issue-1996-06-12•Federal Register proposed rules — 1996-06-12
Federal Register proposed rules — 1996-06-12
issue-1996-06-12Federal Register proposed rules — 1996-06-12Proposed 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. 96-14927 Limited Access Management of Federal Fisheries In and Off of Alaska; Quota Shares and Individual Fishing Quota
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29728-29729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14927]
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[[Page 29729]]
DEPARTMENT OF COMMERCE
50 CFR Part 676
[I.D. 060496A]
RIN 0648-AI57
Limited Access Management of Federal Fisheries In and Off of
Alaska; Quota Shares and Individual Fishing Quota
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Notice of availability of amendments to fishery management
plans; request for comments.
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SUMMARY: The North Pacific Fishery Management Council (Council) has
submitted Amendment 42 to the Fishery Management Plan (FMP) for the
Bering Sea/Aleutian Islands Groundfish and Amendment 42 to the Fishery
Management Plan for the Gulf of Alaska Groundfish Fishery. The Council
recommended these amendments to alleviate certain restrictions in the
Individual Fishing Quota (IFQ) Program. If approved, these FMP
amendments would allow quota shares (QS) and IFQ assigned to vessels in
larger size categories to be used on smaller vessels. The Council
intends these amendments to increase the flexibility of QS use and
transfer while maintaining the management goals of the IFQ Program and,
thus, provide small boat fishermen with more opportunities to improve
the profitability of their operations. Comments are requested from the
public.
DATES: Comments on the proposed FMP amendments must be received by
August 6, 1996.
ADDRESSES: Send comments to Ronald J. Berg, Chief, Fisheries Management
Division, Attn: Lori Gravel, Alaska Region, National Marine Fisheries
Service, P.O. Box 21668, Juneau, AK 99802. Copies of the proposed
Amendments, and the Environmental Assessment/Regulatory Impact Review/
Initial Regulatory Flexibility Analysis for this action may be obtained
from the North Pacific Fishery Management Council, Suite 306, 605 West
4th Avenue, Anchorage, AK 99501-2252.
FOR FURTHER INFORMATION CONTACT: James Hale, 907-586-7228.
SUPPLEMENTARY INFORMATION:
Background
The Magnuson Fishery Conservation and Management Act (Magnuson Act)
requires that each Regional Fishery Management Council submit any
fishery management plan or plan amendment it prepares to NMFS for
review and approval, disapproval, or partial disapproval. The Magnuson
Act also requires that NMFS, upon reviewing the plan or amendment, must
immediately publish a notice that the plan or amendment is available
for public review and comment.
Amendment 42 to each of the FMPs governing Federal fisheries in and
off of Alaska would redefine IFQ vessel categories to allow QS and IFQ
assigned to larger vessel categories to be used on smaller vessels. An
exception to this change would prohibit QS or IFQ assigned to vessel
category B in regulatory areas 2C (for halibut) and east of 140 deg. W.
long. (for sablefish) to be used on vessels less than 60 ft (18.3 m)
length overall except in QS blocks equivalent to less than 5,000 lb
(2.3 mt).
NMFS will consider the public comments received during the comment
period in determining whether to approve the proposed amendments. The
proposed regulations are scheduled to be published within 15 days of
this document.
Authority: 16 U.S.C. 1801 et seq.
Dated: June 6, 1996.
Richard W. Surdi,
Acting Director, Office of Fisheries Conservation and Management,
National Marine Fisheries Service.
[FR Doc. 96-14927 Filed 6-7-96; 3:52 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-14926 Groundfish Fishery of the Bering Sea and Aleutian Islands; Delay of Pollock Season
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29726-29728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14926]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 675
[Docket No. 960603156-6156-01; I.D. 052896A]
RIN 0648-A158
Groundfish Fishery of the Bering Sea and Aleutian Islands; Delay
of Pollock Season
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Proposed rule; request for comments.
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SUMMARY: NMFS proposes to delay from August 15 to September 1 of each
fishing year, the opening of the second (non-roe) directed fishing
season for pollock in the Bering Sea and Aleutian Islands management
area (BSAI). This action is necessary to allow some pollock processor
vessels and shoreside processing plants to more fully realize potential
salmon processing opportunities, particularly for late-run pink salmon.
This action is intended to further the objectives of the Fishery
Management Plan for the Groundfish Fishery of the Bering Sea and
Aleutian Island Area (FMP).
DATES: Comments must be received by July 8, 1996.
ADDRESSES: Comments may be sent to Ronald J. Berg, Chief, Fisheries
Management Division, Alaska Region, NMFS, P.O. Box 21668, Juneau, AK
99802, Attn: Lori Gravel or delivered to the Federal Building, 709 West
9th Street, Juneau, AK.
Copies of the environmental assessment/regulatory impact review/
final regulatory flexibility analysis (EA/RIR/FRFA) prepared for the
original 1993 ``B'' season delay or the supplemental EA/RIR prepared
for this action may be obtained from the North Pacific Fishery
Management Council, 605 West 4th Ave., Suite 306, Anchorage, AK 99510-
2252; telephone: 907-271-2809.
FOR FURTHER INFORMATION CONTACT: Kaja Brix, 907-586-7228.
SUPPLEMENTARY INFORMATION:
Fishing for groundfish by U.S. vessels in the exclusive economic
zone of the BSAI is managed by NMFS according to the FMP. The FMP was
prepared by the North Pacific Fishery Management Council (Council)
under the Magnuson Fishery Conservation and Management Act (Magnuson
Act) and is implemented
[[Page 29727]]
by regulations that appear at 50 CFR parts 675 and 676. General
regulations that also govern U.S. fisheries appear at 50 CFR part 620.
Under regulations at Sec. 675.20(a)(2)(ii), the initial total
allowable catch (TAC) amounts specified for pollock in the Bering Sea
and Aleutian Islands subareas, and the Bogoslof district are divided
into two seasonal allowances. Subject to other regulatory provisions,
the first seasonal allowance is available for directed fishing from
January 1 until noon, A.l.t., April 15 (the ``roe'' or ``A'' season).
The second seasonal allowance is available for directed fishing from
noon A.l.t., August 15 through the end of the fishing year (the ``non-
roe'' or ``B'' season). NMFS annually apportions the initial pollock
TACs between the roe and non-roe seasons after consultation with the
Council during the annual groundfish TAC specification process set
forth at Sec. 675.20(a).
Prior to 1993 the opening of the non-roe season was June 1.
However, at its December 1992 meeting, the Council requested an
analysis to examine the alternatives for delaying the June 1 opening
date of the pollock ``B'' season. The original EA/RIR/FRFA, dated
February 2, 1993, contains a comprehensive examination of alternatives
to delay the pollock ``B'' season from June 1 to either July 1, August
1, or September 1. Based on the February 2, 1993, EA/RIR/FRFA, the
Council recommended a delayed opening date of August 15 for the pollock
``B'' season. This action was implemented by NMFS for the 1993 ``B''
season (58 FR 30997, May 28, 1993) and was intended to increase the
value of the pollock harvested during the ``B'' season by delaying the
directed fishery for pollock until pollock flesh quality and product
recovery rates were improved. The original delay also was intended to
provide participants in the pollock fishery increased opportunities to
fish in other groundfish fisheries and to develop salmon processing
capabilities during summer months.
Recent high abundance of Alaska pink salmon as well as poor salmon
market conditions, have caused renewed interest by the salmon industry
and groundfish processors to explore opportunities for new salmon
product types and markets. This interest has prompted the Council to
reconsider the opening date of the pollock ``B'' season to provide
pollock processors the opportunity to participate in the processing
operations for late-run pink salmon.
At its December 1995 meeting, the Council directed staff to prepare
an additional analysis for delaying the opening date of the pollock
``B'' season to September 1. An analysis was prepared to supplement the
original EA/RIR/FRFA prepared in 1993. This supplemental analysis
includes: (1) A summary of the original analysis from 1993 that
resulted in the current opening date of August 15, and (2)
supplementary information relevant to the current proposal to delay the
opening an additional 2 weeks until September 1.
After considering the original and supplemental analyses at its
April 1996 meeting, the Council recommended the September 1 opening
date for the pollock ``B'' season for both the inshore and the offshore
components, with a fixed season ending date of November 1 of each year.
Vessels participating in the Community Development Quota (CDQ) directed
pollock fishery would be exempt from the season ending date
restriction.
The Council's action also included a measure that would prohibit
vessels from participating in the directed pollock fishery during the 7
days after the September 1 opening (i.e., from noon A.l.t. September 1
until noon A.l.t. September 8) if the vessel participated in any
groundfish fishery in either the BSAI or the Gulf of Alaska (GOA)
during any portion of the 7-day period prior to the opening of the
pollock ``B'' season (i.e., from noon A.l.t., August 25th until noon,
September 1, A.l.t.). Vessels participating in the directed CDQ pollock
fishery would be exempt from this measure.
``B'' Season Delay
The impact of delaying the ``B'' season until September 1 was
examined in detail in the EA/RIR/FRFA (February 2, 1993) prepared for
the original season delay implemented in 1993. Additional information
is presented in the March 22, 1996, supplemental analysis prepared for
the current action (see ADDRESSES).
The 1993 analysis indicates that the impacts of a ``B'' season
delay would vary widely between different regions and species, as well
as from year to year. That analysis also indicates that, if the B
season is delayed until September 1, floating processors who
participated in the pollock ``B'' season would generally tend to
benefit from an additional economic opportunity to process salmon.
Onshore processors could lose as a result of increased competition in
the processing sector, which might lead to increased ex-vessel prices.
Salmon fishermen could benefit, at least in the short term, from
additional markets and increased competition, which might result in
higher ex-vessel prices. The effect on local Alaskan communities can
not be determined at the present time. It would depend on the net
effects of the ``B'' season delay on fishermen and processors and the
relative economic contribution of each to the communities.
A delay of the ``B'' season until September 1 could have impacts on
salmon bycatch. In previous years, the incidence of high chum salmon
bycatch has been greater around the opening of the pollock ``B'' season
compared to the incidence of chinook salmon bycatch that generally has
occurred later in the pollock ``B'' season. Shifting the opening of the
pollock ``B'' season to September 1 could decrease the likelihood of
high chum salmon bycatch and increase the likelihood of chinook salmon
bycatch. However, much of the bycatch occurrence is dependent on the
spatial and temporal distribution of the bycatch species and can change
from year to year. The impacts of shifting the pollock ``B'' season 2
weeks later in the year are difficult to quantify.
November 1 ``B'' Season End Date
Some concern exists about the potential effects of the continuation
of the pollock fishery later in the year when the pollock resource is
critical to the sea lion population. During the midwinter months of the
year (November, December, and January), pollock is a particularly
important element of the juvenile sea lion diet, as alternative prey
species are less available during this period. Juvenile sea lions also
are learning to forage on their own at this time and may be dependent
on concentrations of prey species to forage successfully.
To mitigate any potential adverse impacts on the sea lion
population, the Council recommended a ``B'' season ending date of
November 1, regardless of whether the directed pollock total allowable
catch (TAC) is taken by that time. Current estimates indicate that the
pollock fisheries for both the inshore and offshore sectors would
likely be completed by early October.
From a fisheries management perspective, placing a season ending
date of November 1 on the pollock ``B'' season could limit NMFS ability
to provide for a ``C'' season or ``clean-up'' fishery, which has in the
past been designed to allow harvest of remaining pollock TAC.
Typically, after the closure of the ``B'' season, the in-season
catch data from the pollock fishery are analyzed to determine if any
pollock TAC remains available for a directed fishery. Should sufficient
amounts remain, then NMFS can announce a ``C'' season opening.
[[Page 29728]]
However, under the circumstances of a delayed opening, which could
extend the ``B'' season into early October, reassessing the status of
the pollock TAC and announcing and possibly prosecuting a ``C'' season
fishery before the November 1 deadline may be difficult.
Seven-day ``No-trawl'' Measure
Data from the yellowfin sole fishery indicate that the amount of
halibut bycatch is much greater during the 2 weeks prior to the August
15 opening of the pollock ``B'' season than the amount of halibut
bycatch in subsequent weeks. This high halibut bycatch appears to be
due to a few vessels that experienced higher halibut bycatch than other
vessels fishing in the yellowfin sole fishery prior to the opening of
the ``B'' season. Crowding effects of the pollock vessels in the
yellowfin sole fishery may cause some vessels to fish in areas where
more halibut occur. High halibut bycatch in the yellowfin sole fishery
can cause a premature closure of the yellowfin sole fishery due to the
halibut prohibited species catch allowance being reached before the
yellowfin sole TAC is reached.
The high halibut bycatch and the Council's concerns about
preemption in the yellowfin sole fishery prompted the Council to
recommend a ``no-trawl'' fishing prohibition for vessels participating
in the pollock ``B'' season to reduce the likelihood that the pollock
vessels would participate in the yellowfin sole fisheries or
redistribute fishing effort to other trawl fisheries prior to the
opening of the pollock ``B'' season. Any vessel that fishes for
groundfish with trawl gear in the BSAI or GOA, during any portion of
the 7 days prior to the September 1 opening date of the pollock ``B''
season would be prohibited from directed fishing for pollock in the 7
days after September 1. Vessels participating in the CDQ directed
pollock fishery would be exempt from this prohibition.
Classification
The Council prepared an EA/RIR/FRFA in 1993, and a supplemental
analysis was prepared in 1996. The 1993 analysis, as supplemented, was
reviewed, and the economic analysis was found to be still valid. These
documents combine to comprise an initial regulatory flexibility
analysis for this action. The analysis indicates that the impacts could
vary across regions and from year to year. However, in general, as
stated above, floating processors who participate in the pollock B
season would tend to benefit from an additional economic opportunity to
process salmon. Onshore processors could lose revenues as a result of
increased competition among pollock processors. Finally, the effect on
local Alaskan communities can not be reliably determined at present and
would depend on the net impact of the delay. A copy of the 1993 EA/RIR/
FRFA and the 1996 supplement are available from the Council (see
ADDRESSES).
An informal section 7 consultation under the Endangered Species Act
was initiated for the proposed rule to determine any adverse effects of
the BSAI ``B'' season delay on Steller sea lions. The consultation
determined that the proposed delay in the fishery and the November 1
ending date of the ``B'' season would not likely result in any adverse
effects on Steller sea lions or critical habitat.
This proposed rule has been determined to be not significant for
purposes of E.O. 12866.
List of Subjects in 50 CFR Part 675
Fisheries, Reporting and recordkeeping requirements
Dated: June 7, 1996.
Gary Matlock,
Program Management Officer, National Marine Fisheries Service.
For the reasons set out in the preamble, 50 CFR part 675 is
proposed to be amended as follows:
PART 675--GROUNDFISH OF THE BERING SEA AND ALEUTIAN ISLANDS AREA
1. The authority citation for part 675 continues to read as
follows:
Authority: 16 U.S.C. 1801 et seq.
2. In Sec. 675.20, paragraph (a)(2)(ii) is revised to read as
follows:
Sec. 675.20 General limitations.
(a) * * *
(2) * * *
(ii) The TAC of pollock in each subarea or district will be
divided, after subtraction of reserves, into two allowances. The first
allowance will be available for directed fishing from January 1 until
noon, Alaska local time (A.l.t.), April 15. The second allowance will
be available for directed fishing from noon, A.l.t., September 1 until
noon A.l.t., November 1, of each fishing year. Within any fishing year,
unharvested amounts of the first allowance will be added to the second
allowance, and harvests in excess of the first allowance will be
deducted from the second allowance.
* * * * *
3. In Sec. 675.23, paragraph (e) is revised to read as follows:
Sec. 675.23 Seasons.
* * * * *
(e) Directed fishing for pollock. (1) Subject to other provisions
of this part, and except as provided in paragraphs (e)(2) and (e)(3) of
this section, directed fishing for pollock is authorized from 00:01
a.m., A.l.t., January 1, until noon, A.l.t, April 15, and from noon
A.l.t., September 1 until noon A.l.t, November 1, of each fishing year.
(2) Applicable through December 31, 1998. (i) Subject to other
provisions of this part and except as provided in paragraphs (e)(2)(ii)
and (e)(2)(iii) of this section, directed fishing for pollock by the
offshore component, defined at Sec. 672.2 of this chapter, or by
vessels delivering pollock to the offshore component, is authorized
from noon A.l.t., January 26, until noon A.l.t., April 15. Directed
fishing for pollock under the Western Alaska Community Development
Quota program pursuant to Sec. 675.27 of this part is authorized from
January 1, through the end of the fishing year.
(ii) Directed fishing for pollock by the offshore component, as
defined at Sec. 672.2 of this chapter, or vessels delivering pollock to
the offshore component is prohibited until noon, A.l.t., February 5,
for those vessels that are used to fish prior to noon, A.l.t., January
26, for groundfish in the Bering Sea and Aleutian Islands management
area, groundfish in the Gulf of Alaska, as defined at Sec. 672.2 of
this chapter, or king or Tanner crab in the Bering Sea and Aleutian
Islands area, as defined at Sec. 671.2 of this chapter.
(iii) Neither paragraphs (e)(2)(ii) nor (e)(3) of this section
apply to vessels used to fish exclusively in a directed fishery for
pollock prior to noon, A.l.t., January 26, or during the period that
extends from noon, A.l.t., August 25, through noon A.l.t., September 1,
under the Western Alaska Community Development Quota program pursuant
to Sec. 675.27.
(3) Directed fishing for pollock is prohibited during the second
pollock season defined at paragraph (e)(1) of this section until noon,
A.l.t., September 8, for any vessel that is used to fish with trawl
gear for groundfish in the Bering Sea and Aleutian Islands management
area or the Gulf of Alaska as defined at Sec. 672.2 of this chapter,
between noon A.l.t., August 25, and noon A.l.t., September 1.
[FR Doc. 96-14926 Filed 6-7-96; 1:29 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-14919 Investment and Deposit Activities
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Page 29697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14919]
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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.
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Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 /
Proposed Rules
[[Page 29697]]
NATIONAL CREDIT UNION ADMINISTRATION
12 CFR Part 703
Investment and Deposit Activities
AGENCY: National Credit Union Administration (NCUA).
ACTION: Proposed rule; Extension of comment period.
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SUMMARY: On November 29, 1995 (60 FR 61219), the National Credit Union
Administration (NUCA) published for public comment a proposed rule
regarding investment and deposit activities for credit unions. The
comment period for this proposed rule was to have expired on March 28,
1996. The original comment period was extended to June 26, 1996 (61 FR
8499). A national trade association has requested an additional
extension in which to respond in order to review the proposed rule
concurrently with the proposed rule governing corporate credit unions
which was issued by the NCUA Board on May 22, 1996 with a 90-day
comment period. To encourage additional comments, the NCUA Board has
decided to extend the comment period on the proposed rule. The extended
comment period now expires September 30, 1996.
DATES: The comment period has been extended and now expires September
30, 1996. Comments must be received on or before September 30, 1996.
ADDRESSES: Comments should be directed to Becky Baker, Secretary of the
Board. Mail or hand-deliver comments to: National Credit Union
Administration Board, 1775 Duke Street, Alexandria, Virginia 22314-
3428. Fax comments to (703) 518-6480. Please send comments by one
method only.
FOR FURTHER INFORMATION CONTACT:
David M. Marquis, Director, Office of Examination and Insurance, (703)
518-6360, or Daniel Gordon, Senior Investment Officer, (703) 518-6620,
or at the above address.
By the National Credit Union Administration Board on June 3,
1996.
Becky Baker,
Secretary of the Board.
[FR Doc. 96-14919 Filed 6-11-96; 8:45 am]
BILLING CODE 7535-01-M
Complete official Federal Register PDF
FR Doc. 96-14912 National Ambient Air Quality Standards for Ozone and Particulate Matter
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29719-29725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14912]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 50
[AD-FRL-5519-4]
National Ambient Air Quality Standards for Ozone and Particulate
Matter
AGENCY: Environmental Protection Agency.
ACTION: Advance Notice of Proposed Rulemaking.
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SUMMARY: In accordance with sections 108 and 109 of the Clean Air Act,
the Environmental Protection Agency (EPA) is nearing completion in its
reviews of the air quality criteria and national ambient air quality
standards (NAAQS) for ozone (O3) and particulate matter (PM). This
action announces the Agency's plans to propose decisions on whether to
retain or revise the O3 and PM NAAQS under the same schedule, by
November 29, 1996, with final action scheduled for mid-1997. Further,
this action announces the Agency's process for developing integrated
strategies for the implementation of potential new O3 and PM
NAAQS, as well as a regional haze program. This action reflects the
Agency's recognition of important scientific and technical factors with
both these pollutants, associated standards, and implementation
strategies to meet such standards. Through this action, the Agency is
providing advance notice of key issues that are being considered in the
reviews of these standards to allow more time for the public to develop
input and comments beyond that which will be provided following the
notices of proposed rulemaking.
FOR FURTHER INFORMATION CONTACT: Dr. David McKee on the O3 NAAQS
review, MD-15, Air Quality Standards and Strategies Division, Office of
Air Quality Planning and Standards, U.S. Environmental Protection
Agency, Research Triangle Park, North Carolina 27711 (919-541-5288);
Dr. Jane Caldwell on the PM NAAQS review, same address (919-541-0328);
and Ms. Denise Gerth on the integrated implementation strategy
development process, same address (919-541-5550).
SUPPLEMENTARY INFORMATION:
Availability of Related Information
A. Documents Related to the O3 and PM NAAQS Reviews
The Air Quality Criteria for Ozone and Other Photochemical Oxidants
(EPA/600/P-93-004aF thru EPA/600/P-93-004cF); Review of the National
[[Page 29720]]
Ambient Air Quality Standards for Ozone: Assessment of Scientific and
Technical Information: OAQPS Staff Paper (EPA-452/R-96-007); the Air
Quality Criteria for Particulate Matter (EPA/600/P-95-001aF thru EPA/
600/P-95-001cF); and Review of the National Ambient Air Quality
Standards for Particulate Matter: Policy Assessment of Scientific and
Technical Information: OAQPS Staff Paper (EPA-452/R-96-xxx) are now
available on the Agency's Office of Air Quality Planning and Standards'
(OAQPS) Technology Transfer Network (TTN) Bulletin Board System (BBS).
The telephone number for the TTN BBS is (919) 541-5742. To access the
bulletin board a modem and communications software are necessary. The
following parameters on the communications software are required: Data
Bits-8; Parity-N; and Stop Bits-1. The documents will be located on the
Clean Air Act Amendments BBS, under Title I, Policy/Guidance Documents.
If assistance is needed in accessing the system, call the help desk at
(919) 541-5384 in Research Triangle Park, NC.
