Fuels and Fuel Additives Registration Regulations; Final Rule ENVIRONMENTAL PROTECTION AGENCY
Federal RegisterJun 27, 1994
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SUMMARY: This final rule establishes new requirements for the
registration of designated fuels and fuel additives (F/FAs) as
authorized by sections 211(b)(2) and 211(e) of the Clean Air Act (CAA).
The registration requirements are organized within a three-tier
structure. Tier 1 requires F/FA manufacturers to perform a literature
search on the health and welfare effects of F/FA emissions,
characterize the emissions, and provide qualitative exposure
information. Tier 2 requires biological testing for the examination of
subchronic systemic and organ toxicity, as well as the assessment of
specific health effects endpoints. When necessary, Tier 3, which
includes follow-up studies or other additional tests, may be required.
The rule permits adequate existing test data to be submitted in lieu of
conducting new duplicative tests. It also includes special provisions
for small businesses and certain types of products, and a grouping
system which permits manufacturers of similar F/FA products to share
the costs of compliance.
DATES: This regulation is effective May 27, 1994. The incorporation by
reference of certain publications listed in the regulations is approved
by the Director of the Federal Register as of June 27, 1994.
The information collection requirements contained in 40 CFR 79.51,
79.52, and 79.57 through 79.68 have not been approved by the Office of
Management and Budget (OMB) and are not effective until OMB has
approved them. EPA will publish a document in the Federal Register
announcing OMB approval of the information collection requirements.
ADDRESSES: The record for this rulemaking is contained in Docket No. A-
90-07. The docket is located at the Air Docket, Room M-1500, 401 M
Street SW., Washington, DC 20460; phone (202) 260-7548 or 7549; fax
(202) 260-4000. The docket is open for public inspection from 8 a.m.
until 4 p.m., Monday through Friday. As provided in 40 CFR part 2, a
reasonable fee may be charged by EPA for photocopying services.
Electronic copies of major F/FA rulemaking documents can be obtained
through the Office of Air Quality Planning and Standards (OAQPS)
Technology Transfer Network Bulletin Board System (TTNBBS). Details on
how to access TTNBBS are included in Section XIV of this preamble.
FOR FURTHER INFORMATION CONTACT: Regarding F/FA registration
procedures: James Caldwell (phone 202-233-9303) or Joseph Fernandes
(phone 202-233-9016). USEPA, OMS Field Operations and Support Division,
Mail Code 6406J, 401 M Street SW., Washington, DC 20460. Regarding
technical requirements: Kent Helmer (phone 313-741-7825). USEPA, OMS
Regulation Development and Support Division, Mail Code RDSD-12, 2565
Plymouth Road, Ann Arbor, MI 48105.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. Background
A. Legal Authority and Statutory History
B. Public Participation
C. Additional Information on the Effective Date
III. Overview of Program Requirements
A. Overall Scope and Approach
B. Health Evaluation Requirements
C. Welfare Evaluation Requirements
D. Requirements for Emission Control System Testing
IV. Grouping System
A. Objectives and Rationale
B. Grouping Approach and Criteria
C. Implementation of Grouping System and Cost-Sharing Provisions
V. Base Fuel Specifications and Formulation Requirements
A. Gasoline
B. Diesel
C. Alternative Fuels
VI. Emission Generation
A. General Approach
B. Combustion Emission Generation
C. Evaporative Emission Generation
D. Vehicle Selection
E. Mileage Accumulation
F. Special Requirements for Additives
VII. Tier 1 Requirements
A. Literature Search
B. Characterization of Emissions
C. Exposure Analysis
VIII. Tier 2 Requirements
A. General Methodology
B. Subchronic Inhalation Study and Endpoint Tests
C. Adequate Endpoint Information in Lieu of Tier 2 Tests
D. Alternative Tier 2 Provision
IX. Tier 3 Requirements
A. Scope
B. Criteria for Referral to Tier 3
C. Potential Tier 3 Tests
X. Special Provisions
A. Experimental F/FAs
B. Relabeled Products
C. Aerosols
D. Small Business Provisions
XI. Timing and Compliance Requirements
XII. Reporting Requirements
A. Basic Registration Data
B. Summary Report
C. Appendices
D. Tier 3 Report
E. Confidential Business Information
XIII. Administrative Requirements
A. Administrative Designation and Regulatory Analysis
B. Regulatory Flexibility Act
C. Recordkeeping Requirements
XIV. Electronic Availability of Rulemaking Documents
I. Introduction
Over 2,300 fuels and 4,800 fuel additives were registered by EPA as
of March 1994 and, to some degree, each of them produces emissions
which may contribute to potentially harmful air pollution. The primary
purpose of today's rule is to establish registration requirements which
will provide information for identifying and evaluating the potential
adverse effects of designated F/FA emissions and for guiding the
direction of related regulatory actions in the future as specified in
section 211 of the CAA.
Previous actions have implemented CAA sections 211(a) and
211(b)(1), which govern the general registration of F/FAs, as well as
CAA section 211(f). Today's rule amends 40 CFR part 79 by adding
regulatory provisions requiring the testing of F/FAs as a requirement
for registration, as stipulated in section 211(b)(2) and section 211(e)
of the CAA.
In addressing these additional statutory provisions, this rule
focuses on the identification and evaluation of potential adverse
health effects associated with F/FA evaporative and combustion
emissions. The required health effects evaluation is organized in a
tiered structure, and includes emission characterization, literature
search, and biological testing requirements. Although this testing
framework focuses on the evaluation of health effects, F/FA
manufacturers are also required to perform data searches to obtain
information on the potential welfare effects of F/FA emissions. In
addition, EPA will continue to use existing procedures under CAA
section 211(f) for the evaluation of potential effects of F/FAs on ECS
performance.
The ultimate use of the registration information to be submitted in
compliance with this rule is to guide EPA in potential future
regulatory actions under CAA section 211(c). Section 211(c) provides
authority for the possible control or prohibition of any fuel or fuel
additive whose emission products cause or contribute to air pollution
which may reasonably be anticipated to endanger the public health or
welfare. Evidence of adverse effects of F/FA emissions on ECS
performance, obtained under CAA section 211(f) or from other sources,
could also be used by EPA to support such regulatory decisions.
II. Background
A. Legal Authority and Statutory History
The legal authority for the F/FA registration program is provided
by section 211 of the CAA. Section 211(a), 42 U.S.C. section 7545,
authorizes EPA to designate any fuel or fuel additive and prohibits
manufacturers of designated fuels or additives from selling such
products unless they have been registered by EPA in accordance with CAA
section 211(b). In 1975, EPA issued regulations (40 CFR part 79)
implementing basic registration requirements, as stipulated by CAA
section 211(b)(1), that included: commercial identifying information,
range of concentration, purpose-in-use, and chemical composition.
Section 211(b)(2) of the CAA also gives EPA discretionary authority
to establish additional registration requirements. According to this
section, EPA ``may also require the manufacturer of any fuel or fuel
additive to conduct tests to determine potential public health effects
of such fuel or fuel additive (including, but not limited to,
carcinogenic, teratogenic, or mutagenic effects),'' and to furnish
other ``reasonable and necessary'' information to identify F/FA
emissions and determine their effects on vehicular emission control
performance and on the public health and welfare. The statute further
stipulates that testing for health effects is to be conducted according
to procedures and protocols established by the Administrator, and that
test results will not be considered confidential. Once the manufacturer
has completed registration requirements and has given assurances that
the Agency will be notified of future changes in that information, CAA
section 211(b)(3) directs the Administrator to register the fuel or
fuel additive.
