. C. Bennett, editors,
Harcourt Brace Jovanevich, Inc., Philadelphia, p. 293, 1992.
34. USP, ``The National Formulary,'' US Parmacopeial Convention,
Inc., Rockville, MD, UPS 23, NF 18, p. 1341, 1995.
35. Saltsman, J., Memo to file with Table 1: ``Summary of
clinical trials: psyllium and CHD,'' and Table 2: ``Psyllium and
CHD,'' January 28, 1997.
36. Goodlad, R. A., B. Ratcliffe, C. Y. Lee, and N. A. Wright,
``Dietary Fibre and the Gastrointestinal Tract: Differing Trophic
Effects on Muscle and Mucosa of the Stomach, Small Intestine, and
Colon,'' European Journal of Clinical Nutrition, 49(Suppl. 3):S178-
S181, 1995.
37. Wasan, H. S. and R. A. Goodlad, ``Fibre-supplemented Foods
May Damage Your Health, Lancet, 348:319-320, 1996.
List of Subjects in 21 CFR Part 101
Food labeling, Incorporation by reference, Nutrition, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.81 is amended by revising the section heading, the
heading for paragraphs (a) and (b), and paragraphs (a)(3), (b)(2),
(c)(2)(i) introductory text, (c)(2)(i)(A), (c)(2)(i)(E), (c)(2)(i)(F),
(c)(2)(iii)(A), (d)(2), (d)(3), and (e), and by adding paragraph
(c)(2)(ii)(B) to read as follows:
Sec. 101.81 Health claims: Soluble fiber from certain foods and risk
of coronary heart disease (CHD).
(a) Relationship between diets that are low in saturated fat and
cholesterol and that include soluble fiber from certain foods and the
risk of CHD.
* * * * *
(3) Scientific evidence demonstrates that diets low in saturated
fat and cholesterol may reduce the risk of CHD. Other evidence
demonstrates that the addition of soluble fiber from certain foods to a
diet that is low in saturated fat and cholesterol may also help to
reduce the risk of CHD.
(b) Significance of the relationship between diets that are low in
saturated fat and cholesterol and that include soluble fiber from
certain foods and the risk of CHD.
* * * * *
(2) Intakes of saturated fat exceed recommended levels in the diets
of many people in the United States. One of the major public health
recommendations relative to CHD risk is to consume less than 10 percent
of calories from saturated fat and an average of 30 percent or less of
total calories from all fat. Recommended daily cholesterol intakes are
less than 300 mg per day. Scientific evidence demonstrates that diets
low in saturated fat and cholesterol are associated with lower blood
total and LDL-cholesterol levels. Soluble fiber from certain foods,
when included in a low saturated fat and cholesterol diet, also helps
to lower blood total and LDL-cholesterol levels.
(c) * * *
(2) * * *
(i) Nature of the claim. A health claim associating diets that are
low in saturated fat and cholesterol and that include soluble fiber
from certain foods with reduced risk of heart disease may be made on
the label or labeling of a food described in paragraph (c)(2)(iii) of
this section, provided that:
(A) The claim states that diets that ar
FR Doc. 97-13379 Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Coronary Heart Disease
e low in saturated fat and
cholesterol and that include soluble fiber from certain foods ''may``
or ''might`` reduce the risk of heart disease.
* * * * *
(E) The claim does not attribute any degree of risk reduction for
CHD to diets that are low in saturated fat and cholesterol and that
include soluble fiber from the eligible food sources from paragraph
(c)(2)(ii) of this section; and
(F) The claim does not imply that consumption of diets that are low
in saturated fat and cholesterol and that include soluble fiber from
the eligible food sources from paragraph (c)(2)(ii) of this section is
the only recognized means of achieving a reduced risk of CHD.
(ii) * * *
(B)(1) Psyllium husk from the dried seed coat (epidermis) of the
seed of Plantago (P.) ovata, known as blond psyllium or Indian
psyllium; P. indica; or P. psyllium. To qualify for this claim,
psyllium shall have a purity of no less than 95 percent, such that it
contains 3 percent or less protein, 4.5 percent or less of light
extraneous matter, and 0.5 percent or less of heavy extraneous matter,
but in no case may the combined extraneous matter exceed 4.9 percent,
as determined by U.S. Pharmacopeia (USP) methods described in USP's
''The National Formulary,`` USP 23, NF 18, p. 1341, (1995), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the U.S. Pharmacopeial Convention,
Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or may be examined at
the Center for Food Safety and Applied Nutrition's Library, 200 C St.
SW., rm. 3321, Washington, DC, or at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC;
(2) FDA will determine the amount of soluble fiber that is provided
by psyllium by using a modification of the Association of Official
Analytical Chemists' (AOAC's) method for soluble dietary fiber (991.43)
described by Lee et al., ''Determination of Soluble and Insoluble
Dietary Fiber in Psyllium-containing Cereal Products,`` Journal of the
AOAC International, 78(No. 3):724-729, 1995, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the Association of Official Analytical Chemists
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877-2504, or may be examined at the Center for Food Safety and
Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC,
or at the Office of the Federal Register, 800 North Capitol St. NW.,
suite 700, Washington, DC;
(iii) * * *
(A) The food product shall include:
(1) One or more of the whole oat foods from paragraph (c)(2)(ii)(A)
of this
[[Page 28244]]
section, and the whole oat foods shall contain at least 0.75 gram (g)
of soluble fiber per reference amount customarily consumed of the food
product; or
(2) Psyllium that complies with paragraph (c)(2)(ii)(B) of this
section, and the psyllium food shall contain at least 1.7 g of soluble
fiber per reference amount customarily consumed of the food product;
* * * * *
(d) * * *
(2) The claim may state that the relationship between intake of
diets that are low in saturated fat and cholesterol and that include
soluble fiber from the eligible food sources from paragraph (c)(2)(ii)
of this section and reduced risk of heart disease is through the
intermediate link of ''blood cholesterol`` or ''blood total- and LDL-
cholesterol;``
(3) The claim may include information from paragraphs (a) and (b)
of this section, which summarize the relationship between diets that
are low in saturated fat and cholesterol and that include soluble fiber
from certain foods and coronary heart disease and the significance of
the relationship;
* * * * *
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between diets that
are low in saturated fat and cholesterol and that include soluble fiber
from certain foods and reduced risk of heart disease:
(1) Soluble fiber from foods such as [name of soluble fiber source
from paragraph (c)(2)(ii) of this section and, if desired, the name of
the food product], as part of a diet low in saturated fat and
cholesterol, may reduce the risk of heart disease.
