issue-1996-07-09•Federal Register proposed rules — 1996-07-09
Federal Register proposed rules — 1996-07-09
issue-1996-07-09Federal Register proposed rules — 1996-07-09Proposed 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. 96-17478 Sheep Promotion, Research, and Information Program
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35982-35984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17478]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1280
[Docket Number LS-96-006]
Sheep Promotion, Research, and Information Program
AGENCY: Agricultural Marketing Service; USDA.
ACTION: Notice of Referendum; Referendum Order.
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SUMMARY: The Agricultural Marketing Service (AMS) is announcing that a
second referendum will be conducted among eligible sheep producers,
sheep feeders, and importers of sheep and sheep products to determine
whether the Sheep and Wool Promotion, Research, Education, and
Information Order (Order) will become effective as authorized under the
Sheep Promotion, Research, and Information Act of 1994 (Act). This
action is a result of a review conducted by the Department of
Agriculture (Department) that revealed that the referendum rules were
applied inconsistently at the official polling places during the
February 6, 1996, nationwide referendum. Consequently, the results of
the February 6, 1996, nationwide referendum were voided.
DATES: Referendum Dates: In-person voting in the referendum will be
conducted on October 1, 1996, by county Cooperative Extension Service
(CES) offices. Absentee ballots will be available at county CES offices
from August 26, 1996, through September 17, 1996. The representative
period to establish voter eligibility will be the period from January
1, 1994, through December 31, 1994.
[[Page 35983]]
FOR FURTHER INFORMATION CONTACT: Ralph L. Tapp, Chief, Marketing
Programs Branch, Livestock and Seed Division, AMS, USDA, Room 2606-S;
P.O. Box 96456; Washington, D.C. 20090-6456. Telephone number 202/720-
1115.
SUPPLEMENTARY INFORMATION: The Act (7 U.S.C. 7101-7111), enacted
October 22, 1994, provides for the establishment of a national sheep
and wool promotion, research, education, and information program,
designed to strengthen the sheep industry's position in the
marketplace, maintain and expand existing markets, and develop new
markets and uses for sheep and sheep products.
The program will be funded by a mandatory assessment on domestic
sheep producers, sheep feeders, and exporters of live sheep and greasy
wool of 1 cent per pound on live sheep sold and 2 cents per pound on
greasy wool sold. Importers will be assessed 1 cent per pound on live
sheep imported and the equivalent of 1 cent per pound of live sheep for
sheep products imported and 2 cents per pound of degreased wool or the
equivalent of degreased wool for wool and wool products imported.
Imported raw wool will be exempt from assessments. Each person who
processes or causes to be processed sheep or sheep products of that
person's own production, and who markets the processed products, will
be assessed the equivalent of 1 cent per pound of live sheep sold and 2
cents per pound of greasy wool sold. All assessment rates may be
adjusted in accordance with applicable provisions of the Act.
The Act requires that a referendum be conducted after an Order is
issued to determine whether the Order will go into effect. An Order was
published in the Federal Register on December 5, 1995 (60 FR 62298).
The referendum is to be conducted among persons who were sheep
producers, sheep feeders, or importers of sheep and sheep products
during a representative period specified by the Secretary. Importers
who import only raw wool are not eligible to participate in the
referendum because raw wool is exempt from assessments under the Act.
The Order would become operational only if it is approved by a majority
of the producers, feeders, and importers voting in the referendum, or
by producers, feeders, and importers voting in the referendum who
account for at least two-thirds of the production represented by
persons voting in the referendum. If the Order is not approved by
persons voting in the referendum, the program will not become
operational.
To vote in the referendum, eligible persons will complete the
registration and certification form, mark their ballots and, if they
want to vote according to their volume of production, record that
number on the ballot. Producers, feeders, and importers who vote their
volume of production must determine that number before they register
and vote in the referendum. For producers and feeders, the volume of
production is the largest number of head of domestic sheep owned for
any single, consecutive, 30-day period during the representative
period. For importers, the volume of production is the number of live
sheep or live sheep equivalents imported during the representative
period. The final referendum rules published in the Federal Register on
December 15, 1995 (60 FR 64297), provide guidance for calculating
import volume of production in sheep equivalents.
As required by the Act, the Department conducted an up-front
referendum among eligible domestic sheep producers and sheep feeders,
as well as importers of sheep and sheep products, to determine if the
Order would become operational. To become effective, the Order had to
be approved either by a majority of producers, feeders, and importers
voting in the referendum or by voters who accounted for at least two-
thirds of the production represented by all persons voting in the
referendum. Of the 19,801 valid ballots cast in the February 6, 1996,
referendum, 10,707 (54 percent) favored implementation of the Order and
9,094 (46 percent) opposed implementation of the Order.
AMS published the final Order (61 FR 19514) on May 2, 1996, to
implement a national sheep and wool, promotion, research, education,
and information program, designed to strengthen the position of sheep
and sheep products in the marketplace, as provided for under the Act.
The effective date of the Order was May 3, 1996, except that the
collection and remittance sections of the Order--Sec. 1280.224-
Sec. 1280.228--were scheduled to become effective on July 1, 1996. The
final Rules and Regulations (61 FR 21053), which set forth the
collection and remittance procedures to be used beginning July 1, 1996,
and the Certification and Nomination procedures (61 FR 21049), which
outline eligibility criteria and the nomination process used to obtain
nominations for appointment to the National Sheep Promotion, Research,
and Information Board which would administer the program, were both
published on May 9, 1996.
After the referendum was held, however, the Department received
voter complaints of alleged inconsistencies in the application of the
referendum rules in conducting the referendum. The Department initiated
a review of these allegations. Based on findings of the review which
revealed that the referendum rules were applied inconsistently, the
Department voided the results of the February 6, 1996, referendum,
suspended the Order and the Certification and Nomination Regulations
and postponed indefinitely the announced July 1, 1996, effective date
of (1) the implementing Rules and Regulations, (2) the collection of
assessments, and (3) the collection and remittance sections of the
Order--Sec. 1280.224-Sec. 1280.228. The second referendum will be
conducted under the final referendum rules published December 15, 1995
(60 FR 64297), in the Federal Register.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Office of Management and Budget (OMB) has approved the
information collection requirements concerning the conduct of a
referendum including ballots and other voting materials. The control
number assigned to the information collection requirements by OMB is
OMB 0581-0093. It is estimated that it will take an average of 6.5
minutes for each of the approximately 87,350 domestic sheep producers
and sheep feeders and the approximately 9,000 importers of sheep and
sheep products to cast a ballot.
Referendum Order
It is hereby directed that a referendum be conducted among eligible
sheep producers, sheep feeders, and importers of sheep and sheep
products to determine whether an Order will become effective if
approved by those eligible persons voting in the referendum. In-person
voting in the referendum will be conducted on October 1, 1996, by the
county CES offices. Absentee ballots will be available at the county
CES offices from August 26, 1996, through September 17, 1996. The
representative period to establish voter eligibility will be the period
from January 1, 1994, through December 31, 1994.
List of Subjects in 7 CFR Part 1280
Administrative practice and procedure, Advertising, Agricultural
research, Marketing agreements, Sheep and sheep products, Reporting and
recordkeeping requirements.
Authority: 7 U.S.C. 7101-7111.
[[Page 35984]]
Dated: July 3, 1996.
Lon Hatamiya,
Administrator.
[FR Doc. 96-17478 Filed 7-3-96; 3:48 pm]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-17468 Rules and Regulations Under the Textile Fiber Products Identification Act
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35992-35994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17468]
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FEDERAL TRADE COMMISSION
16 CFR Part 303
Rules and Regulations Under the Textile Fiber Products
Identification Act
AGENCY: Federal Trade Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: On October 30, 1992. Teijin Limited (``Teijin'') filed an
application with the Federal Trade Commission (``Commission'')
requesting the establishment of a new generic fiber name and
definition. The application was filed pursuant to Rule 8 of the Rules
and Regulations Under the Textile Fiber Products Identification Act
(the ``Textile Act''--15 U.S.C. 70; implementing regulations at 16 CFR
part 303). The
[[Page 35993]]
application maintains that its new fiber, ``manufactured from poly
tetramethylene ether/poly butylene glycol terephthalate copolymer,''
has a unique chemical composition and distinctive physical
characteristics such that it cannot be identified by any of the generic
names already established by the Commission in Rule 7 (16 CFR 303.7).
The application also states that Teijin intends to market the fiber
commercially, and subsequent information from the applicant states that
the fiber is now being used in the U.S. Teijin recommends that the new
fiber be given one of the following generic names, in descending order
of preference: (1) ``Polyetherester,'' (2) ``Elastoester,'' or (3)
``Estelast.'' The Teijin application includes a proposed definition for
the new fiber.
The Commission now solicits comments as to whether Rule 7 should be
amended to include a new generic name and definition covering Teijin's
fiber.
DATES: Written comments will be accepted through September 9, 1996.
ADDRESSES: Submit written comments and other submissions to: Secretary,
Federal Trade Commission, Room H-159, Sixth & Pennsylvania Avenue,
N.W., Washington, D.C. 20580. Submissions should be marked: ``Rule 7
Under the Textile Act--Comment.''
FOR FURTHER INFORMATION CONTACT:
Bret S. Smart, Program Advisor, Los Angeles Regional Office, Federal
Trade Commission, 11000 Wilshire Boulevard, #13209, Los Angeles, CA
90024, (310) 235-4040.
SUPPLEMENTARY INFORMATION:
I. Background
Rule 6 (16 CFR 303.6) of the Rules and Regulations under the
Textile Fiber Products Identification Act requires manufacturers to use
the generic names of the fibers contained in their textile fiber
products in making required disclosures of the fiber content of the
products. Rule 7 (16 CFR 303.7) sets forth the generic names and
definitions that the Commission has established or synthetic fibers.
Rule 8 (16 CFR 303.8) sets forth the procedures for establishing new
generic names.
Teijin submitted its initial application in this matter to the
Commission on October 30, 1992, and subsequently submitted additional
information. The application and related materials have been placed on
the rulemaking record. After an initial analysis, the Commission, on
December 29, 1992, issued the designation ``TL 0001'' for temporary use
in identifying the Teijin fiber until a final determination can be made
as to the merits of the application for a new generic name.
II. Chemical Composition, Physical and Chemical Properties
In its application, Teijin describes the fiber, its composition,
and its physical and chemical properties, as follows:
The general formula of the chemical composition of poly
tetramethylene ether/poly butylene glycol terephthalate copolymer, -
[(CH2CH2CH2CH2O)m] -
(COC6H4COOCH2CH2CH2CH2O)n-, consists
of:
Poly tetramethylene ether (CH2CH2CH2CH2O)m: 60%
by weight
Poly butylene glycol terephthalate
(COC6H4COOCH2CH2CH2CH2O)n: 40% by
weight
* * * * *
Assuming that poly(tetramethylene ether) glycol is considered a
part of glycol components, then Applicant's fiber is somewhat
similar to polyester. Nonetheless, Applicant's fiber is not
``composed of at least 85% by weight of an ester of a substituted
aromatic carboxylic acid'' since poly tetramethylene ether is only
60%. Thus Applicant's fiber manufactured from poly tetramethylene
ether/poly butylene glycol terephthalate copolymer does not fall
under the Commission's definition of polyester fiber found in 16 CFR
303.7(c).
* * * * *
The physical and chemical characteristics of Applicant's fiber.
. .are distinctively different from the characteristics of those
fibers identified by generic names listed in 16 CFR 303.7.
The physical properties of Applicant's fiber are shown in [the
following Table:]
------------------------------------------------------------------------
Applicant's Polyester Spandex
fiber fiber fiber
------------------------------------------------------------------------
Tenacity (g/de)....................... 1.0 3.0-5.0 0.6-1.2
Elongation (%)........................ 650 20-40 450-800
Elastic recovery (%) 200% extension... 78 Break 90
------------------------------------------------------------------------
As shown in the table, physical properties of Applicant's fiber
are quite different from those of polyester but similar to those of
the spandex fiber.
* * * * *
Applicant provides additional information, specifically
technical data, which may be pertinent to this application. Typical
properties of Applicant's fiber manufactured from poly
tetramethylene ether/poly butylene glycol terephthalate copolymer
include:
1. Physical Properties
Melting point.............................. 180-210 C
Specific gravity........................... 1.1-1.2
Tenacity................................... 1.0 g/de
Elongation................................. 650%
Elastic recovery........................... 78%
Boiling water shrinkage.................... 14%
2. Resistance to Chemicals
Solubility at room temperature
70% H2SO4................................. Insoluble for 3 minutes.
20% HCL................................... Do.
Conc. HNO3................................ Do.
Acetic Acid............................... Do.
5% NaOH................................... Do.
Acetone................................... Do.
Toluene................................... Do.
Ethyl acetate............................. Do.
Methyl alcohol............................ Do.
Chloroform................................ Soluble.
m-Cresol.................................. Do.
Solubility at boiling temperature
Dioxane................................... Soluble.
Xylene.................................... Do.
Nitrobenzene.............................. Do.
Chlorobenzene............................. Do.
Dimethylformamide......................... Do.
Additionally, information submitted by Teijin indicates that,
relative to spandex, REXE has the ability to withstand high
temperatures when wet. This is particularly important with respect to
dyeing. Teijin further states that REXE's tolerance of high temperature
will allow the development of elastic fabrics with many of the
properties of polyester. For example, fabrics made of REXE and
polyester should have excellent washability. Finally, fabrics made of
REXE and polyester are, according to Teijin, less discolored or
adversely affected by chlorine than, for example, swimming suits made
of nylon and spandex.
III. Suggested Generic Names
Applicant suggests the following generic names, in descending order
of preference, for its new fiber:
1. ``Polyetherester''
2. ``Elastoester''
[[Page 35994]]
3. ``Estelast''
IV. Proposed Definition
The Commission proposes the following definition for Teijin's new
fiber:
A manufactured fiber in which the fiber-forming substance is a
long-chain synthetic polymer composed of at least 50% by weight of
aliphatic polyether and at least 35% by weight of polyester, as defined
in 16 CFR 303.7(c).
V. Invitation to Comment
The Commission is soliciting comment on Teijin's application
generally, but is especially interested in comments on whether the
application meets the following criteria, which the Commission has
identified as grounds for granting applications for new generic names:
[T]he Commission, in the interest of elucidating the grounds on
which it has based this decision and shall base future decisions as
to the grant of generic names for textile fibers, sets out the
following criteria for grant of such generic names.
1. The fiber for which a generic name is requested must have a
chemical composition radically different from other fibers, and that
distinctive chemical composition must result in distinctive physical
properties of significance to the general public.
2. The fiber must be in active commercial use or such use must
be immediately foreseen.
3. The grant of the generic name must be of importance to the
consuming public at large, rather than to a small group of
knowledgeable professionals such as purchasing officers for large
Government agencies.
The Commission believes it is in the public interest to prevent
the proliferation of generic names, and will adhere to a stringent
application of the above-mentioned criteria in consideration of any
future applications for generic names and in a systematic review of
any generic names previously granted which no longer meet these
criteria.
* * * * *
In addition, [the Commission] notes that where appropriate, in
considering applications for new generic names for fibers that are
of the same general chemical composition as those for which a
generic name already has been established, rather than of a chemical
composition that is radically different, but that have distinctive
properties of importance to the general public as a result of a new
method of manufacture of their substantially differentiated physical
characteristics, such as their fiber structure, it may allow such
fiber to be designated in required information disclosures by either
its generic name, or alternatively, by its ``subclass'' name. The
Commission will consider this disposition when the distinctive
feature or features of the subclass fiber make it suitable for uses
for which other fibers under the established generic name would not
be suited or would be significantly less well suited.
60 FR 62352, 62353 (Dec. 6, 1995) (reaffirming and clarifying criteria
first announced at 38 FR 34114 (Nov. 12, 1973)).
The Commission additionally requests comments on the suggested
names and proposed definition, set out above.
Before deciding whether to amend Rule 7, the Commission will
consider any written comments submitted to the Secretary of the
Commission within the above-mentioned comment period. Comments that are
submitted will be available for public inspection, in accordance with
the Freedom of Information Act, 5 U.S.C. 552, and Commission
Regulation, 16 CFR 4, on normal business days between the hours of 8:30
a.m. and 5:00 p.m. at the Public Reference Room, Room 130, Federal
Trade Commission, 6th & Pennsylvania Avenue, N.W., Washington, D.C.
20580.
VI. Regulatory Flexibility Act
The provisions of the Regulatory Flexibility Act relating to an
initial regulatory analysis (5 U.S.C. 603-604) are not applicable to
this proposal because the Commission believes that the amendment, if
promulgated, will not have a significant economic impact on a
substantial number of small entities. The Commission has tentatively
reached this conclusion with respect to the proposed amendment because
the amendment would impose no additional obligations, penalties, or
costs. The amendment would simply allow covered companies to use a new
generic name for a new fiber that may not appropriately fit within
current generic names and definitions. The amendment would impose no
additional labeling requirements.
To ensure, however, that no substantial economic impact is being
overlooked, public comment is requested on the effect of the proposed
amendment on costs, profits, and competitiveness of, and employment in
small entities. Subsequent to the receipt of public comments, the
Commission will decide whether the preparation of a final regulatory
flexibility analysis is warranted. Accordingly, based on available
information, the Commission hereby certifies, pursuant to the
Regulatory Flexibility Act (5 U.S.C. 605(b)), that the proposed
amendment, if promulgated, would not have a significant economic impact
on a substantial number of small entities.
VII. Paperwork Reduction Act
This proposed amendment does not constitute a ``collection of
information'' under the Paperwork Reduction Act of 1995 (Pub. L. 104-
13, 109 Stat. 163) and its implementing regulations (5 CFR part 1320).
The collection of information imposed by the procedures for
establishing generic names (Rule 8, 16 CFR 303.8) has been submitted to
OMB and has been assigned a control number of 3084-0101.
List of Subjects in 16 CFR Part 303
Labeling, Textile, Trade practices.
Authority: Sec. 7(c) of the Textile Fiber Products
Identification Act (15 U.S.C. 70e(c)).
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 96-17468 Filed 7-8-96; 8:45 am]
BILLING CODE 6750-01-M
Complete official Federal Register PDF
FR Doc. 96-17459 Approval and Promulgation of State Implementation Plans: Washington
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35998-36004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17459]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[WA3-1-5479; FRL-5534-9]
Approval and Promulgation of State Implementation Plans:
Washington
AGENCY: Environmental Protection Agency.
ACTION: Notice of proposed rulemaking.
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SUMMARY: In this action, Environmental Protection Agency (EPA) invites
public comment on its proposed approval of certain elements of the
Spokane PM-10 attainment plan, including control measures, and the
granting of a temporary waiver of the attainment date for the Spokane,
Washington particulate nonattainment area. This is based on EPA's
review of the State implementation plan (SIP) revision submitted by the
State of Washington for the purpose of attaining the national ambient
air quality standards (NAAQS) for particulate matter with an
aerodynamic diameter less than or equal to a nominal 10 micrometers
(PM-10). The implementation plan was submitted by the State to satisfy
certain federal Clean Air Act requirements for an approvable moderate
nonattainment area PM-10 SIP for Spokane, Washington due on November
15, 1991.
DATES: Comments on this proposed action must be postmarked by August 8,
1996.
ADDRESSES: Written comments should be addressed to: Montel Livingston,
SIP Manager, United States Environmental Protection Agency, Office of
Air Quality (OAQ 107), 1200 Sixth Avenue, Seattle, Washington 98101.
Copies of the State's submittals and other information supporting
this proposed action are available for inspection during normal
business hours at the following locations: United States Environmental
Protection Agency, Office of Air Quality, 1200 Sixth Avenue (AT-082),
Seattle, Washington 98101, and the State of Washington Department of
Ecology, 300 Desmond Drive, Lacey, Washington 98503.
FOR FURTHER INFORMATION CONTACT: George Lauderdale, Office of Air
Quality (OAQ 107), US Environmental Protection Agency, 1200 Sixth
Avenue, Seattle, Washington 98101, (206) 553-6511.
SUPPLEMENTARY INFORMATION:
I. Background
The Spokane, Washington, area was designated nonattainment for PM-
10 and classified as moderate under sections 107(d)(4)(B) and 188(a) of
the Clean Air Act, by operation of law upon enactment of the Clean Air
Act Amendments of 1990.1 See 56 FR 56694 (Nov. 6, 1991)(official
designation codified at 40 CFR 81.348). The air quality planning
requirements for moderate PM-10 nonattainment areas are set out in
subparts 1 and 4 of Part D, Title I of the Act.2 The EPA has
issued a ``General Preamble'' describing EPA's preliminary views on how
EPA intends to review SIP's and SIP revisions submitted under Title I
of the Act, including those State submittals containing provisions to
implement the moderate PM-10 nonattainment area SIP requirements [see
generally 57 FR 13498 (April 16, 1992) and 57 FR 18070 (April 28,
1992)]. Because EPA is describing its interpretations here only in
broad terms, the reader should refer to the General Preamble for a more
detailed discussion of the interpretations of Title I advanced in this
proposal and the supporting rationale. In this rulemaking action on the
Washington moderate area PM-10 SIP revision for the Spokane
nonattainment area, EPA is proposing to apply its interpretations,
taking into consideration the specific factual issues presented.
Additional information supporting EPA's action on this particular area
is available for inspection at the address indicated above. EPA will
consider any timely
[[Page 35999]]
submitted comments before taking final action on today's proposal.
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\1\ The 1990 Amendments to the Clean Air Act made significant
changes to the Act. See Pub. L. No. 101-549, 104 Stat. 2399.
References herein are to the Clean Air Act, as amended (``the
Act''). The Clean Air Act is codified, as amended, in the U.S. Code
at 42 U.S.C. sections 7401, et seq.
\2\ Subpart 1 contains provisions applicable to nonattainment
areas generally and subpart 4 contains provisions specifically
applicable to PM-10 nonattainment areas. At times, subpart 1 and
subpart 4 overlap or conflict. EPA has attempted to clarify the
relationship among these provisions in the ``General Preamble'' and,
as appropriate, in today's notice and supporting information.
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Those States containing initial moderate PM-10 nonattainment areas
(those areas designated nonattainment under section 107(d)(4)(B)) were
required to submit an implementation plan that includes, among other
things, the following by November 15, 1991:
1. Provisions to assure that reasonably available control measures
(RACM) (including such reductions in emissions from existing sources in
the area as may be obtained through the adoption, at a minimum, of
reasonably available control technology--RACT) shall be implemented no
later than December 10, 1993;
2. Either a demonstration (including air quality modeling) that the
plan will provide for attainment as expeditiously as practicable but no
later than December 31, 1994, or a demonstration that attainment by
that date is impracticable;
3. Quantitative milestones which are to be achieved every 3 years
and which demonstrate reasonable further progress (RFP) toward
attainment by December 31, 1994; and
4. Provisions to assure that the control requirements applicable to
major stationary sources of PM-10 also apply to major stationary
sources of PM-10 precursors except where the Administrator determines
that such sources do not contribute significantly to PM-10 levels which
exceed the NAAQS in the area. See sections 172(c), 188, and 189 of the
Act.
Some provisions were due at a date later than November 15, 1991.
States with initial moderate PM-10 nonattainment areas were required to
submit a permit program for the construction and operation of new and
modified major stationary sources of PM-10 by June 30, 1992 (see
section 189(a)). Such States also were to submit contingency measures
by November 15, 1993, which become effective without further action by
the State or EPA upon a determination by EPA that the area has failed
to achieve RFP or to attain the PM-10 NAAQS by the applicable statutory
deadline (see section 172(c)(9) and 57 FR 13543-44).
II. Today's Action
Section 110(k) of the Act sets out provisions governing EPA's
review of SIP submittals (see 57 FR 13565-66). For PM-10 nonattainment
areas, Section 188(f), Waivers for Certain Areas, can apply as well.
In this action, EPA is proposing to approve portions of the PM-10
nonattainment area plan for Spokane, Washington that apply to sources
of PM-10 other than windblown dust. For PM-10 24-hour exceedences
caused primarily by windblown dust sources EPA is proposing to grant a
temporary waiver of the attainment date for the Spokane area.
Discussion of EPA's requirements for a temporary waiver are detailed in
59 FR 41998-42017 (August 16, 1994). In this guidance EPA provides
certain flexibility for areas where the relative significance of
anthropogenic and nonanthropogenic sources is unknown. The Washington
Department of Ecology (Ecology) has presented preliminary data, based
on an analysis of the relative contributions of anthropogenic and
nonanthropogenic sources of PM-10 contributing to eastern Washington
exceedences, indicating that nonanthropogenic sources may be
significant in the Spokane nonattainment area during windblown dust
events. EPA proposes to accept this preliminary information and grant a
temporary waiver of the moderate area attainment date to December 31,
1997. This temporary waiver allows Ecology and EPA to evaluate further
the windblown dust PM-10 problems in the Spokane PM-10 nonattainment
area. Once the evaluation is completed and reviewed, and/or the
temporary waiver expires, EPA will make a final determination on the
designation and classification for the Spokane nonattainment area.
In order to move forward with consideration of the temporary
waiver, a Memorandum of Agreement was signed in August 1995, by Chuck
Clarke, Regional Administrator EPA, Region 10, and Mary Riveland,
Director, Washington State Department of Ecology. This agreement
outlines the approach each agency will take in completing work on the
PM-10 problems in both the Spokane and Wallula nonattainment areas. The
agreement contains commitments and conclusions including:
EPA will propose and, subject to public comment, grant a
conditional, temporary, waiver of the attainment date for 24-hour
PM-10 exceedances during windblown dust events for Spokane and
Wallula until the end of 1997 (12/31/97). The waiver would expire on
12/31/97, and throughout its effective period, will apply only where
windblown dust (both anthropogenic and nonanthropogenic) is an
important contributor to the exceedances.
The Spokane and Wallula nonattainment areas will retain the
classification of a moderate PM-10 nonattainment area, until 12/31/
97 unless PM-10 air quality data indicates that the area has failed
to attain the 24-hour health standard because of exceedances that
cannot be primarily attributed to windblown dust.
As required in the EPA guidance, Ecology and EPA are proceeding
under written agreements which include a protocol for both technical
analysis (emission inventory, emission factor development, dispersion
modeling, receptor modeling, etc.) and evaluation of alternative
control measures, including Best Available Control Measures. The
activities required under the protocol are generally referred to as the
Columbia Plateau PM-10 Project funded by EPA, Ecology, and the U.S.
Department of Agriculture (USDA). Cooperating agencies include USDA's
Agricultural Research Service and Natural Resources Conservation
Service, as well as several local conservation districts, Washington
State University, the University of Idaho, and others.
The temporary waiver of the attainment date, if finalized by EPA,
will defer approval/disapproval actions on several otherwise required
elements of the moderate area plan for Spokane. Since the purpose of
the above described MOA is to have control measures in place that
assure that the PM-10 NAAQS will not be violated from sources that are
primarily urban in nature, the submission of an attainment
demonstration, emission inventory, and contingency measures for such
urban sources are necessary and required. However, if the temporary
waiver is finalized, the attainment demonstration, emission inventory,
control measures and contingency measures for windblown dust sources
(e.g. agriculture and natural sources) will be deferred. EPA will take
final action on the windblown dust elements after the Columbia Plateau
analysis is completed and/or the expiration of the temporary waiver.
EPA's reasoning for this approach is described in more detail under the
various SIP element headings of this notice.
In this action EPA is also proposing to approve regulatory orders
for the Kaiser, Trentwood facility that will allow use of alternative
opacity standards under certain very specific conditions. These orders
will lower the allowable emissions from the facility and thus would not
have an adverse impact on the attainment demonstration for other than
windblown dust sources in the Spokane area.
EPA is also proposing to approve the exclusion from precursor
controls as described in part II. 5 below. EPA invites public comment
on the proposed action described in this section.
This action is EPA's response to Washington State Implementation
Plan revision submitted for the Spokane PM-10 nonattainment area on
November 15, 1991, January 31, 1992, and December 9,
[[Page 36000]]
1994. In addition, supplemental information was submitted by Ecology on
May 18, 1995.
A. Analysis of State Submission
1. Procedural Background
The Act requires States to observe certain procedural requirements
in developing implementation plans and plan revisions for submission to
EPA. Section 110(a)(2) of the Act provides that each implementation
plan submitted by a State must be adopted after reasonable notice and
public hearing.3 Section 110(l) of the Act similarly provides that
each revision to an implementation plan submitted by a State under the
Act must be adopted by such State after reasonable notice and public
hearing. The EPA also must determine whether a submittal is complete
and therefore warrants further EPA review and action (see section
110(k)(1) and 57 FR 13565). The EPA's completeness criteria for SIP
submittals are set out at 40 CFR Part 51, Appendix V (1992). The EPA
attempts to make completeness determinations within 60 days of
receiving a submission. However, a submittal is deemed complete by
operation of law if a completeness determination is not made by EPA six
months after receipt of the submission.
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\3\ Section 172(c)(7) of the Act requires that plan provisions
for nonattainment areas meet the applicable provisions of section
110(a)(2).
---------------------------------------------------------------------------
Ecology held a public hearing to receive public comment on the
November 15, 1991, Spokane PM-10 SIP revision on October 23, 1991. WDOE
adopted the SIP revision for the area on November 14, 1991, and the
plan was submitted to EPA on November 15, 1991. Ecology submitted an
addendum to the November SIP revision that contained a regulatory order
on January 31, 1992. The SIP revision submittals were reviewed by EPA
to determine completeness in accordance with the completeness criteria
set out at 40 CFR Part 51, Appendix V. A letter dated May 5, 1992, was
forwarded to the WDOE indicating the completeness of the submittals and
the next steps to be taken in the review process. On December 9, 1994,
Ecology submitted another SIP revision for the Spokane PM-10
nonattainment area. This 1994 revision contained additional control
measures, a more detailed technical analysis of the problem, and other
improvements to the November 15, 1991 submittal.
2. PM-10 Emissions Inventory
Section 172(c)(3) of the Act requires that nonattainment plan
provisions include a comprehensive, accurate, current inventory of
actual emissions from all sources of relevant pollutants for the base
year in the nonattainment area. Because the submission of the emissions
inventory is a necessary adjunct to an area's attainment demonstration
(or demonstration that the area cannot practicably attain) the
emissions inventory must be received with the demonstration (see 57 FR
13539).
In the December 9, 1994, Spokane plan Ecology submitted an
emissions inventory of all PM-10 sources, except windblown dust, which
estimated actual annual emissions for the base year of 1990, allowable
emissions for the attainment year of 1994 and allowable emissions for
the 3-year maintenance year of 1997. Ecology concluded that, after
excluding windblown dust, Spokane has three very different emission
scenarios that could cause PM-10 short-term, 24-hour standard
violations. Each scenario occurs at a different time of the year, has
different meteorological conditions, and each has one source that
dominates the source mix. Ecology illustrated the three scenarios by
presenting separate 24 hour emission inventories for the following
worst case days: an October 21, 1987 inventory for conditions where
unpaved roads were the major source, a March 12, 1993 inventory where
paved roads were the dominant source, and a January 21, 1987 analysis
for residential wood combustion exceedences.
For windblown dust, Ecology prepared and submitted as an appendix
to the Spokane plan, a report titled ``An Analysis of the Impact of
Biogenic PM-10 Sources on the Spokane PM-10 Nonattainment Area'',
February 1992, which presented the most recent information on the
emission sources in the Columbia Plateau region of eastern Washington.
The report estimates gross annual emissions from anthropogenic and
nonanthropogenic sources of PM-10 from a large area. Preliminary
information is presented indicating that about 40% of the annual
emissions in eastern Washington are from anthropogenic sources and 60%
from nonanthropogenic sources. No attempt was made to estimate the
highest 24-hour emissions which, depending on the location, is expected
to vary greatly. This information suggests, but does not conclusively
show, that nonanthropogenic sources contribute significantly to the
Spokane nonattainment area.
In summary, the 1994 annual emission inventory, excluding windblown
dust, indicated that the largest sources of PM-10 were: unpaved roads
(43%), paved roads (20%), residential wood combustion (18%) and
industrial (14%). The SIP revision also includes 24-hour emission
inventories for each of the three scenarios mentioned above.
The emissions inventory estimating actual emissions for all
significant sources except for windblown dust sources appears to be
accurate and comprehensive consistent with the requirements of section
172(c)(3) of the Clean Air Act and national guidance.4 Recent
information from the Columbia Plateau study indicates that the emission
factors used for the windblown dust report may be inappropriate.
However, EPA thinks that the assumptions used were the best available
at the time the Spokane plan was prepared. The Columbia Plateau PM-10
Project will include the development of emission factors specifically
for eastern Washington and preparation of regional emission inventories
that will be used to update the Spokane plan.
---------------------------------------------------------------------------
\4\ The EPA issued guidance on PM-10 emissions inventories prior
to the enactment of the Clean Air Act Amendments in the form of the
1987 PM-10 SIP Development Guideline. The guidance provided in this
document is consistent with the Act.
---------------------------------------------------------------------------
One final emission inventory issue relates to the use of actual
emission estimates from two major stationary (stack) PM-10 sources.
Ecology appropriately used allowable emissions for most of the
stationary sources that had allowable emission limits. However, Ecology
underestimated the allowable emissions for the two major stationary PM-
10 sources, the Kaiser primary aluminum smelter at Mead, and the Kaiser
aluminum rolling mill facility at Trentwood. Supplemental information
submitted on May 18, 1995, concludes that the allowable emissions for
those facilities are greater (by a factor of 2 for Kaiser-Trentwood)
than the emissions used in the plan. The Spokane County Air Pollution
Control Agency (SCAPCA) has corrected this problem for the Kaiser-
Trentwood facility by issuing new regulatory orders which specifically
limit the PM-10 emissions from the facility. The allowable emissions
from the Kaiser-Mead facility are not significantly greater than the
original allowable emission estimates used by Ecology and would not
adversely impact the attainment demonstration for sources considered in
the plan.
EPA proposes to approve the emission inventories, excluding
windblown dust, at this time. The windblown dust inventory is being
prepared as part of the Columbia Plateau project. When the project is
completed the detailed
[[Page 36001]]
emission inventory will be used for analysis of windblown dust.
Therefore EPA proposes to defer action on the windblown dust emission
inventory until after the temporary waiver expires.
3. RACM (Including RACT)
As noted above, the initial moderate PM-10 nonattainment areas must
submit provisions to assure that RACM (including RACT) are implemented
no later than December 10, 1993 (see sections 172(c)(1) and
189(a)(1)(C)). The General Preamble contains a detailed discussion of
EPA's interpretation of the RACM (including RACT) requirement (see 57
FR 13539-45 and 13560-61).
The Spokane annual emission inventory identified four urban (non
windblown dust) sources as major contributors of PM-10 emissions; paved
roads, unpaved roads, residential wood combustion and industrial
sources. However, analysis of the 24-hour PM-10 problems conclude that
industrial sources are not a major contributor. Ecology prepared RACM
evaluations for paved and unpaved roads and residential wood combustion
sources. Ecology did not present an evaluation of the controls that are
currently being applied to agricultural sources likely impacting the
Spokane PM-10 problem. For unpaved roads, the City of Spokane has spent
more than six million dollars to pave over 16 miles of roads. Road
paving is estimated to result in a PM-10 reduction of at least 90% from
an unpaved road surface.
SCAPCA also adopted an unpaved road control regulation which
requires that the City of Spokane, Spokane County, and the Town of
Millwood submit emission reduction and control plans for unpaved
surfaces in their respective jurisdiction. SCAPCA approves the plans
and the respective jurisdictions are required to implement the plans.
In addition, to address the paved road emissions the City of Spokane
adopted resolutions committing to conduct additional (more frequent and
earlier) street sweeping to better control PM-10. The City also
committed to reduce the use of sand for traction material by 50%,
increase the use of liquid deicers, plow major arterials more
frequently, and sweep the arterial as soon as practical after sanding.
EPA proposes to accept Ecology's RACM analysis for paved and
unpaved roads and concludes that reasonable measures are being
implemented.
Residential wood combustion is regulated by SCAPCA through a
comprehensive regulation that is based on state statute. The program
contains limitations on opacity, curtails wood burning on days of poor
air quality, prohibits the burning of inappropriate fuels, and other
emission reducing measures. Curtailment of uncertified woodstoves and
fireplaces is initiated when PM-10 levels are estimated to be 75 ug/m3.
Ecology estimates an 80% reduction in emissions for the program. EPA
proposes to determine that Spokane is implementing RACM for residential
wood combustion sources.
The only two major (greater than 100 tons per year) stationary
source facilities within the nonattainment area, the Kaiser aluminum
facilities at Trentwood and Mead, were not evaluated specifically for
RACT by either Ecology or SCAPCA. However, attainment is demonstrated
for the PM-10 sources other than windblown dust, using allowable
emissions from the facilities. Therefore a RACT determination is not
necessary and the SIP revision does not include any additional emission
reductions from any stationary sources. It is important to note that
the Kaiser Trentwood facility is under a federal consent decree and
final judgement which will reduce PM-10 emissions from the facility in
the future.
The final source of PM-10 impacting the Spokane nonattainment area
is windblown dust. There are two principal sources of windblown dust:
undisturbed land and agricultural fields. Ecology did not perform a
RACM analysis for agricultural sources in the Spokane nonattainment
plan. However, Ecology had previously submitted an analysis of RACM for
agricultural sources for the Wallula, Washington, PM-10 nonattainment
area which has similar windblown dust issues. In that SIP revision
Ecology concluded that RACM is being applied for agriculture sources of
PM-10 based on soil conservation measures required by the federal
government's implementation of the United States Department of
Agriculture's (USDA) Food Security Act (FSA) of 1985. EPA Title I
preamble guidance suggests states ``rely upon the soil conservation
requirements (e.g. conservation plans, conservation reserve) of the
Food Security Act to reduce emissions from agricultural operations''
(see 57 FR 18072).
EPA proposes to determine that RACM is being applied to
agricultural sources not only in the Spokane nonattainment area but
throughout the region surrounding Spokane. Ecology did not evaluate the
application of reasonable controls on undisturbed lands. This analysis
will be accomplished after completion of the Columbia Plateau PM-10
Project.
Where sources of PM-10 contribute insignificantly to the PM-10
problem in the area, EPA's policy is that it would be unreasonable (and
would not constitute RACM) to require the implementation of potentially
available control measures. 57 FR 13540. Further, EPA has indicated
that for some sources in areas which demonstrate attainment, RACM does
not require the implementation of otherwise available control measures
that are not ``reasonably'' available because their implementation
would not expedite attainment (See 57 FR 13543).
EPA is proposing to grant a temporary waiver of the attainment date
to December 31, 1997, which will allow Ecology and EPA to determine
conclusively the significance of anthropogenic and nonanthropogenic
sources impacting Spokane. This action does not relieve the area from
the requirement to implement RACM. In the Spokane situation EPA is
proposing to determine that the major sources of PM-10 have been
reasonably controlled. Thus, EPA thinks it would not be reasonable to
require other smaller sources of PM-10 in the area to implement
reasonably available control measures or technology. Further, EPA
believes implementation of such additional controls in this area would
not expedite attainment.
A more detailed discussion of the individual source contributions,
their associated control measures and an explanation as to why certain
available control measures were not implemented, can be found in the
Spokane SIP revision. EPA has reviewed the State's explanation and
associated documentation and is proposing to conclude that it
adequately justifies the control measures being implemented.
4. Demonstration
As noted, the initial moderate PM-10 nonattainment areas must
submit a demonstration (including air quality modeling) showing that
the plan will provide for attainment as expeditiously as practicable
but no later than December 31, 1994 (see section 189(a)(1)(B) of the
Act). The General Preamble sets out EPA's guidance on the use of
modeling for moderate area attainment demonstrations (57 FR 13539).
Alternatively, if the State does not submit a demonstration of
attainment, the State must show that attainment by December 31, 1994 is
impracticable (section 189(a)(1)(B)(ii).
The SIP utilized dispersion modeling for demonstrating attainment
for all major sources of PM-10 except windblown dust. As mentioned in
the emission inventory discussion above, Spokane has different sources
that are major contributors at different times of
[[Page 36002]]
the year. Ecology provided an attainment demonstration which included
each of the three source scenarios. The attainment demonstration
included days when residential wood combustion emissions dominated the
area, also days when unpaved roads were the major source, and days
dominated by paved road emissions. The dispersion modeling analysis
demonstrated attainment of the 24-hour standard. EPA proposes to find
the attainment demonstration for the major PM-10 sources, except for
windblown dust, is adequate.
The attainment evaluation does not address the windblown dust issue
including the anthropogenic and nonanthropogenic mix. In the 1994,
Spokane SIP submittal, Ecology demonstrated attainment of the annual
and 24-hour PM-10 standards for all sources of PM-10 except windblown
dust by December 31, 1994. Ecology did not address exceedences of the
24-hour standard that were primarily due to windblown dust. As
mentioned previously, EPA is proposing to temporarily set aside certain
SIP requirements for windblown dust sources, including the attainment
demonstration.
Since EPA is proposing to grant a temporary, three year waiver of
the attainment date, EPA is also proposing that the approval or
disapproval of the attainment demonstration for windblown dust PM-10
exceedences, be deferred until after expira-tion of the temporary
waiver. EPA proposes to make a final decision on the attainment status
and classification of the area after the temporary waiver expires on
December 31, 1997. The alternative decisions include, but are not
limited to, reclassi-fying the area to a serious PM-10 nonattainment
area; applying the May 30, 1996, Memorandum from Mary D. Nichols,
Assistant Administrator for Air and Radiation, regarding ``Areas
Affected by PM-10 Natural Events; or granting the area a permanent
waiver. EPA invites comments on these possible approaches.
5. PM-10 Precursors
The control requirements which are applicable to major stationary
sources of PM-10, also apply to major stationary sources of PM-10
precursors unless EPA determines such sources do not contribute
significantly to PM-10 levels in excess of the NAAQS in that area (see
section 189(e) of the Act). The General Preamble contains guidance
addressing how EPA intends to implement section 189(e) (see 57 FR
13539-40 and 13541-42).
The relatively small contribution of stationary sources in the
Spokane nonattainment area suggests that stationary sources of
precursors provide an insignificant contribution to the Spokane ambient
PM-10 concentration. This conclusion is also supported by limited
receptor analysis conducted in 1993. Based on that information Ecology
concluded that the only major stationary source of PM-10 precursors,
Kaiser-Mead, does not contribute significantly to PM-10 levels.
EPA is proposing to grant the area an exclusion from PM-10
precursor control requirements authorized under section 189(e) of the
act. Note that while EPA is proposing to make a general finding for
this area, this proposed finding is based on the current character of
the area including, for example, the existing mix of sources in the
area. It is possible, therefore, that future growth could change the
significance of precursors in the area. EPA intends to issue future
guidance addressing such potential changes in the significance of
precursor emissions in an area.
6. Quantitative Milestones and Reasonable Further Progress (RFP)
The PM-10 nonattainment area plan revisions demonstrating
attainment must contain quantitative milestones which are to be
achieved every three (3) years until the area is redesignated
attainment and which demonstrate RFP, as defined in section 171(1),
toward attainment by December 31, 1994 (see section 189(c) of the Act).
Reasonable further progress is defined in section 171(1) as such annual
incremental reductions in emissions of the relevant air pollutant as
are required by Part D or may reasonably be required by the
Administrator for the purpose of ensuring attainment of the applicable
NAAQS by the applicable date.
In the Spokane situation, EPA is proposing to approve the
reasonable further progress requirement for all significant sources of
PM-10 except windblown dust. The dispersion modeling conducted by
Ecology indicates that the 24-hour standard was attained in 1994 and
air quality will be maintained below the standard until at least 1997
(except for windblown dust). As stated previously, EPA is proposing to
grant a temporary waiver of the attainment date for the Spokane area
for windblown dust sources. If granted, the area would not be required
to meet RFP for windblown dust sources. In 1998 EPA will determine the
designation and classification of the Spokane area.
7. Enforceability Issues
All measures and other elements in the SIP must be enforceable by
Ecology and EPA (see sections 172(c)(6), 110(a)(2)(A) and 57 FR 13556).
EPA criteria addressing the enforceability of SIP's and SIP revisions
were stated in a September 23, 1987 memorandum (with attachments) from
J. Craig Potter, Assistant Administrator for Air and Radiation, et al.
(see 57 FR 13541). Nonattainment area plan provisions must also contain
a program that provides for enforcement of the control measures and
other elements in the SIP (see section 110(a)(2)(C)).
Ecology's and SCAPCA's control measures and regulations for control
of particulate matter, which are contained in the SIP, are addressed
above under the section headed ``RACM (including RACT).'' These control
measures apply to the types of activities identified in that discussion
including, for example, fugitive emissions from unpaved roads. The SIP
provides that the affected activities will be controlled throughout the
entire nonattainment area.
The Clean Air Act requires that all the applicable RACM provisions
be implemented by December 10, 1993 (section 189(a)(1)(C). In addition
to the applicable control measures, this includes the applicable
record-keeping requirements which are addressed in the supporting
technical information document (TSD).
EPA is proposing to approve a December 12, 1991, SCAPCA Order No.
91-01. This order provides for the use of an alternate opacity limit
for the Kaiser-Trentwood aluminum facility. EPA has evaluated
information presented in the 1994 SIP revision for Spokane and other
information and has concluded that the order will not have a
significant impact on the ambient air quality in Spokane. EPA is
further proposing to approve SCAPCA Order #96-03, Order #96-04, Order
#96-05, and Order #96-06, for the Kaiser-Trentwood facility which will
significantly lower the allowable emissions from the facility. The new
allowable emission totals are the same as the amount used by Ecology in
the attainment demonstration. Upon final approval by EPA as part of the
SIP, the orders will be federally enforceable.
The TSD contains further information on enforceability requirements
including enforceable emission limitations; a description of the rules
contained in the SIP and the source types subject to them; test methods
and compliance schedules; malfunction provisions; excess emission
provisions; correctly cited references of
[[Page 36003]]
incorporated methods/rules; and reporting and recordkeeping
requirements. Ecology and SCAPCA have the primary responsibility for
implementing the measures in the plan. Ecology and SCAPCA have
compliance inspectors and EPA considers the staffing level adequate to
assure that the RACM provision in the Spokane attainment plan are fully
implemented. As a necessary adjunct of its enforcement program, Ecology
and SCAPCA also have broad powers to adopt rules and regulations, issue
orders, require access to records and information, and receive and
disburse funds.
8. Contingency Measures
As provided in section 172(c)(9) of the Act, all moderate
nonattainment area SIP's that demonstrate attainment must include
contingency measures (see generally 57 FR 13543-44). Contingency
measures should consist of other available measures that are not part
of the area's control strategy. These measures must take effect without
further action by the State or EPA, upon a determination by EPA that
the area has failed to make RFP or attain the PM-10 NAAQS by the
applicable statutory deadline.
Ecology submitted several measures that were identified as
contingency measures. As with their control measures necessary to
demonstrate attainment, Ecology and SCAPCA, adopted contingency
measures for each of the three significant sources of PM-10 other than
windblown dust. The contingency measures include additional treatment
of unpaved roads, early implementation of paved road controls
(additional reductions from what is included in the attainment program)
and banning the use of uncertified stoves if an exceedence is primarily
due to residential wood combustion sources.
The plan does not contain a contingency measure for windblown dust.
Since the action proposed in this Federal Register notice would allow
for a temporary extension of the attainment date for windblown dust
sources, EPA proposes to take no action on a contingency measure for
windblown dust until after the temporary waiver has elapsed.
III. Implications of Today's Action
EPA is proposing to approve those portions of the 1994 PM-10
attainment plan for Spokane submitted by Ecology to control significant
sources of PM-10 except for windblown dust, as meeting RACM and
demonstrating attainment of the 24-hour standard by the statutory
deadline of December 31, 1994. EPA is further proposing to grant a
temporary waiver of the December 31, 1994, attainment date to December
31, 1997 for windblown dust-caused exceedences of the PM-10 24-hour
standard. If this action is finalized, Ecology and SCAPCA will continue
to implement the adopted control measures and Ecology will determine
the significance of anthropogenic and nonanthropogenic windblown dust
sources impacting the Spokane PM-10 nonattainment area. If any of the
non-windblown dust sources cause any exceedences of the PM-10 24-hour
standard the area could be reclassified to a serious PM-10
nonattainment area. When Ecology has completed its analysis on
windblown dust, and/or the temporary waiver expires, EPA will make a
final determination of the nonattainment status of the Spokane area.
EPA is also proposing to approve several SCAPCA orders, including an
alternate opacity order for the Kaiser-Trentwood facility in Spokane.
Finally, EPA is proposing to grant an exclusion from precursor control
requirements as described in part II. 5 of this notice.
IV. Request for Public Comments
EPA is requesting comments on all aspects of today's proposal. As
indicated at the beginning of this notice, EPA will consider any
comments postmarked by August 8, 1996.
V. Administrative Review
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000.
SIP approvals under section 110 and subchapter I, Part D of the CAA
do not create any new requirements, but simply approve requirements
that the State is already imposing. Therefore, because the federal SIP-
approval does not impose any new requirements, I certify that it does
not have a significant impact on small entities affected. Moreover, due
to the nature of the federal-state relationship under the CAA,
preparation of a regulatory flexibility analysis would constitute
federal inquiry into the economic reasonableness of state action. The
CAA forbids EPA to base its actions concerning SIPs on such grounds.
Union Electric Co. v. U.S. E.P.A., 427 U.S. 246, 256-66 (S.Ct. 1976);
42 U.S.C. section 7410(a)(2).
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under Section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
EPA has determined that the proposed action promulgated does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. This Federal action approves pre-
existing requirements under State or local law, and imposes no new
Federal requirements. Accordingly, no additional costs to State, local,
or tribal governments, or to the private sector, result from this
action.
Nothing in this action should be construed as permitting or
allowing or establishing a precedent for any future request for
revision to any state implementation plan. Each request for revision to
the state implementation plan shall be considered separately in light
of specific technical, economic and environmental factors and in
relation to relevant statutory and regulatory requirements.
This action has been classified as a Table 3 action by the Regional
Administrator under the procedures published in the Federal Register on
January 19, 1989 (54 FR 2214-2224), as revised by a July 10, 1995
memorandum from Mary Nichols, Assistant Administrator for Air and
Radiation. The Office of Management and Budget (OMB) has exempted this
regulatory action from E.O. 12866 review.
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Intergovernmental
relations, Particulate matter.
Authority: 42 U.S.C. 7401-7671q.
[[Page 36004]]
Dated: June 27, 1996.
Jane S. Moore,
Acting Regional Administrator.
[FR Doc. 96-17459 Filed 7-8-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-17458 Outer Continental Shelf Air Regulations; Consistency Update for California
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 36012-36016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17458]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 55
[FRL-5534-7]
Outer Continental Shelf Air Regulations; Consistency Update for
California
AGENCY: Environmental Protection Agency (``EPA'').
ACTION: Notice of proposed rulemaking; consistency update.
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SUMMARY: EPA is proposing to update a portion of the Outer Continental
Shelf (``OCS'') Air Regulations. Requirements applying to OCS sources
located within 25 miles of states' seaward boundaries must be updated
periodically to remain consistent with the requirements of the
corresponding onshore area (``COA''), as mandated by section 328(a)(1)
of the Clean Air Act (``the Act''), the Clean Air Act Amendments of
1990. The portion of the OCS air regulations that is being updated
pertains to the requirements for OCS sources for which the South Coast
Air Quality Management District (South Coast AQMD) and the Ventura
County Air Pollution Control District (Ventura County APCD) are the
designated COAs. The OCS requirements for the above Districts,
contained in the Technical Support Document, are proposed to be
incorporated by reference into the Code of Federal Regulations and are
listed in the appendix to the OCS air regulations. Proposed changes to
the existing requirements are discussed below.
DATES: Comments on the proposed update must be received on or before
August 8, 1996.
ADDRESSES: Comments must be mailed (in duplicate if possible) to: EPA
Air Docket (A-5), Attn: Docket No. A-93-16 Section XII, Environmental
Protection Agency, Air and Toxics Division, Region 9, 75 Hawthorne St.,
San Francisco, CA 94105.
Docket: Supporting information used in developing the proposed
notice and copies of the documents EPA is proposing to incorporate by
reference are contained in Docket No. A-93-16 Section XII. This docket
is available for public inspection and copying Monday-Friday during
regular business hours at the following locations:
EPA Air Docket (A-5), Attn: Docket No. A-93-16 Section XII,
Environmental Protection Agency, Air and Toxics Division, Region 9, 75
Hawthorne St., San Francisco, CA 94105.
EPA Air Docket (LE-131), Attn: Air Docket No. A-93-16 Section XII,
Environmental Protection Agency, 401 M Street SW, Room M-1500,
Washington, DC 20460. A reasonable fee may be charged for copying.
FOR FURTHER INFORMATION CONTACT: Christine Vineyard, Air and Toxics
Division (A-5-3), U.S. EPA Region 9, 75 Hawthorne Street, San
Francisco, CA 94105, (415) 744-1197.
SUPPLEMENTARY INFORMATION:
Background
On September 4, 1992, EPA promulgated 40 CFR part 551, which
established requirements to control air pollution from OCS sources in
order to attain and maintain federal and state ambient air quality
standards and to comply with the provisions of part C of title I of the
Act. Part 55 applies to all OCS sources offshore of the States except
those located in the Gulf of Mexico west of 87.5 degrees longitude.
Section 328 of the Act requires that for such sources located within 25
miles of a state's seaward boundary, the requirements shall be the same
as would be applicable if the sources were located in the COA. Because
the OCS requirements are based on onshore requirements, and onshore
requirements may change, section 328(a)(1) requires that EPA update the
OCS requirements as necessary to maintain consistency with onshore
requirements.
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\1\ The reader may refer to the Notice of Proposed Rulemaking,
December 5, 1991 (56 FR 63774), and the preamble to the final rule
promulgated September 4, 1992 (57 FR 40792) for further background
and information on the OCS regulations.
---------------------------------------------------------------------------
Pursuant to Sec. 55.12 of the OCS rule, consistency reviews will
occur (1) at least annually; (2) upon receipt of a Notice of Intent
under Sec. 55.4; or (3) when a state or local agency submits a rule to
EPA to be considered for incorporation by reference in part 55. This
notice of proposed rulemaking is being promulgated in response to the
submittal of rules by two local air pollution control agencies. Public
comments received in writing within 30 days of publication of this
notice will be considered by EPA before publishing a notice of final
rulemaking.
Section 328(a) of the Act requires that EPA establish requirements
to control air pollution from OCS sources located within 25 miles of
states' seaward boundaries that are the same as onshore requirements.
To comply with this statutory mandate, EPA must incorporate applicable
onshore rules into part 55 as they exist onshore. This limits EPA's
flexibility in deciding which requirements will be incorporated into
part 55 and prevents EPA from making substantive changes to the
requirements it incorporates. As a result, EPA may be incorporating
rules into part 55 that do not conform to all of EPA's state
implementation plan (SIP) guidance or certain requirements of the Act.
Consistency updates may result in the inclusion of state or local rules
or regulations into part 55, even though the same rules may ultimately
be disapproved for inclusion as part of the SIP. Inclusion in the OCS
rule does not imply that a rule meets the requirements of the Act for
SIP approval, nor does it imply that the rule will be approved by EPA
for inclusion in the SIP.
EPA Evaluation and Proposed Action
In updating 40 CFR part 55, EPA reviewed the rules submitted for
inclusion in part 55 to ensure that they are rationally related to the
attainment or maintenance of federal or state ambient air quality
standards or part C of title I of the Act, that they are not designed
expressly to prevent exploration and development of the OCS and that
they are applicable to OCS sources. 40 CFR 55.1. EPA has also evaluated
the rules to ensure they are not arbitrary or capricious. 40 CFR 55.12
(e). In addition, EPA has excluded administrative or procedural
rules,2 and requirements that regulate toxics which are not
related to the attainment and maintenance of federal and state ambient
air quality standards.
---------------------------------------------------------------------------
\2\ After delegation, each COA will use its administrative and
procedural rules as onshore. In those instances where EPA does not
delegate authority to implement and enforce part 55, EPA will use
its own administrative and procedural requirements to implement the
substantive requirements. 40 CFR 55.14 (c)(4).
---------------------------------------------------------------------------
A. After review of the rules submitted by South Coast AQMD against
the criteria set forth above and in 40 CFR part 55, EPA is proposing to
make the following rules applicable to OCS sources for which the South
Coast AQMD is designated as the COA.
1. The following rules were submitted as revisions to existing
requirements:
Rule 102 Definition of Terms (Adopted 11/17/95)
[[Page 36013]]
Rule 212 Standards for Approving Permits and Proposed Amended
Regulation XIII--New Source Review (Adopted 12/7/95) except (e)
Rule 301 Permit Fees (Adopted 10/13/95)
Rule 431.1 Sulfur Content of Gaseous Fuels (Adopted 11/17/95)
Rule 701 Air Pollution Emergency Contingency Actions (Renamed)
(Adopted 9/8/95)
Rule 1134 Emissions of Oxides of Nitrogen from Stationary Gas Turbines
(Adopted 12/7/95)
Rule 1149 Storage Tank Degassing (Adopted 7/14/95)
Rule 1301 General (Adopted 12/7/95)
Rule 1302 Definitions (Adopted 12/7/95)
Rule 1303 Requirements (Adopted 12/7/95)
Rule 1304 Exemptions (Adopted 12/7/95)
Rule 1306 Emission Calculations (Adopted 12/7/95)
Rule 1313 Permit to Operate (Adopted 12/7/95)
Rule 1610 Old-Vehicle Scrapping (Adopted 10/13/95)
Rule 1612 Credits for Clean On-Road Vehicles (Adopted 9/8/95)
Rule 1620 Credits for Clean Off-Road Mobile Equipment (Adopted 9/8/95)
Rule 2000 General (Adopted 12/7/95)
Rule 2001 Applicability (Adopted 12/7/95)
Rule 2002 Allocations for Oxides of Nitrogen (NOx) and Oxides of
Sulfur (SOx) (Adopted 12/7/95)
Rule 2004 Requirements (Adopted 12/7/95)
Rule 2005 New Source Review for RECLAIM (Adopted 12/7/95) except (i)
Rule 2006 Permits (Adopted 12/7/95)
Rule 2007 Trading Requirements (Adopted 12/7/95)
Rule 2015 Backstop Provisions (Adopted 12/7/95) except (b)(1)(G) and
(b)(3)(B)
Appendix A Volume IV--(Protocol for oxides of sulfur) (Adopted 9/8/95)
Appendix A Volume V--(Protocol for oxides of nitrogen) (Adopted 9/8/
95)
Rule 2100 Registration of Portable Equipment (adopted 12/8/95)
2. The following rule was submitted to be added as a new
requirement:
Rule 118 Emergencies (Adopted 12/8/95)
3. The following rules were submitted but will not be included
because they are Administrative and/or Procedural:
Rule 301.2 Annual Operating Permit Fee-Reduced Penalty for
Underpayment (Adopted 8/11/95)
Rule 310 Amnesty for Unpermitted Equipment (Adopted 10/13/95)
Rule 1309 Emission Reduction Credits (Adopted 12/7/95)
Rule 1309.1 Priority Reserve (Adopted 12/7/95)
Rule 1310 Analysis and Reporting (Adopted 12/7/95)
Rule 1501 Work Trip Reduction Plans (Adopted 12/8/95)
Rule 1501.1 Alternatives to Work Trip Reduction Plans (Adopted 12/8/
95)
Rule 2202 On-Road Motor Vehicle Mitigation Options (Adopted 12/8/95)
4. The following rules were submitted but will not be included
until the District submits the resolution for these rules:
Rule 2011 Requirements for Monitoring, Reporting, and Recordkeeping
for Oxides of Sulfur (SOx) Emissions (Adopted 12/7/95)
Rule 2012 Requirements for Monitoring, Reporting, and Recordkeeping
for Oxides of Nitrogen (NOx) Emissions (Adopted 12/7/95)
5. The following rules were submitted but will not be included
until the District's Title V Operating Permits program has been
approved:
Rule 518 Variance Procedures for Title V Facilities (Adopted 8/11/95)
Rule 518.1 Permit Appeal Procedures for Title V Facilities (Adopted 8/
11/95)
Rule 518.2 Federal Alternative Operating Conditions (Adopted 1/12/96)
Rule XXX Title V Permits (Adopted 8/11/95)
6. The following rules were submitted but will not be included
because they do not apply to OCS Sources:
Rule 461 Gasoline Transfer and Dispensing (Adopted 9/8/95)
Rule 462 Organic Liquid Loading (Adopted 6/9/95)
Rule 1130 Graphic Arts (Adopted 9/8/95)
Rule 1166 Volatile Organic Compound Emissions from Decontamination of
Soil (Adopted 7/14/95)
B. After review of the rules submitted by Ventura County APCD
against the criteria set forth above and in 40 CFR part 55, EPA is
proposing to make the following rules applicable to OCS sources for
which Ventura County APCD is designated as the COA.
1. The following rules were submitted as revisions to existing
requirements:
Rule 26.1 New Source Review--Definitions (Adopted 2/13/96)
Rule 26.2 New Source Review--Requirements (Adopted 2/13/96)
Rule 26.3 New Source Review--Exemptions (Adopted 2/13/96)
Rule 42 Permit Fees (Adopted 3/12/96)
Rule 44 Exemption Evaluation Fee (Adopted 10/10/95)
Rule 74.7 Fugitive Emissions of Reactive Organic Compounds (ROC) at
Petroleum Refineries and Chemical Plants (Adopted 10/10/95)
Rule 74.23 Stationary Gas Turbines (Adopted 10/10/95)
2. The following rule was submitted but will not be included
because they are Administrative and/or Procedural:
Rule 9 Arrest Authority (Adopted 3/12/96)
Rule 26.4 New Source Review--Emission Banking (Adopted 2/13/96)
Rule 26.5 New Source Review--Community Bank (Adopted 2/13/96)
3. The following is a new rule to be included:
Rule 76 Federally Enforceable Limits on Potential to Emit (Adopted 10/
10/95)
Executive Order 12291 (Regulatory Impact Analysis)
The Office of Management and Budget has exempted this rule from the
requirements of Section 3 of Executive Order 12291. This exemption
continues in effect under Executive Order 12866 which superseded
Executive Order 12291 on September 30, 1993.
Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 requires each federal agency
to perform a Regulatory Flexibility Analysis for all rules that are
likely to have a ``significant impact on a substantial number of small
entities.'' Small entities include small businesses, organizations, and
governmental jurisdictions.
As was stated in the final regulation, the OCS rule does not apply
to any small entities, and the structure of the rule averts direct
impacts and mitigates indirect impacts on small entities. This
consistency update merely incorporates onshore requirements into the
OCS rule to maintain consistency with onshore regulations as required
by section 328 of the Act and does not alter the structure of the rule.
The EPA certifies that this notice of proposed rulemaking will not
have a significant impact on a substantial number of small entities.
List of Subjects in 40 CFR Part 55
Environmental protection, Administrative practice and procedures,
Air pollution control, Hydrocarbons,
[[Page 36014]]
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Nitrogen oxides, Outer Continental Shelf, Ozone, Particulate
matter, Permits, Reporting and recordkeeping requirements, Sulfur
oxides.
Dated: June 30, 1996.
Felicia Marcus,
Regional Administrator.
Title 40 of the Code of Federal Regulations, part 55, is proposed
to be amended as follows:
PART 55--[AMENDED]
1. The authority citation for part 55 continues to read as follows:
Authority: Section 328 of the Clean Air Act (42 U.S.C. Sec. 7401
et seq.) as amended by Public Law 101-549.
2. Section 55.14 is proposed to be amended by revising paragraphs
(e)(3)(ii)(G), and (e)(3)(ii)(H) to read as follows:
Sec. 55.14 Requirements that apply to OCS sources located within 25
miles of states seaward boundaries, by state.
* * * * *
(e) * * *
(3) * * *
(ii) * * *
(G) South Coast Air Quality Management District Requirements
Applicable to OCS Sources (Part I and Part II).
(H) Ventura County Air Pollution Control District Requirements
Applicable to OCS Sources.
* * * * *
3. Appendix A to CFR Part 55 is proposed to be amended by revising
paragraph (b)(7) and (8) under the heading ``California'' to read as
follows:
Appendix A to 40 CFR Part 55--Listing of State and Local Requirements
Incorporated by Reference Into Part 55, by State
* * * * *
California
* * * * *
(b) * * *
* * * * *
(7) The following requirements are contained in South Coast Air
Quality Management District Requirements Applicable to OCS Sources:
Rule 102 Definition of Terms (Adopted 11/17/95)
Rule 103 Definition of Geographical Areas (Adopted 1/9/76)
Rule 104 Reporting of Source Test Data and Analyses (Adopted 1/9/
76)
Rule 108 Alternative Emission Control Plans (Adopted 4/6/90)
Rule 109 Recordkeeping for Volatile Organic Compound Emissions
(Adopted 3/6/92)
Rule 118 Emergencies (Adopted 12/8/95)
Rule 201 Permit to Construct (Adopted 1/5/90)
Rule 201.1 Permit Conditions in Federally Issued Permits to
Construct (Adopted 1/5/90)
Rule 202 Temporary Permit to Operate (Adopted 5/7/76)
Rule 203 Permit to Operate (Adopted 1/5/90)
Rule 204 Permit Conditions (Adopted 3/6/92)
Rule 205 Expiration of Permits to Construct (Adopted 1/5/90)
Rule 206 Posting of Permit to Operate (Adopted 1/5/90)
Rule 207 Altering or Falsifying of Permit (Adopted 1/9/76)
Rule 208 Permit for Open Burning (Adopted 1/5/90)
Rule 209 Transfer and Voiding of Permits (Adopted 1/5/90)
Rule 210 Applications (Adopted 1/5/90)
Rule 212 Standards for Approving Permits (Adopted 12/7/95) except
(e)
Rule 214 Denial of Permits (Adopted 1/5/90)
Rule 217 Provisions for Sampling and Testing Facilities (Adopted 1/
5/90)
Rule 218 Stack Monitoring (Adopted 8/7/81)
Rule 219 Equipment Not Requiring a Written Permit Pursuant to
Regulation II (Adopted 8/12/94)
Rule 220 Exemption--Net Increase in Emissions (Adopted 8/7/81)
Rule 221 Plans (Adopted 1/4/85)
Rule 301 Permit Fees (Adopted 10/13/95)
Rule 304 Equipment, Materials, and Ambient Air Analyses (Adopted 6/
10/94)
Rule 304.1 Analyses Fees (Adopted 6/10/94)
Rule 305 Fees for Acid Deposition (Adopted 10/4/91)
Rule 306 Plan Fees (Adopted 6/10/94)
Rule 309 Fees for Regulation XVI (Adopted 6/10/94)
Rule 401 Visible Emissions (Adopted 4/7/89)
Rule 403 Fugitive Dust (Adopted 7/9/93)
Rule 404 Particulate Matter--Concentration (Adopted 2/7/86)
Rule 405 Solid Particulate Matter--Weight (Adopted 2/7/86)
Rule 407 Liquid and Gaseous Air Contaminants (Adopted 4/2/82)
Rule 408 Circumvention (Adopted 5/7/76)
Rule 409 Combustion Contaminants (Adopted 8/7/81)
Rule 429 Start-Up and Shutdown Provisions for Oxides of Nitrogen
(Adopted 12/21/90)
Rule 430 Breakdown Provisions,(a)and e)only (Adopted 5/5/78)
Rule 431.1 Sulfur Content of Gaseous Fuels (Adopted 11/17/95)
Rule 431.2 Sulfur Content of Liquid Fuels (Adopted 5/4/90)
Rule 431.3 Sulfur Content of Fossil Fuels (Adopted 5/7/76)
Rule 441 Research Operations (Adopted 5/7/76)
Rule 442 Usage of Solvents (Adopted 3/5/82)
Rule 444 Open Fires (Adopted 10/2/87)
Rule 463 Organic Liquid Storage (Adopted 3/11/94)
Rule 465 Vacuum Producing Devices or Systems (Adopted 11/1/91)
Rule 468 Sulfur Recovery Units (Adopted 10/8/76)
Rule 473 Disposal of Solid and Liquid Wastes (Adopted 5/7/76)
Rule 474 Fuel Burning Equipment-Oxides of Nitrogen (Adopted 12/4/
81)
Rule 475 Electric Power Generating Equipment (Adopted 8/7/78)
Rule 476 Steam Generating Equipment (Adopted 10/8/76)
Rule 480 Natural Gas Fired Control Devices (Adopted 10/7/77)
Addendum to Regulation IV (Effective 1977)
Rule 701 Air Pollution Emergency Contingency Actions (Adopted 9/8/
95)
Rule 702 Definitions (Adopted 7/11/80)
Rule 704 Episode Declaration (Adopted 7/9/82)
Rule 707 Radio--Communication System (Adopted 7/11/80)
Rule 708 Plans (Adopted 7/9/82)
Rule 708.1 Stationary Sources Required to File Plans (Adopted 4/4/
80)
Rule 708.2 Content of Stationary Source Curtailment Plans (Adopted
4/4/80)
Rule 708.4 Procedural Requirements for Plans (Adopted 7/11/80)
Rule 709 First Stage Episode Actions (Adopted 7/11/80)
Rule 710 Second Stage Episode Actions (Adopted 7/11/80)
Rule 711 Third Stage Episode Actions (Adopted 7/11/80)
Rule 712 Sulfate Episode Actions (Adopted 7/11/80)
Rule 715 Burning of Fossil Fuel on Episode Days (Adopted 8/24/77)
Regulation IX--New Source Performance Standards (Adopted 4/8/94)
Rule 1106 Marine Coatings Operations (Adopted 1/13/95)
Rule 1107 Coating of Metal Parts and Products (Adopted 5/12/95)
Rule 1109 Emissions of Oxides of Nitrogen for Boilers and Process
Heaters in Petroleum Refineries (Adopted 8/5/88)
Rule 1110 Emissions from Stationary Internal Combustion Engines
(Demonstration) (Adopted 11/6/81)
Rule 1110.1 Emissions from Stationary Internal Combustion Engines
(Adopted 10/4/85)
Rule 1110.2 Emissions from Gaseous and Liquid-Fueled Internal
Combustion Engines (Adopted 12/9/94)
Rule 1113 Architectural Coatings (Adopted 9/6/91)
Rule 1116.1 Lightering Vessel Operations-Sulfur Content of Bunker
Fuel (Adopted 10/20/78)
Rule 1121 Control of Nitrogen Oxides from Residential-Type Natural
Gas-Fired Water Heaters (Adopted 3/10/95)
Rule 1122 Solvent Cleaners (Degreasers) (Adopted 4/5/91)
Rule 1123 Refinery Process Turnarounds (Adopted 12/7/90)
Rule 1129 Aerosol Coatings (Adopted 11/2/90)
[[Page 36015]]
Rule 1134 Emissions of Oxides of Nitrogen from Stationary Gas
Turbines (Adopted 12/7/95)
Rule 1136 Wood Products Coatings (Adopted 9/8/95)
Rule 1140 Abrasive Blasting (Adopted 8/2/85)
Rule 1142 Marine Tank Vessel Operations (Adopted 7/19/91)
Rule 1146 Emissions of Oxides of Nitrogen from Industrial,
Institutional, and Commercial Boilers, Steam Generators, and Process
Heaters (Adopted 5/13/94)
Rule 1146.1 Emission of Oxides of Nitrogen from Small Industrial,
Institutional, and Commercial Boilers, Steam Generators, and Process
Heaters (Adopted 5/13/94)
Rule 1148 Thermally Enhanced Oil Recovery Wells (Adopted 11/5/82)
Rule 1149 Storage Tank Degassing (Adopted 7/14/95)
Rule 1168 Control of Volatile Organic Compound Emissions from
Adhesive Application (Adopted 12/10/93)
Rule 1171 Solvent Cleaning Operations (Adopted 5/12/95)
Rule 1173 Fugitive Emissions of Volatile Organic Compounds (Adopted
5/13/94)
Rule 1176 Sumps and Wastewater Separators (Adopted 5/13/94)
Rule 1301 General (Adopted 12/7/95)
Rule 1302 Definitions (Adopted 12/7/95)
Rule 1303 Requirements (Adopted 12/7/95)
Rule 1304 Exemptions (Adopted 12/7/95)
Rule 1306 Emission Calculations (Adopted 12/7/95)
Rule 1313 Permit to Operate (Adopted 12/7/95)
Rule 1403 Asbestos Emissions from Demolition/Renovation Activities
(Adopted 4/8/94)
Rule 1610 Old-Vehicle Scrapping (Adopted 10/13/95)
Rule 1612 Credits for Clean On-Road Vehicles (Adopted 9/8/95)
Rule 1620 Credits for Clean Off-Road Mobile Equipment (Adopted 9/8/
95)
Rule 1701 General (Adopted 1/6/89)
Rule 1702 Definitions (Adopted 1/6/89)
Rule 1703 PSD Analysis (Adopted 10/7/88)
Rule 1704 Exemptions (Adopted 1/6/89)
Rule 1706 Emission Calculations (Adopted 1/6/89)
Rule 1713 Source Obligation (Adopted 10/7/88)
Regulation XVII Appendix (effective 1977)
Rule 1901 General Conformity (Adopted 9/9/94)
Rule 2000 General (Adopted 12/7/95)
Rule 2001 Applicability (Adopted 12/7/95)
Rule 2002 Allocations for oxides of nitrogen (NOX) and oxides
of sulfur (SOX) Emissions (Adopted 12/7/95)
Rule 2004 Requirements (Adopted 12/7/95)
Rule 2005 New Source Review for RECLAIM (Adopted 12/7/95) except
(i)
Rule 2006 Permits (Adopted 12/7/95)
Rule 2007 Trading Requirements (Adopted 12/7/95)
Rule 2008 Mobiles Source Credits (Adopted 10/15/93)
Rule 2010 Administrative Remedies and Sanctions (Adopted 10/15/93)
Rule 2011 Requirements for Monitoring, Reporting, and Recordkeeping
for Oxides of Sulfur (SOx) Emissions (Adopted 10/15/93)
Appendix A Volume IV--(Protocol for oxides of sulfur) (Adopted 9/8/
95)
Rule 2012 Requirements for Monitoring, Reporting, and Recordkeeping
for Oxides of Nitrogen (NOx) Emissions (Adopted 10/13/93)
Appendix A Volume V--(Protocol for oxides of nitrogen) (Adopted 9/
8/95)
Rule 2015 Backstop Provisions (Adopted 12/7/95) except (b)(1)(G)
and (b)(3)(B)
Rule 2100 Registration of Portable Equipment (Adopted 12/7/95)
XXXI Acid Rain Permit Program (Adopted 2/10/95)
(8) The following requirements are contained in Ventura County
Air Pollution Control District Requirements Applicable to OCS
Sources:
Rule 2 Definitions (Adopted 12/15/92)
Rule 5 Effective Date (Adopted 5/23/72)
Rule 6 Severability (Adopted 11/21/78)
Rule 7 Zone Boundaries (Adopted 6/14/77)
Rule 10 Permits Required (Adopted 6/13/95)
Rule 11 Definition for Regulation II (Adopted 6/13/95)
Rule 12 Application for Permits (Adopted 6/13/95)
Rule 13 Action on Applications for an Authority to Construct
(Adopted 6/13/95)
Rule 14 Action on Applications for a Permit to Operate (Adopted 6/
13/95)
Rule 15.1 Sampling and Testing Facilities (Adopted 10/12/93)
Rule 16 BACT Certification (Adopted 6/13/95)
Rule 19 Posting of Permits (Adopted 5/23/72)
Rule 20 Transfer of Permit (Adopted 5/23/72)
Rule 23 Exemptions from Permits (Adopted 12/13/94)
Rule 24 Source Recordkeeping, Reporting, and Emission Statements
(Adopted 9/15/92)
Rule 26 New Source Review (Adopted 10/22/91)
Rule 26.1 New Source Review--Definitions (Adopted 2/13/96)
Rule 26.2 New Source Review--Requirements (Adopted 2/13/96)
Rule 26.3 New Source Review--Exemptions (Adopted 2/13/96)
Rule 26.6 New Source Review--Calculations (Adopted 10/22/91)
Rule 26.8 New Source Review--Permit To Operate (Adopted 10/22/91)
Rule 26.10 New Source Review--PSD (Adopted 10/22/91)
Rule 28 Revocation of Permits (Adopted 7/18/72)
Rule 29 Conditions on Permits (Adopted 10/22/91)
Rule 30 Permit Renewal (Adopted 5/30/89)
Rule 32 Breakdown Conditions: Emergency Variances, A., B.1., and D.
only. (Adopted 2/20/79)
Rule 33 Part 70 Permits--General (Adopted 10/12/93)
Rule 33.1 Part 70 Permits--Definitions (Adopted 10/12/93)
Rule 33.2 Part 70 Permits--Application Contents (Adopted 10/12/93)
Rule 33.3 Part 70 Permits--Permit Content (Adopted 10/12/93)
Rule 33.4 Part 70 Permits--Operational Flexibility (Adopted 10/12/
93)
Rule 33.5 Part 70 Permits--Timeframes for Applications, Review and
Issuance (Adopted 10/12/93)
Rule 33.6 Part 70 Permits--Permit Term and Permit Reissuance
(Adopted 10/12/93)
Rule 33.7 Part 70 Permits--Notification (Adopted 10/12/93)
Rule 33.8 Part 70 Permits--Reopening of Permits (Adopted 10/12/93)
Rule 33.9 Part 70 Permits--Compliance Provisions (Adopted 10/12/93)
Rule 33.10 Part 70 Permits--General Part 70 Permits (Adopted 10/12/
93)
Rule 34 Acid Deposition Control (Adopted 3/14/95)
Appendix II-B Best Available Control Technology (BACT) Tables
(Adopted 12/86)
Rule 42 Permit Fees (Adopted 3/12/96)
Rule 44 Exemption Evaluation Fee (Adopted 10/10/95)
Rule 45 Plan Fees (Adopted 6/19/90)
Rule 45.2 Asbestos Removal Fees (Adopted 8/4/92)
Rule 50 Opacity (Adopted 2/20/79)
Rule 52 Particulate Matter-Concentration (Adopted 5/23/72)
Rule 53 Particulate Matter-Process Weight (Adopted 7/18/72)
Rule 54 Sulfur Compounds (Adopted 6/14/94)
Rule 56 Open Fires (Adopted 3/29/94)
Rule 57 Combustion Contaminants-Specific (Adopted 6/14/77)
Rule 60 New Non-Mobile Equipment-Sulfur Dioxide, Nitrogen Oxides,
and Particulate Matter (Adopted 7/8/72)
Rule 62.7 Asbestos--Demolition and Renovation (Adopted 6/16/92)
Rule 63 Separation and Combination of Emissions (Adopted 11/21/78)
Rule 64 Sulfur Content of Fuels (Adopted 6/14/94)
Rule 66 Organic Solvents (Adopted 11/24/87)
Rule 67 Vacuum Producing Devices (Adopted 7/5/83)
Rule 68 Carbon Monoxide (Adopted 6/14/77)
Rule 71 Crude Oil and Reactive Organic Compound Liquids (Adopted
12/13/94)
Rule 71.1 Crude Oil Production and Separation (Adopted 6/16/92)
Rule 71.2 Storage of Reactive Organic Compound Liquids (Adopted 9/
26/89)
Rule 71.3 Transfer of Reactive Organic Compound Liquids (Adopted 6/
16/92)
Rule 71.4 Petroleum Sumps, Pits, Ponds, and Well Cellars (Adopted
6/8/93)
Rule 71.5 Glycol Dehydrators (Adopted 12/13/94)
Rule 72 New Source Performance Standards (NSPS) (Adopted 6/28/94)
Rule 74 Specific Source Standards (Adopted 7/6/76)
Rule 74.1 Abrasive Blasting (Adopted 11/12/91)
Rule 74.2 Architectural Coatings (Adopted 08/11/92)
[[Page 36016]]
Rule 74.6 Surface Cleaning and Degreasing (Adopted 5/8/90)
Rule 74.6.1 Cold Cleaning Operations (Adopted 9/12/89)
Rule 74.6.2 Batch Loaded Vapor Degreasing Operations (Adopted 9/12/
89)
Rule 74.7 Fugitive Emissions of Reactive Organic Compounds (ROC) at
Petroleum Refineries and Chemical Plants (Adopted 10/10/95)
Rule 74.8 Refinery Vacuum Producing Systems, Waste-water Separators
and Process Turnarounds (Adopted 7/5/83)
Rule 74.9 Stationary Internal Combustion Engines (Adopted 12/21/93)
Rule 74.10 Components at Crude Oil Production Facilities and
Natural Gas Production and Processing Facilities (Adopted 6/16/92)
Rule 74.11 Natural Gas-Fired Residential Water Heaters-Control of
NOX (Adopted 4/9/85)
Rule 74.12 Surface Coating of Metal Parts and Products (Adopted 12/
13/94)
Rule 74.15 Boilers, Steam Generators and Process Heaters (5MM BTUs
and greater) (Adopted 11/8/94)
Rule 74.15.1 Boilers, Steam Generators and Process Heaters (1-5MM
BTUs)(Adopted 6/13/95)
Rule 74.16 Oil Field Drilling Operations (Adopted 1/8/91)
Rule 74.20 Adhesives and Sealants (Adopted 6/8/93)
Rule 74.23 Stationary Gas Turbines (Adopted 10/10/95)
Rule 74.24 Marine Coating Operations (Adopted 3/8/94)
Rule 74.26 Crude Oil Storage Tank Degassing Operations (Adopted 11/
8/94)
Rule 74.27 Gasoline and ROC Liquid Storage Tank Degassing
Operations (Adopted 11/8/94)
Rule 74.28 Asphalt Roofing Operations (Adopted 5/10/94)
Rule 74.30 Wood Products Coatings (Adopted 5/17/94)
Rule 75 Circumvention (Adopted 11/27/78)
Rule 76 Federally Enforceable Limits on Potential to Emit (Adopted
10/10/95)
Appendix IV-A Soap Bubble Tests (Adopted 12/86)
Rule 100 Analytical Methods (Adopted 7/18/72)
Rule 101 Sampling and Testing Facilities (Adopted 5/23/72)
Rule 102 Source Tests (Adopted 11/21/78)
Rule 103 Stack Monitoring (Adopted 6/4/91)
Rule 154 Stage 1 Episode Actions (Adopted 9/17/91)
Rule 155 Stage 2 Episode Actions (Adopted 9/17/91)
Rule 156 Stage 3 Episode Actions (Adopted 9/17/91)
Rule 158 Source Abatement Plans (Adopted 9/17/91)
Rule 159 Traffic Abatement Procedures (Adopted 9/17/91)
Rule 220 General Conformity (Adopted 5/9/95)
* * * * *
[FR Doc. 96-17458 Filed 7-8-96; 8:45 am]
BILLING CODE 6050-50-P
Complete official Federal Register PDF
FR Doc. 96-17440 Change in Disease Status of the Czech Republic and Italy Because of Rinderpest and Foot-and-Mouth Disease
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35987-35990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17440]
=======================================================================
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 94
[Docket No. 96-027-1]
Change in Disease Status of the Czech Republic and Italy Because
of Rinderpest and Foot-and-Mouth Disease
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to declare the Czech Republic and Italy free
of rinderpest and foot-and-mouth disease and to add these two countries
to the list of countries that, although declared free of rinderpest and
foot-and-mouth disease, are subject to special restrictions on the
importation of their meat and other animal products into the United
States. This proposed rule would remove the prohibition on the
importation into the United States, from the Czech Republic and Italy,
of live ruminants and fresh, chilled, and frozen meat from ruminants
and would relieve restrictions on the importation of milk and milk
products from ruminants from these two countries. However, because the
Czech Republic and Italy are not declared to be free of certain
diseases of swine, including hog cholera and swine vesicular disease,
the importation from these countries of swine and fresh, chilled, and
frozen meat from swine would continue to be restricted.
DATES: Consideration will be given only to comments received on or
before September 9, 1996.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 96-027-1, Regulatory Analysis and Development, PPD, APHIS,
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 96-027-1. Comments
received may be inspected at USDA, room 1141, South Building, 14th
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and
4:30 p.m., Monday through Friday, except holidays. Persons wishing to
inspect comments are requested to call ahead on (202) 690-2817 to
facilitate entry into the comment reading room.
FOR FURTHER INFORMATION CONTACT: Dr. John Cougill, Staff Veterinarian,
Products Program, National Center for Import and Export, VS, APHIS,
4700 River Road Unit 40, Riverdale, MD 20737-1228, (301) 734-3399.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 94 (referred to below as the
regulations) govern the importation into the United States of specified
animals and animal products in order to prevent the introduction into
the United States of various diseases, including rinderpest, foot-and-
mouth disease (FMD), bovine spongiform encephalopathy, African swine
fever, hog cholera, and swine vesicular disease. These are dangerous
and destructive communicable diseases of ruminants and swine.
[[Page 35988]]
Section 94.1(a)(1) of the regulations provides that rinderpest or
FMD exists in all countries of the world except those listed in
Sec. 94.1(a)(2), which have been declared to be free of these diseases.
We will consider declaring a country to be free of rinderpest and FMD
if, among other things, there have been no cases of these diseases
reported there for at least the previous 1-year period and no
vaccinations for rinderpest or FMD have been administered to swine or
ruminants in that country for at least the previous 1-year period.
Rinderpest has not existed in the Czech Republic since 1881, and
vaccination for rinderpest has never occurred in the Czech Republic.
The last diagnosed case of FMD in the Czech Republic occurred in 1974,
and the government of the Czech Republic has prohibited vaccinations
for FMD since 1991. The last case of rinderpest in Italy occurred in
1949, and Italy has never used vaccinations for rinderpest. The last
outbreak of FMD in Italy occurred in 1993, and vaccinations for FMD in
that country ceased in 1991.
The Czech Republic and Italy have individually applied to the U.S.
Department of Agriculture (USDA) to be recognized as free of rinderpest
and FMD. The Animal and Plant Health Inspection Service (APHIS) has
reviewed the documentation submitted by the governments of the Czech
Republic and Italy in support of their requests. The documentation
supplied separately by the Czech Republic and Italy included, among
other things, information about the capability of each country's
veterinary services, laboratory and diagnostic procedures, vaccination
practices, and the administration of laws and regulations to ensure
against the introduction into the Czech Republic and Italy of
rinderpest and FMD through the importation of live animals, meats, and
animal products.
Based on the information discussed above, we believe that the Czech
Republic and Italy qualify to be designated as free of rinderpest and
FMD. Therefore, we are proposing to add the Czech Republic and Italy to
the list in Sec. 94.1(a)(2) of countries declared free of rinderpest
and FMD. This action would remove the prohibition on the importation,
from the Czech Republic and Italy, of live ruminants and fresh,
chilled, or frozen meat from ruminants and would relieve restrictions
on the importation, from these two countries, of milk and milk products
from ruminants. The importation, from the Czech Republic and Italy, of
live swine and fresh, chilled, or frozen meat from swine would continue
to be restricted under 9 CFR part 94 because these countries have not
been declared free of hog cholera and swine vesicular disease, and also
because Italy has not been declared free of African swine fever.
Special Restrictions
We also propose to add the Czech Republic and Italy to the list in
Sec. 94.11(a) of countries declared free of rinderpest and FMD that are
subject to special restrictions on the importation of their meat and
other animal products into the United States. The countries listed in
Sec. 94.11(a) are subject to these special restrictions because they:
(1) Supplement their national meat supply by importing fresh, chilled,
or frozen meat of ruminants or swine from countries that are designated
in Sec. 94.1(a) as infected with rinderpest or FMD; or (2) have a
common land border with countries designated as infected with
rinderpest or FMD; or (3) import ruminants or swine from countries
designated as infected with rinderpest or FMD under conditions less
restrictive than would be acceptable for importation into the United
States.
Both the Czech Republic and Italy supplement their national meat
supplies by the importation of fresh, chilled, and frozen meat of
ruminants and swine from countries designated in Sec. 94.1(a)(1) as
countries in which rinderpest or FMD exists. In addition, the Czech
Republic shares a common land border with Russia, and Italy shares a
common land border with Yugoslavia. Both Russia and Yugoslavia are
designated in Sec. 94.1(a)(1) as being countries in which rinderpest or
FMD exists. Furthermore, both Italy, as a member of the European Union,
and the Czech Republic import live ruminants and swine from countries
not recognized as being free of FMD under conditions less restrictive
than would be acceptable for importation into the United States. As a
result, even though we propose to designate the Czech Republic and
Italy as being free of rinderpest and FMD, the meat and other animal
products produced in these countries may be commingled with the fresh,
chilled, or frozen meat of animals from a country in which rinderpest
and FMD exists, resulting in an undue risk of introducing rinderpest or
FMD into the United States.
Therefore, we are proposing that meat and other animal products of
ruminants and swine and the ship stores, airplane meals, and baggage
containing these meat or animal products imported into the United
States from the Czech Republic and Italy be subject to the restrictions
specified in Sec. 94.11 of the regulations, in addition to other
applicable requirements of the USDA's Food Safety and Inspection
Service at 9 CFR Chapter III. Section 94.11 generally requires that the
meat and other animal products of ruminants and swine be: (1) Prepared
in an inspected establishment that is eligible to have its products
imported into the United States under the Federal Meat Inspection Act;
and (2) accompanied by an additional certificate, issued by a full-time
salaried veterinary official of the national government of the
exporting country, assuring that the meat or other animal products have
not been commingled with or exposed to meat or other animal products
originating in, imported from, or transported through a country
infected with rinderpest or FMD.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
For this action, the Office of Management and Budget has waived its
review process required by Executive Order 12866.
This proposed rule would alter the restrictions placed upon imports
of live ruminants and meat, meat products, and dairy products derived
from ruminants from the Czech Republic and Italy. The regulations in 9
CFR part 94 describe prohibited and restricted importations due to
rinderpest, FMD, and other animal diseases. APHIS believes that the
Czech Republic and Italy meet the criteria for being recognized as free
of rinderpest and FMD. However, because the Czech Republic and Italy
share land borders and maintain trading relationships with FMD-affected
countries, imports into the United States of live ruminants and meat,
meat products, and dairy products derived from ruminants from the Czech
Republic and Italy would still be restricted under this proposed rule.
The proposed rule would not relieve any restrictions imposed on the
importation of swine and pork products because the Czech Republic and
Italy are still considered to be affected with hog cholera and swine
vesicular disease, and Italy is also considered to be affected with
African swine fever.
We anticipate that the quantity of imports of live cattle, sheep,
and goats from the Czech Republic and Italy into the United States
would be minimally affected by the proposed rule. Live cattle imports
would still be restricted due to the trade practices of the Czech
Republic and Italy and the fact that these countries share land borders
with FMD-affected countries. In addition, the cattle industries in the
Czech Republic and Italy are small relative to the enormous domestic
market. Cattle
[[Page 35989]]
inventories for 1994 were estimated to be 2.5 million head for the
Czech Republic, 7.5 million head for Italy, and over 100 million head
for the United States. Also, of the 2.5 million cattle and calves
imported into the United States in 1994, more than 99 percent were from
Canada and Mexico.
The population of sheep and goats in the Czech Republic is also
very small relative to that of the United States (less than 2.5 percent
of the size of the U.S. population in 1993). Italy has a sheep
population that is slightly higher than that of the United States (11.7
million head in Italy and 10.9 million head in the United States in
1993). However, Italy is a strong net importer of sheep and goats
(190,556 head imported and only 1,450 exported in 1993), while the
United States is a strong net exporter of sheep and goats (28,420 head
imported and 894,100 head exported in 1993). Of the few sheep that the
United States does import, more than 99 percent are from Canada and
Mexico.
The Czech Republic exports few live ruminants to the United States.
In 1994, less than 0.0001 percent of the total value of total U.S.
imports of live ruminants were from the Czech Republic. Italy exported
no live ruminants to the United States in 1994. In fact, the United
States did not import any cattle or sheep from the European Union in
1994. Neither Eastern nor Western Europe are usual sources of live
ruminants for the United States, and any increase in ruminant
importations from the Czech Republic or Italy prompted by this proposed
rule would likely be negligible. Therefore, the impact on small
domestic farmers of cattle, sheep, and goats would likely be minimal.
Czech production of beef, veal, mutton, and goat meat in 1994 was
about 2 percent of the size of U.S. production. Italian production of
beef, veal, mutton, and goat meat in 1994 was about 1.2 million metric
tons, or about 11 percent of the U.S. production of 11.3 million metric
tons. The United States imports very little in the way of ruminant meat
and ruminant meat products from Eastern or Western Europe in general.
Moreover, more than 88 percent of the imports of ruminant meat and
ruminant meat products that come into the United States are from
Australia, Canada, and New Zealand. It is unlikely that either the
Czech Republic or Italy would be willing or able to redirect a
significant portion of its ruminant meat production for export
exclusively to the United States as a result of the proposed rule,
given that restrictions would remain in place for imports into the
United States. Even if the Czech Republic were able to redirect its
entire production of these products for export to the United States,
this production was only one-fifth the size of total U.S. imports of
these products in 1994. Moreover, Italy is a significant net importer
of beef, veal, mutton, and other products such as offal and meat
extracts. Therefore, any effect of the proposed rule on domestic prices
or supplies would likely be negligible, and thus the impact on small
domestic producers would be minimal.
We also anticipate that the effect of the proposed rule on the
importation of dairy products from the Czech Republic and Italy would
be minimal. Czech production of dairy products is small relative to
that of the United States. In 1993, Czech dairy product production was
about 5 percent of the value of U.S. production. The United States
imports little in the way of dairy products from the Czech Republic or
from Eastern Europe in general. In 1994, U.S. imports of dairy products
were valued at $963.4 million; of this total, less than 5 percent
originated in Eastern Europe and less than 0.1 percent in the Czech
Republic. The Czech Republic is a significant producer and exporter of
butter. However, butter is already exempt from the provisions of 9 CFR
part 94 and thus would be unaffected by the proposed rule. For dairy
products in general, Italy is a significant net importer and not likely
to be willing or able to redirect a significant portion of its
production exclusively to the United States, which is a significant net
exporter. Italy's major dairy export to the United States is cheese.
Because solid cheeses are already exempt from the provisions of 9 CFR
part 94, there is no reason to believe that imports of cheese would
increase significantly due to this proposal. For these reasons and
given the fact that restrictions will remain in place, it is unlikely
that the proposed rule would significantly alter imports of dairy
products into the United States. Therefore, the impact on small
domestic dairy producers should be minimal.
Any effects of the proposed rule on importers of embryos, semen,
other genetic material, or breeding animals would also likely be
minimal. We anticipate that, if the proposal is made final for the
Czech Republic and Italy, there could be an initial increase in the
volume of these products flowing into the United States to diversify
the genetic composition of domestic cattle. (In particular, there has
been a great deal of interest expressed in obtaining genetic material
of beef cattle from Italy.) However, any temporary increase in volume
would most likely be small relative to total U.S. imports of these
products. The United States is a net exporter of both bovine semen and
cattle embryos. In 1994, the value of U.S. bovine semen and cattle
embryo imports was $4.3 million and $266,000, respectively, while U.S.
exports of bovine semen and cattle embryos were valued at $7.9 million
and $6.4 million, respectively. Given this trade balance and the size
differences between the U.S. and Czech and Italian cattle industries,
the amount imported of each type of genetic material would be minimal
and have a minimal impact on small domestic cattle producers.
In conclusion, declaring the Czech Republic and Italy free of
rinderpest and FMD would likely have a negligible impact on domestic
small entities. Imports from the Czech Republic and Italy of ruminants
and ruminant products would continue to be restricted. In addition, the
U.S. markets for these products are large relative to the Czech and
Italian markets, and Italy is a net importer of most of these products.
Under these conditions, it is unlikely that either the Czech Republic
or Italy would be willing or able to redirect a significant portion of
the production of these products exclusively to the United States.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
approved by the Office of Management and Budget (OMB). The assigned OMB
control number is 0579-0015.
List of Subjects in 9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
Accordingly, 9 CFR part 94 would be amended as follows:
[[Page 35990]]
PART 94-RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), VELOGENIC VISCEROTROPIC NEWCASTLE DISEASE, AFRICAN SWINE
FEVER, HOG CHOLERA, AND BOVINE SPONGIFORM ENCEPHALOPATHY:
PROHIBITED AND RESTRICTED IMPORTATIONS
1. The authority citation for part 94 would continue to read as
follows:
Authority: 7 U.S.C. 147a, 150ee, 161, 162, and 450; 19 U.S.C.
1306; 21 U.S.C. 111, 114a, 134a, 134b, 134c, 134f, 136, and 136a; 31
U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and
371.2(d).
Sec. 94.1 [Amended]
2. In Sec. 94.1, paragraph (a)(2) would be amended by adding the
words ``Czech Republic,'' immediately after the words ``Costa Rica,''
and by adding the word ``Italy,'' immediately after the word
``Ireland,''.
Sec. 94.11 [Amended]
3. In Sec. 94.11, the first sentence in paragraph (a) would be
amended by adding the words ``Czech Republic,'' immediately after the
word ``Chile,'' and by adding the word ``Italy,'' immediately after the
word ``Hungary,''.
Done in Washington, DC, this 2nd day of July 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-17440 Filed 7-8-96; 8:45 am]
BILLING CODE 3410-34-P
Complete official Federal Register PDF
FR Doc. 96-17420 Recommendations on Uniform Forms and Procedures for the Transportation of Hazardous Materials
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 36016-36020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17420]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
49 CFR Part 397
[FHWA Docket No. MC-96-10]
Recommendations on Uniform Forms and Procedures for the
Transportation of Hazardous Materials
AGENCY: Federal Highway Administration (FHWA), DOT.
ACTION: Notice of report availability; request for comments.
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SUMMARY: The FHWA is requesting public comment on the final report and
recommendations of the Alliance for Uniform HazMat Transportation
Procedures (the Alliance) concerning the implementation of 49 U.S.C.
5119--formerly referred to as section 22 of the Hazardous Materials
Transportation Uniform Safety Act of 1990 (HMTUSA). Section 5119
requires the Secretary of Transportation (the Secretary) to establish a
working group of State and local government officials to establish
uniform forms and procedures for the registration of persons that
transport hazardous materials by motor vehicle, and to decide whether
to limit the filing of State registration and permit forms and the
collection of filing fees. The Alliance is the working group created to
fulfill the requirements of the HMTUSA, and accordingly, has published
its final report with recommendations which is now available to the
public.
DATES: Written comments must be received on or before November 6, 1996.
ADDRESSES: Submit written, signed comments to FHWA Docket No. MC-96-
10, room 4232, HCC-10, Office of the Chief Counsel, Federal Highway
Administration, 400 Seventh Street, SW., Washington, D. C. 20590. All
comments received will be available for examination at the above
address from 8:30 a.m. to 3:30 p.m., e.t., Monday through Friday,
except Federal holidays. Those desiring notification of receipt of
comments must include a self-addressed, stamped postcard.
FOR FURTHER INFORMATION CONTACT: Mr. Larry W. Minor, Office of Motor
Carrier Research and Standards, (202) 366-4009; Mr. James D. McCauley,
Office of Motor Carrier Safety and Technology, (202) 366-9579; or Mr.
Raymond W. Cuprill, Office of Chief Counsel, (202) 366-0834, Federal
Highway Administration, 400 Seventh Street, SW., Washington, D. C.
20590. Office hours are from 7:45 a.m. to 4:15 p.m., e.t., Monday
through Friday, except Federal holidays.
SUPPLEMENTARY INFORMATION:
Background
Section 5119 of Title 49, United States Code, requires that the
Secretary establish a working group of State and local government
officials to develop recommendations on uniform forms and procedures
that the States can use to register and permit persons that transport,
or cause the transportation of, hazardous materials by motor vehicle.
The working group is also required to make recommendations as to
whether the filing of registration and permit forms, and the collection
of related fees, should be limited to the State in which a person
resides or has its principal place of business. In developing its
recommendations, the group is required to consult with persons who are
subject to these registration and permit requirements. The
recommendations of the working group are to be included in a final
report to the Secretary of Transportation.1 Finally, section 5119
requires the issuance of regulations implementing those recommendations
with which the Secretary agrees.
---------------------------------------------------------------------------
\1\ The report is to be also submitted to the Committee on
Commerce, Science, and Transportation of the Senate, and the
Committee on Public Works and Transportation of the House of
Representatives.
---------------------------------------------------------------------------
Section 5119 was originally enacted as section 22 of the Hazardous
Materials Transportation Uniform Safety Act of 1990 (Pub. L. 101-615,
104 Stat. 3244; November 16, 1990). The HMTUSA amended the Hazardous
Materials Transportation Act of 1974 (HMTA), Public Law 93-633, 88
Stat. 2156, which granted regulatory and enforcement authority to the
Secretary to provide adequate protection against the risks to life and
property inherent in the transportation of hazardous materials in
commerce. The HMTA was designed to replace a patchwork of State and
Federal laws and regulations concerning hazardous materials
transportation with a scheme of uniform, national regulations. The HMTA
and HMTUSA were repealed by Public Law 103-272 (108 Stat. 745, 1379;
July 5, 1994) with the statutory provisions applicable to the
transportation of hazardous materials recodified at 49 U.S.C. 5101 et
seq.
Implementation of Section 5119
A. Creation of the Alliance for Uniform HazMat Transportation
Procedures
In 1991, the National Governors' Association (NGA) and the National
Conference of State Legislatures (NCSL) were awarded a contract to
coordinate the staffing and operations of the
[[Page 36017]]
working group. The NGA and NCSL presented recommendations to the
Secretary for the establishment of a panel to carry out the tasks of
the working group. The panel was approved by the Secretary and held its
first meeting in January 1992, at which time it selected the title
``the Alliance for Uniform HazMat Transportation Procedures'' or ``the
Alliance.''
The Alliance authorized the formation of four subgroups to address
specific areas of State hazardous materials transportation regulation.
Industry representatives were invited to participate in the subgroups.
The subgroups were:
1. Shipper and Carrier Registration Subgroup;
2. Shipper and Carrier Permitting and Licensing Subgroup;
3. Operational Issues Subgroup; and,
4. Audit and Enforcement Subgroup.
Each subgroup was asked to examine current State practices,
identify the extent to which State practices are uniform, identify
barriers to uniformity, and make recommendations for criteria on which
a uniform State program would be based.
One of the key decisions to come out of the registration subgroup
concerned shippers. After reviewing results from surveys of the States,
the subgroup decided not to recommend a shipper registration program
separate from the Federal program operated by the Research and Special
Programs Administration (RSPA).2 (The RSPA's hazardous materials
registration and fee assessment program are discussed later in this
document.) Therefore, the following discussion of the Alliance's
program only pertains to motor carriers.
2 Alliance Phase One Subgroup Reports, National Governors'
Association-National Conference of State Legislatures, June 1992. A
copy of this document is included in the docket file.
---------------------------------------------------------------------------
B. Pilot Study
In May of 1992, the Alliance proceeded with the design and
implementation of a two-year pilot project. The project was based upon
the following assumptions/recommendations:
1. Base-state system for registration and collection of fees;
2. Reciprocity between states that require permits;
3. Additional information for hazardous waste transporters;
4. Individual state enforcement authority;
5. Participation by localities; and,
6. Establishment of a governing board to manage the pilot project.
Based upon the Alliance's recommendations, the FHWA funded a two-
year demonstration program for four States. During the first year, each
State would develop the internal administrative procedures and
organization to conduct a test of the Alliance's recommended program.
During the second year, the States would implement the program for
motor carriers involved in the transportation of hazardous materials.
In November of 1992, the Alliance contacted State hazardous
materials transportation program administrators to solicit
participation in the pilot study. The States of Minnesota, Nevada,
Ohio, and West Virginia were chosen based upon the following criteria
established by the Alliance:
1. The Governor and State legislature were committed to taking the
necessary legislative and administrative actions to conduct the State's
hazardous materials transportation programs under the principles and
operating procedures of the Alliance's recommendations;
2. The regulated community within the State was committed to
supporting participation in the program;
3. The State had experience in the registration and permitting of
hazardous materials, and/or in the transportation of radioactive
materials;
4. The group of States chosen reflected ``geographic diversity;''
5. At least one pilot State had a ``major locality'' with a
hazardous materials transportation registration or permitting program.
On July 1, 1993, the pilot States began registering and permitting
motor carriers in accordance with the Alliance's recommendations. Each
participating State was given the opportunity to select one of the
following three options for implementing the Alliance's Uniform
Program:
1. The State could apply the requirements of the Uniform Program to
all motor carriers (interstate and intrastate); or
2. The State could apply the requirements only to domiciled,
interstate motor carriers that operate in two or more of the pilot
States; or,
3. The State could select an even smaller sample of interstate
motor carriers.
Minnesota, Ohio, and West Virginia used option one while Nevada
selected option two for the first round of registration and permitting
with the intent of expanding the program to all motor carriers during
the second program year.
C. The Alliance's Findings and Conclusions
On March 15, 1996, the Alliance submitted its final report and
recommendations to the FHWA. The Alliance concluded that the pilot
study met the uniformity mandate of 49 U.S.C. 5119. The report states
that all of the pilot States support the program and believe that other
States should join the program to increase the benefits provided by
this uniform program and to spread the administrative load presented by
multi-state carriers. The report claims that industry participants also
support making the program uniform in all States, although the industry
believes that a shorter application form and a simplified formula for
calculating fees should be used.
The Alliance recommends that the Secretary:
1. Explore options for the consolidation of Federal and State
registration programs;
2. Consider waiving the Federal requirement for motor carriers that
have obtained a permit under the Uniform Program; and
3. Promote a one-stop repository for up-to-date information on
hazardous materials routing designations.
In addition, the Alliance's Governing Board, which was responsible
for managing the pilot program, recommends that the Congress amend
section 5119 to require that any jurisdiction that elects to register
and/or permit motor carriers to transport hazardous materials, must do
so in conformity with the Alliance's Uniform Program. The Board
recommends that the Secretary retain the authority to preempt any State
program or program provision that the Secretary determines is
inconsistent with the uniformity mandate. Additionally, the Board
recommends that the Congress establish a deadline (not less than three
years) for compliance with the mandate and provide financial support to
the Alliance to facilitate State entry into the Uniform Program.
Other Federal and State Initiatives
There are several major activities underway which may have an
impact or may be related to the State hazardous materials
transportation registration and permitting processes. These activities
include: (1) The FHWA's motor carrier safety permits and inspection
rulemaking; (2) the Research and Special Program Administration's
(RSPA) Hazardous Materials Registration and Fee Assessment Program; (3)
the Commercial Vehicle Information System (CVIS) feasibility study; and
(4) the elimination of the Interstate Commerce Commission (ICC) and the
transfer of the ICC's registration (operating authority) and insurance
programs to the FHWA. All of these
[[Page 36018]]
initiatives, as well as the FHWA's motor carrier registration
requirement--the motor carrier identification report (Form MCS-150)
required by 49 CFR 385.21 and used by the FHWA to assign USDOT
numbers--and the registration and insurance filings of for-hire motor
carriers required by many States (Single State Registration System),
are very similar or related. However, these programs are commonly
administered as separate functions by several agencies within a State.
These activities may have a significant bearing on the public
comments offered in response to this notice and on the ultimate
direction of any resulting rulemaking actions affecting Federal and
State registration and permitting of transporters and shippers of
hazardous materials. The FHWA encourages comments on the relationship
between the recommendations of the Alliance and the activities
discussed in this notice.
FHWA Rulemaking on Motor Carrier Safety Permits and the Inspection of
Vehicles Transporting Highway-Route-Controlled Quantities of
Radioactive Materials [49 U.S.C. 5109(a) and 5105(e)]
Section 5109(a), Motor Carrier Safety Permits (originally enacted
as one of the provisions of section 8 of the HMTUSA), provides that a
motor carrier shall only transport, or cause the transportation of,
hazardous materials in commerce if the carrier holds a safety permit
issued by the Secretary and keeps a copy of the permit, or other proof
of its existence, in the vehicle. The Secretary is required to
prescribe by regulation the hazardous materials and amounts to which
the permit requirement applies. However, the list of hazardous
materials must include, at a minimum and in amounts established by the
Secretary, the following:
(1) Division 1.1, 1.2, and 1.3 (class A or B explosives);
(2) liquefied natural gas;
(3) hazardous material the Secretary designates as extremely toxic
by inhalation; and
(4) a highway-route-controlled quantity of radioactive material, as
defined by the Secretary.
Section 5105(e), Inspections of Motor Vehicles Transporting Certain
Material (originally enacted as section 15 of the HMTUSA), directs the
Secretary to issue regulations requiring that each motor vehicle
transporting a highway-route-controlled quantity of Class 7
(radioactive) material in commerce be inspected and certified as
complying with the Federal hazardous materials and motor carrier safety
laws and regulations. The Secretary may require the inspections to be
conducted by Federal inspectors or in accordance with appropriate State
procedures. The Secretary may allow self-certification by motor
carriers using employees that meet minimum qualifications set by the
Secretary.