EPA did not exercise its discretionary authority to require testing
of F/FAs under CAA section 211(b)(2) as part of the general
registration regulations issued in 1975. However, in the CAA Amendments
of 1977 (PL 95-95, August 7, 1977), Congress added section 211(e),
which made implementation of section 211(b)(2) mandatory and contained
additional provisions requiring the implementation of the regulations
within one year of enactment of the CAA Amendments. In an effort to
fulfill this requirement, EPA published an Advanced Notice of Proposed
Rulemaking (ANPRM) in 1978 (see 43 FR 38607, August 29, 1978; Docket
ORD-78-01). However, the rulemaking process did not go forward during
the next ten years and the rule was not finalized. Nevertheless, this
action remained on EPA's regulatory agenda and a development plan for
the rulemaking was created in 1988.
In 1989, a citizens group brought a lawsuit [Thomas v. Browner,
C.A. No. 89-6269 (D. Oreg. 1989)] challenging EPA's failure to
promulgate F/FA testing regulations within the one-year deadline
stipulated in CAA section 211(e). EPA entered into a Consent Decree in
settlement of this lawsuit which, together with subsequent
modifications, established the rulemaking schedule. Accordingly, a new
ANPRM was published on August 7, 1990 (55 FR 32218) and a Notice of
Proposed Rulemaking (NPRM) was published on April 15, 1992 (57 FR
13168). Public hearings as well as periods for written commentary
followed both of these publications. On February 24, 1994, EPA
published a Notice of Reopening of Comment Period (59 FR 8886)
requesting public comment on several compliance-related and technical
issues that needed clarification and/or reconsideration. Today's action
culminates the rulemaking process by promulgating F/FA registration
requirements under CAA sections 211(b)(2) and 211(e).
B. Public Participation
In the months following the publication of the ANPRM (55 FR 32218)
and the associated public hearing (on September 26, 1990), EPA explored
the feasibility and appropriateness of applying regulatory negotiation
procedures (under the provisions of section 583 of the Negotiated
Rulemaking Act of 1990) to the development of this rule. Interviews and
meetings were held with representatives of a variety of affected
industry groups and environmental organizations, to assess their
interest and willingness to participate in potential negotiations. This
process indicated that there was insufficient support for regulatory
negotiation among a number of key parties. A traditional rulemaking
procedure was then followed to develop this rule.
Following publication of the proposed rule, EPA held a public
hearing on May 28, 1992, and accepted comments until June 30, 1992.
Public response on the NPRM included five oral presentations at the
hearing and the subsequent submission of 42 written comments. EPA also
received 13 written comments on the issues discussed in the Notice of
Reopening of Comment Period (referred to as the ``Reopening Notice'' in
later portions of this document). A transcript of both public hearings
and copies of all written comments are available in public Docket No.
A-90-07.
A discussion of comments received since the NPRM and EPA's
responses are included in the ``Summary and Analysis of Comments for
the Fuels and Fuel Additives Registration Regulations,'' which is
available in the public docket referenced above. All public commentary
was carefully considered in developing this final rule. Major areas of
comment are described in the relevant sections of this preamble.
C. Additional Information on the Effective Date
The effective date of this rule is May 27, 1994. EPA notes that the
general requirement (under 5 U.S.C. 553(d), the Administrative
Procedure Act (APA)), that publication or service of a substantive rule
be made not less than 30 days before its effective date, does not apply
here. Under 5 U.S.C. 559, the APA states that a subsequent statute does
not supersede or modify the APA except to the extent that it does so
expressly. CAA section 307(d)(1)(E) specifically applies to the
promulgation or revision of any regulation pertaining to any fuel or
fuel additive under CAA section 211. CAA section 307(d)(1) further
provides that ``[t]he provisions of sections 533 through 557 and
section 706 of title VI shall not, except as expressly provided in this
subsection, apply to actions to which this subsection applies.''
Nowhere does subsection 307(d) expressly provide that section 553(d) of
title 5 applies.
Further, CAA section 211(e)(2) expressly provides that the time
period for providing the ``requisite information'' under section
211(e)(2) is based on the ``date of promulgation'' of the rule.
Therefore, the requirements under CAA section 211(e)(2) are effective
on May 27, 1994. Additionally, even if section 553(d) were to apply to
the portion of the rule promulgated under the authority of section
211(b) of the CAA, there is good cause under section 553(d)(3) of the
APA to provide less than 30 days notice following publication in order
to simplify implementation of the rule by establishing one effective
date for the rule's requirements. As discussed in the following
sections, this final rule provides a six year time period for
completing Tier 2 testing, commencing on May 27, 1994. EPA believes
this to be sufficient for the regulated industry to comply with the
rule and that, given this compliance schedule, a reasonable amount of
notice is provided for this type of information-gathering regulation.
Finally, EPA has taken steps to provide notice of this final action to
the regulated industry upon signature of the rule. For these reasons,
EPA believes that establishing the effective date as May 27, 1994 is
reasonable.
III. Overview of Program Requirements
A. Overall Scope and Approach
The requirements of this rule apply to all types of F/FAs which
have been designated to be registered by EPA (see Section III.A.3).
Based on the provisions of CAA section 211(e), the requirements must be
satisfied both by manufacturers of F/FA products registered at the time
of promulgation as well as manufacturers of F/FA products seeking
registration after promulgation. Considering the large number of F/FA
products to be evaluated and the potential burden of the program on the
regulated industry, this final rule maintains the grouping system and
the tiered approach proposed in the NPRM.
The grouping system allows manufacturers of similar products to
share the costs of testing. Rather than mandating comprehensive testing
as a routine registration requirement for every registered fuel and
fuel additive, the grouping system permits the testing of one product
as a representative of all relatively similar products (see Section IV
of this preamble). In addition, the testing program is designed to
address testing needs on a tiered basis, with allowance for more
rigorous, resource-intensive requirements contained in each successive
tier. A detailed description of the scope and requirements of each
individual tier is provided in Sections VII, VIII, and IX of this
preamble, and procedures for generating the emissions to be tested are
explained in Section VI. Additional special provisions to reduce the
burden on the regulated industry are discussed in Section X.
EPA believes that the program required by this final rule is
consistent with the CAA and reflects a reasonable and cost-conscious
approach to a very complex regulatory area. The following sections
present a general overview of the main provisions of the rule.
1. Tiered Approach
As depicted in Figure 1, the registration program's requirements
are organized within a three-tier structure. In part, each tier is
intended to function as a screen for determining the need for more
rigorous requirements in subsequent tiers. Consistent with CAA section
211(e)(3), which authorizes EPA to avoid duplication of effort, the
tiered approach permits F/FA manufacturers to use test results and
other information which may already be available about their products.