(2) Diets low in saturated fat and cholesterol that include soluble
fiber from [name of soluble fiber source from paragraph (c)(2)(ii) of
this section and, if desired, the name of the food product] may reduce
the risk of heart disease.
Dated: May 15, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-13379 Filed 5-21-97; 8:45 am]
BILLING CODE 4160-01-F
Note: The following table will not appear in the Code of Federal
Regulations.
Table 1.--Summary of Clinical Trials with Hypercholesterolemics: Psyllium and Coronary Heart Disease
----------------------------------------------------------------------------------------------------------------
Supplements
(Psyllium, Diet Intake Magnitude of
Study Duration Treatment Number of Placebo) of groups: Magnitude of Placebo
Subjects Soluble Fiber Sat fat % E; PSY Effect* Effect
g/d CHOL mg/d
----------------------------------------------------------------------------------------------------------------
Levin et Base: 8-wk Step 1; Tx: 16- PSY: 30 (26 10.2 g/d bulk Sat fat: PSY- CHOL: -13 mg/ CHOL: 0; LDL-
al. wk Step 1+supplement men) laxative, 6.7%; C- dL (5.6%) C -2.2%; HDL-
(Ref. 19) Pla: 28 (23 cellulose 6.3% LDL-C: -13 mg/ C:
men) PSY: CHOL: PSY- dL (8.6%)
166 mg; C- +6% (sig
7 g SF 135 mg from PSY)
Bell et Base: 12-wk Step 1; Tx: 8- PSY: 40 (20 10.2 g/d bulk Sat fat: PSY- CHOL: -9 mg/ CHOL: 0; LDL-
al. wk Step 1+supplement men) laxative, 8-10%; C- dL (4.2%) C -0.2%; HDL-
(Ref. 14) Pla: 35 (18 cellulose 7.7-8.6% LDL-C: -12 mg/ C no sig dif
men) PSY: CHOL: PSY- dL (7.7%) (grps)
168 mg; C-
7 g SF 206 mg
Davidson Base: 8-wk Step 1; Tx: 24- PSY 1 56 (31 3.4 g, 6.8 g, Sat fat: PSY- CHOL: -3% CHOL: +1.7%;
et al. wk Step 1 + PSY or men) 10.2 g/d; 7-8.6%; C- 7- (PSY 3) LDL-C: +3%
(Ref. 15) control food (3 servings/ PSY 2 40 (24 incorporated 8.6% LDL-C: -5% HDL-C: No sig
d) men) into foods: CHOL: PSY 1- (PSY 3) dif (grps)
PSY 3 43 (28 C foods: no 151 mg; PSY
men) PSY 2- 181; PSY
C 59 PSY 1: 3- 169C- 145
mg
2.3 g SF,
PSY 2:
.6 g;
PSY 3:
7 g
Everson Regular diet; 5-d Base; 2 20 men 15.3 g/d bulk Sat fat: PSY- CHOL: -14 mg/ CHOL: -1.9%;
et al. 40-d periods; 11-d laxative, 12%; C- 13.2 dL (-5%) LDL-C: -2.7%
(Ref. 16) washout; crossover cellulose % LDL-C: -15 mg/ HDL-C: No sig
PSY: CHOL: PSY- dL (8%) dif (grps)
296 mg; C-
10 g SF 274 mg
Jenkins Base: 2-mo Step 2; Tx: 2 1- 12 Ss (3m/9f) Mean intake: Sat fat: 4% CHOL: -16.6 HDL-C: No sig
et al. mo Step 2 metabolic 9.35 g/d PSY all grps mg/dL dif (grps)
(Ref. 30) diets, crossover, washout in cereal PSY: 36 mg; Tx
PSY: 6.8 g SF C: 29 mg difference:
CHOL PSY- 36 3.4%
mg; C-29 mg LDL-C: -9.3
mg/dL
Tx
difference:
5.1%
Stoy et 4-wk Step 1; Step 1 + 23 men Estimated Sat fat: PSY: CHOL: -10 mg/ HDL-C: No sig
al. (8x5x5 wks): Grp 1: PSY- 11.6 g/d PSY 5.1% (Grp 1) dL (4%) dif (grps)
(Ref. 23) Pla-PSY; Grp 2: Pla-PSY- from cereal: and 5.1% LDL-C: -11 mg/
Pla (Grp 2) dL (6%)
8 g SF; Wheat: 4.5%
Wheat (Grp 1) and
cereal: 5.0% (Grp 2)
CHOL: PSY 141-
3 g SF 165 mg
Wheat: 164 mg
(Grp 1), 117-
170 (Grp 2)
[[Page 28245]]
Stoy et 4-wk Step 1; Step 1 + 22 men Estimated Sat fat: PSY: CHOL: -10 mg/ HDL-C: No sig
al. (8x5x5 wks): Grp 1: PSY- 11.6 g/d PSY 4.8 (Grp 1) dL (4%) dif (grps)
(Ref. 24) Pla-PSY; Grp 2: Pla-PSY- from cereal: and 5.2% LDL-C: -11 mg/
Pla (Grp 2) dL (6%)
8 g SF; Wheat: 4.7%
Wheat (Grp 1) and
cereal: 5.6% (Grp 2)
CHOL: PSY 155-
3 g SF 163 mg
Wheat: 133 mg
(Grp 1), 169-
172 (Grp 2)
----------------------------------------------------------------------------------------------------------------
* Significant differences between treatment and placebo groups unless otherwise indicated.
Abbreviations Used in Table 1
C Control
CHOL Blood total cholesterol
d Day
E Energy
g Gram
grp Group
HDL-C High density lipoprotein cholesterol
LDL-C Low density lipoprotein cholesterol
m/f Number of males, number of females
mg/dL Milligrams per deciliter
mo Months
oz Ounces
Pla Placebo
Pro Protein
PSY Psyllium
Sat fat Saturated fat
SF Soluble fiber
Sig Dif Statistically significant difference
Step 1 30% kcals fat, 55% CHO, 15% Pro, <300
mg cholesterol
Tx Treatment
wk week
approximately
% Percent
[FR Doc. 97-13379 Filed 5-21- 97; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 97-13324 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 27998-28000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13324]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 300
[FRL-5827-9]
National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List
AGENCY: Environmental Protection Agency.
ACTION: Notice of intent to delete the Tri-State Plating Superfund Site
from the National Priorities List; request for comments.