On June 17, 1993, the FHWA published a notice of proposed
rulemaking (NPRM) to implement the requirements of 49 U.S.C. 5109 and
5105 (58 FR 33418). The FHWA proposed to amend part 397 of the Federal
Motor Carrier Safety Regulations (FMCSRs) by adding a new subpart B,
Motor Carrier Safety Permits. The notice proposed to initially limit
the safety permit program to the transportation of the four classes of
hazardous materials set forth in the statute, with phase-in periods for
Division 1.1, 1.2 and 1.3 materials (Class A and B explosives) 3
and limiting the materials considered extremely toxic by inhalation to
those that meet the criteria of Division 2.3, Hazard Zone A, or
Division 6.1, Packing Group I, Hazard Zone A (see 49 CFR 173.115 and
173.132) and are transported in quantities of more than 1 liter (1.06
quarts). The proposed permit procedures made extensive use of existing
FHWA programs, forms and procedures, and as a result, the agency
proposed not to assess permit fees. To obtain a permit, a motor carrier
would be required to submit a revised MCS-150 (Motor Carrier
Identification Report) to the Regional Director, Office of Motor
Carriers, for the region in which the motor carrier has its principal
place of business. Determinations on safety permit applications would
be based upon a safety fitness finding made pursuant to 49 CFR part
385. A ``satisfactory'' safety rating would be a prerequisite to the
granting of a safety permit. A less than ``satisfactory'' safety rating
would result in a denial of the permit application. The FHWA would have
the discretion to issue a temporary safety permit (120 days) to an
unrated motor carrier pending a safety fitness determination. Safety
permits would be valid for three years and would be renewable. Reviews
of the FHWA's determinations on permit issuance would be handled
pursuant to the existing procedures applicable to safety rating reviews
(49 CFR 385.15 and 385.17). The current safety rating notification
letter would be modified to serve as the safety permit. The letter
would bear a safety permit number, which would be the motor carrier's
identification or census number assigned by the FHWA when the motor
carrier submits the MCS-150 required by Sec. 385.21. Motor carriers
would be required to display this permit number on the shipping papers
and on the commercial motor vehicles used.
---------------------------------------------------------------------------
\3\ The proposed phase-in period was to be implemented as
follows:
Effective date and covered quantities of class A and/or B
explosives:
Nov. 16, 1993--454 kilograms (1,000 pounds) or more.
Nov. 16, 1994--227 kilograms (500 pounds) or more.
Nov. 16, 1995--25 kilograms (55 pounds) or more.
---------------------------------------------------------------------------
With regard to the inspection requirements of 49 U.S.C. 5105, the
FHWA proposed that motor carriers transporting highway-route-controlled
quantities of Class 7 (radioactive) materials be required to inspect
each commercial motor vehicle used before each trip and that a written
certification by a qualified inspector be maintained. It was proposed
that these vehicles be inspected through the use of the general
inspection requirements contained in 49 CFR part 396, ``Inspection,
Repair, and Maintenance,'' and the more detailed inspection standards
found in appendix G to 49 CFR subchapter B, ``Minimum Periodic
Inspection Standards.'' The inspector qualification requirements for
the periodic inspection (specified in 49 CFR 396.19) would be used to
ensure that inspectors are qualified to perform the vehicle
inspections.
The FHWA carefully reviewed the various registration and permitting
requirements of the Federal law and decided not to proceed with further
rulemaking action to implement the requirements of 49 U.S.C. 5109 and
5105 until it had considered the final report and recommendations of
the Alliance for implementing section 5119. This was considered the
most effective way to satisfy all of these related statutory
requirements, as the Alliance's recommendations would have a
significant bearing on the implementation of the Federal safety permit
and inspection requirements.
Federal Hazardous Materials Registration and Fee Assessment Program and
the Hazardous Materials Emergency Preparedness Grant Program
Section 5108(a)(1) (originally enacted as one of the provisions of
section 8 of the HMTUSA) requires that each person transporting or
causing to be transported in commerce the following hazardous materials
must file a ``registration statement'' with the Secretary:
(1) Highway-route-controlled quantities of Class 7 (radioactive)
materials;
(2) more than 25 kilograms of Division 1.1, 1.2 and 1.3
(explosives) materials;
[[Page 36019]]
(3) more than 1 liter in each package of a hazardous material which
has been designated by the Secretary as extremely toxic by inhalation;
(4) hazardous material in a bulk package, container, or tank as
defined by the Secretary if the package, container, or tank has a
capacity of 13,249 or more liters (3,500 or more gallons) or has a
volume greater than 13.25 cubic meters (468 cubic feet);
(5) a shipment of at least 2,268 kg (5,000 pounds) (except in a
bulk packaging) of a class of hazardous material requiring a placard.
In addition, section 5108(a)(2) provides the Secretary with
discretionary authority to require any of the following persons to file
a registration statement:
(1) A person transporting or causing to be transported hazardous
materials in commerce and not covered by section 5108(a)(1);
(2) a person manufacturing, fabricating, marking, maintaining,
reconditioning, repairing, or testing a package or container the person
represents, marks or certifies, or sells for use in transporting in
commerce hazardous material the Secretary designates.
Paragraph (g) of section 5108 authorizes the Secretary to
establish, impose, and collect a fee for the processing of the
registration statement as well as an annual fee.
Implementation of these requirements was delegated by the Secretary
to the RSPA. Federal registration of hazardous materials offerors and
transporters began in 1992 (57 FR 30620, July 9, 1992). Federal
registration is required of persons engaged in certain activities that
involve the offering or transporting of hazardous materials in
interstate, intrastate, or foreign commerce by highway, rail, air, or
water. Less than half of the current registrants have identified
themselves as highway carriers. The Federal registration program has no
preemptive effect upon State and local hazardous materials registration
programs.
The annual fee is used to fund grants to State and Indian tribal
governments for hazardous materials planning and training purposes. The
funds are allocated through the RSPA's Federal Hazardous Materials
Emergency Preparedness (HMEP) Grant Program with the first grants
awarded to qualifying State and Indian tribal governments in 1993.
In cooperation with the Alliance's pilot program, the concept of
``one-stop shopping'' for Federal and State registration of motor
carriers was tested by the Public Utilities Commission of Ohio (PUCO)
and the RSPA. Motor carriers required to register with the State of
Ohio were provided with the option of also submitting the Federal
registration statement and fee to the PUCO for transmittal to the RSPA.
For the 1994-95 registration year (from July 1, 1994 to June 30, 1995),
approximately 200 persons registered in the Federal program through the
PUCO. During the 1995-96 registration year, the number of persons
choosing this option decreased sharply to 76 persons. Only 16 of the
participants in the 1994-95 registration year elected to use this
process for the 1995-96 registration year.
The Alliance's report, discussed above, recommends that the
Secretary explore the consolidation of Federal and State registration
programs. The FHWA notes, however, that there are substantial
differences between the existing Federal registration program and the
program recommended by the Alliance. Commenters should familiarize
themselves thoroughly with the purpose and scope of coverage of each
program in preparation for providing comments regarding this
recommendation by the Alliance.
The Commercial Vehicle Information System (CVIS)
The CVIS project is a feasibility study mandated by 49 U.S.C.
31106, which was originally enacted by section 4003 of the Intermodal
Surface Transportation Efficiency Act of 1991 (ISTEA) (Pub. L. 102-240,
105 Stat. 1914, 2144; December 8, 1991). Specifically, the CVIS ties
commercial motor vehicle registration privileges to a motor carrier's
safety performance. For the first time, chronically unsafe motor
carriers risk losing their vehicle registration privileges if they
prove unable or unwilling to improve their operational safety levels
after a designated period. The project is a cooperative effort
involving the FHWA and five pilot States: Iowa (the lead State),
Oregon, Colorado, Minnesota, and Indiana.
Motor carriers are identified for inclusion in the CVIS improvement
process (MCSIP--Motor Carrier Safety Improvement Process) through the
application of a carrier identification and prioritization algorithm
referred to as the Safestat Identification Algorithm (Safestat).
Safestat identifies ``At Risk'' motor carriers by producing a safety
score for every interstate motor carrier. Motor carriers are ranked on
a worst-first basis. Motor carriers with the lowest scores are
considered to be ``At Risk'' and are scheduled for a compliance review
(on-site visit), while motor carriers with less severe safety scores
receive ``warning letters.'' Once a motor carrier has been identified
for entry into the MCSIP, its safety performance is monitored using a
second algorithm called the Safestat Monitoring Algorithm. The MCSIP
process has been designed to provide numerous opportunities for motor
carriers to improve their safety performance. Failure to improve safety
performance, however, will result in progressively more severe
penalties leading eventually to suspension or revocation of vehicle
registration privileges.
The CVIS could be used to identify hazardous materials (HM)
carriers that are ``At Risk'' by modifying the Safestat Identification
Algorithm to include additional information about HM motor carriers. In
fact, it has been suggested that a separate safety evaluation area
relating to HM be included in the Safestat Identification Algorithm.
Under this proposal, HM carriers that have been identified for entry
into the MCSIP process and continue to score poorly may have their HM
permits denied or suspended.
Interstate Commerce Commission's (ICC) Carrier Registration and
Insurance Requirements
On December 29, 1995, the President signed the ICC Termination Act
of 1995 (the Act) (Pub.L. 104-88, 109 Stat. 803), which eliminates the
ICC and transfers certain motor carrier regulatory functions from the
ICC to the FHWA. The principal functions being transferred are the
licensing/registration activities, insurance tracking, Mexican motor
carrier oversight, and responsibilities for brokers, freight
forwarders, and household goods carriers. All past operating authority
licenses and financial responsibility filings will remain valid, and
all pending applications and financial responsibility filings will be
processed by the FHWA. Future applications and insurance filings will
continue to be accepted by the FHWA. The Act provides that registration
generally remains in effect for up to five years unless it is
suspended, amended, or revoked. Reasons for suspension or revocation
may include unsafe operations, lack of the required financial
responsibility coverage, or failure to comply with regulatory
requirements.
The ICC and the FHWA motor carrier programs have the common goal of
ensuring that motor carriers are properly identified, have adequate
levels of financial responsibility, and operate in a safe manner. Under
the present programs, for-hire motor carriers are registered and must
show proof of
[[Page 36020]]
financial responsibility and familiarity with the FHWA's safety
regulations. The financial responsibility coverage of for-hire motor
carriers is continuously monitored. Policy pre-expiration notices
obtained from the insurance companies as well as internal audits are
used to determine compliance. Prior to an insurance policy lapsing, the
carrier is contacted. Enforcement action, including litigation, can be
used to stop the carrier from operating without financial
responsibility. A carrier's operating authority can be revoked if
financial responsibility is not obtained. A similar procedure applies
to motor carriers that have been authorized to self-insure.
The Single State Registration System (SSRS) program was created to
succeed the ``bingo card'' program administered by the ICC. The SSRS
program is a base-State system whereby a motor carrier registers its
interstate operating authority with and provides proof of financial
responsibility coverage to one State (a base-State) instead of multiple
States. The base State then distributes the collected fees to other
participating States in which the motor carrier's vehicles operate.
State participation in the System was limited to those States
participating in the bingo card program prior to January 1991. Fee
amounts were limited to those imposed prior to November 1991, not to
exceed $10 per vehicle.
Under the Act, the SSRS will continue to operate. However, the
Department is required to consolidate the current USDOT identification
number system, the SSRS, the ICC registration system (including
financial responsibility registration) into a single, on-line Federal
system. The new system will contain information on, and identification
of, all foreign and domestic motor carriers, brokers, and freight
forwarders (as well as others required to register with the Department
of Transportation) as well as information on safety fitness and
compliance with the required levels of financial responsibility
coverage. The Secretary may establish fees to fully operate the system,
including any personnel to support the overall registration and
financial responsibility filing system.
Request for Comments
The FHWA requests comments on the Alliance's final report and
recommendations, as outlined in this notice. As discussed above,
several major activities related to the hazardous materials
transportation registration and permitting processes are also underway.
The FHWA encourages commenters to consider these activities and their
relationship to the final report and recommendations of the Alliance.
Based upon the comments received, the FHWA may hold public meetings to
further discuss these issues.
Copies of the report (``Final Report: Uniform Program Pilot
Project,'' March 15, 1996) may be ordered at no charge from the
National Governors' Association. Requests should be addressed to:
National Governors' Association, c/o Mr. Kyle Winston, Hall of the
States, 444 North Capitol Street, Suite 267, NW., Washington, D.C.
20001-1512. Request for copies may also be made by calling the NGA at
(202) 624-5300 or via fax (202) 624-5395.
All comments received before the close of business on the comment
closing date indicated above will be considered and will be available
for examination in the docket at the above address. Comments received
after the comment closing date will be filed in the docket and will be
considered to the extent practical. In addition to late comments, the
FHWA will also continue to file relevant information in the docket as
it becomes available after the closing date. Interested persons should
continue to examine the docket for new material.
List of Subjects in 49 CFR Part 397
Hazardous materials transportation, Highway safety, Motor carriers.
Issued on: July 2, 1996.
Rodney E. Slater,
Federal Highway Administrator.
[FR Doc. 96-17420 Filed 7-8-96; 8:45 am]
BILLING CODE 4910-22-P
Complete official Federal Register PDF
FR Doc. 96-17418 Proposed Revision of Class E Airspace; Russellville, AR
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35991-35992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17418]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Airspace Docket No. 96-ASW-13]
Proposed Revision of Class E Airspace; Russellville, AR
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This notice proposes to revise the Class E airspace extending
upward from 700 feet above ground level (AGL) at Russellville, AR. A
new Global Positioning System (GPS) Standard Instrument Approach
Procedure (SIAP) to Runway (RWY) 25 at Russellville Municipal Airport
has made this proposal necessary. The intended effect of this proposal
is to provide adequate controlled airspace for aircraft executing the
GPS SIAP to RWY 25 at Russellville Municipal Airport, Russellville, AR.
DATES: Comments must be received on or before September 6, 1996.
ADDRESSES: Send comments on the proposal in triplicate to Manager,
Operations Branch, Air Traffic Division, Federal Aviation
Administration, Southwest Region, Docket No. 96-ASW-13, Fort Worth, TX
76193-0530. The official docket may be examined in
[[Page 35992]]
the Office of the Assistant Chief Counsel, Federal Aviation
Administration, Southwest Region, 2601 Meacham Boulevard, Fort Worth,
TX, between 9:00 a.m. and 3:00 p.m., Monday through Friday, except
Federal holidays. An informal docket may also be examined during normal
business hours at the Operations Branch, Air Traffic Division, Federal
Aviation Administration, Southwest Region, 2601 Meacham Boulevard, Fort
Worth, TX.
FOR FURTHER INFORMATION CONTACT:
Donald J. Day, Operations Branch, Air Traffic Division, Federal
Aviation Administration, Southwest Region, Fort Worth, TX 76193-0530;
telephone: (817) 222-5593.
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 under the caption
ADDRESSES. Commenters wishing the FAA to acknowledge receipt of their
comments on this notice must submit, with those comments, a self-
addressed, stamped, postcard containing the following statement:
``Comments to Airspace Docket No. 96-ASW-13.'' The postcard will be
date and 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 in
the Office of the Assistant Chief Counsel, Federal Aviation
Administration, Southwest Region, 2601 Meacham Boulevard, Fort Worth,
TX, 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 Notice of Proposed Rulemaking
(NPRM) by submitting a request to the Operations Branch, Air Traffic
Division, Federal Aviation Administration, Southwest Region, Fort
Worth, TX 76193-0530. 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
that 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 revise the Class E airspace,
controlled airspace extending upward from 700 feet AGL, at Russellville
Municipal Airport, Russellville, AR. A new GPS SIAP to RWY 25 has made
this proposal necessary. The intended effect of this proposal is to
provide adequate Class E airspace for aircraft executing the GPS SIAP
to RWY 25 at Russellville Municipal Airport, Russellville, AR.
The coordinates for this airspace docket are based on North
American Datum 83. Designated Class E airspace areas extending upward
from 700 feet or more above ground level 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 that need frequent and
routine amendments 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 Procedure (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 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. 40103, 40113, 40120; E.O. 10854, 24 FR
9565, 3 CFR, 1959-1963 Comp., p. 389; 49 U.S.C. 106(g); 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 the surface of the earth.
* * * * *
ASW AR E5 Russellville, AR [Revised]
Russellville, Russellville Municipal Airport, AR
(lat. 35 deg.15'33''N., long. 93 deg.05'38''W.)
Russellville NDB
(lat. 35 deg.15'26''N., long. 93 deg.05'40''W.)
That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Russellville Municipal Airport, and
within 2.4 miles each side of the 184 deg. bearing from the
Russellville NDB extending from the 6.4-mile radius to 6.6 miles
south of the airport, and within 4 miles each side of the 075 deg.
bearing from the airport extending from the 6.4-mile radius to 18
miles northeast of the airport, excluding that airspace which
overlies the Morrilton, AR, Class E airspace area.
* * * * *
Issued in Fort Worth, TX on June 17, 1996.
Albert L. Viselli,
Acting Manager, Air Traffic Division, Southwest Region.
[FR Doc. 96-17418 Filed 7-8-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-17390 Endangered and Threatened Wildlife and Plants: 90-day Finding on a Petition to List the Santa Ana Speckled Dace, Santa Ana Sucker, and the Shay Creek Threespine Stickleback as Endangered
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 36021-36023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17390]
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
50 CFR Part 17
Endangered and Threatened Wildlife and Plants: 90-day Finding on
a Petition to List the Santa Ana Speckled Dace, Santa Ana Sucker, and
the Shay Creek Threespine Stickleback as Endangered
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Notice of 90-day petition finding.
-----------------------------------------------------------------------
SUMMARY: The U. S. Fish and Wildlife Service (Service) announces a 90-
day finding on a petition to list three fish as endangered, pursuant to
the Endangered Species Act of 1973, as amended. The Service finds that
the petition did not present substantial scientific or commercial
information indicating the petitioned action may be warranted for two
of the three species because it does not substantiate that the Santa
Ana speckled dace and Shay Creek threespine stickleback are described
subspecies or distinct vertebrate population segments as described in
the Service's vertebrate population policy. Furthermore, the Service
presently regards the Shay Creek threespine stickleback as a population
of the unarmored threespine stickleback (Gasterosteus aculeatus
williamsoni), a species that is already listed as endangered. Regarding
the third fish species, the Service finds that substantial information
exists to support a decision that listing may be warranted for the
Santa Ana sucker.
DATES: The finding announced in this notice was made on June 28, 1996.
Comments and materials may be submitted until further notice.
ADDRESSES: Data, information, comments, or questions concerning the
finding should be submitted to the Field Supervisor, Carlsbad Field
Office, U.S. Fish and Wildlife Service, 2730 Loker Avenue West,
Carlsbad, California 92008. The petition, finding, and supporting data
are available for public inspection, by appointment, during normal
business hours at the above address.
FOR FURTHER INFORMATION CONTACT: Paul J. Barrett (see ADDRESSES above),
telephone (619) 431-9440.
SUPPLEMENTARY INFORMATION:
Background
Section 4(b)(3)(A) of the Endangered Species Act (Act) of 1973, as
amended (16 U.S.C. 1531 et seq.) requires that the Service make a
finding on whether a petition to list, delist, or reclassify a species
presents substantial scientific or commercial information indicating
that the petitioned action may be warranted. To the maximum extent
practicable, this finding is to be made within 90 days of the receipt
of the petition, and the finding is to be published promptly in the
Federal Register. This finding is based on information contained in the
petition, supporting information submitted with the petition, and
otherwise available to the Service at the time the finding is made. If
the Service determines that the petitioned action may be warranted, the
Service will commence a review of the status of the involved species.
Status reviews will be commenced in accordance with priorities
established by the Service pursuant to the May 16, 1996, Final Listing
Priority Guidance (61 Fed Reg 24722).
On September 6, 1994, the Service received a petition dated
September 2, 1994, to list the Santa Ana speckled dace (Rhinichthys
osculus ssp.), Santa Ana sucker (Catostomus santaanae), and the Shay
Creek threespine stickleback (Gasterosteus aculeatus ssp.) as
endangered species. The petition was submitted by the Sierra Club Legal
Defense Fund, Inc., on behalf of seven groups. The seven groups are the
California-Nevada Chapter of the American Fisheries Society, The Nature
School, The California Sportfishing Protection Alliance, Friends of the
River, Izaak Walton League of America, California Trout, and Trout
Unlimited. The letter clearly identified itself as a petition and
contained the names, signatures, and addresses of the petitioners.
Accompanying the petition was supporting information relating to
taxonomy, ecology, and past and present distribution of all three
species.
The petition, supporting documentation, and other information
available in the Service files has been reviewed to determine if
substantial information is available to indicate that the requested
actions may be warranted. On the basis of the best scientific and
commercial information available, the Service finds the petitioned
action may be warranted for the Santa Ana sucker because of the threats
to low population numbers, and is not warranted for the Santa Ana
speckled dace based on taxonomic uncertainty. While the petitioners
failed to present substantial information indicating that the Shay
Creek threespine stickleback should be listed as a subspecies or
distinct vertebrate population segment, the Shay Creek threespine
stickleback is presently regarded as a population of the unarmored
threespine stickleback and already receives the protections of the Act.
A status review will be commenced in accordance with the Final Listing
Priority Guidance for the Santa Ana sucker.
Santa Ana Sucker
The Santa Ana sucker (Catostomus santaanae) is a member of the
sucker family (Catostomidae). The Santa Ana sucker was originally
described as Pantosteus santa-anae by Snyder (1908, as in Moyle 1976).
The genus Pantosteus was reduced to a subgenus of Catostomus and the
hyphen omitted from the specific name in a subsequent revision of the
nomenclature (Smith 1966). The American Fisheries Society
[[Page 36022]]
recognizes the Santa Ana sucker as the full species, C. santaanae
(Robins et al. 1991).
The Santa Ana sucker's historical range includes the Los Angeles,
San Gabriel, and Santa Ana River drainage systems located in southern
California (Smith 1966). An introduced population also occurs in the
Santa Clara River drainage system in southern California (Moyle 1976).
Moyle and Yoshiyama (1992) state that only the San Gabriel River
population can be considered relatively viable and self-sustaining
within the native range.
Although the Santa Ana sucker was described as common in the 1970s
(Moyle 1976), the species has experienced dramatic declines throughout
most of its range (Moyle and Yoshiyama 1992). Santa Ana suckers have
adaptations such as short generation time, high fecundity and a
relatively prolonged spawning period that presumably allows them to
rapidly repopulate streams after severe flooding events (Greenfield et
al. 1970). Nevertheless, they are intolerant of polluted or highly
modified streams (Moyle and Yoshiyama 1992).
This apparent, overall decline is of concern given this species'
high fecundity and apparent broad habitat tolerances. Urbanization,
water diversions, dams, pollution, heavy recreational use, gold mining
wastes, gravel extraction, and introduced competitors and or predators
have probably contributed in the decline of the species (Moyle and
Yoshiyama 1992, Swift et al, 1993).
Swift (in Moyle and Yoshiyama 1992) summarized the status and
threats facing each of the populations in their native range.
Los Angeles River (Big Tujunga Creek below Big Tujunga
Dam)--Extreme fluctuations in water quality pose problems for all
fishes in this reach. The Santa Ana sucker is very rare and may already
be lost here.
San Gabriel River (contiguous West, North, and East forks
about 40 km below Cogswell Dam)--The West Fork is threatened by
accidental high flows from Cogswell Reservoir that have devastated this
reach in the past. The Cattle Canyon tributary of the East Fork is
impacted by increased gold mining (suction dredging) and the population
has been much reduced or may be absent in Cattle Canyon.
Santa Ana River--Several hundred fish were observed below
Prado Dam in 1986 and 1987, although sampling above the dam in 1987
yielded only five Santa Ana suckers. Water quality is threatened by
many and various local inputs, such as runoffs from light industry and
surrounding farmed lands (T. Haglund, personal communication).
Subsequent to the receipt of the petition, a general fish survey of
the Santa Ana River below Prado Dam yielded only 5 suckers from a total
of approximately 150 fishes captured (Mike Guisti, California Game and
Fish Department, pers. comm.). A survey of the East Fork of the San
Gabriel River above the confluence with Cattle Canyon found the sucker
to be relatively common, 125 of 382 fish captured (Paul Barrett, pers.
obs., Fish and Wildlife Service files). The Santa Ana sucker's present
status in the Los Angeles River is unknown.
The Service finds that the petitioners provided substantial
evidence that the petitioned action may be warranted for the Santa Ana
sucker.
Santa Ana Speckled Dace
The Santa Ana speckled dace is found in the headwaters of the Santa
Ana and San Gabriel river drainages, often in isolated stocks. The
petitioners presented a variety of information suggesting that the
Santa Ana speckled dace is an undescribed subspecies of Rhinichthys
osculus, member of the Cyprinidae family. While the petitioners assert
that the Santa Ana speckled dace is a valid subspecies, they did not
provide a peer-reviewed paper supporting that conclusion, nor did they
provide a draft manuscript that the Service could subject to peer
review. In fact, citing Moyle (1976), the petitioners actually point
out difficulties with speckled dace systematics, ``Although
systematists now seem to have little trouble placing the many forms
into Rhinichtys osculus (Hubbs, Miller, and Hubbs, 1974), the status of
the many described (and undescribed) subspecies can only be called
chaotic.'' The primary support for subspecific status includes
reference to a Master's thesis (Cornelius 1969) which was not included
with the petition, and reference to unpublished genetic data. Other,
anecdotal evidence supporting subspecific status includes a species
account written by C.C. Swift that was included as pages 207-212 in a
document entitled Fishes, Aquatic Diversity Management Areas, and
Endangered Species: A Plan to Protect California's native Aquatic
Biota, edited by Moyle and Yoshiyama (1992). This account cites a paper
by Hubbs et al. (1979) that includes the Santa Ana speckled dace as an
unnamed subspecies, but a copy of the paper was not provided and the
literature cited section of the account did not include a citation that
would allow the Service to identify the paper.
Shay Creek Threespine Stickleback
The petitioners indicated that the Shay Creek threespine
stickleback is an undescribed form of the threespine stickleback
(Gasterosteus aculeatus) that should be listed separately from the
endangered unarmored threespine stickleback. The Service regards the
Shay Creek threespine stickleback as a population of the Federally
listed unarmored threespine stickleback and the petitioners failed to
present substantiated scientific information indicating that the
petitioned action may be warranted. Specifically, the petitioners did
not present peer-reviewed information supporting their claim that the
Shay Creek threespine stickleback is a separate subspecies or distinct
vertebrate population. In light of this decision and until the Service
is presented with substantiated information to the contrary, the Shay
Creek threespine stickleback remains a population of the Federally
endangered unarmored threespine stickleback.
It is Service policy to issue not-substantial 90-day findings on
petitions for species or subspecies if that designation has not passed
scientific peer review either as part of acceptance for publication or
through some other equivalent review. The Santa Ana speckled dace and
Shay Creek threespine stickleback are not so named. Should the Santa
Ana speckled dace or Shay Creek threespine stickleback be determined to
be a valid subspecies as evidenced by a description in a peer-reviewed
scientific journal, or a distinct population segment in accord with the
February 7, 1996, ``Recognition of Distinct Vertebrate Population
Segments Under the Endangered Species Act `` (61 FR 4722), the Service
may consider a proposal to list this species in accordance with the
Service's listing priority guidance. In addition to taxonomic
information, any new petition should clearly identify threats to the
taxa, including estimates of the probability of catastrophic events to
the populations.
The Service will continue to seek information regarding the Santa
Ana speckled dace. As additional data becomes available in the future,
the Service may reassess the need for preparing a proposal to list this
species, in accordance with the final Listing Priority Guidance.
Conformance with Listing Priority Guidance
On May 16, 1996 the Service published a description of how it will
prioritize the various listing actions for the remainder of fiscal year
1996 (61 FR
[[Page 36023]]
24722-24728). Based on the listing priority guidance, the subject
finding would characteristically have been assigned to tier 3 and
processing would have been delayed until a later date. Despite requests
for deference to the listing priority guidance, however, the Service
has received no relief and is compelled by court order to issue this
finding.
References Cited
Buth, D. G. and C. B. Crabtree. 1982. Genetic variability and
population structure of Catostomus santaanae in the Santa Clara
drainage. Copeia, 1982:439-444.
Greenfield, D. W., S. T. Ross, and G. D. Deckert. 1970. Some aspects
of the life history of the Santa Ana sucker, Catostomus (Pantosteus)
santaanae (Snyder). California Fish and Game 56:166-179.
Haglund, T. A. and D. G. Buth. 1988. Allozymes of the unarmored
threespine stickleback (Gasterosteus aculeatus williamsoni) and
identification of the Shay Creek population. Isozyme Bulletin,
21:196.
Hubbs, W. I. Follett, and L. C. Hubbs. 1979. List of fishes of
California. Occasional Papers of the California Academy of Sciences,
No. 133, 51 pp.
Moyle, P. B. 1976. Inland Fishes of California. University of
California Press, 405 pp.
Moyle, P. B. and R. M. Yoshiyama. 1992. Fishes, aquatic diversity
management areas, and endangered species: Plan to protect
California's native aquatic biota. The California Policy Seminar,
University of California.
Robins, C. R., R. M. Baily, C. E. Bond, J. R. Brooker, E. A.
Lachner, R. N. Lea, and W. B. Scott. 1991. Common and scientific
names of fishes of the United States and Canada. American Fisheries
Society Special Publication 20. Bethesda, Maryland.
Swift, C. C., T. R. Haglund, M. Ruiz, and R. N. Fisher. 1993. The
status and distribution of the freshwater fishes of southern
California. Bulletin of the Southern California Academy of Sciences,
92:1-67.
Author
This notice was prepared by Paul J. Barrett, Carlsbad Field Office
(see ADDRESSES section above).
Authority
The authority for this action is the Endangered Species Act of
1973, as amended (16 U.S.C. 1531 et seq.).
Dated: June 28, 1996.
John G. Rogers,
Acting Director, Fish and Wildlife Service.
[FR Doc. 96-17390 Filed 7-8-96; 8:45 am]
BILLING CODE 4310-55-P
Complete official Federal Register PDF
FR Doc. 96-17361 Elimination of Prior Approval Requirements for Establishment Drawings and Specifications, Equipment, and Certain Partial Quality Control ProgramsReopening of Comment Period
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Page 35990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17361]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
9 CFR Parts 304, 308, and 381
[Docket No. 95-032E]
RIN 0583-AB93
Elimination of Prior Approval Requirements for Establishment
Drawings and Specifications, Equipment, and Certain Partial Quality
Control Programs--Reopening of Comment Period
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is extending the
comment period for the proposed rule, ``Elimination of Prior Approval
Requirements for Establishment Drawings and Specifications, Equipment,
and Certain Partial Quality Control Programs'' (61 FR 19578, May 2,
1996) for 60 days.
DATES: Comments must be received on or before September 9, 1996.
ADDRESSES: Submit one original and two copies of written comments to:
FSIS Docket Clerk, DOCKET #95-032P, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 4352, 1400 Independence Ave.,
SW, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Associate Deputy
Administrator, Science and Technology; (202) 205-0699.
Done in Washington, DC, July 2, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-17361 Filed 7-8-96; 8:45 am]
BILLING CODE 3410-DM-P
Complete official Federal Register PDF
FR Doc. 96-17360 Performance Standards for the Production of Certain Cooked Meat and Poultry ProductsReopening of Comment Period
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Page 35990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17360]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 318, 320, and 381
[Docket No. 95-033E]
RIN 0583-AB94
Performance Standards for the Production of Certain Cooked Meat
and Poultry Products--Reopening of Comment Period
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is extending the
comment period for the proposed rule, ``Performance Standards for the
Production of Certain Cooked Meat and Poultry Products'' (61 FR 19564,
May 2, 1996) for 60 days.
DATES: Comments must be received on or before September 9, 1996.
ADDRESSES: Submit one original and two copies of written comments to:
FSIS Docket Clerk, DOCKET #95-033P, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 4352, 1400 Independence Ave.,
SW, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Associate Deputy
Administrator, Science and Technology; (202) 205-0699.
Done in Washington, DC, July 2, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-17360 Filed 7-8-96; 8:45 am]
BILLING CODE 3410-DM-P
Complete official Federal Register PDF
FR Doc. 96-17319 Clean Air Act Approval and Promulgation of State Implementation Plan for Colorado; Carbon Monoxide Attainment Demonstrations and Related SIP Elements for Denver and Longmont; Clean Air Act Reclassification
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 36004-36012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17319]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52 and 81
[CO43-2-6865; CO43-1-6931; FRL-5532-07]
Clean Air Act Approval and Promulgation of State Implementation
Plan for Colorado; Carbon Monoxide Attainment Demonstrations and
Related SIP Elements for Denver and Longmont; Clean Air Act
Reclassification
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Proposed Rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency today proposes approval of
the State Implementation Plan (SIP) revisions submitted by the State of
Colorado for the purpose of bringing about the attainment of the
national ambient air quality standards (NAAQS) for carbon monoxide
(CO). The implementation plan revisions were submitted by the State to
satisfy certain Federal requirements for an approvable nonattainment
area CO SIP for Denver and Longmont. This action includes proposed
approval of revisions to Colorado Regulations 11 (vehicle inspection
and maintenance) and 13 (oxygenated fuels) submitted to satisfy
conditions in the SIP. It also includes proposed reclassification of
the Denver CO nonattainment area from Moderate to Serious. The
rationale for the approvals and reclassification are set forth in this
document. Additional information is available at the address indicated
below.
DATES: Comments on this proposed action must be received in writing by
August 8, 1996.
ADDRESSES: Comments should be addressed to: Richard R. Long, Director
of Air Programs (8P2-A), Environmental Protection Agency, Region VIII,
999 18th Street, Suite 500, Denver, Colorado 80202-2466.
Copies of the State's submittals and other information are
available for inspection during normal business hours at the following
locations: Environmental Protection Agency, Region VIII, Air Programs,
999 18th Street, 3rd Floor, South Terrace, Denver, Colorado 80202-2466;
and Colorado Air Pollution Control Division, 4300 Cherry Creek Dr.
South, Denver, Colorado 80222-1530.
FOR FURTHER INFORMATION CONTACT: Jeff Houk at (303) 312-6446.
SUPPLEMENTARY INFORMATION:
I. Background
The air quality planning requirements for moderate CO nonattainment
areas are set out in sections 186-187 of the Clean Air Act (Act)
Amendments of 1990 (CAAA) which pertain to the classification of CO
nonattainment areas and to the submission requirements of the SIP's for
these areas, respectively. The EPA has issued a ``General Preamble''
describing EPA's preliminary views on how EPA intends to review SIP's
and SIP revisions submitted under Title I of the Act, [see generally 57
FR 13498 (April 16, 1992) and 57 FR 18070 (April 28, 1992)]. Because
EPA is describing its interpretations here only in broad terms, the
reader should refer to the General Preamble for a more detailed
discussion of the interpretations of Title I advanced in today's
proposal and the supporting rationale. In today's rulemaking action on
the Denver and Longmont CO SIPs, EPA is proposing to apply its
interpretations taking into consideration the specific factual issues
presented. Thus, EPA will consider any timely submitted comments before
taking final action on today's proposal.
This Federal Register document specifically addresses several
requirements of the 1990 CAAA which were required to be submitted no
later than November 15, 1992, and which the State did not submit by
that date. These requirements include an attainment demonstration,
contingency measures and, for Denver, a vehicle miles travelled
forecasting and tracking program and transportation control measures.
EPA made a formal finding that the State had failed to submit these SIP
revisions in a letter to Governor Roy Romer dated January 15, 1993.
This Federal Register document also addresses revisions to Regulations
11 and 13, submitted by the State of Colorado to implement portions of
the control strategy relied upon by the attainment demonstration.
Section 187(a)(7) required those States containing CO nonattainment
areas with design values greater than 12.7 parts per million (ppm) to
submit, among other things, an attainment demonstration by November 15,
1992, demonstrating that the plan will provide for attainment by
December 31, 1995 for moderate CO nonattainment areas and December 31,
2000 for serious CO nonattainment areas. The attainment demonstration
must include a SIP control strategy, which is also due by November 15,
1992. The SIP control strategy for a given nonattainment area must be
designed to ensure that the area meets the specific annual emissions
reductions necessary for reaching attainment by the deadline. In
addition, section 187(a)(3) requires these areas to implement
contingency measures if any estimate of actual vehicle miles travelled
(VMT) or any updated VMT forecast for the area contained in an annual
report for any year prior to attainment exceeds the number predicted in
the most recent VMT forecast. Contingency measures are also triggered
by failure to attain the NAAQS for CO by the attainment deadline.
Contingency measures must be submitted with the CO SIP by November 15,
1992. Finally, a vehicle miles travelled forecasting and tracking
program is required by Section 187(a)(2)(A), and transportation control
measures are required for Denver by Section 187(a)(2)(B). These
requirements are discussed in more detail below and in the Technical
Support Document for this proposed action.
Longmont had been designated as unclassifiable/attainment prior to
passage of the 1990 CAAA. However, a special monitoring study in 1988-
89 recorded an exceedance of the NAAQS in Longmont. As a result, EPA
Region VIII recommended that the Governor designate this area
nonattainment, and on March 15, 1991, the Governor submitted a
nonattainment designation for this area that was later codified by EPA
at 40 CFR Part 81. Since this area had never had a SIP, EPA interpreted
Section 172 of the Act to require an attainment demonstration for
Longmont. Contingency measures under Section 172(c)(9) were also
required. On January 15, 1993, EPA made a formal finding that the State
had failed to submit these SIP revisions for Longmont.
On July 11, 1994 and July 13, 1994, Governor Roy Romer submitted
comprehensive revisions to the Colorado SIP. The carbon monoxide SIP
element submittals for Denver and Longmont addressed the outstanding
CAA requirements discussed above, as well as other CAA mandates. The
July 11, 1994 CO SIP revision for Denver was developed primarily by the
Colorado Department of Health's Air Pollution Control Division (APCD),
the Colorado Air Quality Control Commission (AQCC), and the Regional
Air Quality Council (RAQC), which represents local government and
citizen interests. The July 13, 1994 CO SIP revision for Longmont was
developed primarily by the APCD, in consultation with the City of
Longmont.
[[Page 36005]]
The Act requires States to observe certain procedural requirements
in developing implementation plans and plan revisions for submission to
EPA. Section 110(a)(2) of the Act provides that each implementation
plan submitted by a State must be adopted after reasonable notice and
public hearing.1 Section 110(l) of the Act similarly provides that
each revision to an implementation plan submitted by a State under the
Act must be adopted by such State after reasonable notice and public
hearing.
---------------------------------------------------------------------------
\1\ Also, Section 172(c)(7) of the Act requires that plan
provisions for nonattainment areas meet the applicable provisions of
section 110(a)(2).
---------------------------------------------------------------------------
The EPA also must determine whether a submittal is complete and
therefore warrants further EPA review and action [see section 110(k)(1)
and 57 FR 13565]. The EPA's completeness criteria for SIP submittals
are set out at 40 CFR Part 51, Appendix V (1991), as amended by 57 FR
42216 (August 26, 1991). The EPA attempts to make completeness
determinations within 60 days of receiving a submission. However, a
submittal is deemed complete by operation of law if a completeness
determination is not made by EPA within six months after receipt of the
submission.
The AQCC held a public hearing on June 16, 1994 to entertain public
comment on the implementation plan revisions for Denver and Longmont.
Following the public hearing, the SIP revisions were adopted by the
AQCC, and forwarded to the Colorado Legislative Council for review.
(Under Colorado law, SIP revisions imposing new or revised controls on
mobile sources must be reviewed and accepted by the Colorado
Legislative Council.) The AQCC held an emergency hearing on July 7,
1994, to address concerns with the Denver SIP raised by the Legislative
Council, and on July 11 and July 13, 1994, the SIP revisions were
submitted to EPA by the Governor for approval.
The SIP revision was reviewed by EPA to determine completeness
shortly after its submittal, in accordance with the completeness
criteria set out at 40 CFR Part 51, Appendix V (1991), as amended by 57
FR 42216 (August 26, 1991). The submittal was found to be complete, and
a letter dated July 14, 1994 was forwarded to the Governor indicating
the completeness of the submittal and the next steps to be taken in the
review process. The applicable Clean Air Act requirements and EPA's
rationale for its proposed actions are discussed below.
Denver
A. Attainment Demonstration and Control Strategies
(1) Attainment Demonstration
As noted, CO nonattainment areas with design values greater than
12.7 ppm were required to submit a demonstration by November 15, 1992,
that the plan will provide for attainment by December 31, 1995 for
moderate CO nonattainment areas and December 31, 2000 for serious CO
nonattainment areas. APCD conducted an attainment demonstration using
urban areawide modeling in conjunction with intersection modeling for a
modeling region encompassing the Denver nonattainment area.
The CO NAAQS are for 1-hour and 8-hour periods and are not to be
exceeded more than once per year. The 1-hour CO NAAQS is 35 ppm (40 mg/
m3) and the 8-hour CO NAAQS is 9 ppm (10 mg/m3). The
demonstration predicted that the highest 8-hour design concentration as
of the attainment date will be 8.91 ppm, thus demonstrating attainment
of the 8-hour CO NAAQS. No demonstration was required to be carried out
for the 1-hour NAAQS, as Denver has not violated this NAAQS since
before the 1990 CAAA were enacted. The same strategies which bring the
area into attainment with the 8-hour NAAQS will also contribute to
reduced 1-hour concentrations. The modeled attainment demonstration is
discussed in greater detail below.
(a) Policy Issues: Reclassification to Serious and Applicability of
Serious Area SIP Requirements
(i) Reclassification to Serious. During the SIP development
process, the RAQC conducted an exhaustive review of control strategies
for use in demonstrating attainment of the CO NAAQS by the Clean Air
Act-mandated deadline for moderate areas of December 31, 1995. Even
with the oxygenated fuels program and an enhanced I/M program in place,
the RAQC and APCD determined that a 30% reduction in emissions would
still be needed to attain the NAAQS by this date. Any measures would
need to be implemented in the 18-month period between SIP adoption (in
June 1994) and the attainment date, ruling out many potential
strategies with longer implementation horizons. The RAQC considered
several aggressive strategies, including a mandatory no-drive day for
high emitting vehicles, but was unable to identify a package of
strategies that would provide the necessary emission reductions by
December 31, 1995.
As a result, the RAQC recommended to the AQCC that the Denver area
seek reclassification to serious. If Denver were reclassified to
serious, the applicable attainment date would become December 31, 2000
(CAA Section 186(a)(1)). The AQCC adopted this recommendation, and the
Governor formally requested reclassification to serious in his July 11,
1994 letter submitting the SIP. As part of this Federal Register
document, EPA is proposing to reclassify the Denver-Boulder
nonattainment area to serious.
EPA had originally intended to rely upon the authority for
reclassification provided by Section 110(k)(6) of the Clean Air Act.
This paragraph provides broad authority for EPA to correct previous
approvals, disapprovals, designations, and classifications based on new
information. However, air quality data collected during calendar year
1995 show that the Denver area experienced two exceedances of the CO
NAAQS in 1995 at the CAMP monitor. Because of this, Denver cannot
demonstrate attainment of the NAAQS by the statutory December 31, 1995
attainment date for moderate areas, and must be reclassified, by
operation of law, to serious. Under Section 186(b)(2)(A), a moderate
carbon monoxide nonattainment area must be reclassified as serious by
operation of law if the Administrator finds that the area has failed to
attain the CO NAAQS. Pursuant to Section 186(b)(2)(B), EPA must publish
a document in the Federal Register identifying those areas that failed
to attain the NAAQS and the resulting classifications. In this
document, EPA is proposing to find that the Denver/Boulder carbon
monoxide nonattainment area did not attain the NAAQS by the required
attainment date of December 31, 1995, and to revise the area's
classification for carbon monoxide in 40 CFR Part 81 from moderate to
serious.
(ii) Impacts of Reclassification to Serious. Areas classified as
serious are required to attain the CO NAAQS no later than December 31,
2000. In addition, the following additional requirements of CAA Section
187 apply:
Gasoline sold during the winter months must contain a level of
oxygen necessary to attain the NAAQS. (CAA Section 187(b)(3))
A mandatory employer-based trip reduction program must be adopted
and implemented, unless it can be shown that such a program is not
necessary to demonstrate attainment of the NAAQS. (CAA Section
187(b)(2), referencing CAA Section 182(d)(1)(B))
A December 31, 1995 milestone must be identified, and an economic
[[Page 36006]]
incentive program must be adopted and implemented if the milestone is
not achieved or if the area fails to attain the CO NAAQS by December
31, 2000. (CAA Section 187(d))
Vehicle miles travelled forecasts must be submitted for the period
1996-2000 (submittal of vehicle miles traveled forecasts for 1993-1995
is required for moderate areas). (CAA Section 187(a)(2)(A))
Additional requirements for the content and analysis of
transportation plans, programs and projects apply under the EPA/DOT
transportation conformity regulations (58 FR 62215, November 24, 1993).
The oxygenated gasoline, VMT forecast, and conformity requirements
are discussed elsewhere in this document.
(iii) December 31, 1995 milestone demonstration. CAA Section 187(d)
requires areas classified as serious to submit a demonstration no later
than March 31, 1996, that the area has achieved CO emission reductions
equivalent to the total of the specified annual emission reductions
required by December 31, 1995. The Act does not provide further
guidance on the form or content of the milestone itself, the specified
annual emission reductions, or the nature of the milestone
demonstration. EPA has not issued guidance on this matter.
Since the Act does not prescribe a methodology for determining a
milestone and EPA has not issued guidance for this purpose, the State
has chosen to use its 1995 base case emission inventory as the
milestone (Section XII-D of the SIP). The milestone level is 1396 tons
per day in the nonattainment area; this level represents progress
toward attainment from the 1988 level of 1709 tons per day.
(iv) Employer-based trip reduction program (the ECO program). CAA
Section 187(b)(2) requires areas classified as serious to adopt the
measures required by Section 182(d)(1). These measures consist of
transportation control measures (CAA Section 182(d)(1)(A)) and a
mandatory employer-based travel reduction program (commonly known as
the Employee Commute Options, or ECO, program) (CAA Section
182(d)(1)(B)). Section 187(b)(2) also provides that, in any area
defined as a ``covered area'' under the Clean Fuel Fleet Program
requirements of Section 246(a)(2)(B) (the Denver area meets this
definition), a SIP may exclude any of the Section 182(d)(1) measures if
(1) the SIP includes an explanation of why any measure was not adopted
and what emission reduction measure was adopted to provide comparable
reduction in emissions, or (2) the SIP contains reasons why such
reduction is not necessary to attain the national primary ambient air
quality standard for CO. (As a moderate area, Denver was already
required by the ``Special Rule for Denver,'' Section 187(a)(2)(B), to
address the transportation control measure requirements of Section
182(d)(1)(A). These requirements are discussed in Chapter X of the
SIP.)
The SIP demonstrates that no TCMs are necessary to provide for
attainment of the NAAQS by December 31, 2000 (attainment demonstration,
Tables XII-1 and XII-2). However, several TCMs were adopted as part of
the SIP, including transportation management associations to encourage
and provide technical support for voluntary employer-based trip
reduction activities; financial incentives for subsidized employee
transit passes and other travel reduction strategies for downtown
Denver employees; transit passes for students at the Auraria campus in
downtown Denver; high-occupancy vehicle lanes on Broadway and Lincoln,
two major arterials providing access to the central business district;
and improved traffic signalization in the central business district and
elsewhere in the nonattainment area. Appendix X-A of the SIP also
discusses several other TCMs that were adopted and implemented as part
of the 1979 and 1982 SIPs for Denver and remain in effect.
Section X.F. of the SIP provides the formal justification for
exclusion of the ECO program from the Denver SIP. However, on December
23, 1995, the President signed revisions to the ECO requirements of the
Clean Air Act. These revisions amended the Act to make submittal of a
SIP revision providing for the ECO program voluntary for areas which
are bumped up to a higher classification (and thus, newly made subject
to the requirement). Thus, the State would have no longer been required
to submit such program, even if EPA had initially interpreted the Act
to require this program for Denver.
(b) Technical Evaluation of Attainment Demonstration
EPA is proposing to approve the State's attainment demonstration
for Denver. EPA has determined that the State correctly applied
national guidance in conducting modeling of the entire region and of
six intersections that could potentially cause violations of the CO
NAAQS. In addition, the State complied with a Region VIII request to
conduct modeling of downtown intersections above and beyond the six
required by national guidance. However, due to the factors described
below, the model could not be properly applied to two high-traffic
downtown intersections: Speer/Auraria and Broadway/Colfax. Model
predictions at these two sites were affected by uncertainties in
meteorological and motor vehicle emissions inputs. In addition, the
modeled predictions of high ambient values at these intersections were
not supported by saturation monitoring data obtained at the same
locations. Thus, the attainment demonstration is based on modeled and
monitored values at a third downtown intersection, CAMP, which has
historically recorded the highest CO concentrations in the Denver metro
area. These issues are discussed in greater detail below.
A variety of specialized models were used to model the Denver area
carbon monoxide concentrations in accordance with EPA guidance. The
Urban Airshed Model (UAM) was used to simulate regional concentrations
during two historical episodes when very high carbon monoxide levels
occurred. During these same episodes the CAL3QHC model was used to
simulate concentrations from local streets and roadways. The outputs
from both models were added together so that total predicted
concentrations could be compared with values actually measured at the
monitoring sites during these episodes. These comparisons determine if
the modeling meets the performance criteria prescribed in the UAM
guidance document, and in the modeling protocol. For both episodes
there was a tendency for the UAM/CAL3QHC model to underpredict
concentrations. However, the degree of underprediction was within the
limits specified in EPA UAM Guidance documents, and in the modeling
protocol.
The validated UAM/CAL3QHC model was then applied in the attainment
year (2000) to determine whether proposed control strategies are
sufficient to meet the 8-hour ambient air quality standard (9.0 ppm).
The same meteorological conditions used in the model validation runs
were used in the 2000 model runs. However, the 2000 runs were modeled
with revised emission input files to examine the benefits of the
various control strategies. The 2000 attainment runs showed that the
control strategies in the SIP are sufficient to reduce carbon monoxide
concentrations to less than 9.0 ppm at all locations in the
nonattainment area.
The Denver CO modeling protocol was approved by EPA Region VIII in
[[Page 36007]]
May 1992. Specific intersections to be modeled were not identified in
the protocol. The State showed attainment on each of the six highest
ranked intersections selected for modeling, following screening
criteria contained in ``Guideline for Modeling CO from Roadway
Intersections'', EPA-454/R-92-005. The State subsequently found that
the six busiest intersections for traffic congestion were located in
the suburban areas, where background air quality levels are relatively
low. Application of CAL3QHC at these six locations, combined with UAM
predicted background levels, showed the year 2000 concentrations at
levels well within the CO NAAQS. The Region requested the State to
model an additional intersection in the central business district, to
ensure that control strategies provide for attainment at hot spot
locations in the urban core area, not just at suburban locations
exposed to significantly lower background concentrations.
The State performed preliminary CAL3QHC modeling at three
additional intersections in the Downtown area: Speer & Auraria;
Broadway & Colfax; and Broadway & Champa. These preliminary 1995
results showed predicted concentrations at Speer/Auraria and Broadway/
Colfax up to 6 ppm higher than concentrations modeled at the CAMP
monitor (Broadway & Champa). Because of uncertainties related to the
validity of meteorological inputs used in the model, the State opted
not to include the CAL3QHC modeling results for the two higher
intersections in the current SIP, deferring consideration of these
locations until additional saturation monitoring studies could be
conducted at these intersections. The State selected Broadway and
Champa as the intersection to use in the SIP attainment demonstration
because the on-site air quality and meteorology monitoring data
available at this location provided more confidence in the results,
i.e., produced modelled concentrations that were in good agreement with
concentrations actually monitored at the site. There are significant
and unique micro-meteorological effects influencing each of the three
central business district intersections, including: high-rise office
buildings, channeling of the wind down ``urban street canyons'', and
urban heat island effects. Since the Diagnostic Wind Model (DWM) used
with UAM does not include any of these effects, the State did not
consider the meteorological outputs from DWM appropriate for use in
microscale modeling.
The State's intersection analysis is consistent with national
policy and other recent UAM/CAL3QHC modeling applications. Additional
information on the attainment demonstration modeling is included in the
Technical Support Document for this action.
(2) Control Strategies
Section 172(c)(1) requires the plans for all nonattainment areas to
provide for the implementation of RACM (including RACT) as
expeditiously as practicable and to provide for attainment of the
NAAQS. The EPA interprets this requirement to impose a duty on all
nonattainment areas to consider the available control measures, and to
adopt and implement such measures as are reasonably available for
implementation in the area and necessary for attainment of the NAAQS as
components of the area's attainment demonstration. The EPA has reviewed
the State's explanation and associated documentation and concluded that
it adequately justifies the control measures to be implemented. EPA is
proposing to approve several of the control strategies. The exact
nature of EPA's proposed approvals is discussed in more detail below
and in the Technical Support Document for today's action.
The Denver CO SIP takes credit for several control programs in the
attainment demonstration. Those identified in Chapter V of the SIP as
``baseline strategies'' are measures which were in existence at the
time of CO SIP development, and for which no further State regulatory
action was required. EPA is not taking action on these control
strategies through this SIP revision, as these are strategies which
have been adopted through previous SIP revisions and have been or are
being acted on in other Federal Register documents. Those identified as
``additional control strategies'' are measures which were newly-
considered and adopted for the attainment demonstration, and which are
being acted on in this SIP revision.
The baseline strategies include the Federal motor vehicle control
program, the 2.7% oxygenated fuels program (approved in the Federal
Register on July 25, 1994 (59 FR 37698)), the Enhanced inspection and
maintenance (I/M) program (conditionally approved in the Federal
Register on November 8, 1994 (59 FR 55584)), various transportation
system improvements, and the woodburning control measures adopted as
part of the Denver PM10 SIP (approved in the Federal Register on July
25, 1994 (59 FR 37698)).
In addition, Section 246 of the Clean Air Act requires that the
State adopt and implement the Clean Fuels Fleet Program, an alternative
fuels program for certain commercial and governmental fleet operations.
AQCC Regulation 17, the Clean Fuels Fleet Program regulation, was
adopted by the AQCC on May 5, 1994, and submitted with the Denver CO
SIP. (The full Clean Fuels Fleet Program SIP was submitted to EPA on
October 17, 1994.) A wide variety of non-mandated alternative fuels
programs are also underway in the Denver area. No credit is taken for
Regulation 17 or any of the other programs in the attainment
demonstration, and EPA will act on the Clean Fuels Fleet Program in the
Federal Register at a later date.
Several additional control strategies have been formally
incorporated into or committed to in the Denver CO SIP to provide for
attainment of the CO NAAQS by December 31, 2000. These measures are
described in Chapter VI of the SIP and are discussed below.
(a) 3.1% oxygenated fuels program. In the CO SIP, the State made a
commitment, which has since been met, to implement and adopt a 3.1%
oxygenated fuels program, providing additional benefit over the 2.7%
program already required of the area by Section 211(m) of the Act. The
program is being implemented in two phases. In the winter of 1994-95, a
``maximum blending'' program took effect, which requires gasoline
suppliers using methyl tert-butyl ether as an oxygenate to blend at the
2.7% oxygen level (the maximum allowed by Federal regulations), and
suppliers using ethanol as an oxygenate to blend at the 3.5% oxygen
level (also the maximum allowed by Federal regulations). The market
share of ethanol in the Denver area has exceeded 50% in recent years,
and this approach is expected to result in at least a 3.1% oxygen
content during each winter season. If the maximum blending approach
should fail to provide for at least a 3.1% oxygen content, the SIP
provides that in subsequent winter seasons an averaging program,
pursuant to EPA guidance for such programs, will take effect.
AQCC Regulation 13 governs the oxygenated fuels program. The SIP
committed to revise this regulation in two steps. Reg 13 was revised to
incorporate the maximum blending approach for the winter of 1994-95 by
the AQCC on July 19, 1994. Reg 13 was revised to incorporate the more
complex 3.1% averaging program on October 20, 1994. Both sets of
regulation revisions were submitted by the Governor for EPA approval on
September 29, 1995. The
[[Page 36008]]
September 29, 1995 submittal was determined complete on November 30,
1995.
(b) Increased I/M failure rate for pre-1982 vehicles. The SIP
includes a commitment, which has since been met, to revise Regulation
11, which governs the I/M program, to incorporate more stringent
emissions cutpoints which will increase the failure rate for pre-1982
vehicles from the current 14-26% to approximately 40%. Pre-1982
vehicles have less advanced emission control system technology,
resulting in higher CO emission levels, and the more stringent
cutpoints for these vehicles will result in the identification and
repair of a greater number of high-emitting vehicles than are captured
by the present I/M program (an increase of approximately 70,000
vehicles per year). These regulation revisions were adopted by the AQCC
on September 22, 1994, and submitted by the Governor for EPA approval
on September 29, 1995. The September 29, 1995 submittal was determined
complete on November 30, 1995.
(c) Prohibition on the re-registration of abandoned and impounded
pre-1982 vehicles sold at auction. This element of the SIP requires
local governments in the Denver area to modify their ordinances or
procedures for disposing of pre-1982 abandoned and impounded vehicles
to prohibit purchasers from obtaining any form of title to the
vehicles. These vehicles may be sold for scrappage or dismantling only.
This measure will accelerate the normal rate of removal of vehicles of
this age from the fleet, by preventing up to 5,000 vehicles of this
type from being re-registered. Elimination of this many pre-1982
vehicles could reduce regional CO emissions by up to 5 tons per day.
However, because of the difficulty of defining a concise emission
reduction, the State does not take credit for this strategy in the
attainment demonstration.
B. Transportation Control Measures
Section 187(a)(2)(B) (Special Rule for Denver) requires the State
to submit a SIP revision that includes the TCMs as required in Section
182(d)(1)(A) of the Act, for the purpose of reducing CO emissions. The
SIP may exclude any of the Section 182(d)(1)(A) measures if 1) the SIP
includes an explanation of why any measure was not adopted and what
emission reduction measure was adopted to provide comparable reduction
in emissions, or 2) the SIP contains reasons why such reduction is not
necessary to attain the national primary ambient air quality standard
for CO.
The TCM SIP revision is contained in Chapter X of the Denver CO
SIP. The TCMs adopted as part of the SIP are listed below. See the
Technical Support Document for today's document and the SIP itself for
a more detailed description of these measures.
(1) Employer-based transportation emission management programs
promoted and encouraged by transportation management associations and
financial incentives.
(2) Auraria transit pass.
(3) Conversion of Broadway/Lincoln Bus Lanes to Bus/HOV.
(4) Improved Traffic Signalization.
(5) Other Measures.
Appendix X-A contains the State's assessment of the measures listed
in Section 108(f), including a comprehensive description of strategies
already in place in Denver and the newly-adopted measures. Several TCMs
have already been adopted as part of the SIP in previous ozone and CO
SIP revisions, and have been approved by EPA (45 FR 51199, August 1,
1980, and 48 FR 55284, December 12, 1983). Appendix X-A also describes
projects and programs which are not being included in the SIP but
nevertheless provide some emission reduction benefit.
EPA is proposing to approve this element of the Denver CO SIP. The
SIP satisfies the requirement of Section 187(a)(2)(B) to either include
the TCMs or provide a justification for not including them. The
attainment demonstration for the SIP does not include credit for any of
the TCMs; however, the above measures were adopted as enforceable
provisions of the SIP.
C. Vehicle Miles Traveled Forecasting and Tracking
Section 187(a)(2)(A) of the Clean Air Act Amendments of 1990
required EPA, in consultation with the U.S. Department of
Transportation (DOT), to develop guidance for states to use in
complying with the VMT forecasting and tracking provisions of Section
187. A Notice of Availability for the resulting Section 187 VMT
Forecasting and Tracking Guidance was published in the Federal Register
on March 19, 1992. Section 187(a)(2)(A) requires Denver to submit a SIP
revision providing for a VMT forecasting and tracking program, and
contingency measures for implementation in the event that a VMT
forecast is exceeded. The specific requirements are discussed in detail
in the Technical Support Document for today's action.
The State of Colorado has submitted a SIP revision to EPA in order
to satisfy the requirements of Section 187(a)(2)(A) and Section
187(a)(3). In order to gain approval, the State submittal must provide
for each of the following mandatory elements: (1) a forecast of VMT in
the non-attainment area for each year prior to the attainment year; (2)
a provision for annual updates of the forecasts along with a provision
for annual reports describing the extent to which the forecasts proved
to be accurate; these reports shall provide estimates of actual VMT in
each year for which a forecast was required; (3) adopted and
enforceable contingency measures to be implemented without further
action by the State or the Administrator if actual annual VMT or an
updated forecast exceeds the most recent prior forecast or if the area
fails to attain the CO NAAQS by the attainment date.
(1) VMT Forecasts
Section 187(a)(2)(A) requires that the State include in its SIP
submittal a forecast of VMT in the non-attainment area for each year
before the year in which the SIP projects the National Ambient Air
Quality Standard for CO will be attained. The forecasts are to be based
on guidance developed by EPA in consultation with DOT, i.e., the
Section 187 VMT Forecasting and Tracking Guidance. Table XIV-2 of the
SIP contains the required forecasts of annual VMT for the years 1993-
2001.
(2) Annual VMT Updates/Reports
Section 187(a)(2)(A) specifies that the SIP revision provide for
annual updates of the VMT forecasts and annual reports that describe
the accuracy of the forecasts and that provide estimates of actual VMT
in each year for which a forecast was required. The Section 187 VMT
Forecasting and Tracking Guidance specifies that annual reports should
be submitted to EPA by September 30 of the year following the year for
which the VMT estimate is made. The SIP commits to the submission of
these annual reports and identifies responsibilities among the various
transportation agencies in Denver to develop the reports.
(3) Contingency Measures
Section 187(a)(3) specifies that the State, in its SIP revision,
adopt specific, enforceable contingency measures to be implemented if
the annual estimate of actual VMT or a subsequent VMT forecast exceeds
the most recent prior forecast of VMT or if the area fails to attain
the CO NAAQS by the attainment date. Implementation of the identified
contingency measures must not require further rulemaking activities by
the
[[Page 36009]]
State or EPA. Certain actions, such as notification of sources, would
probably be needed before a measure could be implemented effectively.
The State has met this requirement, as discussed in Section D. below.
The State of Colorado has submitted a SIP revision implementing each of
the required elements required by Section 187(a)(2)(A) and Section
187(a)(3) of the CAAA.
D. Contingency Measures
The Clean Air Act requires each CO nonattainment area with a design
value above 12.7 ppm at the time of classification to adopt contingency
measures that will take effect without further action by the State or
EPA upon a determination by EPA that an area failed to make reasonable
further progress or to attain the standards, as described in
Sec. 172(c)(9), or that actual or forecasted VMT exceeded a previous
forecast. Section 187(a)(3) requires the State to submit a SIP revision
containing contingency measures no later than November 15, 1992. The
State submitted these measures as part of the Denver CO SIP on July 11,
1994.
States may implement contingency measures early to obtain
additional emission reductions, without being required to adopt
replacement contingency measures to put in place should one of the
triggering events for implementation of contingency measures occur.
This policy is described in a memorandum from Tom Helms, Chief of the
OAQPS Ozone Policy and Strategies Group entitled ``Early Implementation
of Contingency Measures for Ozone and Carbon Monoxide Nonattainment
Areas,'' August 13, 1993.
As noted above, the State did not take credit in the attainment
demonstration for the TCMs adopted to meet the requirements of Section
187(a)(2)(B). Because these measures are surplus to the reductions
needed for attainment, the State has adopted these as the required
contingency measures as well. The Denver region is proceeding with
early implementation of these measures to obtain the additional
emission reductions they provide.
If a triggering event for contingency measures occurs, EPA will
review the status of implementation of the TCMs adopted in Chapter X of
the SIP. Each of the TCMs must be fully implemented in order to satisy
the contingency measures requirements of Sections 172 and 187. In
addition, the EPA/DOT transportation conformity regulation (58 FR
62235, November 24, 1993) requires DRCOG and USDOT to demonstrate that
SIP TCMs are being implemented or are on schedule for implementation
before making a conformity determination for transportation plans or
TIPs. This provides an extra degree of assurance that the contingency
measures will be implemented if needed.
Section XIII.C. of the SIP defines the target emissions reduction
level for contingency measures. Based on average projected annual VMT
growth between 1995 and 2000 and the modeled fleet emission factors for
those years, the State determined that minimum emission reductions of
26 tons per day in 1995 and 16 tons per day in 2000 represented the
minimum emission reduction levels for contingency measures pursuant to
EPA guidance. The TCMs, when fully implemented, are projected to
produce an emission reduction of 34 tons per day in the year 2000. The
emission reductions would be higher in earlier years, since the
baseline fleet emission factors to which the contingency measure
effectiveness would be applied are higher. Thus, the submittal
satisfies EPA's minimum criteria for contingency measure effectiveness.
E. Mobile Source Emissions Budgets and Transportation Conformity
Section 176(c)(1) of the Act directs that no department, agency, or
instrumentality of the federal government may permit any activity that
does not conform to a SIP. Section 176(c)(2) further specifies that
federally funded transportation improvement programs (TIPs), regional
transportation plans, and projects must conform to the SIP in order to
be adopted by the metropolitan planning organization. EPA and DOT
promulgated implementing regulations for this CAA provision on November
24, 1993 (58 FR 62235).
One key provision of the conformity regulations requires a
demonstration that emissions from the transportation plan and TIP are
consistent with the emissions budget in the SIP (Sections 93.118 and
93.119 of the conformity rule). The emissions budget is defined as the
level of mobile source emissions relied upon in the attainment and/or
maintenance demonstration to achieve compliance with the NAAQS in the
nonattainment area. The rule's requirements and EPA's policy on
emissions budgets are found in the Preamble to the transportation
conformity rule (58 FR 62193-96) and in the sections of the rule
referenced above. The SIP defines emissions budgets for the 1995
milestone year and the 2000 attainment year.
The 1995 budget is consistent with the mobile source emissions
estimate for the milestone year and is 1125 tons per day in the
nonattainment area. This budget no longer applies for conformity, since
that date has passed. For the year 2000, the SIP includes modeling for
scenarios with and without TCMs. The RAQC recommended that the AQCC
adopt the emissions budget for the scenario without TCMs as the budget
to be used for conformity (825 tons per day in the nonattainment area).
However, the AQCC adopted (and the Governor submitted) an emission
budget of 808 tons per day in the nonattainment area. This lower budget
reflected some (not all) of the emissions reductions associated with
the implementation of the TCMs. The AQCC felt that this lower budget
would provide a margin of safety for attainment and would provide an
extra incentive (through the conformity requirements) for
implementation of the TCMs.
Subsequent to submittal of the SIP, DRCOG completed an initial
conformity analysis for the 2015 transportation plan and the 1995-2000
TIP, and found that the plan and TIP could not conform to the lower
budget adopted by the AQCC and submitted to EPA. In response, the RAQC
adopted a resolution requesting that the AQCC revise the SIP to raise
the emission budget to the attainment level of 825 tons per day. The
AQCC adopted this SIP revision after a public hearing on February 16,
1995, and the Governor submitted this SIP revision on July 18, 1995.
The Governor's July 18, 1995 letter withdraws the 808 ton per day
emission budget submitted on July 11, 1994. This leaves the default
budget of 825 tons per day from the attainment demonstration as the
applicable budget under EPA's conformity rule. Since EPA is proposing
to approve the attainment demonstration, the 825 ton per day budget
that the attainment demonstration is based on would be approved by
default, and no separate action is necessary on the July 18, 1995
submittal of this budget.
Section 93.106(b) of the conformity rule requires that the
transportation plans in moderate nonattainment areas reclassified to
serious meet certain content and analysis requirements. These new
requirements would affect plans adopted two years after
reclassification to serious. Once EPA reclassifies the Denver area to
serious, these requirements will take effect two years thereafter.
DRCOG's transportation planning methodologies already meet many of
these requirements.
[[Page 36010]]
Longmont
A. Background of Sip Revision
Pursuant to the requirements of the 1990 Clean Air Act Amendments,
each State was required to identify its nonattainment areas and submit
descriptions of these areas for EPA promulgation in 40 CFR Part 81.
Longmont had been designated as unclassifiable/attainment prior to
passage of the 1990 Amendments. However, a special monitoring study in
1988-89 recorded an exceedance of the NAAQS in Longmont. (This study is
described in Chapter II of the Longmont SIP.) As a result, EPA Region
VIII recommended that the Governor designate this area nonattainment in
a letter dated January 15, 1991. In a letter dated March 15, 1991,
Governor Roy Romer submitted a request that Longmont be designated a
moderate nonattainment area, and submitted boundaries for the new area.
The designation, classification and boundaries were promulgated by EPA
in the Federal Register on November 6, 1991 (56 FR 56733).
Since this area had never had a SIP, EPA interpreted Section 172 of
the Act to require an attainment demonstration for Longmont. As a
moderate area, the applicable attainment date for Longmont is December
31, 1995. Contingency measures under Section 172(b)(9) were also
required. On January 15, 1993, EPA made a formal finding that the State
had failed to submit these SIP revisions for Longmont.
On July 13, 1994, Governor Roy Romer submitted comprehensive
revisions to the Colorado SIP. The carbon monoxide SIP element
submittal for Longmont addressed the outstanding CAA requirements
discussed above, as well as other CAA mandates. EPA found this SIP
element complete on July 14, 1994. The CO SIP revision for Longmont was
developed primarily by APCD, in consultation with the City of Longmont.
The SIP development process is discussed in Chapter I of the SIP.
Throughout the remainder of this Federal Register document,
references are made to the ``Longmont area.'' This is a matter of
convenience; these references apply to the Longmont CO nonattainment
area as defined in 40 CFR Part 81 unless otherwise noted.
B. Attainment Demonstration and Control Strategies: Longmont
(1) Attainment Demonstration
A different approach was used for demonstrating attainment in
Longmont than the methodology used in Denver. Originally, the State
planned to develop the attainment demonstration for Longmont as part of
the modeling for Denver. However, it was discovered that the ambient
conditions which led to exceedances of the CO NAAQS in Denver were not
directly applicable to Longmont. After reviewing the results of the
1988-89 special monitoring studies, which suggested that exceedances
occur due to emissions on a neighborhood scale, and in consideration of
Longmont's small size and low traffic counts relative to conditions in
Denver, EPA concluded that the complex UAM/CAL3QHC modeling methodology
used in Denver was not necessary for demonstrating attainment in
Longmont. EPA recommended that a simple rollforward analysis, similar
to that used in attainment demonstrations for Colorado's smaller PM10
nonattainment areas, be used for Longmont. This decision is documented
in a July 26, 1993 letter from EPA to APCD.
The methodology used and the results are presented in Chapter IV of
the SIP. The SIP projects a second maximum concentration of 6.97 ppm at
the end of 1995, well below the 9.0 ppm NAAQS.
(2) Control Strategies
Section 172(c)(1) of the Act requires the plans for all
nonattainment areas to provide for the implementation of RACM
(including RACT) as expeditiously as practicable and to provide for
attainment of the NAAQS. EPA interprets this requirement to impose a
duty on all nonattainment areas to consider the available control
measures, and to adopt and implement such measures as are reasonably
available and necessary for attainment of the NAAQS as components of
the area's attainment demonstration. EPA has reviewed the State's
explanation and associated documentation and concluded that it
adequately justifies the control measures being implemented.
The Longmont CO SIP takes credit for several control programs in
the attainment demonstration. These control strategies, identified in
Table III.3 and discussed in Chapter V of the SIP, are measures which
were in existence at the time of CO SIP development, and for which no
further State regulatory action was required. EPA is not taking action
on these control strategies in this Federal Register document, as these
are strategies which have been adopted through previous SIP revisions
and have been or are being acted on in other Federal Register
documents. The attainment demonstration does not take credit for any
newly-adopted control strategies, nor are any such strategies included
in the SIP. In addition, Chapter V discusses several other activities
underway in the Longmont area that have emission reduction benefits.
However, these activities are not identified as control strategies and
are not reflected in the 1995 attainment emission inventory, and thus,
EPA is not incorporating these measures into the SIP.
The control strategies relied upon for the Longmont attainment
demonstration include the Federal motor vehicle control program, the
2.7% oxygenated fuels program (approved in the Federal Register on July
25, 1994 (59 FR 37698)), the enhanced inspection and maintenance (I/M)
program (conditionally approved in the Federal Register on November 8,
1994 (59 FR 55594)), various ongoing travel reduction strategies and
transportation system improvements, and woodburning control measures
from the Denver PM10 SIP (the woodburning program was approved in the
Federal Register on July 25, 1995 (59 FR 37698)).
The package of strategies incorporated in the attainment
demonstration is expected to reduce emisssions from 55.070 tons per day
in 1988 to 37.292 tons per day in 1995, for an overall reduction of
approximately 32%. The strategies result in a 1995 projected second
maximum concentration of 6.97 ppm.
C. Contingency Measures: Longmont
EPA's requirements for contingency measures are described above.
Unlike Denver, Longmont is not subject to the CAA Section 187(a)(2)(A)
requirement for a VMT forecasting and tracking program, and thus is not
required to implement contingency measures in the event that a VMT
forecast is exceeded. Contingency measures for Longmont were submitted
as part of the July 13, 1994 SIP.
The 3.1% oxygenated fuels program, adopted as part of the Denver CO
SIP, has been adopted as the contingency measure for Longmont. This
measure is being implemented in the entire six-county Denver
metropolitan area as required by the Clean Air Act, and thus is being
implemented in Longmont, even though it is not credited in the
attainment demonstration. EPA considers this to be early implementation
of the contingency measure, as provided for in the August 13, 1993 Tom
Helms memorandum referenced above.
Section V.C. of the SIP defines the target emissions reduction
level for contingency measures. VMT growth in Longmont was estimated at
3.1% per
[[Page 36011]]
year, which equates to CO emissions growth of 0.92 tons per year. The
3.1% oxygenated fuels program gives Longmont an additional incremental
emission reduction over the 2.7% program of 1.01 tons per year, which
exceeds the minimum emission reduction level. Thus, EPA's minimum
requirements for contingency measures are satisfied by the State's
submittal.
II. Implications of This Action
In today's action, EPA is proposing to approve SIP revisions
submitted by the Governor on July 11, 1994, July 13, 1994, and
September 29, 1995. Specifically, EPA is proposing to (1) approve the
July 11, 1994 attainment demonstration, VMT tracking and forecasting
program, TCM, and contingency measures submittals for Denver; (2)
approve the July 13, 1994 attainment demonstration and contingency
measures submittals for Longmont; and (3) approve the control
strategies for Denver, including the September 29, 1995 submittal of
revisions to Regulations 11 and 13 (I/M and oxygenated fuels).
In this document, EPA is also proposing to find that the Denver/
Boulder carbon monoxide nonattainment area did not attain the NAAQS by
the required attainment date of December 31, 1995, and to revise the
area's classification for carbon monoxide in 40 CFR Part 81 from
moderate to serious. This proposed finding is based on air quality data
revealing more than one exceedance of the CO NAAQS during calendar year
1995, resulting in a design value higher than the NAAQS for the period
1994-95. By action dated December 20, 1994, the EPA Administrator
delegated to the Regional Administrators the authority to determine
whether CO nonattainment areas attained the NAAQS, and to reclassify
those that did not.
III. Request for Public Comments
EPA is requesting comments on all aspects of today's proposal. As
indicated at the outset of this document, EPA will consider any
comments received by August 8, 1996.
IV. Executive Order (EO) 12866
Under EO 12866, 58 FR 51735 (October 4, 1993), EPA is required to
determine whether regulatory actions are significant and therefore
should be subject to OMB review, economic analysis, and the
requirements of the EO. The EO defines a ``significant regulatory
action'' as one that is likely to result in a rule that may meet at
least one of the four criteria identified in section 3(f) of the EO,
including, under paragraph (1), that the rule may ``have an annual
effect on the economy of $100 million or more or adversely affect, in a
material way, the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities.''
The SIP-related actions proposed today have been classified as
Table 3 actions for signature by the Regional Administrator under the
procedures published in the Federal Register on January 19, 1989 (54 FR
2214-2225), as revised by a July 10, 1995 memorandum from Mary Nichols,
Assistant Administrator for Air and Radiation. The Office of Management
and Budget has exempted these regulatory actions from EO 12866 review.
Likewise, EPA has determined that the finding of failure to attain
proposed today would result in none of the effects identified in
section 3(f) of the EO. Under Section 186(b)(2) of the Clean Air Act,
findings of failure to attain and reclassification of nonattainment
areas are based upon air quality considerations and must occur by
operation of law in light of certain air quality conditions. They do
not, in and of themselves, impose any new requirements on any sectors
of the economy. In addition, because the statutory requirements are
clearly defined with respect to the differently classified areas, and
because those requirements are automatically triggered by
classifications that, in turn, are triggered by air quality values,
findings of failure to attain and reclassification cannot be said to
impose a materially adverse impact on State, local, or tribal
governments or communities.
V. Regulatory Flexibility
Under the Regulatory Flexibility Act, 5 U.S.C. section 600 et.
seq., EPA must prepare a regulatory flexibility analysis assessing the
impact of any proposed or final rule on small entities (5 U.S.C.
sections 603 and 604). Alternatively, EPA may certify that the rule
will not have a significant impact on a substantial number of small
entities. Small entities include small businesses, small not-for-profit
enterprises, and government entities with jurisidiction over
populations that are less than 50,000.
SIP revision approvals under Section 110 and Subchapter I, Part D,
of the CAA do not create any new requirements, but simply approve
requirements that the State is already imposing. Therefore, because the
Federal SIP approval process does not impose any new requirements, EPA
certifies that this proposed rule would not have a significant impact
on any small entities affected. Moreover, due to the nature of the
Federal-State relationship under the CAA, preparation of a regulatory
flexibility analysis would constitute Federal inquiry into the economic
reasonableness of State actions. The CAA forbids EPA to base its
actions concerning SIPs on such grounds. Union Electric Co. v.
U.S.E.P.A., 427 U.S. 246, 256-266 (S. Ct. 1976); 42 U.S.C. section
7410(a)(2).
As discussed in section IV. of this document, findings of failure
to attain and reclassification of nonattainment areas under Section
186(b)(2) of the CAA do not, in and of themselves, create any new
requirements. Therefore, I certify that today's proposal does not have
a significant impact on small entities.
VI. Unfunded Mandates
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate, or to
the private sector, of $100 million or more. Under Section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
EPA has determined that the SIP approval actions proposed today do
not include a Federal mandate that may result in estimated costs of
$100 million or more to either State, local or tribal governments in
the aggregate, or to the private sector. These Federal actions approve
pre-existing requirements under State or local law, and impose no new
Federal requirements. Accordingly, no additional costs to State, local
or tribal governments, or to the private sector, result from these
actions.
Likewise, EPA believes, as discussed in section IV of this
document, that the proposed finding of failure to attain and
reclassification to serious are factual determinations based upon air
quality data and must occur by operation of law and, hence, do not
impose any federal intergovernmental mandate, as defined in section 101
of the Unfunded Mandates Act.
[[Page 36012]]
List of Subjects
40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Reporting recordkeeping requirements.
40 CFR Part 81
Air pollution control.
Authority: U.S.C. 7401-7671q.
Dated: June 24, 1996.
Jack W. McGraw,
Acting Regional Administrator.
[FR Doc. 96-17319 Filed 7-8-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-17286 National Environmental Policy Act Implementing Procedures
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35990-35991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17286]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF ENERGY
10 CFR Part 1021
RIN 1901-AA67
National Environmental Policy Act Implementing Procedures
AGENCY: Department of Energy.
ACTION: Proposed rule; limited reopening of the comment period.
-----------------------------------------------------------------------
SUMMARY: This Notice announces a limited reopening of the comment
period with respect to the proposed rule on implementation of the
National Environmental Policy Act (NEPA). DOE has decided to solicit
further input on certain proposed amendments that pertain primarily to
Federal power marketing activities. In a related document published
elsewhere in this issue, DOE is publishing final amendments to 10 CFR
1021 not affected by this limited reopening of the comment period.
DATES: The limited reopening of the comment period will end August 8,
1996. Comments must be received by that date to ensure consideration.
Late comments will be considered to the extent practicable.
ADDRESSES: Comments should be addressed to Carol M. Borgstrom,
Director, Office of NEPA Policy and Assistance, EH-42, U.S. Department
of Energy, 1000 Independence Avenue, S.W., Washington, D.C. 20585-0119.
Comments may be hand-delivered to room 3E-080 at the Forrestal Building
on workdays between the hours of 8:00 a.m. and 4:30 p.m. Comments may
also be sent by facsimile to (202) 586-7031 or by electronic mail to
the following Internet address: [email protected]. All comments
will be available for public inspection at the U.S. Department of
Energy Freedom of Information Reading room, 1E-110 Forrestal Building,
1000 Independence Avenue S.W., Washington, D.C. 20585-0119, phone (202)
586-6020.
FOR FURTHER INFORMATION CONTACT:
John Pulliam, Office of NEPA Policy and Assistance, at the above
address, or telephone (202) 586-4600 or leave a message at (800) 472-
2756.
SUPPLEMENTARY INFORMATION: On February 20, 1996 (61 FR 6414), the
Department of Energy (DOE) published a Notice of Proposed Rulemaking to
amend its implementing procedures under the National Environmental
Policy Act (NEPA) (10 CFR part 1021). Publication of the proposed
rulemaking began a 45-day public comment period that originally ended
on April 5, 1996.
[[Page 35991]]
In response to public requests, the comment period was reopened on
April 19 and extended until May 10, 1996. A public hearing was also
held in Washington, D.C. on May 6, 1996. DOE has decided to solicit
further input, especially from state and Federal agencies that have
responsibility for environmental review of comparable non-Federal
utility projects in the Pacific Northwest, on the following proposed
amendments to Subpart D, typical Classes of Action primarily affecting
power marketing activities: B4.1, Contracts/marketing plans/policies
for excess electric power; B4.2, Export of electric energy; B4.3,
Electric power marketing rate changes; B4.6, Additions/modifications to
electric power transmission facilities within previously developed
area; B4.10, Deactivation, dismantling and removal of electric
powerlines and substations; B4.11, Construction or modification of
electric power substations; B4.12, Construction of electric powerlines
(generally less than 10 miles in length), not integrating major new
sources; B4.13, Reconstruction and minor relocation of existing
electric powerlines (generally less than 20 miles in length); C4,
Upgrading and constructing electric powerlines; C7, Allocation of
electric power, no major new generation resource/major changes in
operation of generation resources/major new loads; and D7, Allocation
of electric power, major new generation resources/major changes in
operation of generation resources/major loads. DOE is reopening the
comment period on these proposed amendments only. The final rule on all
of the proposed amendments other than those that pertain to power
marketing activities is being published separately.
In response to a request, DOE is providing further clarification of
the rationale for two of the proposed amendments: B4.1, Contracts/
marketing plans/policies for excess electric power, and B4.3, Electric
power marketing rate changes. For ease of comparison, the current B4.1
and B4.3 as they now appear in the DOE NEPA regulations (57 FR 15122,
1992) are reprinted below, followed by the amended language from the
February 1996 proposed rule, and the clarified rationale for the
amendment.
Current B4.1
Establishment and implementation of short-term contracts, marketing
plans, policies, annual operating plans, allocation plans or
acquisition of excess power, the terms of any of which do not exceed
five years and would not cause changes in the normal operating limits
of generating projects, and if transmission would occur over existing
transmission systems.
Proposed B4.1
Establishment and implementation of contracts, marketing plans,
policies, allocation plans or acquisition of excess electric power that
does not involve: (1) The integration of a new generation resource, (2)
physical changes in the transmission system beyond the previously
developed facility area, unless the changes are themselves
categorically excluded, or (3) changes in the normal operating limits
of generation resources.
Rationale for Amendment
The existing five-year term limit was proposed for elimination from
this categorical exclusion because past experience has demonstrated
that the mere length of a contract, policy, or plan does not have the
potential for environmental impacts. Rather, the development or
integration of new generating resources, changes in the operation of
existing generation resources, or construction of transmission
facilities, are the types of activities that have shown the potential
for environmental impacts. By not allowing these changes in generation,
operation or transmission, the proposed categorical exclusion would
ensure that only those actions which have no potential for
environmental impact would be categorically excluded. Those contracts,
plans, and policies that do not satisfy the proposed criteria would
require further NEPA analysis to ascertain the associated environmental
impacts.
Current B4.3
Changes in rates for electric power, power transmission, and other
products or services provided by a Power Marketing Administration that
are based on a change in revenue requirements that does not exceed the
change in the overall price level in the economy (inflation), as
measured by the GNP fixed weight price index published by the
Department of Commerce, during the period since the last rate
adjustment for that product or service or, if the rate change does
exceed the change in the GNP fixed weight price index, the rate change
would have no potential for affecting the operation of power generation
resources.
Proposed B4.3
Changes in rates for electric power, power transmission, and other
products or services provided by a Power Marketing Administration that
are based on a change in revenue requirements if the operations of
generation projects would remain within the normal operating limits.
Rationale for Amendment
The proposed change would eliminate the existing restriction that,
in order to be categorically excluded, a proposed rate change must not
exceed the rate of inflation, a condition that DOE has found is not
relevant to the action's potential for environmental impacts. Any
environmental impacts resulting from rate changes would be caused only
if the rate change involved associated changes in generation resources.
This categorical exclusion would only apply to those rate changes that
would not affect the operation of generation projects. Those rate
changes that could affect the operation of generation projects would
require further NEPA analysis.
Issued in Washington, D.C., June 28, 1996.
Tara O'Toole,
Assistant Secretary, Environment, Safety and Health.
[FR Doc. 96-17286 Filed 7-8-96; 8:45 am]
BILLING CODE 6450-01-M
Complete official Federal Register PDF
FR Doc. 96-17265 Procedures for Filing a Derivative Petition (Form I-730) for a Spouse and Unmarried Children of a Refugee/Asylee
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35984-35987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17265]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Immigration and Naturalization Service
8 CFR Parts 207 and 208
[INS No. 1639-93]
RIN 1115-AD59
Procedures for Filing a Derivative Petition (Form I-730) for a
Spouse and Unmarried Children of a Refugee/Asylee
AGENCY: Immigration and Naturalization Service, Justice.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This rule proposes to amend the Immigration and Naturalization
Service (Service) regulations by providing procedures which must be
followed by a refugee to bring his/her spouse and unmarried, minor
child(ren) (derivatives) into the United States. This proposed rule is
intended to respond to the family reunification needs of refugees by
establishing an equitable and consistent following-to-join policy for
refugees which parallels the current following-to-join procedures for
asylees. This rule also proposes to amend asylum regulations by
removing from the definition of qualifying relationship child(ren) born
to or legally adopted by the principal alien and spouse after approval
of the principal alien's asylum application.
DATES: Written comments must be submitted on or before September 9,
1996.
ADDRESSES: Please submit written comments, in triplicate, to the Policy
Directives and Instructions Branch, Immigration and Naturalization
Service, 425 I Street, NW., Room 5307, Washington, DC 20536, Attention:
Public Comment Clerk. To ensure proper handling, please reference INS
No. 1639-93 on your correspondence. Comments will be available for
public inspection at this location by calling (202) 514-3048 to arrange
an appointment.
FOR FURTHER INFORMATION CONTACT: Ramonia Law-Hill, Senior Adjudications
Officer, Adjudications Division, Immigration and Naturalization
Service, 425 I Street, NW., Room 3214, Washington, DC 20536, telephone
(202) 514-5014.
SUPPLEMENTARY INFORMATION:
A. Background
The United States refugee program places strong emphasis on family
reunification and assigns priority for interviews to those refugee
applicants who have immediate family members already in the United
States. This emphasis on reunifying families also extends to those
refugees who have been resettled in the United States, but who remain
separated from their spouse and/or child(ren). In such cases, refugees
may file to have their spouse and/or child(ren) ``follow-to-join'' them
in the United States. The following-to-join provisions for refugees is
found in section 207(c)(2) of the Immigration and Nationality Act
(Act).
To apply for such benefits, refugees file Form I-730, Refugee/
Asylee Relative Petition, with the designated Service office. Such
designation will be through separate action in the Federal Register.
Spouses and unmarried, minor children (derivatives) who follow-to-join
a refugee already in this country are admitted as refugees.
B. Need for Procedural Review and Revised Regulation
Over the past year, it has become apparent that existing Service
procedures regarding following-to-join benefits for refugees is
inadequate and has resulted in confusion for the general public.
Regulations are necessary to clarify procedures and to establish an
equitable and consistent following-to-join policy for refugees which
parallels that found in the current following-to-join regulations for
asylees, who are also eligible to file Form I-730.
In recent months the Service has received numerous telephone
inquiries from members of Congress, the general public, voluntary
agencies, and attorneys representing clients concerning the application
of the following-to-join provisions found in section 207(c)(2) of the
Act. Of primary concern has been the Service's requirement that the
refugee's relationship to the spouse and/or child predates the date on
which the refugee was granted refugee status. A Service memorandum
issued on January 8, 1987, defined this date as the date of tentative
approval, which has been interpreted by some as being the day of the
refugee's interview. That interpretation, however, has not received
Servicewide acceptance.
The Service's recent initiative to combine the Form I-730 with the
revised Form I-130 (Petition for Alien Relative), revealed differing
practices for processing following-to-join petitions filed by refugees
and those filed by aslyees. It was, therefore, determined that rather
than consolidate the forms, the Service needed to review and, if
necessary, revise existing policies relating to refugees and asylees.
C. Following-to-Join Issue
In the absence of a time limit on the following-to-join
regulations, individuals who entered the United States as conditional
entrants in the late 1970s and refugees in the early 1980s are filing
Form I-730 petitions for a spouse and/or child(ren). Following-to-join
benefits are available to help refugees make the difficult transition
to a new life with the support of their immediate family members. Forms
I-730 filed ten or more years after admission no longer serve the
purpose for which they were originally intended. Instead, they deplete
limited refugee admission numbers and refugee resettlement monies
needed for emerging refugee populations. The proposed regulations are
intended to respond more fully to the family reunification needs of
refugees, while establishing specific guidelines on the following-to-
join process.
Current interpretations of the following-to-join benefits for
refugees have created confusion for Service officers, attorneys,
refugees, and the general public. While some interpret following-to-
join eligibility based on the refugee's date of admission, current
practice requires the relationship to exist prior to the tentative
approval date of the principal's application for refugee status. The
Service determined that the current interpretation of following-to-join
for refugees is too restrictive since it requires a refugee to meet a
heavier burden for establishing a relationship with his/her spouse and
unmarried, minor child(ren), than is required by regulation for a
spouse and unmarried minor child(ren) of a citizen or lawful permanent
resident of the United States. To resolve this disparity, the Service
is adopting a more generous interpretation of the point at which a
qualifying relationship exists for following-to-join benefits. This
rule proposes that the refugee's date of admission be used to determine
following-to-join eligibility. A refugee will then be able to file a
separate Form I-730 for his/her spouse and/or each individual child if
the relationship predates the refugee's date of admission to the United
States, rather than the date of interview. The Service believes this
proposal reflects the intent of Congress to reunite refugees with their
families. Further, it alleviates inconsistencies in determining
eligibility as is currently encountered
[[Page 35985]]
because of the difficulty in determining the date of tentative
approval.
Additionally, the Service has found that the benefit accorded
asylees regarding children is too broad in that current asylum
regulations extend following-to-join benefits to children born to, or
adopted by, asylees at any point after the date of their approval. As a
result, this rule will amend existing asylum regulations by requiring
that, for purposes of filing a Form I-730, the asylee's relationship to
a child exists on the date the asylee is granted asylum.
Only refugees who entered the United States as principal aliens
will be eligible to file the Form I-730 for following-to-join benefits
for a spouse and/or each individual unmarried, minor child under this
proposed rule. Those individuals who have derived their refugee status
from the principal alien will not be eligible to file Form I-730.
Past practice has allowed for the adjudication of Form I-730 filed
by a son or daughter who claimed to be single in order to qualify as a
member of a parent's refugee case, and who then petitioned for his/her
spouse after arrival to the United States. As the proposed rule does
not permit the filing of a Form I-730 by derivatives, this type of
misrepresentation should be reduced. Only the spouse and unmarried,
minor child(ren) of a refugee may benefit under the proposed following-
to-join regulation.
Currently there is no established time to file for and receive
following-to-join benefits, either for asylees or refugees. The
proposed regulation will impose a 1-year time limit from the date of
the principal's admission, within which a refugee or asylee must file a
separate Form I-730 for each individual qualifying family member,
unless it is clearly established that compelling circumstances preclude
the timely filing of the application. Refugees or asylees who have
resided in the United States for more than 1 year when this regulation
becomes effective will be granted 1 year from the effective date of the
final regulation in which to file Form I-730 for following-to-join
benefits for their spouse and unmarried, minor child(ren). The Service
may, however, waive the 1-year limit when it is determined that
humanitarian reasons for extending the filing period exist. The 1-year
limit refers only to the filing of the Form I-730. Such limit is not
imposed on family members' travel to the United States, as the Service
is aware of the impediments which may delay family members' travel for
years following the refugee's arrival in the United States. The filing
of the Form I-730 will serve to notify the Service of a refugee's or
asylee's intent to have his/her spouse and/or child(ren) join him/her
in the United States. The approval of the Form I-730 shall remain valid
for the duration of the relationship to the refugee or asylee, and in
the case of a child, while the child is under 21 years of age and
unmarried, provided also that the principal's status has not been
revoked.
The Service has established what it believes to be a reasonable
time limit on the filing of the Form I-730. It is further believed that
derivative benefits for spouses and children of refugees was intended
for the purpose of reuniting families and to avoid lengthy delays due
to visa quotas. Timely filings will expedite the reunification of
refugee families and ensure the removal of spouses and children of
refugees from a country subjecting them to persecution on the basis of
that relationship. Thus, refugees must file following-to-join petitions
within 1 year of the date of their admissions; asylees within 1 year of
being granted asylum status.
While the rule proposes necessary bounds, such as adding
eligibility requirements and establishing a filing period for
following-to-join benefits, it is liberal in defining the point at
which a qualifying relationship exists for this benefit. The proposed
rule will clarify the Service's following-to-join policy for Service
officers and the general public by standardizing refugee and asylee
following-to-join procedures.
Regulatory Flexibility Act
The Commissioner of the Immigration and Naturalization Service, in
accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has
reviewed this regulation and, by approving it, certifies that the rule
will not have a significant economic impact on a substantial number of
small entities because it is administrative in nature and merely
imposes specific regulatory restraints, which parallel procedures
currently found in asylum regulations.
Executive Order 12866
This rule is not considered by the Department of Justice,
Immigration and Naturalization Service, to be a ``significant
regulatory action'' under Executive Order 12866, section 3(f),
Regulatory Planning and Review, and the Office of Management and Budget
and waived its review process under section 6(a)(3)(A).
Executive Order 12612
The regulations proposed herein will 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 rule
does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
The Commissioner of the Immigration and Naturalization Service
certifies that she has assessed this rule in light of the criteria in
Executive Order 12606 and has determined that this regulation will
enhance family well-being by establishing an equitable and consistent
following-to-join policy for refugees which parallels the current
following-to-join policy for asylees.
Paperwork Reduction Act
The information collection requirement (Form I-730) contained in
this rule is being revised by the Immigration and Naturalization
Service. In accordance with the Paperwork Reduction Act, the Service
published a notice in the Federal Register on May 3, 1996, at 61 FR
19958, notifying the public of the revision to the Form I-730.
List of Subjects
8 CFR Part 207
Immigration, Refugees, Reporting and recordkeeping requirements.
8 CFR Part 208
Administrative practice and procedure, Aliens, Immigration,
Reporting and recordkeeping requirements.
Accordingly, chapter I of title 8 of the Code of Federal
Regulations is proposed to be amended as follows:
PART 207--ADMISSION OF REFUGEES
1. The authority citation for part 207 is revised to read as
follows:
Authority: 8 U.S.C. 1103, 1157, 1159; 8 CFR Part 2.
Sec. 207.1 [Amended]
2. Section 207.1 is amended by removing paragraph (e).
Secs. 207.7 and 207.8 [Redesignated as Sec. 207.8 and Sec. 207.9]
3. Sections 207.7 and 207.8 are redesignated as Sec. 207.8 and
207.9 respectively.
4. A new Sec. 207.7 is added to read as follows:
Sec. 207.7 Derivatives of refugees.
(a) Eligibility. A spouse, as defined in section 101(a)(35) of the
Act, and/or child(ren), as defined in section 101(b)(1)(A), (B), (C),
(D), or (E) of the
[[Page 35986]]
Act, may be granted refugee status if accompanying or following-to-join
the principal alien. An accompanying derivative is a spouse or child of
a refugee who is in the physical company of the principal refugee when
he or she is admitted to the United States, or a spouse or child of a
refugee who is admitted within 4 months of the principal refugee's
admission. A following-to-join derivative, on the other hand, is a
spouse or child of a refugee who seeks admission more than 4 months
after the principal refugee's admission to the United States.
(b) Ineligibility. The following relatives of refugees are
ineligible for accompanying or following-to-join benefits:
(1) A spouse or child who has previously been granted asylee or
refugee status;
(2) An adopted child, if the adoption took place after the child
became 16 years old, or if the child has not been in the legal custody
and living with the parent(s) for at least 2 years;
(3) A stepchild, if the marriage that created this relationship
took place after the child became 18 years old;
(4) A husband or wife if each/both were not physically present at
the marriage ceremony, and the marriage was not consummated;
(5) A husband or wife if the U.S. Attorney General has determined
that such alien has attempted or conspired to enter into a marriage for
the purpose of evading immigration laws;
(6) A parent, sister, brother, grandparent, grandchild, nephew,
niece, uncle, aunt, cousin or in-law.
(c) Relationship. The relationship of a spouse and child as defined
in sections 101(a)(35) and 101(b)(1)(A), (B), (C), (D), or (E),
respectively, of the Act, must have existed prior to the refugee's
admission to the United States and must continue to exist at the time
of filing for following-to-join benefits and admission to the United
States. If the refugee proves that the refugee is the parent of a child
who was born after the refugee's admission as a refugee, but who was in
utero on the date of the refugee's admission as a refugee, the child
shall be eligible to follow-to-join the refugee. The child's mother, if
not the principal refugee shall not be eligible to follow-to-join the
principal refugee unless the child's mother was the principal refugee's
spouse on the date of the principal refugee's admission as a refugee.
(d) Filing. A refugee may request following-to-join benefits for
his/her spouse and unmarried, minor child(ren) (whether the spouse and
children are in or outside the United States) by filing a separate Form
I-730, Refugee/Asylee Relative Petition, for each qualifying family
member with the designated Service office. Persons who derive their
refugee status from the principal applicant are not eligible to file
Form I-730. The Form I-730 may only be filed by the principal
applicant. Family members, such as unmarried sons and daughters who
derived their refugee status, are not eligible to file the Form I-730
on behalf of their spouse and child(ren). A separate Form I-730 must be
filed for each qualifying family member within 1 year of the refugee's
admission to the United States, unless the Service determines that the
filing period should be extended for humanitarian reasons. There is,
however, no time limit imposed on family members' travel to the United
States once the Form I-730 for following-to-join benefits has been
approved, provided approval of the Form I-730 petition has not been
subsequently revoked. There is no fee for filing this petition.
(e) Evidence. Documentary evidence consists of those documents
which establish that the petitioner is a refugee, and evidence of the
claimed relationship of the petitioner to the beneficiary. The burden
of proof is on the petitioner to establish by a preponderance of the
evidence that any person on whose behalf he/she is making a request
under this section is an eligible spouse or unmarried, minor child.
Evidence to establish the claimed relationship for a spouse or
unmarried, minor child as set forth in 8 CFR part 204 must be submitted
with the request for following-to-join benefits. Where possible this
will consist of the documents specified in Sec. 204.2(a)(1)(i)(B),
(a)(1)(iii)(E), (a)(2), (d)(2), and (d)(5) of this chapter. In
addition, a recent photograph of each derivative must accompany the
Form I-730. Although the photograph need not meet Alien Documentation
Identification and Telecommunication System (ADIT) specifications, it
must clearly identify the derivative. The photograph will be made part
of the derivative's immigration record for identification purposes.
(f) Approvals. (1) Spouse or child in the United States. When a
spouse or child of a refugee is in the United States and the Form I-730
is approved, the Service will notify the refugee of such approval on
Form I-797, Notice of Action. Employment will be authorized incident to
status.
(2) Spouse or child outside the United States. When a spouse or
child of a refugee is outside the United States and the Form I-730 is
approved, the Service will notify the refugee of such approval on Form
I-797. The approved Form I-730 will be sent by the Service to the
Department of State for forwarding to the American Embassy or Consulate
having jurisdiction over the area in which the refugee's spouse or
child is located.
(3) Benefits. The approval of the Form I-730 shall remain valid for
the duration of the relationship to the refugee and, in the case of a
child, while the child is under 21 years of age and unmarried, provided
also that the principal's status has not been revoked. However, the
approved Form I-730 will cease to confer immigration benefits after it
has been used by the beneficiary for admission to the United States as
a derivative of a refugee. To demonstrate employment authorization, the
Service will issue a Form I-94, Arrival-Departure Record, which also
reflects the derivative's current status as a refugee, or the
derivative may apply under Sec. 274a.12(a) of this chapter, using Form
I-765, Application for Employment Authorization, and a copy of the Form
I-797.
(g) Denials. If the spouse or child of a refugee is found to be
ineligible for derivative status, a written notice explaining the basis
for denial shall be forwarded to the refugee. There shall be no appeal
from this decision. However, the denial shall be without prejudice to
the consideration of a new petition or motion to reopen the refugee and
asylee relative petition proceedings, if the refugee establishes
eligibility for the following-to-join benefits contained in this part.
PART 208--PROCEDURES FOR ASYLUM AND WITHHOLDING OF DEPORTATION
5. The authority citation for part 208 continues to read as
follows:
Authority: 8 U.S.C. 1103, 1158, 1226, 1252, 1282; 31 U.S.C.
9701; 8 CFR part 2.
6. In Sec. 208.21, paragraphs (b), (c), (d), and (f) are revised to
read as follows:
Sec. 208.21 Admission of asylee's spouse and children.
* * * * *
(b) Relationship. The relationship of spouse and child as defined
in sections 101(a)(35) and 101(b)(1) of the Act must have existed at
the time the principal alien's asylum application was approved. If the
asylee proves that the asylee is the parent of a child who was born
after asylum was granted, but who was in utero on the date of the
asylum grant, the child shall be eligible to follow-to-join the asylee.
The child's mother, if not the principal asylee, shall
[[Page 35987]]
not be eligible to follow-to-join the principal asylee unless the
child's mother was the principal asylee's spouse on the date of the
principal asylee's grant as an asylee.
(c) Spouse or child in the United States. When a spouse or child of
an alien granted asylum is in the United States, but was not included
in the asylee's application, the asylee may request following-to-join
benefits for his/her spouse or child by filing for each qualifying
family member a separate Form I-730, Refugee/Asylee Relative Petition,
and supporting evidence, with the designated Service office, regardless
of the status of that spouse or child in the United States. The Form I-
730 must also be accompanied by a recent, clear non-ADIT style
photograph for each derivative. The photograph will be used for
identification purposes and will be placed in the derivative's
immigration record. Additionally, a separate Form I-730 must be filed
by the asylee for each qualifying family member within 1 year of the
date in which he/she was granted asylum status, unless it is determined
by the Service that this period should be extended for humanitarian
reasons. Upon approval of the Form I-730, the Service will notify the
asylee of such approval on Form I-797 ``Notice of Action.'' Employment
will be authorized incident to status. To demonstrate employment
authorization, the Service will issue a Form I-94, Arrival-Departure
Record, which also reflects the derivative's current status as an
asylee, or the derivative may apply under Sec. 274a.12(a) of this
chapter, using Form I-765, Application for Employment Authorization,
and a copy of the Form I-797. The approval of the Form I-730 shall
remain valid for the duration of the relationship to the asylee and, in
the case of a child, while the child is under 21 years of age and
unmarried, provided also that the principal's status has not been
revoked. However, the approved Form I-730 will cease to confer
immigration benefits after it has been used by the beneficiary for
admission to the United States as a derivative of an asylee.
(d) Spouse or child outside the United States. When a spouse or
child of an alien granted asylum is outside the United States, the
asylee may request following-to-join benefits for his/her spouse or
child(ren) by filing a separate Form I-730 for each qualifying family
member with the designated Service office, setting forth the full name,
relationship, date and place of birth, and current location of each
such person. The Form I-730 must be accompanied by a recent, clear non-
ADIT style photograph for each derivative. A separate Form I-730 for
each qualifying family member must be filed within 1 year of the date
in which the asylee was granted asylum status, unless the Service
determines that the filing period should be extended for humanitarian
reasons. When the Form I-730 is approved, the Service will notify the
asylee of such approval on Form I-797. The approved Form I-730 shall be
forwarded by the Service to Department of State for delivery to the
American Embassy or Consulate having jurisdiction over the area in
which the asylee's spouse or child is located. The approval of the Form
I-730 shall remain valid for the duration of the relationship to the
asylee and, in the case of a child, while the child is under 21 years
of age and unmarried, provided also that the principal's status has not
been revoked. However, the approved Form I-730 will cease to confer
immigration benefits after it has been used by the beneificary for
admission to the United States as a derivative of an asylee.
* * * * *
(f) Burden of proof. To establish the claimed relationship of
spouse or child as defined in sections 101(a)(35) and 101(b)(1) of the
Act, evidence must be submitted with the request as set forth in part
204 of this chapter. Where possible this will consist of the documents
specified in Sec. 204.2 (a)(1)(i)(B), (a)(1)(iii)(E), (a)(2), (d)(2)
and (d)(5) of this chapter. The burden of proof is on the principal
alien to establish by a preponderance of the evidence that any person
on whose behalf he or she is making a request under this section is an
eligible spouse or child.
* * * * *
Dated: May 7, 1996.
Doris Meissner,
Commissioner, Immigration and Naturalization Service.
[FR Doc. 96-17265 Filed 7-8-96; 8:45 am]
BILLING CODE 4410-10-M
Complete official Federal Register PDF
FR Doc. 96-17248 Federal Employees Health Benefits Program: Opportunities to Enroll and Change Enrollment
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35973-35982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17248]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 /
Proposed Rules
[[Page 35973]]
OFFICE OF PERSONNEL MANAGEMENT
5 CFR Part 890
RIN 3206-AH46
Federal Employees Health Benefits Program: Opportunities to
Enroll and Change Enrollment
AGENCY: Office of Personnel Management.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Office of Personnel Management (OPM) is issuing proposed
regulations to simplify and clarify the existing Federal Employees
Health Benefits (FEHB) Program regulations concerning opportunities to
enroll and change enrollment. The proposed regulations would make it
easier for employing offices to determine whether circumstances permit
individuals to enroll or change enrollment, and would result in a
reduced potential for error and improved customer service.
DATE: We must receive comments on or before September 9, 1996.
ADDRESSES: Send written comments to Lucretia F. Myers, Assistant
Director for Insurance Programs, Retirement and Insurance Service,
Office of Personnel Management, P.O. Box 57, Washington, DC 20044, or
deliver to OPM, Room 3451, 1900 E Street NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Barbara Myers (202) 606-0004.
SUPPLEMENTARY INFORMATION: The events that permit individuals to enroll
for FEHB coverage or change enrollment are specified in regulation.
When the FEHB Program first began over thirty years ago, there were few
events that permitted individuals to enroll or change their enrollment.
Since then, additional events have been added to accommodate changes to
FEHB law, establishment of other Federal programs that affected Federal
employees and retirees, and changes in the personal circumstances of
employees and annuitants.
Among the changes to FEHB law have been (1) extending FEHB coverage
to certain former spouses and temporary employees, (2) providing
temporary continuation of coverage (TCC) for enrollees and family
members who lose coverage under certain conditions, and (3) prorating
of premiums for part-time employees. Some other Federal programs that
have been established since the FEHB Program began that affect Federal
employees and retirees are Medicare and the Federal Employees
Retirement System (FERS). Also, to adapt to changes in the personal
circumstances of employees and annuitants, FEHB regulations now permit
enrollment upon loss of non-Federal coverage under certain conditions.
The inquiries we receive from the White House, Members of Congress,
Federal agencies, employees, and other individuals indicate that it is
becoming increasingly difficult for employing offices to locate and
interpret the appropriate regulation when an individual request to
enroll or change his or her enrollment. In addition, when an employing
office denies a request because they do not believe the circumstances
comply with the regulations, the individual usually asks for
reconsideration of that decision.
OPM has issued final regulations (59 FR 66434, December 27, 1994)
that delegate to Federal agencies the authority to reconsider disputes
over coverage and enrollment and to make retroactive as well as
prospective corrections of administrative errors. Our proposed
regulations would also give agencies the authority to correct enrollee
errors under certain circumstances. We believe that these proposed
regulations would help to reduce both the number of agency denial of
enrollee requests and the volume of reconsideration requests.
More specifically, we believe these proposed regulations would
improve administration of the FEHB Program by:
1. Organizing the opportunities to enroll and change enrollment
into separate sections for employees, annuitants, former spouses, and
those on Temporary Continuation of Coverage. This would reduce the time
it takes for the employing office to locate the regulation applicable
to the individual that is being assisted.
2. Grouping several of the enrollment opportunities within each
section by similar characteristics, such as opportunities based on a
change in employment status, or a loss of health benefits coverage.
This further organization of the events would make it easier for the
reader to locate the event that is needed.