Copies of each of these documents are available for public
inspection at the EPA Air Docket and the EPA library, both at
Headquarters, Waterside Mall, 401 M Street, Washington, DC. EPA Air
Docket hours, in Room M1500 of Waterside Mall, are 8 a.m. to 5:30 p.m.,
Monday through Friday, excluding holidays. EPA Library hours are from
10 a.m. until 2 p.m., excluding holidays. The EPA docket numbers for
the O3 and PM NAAQS reviews are A-95-58 and A-95-54, respectively.
A limited number of copies of other technical support documents for
these standard reviews, such as documents pertaining to air quality,
human exposure, health risk, and economic analyses, are available and
can be obtained from: U.S. Environmental Protection Agency Library (MD-
35), Research Triangle Park, NC 27711, telephone (919) 541-2777. These
and other related documents are also available for inspection in the
EPA dockets identified above.
B. Documents Related to the Development of Integrated Implementation
Strategies
Documents associated with the development of integrated
implementation strategies are filed in EPA docket number A-95-38, and
are available from this docket as described above.
Background and Schedules
The Clean Air Act requires the establishment, review, and revision
of NAAQS, and directs the Administrator to identify pollutants which
``may reasonably be anticipated to endanger public health and welfare''
and to issue air quality criteria for them (42 U.S.C. 7408, 7409).
These air quality criteria are to ``accurately reflect the latest
scientific knowledge useful in indicating the kind and extent of all
identifiable effects on public health or welfare which may be expected
from the presence of [a] pollutant in the ambient air * * *.'' The
Administrator is directed to propose and promulgate both ``primary''
and ``secondary'' NAAQS for such pollutants. A primary standard is
defined as one ``the attainment and maintenance of which, in the
judgment of the Administrator, based on the criteria and allowing an
adequate margin of safety, [is] requisite to protect the public
health.'' A secondary standard must ``specify a level of air quality
the attainment and maintenance of which, in the judgment of the
Administrator, based on [the] criteria, is requisite to protect the
public welfare from any known or anticipated adverse effects associated
with the presence of [the] pollutant in the ambient air.'' 1
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\1\ Welfare effects as defined by the Act include, but are not
limited to, effects on soils, water, crops, vegetation, manmade
materials, animals, wildlife, weather, visibility and climate,
damage to and deterioration of property, and hazards to
transportation, as well as effects on economic values and on
personal comfort and well-being.
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The Act requires periodic review and, if appropriate, revision of
existing air quality criteria and NAAQS. The Act also requires
appointment of an independent scientific review committee to review
criteria and standards and recommend to the Administrator new standards
or revisions of existing criteria and standards, as appropriate. This
committee is known as the Clean Air Scientific Advisory Committee
(CASAC), a standing committee of EPA's Science Advisory Board.
The EPA initiated action to update the air quality criteria
documents for O3 in August 1992 (57 FR 38832) and for PM in April
1994 (59 FR 17375). As discussed more fully in the next two sections of
this notice, both reviews have included a series of peer-review
workshops on the air quality criteria, as well as CASAC and public
reviews of draft air quality criteria documents and staff papers. The
staff papers evaluate the policy implications of key studies and
scientific information contained in the criteria documents; identify
factors relevant to the evaluation of current primary and secondary
NAAQS; summarize air quality, exposure, and risk analyses, to the
extent possible, of alternative standards; and present staff
conclusions and recommendations of suggested options for the
Administrator to consider in her review of the NAAQS.
In conjunction with the reviews of the O3 and PM NAAQS, the
EPA has also initiated action to address strategies for the
implementation of potential new NAAQS. This action includes examining
the ramifications of any changes to the NAAQS on current implementation
efforts, and, if appropriate, developing new implementation control
strategies. In addition, the EPA is reviewing options to ensure a
smooth transition for implementation of any new NAAQS. A process for
providing significant stakeholder involvement in the development of
such strategies and options is outlined in the final section of this
notice.
These ongoing reviews and related implementation strategy
activities to date have brought out important common factors between
O3 and PM. Several similar health effects have been associated
with exposure to O3 and PM, including for example aggravation of
respiratory disease (e.g., asthma), increased respiratory symptoms, and
increased hospital admissions and emergency room visits for respiratory
causes. Other similarities in pollutant sources, formation, and control
exist between O3 and PM, in particular the fine fraction of
particles addressed by the current PM NAAQS.2 These similarities
include (1) atmospheric residence times of several days, leading to
regional-scale transport of the pollutants; (2) similar gaseous
precursors, including compounds of nitrogen (NOX) and volatile
organic compounds (VOC), which contribute to the formation of both
O3 and PM in the atmosphere; (3) similar combustion-related source
categories, such as coal and oil-fired power generation and industrial
boilers and mobile sources, which emit particles directly as well as
gaseous precursors of particles (e.g., SOX, NOX, VOC) and
O3 (e.g., NOX, VOC); and (4) similar atmospheric chemistry
driven by the same chemical reactions and intermediate chemical species
which favor both high O3 and fine particle levels. High fine
particle levels are also associated with significant impairment of
visibility on a regional scale. These similarities provide
opportunities for optimizing technical analysis tools (i.e., monitoring
[[Page 29721]]
networks, emission inventories, air quality models) and integrated
emission reduction strategies to yield important co-benefits across
various air quality management programs. This integration could result
in a net reduction of the regulatory burden on some source category
sectors that would otherwise be impacted separately by O3, PM, and
visibility protection control strategies.
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\2\ The current PM NAAQS addresses particles with an aerodynamic
diameter less than or equal to a nominal 10 microns (PM10). The
fine fraction of such particles is generally taken to address
particles with an aerodynamic diameter less than or equal to a
nominal 2.5 microns (PM2.5).
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In recognition of the potential benefits of integrating the
Agency's approaches to providing for appropriate protection of public
health and welfare from exposure to O3 and PM, the Agency plans to
complete these NAAQS reviews and develop associated implementation
strategies under coordinated schedules. Thus, the Agency plans to
propose decisions on whether to retain or revise the O3 and PM
NAAQS by November 29, 1996, with final action planned for June 1997,
consistent with the current schedule established by court order for the
PM NAAQS review.3 Proposal of various key aspects of integrated
implementation strategies for potential new NAAQS is planned for June
1997, consistent with final action on the NAAQS reviews, with proposal
of full implementation strategies planned for June 1998.
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\3\ In response to a suit filed by the American Lung Association
in February 1994 to compel EPA to complete the present review of the
PM NAAQS, the U.S. District Court for the District of Arizona has
issued orders requiring publication of proposed and final decisions
by November 29, 1996 and June 28, 1997, respectively.
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The EPA encourages involvement of interested parties in these
regulatory actions and is providing opportunities for public
participation and comment throughout the processes. The Agency also
recognizes that these schedules are accelerated relative to past NAAQS
reviews and is thus providing this advance notice to alert potential
participants in the reviews to the important considerations and key
issues which the Administrator will take into account in making
decisions in these actions.
Review of the Ozone NAAQS
The CASAC has completed its review of the O3 Criteria Document
and O3 Staff Paper, and has advised the Administrator that the
documents provide an adequate review of the available scientific data
and relevant studies, as well as an adequate scientific basis for
making regulatory decisions concerning primary and secondary O3
standards (Wolff, 1995a,b, 1996b). Thus, the Administrator is primarily
focusing attention on the staff conclusions and range of staff
recommendations presented in the O3 Staff Paper, together with
specific CASAC recommendations outlined below for the primary and
secondary standards.
A. Primary Standard Issues
In selecting a primary standard, the Administrator must specify an
averaging time, O3 concentration (i.e., level), and form (i.e.,
the air quality statistic to be used as a basis for determining
compliance with the standard). The key factors outlined in the Staff
Paper for selecting these elements of a primary O3 standard
reflect an integration of information on acute 4 and chronic
5 health effects associated with exposure to ambient O3,
expert judgments on the adversity of such effects for individuals, and
policy judgments, informed by air quality and human exposure analyses
and quantitative risk assessment when possible, as to the point at
which risks would be reduced sufficiently to achieve protection of
public health with an adequate margin of safety. Such an approach has
been endorsed by CASAC and is consistent with its advice to the
Administrator (Wolff, 1995b) that ``ozone may elicit a continuum of
biological responses down to background concentrations.'' In such a
case, CASAC has advised that the traditional paradigm of standard
setting cannot be applied in the usual way, and that ``EPA's risk
assessments must play a central role in identifying an appropriate
level.'' Thus, the Administrator is giving preliminary consideration to
the task of selecting a standard level that will reduce risks
sufficiently to protect public health with an adequate margin of
safety, based on her understanding that a zero-risk standard is neither
possible nor required by the Act.
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\4\ Acute effects associated with short-term (1-3 hr) and
prolonged (6-8 hr) exposures to O3 include transient pulmonary
function decrements, increased respiratory symptoms, and effects on
exercise performance, as well as increased airway responsiveness,
susceptibility to respiratory infection, increased hospital
admissions and emergency room visits for respiratory causes (e.g.,
asthma), and acute pulmonary inflammation.
\5\ Chronic effects for which evidence suggests associations
with long-term (months to years) exposure to O3 include
structural damage to lung tissue and accelerated decline in baseline
lung function which could result in decreased quality of life in
later years.
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1. Consideration of New 8-Hour Primary Standard
The Administrator is giving strong preliminary consideration to the
unanimous recommendation of CASAC ``that the present 1-hr standard be
eliminated and replaced with an 8-hr standard'' (Wolff, 1995b). This
recommendation reflects the consensus CASAC view that an 8-hr standard
is more appropriate for a human health-based standard since 8-hr
average exposures to O3 are more directly associated with health
effects of concern at lower ambient O3 concentrations than are 1-
hr average exposures. In considering an appropriate level for a
possible new 8-hr standard, the Administrator notes that during the
last review of the O3 criteria and standards 6, CASAC
concluded that the existing 1-hr standard, set at a level of 0.12 parts
per million (ppm) O3, provided ``little, if any, margin of
safety'' (McClellan, 1989). The Administrator also notes the CASAC
consensus that 0.07 ppm to 0.09 ppm is an appropriate range for
consideration for a new 8-hr standard, and further, that none of the
CASAC panel members have expressed an opinion that such a standard
should be set at a level below 0.08 ppm (Wolff, 1995b). In addition, a
number of CASAC panel members have recommended that, since there is no
apparent threshold for responses and no ``bright line'' in the risk
assessment, a pollution warning system be initiated to allow
particularly sensitive individuals to take appropriate action,
potentially building upon the Agency's Pollutant Standards Index or on
infrastructures already in place in many areas of the country for
designating days when voluntary emission reduction measures may be
encouraged locally.
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\6\ The last review concluded in March 1993 with a final
decision that revisions to the O3 standards were not
appropriate at that time (58 FR 13008).
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2. New Approaches to Defining the Form of the Primary Standard
In giving preliminary consideration to the form of a possible new
8-hr standard, the Administrator is aware that since promulgation of
the current NAAQS in 1979, a number of concerns have been raised about
the current 1-expected-exceedance form. These concerns include, in
particular, the year-to-year stability of the number of exceedances
and, thus, the stability of the attainment status of an area; data
handling conventions, including the procedures for adjusting for
missing data; and the evaluation of air quality on a site-by-site basis
rather than some form of population-weighted averaging across
monitoring sites within an area. The CASAC has advised that such
concerns should be addressed by considering a more robust,
concentration-based form to ``provide some insulation from the impacts
of extreme meteorological events.'' (Wolff, 1995b) In particular, all
CASAC panel members who expressed their opinions in this area favored a
form of the standard that allowed for multiple
[[Page 29722]]
exceedances within the range of 1 to 5 exceedances recommended in the
Staff Paper.
In light of historic concerns and recent advice from CASAC, the
Agency is evaluating new approaches to defining the form of the primary
standard. Such approaches include the use of less extreme and
concentration-based air quality statistics, the specification of a
range of air quality rather than a single measure, and the use of some
form of population-weighted measure of air quality combining data
across monitors. In particular, the Agency is examining potential
advantages of a concentration-based form over an expected-exceedance-
based form. A principal advantage is that a concentration-based form is
more directly related to the ambient O3 concentrations that are
associated with health effects; that is, the degree and extent to which
public health is affected is related to the concentration of O3 in
the ambient air, not just whether that concentration is above or below
some specific level. Further, a concentration-based form has greater
temporal stability than the expected-exceedance form, and, thus, would
facilitate the development of more stable implementation programs by
the States. The specification of a range rather than a single value may
facilitate individual and/or regulatory agency efforts to provide
additional safeguards against responses that may, in a small number of
particularly sensitive individuals, occur at levels even below the
level of a standard that protects public health with an adequate margin
of safety.
Any consideration of some form of population-weighted measure of
air quality raises issues about environmental equity, the adequacy of
the current monitoring network, and the specificity of monitoring
siting requirements. On the other hand, such a conceptual approach may
better reflect population exposure and risk. As part of its review of
the primary standard, the Agency will be interested in particular in
analyses that inform questions about appropriate criteria for using
data from multiple monitors in developing population-weighted measures
of air quality and the distribution of public health protection that
would result from such an approach.
B. Secondary Standard Issues
The Agency's review of a secondary O3 standard has focused on
effects on vegetation 7, including agricultural crops and native
vegetation, recognizing that such effects can indirectly impact natural
ecosystem components such as soils, water, animals, and wildlife. The
key factors outlined in the O3 Staff Paper for selecting a
secondary standard include vegetation effects information in the
O3 Criteria Document, including information on biologically
relevant measures of exposure; analyses of air quality, particularly in
rural areas; and rough estimates of vegetation exposure to ambient
O3 and potential risks in terms of the extent of impacts and,
where possible, the economic values associated with such risks. The
Agency is also considering the potential degree of vegetation
protection that may be afforded by a possible new primary standard.
---------------------------------------------------------------------------
\7\ Vegetation effects that have been associated with O3
exposures include visible foliar injury, growth reductions and yield
loss in annual crops, growth reductions in tree seedlings and mature
trees, and ecosystem level impacts.
---------------------------------------------------------------------------
The Administrator is giving strong preliminary consideration to the
unanimous conclusion of CASAC ``that damage is occurring to vegetation
and natural resources at concentrations below the present 1-hr national
ambient air quality standard,'' and to its unanimous recommendation
``that a secondary NAAQS, more stringent than the present primary
standard, was necessary to protect vegetation from ozone'' (Wolff,
1996b). Further, CASAC recognizes that vegetation response to ambient
O3 is cumulative, suggesting that a secondary standard with some
cumulative, perhaps seasonal, form would better reflect biologically
relevant measures of exposure than a short-term average concentration
form. The Administrator also recognizes, however, that there remains a
diversity of views within the scientific community in general and the
CASAC panel members in particular as to an appropriate level and
measure of exposure for such a standard. This diversity of views is
consistent with the consensus view that significant uncertainties
remain in understanding the nature, degree, and long-term patterns of
responses to O3 exposures across the large number of species of
annual and perennial plants and trees that are part of the commercial
and native vegetation to be addressed by a national O3 standard.
In light of the consensus that the current secondary standard is
not sufficiently protective of vegetation, as well as the diversity of
views with regard to an appropriate level and form for a new standard,
the Agency is giving preliminary consideration to two approaches to
selecting a standard. The first approach is to consider the degree of
protection that may be afforded by a possible new primary standard,
while recognizing that such a form would be only a surrogate for more
biologically relevant cumulative exposure measures. Alternatively, the
Agency is also considering cumulative forms and seasonal averaging
times within the ranges of options presented in the Staff Paper to
identify a reasonable policy choice for such a standard, recognizing
that no one form could reflect all biologically relevant factors across
the broad range of species being addressed. These alternative
approaches are consistent with the range of views expressed by the
CASAC panel members (Wolff, 1996b).
CASAC has also provided the Administrator with its insights as to
why there are such divergent opinions on the selection of a new
secondary standard, citing the lack of sufficient rural O3 data
and the lack of relevant plant exposure studies under field conditions
as the main reasons (Wolff, 1996b). The Agency recognizes the
importance not only of additional vegetation effects research, but also
of enhancing the existing O3 monitoring network to provide better
coverage in more rural areas of agricultural and ecological importance,
regardless of the regulatory approach taken in this review. Thus, the
Agency will be interested in information and analyses that would inform
future decisions as to how to enhance the O3 monitoring network on
an appropriate spatial scale and in a cost-effective manner. Based on
such information, consideration could also be given to spatially
integrating O3 concentrations across multiple monitors in
conjunction with establishing a form for a secondary standard that
could provide a more representative indication of relevant vegetation
exposures over appropriate spatial scales.
Review of PM NAAQS
CASAC has completed its review of the PM Criteria Document and is
nearing completion on the PM Staff Paper. CASAC has advised the
Administrator that the PM Criteria Document included an excellent
integrative summary of the state of knowledge about the health effects
of airborne PM, and that, as revised to reflect CASAC's final comments,
the document provides an adequate review of the available scientific
data and relevant studies of PM and scientific basis for regulatory
decisions on PM (Wolff, 1996a). The schedule calls for CASAC to
complete its review and advice to the Administrator on the PM Staff
Paper and recommendations on
[[Page 29723]]
possible new or revised PM standards by mid-June.
A. Primary Standard Issues: Consideration of Fine Particle Standards
Based on CASAC's review of the PM Criteria Document, the Agency is
focusing on the primary conclusions highlighted in that document as a
basis for its preliminary consideration of possible new PM primary
standards. In particular, the PM Criteria Document concludes that newly
emerging studies of the effects of community air pollution provide
reasonably consistent results indicative of increased mortality and
morbidity effects, including hospital admissions and respiratory
illness, associated with short- and long-term exposures to ambient air
containing PM concentrations currently found in many U.S. urban areas,
including areas which comply with the current 24-hr and annual PM
standards. Further, the PM Criteria Document concludes that analyses of
the epidemiological evidence suggest stronger associations of mortality
and some morbidity effects with fine particles than with the coarse
particles within PM10. For this and other reasons, the PM Criteria
Document concludes that fine and coarse fraction particles, which
together comprise the mix of particles in PM10, should be
considered as separate pollutants. This conclusion was supported by
many CASAC panel members (Wolff, 1996a, Shy et al., 1996), with others
noting important uncertainties to be addressed in using this conclusion
as a basis for selecting possible new fine particle standards. The PM
Criteria Document also concludes that coarse fraction particles have
been more directly associated with some morbidity effects.
In selecting a primary standard or suite of standards for PM, the
Administrator must specify an indicator or indicators to define the
pollutant in terms of which particles, within the broad class of
chemically and physically diverse substances that comprise airborne PM,
a given standard addresses. Based on the conclusions and CASAC advice
outlined above, the Agency is giving preliminary consideration to the
task of selecting a suite of standards that would focus risk management
approaches so as to provide appropriate public health protection across
the range of effects that have been associated with both the fine and
coarse fraction particles within the particle mix that comprises
PM10. The Agency is interested in information and analyses that
will inform decisions as to the most effective and efficient suite of
standards for providing the requisite degree of health protection.
Further, new approaches to defining the form of short-term primary
standards, as discussed above in the section on the O3 primary
standard, are also of interest to the Agency in considering alternative
PM standards.
B. Secondary Standard Issues
The Agency's review of a secondary PM standard is focusing on
visibility impairment that has been associated in particular with fine
particles. The PM Criteria Document notes that the level of this
impairment varies greatly from eastern to western U.S. regions as do
background levels of fine particles and other factors that are
associated with visibility impairment. Because of significant regional
variations in visibility conditions and the problems this presents in
establishing a uniform national standard, the Agency is giving strong
consideration to addressing visibility impairment through a new
regional haze program, under section 169A of Act, rather than through a
secondary NAAQS.
Development of Integrated Implementation Strategies
The Agency has initiated a process designed to provide for
significant stakeholder involvement in the development of integrated
implementation strategies for possible new or revised O3 and PM
NAAQS and a new regional haze program. As described below, this process
involves a new subcommittee of the Agency's Clean Air Act Advisory
Committee (CAAAC), established in accordance with the Federal Advisory
Committee Act (FACA) (5 U.S.C. App.2).
A. Background
The FACA was enacted in 1972 to open the advisory committee process
to public scrutiny and to protect against undue influence by special
interest groups over government decision making. Federal Advisory
Committees may be established by statute, the President, or by the head
of a Federal Agency. An advisory committee or subcommittee is
established under FACA to obtain advice or recommendations from
advisory groups established by or closely tied to the Federal
Government.
The CAAAC was established to provide independent advice and counsel
to the EPA on policy and technical issues associated with the
implementation of the Act. The CAAAC advises EPA on the development,
implementation, and enforcement of several of the new and expanded
regulatory and market-based programs required by the Act.
The CAAAC advises on issues that cut across several program areas.
The programs falling under the purview of the CAAAC include those for
meeting national ambient air quality standards (NAAQS), reducing
emissions from vehicles and vehicle fuels, reducing air toxic
emissions, issuing operating permits and collecting fees, and carrying
out new and expanded compliance authorities. The CAAAC holds meetings,
analyzes issues, conducts reviews, performs studies, produces reports,
makes recommendations, and undertakes other activities necessary to
meet its responsibilities. Comments, evaluations, and recommendations
of the CAAAC and responses from the EPA are made available for public
review, in accordance with Section 10 of FACA.
A new subcommittee of the CAAAC, the Subcommittee for Ozone,
Particulate Matter, and Regional Haze Implementation Programs (the
Subcommittee), was established in August 1995 to address integrated
strategies for the implementation of potential new O3 and PM
NAAQS, as well as a regional haze program. The Subcommittee is composed
of representatives selected from among state, local, and tribal
organizations; environmental groups; industry; consultants; science/
academia; and federal agencies. Recommendations made by the
Subcommittee will be submitted to EPA through CAAAC. To facilitate
communication between the Subcommittee and CAAAC, some members of CAAAC
are on the Subcommittee.
B. Purpose of the Subcommittee on Integrated Implementation Strategies
The Subcommittee is charged with providing advice and
recommendations to EPA on developing new, integrated approaches for
implementing potential revised NAAQS for O3 and PM, as well as for
implementing a new regional haze reduction program. The Subcommittee is
expected to examine key aspects of the implementation programs for
O3 and PM, to provide for more flexible and cost-effective
implementation strategies, as well as to provide new approaches that
could integrate broad regional and national control strategies with
more localized efforts. In addition, the Subcommittee will consider new
and innovative approaches to implementation including market-based
incentives. The focus of the Subcommittee will be on assisting EPA in
developing implementation control strategies, preparing supporting
analyses, and identifying and resolving
[[Page 29724]]
impediments to the adoption of the resulting programs.
Issues involved in possible revision of the O3 and PM NAAQS,
such as the averaging time, level, and form of any revised standards,
are being addressed in accordance with the NAAQS review process
described in the above sections, including review by CASAC, and are not
within the Subcommittee's charge. CASAC is charged with providing
advice and recommendations to the Administrator on all matters
pertaining to the review of and possible revisions to the NAAQS.