-----------------------------------------------------------------------
SUMMARY: The United States Environmental Protection Agency (U.S. EPA)
Region V announces its intent to delete the Tri-State Plating Site from
the National Priorities List (NPL) and requests public comment on this
action. The NPL constitutes Appendix B of 40 CFR part 300 which is the
National Oil and Hazardous Substances Pollution Contingency Plan (NCP),
which U.S. EPA promulgated pursuant to Section 105 of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980
(CERCLA) as amended. This action is being taken by U.S. EPA, because it
has been determined that all Fund-financed responses under CERCLA have
been implemented and U.S. EPA, in consultation with the State of
Indiana, has determined that no further response is appropriate.
Moreover, U.S. EPA and the State have determined that remedial
activities conducted at the Site to date have been protective of public
health, welfare, and the environment.
DATES: Comments concerning the proposed deletion of the Site from the
NPL may be submitted on or before June 23, 1997.
ADDRESSES: Comments may be mailed to Gladys Beard, Associate Remedial
Project Manager, Superfund Division, U.S. EPA, Region V, 77 W. Jackson
Blvd. (SR-6J), Chicago, IL 60604. Comprehensive information on the site
is available at U.S. EPA's Region V office and at the local information
repository located at: Bartholomew County Health Department, 440 3rd
St., Suite 303, Columbus, IN 47201-6798. Requests for comprehensive
copies of documents should be directed formally to the Region V Docket
Office. The address and phone number for the Regional Docket Officer is
Jan Pfundheller (H-7J), U.S. EPA, Region V, 77 W. Jackson Blvd.,
Chicago, IL 60604, (312) 353-5821.
FOR FURTHER INFORMATION CONTACT: Gladys Beard (SR-6J), Associate
Remedial Project Manager, Superfund Division, U.S. EPA, Region V, 77 W.
Jackson Blvd., Chicago, IL 60604, (312) 886-7253 or Dave Novak (P-19J),
Office of Public Affairs, U.S. EPA, Region V, 77 W. Jackson Blvd.,
Chicago, IL 60604, (312) 886-9840.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Intended Site Deletion
I. Introduction
The U.S. Environmental Protection Agency (EPA) Region V announces
its intent to delete the Tri-State Plating Site from the National
Priorities List (NPL), which constitutes Appendix B of the National Oil
and Hazardous Substances Pollution Contingency Plan (NCP), and requests
comments on the proposed deletion. The EPA identifies sites that appear
to present a significant risk to public health, welfare or the
environment, and maintains the NPL as the list of those sites. Sites on
the NPL may be the subject of remedial actions financed by the
Hazardous Substance Superfund Response Trust Fund (Fund). Pursuant to
Sec. 300.425(e)(3) of the NCP, any site deleted from the NPL remains
eligible for Fund-financed remedial actions if the conditions at the
site warrant such action.
The U.S. EPA will accept comments on this proposal for thirty (30)
days after publication of this notice in the Federal Register.
Section II of this notice explains the criteria for deleting sites
from the NPL. Section III discusses procedures that EPA is using for
this action. Section IV discusses the history of this site and explains
how the site meets the deletion criteria.
Deletion of sites from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Furthermore, deletion
from the NPL does not in any way alter U.S. EPA's right to take
enforcement actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist in Agency management.
II. NPL Deletion Criteria
The NCP establishes the criteria the Agency uses to delete sites
from the NPL. In accordance with 40 CFR 300.425(e), sites may be
deleted from the NPL where no further response is appropriate. In
making this determination, U.S. EPA will consider, in consultation with
the State, whether any of the following criteria have been met:
(i) Responsible parties or other persons have implemented all
appropriate response actions required; or
(ii) All appropriate Fund-financed responses under CERCLA have been
implemented, and no further response action by responsible parties is
appropriate; or
(iii) The Remedial Investigation has shown that the release poses
no significant threat to public health or the environment and,
therefore, remedial measures are not appropriate.
III. Deletion Procedures
Upon determination that at least one of the criteria described in
300.425(e) has been met, U.S. EPA may formally begin deletion
procedures once the State has concurred. This Federal Register notice,
and a concurrent notice in the local newspaper in the vicinity of the
site, announce the initiation of a 30-day comment period. The public is
asked to
[[Page 27999]]
comment on U.S. EPA's intention to delete the Site from the NPL. All
critical documents needed to evaluate U.S. EPA's decision are included
in the information repository and the deletion docket.
Upon completion of the public comment period, if necessary, the
U.S. EPA Regional Office will prepare a Responsiveness Summary to
evaluate and address comments that were received. The public is welcome
to contact the U.S. EPA Region V Office to obtain a copy of this
responsiveness summary, if one is prepared. If U.S. EPA then determines
the deletion from the NPL is appropriate, final notice of deletion will
be published in the Federal Register.
IV. Basis for Intended Site Deletion
The Tri-State Plating site is located at 1716 Keller Avenue in a
residential and small business neighborhood in Columbus, Indiana.
Residences lie to the north, east, and the west of the site, and a
small industrial business lies to the south. Prior to the
decontamination and demolition of all on-site structures in 1989, an
electroplating process building and a storage building were located on
the site. The Tri-State Plating Property encompasses an area of
approximately 130 feet by 120 feet. The site is located 800 feet
southwest of the City of Columbus secondary municipal well field and
800 feet west of Haw Creek. The area surrounding the site is relatively
flat, with steeper slopes to the east of the site along Haw Creek.
Metal-plating operations occurred at the site for 40 years prior to
Tri-State Plating under Hull Industries and Quality Plating Service
Company, Inc. The facility was purchased by Tri-State Plating, Inc. on
April 13, 1981. Plating operations were performed by this company from
December 1981 until the facility closed in May 1984.
Environmental problems at the site were brought to the attention of
authorities, on January 25, 1983, when the Bartholomew County Health
Department (BCHD) was summoned to the site following the death of six
birds that reportedly drank from a pool of solutions dumped on site. A
sample of the liquid was collected and elevated concentrations of
cadmium, cyanide, chromium, manganese and lead were detected.
Subsequent investigations by BCHD and the Indiana State Board of Health
(ISBH) conducted in February, March and April 1983 revealed that on-
site surface soils contained extremely high levels of cadmium,
chromium, lead, nickel and cyanide when compared to off-site samples
from surrounding properties. These investigations also discovered
elevated levels of chromium in water from the Arvin Industries well
located 200 feet south of the site, although cyanide and other sites
contaminants were not detected. Also during this period, sampling and
analysis of effluent leaving the Tri-State Plating facility, conducted
by Columbus Utilities, verified that plant wastes were being discharged
to city sewers.