BILLING CODE 6560-50-P
TR27JN94.000
BILLING CODE 6560-50-C
a. Content of Tiers. Except as may be modified by any applicable
special provisions, the requirements of Tiers 1 and 2 are mandatory for
all fuels and fuel additives. These requirements may be satisfied by
manufacturers either on an individual basis or by way of a group
submission consistent with the provisions of the grouping system.
Under Tier 1, F/FA manufacturers are required to perform a
literature search on the health and welfare effects of F/FA emissions,
characterize the emissions, and provide a qualitative exposure analysis
based on total annual production volume and market distribution data
(see Section VII for details on Tier 1 requirements). The modeling
analyses proposed in the NPRM have been eliminated from Tier 1 as
explained in Section III.C of this preamble. Tier 2 (see Section VIII)
includes biological testing for specific health effect endpoints, as
well as general systemic and organ toxicity. The Tier 2 biological
testing requires the exposure of laboratory animals to the whole
emissions of fuels or additive/base fuel mixtures.\1\ To the extent
that previously conducted studies are available which are at least
comparable to the specified guidelines for the chemical and/or
biological tests required in Tiers 1 and 2, such existing data may be
submitted in lieu of performing and reporting on new duplicative tests
(see Section VII.A.2).
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\1\An additive must be mixed with the base fuel of its
associated fuel family prior to generating emissions for testing
(see Sections IV.A and IV.B.1).
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The results of Tiers 1 and 2 are to be reported to EPA according to
the report formats described in Section XII. EPA will evaluate these
results to determine if additional testing or analysis may be indicated
under the provisions of Tier 3. For the purpose of peer review during
this evaluation process, EPA may furnish the submitted data to, and
consult with, other organizations, such as the Health Effects
Institute. Tier 3 tests will be determined on a case-by-case basis at
EPA's discretion, as discussed in Section IX. The specific objectives
and scope of Tier 3 tests will vary depending on the concerns
identified in the earlier tiers or any other information available to
EPA.
b. Timing of Requirements: Registered F/FAs. EPA proposed to
require that Tier 1 and Tier 2 data be submitted within three years for
registered F/FAs. In their comments on the proposal the regulated
industry suggested that it would not be possible to complete Tier 2
testing within three years. As detailed in the Summary and Analysis of
Comments, these commenters stated that the number of F/FAs to be
tested, the time needed for development of detailed test protocols, and
the lack of available test facilities were inconsistent with the three-
year time frame for completion of Tier 1 and Tier 2 for all F/FAs (or
groups). None of the commenters, however, suggested an alternative time
frame within which the testing of all F/FAs (or groups) could be
completed.
EPA has thoroughly considered these comments and, accordingly, has
taken a number of measures to streamline the program. As discussed
later in this preamble, such measures include the deletion from the
final rule of some requirements proposed in the NPRM (e.g.,
quantitative modeling requirements), modification of the Tier 2 testing
scenario for greater efficiency, simplification of some of the grouping
rules, and the addition of special provisions which will result in a
smaller number of F/FA products requiring testing.
Nevertheless, EPA recognizes that the number of laboratory
facilities currently available to conduct the required emission-based
toxicological tests is very limited. EPA expects that the promulgation
of this rule will create a demand for testing laboratories which will
encourage the reactivation, modification, and/or expansion of existing
laboratories, as well as the development of new facilities, to
accommodate the requirements of the F/FA registration program. However,
there is likely to be a lag between the demand for and the availability
of laboratory capacity. Thus, while EPA believes that some groups could
complete the testing required by the rule in three years, it is likely
that not all of the F/FAs to be tested could complete the requirements
in the three-year time frame.
Considering these factors, the final rule allows a six-year period
for the conduct of Tier 2 testing for registered F/FAs. This longer
period will provide the necessary start-up time for laboratories with
previous experience in conducting studies reasonably similar to those
required in Tier 2 to adapt or build the necessary facilities, organize
the key technical personnel, and conduct verification procedures. In
this regard, it is not necessary for each laboratory providing services
for this program to employ experts in each of the toxicology specialty
fields covered by Tier 2. EPA recognizes that some of the required
expertise may be in short supply, and envisions that laboratories may
subcontract with subspecialists as needed for evaluation of test
results. Furthermore, biological laboratories which currently offer
inhalation toxicology testing services, but are not equipped to
generate and deliver engine emissions for such testing, should be able
to obtain the additional equipment and engineering expertise they will
need in a relatively short period of time. Addition of emission
generation capabilities by such laboratories will be facilitated by the
fact that the final rule allows the use of relatively inexpensive and
possibly portable engine dynamometers for generating the required
emissions for toxicological testing related both to light-duty and
heavy-duty engine applications.
EPA estimates that the necessary toxicology laboratory capacity
will begin to come on line within 8-15 months of the effective date of
this rule, with expansion of capacity continuing for an additional 12-
24 months thereafter. The initial period should coincide with the
start-up time needed by the regulated industry prior to beginning the
required Tier 2 testing. Manufacturers' start-up activities will
include review and understanding of the requirements, formation and
functional organization of groups, acquisition of required test fuel
supplies, and contracting for data gathering and testing services. EPA
estimates that these activities can generally be accomplished in 6-12
months.
With six years provided for full Tier 2 completion, sufficient time
should then be available for completion of all Tier 2 testing. However,
this assumes that the regulated industry will not purposely delay the
onset of testing. If all F/FA groups wait until the fourth and fifth
years to begin the Tier 2 testing, it will again become likely that
some will not be able to complete the requirements on time. In such
instances, the responsible manufacturers will have failed to comply
with the requirements of this rule and will be subject to enforcement
action and/or loss of registration.
Thus, in the case of registered F/FA products, this final rule
requires the submission within three years from the effective date of
all applicable Tier 1 requirements plus either: (1) Submittal of all
Tier 2 requirements or (2) evidence of a contractual obligation with a
qualified laboratory to conduct the required Tier 2 tests.\2\ If,
within the first three years, a contract for Tier 2 is submitted rather
than the Tier 2 data itself, then the final Tier 2 report is due to EPA
no later than six years of the effective date of this rule. Both Tiers
1 and 2 are mandatory. Failure to submit Tier 2 data for a registered
F/FA within six years of the effective date of this rule will subject
the manufacturer to enforcement action and/or revocation of the
registration. In the case of F/FAs for which Tier 2 testing is not
required because of special provisions, all applicable requirements are
due to EPA within the initial three-year period after promulgation of
this rule.
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\2\To be qualified, a laboratory must be able to perform
inhalation toxicology tests in compliance with the Good Laboratory
Practice requirement in this rule, including monitoring by an onsite
Quality Assurance Unit. It must also be able to properly and safely
store, transport, and use F/FAs. The study director must be a
professional scientist with a doctoral degree in toxicology or
equivalent. Other individuals engaged in the conduct of the studies
shall have the education, training, and/or experience to enable
proper performance of the assigned functions. The laboratory's
animal handling facility must be registered and in good standing
with the U.S. Department of Agriculture. Accreditation with a
recognized independent organization which sets laboratory animal
handling standards [e.g., the American Association for Accreditation
of Laboratory Animal Care (AAALAC)] is required.