Similarly, selection of the appropriate indicator or units of
measurement for quantifiable changes in visibility are being addressed
through an independent, scientific peer-review process and, thus, will
not be a subject for recommendations by the Subcommittee.
C. Subcommittee Structure
The organization of the Subcommittee includes a coordination group
and four work groups that will address specific issues. The
coordination and work groups consist of members of the Subcommittee, as
well as others recommended by the Subcommittee.
1. Coordination Group
The coordination group is responsible for assuring that the outputs
of the various work groups are coordinated and support the overall
project goals. This group serves as the communication link between the
full Subcommittee and the work groups. It sets the agendas for the
Subcommittee meetings and coordinates presentations of key issues and
related options to the full Subcommittee. The coordination group
provides direction to work group chairs in determining priority issues
to be considered by the full Subcommittee and in setting time frames
for addressing issues and options with the Subcommittee. This group
serves as a ``sounding board'' on potential work group products,
resource needs, and any potential impediments to the progress of the
work groups. It ensures that adequate progress is made by work groups
and that issues are appropriately identified and addressed in
accordance with established time lines. Finally, the coordination group
provides a forum for determining the extent to which work groups
address similar or related issues.
2. Base Program Analyses and Policies Group
The Base Program Analyses and Policies Group is responsible for
conducting a reexamination of the existing base regulatory program to
take into account the potential new NAAQS, as well as the regional haze
program, and to better integrate broader-based regional and national
control programs including the perspective of both receptors and
generators of emissions. This includes reexamination of the designation
and classification process to better reflect the associated health
risks and definition of air quality problems. An important component of
this group's assignment is the development of recommendations that will
facilitate moving from existing to new programs.
3. National and Regional Strategies Group
The National and Regional Strategies Group is responsible for
development of broad regional and national strategies for addressing
transport issues. This group examines broad-based market and trading
approaches and other innovative strategies for achieving emission
reductions. To do this, the group has to consider the technical,
policy, and institutional issues associated with these types of
approaches from the perspective of both generators and receptors of
emissions.
4. Communications and Outreach Group
The Communications and Outreach Group is responsible for developing
a focus on the education of the general public to the nature and extent
of air quality problems and the associated health and welfare impacts.
This includes providing explanations of the measures being taken now
and in the future to address these problems and summaries of associated
costs and benefits. The initial focus of the group was to explain the
current understanding of health and welfare effects information. This
includes the steps EPA is taking to address health and welfare effects
through possible new NAAQS and the regional haze program. Finally, this
group describes how EPA, through the Subcommittee, is developing new
integrated approaches to assure that public health and environmental
objectives are attained as effectively and efficiently as possible.
5. Science and Technical Support Group
The Science and Technical Support Group is responsible for
preparing an assessment of the current state of the art with respect to
emission inventories, air quality models, meteorological models, and
analysis of air quality monitoring data to provide a scientific basis
for decisions on integrated implementation strategies. These efforts
are coordinated with the ongoing work of the Ozone Transport Assessment
Group (OTAG), the Grand Canyon Visibility Transport Commission (GCVTC),
the Southern Appalachian Mountains Initiative (SAMI), and the North
American Regional Strategies for Tropospheric Ozone (NARSTO). The
Science and Technical Support Group assessment is expected to be a
short-term effort to provide baseline information to the other working
groups. In the longer term, this group will provide scientific and
technical support to the other groups as requested.
D. Ongoing Process and Schedule for Addressing Issues
The work groups will develop options and recommendations, and
present these to the Subcommittee for further consideration. When
consensus is not obtained on recommendations, minority and majority
options will be presented to the Subcommittee via the coordination
group. The Subcommittee will then forward its recommendations to the
CAAAC for consideration and recommendation to EPA.
The integrated implementation programs for O3, PM, and
regional haze will be developed in a two-phased approach. In Phase I,
the Subcommittee and work groups will address air quality management
framework issues. EPA plans to propose the resulting Phase I strategy
in June 1997. Phase II of the integrated implementation strategy will
focus on more detailed control strategy development. EPA plans to
propose the Phase II strategy in June 1998.
Generally, Phase I implementation issues include: (1) designations
for new NAAQS and regional haze planning areas, (2) mechanisms to
address regional strategies, (3) integration of NAAQS and regional haze
implementation programs, (4) regional haze program definition, (5) new
source review, and (6) dates for potential new NAAQS and regional haze
programs. Phase II implementation issues include: (1) classifications,
(2) control requirements, (3) economic incentives, (4) State
implementation plan requirements, (5) overall control program
integration, (6) measure of progress, and (7) institutional process.
List of Subjects in 40 CFR Part 50
Environmental protection, Air pollution control, Carbon monoxide,
Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.
[[Page 29725]]
Dated: May 31, 1996.
Mary D. Nichols,
Assistant Administrator for Air and Radiation.
References
McClellan, R.O. (1989) Letter from Chairman of Clean Air Scientific
Advisory Committee to the EPA Administrator concerning ``closure''
on the Ozone Criteria Document Supplement and the Ozone Staff Paper,
dated May 1, 1989.
Shy, C.; Lippmann, M.; Stolwijk, J.; and Speizer, F. (1996). Letter
to Administrator Carol M. Browner regarding Supplement to the
Closure Letter from the Clean Air Scientific Advisory Committee.
March 20, 1996.
Wolff, G.T. (1995a) Letter from George T. Wolff, Chair, Clean Air
Scientific Advisory Committee (CASAC) to Administrator Carol M.
Browner. Closure letter by CASAC on the Air Quality Criteria for
Ozone and Related Photochemical Oxidants. November 28, 1995.
Wolff, G.T. (1995b) Letter from George T. Wolff, Chair, Clean Air
Scientific Advisory Committee (CASAC) to Administrator Carol M.
Browner. Closure letter by CASAC on the Primary Standard Portion of
the Staff Paper for Ozone. November 30, 1995.
Wolff, G.T. (1996a) Letter from George T. Wolff, Chair, Clean Air
Scientific Advisory Committee (CASAC) to Administrator Carol M.
Browner. Closure letter by CASAC on draft Air Quality Criteria for
Particulate Matter. March 15, 1996.
Wolff, G.T. (1996b) Letter from George T. Wolff, Chair, Clean Air
Scientific Advisory Committee (CASAC) to Administrator Carol M.
Browner. Closure letter by CASAC on the Secondary Standard Portion
of the Staff Paper for Ozone. April 4, 1996.
[FR Doc. 96-14912 Filed 6-11-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-14910 Approval and Promulgation of Air Quality Implementation Plans; Tennessee; Approval of Revisions to Process Emission Standards for Total Reduced Sulfur Emissions From Kraft Mills
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29725-29726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14910]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 62
[TN-115-01-9616b; FRL-5519-7]
Approval and Promulgation of Air Quality Implementation Plans;
Tennessee; Approval of Revisions to Process Emission Standards for
Total Reduced Sulfur Emissions From Kraft Mills
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The EPA proposes to approve the State implementation plan
(SIP) revision submitted by the State of Tennessee for the purpose of
revising the current regulations for Total Reduced Sulfur (TRS) from
Kraft Mills. In the final rules section of this Federal Register, the
EPA is approving the State's SIP revision as a direct final rule
without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no adverse
comments. A detailed rationale for the approval is set forth in the
direct final rule. If no adverse comments are received in response to
this proposed rule, no further activity is contemplated in relation to
this proposed rule. If EPA receives adverse comments, the direct final
rule will be withdrawn and all public comments received will be
addressed in a subsequent final rule based on this proposed rule. The
EPA will not institute a second comment period on this document. Any
parties interested in commenting on this document should do so at this
time.
[[Page 29726]]
DATES: To be considered, comments must be received by July 12, 1996.
ADDRESSES: Written comments on this action should be addressed to Karen
Borel, at the EPA Regional Office listed below. Copies of the documents
relative to this action are available for public inspection during
normal business hours at the following locations. The interested
persons wanting to examine these documents should make an appointment
with the appropriate office at least 24 hours before the visiting day.
Air and Radiation Docket and Information Center (Air Docket 6102), U.S.
Environmental Protection Agency, 401 M Street, SW, Washington, DC
20460.
Environmental Protection Agency, Region 4 Air Programs Branch, 345
Courtland Street, NE, Atlanta, Georgia 30365.
Tennessee Department of Environment and Conservation, Division of Air
Pollution Control, 9th Floor L & C Annex, 401 Church Street, Nashville,
Tennessee 37243-1531.
FOR FURTHER INFORMATION CONTACT: Interested persons wanting to examine
documents relative to this action should make an appointment with the
Region 4 Air Programs Branch at least 24 hours before the visiting day.
To schedule the appointment or to request additional information,
contact Karen Borel, Regulatory Planning and Development Section, Air
Programs Branch, Air, Pesticides & Toxics Management Division, Region 4
EPA, 345 Courtland Street, NE, Atlanta, Georgia 30365. The telephone
number is 404/347-3555 extension 4197. Reference file TN115-01-9616.
SUPPLEMENTARY INFORMATION: For additional information see the direct
final rule which is published in the rules section of this Federal
Register.
Dated: May 28, 1996.
A. Stanley Meiburg,
Acting Regional Administrator.
[FR Doc. 96-14910 Filed 6-11-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-14889 Reinvention of Certain Food Additive Regulations
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29711-29714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14889]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 170, 171, 172, 173, 175, 176, 177, 178, 182, and 184
[Docket 96N-0177]
RIN 0910-AA58
Reinvention of Certain Food Additive Regulations
AGENCY: Food and Drug Administration, HHS.
[[Page 29712]]
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is seeking public
comment on possible ways to streamline various food additive
regulations as the result of a page-by-page review of the agency's
regulations. This regulatory review is part of the administration's
``Reinventing Government'' initiative which seeks to streamline
Government and to ease the burden on regulated industry and consumers.
DATES: Written comments by September 10, 1996.
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:
Regarding information concerning the regulations: George H. Pauli,
Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-418-3090.
Regarding general information on FDA's ``reinventing initiative'':
Lisa M. Helmanis, Regulations Policy and Management Staff (HF-26), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
443-3480.
SUPPLEMENTARY INFORMATION: On March 4, 1995, President Clinton
announced plans for reforming the Federal regulatory system as part of
his ``Reinventing Government'' initiative. In his March 4 directive,
the President ordered all Federal agencies to conduct a page-by-page
review of all of their regulations and to ``eliminate or revise those
that are outdated or otherwise in need of reform.'' This notice, which
seeks public comment on possible ``reinventions'', represents FDA's
continuing effort to implement the President's plan. In previous issues
of the Federal Register, FDA proposed revoking or revising other
regulations, and the agency expects to issue future reinvention
proposals in upcoming issues.
In this document, FDA is seeking comments on ways in which the
following food additive regulations could be updated or revised in
order to make them more understandable. The agency is also seeking any
other comments regarding parts 170-184 that would assist FDA in
fulfilling its mission to protect the interest of consumers. The
following is a section-by-section analysis of the regulations that FDA
is considering ``reinventing.''
I. Section-by-Section Analysis:
The agency's section-by-section analysis of the regulations listed
in parts 170, 171, 172, 173, 175, 176, 177, 178, 182, and 184 (21 CFR
parts 170, 171, 172, 173, 175, 176, 177, 178, 182, and 184) has
identified candidate regulations to be considered for change, according
to the similarity of the regulatory action. The consolidation of
multiple listings under one heading would be intended to make the
regulations easier to find and use by the regulated industry.
Eliminating required analytical methodology would allow more
flexibility to use improved methods. Rewriting some sections would be
intended to make the regulations easier to understand.
The agency recognizes, however, that apparently simple revisions
can inadvertently change the original intent of a regulation.
Therefore, care must be taken when revising language to avoid
unintended changes. Also, while revising the regulations would not
entail reevaluation of the scientific data underlying an approval, it
would require agency resources that would otherwise be spent on
reviewing petitions and promulgating regulations authorizing uses of
other food additives. Additionally, the agency recognizes that while
simplification or shortening of the regulations is a useful goal, some
users may prefer the detail currently in the regulations. Therefore,
before committing further resources to develop proposed changes, FDA is
seeking comment on the importance to the regulated community of the
various actions under consideration so that the agency can establish
appropriate priorities for its reform efforts. The agency is interested
in comments both on whether the regulatory actions should be pursued
and, for those changes that are needed, any recommendations regarding
the specific changes to be made in the regulation and the relative
importance of these revisions to interested persons. The agency notes
that, due to their technical nature, some of the changes suggested
below could be accomplished in a final rule; others may require both a
proposed rule and a final rule stage. In some instances, the agency has
suggested a reinvention approach.
II. Consolidate and Delete Regulations
The following additives have been selected as candidates possible
for single listing to minimize redundancy.
A. Food Additives
Glycine is listed in Secs. 170.50 Glycine (aminoacetic acid) in
food for human consumption, 172.320 Amino acids, and 172.812 Glycine.
Should these regulations be consolidated and, if so, how?
B. Food Additives Permitted for Direct Addition to Food for Human
Consumption
Sections 172.836 Polysorbate 60, 172.838 Polysorbate 65, 172.840
Polysorbate 80, and 172.842 Sorbitan monostearate could be simplified
by deleting references to specific combinations of entries of
substances listed within the regulation.
Sections 172.860 Fatty acids, 172.862 Oleic acid derived from tall
oil fatty acids, and 172.863 Salts of fatty acids could be combined and
simplified under one section. Tests and methods could also be
simplified.
Section 172.866 Synthetic glycerin produced by the hydrogenolysis
of carbohydrates could be combined with Sec. 182.1320 to eliminate the
apparent redundancy.
C. Secondary Direct Food Additives Permitted in Food for Human
Consumption
Sections 173.160 Candida guilliermondii and 173.165 Candida
lipolytica could be combined and simplified under one section.
D. Indirect Food Additives: Adhesives and Components of Coatings
Sections 175.360 Vinylidene chloride copolymer coatings for nylon
film and 175.365 Vinylidene chloride copolymer coatings for
polycarbonate film could be combined and simplified under one section.
E. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
Section 178.2010 Antioxidants and/or stabilizers for polymers
contains a listing of antioxidants. Thus the information in
Sec. 178.2550 4-Hydroxymethyl-2,6-di-tert-butylphenol could be added to
the listing in Sec. 178.2010.
Sections 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic
and 178.3650 Odorless light petroleum hydrocarbons are related
substances which could be combined under one section.
Section 178.3600 Methyl glucoside-coconut oil ester could be
deleted and the substance listed as a processing aid under 21 CFR
172.816 and 178.3520.
Sections 178.3610 Methylstyrene-vinyltoluene resin, hydrogenated
and 178.3930 Terpene resins could be deleted and the substances listed
as components for use in olefin polymers under Sec. 177.1520.
[[Page 29713]]
Sections 178.3700 Petrolatum, 178.3710 Petroleum wax and 178.3720
Petroleum wax synthetic could be simplified and combined under one
section.
Section 178.3860 Release agents contains a listing of release
agents. Thus, the information in 21 CFR 178.3290 could be added to the
listing in Sec. 178.3860.
F. Direct Food Substances Affirmed as Generally Recognized as Safe
Sections 184.1271 L-Cysteine and 184.1272 L-Cysteine
monohydrochloride could be simplified under one section.
III. Proposed Deletion of Descriptions of Analytical Methods
Lengthy descriptions of the analytical methods may not be
necessary. Each reference to a method could state that copies are
available from the Center for Food Safety and Applied Nutrition (CFSAN)
and could also specify that equivalent methods are acceptable. Thus,
the descriptions of methods could be deleted from the following
regulations:
A. Indirect Food Additives: Paper and Paperboard Components
Section 176.170 Components of Paper and Paperboard in Contact with
Aqueous and Fatty Foods.
B. Indirect Food Additives: Polymers
Section 177.1010 Acrylic and modified acrylic plastics, semirigid
and rigid.
Section 177.1050 Acrylonitrile/styrene copolymer modified with
butadiene/styrene elastomer.
Section 177.1315 Ethylene-1, 4-cyclohexylene dimethylene
terephthalate copolymers.
Section 177.1330 Ionomeric resins.
Section 177.1500 Nylon resins.
Section 177.1520 Olefin polymers.
Section 177.1640 Polystyrene and rubber-modified polystyrene.
Section 177.1950 Vinyl chloride-ethylene copolymers.
Section 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
Section 177.1980 Vinyl chloride-propylene copolymers.
C. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
Section 178.1010 Sanitizing solutions.
Section 178.3620 Mineral oil.
Section 178.3770 Polyhydric alcohol esters of oxidatively refined
(Gersthofen process) montan wax acids.
Section 178.3910 Surface lubricants used in the manufacture of
metallic articles.
IV. Methodology
The methodology in the following regulations could be simplified.
A. Food Additives Permitted for Direct Addition to Food for Human
Consumption
The method and descriptions in Sec. 172.133 Dimethyl dicarbonate
could be simplified.
The analytical specification in Sec. 172.250 Petroleum naphtha
could be simplified.
In Sec. 172.695 Xanthan gum, the tests as specified in paragraph
(d) could be eliminated.
In Sec. 172.820 Polyethylene glycol (mean molecular weight 200-
9,500), the analytical method referenced for determining ethylene
glycol and diethylene glycol could be simplified.
Section 172.859 Sucrose fatty acid esters could be rewritten to
clarify preparation and methods.
In Sec. 172.864 Synthetic fatty alcohols paragraphs (a) and (c)
could be revised, and refer to analytical methods that are available
from CFSAN.
Section 172.886 Petroleum wax could be simplified and refer to the
analytical procedures that are available from CFSAN.
B. Secondary Direct Food Additives Permitted in Food for Human
Consumption
Section 173.350 Combustion product gas could be simplified and
could state that analytical procedures were available from CFSAN.
V. General provisions applicable to indirect additives
The statement on good manufacturing practice and the general list
of acceptable components in articles that contact food, as referenced
in Sec. 174.5, are applicable to indirect food additives in general.
Therefore, similar statements could be deleted in the following
individual regulations:
A. Indirect Food Additives: Adhesives and Components of Coatings
Section 175.105 Adhesives.
Section 175.125 Pressure-sensitive adhesives.
Section 175.230 Hot-melt strippable food coatings.
Section 175.300 Resinous and polymeric coatings.
Section 175.320 Resinous and polymeric coatings for polyolefin
films.
Section 175.350 Vinyl acetate/crotonic acid copolymer.
Section 175.390 Zinc-silicon dioxide matrix coatings.
B. Indirect Food Additives: Paper and Paperboard Components
Section 176.130 Anti-offset substances.
Section 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
Section 176.200 Defoaming agents used in coatings.
Section 176.210 Defoaming agents used in the manufacture of paper
and paperboard.
Section 176.300 Slimicides.
C. Indirect Food Additives: Polymers
Section 177.1010 Acrylic and modified acrylic plastics, semirigid
and rigid.
Section 177.1030 Acrylonitrile/butadiene/styrene/methyl
methacrylate copolymer.
Seciton 177.1040 Acrylonitrile/styrene copolymer.
Section 177.1200 Cellophane.
Section 177.1210 Closures with sealing gaskets for food containers.
Section 177.1240 1,4-Cyclohexylene dimethylene terephthalate and
1,4-cyclohexylene dimethylene isophthalate copolymer.
Section 177.1310 Ethylene-acrylic acid copolymers.
Section 177.1320 Ethylene-ethyl acrylate copolymers.
Section 177.1350 Ethylene-vinyl acetate copolymers.
Section 177.1400 Hydroxyethyl cellulose film, water-insoluble.
Section 177.1520 Olefin polymers.
Section 177.1550 Perfluorocarbon resins.
Section 177.1630 Polyethylene phthalate polymers.
Section 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-
methylstyrene).
Section 177.1640 Polystyrene and rubber-modified polystyrene.
Section 177.1650 Polysulfide polymer-polyepoxy resins.
Section 177.1660 Poly(tetramethylene terephthalate).
Section 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
Section 177.1980 Vinyl chloride-propylene copolymers.
Section 177.1990 Vinylidene chloride/methyl acrylate copolymers.
Section 177.2000 Vinylidene chloride/methyl acrylate/methyl
methacrylate polymers.
Section 177.2400 Perfluorocarbon cured elastomers.
Section 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.
Section 177.2470 Polyoxymethylene copolymer.
Section 177.2480 Polyoxymethylene homopolymer.
[[Page 29714]]
Section 177.2550 Reverse osmosis membranes.
Section 177.2600 Rubber articles intended for repeated use.
Section 177.2800 Textiles and textile fibers.
D. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
Section 178.1005 Hydrogen peroxide solution.
Section 178.3120 Animal glue.
Section 178.3570 Lubricants with incidental food contact.
Section 178.3850 Reinforced wax.
VI. Regulations Reinvented for Clarity
The agency has noted that some of its food additive regulations
could be rewritten to provide clearer guidance.
A. Food Additives Permitted for Direct Addition to Food for Human
Consumption
The labeling directions in Sec. 172.725 Gibberellic acid and its
potassium salt could be rewritten for clarity.
Section 172.177 Sodium nitrite used in processing smoked chub could
be revised to achieve greater consistency with 21 CFR 172.175.
B. Secondary Direct Food Additives Permitted in Food for Human
Consumption
Section 173.357 Materials used as fixing agents in the
immobilization of enzyme preparations could be revised to give a
clearer statement of components that may be safely used.
Section 173.395 Trifluoromethane sulfonic acid could be revised for
clarity.
C. Indirect Food Additives: General
Section 174.5 General provisions applicable to indirect food
additives could be revised to achieve greater clarity in paragraph
(d)(l) and in the restrictions placed on GRAS substances authorized for
use in this part.
D. Indirect Food Additives: Polymers
In Sec. 177.1560 Polyarylsulfone resins, the agency could add a
definition for ``normal baking temperature.''
In Sec. 177.2490 Polyphenylene sulfide resins, the agency could add
a definition for ``normal baking and frying temperature.''
E. Direct Food Substances Affirmed as Generally Recognized as Safe
In Secs. 184.1257 Clove and its derivatives and 184.1259 Cocoa
butter substitute primarily from palm oil, the description of the
additives could be simplified.
Section 184.1287 Enzyme-modified fats does not contain general
requirements for enzyme preparations. FDA could reinvent this section
to be consistent with the agency's general enzyme provisions.
In Sec. 184.1333 Gum ghatti, the agency could eliminate the
specifications under paragraph (b) and incorporate by reference the
specifications in the Food Chemicals Codex.
In Sec. 184.1408 Licorice and licorice derivatives could be revised
to achieve greater clarity and the regulation could state that methods
of analysis are available from CFSAN.
The description of the additives in Sec. 184.1685 Rennet (animal-
derived) and chymosin preparation (fermentation-derived) could be
simplified.
VII. Request for Comments
Interested persons may, on or before, September 10, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding this notice. 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.
Dated: June 6, 1996.