In May 1984, following several discharges that exceeded the
specified limits, illegal dumping of wastes on the ground surface at
the site, failure to install a waste treatment system, and one severe
spill that interrupted the biological system at the city of Columbus
Waste Water Treatment Facility, sewers from Tri-State Plating were
blocked and the water supply was cut off. The Tri-State Plating site
has been abandoned since this time.
On September 18, 1985, the Site was proposed for the National
Priorities List (NPL), (50 FR 3764). The Site was finalized June 10,
1986, (40 FR 21054).
On September 23, 1986, the current owner, Mr. James Padget, was
notified of EPA's intentions to conduct a Remedial Investigation and
Feasibility Study (RI/FS). He did not offer to perform any studies or
remedial action at the site and informed EPA that he had filed for
bankruptcy.
EPA on-site activities started early in 1987 when the Technical
Assistance Team (TAT) conducted a site assessment. Approximately 60
soil samples, 27 barrels of waste, and four ground-water samples were
submitted for cyanide and metal analysis. These samples included
background samples from local residences. The EPA samples detected
metals and cyanide contamination to a depth of 4 feet on-site, which
was the maximum sampling depth. The well water samples collected did
not detect cyanide contamination; however, low levels of metals were
discovered in Arvin Industries East Well No. 2.
On June 5, 1987, a fence was constructed by EPA to prevent site
access. On August 26 and 27, 20 drums containing inorganic materials
were removed and disposed at a Resource Conservation Recovery Act
(RCRA) compliant facility. During the week of August 29, 1987, TAT
obtained subsurface soil samples to determine the vertical extent of
contamination. Samples were also collected from a residence north of
the site. Additional background soil samples were also collected. A
total of 19 soil samples were collected on and near the site and
submitted for analyses. On September 24, 1987, EPA removed and disposed
of seven remaining drums and took seven samples of building materials,
including ceiling brick and floor materials. Samples were analyzed for
inorganic parameters.
In the Fall of 1987, the EPA performed a site building
decontamination and limited soil removal action. Approximately one foot
of top soil was removed from the open yard areas at the site. Several
areas of visible contamination were noted adjacent to the building
foundation during the top soil removal and a trench approximately four
feet deep was excavated along the northern and southern foundation of
the main process building to remove the discolored materials. All
excavated areas were backfilled and regraded with clean soil.
Contaminated subsurface soils identified during past EPA sampling
activities were left on-site. The EPA also washed the interior surface
of the main process building using caustic-sodium hypochlorite
solution. This was performed in an attempt to remove surface
contamination identified through past EPA sampling efforts.
EPA initiated a two-phased Remedial Investigation at the Tri-State
site beginning in 1987 to determine the nature and extent of any
remaining contamination following EPA's initial removal action
activities. During the first phase of the study, EPA collected samples
from 10 locations on the surface of walls, ceilings, and floors in the
on-site buildings to determine whether the 1987 building
decontamination activities had been successful. In addition, 25 surface
and subsurface soil samples were collected to determine the depth of
soil contamination at the site. EPA also installed four monitoring
wells at the site and collected eight ground-water samples for
laboratory analysis. These Phase I activities, completed in January
1988, revealed elevated levels of cyanide, chromium, copper, and
cadmium on building surfaces and/or in subsurface soils and groundwater
at the site.
Phase II activities involved installing eight new monitoring wells,
collecting two rounds of 19 groundwater samples from on-site monitoring
wells and industrial wells at Arvin Industries, and collecting 46
subsurface soil samples.
Based on the results of the Remedial Investigation, there was
concern that contamination in on-site soil may continue to migrate into
groundwater and that people or animals may come into direct contact
with contaminated on-site buildings. Because of these concerns, the EPA
conducted a second removal action at the site from February
[[Page 28000]]
to March 1989. This removal action, called an Expedited Response Action
(ERA), involved excavating soil, decontaminating and demolishing all
structures on the site, and transporting the soil, building debris, and
asbestos found during the course of the cleanup to state and federally-
regulated landfills. The excavated area was filled with clean soil, the
site fence was removed, and the site was graded and revegetated.
During the ERA, EPA collected 357 subsurface soil samples on the
site to determine the limits of excavation. EPA also collected 21 soil
samples from the base of the excavated areas to determine the
effectiveness of the removal activities. EPA also conducted a
groundwater pump test to determine whether the migration of
contaminated groundwater from the site could be prevented by the
continuous withdrawal of groundwater and to calculate the pumping rate
necessary to accomplish this objective. Groundwater sampling was
conducted to determine the level of contamination in the groundwater
following the groundwater pump test and site cleanup. Contaminated
groundwater collected during the pump test was discharged to and
treated at the Columbus wastewater treatment plant.
Based on the results of the RI/FS, and as described in the Proposed
Plan, EPA recommended a Remedial Action involving the long-term
operation of a groundwater extraction and treatment systen which
utilized the existing on-site extraction well. A groundwater extraction
and treatment system would provide for the long-term protection of
public health and the environment.
On March 30, 1990, a Record of Decision (ROD) was signed which
selected this remedy. The extraction and treatment of contaminated
groundwater continued until the maximum groundwater remediation goals
were met in 1995. The site groundwater was then sampled for a two year
period to assure that the groundwater remediation goals were achieved
permanently and that no further remediation would be required. This
activity was completed in Spring of 1996.
EPA, with concurrence from the State of Indiana, has determined
that all appropriate Fund-financed responses under CERCLA at the Tri-
State Plating Superfund Site have been completed, and no further CERCLA
response is appropriate in order to provide protection of human health
and the environment. Therefore, EPA proposes to delete the site from
the NPL.
Dated: May 9, 1997.
Valdas V. Adamkus,
Regional Administrator, U.S. EPA, Region V.
[FR Doc. 97-13324 Filed 5-21-97; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 97-13323 Announcement of Stakeholders Meeting on National Primary Drinking Water Regulation for Radon-222
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 27991-27992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13323]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Chapter I
[FRL-5828-2]
Announcement of Stakeholders Meeting on National Primary Drinking
Water Regulation for Radon-222
AGENCY: Environmental Protection Agency.
ACTION: Notice of stakeholders meeting.
-----------------------------------------------------------------------
SUMMARY: The U.S. Environmental Protection Agency will be holding a
one-day public meeting on June 26, 1997. The purpose of this meeting is
to present information on EPA plans for activities to develop a
proposed National Primary Drinking Water Regulation (NPDWR) for radon-
222, and solicit public input on major technical and implementation
issues, and on preferred approaches for continued public involvement.