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Existing F/FA registrations are also conditional on satisfaction of
any Tier 3 requirements which might be prescribed by the Agency
pursuant to CAA section 211(b). When Tier 3 testing is prescribed for a
registered F/FA product, the existing registration will be extended for
that time which EPA specifies as necessary for completion of the
additional requirements. Maintenance of registration will depend upon
satisfactory compliance with these requirements.
EPA is promulgating Tier 2 testing requirements under the authority
of both sections 211(b) and 211(e) of the CAA. The requirements for
Tier 2 testing are all within EPA's discretion under section 211(b).
Section 211(b) gives the Administrator broad authority ``for the
purpose of registration of fuels and fuel additives'' to require
manufacturers ``to conduct tests to determine potential public health
effects of such fuel or fuel additive.'' EPA interprets ``for the
purpose of registration'' to encompass both gaining and maintaining
registration for F/FAs. This interpretation is supported by section
211(e), which requires implementation of section 211(b) authority with
respect to both registered and new F/FAs and mandates that EPA require
testing of F/FAs. The legislative history supports such a view. The
1977 House Report,\3\ upon which section 211(e) was based, states:
\3\H. Rept. No. 294, 95th Cong., 1st Sess. 308, reprinted in
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1977, U.S. CODE CONG. & ADMIN. NEWS 1077, 1387.
Section 220 of the Committee bill is intended to express the
Committee's disapproval of EPA's past handling of its authority in
this area and of its proposed future plans * * * Instead, an
aggressive, preventative approach to the gathering of necessary
information is mandated * * *
The bill mandates the Administrator to promulgate regulations
within one year after enactment. * * * These regulations must
require testing by the manufacturer of the fuel or fuel additive,
except insofar as paragraph (3) otherwise permits.
All of these requirements are mandatory.
Tier 2 involves testing ``to determine potential public health
effects'' of F/FAs and, therefore, is within the type of testing that
section 211(b) allows EPA to require. The timing requirements of Tier 2
are also within EPA's discretion under section 211(b), for section
211(b) leaves submission deadlines to EPA's discretion.
The timing for Tier 2 submissions is also governed, at least in
part, by section 211(e)(2). That section requires that, for F/FAs
registered when the rule is promulgated, ``requisite information'' be
submitted within three years of the promulgation date. ``Requisite
information'' is not defined in the statute. EPA proposed to interpret
``requisite information'' as the data required by Tiers 1 and 2. In
part this was based on EPA's understanding that Congress intended that
the testing rule promulgated under section 211(e) would require
manufacturers to conduct testing--not merely conduct a literature
search and compile studies that had already been conducted. As a
practical matter, however, EPA now believes that the Tier 2 tests
cannot be completed for all F/FAs within three years. EPA believes this
makes its proposed definition of ``requisite information'' unreasonable
and requires a different interpretation of ``requisite information.''
EPA considered redefining ``requisite information'' to mean studies
that could be completed for all F/FAs within three years. Given the
time frame, laboratory availability, and the number of groups to be
tested, EPA was not sure that any meaningful health effects testing
could be accomplished for all groups within three years. Certainly,
such testing could not include testing of combustion and evaporation
products for all groups. As discussed elsewhere, EPA believes that the
testing of combustion and evaporative emissions included in Tier 2 is
part of the basic testing necessary to evaluate potential health
effects, because people are exposed to both combustion and evaporative
emissions. Therefore, EPA would require this testing under section
211(b) regardless of whether the testing is required by section
211(e)(2). If EPA had chosen to interpret ``requisite information'' to
be testing that could be done in three years, EPA would have, in any
case, required such testing in addition to the Tier 2 testing required
by this rule. This would likely have delayed submission of the
information that EPA believes to be necessary (i.e., the combustion
emissions testing and evaporative emissions testing).
In today's rule, EPA interprets ``requisite information'' as either
data required by Tiers 1 and 2 or data required by Tier 1 and a
commitment to conduct Tier 2 testing. EPA believes that this meets the
congressional mandate to require emissions speciation testing and a
demonstration that manufacturers are making progress in their testing
by requiring submission of evidence of a contract with a qualified
laboratory to conduct the Tier 2 studies. In addition, this
interpretation imposes testing costs on manufacturers only for types of
studies that EPA believes are necessary and useful, and it requires
manufacturers to finish testing in a time frame that EPA believes is
possible to meet.
Even if ``requisite information'' were interpreted to mean only
data required by Tier 1, EPA would still impose Tier 2 testing and
timing requirements as contained in today's rule. In that case, section
211(e) would require Tier 1 data to be submitted within three years of
this rule's promulgation, and section 211(b) would provide authority
for EPA to impose the Tier 2 testing requirements in the time frame set
forth in this rule.
c. Timing of Requirements: Registrable and New F/FAs. Consistent
with section 211(e), for F/FAs not yet registered, all test
requirements must be satisfied prior to registration, including any
Tier 3 requirements which EPA judges to be necessary. However, as
discussed in the Reopening Notice, this final rule makes a distinction
between ``registrable'' and truly ``new'' F/FA products. Registrable F/
FAs are products\4\ that are not registered as of the effective date of
this rule but that meet the program's criteria for grouping with a
currently registered fuel or bulk additive\5\ in the same fuel
family.\6\ Conversely, a F/FA product not registered as of the
effective date of this rule is designated as ``new'' if it does not
meet the program's criteria for grouping with a currently registered
fuel or bulk additive in the same fuel family. In the above
definitions, the term ``currently'' refers to the date on which EPA
receives the basic registration data for the F/FA product in
question.\7\
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\4\Registration is product-specific. Thus, if a particular fuel
or additive product has not been registered by its manufacturer,
then that manufacturer does not have the right to introduce, market,
and/or sell this product, even if a compositionally similar or
identical product has been registered by another manufacturer.
\5\A ``bulk additive,'' sometimes called a ``general use''
additive, is defined as a product added to fuel at the refinery as
part of the original blending stream or after the fuel is
transported from the refinery, but before the fuel is purchased for
introduction into the fuel tank of a motor vehicle. In contrast, an
``aftermarket additive,'' sometimes called a ``consumer additive,''
is an additive product which is added by the end-user directly to
fuel in a motor vehicle or engine to modify the performance or other
characteristics of the fuel, the engine, or its emissions.
\6\``Fuel family'' refers to the primary categorization of F/FAs
in the grouping system of this registration program, as described in
Section IV. A fuel family is defined as a set of F/FAs which share
basic chemical and physical formulation characteristics and can be
used in the same engine or vehicle. In the definition of
``registrable'', the restriction ``in the same fuel family'' means
that the similarity of an applicant F/FA product to a bulk additive
currently registered for use in another fuel family will not suffice
to make the applicant F/FA product registrable. This restriction is
consistent with the general principles of the grouping system, which
permits grouping of F/FAs only within the defined fuel families.
\7\Revision of an existing registration (e.g., addition or
deletion of a currently-registered bulk additive to an existing fuel
registration) does not constitute a new registration (assuming any
added bulk additive is registered for use in fuels of the same
type). However, test requirements may change if the revision causes
the fuel product to change from one group to another.
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For registrable products, similar testing and compliance
requirements apply as those pertaining to currently registered F/FAs in
the same group. Upon the manufacturer's submittal of the basic
registration data and other pre-Tier 1 application requirements for a
registrable product, registration will be granted by EPA. Once
registered, these products will be legally able to enter the market.