William B. Schultz,
Deputy Commissioner for Policy
[FR Doc. 96-14889 Filed 6-7-96; 3:02 pm]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-14888 Food Standards; Reinvention of Regulations Needing Revisions; Request for Comments on Certain Existing Regulations
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29701-29708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14888]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 70, 71, 80, 101, 107, 170, 172, 173, 174, 175, 177,
178, 184, and 1250
[Docket No. 96N-0149]
Food Standards; Reinvention of Regulations Needing Revisions;
Request for Comments on Certain Existing Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that it
intends to review its human food labeling regulations pertaining to:
The exemption for soft drinks from requirements for the type size and
placement of certain information on the information panel, requirements
for listing ``statements of identity,'' and requirements for flavor
labeling; its infant formula regulations to ensure that they fully
reflect the Federal Food, Drug, and Cosmetic Act (the act); and its
regulations pertaining to the discharge of waste aboard casino ships,
passenger ships, and ferries. The agency is also conducting a review of
its food additive regulations to consolidate existing regulations. As
part of this review of agency regulations, the agency is soliciting
comments from all interested persons on whether the above regulations
should be retained, revised, or revoked. FDA solicits comments on the
benefits or lack of benefits of such regulations in facilitating
domestic, as well as international, commerce and on the value of these
regulations to consumers. The agency also solicits comments on
alternative means of accomplishing the statutory objectives that led to
the adoption of the subject regulations. This review is in response to
the Administration's ``Reinventing Government'' initiative which seeks
to ease the burden on regulated industry and consumers.
DATES: Written comments by September 10,1996.
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: Corinne L. Howley, Center for Food
Safety and Applied Nutrition (HFS-24), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4272.
SUPPLEMENTARY INFORMATION:
I. Background
On March 4, 1995, President Clinton announced plans for the reform
of the Federal regulatory system as part of the Administration's
``Reinventing Government'' initiative. In his March 4 directive, the
President ordered all Federal agencies to conduct a page-by-page review
of all of their regulations to ``eliminate or revise those that are
outdated or otherwise in need of reform.''
In response to this directive, FDA issued proposals to revoke a
number of regulations (60 FR 53480, October 13, 1995; 60 FR 56513 and
56541, November 9, 1995) and an advance notice of proposed rulemaking
(ANPRM) to review standards of identity, quality, and fill of container
(60 FR 67492, December 29, 1995). The agency has completed the review
of its food regulations in response to the President's initiative and
as a result is publishing two documents elsewhere in this issue of the
Federal Register. This document is an ANPRM to review regulations that
the agency believes may need to be revised. In addition to requesting
information on the following issues, FDA requests any other comments
relevant to the regulations discussed herein that would assist the
agency in fulfilling its mission to protect the interest of consumers.
II. Soft Drinks
Elsewhere in this issue of the Federal Register, FDA is proposing a
number of changes in Sec. 101.2 (21 CFR 101.2) pertaining to
information that must appear on the information panel of the label. FDA
explains in that document that it considers a number of exemptions from
the type size and placement requirements in Sec. 101.2 to be obsolete,
and the agency is proposing to remove them. \1\ The exemptions that FDA
is proposing to remove appear in Sec. 101.2(c), but that paragraph also
contains a number of exemptions that the agency is not proposing to
revoke.
---------------------------------------------------------------------------
\1\ The type size and location requirements apply to all
information required to appear on the label of any package of food
under certain regulations that are referenced in Sec. 101.2. The
information must appear either on the principal display panel or the
information panel unless otherwise specified in the regulations.
Section 101.2(a) defines the term ``information panel'' as it
applies to packaged food, and Sec. 101.2(b) identifies referenced
regulations. Section 101.2(c) requires that information required by
the referenced regulations be in letters or numbers of at least one-
sixteenth inch in height, unless otherwise exempted by regulation.
---------------------------------------------------------------------------
Among the latter exemptions is a provision for soft drinks in
Sec. 101.2(c)(4). FDA is undecided about whether to retain this
provision because the agency does not know enough about nationwide
packing practices for these products. For example, this provision
exempts soft drink bottles that were manufactured before October 31,
1975, from the type size and placement requirements. The agency does
not know, however, whether any bottles manufactured before that date
are still in use. If not, this exemption is obsolete and should be
removed. Other soft drink exemptions may also be obsolete, or in need
of revision, to respond more efficiently to changes in labeling
practices that have resulted from the Nutrition Labeling and Education
Act (the 1990 amendments). The agency needs to know more about how
firms are presenting newly required information to consumers on labels
and on labeling materials other than labels (e.g., counter cards,
posters), as well as whether they are encountering any difficulties
associated with such presentation, before it can determine whether it
should pursue further rulemaking activities for soft drinks. For
example, where soft drink manufacturers are using posters for some
label information, there may be ample free space to present ingredient
[[Page 29702]]
information in relatively large type size. Would consumers be better
informed by such a presentation of this information than they would
with smaller type size on the soft drink package itself? If FDA were to
permit alternative labeling locations for information required to
appear on the information panel, would the current soft drink
exemptions still be needed? FDA requests comments on these issues from
all interested parties.
III. Statements of Identity
Section 101.3(a) and (b) (21 CFR 101.3(a) and (b)) requires that
the principal display panel of the label of food in package form bear a
statement of identity of the food product. Specifically, Sec. 101.3
requires that the statement of identity be in terms of the name of the
food as required by Federal law or regulation or, in the absence of
such, of the common or usual name for the food. If no such common or
usual name has been established, the statement of identity must be an
appropriately descriptive term. When the nature of the food is obvious,
however, a fanciful name commonly used by the public for the food may
be used.
This regulation also requires, among other things, that where the
food is marketed in optional forms (whole, slices, diced), the
particular form be considered a necessary part of the name
(Sec. 101.3(c)). This provision does not affect the required
declarations of identity under definitions and standards of identity
for foods that specify other ways of declaring the optional forms of
the food.
Section 101.3(d) requires that the statement of identity be
presented in bold type on the principal display panel of the label, be
in a type size that is reasonably related to the most prominent printed
matter on such panel, and be in lines generally parallel to the base on
which the package rests as it is designed to be displayed. These
provisions were established to meet the prominence and conspicuousness
requirements of section 403(f) of the act (21 U.S.C. 343(f)).
The requirement that the type size in which the statement of
identity appears be reasonably related to the largest type size used on
the principal display panel has been informally interpreted by FDA to
mean that the statement of identity must appear in type not less than
one-half the size of the largest printed matter on the principal
display panel. However, the agency has observed that brand name
identifications and flavor declarations often appear many times larger
than the statement of identity on the food label. The agency requests
comments on whether the statements of identity are sufficiently
conspicuous in light of other representations on the principal display
panel. If they are not, how should the regulation be changed to ensure
that the type size used for the statement of identity will be adequate?
For example, should FDA's informal guidance be established as a
requirement in a regulation? Should a different criterion be
established, perhaps related to the area of the principal display
panel, similar to the requirement for net contents declaration?
FDA is also aware that some identity statements are not placed
parallel to the base on which the container rests. Does this create
problems for consumers in reading labels? Are there specific needs for
variations from this requirement that should be provided for by special
exemptions? For example, do advancements in packaging foods and in
displaying them justify exemptions for certain types of packaging?
Section 101.3(e) defines the term ``imitation'' and how it is to be
used in the labeling of foods. This provision states that a food shall
be deemed to be an imitation, and thus subject to the requirements of
section 403(c) of the act, if it is a substitute for and resembles
another food but is nutritionally inferior to that food. If the food is
an imitation, as so defined, then the label of the food must bear in
type of uniform size and prominence, the word ``imitation'' and,
immediately thereafter, the name of the food imitated.
When section 403(c) of the act was adopted in 1938, Congress was
seeking to protect the consumer from the uninformed purchase of an
inferior substitute product that could be mistaken for a traditional
food product (38 FR 2138, January 19, 1973). In 1973, in proposed
regulations pertaining to imitation foods, the agency noted that vast
strides in food technology had taken place since section 403(c) of the
act was enacted, and that since 1938 many new wholesome and nutritious
food products had entered the marketplace, some of which resembled and
substituted for traditional foods (38 FR 2138). The agency stated that
it was no longer the case that such products were necessarily
substandard compared to the traditional foods for which they
substituted. However, FDA still believed that the consumer must be
protected from the unwitting purchase of a product that is different
from what he or she may reasonably expect (38 FR 2138). FDA proposed
that the term ``imitation'' only be applied to substitute foods that
are nutritionally inferior to the foods for which they substitute (38
FR 2143 at 2148). In its final regulation (38 FR 20703, August 2,
1973), FDA confirmed this view and defined nutritional inferiority as
any reduction in the content of an essential nutrient that is present
in a measurable amount.
Over the years, FDA has received questions as to when a food is
considered to resemble and substitute for a traditional food, so that
it is subject to the provisions of this regulation. The agency has
advised that where there is no standard of identity for the food in
parts 130 through 169 (21 CFR parts 130 through 169), no common or
usual name regulation in part 102 (21 CFR part 102), or no provision
for the food in the nutritional quality guideline that appears in part
104 (21 CFR part 104), the product must be evaluated in terms of
whether it resembles or purports to be (has similar functional,
physical, and organoleptic properties), and whether it substitutes for,
a food product that has a commonly understood identity or common or
usual name. For example, there are products on the market that are
textured, colored, flavored, and shaped to resemble crabmeat. These
products resemble and substitute for crabmeat, and when they are
nutritionally inferior to crabmeat, they must be labeled ``imitation
crabmeat.''
In addition, manufacturers have often sought advice on how a food
should be labeled when it resembles and substitutes for a traditional
food but is not nutritionally inferior to the traditional food. In some
cases, the agency has recommended the use of the term ``substitute'' as
part of the name of such a food. For example, the agency has advised
that a beverage made by replacing the milkfat in milk with vegetable
oil, and which is not nutritionally inferior to milk, could be labeled
as a ``milk substitute.'' The agency stated that the name would be
followed by a descriptive phrase, such as ``made with skim milk and
vegetable oil'' or ``contains 3 percent soybean oil to replace the
milkfat,'' to inform the consumer as to the difference between the milk
substitute and milk.
In view of these questions, the agency is seeking comment on
whether it should develop more in-depth guidance to assist
manufacturers in naming new food products. If so, how should this be
accomplished: through revision of the regulations in Secs. 101.3 or
102.5 (common or usual
name), a Compliance Policy Guide, or other less formal guidance, such
as an addendum to FDA's Food Labeling Guide? In developing comments on
this issue, interested parties should keep in mind that FDA has
published an ANPRM seeking comment on whether
[[Page 29703]]
and how standards of identity and common or usual name regulations
should be revised (60 FR 67492). Many, though not all, of the foods
subject to Sec. 101.3(e) resemble and substitute for foods subject to
those regulations. FDA will evaluate any proposed changes in its policy
on labeling of imitation foods in light of any changes it ultimately
decides to make in its approach to standards of identity and common or
usual name regulations.
In Sec. 101.3(e)(4), FDA has defined nutritional inferiority to
include any reduction in the content of an essential nutrient that is
present in a measurable amount. A measurable amount of an essential
nutrient under this regulation is 2 percent or more of the Daily
Reference Value of protein listed under Sec. 101.9(c)(7)(iii) (21 CFR
101.9(c)(7)(iii)) and of potassium listed under Sec. 101.9(c)(9) and of
the Reference Daily Intake (RDI) of any vitamin or mineral listed under
Sec. 101.9(c)(8)(iv). In the Federal Register of December 28, 1995 (60
FR 67164), FDA established RDI's for several nutrients and revised the
definition of nutritional inferiority to accommodate those new RDI's
where practicable. The agency stated that as substitute products
proliferate, it is important to ensure that these products contain
essential nutrients in amounts consistent with the reference food, so
that consumers can continue to have confidence that a varied diet will
supply adequate nutrition (60 FR 67164 at 67169).
The agency is requesting comment on the appropriateness of the
current definition of nutritional inferiority for the purpose of
determining whether a food is an imitation. Fat and calories are
currently excluded from the nutrients to be considered when determining
nutritional inferiority. The agency did not reevaluate this provision
when it revised the definition of nutritional inferiority in the
December 28, 1995, final rule. Nonetheless, it now seeks comment on
whether that definition should be further revised. Should the
definition be changed to take into account current dietary guidelines?
For example, should sodium, saturated fat, and cholesterol be excluded
from the nutrients to be considered? On the other hand, if a substitute
food is modified to achieve a nutrition goal, such as a reduction in
the sodium content of the diet, and as a consequence the fat or calorie
content of the food is increased to achieve a more palatable product,
should such a product be considered to be nutritionally inferior? Is
there some other way of highlighting such a change on the label?
FDA notes that the concept of nutritional inferiority is widely
used in the agency's regulations and interpretations. For example, FDA
relies on this concept in the definition of the term ``substitute''
food in Sec. 101.13 Nutrient content claims--general principles.
Section 101.13(d) states that a ``substitute'' food is one that may be
used interchangeably with another food that it resembles, i.e., to
which it is organoleptically, physically, and functionally (including
shelf life) similar, and to which it is not nutritionally inferior,
unless it is labeled as an ``imitation.'' In addition, the general
standard of identity, Sec. 130.10 Requirements for foods named by use
of a nutrient content claim and a standardized term (21 CFR 130.10),
explains how to derive statements of identity for foods that substitute
for and resemble traditional standardized foods. This regulation
specifically references Sec. 101.3(e) and provides for the addition of
nutrients to the new food so that it will not be nutritionally inferior
to the traditional standardized food that is named in the statement of
identity. Thus, comments that suggest changes in the definition of
nutritional inferiority in Sec. 101.3(e) should also consider the
effect of such changes on the labeling of foods covered by other
regulations such as those mentioned here.
IV. Flavors
FDA's flavor labeling regulation, Sec. 101.22 (21 CFR 101.22), has
generated many questions over the years. Some representatives of the
food industry have complained that this regulation is so complex that
it is subject to a multitude of differing interpretations. In light of
such complaints, FDA believes that it should attempt to revise this
regulation to make it more user friendly and, at the same time, to make
flavor designations on food labels more meaningful to consumers.
Comments on the existing regulation will help the agency to achieve
this goal.
Section 101.22 lists a variety of characteristics that would make
the flavoring used in a food either ``artificial'' or ``natural.'' The
regulation does not, however, contain an adequate definition for either
term. Before a firm can decide how to describe the flavoring used in
its product, it may have to engage in a rather arduous analysis. For
example:
In Sec. 101.22(a), FDA defines an ``artificial flavor'' or
``artificial flavoring'' as any substance, the function of which is to
impart flavor, which is not derived from a spice, fruit or fruit juice,
vegetable or vegetable juice, edible yeast, herb, bark, bud, root,
leaf, or similar plant material, meat, fish, poultry, eggs, dairy
products, or fermentation products thereof. The term ``artificial
flavor'' also includes those synthetic flavoring substances and
adjuvants listed in Secs. 172.515(b) and 182.60 (21 CFR 172.515(b) and
182.60) except where the flavors are derived from natural sources.
This definition would be simpler if FDA could state that the term
``artificial flavor'' generally connotes a synthetic source. However,
the agency has traditionally viewed this term as having wider
application than simply to synthetic substances. For example, FDA has
advised that when a flavor from a natural source is used in a food
product to simulate a flavor of a food other than the one from which
the flavor is derived, the food to which the flavor is added must be
labeled as ``artificially flavored'' (38 FR 20718, August 2, 1973).
Thus, a ``lemon'' type pie, made with natural flavor derived
predominantly from citrus products, could not be identified simply as
``lemon pie'' without misleading the consumer. It must be labeled as
``citrus pie'' or ``artificially flavored lemon pie.'' This position
has led to considerable confusion because often manufacturers do not
consider the end use of the flavoring, in addition to its source, in
determining whether the food should be labeled as being ``artificially
flavored.''
Further, the exception in the definition of ``artificial flavor''
that permits substances that are listed as synthetic flavoring
substances and adjuvants in Secs. 172.515(b) and 182.60 to be
designated as ``natural'' when they are derived from ``natural
sources'' has resulted in a very broad category of substances labeled
as ``natural flavor.'' There is confusion regarding the interpretation
of ``natural source'' in this context. Should this provision be
retained? If so, how should it be phrased so that it can be interpreted
consistently?
The agency's definition for ``natural flavor'' is also very
complex. In Sec. 101.22(a)(3), FDA defines ``natural flavor'' or
``natural flavoring'' as the essential oil, oleoresin, essence or
extractive, protein hydrolysate, distillate, or any product of
roasting, heating or enzymolysis, that contains the flavoring
constituents derived from a spice, fruit or fruit juice, vegetable or
vegetable juice, edible yeast, herb, bark, bud, root, leaf, or similar
plant material, meat, seafood, poultry, eggs, dairy products, or
fermentation products thereof, whose significant function in food is
flavoring rather than nutritional. Natural flavors include natural
essence or extractives obtained from plants
[[Page 29704]]
listed in 21 CFR 182.10, 182.20, 182.40, and 182.50 and part 184 (21
CFR part 184) and such substances listed in 21 CFR 172.510.
Recognizing that, with advances being made in the technology of
flavor development, the distinctions established in its regulations and
policy statements may need to be modified, FDA requests comments on
whether and, if so, how the definitions of natural and artificial
flavor should be revised. For example, if a substance from a natural
source is used to produce an intermediate product that is further
reacted with another substance from a natural source, e.g., hydrolyzed
by use of enzymes or other substances, should the resultant flavor,
which obviously differs from its original natural source, be permitted
to be labeled as ``natural,'' or should the new flavoring compound be
considered to be ``an artificial flavor'' because the new flavor is not
native to the natural sources? Should hydrolysates and their reaction
products continue to be considered as natural flavors? What about
flavors produced by the Maillard reaction? Would it be better to define
``natural flavor'' and simply provide that ``artificial flavor''
constitutes all flavor that does not fall within that definition, or
vice versa? Does it make sense to simply abandon the distinction
between ``artificial'' and ``natural'' flavoring as no longer being
relevant to the interests and understanding of consumers and to simply
provide for the use of the term ``flavor added'' on the principal
display panel and as part of the ingredient list?
In addition, FDA would like to focus attention on the designation
of characterizing flavors on food labels in accordance with
Sec. 101.22(i). This matter has provided another source of confusion.
Section 101.22(i) provides that if the label or labeling or advertising
makes any direct or indirect representations with respect to the
primary recognizable flavors of a food, by word, vignette (e.g., by
depiction of a fruit) or other means, or if for any reason the
manufacturer or distributor of the food wishes to designate the type of
flavor in the food other than through the statement of ingredients,
such flavor shall be considered to be the characterizing flavor and
shall be designated in the following way:
1. If the food contains no artificial flavor that simulates,
resembles, or reinforces the characterizing flavor, the name of the
food on the principal display panel or panels of the label shall be
accompanied by the common or usual name of the characterizing flavor,
e.g., ``vanilla,'' in letters not less than one-half the height of the
letters used in the name of the food.
2. If the food is one that is commonly expected to contain a
characterizing food ingredient, e.g., strawberries in ``strawberry
shortcake,'' and the food contains natural flavor derived from such
ingredient, but the amount of the characterizing ingredient is
insufficient to independently characterize the food, or the food
contains no such ingredient, the name of the characterizing flavor may
be immediately preceded by the word ``natural'' and shall be
immediately followed by the word ``flavored'' in letters not less than
one-half the height of the letters in the name of the characterizing
flavor, e.g., ``natural strawberry flavored shortcake'' or ``strawberry
flavored shortcake.'' --
3. If none of the natural flavor used in the food is derived from
the product whose flavor is simulated, the food in which the flavor is
used shall be labeled either with the flavor of the product from which
the flavor is derived or as ``artificially flavored.''
4. If the food contains both a characterizing flavor from the
product whose flavor is simulated and other natural flavor that
simulates, resembles, or reinforces the characterizing flavor, the name
of the food shall be immediately followed by the words ``with other
natural flavor'' in letters not less than one-half the height of the
letters used in the name of the characterizing flavor.
5. If the food contains any artificial flavor that simulates,
resembles, or reinforces the characterizing flavor, the name of the
food on the principal display panel or panels of the label shall be
accompanied by the common or usual name of the characterizing flavor,
in letters not less than one-half the height of the letters used in the
name of the food, and the name of the characterizing flavor shall be
accompanied by the words ``artificial'' or ``artificially flavored,''
in letters not less than one-half the height of the letters in the name
of the characterizing flavor, e.g., ``artificial vanilla,''
``artificially flavored strawberry,'' or ``grape artificially
flavored.''
6. Wherever the name of the characterizing flavor appears on the
label (other than in the statement of ingredients) so conspicuously as
to be easily seen under customary conditions of purchase, the words
prescribed by Sec. 101.22(i) shall immediately and conspicuously
precede or follow such name, without any intervening written, printed,
or graphic matter, with certain exceptions.
These provisions are so complex that it is not surprising that they
have frequently been the cause of confusion and varying interpretations
by both manufacturers and regulators. The regulation needs to be
clarified. In addition, developments in food processing since the
regulation was adopted have resulted in the manufacture of more diverse
products using natural and artificial flavors.
The agency requests comment on how the use of flavors should be
declared on the food label. Some manufacturers have contended that
declaration of natural and artificial flavors in the ingredient list is
sufficient to inform consumers of their role in the food. FDA's
position has been that consumers can be misled unless the
characterizing flavor of the food is described as ``flavored'' when
flavoring substances are needed to characterize the food. The agency's
position has been that the term ``artificial'' should be used to
describe the flavor unless it is a natural flavor and is from the same
source as the flavor of the food.
What is the best way to inform the consumer of the use and the role
of a flavoring substance in a food? How should a combination of natural
and artificial flavors be declared? The agency requests suggestions for
revisions of Sec. 101.22(i) and substantiating information regarding
why the suggested revisions are appropriate, and how they would affect
marketing practices.
Further, Sec. 101.22(i) requires that the flavor supplier certify,
in writing, that any flavor it supplies that is designated as
containing no artificial flavor does not, to the best of the supplier's
knowledge and belief, contain any artificial flavor, and that the
supplier has not added any artificial flavor to it. Although the agency
is not aware of any concerns about labeling of flavors supplied to
manufacturers, it requests comments on the suitability of these
requirements.
V. Infant Formula
Part 107 (21 CFR part 107) provides for labeling of infant
formulas, for terms and conditions that a manufacturer must meet with
respect to exempt infant formulas, for required levels of nutrients in
infant formulas as prescribed by statute, and for recalls of infant
formulas in appropriate circumstances. Congress passed the Infant
Formula Act of 1980 (the 1980 act) (Pub. L. 96-359), which amended the
act to add section 412 (21 U.S.C. 350a). In 1985, FDA partially
implemented the 1980 act by establishing subparts B, C, and D in part
107 regarding the labeling of infant formula, exempt infant formulas,
and nutrient requirements for infant
[[Page 29705]]
formula, respectively (50 FR 1833, January 14, 1985; 50 FR 48183,
November 22, 1985; and 50 FR 45106, October 30, 1985). In 1986,
Congress, as part of the Drug Enforcement, Education, and Control Act
of 1986 (the 1986 amendments) (Pub. L. 99-570), completely revamped
section 412 of the act to address concerns that had been expressed by
Congress and consumers about the 1980 act and FDA's implementation of
those provisions.