This meeting is a continuation of stakeholder meetings that started in
1995 to obtain input on the Agency's Drinking Water Program. These
meetings were initiated as part of the Drinking Water Program
Redirection efforts to help refocus EPA's drinking water priorities and
to support strong, flexible partnerships among EPA, States, local
governments, and the public. At the upcoming meeting, EPA is seeking
input from state drinking water and radon programs, the regulated
community (public water systems), public health and safety
organizations, environmental and public interest groups, and other
stakeholders on a number of issues related to developing the NPDWR for
radon. EPA encourages the full participation of stakeholders throughout
this process.
DATES: The stakeholder meeting on the NPDWR for radon will be held on
June 26, 1997 from 9:00 a.m. to 4:30 p.m.
ADDRESSES: To register for the meeting, please contact the Safe
Drinking Water Hotline at 1-800-426-4791 by June 12,
[[Page 27992]]
1997. Those registered for the meeting will receive background
materials prior to the meeting. Members of the public who cannot attend
the meeting in person may participate via conference call and should
register with the Safe Drinking Water Hotline as well. Members of the
public who cannot participate via conference call or in person may
submit comments in writing by July 10, 1997 to Sylvia Malm, at the U.S.
Environmental Protection Agency, 401 M St., SW (4607), Washington, DC,
20460. The meeting will be held in Washington, DC. The address of the
meeting site will be included with the background materials.
FOR FURTHER INFORMATION CONTACT: For general information on meeting
logistics, please contact the Safe Drinking Water Hotline at 1-800-426-
4791. For information on the activities related to developing the NPDWR
for radon and other EPA activities under the Safe Drinking Water Act,
contact the Safe Drinking Water Hotline at 1-800-426-4791. For
information on radon in indoor air, contact the National Safety
Council's National Radon Hotline at 1-800-SOS-RADON.
SUPPLEMENTARY INFORMATION:
A. Background
On July 18, 1991 (56 FR 33050), EPA proposed a Maximum Contaminant
Level Goal (MCLG) and National Primary Drinking Water Regulation
(NPDWR) for radon and other radionuclides in public water supplies. EPA
proposed to regulate radon at 300 pCi/L. Commenters on the 1991
proposed NPDWR for radon raised several concerns, including cost of
implementation, especially for small systems, and the larger risk to
public health from radon in indoor air from soil under buildings.
On August 6, 1996, Congress passed amendments to the Safe Drinking
Water Act (SDWA), which establishes a new charter for the nation's
public water systems, States, and EPA in protecting the safety of
drinking water. The amendments [Sec. 1412(b)(13)] direct EPA to develop
an MCLG and NPDWR for radon. EPA is required to (1) Withdraw the 1991
proposed MCLG and NPDWR for radon-222; (2) arrange for the National
Academy of Sciences (NAS) to conduct an independent risk assessment for
radon in drinking water and an independent assessment of risk reduction
benefits from various mitigation measures to reduce radon in indoor
air; (3) publish a radon health risk reduction and cost analysis for
possible radon Maximum Contaminant Levels (MCLs) for public comment by
February, 1999; (4) propose an MCLG and NPDWR for radon by August,
1999; (5) publish a final MCLG and NPDWR for radon by August, 2000.
If the MCL is ``more stringent than necessary to reduce the
contribution to radon in indoor air from drinking water to a
concentration that is equivalent to the national average concentration
of radon in outdoor air,'' EPA is also required to promulgate an
alternative MCL and publish guidelines for state multimedia mitigation
programs to mitigate radon levels in air. The alternative MCL would
``reduce the contribution from radon in water to radon in indoor air to
a concentration that is equivalent to the national average
concentration of radon in air.'' States may develop and submit to EPA
for approval a multimedia mitigation program to mitigate radon levels
in indoor air. EPA shall approve State multimedia mitigation programs
if they are expected to achieve equivalent or greater health risk
reduction benefits than compliance with the MCL. If EPA approves a
State multimedia mitigation program, public water supply systems within
the State may comply with the alternative MCL. If EPA does not approve
a State program, or the State does not propose a program, public water
supply systems may propose multimedia mitigation programs to EPA, under
the same procedures outlined for States.
B. Request for Stakeholder Involvement
EPA is committed to proposing a timely NPDWR for radon that
incorporates the best available science, treatment technologies,
occurrence data, cost/benefit analyses, and stakeholder input on
technical and implementation issues. EPA has evaluated comments on the
1991 proposed NPDWR for radon and will be considering those comments in
developing the regulation.
The meeting will cover a broad range of issues including: (1) Radon
in drinking water MCL development (treatment technologies, occurrence,
analytical methods); (2) multimedia mitigation program; and (3)
stakeholder involvement processes. Background materials on radon in
drinking water issues will be sent to all registered participants in
advance of the meeting. Issues for discussion and stakeholder input
will be based on the materials provided and include (but may not be
limited to) the following:
(1) Any new information or data;
(2) Issues and concerns related to rule development;
(3) Issues and concerns related to implementing a multimedia
mitigation program from the perspective of your state, water systems,
public health and safety organizations, environmental and public
interest groups, and the public; and
(4) Recommendations on the most beneficial points in the process
for stakeholder input and preferred approaches for stakeholder input.
EPA has announced this public meeting to hear the views of
stakeholders on EPA's plans for activities to develop a NPDWR for
radon. The public is invited to provide comments on the issues listed
above and other issues related to the radon in drinking water
regulation during the June 26, 1997 meeting or in writing by July 10,
1997.
Dated: May 15, 1997.
Richard Kuhlman,
Acting Director, Office of Ground Water and Drinking Water,
Environmental Protection Agency.
[FR Doc. 97-13323 Filed 5-21-97; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 97-13317 Protection of Human Subjects
[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 28156-28159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13317]
[[Page 28155]]
_______________________________________________________________________
Part IV
Department of Education
_______________________________________________________________________
34 CFR Part 97
Protection of Human Subjects; Proposed Rule
Federal Register / Vol. 62, No. 99 / Thursday, May 22, 1997 /
Proposed Rules
[[Page 28156]]
-----------------------------------------------------------------------
DEPARTMENT OF EDUCATION
34 CFR Part 97
RIN 1880-AA75
Protection of Human Subjects
AGENCY: Department of Education.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Secretary proposes to amend the Department's regulations
governing the protection of human research subjects to add special
protections for children who are involved as subjects of research.