3. Standardizing as much as possible the timeframes for individuals
to enroll or change enrollment. In some cases the existing timeframe
will increase from 31 to 60 days after the event. In other situations
the timeframe will be extended to include a period before the event as
well as after. This standardization would reduce the number of belated
enrollment requests the employing offices receive, and help to assure
continuous coverage for employees and family members whose eligibility
to enroll in FEHB or change enrollment is based on a loss of other
coverage.
4. Locating effective date information within the paragraph that
describes the enrollment or change opportunity. Current regulations
provide information on enrollment opportunities in one section and
their corresponding effective dates in another. This revision would
improve processing by making it easier for the reader to determine the
appropriate effective date for a specific enrollment or change
opportunity.
5. Clarifying some of the opportunities by removing certain hard to
define requirements that individuals must meet to become eligible to
enroll or change enrollment. This increased flexibility would make it
easier for employees to provide FEHB coverage for their eligible
children. It would also make it easier for agencies to make enrollment
decisions, and reduce the number of agency denials of requests to
enroll or change enrollment. Several examples of the clarified
opportunities include:
a. Under current regulations (paragraph 890.301(y)), an employee
may enroll, and an employee or annuitant may change enrollment when the
employee or a family member involuntarily loses coverage under a non-
Federal health plan. This requirement has generated numerous questions,
denials, and reconsideration request about whether the loss of non-
Federal coverage in a specific situation is voluntary or involuntary.
To make it
[[Page 35974]]
easier for families to continue their health insurance protection upon
loss of non-Federal coverage, we are no longer requiring agencies to
determine what constitutes an involuntary loss of non-Federal coverage.
We also are extending to enrollees covered under the former spouse and
TCC provisions the opportunity to change from a self-only to self and
family enrollment when an eligible family member loses non-Federal
coverage.
b. Current regulations (paragraph 890.301(e)) permit an employee to
enroll upon a change in marital status, but not upon any other change
in family status. We recognize that in some situations an employee may
have a change in family status without a change in marital status. Such
situations may include (1) birth or acquisition of a child; (2)
issuance of a court order specifically requiring an employee to enroll
for his or her children or provide health benefits protection for them;
(3) issuance or termination of a court order granting interlocutory
divorce, limited divorce, legal separation, or separate maintenance to
the enrollee or spouse; (4) entry into or discharge from military
service of a spouse or of a child under age 22. Therefore, we are
expanding this regulation to also permit an employee to enroll upon any
other change in family status.
Under current regulations, a new enrollment takes effect at the
beginning of the pay period after the enrollment request is received by
the employing office and that follows a pay period during any part of
which the employee is in pay status. We recognize that in some
situations, the birth or acquisition of a child may occur while an
employee is in a leave without pay status. Therefore, in this situation
only, we are allowing the enrollment to take effect on the first day of
the pay period in which the child is born or becomes an eligible family
member, regardless of whether the enrollee was in a pay status the
previous pay period.
c. Under current regulations (paragraph 890.301(g)(4)), an
employee, annuitant, or former spouse who qualifies for FEHB coverage
under section 890.803, who loses coverage because of cancellation of
the covering enrollment must enroll in the same plan and option as that
from which coverage was lost. We recognize that there may be situations
in which the individual enrolled for self and family cancels the
enrollment but the family member who loses coverage does not want to
enroll in the same plan; or the enrollee of a prepaid plan cancels the
enrollment but the family member who loses coverage lives in a
different geographic location. As part of our effort to accommodate the
complex family situations that can occur, we are eliminating this
requirement and permitting enrollment in any plan or option when
coverage is lost because the covering enrollment has been cancelled.
d. Current regulations (paragraph 890.301(t)) permit an employee to
enroll if his or her coverage under the Medicaid program (State program
of medical assistance for the needy) should terminate. They also permit
an employee who is enrolled for self only to change to a self and
family enrollment if a family member loses Medicaid coverage. Under our
proposed regulations, an employee who is not enrolled may enroll if a
family member should lose Medicaid coverage. Enrollees covered under
the former spouse and TCC provisions may change from self only to self
and family if an eligible family member loses Medicaid coverage. We
also are extending to annuitants and former spouses who cancel their
enrollment because they qualify for Medicaid coverage the opportunity
to reenroll in the FEHB Program upon loss of the Medicaid coverage.
e. Under current regulations (paragraph 890.301(h)), an enrollee in
a comprehensive medical plan who loses coverage or access to health
services because of a change of address or place of employment may
change enrollment. The enrollee must provide the employing office with
written notification of his or her move or employment change or
``satisfactory'' evidence of a family member's move. To accommodate
alternative and more automated systems of processing enrollment
changes, and to make it easier for agencies to process enrollment
changes under this event, we are removing the written notification
requirement and no longer requiring agencies to determine what
constitutes ``satisfactory'' evidence.
As part of our continuing effort to improve service to FEHB
enrollees, we are revising paragraph 890.302(f) concerning
determinations of incapacity for children over age 22. Under FEHB law,
a child's coverage ends at age 22 unless the child is determined
incapable of self-support because of a physical or mental disability
that existed before age 22. Since current regulations require the
employing office (the retirement system is the employing office for
annuitants) to make determinations of incapacity, enrollees who contact
their insurance carrier to request continued coverage for a disabled
child are referred back to the employing office. There are certain
medical conditions that would cause children to be incapable of self-
support during adulthood, and if a child has one of these conditions,
we believe that carriers should be able to extend coverage without
going back to the employing agency. Therefore, we are revising the
regulations to permit either the employing office or the carrier to
make determinations of incapacity in such cases. We will provide an up-
to-date list of these medical conditions in a Benefits Administration
Letter and an FEHBP Letter to All Carriers; if we need to add or delete
a condition in the future, we will notify employing offices and
carriers promptly by means of these publications. If a child has a
medical condition that is not on the list, the employing office will
continue to make the determination.
We also will be adding the term ``appropriate request'' to our
definitions. This new definition will allow for alternative and more
automated methods of processing enrollments. These methods, which
include Employee Express, should result in faster enrollment processing
and improved customer service.
Finally, we will be making a conforming change to paragraph
890.803(a)(3)(i) to correct a reference to Sec. 831.606, which has been
redesignated as Sec. 831.613.
Regulatory Flexibility Act
I certify that these regulations will not have a significant
economic impact on a substantial number of small entities because they
primarily affect Federal employees, annuitants, and former spouses.
List of Subjects in 5 CFR Part 890
Administrative practice and procedure, Government employees, Health
facilities, Health insurance, Health professions, Hostages, Iraq,
Kuwait, Lebanon, Reporting and recordkeeping requirements, Retirement.
U.S. Office of Personnel Management.
James B. King,
Director.
Accordingly, OPM proposes to amend 5 CFR Part 890 as follows:
PART 890--FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM
1. The authority citation for part 890 continues to read as
follows:
Authority: 5 U.S.C. 8913; Sec. 890.803 also issued under 50
U.S.C. 403p, 22 U.S.C. 4069c and 4069c-1; subpart L also issued
under sec. 599C of Pub. L. 101-513, 104 Stat. 2064, as amended.
2. In Sec. 890.101, paragraph (a), the definitions for Enrolled and
Enrollee are
[[Page 35975]]
revised, the definitions for Cancellation, Change of enrollment,
Register, and Register to enroll are removed, and the definitions for
Appropriate request, Cancel, Change the enrollment, and Enroll are
added in alphabetical order to read as follows:
Sec. 890.101 Definitions; time computations.
(a) * * *
Appropriate request means a properly completed health benefits
registration form or an alternative method acceptable to both the
employing office and OPM. Alternative methods must be capable of
transmitting to the health benefits plans the information they require
before accepting an enrollment. In addition, for an enrollment or
cancellation to be valid, the signature of the requesting individual
must be on the request, or on a form from the employing office that
notifies the requesting individual of the enrollment or cancellation
and requests his or her confirmation. For changes of enrollments, the
signature of the requesting individual is not required but the
employing office must promptly give the requesting individual notice of
the change of enrollment. For purposes of Sec. 890.301, electronic
signatures, including the use of Personal Identification Numbers (PIN),
have the same validity as a written signature.
* * * * *
Cancel means to submit to the employing office an appropriate
request electing not to be enrolled by an enrollee who is eligible to
continue enrollment.
Change the enrollment means to submit to the employing office an
appropriate request electing a change of enrollment to a different plan
or option, or to a different type of coverage (self only or self and
family).
* * * * *
Enroll means to submit to the employing office an appropriate
request electing to be enrolled in a health benefits plan.
Enrolled means an appropriate request has been accepted by the
employing office and the enrollment in a health benefits plan approved
by OPM under this part has not been terminated or canceled.
Enrollee means the individual in whose name the enrollment is
carried. The term includes employees, annuitants, former employees,
former spouses, or children who are enrolled after completing an
appropriate request under the provisions of Secs. 890.301, 890.306,
890.601, 890.803, or 890.1103 or have continued an enrollment as an
annuitant or survivor annuitant under 5 U.S.C. 8905(b) or Sec. 890.303.
* * * * *
3. In Sec. 890.103, paragraphs (c) and (d) are redesignated as (d)
and (e), and a new paragraph (c) is added to read as follows:
Sec. 890.103 Correction of errors.
* * * * *
(c) The employing office may make retroactive correction of
enrollee enrollment code errors if the enrollee reports the error by
the end of the pay period following the one in which he or she received
the first written documentation (i.e. pay statement or enrollment
change confirmation) indicating the error.
* * * * *
4. Section 890.301 is revised to read as follows:
Sec. 890.301 Opportunities for employees to enroll or change
enrollment; effective dates.
(a) Initial opportunity to enroll. An employee who becomes eligible
may elect to enroll or not to enroll within 60 days after becoming
eligible.
(b) Effective date--generally. Except as otherwise provided, an
enrollment or change of enrollment takes effect on the first day of the
first day period that begins after the date the employing office
receives an appropriate request to enroll or change the enrollment and
that follows a pay period during any part of which the employee is in
pay status.
(c) Belated enrollment. When an employing office determines that an
employee was unable, for cause beyond his or her control, to enroll or
change the enrollment within the time limits prescribed by this
section, the employee may enroll or change the enrollment within 60
days after the employing office advises the employee of its
determination.
(d) Enrollment by proxy. Subject to the discretion of the employing
office, an employee's representative, having written authorization to
do so, may enroll or change the enrollment for the employee.
(e) Change to self only. (1) An employee may change the enrollment
from self and family to self only at any time.
(2) A change of enrollment to self only takes effect on the first
day of the first pay period after the employing office receives an
appropriate request to change the enrollment, except that at the
request of the employee and upon a showing satisfactory to the
employing office that there was no family member eligible for coverage
by the family enrollment, the employing office may make the change
effective on the first day of the pay period following the one in which
there was no family member.
(f) Open season. (1) An open season will be held each year from the
Monday of the second full workweek in November through the Monday of
the second full workweek in December.
(2) The Director of OPM may modify the dates specified in paragraph
(f)(1) of this section or hold additional open seasons.
(3) During an open season, an eligible employee may enroll and an
enrolled employee may change the enrollment from self only to self and
family, from one plan or option to another, or make any combination of
these changes.
(4)(i) An open season new enrollment takes effect on the first day
of the first pay period that begins in the next following year and
which follows a pay period during any part of which the employee is in
a pay status.
(ii) An open season change of enrollment takes effect on the first
day of the first pay period which begins in January of the next
following year.
(5) When a belated open season enrollment or change of enrollment
is accepted by the employing office under paragraph (c) of this
section, it takes effect as required by paragraph (f)(4) of this
section.
(g) Change in family status. (1) An eligible employee may enroll
and an enrolled employee may change the enrollment from self only to
self and family, from one plan or option to another, or make any
combination of these changes when the employee's family status changes,
including a change in marital status or any other change in family
status. The employee must enroll or change the enrollment within the
period beginning 31 days before the date of the change in family
status, and ending 60 days after the date of the change in family
status.
(2) An enrollment or change of enrollment made in conjunction with
the birth of a child, or the addition of a child as a new family member
in some other manner, takes effect on the first day of the pay period
in which the child is born or becomes an eligible family member.
(h) Change in employment status. An eligible employee may enroll
and an enrolled employee may change the enrollment from self only to
self and family, from one plan or option to another, or make any
combination of these changes when the employee's employment status
changes. Except as otherwise provided, an employee must enroll or
change the enrollment within 60 days after the change in employment
status. Employment status changes include, but are not limited to--
[[Page 35976]]
(1) A return to pay status following loss of coverage under
Sec. 890.304(a)(1)(v) due to the expiration of 365 days in leave
without pay (LWOP) status.
(2) Reemployment after a break in service of more than 3 days.
(3) Restoration to a civilian position under part 353 of this
chapter or other similar authority after being ordered to duty in a
uniformed service for 31 days or more.
(4) A change from a temporary appointment in which the employee is
eligible to enroll under 5 U.S.C. 8906a, which requires payment of the
full premium with no Government contribution, to an appointment that
entitles the employee to receive the Government contribution.
(5) Separation from Federal employment when the employee or the
employee's spouse is pregnant and the employee supplies medical
documentation of the pregnancy. An employee who enrolls or changes the
enrollment under this paragraph (h)(5) must do so during his or her
final pay period. The effective date of an enrollment or a change of
enrollment under this paragraph is the first day of the pay period in
which the employing office receives an appropriate request to enroll or
change the enrollment.
(6) A transfer from a post of duty within a State of the United
States or the District of Columbia to a post of duty outside a State of
the United States or the District of Columbia, or the reverse. An
employee enrolling under this paragraph (h)(6) must enroll or change
the enrollment within the period beginning 31 days before leaving the
old post of duty and ending 60 days after arriving at the new post of
duty.
(7) A change, without a break in service or after a separation of 3
days or less, to part-time career employment as defined in 5 U.S.C.
3401(2) and 5 CFR part 340, subpart B, or a change from such part-time
career employment to full-time employment that entitles the employee to
the full Government contribution.
(i) Loss of coverage under this part or under another group
insurance plan. An eligible employee may enroll and an enrolled
employee may change the enrollment from self only to self and family,
from one plan or option to another, or make any combination of these
changes when the employee or an eligible family member of the employee
loses coverage under this part or another group health benefits plan.
Except as otherwise provided, an employee must enroll or change the
enrollment within the period beginning 31 days before the date of loss
of coverage, and ending 60 days after the date of loss of coverage.
Losses of coverage include, but are not limited to--
(1) Loss of coverage under another FEHB enrollment due to the
termination, cancellation, or a change to self only, of the covering
enrollment.
(2) Loss of coverage under another federally-sponsored health
benefits program.
(3) Loss of coverage or loss of access to health services because
the employee or a covered family member in a comprehensive medical plan
moves or becomes employed outside the enrollment or service area, or,
if already outside the enrollment or service area, moves or becomes
employed further from the enrollment or service area. The employee may
change the enrollment upon notifying the employing office of the move
or change of place of employment. The change of enrollment takes effect
on the first day of the pay period that begins after the employing
office receives an appropriate request.
(4) Loss of coverage due to the termination of membership in an
employee organization sponsoring or underwriting an FEHB plan.
(5) Loss of coverage due to the discontinuance of an FEHB plan in
whole or in part. For an employee who loses coverage under this
paragraph (i)(5):
(i) If the discontinuance is at the end of a contract year, the
employee must change the enrollment during the open season, unless OPM
establishes a different time. If the discontinuance is at a time other
than the end of the contract year, OPM must establish a time and
effective date for the employee to change the enrollment.
(ii) If the whole plan is discontinued, an employee who does not
change the enrollment within the time set is considered to have
cancelled the plan in which enrolled.
(iii) If one option of a plan that has two options is discontinued,
an employee who does not change the enrollment is considered to be
enrolled in the remaining option of the plan.
(6) Loss of coverage under the Medicaid program (State program of
medical assistance for the needy).
(7) Loss of coverage under a non-Federal health plan because an
employee moves out of the commuting area to accept another position and
the employee's non-federally employed spouse terminates employment to
accompany the employee. An employee may enroll or change the enrollment
within the period beginning 31 days before the date the employee leaves
employment in the old commuting area and ending 180 days after entry on
duty at place of employment in the new commuting area.
(8) Loss of coverage under a non-Federal health plan.
(j) On becoming eligible for Medicare. An employee may change the
enrollment from one plan or option to another at any time beginning on
the 30th day before becoming eligible for coverage under title XVIII of
the Social Security Act (Medicare). A change of enrollment based on
becoming eligible for Medicare may be made only once.
(k) Salary of temporary employee insufficient to pay withholdings.
If the salary of a temporary employee eligible under 5 U.S.C. 8906a is
not sufficient to pay the withholdings for the plan in which the
employee is enrolled, the employing office shall notify the employee of
the plans available at a cost that does not exceed the employee's
salary. The employee may enroll in another plan whose cost is no
greater than his or her salary within 60 days after receiving such
notification from the employing office. The change of enrollment takes
effect immediately upon termination of the prior enrollment.
5. In Sec. 890.302, paragraph (f) is revised to read as follows:
Sec. 890.302 Coverage of family members.
* * * * *
(f) Determination of incapacity. (1) Except as provided in
paragraph (f)(2) of this section, the employing office shall make
determinations of incapacity.
(2) Either the employing office or the carrier may make a
determination of incapacity if a medical condition, as specified by
OPM, exists that would cause a child to be incapable of self-support
during adulthood.
* * * * *
6. In Sec. 890.303, paragraph (a)(1) is amended by removing
``registration'' and adding in its place ``enrollment'', and paragraph
(a)(3) is revised to read as follows:
Sec. 890.303 Continuation of enrollment.
(a) * * *
(3) For the purpose of this part, an employee is considered to have
enrolled at his or her first opportunity if the employee enrolled
during the first of the periods set forth in Sec. 890.301 in which he
or she was eligible to enroll or was covered at that time by the
enrollment of another employee or annuitant, or whose enrollment was
effective not later than December 31, 1964.
* * * * *
(7) In Sec. 890.304, paragraph (a)(2) is amended by removing
``Sec. 890.301(ee)'' and adding in its place ``Sec. 890.301 (k)'',
paragraph (b)(1) is amended by
[[Page 35977]]
removing ``Sec. 890.301 (q)'' and adding in its place ``Sec. 890.306
(o)'', and the first two sentences of paragraph (d) are revised to read
as follows:
Sec. 890.304 Termination of enrollment.
* * * * *
(d) Cancellation. Except an provided in ``Sec. 890.807(e), an
enrollee may cancel his or her enrollment at any time by filing an
appropriate request with the employing office. The cancellation takes
effect on the last day of the pay period in which the appropriate
request canceling the enrollment is received by the employing office,
except that the cancellation of an enrollee having a monthly or 4-
weekly pay period takes effect at the end of the pay period in which
the appropriate request is received if the request is received between
the first and fifteenth day of the pay period.* * *
* * * * *
8. Section 890.306 is revised to read as follows:
Sec. 890.306 Opportunities for annuitants to change enrollment or to
reenroll; effective dates.
(a) Requirements to continue coverage. (1) To be eligible to
continue coverage in a plan under this part, a former employee in
receipt of an annuity must meet the statutory requirements under 5
U.S.C. 8905(b) of having retired on an immediate annuity and having
been covered by a plan under this part for the 5 years of service
immediately before retirements, or if less than 5 years, for all
service since his or her first opportunity to enroll, unless OPM waives
the requirement under Sec. 890.108.
(2) To be eligible to continue coverage in a plan under this part,
a survivor annuitant must be covered as a family member when the
employee or annuitant dies.
(b) Effective date--generally. Except as otherwise provided, an
annuitant's change of enrollment takes effect on the first day of the
first pay period that begins after the date the employing office
receives an appropriate request to change the enrollment.
(c) Belated enrollment. When an employing office determines that an
annuitant was unable, for clause beyond his or her control, to continue
coverage by enrolling in his or her own name or change the enrollment
within the time limits prescribed by this section, the annuitant may do
so within 60 days after the employing office advises the annuitant of
its determination.
(d) Enrollment by proxy. Subject to the discretion of the
empoloying office, an annuitant's representative, having written
authorization to do so, may continue the annuitant's coverage by
enrolling in the annuitant's own name, or change the enrollment for the
annuitant.
(e) Change to self only. (1) An annuitant may change the enrollment
from self and family to self only at any time.
(2) A change of enrollment to self only takes effect on the first
day of the first pay period after the employing office receives an
appropriate request to change the enrollment, except that at the
request of the annuitant and upon a showing satisfactory to the
employing office that there was no family member eligible for coverage
under the family enrollment, the employing office may make the change
effective on the first day of the pay period following the one in which
was no family member.
(f) Open season. (1) During an open season as provided by
Sec. 890.301(f)--
(i) An enrolled annuitant may change the enrollment from self only
to self and family, from one plan or option to another, or make any
combination of these changes.
(ii) An annuitant who cancelled the enrollment under this part for
the purpose of enrolling in a prepaid health plan under sections 1833
or 1876 of the Social Security Act, and who subsequently voluntarily
disenrolls from the prepaid health plan, may reenroll.
(iii) An annuitant who cancelled the enrollment under this part
because he or she furnished proof of eligibility for coverage under the
Medicaid program (State program of medical assistance for the needy),
and who wishes to reenroll in a plan under this part for reasons other
than an involuntary loss of Medicaid coverage, may do so.
(2) An open season reenrollment or change of enrollment takes
effect on the first day of the first pay period that begins in January
of the next following year.
(3) When a belated open season reenrollment or change of enrollment
is accepted by the employing office under paragraph (c) of this
section, it takes effect as required by paragraph (f)(2) of this
section.
(g) Change in family status. (1) An enrolled former employee in
receipt of an annuity may change the enrollment from self only to self
and family, from one plan or option to another, or make any combination
of these changes when the annuitant's family status changes, including
a change in marital status or any other change in family status. In the
case of an enrolled survivor annuitant, a change in family status based
on additional family members occurs only if the additional family
members are family members of the deceased employee or annuitant. The
annuitant must change the enrollment within the period beginning 31
days before the date of the change in family status, and ending 60 days
after the date of the change in family status.
(2) A change of enrollment made in conjunction with the birth of a
child, or the addition of a child as a new family member in some other
manner, takes effect on the first day of the pay period in which the
child is born or becomes an eligible family member.
(h) Reenrollment of annuitants who cancelled enrollment to enroll
in a Medicare-sponsored Coordinated Care Plan. (1) An annuitant who had
been enrolled (or was otherwise eligible to enroll) for coverage under
this part and cancelled the enrollment for the purpose of enrolling in
a prepaid health plan under sections 1833 or 1876 of the Social
Security Act (as provided by Sec. 890.304(d)), and who is subsequently
involuntarily disenrolled from the prepaid health plan, may immediately
reenroll in any available plan under this part at any time beginning 31
days before and ending 60 days after the disenrollment. A reenrollment
under this paragraph (h) takes effect on the date following the
effective date of the disenrollment as shown on the documentation from
the prepaid health plan.
(2) An annuitant who voluntarily disenrolls from the prepaid health
plan must do so in conjunction with reenrolling in a plan under this
part during the next available open season (as provided by paragraph
(f) of this section) to assure continuing uninterrupted health plan
coverage.
(i) Reenrollment of annuitants who cancelled enrollment because of
eligibility under the Medicaid program. (1) An annuitant who had been
enrolled (or was otherwise eligible to enroll) for coverage under this
part and cancelled the enrollment because he or she furnished proof of
eligibility for coverage under the Medicaid program (State program of
medical assistance for the needy), and who involuntarily loses coverage
under Medicaid, may reenroll in any available plan under this part at
any time beginning 31 days before and ending 60 days after the loss of
Medicaid coverage. A reenrollment under this paragraph (i) takes effect
on the date following the date of loss of Medicaid coverage.
(2) An annuitant who cancelled his or her enrollment because he or
she furnished proof of eligibility for Medicaid coverage, and who
wishes to reenroll in a plan under this part for
[[Page 35978]]
reasons other than an involuntary loss of Medicaid coverage, may do so
during the next available open season as provided by paragraph (f) of
this section.
(j) Annuitants who apply for postponed minimum retirement age plus
10 years of service (MRA plus 10) annuity. (1) A former employee who
meets the requirements for an immediate annuity under 5 U.S.C. 8412(g)
and for continuation of coverage under 5 U.S.C. 8905(b) at the time of
separation, and whose enrollment is terminated under
Sec. 890.304(a)(1)(ii) may enroll in a health benefits plan under this
part within 60 days after OPM mails the former employee a notice of
eligibility. If such former employee dies before the end of this 60-day
election period, a survivor who is entitled to a survivor annuity may
enroll in a health benefits plan under this part within 60 days after
OPM mails the survivor a notice of eligibility.
(2) The former employee's enrollment takes effect on the first day
of the month following the month in which OPM receives the appropriate
request or on the commencing date of annuity, whichever is later. A
survivor's enrollment takes effect on the first day of the month
following the month in which OPM receives the appropriate request.
(k) Restoration of annuity or compensation payments. (1) A
disability annuitant who was enrolled in a health benefits plan under
this part immediately before his or her disability annuity was
terminated because of restoration to earning capacity or recovery from
disability, and whose disability annuity is restored under 5 U.S.C.
8337(e) after December 31, 1983, or 8455(b), may enroll in a health
benefits plan under this part within 60 days after OPM mails a notice
of insurance eligibility. The enrollment takes effect on the first day
of the month after the date OPM receives the appropriate request.
(2) An annuitant who was enrolled in a health benefits plan under
this part immediately before his or her compensation was terminated
because the OWCP determined that he or she had recovered from the job-
related injury or disease, and whose compensation is restored due to a
recurrence of disability, may enroll in a health benefits plan under
this part within 60 days after OWCP mails a notice of insurance
eligibility. The enrollment takes effect on the first day of the pay
period after the date OWCP receives the appropriate request.
(3) A surviving spouse who was covered by a health benefits
enrollment under this part immediately before his or her survivor
annuity was terminated because of remarriage, and whose survivor
annuity is later restored, may enroll in a health benefits plan under
this part within 60 days after OPM mails a notice of eligibility. The
enrollment takes effect on either--
(i) The first day of the month after the date OPM receives the
appropriate request; or
(ii) The date of restoration of the survivor annuity or October 1,
1976, whichever is later.
(4) A surviving child who was covered by a health benefits
enrollment under this part immediately before his or her survivor
annuity was terminated because he or she ceased being a student, and
whose survivor annuity is later restored, may enroll in a health
benefits plan under this part within 60 days after OPM mails a notice
of eligibility. The enrollment takes effect on the first day of the
month after the date OPM receives the appropriate request or the date
of restoration of the survivor annuity, whichever is later.
(5) A surviving spouse who received a basic employee death benefit
under 5 U.S.C. 8442(b)(1)(A) and who was covered by a health benefits
enrollment under this part immediately before remarriage prior to age
55, may enroll in a health benefits plan under this part upon
termination of the remarriage. The survivor must provide OPM with a
certified copy of the notice of death or the court order terminating
the marriage. The surviving spouse must enroll within 60 days after OPM
mails a notice of eligibility. The enrollment takes effect on the first
day of the month after the date OPM receives the appropriate request
and the notice of death or court order terminating the remarriage.
(l) Loss of coverage under this part or under another group
insurance plan. An annuitant who meets the requirements of paragraph
(a) of this section, and who is not enrolled but is covered by another
enrollment under this part may continue coverage by enrolling in his or
her own name when the annuitant loses coverage under the other
enrollment under this part. An enrolled annuitant may change the
enrollment from self only to self and family, from one plan or option
to another, or make any combination of these changes when the annuitant
or an eligible family member of the annuitant losses coverage under
this part or under another group health benefits plan. Except as
otherwise provided, an annuitant must enroll or change the enrollment
within the period beginning 31 days before the date of loss of coverage
and ending 60 days after the date of loss of coverage. Losses of
coverage include, but are not limited to--
(1) Loss of coverage under another FEHB enrollment due to the
termination, cancellation, or a change to self only, of the covering
enrollment;
(2) Loss of coverage under another federally-sponsored health
benefits program;
(3) Loss of coverage or loss of access to health services because
the annuitant or a covered family member in a comprehensive medical
plan moves or becomes employed outside the enrollment or service area,
or, if already outside the enrollment or service area, moves or becomes
employed further from the enrollment or service area. The annuitant may
change the enrollment upon notifying the employing office of the move
or change of place of employment. The change of enrollment takes effect
on the first day of the pay period that begins after the employing
office receives an appropriate request.
(4) Loss of coverage due to the termination of membership in an
employee organization sponsoring or underwriting an FEHB plan;
(5) Loss of coverage due to the discontinuance of an FEHB plan in
whole or in part. For an annuitant who loses coverage under this
paragraph (l)(5)--
(i) If the discontinuance is at the end of a contract year, the
annuitant must change the enrollment during the open season, unless OPM
establishes a different time. If the discontinuance is at a time other
than the end of the contract year, OPM must establish a time and
effective date for the annuitant to change the enrollment;
(ii) If a plan has only one option and is discontinued, an
annuitant who does not change the enrollment is deemed to have enrolled
in the standard option of the Blue Cross and Blue Shield Service
Benefit Plan.
(iii) If a plan has two options, and one option of the plan is
discontinued, an annuitant who does not change the enrollment is
considered to be enrolled in the remaining option of the plan.
(iii) If a plan has two options and both options are discontinued,
an annuitant who does not change the enrollment is deemed to have
enrolled in the corresponding option of the Blue Cross and Blue Shield
Service Benefit Plan. If the annuitant is enrolled in a high option and
his or her annuity is insufficient to pay the withholding for the high
option, the annuitant is deemed to have enrolled in the standard option
of the Blue Cross and Blue Shield Service Benefit Plan. The exemptions
from debt collection
[[Page 35979]]
procedures that are provided under sections 831.1305(d)(2) and
845.205(d)(2) of this chapter apply to elections under this paragraph;
(6) Loss of coverage under the Medicaid program (State program of
medical assistance for the needy).
(7) Loss of coverage under a non-Federal health plan.
(m) Overseas post of duty. An annuitant may change the enrollment
from self only to self and family, from one plan or option to another,
or make any combination of these changes within 60 days after the
retirement or death of the employee on whose service title to annuity
is based, if the employee was stationed at a post of duty outside a
State of the United States or the District of Columbia at the time of
retirement or death.
(n) On return from a uniformed service. An enrolled annuitant who
enters on duty in a uniformed service for 31 days or more may change
the enrollment within 60 days after separation from the uniformed
service.
(o) On becoming eligible for Medicare. An annuitant may change the
enrollment from one plan or option to another at any time beginning on
the 30th day before becoming eligible for coverage under title XVIII of
the Social Security Act (Medicare). A change of enrollment based on
becoming eligible for Medicare may be made only once.
(p) Annuity insufficient to pay withholdings. (1) If an annuity is
sufficient to pay the withholdings for the plan that the annuitant is
enrolled in, the retirement system must provide the annuitant with
information regarding the available plans and written notification of
the opportunity to either--
(i) Pay the premium directly to the retirement system in accordance
with Sec. 890.502(f); or
(ii) Enroll in any plan in which the annuitant's share of the
premium is less than that amount of annuity. If the annuitant elects to
change to a lower cost enrollment, the change takes effect immediately
upon loss of coverage under the prior enrollment.
(2) If the annuitant is enrolled in the high option of a plan that
has two options, and does not change the enrollment to a plan in which
the annuitant's share of the premium is less than the amount of annuity
or does not elect to pay premiums directly, the annuitant is deemed to
have enrolled in the standard option of the same plan, unless the
annuity is insufficient to pay the withholdings for the standard
option.
(3) An annuitant whose enrollment was terminated because the amount
of annuity was insufficient to cover the enrollee's share of the
premium may apply to be reinstated in any available plan or option.
(4) An annuitant who can show evidence that he or she previously
changed to a lower cost option, plan, or to a self only enrollment
prior to May 29, 1990, because the annuity was insufficient to cover
the withholdings for the plan in which he or she was enrolled, may
apply to change the enrollment to any available plan or option in which
the enrollee's share of the total premium exceeds his or her monthly
annuity.
(5) The effective date of the reinstatement of enrollment of an
annuitant whose enrollment was terminated, or the change of enrollment
of an annuitant who previously changed enrollment because his or her
annuity was insufficient to cover the annuitant's share of the total
premium, and who elects to pay premiums directly to the retirement
system in accordance with Sec. 890.502(f) is either--
(i) The first day of the first pay period that begins after the
appropriate request is received by the retirement system; or,
(ii) The later of the date the enrollment was terminated or
changed, or May 29, 1990.
(6) Retroactive reinstatement or change of enrollment is contingent
upon payment of appropriate contributions retroactive to the effective
date of the reinstatement or the change of enrollment. For the purpose
of this paragraph (p)(6), a previous cancellation of enrollment because
of insufficient annuity to cover the full amount of the withholdings is
deemed to be a termination of enrollment.
(q) Sole survivor. When an employee or annuitant enrolled for self
and family dies, leaving a survivor annuitant who is entitled to
continue the enrollment, and it is apparent from available records that
the survivor annuitant is the sole survivor entitled to continue the
enrollment, the office of the retirement system which is acting as
employing office must change the enrollment from self and family to
self only, effective on the commencing date of the survivor annuity. On
request of the survivor annuitant made within 31 days after the first
installment of annuity is paid, the office of the retirement system
which is acting as employing office must rescind the action retroactive
to the effective date of the change to self only, with corresponding
adjustment in withholdings and contributions.
(r) Election between survivor annuities. A surviving spouse,
irrespective of whether his or her survivor annuity continued or was
terminated upon remarriage, who was covered by an enrollment under this
part immediately before the remarriage, may elect to continue an
enrollment under this part acquired as a dependent by virtue of the
remarriage or to enroll in his or her own right (by virtue of
entitlement to the original survivor annuity) in any plan or option
under this part within 60 days after the termination of the remarriage
and entitlement to a survivor annuity.
Sec. 890.602 [Amended]
9. Section 890.602 is amended by removing ``register'' and adding
in its place ``elect to enroll''.
Sec. 890.803 [Amended]
10. In Sec. 890.803, paragraph (a)(3)(i) is amended by removing ``5
CFR 831.606(a) and (b) and 842.605(a) and (b)'' and adding in its place
``Secs. 831.613(a) and (b) and 842.605(a) and (b) of this chapter''.
11. Section 890.806 is revised to read as follows:
Sec. 890.806 Opportunities for former spouses to enroll and change
enrollment; effective dates of enrollment.
(a) Initial opportunity to enroll. A former spouse who has met the
eligibility requirements of Sec. 890.803 and the application time
limitation requirements of Sec. 890.805 may enroll at any time after
the employing office establishes that these requirements have been met.
(b) Effective date--generally. (1) Except as otherwise provided, an
enrollment takes effect on the first day of the first pay period that
begins after the date the employing office receives an appropriate
request and satisfactory proof of eligibility as required by paragraph
(a) of this section. If a former spouse requests immediate coverage,
and the employing office receives an appropriate request and
satisfactory proof of eligibility within 60 days after the date of
divorce, the enrollment may be made effective on the same day that
temporary continuation of coverage under subpart K of this part would
otherwise take effect.
(2) A change of enrollment takes effect on the first day of the
first pay period that begins after the employing office receives the
appropriate request.
(c) Belated enrollment. When an employing office determines that a
former spouse was unable, for cause beyond his or her control, to
enroll or change the enrollment within the time limits prescribed by
this section, the former spouse may do so within 60 days after the
employing office advises the former spouse of its determination.
[[Page 35980]]
(d) Enrollment by proxy. Subject to the discretion of the employing
office, a former spouse's representative, having written authorization
to do so, may enroll or change the enrollment for the former spouse.
(e) Change to self only. (1) A former spouse may change the
enrollment from self and family to self only at any time.
(2) A change of enrollment to self only takes effect on the first
day of the first pay period after the employing office receives an
appropriate request to change the enrollment, except that at the
request of the former spouse and upon a showing satisfactory to the
employing office that there was no family member eligible for coverage
under the family enrollment, the employing office may make the change
take effect on the first day of the pay period following the one in
which there was no family member.
(f) Open season. (1) During an open season as provided by
Sec. 890.301(f)--
(i) An enrolled former spouse may change the enrollment from self
only to self and family provided the family member(s) is eligible for
coverage under Sec. 890.804, from one plan or option to another, or
make any combination of these changes.
(ii) A former spouse who cancelled the enrollment under this part
for the purpose of enrolling in a prepaid health plan under sections
1833 or 1876 of the Social Security Act, and who subsequently
voluntarily disenrolls from the prepaid health plan, may reenroll.
(iii) A former spouse who canceled the enrollment under this part
because he or she furnished proof of eligibility for coverage under the
Medicaid program (State program of medical assistance for the needy),
and who wishes to reenroll in a plan under this part for reasons other
than an involuntary loss of Medicaid coverage, may do so.
(2) An open season reenrollment or change of enrollment takes
effect on the first day of the first pay period that begins in January
of the next following year.
(3) When a belated open season reenrollment or change of enrollment
is accepted by the employing office under paragraph (c) of this
section, it takes effect as required by paragraph (f)(2) of this
section.
(g) Change in family status. (1) An enrolled former spouse may
change the enrollment from self only to self and family, from one plan
or option to another, or make any combination of these changes within
the period beginning 31 days before and ending 60 days after the birth
or acquisition of a child who meets the eligibility requirements of
Sec. 890.804.
(2) A change in enrollment under paragraph (g)(1) of this section
takes effect on the first day of the pay period in which the child is
born or becomes an eligible family member.
(h) Reenrollment of former spouses who canceled enrollment to
enroll in a Medicare-sponsored Coordinated Care Plan. (1) A former
spouse who had been enrolled for coverage under this part and canceled
enrollment for the purpose of enrolling in a prepaid health plan under
sections 1833 or 1876 of the Social Security Act, and who is
subsequently involuntarily disenrolled from the prepaid health plan,
may immediately reenroll in any available plan under this part at any
time beginning 31 days before and ending 60 days after the
disenrollment. A reenrollment under this paragraph (h) takes effect on
the date following the effective date of the disenrollment as shown on
the documentation from the prepaid health plan.
(2) A former spouse who voluntarily disenrolls from the prepaid
health plan must do so in conjunction with reenrolling in a plan under
this part during the next available open season as provided by
paragraph (f) of this section to assure continuing uninterrupted health
plan coverage.
(i) Reenrollment of former spouses who canceled enrollment because
of eligibility under the Medicaid program. (1) A former spouse who had
been enrolled (or was otherwise eligible to enroll) for coverage under
this part and canceled the enrollment because he or she furnished proof
of eligibility for coverage under the Medicaid program (State program
of medical assistance for the needy), and who involuntarily loses
coverage under Medicaid, may reenroll in any available plan under this
part at any time beginning 31 days before and ending 60 days after the
loss of Medicaid coverage. A reenrollment under this paragraph (i)
takes effect on the date following the date of loss of Medicaid
coverage.
(2) A former spouse who canceled his or her enrollment because he
or she furnished proof of eligibility for Medicaid coverage, and who
wishes to reenroll in a plan under this part for reasons other than an
involuntary loss of Medicaid coverage, may do so during the next
available open season as provided by paragraph (f) of this section.
(j) Loss of coverage under this part or under another group
insurance plan. A former spouse who has established eligibility for
health benefits under Sec. 890.803 and met the application time
limitations of Sec. 890.805, and who is not enrolled as a former spouse
but is covered by another enrollment under this part or under another
group health benefits plan, may enroll upon loss of the other coverage.
An enrolled former spouse may change the enrollment from self only to
self and family, from one plan or option to another or make any
combination of these changes when the former spouse or a child who
meets the eligibility requirements under Sec. 890.804 loses coverage
under another enrollment under this part or under another group health
benefits plan. Except as otherwise provided, the former spouse must
enroll or change the enrollment within the period beginning 31 days
before and ending 60 days after the loss of coverage, provided he or
she continues to meet the eligibility requirements under Sec. 890.803.
Losses of coverage include but are not limited to--
(1) Loss of coverage under another FEHB enrollment due to the
termination, cancellation, or a change to self only, of the covering
enrollment;
(2) Loss of coverage under another federally sponsored health
benefits program;
(3) Loss of coverage or access to health services because the
former spouse or a covered family member in a comprehensive medical
plan moves or becomes employed outside the enrollment or service area,
or, if already outside the enrollment or service area, moves or becomes
employed further from the enrollment or service area. The former spouse
may change the enrollment upon notifying the employing office of the
move or change of place of employment. The change of enrollment takes
effect on the first day of the pay period that begins after the
employing office receives an appropriate request.
(4) Loss of coverage due to the termination of membership in an
employee organization sponsoring or underwriting an FEHB plan;
(5) Loss of coverage due to the discontinuance of an FEHB plan in
whole or in part. For a former spouse who loses coverage under this
paragraph (j)(5)--
(i) If the discontinuance is at the end of a contract year, the
former spouse must change the enrollment during the open season, unless
OPM establishes a different time. If the discontinuance is at a time
other than the end of the contract year, OPM must establish a time and
effective date for the former spouse to change the enrollment;
(ii) If the whole plan is discontinued, a former spouse who does
not change the enrollment within the time set is
[[Page 35981]]
considered to have cancelled the plan in which enrolled.
(iii) If one option of a plan that has two options is discontinued,
a former spouse who does not change the enrollment is considered to be
enrolled in the remaining option of the plan.
(6) Loss of coverage under the Medicaid program (State program of
Medical assistance for the needy).
(7) Loss of coverage under a non-Federal health plan.
(k) On becoming eligible for Medicare. A former spouse may change
the enrollment from one plan or option to another at any time beginning
on the 30th day before becoming eligible for coverage under title XVIII
of the Social Security Act (Medicare). A change of enrollment based on
becoming eligible for Medicare may be made only once.
(1) Annuity insufficient to pay withholdings. (1) If the annuity of
a former spouse is insufficient to pay the full subscription charge for
the plan in which he or she is enrolled, the retirement system must
provide the former spouse with information regarding the available
plans and written notification of the opportunity to either--
(i) Pay the premium directly to the retirement system in accordance
with Sec. 890.808(d); or
(ii) Enroll in any plan with a full premium that is less than the
amount of annuity. If the former spouse elects to change to a lower
cost enrollment, the change takes effect immediately upon loss of
coverage under the prior enrollment.
(2) If the former spouse is enrolled in the high option of a plan
that has two options, and does not elect a plan with a full premium
that is less than the annuity or does not elect to pay premiums
directly, he or she is deemed to have enrolled in the standard option
of the same plan unless the annuity is insufficient to pay the full
subscription charge for the standard option.
(3) A former spouse who is enrolled in a plan with only one option,
who fails to make the election required by this paragraph will be
subject to the provisions of section 890.807(c).
(12) Section 890.807 is amended by revising the heading for
paragraph (c) and revising paragraph (c)(1) to read as follows:
Sec. 890.807 Termination of enrollment.
* * * * *
(c) Failure to make an election under Sec. 890.806(l). (1) If the
annuity is insufficient to pay the full subscription charge due for the
plan in which the former spouse is enrolled, the former spouse may
elect one of the two opportunities offered under Sec. 890.806(l)
(electing a plan with a full subscription charge that is less than the
annuity; or paying premiums directly to the retirement system in
accordance with Sec. 890.808(d). Except as provided in paragraph (c)(3)
of this section the enrollment of a former spouse who fails to make an
election within the specified time frame will be terminated.
* * * * *
13. In section 890.808, paragraph (e) is revised to read as
follows:
Sec. 890.808 Employing office responsibilities.
* * * * *
(e) Withholding from annuity. The retirement system acting as
employing office for a former spouse will establish a method for
withholding the full subscription charge from the former spouse's
annuity check. When the annuity is insufficient to cover the full
subscription charge, the retirement system will follow the procedures
specified in section 890.806(l).
14. Section 890.1105 is amended by revising the section heading and
adding headings for paragraphs (b), (c), (d), and (f), by revising
paragraphs (d) and (f), and by adding a new paragraph (g) to read as
follows:
Sec. 890.11.05 Initial election of temporary continuation of coverage;
application time limitations and effective dates.
* * * * *
(b) Former employees. * * *
(c) Children. * * *
(d) Former spouses. (a) A former spouse's election must be received
by the employing office within 60 days after the later of--
(i) The date of the qualifying event; or
(ii) The date coverage under subpart H of this part was lost
because of remarriage or loss of qualifying court order, if the loss of
coverage under subpart H occurred before the expiration of the 36-month
period specified in Sec. 890.1107(c); or
(iii) If the employee or former spouse notified the agency of the
termination of the marriage within the time period specified in
Sec. 890.1104(c)(1), the date the former spouse received the notice
from the agency described in Sec. 890.1104(c)(2). If neither the
employee nor the former spouse notified the agency within the specified
time period, the former spouse's opportunity to elect continued
coverage ends 60 days after the qualifying event.
(2) The effective date of former spouse coverage is the later of--
(i) The date determined under paragraph (g) of this section; or
(ii) The date of the divorce or annulment.
* * * * *
(f) Belated elections. Except as provided in paragraphs (c)(2) and
(d)(1)(iii) of this section, when an employing office determines that
an eligible individual was unable, for cause beyond his or her control,
to elect temporary continuation of coverage within the time limits
prescribed by this section, that office must accept the election within
60 days after it advises the individual of that determination.
(g) Effective date of coverage. Except as provided in paragraph
(d)(2)(ii) of this section, the effective date of temporary
continuation of coverage is the day after other coverage under this
part expires, including the 31-day temporary extension of coverage
under Sec. 890.401. If an individual elects temporary continuation of
coverage after the 31-day temporary extension of coverage expires, but
before the expiration of the applicable election period specified in
this section, coverage is restored retroactively, with appropriate
contributions and claims, to the same extent and effect as though no
break in coverage occurred.
15. Section 890.1108 is revised to read as follows:
Sec. 890.1108 Opportunities to change enrollment; effective dates.
(a) Effective date--generally. Except as otherwise provided, a
change of enrollment takes effect on the first day of the first pay
period that begins after the employing office receives an appropriate
request to change the enrollment.
(b) Belated change of enrollment. When an employing office
determines that an enrollee was unable, for cause beyond his or her
control, to change the enrollment within the time limits prescribed by
this section, the enrollee may do so within 60 days after the employing
office advises the enrollee of its determination.
(c) Change of enrollment by proxy. Subject to the discretion of the
employing office, an enrollee's representative, having written
authorization to do so, may change the enrollment for the enrollee.
(d) Change to self only. (1) An enrollee may change the enrollment
from self and family to self only at any time.
(2) A change of enrollment to self only takes effect on the first
day of the first pay period after the employing office receives an
appropriate request to change the enrollment, except that at the
request of the enrollee and upon a showing satisfactory to the
employing office that there was no family member eligible for coverage
under the family enrollment, the employing office may make the change
effective on the first
[[Page 35982]]
day of the pay period following the one in which there was no family
member.
(e) Open season. (1) During the open season as provided by
Sec. 890.301(f), an enrollee (except for a former spouse who is
eligible for continued coverage under Sec. 890.1103(3)) may change the
enrollment from self only to self and family, from one plan or option
to another, or make any combination of these changes. A former spouse
who is eligible for continued coverage under Sec. 890.1103(3) may
change from one plan or option to another, but may not change from self
only to self and family unless the individual to be covered under the
family enrollment qualifies as a family member under
Sec. 890.1106(a)(2).
(2) An open season change of enrollment takes effect on the first
day of the first pay period that begins in January of the next
following year.
(3) When a belated open season change of enrollment is accepted by
the employing office under paragraph (b) of this section, it takes
effect as required by paragraph (e)(2) of this section.
(f) Change in family status. (1) Except for a former spouse, an
enrollee may change the enrollment from self only to self and family,
from one plan or option to another, or make any combination of these
changes when the enrollee's family status changes, including a change
in marital status or any other change in family status. The enrollee
must change the enrollment within the period beginning 31 days before
the date of the change in family status, and ending 60 days after the
date of the change in family status.
(2) A former spouse who is covered under this section may change
the enrollment from self alone to self and family, from one plan or
option to another, or make any combination of these changes within the
period beginning 31 days before and ending 60 days after the birth or
acquisition of a child who qualifies as a covered family member under
Sec. 890.1106(a)(2).
(3) A change of enrollment made in conjunction with the birth of a
child, or the addition of a child as a new family member in some other
manner, takes effect on the first day of the pay period in which the
child is born or becomes an eligible family member.
(g) Reenrollment of individuals who lose other coverage under this
part. An individual whose continued coverage under this section
terminates because of the provisions of Sec. 890.1110(a)(3)
(termination due to other coverage under another provision of this
part) may reenroll if the coverage that terminated the enrollment under
this part ends, but not later than the expiration of the period
described in Sec. 890.1107. Coverage does not extend beyond the
expiration of the period described in Sec. 890.1107. The effective date
of the reenrollment is the day following the termination of the
coverage described in Sec. 890.1110(a)(3).
(h) Loss of coverage under this part or under another group
insurance plan. An enrollee may change the enrollment from self only to
self and family, from one plan or option to another, or make any
combination of these changes when the enrollee loses coverage under
this part or a qualified family member of the enrollee loses coverage
under this part or under another group health benefits plan. Except as
otherwise provided, an enrollee must change the enrollment within the
period beginning 31 days before the date of loss of coverage and ending
60 days after the date of loss of coverage. Losses of coverage include,
but are not limited to--
(1) Loss of coverage under another FEHB enrollment due to the
termination, cancellation, or change to self only, of the covering
enrollment.
(2) Loss of coverage under another federally-sponsored health
benefits program.
(3) Loss of coverage or loss of access to health services because
the enrollee or a covered family member in a comprehensive medical plan
moves or becomes employed outside the enrollment or service area, or,
if already outside the enrollment or service area, moves or becomes
employed further from the enrollment or service area. The enrollee may
change the enrollment upon notifying the employing office of the move
or change of place of employment. The change of enrollment takes effect
on the first day of the pay period that begins after the employing
office receives an appropriate request.
(4) Loss of coverage due to the termination of membership in an
employee organization sponsoring or underwriting an FEHB plan.
(5) Loss of coverage due to the discontinuance of an FEHB plan, in
whole or in part. For an enrollee who loses coverage under this
paragraph (h)(5)--
(i) If the discontinuance is at the end of a contract year, the
enrollee must change the enrollment during the open season, unless OPM
establishes a different time. If the discontinuance is at a time other
than the end of the contract year, OPM must establish a time and
effective date for the enrollee to change the enrollment.
(ii) If the whole plan is discontinued, an enrollee who does not
change the enrollment within the time set is considered to have
cancelled the plan in which enrolled;
(iii) If a plan has two options, and one option of the plan is
discontinued, an enrollee who does not change the enrollment is
considered to be enrolled in the remaining option of the plan.
(6) Loss of coverage under the Medicaid Program (State program of
medical assistance for the needy).
(7) Loss of coverage under a non-Federal health plan.
(i) On becoming eligible for Medicare. An enrollee may change the
enrollment from one plan or option to another at any time beginning on
the 30th day before becoming eligible for coverage under title XVIII of
the Social Security Act (Medicare). A change of enrollment based on
becoming eligible for Medicare may be made only once.
[FR Doc. 96-17248 Filed 7-8-96; 8:45 am]
BILLING CODE 6325-01-M
Complete official Federal Register PDF
FR Doc. 96-17222 Endangered and Threatened Wildlife and Plants; Reopening of Comment Period on Proposed Endangered Status for Five Freshwater Mussels and Proposed Threatened Status for Two Freshwater Mussels From Eastern Gulf Slope Drainages of Alabama, Florida, and Georgia
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 36020-36021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17222]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
RIN 1018-AC63
Endangered and Threatened Wildlife and Plants; Reopening of
Comment Period on Proposed Endangered Status for Five Freshwater
Mussels and Proposed Threatened Status for Two Freshwater Mussels From
Eastern Gulf Slope Drainages of Alabama, Florida, and Georgia
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Proposed rule; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Fish and Wildlife Service provides notice that the comment
period is reopened on a proposal to list the fat three-ridge, shiny-
rayed pocketbook, Gulf moccasinshell, Ochlockonee moccasinshell, and
oval pigtoe as endangered, and the Chipola slabshell and purple
bankclimber as threatened, pursuant to the Endangered Species Act of
1973 (Act), as amended. The Service is reopening the comment period on
this proposal to allow members of the public to submit comments on
these proposals.
DATES: The comment period on this proposal is extended until July 26,
1996.
ADDRESSES: Written comments and materials concerning the proposal
should be sent to the Field Supervisor, U.S. Fish and Wildlife Service,
6620 Southpoint Drive South, Suite 310, Jacksonville, Florida, 32216.
Comments and materials received will be available for public
inspection, by appointment, during normal business hours at the above
address.
FOR FURTHER INFORMATION CONTACT: Robert S. Butler at the above address
(telephone: 904/232-2580, fax 904/232-2404).
SUPPLEMENTARY INFORMATION:
Background
On August 3, 1994, the Service proposed to add seven freshwater
mussels (fat three-ridge, shiny-rayed pocketbook, Gulf moccasinshell,
Ochlockonee moccasinshell, oval pigtoe, Chipola slabshell, and purple
bankclimber) to the list of endangered and threatened animals (59 FR
39524). These seven species are endemic to the Apalachicolan Region of
the eastern Gulf Slope, defined as the rivers from the Escambia River
in the west to the Suwannee River in the east. These drainages comprise
southeast Alabama, southwest Georgia, and north Florida.
Section 4(b)(5)(E) of the Endangered Species Act of 1973, as
amended, requires that a public hearing be held if it is requested
within 45 days of the publication of a proposed rule. By September 19,
1994, the Service had received 12 public hearing requests on the
proposal to list these seven mussels. The Service conducted five public
informational meetings and five public hearings in January 1995. A
notice of the public informational meetings, public hearings, and
reopening of the comment period until February 10, 1995, was published
in the Federal Register on December 12, 1994 (59 FR 63987). In a
Federal Register notice appearing on April 24, 1995 (60 FR 20072), the
Service extended the open comment period until May 5, 1995.
A moratorium on listing actions (Public Law 104-6) took effect
April 10,
[[Page 36021]]
1995, and prevented the Service from making a final decision on these
proposals by the August 1995 administrative deadline. The moratorium
was lifted on April 26, 1996, when the appropriation for the Department
of the Interior for the remainder of fiscal year 1996 was enacted into
law. In a Federal Register document published on May 16, 1996 (61 FR
24722), the Service outlined in detail the history of the moratorium
and indicated the priorities it would follow in eliminating the listing
program backlog resulting from the moratorium. Preparation of final
rules for these proposed species is considered a Tier 2 priority--
processing final decisions on proposed listings. For more information
on the moratorium and the priority for backlogged listing actions,
refer to the May 15, 1996, Federal Register notice.
The Service hereby announces another reopening of the comment
period until July 26, 1996. Reopening of the comment period will allow
the Service to accept information on scientific studies conducted since
the comment period last closed on May 5, 1995. Any other comments from
the interested public will also be solicited concerning these
proposals.
Author
The primary author of this notice is Robert S. Butler, Jacksonville
Field Office, U.S. Fish and Wildlife Service, 6620 Southpoint Drive
South, Suite 310, Jacksonville, Florida 32216 (904/232-2580 or fax 904/
232-2404).
Authority: The authority for this action is the Endangered
Species Act (16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C.
4201-4245; Pub. L. 99-625, 100 Stat. 3500, unless otherwise noted).
Dated: July 1, 1996.
Noreen K. Clough,
Regional Director, Southeast Region, Fish and Wildlife Service.
[FR Doc. 96-17222 Filed 7-8-96; 8:45 am]
BILLING CODE 4310-55-P
Complete official Federal Register PDF
FR Doc. 96-17058 Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 36154-36219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17058]
[[Page 36153]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 106 and 107
Current Good Manufacturing Practice, Quality Control Procedures,
Quality Factors, Notification Requirements, and Records and Reports,
for the Production of Infant Formula; Proposed Rule
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 /
Proposed Rules
[[Page 36154]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 106 and 107
[Docket No. 95N-0309]
RIN 0910-AA04
Current Good Manufacturing Practice, Quality Control Procedures,
Quality Factors, Notification Requirements, and Records and Reports,
for the Production of Infant Formula
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to revise
its infant formula regulations to establish requirements for quality
factors and current good manufacturing practice (CGMP); to amend its
quality control procedure, notification, and records and report
requirements for infant formulas; to require that infant formulas
contain, and be tested for, required nutrients and for any nutrient
added by the manufacturer throughout their shelf life, and that they be
produced under strict microbiological controls; and to require that
manufacturers implement the CGMP and quality control procedure
requirements by establishing a production and in-process control system
of their own design. This action is being taken to improve the
protection of infants that use infant formula products.
DATES: Comments by October 7, 1996, except that comments regarding
information collection should be submitted by August 8, 1996. The
agency proposes that any final rule that may issue based on this
proposal become effective 120 days after its date of publication.
ADDRESSES: Submit written comments, data, or information to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Comments regarding information
collection to the Office of Information and Regulatory Affairs, OMB,
New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC
20503, ATTN: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Carolyn W. Miles, Center for Food
Safety and Applied Nutrition (HFS-456), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-401-9858.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Infant Formula Act of 1980
In 1978, a major manufacturer of infant formula reformulated two of
its soy products by discontinuing the addition of salt. This
reformulation resulted in infant formula products that contained an
inadequate amount of chloride, an essential nutrient for growth and
development in infants. By mid-1979, a substantial number of infants
had been diagnosed with hypochloremic metabolic alkalosis, a syndrome
associated with chloride deficiency. Development of this syndrome in
these infants was found to be associated with prolonged exclusive use
of chloride-deficient soy formulas.
After reviewing the matter, Congress determined that, to improve
protection of infants using infant formula products, greater regulatory
control over the formulation and production of infant formula was
needed, including modifications of industry's and FDA's recall
procedures. Accordingly, Congress passed, and the President signed into
law on September 26, 1980, the Infant Formula Act of 1980 (the 1980
act) (Pub. L. 96-359). This law amended the act to include section 412
(21 U.S.C. 350a).
In 1982, FDA adopted infant formula recall procedures, establishing
subpart D of part 107 of its regulations (21 CFR part 107) (47 FR
18832, April 30, 1982), and infant formula quality control procedures
(21 CFR part 106 (47 FR 17016, April 20, 1982)). In 1985, FDA further
implemented the 1980 act by establishing subparts B, C, and D in 21 CFR
part 107 regarding the labeling of infant formula, exempt infant
formulas, and nutrient requirements for infant formula, respectively
(50 FR 1833, January 14, 1985; 50 FR 48183, November 22, 1985; and 50
FR 45106, October 30, 1985).
B. The 1986 Amendments to the Infant Formula Act
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 that statute. These concerns included whether the
quality control testing, CGMP, recordkeeping, and recall requirements
that FDA had adopted would prevent children ``from ever again being
threatened by defective baby formula'' (Ref. 1). The 1986 amendments:
(1) State that an infant formula is deemed to be adulterated unless it
provides certain required nutrients, meets the quality factor
requirements established by the Secretary of Health and Human Services
(the Secretary) (and, by delegation, FDA), and is manufactured in
accordance with CGMP and quality control procedures established by the
Secretary; (2) require that the Secretary issue regulations
establishing requirements for quality factors and CGMP, including
quality control procedures; (3) require that infant formula
manufacturers regularly audit their operations to ensure that those
operations comply with CGMP and quality control procedure regulations;
(4) expand the circumstances in which manufacturers must make a
submission to the agency to include when a manufacturer makes major
changes in an infant formula, and when a manufacturer makes changes
that may affect whether the formula is adulterated; (5) specify the
nutrient quality control testing that must be done on each batch of
infant formula; (6) modify the infant formula recall requirements; and
(7) give the Secretary authority to establish requirements for
retention of records, including records necessary to demonstrate
compliance with CGMP and quality control procedures.
In 1989, the agency responded to the provisions of the 1986
amendments on recalls (sections 412(f) and (g) of the act) by
establishing subpart E in part 107 (54 FR 4006, January 27, 1989). In
1991, the agency adopted infant formula record and record retention
requirements that implemented the 1986 amendments by revising
Sec. 106.100 (56 FR 66566, December 24, 1991).
Although the agency has adopted regulations that respond to a
number of the provisions of the 1986 amendments, it has not issued
regulations on infant formula CGMP and quality factors or revised the
notification procedures and quality control procedures to reflect the
1986 amendments. Since the passage of the 1986 amendments, agency
representatives have visited infant formula plants to observe the
manufacturing practice and quality control procedures that they employ,
and the agency has solicited and received recommendations on CGMP from
the Infant Formula Council. In addition, FDA has contracted with the
Committee on Nutrition of the American Academy of Pediatrics (CON/AAP)
to obtain expert advice on clinical testing of infant formulas with
respect to the quality factor requirements. Moreover, both industry and
the agency have
[[Page 36155]]
increased experience with the quantity and quality of information that
should be submitted to meet the notification requirements of section
412(c) and (d) of the act.
This proposal addresses CGMP, quality control procedures, quality
factors, and notification procedures and incorporates information
resulting from the interactions between FDA and industry and between
FDA and AAP. This proposal updates the language in part 107 to reflect
the 1986 amendments and the November 1992 reorganization of the Center
for Food Safety and Applied Nutrition (CFSAN).
C. FDA's Regulations on Nutrient Requirements
Section 412(i) of the act includes a table that lists nutrients
that every infant formula must contain. This section also establishes a
minimum level for each of the listed nutrients and a maximum level for
eight of the listed nutrients. In addition, section 412(i)(2) of the
act grants the Secretary (and by delegation FDA) the authority to
revise the list of nutrients in section 412(i), and the minimum and
maximum levels of those nutrients, by regulation. In the Federal
Register of October 30, 1995, FDA established the nutrient requirements
for infant formulas in Sec. 107.100 (50 FR 45106). For the purpose of
this document, the nutrients that are required to be in infant formula
under Sec. 107.100 will be referred to as ``required nutrients,'' and
the levels of these required nutrients established in Sec. 107.100 will
be referred to as ``required levels.''
II. The Need for Regulation
Relative to per unit of body weight, nutrient requirements are
generally greater in infancy than at any other time during life. During
the first year, the rate of growth is at its maximum, with birth weight
typically doubling by 4 months of age and tripling by 1 year (Refs. 2
and 3). Moreover, the metabolic rate in infants is greater, and the
turnover of nutrients is more rapid, than in adults (Ref. 4). Thus,
infants must ingest adequate nutrients to support a rapid rate of
growth and of developmental changes and to supply maintenance needs.
Without adequate nutrition, infants would be unable to achieve their
genetic potential for growth and development.
These nutritional needs must be met in early infancy by food in
liquid form. Sucking and involuntary swallow reflexes are the
mechanisms by which very young infants ingest food until teeth and
motor coordination develop. Consequently, for infants who are not fed
breast milk, infant formula often serves as the sole source, or the
major source, of nutrition during this time of rapid growth and
development.
Therefore, the importance of proper infant formula manufacture,
composition, and nutrient levels cannot be overstated. Senator
Metzenbaum explained why infant formula needs more regulation than
other foods when he stated ``there is simply no margin for error in the
production of baby formula. An infant relies on the formula to sustain
life and provide the proper nourishment at a time of rapid physical and
mental development'' (Ref. 1). The requirements contained in this
proposal are designed to ensure that the formula fed to American
infants fulfills its important function.
The CGMP and quality control procedures that FDA is proposing are
designed to prevent the production of an adulterated infant formula.
Defining CGMP will help to ensure that all of the required nutrients
are included at appropriate levels in the formula, and that the formula
is not contaminated with microorganisms or other materials that may be
harmful to the infant.
Quality control procedures are designed to ensure that an infant
formula contains the nutrients that are necessary to support growth and
development, at the appropriate levels, not only when it enters into
commerce but throughout its shelf life. FDA is proposing that each
batch of infant formula be tested for all required nutrients and any
nutrient added by the manufacturer, and that finished batches be
periodically sampled and tested for nutrients throughout the shelf life
of the product.
Quality factors are designed to ensure that the required nutrients
and any nutrient added by the manufacturer actually reach the infant in
a useable form. Quality factors ``pertain to the bioavailability of a
nutrient and the maintenance of level or potency of nutrients during
the expected shelf life of the product'' (Ref. 5). The 1986 amendments
directed that the Secretary, by regulation, ``establish requirements
for quality factors for infant formulas to the extent possible
consistent with current scientific knowledge, including quality factor
requirements for the nutrients required by (section 412(i) of the
act).''
In 1986, FDA advised Congress that the technology and science with
respect to quality factors was still evolving, and that it was only
possible to establish a quality factor for one nutrient. The agency
said that it had already done so. However, in the 1986 Congressional
Record (Ref. 1), Senator Metzenbaum stated that ``the legislation
contemplates that the Secretary will move to promptly develop and issue
appropriate quality factor standards for different nutrients as the
state of the science progresses.'' Since that time, as stated above,
FDA has contracted with CON/AAP to obtain expert advice on quality
factors; i.e., on the clinical testing of infant formula with respect
to its nutritional safety and suitability for term infants.
In 1988, CON/AAP submitted a report (Ref. 6) under the contract
that identified and discussed the types of clinical studies that might
be considered for evaluation of the nutritional suitability of a
formula for normal term infants. FDA has reviewed this report and the
available scientific literature and has identified quality factors for
protein and for complete infant formulas. The agency is proposing to
adopt these quality factors as part of these regulations.
FDA has received numerous inquiries from industry for specific
guidance on what information must be submitted to meet the requirements
of sections 412(c) and (d) of the act, which state when a manufacturer
must register with, submit to, or notify the agency about a new or
changed infant formula, and what must be in the registration,
submission, or notification. The agency is responding to these requests
in this proposal. The agency is providing this information not only in
response to these inquiries but also to facilitate more consistent
registrations, submissions, and notifications. The lack of consistency
in the format and content of registrations, submissions, and
notifications has caused inefficiencies and delays in the agency's
review. Accordingly, the agency is proposing to establish a consistent
format and content for infant formula registrations, submissions, and
notifications.
Within the past year, FDA has investigated a number of instances in
which infant formula manufactured in the United States has been
diverted from normal distribution channels and relabeled, sometimes
with counterfeit labels for the same brand of infant formula but in
other instances with counterfeit labels for different formulations.
Infant formula bearing counterfeit labels is a potentially serious
public health problem. It could cause infant formula that is past the
use by date to enter the marketplace if the counterfeit label bears an
incorrect use by date. The more serious consequence of this practice,
however, is that it could cause infants that are intolerant to certain
infant formula ingredients to be fed an incorrect formula, with serious
consequences to the health of the infant,
[[Page 36156]]
if an infant formula has been relabeled with an incorrect label (e.g.,
a milk-based infant formula relabeled to indicate that it is a soy-
based infant formula). Therefore, as part of this proposed regulation,
the agency is requesting comments on new or modified procedures or
controls that could be instituted during the labeling, packaging, or
distribution of infant formula and that would be effective in
preventing or reducing the potential for the diversion of infant
formula from normal distribution channels and its relabeling with
counterfeit labels.
III. Scope of this Document
To implement the 1986 amendments, the agency is proposing to amend
its regulations by adding new subparts B, D, and E to part 106 and by
redesignating existing subparts B, C, and D as subparts C, F, and G.
Table 1 sets out the current and proposed subpart designations.
Table 1
----------------------------------------------------------------------------------------------------------------
Subparts Current regulation Proposed regulation
----------------------------------------------------------------------------------------------------------------
A................. General Provisions........................... General Provisions.
B................. Quality Control Procedures for Assuring Current Good Manufacturing Practice.
Nutrient Content of Infant Formulas.
C................. Records and Reports.......................... Quality Control Procedures.
D................. Notification Requirements.................... Conduct of Audits.
E................. None......................................... Quality Factors for Infant Formulas.
F................. None......................................... Records and Reports.
G................. None......................................... Registration, Submission, and Notification
Requirements.
----------------------------------------------------------------------------------------------------------------
The proposed regulation adds a new Sec. 107.1 and will amend
Sec. 107.10(a)(2) by requiring that ``any nutrient added by the
manufacturer'' be listed on the label. The proposed regulation amends
Secs. 107.240 and 107.250 by changing the reference to the Division of
Regulatory Guidance to the Division of Enforcement to reflect the
November 1992 reorganization of CFSAN.
IV. The Proposed Regulations
A. General Provisions
To reflect the expanded scope of the proposed regulations, FDA is
revising the heading of part 106 to read, ``Infant Formula-Requirements
Pertaining to Current Good Manufacturing Practice, Quality Control
Procedures, Quality Factors, Records and Reports, and Notifications.''
1. Status and Applicability of the Regulations in Part 106
Proposed Sec. 106.1 sets out the authority for each of the proposed
subparts and the consequences under the act of failure to comply with
any of the regulations in the proposed subparts. FDA is including
proposed Sec. 106.1 because it is important for manufacturers to be
aware of the legal consequences of failure to comply with these
regulations, which are being issued to implement specific sections of
the act.
2. Definitions
The agency is proposing to amend Sec. 106.3 by adding several
definitions that are needed to explain activities that specifically
concern the infant formula industry. It is important whenever possible
to maintain consistent terminology throughout the agency's regulations.
Therefore, as described in detail below, FDA has relied, where
possible, on existing definitions in 21 CFR parts 105, 110, and 210 in
arriving at these proposed definitions. Other definitions were derived
from specific provisions in the act.
Proposed Sec. 106.3(a), (g), (h), and (p) incorporate into part 106
the definitions for ``batch,'' ``lot,'' ``lot number, control number,
or batch number,'' and ``representative sample'' derived from 21 CFR
210.3(b)(2), (b)(10), (b)(11), and (b)(21), respectively. In addition
to promoting consistency in the agency's regulations, FDA has
tentatively determined that use of these definitions in part 106 is
appropriate because they permit the agency to refer to the product in
terms that reflect the fact that it is produced in bulk rather than on
a unit-by-unit basis.
Proposed Sec. 106.3(k), (q), and (r) incorporate into part 106 the
definitions for ``microorganisms,'' ``shall,'' and ``should'' from 21
CFR 110.3(i), (p), and (q), respectively. In addition to promoting
consistency, these definitions reflect the generally recognized
scientific or legal meaning of these terms.
Proposed Sec. 106.3(c), (f), (j), and (n) incorporate into part 106
the definitions for ``indicator nutrient,'' ``in-process batch,''
``manufacturer,'' and ``nutrient premix'' from current Sec. 106.3. The
definition of ``manufacturer'' in proposed Sec. 106.3(j) warrants
particular note. In the past there has been some confusion about who is
and who is not a manufacturer of infant formula. This definition makes
clear that a manufacturer is not only a person who combines raw
ingredients together to produce an infant formula but also is a person
who reconstitutes or otherwise changes the physical or chemical
characteristics of an infant formula or who packages or labels the
product in a container for distribution. For example, the agency is
aware of a firm that reconstitutes powdered infant formulas and puts
the reconstituted formula in bottles to sell to hospitals. This
definition makes clear that this firm is a ``manufacturer.''
Proposed Sec. 106.3(d) incorporates into part 106 the definition
for ``infant'' from 21 CFR 105.3(e).
In addition to the definitions derived from FDA's existing
regulations, the agency is proposing to amend Sec. 106.3 by adding
definitions that are derived from the definitions provided by Congress
in the act.
Proposed Sec. 106.3(e) and (l) incorporate into part 106 the
definitions for ``infant formula'' and ``new infant formula'' from
sections 201(aa) (21 U.S.C. 321(aa)) and 412(c)(2), respectively.
Proposed Sec. 106.3(e) defines ``infant formula'' as a food that
purports to be or is represented for special dietary use solely as a
food for infants by reason of its simulation of human milk or its
suitability as a complete or partial substitute for human milk. The
phrase ``solely as a food for infants'' is somewhat ambiguous. Where
there is an ambiguity in a statutory provision, it is appropriate to
look to the legislative history to determine the appropriate
interpretation. In the legislative history of the Infant Formula Act,
whenever the words ``sole'' or ``solely'' are used, they appear in the
context of describing infant formula as the ``sole'' or primary source
of nutrition for infants or babies. For example, in explaining how the
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1980 act would change existing laws, then-Congressman Gore stated:
``First it would require that any infant formula marketed in the United
States as the sole source of nutrition for normal babies include
minimum amounts of all essential nutrients.'' (Ref. 7.) Congressman
Mottl stated that the 1980 act ``is concerned with human lives at their
most vulnerable stage. We are talking about food that may be the sole
source of nourishment for infants.'' (Ref. 7.) This language and other
similar language in the legislative history evidence that Congress
intended the act to apply to any food that purports to be or that is
represented as an infant formula, regardless of whether other possible
uses of the product are suggested in its labeling. If the law only
applied to foods that are represented only for use as infant formula,
then manufacturers could easily evade the requirements of the act for
infant formula by representing their products for a second purpose.
Such an interpretation would be inconsistent with the remedial purposes
of the infant formula provisions of the act.
Proposed Sec. 106.3(b) incorporates into part 106 the definition
for ``final-product-stage'' derived from section 412(b)(3)(E) of the
act. FDA has modified the definition, however, by adding the phrase
``due to processing'' at the end of the definition to clarify that the
final-product-stage is when the infant formula ``is homogeneous and is
not subject to further degradation due to processing'' and to
distinguish the point in time after which the formula is subject to
further degradation during the shelf life of the product.
Proposed Sec. 106.3(i) incorporates into part 106 a definition of
``major change'' that is derived from section 412(c)(2)(B) of the act,
which states that ``* * * the term `major change' has the meaning given
to such term in section 106.30(c)(2) of title 21, Code of Federal
Regulations (as in effect on August 1, 1986), and guidelines issued
thereunder'' (Ref. 8). Proposed Sec. 106.3(i) defines ``major change''
as it is defined in current Sec. 106.30(c)(2). It also provides a
number of examples of infant formulas deemed to differ fundamentally in
processing or in composition. These examples are derived from the
guidelines that were issued by the agency and were incorporated into
the definition of ``major change'' in section 412(c) of the act by the
1986 amendments.
Proposed Sec. 106.3(m) revises the definition for ``nutrient'' in
current Sec. 106.3(d) to reflect changes to the act made by the 1986
amendments. As stated above, the 1986 amendments moved the nutrient
table from section 412(g) to section 412(i)(1) and moved the provision
on promulgation of standards for nutrients from section 412(a)(2)(A) to
section 412(i)(2). The proposed regulation references the new section
numbers. Proposed Sec. 106.3(m) also includes the statement that
nutrients are substances determined to be essential by the Food and
Nutrition Board of the National Research Council or by FDA. The agency
is including this statement in the proposed definition to provide
consistency with Sec. 107.10(b)(5) on labeling nutrient information.
This paragraph allows such information to include any vitamin or
mineral in the formula, provided that the nutrient has been identified
as essential by the National Academy of Sciences through its
development of a recommended dietary allowance or an estimated safe and
adequate daily dietary intake range, or the nutrient has been
identified as essential by FDA through a Federal Register publication.
Proposed Sec. 106.3(o) defines ``quality factors.'' The definition
that FDA is proposing derives from the language of the act and its
legislative history. Section 412(b)(1) of the act states that the
Secretary shall ``establish requirements for quality factors for infant
formulas * * *, including quality factor requirements for the nutrients
required by subsection (i).'' House Report 96-936 (Ref. 5) states that
quality factors ``pertain to the bioavailability of a nutrient and the
maintenance of level or potency of nutrients during the expected shelf
life of the product.'' The language of the act and the House report
show that Congress intended that infant formulas marketed in the United
States should not only be safe, and contain all of the nutrients
required to support infant growth and health, but should provide those
nutrients in a bioavailable form that will mean that, throughout its
shelf life, the formula will support optimal infant growth and health.
Thus, quality factors encompass something different than the
analyzable nutrient content of the finished infant formula. Quality
factor requirements not only ensure that the nutrient potency and
biological effectiveness of a formula, as formulated, are adequate to
support healthy growth, but also that subsequent processing, ingredient
interactions, and time do not reduce the biological effectiveness of a
formula. Quality factor requirements also ensure that unsafe nutrient
``super potencies'' or by-products are not created from ingredient
breakdowns or interactions caused by processing or time.
B. CGMP
1. Introduction
The agency is proposing to adopt a new subpart B to implement the
CGMP requirements in section 412(b)(2) of the act. Proposed Sec. 106.5
is introductory. It reflects FDA's tentative view that the CGMP
requirements set out in subpart B are the minimum necessary to ensure
that the infant formula that is produced contains all the requisite
nutrients and is not otherwise adulterated.
To develop the proposed CGMP regulations, as stated above, agency
representatives visited infant formula plants to observe the
manufacturing practice that they employ, and the agency has solicited
and received recommendations on CGMP from the infant formula industry
through the Infant Formula Council (Ref. 9). The agency also is relying
on its knowledge of industry manufacturing practices gained through
inspections of infant formula manufacturing establishments, review of
infant formula submissions received from industry since 1986, and
monitoring of infant formula recalls.
The proposed CGMP regulations also are based in part on FDA's
existing regulations concerning CGMP for foods (21 CFR part 110) and
for drugs (21 CFR part 211). Because infant formulas are foods, they
should, at a minimum, be manufactured in a manner that is consistent
with CGMP for all foods under section 402(a)(4) of the act (21 U.S.C.
342(a)(4)). Moreover, infant formulas are often the sole source of
nutrition for infants during a period of rapid growth and development
and, hence, are used during a period of nutritional vulnerability.
Thus, if the formula is to promote optimal infant health and growth,
each batch of infant formula must provide the nutrients prescribed
under section 412(i) of the act at the levels specified in that
section, much like each batch of drugs must meet compositional
requirements for active ingredients if they are to have their intended
effect. Therefore, FDA has tentatively concluded that some of the
manufacturing practices required of drug manufacturers are relevant to
infant formula manufacturers.
2. Production and In-Process Control System
Section 412(b)(2)(B)(iii) of the act states that CGMP and quality
control procedures shall include requirements for ``in-process controls
including, where necessary, testing required by CGMP designed to
prevent adulteration of each batch of infant formula.'' In the past,
manufacturers of infant formula have referred to production and in-
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process control systems intended to ensure that required nutrients are
included in the formula and to prevent adulteration by such terms as
``quality control plans,'' ``standard operating procedures,'' or
``master manufacturing procedures.'' Infant formula manufacturers also
have investigated adopting a system, known as the ISO.9000 series,
developed by the International Organization for Standardization (ISO).
The agency is proposing to establish a framework in which decisions
about the production of infant formula are left to the manufacturer but
that charges the manufacturer with incorporating into its production
process measures that are designed to ensure the safety and nutritional
quality of the formula.
For example, proposed Sec. 106.10(a) requires that there be
sufficient personnel, qualified by training and experience, to perform
all operations, including all required recordkeeping, in the
manufacture, processing, packing, and holding of each infant formula
and to supervise such operations to ensure that they are correctly and
fully performed. This provision is a performance standard for
determining how many employees are necessary, i.e., that there be
enough to achieve, maintain, and document CGMP. FDA is not proposing to
provide the specific number of employees required, the specific type of
training that they must have, the specific task they are to perform, or
the specific method by which records are to be kept.
In another example, proposed Sec. 106.35(b)(4) requires that infant
formula manufacturers ensure that automatic (mechanical or electronic)
systems are validated before their first use to manufacture commercial
product. However, in this provision, the agency is not stipulating any
standards or specifications for the validation process because the
extent of the validation that is necessary is related to the level of
risk that each component of the system presents. These decisions about
the validation necessary are left to the infant formula manufacturer to
make.
As a third example, proposed Sec. 106.91(b) requires that the
manufacturer conduct nutrient stability testing at the beginning,
midpoint, and end of the shelf life of the infant formula and with
sufficient frequency to ensure that the formula complies with
Sec. 107.100 throughout its shelf life. Because manufacturers have
experience with the nutrient stability of the infant formula matrices
that they produce and are in a position to determine how frequently
testing is necessary, the agency is proposing only to require testing
``with sufficient frequency,'' instead of specifying what frequency is
required.
Proposed Sec. 106.6(a) requires that infant formula manufacturers
comply with the requirements of subpart B of part 106 by implementing a
system of production and in-process controls that covers all stages of
processing, from receipt and acceptance of raw materials, ingredients,
and components through storage and distribution of finished product,
and that is designed to ensure that all requirements of subpart B of
part 106 are met.
Infant formula manufacturing requires a degree of sophistication
(e.g., in research and development, production equipment and
procedures, and analytical equipment and methodology) that a vast
majority of companies in the food processing industry do not have. A
manufacturer must maintain constant control because a seemingly
innocuous change in formulation or in a preparation method, or exposure
to an unanticipated environmental condition, could create a health
hazard. Moreover, infant formula manufacturers must be concerned not
only that something is present in the formula that may adulterate that
formula, such as a contaminant or a level of a required nutrient that
exceeds the maximum level allowed by Sec. 107.100, but also that
something is absent from the formula, such as the lack or
unavailability of a required nutrient. For example, the lack of a
nutrient or the unavailability of an added nutrient has been
responsible for a number of documented problems that have occurred in
infant formulas (Ref. 1). Thus, FDA has tentatively concluded that the
use of a production and in-process control system covering all stages
of processing is necessary to ensure that the infant formula is
manufactured in a manner that will prevent adulteration of the infant
formula.
Proposed Sec. 106.6(b) requires that the production and in-process
control system be set out in a written plan, or set of procedures, that
is designed to ensure that the infant formula is manufactured in a
manner that will prevent adulteration of the formula. FDA has
tentatively concluded that requiring that the production and in-process
control system be set out in a written plan or a set of procedures is
necessary to provide consistency in production of different batches of
infant formula and to facilitate the preparation of each batch of
infant formula. Consistency is provided because the plan means that
there is a single set of procedures established that are to be followed
in producing the formula. The plan also facilitates preparation of the
formula because, given the sophistication of the infant formula
manufacturing process, a written plan to which ready and easy reference
can be had is essential. The importance of a written plan is well-
recognized by industry. The use of a written plan or set of procedures
for production of a batch of infant formula is already a wide-spread
practice.
The agency has sought to develop a basic list of items that a firm
would need to consider in developing its plan or procedures, but the
agency is reluctant to offer such a list at this stage of the
rulemaking, before it has received comments on the proposed good
manufacturing practice regulations. The agency requests comments on
whether such a basic list, over and above the provisions of Subpart B
itself, is possible or desirable, and if it is, what such a list should
include.
The agency would conceive of such a list, at a minimum, as
consisting of a number of items. It would need to direct the
manufacturer to establish the safeguards that it will rely upon to
protect against the foreseeable sources of adulteration in the
production of infant formula. It would also need to direct the
manufacturer to establish procedures for ensuring that the
manufacturing process functions properly. Several of the procedures
that would have to be established to do so are defined in the proposed
regulations, including: (1) Procedures, in accordance with proposed
Sec. 106.35(b)(2), to calibrate, inspect, and check hardware; (2)
specifications, in accordance with proposed Sec. 106.40(d), for the
acceptance or rejection of ingredients, containers, and closures used
in infant formula manufacture; (3) the master manufacturing orders in
accordance with proposed Sec. 106.50(a)(1); and (4) testing procedures,
under proposed Sec. 106.55(b), to ensure that powdered infant formula
complies with the microbiological quality standards. Other items that
would also seem to be appropriately included on such a list would be
procedures for controlling the release of product, for ensuring its
traceability, and for conducting GMP audits. However, FDA requests
comments on whether these items provide an adequate checklist for the
development of the type of written plan that is necessary under these
proposed regulations.
For now, FDA is leaving the specific content of the procedures that
are in the written plan to the manufacturer's discretion. FDA requests
comment on whether the agency should develop guidance on the content of
any of the
[[Page 36159]]
procedures that are part of the written plan.
Proposed Sec. 106.6(c) specifies requirements for a manufacturer's
handling of any point, step, or stage in its production process where
control of the process is necessary to prevent adulteration of the
formula. These in-process control points, steps, or stages may include
retorting or other heating steps, cooling steps, points where specific
sanitation procedures are needed, product formulation control steps,
points where cross contamination may occur, and steps where employee
and environmental hygiene are necessary to prevent adulteration of the
product.
Proposed Sec. 106.6(c)(1) requires that infant formula
manufacturers establish standards or specifications to be met at such
points, steps, or stages. These standards or specifications establish
the boundaries of safety at the point, step, or stage. Such standards
or specifications may include, for example, upper and lower limits for
parameters such as temperature, time, pH, visual appearance, and
moisture level as well as chemical, nutrient, and microbiological
specifications for raw materials. These standards or specifications can
be set based on published or unpublished studies, on regulatory levels
established by FDA, or on consultation with experts in infant formula
production. As discussed in more detail below, FDA is proposing (see
proposed Sec. 106.100(e)(3)(i)) that manufacturers make and retain a
list of the standards and specifications that they establish under
proposed Sec. 106.6(c)(1) including documentation of the scientific
basis for each standard or specification. Maintaining such a list will
mean that these standards and specifications are readily available for
comparison to the actual values obtained in monitoring (i.e., making a
planned sequence of observations or measurements) the production and
in-process control system.
Proposed Sec. 106.6(c)(2) requires that infant formula
manufacturers monitor the points, steps, or stages in their production
process where control is necessary to prevent adulteration of the
infant formula. Regular monitoring of these points is necessary to
ensure that the product meets the standards and specifications set
under proposed Sec. 106.6(c)(1) and to ensure that any trend toward
loss of control is quickly identified. Quick identification will mean
that adjustments can be made to prevent a deviation from occurring, or,
in the event that a deviation does occur, that effective corrective
actions can be taken to remove adulterated product from the system.
For many standards or specifications, continuous monitoring is
possible. For example, temperature and time for a scheduled thermal
process can be recorded continuously on temperature- recording charts.
When it is not possible to monitor a particular point, step, or stage
on a continuous basis, monitoring intervals need to be reliable enough
to permit the manufacturer to determine whether the production control
point is under control.
Monitoring involves not only making observations at an appropriate
frequency but also ensuring that the instruments and equipment, such as
thermometers, temperature-recording devices, and computer software,
that the manufacturer relies on to make its observations are accurate
and reliable (see proposed Sec. 106.30(d)).
Proposed Sec. 106.6(c)(3) requires that infant formula
manufacturers establish corrective action plans for use when a standard
or specification established in accordance with proposed
Sec. 106.6(c)(1) is not met. FDA has tentatively concluded that this
requirement is necessary because a manufacturer will often need to take
corrective action quickly, and the best way to ensure that a corrective
action is appropriate is to determine the action in advance. The
corrective action plans should provide, for example, for the
disposition of any infant formula or of any partially manufactured
infant formula that was produced when a deviation was occurring.
Proposed Sec. 106.6(c)(4) requires that infant formula
manufacturers review the results of the monitoring required under
proposed Sec. 106.6(c)(2). This review will reveal whether the
monitoring is actually being done and being done correctly, and whether
standards and specifications are being met.
Proposed Sec. 106.6(c)(4) further requires that infant formula
manufacturers review, and evaluate the public health significance of,
any deviations from standards or specifications established in
accordance with proposed Sec. 106.6(c)(1). This proposed requirement is
necessary to ensure that products that may have been affected by a
deviation do not enter commerce if they are likely to be unsafe. It
also will ensure that the disruption of a manufacturer's business is
minimized when a deviation does occur. For example, if review of
monitoring records reveals that an ingredient premix does not contain
the required nutrients at the required levels, the manufacturer can
take steps to dispose of the premix before it is used in the
manufacture of an infant formula. If the monitoring records are not
reviewed, a product made with a deficient premix may be placed on the
market, and a costly and embarrassing recall may be required.
Proposed Sec. 106.6(c)(4) also requires that this review be
conducted by an individual qualified by training and experience to
conduct such reviews. This proposed requirement is necessary to ensure
that the review is conducted by a person who understands the production
and in-process control system, understands the significance of a
processing deviation, and knows how to respond to a deviation. Such
understanding and knowledge will ensure that the review is
appropriately conducted, and that the response to any deviation is
measured and appropriate.
Proposed Sec. 106.6(c)(5) requires that infant formula
manufacturers establish recordkeeping procedures, in accordance with
proposed Sec. 106.100(e)(3), that ensure that compliance with the
requirements of proposed Sec. 106.6(c) is documented. As discussed
below in the description of the proposed revisions to subpart F of part
106, FDA has authority to require that these records be made and
retained under section 412(b)(4)(A)(i) of the act. FDA is proposing to
provide a complete description of all recordkeeping requirements in
subpart F. When applicable, FDA is including cross-references to these
recordkeeping requirements in the regulations in subparts B, C, and D.
These records will allow manufacturers to discern trends or to pinpoint
the onset of a problem if a standard or specification is not being met
at a point where control is deemed necessary to prevent adulteration,
or if a batch of infant formula is associated with an adverse event.
3. Controls to Prevent Adulteration by Workers
Proposed Sec. 106.10(a) requires that there be sufficient
personnel, qualified by training and experience, to perform all
operations, including all required recordkeeping, in the manufacture,
processing, packing, and holding of each infant formula and to
supervise such operations to ensure that they are correctly and fully
performed. Proposed Sec. 106.10(a) is consistent with existing
regulations concerning CGMP for foods (Sec. 110.10(c)) and drugs
(Sec. 211.25). In this provision, FDA is proposing a general standard
for determining how many employees are necessary, i.e., that there be
enough to achieve, maintain, and document CGMP. However, FDA is leaving
the determination of the actual number of employees necessary to the
manufacturer's discretion.
[[Page 36160]]
Proposed Sec. 106.10(a) also requires that such personnel be
qualified by training and experience. Training is necessary to ensure
that employees know how to correctly and fully perform the operations
in question and to ensure that employees are competent to produce a
safe and clean infant formula. The extent and frequency of training is
left to the manufacturer's discretion.
Proposed Sec. 106.10(b) requires that personnel working directly
with infant formula, infant formula raw materials, infant formula
packaging, or infant formula equipment or utensil contact surfaces
practice good personal hygiene to protect the product against
contamination. Proposed Sec. 106.10(b) is consistent with existing
regulations concerning CGMP for foods (Sec. 110.10(b)) and drugs
(Sec. 211.28(a) and (b)). FDA has tentatively concluded that it is
necessary that these employees practice good hygiene so that they will
not transmit disease to others in the workforce, and so that they will
not transmit filth or pathogenic microorganisms to the infant formula.
In addition, proposed Sec. 106.10(b) enumerates the basic elements
of good personal hygiene. Proposed Sec. 106.10(b)(1) lists clean outer
garments and protective apparel as one element. To be ``clean,''
clothing must be free of filth or microorganisms that may contaminate
the infant formula. Protective apparel, such as head, face, hand, and
arm coverings, will help to ensure that the infant formula is protected
from contaminants such as hair.
Proposed Sec. 106.10(b)(2) states that good personal hygiene
includes workers washing their hands thoroughly in a hand washing
facility with soap and running water at a suitable temperature before
starting work, after each absence from the work station, and at any
other time when hands may become soiled or contaminated. Filth and
pathogenic microorganisms can be brought into the processing
environment on the employee's hands from outside areas, restrooms,
contaminated raw materials, waste or waste receptacles, and other
insanitary objects (Refs. 10, 11, and 12). FDA has tentatively
concluded that requiring workers to practice good personal hygiene by
washing their hands at the times specified will help to prevent the
introduction of this type of contamination into infant formula.
Proposed Sec. 106.10(c) requires that any person who reports that
he or she has, or appears by medical examination or supervisory
observation to have, an illness, open lesion, including boils, sores,
or infected wounds, or any other source of microbial contamination that
creates a reasonable possibility that the safety of the formula may be
adversely affected, be excluded from direct contact with ingredients,
containers, closures, in-process materials, equipment, utensils, and
infant formula product until the condition is corrected or determined
by competent medical personnel not to jeopardize the safety of the
infant formula. Proposed Sec. 106.10(c) is consistent with existing
regulations concerning CGMP for foods (Sec. 110.10(a)) and drugs
(Sec. 211.28(d)). Employees can transmit the organisms responsible for
diseases, such as salmonellosis, shigellosis, and hepatitis, to the
infant formula. Additionally, open sores, boils, or infected wounds
present the potential for contamination of the infant formula with such
pathogenic microorganisms as Staphylococcus aureus (Refs. 14 and 15).
Thus, proposed Sec. 106.10(c) will exclude employees who carry
potential microbial contamination that may adversely affect the safety
of the formula from direct contact with the infant formula and from
direct contact with materials and surfaces that come in contact with
the infant formula and thus will minimize the potential for employees
to transmit microorganisms to the infant formula that may cause the
infant formula to pose a health hazard to the infant.
4. Controls to Prevent Adulteration Caused by Facilities
Proposed Sec. 106.20(a) requires that buildings used in the
manufacture, processing, packing, or holding of infant formula be
maintained in a clean and sanitary condition. This proposed requirement
is necessary to prevent contamination of the infant formula. It is
consistent with FDA's existing regulations concerning CGMP for foods
(Secs. 110.20(b) and 110.35(a)) and drugs (Sec. 211.42). Trash, litter,
and waste must be disposed of to avoid creating conditions that attract
and harbor potentially pathogenic microorganisms and attract and harbor
pests, such as rodents or insects. Such pests can carry a variety of
human disease agents, including microorganisms that are potentially
pathogenic in infants, and introduce them into the manufacturing
environment (Refs. 10 and 12). They are also sources of feces and hair
that can contaminate infant formula.
Proposed Sec. 106.20(a) also requires that buildings used in the
manufacture of infant formula have space for the separation of
incompatible operations, such as the handling of raw materials, the
manufacture of the product, and packaging and labeling operations. If
raw materials are not separated from the site of product manufacture,
there is a significant possibility that they will be used in infant
formula manufacture before they have been tested and found acceptable
for use in infant formula. Therefore, FDA has tentatively concluded
that the separation of incompatible operations is necessary to ensure
that infant formula is manufactured in a manner designed to prevent
adulteration. The proposed requirement that incompatible operations be
separated is consistent with FDA's existing regulations concerning CGMP
for foods (Sec. 110.20(b)(2)) and drugs (Sec. 211.42(c)) and is
consistent with the recommendations made to FDA by the Infant Formula
Council (Ref. 9).
Proposed Sec. 106.20(b) requires separate holding areas to protect
against mixups that could lead to contamination of infant formula.
Failure to separate raw materials or in-process materials that have not
been released, or that have been rejected but not disposed of, from
those that have been released creates the potential for the use of
ingredients that do not meet the applicable specifications and thereby
can lead to the production of finished infant formula that is
adulterated. Similar types of problems can develop if final product
that has not been released, or that has been rejected but not disposed
of, is not separated from final product that has been released.
Proposed Sec. 106.20(b) is consistent with FDA's existing regulations
concerning CGMP for drugs (Sec. 211.42(c)).
Proposed Sec. 106.20(c) defines a standard for adequate lighting
and allows the manufacturer to exercise discretion in determining the
precise level of lighting that is sufficient to meet that standard.
Adequate lighting is important. Inadequate lighting may make it
difficult to read a label or an instrument, and as a result incorrect
ingredients may be used in infant formula production, or instruments
may be read incorrectly, which increases the risk of producing an
adulterated infant formula.
Proposed Sec. 106.20(c) also requires that any lighting fixtures
directly over or adjacent to exposed raw materials, in- process
materials, or bulk (unpackaged) finished product be protected to
prevent glass from contaminating the product in the event of breakage.
Glass in an infant formula may be a safety hazard and would render the
formula adulterated (Ref. 14). Proposed Sec. 106.20(c) is consistent
with FDA's existing regulations concerning CGMP's for food
(Sec. 110.20(b)(5)) and drugs (Sec. 211.44).
FDA is proposing a requirement in Sec. 106.20(d) for air filtration
systems to improve air quality in production areas
[[Page 36161]]
and thus reduce the potential for contamination by air-borne sources
(Ref. 15). This proposed requirement is consistent with FDA's existing
regulations concerning CGMP for drugs (Sec. 211.46(c)).
Proposed new requirements in Sec. 106.20(e) protect against the
contamination of infant formula by pest control agents and cleaning
agents. The agency recognizes that these agents are needed in infant
formula facilities. However, because many of them are toxic, they must
be handled and stored in a manner that prevents contamination of the
infant formula. Proposed Sec. 106.20(e) is consistent with FDA's
existing regulations concerning CGMP for food (Sec. 110.35(b)(2)) and
drugs (Sec. 211.56(c)).
Proposed Sec. 106.20(f)(1) states that potable water used in the
manufacturer of infant formula must meet the Environmental Protection
Agency's (EPA's) Primary Drinking Water Regulations (40 CFR part 141)
(with the one exception that the fluoride level be as low as possible,
as discussed below). This proposed regulation is consistent with FDA's
existing regulations concerning CGMP for drugs (Sec. 211.48(a)).
The Safe Drinking Water Act gives EPA the responsibility for
establishing standards for public drinking water. Therefore, FDA is
proposing to use EPA's standards for water used in the production of
infant formulas. Application of these standards will ensure that the
water used in infant formula is safe. The agency is proposing to
require that water from both municipal sources and the firm's own wells
meet these standards.
The safety and sanitary quality of water from public water systems
is generally ensured through public water treatment, chlorination, or
monitoring and control by local health authorities. Private sources of
water, however, particularly surface waters or water from shallow
wells, may be subject to microbiological, chemical, or radiological
contamination attributable to the source itself or to surface
contamination at the well head or intake. Private sources are also
frequently untreated or minimally treated. Thus, under the proposed
regulation, when a manufacturer uses a private source of water, it will
need to take steps to ensure that the water is safe and sanitary. These
steps may include ensuring that the well design has been approved by
the local health authority, ensuring that the well meets coliform test
standards, performing periodic inspections of the sanitary condition of
the well head and source intake, and performing and monitoring
appropriate water treatment procedures, including filtration,
sedimentation, and chlorination. The type and frequency of controls
exercised by the manufacturer will be based upon the type of source
water and its historic safety and sanitary quality.
Proposed Sec. 106.20(f)(1) makes one exception to the use of EPA
standards for drinking water. On April 2, 1986, EPA issued a maximum
contaminant level (MCL) for fluoride in drinking water of 4 milligrams
per liter (mg/L) (51 FR 11396) and reaffirmed this level on December
29, 1993 (58 FR 68826). The National Academy of Sciences (NAS)
recommends 0.1 to 0.5 mg/day as the safe and adequate intake for
infants from 0 to 6 months of age. Mottling of teeth in children has
been observed at 2 to 8 milligrams/kilogram (mg/kg) concentration of
fluoride in diet and drinking water (Ref. 16). Thus, if 4 mg of
fluoride/L of water was allowed in the water used in infant formula
manufacture, infants consuming ready-to-feed infant formula could
receive enough fluoride to adversely affect their teeth. Currently, no
infant formulas are manufactured with fluoridated water (Ref. 17), so
that the pediatrician or other health care provider is able to decide
whether a fluoride supplement is appropriate for formula-fed infants,
principally by considering whether the formula was diluted with
fluoridated water (Ref. 18).
NAS has established a safe and adequate daily dietary intake of
fluoride for infants (Ref. 19). The agency is considering proposing to
revise the infant formula nutrient requirements in Sec. 107.100 to
include fluoride and other nutrients that NAS has determined are
essential for infants. FDA will consider fluoride levels for infant
formulas at that time. FDA has tentatively concluded that, until it has
revised the levels of required nutrients, manufacturers should continue
their practice of not using fluoridated water in the manufacture of
infant formula.
Proposed Sec. 106.20(f)(1) also requires that the water be supplied
under continuous positive pressure in a plumbing system that is free of
defects that could contaminate an infant formula. FDA has tentatively
concluded that this requirement is necessary to ensure that all potable
water coming into the plant is not adversely affected by the in-plant
plumbing. Contaminated water can serve as a vehicle for contamination
of infant formula, both when used as an ingredient in the infant
formula and when allowed to enter the product indirectly, as can occur,
for example, when water is used to cool the product after retorting.
Thus, FDA tentatively concludes that it is appropriate to include this
positive requirement in this regulation.
Proposed Sec. 106.20(f)(2), which sets forth requirements for
testing representative samples of potable water used in infant formula
manufacturing, is necessary to provide assurance that the water used in
infant formula manufacturing meets EPA's standards. Proposed
Sec. 106.20(f)(3) requires that manufacturers conduct these tests with
appropriate frequency. The regulation allows manufacturers some
discretion in determining the testing frequency necessary to ensure
that EPA standards are met, but it requires a minimum frequency of
testing for certain contaminants (i.e., chemical contaminants,
radiological contaminants, and bacteriological contaminants). FDA is
basing these proposed minimum frequencies on those adopted by EPA for
primary drinking water. This frequency of testing is consistent with
FDA's own regulations concerning processing and bottling of bottled
drinking water (Sec. 129.35(a)(3)).
Proposed Sec. 106.20(f)(4) requires that manufacturers make and
retain records of the frequency and the results of the testing that
they do on the water used in the production of infant formula. These
records will document that the manufacturer is complying with the
potable water testing requirements of Sec. 106.20(f)(2) and (f)(3), and
that the water complies with EPA standards. They will identify any
trend toward loss of compliance with these standards, so that the
manufacturer can take corrective actions before the water becomes
inappropriate for use in infant formula. As discussed below in the
description of the proposed revisions to subpart F, FDA has authority
to require the creation and retention of these records under section
412(b)(4)(A)(i) of the act.
In proposed Sec. 106.20(g), FDA sets out requirements regarding
piping systems to prevent a source of contamination (i.e., waste water)
from coming in contact with the infant formula. Cross connections could
allow back siphonage into a potable system from a nonpotable system
under negative pressure conditions and thus could result in the
chemical or microbiological contamination of the potable water system
(Ref. 20). Proposed Sec. 106.20(g) is consistent with FDA's regulations
concerning CGMP for food (Sec. 110.37(b)(5)) and drugs
(Sec. 211.48(b)).
Proposed Sec. 106.20(h) requires that steam that comes in direct
contact with infant formula be safe and free of rust
[[Page 36162]]
and other particulate matter that could contaminate the formula. Steam
comes in direct contact with infant formula when the steam is injected
into the head space of a can of infant formula to create a vacuum.
Thus, this proposed requirement is necessary to ensure that the steam
does not adulterate the infant formula.
Proposed Sec. 106.20(h) also requires that boiler water additives
in the steam meet safety standards set forth in FDA regulations at 21
CFR 173.310 which lists boiler water additives that may be safely used
in the preparation of steam that will contact food and the conditions
for the safe use of those boiler water additives. This proposed
requirement is necessary because boiler water additives dissolve in
water and can be carried over as a residue in the steam. A proposed
requirement that boiler water additives in the steam comply with
Sec. 173.310 will ensure that any residue is safe to come in contact
with the infant formula.
Proposed Sec. 106.20(i) requires that each infant formula
manufacturing site provide its employees with readily accessible toilet
and hand washing facilities. This proposed requirement is consistent
with good sanitary practice common to all food-processing facilities
and is consistent with FDA's CGMP regulations for foods (Sec. 110.37(d)
and (e)) and drugs (Sec. 211.52). The requirement is also a necessary
adjunct to the requirement in proposed Sec. 106.10(b)(2) that employees
wash their hands before starting work, after each absence from the work
station, and at any other time when the hands may become soiled or
contaminated. Hand-washing facilities are not likely to be used in an
appropriate manner by employees if the facilities are not conveniently
located.
Proposed Sec. 106.20(i) also requires that these facilities be
equipped with hot and cold water, ordinary soap or detergent, and
single-service towels to ensure that microbiological contamination does
not occur through the repeated use of the same towel by several
individuals.
In addition, proposed Sec. 106.20(i) requires that toilet
facilities be maintained in good repair and in a sanitary condition at
all times, and that these facilities provide for proper disposal of
sewage, so that the processing environment is protected against
pathogenic microorganisms shed in fecal material. Restroom floors and
the grounds around the processing facility can become contaminated with
pathogens if fecal material is not removed by an adequate sewage
system. Foot traffic over the affected areas can introduce pathogens
into the processing room and cause product contamination. Insanitary
toilet facilities can also increase the potential for contamination of
employees' hands and, ultimately, of the product itself (Refs. 10 and
11). Proposed Sec. 106.20(i) further protects against potential
microbiological contamination by setting forth requirements for the
positioning of toilet facility doors.
5. Controls to Prevent Adulteration Caused by Equipment or Utensils
Equipment used in infant formula manufacture, packaging, or holding
that is of an inappropriate design or an inadequate size, or that is
installed improperly, can result in a variety of problems. For example,
a mixer for the blending of powdered ingredients will not properly
perform its function if the blade is too small relative to the size of
the mixer, or if the mixer blade or auger is not properly positioned in
the inside of the mixer. Such a mixer may produce infant formula that
is not uniform in composition throughout a batch and that is,
consequently, adulterated because the required nutrients are not
provided at the required levels throughout the batch.
Installing equipment in a manner that will facilitate its cleaning
and maintenance is also important in preventing adulteration. Equipment
that is not properly cleaned can be the source of contaminants that
adulterate the infant formula. Equipment that is not properly
maintained can result in a variety of problems. For example, improper
maintenance of equipment such as a mixer may result in inadequate
compositional uniformity in a batch of formula. Improper maintenance of
equipment used to measure a parameter such as temperature may result in
the processing of the infant formula at a temperature that can
adversely affect the product. In either case, the product would be
adulterated. Design and installation of equipment also needs to be
checked when the equipment is modified or repaired to ensure that the
equipment is still designed and installed to function as intended as
part of the manufacturing process. Thus, proposed Sec. 106.30(a)
requires that equipment be appropriately designed and installed. This
proposed requirement is consistent with FDA's CGMP regulations for
foods (Sec. 110.40(a)) and drugs (Sec. 211.63).
If a food-contact surface is constructed of toxic material, the
product may be directly contaminated with that material (Ref. 11).
Therefore, FDA is proposing to require in Sec. 106.30(b) that equipment
and utensils be made of materials that are not reactive or absorptive,
so that the equipment and utensil materials do not contaminate the
infant formula and cause it to be adulterated. Proposed Sec. 106.30(b)
also requires that such equipment and utensils be designed to be easily
cleanable because they can be vehicles for microbial contamination of
both raw and finished products. Utensils, equipment, and other food-
contact surfaces that are made of corrosive material, or that contain
breaks, pits, cuts, or grooves, are difficult to clean because the
pores and crevices shield the microorganisms from the action of
cleaning and sanitizing agents (Ref. 21). In addition proposed
Sec. 106.30(b) requires that equipment and utensils be designed to
withstand the environment in which they are used. This requirement will
ensure that equipment and utensils are constructed of materials that
will not corrode or undergo other types of chemical or physical
degeneration resulting from their use in infant formula production.
Degeneration of the equipment and utensils may introduce contaminants
into the formula and thereby lead to adulteration. Surfaces that are
not adequately cleaned and sanitized can be a source of filth, an
attractant for vermin, and a reservoir for microorganisms.
Proposed Sec. 106.30(b) requires regular, effective cleaning and
sanitizing of all food-contact surfaces to minimize the probability of
contamination of the infant formula (Ref. 21) and prescribes
requirements for effective sanitizing agents. An effective sanitizing
agent is one that has a good bactericidal effect on the types of
microorganisms normally present in the plant environment and that is
safe, stable, and convenient for use (Ref. 22). Sanitizing agents are
indirect food additives and must be used in accordance with 21 CFR
178.1010, which prescribes their conditions of safe use. Examples of
sanitizing agents that comply with Sec. 178.1010 include hypochlorites,
iodophors, and quaternary ammonium compounds. However, sanitizers can
achieve their intended effect only if they are applied to a surface
that has been thoroughly cleaned, and if they are applied at a proper
concentration (Ref. 22).
Thus, it is important that effective cleaning compounds be used. An
effective cleaning compound is one that will lower the surface tension
of water so that spills can be lifted and flushed away (Ref. 23).
Ordinary soap has a limited ability to solubilize fats, oils, and
proteins, and inorganic alkaline
[[Page 36163]]
detergents can dissolve food solids such as fats and proteins, but
mineral deposits will frequently require the use of acid cleaners (Ref.
23).
In order to ensure that infant formula is not contaminated with
unsafe substances that are a part of the manufacturing process, FDA is
proposing requirements in Sec. 106.30(c) regarding substances necessary
for the operation of equipment, such as lubricants or coolants.
Proposed Sec. 106.30(d)(1) sets forth requirements for maintaining
the accuracy of instruments, since an instrument that is not easily
read, or that is not properly calibrated, may not provide accurate
measurements. If an instrument is not properly maintained, it may not
be reliable over time, and the readings obtained from it may lead to
adulteration of the infant formula during processing. This proposed
regulation also requires that such instruments be sufficient in number
for their intended use. For example, if the temperature of a large
piece of equipment needs to be monitored, several temperature-
indicating devices may be needed to accurately monitor the temperature
in all parts of the equipment. Also, instruments and controls must be
tested for accuracy (i.e., calibrated) against a known reference
standard before first use and at routine intervals thereafter, as
specified in writing by the manufacturer of the instrument or control,
or as otherwise deemed necessary to ensure the accuracy of the
instrument. FDA has tentatively concluded that this requirement is
necessary because equipment used to manufacture infant formula must
operate properly to ensure production of a safe, uniform product with a
consistent nutrient content throughout a lot or a batch.
The accuracy of an instrument is the degree to which it produces a
correct result. The instruments used to measure parameters such as
temperature or pressure at points where control is deemed necessary to
prevent adulteration must reflect the true measurement so that, for
example, a manufacturer can have confidence that when a thermometer
indicates that the temperature is 240 deg.F, the temperature really is
240 deg.F. FDA's experience is that calibration of the instrument
using a reference standard is the most reliable method to ensure
accuracy. FDA is proposing to require that this test for accuracy be
done before first use to provide assurance that the instruments and
controls will perform as intended and at routine intervals afterward to
ensure that the instruments and controls continue to perform as
intended.