In 1990, Congress passed the 1990 amendments which amended the act
to add paragraphs (q) and (r) to section 403. While the 1990 amendments
exempt infant formulas subject to section 412 of the act from the
nutrition labeling provisions of section 403(q) of the act, only infant
formulas subject to section 412(h) of the act (exempt infant formulas)
are exempt from the nutrient content and health claims provisions of
section 403(r).
The agency is considering what changes need to be made to part 107
in light of the 1986 and 1990 amendments to the act. Subpart D of part
107-- Nutrient Requirements was not affected by either the 1986 or 1990
amendments and is not being reconsidered under this review. In 1989,
the agency responded to the provisions of the 1986 amendments on
recalls by establishing subpart E in part 107--Infant Formula Recalls
(54 FR 4006, January 27, 1989). To assist in the update of subparts B
(Labeling) and C (Exempt Infant Formulas) of part 107, the agency
requests comments on what matters need to be addressed.
Section 412(h)(1) of the act states that ``any infant formula which
is represented and labeled for use by an infant--(A) who has an inborn
error of metabolism or a low birth weight, or (B) who otherwise has an
unusual medical or dietary problem, is exempt from the requirements of
* * *'' section 412(a) (adulteration provisions of the act for failure
to meet the nutrient requirements of the act, failure to meet the
quality factor requirements, and failure to process the infant formula
in compliance with the good manufacturing practices and quality control
procedures), (b) (quality factors and good manufacturing requirements
including quality control procedures), and (c) (registration,
submission, and notification requirements). Section 412(h)(2) of the
act provides that the Secretary of Health and Human Services (and by
delegation FDA) may by regulation establish terms and conditions for
the exemption of an infant formula from the requirements of section
412(a), (b), and (c).
In 1980, the House Committee on Interstate and Foreign Commerce
stated:
The Committee recognizes the need to make special formulas
available without the imposition of cumbersome regulations which may
discourage formula manufacturers from committing resources into this
vital public service. Conditions on exemptions promulgated under
this authority should not make access to special formulas difficult.
Instead, they should insure that such formulas are manufactured to
the same high standards of quality required of formulas for normal
infants. The Committee recognizes the importance of these products
and the continued need to make them and new products like them,
readily available to the public.
(H. Rept. 96-936, 96th Cong., 2d sess., 1980, p.10.)
The agency is soliciting comment on what terms and conditions
should be set for the exemption of an infant formula from the
requirements of section 412(a), (b), and (c) of the act.
In the past, FDA and infant formula manufacturers have disagreed on
how to interpret section 412(h) of the act in light of the current
regulations on exempt infant formula in Sec. 107.50. One manufacturer
stated that the statute and regulations do not envision a premarket
designation or clearance for exempt formulas. Another manufacturer
asserted that section 412(h)(1) of the act exempts these formulas from
section 412(c) (registration and submissions), and that
Sec. 107.50(b)(4) only requires notification to FDA of any change in
ingredients or processes that may result in an adverse impact on the
levels of nutrients or on the availability of nutrients before the
first processing of the infant formula. This manufacturer argued that,
consequently, there is no requirement to give notice to the agency 90
days before marketing any exempt infant formula that has been changed
in formulation or processing.
The agency has deep reservations about both of these industry
assertions. The first would mean that infants who need an exempt
formula, and who are by definition among the most vulnerable, would
receive the least protection from the law. The second would raise
significant questions about the agency's ability to carry out its
mandate to ``insure that such formulas are manufactured to the same
high standards of quality required of formulas for normal infants.''
The agency would be unable to do so unless it receives notification of
``major changes'' in exempt infant formula at least 90 days before the
marketing of the changed formula. The agency requests comment on what
terms and conditions should be set for the exemption of an infant
formula from the requirements of section 412(c) of the act
(registration and submissions).
Problems also have occurred in the regulation of infant formulas
that meet the statutory definition of an exempt infant formula, i.e.,
formulas that are intended for infants who have an inborn error of
metabolism or a low birth weight, or who otherwise have an unusual
medical or dietary problem, but that do not need an exemption from any
of the nutrient, quality factor, or good manufacturing requirements
(including quality control procedures) of the act. In 1980, the House
Committee on Interstate and Foreign Commerce stated that it recognized
that infants suffering from special medical disorders, such as
phenylketonuria, or severe kidney diseases, require formulas tailored
specifically to their medical needs. The Committee recognized also the
need to exempt these formulas from the nutritional standards applicable
to formulas intended for normal, fullterm infants. (Id.)
However, infant formulas are now being developed that meet the
nutritional standards applicable to formulas for normal, fullterm
infants, i.e, the nutrient requirements of Sec. 107.100, but that are
for infants with low birth weight or with unusual medical or dietary
problems. Thus, these formulas apparently are exempt infant formulas
under section 412(h) of the act. The agency requests comment on what
terms and conditions should be set for the exemption of an infant
formula from the requirements of section 412(a) of the act. Should
infant formulas that are intended for special populations of infants
but that meet the nutrient requirements of the act be exempted from
being deemed to be adulterated if they do not meet the same quality
factor requirements or good manufacturing practices and quality control
procedures that are required of infant formulas for normal, fullterm
infants? Should infant formulas that meet the definition in the act for
an ``exempt infant formula'' be exempted from meeting the quality
factor and good manufacturing practice requirements when they are fully
capable of meeting these requirements?
Current Sec. 107.50(b)(3) requires the submission of the label and
other labeling in the notification required to retain the exempt status
of an infant formula. Current Sec. 107.50(b)(3) further states that FDA
will review the submitted information under Sec. 107.50(d), and current
Sec. 107.50(d)(4) lists the criteria that FDA will use to determine
whether a deviation from the requirements of subpart C of part 107
(Exempt Infant Formulas) is necessary and will adequately protect the
public
[[Page 29706]]
health. One such criterion is whether a deviation from the labeling
requirements of subpart B of part 107 is necessary because, without an
exemption, the label information, including pictograms and symbols,
could lead to inappropriate use of the infant formula
(Sec. 107.50(d)(4)(iii)).
FDA has held that, for an exempt infant formula to be eligible to
make label claims that deviate in any way from the requirements of
subpart B of part 107, a firm must show that the labeling claims are
necessary to ensure appropriate use of the product
(Sec. 107.50(d)(4)(iii)), and that the public health will be adequately
protected if these claims are made (Sec. 107.50(d)(4)). This showing
must be made based on a persuasive medical, nutritional, scientific, or
technological rationale (including any appropriate animal or human
clinical studies) (Sec. 107.50(b)(5)). The agency has held that failure
to submit information that supports that an exemption is necessary to
ensure the proper use of a formula, and failure to show that the public
health will be adequately protected if such an exemption is continued,
provide grounds for revoking the exempt status of a formula. Revoking
the exempt status of a formula would mean that its label could not
deviate in any way from the labeling requirements of subpart B of part
107, and thus it would not be able to bear the claims in question. The
agency solicits comments on any changes that need to be made to
Sec. 107.50 (exempt infant formulas) to ensure that the labeling of
these products will be consistent with the public health and will not
lead to the inappropriate use of the product.
The agency also solicits comments on any changes to subpart B of
part 107 (Labeling) that may be necessary to ensure that exempt infant
formulas are labeled appropriately. Further, the agency solicits
comments on any changes that it needs to make in the regulations
governing the labeling of exempt infant formulas to ensure that the
representations made for these products are truthful and not
misleading. The 1990 amendments exclude exempt infant formulas from the
requirements on nutrition labeling, nutrient content claims, and health
claims (section 403(q)(5)(A)(iii) and (r)(5)(A) of the act). The
regulations issued in response to the 1990 amendments reflect this fact
(Sec. 101.9(j)(7) (nutrition labeling), Sec. 101.13(q)(4) (nutrient
content claims), and (Sec. 101.14(f)(1) (health claims)). The agency
solicits comments on any changes that should be made to subpart B of
part 107 (Labeling) to ensure that exempt infant formulas are labeled
in a manner that will adequately protect the public health and that
will ensure appropriate use of the product.
VI. Food Additive Regulations
The agency has identified the following candidates for changes to
make the regulations on food ingredients easier to understand and to
consolidate certain existing regulations under a single listing to
minimize redundancy.
A. Carrageenan, Carrageenan With Polysorbate 80, Salts of Carrageenan,
Furcelleran, and Salts of Furcelleran
In the Federal Register of October 6, 1961 (26 FR 9411 and 9412),
FDA published final rules permitting the use of the food additives
carrageenan, salts of carrageenan, furcelleran, and salts of
furcelleran in food. The agency later published an additional final
rule permitting the use of carrageenan processed with polysorbate 80 in
food. The original food additive petitions requesting the use of
carrageenan and furcelleran in food were submitted to FDA by competing
producers of these two additives. Thus, the agency issued separate
regulations for these additives even though there are similarities in
the structure and functionality of carrageenan and furcelleran. It may
now be appropriate to combine the regulations on carrageenan, salts of
carrageenan, furcelleran, salts of furcelleran, and carrageenan with
polysorbate 80 into a single regulation.
Carrageenan and furcelleran are refined hydrocolloids that are
produced by extraction of certain species of red seaweed in aqueous
alkali, and they are regulated for use as emulsifiers, thickeners, and
stabilizers in food under Secs. 172.620 and 172.660 (21 CFR 172.620 and
172.660). The functional properties of carrageenan derive from the
sulfated polysaccharide that is the major component of the additive.
This polysaccharide is composed of galactose and anhydrogalactose
hexose units.
The primary difference between carrageenan as regulated under
Sec. 172.620 and furcelleran as regulated under Sec. 172.660 is the
degree of sulfation of the hexose units composing the polysaccharide.
Furcelleran has a sulfate range of 8 to 19 percent on a dry weight
basis, while carrageenan may have a sulfate content of between 20 and
40 weight percent. The degree of sulfation of the additive is believed
to be the determining factor regarding the additive's ability to bind
to proteins and thus determines the additive's functionality in certain
food applications, including dairy applications. In addition, the
functionality of the carrageenan complying with Sec. 172.620 is known
to vary with the seaweed species used to produce the additive and with
the dominant cation in aqueous solutions of the additive. This
variation reflects the level of three principal polysaccharide types in
commercial carrageenan. These are known as kappa, iota, and lambda
carrageenan and differ in the number and location of the sulfate groups
on the hexose units.
In commerce, carrageenan may consist of a relatively pure form of
one of the three polysaccharides or a mixture of kappa, lambda, and
iota polysaccharides along with cellulosic material, protein, and
inorganic salts. The relative amounts of polysaccharides can vary
naturally based on their content in the native seaweed, or carrageenan
can be formulated from relatively pure kappa, lambda, and iota
carrageenan either by processing or by seaweed choice. The ability to
produce carrageenan consisting of relatively pure forms of one or the
other of the polysaccharides facilitates the production of carrageenans
with a wide variation in properties. Thus, the industry is able to
develop carrageenans with specific properties for specific applications
in food.
The only distinguishing characteristics that FDA incorporated into
the regulations for furcelleran and carrageenan were a limitation on
the degree of sulfation for the polysaccharide that is the functional
component of each additive and a listing of the different seaweed
sources of the additives. The differing specifications (sulfate content
and seaweed source) incorporated into the regulations for carrageenan
and furcelleran were included solely to differentiate between these two
similar additives. There is no safety concern regarding the sulfate
content of the respective additives. Given this fact, there is no
reason to distinguish between the additives on the basis of sulfate
content, and no reason why the sulfate specifications for the two
additives could not be combined in one regulation.
The first detailed specifications that FDA adopted for furcelleran
and carrageenan were the specifications included in the first edition
of the Food Chemicals Codex (FCC). The specifications for furcelleran
in the first edition of the FCC were identical to those for carrageenan
except for the percent sulfate content of the additive and the listed
seaweed sources. Subsequent editions of the FCC did not include a
separate specification for
[[Page 29707]]
furcelleran, in part because the additive was so similar to carrageenan
that it was generally considered as a form of carrageenan, and in part
because the total use level of furcelleran was only a fraction of the
use level of carrageenan. Indeed, the current specification for
carrageenan adopted by the Food and Agriculture Organization/World
Health Organization Joint Expert Committee on Food Additives (JECFA)
includes the additive regulated in the United States as furcelleran.
Therefore, inclusion of furcelleran under the U.S. regulation for
carrageenan would be a step toward harmonizing U.S. regulations with
the JECFA specification recognized internationally.
When FDA issued separate regulations for salts of carrageenan and
salts of furcelleran, the agency was primarily concerned about the
possibility of economic deception resulting from an artificial increase
of one or more of the inorganic salts that are typically components of
these additives. In addition, the agency's concern in issuing a
separate regulation for carrageenan with polysorbate 80 was to ensure
that carrageenan processed with polysorbate 80 would be properly
labeled. At the time the regulations for carrageenan, furcelleran,
salts of carrageenan, salts of furcelleran, and carrageenan with
polysorbate 80 were issued, the chemistry of carrageenan and of
furcelleran was well known. At that time, it was known that the
addition of salts containing one or another cation would alter
significantly the gelation properties of given forms of the additive.
The level of sophistication with which carrageenan and carrageenan-
like substances such as furcelleran are developed, marketed, and used
reflects a high degree of understanding in the industry regarding the
identity and functionality when used in food. Therefore, it may well be
advantageous to simplify the regulation of salts of carrageenan,
furcelleran, salts of furcelleran, and carrageenan with polysorbate 80
by eliminating the separate regulations for these substances and by
providing for all of them to be marketed as carrageenan. The agency is
specifically soliciting comments regarding whether such a change should
be made, and, if so, what changes to existing specifications, and what
additional specifications, may be required in a regulation to permit
the combining of referenced regulations.
B. Use of Metals in Contact With Food
FDA is considering publishing a proposal to list, in 21 CFR part
182, certain metals as generally recognized as safe (GRAS) for use in
contact with food. In addition, FDA is considering ways to make
publicly available those uses of metals that have been the subject of a
favorable opinion letter issued by agency employees because of the
insignificant potential for the metals to migrate into food.
Historically, the use of metals as components of food-contact
articles has generally resulted in low dietary exposure. The chemical
inertness and hardness of many metals is such that there is little or
no likelihood that the metal will migrate to food in other than
insignificant amounts. In addition, because metals are typically used
in the manufacture of repeat-use articles, the concentration of any
migrant would be extremely low because of the large volume of food
processed.
While FDA employees have issued opinion letters over the past three
decades on the agency's lack of safety concern about the low exposure
from such uses of metals, this information has not been made publicly
available in any sort of systematic and widespread way. As a result,
the agency continues to receive inquiries on the same metals that have
been previously found to be acceptable for use in contact with food,
either because their use is GRAS, or because the potential for them to
migrate to food is insignificant.
To help alleviate this situation, the agency is considering whether
to list in part 182 those metals that FDA has stated in opinion letters
are GRAS for use as indirect food additives. FDA has reviewed its files
and is aware of opinion letters stating that the following metals are
GRAS for use in contact with food: Aluminum and aluminum foil;
stainless steel (grades 302, 303, 304, 304F, 316, 321); 416 and 440C
stainless steel for use as a ring on filter bags; tin plate; and iron
for food contact use in breweries.
The agency is interested in information on whether other metals are
GRAS when used in contact with food and the basis for such a finding.
In addition to the metals listed above, the agency is aware of
opinion letters that have been written by agency employees on various
metals agreeing that their use as a component of food-contact articles
would not require a food additive petition or regulation because of an
insignificant potential for migration to food. FDA has considered that,
in some cases, the composition of some of the metal alloys that have
been the subject of such letters may be confidential information. The
agency is interested in comments on what procedures for making such
letters publicly available would be most effective as well as in
information that would help it to determine whether data in such
letters, such as the composition of alloys, are confidential, and thus
not releasable, or are common information that can be made public.
FDA invites public comment on all of these matters.
VII. Interstate Conveyance Sanitation (21 CFR Part 1250)
FDA regulates the construction and operation of conveyances
(trains, planes, buses, and vessels) in interstate traffic under parts
1240 and 1250 (21 CFR parts 1240 and 1250) of its regulations. These
regulations cover environmental health and food safety requirements for
the conveyances themselves, including their water and waste systems.
They also cover the conveyance servicing areas and vehicles used for
boarding drinking water and food and for offloading wastes.
In Sec. 1250.93, FDA focuses on vessels operating in fresh water
lakes and rivers and specifically prohibits the discharge of sewage and
ballast or bilge water within areas adjacent to domestic water intakes.
C. Concerns
1. FDA regulates vessels in interstate traffic that operate in both
fresh and salt waters.
2. These vessels generate several waste streams involving both
liquid and solid wastes. Improper disposal of some of these wastes have
important public health implications beyond the possible contamination
of public drinking water supplies addressed by the existing regulation.
One example is the possible contamination of molluscan shellfish
growing and harvesting areas, which is of concern because shellfish are
often consumed raw.
3. The National Research Council's Marine Board and its Committee
on Shipborne Wastes, on September 6, 1995, released a new report
entitled ``Clean Ships, Clean Ports, Clean Oceans: Controlling Garbage
and Plastic Wastes at Sea.'' The report concludes that U.S. activities
to implement the provisions of the International Convention for the
Prevention of Pollution from Ships (1973) and its 1978 protocol are far
from complete and effective.
The report recommends interagency cooperation among relevant
Federal agencies to promote a systems approach to enhance total
management and control of vessel wastes in nine specific maritime
sectors. One of these sectors is passenger day boats, casino ships, and
ferries, over which FDA has regulatory
[[Page 29708]]
responsibility under the Public Health Service Act.
Lead Federal agencies in the matter of controlling shipborne wastes
include the U. S. Coast Guard and the Environmental Protection Agency.
Other Federal agencies involved include the Department of State, the
National Oceanic and Atmospheric Administration and its National Marine
Fisheries Service, the United States Department of Agriculture's Animal
and Plant Health Inspection Service, and the Maritime Administration.
D. Request for Information
FDA is considering proposing to revise Sec. 1250.93 of the
Interstate Travel Sanitation regulations to prohibit discharges that
would pollute salt water and shellfish growing areas as well as fresh
water. Other agency objectives include harmonizing FDA's vessel waste
control requirements with those of other Federal agencies and
contributing to meeting U. S. obligations under ratified international
agreements. FDA requests information on what changes could be made to
Sec. 1250.93 to assist the agency in establishing standards for
discharges of waste from passenger boats, casino ships, and ferries.
The agency requests information on the effects that any suggested
changes would have on the waste discharge practices of affected
vessels.
VIII. Comments
Interested persons may, on or before September 10, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding this ANPRM. 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.
Dated: May 31, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-14888 Filed 6-7-96; 12:17 pm]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-14887 Food and Cosmetic Labeling; Revocation of Certain Regulations; Opportunity for Public Comment
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29708-29711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14887]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 101 and 730
[Docket No. 96N-0174]
RIN 0910-AA69
Food and Cosmetic Labeling; Revocation of Certain Regulations;
Opportunity for Public Comment
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke
certain regulations that appear to be obsolete. These regulations have
been identified for revocation as a result of a page-by-page review of
the agency's regulations that FDA conducted in response to the Clinton
administration's ``Reinventing Government'' initiative, which seeks to
streamline Government to ease the burden on regulated industry and
consumers. The agency is providing an opportunity for comments on this
proposed rule.
DATES: Written comments by August 26, 1996. The agency is proposing
that any final rule that may issue based upon this proposal become
effective 75 days following date of publication of the final rule.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Corinne L. Howley, Center for Food
Safety and Applied Nutrition (HFS-24), Food and Drug Administration,
200 C St., SW., Washington, DC 20204, 202-205-4272.
SUPPLEMENTARY INFORMATION:
I. Background
On March 4, 1995, President Clinton announced plans for the reform
of the Federal regulatory system as part of the administration's
``Reinventing Government'' initiative. In his March 4, 1995, directive,
the President ordered all Federal agencies to conduct a page-by-page
review of all of their regulations to ``eliminate or revise those that
are outdated or otherwise in need of reform.''
In response to this directive, FDA issued proposals to revoke a
number of regulations (see, e.g., 60 FR 53480, October 13, 1995; 60 FR
56513 and 56541, November 9, 1995) and an advance notice of proposed
rulemaking (ANPRM) to review standards of identity, quality, and fill
of container (60 FR 67492, December 29, 1995). The agency has completed
its review of its food and cosmetic regulations in response to the
President's initiative and as a result is publishing two documents in
this issue of the Federal Register. This document announces additional
regulations that FDA is proposing to eliminate or revise, and the
second document is an ANPRM that seeks information on other food and
cosmetic regulations that appear to be in need of revision.
II. The Proposal
A. Food Labeling Regulations
FDA has identified several food labeling regulations in part 101
(21 CFR part 101) as candidates for revocation or revision and is
seeking comments from interested parties regarding its tentative
conclusions on these matters. The following is a list of those
regulations and the agency's tentative conclusions concerning the
needed changes:
1. Section 101.2 Information panel of package form food
In Sec. 101.2, paragraph (a) defines the term ``information panel''
as it applies to packaged food, and in paragraph (b), the regulation
provides that all information required to appear on the label of any
package of food under certain referenced regulations appear either on
the principal display panel or on the information panel unless
otherwise specified in the regulations. The referenced regulations are:
Sec. 101.4 Food; designation of ingredients, Sec. 101.5 Food; name and
place of business of manufacturer, packer, or distributor), Sec. 101.8
Labeling of food with number of servings, Sec. 101.9 Nutrition labeling
of food, Sec. 101.12 Reference amounts customarily consumed per eating
occasion, Sec. 101.13 Nutrient content claims general principles,
Sec. 101.17 Food labeling warning and notice statements, Part 101--
Subpart D--Specific requirements for nutrient content claims, and Part
105--Foods for special dietary use (21 CFR 105). Paragraph (c) of
Sec. 101.2 requires that information required by the referenced
regulations be in letters or numbers of at least one-sixteenth inch in
height, unless otherwise exempted by regulation. Paragraph (c) of
Sec. 101.2 also provides exemptions to this type size requirement. FDA
tentatively concludes that certain of these exemptions are obsolete.
a. Exemptions for small packages
There are exemptions in paragraphs (c)(1) through (c)(3) of
Sec. 101.2 for small packages (defined according to the surface area
available to bear labeling). These exemptions were established before
the enactment of the Nutrition Labeling and Education Act of 1990 (the
1990 amendments) (Pub. L. 101-535). They were designed to encourage
firms to provide nutrition information in accordance with Sec. 101.9,
as well as a full list of ingredients in accordance with the
regulations in Sec. 101.4 and the agency's policy regarding declaration
of ingredients on standardized foods as set out in Sec. 101.6 (see 39
FR 15268, May 2, 1974). Before the enactment of the 1990
[[Page 29709]]
amendments, nutrition information was voluntary unless a nutrient was
added to the food or a claim about the nutrient content of the food was
made in its labeling. The agency also did not have authority under the
Federal Food, Drug, and Cosmetic Act (the act) to require that all
ingredients used in standardized foods be declared on the label.