These amendments to the Department's regulations are needed to secure
additional protections for children who are involved as subjects of
research. The proposed regulations would, for research involving
children as subjects, remove exemptions for certain kinds of research,
modify the informed consent provisions, and further limit the risks to
which children may be made vulnerable. These amendments will make the
Department's policy regarding the protection of children as research
subjects consistent with the regulations of the Department of Health
and Human Services and the Federal Policy for the Protection of
Children as practiced by other research agencies of the Federal
government.
DATES: Comments must be received on or before July 21, 1997.
ADDRESSES: All comments concerning these proposed regulations should be
addressed to Kent H. Hannaman, Attention: Protection of Human Subjects
in Research, U.S. Department of Education, Seventh and D Streets, S.W.,
Room 5624, Regional Office Building 3, Washington, D.C. 20202-4651.
Comments may also be sent through the Internet to
(Human__S[email protected]).
FOR FURTHER INFORMATION CONTACT: Ivor Pritchard, U.S. Department of
Education, 555 New Jersey Avenue, N.W., Washington, D.C. 20208-5573.
Telephone: (202) 219-2231. Individuals who use a telecommunications
device for the deaf (TDD) may call the Federal Information Relay
Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern
time, Monday through Friday.
SUPPLEMENTARY INFORMATION: The Secretary proposes to adopt for the
Department of Education regulations that are already in effect for
research supported or conducted by the Department of Health and Human
Services (DHHS), Subpart D--Additional DHHS Protections for Children
Involved as Subjects in Research (Subpart D). These regulations contain
provisions specifically designed to protect children who are involved
in research as subjects. Children are involved as subjects of important
research that will benefit the Nation's children. Balancing the
importance of this research with the needs of children, the Secretary
believes that these protections should be added because the research
activities supported by the Department often include children, and the
Department has a particular interest in protecting the welfare of
children.
Current Government-Wide and ED Policy
The Federal Policy requires institutions receiving support from
Federal agencies or offices for research activities involving human
subjects to assure that covered research activities will be reviewed by
an Institutional Review Board (IRB). The purpose of the IRB review is
to ensure that persons not involved in carrying out the research
activities determine that adequate provisions have been made to protect
the research subjects involved in the proposed activities. The adequacy
of the protections is judged by the IRB, which consists of qualified
individuals at the institutions where the research takes place, and by
other individuals in the local community who are familiar with the
research population and with local community standards.
Additional Protections Afforded by Subpart D
The amendments regarding children substantially modify the Federal
Policy in three ways. First, they remove an exemption from IRB review
of research involving surveys, interviews, or observation of public
behavior if the research investigators interact with subjects who are
children. Second, they modify the procedures for obtaining informed
consent from research subjects who are children, by including
procedures for proxy consent by the parent or guardian, and assent by
the children themselves. Third, they limit the kind of risks to which
children may be made vulnerable during the research activity, if the
child's participation in the research contains no prospects of benefits
to the individual child. IRBs are charged with the responsibility of
ensuring that these modifications are included in research activities
taking place at their institutions, or sponsored by their institutions,
whenever children are involved as subjects.
The Secretary believes that adopting Subpart D protections through
rulemaking is an important part of meeting the Department's obligation
to fully implement the Federal Policy. Children are a primary focus of
the Department's mission and activities, and protections designed
specifically for children serving as research subjects are appropriate.
With the Subpart D protections, children involved as research subjects
would have more protections than they would have if Subpart D is not
adopted, and the Secretary believes that there is good reason to
protect children in this manner. In addition, the adoption of the
Subpart D protections would make the Department's policy more
consistent with that of DHHS and certain other Federal agencies and
offices, which was the original intent of the Common Rule.
The Secretary considered but rejected implementing Subpart D on a
case-by-case basis as a matter of policy without formal rulemaking. The
effect of the case-by-case approach would be to make Subpart D
application a matter of negotiation between the Department and some
institutions receiving support for relevant research activities. It
would be more costly, burdensome, and confusing for researchers and
institutions requesting Department support and for the Department's own
administration of the Federal Policy. It would also increase the
possibility that sponsored research projects would not be fully
reviewed for appropriate protections.
The Secretary recognizes that this action will produce some
additional costs and administrative burdens. More resources will be
expended inside and outside the Government to ensure that children who
are research subjects are protected. More research protocols will be
reviewed by Institutional Review Boards, the protocols will have to
meet higher standards for approval with respect to the potential
benefits to the individual subjects where the research poses more than
minimal risk, and parental consent and a child's assent will be
required when it otherwise would not be. It is not possible to provide
an accurate estimate of the additional costs. The Secretary, however,
believes that the important benefits of providing consistent
protections for children as research subjects outweigh the burden of
additional administrative costs.
The Secretary also recognizes that some additional protections for
children as education research subjects exist even if Subpart D is not
adopted. The applicability of DHHS multiple project assurances
1 at some three hundred
[[Page 28157]]
institutions means that education research supported by those
institutions is already regulated by Subpart D. The Protection of Pupil
Rights Amendment (PPRA) (20 U.S.C. 1232h) and the Family Educational
Rights and Privacy Act (FERPA) (20 U.S.C. 1232g) both provide some
protections. However, the safeguards provided by the PPRA and the FERPA
are enforced retrospectively, after infractions have occurred. In
contrast, these regulations assure compliance before research is
initiated. Therefore, the Secretary believes that adoption of Subpart D
is important to ensure the highest degree of protection for children as
human research subjects.
---------------------------------------------------------------------------
\1\ DHHS issues multiple project assurances to some
institutions. A multiple project assurance is an agreement between
DHHS and an institution that sets forth the institution's commitment
to employ the basic ethical principles of ``The Ethical Principles
and Guidelines for the Protection of Human Subjects of Research'',
known as the Belmont Report, and to comply with DHHS regulations for
the protection of human subjects. The assurances are issued for a
five-year period and are approved for Federal-wide use. Institutions
with DHHS-approved multiple project assurances must abide by the
provisions of Title 45 CFR Part 46 Subpart D.
---------------------------------------------------------------------------
Executive Order 12866
Assessment of Costs and Benefits
These proposed regulations have been reviewed in accordance with
Executive Order 12866. Under the terms of the order, the Secretary has
assessed the potential costs and benefits of this regulatory action.
The potential costs associated with the proposed regulations are
those resulting from statutory requirements and those determined by the
Secretary as necessary for administering the Department's programs
effectively and efficiently. As stated under the heading Paperwork
Reduction Act of 1995 in this preamble, this proposed rule contains no
paperwork burdens.
In assessing the potential costs and benefits--both quantitative
and qualitative--of these proposed regulations, the Secretary has
determined that the benefits of the proposed regulations justify the
costs.