Reliability is the instrument's accuracy over time. The reliability
of the instrument will determine the length of time that it can be used
before it begins to lose accuracy. The manufacturer of the instrument
is in the best position to establish how frequently recalibration is
needed because that manufacturer is responsible for putting together
the technology by which the instrument operates. However, if the infant
formula manufacturer's experience with the instrument demonstrates that
the instrument needs to be calibrated more frequently than the
instrument manufacturer suggests, FDA has tentatively concluded that
the infant formula manufacturer must act on its own experience with the
instrument and calibrate it as often as necessary to ensure the
accuracy of the instrument.
Proposed Sec. 106.30(d)(1) further requires that the known
reference standard be certified for accuracy at routine intervals
specified in writing by the manufacturer of the instrument, or as
otherwise deemed necessary. Known reference standard devices are
accompanied by certificates of accuracy, but these certificates do not
preclude the possibility that these instruments will go out of
calibration. Just as a calibration routine needs to be established for
the process instrumentation, a recertification of the known reference
standard needs to be established in accordance with the equipment
manufacturer's recommendations. For example, the length of time that a
certified thermometer can be considered reliable will depend on the
materials used in its manufacture, the degree of control exercised in
its manufacture, and its use, as would be the case for the indicating
thermometer used in the production line. The accuracy of a calibrated
thermometer is only going to be as good as the accuracy of the known
reference standard that is used during its calibration.
Proposed Sec. 106.30(d)(1) also requires that manufacturers make
and retain records of accuracy checks in accordance with the provisions
of proposed Sec. 106.100(f)(2). As discussed below in the description
of the proposed revisions to subpart F of part 106, FDA has authority
to require these records under section 412(b)(4)(A)(i) of the act.
These records will enable the manufacturer to establish the historical
performance of the instrument to determine whether the calibration
schedule is sufficient to ensure the accuracy of the instrument and
will provide information on when and how the instruments were
calibrated to assist the manufacturer in identifying the cause of a
problem that may arise with a batch of infant formula.
Proposed Sec. 106.30(d)(2) requires that instruments and controls
that cannot be adjusted to agree with the reference standard be
repaired or replaced. FDA is proposing this requirement because an
instrument or control cannot be trusted for use in infant formula
production if it cannot be adjusted to agree with the reference
standard. Adjustments made to reach agreement with a known accurate or
reference standard must also be done in accordance with any adjustment
range limitations specified by the vender of the ins
FR Doc. 96-17058 Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula
trument.
Proposed Sec. 106.30(d)(3) provides that if calibration of an
instrument (testing for accuracy against a known reference standard)
shows that a specification or standard has not been met at a point
where control is deemed necessary to prevent adulteration, a written
evaluation must be made of all affected product and of any actions that
need to be taken. FDA has tentatively concluded that this written
evaluation is necessary because if an instrument has been giving
inaccurate readings, all infant formula produced subject to such
inaccuracies must be identified and evaluated for the possibility that
the inaccuracies resulted in the production of adulterated formula. If
the manufacturer determines that adulterated formula has been produced,
the firm must decide what actions, if any, need to be taken to prevent
such formula from reaching infants.
FDA is also requiring that this written evaluation needs to be
maintained in the firm's records. FDA tentatively concludes that this
record is necessary to demonstrate that the firm has complied with
CGMP. As discussed below in the description of the proposed revisions
to subpart F of part 106, FDA has authority to require that these
records be retained under section 412(b)(4)(A)(i) of the act.
Proposed Sec. 106.30(e)(1) requires that the temperature in cold
storage compartments used to store raw materials, in-process materials,
or final product, as well as the temperature of thermal processing
equipment used at points where temperature control is necessary to
prevent adulteration, be monitored with such frequency as is necessary
to ensure that temperature control is maintained. The frequency of the
monitoring is left to the manufacturer to determine. Growth of
microorganisms can occur and cause spoilage if materials that should be
kept in cold storage compartments are not maintained at the proper
temperature. Infant formula may also be adulterated if thermal
processing equipment is not
[[Page 36164]]
operated at the proper temperature, and the final liquid infant formula
product is not commercially sterile. Therefore, FDA tentatively
concludes that their requirement is appropriate.
In addition, FDA is proposing that a temperature of 40 deg.F (4.4
deg.C) is appropriate in cold storage compartments to minimize the
growth of pathogens (Ref. 24) and the deterioration of liquid
ingredients, nutrients, and the formulated product before canning
(proposed Sec. 106.30(e)(2)).
Proposed Sec. 106.30(e)(3)(i) requires that cold storage
compartments and thermal processing equipment be equipped with easily
readable, accurate temperature-indicating devices. These devices are
necessary to ensure that the manufacturer can monitor the temperatures
where materials are stored or where product is processed. Proposed
Sec. 106.30(e)(3)(ii) requires that thermal processing equipment be
equipped with temperature-recording devices that reflect the true
temperature on a continuing basis, so that the manufacturer will be
able to determine whether the product was thermally processed at a
minimum temperature for an appropriate period of time. Two factors,
temperature and time, are relevant in ensuring that thermal processing
is conducted in a manner that will produce commercially sterile infant
formula after retorting. Thus, recording the temperature that is
maintained during the time period used will show whether the thermal
process is conducted properly.
Proposed Sec. 106.30(e)(3)(ii) also requires that cold storage
compartments be equipped with either a temperature-recording device
that will reflect the true temperature within the compartment on a
continuing basis, or a high-temperature alarm or a maximum-indicating
thermometer that has been verified to function properly. These
temperature records will show whether the materials were stored at an
appropriate temperature to minimize the growth of pathogens and the
deterioration of ingredients and formulated product. If the
manufacturer does not wish to equip cold storage compartments with such
temperature- recording devices, FDA is proposing to require that it
maintain a temperature log in which the temperature in the compartment
is noted with such frequency as is necessary to achieve control. The
agency is leaving it to the manufacturer's discretion to determine what
frequency of temperature notation is necessary to achieve control.
The agency has tentatively concluded that it is not necessary for
the manufacturer to record the temperature of the cold storage
compartment on a continuous basis as long as the manufacturer can
determine that the temperature of the cold storage compartment has gone
above 40 deg.F. A high-temperature alarm set to go off when the cold
storage compartment goes above 40 deg.F will allow the manufacturer to
make this determination. Likewise, a maximum-indicating thermometer
will remain at the highest temperature that it ever reaches. If the
maximum indicating thermometer indicates a temperature above 40 deg.F,
the infant formula manufacturer must assume that the temperature has
been above 40 deg.F since the last check of the thermometer. Thus, FDA
has tentatively concluded that either a high-temperature alarm or a
maximum-indicating thermometer are acceptable alternatives for
determining whether the cold storage compartment has gone above 40
deg.F.
In some cases, the actual location of the sensors may be an
important factor in ensuring the accurate representation of
temperature. For example, one sensor located at the end of a large
piece of thermal processing equipment may not accurately represent the
temperature in the whole piece of equipment. In addition, these
temperature devices must often be read under less than ideal plant
conditions, so they should be installed in a location that facilitates
easy reading. Temperature-recording devices can be easily jarred and
rendered inaccurate. They can be recalibrated against a reference
temperature-indicating device (e.g., a thermometer) quite easily,
however. Manufacturers should do so at least at the beginning and end
of each production day in order to determine whether the instrument was
accurate throughout the day's production. For thermal processing
equipment used to produce commercially sterile liquid infant formula,
the mandatory and recommended procedures of 21 CFR part 113 apply.
FDA is also proposing that manufacturers make and retain records,
in accordance with the provisions of proposed Sec. 106.100(f)(3), of
the temperatures indicated or recorded by these devices (see
Sec. 106.30(e)(3)). As discussed below in the description of the
proposed revisions to subpart F of part 106, FDA has authority to
require these records under section 412(b)(4)(A)(i) of the act. They
are needed to show that the thermal processing equipment or cold
storage compartments are being maintained at the correct temperatures
to prevent adulteration of the product. They also will enable the
manufacturer to identify trends in temperature fluctuations that can
signal the need to perform nonscheduled maintenance.
Proposed Sec. 106.30(e)(4) requires that for thermal processing,
the temperature-recording device not read higher than the calibrated
temperature-indicating device because it is important to ensure that
the infant formula is processed at a minimum temperature for a
continual period of time. A temperature-recording device reading higher
than the reference temperature-indicating device for thermal processing
equipment would show that the product had been processed at a
temperature higher than the true processing temperature. Because
thermal processing is used to destroy microorganisms, a temperature-
recording device reading higher than the true processing temperature
may mean that the product has not been processed at a temperature that
is high enough to destroy all microorganisms.
For cold storage compartments, the temperature-recording device
must not read lower than the temperature-indicating device because when
raw materials, in-process materials, or finished product must be stored
at a cold temperature, it is important to ensure that the infant
formula was not exposed to a temperature above the maximum temperature.
A temperature-recording device reading lower than the reference
temperature-indicating device for cold storage equipment would show the
materials in the compartment as having been held at a lower temperature
than the true temperature. Because cold storage is used to prevent
microbiological growth, a temperature-recording device reading lower
than the reference temperature-indicating device would mean that the
material was actually being stored at a higher temperature than the
recorded temperature, and that, as a result, microbial growth may have
occurred.
Proposed Sec. 106.30(f) requires that all equipment and utensils
used in the manufacture of infant formula be cleaned, sanitized, and
maintained at regular intervals to prevent adulteration of the infant
formula. Any equipment or utensil that is not cleaned and maintained
properly can be a source of contamination. FDA is therefore proposing
to require that cleaning, sanitizing, and maintaining be done at
regular intervals. The details of sanitation procedures e.g., equipment
cleaning, can differ from plant to plant depending upon the type of
operation and other conditions. In one plant, it may be necessary to
disassemble all or part of the equipment to clean it. In other plants,
breaking down the
[[Page 36165]]
equipment may not be necessary. Likewise, different cleaning compounds
may be needed from one plant to another to solve specialized problems
such as buildups of mineral deposits. Each manufacturer should study
its own plant and develop a procedure that is tailored to that plant's
needs and circumstances.
FDA considers that cleaning, sanitizing, and maintaining equipment
and utensils is so important for ensuring that adulterated infant
formula is not produced that it is proposing to require that the
cleaning, sanitizing, and maintenance be checked for satisfactory
completion by an individual qualified to conduct such a review. Such an
individual will understand the importance of ensuring that cleaning,
sanitizing, and maintenance is properly done, so that equipment and
utensils do not contribute to the adulteration of the infant formula.
Also, the agency has tentatively concluded that this requirement will
ensure that there is accountability for proper performance of this
function.
In addition, proposed Sec. 106.30(f) requires that manufacturers
make and retain records on equipment cleaning, sanitizing, and
maintenance in accordance with proposed Sec. 106.100(f)(4). As
discussed below in the description of the proposed revisions to subpart
F, FDA has authority to require these records under section
412(b)(4)(A)(i) of the act. These records will document when the
cleaning, sanitizing, and maintenance of equipment occurs and will
allow the manufacturer to trace all formula that may be affected if
cleaning, sanitizing, or maintenance is not properly performed.
In order to ensure that compressed air or other gases will not
contaminate the infant formula with unlawful indirect food additives or
other chemical, physical, or microbiological contaminants, FDA is
proposing to require in Sec. 106.30(g) that they be appropriately
treated. Air or other gases that are not properly treated and filtered,
or air that is not of the proper purity, can introduce contaminants
into the infant formula that may render it adulterated. Also,
compressed gases can be contaminated with oil from the compressor or
with filth or microbiological contaminants from the compression,
storage, or distribution equipment. Filtration at the air intake and
after compression, storage, and distribution is an effective means of
reducing the risk that such contaminants will enter the gases and,
thereby, the food. Therefore, FDA is also proposing in Sec. 106.30(g)
to require the use of a filter when compressed gases are used at
product filling machines to replace air removed from the headspace of
containers. The filter will prevent contaminants from entering the
infant formula during that operation (Ref. 25).
6. Controls to Prevent Adulteration Due to Automatic (Mechanical or
Electronic) Equipment
Manufacturers of infant formula are increasingly relying on
automatic equipment (including mechanical and electronic equipment) in
production and quality control. In some cases, manufacturers are
replacing manually initiated processing procedures with automated
process control systems to ensure proper formulation (addition of
ingredients and premixes), mixing, or processing of an infant formula
or to test a batch of infant formula. Such automated process control
systems frequently consist of a computer or system of computers that
controls many or all stages of production, in-process sampling, and
testing. In other cases, manufacturers are relying on programmable
equipment (such as an autoanalyzer) to perform a critical function,
such as testing a batch of infant formula to ensure that the batch
meets the nutrient requirements of the act. In all cases, it is
important that such systems and equipment function as expected to
ensure that the infant formula contains the required nutrients at the
required levels and is manufactured according to the CGMP and quality
control procedures prescribed under section 412(b)(2) of the act and
therefore is not adulterated under section 412(a)(1) or (a)(3) of the
act.
FDA is proposing to define ``hardware,'' ``software,'' ``system,''
and ``validation'' in Sec. 106.35 because the use of these terms will
simplify the language of the proposed regulations and will clarify
which sections of the proposed regulations apply to hardware only, to
software only, or to systems consisting of both hardware and software.
The definition of ``hardware'' in proposed Sec. 106.35(a)(1) is
based on common usage of the term and makes clear that the regulations
in proposed Sec. 106.35 apply to all automatic equipment, whether the
equipment is mechanical or electronic in nature. Proposed
Sec. 106.35(a)(1) also makes clear that electronic equipment includes,
but is not limited to, computers. This definition of ``hardware''
distinguishes those elements of equipment that have a physical form
from the elements considered to be intellectual property that may be
encoded on a physical element such as a diskette, tape, or
microprocessing chip.
Software may be developed by an infant formula manufacturer, by a
manufacturer of equipment purchased by the infant formula manufacturer,
or by a third party vendor (such as the vendor of a computer operating
system). The definition of ``software'' in proposed Sec. 106.35(a)(2)
derives from the ISO International Guideline ISO-9000-3 1 (Ref.
26) and the Institute for Electrical and Electronics Engineers, Inc.
(IEEE) Standard 610-12-1990 2 (Ref. 27) and is consistent with the
definition of software in FDA's ``Glossary of Computerized Systems and
Software Development Terminology (Ref. 28). FDA is proposing to
incorporate this definition into the agency's infant formula
regulations because the definition is derived from internationally
accepted definitions, includes documentation, applies to the operation
of all types of hardware (rather than the narrowly defined ``data
processing system'' or ``computer system'' included in the definitions
from the ISO and IEEE, respectively), and is consistent with current
FDA terminology. Software documentation consists of the instructions on
how to use the software. FDA has tentatively concluded that such
instructions need to be included in the definition of ``software'' to
ensure the proper operation of the software.
---------------------------------------------------------------------------
\1\ ISO is a world-wide federation of national standards bodies
that set quality assurance guidelines for products that will enter
international commerce. The ISO defines software as an
``intellectual creation comprising the programs, procedures, rules
and any associated documentation pertaining to the operation of a
data processing system'' (Ref. 26).
\2\ IEEE is a trade organization comprised of several societies.
IEEE standards are developed within the technical committees of the
IEEE societies and represent a consensus opinion of experts from
within IEEE as well as experts who are not members of IEEE. IEEE
defines software as ``computer programs, procedures, and possibly
associated documentation and data pertaining to the operation of a
computer system'' (Ref. 27).
---------------------------------------------------------------------------
The definition of ``system'' in proposed Sec. 106.35(a)(3) derives
from the IEEE Standard 610.12-1990 (Ref. 27). FDA is proposing to
incorporate this definition because many of the requirements in
proposed Sec. 106.35 cannot be related to software or hardware alone
but rather to systems in which software is used in conjunction with
hardware. For example, testing software under simulated conditions of
use may be beneficial during the early and middle stages of software
development, but validation of the software must be performed in
conjunction with the relevant hardware in the operational environment
it is
[[Page 36166]]
intended to be used in. Therefore in proposed Sec. 106.35(b)(4), FDA is
proposing that all systems be validated ``before their first use to
manufacture commercial product.''
Proposed Sec. 106.35(a)(4) defines ``validation'' as establishing
documented evidence that provides a high degree of assurance that a
system will consistently produce a product meeting its predetermined
specifications and quality characteristics. It is important that a
process control system comply with specified requirements each time it
operates. The proposed definition is derived from the ISO International
Guideline ISO-9000-3, (which defines ``validation'' as ``the process of
evaluating software to ensure compliance with specified requirements''
(Ref. 26)); the IEEE Standard 610.12-1990, which (defines it as ``the
process of evaluating a system or component during or at the end of the
development process to determine whether it satisfies specified
requirements'' (Ref. 27)); and FDA's ``Glossary of Computerized System
and Software Development Terminology,'' which defines it as
``establishing documented evidence which provides a high degree of
assurance that a specific process will consistently produce a product
meeting its predetermined specifications and quality characteristics''
(Ref. 28). FDA is proposing to incorporate these definitions into its
regulations because they are applicable to the types of systems used in
infant formula manufacture, are derived from internationally accepted
definitions, are consistent with existing FDA terminology, make clear
that the process of evaluation includes the complete system (i.e., the
hardware used in conjunction with the software), and include the
concept of consistency.
Proposed Sec. 106.35(b)(1) sets forth requirements for designing,
installing, testing, and maintaining all systems so that they function
as intended. Some systems may work properly only within a narrow range
of environmental conditions, such as temperature and humidity, and some
might be particularly sensitive to electromagnetic interference. The
actual conditions of use of a system should be considered as early as
possible in its design and development. Systems need to be installed in
a manner that takes into account the inherent limitations of the
system, tested under conditions that reflect actual conditions of use,
and properly maintained to ensure that they continue to function as
expected during their lifetime.
Proposed Sec. 106.35(b)(2) requires that the manufacturer ensure
that all hardware is routinely calibrated, inspected, and checked
according to written procedures. FDA has tentatively concluded that
this provision is necessary to ensure that any infant formula
manufactured under the control of automatic equipment meets the
requirements of the act and is manufactured in a manner designed to
prevent adulteration. For example, a batch of infant formula may lack
the required levels of nutrients if equipment used for the automatic
dispensing of a nutrient premix is out of calibration or has a clogged
delivery line. The routine calibration, inspection, and checking of
hardware will ensure that it continues to perform as intended, and that
its operation will not result in a process that deviates from
established specifications. The establishment of written procedures for
the calibration, inspection, and checking of hardware will ensure that
these procedures are performed consistently and in an appropriate way.
The incorporation of software into the operation of automatic
equipment has not only increased the complexity of such equipment but
also has resulted in a process that may operate differently for each
execution because a software-based control system can be configured at
will by the operator or by the system itself. Therefore, proposed
Sec. 106.35(b)(3), (b)(4), and (b)(5) require that manufacturers
exercise appropriate controls over systems and, in particular, over the
software used in the systems.
Proposed Sec. 106.35(b)(3) prescribes procedures for ensuring that
systems are checked for input and output errors resulting from faulty
data entry, faulty programming, or equipment malfunction. Such errors
can result in serious production or quality control errors leading to a
contaminated or adulterated infant formula. For example, a faulty
position sensor on a downstream valve that improperly indicates that it
is closed may result in a post-sterilization contamination. An
improperly installed (or empty) ink cartridge in a color printer or
multi-pen recorder may cause portions of a record to not be printed.
FDA has tentatively concluded that the regulation is necessary to
ensure that the infant formula produced or analyzed using the system is
not adulterated. However, proposed Sec. 106.35(b)(3) also provides that
the degree and frequency of input/output checks are to be based on the
complexity and reliability of the system and the level of risk
associated with the safe operation of the system.
Proposed Sec. 106.35(b)(4) requires that manufacturers ensure that
all systems are validated before their first use to manufacture
commercial product. FDA has tentatively concluded that it is necessary
that software programs that are used in a process control system to
monitor and control established points deemed necessary to prevent
adulteration (such as the speed of a pump, temperature of a heat
exchanger, addition of vital nutrients, and air overpressure in an
aseptic storage tank) be validated to ensure that use of the process
control system will produce compliance with the specifications or
standards at each control point. For example, if a continuous flow
process is designed to heat an in-process batch of infant formula in a
plate-to-plate heat exchanger to a specification of 271 deg.F, as
indicated by the temperature at the end of the hold tube, and the
system is mistakenly programmed to divert the product to the raw
(unsterilized) surge tank only if the temperature drops below 261
deg.F, an in-process batch of infant formula heated to 261 deg.F would
not be diverted to the raw surge tank but rather would be handled by
the computer as if it were adequately processed. Such an underprocessed
batch of infant formula would likely pose a foodborne biological
hazard. Thus, FDA has tentatively concluded that the validation
required under proposed Sec. 106.35(b)(4) is necessary to ensure that
infant formula that is produced or analyzed using the system is not
adulterated.
The validation of software ordinarily includes the following
elements: Requirements development, design, coding, debugging, testing
(with the hardware), and maintenance (Refs. 29, 30, and 31). Software
validation also includes a review for correctness of the software
documentation to ensure that the instructions prompt the input of the
proper commands or data by the user. However, depending on the nature
of the software and the hardware that it controls, some or all of these
aspects of the validation process may be done by the infant formula
manufacturer, by the manufacturer of equipment that is purchased by the
infant formula manufacturer, or by a third party vendor.
Proposed Sec. 106.35(b)(4) leaves the identity of the person that
does the validation to the discretion of the infant formula
manufacturer but makes clear that the infant formula manufacturer is
responsible for ensuring that the system is validated. The proposal
does not stipulate any standards or specifications for the validation
process because the extent of the validation necessary is
[[Page 36167]]
related to the level of risk that each component of the system
presents.
More emphasis should be placed on validating portions of the system
that represent major risk than on those that confer moderate or minor
risk. A major risk is associated with systems that control or monitor a
point where such control or monitoring is deemed necessary to prevent
adulteration of the infant formula; for example, systems that control
or monitor nutrient addition or processing temperature present a major
risk. A moderate risk is associated with systems that influence, but
that do not control or monitor, a point where control or monitoring is
deemed necessary to prevent adulteration of the infant formula. For
example, the speed of computer processing presents a moderate risk if
software that is designed to be used on a high-speed computer is used
on a slower computer. A minor risk is associated with systems that do
not involve a point where control or monitoring is deemed necessary to
prevent adulteration. For example, systems that control pallet stacking
or product conveying present a low risk.
Proposed Sec. 106.35(b)(5) requires that any system that is
modified be revalidated after any modification and before use of the
modified system to manufacture commercial product. FDA has tentatively
concluded that revalidation is necessary to ensure that no errors are
introduced into the system during the modification and to ensure that a
modification in one aspect of a process control system does not,
unknowingly but adversely, affect other aspects of the process control
system, particularly those operations that follow the modified aspect
of the system.
Under Sec. 106.35(b)(5), FDA is also proposing that a specific
individual (or group of individuals) is designated to modify software
to prevent the indiscriminate modification of software and to ensure
that all modifications are made consistently. The designated individual
may be employed by the infant formula manufacturer, the manufacturer of
equipment purchased by the infant formula manufacturer, or by a third
party. The regulation states, however, that the infant formula
manufacturer is responsible for ensuring that modified software is
retested or revalidated regardless of who does the modification.
Proposed Sec. 106.35(c)requires that infant formula manufacturers
make and retain records concerning automatic (mechanical or electronic)
equipment. FDA is proposing this requirement under the authority of
section 412(b)(4)(A)(i) of the act, which requires the retention of all
records necessary to demonstrate compliance with the CGMP and quality
control procedures prescribed under section 412(b)(2) of the act,
including the results of all testing required under section
412(b)(2)(B) of the act. These records will allow manufacturers to
readily determine whether this crucial equipment is being appropriately
operated and maintained. They will allow manufacturers to troubleshoot
and to operate these systems with a minimum of downtime when problems
occur because the records will include a copy of all software used and
a backup file of data entered into the computer or related system which
can be used to reload the system. The records will also provide
information that the manufacturer can use in trying to determine why a
problem with the system is occurring or why the system is not producing
an infant formula that complies with the manufacturer's specifications
for the product.
7. Controls to Prevent Adulteration Caused by Ingredients, Containers,
and Closures
Proposed Sec. 106.40(a) specifies that the only substances that may
be used in infant formulas are food ingredients that are generally
recognized as safe (GRAS) for use in infant formula, that are used in
accordance with the agency's food additive regulations, or that are
authorized by a prior sanction issued by FDA. Under section
412(b)(2)(A) of the act, FDA is to establish CGMP's that it determines
are necessary to ensure that the infant formula is manufactured in a
way that is designed to prevent adulteration of the formula. Unless the
safety of the ingredients of an infant formula has been established,
the formula is adulterated under section 402(a)(1) and (a)(2)(C) of the
act. Thus, the agency has tentatively concluded that CGMP requires that
the manufacturer ensure that the ingredients that it uses in its
formula are safe and suitable.
Proposed Sec. 106.40(b) requires that infant formula containers and
closures not be reactive or absorptive so as to affect the safety of
the infant formula, and that all packaging material that comes in
contact with an infant formula be composed of authorized substances and
be used in accordance with any prescribed limitations. Various
regulations that authorize the use of a material in contact with the
food product also set conditions and limitations on that use. Thus, the
agency proposes to require that the manufacturer not only use only
materials specified in proposed Sec. 106.40(b), but also that the
materials be used as specified in the regulations authorizing their
use. This provision will ensure that the food contact surface of
containers and closures will not adulterate the infant formula.
In order for the manufacturer to maintain a complete record of how
each ingredient, container, or closure was used and to determine which
lots of infant formula are adulterated if a problem is ultimately
identified with a particular lot of ingredients, containers, or
closures, FDA is proposing, in Sec. 106.40(c), that they be identified
with batch or lot numbers. This batch or lot number can be used to
identify ingredients, containers, or closures that have been released
for use in infant formula or rejected for use in infant formula
manufacture. It also can be used to track the ingredients, containers,
or closures that were used in the manufacture of each batch of infant
formula.
Proposed Sec. 106.40(d) requires that infant formula manufacturers
develop written specifications that stipulate the standards for
acceptance or rejection of ingredients, containers, and closures.
Stipulating the standards for acceptance or rejection of ingredients
used to supply nutrients is important to ensure that all the required
nutrients are present in the formula at the required levels. For
example, the level of endogenous nutrients that a manufacturer expects
will be supplied by an ingredient should be stipulated as a standard
for acceptance or rejection of that ingredient. Endogenous nutrients
are nutrients provided as a part of other nutrients, such as minerals
provided as a part of the protein source. Sodium, for example, is
frequently provided as part of the protein ingredient ``caseinate.''
To ensure that the mineral is provided in the infant formula at at
least the minimal level, and not above the maximum level, required by
Sec. 107.100, the infant formula manufacturer must know what amount of
a mineral is provided to the formula by all ingredients that are
sources of the mineral. Thus, a standard for the level of the
endogenous nutrient that is to be provided by an ingredient is an
appropriate specification for the manufacturer to develop. If the level
of the mineral is too high in the ingredient, it may cause the formula
to exceed the maximum established in Sec. 107.100. Similarly, if the
level is too low, the formula may not meet the required minimal level.
Developing standards for acceptance or rejection of ingredients
used in infant formula manufacture is also important to ensure that
contaminants in the
[[Page 36168]]
ingredients that may lead to adulteration of the product are not
present in the formula. Examples of contaminants that may lead to
adulteration of an infant formula include certain heavy metals, such as
lead. Infant formula manufacturers are currently setting standards for
the lead in the ingredients that they use in infant formula to ensure
that the lead level in infant formulas is at or below the
quantification limit of the method used for lead determination (Ref.
32).
Stipulating the standards for acceptance or rejection of containers
or closures used in infant formula manufacture is important to ensure
that the integrity of the container and of the closure is maintained to
prevent leakage of the formula and to prevent an infant formula from
becoming adulterated, which can occur if the container or closure is
not impenetrable to air (which can cause nutrient degradation), or if
the container or closure allows outside contaminants to get into the
infant formula.
Proposed Sec. 106.40(d) also requires that manufacturers establish
written specifications that stipulate the procedures for determining
whether the ingredients, containers, and closures meet the standards.
Examples of procedures manufacturers may use to determine whether they
meet the standards are acceptance of a supplier's guarantee or
certification and testing conducted by the infant formula manufacturer.
In some cases, manufacturers must conduct their own testing to ensure
that the standards for acceptance or rejection of the ingredient are
met. For example, section 412(b)(3)(B) of the act requires that
manufacturers test each nutrient premix for each relied-upon nutrient
to ensure that the premix complies with its specifications or
certifications by a premix supplier, but the act does not require
testing of individual nutrient ingredients when such nutrients are not
supplied as a nutrient premix. However, a manufacturer may find through
experience that the best way to ensure that the final product will meet
all specifications is to test certain nutrient ingredients for
identity, purity, and potency before using them in the infant formula.
In addition, manufacturers should have controls in place to ensure
that any ingredients, containers, or closures that do not meet any of
their specifications are not used in production of a batch of infant
formula. However, if these controls fail, and any such ingredients,
containers, or closures are used in a batch of formula, FDA is
proposing under Sec. 106.40(d) that an individual qualified by training
or experience conduct an investigation to ensure that the failure does
not lead to release into the marketplace of an adulterated product.
Proposed Sec. 106.40(e) requires that ingredients, containers, and
closures be stored in areas clearly designated for materials pending
release for use, materials released for use, or materials rejected for
use in infant formula production in order to prevent mixups in using
materials that are inappropriate for infant formula manufacturing. FDA
is further proposing to require that any lot of ingredients,
containers, or closures that does not meet the manufacturer's
specifications be rejected and controlled under a quarantine system
designed to prevent its use in the manufacture of infant formula.
Failure to protect against the use of these materials would
significantly increase the likelihood that an adulterated product will
be produced.
Some ingredients used in infant formula are vulnerable to
degradation when they are exposed to heat or air. Moreover, containers
or closures may be exposed to air containing dust and dirt and become
contaminated. Thus, the ingredients, containers, and closures may need
to be reexamined after they are exposed to air, heat, or other
conditions that may adversely affect them to ensure that they still
meet the manufacturer's specifications. Thus, FDA is proposing, in
Sec. 106.40(f), to require retesting or reexamination after approved
materials have been exposed to conditions that may adversely affect
them.
Proposed Sec. 106.40(g) requires that manufacturers make and retain
records on ingredients, containers, and closures used in the
manufacture of infant formula so that if adulteration of formula
occurs, the manufacturer will be able to determine the source of the
material, so that its use can be halted. In addition, the records will
show the basis on which each ingredient, container, and closure was
released for use in infant formula production, if questions about such
release later arise. FDA has authority to require these records, under
section 412(b)(4)(A)(i) of the act.
8. Controls to Prevent Adulteration During Manufacturing
The infant formula manufacturing process involves a number of
complicated processes that may cause adulterated formula to be produced
if the processes are not properly conducted or monitored. Therefore,
FDA is proposing, under section Sec. 106.50, to require that
manufacturers establish controls to minimize the risk that
manufacturing process errors will produce an adulterated or unsafe
formula. The proposed requirements reflect many of the practices
currently used by infant formula manufacturers and manufacturers of
other commodities that require strict production controls to prevent
product adulteration (e.g., Ref. 9 and 21 CFR 211.100 through 211.115).
Proposed Sec. 106.50(a)(1) carries forward and amends the
requirement in current Sec. 106.25(a) that a master manufacturing order
be prepared and followed. A master manufacturing order is necessary to
ensure that the manufacturer will produce each batch of a particular
infant formula the same way. If the master manufacturing order is not
followed, all necessary ingredients may not be added to the formula in
the appropriate concentrations and in the appropriate manner.
FDA is also proposing that manufacturers make and retain records
that include complete information relating to the production and
control of the batch at the time each manufacturing operation is
performed (see proposed Sec. 106.50(a)(2)). This proposed requirement
will ensure that the complete history of each batch of infant formula
is available for review in the event that a problem arises with a
particular batch.
Proposed Sec. 106.50(a)(2) also requires that an individual
qualified by training or experience conduct an investigation of any
deviations from the master manufacturing order and any corrective
actions taken. This investigation is necessary to ensure that any
deviations from the master manufacturing order do not lead to an
adulterated product.
If any changes are made to the master manufacturing order, proposed
Sec. 106.50(a)(3) requires that they be drafted, reviewed, and approved
by a responsible official and include an evaluation of the effect of
the change on the nutrient content and the suitability of the formula
for infants. This process is necessary to prevent unintended adverse
effects that could result from changes to the master manufacturing
order made by persons not qualified to assess their impact. The
production of infant formula is a sophisticated process, and all
organizational units that are involved in critical formulation and
production steps, such as production, engineering, research, and
regulatory affairs, should review and approve changes to the master
manufacturing order. FDA has tentatively concluded, however, that all
changes to the master manufacturing order need to be
[[Page 36169]]
reviewed by at least one responsible official, and that this official
will need to evaluate how the change will affect the nutrient content
and the suitability of the product for infants, to ensure that the
infant formula is not adulterated.
A significant change in the master manufacturing order without
proper approval may result in the production of an infant formula that
lacks a required nutrient or that is not manufactured in an appropriate
way. For example, homogenization of an infant formula is done to ensure
a uniform dispersion throughout the formula of the lipid ingredients as
well as the fat-soluble nutrients. If the master manufacturing order
were changed, and the homogenization process done before the fat source
was added, the fat-soluble nutrients would not be uniformly dispersed
in the formula, and the formula would be adulterated. The system of
review and approval required by proposed Sec. 106.50(a)(3) will
minimize the possibility that a significant change could result in an
adulterated product.
In order to ensure that the appropriate ingredients are added
during the manufacturing process, and that the formula contains all of
the nutrients required by Sec. 107.100 and therefore is not
adulterated, FDA is proposing in Sec. 106.50(b) that each raw or in-
process ingredient required by the master manufacturing order be
examined by one person and checked by a second person or system. This
requirement will ensure that there will be a check to prevent mixups in
the use of ingredients and to prevent the use of unapproved
ingredients. Confirmation that the master manufacturing order is being
followed, and that ingredients are being properly added, is
particularly important because these matters are fundamental to
ensuring that the formula is manufactured correctly, and that it
contains the nutrients required by Sec. 107.100 but not unapproved
ingredients that might adulterate the formula.
In proposed Sec. 106.50(c), FDA is requiring the identification of
all compounding and storage containers, processing lines, and major
equipment used during the production of a batch of infant formula.
Identification of these items will enable the manufacturer to
accurately determine the status of all batches of infant formula during
all stages of the manufacturing process, will help to prevent mixups in
the addition of ingredients to the formula, and will facilitate prompt
action by the manufacturer if any problems in processing are
identified. For example, identifying that a particular storage
container contains a batch of formula that has not yet had all
ingredients added to it will prevent a manufacturer from inadvertently
final-stage packaging the product and thus will help to ensure that
adulterated product is not introduced into interstate commerce. The
presence of the lot or batch number will help to identify the product
if a problem does occur.
Proposed Sec. 106.50(d) requires that manufacturers establish
controls to ensure that required nutrient levels are maintained in the
formula, and that the formula is not contaminated with microorganisms
or other contaminants and thereby adulterated. In addition, the agency
is proposing to require establishment of controls for mixing time,
speed, temperature, and flow rate of product and other critical
parameters necessary to ensure the addition of required ingredients to,
and the homogeneity of, the formula. These parameters are determined by
the manufacturer according to its experience and knowledge of what will
result in a homogeneous, safe, and uniform product. It is essential
that controls be established for each of these parameters, or the
likelihood that there will be inconsistencies in production from batch
to batch will be greatly increased. For example, if processing
temperatures are not specified, the formula could be processed at high
temperatures that can destroy vitamins or other essential nutrients,
resulting in a product that is adulterated because it does not meet the
nutrient requirements specified in section 412(i) of the act.
Similarly, without established procedures for mixing time and speed,
the product may be produced using processing parameters that will not
result in formula that is uniformly mixed and thus does not contain all
nutrients at the required levels.
FDA is proposing to require that manufacturers establish controls
for the spray-drying process for powdered infant formula to prevent
microbial and other contamination (Sec. 106.50(d)(2)). Although spray
drying involves a heat treatment, the temperature is not sufficient to
sterilize the formula. Consequently, powdered infant formulas are
vulnerable to microbial contamination during the spray-drying process.
Even if the equipment and the formula are free of microbial and other
forms of contamination initially, the spray-drying process may permit
contamination of the product as a result of dust or other air-borne
gross particulates in the intake air. Thus, FDA has tentatively
concluded that it is important that the manufacturer establish controls
for the spray-drying process that will ensure that the powdered formula
does not become contaminated with microorganisms or other contaminants.
The controls that manufacturers should consider include: (1) Using
equipment constructed to ensure that static accumulation of particulate
matter is controlled; (2) using and maintaining equipment constructed
to protect the product from dust and environmental contamination; (3)
controlling condensation, moisture, and temperature conditions
throughout the plant to prevent Salmonella and Listeria growth in
static materials; (4) controlling condenser cooling water to prevent
potential Salmonella and other bacterial contamination; (5) controlling
sampling and cleanout ports on the evaporator for buildup of static
material and avenues for airborne contaminants; and (6) controlling
product flow through the plant to prevent unnecessary product movement
between areas that may increase the likelihood of cross-contamination.
As stated above, contaminants may enter the product in the air
introduced into the spray-drying equipment during the spray- drying
process. Air can contain free microorganisms or particulate material
that is contaminated with microorganisms. Controls to prevent microbial
contamination of the formula by airborne sources must address not only
the presence of microorganisms themselves but also the sources of dust,
moisture, and other airborne contaminants that may be sources of
microbial contamination. Therefore, proposed Sec. 106.50(d)(2) requires
that manufacturers filter the intake air before heating to remove dust
or other air-borne gross particulates that can result in the production
of adulterated formula.
FDA is proposing to require that manufacturers control the removal
of air from finished product containers (proposed Sec. 106.50(d)(3))
and ensure that containers of finished products are properly sealed
(proposed Sec. 106.50(d)(4)), that visible closure and seal defects are
detected (proposed Sec. 106.50(d)(4)(i)), and that destructive tests
are performed to determine closure strength (proposed
Sec. 106.50(d)(4)(ii)). These requirements are necessary to prevent
oxidation and deterioration of nutrients in the formula caused by air
or contaminants during the product's shelf life. FDA is also proposing
that equipment that is used to prevent adulteration be monitored,
either by personnel or monitoring equipment, to alert the manufacturer
to malfunctions (see Sec. 106.50(e)). As a result of such monitoring,
the manufacturer will be
[[Page 36170]]
able to minimize the amount of product produced subject to a
malfunction that may develop and to take prompt corrective actions.
In order to prevent rejected in-process materials from being
inadvertently commingled with acceptable materials, FDA is proposing
that manufacturers establish controls that ensure that the rejected
materials are clearly identified and quarantined, and that reprocessed
materials will not produce adulterated formula (see Sec. 106.50(f)).
9. Controls to Prevent Adulteration from Microorganisms
An infant formula that is contaminated with microorganisms may,
depending on the characteristics of the microorganisms, raise a safety
concern that would cause the infant formula to be adulterated under
section 402(a)(1) of the act. For example, all serotypes of the genus
Salmonella can cause illness (often gastrointestinal) in infants and
adults (Refs. 33 and 34) and the infectious dose is low (Ref. 35).
Moreover, microorganisms that are generally harmless in older children
and adults can cause serious bacterial infections in infants because
the immune systems of infants are still developing (Ref. 36). For
example, newborns and infants are susceptible to infection with
Listeria monocytogenes that may cause severe illness or death (Ref. 37)
and, as in the case of Salmonella, the infectious dose is believed to
be low (Ref. 38).
Likewise, Staphylococcus aureus is harmful to infants because some
strains of this microorganism produce an enterotoxin that causes acute
gastrointestinal illness (nausea, vomiting, cramps) soon after the food
is ingested (Ref. 39). Bacillus cereus can produce diarrhea and
vomiting in adult humans (Ref. 40) when food contaminated with at least
10\5\ B. cereus cells is consumed. The infectious dose of B. cereus for
infants is not known; however, as already noted, infants are more
susceptible to bacterial infections than are healthy adults and older
children because the immune systems of infants are not fully developed.
FDA has long held that health concerns may arise due to the
presence of any detectable Salmonella, Listeria, or S. aureus bacteria
in infant formula or due to levels of B. cereus that exceed 1,000
``colony forming units'' (CFU's) per gram (g) of a powdered infant
formula. Such health concerns would cause the agency to consider an
infant formula that is so contaminated to be adulterated under section
402(a)(1) of the act (see 54 FR 3783, Jan. 26, 1989, and 56 FR 66566,
Dec. 24, 1991).
Moreover, the presence of microorganisms in an infant formula
reflects that the formula was prepared, packed, or held under
insanitary conditions whereby it may have been rendered injurious to
health and therefore is adulterated under sections 402(a)(4) and 412 of
the act. For example, the presence of Escherichia coli in a sample of
infant formula is an indicator of fecal contamination, implying that
the infant formula has been contaminated by manufacturing practices
conducted under insanitary conditions and therefore is adulterated
under sections 402(a)(4) and 412 of the act. In addition, consistent
with the standard adopted by the International Commission on
Microbiological Specifications for Foods (ICMSF) of the Food and
Agricultural Organization of the United Nations and the World Health
Organization (WHO) and based on the results from FDA and Canadian
Surveys (Refs. 41, 42, and 43), an aerobic plate count (APC) (i.e., the
number of microorganisms that will grow under certain specified
conditions) that is greater than 10,000 CFU's per g of a powdered
infant formula evidences that the formula has been prepared, packed, or
held under insanitary conditions.
Illnesses from the use of microbiologically contaminated infant
formulas have occurred (Ref. 33). Moreover, as recently as May 1993,
infant formula contaminated with Salmonella bacteria was the subject of
a recall (Ref. 44). Thus, contamination of infant formula with
microorganisms of public health significance is more than a theoretical
possibility. Therefore, FDA has tentatively concluded that
manufacturers need to have in place controls to ensure that formulas
are not microbiologically contaminated at levels of public health
significance, and that, if they are, those formulas do not enter
interstate commerce. Proposed Sec. 106.55 requires manufacturers to
establish such controls.
Proposed Sec. 106.55(a) requires that manufacturers of liquid
infant formula comply with the procedures specified in part 113. These
products are thermally-processed low-acid foods that are packaged in
hermetically sealed containers that are heated to achieve commercial
sterility. Therefore, they are appropriately subject to the
requirements of part 113.
Proposed Sec. 106.55(b) requires that manufacturers of powdered
infant formula test representative samples of every batch of the
formula at the final product stage, before distribution, to ensure that
the infant formula meets the microbiological quality standards
specified in proposed Sec. 106.55(c). This proposed requirement is
necessary because although powdered infant formulas are heat treated
during processing, they are not thermally processed to achieve
commercial sterility. Proposed Sec. 106.55(b) requires testing at the
final product stage because microbiological contamination can be
inadvertently introduced by ingredients at any time during production
or through improper processing or holding procedures (Ref. 45).
Proposed Sec. 106.55(c) establishes that any powdered infant
formula that contains any microorganism at levels that exceed the
microbiological quality standards for that microorganism as listed in
this section will be deemed to be adulterated under sections 402 and
412 of the act. Proposed Sec. 106.55(c) defines microbiological quality
standards as the maximum allowable number of microorganisms present in
1 g of dry formula, expressed as CFU/g or ``most probable number''
(MPN)/g, and herein designated the ``M value'' for the specific
microorganism.
The microorganisms for which FDA is proposing M values are those
that are of known public health significance or that are indicators
that the formula have been prepared, packed, or held under insanitary
conditions. The microorganisms and each proposed M value listed in
proposed Sec. 106.55(c) are adapted from guidelines previously
published and discussed in the proposed and final rules on infant
formula record and record retention requirements (see 54 FR 3783, Jan.
26, 1989, and 56 FR 66566, Dec. 24, 1991, respectively). The agency
notes, however, that microorganisms that must be tested for in infant
formula and the proposed M values for each microorganism listed in this
proposed rule represent minimum requirements for the microbiological
quality of an infant formula based on standards and methods currently
available.
a. Aerobic plate count (APC). Proposed Sec. 106.55(c) establishes
an APC M value of 10,000 CFU/g as the maximum level that is consistent
with sanitary conditions in the facility in which a powdered infant
formula is produced. An APC M value greater than the proposed standard
indicates that the formula was produced under insanitary conditions
whereby it may have been rendered injurious to health and thus is
adulterated under sections 402(a)(4) and 412 of the act.
The APC is the number of microorganisms that will grow on the APC
nutrient medium, incubated at 35 deg.C for 24 hours in air (Ref. 46).
``Microorganisms'' (as defined in
[[Page 36171]]
proposed Sec. 106.3(k)) include yeasts, molds, bacteria, and viruses.
The APC medium supports the growth of most microorganisms, including
yeasts, molds, and all bacteria required to be tested for under
proposed Sec. 106.55(c); however, the APC medium does not support the
growth of viruses. The APC count is expressed in CFU's because multiple
microorganisms may adhere together or attach to the same location on an
agar plate, and microbiologists cannot determine whether one or several
individual microorganisms initiated the colony that they detect growing
on the plate.
This M value for the APC proposed in Sec. 106.55(c) is consistent
with the standard adopted by the ICMSF and the WHO and the results from
FDA and Canadian Surveys (Refs. 41, 42, and 43). The ICMSF based its
standards on the degree of health hazard the microorganisms present and
conditions of use of the product (Ref. 41).
FDA has tentatively arrived at this APC M value because the
microbial quality of products consumed by infants is of primary concern
(Ref. 43). When infant formulas are produced under good commercial
processing, the available evidence shows that the APC will be below
this M value (Refs. 42 and 43). The agency is notaware of adverse
events occurring in infants who consumed products with an APC below
this M value.
b. Coliforms, fecal coliforms, and E. coli. E. colli are bacteria,
including some strains that are pathogenic for infants, that thrive in
the human intestinal tract. The presence of E. coli in a sample of
powdered infant formula is an indicator that the infant formula has
been contaminated by manufacturing practices conducted under insanitary
conditions and therefore is adulterated under sections 402(a)(4) and
412 of the act.
E. coli bacteria are a subset of a more diverse group of bacteria
known collectively as fecal coliforms, which also thrive in the human
intestinal tract and therefore are also indicators of fecal
contamination. Fecal coliforms are destroyed by pasteurization, and the
presence of these microorganisms in a pasteurized product evidences
that there has been post-process contamination of the formula (Ref.
47). Fecal coliforms in turn are a subset of a still further diverse
group of bacteria known as coliforms, which include bacteria that may
or may not be indicators of fecal contamination. However, contamination
with coliforms is a reliable indicator of post-process contamination of
the formula, even if the source of the contamination is not fecal.
In previously issued guidelines, the agency recommended that
powdered infant formulas be tested for the presence of E. coli (54 FR
3783); however, one comment on this recommendation suggested that, to
allow greater flexibility and reduce the cost for manufacturers, the
manufacturer should be given the option of testing for coliforms, fecal
coliforms, or E. coli. Specific tests for contamination with E. coli
provide the most definitive evidence of fecal contamination, but tests
for specific bacteria are more cumbersome than general tests for a
group of bacteria such as fecal coliforms. Similarly, general tests for
fecal coliforms are more cumbersome than universal tests for an even
more diverse group of bacteria such as coliforms.
The agency is proposing in Sec. 106.55(c) that manufacturers screen
their samples of powdered infant formula for evidence of contamination
with E. coli using sequential tests for detecting and enumerating
coliforms and fecal coliforms. Under the proposal, manufacturers
ordinarily would only perform the simplest test (i.e., the test for
coliforms) using a test sample of the infant formula. The results of
the coliform test determine whether the manufacturer needs to followup
with a more specific test for fecal coliforms using as the test sample
cultured bacteria prepared during the coliform test. As discussed
below, the agency is not proposing that manufacturers followup a
positive result in the fecal coliform test with a more specific test
for E. coli but rather is proposing that a violative sample in the
fecal coliforms test will represent conclusive evidence that the infant
formula is adulterated.
The general test for coliforms is an example of an MPN test. MPN
counts are estimates of the number of organisms present in a sample.
Methods resulting in an MPN require inoculation of multiple tubes of
liquid culture medium with multiple dilutions of the sample. The method
specified in FDA's Bacteriological Analytical Manual (BAM) (Ref. 46)
requires inoculation of 3 replicate tubes of culture medium with each
of 3 sample dilutions, for a total of 9 tubes. The tubes contain
culture medium selective for the microorganism of interest. After
appropriate incubation (time, temperature, and atmosphere), each tube
is scored as positive or negative for the presence of the organism.
Examples of a positive result include the presence of growth, a
biochemical color change, and the production of gas.
A mathematical formula is used to calculate the MPN of
microorganisms present based on the number of positive tubes in each of
the three separate dilutions. Since the calculation in question
involves a repetitious process, the mathematical formula used to
calculate the MPN has been employed to create easy-to-use tables that
are available in the BAM and in other books of statistical tables. Most
tables present both a value for the MPN and confidence limits for that
value. The calculated table values for the MPN, using BAM methods, are
dependent on the level of the dilution in which a positive result is
found. The following table values are based on an inoculation series of
0.1, 0.01 g, and 0.001 g (or mL) of the infant formula. When no tubes
in any dilution produce a positive result, the calculated MPN value is
zero.3 When a single tube in the greatest dilution (least
concentrated) produces a positive result, the calculated MPN value is
equal to 3.01.4 When a single tube in the middle dilution produces
a positive result, the calculated MPN value is equal to 3.05.5 In
all other situations in which there is a positive result in at least
one tube (including a single positive tube in the lowest dilution
(greatest concentration)), the calculated MPN value is greater than
3.05.
---------------------------------------------------------------------------
\3\ The calculated MPN value of zero when no tubes in any
dilution produce a positive result is a recent change that appears
in the MPN tables of the 8th ed. of the BAM. In previous editions of
the BAM, the calculated MPN value when no tubes in any dilution
produce a positive result was ``less than 3.''
\4\ The calculated MPN value of 3.01 when a single tube in the
greatest dilution produces a positive result is a recent change that
appears in the MPN tables of the 8th ed. of the BAM. In previous
editions of the BAM, the calculated MPN value when a single tube in
the greatest dilution produces a positive result was 3.
\5\ The calculated MPN value of 3.05 when a single tube in the
middle dilution produces a positive result is a recent change that
appears in the MPN tables of the 8th ed. of the BAM. In previous
editions of the BAM, the calculated MPN value when a single tube in
the middle dilution produces a positive result was 3.
---------------------------------------------------------------------------
If no tubes in any dilution produce a positive result in a test for
bacterial contamination of a powdered infant formula (i.e., if the MPN
is zero), such contamination is unlikely. If a single tube in any
dilution produces a positive result in a test for bacterial
contamination of the product, such contamination is a possibility.
However, there are two situations in which a single positive tube is
generally considered to reflect a false positive test result: (1) When
no tube in the lowest dilution (greatest concentration) produces a
positive result, but a single tube in the middle dilution produces a
[[Page 36172]]
positive result (i.e., the calculated MPN value is equal to 3.01); or
(2) when no tube in the lowest dilution produces a positive result, but
a single tube in the greatest dilution (least concentration) produces a
positive result (i.e., the calculated MPN value is equal to 3.05). FDA
considers that if a sample of a powdered infant formula produces
positive test results that reflect one of these two situations,
bacterial contamination also is unlikely.
However, in all other situations (e.g., if a single tube in the
lowest dilution (greatest concentration) produces a positive result, or
if two or more tubes in any dilution produce a positive result),
bacterial contamination of a powdered infant formula is likely.
Therefore, when the calculated MPN value in a test for bacterial
contamination is greater than 3.05, that is if a sample of powdered
infant formula produces positive test results in which a single tube in
the lowest dilution produces a positive result or in which two or more
tubes in any dilution produce a positive result, the powdered infant
formula likely is contaminated with bacteria.
FDA is proposing to use the calculated MPN values in the BAM as a
means of setting a numerical specification because these tables are
generally available, represent standard practice in the industry, and
provide a simple way to classify samples as violative or nonviolative.
Based on the above discussion of calculated MPN values, FDA is
proposing in Sec. 106.55(c) that powdered infant formula be classified
as nonviolative for coliforms in all situations in which the calculated
MPN value is less than or equal to 3.05 and classified as presumptively
violative for coliforms in all situations in which the calculated MPN
value is greater than 3.05. In other words, FDA is proposing that an
MPN value of 3.05 represents the maximum allowable number of coliforms
present in 1 g of dry infant formula. This proposal is consistent with
current FDA infant formula microbiological guidelines. The agency
requests comment on the specification of 3.05 MPN/g as the maximum
allowable number of coliforms in dry infant formula.
FDA has stated that infant formula with a calculated MPN value of
greater than 3.05 in the coliform test is presumptively violative
because, under proposed Sec. 106.55(c), the manufacturer may either
consider the sample violative without further testing or may conduct an
additional test, the fecal coliform test. Although an MPN value of
greater than 3.05 MPN/g is a valid quality indicator of microbial
contamination, coliform contamination may not be fecal in origin, and
it may not reflect the presence of infant pathogenic microorganisms.
Therefore, FDA has tentatively concluded that an infant formula for
which an MPN value of greater than 3.05 MPN/g is found in the coliform
test need not be considered violative if a negative result is found in
a more specific test for fecal coliforms.
If the coliform test using powdered infant formula samples results
in an M value greater than 3.05 MPN/g, the manufacturer may use the
cultured bacteria from one or more of the tubes producing the positive
result as a sample inoculum for the fecal coliform test. A sample
inoculum producing an MPN value in the fecal coliform test of less than
or equal to 3.05 would indicate that the coliform contamination is not
fecal in origin, because under incubation conditions that are specific
for fecal coliforms, the bacteria were not detected. The testing would
effectively screen out coliforms that are not of concern, which is not
possible with the more general test. Therefore, FDA has tentatively
concluded that an MPN value less than or equal to 3.05 in the fecal
coliform test be classified as nonviolative. FDA also has tentatively
concluded that an MPN value greater than 3.05 in the fecal coliform
test is a valid quality indicator demonstrating that the formula
contains fecal coliforms such as E. coli and, therefore, is adulterated
under sections 402(a)(4) and 412 of the act. The agency is proposing
that powdered infant formula that results in an MPN value greater than
3.05 in the fecal coliform test be classified as violative.
If the E. coli test was performed, the sample inoculum would be the
cultured bacteria from positive tubes in the fecal coliforms test.
However, the agency is not proposing to require specific testing for
the presence of E. coli, or to set a specification for an M value for
E. coli, because the specification of less than or equal to 3.05 MPN/g
in the fecal coliforms test is sufficient to ensure that nonviolative
samples do not contain E. coli since E. coli is a type of fecal
coliform. Moreover, FDA has tentatively concluded that an MPN value
greater than 3.05 in the fecal coliform test is a sufficient quality
indicator of fecal contamination that the agency need not propose, as
an option, that a manufacturer may conduct an additional specific test
for the presence of E. coli. The agency requests comments on the
proposed requirements for sequential testing for coliforms and fecal
coliforms, with no testing for E. coli.
c. Salmonella. Tests for the presence of Salmonella involve the
enrichment in a broth of the entire analytical unit followed by plating
onto culture plates rather than the culture of a series of dilutions
that is performed in tests for coliforms. A positive result in a test
for Salmonella is based on the detectable presence of the microorganism
on the culture plate rather than on the mathematical calculations that
result in a MPN.
Proposed Sec. 106.55(c) requires that powdered infant formula be
tested for Salmonella and provides that the formula is adulterated if
any Salmonella is found. All serotypes of this genus of bacteria can
cause illness (often gastrointestinal) in infants and adults (Refs. 33
and 34). The presence of any Salmonella in infant formula could render
it injurious to an infant who consumes it because the infectious dose
of these bacteria is low (Ref. 35). Therefore, FDA has tentatively
concluded that the risk from Salmonella is of such significance that an
M value of zero (i.e., none detectable) for Salmonella in infant
formula is necessary to protect the health of infants.
d. Listeria monocytogenes. Tests for the presence of L.
monocytogenes are similar to those for Salmonella and a positive result
is based on the detectable presence of the microorganism on the culture
plate rather than on the mathematical calculations that result in a
MPN.
Proposed Sec. 106.55(c) requires that powdered infant formula be
tested for L. monocytogenes and provides that the formula is
adulterated if any L. monocytogenes is found. Individuals with immune
systems that make them susceptible to infections, such as newborns and
infants with incompletely developed immune systems, are susceptible to
infection with L. monocytogenes which may cause severe illness or death
(Ref. 37). The infectious dose of this bacterium is believed to be low
(Ref. 38). Because the specific dose of this bacterium that may cause
illness is not known but is believed to be low, FDA has tentatively
concluded that the risk from L. moncytogenes is of such significance
that an M value of zero (i.e., none detectable) for L. monocytogenes in
powdered infant formula is necessary to protect the health of infants.
The agency requests comment on this proposed specification for L.
monocytogenes.
e. Staphylococcus aureus. S. aureus is harmful to infants because
some strains of this microorganism produce an enterotoxin that causes
acute gastrointestinal illness (nausea,
[[Page 36173]]
vomiting, cramps) soon after the food is ingested (Ref. 39). Tests for
S. aureus involve liquid culture of series of dilutions as was
discussed previously in reference to coliform and fecal coliform
testing and results are calculated as MPN based on tables in the BAM.
Proposed Sec. 106.55(c) requires that powdered infant formula be tested
for S. aureus and establishes an M value of 3.05 for this
microorganism. FDA has tentatively concluded that the risk from S.
aureus is of such significance that an M value of 3.05 is necessary to
protect the health of infants.
f. Bacillus cereus. Tests for B. cereus involve liquid culture of a
series of dilutions as was discussed previously in reference to
coliform and fecal coliform testing and results are calculated as MPN
based on tables in the BAM. Proposed Sec. 106.55(c) requires that
powdered infant formula be tested for B. cereus when the APC exceeds
100 CFU/g and establishes an M value for B. cereus of 100 MPN/g or 100
CFU/g. This proposed M value for B. cereus is lower than the M value of
1,000 MPN/g or 1,000 CFU/g in the current recommended infant formula
microbiological guidelines (54 FR 3783). B. cereus can produce diarrhea
and vomiting in adult humans (Ref. 40) when food contaminated with at
least 105 B. cereus cells is consumed. The infectious dose of B.
cereus for infants is not known; however, because the immune systems of
infants are not fully developed, infants are more susceptible to
bacterial infections than are healthy adults and older children. In the
absence of data on the dose of B. cereus capable of causing disease in
infants, the agency is concerned that a safety standard of 1,000 MPN/g
or 1,000 CFU/g poses a potential risk to infants who consume rehydrated
formula because B. cereus in rehydrated powdered infant formula is
capable of rapid growth and can reach 4.9 x 106 cells/g within 24
hours at 26 deg.C (Ref. 48), a level sufficient to cause disease.
Therefore, FDA has tentatively concluded that the risk from B. cereus
is of such significance that an M valve that is lower than the current
standard of 1,000 MPN/g or 1,000 CFU/g is necessary to protect the
health of infants.
Powdered infant formulas and similar products (e.g., powdered milk)
produced under CGMP contain less than 100 MPN/g or 100 CFU/g of B.
cereus (Refs. 43 and 48). Additionally, an FDA survey of different
production lots of milk-, soy-, and protein hydrolysate-based powdered
infant formulas (Ref. 49) showed that the maximum APC was 103 CFU/g,
and that the proportion of B. cereus in the samples ranged from 1.2 to
63.9 percent of the APC. Therefore, FDA has tentatively concluded that
an M value of 100 MPN/g or 100 CFU/g for B. cereus will adequately
protect the health of infants. Moreover, because this M value is higher
than the B. cereus levels typically found in infant formula currently
being produced (Refs. 43, 48, and 49), the proposed M value of 100 MPN/
g or 100 CFU/g will not be overly burdensome.
g. Methods. Proposed Sec. 106.55(c) states that the agency intends
FR Doc. 96-17058 Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula
to determine compliance with the proposed M values using the methods in
the BAM. These methods provide reproducible, consistent, and accurate
results at different laboratories. The agency proposes to incorporate
the BAM by reference in Sec. 106.55(c) in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. While manufacturers may use other equivalent
methods, a manufacturer who uses methods that do not provide results
that are consistent with the results obtained by methods approved by
FDA will bear the risk that the firm's product is not in compliance
with the law.
The agency intends to test for Salmonella using the method
described in Chapter 5, BAM, including the sample preparation
procedures described in section C, paragraph 1 and the sampling plan
described in Chapter 1, BAM; for L. monocytogenes using the method
described in Chapter 10, BAM and the sampling plan described in Chapter
1, BAM; for coliforms, fecal coliforms, and E. coli using the MPN
method described in Chapter 4, BAM; for S. aureus using the MPN method
described in Chapter 12, BAM; for B. cereus using the MPN or plate
count method described in Chapter 14, BAM. The agency intends to
determine the APC using the method described in Chapter 3, BAM. All
chapter references are to the 8th ed. BAM. FDA intends to update the
reference to reflect the most recent edition of the BAM at the time the
final rule based on this proposed rule is issued.
h. Records. Proposed Sec. 106.55(d) requires that manufacturers
make and retain records, in accordance with proposed Sec. 106.100
(e)(5)(ii) and (f)(7) on the testing of infant formula for
microorganisms. As discussed in the description of the revisions to
proposed subpart F of part 106, FDA has the authority to require such
records under section 412(b)(4)(A)(i) of the act. These records will
document whether the batch of powdered infant formula meets the
microbiological quality standards of proposed Sec. 106.55(c) and is
therefore not adulterated. Records that describe the full methodology
for testing powdered infant formula for microbiological quality will
provide consistency in the testing of the microbiological quality of
the formula, even if different laboratory personnel conduct the tests.
The accuracy and reproducibility of microbiological quality testing
depend on the procedure used to conduct the test. In addition, the
records will provide the manufacturer with data to evaluate any
complaints received associated with a particular batch of infant
formula by showing whether microbiological contamination could have
contributed to the adverse event.
10. Controls to Prevent Adulteration During Packaging and Labeling of
Infant Formula
Because consumers rely on correct labels to select a formula to
meet their childrens' individual needs and to have proper instructions
for the use of the formula, FDA is proposing Sec. 106.60(a) which
requires manufacturers examine packaged and labeled infant formula to
ensure that containers and packages bear the correct labels, use-by
dates, and traceability codes. The proposal also requires that labels
be designed, printed, and applied so that they remain attached and
legible during processing, handling, storage, and use (proposed
Sec. 106.60(b)), and that all formula held in a single package be the
same product bearing the same traceability code, and that the package
carry the product name, name of the manufacturer, and the code
(proposed Sec. 106.60(c)).
These proposed requirements will ensure that infants who have
allergies will not be placed at risk by consuming formula containing
ingredients to which they are allergic, and that consumers will be
aware of the date when the product may no longer be appropriate for
use. In addition, the traceability codes will show the origin of the
product if there were a recall, and the packaging requirements will
make it more difficult for counterfeit formula, or formula with
counterfeit labels, to be shipped in interstate commerce. There have
been cases of counterfeit shipments in which a single package held more
than one product, or held a single product which bore more than one
code. The proposed regulations are not only intended to reduce the
incidence of counterfeit activities, but to ensure that firms that
receive the formula are aware that only one product should be in the
packaging, and that all containers should be identified with the code
shown on the package. This requirement will not impose an additional
burden on industry because manufacturers routinely package a
[[Page 36174]]
single infant formula product bearing the same code.
11. Controls on the Release of Finished Infant Formula
Proposed Sec. 106.70(a) requires that the manufacturer determine
that each batch of formula meets all of the manufacturer's
specifications before releasing the batch for distribution.
Specifically, each batch must meet the requirements of Sec. 106.55 on
microbiological contamination to ensure that the infant formula does
not contain microorganisms at levels that may be injurious to the
health of infants and render the formula adulterated and must meet the
requirements of Sec. 106.91(a) on quality control procedures to ensure
that the infant formula provides the required nutrients at the required
levels, and that it provides any nutrient added by the manufacturer.
Proposed Sec. 106.70(a) is designed to ensure that any infant formula
that fails to meet the manufacturer's specifications, or that is
adulterated for any reason, will not be introduced into interstate
commerce.
Proposed Sec. 106.70(b) requires that each batch of infant formula
that fails to meet the manufacturer's specifications be rejected.
Although proposed Sec. 106.70(b) recognizes that the formula may be
reprocessed, it requires that the reprocessed product be shown to meet
the requirements of Sec. 106.70(a) before the product is released. FDA
has tentatively concluded that this proposed requirement is necessary
to ensure that any defect that caused a batch of infant formula to be
rejected is corrected before the formula is released into commerce.
Proposed Sec. 106.70(c) requires that an individual qualified by
training or experience conduct an investigation of a finding that a
batch of infant formula fails to meet any manufacturer's
specifications. This investigation is necessary to determine why such a
failure occurred and to assist the manufacturer in developing controls
to ensure that such a failure does not reoccur. FDA has proposed to
require that the individual who conducts the investigation be qualified
to ensure that the investigation is properly conducted.
12. Traceability
Section 412(g)(1) of the act requires that each manufacturer make
and retain such distribution records as may be necessary to effect and
monitor recalls of the formula, and section 412(b)(4)(A)(vi) requires
that each manufacturer retain all complaints concerning infant formulas
that may reveal the possible existence of a hazard to health.
Therefore, infant formulas must be traceable to permit identification
of the product that is the subject of a complaint and to make it
possible to determine whether that batch of infant formula presents a
possible hazard to health. Traceability of an infant formula is also
necessary so that the recall requirements of the act can be met.
The agency's view, based on its experience, is that coding is the
most effective method for ensuring traceability. It provides a uniform
system that is able to identify large numbers of batches of infant
formula with a distinctive code that is easily understood and that can
be used by manufacturers, retailers, and consumers. A code also allows
a large amount of information to be presented on the container of
infant formula in a very small space. Therefore, the agency is
proposing, under sections 412 (b)(4)(A)(vi) and (g)(1) and 701(a) of
the act that batches of infant formula be identified with a distinctive
code that will allow the traceability of an infant formula.
Current Sec. 106.90 requires that manufacturers ensure traceability
by coding all infant formulas in conformity with the coding
requirements in Sec. 113.60(c) for thermally processed low- acid foods
packaged in hermetically sealed containers. Section 113.60(c) requires
that the code identify the establishment where the product is packed,
the product contained therein, the year packed, the day packed, and the
period during which packed, and that the packing period code be changed
with sufficient frequency to permit ready identification of lots during
their sale and distribution. FDA is proposing to carry the requirement
that manufacturers code their product in accordance with Sec. 113.60(c)
forward in proposed Sec. 106.80(a).
FDA has tentatively determined that it is appropriate to code
liquid infant formulas in this manner because they are thermally
processed low-acid foods, and a batch is produced in a relatively short
period of time, usually a day. It also may be appropriate for coding
some powdered infant formulas in this manner if they are processed in a
short enough time to make the day packed and the period during which
packed meaningful information.
Proposed Sec. 106.80(b) allows for alternative coding of batches of
powdered infant formula. Powdered infant formula is usually
manufactured in stages over a longer period of time than liquid infant
formula. Some powdered infant formulas are dry mixed in a number of
stages over an extended period of time. In other cases, powdered infant
formula is mixed in liquid form at one manufacturing facility and
shipped to a second site for spray drying and packaging. Powdered
infant formula manufacturing is often not completed in a short enough
period of time for coding based on the date packed or the period of
time in which it was packed to be meaningful information. Therefore,
under the alternate method that FDA is proposing, a sequential code
would be assigned so that all the essential information needed to track
any problems with the infant formula could be determined.
13. Audits of CGMP
Proposed Sec. 106.90 requires that manufacturers (or their agents)
conduct regularly scheduled audits to determine whether they are
complying with CGMP. This provision derives from section
412(b)(2)(B)(iv) of the act, which requires that the CGMP include ``the
conduct by the manufacturer of an infant formula or an agent of such
manufacturer of regularly scheduled audits to determine that such
manufacturer has complied with the regulations prescribed under''
section 412(b)(2)(A) of the act. Section 412(b)(2)(A) requires that the
Secretary (and by delegation FDA) establish CGMP's by regulation.
FDA is proposing to require that regularly scheduled audits be part
of CGMP because such audits are the best way to ensure overall
compliance with CGMP and to identify recurring problems that may
dictate an alteration in the master manufacturing order. For example,
regularly scheduled audits of all deviations from the manufacturer's
specifications or procedures will accentuate deviations that occur
repeatedly and will enable the manufacturer to identify specifications
or procedures that should be reassessed.
Section 412(b)(2)(B)(iv) of the act also specifies that such audits
are to ``be conducted by appropriately trained individuals who do not
have any direct responsibility for the manufacture or production of
infant formula.'' FDA is therefore proposing that an individual be
knowledgeable in all aspects of infant formula production perform the
audit. Without such broad knowledge, the individual conducting the
audit will not be able to adequately evaluate the manufacturer's
production and in-process control procedures. In addition, because the
purpose of the audit is to determine whether the manufacturer is
complying with the CGMP regulations issued under section 412(b)(2)(A)
of the act, the agency has tentatively concluded that the person
conducting the audit needs to be knowledgeable in
[[Page 36175]]
these regulations. Without such knowledge, the person would be unable
to make the determinations that are the very purpose of the audit.
The requirement that the audit be performed by an individual who
has no direct responsibility for the matters being audited is one way
to ensure the objectiveness of the audit process. The person should be
free of any past involvement in the activities being audited because
the audit is intended to uncover any problems or shortcomings in the
manufacturer's procedures. A person who has been involved may feel that
finding problems will reflect poorly on his or her work. Therefore, FDA
has tentatively concluded that the audit must be conducted by someone
who has no direct interest in the outcome of the audit.
C. Quality Control Procedures
1. Introduction
FDA is proposing to redesignate and revise subpart B of part 106 as
subpart C of part 106. Under this proposal, several sections of the
current regulations will be revoked, and several sections will be
redesignated without change. The latter sections are being recodified,
however, to fit the organization of the proposed regulations. Table II
describes the current and proposed regulations as follows:
Table II
------------------------------------------------------------------------
Current regulation Proposed regulation
------------------------------------------------------------------------
INGREDIENT CONTROL
------------------------------------------------------------------------
Sec. 106.20(a), Sec. 106.20(b)(1), Sec. Changed by Secs.
106.20(b)(2). 106.91(a)(1) and 106.40(d).
------------------------------------------------------------------------
IN-PROCESS CONTROL
------------------------------------------------------------------------
Sec. 106.25(a)........................... Sec. 106.50(a)(1).
Sec. 106.25(b)(1)........................ Omitted.
Sec. 106.25(b)(2)........................ Sec. 106.91(a)(4).
Sec. 106.25(b)(3)........................ Sec. 106.91(a)(2).
Sec. 106.25(b)(4)........................ Sec. 106.91(a)(4) with
modification.
Sec. 106.25(b)(5)........................ Sec. 106.91(a)(3) with
modification.
------------------------------------------------------------------------
FINISHED PRODUCT EVALUATION
------------------------------------------------------------------------
Sec. 106.30(a)........................... Sec. 106.91(a).
Sec. 106.30(b)(1)(i)..................... Sec. 106.91(a)(3).
Sec. 106.30(b)(1)(ii).................... Sec. 106.91(a) with
modification.
Sec. 106.30(b)(2), Sec. 106.30(b)(3).... Sec. 106.91(b) with
modification.
Sec. 106.30(c)(1)........................ Omitted.
Sec. 106.30(c)(2)........................ Sec. 106.3(i)
Secs. 106.91(b)(1) and
106.97(b)(1) with
elimination of the
osmolality and vitamin D
assay.
Sec. 106.30(d)........................... Omitted.
------------------------------------------------------------------------
FDA is proposing quality control procedures under the authority
granted by section 412(b)(2), (b)(3), and (b)(4) of the act, which
direct the Secretary (and by delegation, FDA) to establish by
regulation the quality control procedures that he or she determines are
necessary to ensure that an infant formula provides the required
nutrients at the required levels. In the Congressional Record of
September 27, 1986, Senator Metzenbaum stated: ``The most important
provision of this amendment is the simple requirement that each batch
of formula must be tested for each essential nutrient that must be
contained in the formula'' (Ref. 1). The quality control procedures in
proposed subpart C of part 106 are the minimum practices that
manufacturers must implement to ensure that the infant formula that
they produce contains the required nutrients at the required levels
throughout the shelf life of the product. Under section 412(a)(3) of
the act, an infant formula is deemed to be adulterated if the
processing of the formula does not comply with quality control
procedures prescribed by the Secretary.
2. Nutrient Testing
Proposed Sec. 106.91(a) describes the testing that FDA has
tentatively concluded each manufacturer must conduct on each batch of
infant formula to ensure that it provides the required nutrients at the
required levels and provides any nutrient added by the manufacturer.
FDA is proposing these requirements under the authority of two sections
of the act. Section 412(b)(2)(B)(i) of the act provides that the
quality control procedures shall include requirements for testing, in
accordance with section 412(b)(3), of each batch of infant formula for
each required nutrient, before distribution of such batch. Section
412(b)(3)(D) of the act states that if the Secretary adds a required
nutrient, the Secretary must require that the manufacturer of the
infant formula test each batch of such formula for that nutrient in
accordance with section 412(b)(3)(A), (b)(3)(B), and (b)(3)(C) of the
act.
Current Sec. 106.20(a) and (b)(2), which FDA is proposing to
replace with Sec. 106.91(a)(1), do not require that manufacturers
analyze nutrient premixes if the premixes come with a supplier's
guarantee or certification. Proposed Sec. 106.91(a)(1), however,
requires that each nutrient premix used in the manufacture of an infant
formula be tested by the formula manufacturer for each nutrient that
the manufacturer is relying on the premix to provide to ensure that the
premix complies with the manufacturer's specification. This change is
required by section 412(b)(3)(B) of the act. Section 412(b)(3)(B) was
included in the 1986 amendments because infant formula manufacturers
were increasingly relying on the use of formula premixes, and Congress
felt that relying on a premix supplier's written assurance that its
premix product was properly tested was inadequate (Ref. 1). In 1985,
the Department of Justice sought an injunction against a premix
supplier because, ``as a result of inadequate quality control, numerous
* * * vitamin and mineral mixes--used in infant formula--have been
misbranded and adulterated'' (Ref. 3). The premix supplier entered into
a consent decree of permanent injunction that enjoined it from shipping
any of its vitamin/mineral premixes for use in infant formulas until it
completed a number of specific acts that were designed to improve its
quality control (Ref. 50).
FDA is proposing to redesignate current Sec. 106.25(b)(3) as
Sec. 106.91(a)(2), which requires that after the addition of the
premix, or at the final-product stage but before distribution, each
batch of infant formula be tested to confirm that the nutrients
contained in any nutrient premix used in such infant formula are
present in each batch of infant formula in the proper concentration.
This requirement implements section 412(b)(3)(C)(ii) of the act, which
requires that infant formula be tested to ensure that any nutrient
premixes used by the manufacturer are actually included in the batch of
infant formula in the proper amount. Without this check, inadvertent
failure to include the premix could go undetected, and infant formula
that is deficient in the nutrients that were to be provided by the
premix would be introduced into the market.
Current Sec. 106.30(b)(1)(i) requires that the manufacturer analyze
representative samples of each batch of finished infant formula for
specific nutrients to assess process degradation. FDA is carrying
forward a modified version of this requirement in proposed
Sec. 106.91(a)(3), which requires that each batch of infant formula be
tested for vitamins A, C, and
[[Page 36176]]
E and thiamin at the final-product stage, before distribution. This
regulation is proposed under section 412(b)(3)(A) of the act, which
states: ``At the final product stage, each batch of infant formula
shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E * *
*.'' In the Congressional Record, Senator Metzenbaum stated that
testing for these vitamins is required at the final-product stage
because they are vulnerable to degradation (Ref. 1). Testing at the
final-product stage will ensure that these nutrients are present in the
infant formula at the end of all the processing steps that may destroy
them.
Proposed Sec. 106.91(a)(4) requires that, before distribution, each
batch of infant formula be tested for all nutrients required to be
included, and any others that have been included, but for which testing
to comply with Sec. 106.91(a)(1) or (a)(3) was not conducted. This
proposed provision takes a markedly different tack than current
Sec. 106.30(b)(1)(ii), which states that no analyses are needed for
linoleic acid, vitamin D, vitamin K, choline, inositol, and biotin
before release of a batch of infant formula for commercial or
charitable distribution. This change in approach is necessary because
section 412(b)(3)(C) of the act, which was added by the 1986
amendments, states that each batch of formula must be tested for each
nutrient required by the law to be present in an infant formula. Also,
manufacturers are adding nutrients not required by Sec. 107.100, such
as selenium, to infant formulas. These nutrients meet the definition
for ``nutrient'' in proposed Sec. 106.3(m) because they have been
identified as essential for infants by NAS through its development of a
Recommended Dietary Allowance or an Estimated Safe and Adequate Daily
Dietary Intake range. The agency has not objected to the addition of
nutrients not required by Sec. 107.100 to infant formulas. However, it
is important that the level of these added nutrients be controlled, and
that the level of the added nutrient be consistent from batch to batch
and be uniform throughout the batch of infant formula.
The level of a nutrient needs to be controlled because some
nutrients can be toxic to an infant if given at too high a level.
Controlling the level of the added nutrient for consistency from batch
to batch and in a particular batch of infant formula will ensure that
the infant receives the essential nutrient on a consistent basis and
will also ensure that the infant does not receive too high, or too low,
a level of the nutrient because the nutrient was not uniform throughout
the batch of infant formula.
3. Stability Testing
Current Sec. 106.30(c) requires that the manufacturer, using
representative samples collected from finished product batches, conduct
stability analysis for selected nutrients with sufficient frequency to
substantiate the maintenance of nutrient content throughout the shelf
life of the product. The 1986 amendments added subsection
412(b)(2)(B)(ii) to the act, which requires ``regularly scheduled
testing, by the manufacturer of an infant formula or an agent of such
manufacturer, of samples of infant formula during the shelf life of
such formula to ensure that such formulas are in compliance with''
section 412 of the act. To implement this section of the act, the
agency is redesignating and revising current Sec. 106.30(b)(3) as
proposed Sec. 106.91(b), which requires quarterly collection of samples
of infant formula for stability testing to provide a check on nutrient
stability. This periodic check will alert the manufacturer if nutrient
stability has changed in some unpredicted way so that the formula no
longer complies with section 412 of the act. Quarterly testing of
infant formulas for nutrient stability is currently conducted by the
industry (Refs. 51 and 52), and the agency is not aware of any problems
that have resulted from this frequency of testing. The agency requests
comment on whether this proposed frequency of sample collection for
stability testing is appropriate.
The agency has tentatively concluded that this periodic sample
collection to check on nutrient stability must be performed on a batch
of each physical form (powder, ready-to-feed, or concentrate) of each
infant formula, at each different manufacturing facility, because
different forms of the product may contain different ingredients, and
different forms of infant formula are subjected to different processing
procedures. Therefore, ensuring the nutrient stability of one form of
the product, such as the powder, will not answer questions about the
nutrient stability of other forms of the product. Thus, the agency has
tentatively concluded that each form of the infant formula must be
sampled on a periodic basis for nutrient stability. Also, the agency
has tentatively concluded that the sampling of one batch of each
physical form of each infant formula must be conducted at each
manufacturing facility. This proposed requirement is necessary because
manufacturers may produce the same infant formula at more than one
facility, and the manufacturing conditions at one facility may not be
the same as the conditions at another facility. The differences in
conditions cannot be allowed to affect the quality of the formula.
Proposed Sec. 106.91(b) further requires testing at the beginning,
midpoint, and end of the shelf life of the infant formula. Testing at
the beginning of the shelf life shows that the formula is in compliance
with the nutrient requirements of the act when it is released for
distribution. Testing at the midpoint of the shelf life will alert the
manufacturer if any nutrient is deteriorating at a rate different from
that predicted, so that the nutrient may not be in the formula at a
level to comply with the act throughout the formula's shelf life.
Testing at the end of shelf life will ensure that the formula contained
all the nutrients needed to comply with the act throughout its shelf
life and will provide continued justification for the predicted shelf
life.
Additional testing may be necessary to ensure that a formula
complies with section 412 of the act throughout its shelf life. Such
testing is likely to focus on a particular nutrient and its stability
within the matrix of the formulation. This additional testing will
ensure that, if there is a significant deterioration in the level of
the nutrient in the formula, the manufacturer will be aware of this
fact and will be able to take steps promptly to have the product
removed from the market, before a significant number of infants are
exposed to a deficient product.
The agency is not proposing to specify what frequency is required
because manufacturers have experience with the nutrient stability of
the infant formula matrices that they produce and are thus in a
position to determine how frequently testing is necessary. For example,
the manufacturer is in a position to know whether the nutrient levels
of a milk-based infant formula need to be tested on a different basis
than that of a soy-based product, or whether the nutrient levels of an
infant formula that contains hydrolyzed protein needs to be tested more
frequently than that of an infant formula that contains non-hydrolyzed
protein. Manufacturers will be able to comply with section
412(b)(2)(B)(ii) of the act by testing different nutrients at different
frequencies. For example, unstable nutrients, such as vitamins, may
require testing on a more frequent basis than more stable nutrients,
such as minerals. Proposed Sec. 106.91(b) allows the manufacturers the
discretion to determine the necessary frequency of testing to ensure
that their infant formula complies with the nutrient
[[Page 36177]]
requirements of the act, as long as the minimum testing (i.e., at the
beginning, middle, and end of the shelf life) required by proposed
Sec. 106.91(b) is accomplished.
Proposed Sec. 106.91(b)(1) provides for an addition to the
stability testing required under Sec. 106.91(b). FDA is proposing that
the first batch of each form of a new infant formula be subjected to
such testing to ensure that the product complies with the nutrient
requirements of section 412 of the act throughout its shelf life.
Proposed Sec. 106.91(b)(2) requires the sampling of the first batch
of an infant formula in which there has been a change in formulation or
in processing that could affect whether the formula is adulterated
under section 412(a) of the act and requires testing of these samples
for each nutrient that has been, or may have been, affected by the
change. The change in formulation or processing referred to here would
not be a ``major change'' because a ``major change'' would mean that
the formula is a ``new infant formula.'' Examples of the types of
changes that are subject to proposed Sec. 106.91(b)(2) are: (1)
Reducing a ``required nutrient'' in a minor way or increasing a
``required nutrient'' that is subject to maximum limits in Sec. 107.100
in a minor way; (2) replacing one nutrient form with another form, such
as replacing vitamin A acetate with vitamin A palmitate or replacing
calcium carbonate with tricalcium phosphate; (3) changing a time-
temperature condition of preheating, handling, mixing, or sterilizing
an in-process product; or (4) changing the oxygen content of a packaged
product that might have a minimal effect on the level of nutrients.
Requiring sample collection for stability testing when a manufacturer
makes changes such as these in the manufacture of the product will
ensure that the manufacturer can verify the predicted shelf life of the
changed formula.
Proposed Sec. 106.91(b)(2) requires that the manufacturer ensure
that the infant formula meets all the nutrient requirements of section
412 of the act. This provision is proposed under the authority of
section 412(b)(2)(A) of the act, which provides for the establishment
of CGMP's for infant formulas, including quality control procedures
that are necessary to assure that the infant formula provides nutrients
in accordance with section 412 (b) and (i) of the act, as well as
section 412(b)(2)(B)(ii). If the formulation or processing of the
infant formula has been changed, the manufacturer must consider what
nutrients may have been affected by the change and test for each of
these nutrients in the final-product stage of the first batch of the
changed formula. For example, if the manufacturer makes a change in the
amount of a protein source used in the infant formula, the firm must
test the formula for protein content and for any nutrients provided
endogenously to the formula by the protein, such as minerals like
calcium and phosphorus. The manufacturer is aware of how much of each
mineral it is relying on the protein source to provide to the formula.
When the amount of the protein source used in the formula is changed,
the manufacturer must test for the level of all nutrients it relies on
the protein source to provide to the formula to ensure that all
nutrients in the formula meet the requirement of Sec. 107.100.
4. Quality Control Records
Proposed Sec. 106.91(c) requires that manufacturers make and retain
records of the results of all testing performed on the batch of infant
formula in accordance with proposed Sec. 106.100(e)(5)(i) and a full
description of the methodology used in accordance with proposed
Sec. 106.100(f)(7). As discussed in the description of the proposed
revisions to subpart F of part 106, FDA has authority to require these
records under section 412(b)(4)(A)(i) of the act. Providing a record of
the results of quality control testing will verify that each nutrient
required by Sec. 107.100 is present in each batch of infant formula at
the required level, and that any nutrients added by the manufacturer
are present at the appropriate level. These records will show the
levels of nutrients in the formula and will provide data needed to
evaluate a batch of infant formula if problems, such as adverse events
in infants, occur later with that particular batch. Records that
describe the full methodology used to conduct the quality control
testing will provide consistency in the procedure that the manufacturer
is using to test for the nutrients in each batch of infant formula,
even when different laboratory personnel are conducting the testing.
The accuracy and reproducibility of quality control testing depend on
the procedure used to conduct the test.
5. Audits of Quality Control Procedures
Proposed Sec. 106.92 requires that the manufacturer of an infant
formula, or an agent of such a manufacturer, conduct regularly
scheduled quality control audits to ensure that an infant formula
provides required nutrients and has been manufactured in a manner
designed to prevent adulteration. Proposed Sec. 106.92 derives from
section 412(b)(2)(B)(iv) of the act, which requires that the quality
control procedures prescribed by the Secretary include ``the conduct by
the manufacturer of an infant formula or an agent of such manufacturer
of regularly scheduled audits to determine that such manufacturer has
complied with the regulations prescribed under'' section 412(b)(2)(A)
of the act (stating that the Secretary (and FDA by delegation)
establish by regulation ``quality control procedures that the Secretary
determines are necessary to assure that an infant formula provides
nutrients in accordance with'' section 412 (b) and (i) and ``is
manufactured in a manner designed to prevent adulteration of the
formula''. FDA is proposing to require that regularly scheduled audits
be part of quality control procedures because such audits will document
compliance with the quality control procedures and will identify
recurring problems that may dictate an alteration in the master
manufacturing order. For example, regularly scheduled audits of the
results of tests of nutrient levels in infant formulas and of any
deviations from the manufacturer's specifications or procedures for
acceptable nutrient levels will reveal deviations that occur on a
repeated basis and will enable the manufacturer to identify
specifications or procedures that should be reassessed.
Proposed Sec. 106.92 further requires that the audits be performed
by an individual who, as a result of education, training, and
experience, is knowledgeable in all aspects of infant formula
production and of the agency's regulations concerning quality control
procedures, but who has no direct responsibilities for the matters
being audited. The legal authority for this provision, the importance
of the responsible individual's knowledge in all aspects of infant
formula production and the agency's regulations, and the need for the
audit to be performed by an individual who has no direct responsibility
for the matters being audited were discussed previously under the
proposed CGMP regulations in Sec. 106.90.
By proposing different regulations (proposed Secs. 106.90 and
106.92) that require audits of CGMP and of quality control procedures,
the agency is not suggesting that it will require that separate audits
be conducted. These regulations are being proposed separately to make
clear that the regularly scheduled audits required by section
412(b)(2)(B)(iv) of the act are an aspect both of CGMP and of quality
control procedures. The agency would have no objection to a combined
audit
[[Page 36178]]
of CGMP and of quality control procedures.
6. Revocation of the Requirement for Determination of Vitamin D by the
Rat Bioassay Method
FDA is proposing to revoke the requirement in current
Sec. 106.30(c)(2) for the determination of vitamin D by a rat bioassay
method. This rat bioassay for vitamin D is no longer a viable assay
because appropriate animals for conducting this test are difficult to
acquire (Ref. 53), and an alternate analytical method for the
determination of vitamin D in infant formulas has been approved by the
Association of Official Analytical Chemists (Ref. 54).
D. Conduct of Audits
Section 412(b)(2)(B)(iv) of the act provides that CGMP and quality
control procedures include regularly scheduled audits to determine
whether the manufacturer is complying with CGMP, including following
the quality control procedures that are necessary to ensure that an
infant formula provides the required nutrients at the required levels,
and whether it is operating in a manner designed to prevent
adulteration of the formula. FDA is proposing to require in
Sec. 106.94(a) that manufacturers develop and follow a written audit
plan that is available at the manufacturing facility for FDA
inspection. A written audit plan is necessary to provide consistency in
how audits are conducted and to ensure that the auditor can determine
whether the facility is operating in compliance with the applicable
procedures.
Proposed Sec. 106.94(b) requires that the audit plan include the
procedures that the manufacturer uses to determine whether the facility
is operating in accordance with CGMP, with the applicable quality
control procedures, and in a manner designed to prevent adulteration of
the infant formula it produces. This proposed requirement derives from
current Sec. 106.100(j), which defines audit procedures as the methods
used to review the manufacturing and quality control procedures and is
intended to direct the manufacturer's attention to the fundamental
goals of the manufacturing process in formulating its audit plan.
Proposed Sec. 106.94(c) sets out the minimum requirements for the
audit procedures that are to be employed by manufacturers. Under
proposed Sec. 106.94(c)(1) these procedures are to include a review of
how the production and in-process control system established under
Sec. 106.6(b) is operating. In particular, proposed
Sec. 106.94(c)(1)(i) specifies that the evaluation of the production
and in-process control system include observation of the production of
infant formula and a comparison of the observed process to the written
production and in-process control plan required under proposed
Sec. 106.6(b). FDA has tentatively concluded that such observations
will show whether the production and in-process control system is being
followed appropriately, and, if not, they will identify any deviations
from the production and in-process control system, so that the
manufacturer can take corrective actions to ensure that infant formula
is produced in compliance with the production and in-process control
system.
Proposed Sec. 106.94(c)(1)(ii) requires that the evaluation of the
production and in-process control system include a review of records of
the monitoring of points, steps, or stages where control is deemed
necessary to prevent adulteration. As discussed below, proposed
Sec. 106.100(e)(3) requires that the batch production and control
records document the monitoring of all points where control is deemed
necessary to prevent adulteration in the manufacturing of the batch.
FDA has tentatively concluded that proposed Sec. 106.94(c)(1)(ii) is
necessary because the auditor can observe the production of only a
limited number of batches of infant formula. A review of the production
and in-process control records of all batches produced in a given
period of time will ensure that the production and in-process control
system is working appropriately on a continuous basis, will identify
any point that monitoring reveals is out of control on a recurring
basis, and will identify where the production and in-process control
system needs improvement.
Proposed Sec. 106.94(c)(1)(iii) requires that the evaluation of the
production and in-process control system include a review of records of
how deviations from any standard or specification at points, steps, or
stages where control is deemed necessary to prevent adulteration were
handled. As discussed below, proposed Sec. 106.100(e)(4)(iii) requires
that the batch records include the conclusions and followup of an
investigation of the failure to meet any specification or standard at
any point where control is deemed necessary to prevent adulteration. A
review of these records as a part of the audit will identify failures
that occur on a repeated basis and will show how these failures are
handled by the manufacturer. The auditor will be able to evaluate
whether the conclusions and followup of these investigations are
appropriate for each failure to meet the specification or standard.
Proposed Sec. 106.94(c)(2) requires that the audit procedures
include a review of a representative sample of all records maintained
in accordance with proposed Sec. 106.100 (e) and (f). As discussed
below, proposed Sec. 106.100(e) sets out the requirements for the batch
production and control records, and proposed Sec. 106.100(f) sets out
the requirements for records related to observance of CGMP. A review of
a representative sample of these records will show the auditor whether
there has been compliance with the appropriate regulations in producing
the batches of product so that the formula is not adulterated. Section
412(b)(2)(B)(iv) of the act states that the audit is conducted to
determine whether the manufacturer has complied with the regulations
establishing CGMP for infant formulas, including quality control
procedures. FDA has tentatively concluded that review of a
representative sample of the records maintained in accordance with
Sec. 106.100 (e) and (f) is necessary to determine whether the
manufacturer is complying with these regulations.
E. Quality Factors for Infant Formulas
1. What Are Quality Factors?
The agency is proposing to create a new subpart E to implement the
quality factor requirements of sections 412 (a)(2) and (b)(1) of the
act. Section 412(a)(2) of the act states that an infant formula is
adulterated unless it meets the quality factor requirements that are
established under section 412(b)(1). Section 412(b)(1) of the act
states that the Secretary shall by regulation establish requirements
for quality factors, including quality factor requirements for required
nutrients for infant formulas to the extent possible consistent with
current scientific knowledge. Therefore, it is incumbent on
manufacturers to establish that the infant formula that they produce
meets the minimum quality factor requirements that FDA adopts.
What Congress meant by ``quality factors'' is discussed in the
report of the House Committee on Interstate and Foreign Commerce that
accompanied the 1980 act. The report states that quality factors
``pertain to the bioavailability of a nutrient and the maintenance of
levels or potency of nutrients during the expected shelf life of the
product'' (Ref. 5). FDA, in proposed Sec. 106.3(o), has defined
``quality factors'' in a manner that encompasses several basic
concepts, including the concepts of
[[Page 36179]]
``bioavailability'' and of ``healthy growth.''
The concept of ``healthy growth'' was discussed in the report of
the House Committee on Interstate and Foreign Commerce that accompanied
the 1980 act. The report states that infant formulas are often the sole
source of nutrition for infants, and that ``the growth of infants
during the first few months of life often determines the pattern of
development and quality of health in adult life'' (Ref. 5). FDA
considers the concept of ``healthy growth'' to be broad, encompassing
all aspects of physical growth and normal maturational development,
including maturation of organ systems and achievement of normal
functional development of motor, neurocognitive, and immune systems.
All of these growth and maturational developmental processes are major
determinants of an infant's ability to achieve his/her biological
potential, and all can be affected by the nutritional status of an
infant.
``Bioavailability'' of a nutrient for an infant means that the
nutrient is physiologically available in sufficient quantities to
perform its metabolic functions (Ref. 55). In a formula product,
bioavailability of individual nutrients is affected by the net effect
of the formulation and processing of the product on the chemical form
of the nutrient. These processes are influenced by such factors as the
chemical form of the nutrient in the ingredient source, the chemical
form of the nutrient after processing, and the net effect of various
inhibitors and enhancers in a food or meal on the chemical form of the
nutrient and its ability to be absorbed and utilized by the infant. In
the infant, the bioavailability of a nutrient is determined by the net
effect of the amount of nutrient that is converted during digestion to
an absorbable form, the proportion of the nutrient that is absorbed
into the bloodstream, the proportion of the absorbed nutrient that is
converted to its biologically useful form, and the proportion that is
lost through excretory processes (Ref. 55). Bioavailability varies
among nutrients within a given food product and, for a given nutrient,
among foods. The factors affecting nutrient bioavailability are complex
and can be difficult to predict based on analyzed nutrient values
alone.
Bioavailability issues are particularly critical for infants during
the first few months of life, where a single food (infant formula)
serves as the sole source of all nutrients at a period when rapid
physical growth and development and maturation of various organ systems
makes the infant particularly vulnerable to harm by nutritional
insults. Unlike the mixed diet of persons beyond infancy where poor
bioavailability in one food can be compensated for by other foods in
the diet, a problem with bioavailability in an infant formula affects
the total amount of nutrient available to that infant for several
months after birth. Furthermore, requirements for nutrients are higher
per kilogram body weight during early infancy than at any other time
during the life cycle. Because numerous critical developmental
milestones (e.g., neurocognitive or immune functions) must be achieved
by young infants, a nutrient insufficiency during infancy can quickly
develop into serious, and in some cases, permanent adverse effects on a
range of developmental processes, including physical growth and organ
maturation. Thus, a problem with bioavailability is far more critical
for a food such as infant formula than it is for foods that are used as
part of a mixed diet by the general population.
Furthermore, the rapidly changing and increasingly complex
physical, chemical, and biologically significant characteristics of
ingredients used in new and reformulated infant formulas make it
important to continually ensure that quality factor requirements are
met. Changes in formulation of infant formulas are made by
manufacturers for a variety of reasons, including enhancing the
functional characteristics of the formula (e.g., to prevent separation
of ingredients or to prevent clumping that will plug nipples on
bottles), to enhance digestibility of the formula (e.g., different
sources or blends of fats), or to improve the nutritional quality
(e.g., a different source of protein or of a vitamin or mineral, or
adding a nonrequired nutrient such as selenium). For example, in some
formulas, novel sources of vegetable oils (e.g., fractions of plant
oils that are particularly rich in certain types of fatty acids) have
partially or fully replaced cow's milk fat as the fat source (Refs. 56
and 57). Whey proteins or highly processed proteins (e.g., hydrolyzed
proteins) are now frequently used as partial or complete replacements
for more traditional cow's milk protein sources. In other cases,
nutrient/nutrient interactions (e.g., high iron inhibiting absorption
of zinc) or nutrient/ingredient interactions (e.g., phytates from soy
protein isolates inhibiting absorption of zinc, or the replacing of the
milk sugar (lactose) that enhances absorption of calcium with a sugar
source that does not have this ability) can adversely affect nutrient
availability.
New processing methods may also have unintended consequences when
used with established ingredients or formulations. For example, a new
processing method that subjects the formula to conditions that are less
denaturing to cow's milk proteins than traditional heat treatments
could produce a formula that is less digestible and that causes
reactivity of the gastrointestinal wall, such as has been seen with
whole cow's milk (Ref. 58).
In summary, consideration of quality factors goes beyond analytical
measures of the presence or absence of a nutrient in the formula
product and is needed to provide assurance that adverse effects on the
nutritional value of the formula for the infant do not unintentionally
or unknowingly occur as a result of the formulation or the processing
of an infant formula. Chemical analysis of the formula product to
define its nutrient composition often overestimates the amount of
nutrient that is bioavailable for physiological use by the infant. The
quality factors, therefore, provide a means of evaluating whether a
nutrient has become less bioavailable than would be expected, so that
it is not sufficiently effective to meet its normal nutritive
functions, or whether its bioavailability has been enhanced to a level
that raises safety concerns.
Quality factor requirements are distinctly different from quality
control procedures. While ``quality control procedures are intended to
insure that the safety and nutritional potency of a formula is built
into the manufacturing process'' (Ref. 5), quality factors are intended
to ensure that an infant formula contains an adequate amount of each
nutrient in a form that can be digested, absorbed, and utilized so that
the infant's physiological needs for these nutrients will be met (Ref.
5). Changes in ingredient sources and processing can affect the
chemical forms of nutrients in the formula product. Such changes can
affect the digestion and absorption of food nutrients such that: (1)
Absorption is incomplete, (2) absorbed nutrients are not in a form that
allows use by metabolic pathways, or (3) the nutrient may interact with
other dietary substances to cause excessive excretion. Thus, the amount
of nutrients (i.e., the analyzable amounts) in formulas must generally
be higher than the physiological requirements of infants (i.e., the
amounts of nutrients needed by the body to meet metabolic and growth
needs of infants). Although these inefficiencies are generally taken
into account when recommending nutrient levels for infant formulas,
there
[[Page 36180]]
is always the potential for affecting nutrient bioavailabilities in
unexpected ways.
In summary, a demonstration that both the quantitative and quality
factor requirements for essential nutrients in an infant formula are
met is necessary to ensure that the infant formula is likely to meet
all of the known physiological nutritional needs of infants and to
ensure that healthy growth and nutritional well-being will be achieved
by an infant consuming the infant formula as the sole source of
nutrition.
2. Identification of Quality Factors
In testimony before the passage of the 1986 amendments, the agency
informed the Senate that the state of knowledge and science with
respect to quality factors was still evolving, and that, therefore,
there was a basis for only one quality factor for a nutrient. (Although
the testimony to the Senate does not specify the identity of the
nutrient for which there was a basis for a quality factor, the quality
factor was the protein efficiency ratio used for assessing protein
quality (Ref. 1).) Senator Metzenbaum stressed that the amendments
contemplated that additional quality factors would emerge, and that the
Secretary should implement requirements for such factors as quickly as
scientific advances would allow.
The agency subsequently took a major step toward establishing
quality factors through a contract in 1986 with the CON/AAP. The AAP
earlier had published recommendations regarding the quantities of
nutrients needed in infant formulas (Ref. 59). These recommendations
were relied upon during the development of the nutrient specifications
of the act (Ref. 60). In its report to FDA, ``Clinical Testing of
Infant Formulas with Respect to Nutritional Suitability for Term
Infants'' (Ref. 6), the CON/AAP identified those conditions in which
changes in formula composition warranted clinical testing. The CON/AAP
stated that ``clinical testing is primarily useful for determining (1)
acceptability of the formula, (2) ability of the formula to support
normal growth, and (3) availability of selected nutrients.'' The CON/
AAP also discussed the limitations of the available measurements,
providing an assessment of the limits of scientific knowledge.
The agency has considered the CON/AAP report carefully and has also
considered new scientific information published since the release of
that report to determine what quality factors are appropriate for
nutrients in infant formula. Based on its consideration, FDA is
proposing to adopt Sec. 106.96. This section, if adopted, will require
that all infant formula be of sufficient quality that it meets the
nutritional requirements of infants for healthy growth when fed as the
sole source of nutrition, as indicated by a general quality factor for
physical growth, assessed using anthropometric measures of infants
consuming the formula, and by a nutrient-specific quality factor for
protein biological quality, assessed by an animal bioassay using the
formula.
The agency is not proposing to require that manufacturers measure,
individually, the absorption, metabolism, metabolic transformation, or
utilization of any of the other essential nutrients. These measures are
often technically difficult or unavailable, difficult to interpret, or
invasive, thus causing unnecessary testing of infants without potential
for providing meaningful results. Rather, the agency has tentatively
concluded that current scientific knowledge and ethical and practical
considerations are supportive only of requiring two quality factor
measures: (1) Physical growth of infants consuming the formula as an
integrative indicator of the net effect of the overall nutritional
quality of the formula, and (2) a rat bioassay of protein quality in
the formula product to ensure that the infant's needs for individual
amino acids will be met.
The agency has tentatively determined that these are minimum
requirements. The agency recognizes that, on a case-by-case basis as
warranted by the formulation and intended use of a particular infant
formula, demonstration of additional quality factors may be necessary.
For example, a formula intended for use by premature infants who are at
a particularly vulnerable developmental stage relative to nutritional
needs to support neurocognitive development may need to be subject to
testing that includes measurement of this endpoint to ensure that the
formula supports healthy growth. In addition, a formula in which a
novel fatty acid has been added to enhance the formula's ability to
meet nutritional needs for supporting visual development may need to be
evaluated to determine whether it has adverse nutritional effects on
other aspects of healthy growth (e.g., on development of immune
function).
3. The Regulation
Proposed Sec. 106.96(a) sets forth quality factor requirements that
reflect the minimum measures needed to evaluate the nutritional quality
of an infant formula product, taking into account current scientific
knowledge and the usefulness of the outcome measures for evaluating
quality factors, while minimizing unnecessary testing of infants
serving as subjects in clinical trials. Infant formula is defined in
the act as a complete or partial substitute for human milk (section
201(aa) of the act). Obviously, the greatest need for a nutritionally
complete formula that meets all quality factors is when the formula is
used as a complete substitute for human milk. When no other form of
nutriture is available to the infant, the formula must provide all of
the nutrients needed for the healthy growth of the infant. There is no
room for error or miscalculation. The absence or an inadequate level of
an essential nutrient will be evidenced by growth failure and other
signs or symptoms resulting from nutritional insufficiencies. FDA has
tentatively concluded, therefore, that an evaluation of the ability of
a formula to support healthy growth must be made under its most
demanding conditions of use, i.e., when it is used as the sole source
of nutrition, because other foods may mask or compensate for
deficiencies in the formula that would occur if the formula were used
as a complete substitute for human milk, which would produce results
that cannot be meaningfully interpreted.
Proposed Sec. 106.96(b) identifies ``normal physical growth'' as a
quality factor. This quality factor reflects the CON/AAP recommendation
that the determination of physical growth rate is the most valuable
component of the clinical evaluation of an infant formula (Ref. 6).
Physical measures of growth such as weight gain are the most widely
accepted and used markers of a young infant's overall ability to digest
and utilize those nutrients provided by the formula. The very rapid
rate of growth in early infancy means that abnormalities in growth rate
can be detected in a few months, providing an easily measured and
sensitive, although nonspecific, indication of nutritional
insufficiencies (Ref. 4). Physical measures of growth rate are easily
done, are familiar to both parents and health professionals, and are a
normal part of routine office visits. They are noninvasive and pose
little or no risk to infants and provide meaningful results for
evaluating the ability of an infant formula to support physical growth
in very young infants. Thus, the agency has tentatively concluded that
the ability of the formula, when fed as a sole source of nutrition, to
meet the nutritional requirements of young infants for normal physical
growth is a
[[Page 36181]]
necessary indicator of the overall nutritional quality of the formula.
Proposed Sec. 106.96(c) requires that the protein in infant
formulas be of sufficient biological quality to meet the protein
nutritional requirements of infants. Protein, while generally discussed
as a single nutrient, depends for its nutritive value on the inclusion
of all essential amino acids at levels and relative proportions needed
to support healthy growth. The protein requirement is really the sum of
different requirements for 10 essential amino acids that occur at
different levels and proportions in various food protein sources.
Protein quality is also affected by differences in digestibility of
different protein sources, by factors that modify digestion, and by
chemical reactions that affect the ability of enzymes in the infant's
gastrointestinal tract to digest and absorb the amino acids in the
protein source. Once absorbed, the relative proportions of the amino
acids can affect their uptake by body tissues because of competition
for receptors and transport systems. Thus, protein quality depends on a
number of complex interactions and conditions that can be difficult to
predict.
Chemical analysis of foods generally only measures the amount of
total protein present and does not identify specific amino acids or
their ability to meet the physiological needs of infants for the
essential amino acids. Chemical analysis alone, therefore, is not
capable of predicting whether adequate amounts of all essential amino
acids are present, or whether the amino acids present are able to
support healthy growth in infants. Yet ensuring that the protein in an
infant formula's is of high biological value is critical to an infant's
health. For example, during the first year of life, the protein content
of an infant's body increases from 11 to 15 percent at the same time
that the infant's body weight increases by 7 kg. The average increase
in body protein is about 3.5 g/day for the first 4 months of life and
about 3.1 g/day for the next 8 months. These protein requirements must
be met by a formula that not only contains adequate protein but also
contains protein of high biological quality in a form that can be
utilized by the infant. Because biological quality varies among protein
sources and may be adversely affected by processing methods and other
constituents present in the formula, the agency has tentatively
concluded that the biological quality of the protein in an infant
formula is a necessary quality factor. This quality factor will require
an evaluation of whether the formula contains the essential amino acids
and total nitrogen in the amounts and proportions necessary to permit
normal tissue and organ growth and development. As discussed later in
this document, the agency is proposing in Sec. 106.97(b) that the
biological quality of the test protein be measured by the Protein
Efficiency Ratio (PER) rat bioassay and be comparable to the biological
quality of the milk protein casein.
Proposed Sec. 106.96 does not include quality factor requirements
for all nutrients required by infants because methods to determine
whether these requirements are met are not available or are not
practical for most nutrients (e.g., results cannot be meaningfully
interpreted, or methods are invasive, thus causing unnecessary testing
of infants). Nonetheless, FDA has tentatively concluded that, as the
science evolves, establishing quality factor requirements for other
nutrients needed by infants would provide assurance, beyond that
provided by the general quality factor of physical growth in proposed
Sec. 106.96(b) and the specific protein quality factor in
Sec. 106.96(c), that a formula will meet the overall nutritional needs
of infants. As the science evolves, FDA anticipates being able to
progress beyond generalized, nonspecific indicators of overall
nutritional intakes (e.g., measures of physical growth), to more
specific and sensitive measures of biochemical and functional
nutritional status. FDA also has tentatively concluded that, on a case-
by-case basis, additional quality factors may be needed for a specific
formula product if formulation or processing concerns raise sufficient
quality factor questions such that additional measures are necessary to
adequately ensure that the nutritional quality of the formula supports
healthy growth. FDA asks for comment on criteria as to when such
measures are required.
4. Request for Comment on Need for Establishing Requirements for Other
Quality Factors
Proposed Sec. 106.96(b) and (c) set forth minimum requirements for
quality factors (physical growth and protein quality) that all infant
formulas should meet. FDA has tentatively concluded that these quality
factors are consistent with current state-of- the-art science and
provide significant information on the nutritional quality of the
infant formula without requiring unnecessary or meaningless testing of
infant enrollees in studies.
As discussed above, the 1986 amendments contemplated that when
scientific research identified criteria that could be used to establish
quality factors for specific nutrients in infant formula, the agency
would establish quality factor requirements for those nutrients.
Proposed Sec. 106.96 will establish two quality factors (physical
growth and protein quality) because the agency has tentatively
concluded that there is sufficient scientific evidence of the
importance of these quality factors, and because adequate methods exist
to meaningfully and ethically measure these factors.