The manufacturer will have the same period of time after the effective
date of this rule for the completion of Tiers 1 and 2 as the applicable
group of existing F/FAs, and can satisfy these requirements either by
joining the existing group or by testing individually. On the other
hand, manufacturers of new F/FA products (i.e., F/FAs not registered as
of the effective date of this rule and not fitting the registrable
criteria) are required to submit all testing requirements prior to
registration, including Tier 3 when prescribed by the Agency. Thus, if
EPA identifies a need for additional testing at the Tier 3 level for a
new F/FA product, registration will not occur until satisfactory
completion of all such requirements.
As discussed in the NPRM and in the Reopening Notice, EPA
interprets CAA section 211(b) in conjunction with CAA section 211(c),
which gives EPA authority to control or prohibit the manufacture,
introduction into commerce, offering for sale, or sale of any fuel or
fuel additive if the Administrator finds that the emission products of
such fuel or fuel additive ``cause[s], or contribute[s], to air
pollution which may reasonably be anticipated to endanger the public
health or welfare.'' In light of this responsibility, EPA believes that
it should exercise particular caution in registering new F/FA products
and that it should have the necessary information to evaluate fully the
potential public health consequences of such new F/FAs prior to
allowing their introduction into the market. Thus, before granting
registration to manufacturers of new F/FAs, under the authority of CAA
section 211(b), this final rule requires that they comply with all
testing requirements.
Figure 2 summarizes the decision process for determining whether an
unregistered F/FA product (i.e., a F/FA product not registered as of
the effective date of this rule) is ``registrable'' and thus handled
much like a currently registered F/FA product, or whether an
unregistered F/FA product is ``new'' and must complete all testing
requirements before registration is granted.
BILLING CODE 6560-50-P
TR27JN94.001
BILLING CODE 6560-50-C
An unregistered F/FA product which meets the criteria for grouping
only with a currently registered aftermarket additive (and not with a
currently registered fuel and/or bulk additive) is not designated as
registrable. This does not necessarily preclude an unregistered
aftermarket additive from being registrable (since aftermarket
additives can group with fuels and bulk additives), nor does it affect
the registration status of currently registered aftermarket additives.
For example, an unregistered detergent additive (either bulk or
aftermarket) intended for use in gasoline and meeting the criteria for
grouping with baseline gasoline fuels and bulk additives will be
registrable.\8\ On the other hand, an unregistered chromium-containing
additive (either bulk or aftermarket) intended for use in gasoline will
be considered ``new'' rather than ``registrable,'' because there are no
currently registered chromium-containing fuels or bulk additives in the
gasoline fuel family with which the applicant additive could be
grouped. Even if a chromium-containing product had previously been
registered as an aftermarket additive for gasoline [e.g., as a
``grandfathered'' product registered prior to the ban of such
aftermarket additives under CAA section 211(f)(1)(B)]\9\ or as a bulk
additive for use in another fuel family (e.g., diesel fuel), the
applicant additive would still be considered ``new''.
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\8\The grouping criteria for the baseline gasoline category are
described in Section IV.B.2.a.
\9\Until the 1990 CAA Amendments went into effect, the statutory
language of section 211(f) was interpreted as applying only to
unleaded gasoline fuels and related bulk additives. Thus, prior to
November 15, 1990 (the effective date of the CAA Amendments),
aftermarket additives intended for use in unleaded gasoline and
containing elements in addition to carbon, hydrogen, oxygen,
nitrogen, and/or sulfur were allowed to be registered. Under the
1990 CAA Amendments, all types of motor vehicle F/FAs were placed
under section 211(f) jurisdiction. [However, section 211(f)
provisions do not apply until certification requirements are
promulgated for the specific motor vehicle fuel or fuel additive.]
All aftermarket additives that were not ``substantially similar''
and were introduced on or after November 15, 1990 were banned.
However, this ban did not apply retroactively. Thus, ``non-
substantially similar'' gasoline aftermarket additives which had
been registered prior to November 15, 1990 have been allowed to
retain their registrations. These are so-called ``grandfathered''
aftermarket additives.
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As discussed in the Reopening Notice, EPA believes that the
distinctions between registrable and new F/FAs, both in terms of their
definitions and their respective compliance requirements, reflect
reasonable regard for the public health and welfare without undue
interference in the F/FA marketplace. Because registrable F/FAs are
defined such that they must be reasonably similar in composition and
usage to current F/FAs, their entry into the market will generally not
be expected to increase the health or welfare risks potentially related
to current F/FA emission exposures, assuming the overall rate of usage
does not increase substantially.
Today's rule implements EPA's policy that F/FAs that may pose new
or different health risks to the public should not be allowed on the
market until EPA has determined that adequate health testing has been
conducted. Because it would cause significant hardships to pull all
currently used products off the market until they were tested, products
that are already registered may continue to be sold. If these
principles were strictly applied (i.e., EPA refused to register any
specific product that does not currently have a registration), there
could be significant stagnation in the marketplace--a new company that
wanted to sell the same unleaded gasoline that everyone else is selling
would be prevented from getting a registration until it had tested its
gasoline product. Thus, today's rule allows new registrants to sell
products that are similar to registered products in terms of: (1)
Expected health effects; and (2) usage (and, therefore, type or extent
of exposure) currently allowed by law.
If an unregistered product can group with a registered product, EPA
has determined that the products should have similar health effects. To
ensure that usage (and, therefore, type or extent of exposure) is
similar to a registered product, under today's rule, a manufacturer
cannot rely on registration of an aftermarket fuel additive or on a F/
FA in a different fuel family. Considering a fuel or bulk additive to
be registrable based on an aftermarket additive registration could
significantly increase the public exposure to that F/FA. Generally,
aftermarket additives are relatively limited in distribution and usage
and, therefore, in exposure. Thus, in seeking a registration for a new
product, a manufacturer cannot rely on the registration of aftermarket
additives or any F/FA product in a fuel family other than the one for
which the registration is sought.
This is consistent with Congress' intent in CAA section
211(f)(1)(B) to preclude introduction into commerce of new aftermarket
additives which do not fit the ``substantially similar''
criteria.\10\, \11\ Looking only to F/FAs in the same fuel family
to determine registrability is also intended to prevent potential
increases in exposure to untested products. Expanding the use of an
additive from one fuel family to another (e.g., from diesel fuel to
gasoline) would significantly increase the overall size of the
potential market for the product and thus the potential exposure to its
emissions.
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\10\See memorandum from James W. Caldwell to Mary T. Smith
regarding ``Review of Notifications Submitted Pursuant to 40 CFR 79
for Compliance with the `Substantially Similar' Rule for Unleaded
Gasoline,'' available in Docket A-90-07, Item No. IV-B-07.
\11\The grouping criteria in this final rule (see Section IV)
allow aftermarket additives to join the baseline group if they
contain no elements in addition to carbon, hydrogen, oxygen,
nitrogen, and/or sulfur, even if they may sometimes be used by
consumers in an amount greater than the gasoline ``substantially
similar'' restriction of 2500 ppm.