The 1990 amendments amended the act to provide for, among other
things, mandatory nutrition labeling of foods and complete ingredient
listing on all foods. As a result, FDA amended its nutrition labeling
regulations in a number of significant respects, including specifying
minimum type sizes and formats for presenting the nutrition information
on the label (Sec. 101.9). The amended nutrition labeling regulations
include exemptions from the new minimum type size requirements,
depending on the particular format being used and the label space
available to bear the information.
Also, in response to the 1990 amendments, FDA revised the
definitions and standards of identity for foods in parts 131 to 169 (21
CFR parts 131 to 169) to reflect the requirement that all food
ingredients, including the mandatory ingredients of standardized foods,
be listed on the label and Sec. 101.6 be revoked (58 FR 2850 and 2888,
January 6, 1993).
Because the purpose of Sec. 101.2(c)(1), (c)(2), and (c)(3) was to
encourage voluntary declaration of ingredients and nutrition
information on food, FDA has tentatively concluded that they are no
longer needed. Nutrition labeling is now required on most foods, and
the regulations now in effect provide for flexibility in presentation
of the information where space is limited. Declaration of all
ingredients in standardized foods is also required. Because the
exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3) are obsolete, FDA is
proposing to revoke them. If any interested person believes that there
is a need to retain any of the exemptions, he or she should submit
comments explaining that need in response to this proposal. Comments
supporting retention of any of these exemptions should include
information on specific products for which other type size exemptions
are inadequate.
b. Nonretail Individual Serving Size Packages
Section 101.2(c)(5) provides that individual serving size packages
of food served with meals in restaurants, institutions, and on board
passenger carriers, and not intended for sale at retail, are exempt
from the type-size requirements of Sec. 101.2(c) under the following
conditions:
(i) The package has a total area of 3 square inches or less
available to bear labeling;
(ii) There is insufficient area on the package available to print
all required information in a type size of one-sixteenth inch in
height;
(iii) The label information includes a full list of ingredients in
accordance with regulations in part 101 and the policy expressed in
Sec. 101.6; and
(iv) The information required by Sec. 101.2 (b) appears on the
label in accordance with the provisions of this paragraph, except that
the type size is not less than one thirty-second inch in height.
Because declaration of all ingredients in standardized foods is now
required, and Sec. 101.6 has been revoked, reference to Sec. 101.6 is
no longer meaningful. Therefore, FDA is proposing to delete that
reference from Sec. 101.2(c)(5). Specifically, FDA is proposing to
revoke paragraph Sec. 101.2(c)(5)(iii) and redesignate paragraph
(5)(iv) as (5)(iii).
2. Section 101.8 Labeling of foods with number of servings
Section 101.8(a) requires that any package of food that bears a
representation as to the number of servings contained in such package
bear in immediate conjunction with such statement, and in the same size
type as is used for such statement, a statement of the net quantity (in
terms of weight, measure, or numerical count) of each such serving.
However, such statement may be expressed in terms that differ from the
terms used in the required statement of net quantity of contents (for
example, in cups or tablespoons rather than in avoirdupois ounces) when
such differing term is common to cookery and describes a constant
quantity. This paragraph also requires that the statement not be
misleading in any particular. It goes on to state that where nutrition
labeling information is required in accordance with the provisions of
Sec. 101.9, the statement of the net quantity of each serving shall be
consistent with the requirements for serving size expression set forth
in that section (e.g., 10 1-cup (240 milliliters) servings). The
provision also states that a statement of the number of units in a
package is not in itself a statement of the number of servings.
Paragraph (b) of this regulation (Sec. 101.8(b)) provides that, if
there exists a voluntary product standard issued by the Department of
Commerce under the procedures found in 15 CFR part 10, that
quantitatively defines the meaning of the term ``serving'' with respect
to a particular food, then any label representation as to the number of
servings in such packaged food shall correspond with such quantitative
definition. It also states that, ``Copies of published standards are
available upon request from the National Bureau of Standards,
Department of Commerce, Washington, DC 20234.''
The agency has tentatively concluded, based on two factors, that
this regulation is obsolete. The first factor is that the description
of how serving size information should appear on food labels in
Sec. 101.8(a) has been obviated by the recent extensive changes in
FDA's regulations governing mandatory nutrition labeling of foods that
the agency adopted in response to the 1990 amendments. Section 101.9
requires that quantitative nutrition information be declared in
relation to a serving of the food as defined in paragraph (b)(1) of
that section. Section 101.9(b)(1) defines a ``serving'' or ``serving
size'' for the purpose of these regulations as the amount of food,
expressed in a common household measure that is appropriate for the
food, customarily consumed per eating occasion by persons 4 years of
age and older. When the food is specially formulated or processed for
use by infants or by toddlers, a serving or serving size means an
amount of food customarily consumed per eating occasion by infants up
to 12 months of age or by children 1 through 3 years of age,
respectively. Section 101.9(b) also provides specific guidance as to
how the serving or serving size is to be determined for various food
products. Section Sec. 101.12 specifies the reference amount
customarily consumed per eating occasion for 139 food product
categories and requires the declaration of the serving in terms of
metric units and familiar household measures. Among other things, the
serving size regulation provides criteria for determining the serving
size based on the reference amount for the food category, thereby
ensuring that reasonable and uniform serving sizes will be used in
product labeling. Such uniformity in food labeling enhances consumers'
ability to make nutrition comparisons among foods. With Sec. 101.8(a),
however, there is not the same specificity for determining appropriate
serving sizes. Consequently, there is far less assurance under
Sec. 101.8(a) than under Sec. 101.9 that uniform serving sizes will
appear on similar products. Therefore, FDA is proposing to revoke
Sec. 101.8(a).
The second factor is that FDA is aware of no need to continue the
reference in Sec. 101.8(b) to ``voluntary product standards issued by
the
[[Page 29710]]
National Bureau of Standards of the Department of Commerce (DOC)'' that
quantitatively define the meaning of the term ``serving.'' (The agency
notes that the National Bureau of Standards is now known as the
National Institute of Standards and Technology (NIST)). NIST has
advised (Ref. 1) FDA that it no longer issues voluntary product
standards, and it has been withdrawing its voluntary serving size
standards for FDA-regulated food products for some time. NIST stated
that its only standard for an FDA-regulated commodity is one for
carbonated soft drink bottles and that standard is about to be
withdrawn. Therefore, FDA is proposing to revoke Sec. 101.8(b).
3. Section 101.29 Labeling of kosher and kosher-style foods
Section 101.29 is a statement of informal agency policy regarding
the use of the terms ``kosher'' and ``kosher style'' in the labeling of
food products. This policy was excerpted from agency correspondence and
codified in part 101 (formerly codified as Sec. 3.302, see 22 FR 9593
at page 9594, November 30, 1957) because the agency believed that it
was of general interest to the public. Because it was not established
through rulemaking procedures, this provision serves only as guidance
and does not have the force and effect of law. If these terms are used
in a manner that would render the product misbranded, the agency could
take action against such products under section 403(a) of the act (21
U.S.C. 343(a)). Although Sec. 101.29 could be removed without notice
and comment rulemaking, FDA is proposing to remove it in this document
to ensure that its decision is as informed as possible. The agency also
solicits comments on whether it should prepare a Compliance Policy
Guide that reflects the policy that has been codified in Sec. 101.29.
Compliance Policy Guides are used by FDA as informal guidance in
evaluating products and accompanying label statements and in
recommending regulatory actions for efficient enforcement of the act.
B. Cosmetic Regulations (Part 730--21 CFR 730)
Parts 710, 720, and 730 (21 CFR parts 710, 720, and 730) of FDA's
regulations provide for the Voluntary Cosmetic Reporting Program (VCRP)
for the voluntary submission of information relating to cosmetic
products. Part 730 of this program provides for the voluntary filing of
cosmetic product experience reports (VCPE) by the cosmetics industry.
In the Federal Register of October 17, 1973 (38 FR 28914), FDA, in
response to a petition from the Cosmetic, Toiletry and Fragrance
Association, Inc. (CTFA), issued regulations for the voluntary filing
of cosmetic product experiences. The petitioner believed that the VCPE
would serve: ``(1) To provide reliable baseline information against
which to assess or evaluate products or their ingredients, and (2)
prompt information where specific public health questions may be
presented.'' The regulation was implemented in 1974 as the Voluntary
Cosmetic Experience Program. FDA recodified these regulations in 1974
(39 FR 10054, 10062, March 15, 1974) and modified them in 1981 (46 FR
38073, July 24, 1981) and 1986 (51 FR 25687, July 16, 1986).
During the 23 years the CVRP has been in place, companies have
submitted information about adverse reactions that consumers have
reported to them. FDA has performed a statistical assessment of the
data to calculate the ``baseline'' adverse reactions (expected number
of reactions per million units distributed) that occur for the
different cosmetic product categories identified in the program.
While the VCPE has provided useful information regarding relative
adverse reaction baseline rates, it has suffered from some serious
limitations. Industry participation in this portion of the program has
historically been very limited and selective, the reports lack
sufficient details to be useful, and annual reports are sent in long
after the occurrence of an adverse reaction. This limited participation
has persisted even though the program has been modified several times
over the years to make it easier for companies to participate. In this
regard, the VCPE provides a false impression about the ability of the
voluntary program to ensure the safety of cosmetics. Thus, the VCPE
program no longer provides any new information about cosmetic adverse
reactions, and it no longer serves the important purpose of helping to
find harmful cosmetics and to remove them from the marketplace.
With current budgetary constraints on FDA, it is difficult to
justify the continuation of a program that does not contribute directly
to increasing the safety of cosmetics or protecting the public health.
Adding data to the information that FDA has obtained over 20 years
about baseline adverse reaction rates will be unlikely to have any
value. Thus, FDA is proposing to revoke part 730. FDA intends to
perform a thorough evaluation of information received over the years
and will prepare an in-depth report that will be useful to both the
cosmetic industry and the public in understanding adverse reaction
trends for different product categories and the baseline rates of
adverse reactions. Companies will be able to use this in-depth report
for assessing their own individual products without having to report
their information to FDA.
The agency is interested in comments on whether the VCPE should be
eliminated in its entirety, reduced in scope, or some other
alternative. For example, one alternative would be to revoke part 730
but maintain the availability of reporting forms or other means of
access ( e.g., electronic). These forms could be used for the prompt
reporting of any unusually severe adverse reactions or for reporting an
unusually high number of adverse reactions of moderate severity. In
addition to comments on the issues discussed in this proposal, FDA
requests comments on any other related matters that would assist FDA in
fulfilling its mission to protect the interests of consumers.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) and (a)(8),
respectively, that the actions to revoke or revise several food
labeling regulations in part 101, and to eliminate or modify part 730
of the cosmetic regulations, are of a type that do not individually or
cumulatively have a significant effect on the environment. Therefore,
neither an environmental assessment nor an environmental impact
statement is required.
IV. Economic Impact
FDA has examined the economic impact of the proposed rule as
required by Executive Order 12866 and the Regulatory Flexibility Act
(Pub. L. 96-354). 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, safety, distributive, and equity effects). The Regulatory
Flexibility Act requires analyzing options for regulatory relief for
small businesses. FDA finds that the proposed rule does not constitute
a major rule as defined by Executive Order 12866. FDA also finds that
the proposed rule will not have a significant impact on small
businesses.
The proposed rule will remove or revise several provisions in part
101 and all of part 730. The proposed removals include: (1) Certain
type-size exemptions, (2) the labeling of foods with number of servings
other than as specified in the 1990 amendments, (3) guidance on use of
the term ``kosher'',
[[Page 29711]]
and (4) elimination of the Voluntary Cosmetic Experience Program.
Except for the ``kosher'' guidance, all of the targeted provisions have
been rendered obsolete or counterproductive by more recent regulations
and other changes. The ``kosher'' guidance is not obsolete, but, as
mentioned earlier in this preamble, because it does not have the force
and effect of law, it is not necessary for it to be codified in Title
21.
FDA anticipates that the labeling provisions of the proposed rule
will not change the availability of health and safety information to
consumers. Although some labels may change as a result of revising
Sec. 101.2(c) and removing Sec. 101.8, the main effect of the proposal
will be to make FDA's regulations less complicated and easier to
follow. Removing the kosher labeling guidance in Sec. 101.29 should not
affect information used for religious purposes because the agency will
still be providing the same guidance but most likely in the form of an
FDA Compliance Policy Guide. Any information loss that might result
would likely arise from recognition by the affected industry that the
policy does not carry the force and effect of law. Nevertheless, such a
loss would not affect health or safety.
FDA estimates the economic effects of labeling with a general model
described in the November 27, 1991 Federal Register (56 FR 60856). The
net benefits of labeling rules are the difference between the benefits
to consumers of the information on labels and the cost to producers
(and, ultimately, to consumers) of providing that information. The
benefits from labeling can be estimated to be the monetary value of the
health and safety improvements that can be attributed to better-
informed consumers. The costs of labeling regulations include
administrative, analytical, printing, inventory, and product
reformulation costs. FDA believes that the proposed labeling revisions
will not reduce the nutrition and safety information available to
consumers. The health and safety benefits from the labeling rules in
part 101 therefore will not change.
The primary economic effect of the proposal will be changes in
costs. FDA expects compliance costs of labeling to decline, mainly
because the proposed rule will reduce administrative costs. The
administrative costs include interpreting labeling regulations and
determining how they apply to individual products. The more complicated
and confusing the regulations, the more costly it is to interpret them.
For example, the existence of type size exemptions in Sec. 101.2(c)
that differ from those in Sec. 101.9 forces firms to study both
sections before determining how the rules apply to their products. Even
if there were no differences in labeling requirements between sections,
firms would have to interpret both sections to assure themselves
perhaps at considerable cost, that no differences exist.
By streamlining and consolidating labeling rules, the labeling
directions in part 101 will be more user friendly, which in turn will
substantially reduce compliance costs. Although FDA does not possess
enough data to quantify the reduction in costs, the agency is confident
that the compliance cost of labeling regulations will indeed fall as a
result of the proposal.
Eliminating voluntary cosmetic experience reporting will generate
net benefits by reducing costs. FDA receives an average of 125
submissions annually from firms in the industry. The annual cost to FDA
of reviewing, evaluating, summarizing, and storing the experience
reports is approximately $12,000. The annual cost to participating
firms is approximately $12,000. Eliminating the program would therefore
reduce annual agency and industry costs by approximately $24,000,
without affecting public health. FDA tentatively concludes that because
it will reduce the costs but not the benefits of labeling and voluntary
reporting regulations, the proposed rule will generate positive net
benefits. FDA finds no reason to expect the proposal to impose burdens
on small businesses, whose compliance costs could fall.
V. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling or other third party disclosure
requirements. 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 asking for comment on
whether this proposed rule to revoke certain regulations that it
believes are obsolete imposes any paperwork burden.
IV. References
The following reference has been placed on display in the Dockets
Management Brance (HFA-305, Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum to James Taylor, Center for Food Safety and
Applied Nutrition, FDA, from Joan Roenig, the National Institutes of
Standards and Technology, April 2, 1996.
List of Subjects
21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
21 CFR Part 730
Cosmetics, 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 parts 101 and 730 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 101.2 Information panel of package form food is amended
by removing paragraphs (c)(1) through (c)(3) and (c)(5)(iii); and by
redesignating paragraphs (c)(4) and (c)(5) as paragraphs (c)(1) and
(c)(2) respectively.
Sec. 101.8 [Removed]
3. Section 101.8 Labeling of food with number of servings is
removed.
Sec. 101.29 [Removed]
4. Section 101.29 Labeling kosher and kosher-style foods is
removed.
PART 730--VOLUNTARY FILING OF COSMETIC PRODUCT EXPERIENCES
Part 730 [Removed]
5. Part 730 is amended by removing it in its entirety.
Dated: May 31, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-14887 Filed 6-10-96; 12:17 pm]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-14877 Proposed Establishment of Class E Airspace; Grants Pass, Oregon.
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29699-29700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14877]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 96-ANM-012]
Proposed Establishment of Class E Airspace; Grants Pass, Oregon.
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notice of Proposed Rulemaking (NPRM).
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SUMMARY: This proposed rule would establish the Grants Pass, Oregon,
Class E airspace to accommodate a new Global Positioning System (GPS)
standard instrument approach procedure (SIAP) to the Grants Pass
Airport. The area would be depicted on aeronautical charts for pilot
reference.
DATES: Comments must be received on or before July 19, 1996.
ADDRESSES: Send comments on the proposal in triplicate to: Manager,
Operations Branch ANM-530, Federal Aviation Administration, Docket No.
96-ANM-012, 1601 Lind Avenue S.W., Renton, Washington 98055-4056.
The official docket may be examined at the same address.
An informal docket may also be examined during normal business
hours at the address listed above.
FOR FURTHER INFORMATION CONTACT:
James Frala, ANM-532.4, Federal Aviation Administration, Docket No. 96-
ANM-012, 1601 Lind Avenue S.W., Renton, Washington 98055-4056;
telephone number: (206) 227-2535.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy related aspects of the proposal.
Communications should identify the airspace docket number and be
submitted in triplicate to the address listed above. Commenters wishing
the FAA to acknowledge receipt of their comments on this notice must
submit with those comments a self-addressed, stamped postcard on which
the following statement is made: ``Comments to Airspace Docket No. 96-
ANM-012.'' The postcard will be date/time stamped and returned to the
commenter. All communications received on or before the specified
closing date for comments will be considered before taking action on
the proposed rule. The proposal contained in this notice may be changed
in the light of comments received. All comments submitted will be
available for examination at the address listed above both before and
after the closing date for comments. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.
Availability of NPRM's
Any person may obtain a copy of this NPRM by submitting a request
to the Federal Aviation Administration, Operations Branch, ANM-530,
1601 Lind Avenue S.W., Renton, Washington 98055-4056. Communications
must identify the notice number of this NPRM. Persons interested in
being placed on a mailing list for future NPRM's should also request a
copy of Advisory Circular No. 11-2A, which describes the application
procedure.
The Proposal
The FAA is considering an amendment to part 71 of the Federal
Aviation Regulations (14 CFR part 71) to establish Class E airspace at
Grants Pass, Oregon, to accommodate a new GPS SIAP at Grants Pass
Airport. The area would be depicted on aeronautical charts for pilot
reference. The coordinates for this airspace docket are based on North
American Datum 83. Class E airspace areas extending upward from 700
feet or more above the surface of the earth are published in Paragraph
6005 of FAA Order 7400.9C dated August 17, 1995, and effective
September 16, 1995, which is incorporated by reference in 14 CFR 71.1.
The Class E airspace designation listed in this document would be
published subsequently in the Order.
The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).
[[Page 29700]]
The Proposed Amendment
In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:
PART 71--[AMENDED]
1. The authority citation for 14 CFR part 71 continues to read as
follows:
Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389; 14 CFR 11.69.
Sec. 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9C, Airspace Designations and
Reporting Points, dated August 17, 1995, and effective September 16,
1995, is amended as follows:
Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above surface of the earth.
* * * * *
ANM OR E5 Grants, OR
Grants Pass Airport, OR
(Lat. 42 deg.30' 37''N, long. 123 deg.23'17''W)
That airspace extending upward from 700 feet above the surface
within a 7-mile radius of the Grants Pass Airport and within 7 miles
each side of a 331 deg. bearing from the Grants Pass Airport
extending from the 7-mile radius to 25 miles northwest of the
airport.
* * * * *
Issued in Seattle, Washington, on May 28, 1996.
Richard E. Prang,
Acting Assistant Manager, Air Traffic Division, Northwest Mountain
Region.
[FR Doc. 96-14877 Filed 6-11-95; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-14875 Proposed Establishment of Class E Airspace; Libby, Montana
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29700-29701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14875]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 96-ANM-013]
Proposed Establishment of Class E Airspace; Libby, Montana
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: This proposed rule would establish the Libby, Montana, Class E
airspace to accommodate a new Global Positioning System (GPS) standard
instrument approach procedure (SIAP) to the Libby Airport. The area
would be depicted on aeronautical charts for pilot reference.
DATES: Comments must be received on or before July 19, 1996.
ADDRESSES: Send comments on the proposal in triplicate to: Manager,
Operations Branch ANM-530, Federal Aviation Administration, Docket No.
96-ANM-013, 1601 Lind Avenue S.W., Renton, Washington 98955-4056.
The official docket may be examined at the same address.
An informal docket may also be examined during normal business
hours at the address listed above.
FOR FURTHER INFORMATION CONTACT:
James Frala, ANM-532.4, Federal Aviation Administration, Docket No. 96-
ANM-013, 1601 Lind Avenue S.W., Renton, Washington 98055-4056;
telephone number: (206) 227-2535.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interest parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy related aspects of the proposal.
Communications should identify the airspace docket number and be
submitted in triplicate to the address listed above. Comments wishing
the FAA to acknowledge receipt of their comments on this notice must
submit with those comments a self-addressed, stamped postcard on which
the following statement is made: ``Comments to Airspace Docket No. 96-
ANM-013.'' The postcard will be date/time stamped and returned to the
commenter. All communications received on or before the specified
closing date for comments will be considered before taking action on
the proposed rule. The proposal contained in this notice may be changed
in the light of comments received. All comments submitted will be
available for examination at the address listed above both before and
after the closing date for comments. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.
Availability of NPRM's
Any person may obtain a copy of this NPRM by submitting a request
to the Federal Aviation Administration, Operations Branch, ANM-530,
1601 Lind Avenue S.W., Renton, Washington 98055-4056. Communications
must identify the notice number of this NPRM. Persons interested in
being placed on a mailing list for future NPRM's should also request a
copy of Advisory Circular No. 11-2A, which describes the application
procedure.
The Proposal
The FAA is considering an amendment to part 71 of the Federal
Aviation Regulations (14 CFR part 71) to establish Class E airspace at
Libby, Montana, to accommodate a new GPS SIAP to the Libby Airport. The
area would be depicted on aeronautical charts for pilot reference. The
coordinates for this airspace docket are based on North American Datum
83. Class E airspace areas extending upward from 700 feet or more above
the surface of the earth are published in paragraph 6005 of FAA Order
7400.9C dated August 17, 1995, and effective September 16, 1995, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).