However, the CON/AAP report discussed other nutrients necessary for
healthy growth of infants and for which the report recommended
establishing quality factor requirements (Ref. 6). The agency has
studied the evidence supporting the establishment of quality factor
requirements for these other nutrients, and the methods available for
determining whether an infant formula meets quality factor requirements
for these nutrients. FDA has tentatively concluded that establishing
quality factor requirements for the three additional nutrients
recommended by CON/AAP (i.e., (a) fat, as measured by fat balance; (b)
calcium and phosphorus, as measured by calcium and phosphorus balance;
and (c) iron as measured by iron bioavailability) is not warranted at
this time. FDA, however, solicits additional information that it will
consider before reaching a final decision on whether the scientific
evidence and usefulness of results are sufficient to support
establishing these additional quality factor requirements. Therefore,
the agency requests comments and information on: (1) The scientific
evidence on the importance of the amount, type, and sources of fat,
calcium and phosphorus, and iron in infant formula, and (2) the
appropriate methods and interpretative criteria to determine whether an
infant formula meets the nutritional requirements for fat, calcium and
phosphorus, and iron of infants consuming the formula as the sole
source of nutrition. The basis upon which the agency is considering
establishing quality factor requirements for these nutrients is
discussed below.
a. Fat. The agency requests comment on a quality factor for fat
balance that would require that all infant formulas be formulated and
manufactured to provide fat in a manner that allows the fat to be
absorbed and retained by infants at a level that the energy and other
nutritional requirements of the infant are not adversely affected (Ref.
6). Normal, healthy, full-term infants fed various mixtures of the fats
traditionally used in infant formulas in the United States rarely
excrete more than 15 percent of their fat intake (Ref. 6). This level
of fat excretion is an indication
[[Page 36182]]
that the fat is highly digestible. The use of a fat with lower
digestibility would adversely affect energy balance, could reduce the
absorption of fat-soluble vitamins and other nutrients, and could have
a negative impact on healthy growth of the infants.
b. Iron. The agency solicits comment on a quality factor that would
require that all infant formula be formulated and manufactured such
that the iron used is bioavailable and meets the iron requirements of
the growing infant. The maintenance of adequate iron status in the
infant is important because iron is required to transport oxygen in the
red blood cells to body tissues (as a component of hemoglobin), to
supply oxygen to muscle tissue (as a component of myoglobin), and to
support normal mental development. Full-term infants are generally born
with adequate iron stores to meet their iron needs for the first few
months of life, but the iron needs of premature infants and older
infants must be met by the diet.
Iron bioavailability from infant formulas is low compared to the
iron bioavailability from human milk (Refs. 61 and 62).
Nutrient sources and other ingredients, such as protein sources,
can affect the chemical form of iron, thus interfering with its
potential for absorption (Ref. 63). Furthermore, factors that enhance
iron bioavailability from human breast milk are poorly understood and
currently are not present in commercial formulas. Consequently, infant
formulas are fortified with up to 10 times the amount of iron found in
human milk. If, however, the bioavailability of the iron in the infant
formula is substantially improved by a change in the formulation or
processing of the formula, then reductions in the amounts of iron added
to the infant formula may be necessary to prevent the infant from
absorbing excessive amounts of iron which could be unsafe because high
dietary intakes of iron can adversely interfere with the
bioavailabilities of other nutrients (59 FR 51030, October 6, 1994).
If, however, the iron was bound to another ingredient such that it
interfered with absorption, the infant's physiological needs for iron
might not be met. Infant formula iron levels and iron bioavailability,
thus, represent a delicate balance between effectiveness and safety
that cannot be adequately predicted by chemical analysis of the iron
content of the formula, but can best be assessed by measurement of
clinical indicators of iron status.
Early changes in iron nutritional status are not likely to be
detected by the general quality factor of physical growth. Therefore, a
quality factor requirement for an infant formula to meet the iron
requirements of infants, and to contain sufficient bioavailable iron
for this purpose, may be needed. The agency, however, is concerned that
clinical studies, as described in proposed Sec. 106.97(a), in which
selection criteria include requirements that enrollees be healthy,
full-term infants aged 0 to 4 and 5 months, may not be sensitive enough
to detect significant differences in iron bioavailability of a formula
product. Healthy, full-term infants are usually born with adequate iron
stores to maintain normal iron status for the first 3 to 4 months of
life--the period of time that a clinical trial would be conducted.
Without assurance that the test results are meaningful, the agency has
tentatively decided not to require a specific quality factor for iron
bioavailability.
c. Calcium and phosphorus. The agency also requests comment on a
quality factor that would require that all infant formulas be
formulated and manufactured such that the calcium and phosphorus are
bioavailable and meet the calcium and phosphorus needs of infants.
Calcium and phosphorus are essential for healthy bone mineralization
and growth in infants. Calcium bioavailability is of particular concern
because inadequate intakes of calcium impair bone mineralization and
can cause rickets in severe cases (Refs. 64 and 65).
Interactions with other ingredients and manufacturing processes can
reduce calcium and phosphorus bioavailability. High concentrations of
calcium and phosphorus can interact to form insoluble complexes that
may be unavailable (Ref. 66). Calcium can interact with free fatty
acids and form soaps that are not absorbed (Ref. 66). Lactose-free
formulas have been found to have lower calcium absorption than formulas
containing this sugar (Refs. 67 and 68).
Some phosphorus compounds, such as the phytates found in plant
protein sources, may not be readily digested and absorbed by infants
(Ref. 69). Inadequate dietary phosphorus can cause a loss of calcium
from the body as a result of bone resorption (i.e., loss of bone mass)
(Ref. 70). Formulation or processing changes that affect other formula
ingredients that influence calcium and phosphorus absorption require
careful consideration of their potential effects on calcium and
phosphorus bioavailability and the calcium and phosphorus status of the
infant.
A dietary insufficiency of calcium and phosphorus of a magnitude
that decreases bone formation may not be detected by physical measures
of growth (Ref. 71). Therefore, a quality factor requirement for an
infant formula to ensure that it meets the calcium and phosphorous
requirements of infants, and to ensure that it contains sufficient
bioavailable calcium and phosphorus for this purpose, may be needed.
FDA is concerned, however, that meaningful measures for assessing the
bioavailability of calcium and phosphorus may not be available.
d. Summary. FDA has tentatively concluded that the clinical and
nutritional sciences have not reached a state where specific tests are
available that would permit manufacturers to establish that they meet
quality factors for each of the essential nutrients listed in
Sec. 107.100, except for protein. Therefore, except for the quality
factor requirements for physical growth and protein quality discussed
above and set forth in proposed Sec. 106.96 (b) and (c), the agency has
tentatively concluded that it is not useful to propose quality factor
requirements for specific nutrients at this time.
Thus, to meet the nutritional needs of infants consuming formula,
manufacturers must use forms or sources of essential nutrients that are
bioavailable. The agency is concerned that manufacturers could
unintentionally or unknowingly use forms of nutrients that have a
relatively low bioavailability or ingredients or processing methods
that will produce interactions that adversely affect the
bioavailability of nutrients, thereby adulterating the formula because
it no longer meets the nutritional needs of the infant. However, at
this time, FDA is not aware of a means to systematically identify those
circumstances that could adversely affect all nutrient
bioavailabilities. FDA does not believe that it is ethical to
unnecessarily subject infants to testing protocols when meaningful
results cannot be assured. However, because of the potential
seriousness of the public health impact of not meeting quality factors,
FDA also believes that it is desirable to establish additional quality
factors, as soon as they are warranted by evolving scientific
knowledge, to ensure adequate nutrient bioavailability.
FDA, therefore, requests comment on the: (a) Need for routine
testing of quality factors, in addition to measures of physical growth
and protein quality; (b) criteria to be used in determining that such a
need can be meaningfully implemented, and (c) if a need is established,
the type of qualitative and quantitative measurements t
FR Doc. 96-17058 Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula
hat could be
used by manufacturers to demonstrate
[[Page 36183]]
that an infant formula meets with those quality factors. If FDA
receives information demonstrating the need for additional quality
factors, it will consider including them in any final rule that results
from this proceeding.
5. Assurances for Quality Factors
a. Quality factor--physical growth of infants. Proposed
Sec. 106.97(a)(1) requires that the manufacturer conduct an adequate
and well-controlled clinical study to determine whether the formula
supports normal physical growth in infants when it is fed as the sole
source of nutrition. The CON/AAP Task Force on Clinical Testing of
Infant Formulas (Ref. 6) concluded that the capability to support
physical growth is the most widely accepted and used measurement
available of the nutritional adequacy of an infant formula. Gains in
weight and length of young infants reflect the long-term, integrative
physiological processes that can only be achieved if the infant's
nutritional needs are met.
A randomized, controlled study represents the most sensitive type
of study to measure the nutritional adequacy of infant formula. The use
of concurrent treatment and control groups is in agreement with the
CON/AAP Task Force recommendations (Ref. 6) and with the agency's
recommendations for human bioavailability studies of drugs (21 CFR
320.25). Although comparisons to historical controls (e.g., population
reference standards) have been used by some investigators to evaluate
growth of infants consuming a particular formula product, this type of
study lends itself to misleading results because population reference
standards are generally for the total population of infants (regardless
of birth weight, health status, socioeconomic status, or other factors
that can affect growth unrelated to nutritional components). In a study
to evaluate the nutritional adequacy of a formula, on the other hand,
selection criteria are usually used to limit enrollment to healthy,
full-term infants. Thus, differences or similarities in growth between
study infants and population reference standards cannot be meaningfully
interpreted. Therefore, the agency is proposing to require that
adequate and well-controlled clinical studies be conducted to collect
the data needed to determine whether a formula satisfies the quality
factor requirements for physical growth. To assist manufacturers in
understanding the general principles for adequate and well-controlled
clinical studies, FDA has prepared the ``Guideline for the Format and
Content of the Clinical and Statistical Sections of New Drug
Applications,'' U.S. Department of Health and Human Services, July,
1988 (Ref. 72).
FDA has tentatively concluded that it is necessary to enroll
infants into a clinical study shortly after birth, and that the studies
be at least 4 months in duration (see proposed
Sec. 106.97(a)(1)(i)(A)), to ensure that the study focuses on the
period during which infant formula generally serves as the sole source
of nutrition, and, thus, the infant is most vulnerable to a problem
with a formula since the infant is not consuming other foods that could
mask or compensate for a deficiency in the formula. Also, the
sensitivity of growth studies for identifying nutritional problems with
an infant formula is highest during early infancy. Young infants, those
less than 4 to 5 months, allocate a substantially higher percentage of
the intakes of energy, protein, and other nutrients for growth than do
older infants. After this early period of rapid growth, the rate of
physical growth slows, and the allocation of nutrient intakes for
growth is lower. Thus, early infancy is the period of greatest
nutritional risk and is the age associated with the most sensitive
growth phase.
Because of the rapid rate of growth in infants less than 4 months
of age, adverse nutritional impacts that affect growth rate can be
detected within a few months (Ref. 4). Growth studies in older infants,
where growth rates are of smaller magnitude and where solid foods are
also consumed, are not sensitive enough to provide a meaningful
evaluation of the ability of the formula to support healthy growth.
The CON/AAP Task Force (Ref. 6) also recommended that clinical
studies be conducted for a period of 3 to 4 months, and that growth be
examined at least during the first 8 weeks of life, because nutrient
requirements per kg body weight are greatest during this period. It
also pointed out that such a study will cover a period when the infant
is not consuming solid foods, and the infant formula is fed as a sole
source of nutrition.
Therefore, FDA has tentatively concluded that a clinical trial that
lasts at least 4 months will be long enough to detect adverse effects
of nutritional inadequacies on growth rate. FDA also has tentatively
concluded that a clinical trial must be conducted with infants less
than 1 month of age at the time of their entry into the study (see
proposed Sec. 106.97(a)(1)(i)(A)) to ensure that the formula is tested
during the period of time when growth rate and nutrient requirements
are proportionately greatest, and when the infant formula serves as the
sole source of nutrition. These requirements are intended to ensure
that the study assesses the nutritional adequacy of the formula for
supporting normal physical growth in the young infant.
Under proposed Sec. 106.97(a)(1)(i)(B), the manufacturer will be
required to collect and maintain individual and group summary data on
anthropometric measures of physical growth and plot the data on
National Center for Health Statistics (NCHS) reference percentile body
weight and body length curves, which are standard measurements of
infant physical growth (Refs. 73, 74, and 75) and provide the most
widely accepted assessment of infant growth (Ref. 6).
Plotting each infant's anthropometric data on NCHS reference
percentile body weight and body length curves, and providing individual
data on increments of weight gain, provide a means to make a
quantitative assessment of the growth pattern over the 4 months
duration of the study for individual infants. There is normally wide
variation in body weights and lengths among healthy infants, with some
being smaller than average and others average or above average. Single
point measures of weight or length are difficult to interpret relative
to a given infant because one does not know whether, for example, a
smaller than average weight is attributable to inadequate nutrition or
to a healthy and thriving infant whose body size is smaller than
average.
Over time, young infants tend to individualize their track within a
given percentile on population reference growth standards. An infant at
the 25th percentile level for weight shortly after birth tends to stay
at or near the 25th percentile for weight throughout the first few
months of life. When multiple longitudinal measures of weight (or
length) of an infant are plotted on a weight-for-age reference chart, a
reviewer can make a quick assessment as to whether an infant's pattern
of weight or length gain is similar to that expected for healthy
infants of the same age, taking into account the range of normal
individual variation in body weights and lengths and that infant's
percentile track. Similar comparisons can be made with a given infant's
weight or length incremental gain data relative to population reference
standards. These data allow for identification of infants with
unusually slow or rapid growth, an observation that is masked by
grouped data.
Thus, plots of changes in individual infant's weight and length in
conjunction with comparisons of increments per unit time of weight or
length gains against population
[[Page 36184]]
reference standards allow researchers and reviewers to identify those
infants whose growth is not following expected longitudinal patterns
and, therefore, for whom a more thorough review of their medical and
dietary histories is necessary to assess the possibility that the
infant formula is responsible for reduced growth rates in a subgroup of
infants. This careful review of individual infant growth patterns in
addition to group summary data is particularly important because
studies, while adequate to evaluate differences in group means between
test and control formulas, often lack the statistical power to detect
subgroups of infants whose growth patterns deviate from normal. These
data will also provide useful information on possible trends towards
failure to thrive or obesity, or on catchup growth in infants who
experienced transient adverse effects relative to expected growth
rates.
FDA has tentatively concluded that a comparison of a manufacturer's
data to well-established population reference standards can provide the
basis for an evaluation of the growth patterns of individual infants to
identify, and to provide the basis for an investigation of, possible
causes of unusually slow or fast rates of gain. Thus, the agency is
proposing that the NCHS growth charts for individuals and for grouped
data be incorporated by reference into the regulation (proposed
Sec. 106.97(a)(1)(i)(B)).
Proposed Sec. 106.97(a)(1)(i)(C) requires that the manufacturer
collect the anthropometric measurements at the beginning of the
clinical study, at 2 weeks and at 4 weeks of the study, at least
monthly thereafter, and at the conclusion of the study. These
measurements will permit the calculation of incremental gains in the
different measurements. Incremental gains, such as weight gain per unit
of time, are generally considered the most sensitive indicator of the
ability of a formula to support the physical growth of individual
infants over time (Ref. 4). Also, because growth rate and nutritional
requirements are curvilinear rather than linear during early infancy,
multiple measurements help in assessing whether the formula meets the
nutritional needs throughout the period of the clinical study and aids
in more accurately placing infants in their ``correct'' reference
percentile tract, particularly since age of enrollment varies somewhat
among infants (although, if adopted, this regulation should serve to
minimize that variation). Additionally, measures of an infant's body
weight, the most critical anthropometric measure, are subject to a
number of measurement errors unrelated to the nutritional value of the
formula (e.g., timing of weighing of infant relative to feeding or
defecation or urination).
For these reasons, multiple measures over a relatively long period
(e.g., 4 months) provide a more accurate picture of the pattern of
growth of infants than do one or two point measures. The agency has
tentatively concluded that the requirement of four measurements taken 1
month apart will provide a sufficient number of measurements to permit
evaluation of whether the formula meets the nutritional needs for
physical growth of the infant throughout the study period. However, the
agency requests comment, supported by data, on which measurements are
needed to provide evidence that the formula meets the nutritional needs
for physical growth of infants.
FDA has tentatively concluded that more frequent measurements are
needed during the early stages of the study because variations in
measured body weight that are a result of factors unrelated to the
nutritional quality of the formula can be particularly serious in early
infancy. For example, during the first week of life, there is a normal
loss of body weight by the infant because of fluid loss that may reach
6 to 10 percent of body weight (Ref. 76). This weight loss will reduce
the apparent growth of the infant as measured by body weight. This
reduction may affect the ability to evaluate and interpret the weight
gain data collected early in the study. FDA has tentatively concluded
that requiring more frequent anthropometric measurements, especially
for weight, early in the study, increases the ability to accurately
place individual infants in the correct percentile track for monitoring
their growth patterns in relation to the population reference curves
and for monitoring physical growth during the most sensitive part of
their growth phase.
To minimize the burdens of this regulation, FDA has not proposed to
require that blood samples obtained from infants during the time period
of their enrollment in the clinical study, or at completion of the
study, be analyzed for biochemical and clinical indicators of
nutritional and growth status. However, the CON/AAP Task Force (Ref. 6)
recommended that some blood tests be conducted at the conclusion of
required clinical studies to provide a more comprehensive evaluation of
the nutritional adequacy of a formula. Thus, the agency requests
comments on whether it would be useful for the manufacturer to collect
and maintain data on standard laboratory measures, including complete
blood count (white blood cell count and red blood cell count),
hemoglobin concentration or hematocrit percentage, and serum or plasma
concentrations of albumin, urea nitrogen, electrolytes (sodium,
potassium, and chloride), alkaline phosphatase, and creatinine. These
measurements are standard practice when infants are seen clinically and
can be made with very small quantities of blood. The maintenance of
these indicators within normal limits at the end of the study provides
additional assurance over and above measures of physical growth that
the infant's general state of well-being is healthy and ``normal,''
particularly because changes in biochemical measures may occur before
detectable differences in physical growth are identified or may not be
detected by measures of physical growth. General anthropometric
measurements of physical growth provide indirect, although very
important, evidence that the formula is able to help the infant
maintain overall good health, but they are not as specific, and may not
be as sensitive, as are biochemical indicators of health.
FDA also requests comment on whether requiring some, or all, of the
biochemical and clinical tests described above would provide useful and
necessary information for determining whether a formula causes adverse
consequences that may not be reflected in the quality factor
requirements for measurements of physical growth in proposed
Sec. 106.97(a)(1)(i).
The identification of deviations from expected values for these
biochemical and clinical measurements, throughout the duration of the
clinical study, could serve as an early warning of unexpected risk to
infants enrolled in the study and, therefore, result in early actions
to prevent undue risk to infant enrollees in the study. Conversely,
collection of blood samples throughout the study could discourage
parents from continuing their infants in the study, thus causing a high
attrition rate and producing final study results that are difficult to
interpret.
Proposed Sec. 106.97(a)(1)(ii) sets forth guidelines for the design
of clinical study protocols. A comprehensive clinical study protocol
will ensure that individual investigators understand and follow
generally accepted scientific principles for the design and conduct of
clinical trials, thus enhancing the likelihood of interpretable results
while maintaining minimal or no risk to infants enrolled in the
studies. In the conduct of all studies, manufacturers should use the
general principles,
[[Page 36185]]
described in Sec. 314.126 (21 CFR 314.126) for adequate and well-
controlled clinical studies to ensure that the design and conduct of
the study are adequate to permit scientific review and interpretation
of the study's results. Studies that cannot produce meaningful results
because of poor or inadequate study design and conduct mean that
infants will be subjected to unnecessary testing. Such a situation
places infant enrollees at undue risk and is clearly unethical.
In this section, FDA is not establishing mandatory elements for
inclusion in a protocol, nor requiring that manufacturers provide the
agency with the protocol used for a study intended to provide data to
show that an infant formula meets the quality factor requirements.
However, as discussed above, a protocol is an essential part of the
design and execution of a well- controlled scientific study.
Furthermore, a protocol often provides invaluable information that
assists in the analysis and interpretation of the study data.
Consequently, the agency strongly encourages manufacturers to develop
and use protocols that incorporate the specific elements in proposed
Sec. 106.97(a)(1)(ii) in all research studies using infants because
these elements will ensure that the study is designed and conducted in
a manner that will produce results that will permit meaningful
evaluation of the usefulness of the infant formula.
The steps outlined in proposed Sec. 106.97(a)(1)(ii)(A) represent
standard practice in the design and conduct of clinical studies (Ref.
72). Proposed Sec. 106.97(a)(1)(ii)(B) states that the clinical study
protocol should describe the necessary qualifications and experience of
the investigators. It is essential that clinical studies be conducted
by personnel with sufficient experience and training to ensure that
their work will yield interpretable and meaningful results. If a study
is conducted by an investigator who is not qualified, it increases the
likelihood that the study will have to be redone, and that more infants
will be exposed to risk. Therefore, it is important that in the
protocol, the manufacturer define the requisite qualifications to
conduct the study it is designing.
Proposed Sec. 106.97(a)(1)(ii)(C) states that the protocol should
be reviewed and approved by an Institutional Review Board (IRB) in
accordance with part 56 (21 CFR part 56), and that the manufacturer
should establish procedures to obtain written informed consent from the
parents or legal representatives of the infants enrolled in the study
in accordance with part 50 (21 CFR part 50). These steps are necessary
to protect the rights and safety of subjects involved in the studies.
Proposed Sec. 106.97(a)(1)(ii)(D) states that the clinical study
protocol should explain how the study population represents the
population for which the new infant formula is intended. FDA has
tentatively concluded that such an explanation is necessary so that if
questions about the relevance of the study population arise, the answer
is readily available and free of any taint that it is a post hoc
rationalization. For example, FDA has recently had questions about a
study that involved hospitalized infants that were offered to support
use of the product on post-discharge infants. If there had been the
type of explanation available that FDA is proposing in this guideline,
it would have greatly minimized the questions about this product.
Proposed Sec. 106.97(a)(1)(ii)(D) also states that the clinical
study protocol should explain how the study addresses the intended
conditions of use of the formula. FDA has tentatively concluded that,
by having manufacturers consider this question before the study is
conducted, this guideline will prevent clinical studies that are
conducted under conditions of use that do not accurately reflect the
proposed conditions of use. For example, a clinical study protocol for
testing a formula designed to be used by premature infants throughout
infancy should explain how the study design will provide information to
support the claim that the formula supports healthy growth under these
conditions.
Proposed Sec. 106.97(a)(1)(ii)(E) states that the clinical study
protocol should describe the sample size calculations and the power
calculations and the basis for selecting the sample size and study
design. This information is necessary to establish the likelihood that
the study will not fail to detect a real difference, should there be a
difference for the measurements of interest, between the infant formula
being tested and the control. For example, a study might not find a
difference in incremental rate of weight gain between infants consuming
two formulas because too few infants were enrolled in the study to
provide sufficient statistical power to detect this difference.
Inadequate statistical power could mask the nutritional inferiority of
a product and could result in the marketing of a formula that does not
meet the quality factor requirements and, therefore, is not safe for
its intended use. Therefore, FDA has tentatively concluded that this
guideline is needed to ensure that manufacturers design their growth
studies to be capable of detecting biologically meaningful differences
for the endpoints of interest between the two formulas. Identification
of differences would raise safety concerns or serious questions of
nutritional quality of the test formula product.
Proposed Sec. 106.97(a)(1)(ii)(F) states that the clinical study
protocol should include a plan to identify and evaluate any adverse
events. This proposed guideline is necessary to document that
appropriate attention is given to the systematic evaluation and
recording of any adverse events that may occur during the course of the
study. Inadequate planning for and conduct of the monitoring of adverse
events may result in an erroneous conclusion that the formula is safe
and suitable, when in fact the formula is not safe and suitable for
infants under intended conditions of use.
Proposed Sec. 106.97(a)(1)(ii)(G) states that the clinical study
protocol should describe the quality control procedures that the
investigator will use to ensure the validity and reliability of the
measurements collected. This proposed guideline represents standard
practice in the design and conduct of clinical studies and is necessary
to allow a meaningful interpretation of study results. Data obtained
with unreliable measures, or with indicators that do not accurately or
meaningfully measure identified endpoints, may produce misleading study
results that are uninterpretable and that suggest that a formula is
safe and suitable, when more valid or reliable measures would not have
supported this conclusion. The institution of adequate quality control
procedures before beginning a study provides a mechanism for
manufacturers to ensure that the data collected are reliable, and that
the study provides interpretable results.
Proposed Sec. 106.97(a)(1)(ii)(H) states that the clinical study
protocol should describe and compare the composition of the control and
test formulas. These descriptions of the control and the test formulas
are necessary to establish that the formula used as the control
provides an adequate comparison for evaluating the quality factors of
the test formula. If the control formula is not comparable to (i.e.,
bioequivalent to) formulas in current use, differences between the test
and control formulas have no meaning. They cannot be generalized to
projected conditions of use. For example, comparable or enhanced
physical growth in infants consuming a test formula as compared to
infants consuming a control formula when the control formula does not
meet
[[Page 36186]]
requirements in Sec. 107.100 for nutrients, or is not bioequivalent
relative to quality factors to currently marketed formulas in the
United States, cannot be interpreted as supporting healthy growth
because it is not possible to determine whether the apparent ``equal''
or ``enhanced'' physical growth is attributable to the fact that the
formula is nutritionally adequate, or whether the formula looks
adequate because it is being compared to a nutritionally inadequate
formula. The nature of the differences between control and test
formulas will also affect sample size and measurement (endpoint)
considerations.
FDA's experience in reviewing clinical data submitted with 90-day
notifications has been that the absence of information on control
formulas is not uncommon. Thus, FDA has tentatively concluded that a
guideline on the information that needs to be considered in selecting a
control formula is necessary to ensure that study results are
meaningful and interpretable.
If the test formula used in a study is not identical to the formula
that is intended to be marketed in the United States, proposed
Sec. 106.97(a)(1)(ii)(I) states that the clinical protocol should
describe the basis upon which the manufacturer has decided that the
test formula is appropriate for use in the study. This proposed
guideline is necessary to ensure that the manufacturer considers such
factors as the bioequivalence of the studied (test) formula relative to
the formula that is to be marketed in this country and can document why
its choice of test formulas is appropriate. Without this documentation,
it would not be possible to determine whether the marketed formula
meets the quality factor requirement in proposed Sec. 106.96(b).
FDA has had experience under the 1986 amendments in which
manufacturers have submitted data on test formulas that were
significantly different (e.g., in calorie levels) from the formula that
they intended to market as evidence of the safety and suitability of
the latter formula. In these instances, the agency has had considerable
difficulty in interpreting study results. Therefore, if the guidance in
proposed Sec. 106.97(a)(1)(ii)(I) is followed, this significant study
design issue will be critically reviewed by manufacturers before they
initiate their studies, and, as a result, they will be more likely to
design and conduct a study that will produce data that can be
meaningfully interpreted as evidence that an infant formula is safe,
and that it supports healthy growth.
As provided in proposed Sec. 106.97(a)(2), however, FDA recognizes,
that while changes in ingredients or in the processes used in the
manufacture of infant formulas can have a significant adverse impact on
the levels or availability of nutrients that affect healthy growth of
infants, other changes may not be likely to do so. In the latter
circumstances, it may be possible to demonstrate that the quality
factor requirements are met by means of measures or data that do not
involve the use of clinical trials. If such assurances can be provided
without clinical trials, then infants will not be subjected to
unnecessary testing. Therefore, FDA sets out in proposed
Sec. 106.97(a)(2), the circumstances in which a manufacturer can
request an exemption from the clinical study requirement.
Proposed Sec. 106.97(a)(2)(i) provides for an exemption if the
manufacturer can cite experience that shows that the ingredient,
ingredient mixture, or processing method has been used to make an
infant formula that meets the quality factor requirements in proposed
Sec. 106.96(a). For example, if the manufacturer has previously
submitted information to FDA in response to the quality factor
requirements of the act that showed that an infant formula that
contains the ingredient or ingredient mixture, or that was produced by
the processing method, in question supported adequate physical growth,
this information could form the basis on which the new infant formula
could qualify for an exemption from this quality factor requirement.
Under this provision, FDA will evaluate the experience cited in support
of an exemption on a case-by-case basis. FDA requests comment on this
proposed provision.
Proposed Sec. 106.97(a)(2)(ii) provides for an exemption if a
manufacturer that markets a formulation in more than one form (such as
liquid and powdered forms) can demonstrate that the quality factor
requirements are met by the form of the formula that is processed using
the method that has the greater potential for adversely affecting the
formula's nutrient content and bioavailability. For example, the
temperatures used to retort liquid formulas during processing can cause
a loss of protein quality compared to powdered forms processed at lower
temperatures (Refs. 77 and 78). Thus, if the liquid formula is tested
and shown to meet the quality factors requirements, it will provide
reasonable assurance that the powdered form of the formula, that is,
the less processed form is of appropriate nutritional quality. Thus,
FDA tentatively concludes that it would be unnecessary to test the less
processed form.
Proposed Sec. 106.97(a)(2)(iii) provides for an exemption if the
manufacturer can demonstrate that the requirements of proposed
Sec. 106.97(a)(1) are not appropriate for the formula, and an
alternative method or study design for showing that the formula
supports healthy growth in infants fed the formula as a sole source of
nutrition is available. As stated above, double- blind, well-
controlled, clinical studies are generally the most powerful and
sensitive method for demonstrating that an infant formula will support
physical growth. Nonetheless, the agency anticipates that there will be
circumstances in which a clinical study of a new infant formula would
not be appropriate. For example, double-blind clinical studies would
not be appropriate in situations such as those involving some exempt
infant formulas in which they would cause withholding of conventional
treatment and, therefore, would be unethical. Other situations that may
not be amenable to double-blind clinical trials are those in which it
would be difficult to enroll an adequate number of infants (e.g., for
exempt infant formulas where the formula is intended for a rare
disease). Alternative study designs may also be appropriate in
situations in which a manufacturer has access to extensive reference
data, such as a database on many similarly conducted clinical studies
using infants from the same potential study population, provided that
the manufacturer can demonstrate that the reference data apply to the
new infant formula, its intended use, and its study population. FDA has
tentatively concluded that such an exemption will permit flexibility in
the design of suitable experimental protocols but still provide
reasonable and documentable assurance that the study design can
demonstrate the safety and suitability of the infant formula.
b. Specific quality factors. Proposed Sec. 106.97(b) establishes
requirements for demonstrating that a formula meets the protein quality
factor requirement in proposed Sec. 106.96(c) and requires that the
manufacturer collect and maintain data that establish that the
biological quality of protein in an infant formula is sufficient to
meet the protein requirements of infants by demonstrating that the
protein source supports adequate growth using the PER rat bioassay,
which the agency proposes to incorporate by reference. The PER provides
an estimate of the bioavailability and relative proportion of the
essential amino acids in the protein-containing ingredient.
[[Page 36187]]
A chemical analysis of the protein can identify the amino acids
contained in a protein source but does not measure their
bioavailability. A protein source may contain the necessary amino
acids, but they may be in a form that the infant cannot digest and
absorb. Furthermore, processing methods may alter the chemical nature
of the protein source, possibly making the protein more resistant to
digestion by the infant. FDA has tentatively concluded that the rat
bioassay is necessary to establish that the amino acids in a protein
source are present, and that adequate amounts and proportions of all
essential amino acids are capable of being digested by an infant. Such
a showing is particularly important when a manufacturer is using a
novel protein source (e.g., a hydrolyzed protein), a new protein
mixture, a new processing method that could affect the chemical form or
bonding of amino acids, or a formulation that provides an amount of
protein near the minimum required level (<2.0 g/100 kilocalorie (kcal))
specified in Sec. 107.100.
Proposed Sec. 106.97(b)(1) also provides that if the manufacturer
is unable to conduct a PER rat bioassay, it must demonstrate that the
amino acid composition of the protein meets the known amino acid
requirements of infants for whom the formula is intended. For example,
FDA is aware that a PER would not provide useful data for an exempt
infant formula intended for use in infants that cannot metabolize a
specific amino acid and from which that amino acid has been
purposefully omitted or is limited to a level inadequate to support
healthy growth. The lack of that amino acid is necessary for the
dietary management of the intended infant population but would result
in an incomplete protein and would reduce the growth rate of the rat,
invalidating the conditions upon which the PER rat bioassay is based.
FDA is not aware of alternative methods for ensuring bioavailability of
such a protein source. In these circumstances, proposed
Sec. 106.97(b)(1) will provide an alternate means of evaluating whether
the protein at least contains adequate amounts of essential amino acids
to meet the known amino acid requirements of the infant, even though
the bioavailability of these amino acids cannot be assured using
available methods.
Proposed Sec. 106.97(b)(2) establishes the circumstances in which a
manufacturer may request an exemption from the requirements of proposed
Sec. 106.97(b)(1). Proposed Sec. 106.97(b)(2)(i) provides that if the
protein source (including the processing method used to produce it) is
already used in another of the infant formulas marketed by its
manufacturer in the United States, the manufacturer may request an
exemption if it can demonstrate that such other infant formula meets
the quality factor requirements prescribed in Sec. 106.96(b)(1). The
purpose of the PER or amino acid analyses is to estimate the quality of
the protein in the proposed formula. Once a manufacturer has
established standard sources and processing of protein in a formula,
and has demonstrated that the technology is effective, in its hands, in
producing a formula that meets the quality factor requirement for
protein, other formulation changes would not be expected to markedly
affect protein quality. Thus, the quality of the processed protein
would be retained in other formulas. However, under proposed
106.97(b)(2)(i), it will be incumbent on the manufacturer to
demonstrate that the quality of the protein is not affected.
Proposed Sec. 106.97(b)(2)(ii) provides for an exemption if the
protein source, or the processing method used to produce the protein
source, in the infant formula does not constitute a major change from
the infant formula that it replaces, and the manufacturer can
demonstrate that the infant formula that it replaces meets the quality
factor requirements prescribed in Sec. 106.96(b). FDA is proposing to
allow this exemption because it is unlikely that the methods for
assessing protein quality prescribed are sensitive enough to measure
any change in protein quality that is not a major change.
Because FDA has, as a matter of policy, been requesting that infant
formula manufacturers submit data from a PER or amino acid analysis as
part of their submission 90 days prior to marketing infant formula,
many infant formulas that are on the market have been shown to meet the
proposed quality factor requirement for protein. Therefore, if the
proposed exemption criteria in Sec. 106.97(b)(2) are adopted, those
formulas that contain protein sources, or proteins which were produced
using processing methods, that were the subject of a submission to FDA
in response to the quality factor requirements of the act may qualify
for an exemption.
6. Request for Comment on Establishing Assurances for Other Quality
Factors
As discussed above, FDA has solicited comment on whether to
establish quality factor requirements for fat, iron, and calcium and
phosphorus. If such quality factors are adopted, appropriate methods
will be needed to provide assurance that an infant formula meets these
nutrient-specific quality factors. Therefore, FDA discusses below
measurements of fat balance and of calcium and phosphorus balance, as
well as measurements that reflect iron bioavailability. The agency
requests comments and information on these or other methods for these
three quality factors:
a. Apparent fat absorption. Apparent digestibility and apparent
absorption measure the amount of fat that was able to be digested and
absorbed by the infant. Apparent digestibility is expressed as a
percentage of intake, while apparent absorption is expressed in units
of fat (e.g., g) absorbed per day. If a quality factor for fat were
established, manufacturers would be required to collect and maintain
data establishing that the apparent digestibility or apparent
absorption by the infant of the fat in an infant formula is adequate to
meet the infant's energy requirements. These data would be necessary
because fat represents the major dietary source of energy for the
infant and must be readily digested and absorbed if the formula is to
support healthy growth.
The CON/AAP Task Force (Ref. 6) recommended that studies that are
conducted to determine whether a formula meets the quality factor for
fat should use a cross-over experimental design. This type of study
requires that the manufacturer compare apparent fat absorption of
infants fed the test formula at one time and a currently marketed
formula at another time. An experiment using this design would enable a
manufacturer to make measurements of apparent fat absorption using a
small number of infants, since the variance in fat excretion of infants
fed most fat sources currently available is less than 5 percent.
Furthermore, the method is noninvasive, is easily implemented, and does
not require costly or sophisticated equipment to conduct. Other
experimental designs could be used but would require larger numbers of
infants and would be more expensive. Thus, FDA asks for comments on
whether there should be a specific requirement that manufacturers
measure apparent fat absorption using cross-over studies.
The CON/AAP Task Force (Ref. 6) recommended that studies that are
conducted to determine the apparent absorption of fat be conducted such
that measurements are made using infants fed each formula for at least
72 hours. The Task Force report suggested that measurements of apparent
fat absorption for this length of time would accurately reflect the
apparent
[[Page 36188]]
absorption of the fat in the formula being tested. FDA is considering
requiring that a study of at least 72 hours for each formula tested be
conducted and requests comment on what duration would be appropriate.
FDA also is considering whether to require that the manufacturer
document the method that it used to analyze for fat and explain the
reason for choosing that method. The agency believes that this
information is important because the method used to analyze the
excreted fat must be appropriate for the specific type of fat in the
formula.
FDA also is considering whether circumstances exist that would
justify establishing an exemption from the requirements to measure fat
balance. FDA has tentatively concluded that the reasons and
justification for such an exemption are essentially those set forth
above in the discussion of proposed Sec. 106.97(b)(2). FDA requests
comment on whether, if the agency adopts a quality factor for fat, it
should provide for exemptions from testing, to show that the formula
meets that quality factor, such as those set forth in proposed
Sec. 106.97(b)(2), and to allow manufacturers to assure the agency that
their products meet that quality factor requirement without subjecting
infants to unnecessary testing.
b. Calcium and phosphorus balance. If FDA were to establish a
quality factor for calcium and phosphorus, manufacturers would be
required to collect and maintain data from clinical studies conducted
in infants to show that the calcium and phosphorus contained in the
infant formula are sufficient to meet the infant's requirements. There
are currently no satisfactory clinical laboratory measurements that are
practical for directly assessing calcium and phosphorus nutritional
status in infants (Ref. 79). Furthermore, there are no accurate
indirect measurements that could be made on the infant formula itself
that would be useful in predicting how effective the amount and the
sources of calcium and phosphorus in the formula would be in meeting
the needs of infants consuming that formula. Therefore, FDA is
considering requiring that manufacturers implement the recommendations
of the CON/AAP Task Force and make a measurement that provides a
reasonable estimate of the amount of calcium and phosphorus that is
capable of being absorbed and retained for use by infants (i.e.,
calcium and phosphorus balance) from the formula.
FDA asks for comment concerning the appropriateness and usefulness
of a measurement of calcium and phosphorus balance as one that reflects
both the bioavailability of the calcium and phosphorus in the formula
and how well the diet meets the metabolic requirements for these two
minerals. As discussed above with regard to the conduct of trials to
measure apparent fat absorption, FDA requests comment on whether it is
necessary to require that a cross-over study design be used for
clinical studies to measure calcium and phosphorus balance.
FDA also requests comment on what would be an appropriate duration
for studies to measure calcium and phosphorus balance. The CON/AAP task
force suggested that calcium and phosphorus balance studies be
conducted for a 72-hour balance period after an 11-day adaptation
period. FDA requests comment on whether these time periods are
appropriate, both to minimize the effects of previous dietary intake on
the availability of calcium from the formula being tested (Ref. 6) and
to ensure that the results of the balance study are reliable and
interpretable, and on whether they provide a meaningful basis on which
to determine that a formula meets the quality factor requirement for
calcium and phosphorus.
FDA is considering requiring that the formula used as the control
in any clinical studies to measure calcium and phosphorus balance
contain approximately the same calcium and phosphorus levels as the
test formula because the absolute amounts of these nutrients absorbed
and retained by infants may be different between formulas with
different calcium and phosphorus levels. FDA is asking for comment on
requirements for appropriate control formulas for calcium and
phosphorus balance studies.
Amounts of calcium and phosphorus in urine and feces, along with
calculated amounts absorbed and retained expressed in milligrams per
kilogram and as percentages of intake, provide evidence of the rates of
absorption and retention of these nutrients but do not specifically
measure the ability of the formula to provide adequate calcium and
phosphorus for proper bone mineralization, the most important need for
these minerals in the infant. FDA is considering requiring that serum
alkaline phosphatase be measured in situations in which calcium and
phosphorus balance studies are required in order to assess the adequacy
of formula minerals to support normal bone mineralization. Alkaline
phosphatase is an enzyme involved in bone remodeling and in maintaining
serum calcium concentration (Ref. 64). Increased serum alkaline
phosphatase activity may be a marker of reduced bone mineralization
(Ref. 80) and therefore may be useful in determining whether a formula
meets a quality factor requirement for calcium and phosphorus.
Because of the limits of metabolic balance studies, including short
duration, dependence on previous diet, and expense, the agency is
considering the appropriateness of alternative methods for the
assessment of bone mineral accretion. The agency is aware that
sophisticated instruments, such as single-photon absorptiometry and
dual-energy x-ray absorptiometry, have been tested for measuring bone
mineral content in infants (Refs. 81 through 84), and that some
authorities recommend them for determining bone mineralization in
infants (Ref. 85). These types of measurements have the potential to
provide an accurate measure of bone mineral accretion over the duration
of use of the formula, while at the same time reducing many sources of
variation inherent in balance studies. The agency is concerned,
however, that these methods have not been adequately validated in
infants, and that reference standards for mineralization in infants
have not been established to support a requirement for manufacturers to
measure bone mineralization in order to provide assurance that a
formula satisfies a quality factor requirement for calcium and
phosphorus. The agency asks for comment on the usefulness of these
methods of analysis of bone mineral accretion in infants, and on
whether they should be used in lieu of calcium and phosphorus balance
studies as measurements of whether an infant formula meets the quality
factor requirements for calcium and phosphorus assuming that the agency
adopts such a quality factor. The agency also asks for comment on the
criteria that it should use, on a case-by-case basis, in deciding
whether to require these types of measures when there is particular
reason to be concerned that calcium and phosphorus bioavailability may
be problematic.
FDA also is considering whether circumstances exist that would
justify establishing an exemption from a requirement to measure calcium
and phosphorus balance. FDA has tentatively concluded that the reasons
and justification for such an exemption are essentially those set forth
above in the discussion of proposed Sec. 106.97(b)(2), and requests
comment on whether, if it adopts a quality factor for calcium and
phosphorus, it should provide for exemptions from testing to show that
the formula meets the quality
[[Page 36189]]
factor similar to those in proposed Sec. 106.97(b)(2) and allow
manufacturers to assure the agency that their products meet that
requirement without requiring redundant testing.
c. Iron status. If FDA were to adopt a quality factor for iron,
manufacturers would be required to collect and maintain data that
establish that the iron in an infant formula is bioavailable and
maintains the iron status of infants that consume the formula. These
data would be necessary to demonstrate that an infant formula provides
enough iron to prevent iron deficiency and anemia.
Alterations in a number of biochemical measurements are useful
signs associated with inadequate iron intake or the development of iron
deficiency. Early signs of inadequate iron intake, which reflect the
depletion of iron storage sites, are reductions in serum ferritin
concentration and transferrin saturation (Ref. 86). If the dietary
intake of iron remains inadequate, impaired erythropoiesis (i.e., the
process whereby the body produces new red blood cells) may be reflected
in alterations in erythrocyte maturation and increases in erythrocyte
size, erythrocyte protoporphyrin concentration, or serum transferrin
receptor levels. If the period of inadequate iron intake continues,
erythropoiesis is further impaired, and hemoglobin concentration,
hematocrit, and mean corpuscular volume decrease.
Iron deficiency without anemia should be considered to be a risk
factor for iron-deficiency anemia, which may be associated with long-
lasting, adverse effects in infants (Ref. 86). Therefore, FDA is
considering requiring one measurement of iron status that is sensitive
to each of the three stages of inadequate iron intake (stage 1,
decreased stores, normal erythropoiesis; stage 2, decreased stores and
early stage impaired erythropoiesis; and stage 3, decreased stores and
late stage impaired erythropoiesis). For example, FDA is considering
requiring that manufacturers measure: (1) Serum ferritin concentration,
because such a measurement is sensitive to decreased iron stores and
normal erythropoiesis; (2) transferrin saturation or erythrocyte
protoporphyrin concentration, because such measures are sensitive to
decreased iron stores and early stage impaired erythropoiesis; and (3)
hematocrit percentage, hemoglobin concentration, or mean corpuscular
volume, because such measurements are sensitive to decreased iron
stores and late stage impaired erythropoiesis. This approach would be
consistent with the recommendations of the CON/AAP Task Force (Ref. 6).
It would also provide reasonable assurance that low iron availability
in an infant formula would be detected, and that an infant formula that
does not provide sufficient iron to meet the infant's requirement, and
thereby does not meet the quality factor requirement for iron, will not
be marketed.
FDA also is considering whether circumstances exist that would
justify establishing an exemption from the requirements to determine
iron status. FDA has tentatively concluded that the reasons and
justification for such an exemption are essentially those set forth
above in the discussion of proposed Sec. 106.97(b)(2). FDA requests
comment on whether, if it adopts a quality factor for iron, it should
provide for exemptions from testing similar to those set forth in
proposed Sec. 106.97(b)(2) to show that the formula meets that factor
and allow manufacturers to assure the agency that their products meet
that quality factor requirement without requiring redundant testing.
F. Records and Reports
1. Introduction
Under subpart C of part 106, FDA is proposing to revise the
requirements on the records that must be made and retained. FDA is
proposing requirements on batch records; records on CGMP and quality
control procedures; maintenance of distribution records on formulas for
export only; audits; and notifications to FDA. These proposed changes
to current Sec. 106.100 are outlined in Table III below:
Table III
------------------------------------------------------------------------
Current Regulation Proposed Regulation
------------------------------------------------------------------------
Sec. 106.100(a).......................... No Change.
Sec. 106.100(b).......................... No Change.
Sec. 106.100(c).......................... No Change.
Sec. 106.100(d).......................... No Change.
Sec. 106.100(e), (f), and (h)............ Current Sec. 106.100(e),
(f), and (h) will be
incorporated into proposed
Sec. 106.100(e).
New Sec. 106.100(f) will
codify the records required
for the CGMP regulations
found in proposed subpart
B.
Sec. 106.100(g).......................... Current Sec. 106.100(g)
with modification.
Sec. 106.100(h).......................... Current Sec. 106.100(h) is
incorporated into Sec.
106.100(e). Sec.
106.100(h) Reserved.
Sec. 106.100(i).......................... No Change.
Sec. 106.100(j).......................... Current Sec. 106.100(j)
with modification.
Sec. 106.100(k).......................... Current Sec. 106.100(k)
with modification.
Sec. 106.100(l).......................... No Change.
Sec. 106.100(m).......................... No Change.
Sec. 106.100(n).......................... No Change.
Sec. 106.100(o).......................... No Change.
------------------------------------------------------------------------
2. Batch Production and Control Records
Proposed Sec. 106.100(e) requires that manufacturers make and
retain records (hereafter referred to as ``batch records'') that
include complete information relating to the production and control of
each batch of infant formula. Section 412(b)(4)(A)(i) of the act
requires the establishment, by regulation, of requirements for the
retention of all records, including records containing the results of
all testing required under section 412(b)(2)(B) of the act, necessary
to demonstrate compliance with the CGMP requirements and quality
control procedures prescribed under section 412(b)(2). In proposed
Sec. 106.100(e) FDA is proposing to require that manufacturers prepare
and maintain records that include complete information relating to the
production and control of the batch to ensure that the complete history
of each batch of infant formula is available for review in the event
that a problem arises with a particular batch.
Proposed Sec. 106.100(e)(1) requires that the batch records include
the appropriate master manufacturing order. As discussed above,
proposed Sec. 106.50(a) requires that manufacturers produce each infant
formula in accordance with a master manufacturing order that has been
approved by a responsible official of the company. The master
manufacturing order thus provides fundamental information about the
batch. Having all the information concerning the production of a batch
of infant formula, including the master manufacturing order, in one
place as a part of a batch record will ensure that there is a document
available that makes readily apparent whether a batch was properly
produced. It will also ensure that all the information needed to
evaluate the cause of any problem that may develop with a batch of
infant formula is readily available. Thus, FDA has tentatively
concluded that the master manufacturing order is an essential part of
the batch record.
Proposed Sec. 106.100(e)(1)(i) requires that the master
manufacturing order include the significant steps in the production of
the batch of infant formula and the date on which each
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significant step occurred. Thus, the master manufacturing order will
include a list of the significant steps for the production of each
infant formula and a space to write in the date the step was performed.
Thus, it will provide both a check that the step was performed and a
record of when it was performed. FDA has tentatively concluded that
this information is necessary because all production activities for a
specific batch of infant formula may not be accomplished in one day but
may occur over a number of days, and people who begin work the second
day will know what work has been completed, and what has not been.
Moreover, each date is needed so that a batch of formula can be traced
if, at a later date, a problem that may adversely affect an infant
formula is identified at a specific production stage. Having the date
available will allow the manufacturer to identify all batches that may
have been affected by the problem.
Proposed Sec. 106.100(e)(1)(ii) requires that, if the manufacturer
has more than one line or set of equipment in the plant in which the
formula is made, the master manufacturing order include the identity of
equipment and processing lines used in producing the batch of infant
formula. This information will allow the manufacturer to ensure that
the equipment on which the formula was produced met the requirements of
Sec. 106.30. This information also will facilitate the identification
of all batches of formula that may be affected by equipment
malfunctions or that were produced on the same equipment as a batch
that is discovered to be microbiologically contaminated.
Proposed Sec. 106.100(e)(1)(iii) requires that the master
manufacturing order include the identity of each batch or lot of
ingredients, containers, and closures used in producing the batch of
infant formula. All materials used in infant formula will have to meet
the specifications of proposed Sec. 106.40(d) and be identified by a
batch or lot number as specified in proposed Sec. 106.40(c). FDA has
tentatively concluded that it is necessary to propose that the identity
of each batch or lot of ingredients, containers, and closures used in
producing the batch of infant formula be recorded in the master
manufacturing order to enable the manufacturer to ensure that all of
those materials met the requirements of Sec. 106.40, particularly the
standards for acceptance or rejection of the materials. Recording this
information also will allow the manufacturer to evaluate the
contribution of specific ingredients, containers, and closures to any
problem with a batch of infant formula that may develop.
FDA is not proposing to require that the batch records contain the
results of any tests conducted on ingredients, containers, and closures
in accordance with proposed Sec. 106.40(d) because the same lot of raw
materials may be used in multiple batches. The identification of the
batch or lot of all ingredients, containers, and closures in the master
manufacturing order should be sufficient to allow the manufacturer to
locate and review relevant test results if problems arise with a
particular batch of infant formula.
Proposed Sec. 106.100(e)(1)(iv) requires that the master
manufacturing order include the amount of each ingredient to be added
to the batch of infant formula and a check (verification) that the
correct amount was added. As discussed above, proposed Sec. 106.50(b)
requires that the manufacturer establish controls to ensure that raw
and in-process ingredients required by the master manufacturing order
are examined by one person and checked by a second person or system to
ensure that the correct weight or measure of the ingredient is added to
the batch. The agency has tentatively concluded that recording in the
master manufacturing order the amount of each ingredient added to the
batch of formula, and a check (verification) that the correct amount
was added, are appropriate controls to ensure that the correct weight
or measure of the ingredient is added to the batch. This proposed
requirement is necessary to ensure that there is compliance with
proposed Sec. 106.50(b), to provide a record that the batch of infant
formula includes all of the ingredients in the amounts specified in the
master manufacturing order, and to provide assurance that the product
contains all of the required nutrients.
Proposed Sec. 106.100(e)(1)(v) requires that the master
manufacturing order include copies of all labeling used and the results
of the examinations conducted during the finishing operations to ensure
that containers and packages in the batch are correctly labeled. (The
importance of ensuring that containers are correctly labeled was
discussed in conjunction with proposed Sec. 106.60(b).) The inclusion
in the batch records of copies of the labeling used on each batch of
infant formula will provide a record of such labeling and will document
that the finishing operation examinations, required by proposed
Sec. 106.60(b), are conducted.
Proposed Sec. 106.100(e)(2) requires that the batch record include
any deviations from the master manufacturing order and any corrective
actions taken. While the manufacturer's goal should be to produce the
infant formula in accordance with the master manufacturing order, on
occasion deviations may occur. On these occasions, the deviations, and
any corrective actions taken because of the deviations, should become a
part of the batch record. For example, if a batch of liquid infant
formula was thermally processed at a different temperature than the
temperature specified in the master manufacturing order, the batch
record would state the actual processing temperature. The record would
also state any corrective actions taken because of this processing
temperature, such as a change in processing time. A record of
deviations from the master manufacturing order and of the corrective
actions taken by the manufacturer will allow the manufacturer to
quickly determine whether all deviations have been appropriately
addressed, and if they have not been, whether the actions needed to
correct the deviations have been identified. It will also provide
relevant information if a problem arises with that batch of infant
formula.
Proposed Sec. 106.100(e)(3) requires that the batch records include
documentation of the monitoring at any production and in-process
control point, step, or stage where control is deemed necessary to
prevent adulteration. As discussed above, proposed Sec. 106.6(c)(2)
requires this monitoring. FDA is proposing that the documentation that
the monitoring required by proposed Sec. 106.6(c)(2) is occurring be
included in the batch records to ensure that a measurement or
observation made at one particular point in time can be related to a
particular batch. The linkage of the record to the batch is especially
important when a standard or specification is not met. It will enable
the manufacturer to determine what batches may have been affected by a
deviation and to take appropriate action, such as withholding a batch
from distribution.
Proposed Sec. 106.100(e)(3)(i) requires that the batch records
include a list of the standards or specifications established at each
point, step, or stage in the production process where control is deemed
necessary to prevent adulteration, and that it include documentation of
the scientific basis for each standard or specification. As discussed
above, proposed Sec. 106.6(c)(1) requires the establishment of such
standards or specifications. The agency has tentatively concluded that
a list of these standards or specifications must be a part of the batch
record so that the manufacturer will have them readily
[[Page 36191]]
available to compare to the actual values obtained during the
monitoring operation of the production and in-process control system.
Also, the documentation of the scientific basis for each standard or
specification will verify that each was established by trained and
experienced sources. Such documentation will summarize the work
performed to establish the standard or specification and will establish
the source used. If changes to the standard or specification become
necessary, this documentation of the scientific basis for each standard
or specification will assist the manufacturer in making such changes.
Proposed Sec. 106.100(e)(3)(ii) requires that the batch records
include the actual values obtained during the monitoring (such as the
actual temperatures and actual times that the measurements were taken),
any deviations from the established standards or specifications, and
any corrective actions taken. For example, notations that refrigeration
temperatures are satisfactory or unsatisfactory, without a record of
the actual temperatures, are subject to varying interpretation and thus
will not ensure that preventive controls are working. It is important
that the actual values be recorded. In addition, actual values are
necessary to discern trends or to pinpoint the onset of a problem. The
record of any corrective actions taken will show what the manufacturer
did when a standard or specification was violated, and how the
manufacturer is ensuring that the infant formula is not adulterated.
Entry of information on the records at the time of the monitoring
ensures that the record does not rely on the memory of the observer and
thus is as accurate and valid as possible.
Proposed Sec. 106.100(e)(3)(iii) requires that the batch records
identify the person monitoring each point where control is deemed
necessary to prevent adulteration. FDA has tentatively concluded that
it is important that the responsible individuals be identified in the
batch record so that the manufacturer can check that a qualified person
is actually monitoring the point, step, or stage where control is
deemed necessary to prevent adulteration, and so that such individual
can be contacted if a problem with a batch of infant formula is
identified at a later date. These individuals are in the best position
to know of any other information that may not have seemed pertinent at
the time but, in retrospect, could be important in identifying the
cause of the problem and initiating actions to prevent it from
recurring.
Proposed Sec. 106.100(e)(4) requires that the batch records include
the conclusions and followup, along with the identity, of the qualified
individual who investigated any deviations, or failures to meet
specifications, that occurred during the production of the batch. Under
these proposed regulations, individuals qualified by training or
experience must conduct an investigation of any deviation from the
master manufacturing order and of the corrective actions taken
(Sec. 106.50(a)(2)); conduct an investigation of a finding that a batch
or any of its ingredients failed to meet any manufacturer's
specifications (Secs. 106.40(d) and 106.70(c)); and conduct an
investigation of a failure to meet any specification or standard at any
point where control is deemed necessary to prevent adulteration
(Sec. 106.6(c)(4)).
FDA has tentatively concluded that the record of the conclusions
and followup of these investigations is necessary to enable the
manufacturer to ensure that it has complied with proposed
Secs. 106.6(c)(4), 106.40(d), 106.50(a)(2), and 106.70(c). Such records
will provide information on how the production of the batch of infant
formula deviated from established standards or specifications and on
the cause of any problem with the formula, if infants are reported to
have been adversely affected by the product at a later date.
Identification of the qualified individual who conducted the
investigations will ensure that there is responsibility and
accountability for the investigation and will allow the responsible
individuals to be contacted, if necessary. These individuals will be in
the best position to provide information if additional details about
the record are needed.
Proposed Sec. 106.100(e)(5) requires that the batch records include
the results of all testing performed on the batch of infant formula,
including testing on the in-process batch, at the final-product stage,
and on finished product throughout the shelf life of the product.
Section 412(b)(2)(B) of the act requires that manufacturers conduct
such testing. FDA has tentatively concluded that the assembly of such
records in one place will enable the manufacturer to ensure that the
batch of infant formula complies with proposed Secs. 106.55 and 106.91
and will facilitate the review of the test results in the event that a
problem arises with the batch.
Proposed Sec. 106.100(e)(5)(i) states that the batch records are to
include the results of any quality control testing conducted, in
accordance with proposed Sec. 106.91(a) and (b), to verify that each
nutrient required by Sec. 107.100 is present at the required level, and
that any nutrient added by the manufacturer is present at the
appropriate level. Including the results of this testing in the batch
records will provide data needed to evaluate compliance of the batch of
infant formula with proposed Sec. 106.91, and provide data needed to
evaluate a batch of infant formula if problems, such as adverse events
in infants, occur later with that particular batch. These records will
show the levels of nutrients in the formula and will provide
information to help the manufacturer determine whether any problems
associated with the formula are attributable to the nutrient levels in
the product.
Proposed Sec. 106.100(e)(5)(i)(A) requires that manufacturers
maintain a summary table in the batch record that identifies the stages
of the manufacturing process at which the nutrient analysis is
conducted for each nutrient, in accordance with proposed
Sec. 106.91(a). As discussed above, proposed Sec. 106.91(a) provides
flexibility in the stage at which many of the nutrients are tested. A
summary table will facilitate the manufacturer's compliance with
quality control procedures because it will allow a manufacturer to
quickly verify that it has tested for all the nutrients required by
Sec. 107.100 during the production of the infant formula.
Proposed Sec. 106.100(e)(5)(i)(B) requires that the quality control
records in the batch record include a summary table on the stability
testing program, conducted in accordance with proposed Sec. 106.91(b),
including the nutrients tested and the frequency of testing of
nutrients throughout the shelf life of the product. As discussed above,
proposed Sec. 106.91(b) requires that manufacturers test infant formula
at the beginning, midpoint, and end of the shelf life, and with
sufficient frequency to ensure that the manufacturer is aware if there
is a significant deterioration in the required level of a nutrient.
Therefore, proposed Sec. 106.91(b) provides flexibility in the testing
frequency, depending on the shelf life and the characteristics of the
product. A summary table will facilitate the manufacturer's compliance
with quality control procedures because it will allow a manufacturer to
quickly determine whether it has tested for all the nutrients required
by Sec. 107.100 with sufficient frequency to verify that the ``use by''
date on the formula is appropriate.
Proposed Sec. 106.100(e)(5)(ii) requires that the batch records for
powdered infant formula include the results of any testing conducted in
accordance with proposed Sec. 106.55(b) to document that the tests were
done and to verify compliance with the microbiological
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quality standards in proposed Sec. 106.55(c). As discussed above,
proposed Sec. 106.55(b) requires that manufacturers test representative
samples of each batch of powdered infant formula to ensure that the
batch meets the microbiological quality standards in proposed
Sec. 106.55(c) and therefore is not adulterated. This record will also
provide the manufacturer with data to evaluate adverse events that
infants may have experienced after consuming this batch of infant
formula by showing whether microbiological contamination could have
contributed to the adverse event.
3. CGMP Records
Proposed Sec. 106.100(f) identifies the records that manufacturers
must make and retain pertaining to CGMP described in proposed subpart B
of part 106. Section 412(b)(4)(A)(i) of the act requires the
establishment by regulation of requirements for the retention of all
records necessary to demonstrate compliance with the CGMP, including
testing designed to prevent the adulteration of infant formula. FDA has
already discussed proposed regulations (proposed Sec. 106.100(e))
respecting the retention of records relating to each batch of infant
formula. FDA also is proposing regulations respecting the retention of
records relating to the overall operation of the plant and the
maintenance of equipment, because these records are necessary to
demonstrate that the infant formula was manufactured in a manner
designed to prevent adulteration. Maintenance of these records will
help manufacturers identify trends in the processing of the infant
formula, in particular trends that show when the process is breaking
down in a way that will lead to the production of adulterated product.
These records also will provide information to assist the manufacturer
in tracking the cause of adverse events to a formula, if such events
are reported.
Proposed Sec. 106.100(f)(1) requires that manufacturers make and
retain records of the frequency and results of the testing of water
used in the production of infant formula. These records will show if
problems are starting to develop with the water supply so that
manufacturers can take corrective actions before the water is
inappropriate for use in infant formula.
Proposed Sec. 106.100(f)(2) requires that manufacturers make and
retain records, in accordance with Sec. 106.30(d), of accuracy checks
on instruments and controls. Under this proposal, these records must
include a certification of the accuracy of any known reference standard
used and a history of its recertification. As discussed previously, the
accuracy of the reference standard must be ensured before it can be
used to ensure that the production instruments are properly calibrated.
These records also will provide information to assist the manufacturer
in tracing the source of a problem, if one arises, with a batch of
infant formula. For example, if infants have adverse events to a batch
of infant formula, records containing a certification of accuracy of
the reference standards used and a history of their recertification
would assist the manufacturer in determining whether the problem was
created because a production instrument was calibrated with an
inaccurate reference instrument.
FDA is proposing to require that, at a minimum, the records specify
the instrument or control being checked, the date of the accuracy
check, the standard used, the calibration method used, the results
found, any actions taken if the instrument is found to be out of
calibration, and the initials or name of the individual performing the
test. These records will enable the manufacturer to determine, based on
the performance of the instrument, whether the calibration schedule is
sufficient to ensure the accuracy of the instrument. These records also
will provide information on when and how the instruments were
calibrated to assist the manufacturer in identifying the cause of a
problem, if one arises, with a batch of infant formula.
Including the date of the accuracy check in the record will permit
a determination of the accuracy of
FR Doc. 96-17058 Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula
the instrument or control over time;
including the standard used will allow the manufacturer to verify that
the standard was properly calibrated; and including the calibration
method used will ensure that the instrument is being calibrated free
from the variability that can occur when different laboratory personnel
perform the same calibration. The results of the accuracy check in the
record will show whether the instrument or control is accurate, or
whether a correction was necessary. Documenting the actions taken if
the instrument is found to be out of calibration will enable the
manufacturer to ensure that a correction was made. Requiring that the
individual performing the test note his or her initials or name in the
record will document who was last responsible for ensuring the accuracy
of the instrument or control and will allow the manufacturer to discuss
questions that may arise about the record with the person in the best
position to know additional, but unrecorded, details about the record.
If calibration of an instrument shows that a specification or
standard, at a point, step, or stage in the production process where
control is deemed necessary to prevent adulteration, has not been met,
a written evaluation of all affected product, and of any actions that
need to be taken with respect to that product, needs to be made. For
example, if the manufacturer is monitoring temperature to ensure that a
specification or standard of 250 deg.F is maintained as a minimum
temperature, and calibration of the temperature indicating instruments
against a reference standard reveals that it was reading a true
temperature of 248 deg.F, an evaluation of the health hazard
significance of this temperature deviation must be made. This proposed
requirement is necessary because, if an instrument is found to have
been giving inaccurate readings, all infant formula produced subject to
such inaccuracies must be identified and evaluated for the possibility
that the inaccuracies caused the formula to be adulterated. In
identifying the affected product to ensure that the health of
potentially affected infants is fully protected, in the absence of
evidence to the contrary, such evaluation would cover all product
manufactured since the last time the instrument was calibrated and
found to be accurate.
Proposed Sec. 106.100(f)(3) requires that manufacturers make and
retain records, in accordance with proposed Sec. 106.30(e)(3)(ii), of
the temperatures monitored for cold storage compartments and thermal
processing equipment. These records are needed to show that the thermal
processing equipment or cold storage compartments are being maintained
at the correct temperatures to prevent adulteration of the product. The
records of these temperatures will enable the manufacturer to identify
trends in temperature fluctuations that can signal the need to perform
nonscheduled maintenance.
FDA is proposing in Sec. 106.100(f)(4) that equipment cleaning,
sanitizing, and maintenance records, showing the date and time of
maintenance, as well as the lot number of each batch of infant formula
processed between equipment startup and shutdown for cleaning,
sanitizing, and maintenance, be made and maintained. These records will
allow the manufacturer to ensure that equipment and utensils are being
cleaned and maintained regularly and to check that the frequency of
such cleaning, sanitizing, and maintenance is appropriate in light of
the actual, as
[[Page 36193]]
opposed to planned, use of the equipment. For example, a manufacturer
may need to increase the frequency of cleaning, sanitizing, and
maintenance if actual rate of production consistently exceeds the
predicted rate of production. These records also will allow the
manufacturer to trace all formula that may be affected if evidence
becomes available that a particular cleaning, sanitizing, or
maintenance was improperly performed.
Proposed Sec. 106.100(f)(4) also requires that the person
performing and checking the cleaning, sanitizing, or maintenance date
and sign or initial the record indicating that the work was performed.
Identification of the person performing and checking the cleaning,
sanitizing, or maintenance will allow the manufacturer to ensure that a
qualified person is doing these tasks and to discuss questions that may
arise about the record with the person in the best position to know
additional, but unrecorded, details about the record.
Proposed Sec. 106.100(f)(5) requires that manufacturers make and
retain records, in accordance with Sec. 106.35(c), on all automatic
(mechanical or electronic) equipment used in the production or quality
control of infant formula. Proposed Sec. 106.100(f)(5)(i) requires that
the automatic equipment records include a list of all systems used,
with a description of computer files and of the inherent limitations of
each system. The manufacturer cannot effectively operate the system,
and correct problems that arise, if it does not understand the system.
It is not always possible for the individuals who developed and best
understand the system to be present when the system is operating.
Therefore, these records will enable the manufacturer to operate and
troubleshoot the systems even when the individuals who best know the
system are not available.
Proposed Sec. 106.100(f)(5)(ii) requires that the automatic
equipment records include a copy of all software used. Having a copy of
all software used will minimize the manufacturer's down time if
problems occur, and parts of the software are lost from the system. For
example, if a computer virus is found in the software used to run the
processing lines, having a copy of the software to reload into the
hardware will minimize the time lost. Likewise, if there is a problem
with the software used to perform quality control testing, having
copies of this software will ensure that the testing can continue with
a minimum amount of time lost.
Proposed Sec. 106.100(f)(5)(iii) further requires that the
automatic equipment records document installation, calibration, testing
or validation, and maintenance of the systems used. These requirements
are necessary for compliance with section 412(b)(4)(A)(i) of the act.
As discussed more fully above with respect to proposed Sec. 106.35
(b)(1), (b)(2), and (b)(4) CGMP requires that all systems be installed,
calibrated, and maintained in a manner necessary to ensure that they
are capable of performing their intended function and of producing or
analyzing infant formula as intended, and that all systems be validated
before their first use to manufacture commercial product. In addition
to documenting that the manufacturer is complying with CGMP, records
documenting installation, calibration, testing or validation, and
maintenance of systems are necessary to provide information if the
manufacturer later tries to determine why a problem with the system is
occurring or tries to determine why the system is not producing an
infant formula that complies with the manufacturer's specifications for
the product.
Proposed Sec. 106.100(f)(5)(iv) requires that the automatic
equipment records include a list of all persons authorized to create or
modify software. This record will help to minimize delays when the name
of a person with those skills is needed quickly.
Proposed Sec. 106.100(f)(5)(v) requires that the automatic
equipment records document modifications to software, including the
identity of the person who modified it. This documentation will ensure
that the manufacturer is aware of any changes made to the software, and
that it has a record of how the changed system works, so that it can
continue to operate the system even in the absence of the responsible
individual who made the modification to the system. A record of the
identity of the person who modified the software will show who was
responsible for modifying the software if problems arise with the
operation of the system and will identify the person in the best
position to know additional, but unrecorded, details about the software
modification to help in troubleshooting the software problems.
Proposed Sec. 106.100(f)(5)(vi) requires that the automatic
equipment records include documentation of retesting or revalidation of
modified systems. This proposed requirement is necessary for compliance
with section 412(b)(4)(A)(i) of the act. As discussed more fully above
in the section on proposed Sec. 106.35(b)(5), CGMP requires that all
modifications to software be made by a designated individual, and that
all systems be revalidated after any modification to ensure that infant
formula produced or analyzed using the modified software complies with
subparts B and C. FDA has tentatively concluded that records on
retesting or revalidation of the modified systems, just like records on
the initial testing or validation of the system
(Sec. 106.100(f)(5)(iii)), are necessary to document that the work has
been done properly and to provide information if the manufacturer later
tries to determine why a problem with the system is occurring or tries
to determine why the system isnot producing an infant formula that
complies with the manufacturer's specifications for the product.
Proposed Sec. 106.100(f)(5)(vii) requires that the manufacturer
make and retain a backup file of data entered into a computer or
related system. It also requires that this backup file consist of a
hard copy or alternative system, such as duplicate diskettes, tapes, or
microfilm, designed to ensure that backup data are exact and complete,
and that they are secure from alteration, inadvertent erasures, or
loss. This proposed requirement is necessary to ensure compliance with
CGMP because computer files can be easily altered or erased. Backup
files of data will allow the manufacturer to readily reload the files
of data if problems occur in the operation of the computer or related
system, so that the manufacturer's down time is minimized, and so that
the data entered into the system will be an exact copy of the data
previously used in the system.
Proposed Sec. 106.100(f)(6) requires that manufacturers make and
retain records on ingredients, containers, and closures, including the
identity and quantity of each lot, the name of the supplier, the
supplier's lot number, the name and location of the manufacturer (if
different from the supplier), the date of receipt, and the receiving
code as specified (proposed Sec. 106.100(f)(6) (i) through (vi)). These
records will enable the manufacturer to document that it is complying
with proposed Sec. 106.40(g). Moreover, this information is needed to
enable the manufacturer to track the source of each ingredient,
container, or closure used in infant formula if a problem arises. If an
ingredient, container, or closure is found to cause adulteration of the
formula, it is important to be able to determine the source of the
material, so that use of such materials can be halted and prevented in
the future.
Proposed Sec. 106.100(f)(6)(vii) requires that the records on
ingredients, containers, and closures include the results and
conclusions of any test or examination, including retesting and
[[Page 36194]]
reexamination, performed on them and their disposition. These records
will document that appropriate testing is being conducted to ensure
that the ingredients will not adulterate the infant formula, and that
the containers and closures will protect the infant formula against
adulteration. Further, these records will show the basis on which each
ingredient, container, and closure was released for use in infant
formula production if questions about such release later arise.
Individual lots of ingredients, containers, and closures are likely to
be used in a number of different batches of infant formula; therefore,
the agency is proposing that the records on ingredients, containers,
and closures be a part of the records pertaining to CGMP. Retaining
such records in the CGMP records, rather than in each batch record,
will eliminate the duplication of records and simplify the
recordkeeping. The disposition of the ingredients, containers, and
closures will show which materials were destroyed because they did not
meet the manufacturers specifications (and not used in manufacture in
compliance with Sec. 106.40(d)), and which batches of infant formula
were made using each lot of ingredients, containers, or closures. Thus,
the manufacturer will know which lots of ingredients, containers, or
closures were used in making infant formula and will be able to confirm
that those lots complied with proposed Sec. 106.40(d). Moreover, if a
batch of formula is shown to be adulterated, these records will help
the manufacturer to identify the source of the adulteration.
Proposed Sec. 106.100(f)(7) requires that manufacturers make and
retain records that include a full description of the methodology used
to test powdered infant formulas to verify compliance with proposed
Sec. 106.55(c) and the methodology used to conduct quality control
testing in accordance with Sec. 106.91 (a) and (b). The agency has not
specified in these regulations the methodologies that must be used to
conduct microbiological and quality control testing. Thus, FDA has
tentatively concluded that a manufacturer needs to maintain a record
that fully describes the methodology that it has decided to use to test
powdered infant formula for microorganisms and for quality control
testing. Such a record is necessary if there is to be consistency in
the procedure that the manufacturer follows in testing each batch of
infant formula, particularly in light of the fact that the laboratory
personnel conducting the testing are likely to vary. The accuracy and
reproducibility of microbiological and quality control testing depend
on the procedure used to conduct the test.
FDA is proposing that the full description of the methodology be
retained as part of the CGMP records, rather than in the batch record
provided for in proposed Sec. 106.100(e)(5), because these methods will
be used to test multiple batches of infant formula. Retaining such
records in the CGMP records, rather than in each batch record, will
mean that the manufacturer has to maintain only one document, rather
than having to reproduce it each time that it runs a batch of formula.
Thus, the proposed approach will eliminate duplication of records and
simplify recordkeeping.
4. Records on Distribution of Infant Formulas
Proposed Sec. 106.100(g) adds to current Sec. 106.100(g) a
requirement that records pertaining to distribution of the infant
formula show that products intended for export only are in fact
exported. It has recently come to the attention of the agency that
infant formulas produced for export have been diverted and sold in the
United States. All persons introducing any new infant formula into
interstate commerce, which includes persons exporting an infant formula
to a foreign country, are required by section 412(c) of the act to
register and make a submission to the agency 90 days before marketing
the formula. (See discussion of proposed Secs. 106.110 and 106.120.)
As discussed in the section of this preamble on proposed
Sec. 106.120(c), the agency has tentatively concluded that it will not
require manufacturers who produce infant formula for export only to
submit the same information that would be required for products
intended or offered for sale in the United States. In lieu of the
information required by Sec. 106.120(b), FDA is proposing to allow
manufacturers of products for export only to give assurances that the
infant formula will not be sold or offered for sale in domestic
commerce. This provision is based, in part, on section 801(e) of the
act, which states that a food will not be deemed to be adulterated or
misbranded under the act if, among other things, it is not sold or
offered for sale in domestic commerce. Thus, the agency has tentatively
concluded that the additional recordkeeping requirement on distribution
of infant formulas for export only in proposed Sec. 106.100(g) is
necessary so that verification that the infant formula was not in fact
sold or offered for sale in domestic commerce will be readily available
in the manufacturer's records.
5. Audit Records
Proposed Sec. 106.100(j) carries forward the requirement in current
Sec. 106.100(j) that the manufacturer make and retain records, which
include the audit plans and procedures, that pertain to regularly
scheduled audits. As discussed above, the written audit plan, which
includes audit procedures, is required under proposed Sec. 106.94(a)
and (b). The proposed section further requires that records of audits
include the findings of the audit and a listing of any changes made in
response to these findings. This requirement is proposed under the
authority of section 412(b)(4)(A)(v) of the act, which requires that
manufacturers retain all records of the results of regularly scheduled
audits conducted under the requirements prescribed by the Secretary
(and by delegation, FDA) under the authority of section
412(b)(2)(B)(iv).
Proposed Sec. 106.100(j) also requires that the manufacturer make
readily available for authorized inspection the audit plans and
procedures and a statement of assurance that the regularly scheduled
audits are being conducted. This provision implements section
412(b)(4)(B)(ii) of the act, which requires that the manufacturer
provide written assurance that the regularly scheduled audits are being
conducted by the manufacturer. However, proposed Sec. 106.100(j) also
provides that the findings of the audit and any changes made in
response to these findings need not be made available to FDA. This
provision is brought forward from current Sec. 106.100(j) and reflects
section 412(b)(4)(B)(ii) of the act, which states that a ``manufacturer
need only provide written assurances to the Secretary that the
regularly scheduled audits required by'' section 412(b)(2)(B)(iv) of
the act ``are being conducted by the manufacturer, and need not make
available to the Secretary the actual written reports of such audits.''
6. Modification of Current Sec. 106.100(k)(3)
The agency also is revising current Sec. 106.100(k)(3) to reflect
the numbering changes in the regulations on notifying the agency of a
causal relationship between the consumption of an infant formula and an
infant's death. The agency is moving the requirements of current
Sec. 106.120(b) to Sec. 106.150 to reflect the changes it is proposing
in subpart G. Thus, the reference to Sec. 106.120 in Sec. 106.100
(k)(3) will be changed to read ``Sec. 106.150,'' if the
[[Page 36195]]
agency adopts the relevant proposed changes.
G. Registration, Submission, and Notification Requirements
1. Introduction
The act provides for three types of notices that manufacturers of
infant formula must provide to FDA and sets forth the general
information that must be included in each type of notice. First,
manufacturers of a new infant formula must register with FDA, in
accordance with section 412(c)(1)(A) of the act, providing the name and
address of the firm and all establishments that will manufacture the
new infant formula. Second, manufacturers must submit to FDA, in
accordance with section 412(d) of the act, certain information
concerning a new infant formula or an infant formula in which there is
a change in formulation or processing that may affect whether the
formula is adulterated under section 412(a) of the act. Third,
manufacturers must notify FDA, in accordance with section 412(e) of the
act, of any adulterated or misbranded infant formula that has left
their control.
The agency has not specified the information that must be included
in an infant formula registration, submission, or notification. While
firms have been able to function under these requirements since the
1986 amendments were enacted with respect to the notice that
manufacturers must provide to the agency under section 412(c) and (d)
of the act, inquiries from industry suggest that manufacturers are
uncertain about the information that they must provide. Some
manufacturers have needed to make multiple submissions for a new infant
formula because of deficiencies in the initial submission. For example,
some submissions have contained information concerning more than one
formula without clearly identifying which information applied to which
formula. Some submissions have not contained the information required
by section 412(d)(1) of the act. Therefore, FDA recognizes that it will
be useful both to manufacturers and to the agency to issue regulations
to ensure that registrations and submissions required by the act follow
a consistent format and contain the necessary information for the
agency to determine whether there is a basis to object to the marketing
of a new infant formula. Such regulations will facilitate the
manufacturer's preparation of the notice and also will facilitate the
agency's review of the notice once FDA receives it.
These proposed regulations also will make clear when a
registration, notification, or submission to the agency is needed. For
example, as stated above, it has recently come to the attention of the
agency that some firms that manufacture infant formula intended only
for export are not aware of their registration and submission
responsibilities. Section 412(c)(1) of the act requires that a person
introducing a new infant formula into interstate commerce (which
includes export to a foreign country) must register the infant formula
and make the proper submission 90 days before marketing it. These
proposed regulations make clear that registration and submission
requirements apply to infant formulas intended only for export as well
as to infant formula intended for the domestic market.
Finally, for completeness, FDA has decided that it would be useful
to both manufacturers and the agency, to carry forward current
Sec. 106.240, concerning notification of a violative infant formula, as
Sec. 106.150. Doing so will consolidate in one place in the agency's
regulations all requirements concerning notice to the agency to meet
the requirements of section 412(c), (d), and (e) of the act.
2. New Infant Formula Registration
Proposed Sec. 106.110(a) requires that a manufacturer of a new
infant formula register with FDA before introducing the formula, or
delivering it for introduction, into interstate commerce. Because
``interstate commerce'' is defined in section 201(b) of the act as
``(1) commerce between any State or Territory and any place outside
thereof, and (2) commerce within the District of Columbia or within any
other Territory not organized with a legislative body,'' under this
provision, a manufacturer is required to register with FDA before
introducing a new infant formula into the United States market or
before beginning exporting the formula. Proposed Sec. 106.110(a) sets
out how to comply with section 412(c)(1)(A) of the act. Failure to
provide the notice required by section 412(c)(1)(A) of the act is a
prohibited act under section 301(s).
Under section 412(c)(1)(A) of the act, proposed Sec. 106.110(b)
sets out the information required in a new infant formula registration.
While manufacturers may register at any time before introducing a new
formula into interstate commerce, FDA urges that they do so at the same
time that they submit notice of their intent to market a new infant
formula in accordance with section 412(c)(1)(B) and (d)(1) of the act.
Receiving registration and the 90 day submission at the same time will
facilitate the agency's review.
3. New Infant Formula Submission
Section 412(c)(1)(B) of the act requires that manufacturers of a
new infant formula submit to FDA a notice of their intent to market the
new formula that complies with section 412(d)(1) of the act. The notice
must be submitted at least 90 days before the infant formula is
introduced or delivered for introduction into interstate commerce
6. Proposed Sec. 106.120 implements this requirement.
---------------------------------------------------------------------------
\6\ While section 412(c)(1) and (c)(1)(B) of the act state ``No
person shall introduce or deliver for introduction into interstate
commerce any new infant formula unless--such person has at least 90
days before marketing such new infant formula, made the submission
to the Secretary required by'' section 412(c)(1) of the act, FDA has
recognized since 1986 that this citation is in error (see
``Requirements for Infant Formulas'' published by FDA's Industry
Programs Branch, CFSAN), and that the correct citation is section
412(d)(1). This correction agrees with the language of section
412(d)(1) of the act, which states what a submission about any
infant formula subject to section 412(c) of the act should include.
It is also consistent with the rules of statutory construction. See
Colonial Life & Accident Insurance Co. v. American Family Life
Assurance Co., 846 F. Supp. 454, 463 n. 14(D.S.C. 1994) (where the
legislature has made a mistake in reference, and its intent is
manifest, the statute may be read as corrected in order to give
effect to the legislative intent).
---------------------------------------------------------------------------
Proposed Sec. 106.120(a) sets out the requirement that a
manufacturer submit a notice of its intent to market a new infant
formula and provides the address to which such notices are to be
submitted.
Proposed Sec. 106.120(b) sets forth the information that
manufacturers must include in their new infant formula submission. This
proposed regulation implements and specifies the information called for
in section 412(d)(1) of the act.
a. General information required in a 90-day submission. Because the
registration of a new infant formula (proposed Sec. 106.110) need not
accompany the new infant formula submission (proposed Sec. 106.120),
and because a third submission on a newinfant formula that verifies
that the new infant formula, as produced, contains all required
nutrients (see proposed Sec. 106.130) will be submitted separately, FDA
has tentatively concluded that the name of the infant formula is needed
to ensure that all information on a particular infant formula is filed
together and is available to determine whether the agency should object
to the marketing of the formula. Information on the form of the product
is necessary for an accurate evaluation of the product because
different
[[Page 36196]]
requirements may apply to different forms of a formula. For example,
powdered infant formula must meet the microbiological quality
requirements in proposed Sec. 106.55, whereas liquid forms of a formula
do not. Therefore, FDA is proposing to require this information in
Sec. 106.120(b)(1), under the authority of sections 412(d)(1) and
701(a) of the act, even though it is not explicitly required in section
412(d)(1).
Proposed Sec. 106.120(b)(2) requires that the submission include an
explanation of why the formula is a new infant formula to facilitate a
determination by the agency as to the type of evaluation the new infant
formula requires. For example, if the formula is a new infant formula
because a new manufacturing plant will be used to produce it, but the
formulation of the product is not changed, FDA will evaluate the
processing and arrange to inspect the new facility but may conclude
that testing to provide assurance that quality factor requirements have
been met is not necessary. Thus, FDA is proposing to require the
submission of this information, even though, like the information
required under proposed Sec. 106.120(b)(1), submission of this
information is not specifically provided for in the act. The agency
tentatively concludes that this information is necessary for the
efficient enforcement of sections 412(c)(1)(B) and (d)(1) of the act.
b. Formulation and processing information required in a 90-day
submission. Pursuant to section 412(d)(1)(A) of the act, proposed
Sec. 106.120(b)(3) requires that the submission include the
quantitative formulation of the infant formula. The agency is proposing
that, if the notice concerns more than one form of the formula, the
submission include quantitative information on each form of the formula
that is the subject of the notice. FDA is proposing to require that
manufacturers submit the formulation in units per volume (for liquid
formulas) or units per dry weight (for powdered formulas) because
formulations expressed in these units will facilitate agency
understanding of the formula. Manufacturers already will have the
formulation available in these units as a part of the master
manufacturing order, and submitting the formulations in these units
should not require additional calculations by the manufacturer.
Proposed Sec. 106.120(b)(3) also requires, under section
412(d)(1)(B) of the act, that the submission include a description of
any reformulation of the infant formula, including a listing of each
new or changed ingredient and a discussion of the effect of such
changes on the nutrient levels in the formulation. For example, if the
protein source in an infant formula is replaced with a protein source
that contains a different amount of protein (e.g., from casein to a
mixture of casein and whey), it is important to ensure that the amount
of the new protein source used will provide the amount of protein
required by Sec. 107.100. As another example, if an ingredient such as
sodium selenite is added to the formula for the first time, it is
important to ensure that the level of the ingredient provides selenium
(in the form of selenite) at a level that is consistent with the
infant's needs and yet within the safe range of selenium intake.
Proposed Sec. 106.120(b)(4) requires that the submission include a
description, when applicable, of any change in processing of the infant
formula, and that such description identify the specific change in
processing, including side-by-side, detailed schematic diagrams
comparing the new processing to the previous processing (including
processing times and temperatures). This proposed requirement
implements section 412(d)(1)(B) of the act, which states that the
submission must include a description of any change in the processing
of an infant formula. FDA is proposing that the description of the
change in processing include detailed schematic diagrams comparing the
new processing to the previous processing because schematic diagrams
are efficient tools for identifying the nature and significance of
changes in processing.
c. Assurance that the infant formula will not be marketed unless it
meets quality factor and nutrient requirements of the act. Pursuant to
section 412(d)(1)(C) of the act, proposed Sec. 106.120(b)(5) requires
that the submission include an assurance that the infant formula will
not be marketed unless it meets the quality factor requirements of
section 412(b)(1) of the act and the nutrient content requirements of
section 412(i) of the act.
Proposed Sec. 106.120(b)(5)(i) requires that the assurance that the
formula meets the quality factor requirements, which are set forth in
subpart E of part 106, be provided by a submission that complies with
Sec. 106.121. Section 412(d)(1)(C) of the act requires that, 90 days
before marketing a new infant formula, a manufacturer submit assurances
that the infant formula will not be marketed unless it meets the
quality factor requirements established by regulations under section
412(b)(1). Section 412(d)(2) of the act requires that, after the first
production of a new infant formula and before introduction into
interstate commerce of such formula, the manufacturer submit a written
verification that summarizes test results and records demonstrating
that such formula complies with the quality factor requirements.
However, FDA has tentatively concluded that to implement sections 412
(d)(1) and (d)(2) of the act in a way that ensures that the statutory
goals are achieved--that is, to ensure that the agency has all the
relevant information for a sufficient period of time to conduct a
meaningful review of the nutritional adequacy of the formula while
enabling the infant formula manufacturer to market its product as
expeditiously as possible--it is appropriate to require that the
assurances that the quality factors will be met be provided by means of
data that would otherwise be required as part of the verification
submission. FDA notes that such a requirement would only codify current
practice. Since passage of the 1986 amendments, infant formula
manufacturers have been providing data demonstrating that a new infant
formula meets the quality factor requirements as a part of the
submission made 90 days before marketing.
Proposed Sec. 106.120(b)(5)(ii) requires that the assurance that
the formula complies with the nutrient content requirements, which are
set forth in Sec. 107.100, be provided by a statement assuring that the
formula will not be marketed unless it meets the nutrient requirements
of Sec. 107.100, as demonstrated by testing required under subpart C of
part 106.
The agency acknowledges that there is an apparent inconsistency in
how it interprets the word ``assurance'' in section 412(d)(1)(C) of the
act as it relates to assurance that the infant formula meets the
quality factor requirements and assurance that the infant formula meets
nutrient content requirements. FDA has tentatively concluded, however,
that assurance that the formula will meet the quality factor
requirements is a threshold question that must be answered
affirmatively before the effort in setting up the line for first
production of the infant formula would be justified. Therefore, the
agency is proposing to require that the assurance that the infant
formula will meet the quality factor requirements be provided by data
submitted 90 days before marketing the formula.
On the other hand, the agency is proposing that the assurance that
the formula will not be marketed unless it meets the nutrient
requirements of Sec. 107.100 can be provided by a statement to that
effect (as opposed to data) submitted 90 days before marketing of the
formula because the
[[Page 36197]]
data and records demonstrating that the formula complies with the
nutrient requirements of Sec. 107.100 will not be available until the
production line is set up, and the first production of the infant
formula has occurred. FDA will receive verification that the formula
meets the nutrient requirements as a part of the submission required by
section 412(d)(2) of the act (see proposed Sec. 106.130(b)(3), below).
Therefore, FDA has tentatively concluded that it is adequate to receive
a commitment from the manufacturer, 90 days before marketing, that the
infant formula will not be marketed unless it meets the nutrient
requirements of Sec. 107.100.
d. Assurance that the processing of the infant formula complies
with the CGMP and quality control procedures of the act. Under section
412(d)(1)(D) of the act, proposed Sec. 106.120(b)(6) requires that the
submission include assurance that the processing of the infant formula
complies with section 412(b)(2) of the act (CGMP, including quality
control procedures).
Proposed Sec. 106.120(b)(6)(i) requires that the assurance that the
processing of the infant formula complies with section 412(b)(2) of the
act include a statement that the formula will be produced in accordance
with subparts B and C of part 106. This proposed requirement is a
necessary element of the assurance required by section 412(d)(1)(D) of
the act because the requirements for CGMP are set forth in subpart B
and the requirements for quality control procedures are set forth in
subpart C. In the Congressional Record (Ref. 1), Senator Metzenbaum
stated that the amendments to the Infant Formula Act set up
requirements ``which will prevent our Nation's Children from ever again
being threatened by defective baby formula. The most important
provision of this amendment is the simple requirement that each batch
of formula must be tested for each essential nutrient that must be
contained in the formula'' (Ref. 1).
Proposed Sec. 106.120(b)(6)(ii) requires that the assurance that
the processing of the infant formula complies with section 412(b)(2) of
the act include the basis on which the manufacturer has concluded that
each ingredient meets the requirement of proposed Sec. 106.40(a), i.e.,
that the ingredient is an approved food additive, is authorized by a
prior sanction issued by the agency, or is GRAS for its intended use.
The statute provides that the manufacturer submit, 90 days before
marketing a new infant formula, assurance that the processing of the
formula complies with the CGMP regulations, and that the formula is
manufactured in a way that is designed to prevent its adulteration. FDA
has tentatively concluded that, to implement the act in a way that will
ensure that the statutory goals are achieved, that is, to ensure that
the agency has all the relevant information for a sufficient period of
time to conduct a meaningful review of the formula while enabling the
manufacturer to market its product as expeditiously as possible, it is
appropriate to require that the assurance that none of the ingredients
will adulterate the formula be provided by an explanation of how each
ingredient meets proposed Sec. 106.40(a). FDA has tentatively concluded
that this approach is appropriate because, like the evidence that the
formula meets the quality factors, evidence that all the ingredients in
the infant formula are safe goes to a threshold question that must be
answered affirmatively before the effort in setting up the production
line for the first production of the infant formula would be justified.
Moreover, an infant formula manufacturer would want to have information
demonstrating that each of the ingredients in the formula is safe
before marketing the formula, because without such information, a
responsible manufacturer would not include the ingredient in its
product.
FDA will review the new infant formula submission to ensure that a
safe product will be produced (sections 201(s), 402(a)(1) and (a)(2),
and 409 of the act). If the agency is not presented with basis on which
it can be satisfied that the use of an ingredient in an infant formula
will be safe, FDA will not be able to acquiesce in the marketing of the
formula. The legislative history of the 1986 amendments supports that
Congress anticipated that FDA would provide this type of review. In the
Congressional Record of September 27, 1986, Senator Metzenbaum stated:
I continue to be concerned, however, that our food and drug laws
do not differentiate between foods and infant formulas. But they are
fundamentally different. An infant formula is designed as the sole
source of nutrition for a baby. An infant formula is used daily. A
baby must thrive from its content for the first and most formative
months of his or her life. I expect the Secretary to look closely at
whether or not our standards in this area for foods are adequate
standards for infant formula. I have no reason at this time to
suspect that there is a problem here. But I continue to urge the
Secretary to give thorough consideration to the important
distinctions between infant formula and other foods, as well as food
additives which may be used with infant formulas. (Ref. 1)
One way for a manufacturer to satisfy the agency that proposed
Sec. 106.40(a) is met would be for the manufacturer to use only
ingredients that are: (1) Listed as GRAS for such use in 21 CFR part
182 or affirmed as GRAS for such use in 21 CFR part 184 or otherwise
GRAS for such use under the regulations included in those parts; (2)
approved for such use by a food additive regulation; or (3) authorized
by a prior sanction issued by FDA.
Alternatively, the requirements of proposed Sec. 106.40(a) can be
met by a showing that the substance is GRAS within the meaning of
Sec. 170.30 (21 CFR 170.30), which states that ``general recognition of
safety may be based only on the view of experts qualified by scientific
training and experience to evaluate the safety of substances directly
or indirectly added to foods'' (Sec. 170.30(a)). To clarify this point,
Sec. 170.30(a) states that ``[g]eneral recognition of safety requires
common knowledge about the substance throughout the scientific
community knowledgeable about the safety of substances directly or
indirectly added to food.'' The qualified experts can base their views
on either: (1) Scientific procedures, or (2) in the case of a substance
used in food prior to January 1, 1958, through experience based on
common use in food (section 201(s) of the act).
Under Sec. 170.30(b), general recognition of safety based upon
scientific procedures requires the same quantity and quality of
scientific evidence as is required to obtain approval of the ingredient
as a food additive, and it must ordinarily be based on published
studies, which may be corroborated by unpublished studies and other
data and information. If the manufacturer of an infant formula wishes
to use an ingredient because there is general recognition of safety
based upon scientific procedures, FDA is proposing to require in
Sec. 106.120(b)(6)(ii) that the manufacturer include as a part of its
new infant formula 90-day submission the rationale for why the
ingredient is GRAS and the evidence that demonstrates that there is
common knowledge about the safety of the substance throughout the
scientific community knowledgeable about the safety of such substance.
FDA is proposing that this evidence include a bibliography of published
studies, copies of those scientific publications about the substance,
and an explanation as to why, based on the published studies, the use
of the substance in infant formula is GRAS.
Under Sec. 170.30(c)(1), if a substance is GRAS based on common use
in food prior to January 1, 1958, this determination must be based
solely on
[[Page 36198]]
food use of the substance before January 1, 1958, and must ordinarily
be based upon generally available data and information. Thus, GRAS
based on common use in food prior to January 1, 1958, may be determined
without the quantity or quality of scientific procedures required for
approval of a food additive regulation. If the manufacturer of an
infant formula wishes to use an ingredient based solely on food use of
the substance prior to January 1, 1958, it should provide as a part of
the new infant formula 90-day submission the evidence supporting that
the ingredient was in common use in infant formula prior to January 1,
1958, and an explanation of why that use provides the basis for general
recognition of the safety of the substance.
FDA has recognized that it is impractical to list all substances
that are GRAS for their intended use based on their common use in food
prior to 1958 (see 21 CFR 182.1(a)). The agency regards such common
food ingredients as salt, pepper, vinegar, and baking powder as safe
for their intended use. Also, current Sec. 170.30(d) provides that a
``food ingredient of natural biological origin that has been widely
consumed for its nutrient properties in the United States prior to
January 1, 1958, without known detrimental effects, which is subject
only to conventional processing as practiced prior to January 1, 1958,
and for which no known safety hazard exists, will ordinarily be
regarded as GRAS * * *.'' Some ingredients are used in infant formulas
even though they are not listed or affirmed as GRAS by the agency for
their intended use. Vitamin K, for example, is required to be a part of
an infant formula under section 412(i) of the act and, in the form of
phylloquinone, is considered to be safe and suitable for infant
formulas when used in accordance with prescribed levels in
Sec. 107.100, although no source of vitamin K, such as phytonadione or
phylloquinone, has been listed or affirmed as GRAS by the agency.
Likewise, sodium selenite has been added to infant formulas to provide
the amount of selenium that has been determined to be essential for
infants by NAS (Ref. 19). Published experimental and clinical data
provide a basis upon which experts qualified by scientific training and
experience could evaluate the safety of sodium selenite as a source of
selenium for use in infant formula and could conclude that it is safe.
The agency anticipates that other ingredients may be shown to be GRAS
because they are generally accepted sources of substances that are
established as essential for infants by an authoritative body such as
NAS. However, manufacturers should not take this acknowledgment to mean
that they are free to declare that the use of any ingredient they want
to use is GRAS. Any ingredient that cannot meet the standard of
Sec. 170.30 for a GRAS determination will be viewed by the agency as a
food additive, and any infant formula that contains a food additive
that the agency has not approved for use in infant formula is subject
to being acted against by the agency.
If the safety of an ingredient is not expressly recognized in an
FDA regulation, the burden will rest on the manufacturer of the infant
formula to include in its new infant formula submission an explanation
of why the substance is GRAS under Sec. 170.30, along with the
published and other information that provides the basis for that
explanation, in accordance with proposed Sec. 106.120(b)(6)(ii). If the
agency adopts this approach, a failure of the agency to object to a
manufacturer's determination that an ingredient is GRAS in a new infant
formula submission will not constitute a GRAS affirmation by the
agency. However, if FDA knows of no reason to question the safety of an
ingredient to be used in infant formula, the agency will not object to
the manufacturer's relying on its own determination that use of the
substance is GRAS.
e. Submission 90 days before marketing a new infant formula
intended only for export. When a new infant formula is intended only
for export, proposed Sec. 106.120(c) provides that manufacturers may
submit, in lieu of the information required under proposed
Sec. 106.120(b), a statement that the infant formula meets the
specifications of the foreign purchaser, does not conflict with the
laws of the country to which it is to be exported, is labeled on the
outside of the shipping package to indicate that it is intended for
export only, and will not be sold or offered for sale in domestic
commerce. This proposed requirement recognizes that under section
801(e) of the act, in certain limited circumstances, manufacturers may
lawfully export products that are adulterated or misbranded. The
information required under proposed Sec. 106.120(c) will demonstrate
that those limited circumstances exist. FDA has tentatively concluded
that proposed Sec. 106.120(c) will provide manufacturers with the
flexibility allowed under section 801(e) of the act while meeting the
requirements of sections 412(c) and (d) of the act.
f. Submission 90 days before marketing--administrative procedures.
Proposed Sec. 106.120(d) states that the submission will not constitute
notice under section 412 of the act unless it complies fully with
Sec. 106.120(b), and the information that it contains is set forth in a
manner that is readily understandable, so that FDA can complete its
review in a timely manner and advise the manufacturer if it has any
concerns about the marketing of the formula before the 90 days is up.
Proposed Sec. 106.120(d) makes clear that the agency will notify the
submitter if the notice is not adequate because it does not meet the
requirements of sections 412(c) and (d) of the act.
Proposed Sec. 106.120(e) provides that if a new infant formula
submission contains all the information required by proposed
Sec. 106.120(b), FDA will acknowledge its receipt and notify the
manufacturer of the date of receipt, which will be the filing date for
the submission (and the manufacturer will be able to plan those actions
necessary to begin marketing the new formula in reliance on that date).
Further, pursuant to section 412(c)(1)(B) of the act, proposed
Sec. 106.120(e) also requires that the manufacturer not market the new
infant formula until 90 days after the filing date. Congress provided
for 90-day notice so that the agency would have sufficient time to
examine all of the material submitted and decide whether there is any
basis for concern about the marketing of the formula.
Proposed Sec. 106.120(f) makes clear that if the manufacturer
provides additional information in support of a new infant formula
submission, FDA will determine whether it represents a substantive
amendment to the submission, and that, if it does, FDA will assign the
new infant formula submission a new filing date. FDA is proposing to
adopt Sec. 106.120(f) to clarify how it will treat amendments to infant
formula notifications. In the 9 years since the passage of the 1986
amendments, the treatment of additional submissions has been the source
of some confusion. FDA has tentatively concluded that it is necessary
to give a new filing date to a new infant formula submission when a
substantive amendment is made to it so that the agency has time to
examine all of the material submitted and to determine whether there is
any basis for concern about the marketing of the formula.
4. Quality Factor Submission
Proposed Sec. 106.121 sets forth the requirements for specific
information that a manufacturer must submit to
[[Page 36199]]
FDA, in accordance with proposed Sec. 106.120(b)(5), to provide
assurance that the infant formula meets the quality factor requirements
set forth in subpart E of part 106. FDA has tentatively concluded that
agency access to study records and data are necessary so that it can
ensure that study results are meaningfully interpretable, and that the
manufacturer's conclusion that the infant formula meets the quality
factor requirements withstands scientific scrutiny and evaluation.
Failure to adequately document study results and interpretation raises
questions as to the validity of conclusions and could mean that infants
have been unnecessarily subjected to testing procedures.
Proposed Sec. 106.121(a) requires that the manufacturer submit an
explanation, in narrative form, setting forth its conclusions on how
all quality factor requirements of subpart E of part 106 have been met.
This narrative will facilitate the agency's review by summarizing the
results, and their interpretation, that provide the basis on which the
manufacturer has concluded that the quality factor requirements have
been met, or that the subject infant formula is eligible for the
exemptions described in proposed Sec. 106.97(a)(2) and (b)(2).
Proposed Sec. 106.121(b) requires that the manufacturer submit
records that contain the information collected during the study for
each infant enrolled in the study. The measurements and information
collected for each infant enrolled in the study are necessary to an
evaluation of whether the infant formula supported healthy growth.
Proper identification of the records is necessary for proper use and
analysis of the records.
Proposed Sec. 106.121(c)(1) requires that the manufacturer submit a
statistical evaluation of the data from the clinical study, including
group means, group standard deviations, and measures of statistical
significance for all measurements for each feeding group at the
beginning of the study and at every point where measurements were made
throughout the study. This evaluation forms the basis for the
manufacturer's conclusion as to whether the formula meets the quality
factor requirements. Without knowledge of the statistical basis upon
which the manufacturer drew its conclusions, FDA would not have
sufficient information to evaluate the conclusions reported by the
manufacturer.
Proposed Sec. 106.121(c)(2) requires that the manufacturer submit a
calculation of the statistical power of the study at its completion.
Proposed Sec. 106.97(a)(1)(ii)(E) recommends that the power calculation
used to design the study be included in the study protocol. FDA is
aware that circumstances (e.g., attrition, difficulty in recruiting
sufficient numbers of infants, unexpectedly high measurement error in a
particular variable) may unintentionally result in sample sizes and
feeding group assignments that lack adequate statistical power for
detecting differences between treatment and control groups, regardless
of the apparent adequacy in planning for the study protocol. Reviewers
must be aware of changes in the statistical power of a study so that
they do not inadvertently misinterpret the absence of differences that
occur between different formulas as meaning there are no differences.
Failure to detect differences, if they are real, could result in
erroneously concluding that a formula is safe and suitable for its
intended use when, in fact, it is not. The agency is proposing to
require that the manufacturer submit this calculation to FDA so that
the agency can meaningfully review and interpret the data and study
results contained in the submission.
Proposed Sec. 106.121(d) requires that the manufacturer submit
reports on attrition and on all occurrences of adverse events during
the study.
FDA has tentatively found that information on the occurrence of
adverse events is a critical element of the data that must be evaluated
to determine whether a formula meets quality factor requirements and is
safe and suitable for infants. Adverse events associated with the use
of an infant formula, although unexpected, can be a sign or symptom of
a nutritional inadequacy or of a safety problem with the infant
formula, and failure to use these results could result in inadvertent
release of an unsafe product. Conversely, adverse events can be
unrelated to a formula product (e.g., flu), but their occurrence can
affect the way in which results are interpreted and used. For example,
illnesses can influence the interpretation of growth data and of the
laboratory measurements collected to evaluate the infant formula.
For these reasons, FDA has tentatively concluded that complete
reports, including the results of followup investigations, on the
occurrence of all adverse events during the study, regardless of
whether the adverse events are attributable to the use of the new
infant formula or to some other illnesses, are necessary to properly
evaluate the conclusions drawn from a clinical study (proposed
Sec. 106.121(d)(1)). FDA has tentatively concluded that a complete
report on the occurrence of an adverse event must include
identification of the infant by subject number to permit evaluation of
infant growth measurements; identification of the feeding group to show
whether there is a pattern of adverse events in one feeding group
versus another; and a complete description of the adverse event,
including comparisons of the frequency of occurrence in each feeding
group and information on the health of the infants during the course of
the study, including the occurrence and duration of any illness, that
occurred during the trial, so that it is possible to evaluate the
significance of the illness.
As discussed above, it is very important to be able to evaluate
whether the adverse event is a result of a nutritional quality factor
problem with the formula product. The results and evaluation of the
infant's clinical status are essential to make this evaluation, and the
health of the infant is also relevant to interpreting study endpoints,
for example, growth data. Therefore, knowledge of the infant's health
status is an essential piece of information in evaluating the
circumstances surrounding an observed adverse event associated with use
of a formula product. Thus, FDA has tentatively concluded that
evaluations by a health care professional are necessary to provide the
agency with relevant information on the circumstances surrounding the
adverse event (see Sec. 106.121(d)(2)) to assist the agency in
evaluating the nutritional adequacy and safety of the formula product
for supporting healthy growth in infants. In some cases, this clinical
assessment may be carried out by the infant's health care provider,
rather than the investigators conducting this clinical study, because
some parents will contact the infant's health care provider if the
infant experiences any adverse event during the course of the study.
The agency expects that the study investigators will take sufficient
measures to obtain all available information to enhance the likelihood
of being able to meaningfully interpret the likely relationship of the
adverse event to the formula product and its impact on study
conclusions.
Attrition of infants from a study can result not only from adverse
events and illnesses but also from a variety of reasons having no
bearing on whether the new infant formula meets the quality factor
requirements. For example, an infant enrolled in the study may be
withdrawn from the study because the parents moved from the area. The
effect of attrition on study results, however, must be evaluated in
order to be able to meaningfully
[[Page 36200]]
interpret those results. To properly evaluate the impact of attrition
on study results, FDA must have information that permits it to evaluate
the likely cause of the attrition and its relationship to product use
and study measurements. Therefore, the agency is proposing to require
the submission of this information on attrition under
Sec. 106.121(d)(3).
Proposed Sec. 106.121(e) requires that the manufacturer submit the
results of the Protein Efficiency Ratio. This proposed submission
requirement is necessary to provide assurance that the manufacturer has
complied with proposed Sec. 106.97(b) and to provide assurance that the
infant formula meets the specific quality factor for protein quality.
Under proposed Sec. 106.121(f), the manufacturer is required to
submit a statement certifying that it has collected and considered all
information and data on the ability of the infant formula to meet the
quality factor requirements, and that it is not aware of anything that
would show that the formula does not meet the quality factors. This
proposed requirement is necessary to provide assurance that the
manufacturer has complied with the regulations and considered all
information and data of which it is aware, and that it has not made a
selective submission of information that gives a false impression of
the degree or extent to which a formula meets the quality factor
requirements.
5. Verification Submissions
Proposed Sec. 106.130(a) requires that manufacturers, after the
first production, but before the introduction into interstate commerce,
of a new infant formula, verify in a written submission that the infant
formula complies with the requirements of the act and is not
adulterated. This proposed requirement implements section 412(d)(2) of
the act, which requires the submission of a written verification that
summarizes test results and records demonstrating that a formula meets
the requirements of section 412(b)(1), (b)(2)(A), (b)(2)(B)(i),
(b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i) of the act. The failure
to provide the notice required by section 412(d) of the act is a
prohibited act under section 301(s) of the act.
Proposed Sec. 106.130(b)(1) requires that the verification
submission include the name of the new infant formula, the filing date
for the new infant formula submission required under proposed
Sec. 106.120, and the identification number assigned by FDA to the new
infant formula submission, so that FDA is able to match the
verification submission with the appropriate new infant formula
submission.
Proposed Sec. 106.130(b)(2) requires that the verification
submission include a statement that the infant formula to be introduced
into interstate commerce is the same as that which was the subject of
the new infant formula submission and for which the manufacturer
provided assurances in accordance with the requirements of proposed
Sec. 106.120. FDA has tentatively concluded that if this statement can
be made by the manufacturer, it means that the assurances that the
manufacturer provided in the new infant formula submission with respect
to the quality factor requirements and the safety of the ingredients
remain relevant and applicable to the product. Thus, no additional
information need be included in the verification to demonstrate
compliance, in accordance with section 412(d)(2) of the act, with
section 412(b)(1) or with this aspect of section 412(b)(2)(A).
Proposed Sec. 106.130(b)(3) requires a summary of test results that
show the levels of each nutrient required by Sec. 107.100 in the
formula and of any nutrient added by the manufacturer. This proposed
requirement is necessary to demonstrate compliance with section 412(i)
of the act. Section 412(i) of the act sets forth those nutrients that
an infant formula must contain in order not to be adulterated, and the
submission of a summary of test results as required by section
412(d)(2), and implemented by Sec. 106.130(b)(3), is necessary to show
that an infant formula, after the first production, contains all of the
required nutrients at the required levels.