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EPA interprets section 211(e) to support the distinction between
registered or registrable F/FAs and new F/FAs. EPA believes that the
reference in CAA section 211(e)(2) (A) and (B) to a ``fuel or fuel
additive which is registered'' or ``which is not registered'' is
ambiguous as to whether it refers to the F/FA product generally or to a
particular product-specific registration. Given this ambiguity, EPA
believes that it is reasonable to interpret the phrase ``fuel or fuel
additive which is registered'' to refer to the F/FAs generally. A
contrary interpretation would result in EPA allowing numerous types of
unleaded gasoline to be sold under existing registrations, while at the
same time denying a registration (until completion of necessary
testing) to a new company that wanted to sell the same type of unleaded
gasoline that many others now sell. As discussed above, for
``registrable'' products, such an interference in the market would not
likely result in any public health benefit. Therefore, EPA believes it
is reasonable to interpret the phrase ``registered'' to include both F/
FAs that are either ``registered'' or ``registrable.'' ``Registrable''
F/FAs are sufficiently similar in composition and use to existing F/FAs
that one would not expect them to have dissimilar health effects; and
therefore, it is reasonable to interpret the phrase ``registered fuel
or fuel additive'' to include not only those F/FAs that are identical,
but also those that can group with existing F/FAs.
Alternatively, EPA believes that the above approach is consistent
with section 211 because EPA interprets section 211(e)(3) (A) and (B)
in conjunction with section 211(e)(3)(C), which gives EPA authority to
exempt any F/FA product from duplicative testing. Thus, even if one
interprets the phrase ``fuel or fuel additive which [is/is not]
registered'' to mean either that an identical F/FA product must already
have a registration, or to refer to a product-specific registration,
EPA believes it is reasonable to interpret section 211(e)(3)(C) to
allow F/FAs that are similar in composition and usage to those already
on the market to group with those similar F/FAs and complete the
testing with the other F/FAs in their group. At the same time, EPA
believes that for F/FAs that differ significantly in composition or
usage from currently registered F/FAs, such testing would not be
duplicative of testing of registered F/FAs; and therefore, EPA is
authorized under section 211(e) to require this information prior to
registration. Under either theory, EPA's authority to obtain
information prior to registration is not limited to Tier 1 and Tier 2
data, because section 211(b)(2)(B) gives EPA authority to require for
registration any information necessary to assess the effects of
emissions on public health or welfare. Therefore, EPA interprets
section 211 (e) and (b) to give it the authority to require any
necessary health or welfare effects information for F/FAs that are
significantly different in composition or usage from currently
registered products.
d. Changes to 40 CFR Part 79. This final rule includes revisions to
the current 40 CFR part 79 registration regulations which are necessary
to properly implement the new testing requirements in Subpart F. These
consist of various conforming changes in registration procedures,
requirements, and terminology.
The submission by which a manufacturer requests registration of a
fuel or fuel additive product is now called an ``application'' rather
than a ``notification,'' in order to better reflect the additional
submissions and requirements upon which registration is now contingent,
and to avoid confusion with the various notifications concerning
testing requirements which will be transmitted to applicants and
registrants by EPA. Conforming changes have been made in procedures for
notifying an applicant that a submission does not comply with
registration requirements and for granting registration.
As discussed in Section IV of this preamble, in order to determine
in which of the F/FA group(s) established under the criteria set forth
in this rule (see Sec. 79.56) a particular fuel additive should be
enrolled, and to administer applicable testing requirements separately
for each such F/FA group, it is essential that fuel additives be deemed
to be registered only for those specific types of fuel for which they
will be sold and used. The Agency interprets and is already
administering the existing part 79 in this manner. However, in the
conforming changes included in this rule, part 79 has been clarified to
confirm that registration of fuel additives is fuel specific, and that
EPA considers sale or distribution of a fuel additive product for use
in a fuel for which it is not registered to be unlawful.
In addition, a manufacturer seeking to register a fuel product or a
fuel additive product for use in vehicles manufactured after 1974 must
demonstrate that it is ``substantially similar'' to fuels or additives
utilized in the certification of vehicles for 1975 or subsequent model
years, or that the manufacturer has obtained a waiver under CAA section
211(f)(4). This expressly codifies the manner in which EPA has
administered the registration program since it adopted criteria
implementing the statutory prohibition in CAA section 211(f)(1) on
introduction into commerce of fuels and fuel additives which are not
``substantially similar.''
2. Program Focus On Emissions
CAA section 211 gives the Agency discretion to determine the focus
of the F/FA testing program under CAA section 211(b). EPA is exercising
its discretion by focusing this rule on the testing of emissions,
because the main purpose of the testing program is to provide EPA with
information that can be used in regulatory decision-making under CAA
section 211(c).
Section 211(c) of the CAA gives EPA the authority to regulate F/FAs
based on the impact of their emissions on public health or welfare.
Specifically, it allows the Administrator to control or prohibit the
manufacture, introduction into commerce, or sale of any fuel or fuel
additive whose emission product(s) cause or contribute to harmful air
pollution. The legislative history of the provision also supports a
focus on emissions, since House and Senate Reports on the CAA
Amendments of 1970 link the information to be obtained under CAA
section 211(b) to EPA's authority to regulate emissions under CAA
section 211(c).\12\ Thus in the NPRM, EPA proposed to focus this rule's
requirements on the potential emissions-based effects of F/FAs rather
than on the effects of the raw (i.e., uncombusted) F/FA product. Public
comment received after publication of the NPRM generally supported the
proposed emissions-based focus of the rule. Accordingly, EPA has
retained this focus in today's action. The health effects testing
requirements of this final rule specifically address the effects of
inhalation exposure to F/FA combustion and evaporative emissions. The
required testing focuses on the evaluation of health effects of the
whole emissions of the fuel or additive/base fuel mixture of interest
and not on the toxicity of the individual emission products.
---------------------------------------------------------------------------
\12\H. Rep. No. 1146, 91st Cong. 2nd Sess. (1980) at 13,
reprinted in Environment and Natural Resources Division of the
Library of Congress, 93rd Cong., 2nd Sess.; A Legislative History of
the Clean Air Act Amendments of 1970 (Comm. Print 1974) (``Leg.
Hist.'' at 433-434).
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For the purposes of this rule, combustion emissions are the primary
exhaust products of the combustion of a fuel or additive/base fuel
mixture in a motor vehicle engine and do not include secondary
atmospheric transformation products. EPA recognizes that secondary air
pollutants are a factor in the characterization of overall risks
associated with F/FA emissions. However, it is not feasible to include
this type of laboratory testing as a standard requirement at this time.
When required in specific instances, transformation products will be
addressed under Tier 3, as described in Section III.C.
As proposed, evaporative emission testing is to be performed for F/
FAs meeting specific volatility criteria. While some commenters asked
EPA to eliminate the evaporative emission testing from the program,
today's rule maintains this requirement. EPA's decision is supported by
the legislative history, which expresses the concerns of Congress about
the public health impacts of emissions from both combustion and
evaporative sources. Public exposure to evaporative emissions is still
significant and, for many F/FAs, the toxicity of evaporative emissions
as a whole mixture has not been characterized. Thus, this rule includes
requirements for the characterization and biological testing of
evaporative emissions in certain circumstances.