The Proposed Amendment
In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:
PART 71--[AMENDED]
1. The authority citation for 14 CFR part 71 continues to read as
follows:
Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389; 14 CFR 11.69.
Sec. 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation
[[Page 29701]]
Administration Order 7400.9C, Airspace Designations and Reporting
Points, dated August 17, 1995, and effective September 16, 1995, is
amended as follows:
Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.
* * * * *
ANM MT E5 Libby, MT
Libby Airport, MT
(Lat 48 deg.17'02''N, long. 115 deg.29'25''W)
That airspace extending upward from 700 feet above the surface
within a 7-mile radius of the Libby Airport and within 4 miles each
side of the 345 deg. bearing from the Libby Airport extending from
the 7-mile radius to 10 miles northwest of the airport; that
airspace extending upward from 1,200 feet above the surface within
an area bounded by a line beginning at lat. 48 deg.19'00''N, long.
115 deg.42'00''W; to lat. 48 deg.19'00''N, long 115 deg.16'00''W; to
lat. 48 deg.45'00''N, long. 115 deg.22'00''W; to lat.
48 deg.45'00''N, long. 115 deg.50'00''W, to point of beginning.
* * * * *
Issued in Seattle, Washington, on May 28, 1996.
Richard E. Prang,
Acting Assistant Manager, Air Traffic Division, Northwest Mountain
Region.
[FR Doc. 96-14875 Filed 6-11-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-14866 Airworthiness Directives; Rolls-Royce plc RB211-535E4 and -535E4- B Series Turbofan Engines
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29697-29699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14866]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 96-ANE-09]
RIN 2120-AA64
Airworthiness Directives; Rolls-Royce plc RB211-535E4 and -535E4-
B Series Turbofan Engines
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 Rolls-Royce plc RB211-535E4 and -
535E4-B series turbofan engines. This proposal would require
installation of an improved fuel flow governor that incorporates
revised minimum compressor discharge P4 stop settings. This proposal is
prompted by reports of engine rundowns during low idle descent during
icing conditions. The actions specified by the proposed AD are intended
to prevent compressor stall and subsequent engine rundown on one or
both engines.
DATES: Comments must be received by August 12, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), New England Region, Office of the Assistant Chief
Counsel, Attention: Rules Docket No. 96-ANE-09, 12 New England
Executive Park, Burlington, MA 01803-5299. Comments may also be
submitted to the Rules Docket by using the following Internet address:
``[email protected]''. Comments may be inspected at this
location between 8:00 a.m. and 4:30 p.m., Monday through Friday, except
Federal holidays.
The service information referenced in the proposed rule may be
obtained from Rolls-Royce plc, P.O. Box 31, Moor Lane, Derby, DE248BJ,
United Kingdom; telephone 1332-249428, fax 1332-249423. This
information may be examined at the FAA, New England Region, Office of
the Assistant Chief Counsel, 12 New England Executive Park, Burlington,
MA.
FOR FURTHER INFORMATION CONTACT: Daniel Kerman, Aerospace Engineer,
Engine Certification Office, FAA, Engine and Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803-5299; telephone (617)
238-7130, fax (617) 238-7199.
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 should 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-ANE-09.'' 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, New England Region, Office of the Assistant Chief Counsel,
Attention: Rules Docket No. 96-ANE-09, 12 New England Executive Park,
Burlington, MA 01803-5299.
[[Page 29698]]
Discussion
The Civil Aviation Authority (CAA), which is the airworthiness
authority for the United Kingdom, recently notified the Federal
Aviation Administration (FAA) that an unsafe condition may exist on
Rolls-Royce plc (R-R) RB211-535 series turbofan engines. The CAA
advises that they have reports of seven engine rundown events on the R-
R RB211-535E4 and -535E4-B engines installed on Boeing 757-200 series
aircraft since January 1992. All of the events occurred within a narrow
band of altitude between 25,000 and 29,000 feet. In four of the seven
events, the second engine installed on the aircraft surged and
recovered. In six of the seven events, the engine rundowns occurred
approximately 3 to 5 seconds following selection of inlet cowl anti-ice
during the descent phase of flight. Selection of cowl inlet anti-ice
results in an engine acceleration from low idle to high idle thrust,
which can cause liberation of accreted ice within the engine core. In
one event, the rundown occurred following an auto-throttle initiated
acceleration.
Rolls-Royce plc has performed extensive analysis and testing and
has concluded that the engine rundown is due to the following: (1) Ice
accretion at the inlet to the Intermediate Pressure Compressor (IPC)
induces a rotating compressor stall during descent, which leads to a
High Pressure Compressor (HPC) surge on acceleration; and (2) Ice
accretion at the inlet to the IPC during descent is released into the
core engine, which in turn causes an HPC surge. This condition, if not
corrected, could result in compressor stall and subsequent engine
rundown on one or both engines.
The manufacturer has determined that the proposed solution for
preventing engine rundown is to raise the minimum compressor discharge
P4 stop setting in the fuel flow governor (FFG), which will increase
the low idle schedule above the engine idle conditions experienced
during all of the prior engine rundown events. This schedule increase
will result in a substantial increase in IPC stall margin, a moderate
increase in HPC stall margin, as well as provide the additional benefit
of increased ice accretion tolerance due to increased compressor
airflow.
Rolls-Royce plc has issued Mandatory (SB) No. RB.211-73-B869,
Revision 1, dated May 24, 1996, that specifies installation of an
improved FFG, which incorporates an increased minimum compressor
discharge pressure P4 stop setting, which will result in increased
engine idle speeds.
The FAA Transport Airplane Directorate issued AD 96-04- 11,
Amendment 39-9523, (61 FR 6935, February 23, 1996) applicable to Boeing
757-200 series airplanes equipped with R-R Model RB211-535E4 and -
535E4-B engines, that requires revision of the limitations section of
the FAA-approved Airplane Flight Manual (AFM) to require the flight
crew to activate engine inlet cowl thermal anti-ice systems on both
engines prior to descent. Installation of the improved FFG on both
engines for each aircraft would constitute terminating action to the
AFM revision requirements of AD 96- 04-11.
This engine model is manufactured in the United Kingdom 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 CAA has kept the FAA informed of
the situation described above. The FAA has examined the findings of the
CAA, 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.
Since an unsafe condition has been identified that is likely to
exist or develop on other engines of the same type design registered in
the United States, the proposed AD would require installation of
improved FFGs that incorporate revised minimum compressor discharge P4
stop settings. This revised setting will raise the steady state low
idle schedule above the idle conditions experienced during any of the
prior engine rundown events. This schedule increase will result in a
substantial increase in IPC stall margin, a moderate increase in HPC
stall margin, as well as provide the additional benefit of increased
ice accretion tolerance due to increased compressor airflow. This
proposed action must be accomplished at the next shop visit, or within
9 calendar months after the effective date of this AD, whichever occurs
first. The FAA has determined the calendar end-date based on the time
interval required for fleet modification. The actions would be required
to be accomplished in accordance with SB described previously.
There are approximately 770 engines of the affected design in the
worldwide fleet. The FAA estimates that 381 engines installed on
aircraft of U.S. registry would be affected by this proposed AD, that
it would take approximately 3 work hours per engine to accomplish the
proposed actions, and that the average labor rate is $60 per work hour.
The affected FFGs would be modified to incorporate the changes required
by this proposed AD on a free-of-charge basis per engine. Based on
these figures, the total cost impact of the proposed AD on U.S.
operators is estimated to be $68,580.
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:
Rolls-Royce plc: Docket No. 96-ANE-09.
Applicability: Rolls-Royce plc. (R-R) Models RB211- 535E4 and -
535E4-B turbofan engines installed on Boeing 757- 200 series
aircraft.
[[Page 29699]]
Note: This airworthiness directive (AD) applies to each engine
identified in the preceding applicability provision, regardless of
whether it has been modified, altered, or repaired in the area
subject to the requirements of this AD. For engines that have been
modified, altered, or repaired so that the performance of the
requirements of this AD is affected, the owner/operator must use the
authority provided in paragraph (d) to request approval from the
Federal Aviation Administration (FAA). This approval may address
either no action, if the current configuration eliminates the unsafe
condition, or different actions necessary to address the unsafe
condition described in this AD. Such a request should include an
assessment of the effect of the changed configuration on the unsafe
condition addressed by this AD. In no case does the presence of any
modification, alteration, or repair remove any engine from the
applicability of this AD.
Compliance: Required as indicated, unless accomplished
previously.
To prevent compressor stall and subsequent engine rundown on one
or both engines, accomplish the following:
(a) At the next shop visit, but no later than 9 calendar months
after the effective date of this AD, install a fuel flow governor
(FFG) that incorporates a revised minimum compressor discharge P4
stop setting, in accordance with R-R Mandatory Service Bulletin (SB)
No. RB.211-73-B869, Revision 1, dated May 24, 1996.
(b) Installation of improved FFG's on both engines for each
Boeing 757 aircraft in accordance with paragraph (a) of this AD
constitutes terminating action to the requirements of AD 96-04-11.
(c) For the purpose of this AD, a shop visit is defined as
removal of the engine from the aircraft for maintenance.
(d) 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, Engine Certification Office. The
request should be forwarded through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Engine Certification Office.
Note: Information concerning the existence of approved
alternative methods of compliance with this airworthiness directive,
if any, may be obtained from the Engine Certification Office.
Issued in Burlington, Massachusetts, on May 22, 1996.
Robert E. Guyotte,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 96-14866 Filed 6-11-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-14785 Approval and Promulgation of State Implementation Plans; California State Implementation Plan Revision, Five Local Air Pollution Control Districts
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Page 29725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14785]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[CA 014-0003b; FRL-5464-5]
Approval and Promulgation of State Implementation Plans;
California State Implementation Plan Revision, Five Local Air Pollution
Control Districts
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to approve revisions to the California State
Implementation Plan (SIP) which concern the control of volatile organic
compound (VOC) emissions from graphic arts operations.
The intended effect of proposing approval of these rules is to
regulate emissions of VOCs in accordance with the requirements of the
Clean Air Act, as amended in 1990 (CAA or the Act). In the Final Rules
Section of this Federal Register, the EPA is approving the state's SIP
revision as a direct final rule without prior proposal because the
Agency views this as a noncontroversial revision and anticipates no
adverse comments. A detailed rationale for this approval is set forth
in the direct final rule. If no adverse comments are received in
response to this proposed rule, no further activity is contemplated in
relation to this rule. If EPA receives adverse comments, the direct
final rule will be withdrawn and all public comments received will be
addressed in a subsequent final rule based on this proposed rule. The
EPA will not institute a second comment period on this action. Any
parties interested in commenting on this action should do so at this
time.
DATES: Comments on this proposed rule must be received in writing by
July 12, 1996.
ADDRESSES: Written comments on this action should be addressed to:
Daniel A. Meer, Rulemaking Section (A-5-3), Air and Toxics Division,
U.S. Environmental Protection Agency, Region 9, 75 Hawthorne Street,
San Francisco, CA 94105-3901.
Copies of the rules and EPA's evaluation report of each rule are
available for public inspection at EPA's Region 9 office during normal
business hours. Copies of the submitted rules are also available for
inspection at the following locations:
California Air Resources Board, Stationary Source Divison, Rule
Evaluation Section, 2020 ``L'' Street, Sacramento, CA 95812
El Dorado County APCD, 2850 Fairlane Court, Placerville, CA 95667
Kern County APCD, 2700 M. Street, Suite 290, Bakersfield, CA 93301
Placer County APCD, 11464 B. Avenue, Auburn, CA 95603
Santa Barbara County APCD, 26 Castilian Drive, B-23, Goleta, CA 93117
South Coast AQMD, 21865 E. Copley Drive, Diamond Bar, CA 91765-4182
FOR FURTHER INFORMATION CONTACT: Erik H. Beck, Rulemaking Section (A-5-
3), Air and Toxics Division, U.S. Environmental Protection Agency,
Region 9, 75 Hawthorne Street, San Francisco, CA 94105-3901, Telephone:
(415) 744-1190, Internet E-Mail: [email protected].
SUPPLEMENTARY INFORMATION: This action concerns: El Dorado County Air
Pollution Control District (EDCAPCD) Rule 231 ``Graphic Arts
Operations''; Kern County Air Pollution Control District (KCAPCD) Rule
410.7, ``Graphic Arts''; Placer County Air Pollution Control District
(PCAPCD) Rule 239 ``Graphic Arts Operations''; Santa Barbara County Air
Pollution Control District (SBCAPCD) Rule 354, ``Graphic Arts''; and
South Coast Air Quality Management District (SCAQMD) Rule 1130.1,
``Screen Printing Operations''. These rules were submitted by the
California Air Resources Board (CARB) to EPA on the following dates in
respective order: November 30, 1994; May 30, 1991; October 13, 1995;
July 13, 1994; and November 18, 1993. For further information, please
see the information provided in the Direct Final action which is
located in the Rules Section of this Federal Register.
Authority: 42 U.S.C. 7401-7671q.
Dated: April 13, 1996.
Felicia Marcus,
Regional Administrator.
[FR Doc. 96-14785 Filed 6-11-96; 8:45 am]
BILLING CODE 6560-50-W
Complete official Federal Register PDF
FR Doc. 96-14721 Redress Provisions for Persons of Japanese Ancestry: Guidelines for Individuals Who Relocated to Japan as Minors During World War II
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29716-29719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14721]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
28 CFR Part 74
[AG Order No. 2033-96]
RIN 1190-AA42
Redress Provisions for Persons of Japanese Ancestry: Guidelines
for Individuals Who Relocated to Japan as Minors During World War II
AGENCY: Department of Justice.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Justice (``Department'') hereby proposes a
change to the regulations governing redress provisions for persons of
Japanese ancestry. This change will amend the standards of the Civil
Liberties Act of 1988 to make eligible for payments of $20,000 those
persons who are otherwise eligible for redress under these regulations,
but who involuntarily relocated during World War II to a country with
which the United States was at war. In practice, this amendment will
make potentially eligible those persons who were evacuated, relocated,
or interned by the United States Government; who, as minors, relocated
to Japan during World War II, and otherwise were unemancipated and
lacked the legal capacity to leave the custody and control of their
parents (or legal guardians) who chose to relocate to Japan during the
war; and who did not enter active military service on behalf of the
Japanese Government or another enemy government during the statutorily-
defined war period.
DATES: Comments must be submitted on or before July 12, 1996.
ADDRESSES: Comments may be mailed to the Office of Redress
Administration, PO Box 66260, Washington, DC 20035-6260.
FOR FURTHER INFORMATION CONTACT:
Tink D. Cooper or Emlei Kuboyama, Office of Redress Administration,
Civil Rights Division, U.S. Department of Justice, PO Box 66260,
Washington, DC 20035-6260; (202) 219-6900 (voice) or (202) 219-4710
(TDD). These are not toll-free numbers.
SUPPLEMENTARY INFORMATION:
I. Background
The Civil Liberties Act of 1988, Pub. L. No. 100-383 (codified at
50 U.S.C. app. 1989 et seq., as amended) (``the Act''), enacted into
law the recommendations of the Commission on Wartime Relocation and
Internment of Civilians (``Commission'') established by Congress in
1980. See Commission on Wartime Relocation and Internment of Civilians
Act, Pub. L. No. 96-317 (1980). This bipartisan commission was
established: (1) To review the facts and circumstances surrounding
Executive Order 9066, issued February 19, 1942, and the impact of that
Executive Order on American citizens and permanent resident aliens of
Japanese ancestry; (2) to review directives of United States military
forces requiring the relocation and, in some cases, detention in
internment camps of these American citizens and permanent resident
aliens; and (3) to recommend appropriate remedies. The Commission
submitted to Congress in February 1983 a unanimous report, Personal
Justice Denied, which extensively reviewed the history and
circumstances of the decisions to exclude, remove, and then to detain
Japanese Americans and Japanese resident aliens from the West Coast, as
well as the treatment of Aleuts during World War II. Redress Provisions
for Persons of Japanese Ancestry, 54 FR 34,157 (1989). The final part
of the Commission's report, Personal Justice Denied Part 2:
Recommendations, concluded that these events were influenced by racial
prejudice, war hysteria, and a failure of political leadership, and
recommended remedial action to be taken by Congress and the President.
Id.
On August 10, 1988, President Ronald Reagan signed the Act into
law. The purposes of the Act were to acknowledge and apologize for the
fundamental injustice of the evacuation, relocation, and internment of
Japanese Americans and permanent resident aliens of Japanese ancestry,
to make restitution, and to fund a public education program to prevent
the recurrence of any similar event in the future. 50 U.S.C. app. 1989-
1989a.
Section 105 of the Act makes the Attorney General responsible for
identifying, locating, an authorizing payment of redress to eligible
individuals. Id. 1989b-4. The Attorney General delegated the
responsibilities and duties assigned to her to the Assistant Attorney
General for Civil Rights, who, in keeping with precedent, has
designated ORA in the Civil Rights Division to carry out the execution
of the responsibilities and duties under the Act. The regulations
governing the eligibility and restitution were drafted by ORA and
published under the authority of the Justice Department in 1989. 54 FR
34,157 (1989) (final rule) (codified at 28 CFR part 74).
ORA is charged with the responsibility of identifying and locating
persons eligible for redress under the Act. To date, restitution has
been paid to a total of 79,911 Japanese Americans and permanent
resident aliens of Japanese ancestry.
Section 108 of the Act articulates the standards for redress
eligibility. 50 U.S.C. app. 1989b-7(2). Among those excluded from
eligibility under that section are those ``who, during the period
beginning on December 7, 1941, and ending on September 2, 1945,
relocated to a country while the United States was at war with that
country * * *.'' Id. As part of a citizen exchange program during World
War II, the United States returned formerly interned persons of
Japanese ancestry to Japan on two occasions. On June 18, 1942,
approximately 1,083 persons of Japanese ancestry returned to Japan
aboard the M.S. Gripsholm, and on September 2, 1943, the Gripsholm
returned another 1,340 persons of Japanese ancestry to Japan. A number
of these persons asserted claims for redress based on their evacuation
and internment by the United States Government prior to their return to
Japan. However, based on section 108 of the Act and 28 CFR 74.4, ORA
found them ineligible for redress. 54 FR 34,162 (1989). In all, 175
persons who returned to Japan aboard the Gripsholm claimed compensation
under the Act; approximately 124 of these claimants were persons who
were under the age of 21 upon their departure from the United States.
ORA's denial of redress to these claimants was upheld during the
administrative appeal process set forth in 28 CFR 74.17. 54 FR 34,164-
65 (1989).
It is helpful to describe the circumstances of these individuals.
The West Coast voluntary evacuation period began with the issuance of
Proclamation No. 1, on March 2, 1942, and ended with the issuance of
Proclamation No. 4, effective on March 29, 1942. After this date,
persons of Japanese ancestry were prohibited from leaving the West
Coast because the Government was preparing to forcibly relocate and
intern them later. Over 120,000 Japanese Americans were eventually
interned. Of these 120,000, approximately 124 were minor children whose
parents decided to depart the United States for Japan during the war on
one of the M.S.
[[Page 29717]]
Gripsholm sailings prior to September 2, 1945. The majority of the
passengers on the first sailing were Japanese diplomats, while many of
the passengers on the second sailing were American citizens or
permanent resident aliens. Also aboard were some Japanese nationals who
had left Japan to live and work in the United States and who, by law,
were ineligible to apply for United States citizenship. Many of these
individuals returned to Japan with their American-born children.
These American children persevered through an arduous period during
which they were forcibly evacuated from their homes on the West Coast
and interned with their parents. The minors were unable legally to
return to their homes in the prohibited military zones on the West
Coast and were required to travel to Japan with their parents on a long
and difficult journey.
The loyalty of most of these American children, however, apparently
never waned. According to ORA research, the vast majority of them did
not enter into the active military service on behalf of an enemy
government during World War II. Furthermore, almost all returned to the
United States after the war. Out of the approximately 124 minors who
have filed for redress, and who relocated to Japan with their parents
during World War II, 108 subsequently returned to the United States,
while only 16 remained in Japan.
II. Revised Interpretation
Following publication of the draft regulations in 1989, the
Department received 61 comments concerning the eligibility of persons
who, as minors, returned to Japan aboard the Gripsholm. Based on the
comments received at that time, however, it found no reason to
differentiate between adults who returned to Japan during World War II
and minors. As a result, in the preamble of the final regulation, the
Department stated that ``the exclusionary language of the Act would
preclude from eligibility the minors, as well as adults, who were
relocated to Japan during [the relevant] time period.'' 54 FR 34,160
(1989).
The Department, based on an argument not previously presented, now
proposes to revise its interpretation regarding the eligibility of
persons who relocated to Japan during World War II. Specifically, it
proposes to revise its determination of eligibility with regard to
persons who were under the age of 21 and not emancipated as of their
dates of departures from the United States, who did not participate in
the active military service on behalf of an enemy government during
World War II, and who are otherwise eligible for redress under these
regulations.
In proposing this revision, the Department is operating within the
established framework of Chevron v. N.R.D.C., 467 U.S. 837, 842-43.
Under Chevron, an agency must give effect to the unambiguously
expressed intent of Congress when interpreting a statute. However,
where an act is silent or ambiguous with respect to a specific issue,
Congress has assigned to the agency the responsibility to elucidate a
specific provision of the statute by regulation. Id. at 843-44. For the
reasons set forth below, the Department believes that the proscription
of section 108 is ambiguous with respect to its coverage of the class
of individuals described above, and that the proposed revision is a
reasonable interpretation of the statute.
As enacted, section 108 expressly excludes from eligibility ``any
individual who, during the period beginning on December 7, 1941, and
ending on September 2, 1945, relocated to (another) country while the
United States was at war with that country.'' 50 U.S.C. app. 1989b-7
(emphasis added). This language does not specifically resolve whether
the exclusion applies to individuals who relocated involuntarily.
This issue is suggested on the face of the statute when it is read
as a whole because, while the statute uses the active voice in section
108's exclusion clause, the eligibility clauses of the statute use the
passive voice. For example, section 108 begins by defining an
``eligible individual'' as a person of Japanese ancestry ``who, during
the evacuation, relocation and internment period--* * * was confined,
held in custody, relocated, or otherwise deprived of liberty or
property as a result of * * * (various Executive Orders and Acts).'' 50
U.S.C. app. 1989b-7(2) (emphasis added). Title II of the Act, which
provides reparations to Aleuts evacuated from their home islands during
World War II, similarly defines an eligible Aleut as a person ``who, as
a civilian, was relocated by authority of the United States from his or
her home village * * * to an internment camp * * *.'' 50 U.S.C. app.
1989c-1(5) (emphasis added). The contrasting use of the active voice in
the exclusion clause suggests the possibility that section 108 might be
read to exclude only those individuals who voluntarily relocated to an
enemy country during the war.