FDA has tentatively concluded that it is not necessary to require
that the verification submission summarize test results or records
demonstrating compliance with sections 412(b)(2)(A) and (b)(2)(B)(iii)
of the act because the underlying records will be available for
inspection by FDA. FDA has tentatively concluded that to require the
manufacturer to create a report based on these records would be to
require an unnecessary expenditure of effort. However, the agency is
proposing to require (under Sec. 106.130(b)(4)) that the manufacturer
certify as a part of its verification submission that it has
established procedures that comply with sections 412(b)(2)(A) and
(b)(2)(B)(iii) of the act.
FDA has tentatively concluded that requiring additional test
results or records demonstrating compliance with section
412(b)(2)(B)(i), (b)(3)(A), and (b)(3)(C) of the act would be
unnecessary because such showings would be subsumed in the testing to
show whether the formula meets the requirements of Sec. 107.100 (under
Sec. 106.130(b)(3)).
Proposed Sec. 106.130(c) makes clear the consequences of failing to
comply with Sec. 106.130 and that in such circumstances, the agency
will notify the submitter that the notice is not adequate, and that the
manufacturer has not met the requirements of section 412(d)(2) of the
act.
6. Submissions Concerning a Change in Infant Formula That May
Adulterate the Product
Proposed Sec. 106.140(a) provides that, when a manufacturer makes a
change in the formulation or processing of the formula that may affect
whether the formula is adulterated under section 412(a) of the act, it
shall make a submission to FDA before the first processing of such
formula. This proposed requirement implements section 412(d)(3) of the
act, which requires that manufacturers make the submission to FDA
required by section 412(d)(1) of the act before first processing when
they determine that a change in formulation or in the processing of an
infant formula may affect whether the formula is adulterated under
section 412(a) of the act. Examples of changes that may affect whether
a formula is adulterated under section 412(a) of the act include, but
are not limited to:
(1) A change in the level of an ingredient that does not constitute
a major change but that may affect whether the formula meets the
requirements of section 412(i) of the act (for example, decreasing the
amount of an ingredient such as sodium chloride could affect whether
the formula provides two nutrients required by Sec. 107.100);
(2) A change in an ingredient in an infant formula that does not
constitute a major change but that may affect whether the formula meets
the quality factor requirements of subpart E of part 106 (for example,
a change in the level of an emulsifier could result in a change in the
bioavailability of fat because the emulsifier may interfere with fat
digestion); or
(3) A change in the processing of the infant formula that does not
constitute a major change but that may affect whether the CGMP
requirements or the quality control procedures of subparts B and C of
part 106 are met (for example, a change in the processing of the infant
formula may affect whether a specification or a standard for a
particular point in the manufacturing process where control is deemed
[[Page 36201]]
necessary to prevent adulteration is met; a change in a processing
temperature or holding time may allow microorganisms to develop in
violation of Sec. 106.55; or a change in a processing temperature may
affect the level of a labile (temperature sensitive) nutrient in the
formula).
Proposed Sec. 106.140(b)(1) requires that the submission include
information on the name and physical form of the product, so that the
change in the formula can be evaluated with other information that the
agency has received on the formula, and so that an accurate evaluation
of the product can be made because different requirements may apply to
different forms of a formula.
Proposed Sec. 106.140(b)(2) requires an explanation of why the
change in formulation or processing may affect whether the formula is
adulterated, so that the agency can determine what type of evaluation
the submission requires. For example, if a change in formulation may
affect nutrient levels, the agency needs to evaluate the nutrient
content of the formula to be assured that this formulation change will
not lead to production of a formula that will not provide a required
nutrient at the required amount. Likewise, if a change in processing
may affect whether the formula is adulterated, the agency will need to
evaluate the formula's processing to be assured that the processing of
the formula will still comply with the CGMP regulations in subpart B of
part 106.
Proposed Sec. 106.140(b)(3) requires that the submission comply
with Sec. 106.120(b)(3), (b)(4), (b)(5), and (b)(6). This proposed
requirement implements section 412(d)(3) of the act, which provides
that manufacturers make the submission required by section 412(d)(1).
FDA has tentatively concluded that requiring that the submission comply
with these aspects of Sec. 106.120(b) will promote consistency in the
form and substance of the information that industry must submit, and
FDA must review. If the information required on processing by
Sec. 106.120(b)(4) has already been provided in compliance with
Sec. 106.140(b)(2) as a part of the explanation of why the change in
processing may affect whether the formula is adulterated, the same
information does not need to be repeated in the submission. To avoid
redundant submissions, proposed Sec. 106.140(b)(3) further provides
that if the information required by Sec. 106.120(b)(3), (b)(4), (b)(5),
or (b)(6) has been provided to the agency previously, and that
information is not affected by the change that is the subject of the
submission, a statement to that effect, together with the
identification number assigned by the agency to the relevant infant
formula submission, can be provided in lieu of a new submission.
Proposed Sec. 106.140(b)(3) requires inclusion of the
identification number assigned by the agency to the infant formula
submission so that the agency can have ready access to the relevant
information that was previously submitted. For example, if the
manufacturer makes a submission as a result of a change in processing,
but the formulation will remain the same, the manufacturer need not
provide the information required by Sec. 106.120(b)(3). Likewise, if
the manufacturer makes a submission as a result of a change in
formulation, but the processing of the formula remains the same, the
manufacturer need not submit the information required by
Sec. 106.120(b)(4).
A determination of whether the assurances required by
Sec. 106.120(b)(5) and (b)(6) need to be given is based on the
manufacturer's reason for providing the submission. For example, if the
submission is provided because a change in formulation or processing
may affect whether the formula is adulterated because it does not meet
the quality factors set forth in subpart E of part 106, the assurance
required by Sec. 106.120(b)(5)(i) would have to be provided. Likewise,
if the submission is provided because a change in formulation or
processing may affect whether the formula is adulterated because it
does not meet the nutrient requirements of Sec. 107.100, the assurance
required by Sec. 106.120(b)(5)(ii) would have to be provided. Further,
if the submission is provided because a change in processing may affect
whether the formula is adulterated because the processing of such
formula may no longer be in compliance with CGMP or with appropriate
quality control, as set forth in subparts B and C of part 106, or
whether the formula is manufactured in a manner designed to prevent
adulteration, the assurance required by Sec. 106.120(b)(6) would have
to be provided.
In proposed Sec. 106.140(c), the agency sets forth requirements
necessary to ensure that the data and other information provided in the
submission are in a form that will allow FDA to complete its review in
a timely manner and to advise the manufacturer if the agency has any
concerns about the marketing of the formula. Proposed Sec. 106.140(c)
also makes clear that the agency will notify the submitter if the
notice is not adequate because it does not meet the requirements of
section 412(d)(3) of the act.
7. Notification of an Adulterated or Misbranded Infant Formula
If FDA adopts the other regulations that it has proposed, it will
redesignate current Secs. 107.240(a) and (b) as Sec. 106.150 so that
all notification requirements on infant formulas can be found in one
place in the agency's regulations. In Sec. 106.150(b), FDA has revised
the address to reflect the reorganization of CFSAN.
H. Conforming and Editorial Changes to Part 107--Infant Formula
The agency is making conforming and editorial changes to part 107
to reflect the changes made by the 1986 amendments and the regulations
that FDA is proposing to adopt in part 106. The references in part 107
to the Division of Regulatory Guidance are being changed to the
Division of Enforcement to reflect the reorganization of CFSAN in
November 1992.
1. Changes in Subpart A
The agency is proposing to add a new Sec. 107.1 which will parallel
proposed Sec. 106.1. Proposed Sec. 107.1 describes the authority for
each of the proposed subparts and the consequences under the act of
failure to comply with any of the regulations in the proposed subparts.
2. Changes in Subpart B of Part 107--Labeling
The agency is proposing to amend Sec. 107.10 to require a statement
of the amount, supplied by 100 kcal, of each of any nutrient added by
the manufacturer as well as of the listed nutrients. As discussed
previously in the quality control section of this document, infant
formula manufacturers are adding ingredients to infant formula to
provide nutrients, such as selenium, that are not required by
Sec. 107.100 to be in infant formulas. The proposed change to
Sec. 107.10 requires that the amount of the added nutrients supplied by
100 kcal of the formula be declared on the label of the infant formula.
This proposed requirement is necessary to inform the consumer on a
consistent basis of the level of all nutrients included in an infant
formula.
3. Subpart C of Part 107--Exempt Infant Formulas
At this time the agency is not proposing to revise the regulations
in Sec. 107.50 pertaining to infant formulas that are subject to
section 412(h) of the act. These regulations were finalized in 1985 (50
FR 48183), before passage of the 1986 amendments. In the near future,
the agency intends to reevaluate
[[Page 36202]]
the exempt infant formula regulations and the effect of the 1986
amendments on exempt infant formulas and to issue a proposed rule to
reflect the results of this reevaluation. The agency also plans to
evaluate the effect of the Nutrition Labeling and Education Act of 1990
(Pub. L. 101-535) (the 1990 amendments) on the regulations for exempt
infant formulas. Exempt infant formulas are specifically exempted from
requirements for health claims and nutrient content claims by section
403(r)(5)(A) of the act. The basis for being an exempt infant formula,
according to section 412(h)(1) of the act, is how the product is
represented and labeled for use. This category of infant formula
recognizes that infants who suffer from special medical disorders, such
as maldigestion and malabsorption, inborn errors of metabolism such as
phenylketonuria or maple syrup urine disease, or severe kidney disease,
require formulas tailored specifically to their medical needs.
Therefore, it is important that any claims made for these products be
truthful, not misleading, and adequately substantiated because these
infants make up a vulnerable population and must receive the
appropriate nutrients for their medical condition. Because these
formulas are exempt from the regulations governing claims that were
developed under the 1990 amendments, the agency plans to evaluate how
claims for these products need to be substantiated to ensure that
infants with special nutritional needs are receiving appropriate infant
formulas.
4. Subpart E--Infant Formula Recalls
Current Sec. 107.240(a) sets out the requirements for notification
of a violative infant formula, and current Sec. 107.240(b) sets out the
method of notification. As stated above, the agency is moving the
p
FR Doc. 96-17058 Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula
rovisions of current Sec. 107.240(a) and (b) to Sec. 106.150, so that
all of the agency's notification requirements are in one place. The
agency is renumbering current Sec. 107.240(c)(1), (c)(2), and (c)(3) as
Sec. 107.240(a), (b), and (c).
Section 107.250 gives directions on the termination of an infant
formula recall. The agency is changing the reference to the Division of
Regulatory Guidance to the Division of Enforcement in Sec. 107.250 to
reflect the 1992 reorganization of CFSAN.
V. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
VI. Analysis of Impacts
FDA has examined the impacts of the proposed rule under 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 and safety, and other
advantages; distributive impacts; and equity). According to Executive
Order 12866, a regulatory action is ``economically significant'' if it
meets any one of a number of specified conditions, including having an
annual effect on the economy of $100 million or adversely affecting in
a material way a sector of the economy, competition, or jobs. A
regulation is considered ``significant'' under Executive Order 12866 if
it raises novel legal or policy issues.
The Regulatory Flexibility Act requires Federal agencies to
minimize the economic impact of their regulations on small businesses.
FDA finds that this proposed rule is neither an economically
significant nor a significant regulatory action as defined by Executive
Order 12866. In compliance with the Regulatory Flexibility Act, the
agency certifies that this proposed rule, if issued, will not have a
significant impact on a substantial number of small businesses.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required. The agency examined three options in determining the economic
impact of this proposed regulations. A summary of the options follow:
A. Options
FDA has three primary options: (1) Adopt regulations with more
stringent requirements than the proposed regulations; (2) adopt the
proposed regulations; or (3) adopt regulations with less stringent
requirements than the proposed regulations.
1. Option 1--Adopt Regulations More Stringent Than the Proposed
Regulations
FDA believes infant formula manufacturers already comply with most
of the requirements of this proposed rule. One option would be to add
provisions to this proposed rule that would require activity beyond
that which is currently engaged in by infant formula manufacturers or
that is likely to be engaged in by manufacturers entering the infant
formula industry. Potential requirements of this type include specific
production and in- process control systems, specific equipment or types
of personnel, and additional testing and recordkeeping.
Under this option, incumbent manufacturers would face higher
production costs and would pass most of the costs on to consumers of
infant formula. In addition, the startup and operating costs would
increase, and thus discourage entry into the infant formula industry.
The ability of new firms to enter an industry is an important element
in promoting price competition and innovation. These additional
requirements would reduce price competition in the infant formula
industry.
The price of infant formula is probably linked to certain risky
infant feeding practices. With very high infant formula prices, some
consumers may increase risks to infants by improperly diluting formula
with water or other substances; using inappropriate substitutes for
formula or breast milk; or prematurely switching from formula to cow's
milk. For example, preliminary results of an FDA study on infant
formula feeding practices showed that approximately 20 percent of
infants (younger than 2 months) had their formula diluted by cereal,
which is cheaper than infant formula.
2. Option 2--Adopt the Proposed Regulations
There are two types of costs associated with this option: precluded
future cost cutting behavior and direct compliance costs.
a. Future cost cutting behavior. This type of cost may arise
because the proposed rule precludes cost cutting behavior by either
incumbent firms or firms entering the infant formula industry. Infant
formula manufacturers currently undertake a considerable amount of
activity, such as infant growth studies, that is designed to ensure the
safety of infant formula but is not explicitly required by either
current law or regulation. In the absence of this regulation, which
mandates this activity, either incumbent or future manufacturers may
choose not to undertake this activity in the future. However, because
of reputation effects and liability laws, these costs are likely to be
low.
[[Page 36203]]
b. Direct compliance costs. (i). CGMP. FDA believes that infant
formula manufacturers already comply with most of the proposed CGMP's.
These CGMP's include those dealing with: (1) Production and in-process
control systems, including the evaluation of any deviation from these
procedures or from established standards or specifications; (2)
controls designed to prevent adulteration of infant formula by workers,
by facilities, and during packaging and labeling; (3) controls to
prevent adulteration during manufacturing, including recording and
justifying deviations from the master manufacturing order and
evaluating deviations from processing times; (4) controls on the
release and storage of finished infant formula; (5) all requirements
relating to batch production and control records, and to coding; and
(6) all requirements dealing with general quality control procedures,
including the testing of one batch of each physical form of infant
formula at least once every 3 months.
If all manufacturers already comply with these proposed CGMP's,
then no compliance costs will result from them. FDA requests comments
on whether all infant formula manufacturers are already in compliance
with the proposed CGMP's listed above.
FDA believes that all infant formula manufacturers already comply
with the proposed CGMP's dealing with controls to prevent adulteration
caused by ingredients, containers, and closures. The provision that FDA
may object to the use of a particular substance in an infant formula
during its prenotification review of ingredients used in a formula
because it believes that the substance is not safe and suitable for
that use does not represent a change in the way FDA reviews infant
formula ingredients. This provision recognizes the fact that
manufacturers may make independent GRAS determinations about
ingredients. When a manufacturer makes such a determination, that
manufacturer is not necessarily required to have the relevant
ingredient affirmed as GRAS by FDA. However, FDA is reserving the right
to review infant formula ingredient lists and documentation concerning
whether particular ingredients are safe and suitable for use in infant
formula. Theoretically, this provision could lead to a reduction in the
number of ingredients that are independently determined to be GRAS and
a corresponding increase in the number of ingredients for which food
additive petitions are required. Petitions for direct food additives
can take between 1 to 6 years to complete and cost approximately $1
million per year. However, because manufacturers of infant formula
generally obtain FDA concurrence on the safety and suitability of
ingredients used in infant formula before making these determinations,
FDA believes no additional compliance costs will be generated by this
provision.
FDA also believes that infant formula manufacturers already comply
with many of the other proposed CGMP's. Provisions of CGMP's that some
infant formula manufacturers may not currently be in compliance include
the following:
(1) Controls to prevent adulteration caused by equipment or
utensils. Some manufacturers may not repair or replace instruments and
controls when those instruments and controls cannot be adjusted to
within essential agreement with the reference standard. In addition,
most manufacturers probably do not perform a written evaluation of all
affected product, or of actions taken when calibration results indicate
that a specification or standard for a point where control is deemed
necessary to prevent adulteration has not been met. FDA cannot estimate
the repair or replacement costs of instruments and controls at this
time. Written evaluations will take a supervising technician an
estimated 2 hours to complete, which will generate some small
compliance costs.
(2) Controls to prevent adulteration because of automatic,
mechanical, and electronic equipment. Most manufacturers will probably
have to perform additional analysis of software modifications. FDA
preliminarily estimates this analysis will add approximately 1 month to
the time required to analyze programming and software modifications.
One or two software modifications are probably made each year at each
of the fifteen plants that produce infant formula. Assuming that a
single computer scientist works on the additional activity required,
compliance costs are estimated to be about $100,000 per year.
ii. Audits, Quality factors, registration and notification
requirements, and infant formula recalls. FDA believes that infant
formula manufacturers already comply with the following provisions: (1)
Regularly scheduled audits to determine compliance with CGMP's and
Quality Control Procedures (QCP's), (2) growth and development studies
to be submitted under certain conditions and new notification
requirements (FDA already requests and receives these quality factor
growth and development studies and notification material based on FDA's
interpretation of the language of the 1986 amendments), and (3) all
provisions involving registration and notification requirements.
If infant formula manufacturers are already complying with these
provisions, then no compliance costs will be generated by these
provisions.
FDA requests information on whether all infant formula
manufacturers already comply with all provisions listed above,
particularly those provisions dealing with quality factors.
iii. Records. Under the current proposal, the records produced and
maintained by infant formula manufacturers to establish compliance with
FDA regulations will have to be expanded to include all new CGMP's and
QCP's. FDA believes most of the specified records are already being
kept by all firms; however, some records may not be. A plausible
assumption is that current annual industry expenditures on
recordkeeping may increase by about 10 percent, or $450,000 per year
based on information received from industry on current recordkeeping
costs. FDA requests information on the cost of increased recordkeeping.
iv. Administrative costs. Interpreting and implementing changes in
CGMP and QCP regulations generate administrative costs even when all
activity required in those CGMP's and QCP's is already being done. FDA
does not have information on the administrative costs involved in
interpreting and implementing changes in CGMP and QCP regulations;
however, it is plausible to suppose that 20 percent of the total
compliance costs other than administrative costs may be used to reflect
administrative costs.
Administrative costs under this assumption would be approximately
$100,000 and would accrue in the first year only. FDA requests
information on administrative costs.
3. Option 3--Adopt Regulations Less Stringent Than the Proposed
Regulations
Another option is to limit the activity required by this proposed
rule to activity already engaged in by all incumbent infant formula
manufacturers. In this case, there would be no compliance costs based
on current behavior. However, in the absence of this proposed rule,
incumbent or new manufacturers might choose not to undertake all
activity specified in this proposed rule. Therefore, the only costs
associated with this option are the costs associated with precluded
potential future behavior on the part of incumbent or new
manufacturers.
[[Page 36204]]
B. Benefits
1. Option 1--Adopt Regulations More Stringent Than the Proposed
Regulations
More stringent regulations for infant formula would cause infant
formula manufacturers to undertake further activity to ensure the
safety of infant formula. If there were identifiable risks from infant
formula that were not addressed by this proposal, then this additional
activity might decrease those health risks. However, FDA is not aware
of identifiable health risks from infant formula that are not addressed
by this proposal.
2. Option 2--Adopt the Proposed Regulations
The proposed regulation has two primary benefits: A potential
direct reduction in the health risks posed by infant formula, and a
potential reduction in the cost of entering the infant formula
industry. The latter effect could lead to an increase in the
competitiveness of the infant formula industry, resulting in lower
infant formula prices and a reduction in the incidence of risky infant
feeding practices linked to high infant formula prices.
One example of a current activity that can be linked to a direct
reduction in health risks but that is not explicitly required by
current law or regulation is the performance of growth studies for new
infant formulas. FDA currently requests and receives these studies to
demonstrate that the infant formula meets the quality factor
requirements of section 412(b)(1) of the act. However, because section
412(b)(1) of the act does not list specific quality factors that infant
formulas must meet, a quality factor for healthy growth currently is
not expressly stipulated. In the absence of this proposed rule,
manufacturers could decline to perform these growth studies in the
future with a potential consequence that products that do not support
normal growth would be marketed. Low growth rates would not be detected
by existing regulatory and legal requirements that measure only the
levels of required nutrients because the required nutrients may be
present but not be bioavailable, and there is no mechanism for testing
bioavailability other than the proposed studies.
An example of a formula associated with low growth rates that would
not have been detected in the absence of growth studies was an
experimental formula that contained a source of fatty acids not
previously used in infant formula. Because only a small amount of the
new fat source was added to a commercial formula, it is reasonable to
assume that all required nutrients were present within legal
specifications. Consequently, it would likely have met all current
regulations. Nonetheless, this formula was found to result in low
infant growth rates (Ref. 87). In this case, the manufacturer undertook
the necessary growth studies and detected the problem on its own.
However, manufacturers might not undertake these studies on their own
in the future. In addition, even if manufacturers continue to undertake
these studies in the absence of this regulation, they may not do these
studies correctly.
In general, low rates of infant growth are associated with higher
than normal levels of infant morbidity. If a problem of this type were
to occur, a large number of infants could potentially be affected.
Other types of current activity can also be linked to a direct
reduction in health risks and also are not explicitly required by
current law or regulation. In the absence of this regulation, incumbent
or new manufacturers may not undertake this activity in the future.
However, as explained earlier, because of reputation effects and legal
liability, such a refusal seems unlikely.
An example of a health risk from infant formula is the 1978
incident, discussed elsewhere in this document, in which a required
nutrient was missing from an infant formula. Recurrence of this
particular problem is unlikely because section 412(d)(1)(A) of the act
already explicitly requires the submission of the quantitative
formulation of an infant formula as part of the mandatory FDA
notification of a new infant formula. Recurrence of this problem is
also made unlikely because section 412(b)(2) of the act already
explicitly requires the testing of infant formula for all required
nutrients. However, the risk of a formula being sold without a required
nutrient is minimized to the extent possible by specifically clarifying
this part of the infant formula law in the regulation.
Another example of a health risk associated with infant formula is
an incident in which infant formula was found to contain Salmonella. It
appears that the manufacturer was testing for Salmonella in a manner
consistent with the testing requirements of this proposed rule, and
therefore it is not clear that this particular incident would have been
avoided if the proposed rule had been in effect. This proposed rule
will reduce the risk of microbiological contamination, however, because
it requires manufactures to institute a production and in-process
control system. The production and in-process control system
establishes standards or specifications to be met throughout the
production of their product. Other provisions of the proposed
regulation that will also help to prevent microbiological contamination
of infant formulas are controls to prevent adulteration by workers
(proposed Sec. 106.10), controls on the required temperature of cold
storage compartments used for storing ingredients and uncanned infant
formula (proposed Sec. 106.30(e)(2)), controls on the monitoring of the
temperature of both cold storage and thermal processing equipment
(proposed Sec. 106.30(e)), controls on the spray-drying process for
powdered infant formula including the filtering of the intake air
before heating to prevent microbial growth (proposed
Sec. 106.50(d)(2)), and controls to ensure that each container of
finished product is properly sealed (proposed Sec. 106.50(d)(4)).
The incident in which infant formula was found to contain
Salmonella resulted in two reported cases of salmonellosis in infants.
The average value of preventing a single case of salmonellosis is
estimated to be about $2,000 (Ref. 88). If an incident like this is
avoided in the future because of this proposed rule, the value of the
adverse health effects avoided would be a benefit of this proposed
rule.
This incident also resulted in two recalls. FDA estimates a
combined cost, including costs that accrued to both the manufacturer
and FDA of approximately $0.7 million per recall. If an incident like
this is avoided in the future because of this proposed rule, the recall
costs that would otherwise have been associated with this incident
would also be a benefit of this proposed rule.
Another benefit of the proposed regulations is a potential
reduction in the administrative and time costs of entering the infant
formula industry. Currently, infant formula manufacturers must analyze
and interpret the relevant laws to determine the legal requirements
involved in the manufacture of infant formula. Incumbent firms have
tended to accept FDA's interpretations of these laws and have received
information on this interpretation incrementally over time, chiefly
through direct contact with FDA on various issues.
It is reasonable to expect that potential entrants into the infant
formula industry would also prefer to rely on FDA's interpretations of
the relevant laws. However, considerable time and administrative costs
are involved in obtaining this information because there is no
established
[[Page 36205]]
mechanism by which manufacturers can obtain this information other than
direct communication with FDA on various particular issues. By
providing an explicit specification of the activities that are required
by the relevant laws, the proposed regulations, if adopted, will reduce
the time and administrative costs involved in entering this industry.
In order to determine the net effect of the proposed rule on the
cost of entering the infant formula industry, the reduction in time and
administrative costs must be weighed against the additional compliance
costs imposed by this proposed rule on new firms. These countervailing
compliance costs are probably low because new firms will probably
undertake voluntarily the same activity that is currently undertaken
voluntarily by incumbent manufacturers. Therefore, the net effect of
this proposed rule is likely to be the reduction in the cost of
entering the infant formula industry. Publication of the proposed and
final regulations will provide a means of expedited entry for new firms
into the infant formula market.
A reduction in the cost of entering the infant formula industry
will promote both price competition and innovation in this industry.
Increased price competition may lead to health benefits because, as
stated above, high infant formula prices may encourage some consumers
to: (1) Improperly dilute infant formula to reduce the cost per
serving; (2) prematurely switch from infant formula to cow's milk; or
(3) use inappropriate substitutes for breast milk and infant formula.
A final benefit of this proposed rule is the cost savings generated
by the elimination of the current FDA requirement that a vitamin D rat
bioassay be performed for all major changes in infant formula. In 1992,
there were approximately 50 major changes. The cost of a rat bioassay
for vitamin D for infant formula at a private lab is about $1,070 (Ref.
89). Infant formula manufacturers should therefore save approximately
$54,000 in testing costs per year.
3. Option 3--Adopt Regulations Less Stringent than the Proposed
Regulations
Except for the value of the risk reductions resulting from
requirements that go beyond activity currently undertaken by infant
formula manufacturers the benefits of this option are identical to
those of Option 2.
C. Conclusions
In accordance with Executive Order 12286, FDA has analyzed the
economic effects of this proposed rule and has determined that this
rule, if issued, will not be a significant rule as defined by that
order. In accordance with the Regulatory Flexibility Act, FDA certifies
that the proposed rule will not have a significant impact on a
substantial number of small businesses.
The primary compliance costs of Option 2 include both direct costs
of new requirements and precluded production cost reductions which may
occur without this regulation. FDA has estimated direct costs to
incumbent manufacturers to be approximately $0.7 million in the first
year and $0.6 million each additional year. An additional cost to
incumbent manufacturers is the cost of repairing or replacing
instruments and controls when those instruments and controls cannot be
adjusted to agreement with the reference standard. FDA has insufficient
information to estimate this cost. FDA does not expect compliance with
the proposed regulations to cause any significant increase in the price
of infant formula products. However, the agency requests comments about
any potential effects of the proposed regulations on the price of
infant formula products.
The primary benefit of Option 2 is the reduction in the risk that
defective infant formula will be produced, go undetected, and reach the
market. FDA has insufficient information to estimate this potential
benefit. In addition, this proposed rule is also expected to reduce the
time and administrative costs of entering the infant formula industry.
This benefit may increase price competition in the infant formula
industry and reduce the health risks associated with high infant
formula prices. FDA also has insufficient information to estimate these
benefits.
Except for the costs and benefits associated with activity required
by this proposed rule that some incumbent manufacturers do not
currently undertake, the costs and benefits of Option 3 are identical
to those of Option 2. FDA has insufficient information to estimate
either the costs or benefits of this option.
Option 1 is expected to have higher costs and lower benefits than
either Option 2 or Option 3.
VII. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description for the proposed
collection of information are shown below, along with an estimate of
the annual recordkeeping and periodic reporting burden. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the necessary information, and
completing and submitting the registrations, notifications, and other
submissions that would be required under the proposed regulations.
FDA solicits public comment in order to: (1) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (2) evaluate the accuracy of
the agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) enhance the quality, utility, and clarity of the information
to be collected; and (4) minimize the burden of the collection of
information on those who are to respond, including through the use of
automated collection techniques, where appropriate or other forms of
information technology.
Title: Current Good Manufacturing Practice, Quality Control
Procedures, Quality Factors, Notification Requirements, and Records and
Reports, for the Production of Infant Formula.
Description: FDA is proposing regulations on recordkeeping
requirements that include: (1) Records pertaining to batch production
and control; (2) records pertaining to current good manufacturing
practice and quality control; (3) records pertaining to distribution of
the infant formula; and (4) records pertaining to regularly scheduled
audits. FDA is also proposing regulations on reporting requirements
pertaining to: (1) Registration of a new infant formula; (2) submission
requirements for a new infant formula; (3) submission requirements to
provide assurance that an infant formula meets the quality factor
requirements; (4) submission requirements when there is a change in the
formulation or processing of the formula that may affect whether the
formula is adulterated; and (5) submission requirements to provide
assurance that the infant formula complies with the requirements of the
Federal Food, Drug, and Cosmetic Act and is not adulterated.
Description of Respondents: Infant Formula Manufacturers.
[[Page 36206]]
Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual Total
21 CFR No. of frequency of annual Hours per Total hours
recordkeepers recordkeeping records recordkeeping
----------------------------------------------------------------------------------------------------------------
106.6.................................... 5 1 5 200 1,000
106.20(f)(4) and 106.100(f)(1)........... 5 52 260 3 780
106.30(d) and 106.100(f)(2).............. 5 25 125 4 500
106.30(e)(3)(ii) and 106.100(f)(3)....... 5 365 1,825 2 3,650
106.30(f) and 106.100(f)(4).............. 5 365 1,825 3 5,475
106.35(c) and 106.100(f)(5).............. 5 2 10 500 5,000
106.40(d)................................ 5 20 100 30 3,000
106.40(g) and 106.100(f)(6).............. 5 122 610 4 2,440
106.50................................... 5 1 5 200 1,000
106.55(d) 106.100(e)(5)(ii), and
106.100(f)(7)........................... 5 182 910 3 2,730
106.60(c)................................ 5 1 5 40 200
106.91(c), 106.100(e)(5)(i), and
106.100(f)(7)........................... 5 365 1,825 4 7,300
106.94................................... 5 1 5 88 440
106.97................................... 5 0.6 3 225 675
106.100(e)............................... 5 365 1,825 9 16,425
------------
Total................................ ............. ............. ........... ............. 50,615
----------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Annual
No of frequency Total Hours per
21 CFR respondents per annual response Total hours
response responses
----------------------------------------------------------------------------------------------------------------
106.110........................................ 3 NA 20 1 20
106.120........................................ 3 NA 20 49 980
106.121........................................ 3 NA 10 50 500
106.130........................................ 3 NA 20 2 40
106.140........................................ 3 NA 25 5-10 125-250
------------
Total...................................... ........... ........... ........... ........... 1,790
============
Total Recordkeeping and Reporting Burden... 52,405
----------------------------------------------------------------------------------------------------------------
FDA tentatively concludes that there are no capital costs or
operating and maintenance costs associated with the reporting and
recordkeeping provisions of this proposed rule. However, the agency
welcomes comments on any such anticipated costs.
As required by section 3507(d) of the Paperwork Reduction Act of
1995, FDA has submitted a copy of this proposed rule to OMB for its
review of the information collection requirements. Other organizations
and individuals interested in submitting comments regarding this burden
estimate or any aspect of these information collection requirements,
including suggestions for reducing the burden, should direct them to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, ATTN:
Desk Officer for FDA. Written comments on the information collection
should be submitted by August 8, 1996.
VIII. Requests for Comments
Interested persons may, on or before October 7, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
IX. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
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67. Ziegler, E. E., and S. J. Fomon, ``Lactose Enhances Mineral
Absorption in Infancy,'' Journal of Pediatric Gastroenterology and
Nutrition, 2:288-294, 1983.
68. Moya, M., E. Cortes, M. I. Ballester et al., ``Short-term
Polycose Substitution for Lactose Reduces Calcium Absorption in
Healthy Term Babies,'' Journal of Pediatric Gastroenterology and
Nutrition, 14:57-61, 1992.
69. Shenai, J. P., B. M. Jhaveri, J. W. Reynolds et al.,
``Nutritional Balance Studies in Very Low Birth Weight Infants: Role
of Soy Formula,'' Pediatrics, 67:631-637, 1981.
70. Lindroth, M., U. Westgren, and S. Laurin, ``Rickets in Very Low
Birth Weight Infants; Influence of Supplementation with Vitamin D,
Phosphorus, and Calcium,'' Acta Pediatrica Scandinavica, 75:927-931,
1986.
71. Chan, G. M., and L. J. Mileur, ``Posthospitalization Growth and
Bone Mineral Status of Normal Preterm Infants,'' American Journal of
Diseases in Childhood, 139:896-8, 1985.
72. Food and Drug Administration, Public Health Service, U.S.
Department of Health and Human Services, Guidelines for the Format
and Content of the Clinical and Statistical Sections of New Drug
Applications July, 1988.
73. American Academy of Pediatrics. Pediatric Nutrition Handbook, 3d
ed., 1993.
74. Roche, A. F., S. Guo, and W. M. Moore, ``Weight and Recumbent
Length From 1 to 12 Mo of Age: Reference Data for 1-Mo Increments,''
American Journal of Clinical Nutrition, 49:599-607, 1989.
75. Moore, W. M., and A. F. Roche, ``Pediatric Anthropometry,'' Ross
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77. Sarwar, G., R. W. Peace, and H. G. Botting, ``Differences in
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81. Minton, S. D., J. J. Steichen, and R. C. Tsang, ``Bone Mineral
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82. Steichen, J. J., P. A. Steichen Asch, and R. C. Tsang, ``Bone
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in Evaluating Bone, Lean Body Mass, and Fat in Pediatric Subjects,''
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Delmas, and P. J. Meunier, ``Dual Energy X-ray Absorptiometry
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Content in Infants: The New Age,'' Acta Pediatrica, 82:709-10, 1993.
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List of Subjects
21 CFR Part 106
Food grades and standards, Infants and children, Nutrition,
Reporting and recordkeeping requirements, Incorporation by reference.
21 CFR Part 107
Food labeling, Infants and children, Nutrition, Reporting and
recordkeeping requirements, Signs and symbols.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to Commissioner of Food and Drugs, it is proposed
that 21 CFR parts 106 and 107 be amended as follows:
PART 106--INFANT FORMULA--REQUIREMENTS PERTAINING TO CURRENT GOOD
MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY
FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
1. The authority citation for 21 CFR part 106 continues to read as
follows:
Authority: Secs. 201, 412, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 350a, 371).
2. The heading for part 106 is revised to read as set forth above.
3. Section 106.1 is revised to read as follows:
Sec. 106.1 Status and applicability of the regulations in part 106.
(a) The criteria set forth in subparts B, C, and D of this part
prescribe the steps that manufacturers must take under section
412(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (the
act) in processing infant formula. If the processing of the formula
does not comply with any regulation in subparts B, C, or D of this
part, the formula will be deemed to be adulterated under section
412(a)(3) of the act.
(b) The criteria set forth in subpart E of this part prescribe the
quality factor requirements that infant formula must
[[Page 36209]]
meet under section 412(b)(1) of the act. If the formula fails to comply
with any regulation in subpart E of this part, it will be deemed to be
adulterated under section 412(a)(2) of the act.
(c) The criteria set forth in subpart F of this part implement the
record retention requirements established in section 412(b)(4) of the
act. Failure to comply with any regulation in subpart F of this part is
a violation of section 301(e) of the act.
(d) The criteria set forth in subpart G of this part describe the
circumstances in which infant formula manufacturers are required to
register with, submit to, or notify the Food and Drug Administration,
and the content of those registrations, submissions, or notifications,
under section 412(c), (d), and (e) of the act. Failure to comply with
any regulation in subpart G of this part is a violation of section
301(s) of the act.
4. Section 106.3 is revised to read as follows:
Sec. 106.3 Definitions.
The definitions in this section and the definitions contained in
section 201 of the Federal, Food, Drug, and Cosmetic Act (the act)
shall apply to infant formula requirements in 21 CFR part 106 and part
107 of this chapter.
(a) Batch means a specific quantity of an infant formula or other
material that is intended to have uniform character and quality, within
specified limits, and is produced according to a single manufacturing
order during the same cycle of manufacture.
(b) Final-product-stage means the point in the manufacturing
process, before distribution of an infant formula, at which the infant
formula is homogeneous and is not subject to further degradation due to
processing.
(c) Indicator nutrient means a nutrient whose concentration is
measured during the manufacture of an infant formula to confirm
complete addition and uniform distribution of a premix or other
substance of which the indicator nutrient is a part.
(d) Infant means a person not more than 12 months of age.
(e) Infant formula means a food which purports to be or is
represented for special dietary use solely as a food for infants by
reason of its simulation of human milk or its suitability as a complete
or partial substitute for human milk.
(f) In-process batch means a combination of ingredients at any
point in the manufacturing process before packaging.
(g) Lot means a batch, or a specifically identified portion of a
batch, having uniform character and quality within specified limits;
or, in the case of an infant formula produced by continuous process, it
is a specific identified amount produced in a unit of time or quantity
in a manner that assures its having uniform character and quality
within specified limits.
(h) Lot number, control number, or batch number means any
distinctive combination of letters, numbers, symbols, or any
combination of them, from which the complete history of the
manufacture, processing, packing, holding, and distribution of a batch
or lot of infant formula or other material can be determined.
(i) Major change in an infant formula means any new formulation, or
any change of ingredients or processes where experience or theory would
predict a possible significant adverse impact on levels of nutrients or
bioavailability of nutrients, or any change that causes an infant
formula to differ fundamentally in processing or in composition from
any previous formulation produced by the manufacturer. Examples of
infant formulas deemed to differ fundamentally in processing or in
composition include:
(1) Any infant formula produced by a manufacturer who is entering
the U.S. market;
(2) Any infant formula powder processed and introduced for
commercial or charitable distribution by a manufacturer who previously
only produced liquids (or vice versa);
(3) Any infant formula having a significant revision, addition, or
substitution of a macronutrient (i.e., protein, fat, or carbohydrate),
with which the manufacturer has not had previous experience;
(4) Any infant formula manufactured on a new processing line or in
a new plant;
(5) Any infant formula manufactured containing a new constituent
not listed in section 412(i) of the act, such as taurine or L-
carnitine;
(6) Any infant formula processed by a manufacturer on new equipment
that utilizes a new technology or principle (e.g., a change from
terminal sterilization to aseptic processing); and
(7) An infant formula for which there has been a fundamental change
in the type of packaging used (e.g., changing from metal cans to
plastic pouches).
(j) Manufacturer means a person who prepares, reconstitutes, or
otherwise changes the physical or chemical characteristics of an infant
formula or packages or labels the product in a container for
distribution.
(k) Microorganisms means yeasts, molds, bacteria, and viruses and
includes, but is not limited to, species having public health
significance.
(l) New infant formula means:
(1) An infant formula manufactured by a person that has not
previously manufactured an infant formula for the U.S. market, and
(2) An infant formula manufactured by a person that has previously
manufactured infant formula and in which there is a major change in
processing or formulation from a current or any previous formulation
produced by such manufacturer.
(m) Nutrient means any vitamin, mineral, or other substance or
ingredient that is required in accordance with the table set out in
section 412(i)(1) of the act or by regulations issued under section
412(i)(2) or that is identified as essential for infants by the Food
and Nutrition Board of the National Research Council through its
development of a Recommended Dietary Allowance or an Estimated Safe and
Adequate Daily Dietary Intake range, or that has been identified as
essential for infants by the Food and Drug Administration through a
Federal Register publication.
(n) Nutrient premix means a combination of ingredients containing
two or more nutrients received from a supplier or prepared by an infant
formula manufacturer.
(o) Quality factors mean those factors necessary to demonstrate
that the infant formula, as prepared for market, provides nutrients in
a form that is bioavailable and safe as shown by evidence that
demonstrates that the formula supports healthy growth when fed as a
sole source of nutrition.
(p) Representative sample means a sample that consists of a number
of units that are drawn based on rational criteria, such as random
sampling, and intended to ensure that the sample accurately portrays
the material being sampled.
(q) Shall is used to state mandatory requirements.
(r) Should is used to state recommended or advisory procedures or
to identify recommended equipment.
5. Part 106 is amended by redesignating subparts B, C, and D as
subparts C, F, and G, respectively, and adding new subparts B, D, and
E; and by revising newly redesignated subparts C and G to read as
follows:
* * * * *
[[Page 36210]]
Subpart B--Current Good Manufacturing Practice
Sec.
106.5 Current good manufacturing practice.
106.6 Production and in-process control system.
106.10 Controls to prevent adulteration by workers.
106.20 Controls to prevent adulteration caused by facilities.
106.30 Controls to prevent adulteration caused by equipment or
utensils.
106.35 Controls to prevent adulteration due to automatic
(mechanical or electronic) equipment.
106.40 Controls to prevent adulteration caused by ingredients
containers, and closures.
106.50 Controls to prevent adulteration during manufacturing.
106.55 Controls to prevent adulteration from microorganisms.
106.60 Controls to prevent adulteration during packaging and
labeling of infant formula.
106.70 Controls on the release of finished infant formula.
106.80 Traceability.
106.90 Audits of current good manufacturing practice.
Subpart C--Quality Control Procedures
106.91 General quality control.
106.92 Audits of quality control procedures.
Subpart D--Conduct of Audits
106.94 Audit plans and procedures.
Subpart E--Quality Factors for Infant Formulas
106.96 Quality factors in infant formulas.
106.97 Assurances for quality factors.
* * * * *
Subpart G--Registration, Submission, and Notification Requirements
106.110 New infant formula registration.
106.120 New infant formula submission.
106.121 Quality factor submission.
106.130 Verification submission.
106.140 Submission concerning a change in infant formula that may
adulterated the product.
106.150 Notification of an adulterated or misbranded infant
formula.
* * * * *
Subpart B--Current Good Manufacturing Practice
Sec. 106.5 Current good manufacturing practice.
(a) The regulations set forth in this subpart and, for liquid
infant formulas, in part 113 of this chapter define the minimum current
good manufacturing practices that are to be used in, and the facilities
or controls that are to be used for, the manufacture, processing,
packing, or holding of an infant formula. Compliance with these
provisions is necessary to ensure that such infant formula provides the
nutrients required under Sec. 107.100 of this chapter and is
manufactured in a manner designed to prevent its adulteration.
(b) The failure to comply with any regulation set forth in this
subpart or, for liquid infant formulas, in part 113 of this chapter in
the manufacture, processing, packing, or holding of an infant formula
shall render such infant formula adulterated under section 412(a)(3) of
the Federal Food, Drug, and Cosmetic Act (the act).
Sec. 106.6 Production and in-process control system.
(a) Manufacturers shall conform to the requirements of this subpart
by implementing a system of production and in-process controls. This
production and in-process control system shall cover all stages of
processing, from the receipt and acceptance of the raw materials,
ingredients, and components through the storage and distribution of the
finished product and shall be designed to ensure that all the
requirements of this subpart are met.
(b) The production and in-process control system shall be set out
in a written plan, or set of procedures, that is designed to ensure
that an infant formula is manufactured in a manner that will prevent
adulteration of the infant formula.
(c) At any point, step, or stage in the production process where
control is necessary to prevent adulteration, the manufacturer shall:
(1) Establish standards or specifications to be met;
(2) Monitor the production and in-process control point, step, or
stage;
(3) Establish corrective action plans for use when a standard or
specification established in accordance with paragraph (b)(1) of this
section is not met;
(4) Review the results of the monitoring required by paragraph
(c)(2) of this section, and review and evaluate the public health
significance of any deviations from standards or specifications that
have been established in accordance with paragraph (c)(1) of this
section. This review shall be conducted by an individual qualified by
training and experience to conduct such reviews; and
(5) Establish recordkeeping procedures, in accordance with
Sec. 106.100(e)(3), that ensure that compliance with the requirements
of this section is documented.
Sec. 106.10 Controls to prevent adulteration by workers.
(a) There shall be sufficient personnel, qualified by training and
experience, to perform all operations, including all required
recordkeeping, in the manufacture, processing, packing, and holding of
each infant formula and to supervise such operations to ensure that
they are correctly and fully performed.
(b) Personnel working directly with infant formula, infant formula
raw materials, infant formula packaging, or infant formula equipment or
utensil contact surfaces shall practice good personal hygiene to
protect the infant formula against contamination. Good personal hygiene
includes, but is not limited to:
(1) Wearing clean outer garments and, as necessary, protective
apparel such as head, face, hands, and arm coverings; and
(2) Washing hands thoroughly in a hand washing facility with soap
and running water at a suitable temperature before starting work, after
each absence from the work station, and at any other time when the
hands may become soiled or contaminated.
(c) Any person who reports that he or she has, or appears by
medical examination or supervisory observation to have, an illness,
open lesion, including boils, sores, or infected wounds, or any other
source of microbial contamination that creates a reasonable possibility
that the safety of an infant formula may be adversely affected, shall
be excluded from direct contact with ingredients, containers, closures,
in-process materials, equipment, utensils, and infant formula product
until the condition is corrected or determined by competent medical
personnel not to jeopardize the safety of the infant formula.
Sec. 106.20 Controls to prevent adulteration caused by facilities.
(a) Buildings used in the manufacture, processing, packing, or
holding of infant formula shall be maintained in a clean and sanitary
condition and shall have space for the separation of incompatible
operations, such as the handling of raw materials, the manufacture of
the product, and packaging and labeling operations.
(b) Separate areas shall be designated for holding raw materials,
in-processing materials, and final product infant formula:
(1) Pending release for use in infant formula production or pending
release of the final product,
(2) After rejection for use in infant formula and before
disposition, and
(3) After release for use in infant formula production or after
release of the final product.
(c) Lighting shall allow easy identification of raw materials,
[[Page 36211]]
packaging, labeling, in-process materials, and finished products that
have been released for use in infant formula production and shall
permit the easy reading of instruments and controls necessary in
processing, packaging, and laboratory analysis. Any lighting fixtures
directly over or adjacent to exposed raw materials, in-process
materials, or bulk (unpackaged) finished product shall be protected to
prevent glass from contaminating the product in the event of breakage.
(d) Air filtration systems, including prefilters and particulate
matter air filters, shall be used on air supplies to production areas
where ingredients or infant formula are directly exposed to the
atmosphere.
(e) All rodenticides, insecticides, fungicides, fumigating agents,
and cleaning and sanitizing agents shall be stored and used in a manner
that protects against contamination of infant formula.
(f)(1) Potable water used in the manufacture of infant formula
shall meet the standards prescribed in the Environmental Protection
Agency's (EPA's) Primary Drinking Water Regulations set forth in 40 CFR
part 141, except that the fluoride level of the water used in infant
formula manufacturing shall be as low as possible. The water shall be
supplied under continuous positive pressure in a plumbing system that
is free of defects that could contaminate an infant formula.
(2) Manufacturers shall test representative samples of the potable
water drawn at a point in the system at which the water is in the same
condition that it will be when it is used in infant formula
manufacturing.
(3) Manufacturers shall conduct the tests required by paragraph
(f)(2) of this section with sufficient frequency to ensure that the
water meets the EPA's Primary Drinking Water Regulations but shall not
conduct these tests less frequently than annually for chemical
contaminants, every 4 years for radiological contaminants, and weekly
for bacteriological contaminants.
(4) Manufacturers shall make and retain records, in accordance with
Sec. 106.100(f)(1), of the frequency and results of testing of the
water used in the production of infant formula.
(g) There shall be no backflow from, or cross-connection between,
piping systems that discharge waste water or sewage and piping systems
that carry water for infant formula manufacturing.
(h) When steam comes in direct contact with infant formula, it
shall be safe and free of rust and other particulate matter that may
contaminate the formula. Boiler water additives in the steam shall be
used in accordance with Sec. 173.310 of this chapter.
(i) Each infant formula manufacturing site shall provide its
employees with readily accessible toilet facilities and hand washing
facilities that include hot and cold water, soap or detergent, and
single-service towels and that are maintained in good repair and in a
sanitary condition at all times, and that these facilities provide for
proper disposal of the sewage. Doors to the toilet facility shall not
open into areas where infant formula ingredients, containers, or
closures are stored, or where infant formula is processed or stored.
Sec. 106.30 Controls to prevent adulteration caused by equipment or
utensils.
(a) Equipment used in the manufacture, processing, packing or
holding of an infant formula shall be of appropriate design and shall
be installed to facilitate its intended function and its cleaning and
maintenance.
(b) Equipment and utensils used in the manufacture, processing,
packing, or holding of an infant formula shall be constructed so that
surfaces that contact ingredients, in-process materials, or infant
formula are made of nontoxic materials and are not reactive or
absorptive. Such equipment and utensils shall be designed to be easily
cleanable and to withstand the environment of their intended use. All
surfaces that contact ingredients, in-process materials, or infant
formula shall be cleaned, sanitized, and maintained to protect infant
formula from being contaminated by any source. Sanitizing agents used
on food-contact surfaces must comply with Sec. 178.1010 of this
chapter.
(c) Manufacturers shall ensure that substances, such as lubricants
or coolants, that are required for operation of infant formula
manufacturing equipment, but that would render the infant formula
adulterated if they contaminated the formula, do not come in contact
with formula ingredients, containers, closures, or in-process materials
or with infant formula itself.
(d)(1) Manufacturers shall ensure that instruments used for
measuring, regulating, or controlling mixing time and speed,
temperature, pressure, moisture, water activity, or other parameters at
points where control is deemed necessary to prevent adulteration in the
processing of an infant formula are accurate, easily read, properly
maintained, and present in sufficient number for their intended use.
The instruments and controls shall be tested for accuracy (calibrated)
against a known reference standard before first use and thereafter at
routine intervals, as specified in writing by the manufacturer of the
instrument or control, or as otherwise deemed necessary to ensure the
accuracy of the instrument. The known reference standard shall be
certified for accuracy at routine intervals specified in writing by the
manufacturer of the instrument, or as otherwise deemed necessary to
ensure the accuracy of the instrument. Manufacturers shall make and
retain records of the accuracy checks in accordance with
Sec. 106.100(f)(2).
(2) Instruments and controls that cannot be adjusted to agree with
the reference standard shall be repaired or replaced.
(3) If calibration of an instrument (testing for accuracy against a
known reference standard) shows that a specification or standard for a
point where control is deemed necessary to prevent adulteration has not
been met, a written evaluation of all affected product, and of any
actions that need to be taken with respect to that product, shall be
made, in accordance with Sec. 106.100(f)(2).
(e)(1) The temperature in cold storage compartments that are used
to store raw materials, in-process materials, or final product, and in
thermal processing equipment used at points where temperature control
is necessary to prevent adulteration, shall be monitored with such
frequency as is necessary to ensure that temperature control is
maintained.
(2) Cold storage compartments shall be maintained at a temperature
of 40 deg.F (4.4 deg.C) or below.
(3)(i) Cold storage compartments and thermal processing equipment
shall be equipped with easily readable, accurate temperature-indicating
devices.
(ii) Thermal processing equipment shall be equipped with
temperature-recording devices that will reflect the true temperature on
a continuing basis. Cold storage compartments shall be equipped with
either temperature-recording devices that will reflect the true
temperature, on a continuing basis, within the compartment or, in lieu
of a temperature-recording device, a high temperature alarm or a
maximum-indicating thermometer that has been verified to function
properly. If the manufacturer uses either of the latter options, it
shall maintain a temperature log in which it notes temperature with
such frequency as is necessary to achieve control. Manufacturers shall
make and retain records, in accordance with Sec. 106.100(f)(3), of the
temperatures indicated or recorded by these devices.
[[Page 36212]]
(4) When a temperature-recording device is used, such device shall
not read higher than the calibrated temperature-indicating device for
thermal processing equipment or lower than the reference temperature-
indicating device for cold storage compartments.
(f) Equipment and utensils used in the manufacture of infant
formula shall be cleaned, sanitized, and maintained at regular
intervals to prevent adulteration of the infant formula. An individual
qualified by training or experience to conduct such a review shall
check all cleaning, sanitizing, and maintenance to ensure that it has
been satisfactorily completed. Manufacturers shall make and retain
records on equipment cleaning, sanitizing, and maintenance, in
accordance with Sec. 106.100(f)(4).
(g) Compressed air or other gases that are mechanically introduced
into infant formula, that are used to clean any equipment, or that come
into contact with any other surface that contacts ingredients, in-
process materials, or infant formula shall be treated in such a way
that their use will not contaminate the infant formula with unlawful
indirect food additives or other chemical, physical, or microbiological
contaminants. When compressed gases are used at product filling
machines to replace air removed from the headspace of containers, the
manufacturer shall install a 0.5 micrometer or smaller filter as close
to the end of the gas line that feeds gas into the space, as practical.
Sec. 106.35 Controls to prevent adulteration due to automatic
(mechanical or electronic) equipment.
(a)(1) For the purposes of this section, ``hardware''
FR Doc. 96-17058 Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula
means all
automatic equipment, including mechanical and electronic equipment
(including computers), that is used in production or quality control of
a infant formula.
(2) For the purposes of this section, ``software'' means any
programs, procedures, rules, and associated documentation used in the
operation of a system.
(3) For the purposes of this section, ``system'' means a collection
of components (including software and hardware) organized to accomplish
a specific function or set of functions in a specified environment.
(4) For the purposes of this section, ``validation'' means
establishing documented evidence that provides a high degree of
assurance that a system will consistently produce a product meeting its
predetermined specifications and quality characteristics.
(b)(1) All systems shall be designed, installed, tested, and
maintained in a manner that will ensure that they are capable of
performing their intended function and of producing or analyzing infant
formula in accordance with this subpart and subpart C of this part.
(2) The infant formula manufacturer shall ensure that hardware is
routinely calibrated, inspected, and checked according to written
procedures.
(3) The infant formula manufacturer shall check and document the
accuracy of input into, and output generated by, any system used in the
production or quality control of an infant formula. The degree and
frequency of input/output verification shall be based on the complexity
and reliability of the system and the level of risk associated with the
safe operation of the system.
(4) The infant formula manufacturer shall ensure that all systems
are validated before their first use to manufacture commercial product.
(5) The infant formula manufacturer shall ensure that any system
that is modified is revalidated after the modification and before use
of the modified system to manufacture commercial product. All
modifications to software shall be made by a designated individual and
shall be checked by the infant formula manufacturer to ensure that
infant formula that is produced or analyzed using the modified software
complies with this subpart and with subpart C of this part.
(c) The infant formula manufacturer shall make and retain records,
in accordance with Sec. 106.100(f)(5), concerning automatic (mechanical
or electronic) equipment.
Sec. 106.40 Controls to prevent adulteration caused by ingredients,
containers, and closures.
(a) The only substances that may be used in infant formulas are
food ingredients whose use in infant formula is safe and suitable under
the applicable food safety provisions of the Federal Food, Drug, and
Cosmetic Act; that is, the substance is generally recognized as safe
(GRAS) for such use, is used in accordance with the agency's food
additive regulations, or is authorized by a prior sanction.
(b) Infant formula containers and closures shall not be reactive or
absorptive so as to affect the safety of the infant formula, and all
packaging material that comes in contact with infant formula shall be
composed of substances that are GRAS for use in or on food, GRAS for
their intended use in food packaging, authorized by a prior sanction
issued by the agency, or authorized for use as an indirect food
additive. Any packaging material that comes in contact with infant
formula shall be used in accordance with any prescribed limitations.
(c) Ingredients, containers, and closures used in the manufacture
of infant formula shall be identified with a batch or lot number to be
used in recording their disposition.
(d) Infant formula manufacturers shall develop written
specifications for their acceptance or rejection of ingredients,
containers, and closures used in infant formula manufacture. These
specifications shall stipulate the standards for acceptance or
rejection of such ingredients, containers, and closures as well as the
procedures for determining whether the ingredients, containers, and
closures meet that standard. An individual qualified by training or
experience shall conduct an investigation of a finding that any
ingredients, containers, or closures used in a batch of infant formula
failed to meet any of the manufacturer's specifications.
(e) Ingredients, containers and closures shall be stored in areas
clearly designated for:
(1) Materials pending release for use,
(2) Materials released for use, or
(3) Materials rejected for use in infant formula production. Any
lot of ingredients, containers, or closures that does not meet the
manufacturer's specifications shall be rejected and controlled under a
quarantine system designed to prevent its use in the manufacture of
infant formula.
(f) If an ingredient, a container, or a closure that has been
tested and examined is exposed to air, heat, or other conditions that
may adversely affect it, the ingredient, container, or closure shall be
retested or reexamined to ensure that it still meets the manufacturer's
specifications.
(g) Manufacturers shall make and retain records, in accordance with
Sec. 106.100(f)(6), on the ingredients, containers, and closures used
in the manufacture of infant formula.
Sec. 106.50 Controls to prevent adulteration during manufacturing.
(a)(1) Manufacturers shall prepare and follow a written master
manufacturing order that establishes controls and procedures for the
production of an infant formula.
(2) The manufacturer shall make and retain records, in accordance
with Sec. 106.100(e), that include complete information relating to the
production and control of the batch. An individual qualified by
training or experience shall conduct an investigation of any
[[Page 36213]]
deviations from the master manufacturing order and any corrective
actions taken.
(3) Changes made to the master manufacturing order shall be
drafted, reviewed, and approved by a responsible official and include
an evaluation of the effect of the change on the nutrient content and
the suitability of the formula for infants.
(b) The manufacturer shall establish controls to ensure that each
raw or in-process ingredient required by the master manufacturing order
is examined by one person and checked by a second person or system.
This checking will ensure that the correct ingredient is added during
the manufacturing process, that the ingredient has been released for
use in infant formula, and that the correct weight or measure of the
ingredient is added to the batch.
(c) The manufacturer shall identify the contents, including the
processing stage and the lot or batch number of a batch of infant
formula, of all compounding and storage containers, processing lines,
and major equipment used during the production of a batch of an infant
formula.
(d) The manufacturer shall establish controls to ensure that the
nutrient levels required by Sec. 107.100 of this chapter are maintained
in the formula, and that the formula is not contaminated with
microorganisms or other contaminants. Such controls shall include but
not be limited to:
(1) The mixing time; the speed, temperature, and flow rate of
product; and other critical parameters necessary to ensure the addition
of required ingredients to, and the homogeneity of, the formula;
(2) The spray-drying process for powdered infant formula, including
the filtering of the intake air before heating, to prevent microbial
and other contamination;
(3) The removal of air from the finished product to ensure that
nutrient deterioration does not occur;
(4) Ensuring that each container of finished product is properly
sealed. Such controls shall involve use of established procedures,
specifications, and intervals of examination that are designed by
qualified individuals and are sufficient to:
(i) Detect visible closure or seal defects, and
(ii) Determine closure strength through destructive testing.
Manufacturers of liquid infant formulas, which are thermally processed
low-acid foods packaged in hermetically sealed containers, shall
perform such closure integrity testing in accordance with
Sec. 113.60(a) of this chapter.
(e) The manufacturer shall establish controls that ensure that the
equipment used at points where control is deemed necessary to prevent
adulteration is monitored, so that personnel will be alerted to
malfunctions.
(f) The manufacturer shall establish controls that ensure that
rejected in-process materials:
(1) Are clearly identified as having been rejected for use in an
infant formula;
(2) Are controlled under a quarantine system designed to prevent
their use in manufacturing or processing operations for which they are
unsuitable;
(3) Meet the appropriate specifications, if reprocessed, before
being released for use in infant formula.
Sec. 106.55 Controls to prevent adulteration from microorganisms.
(a) Manufacturers of liquid infant formula shall comply with the
procedures specified in part 113 of this chapter for liquid infant
formula.
(b) Manufacturers of powdered infant formula shall test
representative samples of every batch of the formula at the final
product stage, before distribution, to ensure that the infant formula
meets the microbiological quality standards listed in paragraph (c) of
this section.
(c) Any powdered infant formula that contains any microorganism
that exceeds the M value listed for that microorganism in Table 1 of
this section will be deemed to be adulterated under sections 402 and
412 of the Federal Food, Drug, and Cosmetic Act (the act). FDA will
determine compliance with the M values listed below using the
Bacteriological Analytical Manual (BAM), 8th ed. (1995), published by
the AOAC International Association of Official Analytical Chemists,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the Association of
Official Analytical Chemists, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, 200 C St. SW., rm. 3321,
Washington, DC, or may be examined at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
------------------------------------------------------------------------
Microorganism M value \1\
------------------------------------------------------------------------
Aerobic Plate Count (APC)................. 10,000 CFU/gram (g). \2\
Coliforms \3\............................. 3.05 MPN/g. 4,5
Fecal coliforms \6\....................... 3.05 MPN/g.
Salmonella................................ 0. \7\
Listeria monocytogenes.................... 0. \7\
Staphylococcus aureus..................... 3.05 MPN/g.
Bacillus cereus \8\....................... 100 MPN/g or CFU/g.
------------------------------------------------------------------------
\1\ The M value is the maximum allowable number of microorganisms
present in 1 g of dry infant formula.
\2\ CFU/g, colony forming units per g.
\3\ M values for coliforms greater than 3.05 are not violative if
testing for fecal coliforms results in an M value equal to or less
than 3.05.
\4\ MPN/g, most probable number per g.
\5\ The MPN value of 3.05 in this table is derived from the tables of
calculated MPN values that appear in the 8th ed. of the BAM when using
an inoculation series of 0.1, 0.01, and 0.001g (or ml) of the infant
formula sample.
\6\ No testing for fecal coliforms is required when the M value for
coliforms is less than or equal to 3.05.
\7\ None detected.
\8\B. cereus testing must be performed only if the APC exceeds 100 CFU/
g.
(d) Manufacturers shall make and retain records, in accordance with
Sec. 106.100(e)(5)(ii) and (f)(7), on the testing of infant formulas
for microorganisms.
Sec. 106.60 Controls to prevent adulteration during packaging and
labeling of infant formula.
(a) Manufacturers shall examine packaged and labeled infant formula
during finishing operations to ensure that containers and packages in
the lot have the correct label, the correct use-by date, and the
correct code established under Sec. 106.80.
(b) Labels shall be designed, printed, and applied so that the
labels remain legible and attached during the conditions of processing,
storage, handling, distribution, and use.
(c) All infant formula held in a single package shall be the same
product bearing the same code, established under Sec. 106.80. Packaging
used to hold multiple containers of infant formula shall be labeled
with the product name, the name of the manufacturer or shipper, and the
code.
Sec. 106.70 Controls on the release of finished infant formula.
(a) The manufacturer shall hold, or maintain under its control,
each batch of infant formula until it determines that the batch meets
all of its specifications, including those adopted to meet the
requirements of Sec. 106.55 on microbiological contamination and
Sec. 106.91(a) on quality control procedures, and releases the batch
for distribution.
(b) Each batch of infant formula that fails to meet the
manufacturer's specifications shall be rejected. Although the batch may
be reprocessed, any batch of infant formula that is reprocessed shall
be shown to meet the
[[Page 36214]]
requirements of Sec. 106.70(a) before it is released.
(c) An individual qualified by training or experience shall conduct
an investigation of a finding that a batch of infant formula fails to
meet any manufacturer's specifications.
Sec. 106.80 Traceability.
(a) Manufacturers shall ensure traceability by coding infant
formulas in conformity with the coding requirements prescribed in
Sec. 113.60(c) of this chapter for thermally processed low-acid foods
packaged in hermetically-sealed containers, except as provided in
paragraph (b) of this section.
(b) Batches of powdered infant formula that are manufactured in
stages over more than 1 day, in lieu of being coded in accordance with
Sec. 113.60(c) of this chapter, may be coded with a sequential number
that identifies the product and the establishment where the product was
packed and that permits tracing of all stages of manufacture of that
batch, including the year, the days of the year, and the period during
those days that the product was packed, and the receipt and handling of
raw materials used.
Sec. 106.90 Audits of current good manufacturing practice.
Manufacturers of an infant formula, or an agent of such
manufacturers, shall conduct regularly scheduled audits to determine
whether the manufacturer has complied with the current good
manufacturing practice regulations in this subpart. These audits shall
be performed by an individual who, as a result of education, training,
and experience, is knowledgeable in all aspects of infant formula
production and of the agency's regulations concerning current good
manufacturing practice but who has no direct responsibility for the
matters being audited.
Subpart C--Quality Control Procedures
Sec. 106.91 General quality control.
(a) Nutrient testing to ensure that each batch of infant formula
provides nutrients in accordance with Sec. 107.100. Manufacturers shall
test each batch as follows:
(1) Each nutrient premix used in the manufacture of an infant
formula shall be tested for each nutrient that the manufacturer is
relying on the premix to provide to ensure that the premix is in
compliance with the manufacturer's specifications;
(2) During the manufacturing process, after the addition of the
premix, or at the final-product-stage but before distribution, each
batch of infant formula shall be tested for at least one indicator
nutrient for each of the nutrient premixes used in the infant formula
to confirm that the nutrients supplied by each of the premixes are
present, in the proper concentration, in the batch of infant formula.
(3) At the final-product-stage, before distribution of an infant
formula, each batch shall be tested for vitamins A, C, E, and thiamin.
(4) During the manufacturing process or at the final-product-stage,
before distribution, each batch shall be tested for all nutrients
required to be included in such formula under Sec. 107.100 of this
chapter and for any nutrient added by the manufacturer for which
testing is not conducted for compliance with paragraphs (a)(1) or
(a)(3) of this section.
(b) Stability testing. Every 3 months, manufacturers shall collect
representative samples from the final-product-stage of one batch of
each physical form (powder, ready-to-feed, or concentrate) of each
infant formula, at each manufacturing facility. The manufacturer shall
test these samples for each nutrient required under Sec. 107.100 of
this chapter and for any nutrient added by the manufacturer. The
frequency of such testing shall be at the beginning, midpoint, and end
of the shelf life of the infant formula and, depending on the nutrient
and its stability within the matrix of the formulation, with additional
frequency as is necessary to ensure that such formula complies with
section 412 of the Federal Food, Drug, and Cosmetic Act (the act)
throughout the shelf life of the infant formula; except that:
(1) If the infant formula is a new infant formula, manufacturers
shall collect a representative sample from the final-product-stage of
each physical form (powder, ready-to-feed, or concentrate) of the first
batch of the new infant formula and test these samples according to the
requirements of this section; and
(2) If an infant formula has been changed in formulation or in
processing in a way that does not make it a new infant formula but that
may affect whether it is adulterated under section 412(a) of the act,
the manufacturer shall collect a representative sample from the final-
product-stage of each physical form (powder, ready-to-feed, or
concentrate) of the first batch of the infant formula and shall test
these samples according to the frequency required by this section for
each nutrient that has been or may have been affected by the change.
(c) Quality control records. Manufacturers shall make and retain
quality control records in accordance with Sec. 106.100(e)(5)(i) and
(f)(7).
Sec. 106.92 Audits of quality control procedures.
A manufacturer of an infant formula, or an agent of such a
manufacturer, shall conduct regularly scheduled audits to determine
whether the manufacturer has complied with the quality control
procedures that are necessary to ensure that an infant formula provides
nutrients in accordance with section 412(b) and (i) of the Federal
Food, Drug, and Cosmetic Act and is manufactured in a manner designed
to prevent adulteration of the infant formula under section 412(a)(1)
and (a)(3) of the Federal Food, Drug, and Cosmetic Act. These audits
shall be performed by an individual who, as a result of education,
training, and experience, is knowledgeable in all aspects of infant
formula production and of the agency's regulations concerning quality
control procedures but who has no direct responsibility for the matters
being audited.
Subpart D--Conduct of Audits
Sec. 106.94 Audit plans and procedures.
(a) Manufacturers shall develop and follow a written audit plan
that is available at the manufacturing facility for FDA inspection.
(b) The audit plan shall include audit procedures that set out the
methods the manufacturer uses to determine whether the facility is
operating in accordance with current good manufacturing practice, with
the quality control procedures that are necessary to assure that an
infant formula provides nutrients in accordance with section 412(b) and
(i) of the Federal Food, Drug, and Cosmetic Act, and in a manner
designed to prevent adulteration of the infant formula.
(c) The audit procedures shall include, but not be limited to:
(1) An evaluation of the production and in-process control system
established under Sec. 106.6(b) by:
(i) Observing the production of infant formula and comparing the
observed process to the written production and in-process control plan
required under Sec. 106.6(b);
(ii) Reviewing records of the monitoring of points, steps, or
stages where control is deemed necessary to prevent adulteration; and
(iii) Reviewing records of how deviations from any standard or
specification at points, steps, or stages where control is deemed
necessary to prevent adulteration were handled; and
[[Page 36215]]
(2) A review of a representative sample of all records maintained
in accordance with Sec. 106.100(e) and (f).
Subpart E--Quality Factors for Infant Formulas
Sec. 106.96 Quality factors in infant formulas.
(a) All infant formulas shall, when fed to infants as a sole source
of nutrition, be of sufficient quality to meet the nutritional
requirements for healthy growth. The regulations set forth in this
subpart define the minimum quality factors for infant formulas.
(b) All infant formulas shall be capable of supporting normal
physical growth of infants.
(c) All infant formulas shall be formulated and manufactured such
that the protein is of sufficient biological quality to meet the
protein requirements of infants.
Sec. 106.97 Assurances for quality factors.
(a) General quality factor of normal physical growth. (1) The
manufacturer shall conduct an adequate and well-controlled clinical
study, in accordance with good clinical practice, to determine whether
an infant formula supports normal physical growth in infants when the
formula is fed as the sole source of nutrition.
(i) The manufacturer shall:
(A) Conduct a clinical study that is no less than 4 months in
duration, enrolling infants no more than 1 month old at time of entry
into the study.
(B) Collect and maintain data in the study on anthropometric
measures of physical growth, including body weight, recumbent length,
head circumference, and average daily weight increment, and plot the
data on National Center for Health Statistics (NCHS) reference
percentile body weight and body length curves. The NCHS growth charts
are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the Office of Constituent
Operations (HFS-565), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, may
be examined at the Office of Special Nutritionals (HFS-456), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, or the Office of the Federal Register,
800 North Capitol St. NW., suite 700, Washington, DC.
(C) Collect anthropometric measurements at the beginning of the
clinical study, at 2 weeks, at 4 weeks, at least monthly thereafter,
and at the conclusion of the study.
(ii) The clinical study protocol should:
(A) Describe the scientific basis and objectives of the study, the
planned control and treatment feeding regimens, the entrance criteria
used to enroll infants in the study, the method of randomization used
for the assignment of infants to feeding groups, the collection of
specific measurements and other data, the methods used to limit sources
of bias, and the planned methods of statistical analysis;
(B) Describe the necessary qualifications and experience of
investigators;
(C) Be reviewed and approved by an Institutional Review Board (IRB)
in accordance with part 56 of this chapter. The manufacturer shall
establish procedures to obtain written informed consent from parents or
legal representatives of the infants enrolled in the study in
accordance with part 50 of this chapter;
(D) Explain how the study population represents the population for
which the new infant formula is intended and how the study addresses
the intended conditions of use of the formula.
(E) Describe the sample size calculations and the power
calculations and the basis for selecting the sample size and study
design;
(F) Describe the plan to identify and evaluate any adverse effects;
(G) Describe the quality control procedures used to ensure the
validity and reliability of the measurements collected.
(H) Describe and compare the composition of the test and control
formulas.
(I) Describe the basis upon which the test formula is appropriate
for use in evaluating the formula that the manufacturer intends to
market, if the test formula used in a study is not identical to the
formula that is intended to be marketed in the United States.
(2) The manufacturer may request an exemption from the requirements
of paragraph (a)(1) of this section if:
(i) The manufacturer has similar experience using an ingredient, an
ingredient mixture, or a processing method in the production of an
infant formula marketed in the United States and can demonstrate that
infant formula made with that ingredient, ingredient mixture, or
processing method meets the quality factor requirements in Sec. 106.96;
(ii) The manufacturer markets a formulation in more than one form
(e.g., liquid and powdered forms) and can demonstrate that the quality
factor requirements are met by the form of the formula that is
processed using the method that has the greatest potential for
adversely affecting nutrient content and bioavailability;
(iii) The manufacturer can demonstrate that the requirements of
paragraph (a)(1) of this section are not appropriate for evaluation of
a specific infant formula, and that an alternative method or study
design for showing that the formula supports healthy growth in infants
fed it as their sole source of nutrition is available.
(b) Specific quality factor for protein quality of infant formula.
(1) The manufacturer shall collect and maintain data that establish
that the biological quality of protein in an infant formula is
sufficient to meet the protein requirements of infants. The
manufacturer shall establish the biological quality of the protein in
its infant formula by demonstrating that the protein source supports
adequate growth using the Protein Efficiency Ratio (PER) rat bioassay
described in the ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 16th ed., sections 43.3.04 and 43.3.05,
``AOAC Official Method 960.48 Protein Efficiency Ratio Rat Bioassay''
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the Association of
Official Analytical Chemists, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20857, or the Office of Special Nutritionals (HFS-
456), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, or may be examined
at the Office of the Federal Register, 800 North Capitol St. NW.,
Washington, DC. If the manufacturer is unable to conduct a PER rat
bioassay because of the composition of the protein in the formula, then
it shall demonstrate that the amino acid composition of the protein
meets the known amino acid requirements of infants for whom the formula
is intended.
(2) The manufacturer may request an exemption from the requirements
of paragraph (b)(1) of this section if:
(i) The protein source, including any processing method used to
produce the protein source, is already used in another infant formula
marketed in the United States, manufactured by the same manufacturer,
and the manufacturer can demonstrate that such infant formula meets the
quality factor requirements prescribed in Sec. 106.96;
(ii) The protein source, including any processing methods used to
produce the protein source, is not a major change from the infant
formula it replaces, and the manufacturer can demonstrate that the
infant formula it replaces meets the
[[Page 36216]]
quality factor requirements prescribed in Sec. 106.96.
6. In newly redesignated subpart F, Sec. 106.100 is amended by
revising paragraphs (e), (f), (g), (j), and (k)(3), and by removing and
reserving paragraph (h) to read as follows:
Sec. 106.100 Records.
* * * * *
(e) Batch production and control records. For each batch of infant
formula, manufacturers shall prepare and maintain records that include
complete information relating to the production and control of the
batch. These records shall include but are not limited to:
(1) The master manufacturing order. The master manufacturing order
shall include but is not limited to:
(i) The significant steps in the production of the batch and the
date on which each significant step occurred;
(ii) The identity of equipment and processing lines used in
producing the batch, if the plant in which the formula is made includes
more than one set of equipment or more than one processing line;
(iii) The identity of each batch or lot of ingredients, containers,
and closures used in producing the batch of formula;
(iv) The amount of each ingredient to be added to the batch of
infant formula and a check (verification) that the correct amount was
added; and
(v) Copies of all labeling used and the results of examinations
conducted during the finishing operations to provide assurance that
containers and packages in the lot have the correct label.
(2) Any deviations from the master manufacturing order and any
corrective actions taken because of the deviations.
(3) Documentation, in accordance with Sec. 106.6(c), of the
monitoring at any point, step, or stage in their production process
where control is deemed necessary to prevent adulteration. These
records shall include, but not be limited to:
(i) A list of the standards or specifications established at each
point, step, or stage in their production process where control is
deemed necessary to prevent adulteration including documentation of the
scientific basis for each standard or specification;
(ii) The actual values obtained during the monitoring operation,
any deviations from established standards or specifications, and any
corrective actions taken;
(iii) Identification of the person monitoring each point, step, or
stage in their production process where control is deemed necessary to
prevent adulteration.
(4) The conclusions and followup, along with the identity, of the
individual qualified by training or experience who investigated:
(i) Any deviation from the master manufacturing order and any
corrective actions taken;
(ii) A finding that a batch or any of its ingredients failed to
meet the infant formula manufacturer's specifications; and
(iii) A failure to meet any specification or standard at any point,
step, or stage in the production process where control is deemed
necessary to prevent adulteration.
(5) The results of all testing performed on the batch of infant
formula, including testing on the in-process batch, at the final-
product stage, and on finished product throughout the shelf life of the
product. The results recorded shall include but are not limited to:
(i) The results of all quality control testing conducted, in
accordance with Sec. 106.91(a) and (b), to verify that each nutrient
required by Sec. 107.100 of this chapter is present in each batch of
infant formula at the level required by Sec. 107.100, and that any
nutrient added by the manufacturer is present at the appropriate level
with:
(A) A summary table identifying the stages of the manufacturing
process at which the nutrient analysis for each required nutrient under
Sec. 106.91(a) is conducted, and
(B) A summary table on the stability testing program, including the
nutrients tested and the frequency of testing of nutrients throughout
the shelf life of the product under Sec. 106.91(b); and
(ii) For powdered infant formula, the results of any testing
conducted in accordance with Sec. 106.55(b) to verify compliance with
the microbiological quality standards in Sec. 106.55(c).
(f) Manufacturers shall make and retain all records pertaining to
current good manufacturing practice as described in subpart B of this
part, including but not limited to:
(1) Records, in accordance with Sec. 106.20(f)(3), of the frequency
and results of testing of the water used in the production of infant
formula;
(2) Records, in accordance with Sec. 106.30(d), of accuracy checks
of instruments and controls. A certification of accuracy of any known
reference standard used and a history of recertification shall be
maintained. At a minimum, such records shall specify the instrument or
control being checked, the date of the accuracy check, the standard
used, the calibration method used, the results found, any actions taken
if the instrument is found to be out of calibration, and the initials
or name of the individual performing the test. If calibration of an
instrument (testing for accuracy against a known reference standard)
shows that a specification or standard at a point, step, or stage in
the production process where control is deemed necessary to prevent
adulteration has not been met, a written evaluation of all affected
product, and any actions that need to be taken with respect to that
product, shall be made.
(3) Records, in accordance with Sec. 106.30(e)(3)(ii), of the
temperatures monitored for cold storage compartments and thermal
processing equipment.
(4) Records, in accordance with Sec. 106.30(f), on equipment
cleaning, sanitizing, and maintenance that show the date and time of
such cleaning, sanitizing, and maintenance and the lot number of each
batch of infant formula processed between equipment startup and
shutdown for cleaning, sanitizing, and maintenance. The person
performing and checking the cleaning, sanitizing, and maintenance shall
date and sign or initial the record indicating that the work was
performed.
(5) Records, in accordance with Sec. 106.35(c), on all automatic
(mechanical or electronic) equipment used in the production or quality
control of infant formula. These records shall include but not be
limited to:
(i) A list of all systems used with a description of computer files
and the inherent limitations of each system;
(ii) A copy of all software used;
(iii) Records that document installation, calibration, testing or
validation, and maintenance of the systems used;
(iv) A list of all persons authorized to create or modify software;
(v) Records that document modifications to software, including the
identity of the person who modified the software;
(vi) Records that document retesting or revalidation of modified
systems; and
(vii) A backup file of data entered into a computer or related
system. The backup file shall consist of a hard copy or alternative
system, such as duplicate diskettes, tapes, or microfilm, designed to
ensure that backup data are exact and complete, and that they are
secure from alteration, inadvertent erasures, or loss.
(6) Records, in accordance with Sec. 106.40(g), on ingredients,
containers, and closures used in the manufacture of infant formula.
These records shall include, but are not limited to:
[[Page 36217]]
(i) The identity and quantity of each lot of ingredients,
containers, and closures;
(ii) The name of the supplier;
(iii) The supplier's lot numbers;
(iv) The name and location of the manufacturer of the ingredient,
container, and closure, if different from the supplier;
(v) The date of receipt;
(vi) The receiving code as specified; and
(vii) The results of any test or examination (including retesting
and reexamination) performed on the ingredients, containers, and
closures and the conclusions derived therefrom and the disposition of
all ingredients, containers, or closures.
(7) A full description of the methodology used to test powdered
infant formula to verify compliance with the microbiological quality
standards of Sec. 106.55(c) and the methodology used to do quality
control testing, in accordance with Sec. 106.91(a) and (b).
(g) The manufacturer shall maintain all records pertaining to
distribution of the infant formula, including records that show that
products produced for export only are exported. Such records shall
include, but not be limited to, all information and data necessary to
effect and monitor recalls of the manufacturer's infant formula
products in accordance with subpart E of part 107 of this chapter.
(h) [Reserved]
* * * * *
(j) The manufacturer shall make and retain records pertaining to
regularly scheduled audits, including the audit plans and procedures,
the findings of the audit, and a listing of any changes made in
response to these findings. The manufacturer shall make readily
available for authorized inspection the audit plans and procedures and
a statement of assurance that the regularly scheduled audits are being
conducted. The findings of the audit and any changes made in response
to these findings shall be maintained for the time period required
under Sec. 106.100(n), but need not be made available to FDA.
(k) * * *
(3) When there is a reasonable possibility of a causal relationship
between the consumption of an infant formula and an infant's death, the
manufacturer shall, within 15 days of receiving such information,
conduct an investigation and notify the agency as required in
Sec. 106.150.
* * * * *
Subpart G--Registration, Submission, and Notification Requirements
Sec. 106.110 New infant formula registration.
(a) Before a new infant formula may be introduced or delivered for
introduction into interstate commerce, the manufacturer of such formula
shall register with the Food and Drug Administration, Center for Food
Safety and Applied Nutrition, Office of Special Nutritionals, Division
of Programs and Policy Enforcement (HFS-455), Infant Formula
Coordinator, 200 C St. SW., Washington, DC 20204. An original and two
copies of this registration shall be submitted.
(b) The new infant formula registration shall include:
(1) The name of the new infant formula,
(2) The name of the manufacturer,
(3) The place of business of the manufacturer, and
(4) All establishments at which the manufacturer intends to
manufacture such new infant formula.
Sec. 106.120 New infant formula submission.
(a) At least 90 days before a new infant formula is introduced or
delivered for introduction into interstate commerce, a manufacturer
shall submit notice of its intent to do so to the Food and Drug
Administration at the address given in Sec. 106.110(a). An original and
two copies of the notice of its intent to do so shall be submitted.
(b) The new infant formula submission shall include:
(1) The name and physical form (e.g., powder, ready-to feed, or
concentrate) of the infant formula;
(2) An explanation of why the formula is a new infant formula;
(3) The quantitative formulation of each form of the infant formula
that is the subject of the notice in units per volume (for liquid
formulas) or units per dry weight (for powdered formulas). When
applicable, the submission shall include a description of any
reformulation of the infant formula, including a listing of each new or
changed ingredient and a discussion of the effect of such changes on
the nutrient levels in the formulation;
(4) A description, when applicable, of any change in processing of
the infant formula. Such description shall identify the specific change
in processing, including side-by-side, detailed schematic diagrams
comparing the new processing to the previous processing (including
processing times and temperatures);
(5) Assurance that the infant formula will not be marketed unless
the formula meets the quality factor requirements of section 412(b)(1)
of the Federal Food, Drug, and Cosmetic Act (the act) and the nutrient
content requirements of section 412(i) of the act.
(i) Assurance that the formula meets the quality factor
requirements, which are set forth in subpart E of this part, shall be
provided by a submission that complies with Sec. 106.121.
(ii) Assurance that the formula complies with the nutrient content
requirements, which are set forth in Sec. 107.100 of this chapter,
shall be provided by a statement assuring that the formula will not be
marketed unless it meets the nutrient requirements of Sec. 107.100 of
this chapter, as demonstrated by testing required under subpart C of
this part;
(6) Assurance that the processing of the infant formula complies
with section 412(b)(2) of the act. Such assurance shall include but not
be limited to:
(i) A statement that the formula will be produced in accordance
with subparts B and C of this part;
(ii) The basis on which each ingredient meets the requirements of
Sec. 106.40(a), e.g., that it is an approved food additive, that it is
authorized by a prior sanction issued by the agency, or that it is GRAS
for its intended use. Any claim that an ingredient is GRAS shall be
supported by a citation to the agency's regulations or by an
explanation, including a list of published studies and a copy of those
publications, for why, based on the published studies, there is general
recognition of the safety of the use of the ingredient in infant
formula.
(c) For products for export only, a manufacturer may submit, in
lieu of the information required under paragraph (b) of this section, a
statement that the infant formula meets the specifications of the
foreign purchaser, does not conflict with the laws of the country to
which it is intended for export, is labeled on the outside of the
shipping package to indicate that it is intended for export only, and
will not be sold or offered for sale in domestic commerce.
(d) The submission will not constitute notice under section 412 of
the act unless it complies fully with paragraph (b) of this section,
and the information that it contains is set forth in a manner that is
readily understandable. The agency will notify the submitter if the
notice is not adequate because it does not meet the requirements of
section 412(c) and (d) of the act.
(e) If a new infant formula submission is adequate, FDA will
acknowledge its receipt and notify the manufacturer of the date of
receipt. The date that the agency receives the new infant formula
[[Page 36218]]
submission is the filing date for the submission. The manufacturer
shall not market the new infant formula before the date that is 90 days
after the filing date.
(f) If the manufacturer provides additional information in support
of a new infant formula submission, the agency will determine whether
the additional information is a substantive amendment to the new infant
formula submission. If the agency determines that the new submission is
a substantive amendment, FDA will assign the new infant formula
submission a new filing date. FDA will acknowledge receipt of the
additional information and, when applicable, notify the manufacturer of
the new filing date, which is the date of receipt by FDA of the
information that constitutes the substantive amendment to the new
infant formula submission.
Sec. 106.121 Quality factor submission.
To provide assurance that an infant formula meets the quality
factor requirements set forth in subpart E of this part, the
manufacturer shall submit the following data and information:
(a) An explanation, in narrative form, setting forth how all
quality factor requirements of subpart E of this part have been met.
(b) Records that contain the information required by proposed
Sec. 106.97 (a)(1)(i) and (a)(1)(ii) collected during the study for
each infant enrolled in the study. The records shall be identified by
subject number, age, feeding group, gender, and study day of
collection.
(c)(1) Statistical evaluation for all measurements, including:
Group means, group standard deviations, and measures of statistical
significance for all measurements for each feeding group at the
beginning of the study and at every point where measurements were made
throughout the study.
(2) Calculation of the statistical power of the study at its
completion.
(d) A report on attrition and on all occurrences of adverse events
during the study, which shall include:
(1) Identification of the infant by subject number and feeding
group and a complete description of the adverse event, including
comparisons of the frequency and nature of occurrence in each feeding
group and information on the health of the infant during the course of
the study, including the occurrence and duration of any illness;
(2) A clinical assessment, by a health care provider, of the
infant's health during each suspected adverse event;
(3) A complete listing of all infants who did not complete the
study, including the infant's subject number and the reason that each
infant left the study.
(e) The results of the Protein Efficiency Ratio, in accordance with
Sec. 106.97(b).
(f) A statement certifying that the manufacturer has collected and
considered all information and data concerning the ability of the
infant formula to meet the quality factor requirements, and that the
manufacturer is not aware of any information or data that would show
that the formula does not meet the quality factors requirements.
Sec. 106.130 Verification submission.
(a) Manufacturers shall, after the first production and before the
introduction into interstate commerce of the new infant formula, verify
in a written submission to FDA at the address given in Sec. 106.110(a),
that the infant formula complies with the requirements of the Federal
Food, Drug, and Cosmetic Act (the act) and is not adulterated. An
original and two copies of this verification shall be submitted.
(b) The verification submission shall include the following
information:
(1) The name of the new infant formula; the filing date for the new
infant formula submission, in accordance with Sec. 106.120, for the
subject formula; and the identification number assigned by the agency
to the new infant formula submission;
(2) A statement that the infant formula to be introduced into
interstate commerce is the same as the infant formula that was the
subject of the new infant formula notification and for which the
manufacturer provided assurances in accordance with the requirements of
Sec. 106.120;
(3) A summary of test results of the level of each nutrient
required by Sec. 107.100 of this chapter and any nutrient added by the
manufacturer in the formula, presented in units per 100 kilocalories at
the final-product-stage.
(4) A certification that the manufacturer has established current
good manufacturing practices including quality control procedures and
in-process controls, including testing required by current good
manufacturing practice, designed to prevent adulteration of this
formula in accordance with subparts B and C of this part.
(c) The submission will not constitute written verification under
section 412(d)(2) of the act when any data prescribed in paragraph (b)
of this section are lacking or are not set forth so as to be readily
understood. In such circumstances the agency will notify the submitter
that the notice is not adequate.
Sec. 106.140 Submission concerning a change in infant formula that may
adulterate the product.
(a) When a manufacturer makes a change in the formulation or
processing of the formula that may affect whether the formula is
adulterated under section 412(a) of the Federal Food, Drug, and
Cosmetic Act (the act), it shall, before the first processing of such
formula, make a submission to the Food and Drug Administration at the
address given in Sec. 106.110(a). An original and two copies shall be
submitted.
(b) The submission shall include:
(1) The name and physical form of the infant formula (i.e., powder,
ready-to-feed, or concentrate);
(2) An explanation of why the change in formulation or processing
may affect whether the formula is adulterated; and
(3) A submission that complies with Sec. 106.120(b)(3), (b)(4),
(b)(5), and (b)(6). When appropriate, a statement to the effect that
the information required by Sec. 106.120(b)(3), (b)(4), (b)(5), or
(b)(6) has been provided to the agency previously and has not been
affected by the changes that is the subject of this submission,
together with the identification number assigned by the agency to the
relevant infant formula submission, may be provided in lieu of such
submission.
(c) The submission will not constitute notice under section 412 of
the act unless it complies fully with paragraph (b) of this section,
and the information that it contains is set forth in a manner that is
readily understandable. The agency will notify the submitter if the
notice is not adequate because it does not meet the requirements of
section 412(d)(3) of the act.
Sec. 106.150 Notification of an adulterated or misbranded infant
formula.
(a) A manufacturer shall promptly notify FDA in accordance with
paragraph (b) of this section, when the manufacturer has knowledge
(that is, the actual knowledge that the manufacturer had, or the
knowledge which a reasonable person would have had under like
circumstances or which would have been obtained upon the exercise of
due care) that reasonably supports the conclusion that an infant
formula that has been processed by the manufacturer and that has left
an establishment subject to the control of the manufacturer:
(1) May not provide the nutrients required by section 412(i) of the
act or by regulations issued under section 412(i)(2); or
[[Page 36219]]
(2) May be otherwise adulterated or misbranded.
(b) The notification made according to paragraph (a) of this
section shall be made by telephone, to the Director of the appropriate
Food and Drug Administration district office. After normal business
hours (8 a.m. to 4:30 p.m.), FDA's emergency number, 202-857-8400,
shall be used. The manufacturer shall send written confirmation of the
notification to the Food and Drug Administration, Center for Food
Safety and Applied Nutrition, Office of Special Nutritionals, Division
of Programs and Policy Enforcement (HFS-455), Infant Formula
Coordinator, 200 C St. SW., Washington, DC 20204, and to the
appropriate Food and Drug Administration district office specified in
Sec. 5.115 of this chapter.
PART 107--INFANT FORMULA
7. The authority citation for 21 CFR part 107 continues to read as
follows:
Authority: Secs. 201, 403, 412, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 343, 350a, 371).
8. Section 107.1 is added to subpart A to read as follows:
Sec. 107.1 Status and applicability of the regulations in part 107.
(a) The criteria set forth in subpart B of this part describes the
labeling requirements applicable to infant formula under section 403 of
the Federal Food, Drug, and Cosmetic Act (the act). Failure to comply
with any regulation in subpart B of this part will render an infant
formula misbranded under that section of the act.
(b) The criteria set forth in subpart C of this part describes the
terms and conditions for the exemption of an infant formula from the
requirements of section 412(a), (b), and (c) of the act. Failure to
comply with any regulations in subpart C of this part will result in
the withdrawal of the exemption given under section 412(h)(1) of the
act.
(c) Subpart D of this part sets forth the nutrient requirements for
infant formula under section 412(i) of the act. Failure to comply with
any regulation in subpart D of this part will render an infant formula
adulterated under section 412(a)(1) of the act.
9. Section 107.10 is amended by revising the introductory text of
paragraph (a)(2) to read as follows:
Sec. 107.10 Nutrient information.
(a) * * *
(2) A statement of the amount, supplied by 100 kilocalories, of
each of the following nutrients and of any nutrient added by the
manufacturer:
* * * * *
10. Section 107.240 is revised to read as follows:
Sec. 107.240 Notification requirements.
(a) Telephone report. When a determination is made that an infant
formula is to be recalled, the recalling firm shall telephone within 24
hours the appropriate Food and Drug Administration district office
listed in Sec. 5.115 of this chapter and shall provide relevant
information about the infant formula that is to be recalled.
(b) Initial written report. Within 14 days after the recall has
begun, the recalling firm shall provide a written report to the
appropriate Food and Drug Administration district office. The report
shall contain relevant information, including the following cumulative
information concerning the infant formula that is being recalled:
(1) Number of consignees notified of the recall and date and method
of notification, including recalls required by Sec. 107.200,
information about the notice provided for retail display and the
request for its display.
(2) Number of consignees responding to the recall communication and
quantity of recalled infant formula on hand at the time it was
received.
(3) Quantity of recalled infant formula returned or corrected by
each consignee contacted and the quantity of recalled infant formula
accounted for.
(4) Number and results of effectiveness checks that were made.
(5) Estimated timeframes for completion of the recall.
(c) Status reports. The recalling firm shall submit to the
appropriate Food and Drug Administration district office a written
status report on the recall at least every 14 days until the recall is
terminated. The status report shall describe the steps taken by the
recalling firm to carry out the recall since the last report and the
results of these steps.
11. Section 107.250 is amended by revising the introductory text to
read as follows:
Sec. 107.250 Termination of an infant formula recall.
The recalling firm may submit a recommendation for termination of
the recall to the appropriate Food and Drug Administration district
office listed in Sec. 5.115 of this chapter for transmittal to the
Division of Enforcement (HFS-605), Office of Field Programs, Center for
Food Safety and Applied Nutrition, for action. Any such recommendation
shall contain information supporting a conclusion that the recall
strategy has been effective. The agency will respond within 15 days of
receipt by the Division of Enforcement (HFS-605), Office of Field
Programs, Center for Food Safety and Applied Nutrition, of the request
for termination. The recalling firm shall continue to implement the
recall strategy until it receives final written notification from the
agency that the recall has been terminated. The agency will send such
notification, unless it has information, from FDA's own audits or from
other sources demonstrating the recall has not been effective. The
agency may conclude that a recall has not been effective if:
* * * * *
Dated: April 19, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-17058 Filed 7-8-96; 8:45 am]
BILLING CODE 4160-01-P
Complete official Federal Register PDF
FR Doc. 96-16591 Transportation Conformity Rule Amendment and Solicitation for Participation in the Transportation Conformity Pilot Program
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 35994-35998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16591]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 51 and 93
[FRL-5527-9]
RIN 2060-AG16
Transportation Conformity Rule Amendment and Solicitation for
Participation in the Transportation Conformity Pilot Program
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to amend the transportation conformity rule
to allow EPA to create and implement a conformity pilot program. The
conformity rule requires that transportation activities conform to
state air quality implementation plans and establishes the criteria and
procedures for determining whether or not they do. Conformity to an air
quality plan means that transportation activities will not produce new
air quality violations, worsen existing violations, or delay timely
attainment of national ambient air quality standards.
The pilot program would exempt up to six areas from some of the
existing rule's requirements. After EPA approval, the areas will
experiment with alternative conformity procedures for the three-year
duration of the program. Today's notice invites applications for
participation in the pilot program and presents the application and
selection process, which will be finalized in the final rule.
Along with recent amendments to the conformity rule, the pilot
program is part of an EPA strategy to provide states and localities
greater flexibility in meeting federal transportation conformity
requirements while reinforcing Clean Air Act commitments.
[[Page 35995]]
This strategy results from experience gained in implementing the
conformity rule.
The conformity pilot program would allow state and local
transportation and air quality agencies the additional flexibility to
seek out and test the conformity procedures that work best in their
area. Participating areas' experiences will be evaluated and it is
possible that successful pilot programs may ultimately lead to further
changes in the conformity rule.
DATES: Comments on this action must be received by August 8, 1996.
Applications may be submitted beginning July 9, 1996. EPA requests
expressions of interest by August 23, 1996.
ADDRESSES: Interested parties may submit written comments (in
duplicate, if possible) to: Air and Radiation Docket and Information
Center, U.S. Environmental Protection Agency, Attention: Docket No. A-
95-55, 401 M. Street, S.W., Washington, DC 20460.
Materials relevant to this proposal have been placed in Public
Docket A-95-55 by EPA. The docket is located at the above address in
room M-1500 Waterside Mall (ground floor) and may be inspected from 8
a.m. to 4 p.m., Monday through Friday, including all non-governmental
holidays.
For informational purposes, areas which submit expressions of
interest and applications will be listed on the EPA's Technology
Transfer Network (TTN) bulletin board, on the Office of Mobile Sources
(OMS) bulletin board under the Rulemaking: Transportation: Conformity
file area. TTN files can be accessed on the first call to (919) 541-
5742 or through the internet at TELNET ttnbbs.rtpnc.epa.gov. TTN is
off-line every Monday from 8:00 a.m.-12 Noon, and the TTN voice help
line is (919) 541-5384.
FOR FURTHER INFORMATION CONTACT: Elizabeth Cummings, Transportation and
Market Incentives Group, Regional and State Programs Division, U.S.
Environmental Protection Agency, 2565 Plymouth Road, Ann Arbor, MI
48105, (313) 741-7857 or Lucy Garliauskas, Environmental Analysis
Division, Office of Environment and Planning, Federal Highway
Administration, 400 Seventh Street S.W., Washington, DC 20590, (202)
366-2068.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially regulated by the conformity rule are those
which adopt, approve, or fund transportation plans, programs, or
projects under the Intermodal Surface Transportation Efficiency Act or
Federal Transit Laws. Regulated categories and entities include:
------------------------------------------------------------------------
Examples of regulated
Category entities
------------------------------------------------------------------------
Local government.......................... Local transportation and air
quality agencies.
State government.......................... State transportation and air
quality agencies.
Federal government........................ EPA and Department of
Transportation (Federal
Highway Administration and
Federal Transit
Administration).
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by the conformity rule. Other types of
entities not listed in the table could also be affected. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
The contents of today's preamble are listed in the following
outline:
I. Background of Transportation Conformity
II. Transportation Conformity Pilot Program
A. Program Objective
B. Exemptions from Certain Conformity Requirements
C. Eligibility
D. Submission of Applications
E. Selection Criteria
F. Selection Process
III. Conformity SIPs
IV. Administrative Requirements
A. Administrative Designation
B. Reporting and Recordkeeping Requirements
C. Regulatory Flexibility Act
D. Unfunded Mandates
I. Background of Transportation Conformity
The transportation conformity rule, ``Criteria and Procedures for
Determining Conformity to State or Federal Implementation Plans of
Transportation Plans, Programs, and Projects Funded or Approved Under
Title 23 U.S.C. or the Federal Transit Act,'' was published November
24, 1993 (58 FR 62188) and amended 40 CFR Parts 51 and 93. It was
subsequently amended on August 7, 1995 (60 FR 40098) and November 14,
1995 (60 FR 57179). In addition, EPA is proposing a third set of
conformity amendments to further streamline and simplify the conformity
rule.
Required under section 176(c) of the Clean Air Act, as amended in
1990, the transportation conformity rule established the criteria and
procedures by which the Federal Highway Administration (FHWA), the
Federal Transit Administration (FTA), and metropolitan planning
organizations (MPOs) determine the conformity of federally funded or
approved highway and transit plans, programs, and projects to state
implementation plans (SIPs). The Clean Air Act requires that federally
supported activities conform to the implementation plan's purpose of
expeditiously attaining and of maintaining the national ambient air
quality standards.
Since publication of the transportation conformity rule in November
1993, EPA, the Department of Transportation (DOT), and state and local
air and transportation officials have had considerable experience
implementing the criteria and procedures in the rule. It is that mutual
experience which has lead EPA and DOT to undertake a number of
initiatives to streamline the transportation conformity rule. In
addition to significant revisions of the conformity rule through three
sets of amendments, today's proposal would provide further flexibility
through the creation and implementation of a transportation conformity
pilot program.
II. Conformity Pilot Program
The purpose of this notice is to propose an amendment to 40 CFR
Parts 51 and 93 to create a transportation conformity pilot program.
This amendment would allow EPA and DOT to select up to six areas to
participate in the program and would allow EPA to exempt the selected
areas from certain provisions of the transportation conformity
regulation for a period of three years. This notice also describes the
pilot program's objectives, application and selection process, and
participation requirements, and solicits applications for the program.
A. Conformity Pilot Program Objective
The overall objective of the conformity pilot program would be to
seek out and test innovative methods of streamlining regulatory
requirements while ensuring that Clean Air Act objectives and
requirements are met. EPA and DOT are committed to continuing to
encourage procedures which improve the conformity process. Under the
pilot program, state and local air and transportation agencies could
identify the conformity processes and procedures that work best for
their area, and EPA and DOT would select the applications expected to
lead to a more effective conformity process. It is
[[Page 35996]]
possible that successful pilot projects may ultimately lead to further
changes in the federal transportation conformity regulation.
The pilot program would enable as many as six areas to exercise
flexibility in meeting certain requirements of the conformity
regulation in three areas: modeling, consultation, and coordination of
the Intermodal Surface Transportation Efficiency Act (ISTEA) schedules
and procedures with conformity deadlines and schedules. EPA would also
consider proposals from applicants to extend this flexibility to other
aspects of the conformity requirements.
During the third year of the pilot program, EPA and DOT would
conduct a national evaluation to see if transportation policy, project
selection and investment choices changed as a result of a more flexible
approach to meeting the Clean Air Act conformity requirements; if
interagency consultation and public participation improved as a result
of new procedures; and if Clean Air Act compliance costs were reduced
and efficiencies implemented while still ensuring that Clean Air Act
goals and requirements were met. Pilot program areas would also propose
methods for self-evaluation of their conformity pilot program and
cooperate with the national evaluation.
B. Exemption From Certain Conformity Requirements
This proposal would allow EPA and DOT to exempt no more than six
areas for no more than three years from certain requirements of 40 CFR
Parts 51 and 93, if these areas are selected to participate in this
conformity pilot program. EPA and DOT approval of the alternative
requirements developed by the applicant areas would be required for
selection to participate in the pilot program. In order to obtain EPA
and DOT approval, each area would be required to provide an opportunity
for public comment on its proposed alternative conformity requirements.
The alternative conformity requirements would be proposed to achieve
results equivalent to or better than the requirements of 176(c) of the
Clean Air Act. Areas selected to participate in the pilot program must
comply with their final project agreements. After the three-year
duration of the pilot program has expired, the selected areas would
again be subject to all of the requirements of 40 CFR Parts 51 and 93.
However, EPA may revise 40 CFR Parts 51 and 93 to incorporate elements
of effective pilot programs based on results from evaluating the first
two years of program implementation.
C. Eligibility
Up to six areas currently subject to the requirements of the
transportation conformity regulation would be selected by EPA and DOT
to participate in the pilot program. Applications may be submitted by
either an MPO, a local air quality agency, a state air quality agency,
or a state department of transportation acting as a lead contact for
purposes of the pilot program. When submitting its application, the
lead agency must demonstrate that its proposal is endorsed by all state
and local air and transportation agencies that participate in the
area's interagency consultation process. In certain cases, for example,
an MPO that covers more than one nonattainment area or a nonattainment
area that covers more than one state, EPA and DOT may subsequently
request further endorsement from additional agencies affected by the
proposal.
D. Submission of Applications
Applications may be submitted to Elizabeth Cummings, Transportation
and Market Incentives Group, Regional and State Programs Division, U.S.
Environmental Protection Agency, 2565 Plymouth Road, Ann Arbor, MI
48105. Applications will be accepted beginning July 9, 1996. EPA will
begin accepting applications prior to final action on this rule
amendment. If the final rule is different than this proposal, due to
public comment received, areas that have already submitted applications
may be asked to supplement their application materials.
EPA requests that areas considering applying to the pilot program
submit a non-binding ``expression of interest'' before August 23, 1996.
The ``expression of interest'' letter could be submitted by the lead
agency and would not need to include any preliminary description or
endorsement of the application. This would provide EPA and DOT with an
approximate number of applications to expect. EPA would list the areas
that have submitted expressions of interest and applications on EPA's
Technology Transfer Network (TTN) bulletin board. EPA would also place
copies of the submitted applications in the public docket. (See
ADDRESSES for information on the TTN bulletin board and the public
docket.)
Once EPA has taken final action on this proposal, EPA and DOT would
be able to jointly select up to six pilot program participants on a
rolling basis until six participants are selected, unless the agencies
decide to select fewer than six participants. If fewer than six
participants are selected in the first iteration of the selection
process, EPA and DOT would continue to process applications on a
rolling basis.
The following information will enable EPA and DOT to consider an
application: (1) A particular proposal for flexibility in applying
elements of the conformity regulation; (2) the rationale for change,
including: (i) The particular problems in the existing requirements
that the proposal intends to address, and (ii) the benefits that the
alternative proposal would create (e.g., air quality benefits, resource
savings); (3) a description of the alternative methods and/or
procedures to be used in meeting conformity requirements; (4) the
proposed schedule for making conformity determinations during the pilot
program (for a period of up to three years); (5) evidence that
sufficient resources to conduct the pilot program will be available
(e.g., some of the pilot program activities may be eligible for title
23 State Planning and Research Funds (SPR) or Planning (PL) funds); (6)
discussion of any potential implementation issues that must be overcome
for the pilot program to be successful; (7) suggestions for self-
evaluation of the pilot program; (8) evidence that the proposal is
endorsed by all the state and local air and transportation agencies;
and (9) evidence that key stakeholders have been or will be consulted
and that appropriate public participation procedures will be
undertaken, which may be incorporated into the area's normal
interagency consultation process.
Applications should be in narrative form and should be concise
while still containing sufficient information to fully describe the
proposal. It is EPA and DOT's intent to use the application to conduct
preliminary reviews. Further details of the proposal would be
incorporated during the consultation stage of the selection process and
would be subject to the project agreement, as described below. The
extent to which the application addresses the information requested and
the application length will depend upon the proposal's complexity.
E. Selection Criteria
Applications would be assessed according to the following criteria:
(1) Whether the proposed flexibilities fulfill all the statutory
requirements for transportation conformity; (2) the degree to which the
application fulfills the pilot program's goals of testing innovative
methods and streamlining the regulatory process, including, but not
limited to, the specified areas of modeling, interagency/public
[[Page 35997]]
consultation, and coordination of ISTEA and Clean Air Act requirements;
(3) the degree of key stakeholder and public support in the geographic
area covered by the proposal; (4) whether the applicant has the
resources necessary to effectively implement and evaluate the proposed
conformity pilot program; (5) whether the area has adequately
demonstrated its intent to comply with Clean Air Act objectives; and
(6) the degree to which data and analysis will be provided to help
assess air quality, resource savings, public participation, and other
program benefits.
In order to assure that the pilot program provides an opportunity
to test innovative approaches to conformity in a broad range of
circumstances, EPA and DOT would attempt to select a group of
participants that is diverse in terms of geographic distribution,
nonattainment pollutants, nonattainment classifications, and rural and
urban development.
F. Selection Process
The selection process would have three stages: application review,
applicant consultation, and project agreement finalization. First, EPA
and DOT will review submitted applications. Applications not selected
by the agencies during the initial application review will be notified;
all other applications will proceed to the consultation stage.
In the consultation stage, EPA and DOT will schedule a conference
call with each applicant to clarify any questions about the applicant's
proposal, permit the federal agencies to clarify their understanding of
what the proposed conformity pilot program would entail, and to
evaluate further the suitability of the proposal for inclusion in the
pilot program. Then EPA and DOT will arrange for a subset of these
applicants to present their proposals in a review session with federal
agency staff. Representatives of the lead agency submitting the pilot
program application and other public agencies involved in the
applicant's geographic area would participate in the presentation.
Based upon the information presented in the application and
consultation stages, EPA and DOT could select up to six applicants to
participate in the pilot program.
In the final stage, and following finalization of this rule
amendment, EPA, DOT and the applicant agencies would negotiate the
final project agreement, which would formalize each area's selection as
a pilot program participant. Before EPA and DOT approve the final
project agreement, the lead agency would be required to demonstrate
that it has provided a public comment period of not less than 30 days
on its proposed alternative conformity requirements. The lead agency
would also be required to demonstrate how it solicited and took into
account any public comments during the public comment period. Upon
finalization, the project agreement would be fully enforceable under
the Clean Air Act.
III. Conformity SIPs
Although this proposal would exempt pilot program participants from
certain conformity rule requirements, it could not exempt a pilot
program participant from requirements in its approved conformity SIP.
Once EPA has approved the conformity SIP, the federal conformity rule
no longer applies to those subjects covered by the conformity SIP, and
the requirements in the conformity SIP have the force of federal and
state law. Therefore, if an area's submitted conformity SIP has already
been approved by EPA, a new SIP would need to be submitted and approved
in order for an area to participate in the pilot program and be
relieved of certain of its conformity SIP requirements. The area's
final project agreement under the pilot program could be submitted as
its new conformity SIP.