While combustion emissions are inevitable products of the engine
combustion process, the significance of evaporative emissions depends
on the type of F/FA product. As proposed in the NPRM, this final rule
specifies criteria for determining the need for evaporative emission
testing. For fuels that are supplied to motor vehicle engines by way of
sealed containment and delivery systems, evaporative emissions testing
is less important, since human and environmental exposure should be
extremely low or nonexistent. Thus, evaporative emissions testing under
this final rule would not apply to methane (compressed natural gas or
liquified natural gas) or propane (liquified petroleum gas)
formulations.
For liquid F/FAs, the significance of vaporization varies widely,
depending largely on the volatility of the fuel or additive/base fuel
mixture. Thus, this final rule uses the Reid Vapor Pressure (RVP) of a
fuel or additive/base fuel mixture to determine its applicability for
evaporative emissions testing. An RVP of 2.0 pounds per square inch
(psi) is designated as the threshold for determining the need for
evaporative emission testing for fuels. That is, fuels with RVP of 2.0
psi or greater are subject to the evaporative emissions testing
requirements, while those with RVP less than 2.0 psi are excused from
the evaporative emission testing requirements under Tier 1 and Tier 2.
With respect to additives, the NPRM proposed to require evaporative
emission testing if the RVP of the additive/base fuel mixture was
increased by 0.1 psi or more in comparison with the RVP of the base
fuel alone. However, methods for measurement of vapor pressure have a
reproducibility of about 0.3 psi.\13\ To account for this limitation of
measurement accuracy, especially when dealing with low pressure
measurements, today's rule uses a 0.4 psi criterion (i.e., 0.1
0.3) for additives. Accordingly, this final rule requires
the evaporative emission testing of additives when the RVP of the
associated fuel in the additive/base fuel mixture is increased by 0.4
psi and the resulting RVP of the additive/base fuel mixture is 2.0 psi
or more.\14\ For example, an additive that causes an increase of 0.6
psi when mixed with a fuel with a vapor pressure of 1.0 psi (i.e., the
resulting RVP of the additive/base fuel mixture is 1.6), need not be
tested for evaporative emissions. On the other hand, an additive that
causes an increase of 1.1 psi when mixed with a fuel with RVP of 1.0
psi is required to undergo evaporative emission testing because the
resulting RVP of the additive/base fuel mixture is 2.1 psi.
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\13\See ``Standard Test Method for Vapor Pressure of Petroleum
Products (Mini Method),'' ASTM D 5191-91.
\14\The requirement to test the evaporative emissions of a
qualifying additive product do not apply if the manufacturer intends
to satisfy the test requirements of the additive as part of a group,
of which another member product or a base fuel serves as the group
representative, and the manufacturer does not specifically test the
additive apart from the group. See Section IV for a discussion on
grouping provisions.
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The above defined thresholds are used by EPA in determining the
applicability of evaporative emission testing for the purposes of Tier
1 and Tier 2. However, EPA retains the authority to require evaporative
emission testing under Tier 3 for fuels or additive/base fuel mixtures
with low vapor pressure, e.g., RVP less than 2.0, if there is a health
or welfare concern associated with the evaporative emissions of the
fuel or additive/base fuel mixture in question. For example, if a
highly toxic substance is present in a fuel or additive/base fuel
mixture, EPA could require evaporative emission testing under Tier 3,
even if the RVP of the F/FA product in question is below 2.0 psi. These
special cases will be handled on a case-by-case basis under Tier 3.
3. Program Applicability
The requirements of this rule apply to manufacturers (including
importers) of designated fuels or fuel additives and to any F/FA
manufacturer [see Sec. 79.2(d) and (f) as amended in this rule] seeking
registration under CAA section 211(a) and 211(b). A fuel is defined to
be any material which is capable of releasing energy or power by
combustion or other chemical or physical reaction [see 40 CFR
Sec. 79.2(c)]. A fuel additive is defined as any substance that is
intentionally added to a fuel (including any added to a motor vehicle's
fuel system) and that is not intentionally removed prior to sale or use
(see 40 CFR Sec. 79.2(e), as amended in this rule), including both bulk
and aftermarket additives.
At the present time, the designation of F/FAs encompasses both
leaded and unleaded gasoline F/FAs and diesel
F/FAs produced and commercially distributed for use in motor vehicles.
F/FAs intended only for off-road use (e.g., farm and construction
equipment, aircraft, boats, railroad engines) are not currently
designated to be registered, and thus are not subject to the
requirements of today's rule. However, if off-road F/FAs become
designated in the future (according to provisions under CAA section
213), this rule will be modified, as needed, to cover them as well.
While the designated F/FAs include leaded gasoline formulations,
CAA section 211(n) provides that ``after December 31, 1995 it shall be
unlawful for any person to sell, offer for sale, supply, offer for
supply, dispense, transport, or introduce into commerce, for use as
fuel in any motor vehicle (as defined in section 7554(a) of this title)
any gasoline which contains lead or lead additives.'' Because of the
upcoming ban of leaded F/FAs, compliance with the requirements in
today's rule will be superfluous for manufacturers of leaded products.
Thus, the leaded fuel family has been deleted from this final rule.
While alternative fuels and their additives are currently on the
market, they are not yet designated and thus not yet required to be
registered. However, because they are currently used and EPA
contemplates their future designation, this final rule includes
provisions for their registration and testing. The alternative fuels
for which provisions are included are: methanol, ethanol, compressed
natural gas (CNG), liquified natural gas (LNG), and liquified petroleum
gas (LPG). EPA is currently developing the proposal for the designation
of these alternative fuels and their additives. In that proposal, EPA
currently intends to propose to set an effective date for the final
designation rule far enough in the future so that these F/FAs could
complete whatever pre-registration testing would be required prior to
the time they would be required to be registered. EPA currently
believes the delay of the effective date of the designation rule would
be justified by the need to minimize disruptions in an existing market
for alternative F/FAs.
This rule contains a number of special provisions which reduce or
modify the program's requirements for certain manufacturers or certain
classes of products. Such special provisions apply to small businesses
(as defined in this rule) and manufacturers of experimental F/FAs,
relabeled products, and aerosols. These provisions are described in
Section X of this preamble.
B. Health Evaluation Requirements
The testing program established in this rule focuses on the
identification and evaluation of potential adverse health effects
associated with inhalation exposure to F/FA emissions. The Tier 2
testing program of this rule addresses, in addition to the areas of
inquiry mandated by the statute (carcinogenicity, teratogenicity, and
mutagenicity), specific assessments designed to detect potential
pulmonary, neurotoxic, and general reproductive effects of F/FA
emissions.
In the NPRM, short-term (42-day) tests were proposed under Tier 2
to address each of the health effect endpoints described above.
However, in response to public commentary and EPA's own analysis, the
Tier 2 testing requirements have been modified in this final rule to
enhance the efficiency and feasibility of the program. Today's rule
uses a comprehensive 90-day subchronic inhalation protocol and
ancillary tests to examine general systemic and organ toxicity
(including pulmonary toxicity), as well as the specific areas of
concern described above.