The Secretary has also determined that this regulatory action does
not unduly interfere with State, local, and tribal governments in the
exercise of their governmental functions.
To assist the Department in complying with the specific
requirements of Executive Order 12866, the Secretary invites comment on
whether there may be further opportunities to reduce any potential
costs or increase potential benefits resulting from these proposed
regulations without impeding the effective and efficient administration
of the program.
Summary of Potential Costs and Benefits
The potential costs and benefits of these proposed regulations are
discussed elsewhere in this preamble under the heading Additional
Protections Afforded by Subpart D.
Clarity of the Regulations
Executive Order 12866 requires each agency to write regulations
that are easy to understand.
The Secretary invites comments on how to make these proposed
regulations easier to understand, including answers to questions such
as the following: (1) Are the requirements in the proposed regulations
clearly stated? (2) Do the regulations contain technical terms or other
wording that interferes with their clarity? (3) Does the format of the
regulations (grouping and order of sections, use of headings,
paragraphing, etc.) aid or reduce their clarity? Would the regulations
be easier to understand if they were divided into more (but shorter)
sections? (A ``section'' is preceded by the symbol ``Sec. '' and a
numbered heading; for example, Sec. 97.401 To what do these regulations
apply?) (4) Is the description of the regulations in the Supplementary
Information section of this preamble helpful in understanding the
regulations? How could this description be more helpful in making the
regulations easier to understand? (5) What else could the Department do
to make the regulations easier to understand?
A copy of any comments that concern how the Department could make
these proposed regulations easier to understand should be sent to
Stanley M. Cohen, Regulations Quality Officer, U.S. Department of
Education, 600 Independence Avenue, S.W. (Room 5121, FB-10B),
Washington, D.C. 20202-2241.
Regulatory Flexibility Act Certification
The Secretary certifies that these proposed regulations would not
have a significant economic impact on a substantial number of small
entities. For the most part, these revisions are adopted to effect
greater consistency in the protection of children as human research
subjects. The proposed revisions would not have a significant impact on
the entities affected. The applicability of Department of Health and
Human Services multiple project assurances at some three hundred
institutions means that education research supported at those
institutions is already regulated by Subpart D. The institutions that
do not have multiple project assurances with DHHS should find the
consistent approach to safeguarding children as research subjects a
workable approach to increased protections.
Paperwork Reduction Act of 1995
These proposed regulations have been examined under the Paperwork
Reduction Act of 1995 and have been found to contain no additional
information collection requirements. (The recordkeeping requirements of
Subpart A, for which DHHS has received OMB approval on behalf of
affected agencies, encompass recordkeeping requirements of Subpart D.)
Invitation to Comment
Interested persons are invited to submit comments and
recommendations regarding these proposed regulations.
All comments submitted in response to these proposed regulations
will be available for public inspection, during and after the comment
period, in Room 5624, Regional Office Building 3, 7th and D Streets,
S.W., Washington, D.C., between the hours of 8:30 a.m. and 4:00 p.m.,
Monday through Friday of each week except Federal holidays.
Assessment of Educational Impact
The Secretary particularly requests comments on whether the
proposed regulations in this document would require transmission of
information that is being gathered by or is available from any other
agency or authority of the United States.
List of Subjects in 34 CFR Part 97
Human subjects, Reporting and recordkeeping Research, requirements.
(Catalog of Federal Domestic Assistance Number does not apply.)
Dated: February 18, 1997.
Richard W. Riley,
Secretary of Education.
The Secretary proposes to amend Part 97 of Title 34 of the Code of
Federal Regulations as follows:
PART 97--PROTECTION OF HUMAN SUBJECTS
1. The authority citation for Part 97 is revised to read as
follows:
Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).
Secs. 97.101, 97.102, 97.103, 97.104, 97.107, 97.108, 97.109, 97.110,
97.111, 97.112, 97.113, 97.114, 97.115, 97.116, 97.117, 97.118, 97.119,
97.120, 97.121, 97.122, 97.123, 97.124 [Redesignated as Subpart A]
Subpart B--[Reserved]
Subpart C--[Reserved]
2. Sections 97.101 through 97.124 are designated as ``Subpart A--
Federal
[[Page 28158]]
Policy for the Protection of Human Subjects (Basic ED Policy for
Protection of Human Research Subjects)'' and Subparts B and C are
reserved.
* * * * *
3. Sections 97.101, 97.102, 97.103, and 97.107 through 97.124 are
amended by adding authority citations to read as follows:
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
4. A new Subpart D containing Secs. 97.401 through 97.409 is added
to read as follows:
Subpart D--Additional ED Protections for Children Who Are Subjects in
Research
Sec.
97.401 To what do these regulations apply?
97.402 Definitions.
97.403 IRB duties.
97.404 Research not involving greater than minimal risk.
97.405 Research involving greater than minimal risk but presenting
the prospect of direct benefit to the individual subjects.
97.406 Research involving greater than minimal risk and no prospect
of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subject's disorder or condition.
97.407 Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children.
97.408 Requirements for permission by parents or guardians and for
assent by children.
97.409 Wards.
Subpart D--Additional ED Protections for Children Who Are Subjects
in Research
Sec. 97.401 To what do these regulations apply?
(a) This subpart applies to all research involving children as
subjects conducted or supported by the Department of Education.
(1) This subpart applies to research conducted by Department
employees.
(2) This subpart applies to research conducted or supported by the
Department of Education outside the United States, but in appropriate
circumstances the Secretary may, under Sec. 97.101(i), waive the
applicability of some or all of the requirements of the regulations in
this subpart for that research.
(b) Exemptions in Sec. 97.101 (b)(1) and (b)(3) through (b)(6) are
applicable to this subpart. The exemption in Sec. 97.101(b)(2)
regarding educational tests is also applicable to this subpart. The
exemption in Sec. 97.101(b)(2) for research involving survey or
interview procedures or observations of public behavior does not apply
to research covered by this subpart, except for research involving
observation of public behavior when the investigator or investigators
do not participate in the activities being observed.
(c) The exceptions, additions, and provisions for waiver as they
appear in Sec. 97.101 (c) through (i) are applicable to this subpart.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
Sec. 97.402 Definitions.
The definitions in Sec. 97.102 apply to this subpart. In addition,
the following definitions also apply to this subpart:
(a) Children are persons who have not attained the legal age for
consent to treatments or procedures involved in the research, under the
applicable law of the jurisdiction in which the research will be
conducted.
(b) Assent means a child's affirmative agreement to participate in
research. Mere failure to object should not, absent affirmative
agreement, be construed as assent.