If a pilot program participant has already submitted a conformity
SIP which EPA has not yet approved, then the conformity SIP (or certain
portions of the conformity SIP applicable to the particular area) would
need to be withdrawn for the duration of the pilot program in order to
ensure that the area could be governed by the final project agreement.
Areas that are selected to participate in the pilot program and
have not yet submitted a conformity SIP would be exempted from the
requirements of Sec. 51.396 (``Implementation plan revision'') so that
they would not be required to submit a conformity SIP for the area for
the duration of participation in the pilot program. In addition, areas
that are selected to participate in the pilot program would be exempted
for the duration of the pilot program from the requirement to submit a
SIP revision in response to conformity rule amendments.
IV. Administrative Requirements
A. Executive Order 12866
Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more,
or otherwise adversely affect in a material way the economy, a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact or entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof;
(4) Raise novel or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the Executive
Order.
It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866. EPA has
submitted this action to OMB for review. Changes made in response to
OMB suggestions or recommendations will be documented in the public
record.
B. Reporting and Recordkeeping Requirements
This rule does not contain any information collection requirements
from EPA which require approval by OMB under the Paperwork Reduction
Act of 1980, 44 U.S.C. 3501 et seq.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 requires federal agencies to
identify potentially adverse impacts of federal regulations upon small
entities. In instances where significant impacts are possible on a
substantial number of these entities, agencies are required to perform
a Regulatory Flexibility Analysis (RFA).
EPA has determined that today's regulations will not have a
significant impact on a substantial number of small entities. This
regulation affects federal agencies and metropolitan planning
organizations, which by definition are designated only for metropolitan
areas with a population of at least 50,000. These organizations do not
constitute small entities.
Therefore, as required under section 605 of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., I certify that this regulation
does not have a significant impact on a substantial number of small
entities.
[[Page 35998]]
D. Unfunded Mandates
Under Sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 22,
1995, EPA must undertake various actions in association with proposed
or final rules that include a federal mandate that may result in
estimated costs of $100 million or more to the private sector, or to
State, local, or tribal governments in the aggregate.
EPA has determined that to the extent this rule imposes any mandate
within the meaning of the Unfunded Mandates Act, this final action does
not include a mandate that may result in estimated costs of $100
million or more to State, local, or tribal governments in the aggregate
or to the private sector. Therefore, EPA has not prepared a statement
with respect to budgetary impacts.
List of Subjects
40 CFR Part 51
Environmental protection, Administrative practice and procedure,
Carbon monoxide, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.
40 CFR Part 93
Administrative practice and procedure, Air pollution control,
Carbon monoxide, Intergovernmental relations, Ozone.
Dated: June 21, 1996.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, title 40, chapter I, Parts
51 and 93 of the Code of Federal Regulations are proposed to be amended
as follows.
PARTS 51 AND 93--[AMENDED]
1. The authority citation for parts 51 and 93 continues to read as
follows:
Authority: 42 U.S.C. 7401-7671q.
2. Parts 51 and 93 are proposed to be amended by adding identical
Secs. 51.446 and 93.137 to read as follows:
Sec. . Special exemptions from conformity requirements for pilot
program areas.
EPA and DOT may exempt no more than six areas for no more than
three years from certain requirements of this subpart if these areas
are selected to participate in a conformity pilot program and have
developed alternative requirements that have been approved by EPA and
DOT. In order to obtain EPA and DOT approval on its final project
agreement, each area must provide a 30-day public comment period and
address comments received on its proposed alternative conformity
requirements. The alternative conformity requirements must be proposed
to fulfill all of the requirements of and achieve results equivalent to
or better than section 176(c) of the Clean Air Act. Areas selected to
participate in the pilot program must comply with their final project
agreements. After the three-year duration of the pilot program has
expired, areas will be subject to the requirements of this subpart.
[FR Doc. 96-16591 Filed 7-8-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-16581 Transportation Conformity Rule Amendments: Flexibility and Streamlining
[Federal Register Volume 61, Number 132 (Tuesday, July 9, 1996)]
[Proposed Rules]
[Pages 36112-36151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16581]
[[Page 36111]]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 51 and 93
Transportation Conformity Rule Amendments: Flexibility and
Streamlining; Proposed Rule
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 /
Proposed Rules
[[Page 36112]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 51 and 93
[FRL-5527-8]
RIN 2060-AG16
Transportation Conformity Rule Amendments: Flexibility and
Streamlining
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a more streamlined and flexible
transportation conformity rule. The conformity rule requires that
transportation plans, programs, and projects conform to state air
quality implementation plans (SIPs) and establishes the criteria and
procedures for determining whether or not they do. Conformity to a SIP
means that transportation activities will not produce new air quality
violations, worsen existing violations, or delay timely attainment of
national ambient air quality standards.
Since publication of the original rule in November 1993, EPA, the
Department of Transportation (DOT), and state and local air and
transportation officials have had considerable experience implementing
the criteria and procedures in the rule. The changes proposed today are
a result of this experience and are intended to make the conformity
rule less complex and make it a more effective planning tool. The
proposed changes will not result in any change in health and
environmental benefits.
This proposed rule would give state and local governments more
authority in setting the performance measures used as tests of
conformity and more discretion when a transportation plan does not
conform to a SIP. The proposal would allow motor vehicle emissions
budgets in a submitted SIP to be used to determine conformity instead
of the ``build/no-build'' test. Modeling requirements would be tailored
for different types of areas, and rural areas would be able to choose
among several conformity tests.
DATES: Comments on this action must be submitted on or before September
9, 1996. EPA will conduct one public hearing on this proposal beginning
at 10 a.m. on Tuesday, August 6, 1996, in Washington, DC. As described
in section XVI. of today's action, the hearing will continue throughout
the day until all testimony has been presented.
ADDRESSES: Interested parties may submit written comments (in
duplicate, if possible) to: Air and Radiation Docket and Information
Center, U.S. Environmental Protection Agency, Attention: Docket No. A-
96-05, 401 M Street, SW., Washington, DC 20460. (Those desiring
notification of receipt of comments must include a self-addressed,
stamped postcard.)
The public hearing will be held in Washington, DC, at the Holiday
Inn Capitol Hill, 550 C Street, SW., Washington, DC 20024, (202) 479-
4000.
Materials relevant to this rulemaking are contained in Public
Docket A-96-05 by EPA. The docket is located at the above EPA address
in room M-1500 Waterside Mall (ground floor) and may be inspected from
8 a.m. to 5:30 p.m., Monday through Friday, including all non-
government holidays.
FOR FURTHER INFORMATION CONTACT: Kathryn Sargeant, Transportation and
Market Incentives Group, Regional and State Programs Division, U.S.
Environmental Protection Agency, 2565 Plymouth Road, Ann Arbor, MI
48105, (313) 668-4441.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially regulated by the conformity rule are those
which adopt, approve, or fund transportation plans, programs, or
projects under the Intermodal Surface Transportation Efficiency Act or
Federal Transit Laws. Regulated categories and entities include:
------------------------------------------------------------------------
Examples of regulated
Category entities
------------------------------------------------------------------------
Local government.......................... Local transportation and air
quality agencies.
State government.......................... State transportation and air
quality agencies.
Federal government........................ EPA and Department of
Transportation (Federal
Highway Administration and
Federal Transit
Administration).
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by the conformity rule. Other types of
entities not listed in the table could also be regulated. To determine
whether your organization is regulated by this action, you should
carefully examine the applicability in Sec. 51.394/Sec. 93.102 of the
conformity rule. If you have questions regarding the applicability of
this action to a particular entity, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.
The contents of this preamble are listed in the following outline:
I. Background on Transportation Conformity Rule
II. Applicability of the Budget Test and Emission Reduction Tests
III. Implementation of the Budget Test
IV. Non-federal Projects
V. Rural Nonattainment and Maintenance Areas
VI. Modeling Requirements
VII. Consequences of SIP Disapproval
VIII. Mismatch in SIP/Transportation Plan Timeframe
IX. Public Participation
X. Interagency Consultation
XI. Streamlining and Clarification
XII. TCM Flexibility
XIII. PM10 Hot Spots
XIV. Signalization Projects
XV. Conformity SIPs
XVI. Public Hearing
XVII. Administrative Requirements
I. Background on Transportation Conformity Rule
Today's action proposes to amend the transportation conformity
rule, ``Criteria and Procedures for Determining Conformity to State or
Federal Implementation Plans of Transportation Plans, Programs, and
Projects Funded or Approved Under Title 23 U.S.C. or the Federal
Transit Act'' (58 FR 62188, November 24, 1993). Required under section
176(c) of the Clean Air Act, as amended in 1990, the transportation
conformity rule established the criteria and procedures by which the
Federal Highway Administration (FHWA), the Federal Transit
Administration (FTA), and metropolitan planning organizations (MPOs)
determine the conformity of federally funded or approved highway and
transit plans, programs, and projects to state implementation plans
(SIPs). Conformity ensures that transportation plans, programs, and
projects do not produce new air quality violations, worsen existing
violations, or delay timely attainment of national ambient air quality
standards (NAAQS). According to the Clean Air Act, federally supported
activities must conform to the implementation plan's purpose of
attaining and maintaining these standards.
Since publication of the transportation conformity rule in November
1993, EPA, the Department of Transportation (DOT), and state and local
air and transportation officials have had considerable experience
implementing the criteria and procedures in the rule. It is that mutual
[[Page 36113]]
experience which leads to today's proposal, which is the third of a
series of three anticipated amendments to the transportation conformity
rule. In each case, the amendments were needed to clarify ambiguities,
correct errors, or make the conformity process more logical and
feasible. The first set of amendments was published as an interim final
rule on February 8, 1995 (60 FR 7449), and was finalized on August 7,
1995 (60 FR 40098). The first set of amendments aligned the dates of
conformity lapses (i.e., halting of new federally funded highway/
transit projects) due to SIP failures with the application of Clean Air
Act highway sanctions for certain ozone areas and all areas with
disapproved SIPs with a protective finding.
The second set of amendments was proposed on August 29, 1995 (60 FR
44790), and was finalized on November 14, 1995 (60 FR 57179). The
second set of amendments allowed any transportation control measure
(TCM) from an approved SIP to proceed during a conformity lapse;
aligned the date of conformity lapses with the date of application of
Clean Air Act highway sanctions for any failure to submit or submission
of an incomplete control strategy SIP; extended the grace period before
which areas must determine conformity to a submitted control strategy
SIP; established a grace period before which transportation plan and
program conformity must be determined in newly designated nonattainment
areas; and corrected the nitrogen oxides (NOx) provisions of the
transportation conformity rule consistent with the Clean Air Act and
previous commitments made by EPA.
Today's proposal would further amend the conformity rule in
response to several issues raised by conformity implementers and other
interested parties. EPA has worked closely with these conformity
stakeholders to develop this proposal. In March 1995, the National
Governors' Association (NGA) and the Environmental Council of States
(ECOS) hosted a meeting of state DOTs, environmental agencies, EPA, and
DOT to discuss the conformity rule. At this meeting, ECOS presented
nine specific proposals to change the conformity rule. EPA and DOT
committed to address all nine issues. EPA requested that state
workgroups prepare white papers examining four issues in greater depth:
the build/no- build test, non-federal projects, rural nonattainment
areas, and adding non-exempt projects to the transportation plan and
transportation improvement program (TIP) without full regional
analysis. The remaining five issues are being addressed
administratively.
In April 1995, EPA hosted in Washington, DC a conformity
stakeholder meeting of state DOTs, state environmental agencies, MPOs,
environmentalists, industry groups, and other public interest groups.
EPA substantially shaped the meeting's agenda around NGA's four white
papers in order to provide groundwork for stakeholder discussion on
these issues. On June 30, 1995, EPA distributed to conformity
stakeholders draft regulatory language addressing the issues discussed
at the April meeting. EPA received written comments and followed up
with a series of four conference calls in July 1995 to solicit
additional reaction to the June draft language. The draft language and
comments are available in the public docket.
On September 1, 1995, EPA distributed a letter to conformity
stakeholders indicating what EPA and DOT intended to propose regarding
key conformity issues. Today's proposal is based substantially on the
approach described in the September letter.
II. Applicability of the Budget Test and Emission Reduction Tests
A. Description of Proposal
The proposal would change the time periods during which the budget
test and the ``emission reduction tests,'' commonly known as the
``build/no-build test,'' are required. The proposal would eliminate the
requirements for the emission reduction tests once a control strategy
SIP or maintenance plan has been submitted to EPA and EPA has had 45
days to review the adequacy of the SIP submission and its motor vehicle
emissions budget(s). The budget test would replace the emission
reduction tests 45 days after the control strategy SIP or maintenance
plan was submitted to EPA (provided EPA has not found the submission
inadequate), or earlier if EPA has found the submission adequate.
Under the existing transportation conformity rule, both the
emission reduction tests and the budget test are required until EPA's
final approval of the control strategy SIP (or maintenance plan, where
control strategy SIPs are not required). In addition, under the
existing rule EPA has a review period of 90 days before the motor
vehicle emissions budget in a newly submitted SIP may replace a
previously submitted motor vehicle emissions budget.
The proposal would streamline the conformity process by eliminating
the existing transportation conformity rule's reliance on the
classification system of ``Phase II interim period,'' ``transitional
period,'' ``control strategy period,'' and ``maintenance period'' to
determine whether the budget test and/or emission reduction tests
apply.
1. Applicability of Nitrogen Oxides (NOX) Emission Reduction
Tests and Budget Tests in Ozone Areas
Under the proposal, the budget test would replace the emission
reduction tests only for those pollutants for which the submitted SIP
establishes a motor vehicle emissions budget. For example, 15% SIPs for
ozone areas are only required to address volatile organic compounds
(VOC), and as a result, most will not address NOX or establish a
NOX emissions budget. In these areas, the VOC emission reduction
tests (``build/no-build'' and less-than-1990 tests) would no longer be
required, but the NOX emission reduction tests would continue to
be required until a NOX budget is established in a submitted SIP
(unless the area had received a NOX waiver). In ozone
nonattainment areas, Phase II attainment SIPs will establish NOX
motor vehicle emissions budgets.
A submitted 15% or Phase I attainment SIP would be considered to
establish a NOX motor vehicle emissions budget if the submitted
SIP contains an explicit NOX budget that is intended to act as a
ceiling on future NOX emissions and if the NOX budget
represents a net reduction from 1990 NOX emissions levels. A
submitted SIP that achieves 15% or reasonable further progress
reductions by substituting some NOX reductions for the required
VOC reductions would establish a NOX motor vehicle emissions
budget.
2. EPA 45-Day Review Period
This proposal would allow conformity to be determined based on
consistency with a submitted SIP's motor vehicle emissions budget(s),
once the submitted SIP had been reviewed by EPA. (Of course, the
submitted SIP cannot override the motor vehicle emissions budgets in an
approved SIP for the years addressed by the approved SIP. See Section
III.A.1.) The submitted SIP budget(s) would be used for conformity
purposes beginning 45 days after the SIP's submission to EPA, provided
EPA had not found the SIP and its budget(s) inadequate. The submitted
SIP budget(s) would be used for determining conformity before EPA's 45-
day review period expires if EPA finds the SIP and its budget(s)
adequate before expiration of such 45-day period.
If EPA finds the submitted SIP and its budget(s) to be inadequate,
they could not be used for conformity purposes, and conformity would
have to be
[[Page 36114]]
determined using the previously established SIP budget(s), or the
emission reduction tests, if there are no previously established SIP
budgets. If EPA finds the submitted SIP and its budget(s) to be
inadequate after EPA's 45-day review period and after conformity had
already been determined using the submitted SIP, the conformity
determination would still be valid. However, that submitted SIP and
budget(s) could not be used for future conformity determinations.
Projects would still be considered to come from a conforming plan and
TIP if they were included in the transportation plan and TIP that were
found to conform to a budget that was later declared inadequate.
In order for EPA to consider a submitted SIP's motor vehicle
emissions budget(s) adequate for transportation conformity purposes,
the submitted SIP must have been endorsed by the Governor (or his or
her designee) and have been subject to a public hearing. The emissions
budget(s) would have to be clearly identified and precisely quantified.
Each emissions budget would have to be consistent with reasonable
further progress, attainment, or maintenance, based upon a
consideration of all emissions sources. The emissions budget(s) would
have to be consistent with the area's emissions inventory and modeling
assumptions for all sources and show a clear relationship between the
control measures, the emissions reductions, and the resulting budgets.
Each revision to a previously submitted SIP would have to identify the
impacts on point, area, and mobile source emissions, as well as changes
to any established safety margins. Changes to previously submitted
budgets and the reasons for the changes would have to be explained and
documented, including the basis for any changes related to emission
factors or estimates of vehicle miles traveled (VMT), and what those
changes imply for control strategies. If the revised emissions budget
requires additional emission control strategies to demonstrate
attainment or maintenance, such new strategies would have to be
specified in the SIP submission. The SIP submission would have to
contain a quantification of the emissions impacts of such new
strategies and, at a minimum, commitments by appropriate agencies to a
schedule for adoption and implementation, and the draft regulations or
other relevant documents. Consultation among federal, state, and local
agencies would have to occur and full documentation and justifications
would have to be provided to EPA before the SIP is submitted. Any EPA
concerns would have to be addressed before submission if the SIP and
its budget(s) are to be found adequate for conformity purposes. If a
SIP submission does not satisfy these conditions, EPA may find it
inadequate for conformity purposes.
EPA's review of the adequacy of a SIP submission for transportation
conformity purposes is separate from EPA's completeness review. EPA may
find a SIP incomplete after 45 days or after finding the SIP submission
adequate for transportation conformity purposes. An incomplete SIP may
still have appropriate motor vehicle emissions budgets for use in the
conformity process, as recognized by EPA's use of ``protective
findings'' under the November 1993 transportation conformity rule. If
the SIP submission is both incomplete and inadequate for transportation
conformity purposes, EPA would have to declare the submission
inadequate for conformity purposes in addition to finding it
incomplete.
3. Areas That Are Not Required to Submit Control Strategy SIPs
Background. Under the existing transportation conformity rule,
areas that are not required to submit control strategy SIPs have two
options for demonstrating conformity. The first option is to satisfy
the ``build/no-build'' and less-than-1990 emission reduction tests; the
second is to submit a SIP that demonstrates attainment and use the
budget test to determine conformity. In the latter option, such an area
would be required under the existing rule to satisfy both of the
emission reduction tests until the SIP is approved by EPA.
Areas affected by proposal. Marginal and below ozone nonattainment
areas, not classified carbon monoxide (CO) nonattainment areas, and
moderate CO nonattainment areas with a design value of 12.7 ppm or less
are not required by the Clean Air Act to submit control strategy SIPs.
These classifications are listed in Secs. 51.464 and 93.136 of the
existing transportation conformity rule.
In addition, some moderate and above ozone nonattainment areas that
are meeting the ozone NAAQS are not required to submit control strategy
SIPs (see May 10, 1995, memorandum from John S. Seitz, Director of the
Office of Air Quality Planning and Standards, to Regional Air Division
Directors, entitled ``Reasonable Further Progress, Attainment
Demonstration, and Related Requirements for Ozone Nonattainment Areas
Meeting the Ozone National Ambient Air Quality Standard'').
Through today's action, EPA is proposing alternatives for
demonstrating conformity for particular pollutants if areas are not
required to submit control strategy SIPs for that pollutant. The first
alternative is currently allowed under the existing transportation
conformity rule and would continue to be available under this proposal
with some additional flexibilities. The second and third options would
provide new alternatives to these areas for demonstrating conformity.
EPA would require these areas to satisfy only one of the alternatives
described below in order to demonstrate conformity.
Create a budget through the SIP process and use the budget test. As
stated above, the existing transportation conformity rule and this
proposal would allow these areas to submit a SIP that establishes a
motor vehicle emissions budget consistent with attainment or
maintenance. These areas would then be required to satisfy the budget
test for each emissions budget. However, unlike the existing rule, this
proposal would allow the SIP budget to be used after the SIP has been
submitted to EPA and before EPA approval. The emission reduction tests
would not be required once a SIP is submitted and EPA's 45-day review
period has occurred (as described above).
Default budget for clean data areas. This proposal would provide
another alternative for demonstrating conformity in areas that are not
required to submit control strategy SIPs, and have monitoring data
indicating attainment of the standard (``clean data''), but have not
yet submitted a maintenance plan. These clean data areas could
demonstrate conformity using the budget test instead of the emission
reduction tests, using as a ``motor vehicle emissions budget'' the
motor vehicle emissions levels in the most recent year of clean data.
The motor vehicle emissions levels in the most recent year of clean
data would be determined by the state air quality agency through the
interagency consultation process. This default ``budget'' would not
have to be submitted as a SIP revision and would not require special
public participation in addition to that otherwise required by the
transportation conformity rule. If a clean data area wishes to use a
budget other than emissions levels in the most recent year of clean
data, the area could submit that budget through the SIP process as
described above.
Emission reduction test flexibility. Today's action would allow
areas that are not required to submit control strategy SIPs another
alternative when demonstrating conformity. If these areas
[[Page 36115]]
do not have a SIP with a motor vehicle emissions budget, this proposal
would allow these areas a choice of emission reduction tests.
Specifically, this proposal would allow them to demonstrate conformity
by either satisfying the build/no-build test or demonstrating that
annual motor vehicle emissions will not be greater than 1990 levels
(i.e., the ``1990 test'').
Under the existing transportation conformity rule, these areas are
required to satisfy both the build/no-build and less-than-1990 emission
reduction tests in the absence of a budget. For the reasons explained
below, this proposal would offer CO and ozone areas not required to
submit control strategy SIPs the same flexibility currently available
to PM10 (particles with an aerodynamic diameter of less than or
equal to a nominal 10 micrometers) and nitrogen dioxide (NO2)
nonattainment areas, which are required to satisfy either the build/no-
build emission reduction test or ensure that annual motor vehicle
emissions will not be greater than 1990 levels.
B. Rationale
1. Elimination of the Emission Reduction Tests
A broad consensus of conformity implementers and interested parties
have advised EPA that the ``build/no-build test'' has limited value in
demonstrating contribution to emission reductions, or serving as the
primary criterion on which conformity is based. Because of the
limitations of currently available modeling tools, the build/no-build
test may yield only slight differences in emissions, well within the
range of modeling error. The parties have indicated that when motor
vehicle emissions budget(s) have been established in submitted SIPs,
they provide a more relevant basis for conformity determinations.
EPA agrees with this assessment by the transportation conformity
stakeholders. EPA originally created the ``build/no build test'' and
less-than-1990 tests (required by Secs. 51.436-51.446 of the November
1993 transportation conformity rule) in order to implement the emission
reduction requirements of Clean Air Act section 176(c)(3)(A)(iii) (for
ozone and CO nonattainment areas), and to ensure that transportation
activities would not increase the frequency or severity of existing
violations (for PM10 and NO2 nonattainment areas), as
required by Clean Air Act section 176(c)(1)(B)(ii). In light of the
stakeholders' input, EPA now believes that consistency with the motor
vehicle emissions budget(s) in a submitted control strategy SIP or
maintenance plan is sufficient to satisfy these Clean Air Act
requirements.
Clean Air Act section 176(c)(3)(A)(iii) requires transportation
plans, TIPs, and projects in ozone and CO nonattainment areas to
contribute to annual emissions reductions consistent with sections
182(b)(1) and 187(a)(7). EPA believes that consistency with the motor
vehicle emissions budgets in a submitted ozone or CO attainment SIP
satisfies Clean Air Act section 176(c)(3)(A)(iii), because these
budgets are intended to represent the emissions reductions necessary to
attain the ozone or CO standard, as required by sections 182(b)(1) and
187(a)(7). Similarly, consistency with a submitted maintenance plan's
emissions budgets fulfills the requirement to contribute to emissions
reductions necessary to attain the standard, because the maintenance
plan's emissions budgets represent emission levels consistent with
attainment.
EPA carefully considered whether the motor vehicle emissions
budget(s) established by an ozone area's submitted 15% SIP or post-1996
reasonable further progress SIP are sufficient to satisfy the
requirements of Clean Air Act section 176(c)(3)(a)(iii), because such
budgets do not necessarily represent the full emissions reductions
necessary to attain the ozone standard. However, the motor vehicle
emissions budgets in these SIPs do represent VOC emission reductions
from 1990 levels. As a result, EPA believes that consistency with such
a VOC budget is sufficient to satisfy the requirement of Clean Air Act
section 176(c)(3)(A)(iii) for contribution to necessary emissions
reductions.
EPA considered not allowing a submitted 15% SIP or post-1996
reasonable further progress SIP to establish a NOX motor vehicle
emissions budget that would be used for determining conformity instead
of the NOX emission reduction tests. The Clean Air Act does not
require such SIPs to address NOX, so a NOX emissions budget
in such a SIP could be unconstrained and would not necessarily be
sufficient to satisfy section 176(c)(3)(A)(iii)'s requirement to
contribute to annual emissions reductions. However, if a state
establishes a NOX emissions budget that it intends to constrain
future emissions and that does represent emissions reductions from 1990
levels, EPA now believes this budget would be a better basis for
determining conformity than the ``build/no-build test.'' As a result,
EPA is proposing that a 15% SIP or post-1996 reasonable further
progress SIP (Phase I attainment SIP) that addresses NOX would be
considered to establish a NOX emissions budget for the purposes of
transportation conformity only if that budget represented net emission
reductions from 1990. Whether or not a SIP establishes a NOX motor
vehicle emissions budget should be determined in consultation with the
SIP agency and the EPA Region.
For PM10 and NO2 nonattainment areas, the ``build/no-
build test'' and the less-than-1990 test were intended to satisfy the
general definition of conformity in section 176(c)(1)(B)(ii) that
transportation activities not increase the frequency or severity of any
existing violation. EPA believes that consistency with the motor
vehicle emissions budget(s) established in the submitted attainment SIP
or maintenance plan ensures that existing violations will not be
worsened by transportation projects, because these budgets represent
emissions levels that are consistent with attainment of the standards.
2. Adequacy of Submitted (But Not Approved) Budgets
The November 1993 transportation conformity rule requires emission
reduction tests as well as budget tests until EPA approves the
submitted SIP, because EPA believed it could not be certain that
submitted emissions budgets are consistent with Clean Air Act
requirements for reasonable further progress, attainment, and
maintenance until EPA approves the SIP. In contrast, this proposal
would allow the motor vehicle emissions budgets established by
submitted SIPs to be the basis of conformity determinations. (Of
course, the submitted SIP cannot override the motor vehicle emissions
budgets in an approved SIP for the years addressed by the approved SIP.
See Section III.A.1.)
EPA now believes this is appropriate because a submitted SIP is a
product of a state's interagency consultation process, which encourages
discussion among state and local air quality and transportation
agencies, and is ultimately endorsed by the Governor (or his/her
designee). During the SIP process, states also gather information and
comment from environmental groups and other interested parties at
public hearings. EPA believes that these processes would ensure the
credibility of a submitted SIP (and its motor vehicle emissions
budgets) for the purposes of transportation conformity especially where
the only alternative conformity test is the emission reduction tests.
Given the limitations to the usefulness of the emission reduction
tests, a submitted SIP's motor vehicle
[[Page 36116]]
emissions budgets are likely to be at least as good a basis for making
conformity determinations, even if they are not yet approved by EPA.
EPA's proposed 45-day review period for newly submitted SIPs is
intended to prevent conformity from being based on motor vehicle
emissions budgets that are clearly not consistent with attainment,
maintenance, or reasonable further progress. If EPA was not consulted,
given sufficient information, or EPA's concerns were not satisfied
prior to SIP submission sufficient for EPA to determine that the motor
vehicle emissions budgets are adequate for conformity purposes during
this 45-day review period, EPA could declare the motor vehicle
emissions budgets inadequate and prevent their use for conformity
purposes. In addition, if EPA finds the motor vehicle emissions budgets
inadequate even after the 45-day review period, further conformity
determinations may not be based on those budgets.
EPA considered a range of review periods after which submitted
motor vehicle emissions budgets could replace emission reduction tests
for determining conformity. Under the November 1993 transportation
conformity rule, EPA has used a 90-day review period before a newly
submitted SIP budget could replace a previously submitted budget. Many
conformity stakeholders suggested a 30-day review period. EPA is
proposing a 45-day review period as a compromise to balance the
conflicting goals of using submitted SIP budgets as quickly as possible
and preventing transportation investments from being made based on
budgets that are not consistent with attainment, maintenance, or
reasonable further progress. If budgets are found inadequate after
conformity has already been determined, future plans and TIPs would
have to offset the emissions from grandfathered projects that may have
been inappropriately allowed under the inadequate budgets. This
disruption could be avoided by allowing EPA enough time initially to
determine the adequacy of budgets and prevent the use of inadequate
budgets.
Regardless of the 45-day review period, EPA cannot ultimately
ensure that a submitted SIP's motor vehicle emissions budget is
consistent with reasonable further progress, attainment, or
maintenance--and thus adequate to fulfill the conformity requirements
of Clean Air Act section 176(c)--until EPA fully approves the SIP
through notice-and-comment rulemaking. As a result, the proposal
provides that reliance on a submitted SIP's motor vehicle emissions
budgets for determining conformity is deemed to be a statement by the
MPO and DOT that they are not aware of any information that would
indicate that emissions consistent with such budgets would cause or
contribute to any new violation of the relevant standard(s); increase
the frequency or severity of any existing violation of the relevant
standard(s); or delay timely attainment of the relevant standards or
any required interim emissions reductions or other milestones. (This
provision clarifies that, in the absence of EPA approval of the SIP,
the MPO and DOT may not base conformity determinations on submitted
SIPs that they have reason to believe do not satisfy Clean Air Act
requirements.)
3. Areas Not Required to Submit Control Strategy SIPs
EPA has received public comment to extend certain flexibilities to
areas that are not required to submit control strategy SIPs. The
existing transportation conformity rule requires these areas to either
satisfy the ``build/no-build'' and less-than-1990 emission reduction
tests or submit a control strategy SIP or maintenance plan and satisfy
the budget test. Today's action proposes additional flexibilities for
areas that are not required to submit control strategy SIPs, including
marginal and below ozone nonattainment areas, not classified CO
nonattainment areas, moderate CO nonattainment areas with a design
value of 12.7 ppm or less, and some moderate and above ozone areas that
are meeting the ozone standard. Please refer to section II.A.3. for
additional background material.
Create a budget through the SIP process and use the budget test.
Although the areas discussed in this section are not required by the
Clean Air Act to submit control strategy SIPs, these areas could choose
to submit a control strategy SIP or maintenance plan (which contains a
motor vehicle emissions budget) and demonstrate conformity by using the
budget test. The existing transportation conformity rule requires
consistency with the SIP's motor vehicle emissions budget as stipulated
in Clean Air Act section 176(c)(2)(A). This option is available both in
the existing transportation conformity rule and this proposal.
Default budget for clean data areas. This proposal would allow
areas with clean monitoring data but no submitted or approved budget to
determine conformity using the budget test, with the motor vehicle
emissions levels in the most recent year of clean data serving as the
``budget.'' In order for data to be considered ``clean,'' it must meet
EPA's requirements and guidance for acceptable monitoring. EPA is also
proposing this second option because many areas would prefer to
determine conformity using a budget test rather than the emission
reduction tests, but are nevertheless unwilling to devote resources to
creating a motor vehicle emissions budget through the SIP process. The
motor vehicle emissions in the most recent year with clean data is an
adequate ``default budget'' that can be determined without using the
formal SIP process. This level of motor vehicle emissions does not
automatically demonstrate attainment, because it does not consider the
levels of emissions from other sources. However, these areas are not
required by the Clean Air Act to submit attainment demonstrations.
Furthermore, this level of motor vehicle emissions does produce clean
data. Therefore, EPA believes that requiring consistency with the level
of motor vehicle emissions in the most recent year of clean data is a
reasonable test, and one that is likely to be more meaningful than the
emission reduction test (for the reasons discussed earlier).
Emission reduction test flexibility. This proposed alternative
would allow areas that are not required to submit control strategy SIPs
that do not choose the other two options in this section to satisfy
either the build/no-build test or demonstrate that annual motor vehicle
emissions will not be greater than 1990 levels (i.e., the ``1990
test''), provided these areas do not have an approved budget in a
control strategy SIP or maintenance plan. EPA is proposing this
flexibility because conformity stakeholders have indicated that, like
PM10 and NO2 areas, the ozone and CO classifications listed
in Secs. 51.464 and 93.136 of the transportation conformity rule and
moderate and above ozone nonattainment areas that are affected by the
May 10, 1995, EPA memorandum (see section II.A.3. for more information)
are not subject to sections 182(b)(1) and 187(a)(7) of the Clean Air
Act.
The existing transportation conformity rule requires that areas
without motor vehicle emissions budgets must satisfy both the build/no-
build and less-than-1990 emission reduction tests in order to
demonstrate conformity. EPA originally created these tests in order to
implement the emission reduction provisions of Clean Air Act section
176(c)(3)(A)(iii), which requires ozone and CO areas to contribute to
annual emission reductions consistent with sections 182(b)(1) and
187(a)(7). However, sections 182(b)(1) and 187(a)(7) only apply to
moderate and above ozone nonattainment areas and
[[Page 36117]]
CO nonattainment areas that are moderate greater than 12.7 ppm.
PM10 and NO2 areas are similarly not required to satisfy
the annual emission reduction provisions of Clean Air Act section
176(c)(3)(A)(iii). The existing transportation conformity rule and this
proposal require PM10 and NO2 areas to satisfy either the
build/no-build or 1990 test in order to demonstrate conformity.
EPA originally required both the build/no-build and less-than-1990
tests for all ozone and CO areas in order to ensure that transportation
planning does not produce new air quality violations, worsen existing
violations, or delay timely attainment of the NAAQS, as required by
Clean Air Act section 176(c)(1)(B). However, EPA now believes that, for
these areas which were never subject to the emission reduction mandate
of section 176(c)(3)(A)(iii), either the build/no-build test or the
1990 test is sufficient to satisfy the requirements of the Clean Air
Act.
III. Implementation of the Budget Test
A. Which Budgets Apply?
1. Approved SIPs Versus Submitted SIPs
Years that are directly addressed by the approved SIP. Motor
vehicle emissions budgets in an approved SIP (i.e., the applicable
implementation plan) must always be used for demonstrating satisfaction
of the budget test for those years in the timeframe of the
transportation plan that are addressed by the approved SIP. That is, if
the approved SIP establishes a motor vehicle emissions budget for a
year in the timeframe of the transportation plan, consistency with that
budget must be demonstrated for that year. A submitted SIP cannot
override the motor vehicle emissions budgets in an approved SIP for the
years addressed by the approved SIP.
Clean Air Act section 176(c) specifically requires conformity to
approved implementation plans. The provisions of an implementation plan
that EPA has approved under Clean Air Act section 110 are enforceable
and cannot be changed on the basis of a submission. As a result,
although some conformity implementers and interested parties requested
that they be permitted to replace approved SIP budgets with submitted
SIP budgets, EPA believes that this cannot be legally allowed. In
addition, approved SIP budgets have been subject to full technical
review and public comment and should not be replaced by budgets that
have not yet been fully analyzed and reviewed.
Years that are not directly addressed by the approved SIP. However,
this proposal would allow a submitted SIP's motor vehicle emissions
budgets to be used instead of the approved SIP's budgets for those
years not directly addressed by the approved SIP. For example, for a
serious ozone nonattainment area, the approved 15% SIP's VOC budget
would have to be used to demonstrate the budget test for 1996, but the
submitted attainment SIP's budget would be used to demonstrate the
budget test for the attainment year (1999).
Similarly, this proposal would allow a submitted maintenance plan's
motor vehicle emissions budgets to be used for the years after the
attainment year, instead of continuing to use the approved attainment
year budget for those subsequent years. Under the existing
transportation conformity rule, a submitted maintenance plan's motor
vehicle emissions budget(s) may not be used for transportation
conformity purposes until the maintenance plan has been approved.
EPA believes this flexibility is appropriate because any given
approved SIP is only intended to address a certain period of time. In
general, attainment SIPs address only the period through the attainment
year, and maintenance plans address at a minimum a ten-year period. EPA
believes that the Clean Air Act's reference to conformity to ``approved
implementation plans'' applies to the years which the approved SIP
addresses, and that this language should not prohibit using as the
relevant test of conformity subsequent SIP submissions that address
later years. EPA believes that the submitted maintenance plan's motor
vehicle emissions budgets are more relevant to the years after the
attainment year than the attainment year budget in the approved
attainment SIP. Similarly, a submitted attainment SIP's budget is more
relevant for the attainment year than an approved post-1996 SIP budget.
EPA had previously required use of the last budget in the approved SIP
for all subsequent years only because there was no other budget against
which to determine conformity. Once such a budget is submitted, it
provides the most relevant basis for testing conformity.
If no SIP is submitted that addresses the years after the approved
SIP, the approved SIP's budget(s) would continue to apply for the
future years in the timeframe of the transportation plan.
Changes to approved SIPs. This proposal would not alter the fact
that proposed changes to an approved SIP cannot be used for the
purposes of transportation conformity until those changes are approved.
For example, if an area submits a proposed revision to a SIP with an
attainment year budget to replace the approved attainment SIP, that SIP
submission cannot be used until it is approved by EPA.
2. Multiple SIP Submissions
How soon can a newly submitted SIP replace a previously submitted
SIP? Under this proposal, the most recent SIP submissions would replace
other prior SIP submissions that have not yet been approved. If an area
submits a SIP to revise motor vehicle emissions budgets in a SIP that
has not yet been approved, the most recent SIP submission would be used
for demonstrating the budget test beginning 45 days after submission to
EPA (provided EPA has not found the submission inadequate), or earlier,
if EPA has found the submission to be adequate.
Under the existing transportation conformity rule, a newly
submitted SIP is not permitted to replace a complete SIP submission for
90 days. If EPA found the newly submitted SIP complete in less than 90
days, either SIP submission could be used for conformity determinations
made during the first 90 days after SIP submission. This proposal would
require the most recent SIP submission to be used for conformity
purposes after 45 days (if it has not been found inadequate), or as
soon as it has been found adequate, if this occurs in less than 45 days
after submission to EPA.
EPA is proposing this change for several reasons. First, due to
conformity stakeholder suggestions that submitted SIPs should be used
sooner for conformity purposes, EPA is proposing to shorten the
existing transportation conformity rule's 90-day grace period to 45
days. In addition, EPA is interested in streamlining the transportation
conformity rule and reducing ambiguity in its implementation. There has
been substantial confusion in implementation of the existing
transportation conformity rule regarding which submitted SIP's budgets
should be used for conformity purposes, and at which times. EPA
believes that it is simpler and truer to the spirit of conformity to
require the most recently submitted SIP (that has undergone 45-day EPA
review) to be used for determining conformity.
EPA believes that the simplicity gained from this change outweighs
any potential limitation to the flexibility of areas to choose among
SIP submissions in the first few weeks after submission. In many
instances, SIP submissions intended to replace previous SIP submissions
were either inspired by conformity considerations or represent a more
accurate basis for conformity. As
[[Page 36118]]
a result, most areas would not choose to use the previous SIP
submission even if given the opportunity.
In addition, the protection EPA originally intended the 90-day
grace period to provide is under the state's control. EPA did not
originally require newly submitted SIPs to be used in the first 90
days, because EPA did not want conformity determinations that were
underway at the time of the SIP submission to be disrupted. However,
this protection is not necessary in the conformity rule itself, because
the state controls when it submits a SIP, and the interagency
consultation process gives state and local agencies an opportunity to
coordinate conformity determinations and SIP submissions to avoid
disruption of the conformity process. EPA believes that the ambiguity
regarding which SIP submission is used for conformity is more
problematic than the remote possibility that a SIP submission would
interfere with a conformity determination that was underway.
When should different submitted SIPs be used? When a series of
control strategy SIPs have been submitted to fulfill different Clean
Air Act requirements for a particular pollutant, the budget test would
be demonstrated using each relevant submitted SIP that is adequate for
conformity purposes. For example, the proposal would require the
submitted post-1996 reasonable further progress SIP's motor vehicle
emissions budgets to be used for demonstrating the budget test for
milestone years, and would require the submitted attainment
demonstration's budget(s) to be used for demonstrating the budget test
for the attainment year. SIP budget(s) that address the latest future
year would apply for all subsequent years in the timeframe of the
transportation plan.
B. Control Strategy SIPs and Maintenance Plans That Do Not Establish
Motor Vehicle Emissions Budgets
This proposal would clarify that the emissions budget test must be
satisfied only for those pollutants and pollutant precursors for which
a motor vehicle emissions budget is established. Normally, a control
strategy SIP or maintenance plan would by its nature include a motor
vehicle emissions budget for each pollutant and pollutant precursor for
which the area was designated nonattainment. These budgets are created
by the control strategy SIP or maintenance plan even if they are not
clearly identified, and failure to clearly identify a motor vehicle
emissions budget does not relieve the requirement to satisfy the budget
test. However, as explained further below, there are some cases in
which a SIP could specifically provide that no motor vehicle emissions
budget was established for transportation conformity purposes, and in
such cases, the budget test would not have to be satisfied for that
pollutant or precursor.
Certain nonclassifiable ozone areas have the option to submit a
``limited maintenance plan,'' which would not establish motor vehicle
emissions budgets. According to the November 16, 1994, memorandum from
Sally Shaver, Director of EPA's Air Quality Strategies and Standards
Division, to EPA Regional Air Division Directors, entitled ``Limited
Maintenance Plan Option for Nonclassifiable Ozone Nonattainment
Areas,'' nonclassifiable ozone areas whose design values are at or
below 0.106 ppm (85% of exceedance levels of the ozone standard) at the
time of redesignation may choose to submit a less rigorous maintenance
plan than required for other areas. This ``limited maintenance plan''
would not be required to project emissions over the maintenance period,
and as a result, no motor vehicle emissions budget would be
established. There are similar policies for CO and PM10 areas that
may also result in no motor vehicle emissions budgets being
established.
In other cases, the control strategy SIP or maintenance plan could
explicitly demonstrate that motor vehicle emissions are not a
significant contributor to the nonattainment problem, and the SIP could
explicitly state that it is not establishing a motor vehicle emissions
budget for transportation conformity purposes. This could occur, for
example, in CO and PM10 areas that are dominated by stationary
sources. In order for EPA to approve or find adequate for conformity
purposes a SIP that makes a claim of insignificance, the SIP would have
to demonstrate that it would be unreasonable to expect that such an
area would experience enough motor vehicle emissions growth for a
violation to occur. Such a demonstration would have to be based on a
number of factors, including the percentage of the inventory comprised
by motor vehicle-related emissions currently and in the future, how
close the monitoring data is to the standard, the absence of SIP motor
vehicle control measures, historical trends in the growth of motor
vehicle emissions and VMT, and projections of motor vehicle emissions
and VMT.
If EPA's 45-day review period expires without EPA finding the SIP
either adequate or inadequate for conformity purposes, the submitted
SIP's claim of insignificance may be used to justify not demonstrating
satisfaction of the budget test (unless or until EPA finds the SIP
inadequate).
When a control strategy SIP or maintenance plan does not establish
motor vehicle emissions budgets, no regional emissions tests would be
required to be satisfied. That is, neither the emissions budget test
nor the emission reduction tests would be required to be satisfied.
C. For Which Years Would the Budget Test Be Demonstrated?
This proposal would clarify (without changing the substance of) the
existing transportation conformity rule's requirements regarding the
years for which the budget test must be demonstrated. The proposal
would explicitly require the budget test to be demonstrated for each
year for which the SIP establishes a motor vehicle emissions budget.
For example, the attainment SIP generally establishes a budget for the
attainment year, and the 15% SIP establishes a VOC budget for 1996.
SIPs may explicitly include motor vehicle emissions budgets for other
years not specifically required to be addressed by the Clean Air Act.
For example, an attainment SIP or a maintenance plan may address more
years than required by the Clean Air Act and explicitly include motor
vehicle emissions budgets for those years. In such cases, the budget
test would have to be demonstrated for the years for which a budget was
specifically established.
The budget test must be demonstrated for the last year of the
maintenance plan and any other years for which the maintenance plan
establishes motor vehicle emissions budgets. An area may choose to
explicitly establish motor vehicle emissions budgets for years in the
timeframe of the maintenance plan other than the last year. In such
cases, compliance with the budget test would have to be demonstrated
for those years. Some maintenance plans may include specific motor
vehicle emissions projections for some or all years in the timeframe of
the maintenance plan, without intending that such projections operate
as limitations on emissions. The budget test would not be required to
be demonstrated for these years unless it was the intent of the
maintenance plan to establish a budget for these years. Such issues
should be addressed when developing the control strategy SIP or
maintenance plan. For control strategy SIPs and maintenance plans that
have already been submitted, the state's intent regarding the use of
motor vehicle emissions budgets may be clarified
[[Page 36119]]
through the interagency consultation process.
In addition to the years for which the SIP establishes a motor
vehicle emissions budget, the budget test must be demonstrated for the
last year of the transportation plan's forecast period. If there are
more than ten years between the years for which the SIP specifically
establishes motor vehicle emissions budgets, the budget test must also
be demonstrated for some intermediate years so that the budget test is
demonstrated at ten-year (or shorter) intervals.
Regional emissions analysis. Satisfaction of the budget test
requires comparison of the motor vehicle emissions budget with regional
emissions predicted for a given year. A regional emissions analysis
must be performed for each pollutant and precursor for the last year of
the transportation plan's forecast period and the attainment year (if
it is in the timeframe of the transportation plan). For the other years
for which the budget test is required to be demonstrated, the estimate
of regional emissions does not necessarily need to be based on a
regional emissions analysis performed for that specific year; the
estimate of regional emissions may be based on an interpolation between
the years for which the regional emissions analysis was performed.
However, the years for which the regional emissions analysis is
performed must be no more than ten years apart.
D. Maintenance Plans
The proposal would require that if the maintenance plan does not
establish motor vehicle emissions budgets for any years other than the
last year of the maintenance plan, the demonstration of consistency
with the motor vehicle emissions budget(s) must be accompanied by a
qualitative finding that there are no factors which would cause or
contribute to a new violation or exacerbate an existing violation in
the years before the last year of the maintenance plan.
Because the maintenance plan is required by the Clean Air Act to
demonstrate maintenance of the standards over a 10-year period, general
consistency between the latest planning assumptions and the maintenance
plan's assumptions and projections is a basis for finding that there
will not be new or worsened violations during that period. Each
maintenance plan will have different assumptions and projections, so
the specific basis for an area's qualitative finding will need to be
determined through the interagency consultation process. The
qualitative finding would be contained in the documentation that
demonstrates that the budget test has been satisfied.
EPA believes a qualitative finding is necessary if the budget only
addresses the last year of the maintenance plan, because the budget
test alone is not sufficient to determine, as required by the Clean Air
Act, that the transportation action will not cause a new violation. The
emissions impacts in the initial ten years of the maintenance plan must
be considered in some manner in order to determine conformity.
EPA believes that requiring a qualitative finding is preferable to
requiring maintenance plans to establish motor vehicle emissions
budgets for specific years. Although maintenance plans contain
projections for intermediate years that could be used as motor vehicle
emissions budgets, EPA believes that the years for which budgets are
established should be decided by the state. EPA is willing to allow
states to establish budgets only for the last year of the maintenance
plan, provided conformity determinations are accompanied by a
qualitative finding addressing the intermediate years. Alternatively,
states could choose to establish motor vehicle emissions budgets for
intermediate years in the maintenance plan, which would then be used to
determine conformity.
IV. Non-federal Projects
A. Description of Proposal
This proposal would allow regionally significant transportation
projects that are funded or approved by a recipient of federal funds
designated under title 23 U.S.C. or the Federal Transit Laws (49 U.S.C.
Chapter 53) which do not rely at all on any FHWA/FTA funding or
approvals (i.e., ``non-federal projects'') to be adopted or approved
during a transportation plan/TIP conformity lapse, provided the project
was included in the regional emissions analysis supporting the most
recent transportation plan and TIP conformity determination. Also, the
project's design concept and scope could not have changed significantly
from that included in the previous emissions analysis.
The existing transportation conformity rule requires a currently
conforming transportation plan and TIP to be in place at the time a
recipient of federal funds adopts or approves a regionally significant
non-federal project. As a result, no regionally significant non-federal
projects can be adopted or approved during a transportation plan/TIP
conformity lapse.
Under both this proposal and the existing transportation conformity
rule, adoption or approval of non-federal projects that are not
regionally significant is not subject to any transportation conformity
requirements. In addition, under both this proposal and the existing
transportation conformity rule, there is a provision for regionally
significant non-federal projects to be added to the existing
transportation plan and TIP's regional emissions analysis, if the
transportation plan and TIP are currently conforming. That is, if a
regionally significant non-federal project has not previously been
included in the regional emissions analysis supporting the
transportation plan and TIP conformity determinations, another regional
emissions analysis could be performed including the transportation plan
and TIP projects and the additional regionally significant non-federal
project. If this analysis demonstrates that the currently conforming
transportation plan and TIP would still conform if the non-federal
project were implemented, the non-federal project could be adopted or
approved.
Some commenters have suggested that if certain non-federal projects
are to be permitted to be adopted or approved during a transportation
conformity lapse as EPA is currently proposing, each such project
should be approved by the Governor. This provision would provide
greater assurance that the emissions consequences of proceeding with
projects during a conformity lapse are consciously accepted. However,
EPA is not proposing this limitation at this time because such a
limitation is not explicitly required by the Clean Air Act, and it is
not clear which state and local government officials should have the
authority to adopt or approve non-federal projects during a conformity
lapse. EPA is interested in receiving comment on this subject.
B. Rationale
EPA is proposing to allow some regionally significant non-federal
projects to be adopted or approved during a conformity lapse in
response to comments from conformity implementers. These comments
stated that state and local governments should have the discretion to
accept the emissions consequences of projects that are under their
control to fund and approve, even when there was not a conforming
transportation plan and TIP. Future transportation plans and TIPs are
required to consider the emissions from regionally significant non-
federal
[[Page 36120]]
projects, so any necessary offsets would ultimately be achieved.
EPA believes this proposal is consistent with the requirements of
Clean Air Act section 176(c). Section 176(c)(2)(C) requires
transportation projects to ``come from a conforming plan and TIP.'' EPA
has interpreted this in the existing conformity rule to mean that a
conforming transportation plan and TIP must be in place at the time of
project adoption or approval, and that the project must be included in
the transportation plan and TIP (or regional emissions analysis
supporting the conformity determination for the transportation plan and
TIP). EPA now believes that because non-federal projects are not
federally funded or approved, it is not necessary for a conforming
transportation plan and TIP to be in place at the time of project
adoption or approval. The transportation plan and TIP are not relevant
as a funding mechanism for non-federal projects. The crucial
requirement for non-federal projects is previous inclusion in the
regional emissions analysis supporting a conforming transportation plan
and TIP. That is, the area had previously considered the emissions of
the non-federal project and concluded that they could be accommodated
in the planned transportation network without adversely affecting air
quality.
The option provided in section 176(c)(2)(D) for new projects that
were not previously included in a transportation plan/TIP or supporting
regional emissions analysis to demonstrate conformity cannot apply
during a transportation plan/TIP conformity lapse, because it requires
a demonstration that ``conforming transportation plans and TIPs'' would
still conform when the emissions of the new project are considered.
Without a conforming transportation plan and TIP in place, this cannot
be demonstrated.
This proposal would require that a regionally significant non-
federal project be included in the regional emissions analysis
supporting the most recent transportation plan and TIP conformity
determinations, rather than any previous conformity determination. This
is because each regional emissions analysis must include all regionally
significant transportation projects in the timeframe of the
transportation plan. Therefore, even if there is no current activity on
a particular non-federal project at the time of the most recent
transportation plan/TIP conformity determination, it still will have
been included in the regional emissions analysis. If a non-federal
project were included in the regional emissions analysis from an older
transportation plan/TIP conformity determination and not from the most
recent, this would indicate that the project is no longer expected to
occur in the timeframe of the transportation plan and TIP. As a result,
it could no longer be assumed that implementation of the project could
be accommodated with no adverse air quality impact.
EPA has received comment opposing the adoption or approval of non-
federal projects during a transportation conformity lapse. Commenters
believe that building new projects during a time when a conforming
transportation plan and TIP has not been developed would only increase
the difficulty of plan/TIP development in the future. However, as
described above, EPA believes that this proposal is consistent with the
Clean Air Act. In addition, the limitation that regionally significant
non-federal projects must have been part of the most recent prior
regional emissions analysis supporting the most recent conforming
transportation plan and TIP ensures that the emissions consequences of
the projects have been considered, and the decision to proceed with
such projects during a conformity lapse could be made with full
knowledge of the possible emissions implications. These non-federal
projects would then have been considered as part of the transportation
planning process, and because these projects are not able to avoid the
scrutiny of the metropolitan planning process during a conformity
lapse, there would not be unequal requirements that would provide an
incentive to shift the funding of projects from federal to non-federal
sources.
EPA has also received comment that any non-federal project, whether
or not it has previously been included in a regional emissions analysis
supporting a transportation plan/TIP conformity determination, should
be allowed to proceed during a transportation plan/TIP conformity
lapse. However, EPA continues to believe, as described in the preamble
to the November 24, 1993, transportation conformity rule, that Clean
Air Act section 176(c)(2)(C)'s requirements for ``transportation
projects'' refer to any highway or transit projects, not just those
that are federally funded or approved. Thus, EPA believes that
regionally significant non-federal projects must have been considered
in a previously conforming emissions analysis in order to be adopted or
approved.
V. Rural Nonattainment and Maintenance Areas
A. Description of Proposal
Isolated rural nonattainment and maintenance areas with submitted
or approved control strategy SIPs or maintenance plans would be
allowed, under this proposal, to choose among several tests for
demonstrating conformity for years after the time period addressed by
the SIP (e.g., years after the attainment year or the last year of the
maintenance plan).
These areas could either (1) demonstrate consistency with the most
recent motor vehicle emissions budget(s), as normally required; (2)
satisfy the emission reduction tests (``build/no-build test'' and/or
less-than-1990 test, depending upon classification); or (3) demonstrate
through air quality dispersion modeling that the FHWA/FTA project, in
combination with all other regionally significant projects expected in
the area in the timeframe of the statewide transportation plan,
satisfies the general definition of conformity in Clean Air Act section
176(c)(1) (i.e., the project will not cause or contribute to any new
violations; increase the frequency or severity of any existing
violation; or delay timely attainment or required interim emission
reductions).
The choice among these conformity tests and the methodology for air
quality dispersion modeling would be determined through the interagency
consultation process and reflect the consensus of the state and local
air and transportation agencies and the project sponsor. EPA and DOT
would also have to be consulted through the usual interagency
consultation process.
Isolated rural areas would be defined as nonattainment and
maintenance areas (or portions thereof) that do not have a metropolitan
transportation plan or TIP and whose projects are not part of the
emissions analysis of any MPO's transportation plan or TIP. This would
not include ``donut'' areas that are outside the metropolitan planning
boundary and inside the nonattainment/maintenance area boundary,
because these projects must be considered in the context of the MPO's
transportation plan and TIP, even if the MPO does not specifically
include them in the transportation plan/TIP or the MPO's own regional
emissions analysis.
Because air quality dispersion modeling for ozone is often complex
and resource-intensive, EPA does not expect that this particular option
will be viable for isolated rural ozone nonattainment and maintenance
areas. However, this is a more realistic option
[[Page 36121]]
for such CO and PM10 nonattainment and maintenance areas and is
being considered at the request of several commenters.
This proposal differs from the existing transportation conformity
rule by offering several options for demonstrating conformity in years
after the time period addressed by the SIP. The existing transportation
conformity rule would require the motor vehicle emissions budget
established for the most recent prior year to be used for the purpose
of demonstrating transportation conformity for all subsequent years in
the timeframe of the transportation plan.
B. Rationale
In response to comments from those implementing conformity as well
as from other interested parties, EPA is proposing flexibility for
isolated rural nonattainment and maintenance areas. The general issue
of conformity for years outside the timeframe of the SIP is explained
below in section VIII., ``Mismatch in SIP/Transportation Plan
Timeframe.'' EPA is here proposing flexibility for isolated rural
nonattainment and maintenance areas, and not for other areas, because
isolated rural areas face unique challenges in addressing this issue.
Isolated rural areas generally do not have a metropolitan
transportation planning process that could serve as a forum for
identifying and addressing long-term growth issues in years not
addressed by the SIP. In addition, regionally significant, federally
funded or approved projects usually occur infrequently in isolated
rural areas. Conformity demonstrations for such areas as required by
the existing conformity rule would place the burden of long-term
planning on a few or even a single transportation project.
EPA believes this places an inappropriately large burden on
sponsors of such federally funded or approved transportation projects.
Although conformity is intended to assure long-term planning, EPA
believes it is appropriate to impose conformity requirements involving
less rigorous long-term planning in areas where comprehensive planning
processes including land use and other issues do not otherwise exist or
are not otherwise required.
Some conformity implementers suggested that the flexibility for
isolated rural areas should apply for ``donut'' areas that are outside
MPO planning boundaries but within urbanized nonattainment areas. EPA
does not believe this is appropriate because donut areas do not face
the same challenges as truly isolated rural areas. Conformity
determinations by the MPO must consider motor vehicle emissions from
all projects in the nonattainment or maintenance area, including
emissions from projects in the donut area. Thus, there is a planning
process that in some manner addresses the donut area. The Intermodal
Surface Transportation Efficiency Act (ISTEA) envisioned that in most
cases, the MPO planning boundary would be consistent with the
nonattainment area boundary. To the extent that conformity poses a
burden on the donut area because the area does not have long-term
planning capabilities, arrangements could be made with the adjacent
MPO.
EPA believes that providing some flexibility for the years not
addressed by the SIP is consistent with the Clean Air Act (see section
VIII. below). The Clean Air Act requirement for consistency with the
SIP's emissions reduction goals could be construed to apply only for
the years that an individual SIP revision addresses. The time period
later than that addressed by SIPs is in some ways analogous to the time
period before SIPs are developed, and as such the emission reduction
tests (``build/no-build'' and less-than-1990 tests) may also be
appropriate for the time period after that addressed by SIPs. Air
dispersion modeling that directly demonstrates satisfaction of the
general definition of conformity is clearly also consistent with Clean
Air Act section 176(c).
EPA is proposing that the choice of conformity tests for isolated
rural areas for years not addressed by a SIP should be made with the
agreement of relevant state and local agencies. EPA believes this is
necessary because MPOs are authorized by the Clean Air Act to determine
conformity and there are no MPOs in isolated rural areas; thus, there
is no single state or local agency with authority for determining
conformity. Various state and local agencies may have differing
perspectives on the practicality and benefits of the different
conformity tests. As a result, EPA believes the method for
demonstrating conformity should be a consensual decision by all
relevant state and local agencies, so that all relevant actors in an
area can weigh the advantages and disadvantages of each method of
demonstrating conformity.
EPA also believes that the methodology for performing air quality
dispersion modeling should have the agreement of all relevant state and
local agencies. The air agency traditionally has responsibility for
performing air quality dispersion modeling, but some other agency may
take responsibility for such modeling with respect to a given project
for the purposes of transportation conformity in rural areas.
Therefore, EPA believes that all agencies should agree on the
methodology to be used.
EPA considered requiring EPA approval of the modeling methodology
used in isolated rural areas, because air quality dispersion modeling
used in SIPs is traditionally governed by EPA guidance and regulations.
If air quality dispersion modeling that is used to demonstrate
conformity with the purpose of the SIP is based on different
assumptions than the SIP itself used, the determination of conformity
could be suspect. However, commenters convincingly argued that
requiring concurrence of the state air agency accomplishes the goal of
assuring consistency with the SIP's air quality dispersion modeling
methodology, and that further concurrence by EPA would be an
unnecessary administrative burden for isolated rural areas.
The option to demonstrate conformity using air quality dispersion
modeling in certain cases was specifically requested by conformity
implementers. Because EPA believes using air quality dispersion
modeling for conformity demonstrations for years not addressed by SIPs
would be consistent with Clean Air Act section 176(c) requirements (see
above), EPA is proposing this additional flexibility for all isolated
rural areas. Areas for which air quality dispersion modeling is too
resource-intensive may of course choose one of the other methods of
demonstrating conformity.
EPA considered allowing isolated rural areas to include non-fe
FR Doc. 96-16581 Transportation Conformity Rule Amendments: Flexibility and Streamlining
deral
projects in either the ``build'' or ``no-build'' case when performing
the ``build/no-build test,'' at the discretion of state and local air
and transportation agencies. Conformity implementers and interested
parties had noted that because regionally significant federally funded
or approved transportation projects occur relatively infrequently in
isolated rural areas, considering (and potentially offsetting) the
emissions impacts of non-federal projects posed an unfair burden on the
few federal projects. However, EPA believes that despite the differing
practical considerations for urban and rural areas, there is no legally
defensible distinction between what constitutes a contribution to
emissions reductions in rural vs. urban areas. Because EPA believes
that the ``build/no-build'' test demonstrates contribution to emissions
reductions only when new non-federal projects are included in the
``build'' case, EPA is not proposing to alter the build/no-build test's
treatment of non-federal projects in rural areas.
[[Page 36122]]
Some conformity implementers suggested to EPA that conformity in
isolated rural areas be demonstrated using a project-level ``build/no-
build test.'' Although it is true that isolated rural areas do not have
local transportation plans and TIPs as referred to in Clean Air Act
section 176(c)(2) (C) and (D), EPA believes that it is the intent of
the Clean Air Act for the regional emissions impacts of transportation
projects to be considered in the context of other transportation
projects in the nonattainment or maintenance area. Furthermore, EPA
questions whether it is possible for areas concerned with regional
pollutants to determine whether a project will cause or contribute to
new violations or exacerbate existing violations without considering
other transportation projects planned for the area. Therefore, EPA is
not proposing the option to use a project-level analysis for the build/
no-build test in rural areas.
VI. Modeling Requirements
A. Network Modeling Requirements
1. Deadline for Use of Network Models
This proposal would require that serious CO and serious, severe,
and extreme ozone areas use network models to support conformity
determinations by January 1, 1997. This requirement would apply only to
those metropolitan planning areas with an urbanized area population
over 200,000. Areas that are already using accepted network modeling
practices would be required to continue using them for conformity
analyses performed before January 1, 1997. Areas would continue to be
required to have a consultation process to select regional models and
assumptions.
The existing transportation conformity rule required that all
serious CO and serious and above ozone areas use network modeling for
conformity analyses by January 1, 1995. This proposal extends the
deadline to January 1, 1997. EPA received several comments related to
the ambitious nature of the 1995 deadline, and it has become
increasingly apparent that the original deadline is creating
difficulties for several areas that have been unable to comply by that
date. Based on comments received, EPA has determined that January 1,
1997, would be a reasonable extension of the deadline. EPA believes
that this deadline would allow areas experiencing difficulties to
improve and implement their network models, while requiring that areas
currently using network modeling continue to do so prior to that date.
In serious CO areas and serious and above ozone areas, conformity
determinations may be made after January 1, 1997, based on regional
emissions analysis that does not use network modeling only if that
regional emissions analysis was performed in support of the proposed
conformity determination before January 1, 1997. It is not necessary
for the MPO or DOT to complete its determination process before January
1, 1997, if the regional emissions analysis supporting the
determination was completed before January 1, 1997. It is also
permissible for a proposed transportation plan or TIP, and/or the
regional emissions analysis associated with it, to be modified to a
reasonable degree after January 1, 1997, as a result of the public
participation process.
This interpretation of the deadline for modeling improvements is
described in a December 30, 1994, letter from Philip A. Lorang, EPA's
Director of Emission Planning and Strategies Division, to Cynthia
Burbank, FHWA's Environmental Analysis Division Chief, and Samuel
Zimmerman, FTA's Director of the Office of Planning.
2. Areas Subject to Deadline for Use of Network Models
This proposal would limit the requirement to use network modeling
to metropolitan planning areas with an urbanized area population over
200,000, whereas the existing rule's requirements apply to all
nonattainment areas in these classifications, regardless of population
or urbanization. The proposed limitation results from a general concern
that the modeling requirements are overly burdensome for small and
rural areas within serious ozone nonattainment areas, such as Martha's
Vineyard Island, Massachusetts. EPA considered but is not proposing a
three-tiered scenario in which an area's modeling requirements would
have varying specificity based on its population and whether it was
urban or rural. Commenters believed that such a detailed proposal would
unnecessarily increase the rule's complexity. As a result, EPA decided
to specify requirements only for those serious, severe and extreme
areas with an urbanized area population over 200,000. The 200,000
population level was chosen because it is also the population level
used to delineate transportation management areas (TMAs). EPA believes
that these limitations would ensure that smaller areas no longer are
required to use unnecessarily stringent network modeling procedures and
methods.
EPA received a comment that suggested a specific, two-part process
for network model improvements in serious CO and serious and above
ozone nonattainment areas. The first part recommended an expanded,
tiered set of deadlines based on nonattainment status, population, and
growth rate, with added flexibility through a waiver provision if
mobile sources were clearly not a factor in an area's nonattainment
problem. The second part suggested that the MPO prepare a strategic
plan for the area's modeling improvements. The MPO would also be
responsible for encouraging public participation in this process and
making available for public comment the documentation of conformity
determinations and information relevant to improving the regional
analysis systems.
EPA decided not to propose this approach for several reasons.
First, the tiered deadline concept would expand the modeling
requirements to areas not currently affected under the existing rule.
EPA believes that these modeling requirements are not necessary in all
nonattainment areas and that this concept would further increase the
rule's complexity. Second, although EPA agrees with the importance of
strategic planning in modeling improvements, the Agency believes that
the existing interagency consultation process provides areas with the
necessary flexibility in planning for modeling improvements.
3. Content of Modeling Requirements: Request for Comment
In today's proposal, EPA is proposing regulatory text that would
amend the requirements addressing the characteristics of network
models. Under Sec. 51.452(b)(93.130(b)) of the November 1993 conformity
rule, network-based models used in serious and above CO and ozone areas
for conformity analyses are required to possess eleven specific
modeling attributes. EPA originally developed these eleven attributes
in consultation with conformity stakeholders and with the understanding
that they represented modeling procedures that are currently available
and in practice. EPA continues to believe that these modeling
attributes would encourage improved network-based modeling.
However, stakeholders have since suggested that the modeling
requirements in the existing rule create too much complexity and
rigidity in the conformity rule. As a result, EPA is proposing
regulatory text today that would remove these eleven modeling
attributes from the rule and replace them with modeling guidance
[[Page 36123]]
periodically issued by EPA and DOT. Today's proposal is described below
as Option 1.
Since several stakeholders have expressed concern over the primary
option EPA is proposing today (Option 1), two alternative options are
also described below. All three of the options described below would
apply to nonattainment areas with urbanized population over 200,000, as
described above. EPA requests comment on all of these options, and
depending on the public comment received, EPA may finalize one of these
alternative approaches, instead of the primary option EPA is proposing
today.
EPA believes that the conformity rule would still be consistent
with the letter and intent of Clean Air Act section 176(c) if any of
the proposed changes to the modeling requirements are adopted. Since
the statute does not specifically address modeling requirements, EPA
believes that so long as the modeling requirements continue to ensure
that conformity determinations are based on sound quantitative
analysis, EPA has the discretion to determine appropriate methods for
implementing those requirements.
Option 1: Address Network Modeling Attributes in Guidance. EPA
proposes today that the specific attributes of network models that are
required under the existing transportation conformity rule be removed
from the regulatory text and instead be addressed in guidance
documentation. EPA believes that this proposal will simplify the
conformity rule and ensure that areas will be able to choose the
modeling procedures that best match their current modeling and air
quality planning needs, resource constraints, and technical expertise
capability.
In order to ensure that appropriate modeling tools are employed,
EPA and DOT will periodically issue modeling guidance comprised of
technical documentation and other references describing available
modeling procedures. This guidance is likely to be a combination of
existing and new documents or references to technical information taken
from a variety of sources. Many of the detailed attributes required
under the existing transportation conformity rule will be referenced in
this guidance. By issuing technical guidance documents on a regular
basis, EPA and DOT will be able to communicate new modeling practices
and encourage continuous improvement over time.
EPA is aware that removing the regulatory requirements governing
network model performance may be perceived by some to be an endorsement
of less rigorous modeling practices. However, EPA and DOT remain
committed to developing and encouraging improved transportation models
and to ensuring that areas continue to employ good modeling practices.
Today's proposal is intended as a streamlining measure, not a
relaxation of standards for acceptable modeling. EPA believes that
guidance regarding available modeling techniques will facilitate model
improvement at least as well as including specific modeling
requirements in the conformity rule, while responding to local needs
for flexibility. The agencies believe that agreement regarding
appropriate modeling techniques and improvements for each area should
be an important focus of the interagency consultation process as
currently required by Sec. 51.402 (c)(1)(i) and (c)(6) and Sec. 93.105
(c)(1)(i) and (c)(6).
Option 2: Retain Network Model Performance Requirements in Existing
Conformity Rule. This option would retain all of the eleven
characteristics of network models that are required in the November
1993 conformity rule. For example, network models in these areas would
continue to be required to meet performance-based standards such as
capacity-sensitive assignment and reasonable agreement between travel
times used in trip distribution and resulting from assignment. EPA
continues to believe that these modeling attributes reflect the current
consensus in the transportation and air quality planning professions on
minimum acceptable modeling practices.
Option 3: Streamline Existing Modeling Attributes and Address
Additional Attributes in Guidance. This option would streamline the
existing conformity rule, but retain certain requirements that provide
for minimum acceptable model performance.
The streamlined requirements would be as follows: (1) Network-based
models must be validated against observed peak and off-peak ground
counts for a base year that is not more than 10 years prior to the date
of the conformity determination; (2) land use, population, employment,
and other network-based modeling inputs must be based on the best
available information and must be appropriate to the validation base
year; (3) peak and off-peak travel demand and travel times must be
provided, and a capacity-sensitive assignment methodology must be used;
(4) the model(s) must use and document a logical correspondence between
the assumed scenario of land development and use and the future
transportation system for which emissions are being estimated; and (5)
network-based models must be reasonably sensitive to trip-making
changes due to changes in the cost, travel time, capacity, and quality
of all travel choices, if the necessary information is available.
EPA would address the remaining attributes in modeling guidance
that would be jointly issued and regularly updated by EPA and DOT.
Conformity stakeholders would be involved in the development of this
modeling guidance to encourage a wide exchange of ideas about current
and available modeling practices. EPA believes that this process itself
would ensure that the modeling guidance is a useful, effective tool in
informing areas about available modeling improvements.
B. Adding Non-exempt Projects to the Plan/TIP Without Regional Analysis
1. Description of Proposal
This proposal would, under some circumstances, allow a
transportation plan and TIP to be amended to include additional non-
exempt projects without a full-scale regional emissions analysis based
on network modeling. The alternate emissions analysis procedure would
require the concurrence of the federal, state, and local air and
transportation agencies. This flexibility would not become effective
until EPA and DOT have completed their review and evaluation of
alternate procedures that are suggested during the public comment
period (see ``Request for Information for Guidance,'' below) and made
this documentation publicly available. This proposal would still
require a conformity determination for the plan/TIP amendment,
including public participation, interagency consultation, and other
relevant requirements of the transportation conformity rule. This
proposal would only change the rigor of the supporting regional
emissions analysis.
Under the existing rule, every plan/TIP and plan/TIP amendment
requires a conformity determination based on a regional emissions
analysis that meets the requirements of Sec. 51.452/Sec. 93.130. The
regional emissions analysis, which includes projects in the plan/TIP
and all other regionally significant projects in the nonattainment or
maintenance area, is used to demonstrate that the budget test and/or
emission reduction tests are satisfied. Under Sec. 51.452, certain
areas are required to use network modeling to perform this regional
emissions analysis.
This proposal would allow less rigorous analysis to demonstrate
that the plan/TIP as amended satisfies the budget test and/or emission
reduction tests. Subsequent plan/TIP conformity
[[Page 36124]]
determinations based on full regional emissions analysis would, of
course, include the recently added projects, because regional emissions
analysis must include all regionally significant projects that are
planned or underway. Any plan/TIP conformity determination based on
less rigorous analysis would not be considered a conformity
determination for the purposes of Sec. 51.400/Sec. 93.104, ``Frequency
of Conformity Determinations,'' which require that conformity
determinations be made no less frequently than every three years. The
less rigorous analysis would not provide a complete consideration of
projects in the transportation plan and TIP using the latest emissions
projections and assumptions. The transportation plan and TIP would
therefore have to be found to conform based on a full-scale regional
emissions analysis (including network modeling, where required) at
least every three years.
2. Rationale
EPA is proposing this change in response to stakeholder requests
for this flexibility. Some stakeholders commented that it may be costly
and resource-intensive to perform a full-scale regional emissions
analysis to add a regionally significant project to a transportation
plan and TIP. These stakeholders proposed that the conformity rule
allow areas the flexibility to establish alternative procedures for
regional emissions analysis that would demonstrate that an additional
project, when considered with emissions projected for the conforming
transportation plan and TIP, does not cause the plan/TIP to exceed the
motor vehicle emissions budget and/or fail to satisfy the emission
reduction tests. Stakeholders supporting this flexibility suggested
that it is necessary only in extraordinary circumstances and would not
be used on a routine basis. Other stakeholders expressed concern that
such flexibility could be used to advance significant projects without
the full scrutiny of the conformity process.
EPA agrees that there may be limited instances where the impact of
regionally significant non-exempt projects on emissions from the
currently conforming transportation plan and TIP could be determined
without full-scale regional analysis, and that exceptional
circumstances may arise where such flexibility is appropriate. However,
this flexibility is to be exercised as an exception and not on a
regular basis.
EPA would allow this flexibility to be used only after a review and
evaluation of types of alternate procedures has been documented,
because of the potential for this flexibility to undermine the
integrity of the conformity process if improperly used. Conformity's
purpose is to consider the long-term impacts of projects and to make
transportation planning decisions within the context of all proposed
projects, instead of on a project-by-project basis. In almost all
cases, regional emissions impacts cannot be determined on a project-by-
project basis or without considering the aggregate of projects in an
area and the interactions among them. The conformity provisions were in
part a response to the difficulty of assessing air quality impacts on a
project-by-project basis. As a result, it is not clear what type of
limited analysis would be appropriate and under what circumstances.
Areas will need guidance to address these issues. This guidance will be
provided in the review, evaluation, and documentation of alternate
procedures that are suggested during the public comment period, through
periodic updates of reasonable and available measures, and through the
interagency consultation process.
Stakeholders proposed that the federal, state, and local
transportation and air agencies should concur on each use of this
flexibility. EPA agrees with such a concurrence requirement since there
are not well-established, existing alternatives and because the
transportation planning process and the conformity process should not
be compromised if there is not agreement among all of the agencies that
the existing circumstances warrant the use of this flexibility. As
described in the conformity rule's consultation requirements, conflicts
among state agencies or between state agencies and an MPO shall be
escalated to the Governor if they cannot be resolved by the heads of
the involved agencies.
EPA foresees instances where use of this flexibility would not be
appropriate. For example, it would not be appropriate if planning
assumptions have changed, or if other information indicates that the
regional emissions analysis supporting the currently conforming
transportation plan and TIP is not adequate to determine that the
budget test and/or the emission reduction tests would be satisfied. It
would also be inappropriate if the transportation plan and TIP
amendment is not only adding projects, but deleting other projects and
changing implementation dates in order to remain fiscally constrained.
In this case, the plan/TIP amendment's scope would be too broad to
justify a limited emissions analysis.
3. Request for Information for Guidance
EPA and DOT recognize that there may be some alternate procedures
for determining the impact projects would have on regional
transportation-related emissions that are more expeditious and less
costly than a network-based analysis. As a result, EPA and DOT are
requesting suggestions for procedures to add non-exempt projects to the
plan/TIP without a complete network-based analysis. If documentation is
available for these procedures, please provide it if possible.
Reasonable methods or approaches may be included in guidance.
However, EPA and DOT believe that the flexibility for non-exempt
projects (as described above) should not be finalized if reasonable
alternate approaches have not been identified for determining the
regional emissions impacts from individual transportation projects.
Therefore, this flexibility would not be offered unless EPA and DOT
receive comment that identifies such alternate methods or approaches.
Some stakeholders commented about the resources needed to perform a
full-scale regional emissions analysis to add a regionally significant
project. EPA and DOT are therefore requesting information in the
following areas: (1) How often the need arises to add non-exempt
projects between TIP update cycles; (2) the number of projects that may
be delayed without this flexibility; (3) the full-scale network
modeling process currently used for the regional emissions analysis to
support conformity determinations (including number of model runs,
number of emissions model runs, etc.); (4) the difference in effort
required to add a single or limited number of projects as compared to a
full-scale conformity analysis; and (5) which agencies are responsible
for socioeconomic data development, travel modeling, and emissions
modeling, including the percentage of each agency's involvement in
conducting the conformity analysis.
VII. Consequences of SIP Disapproval
A. Description of Proposal
In today's action EPA proposes as a primary alternative regulatory
language that specifies that following a 120-day grace period after
final EPA disapproval of a control strategy SIP or maintenance plan
without a protective finding, the only transportation projects that
could be approved (and thus grandfathered from future conformity
lapses) would be those included in the first three years of the
currently conforming transportation plan and TIP (and exempt projects).
No
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new transportation plans, TIPs, plan/TIP amendments or projects (or
projects in the out-years of the transportation plan and TIP) could be
approved. If any single phase of a transportation project is included
in the first three years of the transportation plan/TIP, all phases of
the project would be able to proceed following a disapproval, provided
that all phases of the project were included in the transportation
plan/TIP conformity analysis. Conformity determinations are required to
analyze entire projects rather than individual phases.
The ``freeze'' on new transportation plans, TIPs, and projects
would be removed once an area submits another control strategy SIP or
maintenance plan to replace the disapproved SIP, provided EPA does not
find the motor vehicle emissions budgets inadequate during its 45-day
review period. If such a replacement SIP does not become applicable to
conformity determinations by the time Clean Air Act highway sanctions
are imposed (two years after EPA's final disapproval), conformity would
lapse, and no new project- level conformity determinations could be
made, even for projects in the first three years of the currently
conforming plan and TIP.
During the 120-day grace period, transportation plans, TIPs, and
projects could be found to conform using the disapproved budgets (if no
replacement SIP applies for transportation conformity purposes). This
120-day grace period is intended to allow areas to complete conformity
determinations that were in process at the time of EPA's final
disapproval.
Under both today's proposal and the existing conformity rule,
consequences would occur following any EPA final disapproval action on
a control strategy SIP or maintenance plan without a protective
finding, even if the disapproval is limited or partial. The motor
vehicle emissions budget is sufficient only if the SIP as a whole
satisfies the Clean Air Act requirements for reasonable further
progress, attainment, or maintenance. If one part of a SIP is
disapproved without a protective finding (even if that part does not
address mobile sources), then there is no overall strategy for
reasonable further progress, attainment, or maintenance, and it is not
possible to determine whether consistency with the motor vehicle
emissions budget will result in a level of emissions consistent with
reasonable further progress, attainment, or maintenance.
B. Request for Comment
Pending the opportunity to consider thoughtful comments from all
interested parties, EPA is proposing today as a primary alternative the
regulatory text discussed above because EPA believes it balances the
conflicting goals articulated by stakeholders. EPA requests comment on
how this proposal addresses stakeholder issues and concerns identified
below. EPA also requests comment on whether other approaches are
preferable, such as aligning the conformity lapse timeframe with the
highway sanctions time clocks for SIP disapprovals without protective
findings to make this process consistent with the conformity lapse
process for other SIP failures. Alternatives to the primary option EPA
is proposing today are described below. Depending on the public comment
received, EPA may finalize one of these alternative approaches, instead
of the primary alternative.
C. Discussion of Issue
Conformity stakeholders have raised the issue of the appropriate
conformity consequences when EPA disapproves a control strategy SIP
without making a protective finding. EPA disapproval of a SIP without a
protective finding is essentially a finding that the SIP does not have
identified strategies to reach attainment (or reasonable further
progress or maintenance), and the motor vehicle emissions budget is not
adequate to satisfy Clean Air Act requirements. Final EPA SIP
disapprovals require full notice-and-comment rulemaking.
The November 1993 transportation conformity rule states that after
a 120-day grace period following final EPA SIP disapproval, no new
transportation plans, TIPs, or projects may be approved. Only
previously approved projects (``grandfathered'' projects) and exempt
projects may proceed. In other words, transportation plan/TIP
conformity lapses. The lapse is removed when a new control strategy SIP
or maintenance plan (including motor vehicle emissions budgets) is
submitted to EPA.
Some stakeholders have suggested that conformity should never lapse
as a result of a SIP failure before Clean Air Act highway sanctions are
imposed, because highway sanctions (not transportation conformity) are
the Clean Air Act mechanism for addressing SIP failures. To a
considerable degree EPA agrees with this reasoning, and EPA has amended
the conformity rule to align conformity lapse with highway sanctions
imposition in the case of all SIP failures except disapproval without a
protective finding.
However, there are substantive conformity issues with respect to
SIP disapproval without a protective finding. If an area does not have
sufficient adopted control strategies to attain the standards or make
reasonable further progress towards attainment, should the area be
committing funds to new transportation projects? If so, on what basis?
Should it proceed with projects that already have been planned and upon
which businesses and the public may already be relying in their own
future plans, but stop creating new plans and expectations? In these
cases, how would an area demonstrate that the transportation plan, TIP,
or project would not increase the frequency or severity of existing
violations, or contribute to new violations, or delay attainment?
These issues are particularly important in the context of the
conformity flexibilities in today's proposal. As described in sections
II. and III. of today's action, EPA is proposing that consistency with
submitted SIP budgets would become the sole emissions-related
conformity test for transportation plans and TIPs, even before EPA
approves the SIP and confirms that consistency with its motor vehicle
emissions budget is sufficient to achieve reasonable further progress,
attainment, or maintenance. Some stakeholders are concerned that
because a significant amount of time is likely to elapse between
initial submission of the control strategy SIP and any subsequent EPA
disapproval, a significant number of transportation projects could be
found to conform (and thus grandfathered) on the basis of an ultimately
unacceptable motor vehicle emissions budget before final EPA
disapproval actually occurs. These stakeholders are concerned about
irreversible commitments that might make Clean Air Act requirements
increasingly difficult to meet.
Other stakeholders emphasize that the disruption to the ongoing
transportation planning process should be minimized. They believe that
people and businesses begin to rely on projects in an approved plan and
TIP even though project-level conformity findings have not been made,
and conformity lapse immediately upon EPA's final disapproval is unduly
disruptive.
D. Discussion of Options
Stakeholders have identified a number of options to address the
consequences of EPA SIP disapproval without a protective finding. These
options address the concerns described
[[Page 36126]]
above to varying degrees. EPA is interested in receiving comments on
the alternative options described below and may finalize one of these
options, instead of the primary option described above.
1. No Project Approvals (Conformity Lapse) Beginning Immediately Upon
EPA Final Disapproval Without a Protective Finding
Some stakeholders have suggested that no more projects should be
approved (grandfathered) once EPA issues a final disapproval. However,
these stakeholders generally accept that projects found to conform
between submission and final disapproval should not be halted, even
once the SIP has been disapproved. This option would minimize
commitments that could ultimately be inconsistent with attainment or
maintenance, until another SIP that would be a better basis for
determining conformity is submitted to EPA.
2. Retain Existing Conformity Rule
As described above, the November 1993 transportation conformity
rule allows transportation plans, TIPs, and projects to be approved for
120 days following EPA's final disapproval of a SIP without a
protective finding. Following the 120-day grace period, no
transportation plans, TIPs, or projects can be approved. This approach
is similar to option 1 above, but the 120-day grace period helps reduce
disruption to approvals that are underway at the time of EPA's final
disapproval.
3. Allow Approval of Projects in the First Two Years of the
Transportation Plan/TIP
Some stakeholders advocate allowing previously planned
transportation projects to be approved and grandfathered, but not
approving new transportation plans, TIPs, or projects until a new SIP
has been submitted to EPA. For example, some stakeholders endorsed a
proposal that no transportation plans, TIPs, or amendments should be
found to conform after EPA's final disapproval of a SIP, and only those
projects scheduled for implementation during the first two years of the
TIP, and projects found by the MPO and the state air agency to
contribute to emissions reductions, should be allowed to proceed.
This option is similar to that being proposed by EPA today as the
primary alternative. This option prevents new commitments from being
made, but allows projects previously planned to occur in the short term
to proceed, in order to minimize disruption to the transportation
planning process.
4. No Consequences Until Clean Air Act Highway Sanctions Are Applied
Other stakeholders advocate allowing new transportation plans,
TIPs, and projects to be approved and grandfathered using the build/no-
build test or the disapproved motor vehicle emissions budget until
Clean Air Act highway sanctions are imposed. Highway sanctions under
section 179 would be imposed two years following EPA's final
disapproval unless the deficiency leading to the disapproval has been
corrected prior to that time. These stakeholders believe that it is
more consistent with the Clean Air Act to have Clean Air Act section
179 highway funding sanctions being the trigger for consequences of a
SIP disapproval. This change would also simplify the conformity rule by
having all conformity lapses associated with SIP failures occur when
highway sanctions are imposed.
E. Rationale for Primary Option Being Proposed
EPA believes that the primary option it is proposing today (as
described in section VII.A.) best balances the concerns expressed by
stakeholders. EPA is proposing to allow projects in the first three
years of the transportation plan/TIP to proceed, instead of those in
the first two years, as suggested in option 3. Some conformity
stakeholders expressed concern that restricting the ``grandfathering''
to the first two years of the transportation plan/TIP would be unduly
disruptive to the transportation planning process, especially because
the TIP normally addresses a minimum of three years. EPA believes that
the primary option provides a better balance between the competing
objectives of minimizing new commitments and minimizing disruption to
the transportation planning process.
VIII. Mismatch in SIP/Transportation Plan Timeframe
A. Description of the Issue
The existing transportation conformity rule requires the conformity
of transportation plans and TIPs to be demonstrated for the entire 20-
year timeframe of the transportation plan. However, control strategy
SIPs and maintenance plans generally address a significantly shorter
timeframe. For example, attainment demonstrations are only required to
address the years through the attainment year, and maintenance plans
are only required to initially address a 10-year period (with a
provision for a second 10-year appraisal).
For the years in the timeframe of the transportation plan that are
not addressed specifically by a SIP, the existing conformity rule
requires emissions to be consistent with the SIP motor vehicle
emissions budget(s) for the last year for which the SIP defines control
strategies and budgets. For example, before a maintenance plan has been
submitted, emissions predicted for the years after the attainment year
must be consistent with the attainment year budget(s). Emissions in
years after the first maintenance plan must be consistent with the
motor vehicle emissions budget(s) for the last year of that maintenance
plan.
Several conformity implementers have commented that there should be
a more flexible conformity test for the years that are not specifically
addressed by the SIP. Conformity implementers have pointed out several
difficulties caused by the existing transportation conformity rule's
requirements for the ``out-years'' of the transportation plan.
First, there are generally no adopted control measures to address
VMT growth in years that are not specifically addressed by the SIP. As
a result, it becomes the burden of the conformity process--and
potentially the MPO alone--to address long-term growth issues and
offset emissions increases. Placing the burden on the MPO to offset
emissions from long-term growth can be problematic because MPOs
generally lack the authority to adopt and enforce areawide emission
controls. In areas such as PM10 areas this problem is particularly
acute, because motor-vehicle-related PM10 emissions are directly
related to VMT. Technological improvements in the motor vehicle fleet
over time do not significantly reduce motor vehicle PM10 emissions
related to reentrained dust.
In addition, the existing conformity rule's requirement to use the
budget established for the last year of the maintenance plan for all
subsequent years poses special difficulties. In many areas, the motor
vehicle emissions budget will decline over the 10 years of the first
maintenance plan. This is generally because newer, cleaner cars will be
added to the motor vehicle fleet as older cars are retired, so the
emissions per VMT decrease. At the same time, emissions from stationary
sources are often related to economic and population growth, and are
thus projected to increase over time. As a result, many areas
demonstrate maintenance of air quality standards with declining motor
vehicle emissions
[[Page 36127]]
budgets and increasing stationary source emissions.
However, over time the effect of fleet turnover decreases, because
all cars in the fleet eventually meet applicable standards. In
addition, increases in VMT may begin to offset the emissions decreases
resulting from fleet turnover. Thus, motor vehicle emissions generally
are projected to increase in the years after the first 10-year
maintenance plan, and the motor vehicle emissions budget established
for the last year of that maintenance plan may in fact represent a low
point in the motor vehicle emissions projected for the 20-year
maintenance period. Requiring motor vehicle emissions in the years
after the first maintenance plan to be consistent with the budget for
the last year of that maintenance plan may be difficult without
additional control measures for stationary or mobile sources.
B. Request for Comment
EPA is not proposing specific regulatory text to address this
``mismatch'' issue at this time. However, EPA requests comment on three
options, and EPA proposes to include one of the options in the
regulatory text of the final rule.
1. Existing Transportation Conformity Rule
The first option is to continue the existing conformity rule's
requirements. According to the Clean Air Act, one of the purposes of
conformity is to ensure that transportation improvements do not cause
or contribute to new violations. The motor vehicle emissions budget for
the attainment year represents the level of motor vehicle emissions
that is consistent with attainment of the standard. Therefore, keeping
motor vehicle emissions in future years equal to or less than that
budget should ensure that motor vehicles will not cause or contribute
to a new violation. If motor vehicle emissions increase above levels
that the SIP identifies as necessary for attainment, it may be
difficult to state that a new violation would not result, as conformity
requires.
Regarding the comments that the existing conformity rule
inappropriately places the burden on the MPO to address long-term
growth issues, it is in fact an important goal of conformity to focus
attention on the long-term impacts of transportation investments and
policies. To the extent that an area has not reconciled the impacts of
growth and transportation policy with air quality goals, it is
appropriate that conformity provide the forum and impetus for state and
local governments to do so. Although the MPO may not itself have the
authority to adopt and enforce necessary measures, conformity is
determined through an interagency process which includes the state and
local governments which do have that authority. It is appropriate that
the long-term growth issues affecting a local area be addressed through
the cooperation of state and local air and transportation agencies. The
fact that the MPO has legal responsibility to determine conformity does
not mean it alone must develop and implement the additional control
measures that are necessary. The state also shares an interest in
developing conforming metropolitan transportation plans and TIPs and
would be expected to share responsibility for facilitating conformity.
Maintaining the existing conformity rule's requirements regarding
the applicability of motor vehicle emissions budgets for future years
would also encourage the SIP process to address longer timeframes,
which is ultimately the preferable solution. Doing so should avoid
costs and burdens of not addressing long-term issues now. The
difficulties associated with demonstrating conformity in years that are
not addressed by the SIP would be reduced if the SIP established
acceptable motor vehicle emission levels for such future years. This
has already occurred in some areas.
The existing conformity rule already has some provisions to address
the difficulties associated with using the budget for the last year of
the maintenance plan for subsequent years. For example, the maintenance
plan could establish larger motor vehicle emissions budgets for years
after the last year of the maintenance plan by projecting motor vehicle
emissions and emissions from other source categories in future years.
Provided the projected total emissions are less than the total
emissions in a previous year with clean data, the motor vehicle
emissions projections could be used to establish a motor vehicle
emissions budget. If the projected total emissions are less than the
total emissions in a previous year with clean data, the difference
(``safety margin'') could also be applied to the motor vehicle
emissions budget.
2. Emission Reduction Tests
A second option would be to require the emission reduction tests
(``build/no-build test'' and less-than-1990 test) for demonstrating
conformity in years not addressed by submitted or approved control
strategy SIPs or maintenance plans. Demonstrating conformity for years
later than those addressed by SIPs is in some ways analogous to the
situation of demonstrating conformity for years before SIPs are
submitted, that is, no budget has been specifically developed for
assessing conformity in such years. The Clean Air Act allows for
``contribution to annual emission reductions'' to serve as the test of
conformity in the latter case, so by extension, it could be argued that
such a test is also appropriate for years later than those addressed by
SIPs. The Clean Air Act requirement for consistency with emissions in
SIPs could be argued to apply only for those years that are
specifically addressed by the SIP.
Although this option provides more flexibility than the existing
rule for emissions increases due to population and economic growth, it
has several disadvantages. First, satisfying the emission reduction
tests would not ensure that motor vehicle emissions are at a level
consistent with attainment or maintenance. Although the conformity test
would ensure that motor vehicle emissions are no greater than they
would have been without further transportation improvements, the focus
is not on attainment or maintenance of air quality standards. As a
result, the impact of long-term growth on attainment and maintenance
will not necessarily be addressed.
The Clean Air Act requires a second 10-year maintenance plan to be
submitted eight years after an area's redesignation to attainment, so
the SIP process in redesignated areas will ultimately address the
emissions in the years after the first 10-year maintenance plan. In the
case of areas that have not yet been redesignated, however, allowing
motor vehicle emissions to increase above the attainment year budget
may make it increasingly difficult to develop a SIP demonstrating
maintenance, and thus may delay or complicate redesignation of such
areas to attainment.
Finally, conformity implementers and other interested parties have
commented that the emission reduction tests are not meaningful
indicators of air quality impacts, particularly because transportation
modeling and emission factor modeling are often not sufficiently
precise to determine significant differences between ``build'' and
``no-build'' scenarios. Experience to date has found that the emission
reduction tests are frustrating and difficult to explain because they
do not address the performance-oriented goals of attainment and
maintenance. Although practical alternatives have not been identified
for use during the period before SIPs have been developed, for years
later than those addressed by SIPs,
[[Page 36128]]
the previously established motor vehicle emissions budgets are
available.
3. Default Motor Vehicle Emissions Budget
A third option is to maintain the existing rule's requirements for
the years after the attainment deadline and before a maintenance plan
has been submitted, but to allow a default motor vehicle emissions
budget for the years outside the maintenance plan's timeframe. Instead
of requiring the motor vehicle emissions budget for the last year of
the maintenance plan to continue to apply for subsequent years, the
motor vehicle emissions budget for subsequent years could be the motor
vehicle emissions in the year of redesignation.
Like the emission reduction tests option, this option would not
ensure that motor vehicle emissions are consistent with maintenance of
air quality standards. Without considering emissions from sources other
than motor vehicles, there is no assurance that the motor vehicle
emissions in the year of redesignation will also be consistent with
continued maintenance of the standard in future years. However, this
problem could be at least somewhat reduced with additional features to
this option. For example, the rule could require the default budget to
be established in the maintenance plan and accompanied by some type of
demonstration that when the default motor vehicle emissions budget is
considered together with expected growth in area and stationary source
emissions, the standard will be maintained.
The default emissions budget option may be preferable to the
emission reduction tests option for the years after those addressed by
maintenance plans for two reasons. First, conformity implementers have
expressed a preference for budget tests instead of the more abstract
emission reduction tests. Second, unlike the emission reduction tests
option, this option would provide a cap on motor vehicle emissions
growth. Although the cap is not necessarily tied to maintenance, it
does not allow emissions due to population and economic growth to
revert back to 1990 levels, as the emission reduction tests allow. As a
result, the conformity process could still provide significant
protection for the public while providing the impetus for serious
consideration of long-term growth effects.
Unlike the emission reduction tests option, this option would
maintain the existing rule's requirements (i.e., the attainment budget
would continue to apply for the years after the attainment deadline)
until a maintenance plan is submitted. This will help prevent delays in
attainment and/or redesignation.
Allowing conformity to be demonstrated using a default emissions
budget that is not part of an overall maintenance strategy that
addresses all emissions sources could be considered inconsistent with
the Clean Air Act section 176(c) and the conformity rule's other
interpretations of those provisions. However, it is also possible to
argue that such an allowance is reasonable and defensible in the
special circumstance of demonstrating conformity for years that have
not yet been addressed by the maintenance plan.
For example, the legislative history of the Clean Air Act reveals a
specific choice to require maintenance plans to address 10-year
increments rather than an entire 20-year period. It could therefore be
argued that it is not conformity's responsibility to ensure maintenance
over a 20-year period; provided the transportation community keeps
motor vehicle emissions constrained to some level previously associated
with maintenance, future maintenance plans could address emissions from
other sources and revise motor vehicle emissions budgets as necessary
for an overall maintenance strategy. It could also be argued that the
Clean Air Act's Prevention of Significant Deterioration requirements
are intended to address growth in non-mobile source emissions in years
not addressed by maintenance plans, and that EPA can issue SIP calls if
growth in non-mobile source emissions threatens maintenance.
IX. Public Participation
A. Description of the Proposal
This proposal would clarify the timeframe within which information
must be provided for public access under the public participation
requirements in the existing conformity rule. The proposal would
specify that affected agencies must provide public access to
information considered by the agency in making transportation plan and
TIP conformity determinations at the beginning of the designated public
comment period and prior to taking formal action on conformity
determinations. This proposal would define the information to include
all technical and policy information considered by the agency in
supporting conformity determinations.
This proposal would continue to reference and be consistent with
DOT's metropolitan planning regulation (23 CFR 450.316(b)), which,
among other things, requires at least a 30-day comment period in
serious and above nonattainment areas. Agencies affected by this
proposal would be referred to DOT's January 1995 guidance, ``Public
Involvement and Questions and Answers'' (60 FR 5508-5512), for specific
identification of the types of information to be provided to the
public. EPA expects that affected agencies would refer to this guidance
in providing information for public comment. The guidance specifies
input assumptions such as population projections, land use projections,
fares, tolls, levels of service, the structure and specifications of
travel demand and other evaluation tools.
Since information supporting conformity determinations is stored in
many forms, EPA interprets that this proposal's requirement would apply
to information in written, graphic, and electronic form. Under this
proposal, any charges imposed by affected agencies for public
inspection and copying would be required to be consistent with the fee
schedule in 49 CFR 7.95, which EPA believes would ensure reasonable
public access to the information. EPA also notes that under the DOT
metropolitan planning regulations, each MPO conducts public involvement
under its own custom-tailored public involvement procedures. These
procedures describe how the MPO intends to meet the performance
standards of the conformity rule and metropolitan planning regulations.
B. Discussion of Proposal
EPA is proposing this clarification to address stakeholder concerns
that public participation is hindered when public access to information
relied on for conformity determinations is not provided in enough time
to allow for adequate public involvement. EPA agrees that public access
to all of the information considered by the agency at the beginning of
the public comment period is critical to ensuring effective public
participation in the conformity process.
In its ``Public Involvement and Questions and Answers'' guidance,
DOT emphasizes that an effective public involvement process should
provide for an open exchange of information and ideas between the
public and transportation decisionmakers, and as an overall objective,
an area's public involvement process should be proactive, provide
complete information, timely public notice, full public access to key
decisions, and opportunities for early and continuing involvement. EPA
believes that this
[[Page 36129]]
proposal would not only be consistent with these objectives, but that
it would further the purposes emphasized in the guidance.
EPA does not believe that this proposal would be burdensome for
affected agencies since it would only require that agencies provide
public access to information already in their possession. This proposal
would not require the affected agencies to edit, summarize existing
files, or to compile new files beyond those already prepared as a part
of the plan and TIP development process.
X. Interagency Consultation
This proposal includes several new provisions which require
interagency consultation, including the choice of conformity tests and
modeling methodology for rural areas; the establishment of a ``default
budget'' in clean data areas; and the addition of non-exempt projects
to the transportation plan/TIP without full regional emissions
analysis. EPA is not proposing to amend Sec. 51.402/Sec. 93.105
(``Consultation'') to add these consultation needs to the list of
specific processes that must be included in the conformity SIP's
consultation procedures. EPA believes that it is clear that
consultation procedures must be developed in order to use these new
provisions. As a result, EPA does not believe that the complexity
resulting from adding items to Sec. 51.402 is justified. Furthermore,
the proposed provisions involving additional consultation procedures
are for the most part optional flexibilities for unique situations, so
consultation procedures to implement these flexibilities will not be
relevant for all conformity SIPs.
However, EPA emphasizes that interagency consultation on these
specific provisions is a necessary part of their implementation. EPA
recommends that in order to facilitate future conformity
determinations, areas should develop appropriate consultation
procedures as soon as possible if they expect to use these provisions.
XI. Streamlining and Clarification
This proposal includes numerous wording and organizational changes
that would streamline and clarify the existing transportation
conformity rule. Although these changes affect most sections of the
existing transportation conformity rule, highlights are discussed
below.
A. Frequency of Conformity Determinations
1. Three-year Requirement
This proposal would clarify that both the MPO and DOT must
redetermine conformity of transportation plans/TIPs within three years
of DOT's transportation plan/TIP conformity determination. The existing
transportation conformity rule is not explicit regarding the start of
the three-year clock and which agencies' conformity determinations must
be completed before expiration of that clock. This clarification is
consistent with implementation practice to date and would help reduce
confusion and ambiguity for future implementers.
2. Triggers for Redetermination
This proposal would streamline the paragraph that describes which
events trigger an 18-month clock for redetermination of conformity.
This proposal would also move Sec. 51.448(a)(1)/Sec. 93.128(a)(1), as
amended on November 14, 1995, so that the requirement to determine
conformity within 18 months of the initial submission of a control
strategy SIP or maintenance plan is in the frequency section with the
other triggers for conformity redetermination. Although the substance
of the requirement is unchanged, the restructuring improves the flow
and clarity of the rule.
The relocation of Sec. 51.448(a)(1) highlights the fact that a
conformity determination is required within 18 months of both the
initial submission and final EPA approval of a control strategy SIP or
maintenance plan. Both submission and approval trigger a
redetermination of conformity, because it is not uncommon for the SIP
to change between initial submission and final approval. If conformity
was determined to the initial SIP submission and the SIP did not change
between initial submission and final approval, the requirement to
determine conformity after final approval could be satisfied without
new regional emissions analysis.
3. Requirement for TIP Conformity Within Six Months of Transportation
Plan Conformity
This proposal would clarify existing Sec. 51.400(a)(3)/
Sec. 93.104(a)(3) by specifying that the TIP must be determined by DOT
to conform within six months of DOT's conformity determination on a new
or revised transportation plan. The existing requirement starts the
six-month clock with the date of adoption of the plan.
EPA received comment suggesting that the six-month limit between
transportation plan and TIP conformity determinations is not necessary
and should be removed. EPA believes that this requirement should be
retained because of ISTEA's (and hence, conformity's) expectation that
the TIP will flow from, and be consistent with, the transportation
plan. The conformity rule requires TIP conformity to be based on a
consideration of all projects in the 20-year timeframe of the
transportation plan. As a result, changes to the transportation plan
should be reflected in the TIP's conformity determination in a timely
manner.
EPA expects that in almost all cases, the plan and TIP will be
developed concurrently and one regional emissions analysis will be
performed to support both conformity determinations. In cases where the
transportation plan and TIP are not developed concurrently, EPA
believes the six-month requirement is critical to ensure that, given
the changes to the transportation plan, projects from the TIP would
still result in a level of regional emissions in 20 years that would
not cause a new violation, worsen existing violations, or delay timely
attainment.
B. Criteria and Procedures for Determining Conformity of Transportation
Plans, Programs, and Projects: General
This proposal would consolidate several parts of the existing
transportation conformity rule into Sec. 51.410/Sec. 93.109 in order to
create a section that provides a comprehensive overview of when and in
what circumstances the budget test, emission reduction tests, and hot-
spot tests are required. The section would have separate paragraphs for
ozone, CO, PM10, and NO2 areas and isolated rural areas so
that the rule is easier to use and so that the conformity implications
of Clean Air Act requirements and classifications that are unique to
each pollutant are specifically addressed.
This consolidation would allow the elimination of existing
Sec. 51.464/Sec. 93.136 (``Special provisions for nonattainment areas
which are not required to demonstrate reasonable further progress and
attainment'') and Sec. 51.452(d)/Sec. 93.130(d) (``Projects not from a
conforming plan and TIP in isolated rural nonattainment and maintenance
areas''). The provisions for special situations would be discussed in
the same place as provisions for other areas, thus making these
provisions easier to locate and improving the clarity and user-
friendliness of the rule.
[[Page 36130]]
As discussed in section II., the existing rule's classification
system of ``Phase II interim period,'' ``transitional period,'' and
``control strategy period'' would be eliminated.
C. Latest Planning Assumptions
This proposal would clarify that conformity determinations must use
the latest existing information regarding the effectiveness of all
relevant SIP control measures, including TCMs, that have already been
implemented. This would reduce confusion regarding what emission
reduction credit should be assumed from vehicle inspection and
maintenance programs that are included in approved SIPs and that are
already being implemented.
D. Consultation Criterion
This proposal would clarify Sec. 51.416/Sec. 93.112 (``Criteria and
procedures: Consultation''), which is the section requiring conformity
to be determined according to the consultation procedures of the rule,
the conformity SIP, and DOT's planning regulations.
This proposal would remove the reference to the MPO so that it is
clear that rural areas must also abide by interagency and public
consultation requirements. In addition, this proposal removes ambiguous
language that could imply that areas are not required to comply with
public participation procedures after the conformity SIP is approved.
E. Hot-spot Tests
This proposal would consolidate and streamline existing
Secs. 51.424 and 51.434 (Secs. 93.116 and 93.121), which address
localized CO and PM10 violations (hot spots). The two sections
would be combined, and paragraph (c) of each of these sections would be
moved to the section addressing procedures for determining localized CO
and PM10 concentrations (hot-spot analysis). This would reduce
confusion regarding the distinction between the two hot-spot tests and
streamline the discussion of both the conformity tests and the
methodological requirements.
F. Compliance With PM10 Control Measures
This proposal would clarify the existing requirement of
Sec. 51.426/Sec. 93.117 for SIP PM10 control measures to be
included in the project's final plans, specifications, and estimates.
Because the final plans, specifications, and estimates are generally
not developed until after the project's conformity determination, it is
problematic for the existing rule to make the plans, specifications,
and estimates a condition of the project-level conformity
determination. This proposal would require the conformity determination
to include a written commitment to include SIP PM10 control
measures in the project's plans, specifications, and estimates. Such
commitments would be enforceable, as required by existing Sec. 51.458/
Sec. 93.133 (``Enforceability of design concept and scope and project-
level mitigation and control measures'').
G. Budget Test
This proposal would combine existing Secs. 51.428-51.432
(Secs. 93.118-93.120) into one streamlined section that describes the
budget test for the transportation plan, TIP, and project not from a
conforming plan and TIP. As described in section III. of this preamble,
the implementation of the budget test and the years for which budgets
apply would be clarified.
H. Emission Reduction Tests
This proposal would combine existing Secs. 51.436-51.446
(Secs. 93.122-93.127), which describe the tests for emission reductions
in the interim period for ozone, CO, PM10, and NO2 areas,
into one streamlined section that addresses all pollutants and the
transportation plan, TIP, and project not from a conforming plan and
TIP. This would avoid the repetition of the definitions of the
``Baseline'' and ``Action'' scenarios and improve the readability of
the transportation conformity rule.
This proposal would provide that the first analysis year shall be
no more than five years beyond the year in which the conformity
determination is being made. The existing conformity rule requires the
first analysis year to be 1995 in CO nonattainment areas and 1996 in
ozone nonattainment areas. This requirement is obviously no longer
appropriate, because conformity is not intended to be assessed
retrospectively.
This proposal would also modify the definition of the ``Baseline''
scenario so that only projects that come from the first year of the
previously conforming transportation plan/TIP are required to be
included in the ``Baseline'' scenario. The existing conformity rule
requires projects from the first three years of the previously
conforming transportation plan/TIP to be included in the ``Baseline''
scenario. The proposed modification is intended to correct the perverse
incentive that the existing requirement creates for areas to withhold
projects with air quality benefits. Some stakeholders have commented
that because the air quality benefits of projects in the second and
third year of the TIP are included in the ``Baseline'' after the
initial TIP conformity determination, areas are holding back some
projects for use in future ``Action''/``Baseline'' comparisons.
I. Transition From the Interim Period to the Control Strategy Period
Because the proposal would no longer use the terms ``interim
period'' and ``control strategy period,'' this proposal would
consolidate and streamline existing Sec. 51.448/Sec. 93.128 and better
integrate its provisions into the rest of the transportation conformity
rule.
Under the proposal, this section would address only the conformity
consequences of various SIP failures. This section would streamline the
existing requirements regarding conformity lapse resulting from SIP
failures, as amended August 7, 1995, and November 14, 1995. The term
``protective finding'' would be included in the definitions section in
order to decrease the wordiness of the requirements and improve the
readability of the rule.
Some of the existing requirements of Sec. 51.448 would be
incorporated in the frequency section, the general overview of the
criteria and procedures, and the budget test. Existing paragraphs (e)
through (i) would be eliminated. Existing Sec. 51.448(e) requires
consultation on individual capacity-increasing projects in areas that
have not yet submitted control strategy SIPs. Because all areas that
are already required to submit control strategy SIPs have made such
submissions, EPA believes that the requirements of paragraph (e) are no
longer necessary.
Existing Sec. 51.448(f) describes conditions under which new
regional emissions analysis is not necessary in order to determine
conformity to a newly submitted control strategy SIP. EPA continues to
believe that new regional emissions analysis would not be necessary
under the conditions described in paragraph (f). However, EPA does not
believe that this provision needs to be included in the regulatory
text, because the provision is not commonly used and EPA believes the
provision is sufficiently well understood.
Existing paragraphs 51.448 (g) through (i) are no longer relevant
given the other changes to the transportation conformity rule proposed
in this notice.
J. Procedures for Determining Regional Transportation-Related Emissions
This proposal would generally streamline and clarify existing
Sec. 51.452/Sec. 93.130. Some of the clarifications are highlighted
below.