This possibility is consistent with judicial decisions. The United
States Courts of Appeals for the District of Columbia and the Ninth
Circuits have deemed the use of the active as opposed to the passive
voice relevant for purposes of statutory interpretation. Dickson v.
Office of Personnel Mgmt., 828 F.2d 32, 37 (D.C. Cir. 1987) (isolated
use of passive voice in phrase defining liability is significant and
allows suit against Office of Personnel Management whenever an adverse
determination ``is made,'' even if by another agency); United States v.
Arrellano, 812 F.2d 1209, 1212 (9th Cir. 1987) (clause of statute
defining criminal intent phrased in active voice applies to conduct of
the accused, while second clause phrased in passive voice applies only
to the conduct of others). Thus, the statutory language creates an
ambiguity as to whether eligibility decisions should distinguish
between voluntary relocatees and involuntary relocatees. For the
reasons that follow, we believe the better interpretation is to exclude
only individuals who relocated voluntarily.
The Act's legislative history provides very little significant
insight into congressional intent regarding the eligibility of
involuntary relocatees. As originally introduced, neither the House nor
the Senate bill included a relocation exclusion provision in the
section defining eligible individuals. Entering conference, the House
version of the Act contained the exclusion, while the Senate version
contained no such provision. The conferees agreed to adopt the House
provision, which excluded ``those individuals who, during the period
from December 7, 1941, through September 2, 1945, relocated to a
country at war with the United States.'' H.R. Conf. Rep. No. 785, 100th
Cong., 2d Sess. 22 (1988). There is no additional discussion of the
relocation exclusion in the conference report.
A discussion of whether individuals who returned to Japan should be
included in the definition of ``eligible individuals'' is contained in
a witness statement submitted to the House and Senate subcommittees
considering the legislation. In testimony opposing the enactment of the
bill, the Assistant Attorney General for the Civil Division, Richard K.
Willard, noted that as then written (without the relocation exclusion),
the breadth of the definition would cover any individual who had been
subject to exclusion, relocation, or internment, including persons
living outside the United States. In the Department's view, this
overlooked the fact that at least several hundred of the detainees were
``fanatical pro-Japanese, * * * and (had) voluntarily sought
repatriation to Japan after the end of the war.'' The Department
believed that allowing these disloyal individuals to receive the
benefit of the legislation
[[Page 29718]]
would be unfair to the United States and to loyal persons of Japanese
descent. To Accept the Findings and to Implement the Recommendations of
the Commission on Wartime Relocation and Internment of Civilians:
Hearing on S. 1009 Before the Subcomm. on Federal Services, Post
Office, and Civil Service of the Senate Comm. on Governmental Affairs,
100th. Cong., 1st Sess. 281, 296 (1987) (Hearings). This statement,
however, does not reveal or suggest an opinion that the bill ought to
exclude from redress persons who involuntarily relocated to an enemy
country.
In sum, the Department believes that section 108's exclusion of
persons who relocated to an enemy country during World War II is
susceptible to the interpretation that it does not apply to persons who
relocated involuntarily, that so interpreting the statute gives effect
to the principles Congress meant to embody in the exclusionary
provision, and that this interpretation is otherwise a reasonable
construction of the statute.
The Department further notes that the determination of whether a
person relocated voluntarily to an enemy country during World War II is
extraordinarily difficult to determine at this late date, over half a
century since the period during which the actions that are relevant to
a determination about the state of mind of individual relocatees took
place. Under these circumstances, the Department has discretion to
structure the process for determining redress eligibility in a manner
that avoids the inherent inaccuracy of any attempt to engage in a case-
by-case inquiry into the subjective factor of state of mind, as well as
the potential administrative burdens associated with case-by-case
inquiry, by articulating some reasonable objective criteria to guide
the process.
To that end, the Department proposes two bright line rules to
administer section 108's exclusion provision. First, any person who was
21 years of age or older, or otherwise emancipated by petition of the
court or by marriage, as of the date of his or her departure from the
United States, shall be irrebuttably presumed to have relocated
voluntarily, and will be ineligible for redress under the Act. Second,
any person who served in the Japanese military, or the military of
another enemy country, during the statutorily-defined war period shall
be irrebuttably presumed to have relocated voluntarily and, therefore,
will be ineligible for redress. All otherwise eligible persons falling
outside these categories, that is, persons who were minors and not
otherwise emancipated as of the dates of their departures from the
United States and who did not serve in the Japanese military or the
military of another enemy government during the statutorily-defined war
period, shall be considered involuntary relocatees and therefore
eligible for redress under the Act.
The Supreme Court has affirmed the ability of agencies to employ
generally applicable rules as an alternative to case-by-case
adjudication. See e.g., American Hospital Ass'n v. NLRB, 499 U.S. 606,
611 (1991) (``[Prior decisions of this Court] confirm that, even if a
statutory scheme requires individualized determinations, the decision-
maker has the authority to rely on rulemaking to resolve certain issues
of general applicability unless Congress clearly expresses an intent to
withhold that authority.''). In particular, the Court has noted that
the Congress is free to use prophylactic rules despite their ``inherent
imprecision'' when it wishes to avoid ``the expense and other
difficulties of individual determinations.'' Weinberger v., Salfi, 422
U.S. 749, 777 (1975).
The Department believes that under American Hospital Ass'n and
other authorities agencies enjoy a similar latitude to that enunciated
in Weinberger. As in Weinberger, justifying the use of such bright-line
rules does not require determining whether the rules ``precisely
filter() out those, and only those, who are in the factual position
which generated the congressional concern * * * (n) or * * * whether
(they) filter( ) out a substantial part of the class which caused the *
* * concern, or whether (they) filter() out more members of the class
than nonmembers.'' Id. Rather, the question is whether the Department
could ``rationally have concluded both that * * * particular (rules)
would protect against (the abuse Congress sought to avoid), and that
the expense and other difficulties of individualized determinations
justified (their) inherent imprecision.'' Id. For the reasons that
follow, the proposed rules satisfy this standard.
As stated above, the Department proposes to apply an irrebuttable
presumption that persons who were 21 years of age or older, or
otherwise emancipated by petition of the court or by marriage, as of
the dates of their departures from the United States, were voluntary
relocatees. The Department proposes to apply this irrebuttable
presumption because adult relocatees were more likely than minor
relocatees to have been able to assent freely to their return to Japan.
The age of 21 as of the date of departure was chosen because, during
the period covered by the Act's relocation exclusion, the legal age of
majority in most states was 21.
Noting the dearth of legislative history pertaining to the Act's
exclusion clause, the United States Court of Federal Claims stated in
Suzuki v. United States, 29 Fed. Cl. 688 (1993), that Congress may have
enacted the exclusion clause in an effort to deny benefits to
individuals who had either been disloyal to the United States or ``who,
despite possible continued loyalty to the United States, had aided an
enemy country during war.'' Id. at 695. Nothing in the Department's
revised interpretation of section 108 is inconsistent with this
observation, since both of the possible purposes cited by the court
assume volition on the part of the relocatee to leave the Untied States
and relocate to Japan. If, by contrast, an individual relocatee was not
free to assent to his or her relocation on account of his or her
minority status, it is reasonable for the Department to conclude that
such individual was not the type of person against whom Congress
intended to apply section 108's exclusion provision. By itself, the
relocation of minors during World War II does not raise doubts or
inferences concerning disloyalty. In fact, most American-born minor
relocatees returned to the United States following the war.
Examples of distinctions in the treatment of minors and adults
abound in our law. See Thompson v. Oklahoma, 487 U.S. 815, 823 (1988)
(plurality opinion). Accordingly, it is reasonable for the Department
to apply such a distinction in determining whether individuals who
related to Japan during the statutorily-defined war period did so
voluntarily.
The Department also proposes to apply an irrebuttable presumption
that individuals who served in the military of an enemy government
during the statutorily-defined war period relocated voluntarily because
the Department believes that evidence that an individual entered into
the active military service on behalf of an enemy government following
his or her departure from the United States is a strong indication that
the individual relocated voluntarily. In view of that reasonable belief
and the fact that it is difficult at this time to determine with
complete certainty the motivations of individuals who joined the active
military service against the United States during World War II, and in
light of the increased administrative burdens associated with
individualized efforts to ascertain the 50-year-old motivations of such
individuals, the Department believes it is appropriate to interpret the
[[Page 29719]]
fact that an individual served in the military of an enemy government
following his or her relocation as evidence that the individual
relocated voluntarily.
The Department will thus require individuals who apply for redress
under the Act and who relocated to Japan during the statutorily-defined
war period to provide information as to their ages and emancipation
status upon their dates of departure from the United states to relocate
to Japan, and to state whether or not they participated in the active
military service on behalf of an enemy government, including the
Japanese Government, during World War II. If such individuals state
that they were 21 years of age or older, or emancipated minors, as of
the dates of their departures, they will be deemed ineligible for
redress under the Act. Similarly, if such individuals state that they
participated in the active military service on behalf of an enemy
government during World War II, they also will be deemed ineligible. In
contrast, otherwise eligible relocatees who were under the age of 21
and not otherwise emancipated upon the dates of their departures from
the United States, and who did not serve in the military on behalf of
an enemy government during World War II, will be eligible for redress
under the Act.
III. Regulatory Impact Analysis
The Office of Management and Budget has determined that this
proposed rule is a significant regulatory action under Executive Order
No. 12866 and, accordingly, this proposed rule has been reviewed and
approved by the Office of Management and Budget. Information collection
associated with this regulation has been approved by the Office of
Management and Budget, OMB No. 1190-0010. Comments about this
collection can be filed with the Clearance Officer, Office of Redress
Administration, PO Box 66260, Washington, DC 20035-6260, and the Desk
Officer, Office of Information and Regulatory Affairs, Office of
Management and Budget, New Executive Office building, Washington, DC
20503.
List of Subjects in 28 CFR Part 74
Administrative practice and procedure, Aliens, Archives and
records, Citizenship and naturalization, Civil rights, Indemnity
payments, Minority groups, Nationality, War claims.
For the reasons set forth in the preamble and by the authority
vested in me, including 28 U.S.C. 509 and 510, chapter I of title 28,
part 74, of the Code of Federal Regulations is proposed to be amended
as follows:
PART 74--CIVIL LIBERTIES ACT REDRESS PROVISION
1. The authority citation for Part 74 continues to read as follows:
Authority: 50 U.S.C. app. 1989b.
2. In subpart B, Sec. 74.4 is revised to read as follows:
Subpart B--Standards of Eligibility
Sec. 74.4 Individuals excluded from compensation pursuant to section
108(B) of the Act.
(a) The Term ``eligible individual'' does not include any
individual who, during the period beginning on December 7, 1941, and
ending on September 2, 1945, relocated to a country while the United
States was at war with that country.
(b) Nothing in paragraph (a) of this section is meant to exclude
from eligibility any person who, during the period beginning on
December 7, 1941, and ending on September 2, 1945, relocated to a
country while the United States was at war with that country, and who
had not yet reached the age of 21 and was not emancipated as of the
date of departure from the United States, provided that such person is
otherwise eligible for redress under these regulations and the
following standards:
(1) Persons who were 21 years of age or older, or emancipated
minors, on the date they departed the United States for Japan are
subject to an irrebuttable presumption that they relocated to Japan
voluntarily and will be ineligible.
(2) Persons who served in the active military service on behalf of
the Government of Japan or an enemy government during the period
beginning on December 7, 1941 and ending on September 2, 1945, are
subject to an irrebuttable presumption that they departed the United
States voluntarily for Japan. If such individuals served in the active
military service of an enemy country, they must inform the Office of
such service and, as a result, will be ineligible.
Dated: June 5, 1996.
Janet Reno,
Attorney General.
[FR Doc. 96-14721 Filed 6-11-96; 8:45 am]
BILLING CODE 4410-10-M
Complete official Federal Register PDF
FR Doc. 96-14638 Redress Provisions for Persons of Japanese Ancestry: Guidelines Under Ishida v. United States
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29715-29716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14638]
=======================================================================
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DEPARTMENT OF JUSTICE
28 CFR Part 74
Redress Provisions for Persons of Japanese Ancestry: Guidelines
Under Ishida v. United States
AGENCY: Department of Justice.
ACTION: Notice of extension of deadline for public comment.
-----------------------------------------------------------------------
SUMMARY: On April 22, 1996, the Department of Justice published in the
Federal Register (61 FR 17667) a proposed rule to amend the
Department's regulation governing redress provisions for persons of
Japanese ancestry. This change will amend the standards of the Civil
Liberties Act of 1988 to make eligible for payments of $20,000 those
persons who were born after their parents ``voluntarily'' evacuated
from the prohibited military zones of the West Coast of the United
States as a result of military proclamations issued pursuant to
Executive Order 9066. This change will also make eligible for redress
those persons who were born outside the prohibited military zones in
the United States after their parents were released from internment
camps during the defined war period and whose parents had resided in
the prohibited military zones on the West Coast immediately prior to
their internment.
The period for accepting comments was published as ending on June
6, 1996. Due to a clerical mistake, however, the period for accepting
comments should end on June 20, 1996, upon the expiration of the
standard sixty day comment period. Due to this mistake and requests
from interested parties to have the full sixty day period in which to
submit comments, the comment period is extended through June 20, 1996.
DATES: The comment period is extended to June 20, 1996.
ADDRESSES: Written comments may be mailed to the Office of Redress
Administration, P.O. Box 66260, Washington, D.C. 20035-6260.
FOR FURTHER INFORMATION CONTACT: Tink D. Cooper or Emlei M. Kuboyama,
Office of Redress Administration, Civil Rights Division, U.S.
Department of Justice, P.O. Box 66260, Washington, D.C. 20035-6260;
(202) 219-6900 (voice) or (202) 219-4710 (TDD). These are not toll-free
numbers.
SUPPLEMENTARY INFORMATION: The proposed rule published in the Federal
Register on April 22, 1996, would amend the regulation of the
Department of Justice governing redress provisions for persons of
Japanese ancestry. A number of persons have asserted claims for redress
based on their parents' evacuation or internment by the United States
Government prior to their birth and their subsequent inability to
legally return to their parents' original place of residence in the
prohibited military zones on the West Coast. Based on section 108 of
the Civil Liberties Act of 1988, Public Law No. 100-383 (codified at 50
U.S.C. app 1989 et seq., as amended) and 28 CFR 74.4, the Civil Rights
Division found these persons ineligible for redress. Approximately
1,000 persons who were born after their parents ``voluntarily''
evacuated from the prohibited military zones or after their parents
were released from internment camps claimed compensation under the Act.
Most of these claimants were born prior to midnight on January 2, 1945,
the effective date of Proclamation Number 21, which rescinded the
prohibited military zones on the West Coast and lifted the general
exclusion restrictions on persons of Japanese ancestry. However, the
United States Court of Appeals for the Federal Circuit determined that
the Civil Rights Division's policy of denying such claims was
inconsistent with the terms of the Act. Ishida v. U.S., No. 94-5151
(Fed. Cir., July 6, 1995). In order to conform to the court decision,
the Civil Rights Division proposed this revision to the regulation.
[[Page 29716]]
To be assured of consideration, comments must be in writing and
must be received on or before June 20, 1996.
* * * * *
Dated: June 4, 1996.
Deval Patrick,
Assistant Attorney General.
[FR Doc. 96-14638 Filed 6-11-96; 8:45 am]
BILLING CODE 4410-01-M
Complete official Federal Register PDF
FR Doc. 96-14454 Approval and Promulgation of State Implementation Plans: Idaho
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Page 29726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14454]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 81
[ID14-6994b; FRL-5515-2]
Approval and Promulgation of State Implementation Plans: Idaho
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule, correction.
-----------------------------------------------------------------------
SUMMARY: The EPA proposes to correct EPA's announcement of the boundary
of the Power-Bannock Counties PM-10 nonattainment area (particulate
matter with an aerodynamic diameter less than or equal to a nominal 10
micrometers) in the State of Idaho to exclude that portion east of the
Inkom Gap, a geographic feature separating the Inkom area from the rest
of the nonattainment area. In the Final Rules Section of this Federal
Register, the EPA is approving the State's SIP revision as a direct
final rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no adverse
comments. A detailed rationale for the approval is set forth in the
direct final rule. If no adverse comments are received in response to
this proposed rule, no further activity is contemplated in relation to
this rule. If the EPA receives adverse comments, the direct final rule
will be withdrawn and all public comments received will be addressed in
a subsequent final rule based on this proposed rule. The EPA will not
institute a second comment period on this action.
DATES: Comments on this proposed rule must be received in writing by
July 12, 1996.
ADDRESSES: Written comments should be addressed to Steven K. Body,
Office of Air Quality, at the EPA Regional Office listed below. Copies
of the documents relevant to this proposed rule are available for
public inspection during normal business hours at the following
locations. The interested persons wanting to examine these documents
should make an appointment with the appropriate office at least 24
hours before the visiting day.
U.S. Environmental Protection Agency, Region 10, Office of Air Quality,
1200 6th Avenue, Seattle, WA 98101.
Idaho Division of Environmental Quality, 1410 N. Hilton, Boise, Idaho
83720.
FOR FURTHER INFORMATION CONTACT: Steve Body, Office of Air Quality,
(206) 553-0782, or by mail at the Region 10 address above.
SUPPLEMENTARY INFORMATION: See the information provided in the Direct
Final action which is located in the Rules Section of this Federal
Register.
Dated: May 29, 1996.
Carol M. Browner,
U.S. EPA Administrator.
[FR Doc. 96-14454 Filed 6-11-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-13858 Generation-Skipping Transfer Tax
[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29714-29715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13858]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 26
[PS-22-96]
RIN 1545-AU26
Generation-Skipping Transfer Tax
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This document contains proposed regulations relating to the
final generation-skipping transfer (GST) tax regulations under chapter
13 of the Internal Revenue Code (Code). This document proposes a change
to the final regulations and is necessary to provide guidance to
taxpayers so that they may comply with chapter 13 of the Code.
DATES: Written comments and requests for a public hearing must be
received by September 10, 1996.
ADDRESSES: Send submissions to: CC:DOM:CORP:R (PS-22-96), room 5228,
Internal Revenue Service, POB 7604, Ben Franklin Station, Washington,
DC 20044. In the alternative, submissions may be hand delivered between
the hours of 8 a.m. and 5 p.m. to: CC:DOM:CORP:R (PS-22-96), Courier's
Desk, Internal Revenue Service, 1111 Constitution NW., Washington, DC
20224.
FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulation,
James F. Hogan, (202) 622-3090 (not a toll-free number); concerning
submissions, Christina Vasquez, (202) 622-7180, (not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Background
On December 24, 1992, the IRS published a notice of proposed
rulemaking in the Federal Register (57 FR 61356) containing proposed
regulations under sections 2611, 2612, 2613, 2632, 2641, 2642, 2652,
2653, 2654, and 2663. On December 27, 1995, the IRS published final
regulations in the Federal Register (60 FR 66898) under sections 2611,
2612, 2613, 2632, 2641, 2642, 2652, 2653, 2654, and 2663. This proposed
regulation will delete Sec. 26.2652-1(a)(4) and two related examples.
Explanation of Provision
Section 2652(a)(1) provides generally, that the term transferor
means--(A) in the case of any property subject to the tax imposed by
chapter 11, the decedent, and (B) in the case of any property subject
to the tax imposed by chapter 12, the donor. An individual is treated
as transferring any property with respect to which the individual is
the transferor. Under Sec. 26.2652-1(a)(2), a transfer is subject to
Federal gift tax if a gift tax is imposed under section 2501(a) and is
subject to Federal estate tax if the value of the property is
includable in the decedent's gross estate determined under section 2031
or section 2103. Under Sec. 26.2652-1(a)(4), the exercise of a power of
appointment that is not a general power of appointment is also treated
as a transfer subject to Federal estate or gift tax by the holder of
the power if the power is exercised in a manner that may postpone or
suspend the vesting, absolute ownership, or power of alienation of an
interest in property for a period, measured from the date of the
creation of the trust, extending beyond any specified life in being at
the date of creation of the trust plus a period of 21 years plus, if
necessary, a reasonable period of gestation.
The purpose of the rule in Sec. 26.2652-1(a)(4) was to apply the
GST tax when
[[Page 29715]]
it may not otherwise have applied. It was never intended to (nor could
it) prevent the application of the tax pursuant to the statutory
provisions that apply based on the original taxable transfer. To
eliminate any uncertainty concerning the proper application of the GST
tax, the regulations under section 2652(a) will be clarified by
eliminating Sec. 26.2652-1(a)(4) and Example 9 and Example 10 in
Sec. 26.2652-1(a)(6) from the final regulations.
Proposed Effective Date
These amendments apply to transfers to trusts on or after June 12,
1996.
Special Analysis
It has been determined that this notice of proposed rulemaking is
not a significant regulatory action as defined in EO 12866. Therefore,
a regulatory assessment is not required. It has also been determined
that section 553(b) of the Administrative Procedure Act (5 U.S.C.
chapter 5) and the Regulatory Flexibility Act (5 U.S.C. chapter 6) do
not apply to these regulations, and therefore, a Regulatory Flexibility
Analysis is not required. Pursuant to section 7805(f) of the Internal
Revenue Code, the notice of proposed rulemaking preceding these
regulations was submitted to the Small Business Administration for
comment on its impact on small business.
Comments and Requests for a Public Hearing
Before this proposed regulation is adopted as a final regulation,
consideration will be given to any written comments (a signed original
and eight (8) copies) that are submitted timely to the IRS. All
comments will be available for public inspection and copying. A public
hearing may be scheduled if requested in writing by a person that
timely submits written comments. If a public hearing is scheduled,
notice of the date, time, and place for the hearing will be published
in the Federal Register.
Drafting Information
The principal author of this proposed regulation is James F. Hogan,
Office of the Chief Counsel, IRS. Other personnel from the IRS and
Treasury Department participated in its development.
List of Subjects in 26 CFR Part 26
Estate taxes, Reporting and recordkeeping requirements.
Adoption of Amendments to the Regulations
Accordingly, 26 CFR part 26 is proposed to be amended as follows:
PART 26--GENERATION-SKIPPING TRANSFER TAX REGULATIONS UNDER THE TAX
REFORM ACT OF 1986
Paragraph 1. The authority citation for part 26 continues to read,
in part, as follows:
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 26.2652-1 is amended as follows:
Sec. 26.2652-1 [Amended]
1. Paragraph (a)(4) is removed and paragraphs (a)(5) and (a)(6) are
redesignated as paragraphs (a)(4) and (a)(5), respectively.
2. In newly designated paragraph (a)(5), Examples 9 and 10 are
removed and Example 11 is redesignated as Example 9.
Margaret Milner Richardson,
Commissioner of Internal Revenue.
[FR Doc. 96-13858 Filed 6-11-96; 8:45 am]
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