(c) Permission means the agreement of parent(s) or guardian to the
participation of their child or ward in research.
(d) Parent means a child's biological or adoptive parent.
(e) Guardian means an individual who is authorized under applicable
State or local law to consent on behalf of a child to general medical
care.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
Sec. 97.403 IRB duties.
In addition to other responsibilities assigned to IRBs under this
part, each IRB shall review research covered by this subpart and
approve only research that satisfies the conditions of all applicable
sections of this subpart.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
Sec. 97.404 Research not involving greater than minimal risk.
ED conducts or funds research in which the IRB finds that no
greater than minimal risk to children is presented, only if the IRB
finds that adequate provisions are made for soliciting the assent of
the children and the permission of their parents or guardians, as set
forth in Sec. 97.408.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
Sec. 97.405 Research involving greater than minimal risk but
presenting the prospect of direct benefit to the individual subjects.
ED conducts or funds research in which the IRB finds that more than
minimal risk to children is presented by an intervention or procedure
that holds out the prospect of direct benefit for the individual
subject, or by a monitoring procedure that is likely to contribute to
the subject's well-being, only if the IRB finds that--
(a) The risk is justified by the anticipated benefit to the
subjects;
(b) The relation of the anticipated benefit to the risk is at least
as favorable to the subjects as that presented by available alternative
approaches; and
(c) Adequate provisions are made for soliciting the assent of the
children and permission of their parents or guardians, as set forth in
Sec. 97.408.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
Sec. 97.406 Research involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subject's disorder or condition.
ED conducts or funds research in which the IRB finds that more than
minimal risk to children is presented by an intervention or procedure
that does not hold out the prospect of direct benefit for the
individual subject, or by a monitoring procedure which is not likely to
contribute to the well-being of the subject, only if the IRB finds
that--
(a) The risk represents a minor increase over minimal risk;
(b) The intervention or procedure presents experiences to subjects
that are reasonably commensurate with those inherent in their actual or
expected medical, dental, psychological, social, or educational
situations;
(c) The intervention or procedure is likely to yield generalizable
knowledge about the subjects' disorder or condition that is of vital
importance for the understanding or amelioration of the subjects'
disorder or condition; and
(d) Adequate provisions are made for soliciting assent of the
children and permission of their parents or guardians, as set forth in
Sec. 97.408.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
Sec. 97.407 Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children.
ED conducts or funds research that the IRB does not believe meets
the requirements of Sec. 97.404, Sec. 97.405, or Sec. 97.406 only if--
(a) The IRB finds that the research presents a reasonable
opportunity to further the understanding, prevention, or alleviation of
a serious problem affecting the health or welfare of children; and
[[Page 28159]]
(b) The Secretary, after consultation with a panel of experts in
pertinent disciplines (for example: science, medicine, education,
ethics, law) and following opportunity for public review and comment,
has determined either that--
(1) The research in fact satisfies the conditions of Sec. 97.404,
Sec. 97.405, or Sec. 97.406, as applicable; or
(2)(i) The research presents a reasonable opportunity to further
the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children;
(ii) The research will be conducted in accordance with sound
ethical principles; and
(iii) Adequate provisions are made for soliciting the assent of
children and the permission of their parents or guardians, as set forth
in Sec. 97.408.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b)).
Sec. 97.408 Requirements for permission by parents or guardians and
for assent by children.
(a) In addition to the determinations required under other
applicable sections of this subpart, the IRB shall determine that
adequate provisions are made for soliciting the assent of the children,
if in the judgment of the IRB the children are capable of providing
assent. In determining whether children are capable of assenting, the
IRB shall take into account the ages, maturity, and psychological state
of the children involved. This judgment may be made for all children to
be involved in research under a particular protocol, or for each child,
as the IRB deems appropriate. If the IRB determines that the capability
of some or all of the children is so limited that they cannot
reasonably be consulted or that the intervention or procedure involved
in the research holds out a prospect of direct benefit that is
important to the health or well-being of the children and is available
only in the context of the research, the assent of the children is not
a necessary condition for proceeding with the research. Even if the IRB
determines that the subjects are capable of assenting, the IRB may
still waive the assent requirement under circumstances in which consent
may be waived in accord with Sec. 97.116.
(b) In addition to the determinations required under other
applicable sections of this subpart, the IRB shall determine, in
accordance with and to the extent that consent is required by
Sec. 97.116, that adequate provisions are made for soliciting the
permission of each child's parent(s) or guardian(s). If parental
permission is to be obtained, the IRB may find that the permission of
one parent is sufficient for research to be conducted under Sec. 97.404
or Sec. 97.405. If research is covered by Secs. 97.406 and 97.407 and
permission is to be obtained from parents, both parents must give their
permission unless one parent is deceased, unknown, incompetent, or not
reasonably available, or if only one parent has legal responsibility
for the care and custody of the child.
(c) In addition to the provisions for waiver contained in
Sec. 97.116, if the IRB determines that a research protocol is designed
for conditions or for a subject population for which parental or
guardian permission is not a reasonable requirement to protect the
subjects (for example, neglected or abused children), it may waive the
consent requirements in subpart A of this part and paragraph (b) of
this section, provided an appropriate mechanism for protecting the
children who will participate as subjects in the research is
substituted, and provided further that the waiver is not inconsistent
with Federal, State, or local law. The choice of an appropriate
mechanism depends upon the nature and purpose of the activities
described in the protocol, the risk and anticipated benefit to the
research subjects, and their age, maturity, status, and condition.
(d) Permission by parents or guardians must be documented in
accordance with and to the extent required by Sec. 97.117.
(e) If the IRB determines that assent is required, it shall also
determine whether and how assent must be documented.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
Sec. 97.409 Wards.
(a) Children who are wards of the State or any other agency,
institution, or entity may be included in research approved under
Secs. 97.406 or 97.407 only if that research is--
(1) Related to their status as wards; or
(2) Conducted in schools, camps, hospitals, institutions, or
similar settings in which the majority of children involved as subjects
are not wards.
(b) If research is approved under paragraph (a) of this section,
the IRB shall require appointment of an advocate for each child who is
a ward, in addition to any other individual acting on behalf of the
child as guardian or in loco parentis. One individual may serve as
advocate for more than one child. The advocate must be an individual
who has the background and experience to act in, and agrees to act in,
the best interest of the child for the duration of the child's
participation in the research and who is not associated in any way
(except in the role as advocate or member of the IRB) with the
research, the investigator or investigators, or the guardian
organization.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b).)
[FR Doc. 97-13317 Filed 5-21-97; 8:45 am]
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