[[Page 36131]]
1. Credit for Delayed Measures
This proposal would clarify that if TCMs or any other measures in
the approved SIP are delayed beyond the scheduled date, emission
reduction credit may not be included in the emissions analysis until
implementation is assured. This clarification would ensure that the
requirements for latest planning assumptions and restrictions on
assuming credit for regulatory measures are logically and consistently
applied. As described in the discussion of the clarification to the
``Latest planning assumptions'' section, broadening discussion of TCMs
to include other SIP measures would reduce confusion regarding emission
reduction credit for vehicle inspection and maintenance programs.
2. Credit for Future Measures
This proposal would streamline and clarify the conditions under
which emission reduction credit from future regulatory measures could
be assumed. In addition, the proposal would add language regarding
control measures that do not need a regulation in order to be
implemented, but are not included in the transportation plan/TIP or the
SIP. This language is intended to address measures such as increased
street sweeping or street sanding specifications, which are external to
the usual transportation planning process and which require some form
of commitment that may not be explicitly regulatory or included in the
SIP.
This proposal would allow emission reduction credit from such
measures to be assumed if the conformity determination includes written
commitments to implementation of the measures by appropriate entities
(e.g., government agencies, private project sponsors). The conformity
SIP would have to provide that written commitments that are included in
conformity determinations are enforceable under the SIP. This language
regarding enforceability is similar to that in existing Sec. 51.458/
Sec. 93.133 (``Enforceability of design concept and scope and project-
level mitigation and control measures'') and that included in the
general conformity rule (58 FR 63214, November 30, 1993).
The proposed additional language would reduce confusion regarding
these types of control measures and would allow more explicit
flexibility for these measures to be developed and credited in the
conformity process. The proposal would require written commitments to
be included as part of the conformity determination, but would not
require the commitments to be specifically included in the SIP. By
making such commitments enforceable under the SIP as a general matter,
the SIP would not have to be revised to include each specific
commitment.
The proposal would also allow regional emissions analyses to
include emission reductions from projects, programs, or activities that
are committed to in the control strategy SIP submission or the
maintenance plan submission, similar to the existing conformity rule's
Sec. 51.452(a)(4). Consistent with EPA's SIP policy, SIP commitments
must include a demonstration that the agency making the commitment has
authority to implement the measure and that adequate personnel and
funding are available for implementation.
3. Highway Performance Monitoring System (HPMS)
This proposal would clarify existing Sec. 51.452(b)(2)/
Sec. 93.130(b)(2) to specify that although HPMS estimates of VMT shall
be considered the primary measure of VMT in certain cases, locally
developed count-based programs and other variations from the procedure
described in the conformity rule are permitted subject to the
interagency consultation process. This paragraph applies to serious,
severe, and extreme ozone nonattainment areas and serious CO
nonattainment areas with an urbanized area population over than
200,000.
In its experience implementing the transportation conformity rule
since 1993, EPA has received several questions regarding what should be
used as the measure of VMT in areas that are not serious or above ozone
or CO areas. These areas may use HPMS (including the factoring
procedure described in existing Sec. 51.452(b)(2)/Sec. 93.130(b)(2)) or
other locally developed programs and procedures, subject to the
interagency consultation process.
4. Reliance on Previous Regional Emissions Analysis
This proposal would consolidate in the section on procedures for
regional emissions analysis the discussion of circumstances under which
new regional emissions analysis may not be necessary. This discussion
is currently included in the description of the budget test for TIPs
and projects not from a conforming plan and TIP (Sec. 51.430/
Sec. 93.119 and Sec. 51.432/Sec. 93.120). This change would streamline
these budget test sections and allow a simpler discussion of what must
be demonstrated in order to satisfy the budget test.
K. Procedures for Determining Localized CO and PM10 Concentrations
(Hot-spot Analysis)
This proposal would restructure the procedural requirements for
hot-spot analysis in order to clarify that the hot-spot tests should be
satisfied using EPA ``Guideline'' models in specified cases and in
other cases may be satisfied using other quantitative or qualitative
methods. This proposal would retain the existing rule's description of
what projects should have hot-spot analysis according to EPA's
``Guideline'' models, but would clarify that other methods may be
agreed upon through the interagency consultation process and with the
approval of the EPA Regional Administrator.
EPA is willing to consider methods that identify different
thresholds for determining which projects would require EPA
``Guideline'' models. For example, although the existing rule requires
all projects affecting intersections at Level-of-Service D, E, or F to
be quantitatively modeled using EPA ``Guideline'' models, an area may
develop other thresholds for quantitative analysis based on delay
times, traffic volume, queue lengths, background CO levels, and/or
receptor locations. EPA will consider alternative methods for
thresholds provided they are sufficient to determine that projects will
not cause or contribute to new CO violations or increase the frequency
or severity of existing CO violations (as described by the hot-spot
criterion).
In addition, if an individual project affects multiple
intersections, EPA is willing to approve procedures that require
quantitative modeling initially only for those intersections with the
greatest potential for CO violations. If quantitative modeling of those
intersections does not predict CO violations, the other intersections
affected by the project would not have to be quantitatively modeled.
L. Enforceability of Design Concept and Scope and Project-Level
Mitigation and Control Measures
This proposal would clarify existing Sec. 51.458/Sec. 93.133 by
stating that a waiver of mitigation measures is subject to the
conformity rule's public participation requirements for project-level
conformity determinations. The conformity rule requires public
involvement in conformity determinations for projects where otherwise
required by law (e.g., the National Environmental Policy Act (NEPA)).
This clarification is consistent with EPA's original intent for a
waiver of mitigation measures to be permitted
[[Page 36132]]
through a process similar to the original conformity determination.
This clarification is in response to the May 26, 1994, Petition for
Reconsideration by the Environmental Defense Fund, the Natural
Resources Defense Council, and the Sierra Club Legal Defense Fund.
M. Exempt Projects
This proposal would clarify Table 2 of exist
FR Doc. 96-16581 Transportation Conformity Rule Amendments: Flexibility and Streamlining
ing Sec. 51.460/
Sec. 93.134 by specifying that the advance land acquisitions that are
exempt are those emergency/hardship acquisitions provided for by 23 CFR
712.204(d).
As described in the preamble to the November 1993 conformity rule
(58 FR 62213), the advance land acquisitions referred to in Table 2 are
those ``parcels that are acquired to protect a property from imminent
development and increased costs which would tend to limit a choice of
transportation alternatives, or are acquired to alleviate particular
hardship to a property owner at his or her request. This is only
allowed in emergency or extraordinary cases, and only after the state
department of transportation has given official notice to the public
that a preferred highway or transit location has been selected, held a
public hearing, or provided an opportunity for a public hearing.''
This proposal would make this intention clearer in the rule by
providing the specific citation that enables this type of hardship
acquisition and protective buying.
XII. TCM Flexibility
During the 1995 spring stakeholder meetings, EPA made a commitment
to provide sample language for a SIP mechanism that would allow
substitution of TCMs in a previously approved SIP without additional
EPA approvals. As EPA indicated at that time, EPA believes that such a
substitution mechanism is possible under existing EPA SIP policy, and
no conformity rule amendment is necessary. As a result, EPA is not
proposing language addressing TCM flexibility in today's action.
EPA will be drafting model SIP language and distributing it to
conformity stakeholders for comment.
XIII. PM10 Hot Spots
Section 51.454(d) (93.131(d)) of the existing conformity rule
requires quantitative PM10 hot-spot analysis in certain cases, but
states that the requirements will not take effect until EPA releases
modeling guidance and announces in the Federal Register that the
requirements are in effect.
EPA has not yet released guidance on dispersion modeling for
PM10 hot spots due to transportation projects. As a result, the
requirements for quantitative PM10 hot-spot analysis are not
currently in effect.
EPA has received comment requesting that these requirements should
continue to be deferred until research that is underway by other
organizations has been completed. For example, several PM10
studies are being sponsored by the California Air Resources Board and
the California Department of Transportation.
EPA hereby announces its intention to delay the further development
and issuance of its PM10 hot-spot modeling guidance pending the
completion of research by organizations external to EPA. EPA does not
intend to issue PM10 hot-spot modeling guidance before 1998. As a
result, the requirements of existing Sec. 51.454(d)/Sec. 93.131(d) will
continue to be deferred until such time as EPA releases modeling
guidance and announces in the Federal Register that the requirements
are in effect.
XIV. Signalization Projects
EPA has received several comments suggesting that signalization
projects, including areawide traffic signal synchronization projects
and automated traffic surveillance and control projects, should be
exempt from transportation conformity requirements. However, for the
reasons described below, EPA is not proposing to change the exempt
project lists (Tables 2 and 3 of the conformity rule) to exempt
signalization projects.
A. Background
The transportation conformity rule does not require conformity
determinations for certain types of projects. These ``exempt'' projects
are listed in Table 2 of the conformity rule. In contrast to other
transportation projects, exempt projects can proceed toward
implementation even if a currently conforming transportation plan or
TIP is not in place. These projects are exempt from conformity
requirements because EPA considers them to have a neutral or de minimis
impact on air quality. EPA does not exempt projects that could have
regional impacts--even if those impacts may be positive--because EPA
believes that regionally significant projects must be analyzed
together, in the context of all other regionally significant projects.
In this way, the interactions among projects may be considered, and
there is a meaningful estimate of regional emissions that can be
compared to the SIP's motor vehicle emissions budget.
In addition to the Table 2 projects that are exempt from conformity
requirements, the transportation conformity rule also exempts certain
projects from regional emissions analysis. These projects, which are
listed in Table 3 of the conformity rule, are not required to be
included in the regional emissions analysis for the transportation plan
and TIP, and can proceed toward implementation even if a currently
conforming transportation plan or TIP is not in place. However,
conformity determinations are required for these projects, and the
local effects of these projects on CO and PM10 concentrations must
be considered in CO and PM10 nonattainment and maintenance areas.
The existing transportation conformity rule exempts intersection
signalization projects at individual intersections from regional
emissions analysis, as indicated in Table 2.
B. Comments Supporting Exemption of Signalization Projects
EPA has received comments that advocate the exemption of
signalization projects because of positive air quality and congestion
mitigation impacts of signalization projects and because of the
implementation delays that may result from conformity requirements.
For example, some commenters state that signalization projects
decrease emissions by reducing acceleration, deceleration, and idling.
They cite studies of certain signalization efforts that indicate
significant reductions in CO, VOC, and NOx emissions. In addition,
they state that improved efficiency of the roadway network benefits
buses and high occupancy vehicle (HOV) users.
In addition, some commenters support exempting signalization
projects in order to avoid delays that could result from the
requirement for these projects to be included in the transportation
plan and TIP's regional emissions analysis. Some commenters expressed
concern that signalization projects could be delayed for up to a year
while going through conformity analysis.
C. Rationale For Decision Not To Exempt Signalization Projects
EPA is not proposing to exempt signalization projects from
conformity requirements because some of the projects may be complex,
regionally significant projects whose emissions impacts must be
assessed in the context of all regionally significant projects. For
signalization projects that are not regionally significant, options
exist to decrease the analysis burden and
[[Page 36133]]
potential delay of the conformity requirements, as described below.
As described above, EPA's list of exempt projects is intended to
include only those projects with neutral or de minimis emissions
impacts. The types of signalization projects that commenters suggest
exempting are clearly not de minimis. For example, some signalization
projects are areawide synchronizations that affect hundreds of
intersections. Even the more limited signalization projects are often
complex projects associated with roadway construction and improvement.
Traffic signalization projects are not always limited to simple
upgrades of hardware or installation of new signals.
In addition, signalization projects cannot generally be considered
de minimis because they may affect traffic flow on a regional level.
The emissions impacts may be positive or negative depending on the
pollutant of concern, the speeds on the affected roads, and the effects
on other roads in the network. For example, improved traffic flow and
corresponding increases in traffic speed may reduce CO emissions, but
may increase NOX emissions in certain speed ranges. PM10
emissions may also increase. Significant changes in travel time may
redistribute travel on other roads and affect mode choice. These
effects need to be considered at a regional level, and the cumulative
emissions impacts cannot be qualitatively determined.
EPA recognizes that not all signalization projects at multiple
intersections are regionally significant, particularly if they affect a
small number of miles in a large metropolitan area, or if an area's
modeling capabilities are not sensitive to the more subtle regional
effects of signalization projects. The existing conformity rule allows
projects that are not regionally significant to be amended into the
transportation plan and TIP without a new regional emissions analysis,
if the regional emissions analysis supporting the currently
transportation plan and TIP is still valid (e.g., planning assumptions
have not changed). As a result, EPA believes that there are already
sufficient opportunities to minimize the analysis burden and potential
project implementation delays in cases where the signalization projects
are relatively simple.
EPA considered trying to identify a threshold for determining which
signalization projects at multiple intersections would not be
considered regionally significant, so that these projects could be
included in Table 3's list of projects that are exempt from regional
emissions analysis. However, EPA decided that this approach would be
unnecessarily complex and unlikely to provide a threshold that was
appropriate for all areas. Areas currently have the discretion to
determine which projects are regionally significant through the
interagency consultation process, and thus have sufficient flexibility
to minimize the analysis burden associated with signalization projects
where appropriate.
Finally, although EPA agrees that the conformity process should
minimize project implementation delays as much as possible, EPA does
not believe the delays associated with regionally significant
signalization projects are unreasonable. If signalization projects are
identified at the time the transportation plan and TIP are being
developed, they can be included in the transportation plan and TIP's
regional emissions analysis initially, and implementation delays should
not occur. In many instances TIPs are developed annually. If
transportation plan/TIP amendments between TIP cycles can be avoided
with improved planning, implementation delays could be reduced.
XV. Conformity SIPs
Section 51.396(a) of the existing conformity rule (as amended
November 14, 1995) requires conformity SIP revisions to be submitted to
EPA within 12 months after the date of publication of final amendments
to the conformity rule. As a result, when EPA takes final action on
today's proposal, conformity SIP revisions consistent with that final
action will be due to EPA within 12 months.
As specified in Sec. 51.396(b) of the conformity rule, after EPA
approves a conformity SIP revision, the federal conformity rule does
not govern conformity determinations. Therefore, for areas whose
conformity SIP revision has already been approved by EPA, the final
amendments that will result from today's proposal will not be effective
until they are included in the conformity SIP revision and EPA approves
that SIP revision.
XVI. Public Hearing
Anyone who wants to present testimony about this proposal at the
public hearing (see DATES) should, if possible, notify the contact
person (see FOR FURTHER INFORMATION CONTACT) at least seven days prior
to the day of the hearing. The contact person should be given an
estimate of the time required for the presentation of testimony and
notification of any need for audio/visual equipment. A sign-up sheet
will be available at the registration table the morning of the hearing
for scheduling those who have not notified the contact earlier. This
testimony will be scheduled on a first-come,first-serve basis to follow
the previously scheduled testimony.
EPA requests that approximately 50 copies of the statement or
material to be presented be brought to the hearing for distribution to
the audience. In addition, EPA would find it helpful to receive an
advance copy of any statement or material to be presented at the
hearing at least one week before the scheduled hearing date. This is to
give EPA staff adequate time to review such material before the
hearing. Such advance copies should be submitted to the contact person
listed.
The official records of the hearing will be kept open until the
close of the comment period to allow submission of rebuttal and
supplementary testimony. All such submittals should be directed to the
Air Docket, Docket A-96-05 (see ADDRESSES). The hearing will be
conducted informally, and technical rules of evidence will not apply. A
written transcript of the hearing will be placed in the above docket
for review. Anyone desiring to purchase a copy of the transcript should
make individual arrangements with the court reporter recording the
proceeding.
XVII. Administrative Requirements
A. Administrative Designation
Executive Order 12866
Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more,
or otherwise adversely affect in a material way the economy, a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or state, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof;
(4) Raise novel or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the Executive
Order.
Pursuant to the terms of Executive Order 12866, it has been
determined
[[Page 36134]]
that this rule is a ``significant regulatory action'' because this
action raises novel legal or policy issues arising out of legal
mandates, the President's priorities, and the principles set forth in
the Executive Order. As such, this action was submitted to OMB for
review. Changes made in response to OMB suggestions or recommendations
will be documented in the public record.
B. Reporting and Recordkeeping Requirements
This rule does not contain any information collection requirements
from EPA which require approval by OMB under the Paperwork Reduction
Act of 1980, 44 U.S.C. 3501 et seq.
The information collection requirements of EPA's Transportation
Conformity Rule and these amendments to it are covered under the
Information Collection Request of the Department of Transportation
entitled ``Metropolitan and Statewide Transportation Planning'',
approved by OMB under the Paperwork Reduction Act through 11/96, with
OMB Control Number 2132-0529. Send any comments on the recordkeeping
and reporting requirements of Transportation Conformity to:
Mr. Sean Libberton, US Department of Transportation, TPL11, 400 7th
Street, SW., Washington, DC 20590,
and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Attention: Desk Officer for EPA/OAR, Room 10202, 725 17th
Street, NW., Washington, DC 20503.
In any correspondence please refer to OMB Control Number 2132-0529.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 requires federal agencies to
identify potentially adverse impacts of federal regulations upon small
entities. In instances where significant impacts are possible on a
substantial number of these entities, agencies are required to perform
a Regulatory Flexibility Analysis (RFA).
EPA has determined that today's regulations will not have a
significant impact on a substantial number of small entities. This
regulation affects federal agencies and metropolitan planning
organizations, which by definition are designated only for metropolitan
areas with a population of at least 50,000. These organizations do not
constitute small entities.
Therefore, as required under section 605 of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., I certify that this regulation
does not have a significant impact on a substantial number of small
entities.
D. Unfunded Mandates
Under Sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 22,
1995, EPA must undertake various actions in association with proposed
or final rules that include a federal mandate that may result in
estimated costs of $100 million or more to the private sector, or to
state, local, or tribal governments in the aggregate.
EPA has determined that to the extent this rule imposes any mandate
within the meaning of the Unfunded Mandates Act, this final action does
not include a mandate that may result in estimated costs of $100
million or more to state, local, or tribal governments in the aggregate
or to the private sector. Therefore, EPA has not prepared a statement
with respect to budgetary impacts.
List of Subjects
40 CFR Part 51
Environmental protection, Administrative practice and procedure,
Carbon monoxide, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.
40 CFR Part 93
Administrative practice and procedure, Air pollution control,
Carbon monoxide, Intergovernmental relations, Ozone.
Dated: June 21, 1996.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, 40 CFR parts 51 and 93 are
proposed to be amended as follows:
PART 51--[AMENDED]
1. The authority citation for part 51 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
2. Subpart T is amended by removing Secs. 51.392 through 51.464 and
by revising Sec. 51.390 to read as follows:
Subpart T--Conformity to State or Federal Implementation Plans of
Transportation Plans, Programs, and Projects Developed, Funded or
Approved Under Title 23 U.S.C. or the Federal Transit Laws
Sec. 51.390 Implementation plan revision.
(a) States with areas subject to this rule must submit to the EPA
and DOT a revision to their implementation plan which contains criteria
and procedures for DOT, MPOs and other State or local agencies to
assess the conformity of transportation plans, programs, and projects,
consistent with these regulations. This revision is to be submitted by
November 25, 1994 (or within 12 months of an area's redesignation from
attainment to nonattainment, if the State has not previously submitted
such a revision). Further revisions to the implementation plan required
by amendments to part 93, subpart A of this chapter must be submitted
within 12 months of the date of publication of such final amendments.
EPA will provide DOT with a 30-day comment period before taking action
to approve or disapprove the submission. A State's conformity
provisions may contain criteria and procedures more stringent than the
requirements described in these regulations only if the State's
conformity provisions apply equally to non-federal as well as Federal
entities.
(b) The Federal conformity rules under this subpart and part 93 of
this chapter, in addition to any existing applicable State
requirements, establish the conformity criteria and procedures
necessary to meet the requirements of Clean Air Act section 176(c)
until such time as EPA approves the required conformity implementation
plan revision. Following EPA approval of the State conformity
provisions (or a portion thereof) in a revision to the applicable
implementation plan, conformity determinations would be governed by the
approved (or approved portion of the) State criteria and procedures.
The Federal conformity regulations contained in part 93 of this chapter
would apply only for the portion, if any, of the State's conformity
provisions that is not approved by EPA. In addition, any previously
applicable implementation plan conformity requirements remain
enforceable until the State revises its applicable implementation plan
to specifically remove them and that revision is approved by EPA.
(c) The implementation plan revision required by this section must
meet all of the requirements of part 93, subpart A of this chapter.
(d) In order for EPA to approve the implementation plan revision
submitted to EPA and DOT under this section, the plan must address all
requirements of this subpart in a manner which gives them full legal
effect. In particular, the revision shall incorporate the provisions of
the following sections of this subpart in verbatim form, except insofar
as needed to clarify or to give effect to a
[[Page 36135]]
stated intent in the revision to establish criteria and procedures more
stringent than the requirements stated in these sections of this
chapter: Secs. 93.101, 93.102, 93.103, 93.104, 93.106, 93.109, 93.110,
93.111, 93.112, 93.113, 93.114, 93.115, 93.116, 93.117, 93.118, 93.119,
93.120, 93.121, 93.126, and 93.127 of this chapter.
PART 93--[AMENDED]
3. The authority citation for part 93 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
4. Subpart A is revised to read as follows:
Subpart A--Conformity to State or Federal Implementation Plans of
Transportation Plans, Programs, and Projects Developed, Funded or
Approved Under Title 23 U.S.C. or the Federal Transit Laws
Sec.
93.100 Purpose.
93.101 Definitions.
93.102 Applicability.
93.103 Priority.
93.104 Frequency of conformity determinations.
93.105 Consultation.
93.106 Content of transportation plans.
93.107 Relationship of transportation plan and TIP conformity with
the NEPA process.
93.108 Fiscal constraints for transportation plans and TIPs.
93.109 Criteria and procedures for determining conformity of
transportation plans, programs, and projects: General.
93.110 Criteria and procedures: Latest planning assumptions.
93.111 Criteria and procedures: Latest emissions model.
93.112 Criteria and procedures: Consultation.
93.113 Criteria and procedures: Timely implementation of TCMs.
93.114 Criteria and procedures: Currently conforming transportation
plan and TIP.
93.115 Criteria and procedures: Projects from a plan and TIP.
93.116 Criteria and procedures: Localized CO and PM10
violations (hot spots).
93.117 Criteria and procedures: Compliance with PM10 control
measures.
93.118 Criteria and procedures: Motor vehicle emissions budget.
93.119 Criteria and procedures: Emission reductions in areas
without motor vehicle emissions budgets.
93.120 Consequences of control strategy implementation plan
failures.
93.121 Requirements for adoption or approval of projects by other
recipients of funds designated under title 23 U.S.C. or the Federal
Transit Laws.
93.122 Procedures for determining regional transportation-related
emissions.
93.123 Procedures for determining localized CO and PM10
concentrations (hot-spot analysis).
93.124 Using the motor vehicle emissions budget in the applicable
implementation plan (or implementation plan submission).
93.125 Enforceability of design concept and scope and project-level
mitigation and control measures.
93.126 Exempt projects.
93.127 Projects exempt from regional emissions analyses.
Sec. 93.100 Purpose.
The purpose of this subpart is to implement Sec. 176(c) of the
Clean Air Act (CAA), as amended (42 U.S.C. 7401 et seq.), and the
related requirements of 23 U.S.C. 109(j), with respect to the
conformity of transportation plans, programs, and projects which are
developed, funded, or approved by the United States Department of
Transportation (DOT), and by metropolitan planning organizations (MPOs)
or other recipients of funds under title 23 U.S.C. or the Federal
Transit Laws (49 U.S.C. Chapter 53). This subpart sets forth policy,
criteria, and procedures for demonstrating and assuring conformity of
such activities to an applicable implementation plan developed pursuant
to section 110 and Part D of the CAA.
Sec. 93.101 Definitions.
Terms used but not defined in this subpart shall have the meaning
given them by the CAA, titles 23 and 49 U.S.C., other Environmental
Protection Agency (EPA) regulations, or other DOT regulations, in that
order of priority.
Applicable implementation plan is defined in section 302(q) of the
CAA and means the portion (or portions) of the implementation plan, or
most recent revision thereof, which has been approved under section
110, or promulgated under section 110(c), or promulgated or approved
pursuant to regulations promulgated under section 301(d) and which
implements the relevant requirements of the CAA.
CAA means the Clean Air Act, as amended.
Cause or contribute to a new violation for a project means:
(1) To cause or contribute to a new violation of a standard in the
area substantially affected by the project or over a region which would
otherwise not be in violation of the standard during the future period
in question, if the project were not implemented, or
(2) To contribute to a new violation in a manner that would
increase the frequency or severity of a new violation of a standard in
such area.
Clean data means air quality monitoring data determined by EPA to
meet the requirements of 40 CFR part 58 that indicate attainment of the
national ambient air quality standard.
Control strategy implementation plan revision is the implementation
plan which contains specific strategies for controlling the emissions
of and reducing ambient levels of pollutants in order to satisfy CAA
requirements for demonstrations of reasonable further progress and
attainment (CAA sections 182(b)(1), 182(c)(2)(A), 182(c)(2)(B),
187(a)(7), 189(a)(1)(B), and 189(b)(1)(A); and sections 192(a) and
192(b), for nitrogen dioxide).
Design concept means the type of facility identified by the
project, e.g., freeway, expressway, arterial highway, grade-separated
highway, reserved right-of-way rail transit, mixed-traffic rail
transit, exclusive busway, etc.
Design scope means the design aspects which will affect the
proposed facility's impact on regional emissions, usually as they
relate to vehicle or person carrying capacity and control, e.g., number
of lanes or tracks to be constructed or added, length of project,
signalization, access control including approximate number and location
of interchanges, preferential treatment for high-occupancy vehicles,
etc.
DOT means the United States Department of Transportation.
EPA means the Environmental Protection Agency.
FHWA means the Federal Highway Administration of DOT.
FHWA/FTA project, for the purpose of this subpart, is any highway
or transit project which is proposed to receive funding assistance and
approval through the Federal-Aid Highway program or the Federal mass
transit program, or requires Federal Highway Administration (FHWA) or
Federal Transit Administration (FTA) approval for some aspect of the
project, such as connection to an interstate highway or deviation from
applicable design standards on the interstate system.
FTA means the Federal Transit Administration of DOT.
Forecast period with respect to a transportation plan is the period
covered by the transportation plan pursuant to 23 CFR part 450.
Highway project is an undertaking to implement or modify a highway
facility or highway-related program. Such an undertaking consists of
all required phases necessary for implementation. For analytical
purposes, it must be defined sufficiently to:
(1) Connect logical termini and be of sufficient length to address
environmental matters on a broad scope;
(2) Have independent utility or significance, i.e., be usable and
be a reasonable expenditure even if no
[[Page 36136]]
additional transportation improvements in the area are made; and
(3) Not restrict consideration of alternatives for other reasonably
foreseeable transportation improvements.
Horizon year is a year for which the transportation plan describes
the envisioned transportation system according to Sec. 93.106 of this
subpart.
Hot-spot analysis is an estimation of likely future localized CO
and PM10 pollutant concentrations and a comparison of those
concentrations to the national ambient air quality standards. Hot-spot
analysis assesses impacts on a scale smaller than the entire
nonattainment or maintenance area, including, for example, congested
roadway intersections and highways or transit terminals, and uses an
air quality dispersion model to determine the effects of emissions on
air quality.
Increase the frequency or severity means to cause a location or
region to exceed a standard more often or to cause a violation at a
greater concentration than previously existed and/or would otherwise
exist during the future period in question, if the project were not
implemented.
ISTEA means the Intermodal Surface Transportation Efficiency Act of
1991.
Maintenance area means any geographic region of the United States
previously designated nonattainment pursuant to the CAA Amendments of
1990 and subsequently redesignated to attainment subject to the
requirement to develop a maintenance plan under section 175A of the
CAA, as amended.
Maintenance plan means an implementation plan under section 175A of
the CAA, as amended.
Metropolitan planning organization (MPO) is that organization
designated as being responsible, together with the State, for
conducting the continuing, cooperative, and comprehensive planning
process under 23 U.S.C. 134 and 49 U.S.C. 1607. It is the forum for
cooperative transportation decision-making.
Milestone has the meaning given in sections 182(g)(1) and 189(c) of
the CAA. A milestone consists of an emissions level and the date on
which it is required to be achieved.
Motor vehicle emissions budget is that portion of the total
allowable emissions defined in the submitted or approved control
strategy implementation plan revision or maintenance plan for a certain
date for the purpose of meeting reasonable further progress milestones
or demonstrating attainment or maintenance of the NAAQS, for any
criteria pollutant or its precursors, allocated to highway and transit
vehicle use and emissions.
National ambient air quality standards (NAAQS) are those standards
established pursuant to section 109 of the CAA.
NEPA means the National Environmental Policy Act of 1969, as
amended (42 U.S.C. 4321 et seq.).
NEPA process completion, for the purposes of this subpart, with
respect to FHWA or FTA, means the point at which there is a specific
action to make a determination that a project is categorically
excluded, to make a Finding of No Significant Impact, or to issue a
record of decision on a Final Environmental Impact Statement under
NEPA.
Nonattainment area means any geographic region of the United States
which has been designated as nonattainment under Sec. 107 of the CAA
for any pollutant for which a national ambient air quality standard
exists.
Project means a highway project or transit project.
Protective finding means a determination by EPA that the control
strategy contained in a submitted control strategy implementation plan
revision would have been considered approvable with respect to
requirements for emissions reductions if all committed measures had
been submitted in enforceable form as required by Clean Air Act section
110 (a)(2)(A).
Recipient of funds designated under title 23 U.S.C. or the Federal
Transit Laws means any agency at any level of State, county, city, or
regional government that routinely receives title 23 U.S.C. or Federal
Transit Laws funds to construct FHWA/FTA projects, operate FHWA/FTA
projects or equipment, purchase equipment, or undertake other services
or operations via contracts or agreements. This definition does not
include private landowners or developers, or contractors or entities
that are only paid for services or products created by their own
employees.
Regionally significant project means a transportation project
(other than an exempt project) that is on a facility which serves
regional transportation needs (such as access to and from the area
outside of the region, major activity centers in the region, major
planned developments such as new retail malls, sports complexes, etc.,
or transportation terminals as well as most terminals themselves) and
would normally be included in the modeling of a metropolitan area's
transportation network, including at a minimum all principal arterial
highways and all fixed guideway transit facilities that offer an
alternative to regional highway travel.
Standard means a national ambient air quality standard.
Transit is mass transportation by bus, rail, or other conveyance
which provides general or special service to the public on a regular
and continuing basis. It does not include school buses or charter or
sightseeing services.
Transit project is an undertaking to implement or modify a transit
facility or transit-related program; purchase transit vehicles or
equipment; or provide financial assistance for transit operations. It
does not include actions that are solely within the jurisdiction of
local transit agencies, such as changes in routes, schedules, or fares.
It may consist of several phases. For analytical purposes, it must be
defined inclusively enough to:
(1) Connect logical termini and be of sufficient length to address
environmental matters on a broad scope;
(2) Have independent utility or independent significance, i.e., be
a reasonable expenditure even if no additional transportation
improvements in the area are made; and
(3) Not restrict consideration of alternatives for other reasonably
foreseeable transportation improvements.
Transportation control measure (TCM) is any measure that is
specifically identified and committed to in the applicable
implementation plan that is either one of the types listed in section
108 of the CAA, or any other measure for the purpose of reducing
emissions or concentrations of air pollutants from transportation
sources by reducing vehicle use or changing traffic flow or congestion
conditions. Notwithstanding the above, vehicle technology-based, fuel-
based, and maintenance-based measures which control the emissions from
vehicles under fixed traffic conditions are not TCMs for the purposes
of this subpart.
Transportation improvement program (TIP) means a staged, multiyear,
intermodal program of transportation projects covering a metropolitan
planning area which is consistent with the metropolitan transportation
plan, and developed pursuant to 23 CFR part 450.
Transportation plan means the official intermodal metropolitan
transportation plan that is developed through the metropolitan planning
process for the metropolitan planning area, developed pursuant to 23
CFR part 450.
Transportation project is a highway project or a transit project.
[[Page 36137]]
Sec. 93.102 Applicability.
(a) Action applicability. (1) Except as provided for in paragraph
(c) of this section or Sec. 93.126, conformity determinations are
required for:
(i) The adoption, acceptance, approval or support of transportation
plans and transportation plan amendments developed pursuant to 23 CFR
part 450 or 49 CFR part 613 by an MPO or DOT;
(ii) The adoption, acceptance, approval or support of TIPs and TIP
amendments developed pursuant to 23 CFR part 450 or 49 CFR part 613 by
an MPO or DOT; and
(iii) The approval, funding, or implementation of FHWA/FTA
projects.
(2) Conformity determinations are not required under this rule for
individual projects which are not FHWA/FTA projects. However,
Sec. 93.121 applies to such projects if they are regionally
significant.
(b) Geographic Applicability. The provisions of this subpart shall
apply in all nonattainment and maintenance areas for transportation-
related criteria pollutants for which the area is designated
nonattainment or has a maintenance plan.
(1) The provisions of this subpart apply with respect to emissions
of the following criteria pollutants: Ozone, carbon monoxide (CO),
nitrogen dioxide (NO2), and particles with an aerodynamic diameter
less than or equal to a nominal 10 micrometers (PM10).
(2) The provisions of this subpart apply with respect to emissions
of the following precursor pollutants:
(i) Volatile organic compounds (VOC) and nitrogen oxides (NOX)
in ozone areas;
(ii) NOX in NO2 areas; and
(iii) VOC, NOX, and PM10 in PM10 areas if the EPA
Regional Administrator or the director of the State air agency has made
a finding that transportation-related precursor emissions within the
nonattainment area are a significant contributor to the PM10
nonattainment problem and has so notified the MPO and DOT, or if the
applicable implementation plan (or implementation plan submission)
establishes a budget for such emissions as part of the reasonable
further progress, attainment or maintenance strategy.
(3) The provisions of this subpart apply to maintenance areas for
20 years from the date EPA approves the area's request under section
107(d) of the CAA for redesignation to attainment, unless the
applicable implementation plan specifies that the provisions of this
subpart shall apply for more than 20 years.
(c) Limitations. (1) Projects subject to this regulation for which
the NEPA process and a conformity determination have been completed by
DOT may proceed toward implementation without further conformity
determinations unless more than three years have elapsed since the most
recent major step (NEPA process completion; start of final design;
acquisition of a significant portion of the right-of-way; or approval
of the plans, specifications and estimates) occurred. All phases of
such projects which were considered in the conformity determination are
also included, if those phases were for the purpose of funding, final
design, right-of-way acquisition, construction, or any combination of
these phases.
(2) A new conformity determination for the project will be required
if there is a significant change in project design concept and scope,
if a supplemental environmental document for air quality purposes is
initiated, or if three years have elapsed since the most recent major
step to advance the project occurred.
(d) Grace period for new nonattainment areas. For areas or portions
of areas which have been designated attainment for either ozone, CO,
PM10 or NO2 since 1990 and are subsequently redesignated to
nonattainment for any of these pollutants, the provisions of this
subpart shall not apply for 12 months following the date of final
designation to nonattainment for such pollutant.
Sec. 93.103 Priority.
When assisting or approving any action with air quality-related
consequences, FHWA and FTA shall give priority to the implementation of
those transportation portions of an applicable implementation plan
prepared to attain and maintain the NAAQS. This priority shall be
consistent with statutory requirements for allocation of funds among
States or other jurisdictions.
Sec. 93.104 Frequency of conformity determinations.
(a) Conformity determinations and conformity redeterminations for
transportation plans, TIPs, and FHWA/FTA projects must be made
according to the requirements of this section and the applicable
implementation plan.
(b) Frequency of conformity determinations for transportation
plans.
(1) Each new transportation plan must be demonstrated to conform
before the transportation plan is approved by the MPO or accepted by
DOT.
(2) All transportation plan revisions must be found to conform
before the transportation plan revisions are approved by the MPO or
accepted by DOT, unless the revision merely adds or deletes exempt
projects listed in Sec. 93.126 or Sec. 93.127. The conformity
determination must be based on the transportation plan and the revision
taken as a whole.
(3) The MPO and DOT must determine the conformity of the
transportation plan no less frequently than every three years. If more
than three years elapse after DOT's conformity determination without
the MPO and DOT determining conformity of the transportation plan, the
existing conformity determination will lapse.
(c) Frequency of conformity determinations for transportation
improvement programs.
(1) A new TIP must be demonstrated to conform before the TIP is
approved by the MPO or accepted by DOT.
(2) A TIP amendment requires a new conformity determination for the
entire TIP before the amendment is approved by the MPO or accepted by
DOT, unless the amendment merely adds or deletes exempt projects listed
in Sec. 93.126 or Sec. 93.127.
(3) The MPO and DOT must determine the conformity of the TIP no
less frequently than every three years. If more than three years elapse
after DOT's conformity determination without the MPO and DOT
determining conformity of the TIP, the existing conformity
determination will lapse.
(4) After an MPO adopts a new or revised transportation plan,
conformity of the TIP must be redetermined by the MPO and DOT within
six months from the date of DOT's conformity determination for the
transportation plan, unless the new or revised plan merely adds or
deletes exempt projects listed in Secs. 93.126 and 93.127. Otherwise,
the existing conformity determination for the TIP will lapse.
(d) Projects. FHWA/FTA projects must be found to conform before
they are adopted, accepted, approved, or funded. Conformity must be
redetermined for any FHWA/FTA project if three years have elapsed since
the most recent major step to advance the project (NEPA process
completion; start of final design; acquisition of a significant portion
of the right-of-way; or approval of the plans, specifications and
estimates) occurred.
(e) Triggers for transportation plan and TIP conformity
determinations. Conformity of existing transportation plans and TIPs
must be redetermined within 18 months of the following, or the existing
conformity determination will lapse, and no new project-level
conformity determinations may be made
[[Page 36138]]
until conformity of the transportation plan and TIP has been determined
by the MPO and DOT:
(1) November 24, 1993;
(2) The date of the State's initial submission to EPA of each
control strategy implementation plan or maintenance plan establishing a
motor vehicle emissions budget;
(3) EPA approval of a control strategy implementation plan revision
or maintenance plan which establishes or revises a motor vehicle
emissions budget;
(4) EPA approval of an implementation plan revision that adds,
deletes, or changes TCMs; and
(5) EPA promulgation of an implementation plan which establishes or
revises a motor vehicle emissions budget or adds, deletes, or changes
TCMs.
Sec. 93.105 Consultation.
(a) General. The implementation plan revision required under
Sec. 51.390 of this chapter shall include procedures for interagency
consultation (Federal, State, and local) and resolution of conflicts.
(1) The implementation plan revision shall include procedures to be
undertaken by MPOs, State departments of transportation, and DOT with
State and local air quality agencies and EPA before making conformity
determinations, and by State and local air agencies and EPA with MPOs,
State departments of transportation, and DOT in developing applicable
implementation plans.
(2) Before EPA approves the conformity implementation plan revision
required by Sec. 51.390 of this chapter, MPOs and State departments of
transportation must provide reasonable opportunity for consultation
with State air agencies, local air quality and transportation agencies,
DOT, and EPA, including consultation on the issues described in
paragraph (c)(1) of this section, before making conformity
determinations.
(b) Interagency consultation procedures: General factors. (1)
States shall provide well-defined consultation procedures in the
implementation plan whereby representatives of the MPOs, State and
local air quality planning agencies, State and local transportation
agencies, and other organizations with responsibilities for developing,
submitting, or implementing provisions of an implementation plan
required by the CAA must consult with each other and with local or
regional offices of EPA, FHWA, and FTA on the development of the
implementation plan, the transportation plan, the TIP, and associated
conformity determinations.
(2) Interagency consultation procedures shall include at a minimum
the general factors listed below and the specific processes in
paragraph (c) of this section:
(i) The roles and responsibilities assigned to each agency at each
stage in the implementation plan development process and the
transportation planning process, including technical meetings;
(ii) The organizational level of regular consultation;
(iii) A process for circulating (or providing ready access to)
draft documents and supporting materials for comment before formal
adoption or publication;
(iv) The frequency of, or process for convening, consultation
meetings and responsibilities for establishing meeting agendas;
(v) A process for responding to the significant comments of
involved agencies; and
(vi) A process for the development of a list of the TCMs which are
in the applicable implementation plan.
(c) Interagency consultation procedures: Specific processes.
Interagency consultation procedures shall also include the following
specific processes:
(1) A process involving the MPO, State and local air quality
planning agencies, State and local transportation agencies, EPA, and
DOT for the following:
(i) Evaluating and choosing a model (or models) and associated
methods and assumptions to be used in hot-spot analyses and regional
emissions analyses;
(ii) Determining which minor arterials and other transportation
projects should be considered ``regionally significant'' for the
purposes of regional emissions analysis (in addition to those
functionally classified as principal arterial or higher or fixed
guideway systems or extensions that offer an alternative to regional
highway travel), and which projects should be considered to have a
significant change in design concept and scope from the transportation
plan or TIP;
(iii) Evaluating whether projects otherwise exempted from meeting
the requirements of this subpart (see Secs. 93.126 and 93.127) should
be treated as non-exempt in cases where potential adverse emissions
impacts may exist for any reason;
(iv) Making a determination, as required by Sec. 93.113(c)(1),
whether past obstacles to implementation of TCMs which are behind the
schedule established in the applicable implementation plan have been
identified and are being overcome, and whether State and local agencies
with influence over approvals or funding for TCMs are giving maximum
priority to approval or funding for TCMs. This process shall also
consider whether delays in TCM implementation necessitate revisions to
the applicable implementation plan to remove TCMs or substitute TCMs or
other emission reduction measures;
(v) Identifying, as required by Sec. 93.123(d), projects located at
sites in PM10 nonattainment areas which have vehicle and roadway
emission and dispersion characteristics which are essentially identical
to those at sites which have violations verified by monitoring, and
therefore require quantitative PM10 hot-spot analysis; and
(vi) Notification of transportation plan or TIP revisions or
amendments which merely add or delete exempt projects listed in
Sec. 93.126.
(2) A process involving the MPO and State and local air quality
planning agencies and transportation agencies for the following:
(i) Evaluating events which will trigger new conformity
determinations in addition to those triggering events established in
Sec. 93.104; and
(ii) Consulting on emissions analysis for transportation activities
which cross the borders of MPOs or nonattainment areas or air basins.
(3) Where the metropolitan planning area does not include the
entire nonattainment or maintenance area, a process involving the MPO
and the State department of transportation for cooperative planning and
analysis for purposes of determining conformity of all projects outside
the metropolitan area and within the nonattainment or maintenance area.
(4) A process to ensure that plans for construction of regionally
significant projects which are not FHWA/FTA projects (including
projects for which alternative locations, design concept and scope, or
the no-build option are still being considered), including those by
recipients of funds designated under title 23 U.S.C. or the Federal
Transit Laws, are disclosed to the MPO on a regular basis, and to
ensure that any changes to those plans are immediately disclosed;
(5) A process involving the MPO and other recipients of funds
designated under title 23 U.S.C. or the Federal Transit Laws for
assuming the location and design concept and scope of projects which
are disclosed to the MPO as required by paragraph (c)(4) of this
section but whose sponsors have not yet decided these features, in
sufficient
[[Page 36139]]
detail to perform the regional emissions analysis according to the
requirements of Sec. 93.122.
(6) A process for consulting on the design, schedule, and funding
of research and data collection efforts and regional transportation
model development by the MPO (e.g., household/travel transportation
surveys).
(7) A process for providing final documents (including applicable
implementation plans and implementation plan revisions) and supporting
information to each agency after approval or adoption. This process is
applicable to all agencies described in paragraph (a)(1) of this
section, including Federal agencies.
(d) Resolving conflicts. Conflicts among State agencies or between
State agencies and an MPO shall be escalated to the Governor if they
cannot be resolved by the heads of the involved agencies. The State air
agency has 14 calendar days to appeal to the Governor after the State
DOT or MPO has notified the State air agency head of the resolution of
his or her comments. The implementation plan revision required by
Sec. 51.390 of this chapter shall define the procedures for starting
the 14-day clock. If the State air agency appeals to the Governor, the
final conformity determination must have the concurrence of the
Governor. If the State air agency does not appeal to the Governor
within 14 days, the MPO or State department of transportation may
proceed with the final conformity determination. The Governor may
delegate his or her role in this process, but not to the head or staff
of the State or local air agency, State department of transportation,
State transportation commission or board, or an MPO.
(e) Public consultation procedures. Affected agencies making
conformity determinations on transportation plans, programs, and
projects shall establish a proactive public involvement process which
provides opportunity for public review and comment by, at a minimum,
providing reasonable public access to technical and policy information
considered by the agency at the beginning of the public comment period
and prior to taking formal action on a conformity determination for all
transportation plans and TIPs, consistent with these requirements and
those of 23 CFR 450.316(b). Any charges imposed for public inspection
and copying should be consistent with the fee schedule contained in 49
CFR 7.95. In addition, these agencies must specifically address in
writing all public comments that known plans for a regionally
significant project which is not receiving FHWA or FTA funding or
approval have not been properly reflected in the emissions analysis
supporting a proposed conformity finding for a transportation plan or
TIP. These agencies shall also provide opportunity for public
involvement in conformity determinations for projects where otherwise
required by law.
Sec. 93.106 Content of transportation plans.
(a) Transportation plans adopted after January 1, 1997 in serious,
severe, or extreme ozone nonattainment areas and in serious CO
nonattainment areas. If the metropolitan planning area contains an
urbanized area population greater than 200,000, the transportation plan
must specifically describe the transportation system envisioned for
certain future years which shall be called horizon years.
(1) The agency or organization developing the transportation plan
may choose any years to be horizon years, subject to the following
restrictions:
(i) Horizon years may be no more than 10 years apart.
(ii) The first horizon year may be no more than 10 years from the
base year used to validate the transportation demand planning model.
(iii) If the attainment year is in the time span of the
transportation plan, the attainment year must be a horizon year.
(iv) The last horizon year must be the last year of the
transportation plan's forecast period.
(2) For these horizon years:
(i) The transportation plan shall quantify and document the
demographic and employment factors influencing expected transportation
demand, including land use forecasts, in accordance with implementation
plan provisions and the consultation requirements specified by
Sec. 93.105;
(ii) The highway and transit system shall be described in terms of
the regionally significant additions or modifications to the existing
transportation network which the transportation plan envisions to be
operational in the horizon years. Additions and modifications to the
highway network shall be sufficiently identified to indicate
intersections with existing regionally significant facilities, and to
determine their effect on route options between transportation analysis
zones. Each added or modified highway segment shall also be
sufficiently identified in terms of its design concept and design scope
to allow modeling of travel times under various traffic volumes,
consistent with the modeling methods for area-wide transportation
analysis in use by the MPO. Transit facilities, equipment, and services
envisioned for the future shall be identified in terms of design
concept, design scope, and operating policies that are sufficient for
modeling of their transit ridership. Additions and modifications to the
transportation network shall be described sufficiently to show that
there is a reasonable relationship between expected land use and the
envisioned transportation system; and
(iii) Other future transportation policies, requirements, services,
and activities, including intermodal activities, shall be described.
(b) Moderate areas reclassified to serious Ozone or CO
nonattainment areas which are reclassified from moderate to serious
must meet the requirements of paragraph (a) of this section within two
years from the date of reclassification.
(c) Transportation plans for other areas Transportation plans for
other areas must meet the requirements of paragraph (a) of this section
at least to the extent it has been the previous practice of the MPO to
prepare plans which meet those requirements. Otherwise, the
transportation system envisioned for the future must be sufficiently
described within the transportation plans so that a conformity
determination can be made according to the criteria and procedures of
Secs. 93.109--93.119.
(d) Savings The requirements of this section supplement other
requirements of applicable law or regulation governing the format or
content of transportation plans.
Sec. 93.107 Relationship of transportation plan and TIP conformity
with the NEPA process.
The degree of specificity required in the transportation plan and
the specific travel network assumed for air quality modeling do not
preclude the consideration of alternatives in the NEPA process or other
project development studies. Should the NEPA process result in a
project with design concept and scope significantly different from that
in the transportation plan or TIP, the project must meet the criteria
in Secs. 93.109--93.119 for projects not from a TIP before NEPA process
completion.
Sec. 93.108 Fiscal constraints for transportation plans and TIPs.
Transportation plans and TIPs must be fiscally constrained
consistent with DOT's metropolitan planning regulations at 23 CFR part
450 in order to be found in conformity.
[[Page 36140]]
Sec. 93.109 Criteria and procedures for determining conformity of
transportation plans, programs, and projects: General.
(a) In order for each transportation plan, program, and FHWA/FTA
project to be found to conform, the MPO and DOT must demonstrate that
the applicable criteria and procedures in this subpart are satisfied,
and the MPO and DOT must comply with all applicable conformity
requirements of implementation plans and of court orders for the area
which pertain specifically to conformity. The criteria for making
conformity determinations differ based on the action under review
(transportation plans, TIPs, and FHWA/FTA projects), the relevant
pollutant(s), and the status of the implementation plan.
(b) The following table indicates the criteria and procedures in
Secs. 93.110-93.119 which apply for transportation plans, TIPs, and
FHWA/FTA projects. Paragraphs (c) through (f) of this section explain
when the budget, emission reduction, and hot spot tests are required
for each pollutant. Paragraph (g) of this section addresses isolated
rural nonattainment and maintenance areas.
Table 1.--Conformity Criteria
All Actions at All Times
------------------------------------------------------------------------
Sec. 93.110....... Latest planning
assumptions.
Sec. 93.111....... Latest emissions model.
Sec. 93.112....... Consultation.
------------------------------------------------------------------------
Transportation Plan
------------------------------------------------------------------------
Sec. 93.113(b).... TCMs.
Sec. 93.118 OR Emissions budget OR
Sec. 93.119. Emission reduction.
------------------------------------------------------------------------
TIP
------------------------------------------------------------------------
Sec. 93.113(c).... TCMs.
Sec. 93.118 OR Emissions budget OR
Sec. 93.119. Emission reduction.
------------------------------------------------------------------------
Project (From a Conforming Plan and TIP)
------------------------------------------------------------------------
Sec. 93.114....... Currently conforming plan
and TIP.
Sec. 93.115....... Project from a conforming
plan and TIP.
Sec. 93.116....... CO and PM10 hot spots.
Sec. 93.117....... PM10 control measures.
------------------------------------------------------------------------
Project (Not From a Conforming Plan and TIP)
------------------------------------------------------------------------
Sec. 93.113(d).... TCMs.
Sec. 93.114....... Currently conforming plan
and TIP.
Sec. 93.116....... CO and PM10 hot spots.
Sec. 93.117....... PM10 control measures.
Sec. 93.118 OR Emissions budget OR
Sec. 93.119. Emission reduction.
(c) Ozone nonattainment and maintenance areas. In addition to the
criteria listed in Table 1 that are required to be satisfied at all
times, in ozone nonattainment and maintenance areas conformity
determinations must include a demonstration that the budget and/or
emission reduction tests are satisfied as described in the following
paragraphs.
(1) In ozone areas the budget test must be satisfied as required by
Sec. 93.118 for conformity determinations made:
(i) 45 days after a control strategy implementation plan revision
or maintenance plan has been submitted to EPA, unless EPA has declared
the motor vehicle emissions budget inadequate for transportation
conformity purposes; or
(ii) After EPA has declared that the motor vehicle emissions budget
in a submitted control strategy implementation plan revision or
maintenance plan is adequate for transportation conformity purposes.
(2) In moderate and above ozone nonattainment areas the emission
reduction tests must be satisfied as required by Sec. 93.119 for
conformity determinations made:
(i) During the first 45 days after a control strategy
implementation plan revision or maintenance plan has been submitted to
EPA, unless EPA has declared a motor vehicle emissions budget adequate
for transportation conformity purposes; or
(ii) If EPA has declared the motor vehicle emissions budget in a
submitted control strategy implementation plan revision or maintenance
plan inadequate for transportation conformity purposes, and there is no
previously established motor vehicle emissions budget in the approved
SIP or a previously submitted control strategy implementation plan
revision or maintenance plan.
(3) An ozone nonattainment area must satisfy the emission reduction
test for NOX, as required by Sec. 93.119, if the implementation
plan or plan submission that is applicable for the purposes of
conformity determinations is a 15% SIP or Phase I attainment
demonstration that does not include a motor vehicle emissions budget
for NOX. The implementation plan will be considered to establish a
motor vehicle emissions budget for NOX if the implementation plan
or plan submission contains an explicit NOX motor vehicle
emissions budget that is intended to act as a ceiling on future
NOX emissions, and the NOX motor vehicle emissions budget is
a net reduction from NOX emissions levels in 1990.
(4) Marginal and below ozone nonattainment areas that have three
consecutive years of clean data and that have not submitted a
maintenance plan must satisfy one of the following requirements:
(i) The emission reduction tests as required by Sec. 93.119;
(ii) The State air quality agency shall determine (subject to the
interagency consultation process required by Sec. 93.105) the motor
vehicle emissions of ozone precursors in the most recent year of clean
data. The budget test required by Sec. 93.118 must be satisfied, with
these motor vehicle emission levels serving as the motor vehicle
emissions budget; or
(iii) The State shall submit to EPA an implementation plan revision
that contains motor vehicle emissions budget(s) and an attainment or
maintenance demonstration, and the budget test required by Sec. 93.118
must be satisfied using the submitted motor vehicle emissions budget(s)
(as described in paragraph (c)(1) of this section).
(5) Marginal and below ozone nonattainment areas that do not have
three consecutive years of clean data must satisfy one of the following
requirements:
(i) The emission reduction tests required by Sec. 93.119; or
(ii) The State shall submit to EPA an implementation plan revision
that contains motor vehicle emissions budget(s) and an attainment
demonstration, and the budget test required by Sec. 93.118 must be
satisfied using the submitted motor vehicle emissions budget(s) (as
described in paragraph (c)(1) of this section).
(6) Notwithstanding paragraphs (c)(1) and (c)(2) of this section,
moderate and above ozone nonattainment areas with three years of clean
data that have not submitted a maintenance plan and that EPA has
determined are not subject to the Clean Air Act reasonable further
progress and attainment demonstration requirements must satisfy one of
the following requirements:
(i) The emission reduction tests as required by Sec. 93.119;
(ii) The budget test as required by Sec. 93.118, using the motor
vehicle emissions budgets in the submitted control strategy
implementation plan (subject to the timing requirements of paragraph
(c)(1) of this section); or
(iii) The State air quality agency shall determine (subject to the
interagency consultation process required by
[[Page 36141]]
Sec. 93.105) the motor vehicle emissions of ozone precursors in the
most recent year of clean data. The budget test required by Sec. 93.118
must be satisfied, with these motor vehicle emission levels serving as
the motor vehicle emissions budget.
(d) CO nonattainment and maintenance areas. In addition to the
criteria listed in Table 1 that are required to be satisfied at all
times, in CO nonattainment and maintenance areas conformity
determinations must include a demonstration that the hot spot, budget
and/or emission reduction tests are satisfied as described in the
following paragraphs.
(1) FHWA/FTA projects in CO nonattainment or maintenance areas must
satisfy the hot spot test required by Sec. 93.116 at all times. Until a
CO attainment demonstration or maintenance plan is approved by EPA,
FHWA/FTA projects must also satisfy the hot spot test required by
Sec. 93.116(b).
(2) In CO areas the budget test must be satisfied as required by
Sec. 93.118 for conformity determinations made:
(i) 45 days after a control strategy implementation plan revision
or maintenance plan has been submitted to EPA, unless EPA has declared
the motor vehicle emissions budget inadequate for transportation
conformity purposes; or
(ii) After EPA has declared that the motor vehicle emissions budget
in a submitted control strategy implementation plan revision or
maintenance plan is adequate for transportation conformity purposes.
(3) In moderate CO nonattainment areas with a design value greater
than 12.7 ppm and serious CO nonattainment areas the emission reduction
tests must be satisfied as required by Sec. 93.119 for conformity
determinations made:
(i) During the first 45 days after a control strategy
implementation plan revision or maintenance plan has been submitted to
EPA, unless EPA has declared a motor vehicle emissions budget adequate
for transportation conformity purposes; or
(ii) If EPA has declared the motor vehicle emissions budget in a
submitted control strategy implementation plan revision or maintenance
plan inadequate for transportation conformity purposes, and there is no
previously established motor vehicle emissions budget in the approved
SIP or a previously submitted control strategy implementation plan
revision or maintenance plan.
(4) If a moderate CO nonattainment area with a design value of 12.7
ppm or less or a not classified CO nonattainment area has two
consecutive years of clean data and has not submitted a maintenance
plan, one of the following requirements must be satisfied:
(i) The emission reduction tests as required by Sec. 93.119;
(ii) The State air quality agency shall determine (subject to the
interagency consultation process required by Sec. 93.105) the motor
vehicle emissions of CO in the most recent year of clean data. The
budget test required by Sec. 93.118 must be satisfied, with these motor
vehicle emission levels serving as the motor vehicle emissions budget;
or
(iii) The State shall submit to EPA an implementation plan revision
that contains motor vehicle emissions budget(s) and an attainment or
maintenance demonstration, and the budget test required by Sec. 93.118
must be satisfied using the submitted motor vehicle emissions budget(s)
(as described in paragraph (d)(1) of this section).
(5) If a moderate CO nonattainment area with a design value of 12.7
ppm or less or a not classified CO nonattainment area does not have two
consecutive years of clean data, one of the following requirements must
be satisfied:
(i) The emission reduction tests required by Sec. 93.119; or
(ii) The State shall submit to EPA an implementation plan revision
that contains motor vehicle emissions budget(s) and an attainment
demonstration, and the budget test required by Sec. 93.118 must be
satisfied using the submitted motor vehicle emissions budget(s) (as
described in paragraph (d)(1) of this section).
(e) PM10 nonattainment and maintenance areas. In addition to
the criteria listed in Table 1 that are required to be satisfied at all
times, in PM10 nonattainment and maintenance areas conformity
determinations must include a demonstration that the hot spot, budget
and/or emission reduction tests are satisfied as described in the
following paragraphs.
(1) FHWA/FTA projects in PM10 nonattainment or maintenance
areas must satisfy the hot spot test required by Sec. 93.116.
(2) In PM10 areas the budget test must be satisfied as
required by Sec. 93.118 for conformity determinations made:
(i) 45 days after a control strategy implementation plan revision
or maintenance plan has been submitted to EPA, unless EPA has declared
the motor vehicle emissions budget inadequate for transportation
conformity purposes; or
(ii) After EPA has declared that the motor vehicle emissions budget
in a submitted control strategy implementation plan revision or
maintenance plan is adequate for transportation conformity purposes.
(3) In PM10 nonattainment areas the emission reduction tests
must be satisfied as required by Sec. 93.119 for conformity
determinations made:
(i) During the first 45 days after a control strategy
implementation plan revision or maintenance plan has been submitted to
EPA, unless EPA has declared a motor vehicle emissions budget adequate
for transportation conformity purposes;
(ii) If EPA has declared the motor vehicle emissions budget in a
submitted control strategy implementation plan revision or maintenance
plan inadequate for transportation conformity purposes, and there is no
previously established motor vehicle emissions budget in the approved
SIP or a previously submitted control strategy implementation plan
revision or maintenance plan; or
(iii) The submitted implementation plan revision is a demonstration
of impracticability under CAA section 189(a)(1)(B)(ii) and does not
demonstrate attainment.
(f) NO2 nonattainment and maintenance areas. In addition to
the criteria listed in Table 1 that are required to be satisfied at all
times, in NO2 nonattainment and maintenance areas conformity
determinations must include a demonstration that the budget and/or
emission reduction tests are satisfied as described in the following
paragraphs.
(1) In NO2 areas the budget test must be satisfied as required
by Sec. 93.118 for conformity determinations made:
(i) 45 days after a control strategy implementation plan revision
or maintenance plan has been submitted to EPA, unless EPA has declared
the motor vehicle emissions budget inadequate for transportation
conformity purposes; or
(ii) After EPA has declared that the motor vehicle emissions budget
in a submitted control strategy implementation plan revision or
maintenance plan is adequate for transportation conformity purposes.
(2) In NO2 areas the emission reduction tests must be
satisfied as required by Sec. 93.119 for conformity determinations
made:
(i) During the first 45 days after a control strategy
implementation plan revision or maintenance plan has been submitted to
EPA, unless EPA has declared a motor vehicle emissions budget adequate
for transportation conformity purposes; or
(ii) If EPA has declared the motor vehicle emissions budget in a
submitted control strategy implementation plan revision or maintenance
plan
[[Page 36142]]
inadequate for transportation conformity purposes, and there is no
previously established motor vehicle emissions budget in the approved
SIP or a previously submitted control strategy implementation plan
revision or maintenance plan.
(g) Isolated rural nonattainment and maintenance areas. This
paragraph applies to any nonattainment or maintenance area (or portion
thereof) which does not have a metropolitan transportation plan or TIP
and whose projects are not part of the emissions analysis of any MPO's
metropolitan transportation plan or TIP. This paragraph does not apply
to
FR Doc. 96-16581 Transportation Conformity Rule Amendments: Flexibility and Streamlining
``donut'' areas which are outside the metropolitan planning boundary
and inside the nonattainment/maintenance area boundary.
(1) FHWA/FTA projects in all isolated rural nonattainment and
maintenance areas must satisfy the requirements of Secs. 93.110,
93.111, 93.112, 93.113(d), 93.116, and 93.117. Until EPA approves the
control strategy implementation plan or maintenance plan for a rural CO
nonattainment or maintenance area, FHWA/FTA projects must also satisfy
the requirements of Sec. 93.116(b) (``Localized CO and PM10
violations (hot spots)'').
(2) Isolated rural nonattainment and maintenance areas are subject
to the budget and/or emission reduction tests as described in
paragraphs (c)-(f) of this section, with the following modifications:
(i) When the requirements of Secs. 93.118 and 93.119 apply to
isolated rural nonattainment and maintenance areas, references to
``transportation plan'' or ``TIP'' should be taken to mean those
projects in the statewide transportation plan or statewide TIP which
are in the rural nonattainment or maintenance area.
(ii) In isolated rural nonattainment and maintenance areas that are
subject to Sec. 93.118, FHWA/FTA projects must be consistent with motor
vehicle emissions budget(s) for the years in the timeframe of the
attainment demonstration or maintenance plan. For years after the
attainment year (if a maintenance plan has not been submitted) or after
the last year of the maintenance plan, FHWA/FTA projects must satisfy
one of the following requirements:
(A) Sec. 93.118;
(B) Sec. 93.119 (Emission reductions in areas without motor vehicle
emissions budgets); or
(C) Air quality dispersion modeling must demonstrate that the FHWA/
FTA project, in combination with all other regionally significant
projects expected in the area in the timeframe of the statewide
transportation plan, will not cause or contribute to any new violation
of any standard in any areas; increase the frequency or severity of any
existing violation of any standard in any area; or delay timely
attainment of any standard or any required interim emission reductions
or other milestones in any area. Control measures assumed in the
analysis must be enforceable.
(iii) The choice of requirements in paragraph (g)(2)(ii) of this
section and the methodology used to meet the requirements of paragraph
(g)(2)(ii)(C) of this section must be determined through the
interagency consultation process required in Sec. 93.105 through which
the relevant recipients of title 23 U.S.C. or Federal Transit Laws
funds, the local air quality agency, the State air quality agency, and
the State DOT should reach consensus about the option and methodology
selected. EPA and DOT must be consulted through this process as well.
In the event of unresolved disputes, conflicts may be escalated to the
Governor consistent with the procedure in Sec. 93.105(d), which applies
for any State air agency comments on a conformity determination.
Sec. 93.110 Criteria and procedures: Latest planning assumptions.
(a) The conformity determination, with respect to all other
applicable criteria in Secs. 93.111-93.119, must be based upon the most
recent planning assumptions in force at the time of the conformity
determination. The conformity determination must satisfy the
requirements of paragraphs (b) through (f) of this section.
(b) Assumptions must be derived from the estimates of current and
future population, employment, travel, and congestion most recently
developed by the MPO or other agency authorized to make such estimates
and approved by the MPO. The conformity determination must also be
based on the latest assumptions about current and future background
concentrations.
(c) The conformity determination for each transportation plan and
TIP must discuss how transit operating policies (including fares and
service levels) and assumed transit ridership have changed since the
previous conformity determination.
(d) The conformity determination must include reasonable
assumptions about transit service and increases in transit fares and
road and bridge tolls over time.
(e) The conformity determination must use the latest existing
information regarding the effectiveness of the TCMs and other
implementation plan measures which have already been implemented.
(f) Key assumptions shall be specified and included in the draft
documents and supporting materials used for the interagency and public
consultation required by Sec. 93.105.
Sec. 93.111 Criteria and procedures: Latest emissions model.
(a) The conformity determination must be based on the latest
emission estimation model available. This criterion is satisfied if the
most current version of the motor vehicle emissions model specified by
EPA for use in the preparation or revision of implementation plans in
that State or area is used for the conformity analysis. Where EMFAC is
the motor vehicle emissions model used in preparing or revising the
applicable implementation plan, new versions must be approved by EPA
before they are used in the conformity analysis.
(b) EPA will consult with DOT to establish a grace period following
the specification of any new model.
(1) The grace period will be no less than three months and no more
than 24 months after notice of availability is published in the Federal
Register.
(2) The length of the grace period will depend on the degree of
change in the model and the scope of re-planning likely to be necessary
by MPOs in order to assure conformity. If the grace period will be
longer than three months, EPA will announce the appropriate grace
period in the Federal Register.
(c) Transportation plan and TIP conformity analyses for which the
emissions analysis was begun during the grace period or before the
Federal Register notice of availability of the latest emission model
may continue to use the previous version of the model. Conformity
determinations for projects may also be based on the previous model if
the analysis was begun during the grace period or before the Federal
Register notice of availability, and if the final environmental
document for the project is issued no more than three years after the
issuance of the draft environmental document.
Sec. 93.112 Criteria and procedures: Consultation.
Conformity must be determined according to the consultation
procedures in this rule and in the applicable implementation plan, and
according to the public involvement procedures established in
compliance with 23 CFR part 450. Until the implementation plan revision
required by Sec. 51.390 of this chapter is fully approved by EPA, the
conformity
[[Page 36143]]
determination must be made according to Sec. 93.105(a)(2) and
Sec. 93.105(e) and the requirements of 23 CFR part 450.
Sec. 93.113 Criteria and procedures: Timely implementation of TCMs.
(a) The transportation plan, TIP, or any FHWA/FTA project which is
not from a conforming plan and TIP must provide for the timely
implementation of TCMs from the applicable implementation plan.
(b) For transportation plans, this criterion is satisfied if the
following two conditions are met:
(1) The transportation plan, in describing the envisioned future
transportation system, provides for the timely completion or
implementation of all TCMs in the applicable implementation plan which
are eligible for funding under title 23 U.S.C. or the Federal Transit
Laws, consistent with schedules included in the applicable
implementation plan.
(2) Nothing in the transportation plan interferes with the
implementation of any TCM in the applicable implementation plan.
(c) For TIPs, this criterion is satisfied if the following
conditions are met:
(1) An examination of the specific steps and funding source(s)
needed to fully implement each TCM indicates that TCMs which are
eligible for funding under title 23 U.S.C. or the Federal Transit Laws
are on or ahead of the schedule established in the applicable
implementation plan, or, if such TCMs are behind the schedule
established in the applicable implementation plan, the MPO and DOT have
determined that past obstacles to implementation of the TCMs have been
identified and have been or are being overcome, and that all State and
local agencies with influence over approvals or funding for TCMs are
giving maximum priority to approval or funding of TCMs over other
projects within their control, including projects in locations outside
the nonattainment or maintenance area.
(2) If TCMs in the applicable implementation plan have previously
been programmed for Federal funding but the funds have not been
obligated and the TCMs are behind the schedule in the implementation
plan, then the TIP cannot be found to conform if the funds intended for
those TCMs are reallocated to projects in the TIP other than TCMs, or
if there are no other TCMs in the TIP, if the funds are reallocated to
projects in the TIP other than projects which are eligible for Federal
funding intended for air quality improvement projects, e.g., the
Congestion Mitigation and Air Quality Improvement Program.
(3) Nothing in the TIP may interfere with the implementation of any
TCM in the applicable implementation plan.
(d) For FHWA/FTA projects which are not from a conforming
transportation plan and TIP, this criterion is satisfied if the project
does not interfere with the implementation of any TCM in the applicable
implementation plan.
Sec. 93.114 Criteria and procedures: Currently conforming
transportation plan and TIP.
There must be a currently conforming transportation plan and
currently conforming TIP at the time of project approval.
(a) Only one conforming transportation plan or TIP may exist in an
area at any time; conformity determinations of a previous
transportation plan or TIP expire once the current plan or TIP is found
to conform by DOT. The conformity determination on a transportation
plan or TIP will also lapse if conformity is not determined according
to the frequency requirements specified in Sec. 93.104.
(b) This criterion is not required to be satisfied at the time of
project approval for a TCM specifically included in the applicable
implementation plan, provided that all other relevant criteria of this
subpart are satisfied.
Sec. 93.115 Criteria and procedures: Projects from a plan and TIP.
(a) The project must come from a conforming plan and program. If
this criterion is not satisfied, the project must satisfy all criteria
in Table 1 for a project not from a conforming transportation plan and
TIP. A project is considered to be from a conforming transportation
plan if it meets the requirements of paragraph (b) of this section and
from a conforming program if it meets the requirements of paragraph (c)
of this section. Special provisions for TCMs in an applicable
implementation plan are provided in paragraph (d) of this section.
(b) A project is considered to be from a conforming transportation
plan if one of the following conditions applies:
(1) For projects which are required to be identified in the
transportation plan in order to satisfy Sec. 93.106 (``Content of
transportation plans''), the project is specifically included in the
conforming transportation plan and the project's design concept and
scope have not changed significantly from those which were described in
the transportation plan, or in a manner which would significantly
impact use of the facility; or
(2) For projects which are not required to be specifically
identified in the transportation plan, the project is identified in the
conforming transportation plan, or is consistent with the policies and
purpose of the transportation plan and will not interfere with other
projects specifically included in the transportation plan.
(c) A project is considered to be from a conforming program if the
following conditions are met:
(1) The project is included in the conforming TIP and the design
concept and scope of the project were adequate at the time of the TIP
conformity determination to determine its contribution to the TIP's
regional emissions, and the project design concept and scope have not
changed significantly from those which were described in the TIP; and
(2) If the TIP describes a project design concept and scope which
includes project-level emissions mitigation or control measures,
written commitments to implement such measures must be obtained from
the project sponsor and/or operator as required by Sec. 93.125(a) in
order for the project to be considered from a conforming program. Any
change in these mitigation or control measures that would significantly
reduce their effectiveness constitutes a change in the design concept
and scope of the project.
(d) TCMs. This criterion is not required to be satisfied for TCMs
specifically included in an applicable implementation plan.
Sec. 93.116 Criteria and procedures: Localized CO and PM10
violations (hot spots).
(a) This paragraph applies at all times. The FHWA/FTA project must
not cause or contribute to any new localized CO or PM10 violations
or increase the frequency or severity of any existing CO or PM10
violations in CO and PM10 nonattainment and maintenance areas.
This criterion is satisfied if it is demonstrated that no new local
violations will be created and the severity or number of existing
violations will not be increased as a result of the project. The
demonstration must be performed according to the consultation
requirements of Sec. 93.105(c)(1)(i) and the methodology requirements
of Sec. 93.123.
(b) This paragraph applies for CO nonattainment areas as described
in Sec. 93.109(d)(1). Each FHWA/FTA project must eliminate or reduce
the severity and number of localized CO violations in the area
substantially affected by the project (in CO nonattainment areas).
[[Page 36144]]
This criterion is satisfied with respect to existing localized CO
violations if it is demonstrated that existing localized CO violations
will be eliminated or reduced in severity and number as a result of the
project. The demonstration must be performed according to the
consultation requirements of Sec. 93.105(c)(1)(i) and the methodology
requirements of Sec. 93.123.
Sec. 93.117 Criteria and procedures: Compliance with PM10 control
measures.
The FHWA/FTA project must comply with PM10 control measures in
the applicable implementation plan. This criterion is satisfied if the
project-level conformity determination contains a written commitment
from the project sponsor to include in the final plans, specifications,
and estimates for the project those control measures (for the purpose
of limiting PM10 emissions from the construction activities and/or
normal use and operation associated with the project) that are
contained in the applicable implementation plan.
Sec. 93.118 Criteria and procedures: Motor vehicle emissions budget.
(a) The transportation plan, TIP, and project not from a conforming
transportation plan and TIP must be consistent with the motor vehicle
emissions budget(s) in the applicable implementation plan (or
implementation plan submission). This criterion applies as described in
Sec. 93.109 (c)-(g). This criterion is satisfied if it is demonstrated
that emissions of the pollutants or pollutant precursors described in
paragraph (c) of this section are less than or equal to the motor
vehicle emissions budget(s) established in the applicable
implementation plan or implementation plan submission.
(b) Consistency with the motor vehicle emissions budget(s) must be
demonstrated for each year for which the applicable (and/or submitted)
implementation plan specifically establishes motor vehicle emissions
budget(s), for the last year of the transportation plan's forecast
period, and for any intermediate years as necessary so that the years
for which consistency is demonstrated are no more than ten years apart,
as follows:
(1) Until a maintenance plan is submitted:
(i) Emissions in each year (such as milestone years and the
attainment year) for which the control strategy implementation plan
revision establishes motor vehicle emissions budget(s) must be less
than or equal to that year's motor vehicle emissions budget(s); and
(ii) Emissions in years for which no motor vehicle emissions
budget(s) are specifically established must be less than or equal to
the motor vehicle emissions budget(s) established for the most recent
prior year. For example, emissions in years after the attainment year
for which the SIP does not establish a budget must be less than or
equal to the motor vehicle emissions budget(s) for the attainment year.
(2) When a maintenance plan has been submitted:
(i) Emissions must be less than or equal to the motor vehicle
emissions budget(s) established for the last year of the maintenance
plan, and for any other years for which the maintenance plan
establishes motor vehicle emissions budgets. If the maintenance plan
does not establish motor vehicle emissions budgets for any years other
than the last year of the maintenance plan, the demonstration of
consistency with the motor vehicle emissions budget(s) must be
accompanied by a qualitative finding that there are no factors which
would cause or contribute to a new violation or exacerbate an existing
violation in the years before the last year of the maintenance plan.
The interagency consultation process required by Sec. 93.105 shall
determine what must be considered in order to make such a finding;
(ii) For years after the last year of the maintenance plan,
emissions must be less than or equal to the maintenance plan's motor
vehicle emissions budget(s) for the last year of the maintenance plan;
and
(iii) If an approved control strategy implementation plan has
established motor vehicle emissions budgets for years in the timeframe
of the transportation plan, emissions in these years must be less than
or equal to the control strategy implementation plan's motor vehicle
emissions budget(s) for these years.
(c) Consistency with the motor vehicle emissions budget(s) must be
demonstrated for each pollutant or pollutant precursor in
Sec. 93.102(b)(3) for which the area is in nonattainment or maintenance
and for which the applicable implementation plan (or implementation
plan submission) establishes a motor vehicle emissions budget.
(d) Consistency with the motor vehicle emissions budget(s) must be
demonstrated by including emissions from the entire transportation
system, including all regionally significant projects contained in the
transportation plan and all other regionally significant highway and
transit projects expected in the nonattainment or maintenance area in
the timeframe of the transportation plan.
(1) Consistency with the motor vehicle emissions budget(s) must be
demonstrated with a regional emissions analysis that meets the
requirements of Secs. 93.122 and 93.105(c)(1)(i).
(2) The regional emissions analysis may be performed for any years
in the timeframe of the transportation plan provided they are not more
than ten years apart and provided the analysis is performed for the
attainment year (if it is in the timeframe of the transportation plan)
and the last year of the plan's forecast period. Emissions in years for
which consistency with motor vehicle emissions budgets must be
demonstrated, as required in paragraph (b) of this section, may be
determined by interpolating between the years for which the regional
emissions analysis is performed.
(e) Motor vehicle emissions budgets in submitted control strategy
implementation plan revisions and submitted maintenance plans.
(1) Consistency with the motor vehicle emissions budgets in
submitted control strategy implementation plan revisions or maintenance
plans must be demonstrated if EPA has declared the motor vehicle
emissions budget(s) adequate for transportation conformity purposes, or
beginning 45 days after the control strategy implementation plan
revision or maintenance plan has been submitted (unless EPA has
declared the motor vehicle emissions budget(s) inadequate for
transportation conformity purposes). However, submitted implementation
plans do not supersede the motor vehicle emissions budgets in approved
implementation plans for the years addressed by the approved
implementation plan.
(2) If EPA has declared an implementation plan submission's motor
vehicle emissions budget(s) inadequate for transportation conformity
purposes, the inadequate budget(s) shall not be used to satisfy the
requirements of this section. Consistency with the previously
established motor vehicle emissions budget(s) must be demonstrated. If
there are no previous approved implementation plans or implementation
plan submissions with motor vehicle emissions budgets, the emission
reduction tests required by Sec. 93.119 must be satisfied.
(3) If EPA declares an implementation plan submission's motor
vehicle emissions budget(s) inadequate for transportation conformity
purposes more than 45 days after its submission to EPA, and conformity
of a transportation plan or TIP has already
[[Page 36145]]
been determined by DOT using the budget(s), the conformity
determination will remain valid. Projects included in that
transportation plan or TIP could still satisfy Secs. 93.114 and 93.115,
which require a currently conforming transportation plan and TIP to be
in place at the time of a project's conformity determination and that
projects come from a conforming transportation plan and TIP.
(4) When the motor vehicle emissions budget(s) used to satisfy the
requirements of this section are established by an implementation plan
submittal that has not yet been approved or disapproved by EPA, the MPO
and DOT's conformity determination will be deemed to be a statement
that the MPO and DOT are not aware of any information that would
indicate that emissions consistent with the motor vehicle emissions
budget will cause or contribute to any new violation of any standard;
increase the frequency or severity of any existing violation of any
standard; or delay timely attainment of any standard or any required
interim emission reductions or other milestones.
Sec. 93.119 Criteria and procedures: Emission reductions in areas
without motor vehicle emissions budgets.
(a) The transportation plan, TIP, and project not from a conforming
transportation plan and TIP must contribute to emissions reductions.
This criterion applies as described in Sec. 93.109 (c)-(g). It applies
to the net effect of the action (transportation plan, TIP, or project
not from a conforming transportation plan and TIP) on motor vehicle
emissions from the entire transportation system.
(b) This criterion may be met in moderate and above ozone
nonattainment areas that are subject to the reasonable further progress
requirements of Clean Air Act section 182(b)(1) and in moderate with
design value greater than 12.7 ppm and serious CO nonattainment areas
if a regional emissions analysis that satisfies the requirements of
Sec. 93.12 2 and paragraphs (e) through (h) of this section
demonstrates that for each analysis year and for each of the pollutants
described in paragraph (d) of this section:
(1) The emissions predicted in the ``Action'' scenario are less
than the emissions predicted in the ``Baseline'' scenario, and this can
be reasonably expected to be true in the periods between the analysis
years; and
(2) The emissions predicted in the ``Action'' scenario are lower
than 1990 emissions by any nonzero amount.
(c) This criterion may be met in PM10 and NO2
nonattainment areas; marginal and below ozone nonattainment areas and
other ozone nonattainment areas that are not subject to the reasonable
further progress requirements of Clean Air Act section 182(b)(1), and
moderate with design value less than 12.7 ppm and below CO
nonattainment areas if a regional emissions analysis that satisfies the
requirements of Sec. 93.122 and paragraphs (e) through (h) of this
section demonstrates that for each analysis year and for each of the
pollutants described in paragraph (d) of this section, one of the
following requirements is met:
(1) The emissions predicted in the ``Action'' scenario are less
than the emissions predicted in the ``Baseline'' scenario, and this can
be reasonably expected to be true in the periods between the analysis
years; or
(2) The emissions predicted in the ``Action'' scenario are not
greater than baseline emissions. Baseline emissions are those estimated
to have occurred during calendar year 1990, unless the conformity
implementation plan revision required by Sec. 51.390 of this chapter
defines the baseline emissions for a PM10 area to be those
occurring in a different calendar year for which a baseline emissions
inventory was developed for the purpose of developing a control
strategy implementation plan.
(d) Pollutants. The regional emissions analysis must be performed
for the following pollutants:
(1) VOC in ozone nonattainment areas;
(2) NOX in ozone nonattainment areas, unless the EPA
Administrator determines that additional reductions of NOX would
not contribute to attainment;
(3) CO in CO nonattainment areas;
(4) PM10 in PM10 areas;
(5) Transportation-related precursors of PM10 in PM10
nonattainment areas if the EPA Regional Administrator or the director
of the State air agency has made a finding that such precursor
emissions from within the nonattainment area are a significant
contributor to the PM10 nonattainment problem and has so notified
the MPO and DOT; and
(6) NOX in NO2 nonattainment areas.
(e) Analysis years. The regional emissions analysis must be
performed for analysis years that are no more than ten years apart. The
first analysis year must be no more than five years beyond the year in
which the conformity determination is being made. The last year of
transportation plan's forecast period must also be an analysis year.
(f) ``Baseline'' scenario. The regional emissions analysis required
by paragraphs (b) and (c)(1) of this section must estimate the
emissions that would result from the ``Baseline'' scenario in each
analysis year. The ``Baseline'' scenario must be defined for each of
the analysis years. The ``Baseline'' scenario is the future
transportation system that will result from current programs, including
the following (except that exempt projects listed in Sec. 93.126 and
projects exempt from regional emissions analysis as listed in
Sec. 93.127 need not be explicitly considered):
(1) All in-place regionally significant highway and transit
facilities, services and activities;
(2) All ongoing travel demand management or transportation system
management activities; and
(3) Completion of all regionally significant projects, regardless
of funding source, which are currently under construction or are
undergoing right-of-way acquisition (except for hardship acquisition
and protective buying); come from the first year of the previously
conforming transportation plan and/or TIP; or have completed the NEPA
process.
(g) ``Action'' scenario. The regional emissions analysis must
estimate the emissions that would result from the ``Action'' scenario
in each analysis year. The ``Action'' scenario must be defined for each
of the analysis years. The ``Action'' scenario is the transportation
system that would result from the implementation of the proposed action
(transportation plan, TIP, or project not from a conforming
transportation plan and TIP) and all other expected regionally
significant projects in the nonattainment area. The ``Action'' scenario
must include the following (except that exempt projects listed in
Sec. 93.126 and projects exempt from regional emissions analysis as
listed in Sec. 93.127 need not be explicitly considered):
(1) All facilities, services, and activities in the ``Baseline''
scenario;
(2) Completion of all TCMs and regionally significant projects
(including facilities, services, and activities) specifically
identified in the proposed transportation plan which will be
operational or in effect in the analysis year, except that regulatory
TCMs may not be assumed to begin at a future time unless the regulation
is already adopted by the enforcing jurisdiction or the TCM is
identified in the applicable implementation plan;
(3) All travel demand management programs and transportation system
management activities known to the MPO, but not included in the
applicable implementation plan or utilizing any Federal funding or
approval, which have been fully adopted and/or funded by the enforcing
jurisdiction or
[[Page 36146]]
sponsoring agency since the last conformity determination;
(4) The incremental effects of any travel demand management
programs and transportation system management activities known to the
MPO, but not included in the applicable implementation plan or
utilizing any Federal funding or approval, which were adopted and/or
funded prior to the date of the last conformity determination, but
which have been modified since then to be more stringent or effective;
(5) Completion of all expected regionally significant highway and
transit projects which are not from a conforming transportation plan
and TIP; and
(6) Completion of all expected regionally significant non-FHWA/FTA
highway and transit projects that have clear funding sources and
commitments leading toward their implementation and completion by the
analysis year.
(h) Projects not from a conforming transportation plan and TIP. For
the regional emissions analysis required by paragraphs (b) and (c)(1)
of this section, if the project which is not from a conforming
transportation plan and TIP is a modification of a project currently in
the plan or TIP, the ``Baseline'' scenario must include the project
with its original design concept and scope, and the ``Action'' scenario
must include the project with its new design concept and scope.
Sec. 93.120 Consequences of control strategy implementation plan
failures.
(a) Disapprovals. (1) If EPA disapproves any submitted control
strategy implementation plan revision (with or without a protective
finding), the conformity status of the transportation plan and TIP
shall lapse on the date that highway sanctions as a result of the
disapproval are imposed on the nonattainment area under section
179(b)(1) of the Clean Air Act. No new transportation plan, TIP, or
project may be found to conform until another control strategy
implementation plan revision fulfilling the same Clean Air Act
requirements is submitted and conformity to this submission is
determined.
(2) If EPA disapproves a submitted control strategy implementation
plan revision without making a protective finding, then beginning 120
days after such disapproval, only projects in the first three years of
the currently conforming transportation plan and TIP may be found to
conform. This means that beginning 120 days after disapproval without a
protective finding, no transportation plan, TIP, or project not in the
first three years of the currently conforming plan and TIP may be found
to conform until another control strategy implementation plan revision
fulfilling the same Clean Air Act requirements is submitted and
conformity to this submission is determined. During the first 120 days
following EPA's disapproval without a protective finding,
transportation plan, TIP, and project conformity determinations shall
be made using the motor vehicle emissions budget in the disapproved
control strategy implementation plan, unless another control strategy
implementation plan revision has been submitted and its motor vehicle
emissions budget applies for transportation conformity purposes,
pursuant to Sec. 93.109.
(b) Failure to submit and incompleteness. In areas where EPA
notifies the State, MPO, and DOT of the State's failure to submit a
control strategy implementation plan or submission of an incomplete
control strategy implementation plan revision (either of which
initiates the sanction process under Clean Air Act sections 179 or
110(m)), the conformity status of the transportation plan and TIP shall
lapse on the date that highway sanctions are imposed on the
nonattainment area for such failure under section 179(b)(1) of the
Clean Air Act, unless the failure has been remedied and acknowledged by
a letter from the EPA Regional Administrator.
(c) Federal implementation plans. If EPA promulgates a Federal
implementation plan that contains motor vehicle emissions budget(s) as
a result of a State failure, the conformity lapse imposed by this
section because of that State failure is removed.
Sec. 93.121 Requirements for adoption or approval of projects by other
recipients of funds designated under title 23 U.S.C. or the Federal
Transit Laws.
(a) Except as provided in paragraph (b) of this section, no
recipient of Federal funds designated under title 23 U.S.C. or the
Federal Transit Laws shall adopt or approve a regionally significant
highway or transit project, regardless of funding source, unless the
recipient finds that the requirements of one of the following
paragraphs are met:
(1) The project was included in the regional emissions analysis
supporting the most recent transportation plan and TIP conformity
determination (even if conformity status is currently lapsed), and the
project's design concept and scope has not changed significantly from
those analyses; or
(2) There is a currently conforming transportation plan and TIP,
and a new regional emissions analysis including the project and the
currently conforming transportation plan and TIP demonstrates that the
transportation plan and TIP would still conform if the project were
implemented (consistent with the requirements of Secs. 93.118 and/or
93.119 for a project not from a conforming transportation plan and
TIP).
(b) In isolated rural nonattainment and maintenance areas subject
to Sec. 93.109(g), no recipient of Federal funds designated under title
23 U.S.C. or the Federal Transit Laws shall adopt or approve a
regionally significant highway or transit project, regardless of
funding source, unless the recipient finds that the requirements of one
of the following paragraphs are met:
(1) The project was included in the regional emissions analysis
supporting the most recent conformity determination for the portion of
the statewide transportation plan and TIP which are in the
nonattainment or maintenance area, and the project's design concept and
scope has not changed significantly; or
(2) A new regional emissions analysis including the project and all
other regionally significant projects expected in the nonattainment or
maintenance area demonstrates that those projects in the statewide
transportation plan and statewide TIP which are in the nonattainment or
maintenance area would still conform if the project were implemented
(consistent with the requirements of Secs. 93.118 and/or 93.119 for
projects not from a conforming transportation plan and TIP).
Sec. 93.122 Procedures for determining regional transportation-related
emissions.
(a) General requirements. (1) The regional emissions analysis
required by Secs. 93.118 and 93.119 for the transportation plan, TIP,
or project not from a conforming plan and TIP must include all
regionally significant projects expected in the nonattainment or
maintenance area. The analysis shall include FHWA/FTA projects proposed
in the transportation plan and TIP and all other regionally significant
projects which are disclosed to the MPO as required by Sec. 93.105.
Projects which are not regionally significant are not required to be
explicitly modeled, but vehicles miles traveled (VMT) from such
projects must be estimated in accordance with reasonable professional
practice. The effects of TCMs and similar projects that are not
regionally significant may also be estimated in accordance with
reasonable professional practice.
[[Page 36147]]
(2) The emissions analysis may not include for emissions reduction
credit any TCMs or other measures in the applicable implementation plan
which have been delayed beyond the scheduled date(s) until such time as
their implementation has been assured. If the measure has been
partially implemented and it can be demonstrated that it is providing
quantifiable emission reduction benefits, the emissions analysis may
include that emissions reduction credit.
(3) Emissions reduction credit from projects, programs, or
activities which require a regulatory action in order to be implemented
may not be included in the emissions analysis unless:
(i) The regulatory action is already adopted by the enforcing
jurisdiction;
(ii) The project, program, or activity is included in the
applicable implementation plan;
(iii) The control strategy implementation plan submission or
maintenance plan submission that establishes the motor vehicle
emissions budget(s) for the purposes of Sec. 93.118 contains a
commitment to the project, program, or activity by the agency with
authority to implement it; or
(iv) EPA has approved an opt-in to a Federally enforced program,
EPA has promulgated the program (if the control program is a Federal
responsibility, such as vehicle tailpipe standards), or the Clean Air
Act requires the program without need for individual State action and
without any discretionary authority for EPA to set its stringency,
delay its effective date, or not implement the program.
(4) Emissions reduction credit from control measures that are not
included in the transportation plan and TIP and that do not require a
regulatory action in order to be implemented may not be included in the
emissions analysis unless the conformity determination includes written
commitments to implementation from the appropriate entities.
(i) Persons or entities voluntarily committing to control measures
must comply with the obligations of such commitments.
(ii) The conformity implementation plan revision required in
Sec. 51.390 of this chapter must provide that written commitments to
control measures that are not included in the transportation plan and
TIP must be obtained prior to a conformity determination and that such
commitments must be fulfilled.
(5) A regional emissions analysis for the purpose of satisfying the
requirements of Sec. 93.119 must make the same assumptions in both the
``Baseline'' and ``Action'' scenarios regarding control measures that
are external to the transportation system itself, such as vehicle
tailpipe or evaporative emission standards, limits on gasoline
volatility, vehicle inspection and maintenance programs, and oxygenated
or reformulated gasoline or diesel fuel.
(6) The ambient temperatures used for the regional emissions
analysis shall be consistent with those used to establish the emissions
budget in the applicable implementation plan. All other factors, for
example the fraction of travel in a hot stabilized engine mode, must be
consistent with the applicable implementation plan, unless modified
after interagency consultation according to Sec. 93.105(c)(1)(i) to
incorporate additional or more geographically specific information or
represent a logically estimated trend in such factors beyond the period
considered in the applicable implementation plan.
(7) Reasonable methods shall be used to estimate nonattainment area
vehicle miles traveled on off-network roadways within the urban
transportation planning area, and on roadways outside the urban
transportation planning area.
(b) Regional emissions analysis in serious, severe, and extreme
ozone nonattainment areas and serious CO nonattainment areas must meet
the requirements of paragraphs (b) (1) and (2) of this section if their
metropolitan planning area contains an urbanized area population over
200,000.
(1) By January 1, 1997, estimates of regional transportation-
related emissions used to support conformity determinations must be
made at a minimum using network modeling according to procedures and
methods that are available and in practice and supported by current and
available documentation. These procedures, methods, and practices are
available from DOT and will be updated periodically. Areas performing
network modeling with some or all procedures and methods that are
available and in practice elsewhere as of January 1, 1995, must
continue to do so.
(2) Reasonable methods in accordance with good practice must be
used to estimate traffic speeds and delays in a manner that is
sensitive to the estimated volume of travel on each roadway segment
represented in the network model.
(3) Highway Performance Monitoring System (HPMS) estimates of VMT
shall be considered the primary measure of VMT within the portion of
the nonattainment or maintenance area and for the functional classes of
roadways included in HPMS, for urban areas which are sampled on a
separate urban area basis. For areas with network models, a factor (or
factors) may be developed to reconcile and calibrate the network-based
model estimates of VMT in the base year of its validation to the HPMS
estimates for the same period. These factors may then be applied to
model estimates of future VMT. In this factoring process, consideration
will be given to differences in the facility coverage of the HPMS and
the modeled network description. Locally developed count-based programs
and other departures from these procedures are permitted subject to the
interagency consultation procedures of Sec. 93.105(c)(1)(i).
(4) A transportation plan and TIP may satisfy the requirements of
Secs. 93.118 and 93.119 based on an alternate emissions analysis that
does not use network modeling, if Federal, State, and local air and
transportation agencies concur in the emissions analysis approach, and
if the transportation plan and TIP in question is a revision of the
previously conforming transportation plan and TIP to include a limited
number of additional projects. This paragraph will not be effective
until EPA and DOT review and evaluate suggested alternate methods and
approaches for determining the regional emissions impact of projects
and make documentation of this review and evaluation publicly
available.
(5) A conformity determination based on an alternate emissions
analysis as described in paragraph (b)(4) of this section would not
fulfill the requirements of Sec. 93.104(b)(3) and Sec. 93.104(c)(3)
regarding frequency of conformity determinations. Conformity must be
determined according to all the otherwise applicable criteria and
procedures of this subpart within three years of the last determination
which did not rely on paragraph (b)(4) of this section.
(c) In all areas not otherwise subject to paragraph (b) of this
section, regional emissions analyses must use those procedures
described in paragraph (b) of this section if the use of those
procedures has been the previous practice of the MPO. Otherwise, areas
not subject to paragraph (b) of this section may estimate regional
emissions using any appropriate methods that account for VMT growth by,
for example, extrapolating historical VMT or projecting future VMT by
considering growth in population and historical growth trends for
vehicle miles traveled per person. These methods must also consider
future economic activity, transit alternatives, and transportation
system policies.
[[Page 36148]]
(d) PM10 from construction-related fugitive dust.
(1) For areas in which the implementation plan does not identify
construction-related fugitive PM10 as a contributor to the
nonattainment problem, the fugitive PM10 emissions associated with
highway and transit project construction are not required to be
considered in the regional emissions analysis.
(2) In PM10 nonattainment and maintenance areas with
implementation plans which identify construction-related fugitive
PM10 as a contributor to the nonattainment problem, the regional
PM10 emissions analysis shall consider construction-related
fugitive PM10 and shall account for the level of construction
activity, the fugitive PM10 control measures in the applicable
implementation plan, and the dust-producing capacity of the proposed
activities.
(e) Reliance on previous regional emissions analysis. (1) The TIP
may be demonstrated to satisfy the requirements of Sec. 93.118 (``Motor
vehicle emissions budget'') or Sec. 93.119 (``Emission reductions in
areas without motor vehicle emissions budgets'') without new regional
emissions analysis if the regional emissions analysis already performed
for the plan also applies to the TIP. This requires a demonstration
that:
(i) The TIP contains all projects which must be started in the
TIP's timeframe in order to achieve the highway and transit system
envisioned by the transportation plan;
(ii) All TIP projects which are regionally significant are included
in the transportation plan with design concept and scope adequate to
determine their contribution to the transportation plan's regional
emissions at the time of the transportation plan's conformity
determination; and
(iii) The design concept and scope of each regionally significant
project in the TIP is not significantly different from that described
in the transportation plan.
(2) A project which is not from a conforming transportation plan
and a conforming TIP may be demonstrated to satisfy the requirements of
Sec. 93.118 or Sec. 93.119 without additional regional emissions
analysis if allocating funds to the project will not delay the
implementation of projects in the transportation plan or TIP which are
necessary to achieve the highway and transit system envisioned by the
transportation plan, and if the project is either:
(i) Not regionally significant; or
(ii) Included in the conforming transportation plan (even if it is
not specifically included in the latest conforming TIP) with design
concept and scope adequate to determine its contribution to the
transportation plan's regional emissions at the time of the
transportation plan's conformity determination, and the design concept
and scope of the project is not significantly different from that
described in the transportation plan.
Sec. 93.123 Procedures for determining localized CO and PM10
concentrations (hot-spot analysis).
(a) CO hot-spot analysis. (1) The demonstrations required by
Sec. 93.116 (``Localized CO and PM10 violations'') must be based
on quantitative analysis using the applicable air quality models, data
bases, and other requirements specified in 40 CFR part 51 Appendix W
(``Guideline on Air Quality Models (Revised)'' (1988), supplement A
(1987) and supplement B (1993), EPA publication no. 450/2-78-027R).
These procedures shall be used in the following cases, unless different
procedures are developed through the interagency consultation process
required in Sec. 93.105 and approved by the EPA Regional Administrator:
(i) For projects in or affecting locations, areas, or categories of
sites which are identified in the applicable implementation plan as
sites of violation or possible violation;
(ii) For projects affecting intersections that are at Level-of-
Service D, E, or F, or those that will change to Level-of-Service D, E,
or F because of increased traffic volumes related to the project;
(iii) For any project affecting one or more of the top three
intersections in the nonattainment or maintenance area with highest
traffic volumes, as identified in the applicable implementation plan;
and
(iv) For any project affecting one or more of the top three
intersections in the nonattainment or maintenance area with the worst
level of service, as identified in the applicable implementation plan.
(2) In cases other than those described in paragraph (a)(1) of this
section, the demonstrations required by Sec. 93.116 may be based on
either:
(i) Quantitative methods that represent reasonable and common
professional practice; or
(ii) A qualitative consideration of local factors, if this can
provide a clear demonstration that the requirements of Sec. 93.116 are
met.
(b) PM10 hot-spot analysis: (1) The hot-spot demonstration
required by Sec. 93.116 must be based on quantitative analysis methods
for the following types of projects:
(i) Projects which are located at sites at which violations have
been verified by monitoring;
(ii) Projects which are located at sites which have vehicle and
roadway emission and dispersion characteristics that are essentially
identical to those of sites with verified violations (including sites
near one at which a violation has been monitored); and
(iii) New or expanded bus and rail terminals and transfer points
which increase the number of diesel vehicles congregating at a single
location require hot-spot analysis.
(2) Where quantitative analysis methods are not required, the
demonstration required by Sec. 93.116 may be based on a qualitative
consideration of local factors.
(3) The identification of the sites described in paragraph (b)(1)
(i) and (ii) of this section, and other cases where quantitative
methods are appropriate, shall be determined through the interagency
consultation process required in Sec. 93.105. DOT may choose to make a
categorical conformity determination on bus and rail terminals or
transfer points based on appropriate modeling of various terminal
sizes, configurations, and activity levels.
(4) The requirements for quantitative analysis contained in
paragraph (b) of this section will not take effect until EPA releases
modeling guidance on this subject and announces in the Federal Register
that these requirements are in effect.
(c) General requirements. (1) Estimated pollutant concentrations
must be based on the total emissions burden which may result from the
implementation of the project, summed together with future background
concentrations. The total concentration must be estimated and analyzed
at appropriate receptor locations in the area substantially affected by
the project.
(2) Hot-spot analyses must include the entire project, and may be
performed only after the major design features which will significantly
impact concentrations have been identified. The future background
concentration should be estimated by multiplying current background by
the ratio of future to current traffic and the ratio of future to
current emission factors.
(3) Hot-spot analysis assumptions must be consistent with those in
the regional emissions analysis for those inputs which are required for
both analyses.
(4) PM10 or CO mitigation or control measures shall be assumed
in the hot-
[[Page 36149]]
spot analysis only where there are written commitments from the project
sponsor and/or operator to implement such measures, as required by
Sec. 93.125(a).
(5) CO and PM10 hot-spot analyses are not required to consider
construction-related activities which cause temporary increases in
emissions. Each site which is affected by construction-related
activities shall be considered separately, using established
``Guideline'' methods. Temporary increases are defined as those which
occur only during the construction phase and last five years or less at
any individual site.
Sec. 93.124 Using the motor vehicle emissions budget in the applicable
implementation plan (or implementation plan submission).
(a) In interpreting an applicable implementation plan (or
implementation plan submission) with respect to its motor vehicle
emissions budget(s), the MPO and DOT may not infer additions to the
budget(s) that are not explicitly intended by the implementation plan
(or submission). Unless the implementation plan explicitly quantifies
the amount by which motor vehicle emissions could be higher while still
allowing a demonstration of compliance with the milestone, attainment,
or maintenance requirement and explicitly states an intent that some or
all of this additional amount should be available to the MPO and DOT in
the emissions budget for conformity purposes, the MPO may not interpret
the budget to be higher than the implementation plan's estimate of
future emissions. This applies in particular to applicable
implementation plans (or submissions) which demonstrate that after
implementation of control measures in the implementation plan:
(1) Emissions from all sources will be less than the total
emissions that would be consistent with a required demonstration of an
emissions reduction milestone;
(2) Emissions from all sources will result in achieving attainment
prior to the attainment deadline and/or ambient concentrations in the
attainment deadline year will be lower than needed to demonstrate
attainment; or
(3) Emissions will be lower than needed to provide for continued
maintenance.
(b) If an applicable implementation plan submitted before November
24, 1993, demonstrates that emissions from all sources will be less
than the total emissions that would be consistent with attainment and
quantifies that ``safety margin,'' the State may submit a SIP revision
which assigns some or all of this safety margin to highway and transit
mobile sources for the purposes of conformity. Such a SIP revision,
once it is endorsed by the Governor and has been subject to a public
hearing, may be used for the purposes of transportation conformity
before it is approved by EPA.
(c) A conformity demonstration shall not trade emissions among
budgets which the applicable implementation plan (or implementation
plan submission) allocates for different pollutants or precursors, or
among budgets allocated to motor vehicles and other sources, without a
SIP revision or a SIP which establishes mechanisms for such trades.
(d) If the applicable implementation plan (or implementation plan
submission) estimates future emissions by geographic subarea of the
nonattainment area, the MPO and DOT are not required to consider this
to establish subarea budgets, unless the applicable implementation plan
(or implementation plan submission) explicitly indicates an intent to
create such subarea budgets for the purposes of conformity.
(e) If a nonattainment area includes more than one MPO, the SIP may
establish motor vehicle emissions budgets for each MPO, or else the
MPOs must collectively make a conformity determination for the entire
nonattainment area.
Sec. 93.125 Enforceability of design concept and scope and project-
level mitigation and control measures.
(a) Prior to determining that a transportation project is in
conformity, the MPO, other recipient of funds designated under title 23
U.S.C. or the Federal Transit Laws, FHWA, or FTA must obtain from the
project sponsor and/or operator written commitments to implement in the
construction of the project and operation of the resulting facility or
service any project-level mitigation or control measures which are
identified as conditions for NEPA process completion with respect to
local PM10 or CO impacts. Before a conformity determination is
made, written commitments must also be obtained for project-level
mitigation or control measures which are conditions for making
conformity determinations for a transportation plan or TIP and are
included in the project design concept and scope which is used in the
regional emissions analysis required by Secs. 93.118 (``Motor vehicle
emissions budget'') and 93.119 (``Emission reductions in areas without
motor vehicle emissions budgets'') or used in the project-level hot-
spot analysis required by Sec. 93.116.
(b) Project sponsors voluntarily committing to mitigation measures
to facilitate positive conformity determinations must comply with the
obligations of such commitments.
(c) The implementation plan revision required in Sec. 51.390 of
this chapter shall provide that written commitments to mitigation
measures must be obtained prior to a positive conformity determination,
and that project sponsors must comply with such commitments.
(d) If the MPO or project sponsor believes the mitigation or
control measure is no longer necessary for conformity, the project
sponsor or operator may be relieved of its obligation to implement the
mitigation or control measure if it can demonstrate that the applicable
hot-spot requirements of Sec. 93.116, emission budget requirements of
Sec. 93.118, and emission reduction requirements of Sec. 93.119 are
satisfied without the mitigation or control measure, and so notifies
the agencies involved in the interagency consultation process required
under Sec. 93.105. The MPO and DOT must find that the transportation
plan and TIP still satisfy the applicable requirements of Secs. 93.118
and/or 93.119 and that the project still satisfies the requirements of
Sec. 93.116, and therefore that the conformity determinations for the
transportation plan, TIP, and project are still valid. This finding is
subject to the applicable public consultation requirements in
Sec. 93.105(e) for conformity determinations for projects.
Sec. 93.126 Exempt projects.
Notwithstanding the other requirements of this subpart, highway and
transit projects of the types listed in Table 2 are exempt from the
requirement to determine conformity. Such projects may proceed toward
implementation even in the absence of a conforming transportation plan
and TIP. A particular action of the type listed in Table 2 is not
exempt if the MPO in consultation with other agencies (see
Sec. 93.105(c)(1)(iii)), the EPA, and the FHWA (in the case of a
highway project) or the FTA (in the case of a transit project) concur
that it has potentially adverse emissions impacts for any reason.
States and MPOs must ensure that exempt projects do not interfere with
TCM implementation.
[[Page 36150]]
Table 2.--Exempt Projects
------------------------------------------------------------------------
-------------------------------------------------------------------------
Safety
------------------------------------------------------------------------
Railroad/highway crossing.
Hazard elimination program.
Safer non-Federal-aid system roads.
Shoulder improvements.
Increasing sight distance.
Safety improvement program.
Traffic control devices and operating assistance other than
signalization projects.
Railroad/highway crossing warning devices.
Guardrails, median barriers, crash cushions.
Pavement resurfacing and/or rehabilitation.
Pavement marking demonstration.
Emergency relief (23 U.S.C. 125).
Fencing.
Skid treatments.
Safety roadside rest areas.
Adding medians.
Truck climbing lanes outside the urbanized area.
Lighting improvements.
Widening narrow pavements or reconstructing bridges (no additional
travel lanes).
Emergency truck pullovers.
------------------------------------------------------------------------
Mass Transit
------------------------------------------------------------------------
Operating assistance to transit agencies.
Purchase of support vehicles.
Rehabilitation of transit vehicles.1
Purchase of office, shop, and operating equipment for existing
facilities.
Purchase of operating equipment for vehicles (e.g., radios, fareboxes,
lifts, etc.).
Construction or renovation of power, signal, and communications systems.
Construction of small passenger shelters and information kiosks.
Reconstruction or renovation of transit buildings and structures (e.g.,
rail or bus buildings, storage and maintenance facilities, stations,
terminals, and ancillary structures).
Rehabilitation or reconstruction of track structures, track, and
trackbed in existing rights-of-way.
Purchase of new buses and rail cars to replace existing vehicles or for
minor expansions of the fleet.1
Construction of new bus or rail storage/maintenance facilities
categorically excluded in 23 CFR part 771.
------------------------------------------------------------------------
Air Quality
------------------------------------------------------------------------
Continuation of ride-sharing and van-pooling promotion activities at
current levels.
Bicycle and pedestrian facilities.
------------------------------------------------------------------------
Other
------------------------------------------------------------------------
Specific activities which do not involve or lead directly to
construction, such as:
Planning and technical studies.
Grants for training and research programs.
Planning activities conducted pursuant to titles 23 and 49 U.S.C.
Federal-aid systems revisions.
Engineering to assess social, economic, and environmental effects of the
proposed action or alternatives to that action.
Noise attenuation.
Emergency or hardship advance land acquisitions (23 CFR 712.204(d)).
Acquisition of scenic easements.
Plantings, landscaping, etc.
Sign removal.
Directional and informational signs.
Transportation enhancement activities (except rehabilitation and
operation of historic transportation buildings, structures, or
facilities).
Repair of damage caused by natural disasters, civil unrest, or terrorist
acts, except projects involving substantial functional, locational or
capacity changes.
------------------------------------------------------------------------
\1\ In PM10 nonattainment or maintenance areas, such projects are exempt
only if they are in compliance with control measures in the applicable
implementation plan.
Sec. 93.127 Projects exempt from regional emissions analyses.
Notwithstanding the other requirements of this subpart, highway and
transit projects of the types listed in Table 3 are exempt from
regional emissions analysis requirements. The local effects of these
projects with respect to CO or PM10 concentrations must be
considered to determine if a hot-spot analysis is required prior to
making a project-level conformity determination. These projects may
then proceed to the project development process even in the absence of
a conforming transportation plan and TIP. A particular action of the
type listed in Table 3 is not exempt from regional
[[Page 36151]]
emissions analysis if the MPO in consultation with other agencies (see
Sec. 93.105(c)(1)(iii)), the EPA, and the FHWA (in the case of a
highway project) or the FTA (in the case of a transit project) concur
that it has potential regional impacts for any reason.
Table 3.--Projects Exempt From Regional Emissions Analyses
------------------------------------------------------------------------
-------------------------------------------------------------------------
Intersection channelization projects.
Intersection signalization projects at individual intersections.
Interchange reconfiguration projects.
Changes in vertical and horizontal alignment.
Truck size and weight inspection stations.
Bus terminals and transfer points.
------------------------------------------------------------------------
[FR Doc. 96-16581 Filed 7-8-96; 8:45 am]
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