These evaluations require the exposure of laboratory animals to the
whole emissions of F/FAs. Tier 2 tests are to be conducted for both
combustion and (when applicable) evaporative emissions. The subchronic
inhalation protocol allows the examination of specific endpoints within
the 90-day testing framework. For example, pulmonary and neurotoxic
effects are examined in conjunction with the subchronic study standard
histopathological requirements. The neurotoxicity assessment also
includes a biochemical assay to measure the level of glial fibrillary
acidic protein (GFAP). Coordinated with the 90-day study is a battery
of three assays used in the evaluation of carcinogenicity and
mutagenicity: the in vitro Salmonella assay, the in vivo micronucleus
assay, and the in vivo sister chromatid exchange assay. A fertility
assessment that looks at both reproductive and teratogenic effects is
also coordinated with the general toxicity study. The assessment for
reproductive effects involves the mating of exposed animals, the
measurement of reproductive cycles, and the histopathology of male and
female reproductive organs. The teratogenic assessment requires the
exposure of pregnant females to F/FA emissions and the subsequent
examination of the uterus and its contents just prior to the normal
time of parturition.
In addition to the evaluation of the health effects described
above, EPA retains the authority under Tier 3 to require additional
testing on a case-by-case basis on those endpoints evaluated under Tier
2 and/or on other endpoints of concern. Further discussion about the
specific requirements of Tiers 1, 2, and 3 is provided in Sections VII-
IX.
C. Welfare Evaluation Requirements
CAA section 211(b)(2)(B) states that the Administrator may require
manufacturers to furnish ``reasonable and necessary'' information for
determining ``the extent to which F/FA emissions affect the public
health or welfare''. The term ``welfare effects'' encompasses a variety
of complex and interrelated factors. In terms of motor vehicle F/FA
emissions, welfare effects could include the impact of air pollution on
the public health and the environment, including a broad range of
effects on aquatic and terrestrial ecosystems, cultivated crops and
other vegetation, natural and man-made materials, wildlife, and
stratospheric ozone. Air pollution effects on the public welfare also
include important environmental concerns such as noxious odors or
visibility impairment, which may detract from human well-being.
Except for stipulating that welfare effects should be addressed,
the statute gives EPA broad discretion about how to address welfare
effects. EPA recognizes that, at the present time, scientific
experience and laboratory screening methods for the evaluation of
welfare effects are more limited than in the area of health effects.
Thus, today's rule limits the routinely required welfare evaluation to
requirements that are coincident or concurrent with the evaluation of
health effects. These include the literature search, emission
characterization, and exposure analysis requirements of Tier 1. While
at this time EPA is not requiring biological testing for welfare
effects, the Administrator retains the authority to require additional
evaluation and/or testing of welfare effects at the Tier 3 level, when
the outcome of lower tiers demonstrates both significant environmental
toxicity and exposure potential. EPA will determine the need for Tier 3
welfare effects testing on a case-by-case basis.
In the NPRM, EPA proposed to require modeling analyses for
atmospheric reactivity, environmental fate/partitioning, and exposure
as part of the welfare evaluation. EPA requested comments on the
feasibility of requiring such modeling analyses as a routine
requirement for registration. Commenters urged EPA to limit the
modeling requirements due to the lack of standardized methods in this
area of study. Recognizing the limitations of modeling methods and the
availability of existing data for some of the areas of study of
interest in this rule, this final rule does not require modeling
analyses as part of Tier 1.
EPA recognizes that other EPA programs are actively researching and
controlling mobile and stationary source contributions to major air
pollution problems such as tropospheric/stratospheric ozone, global
warming, and acid rain. Furthermore, modeled ozone reactivity data are
already available for most conventional and alternative fuels. EPA
believes that if additional modeling is deemed necessary, this could be
performed by manufacturers under Tier 3. Also, EPA may conduct simple
modeling, using the emission data submitted by registrants under Tier
1, if needed for regulatory decisions.
Regarding environmental fate and exposure modeling, EPA recognizes
that these types of analyses will be extremely difficult due to the
complex nature of F/FA emissions. Because both environmental
partitioning models and exposure models address single compounds rather
than mixtures, it would be unduly burdensome and unreasonable to
require all registrants to perform these analyses on each individual
emission constituent. Requiring the modeling of each individual
emission product would also result in duplication of information and,
therefore, would be inconsistent with the original intent of the
statute.
In addition, the environmental models are applicable only to a
limited number of emission products for which appropriate physical/
chemical data are available in order to perform the analysis. In terms
of available exposure models, these usually rely on carbon monoxide
monitoring data and related emission rates to estimate potential
exposures. This means that the applicability of available exposure
models is somewhat limited to the analysis of compounds whose chemical/
physical behavior is similar to carbon monoxide.
Based on the above factors, EPA believes that quantitative
evaluations of potential exposures and environmental fate/partitioning
of F/FA emissions will be better addressed at the Tier 3 level on a
case-by-case basis, where they can be focused on specific compounds of
potential environmental concern.
D. Requirements for Emission Control System Testing
CAA section 211(b)(2) requires F/FA manufacturers to provide
information to determine their products' effects on ECS performance.
The NPRM stated that EPA intended to continue addressing ECS
performance through the existing waiver application program under CAA
section 211(f). The waiver program prevents the introduction into
commerce of F/FAs which would significantly degrade the performance of
emission control equipment. Under CAA section 211(f), F/FA formulations
which do not meet specific chemical and physical criteria considered to
be ``substantially similar'' to EPA certification fuel (see
interpretive rule in 56 FR 5352), cannot be introduced into commerce
unless a waiver is issued by EPA. The waiver process then requires the
applicant to demonstrate, through testing if necessary, that ``such
fuel or fuel additive or a specified concentration thereof, and the
emission products of such fuel or fuel additive or a specified
concentration thereof, will not cause or contribute to a failure of any
emission control device or system (over the useful life of any vehicle
in which such device or system is used) to achieve compliance by the
vehicle with the emission standards to which it has been certified.''
For products already registered that do not meet ``substantially
similar'' criteria, i.e., grandfathered products that were registered
prior to the implementation of the waiver application program, EPA
proposed to establish a mechanism that would permit the public to
submit petitions to EPA requesting ECS testing for a particular fuel or
fuel additive of concern.
Today's rule reflects EPA's judgment that the mechanisms already
established under CAA section 211(f) are adequate for the ECS testing
of F/FAs. EPA's previous experience with the waiver application process
has demonstrated the practical value of the ``substantially similar''
concept for determining whether a F/FA product needs to be tested for
its effects on emission control equipment. EPA is not aware of
instances in which products meeting ``substantially similar'' criteria
were later discovered to have adverse effects on vehicular emission
control performance. The implementation of another ECS testing program
under section 211(b) would be duplicative and, therefore, inconsistent
with Congress' intent. Thus, as proposed, today's rule refers to the
waiver application process under CAA section 211(f)\15\ for the ECS
testing of ``substantially similar'' F/FAs and
F/FAs required to obtain a waiver under CAA section 211(f)(4). Products
which conform to applicable ``substantially similar'' criteria are not
required to undergo ECS testing before they can be registered. On the
other hand, new
F/FAs which do not meet ``substantially similar'' criteria are subject
to the standard 211(f) application process prior to registration.
---------------------------------------------------------------------------
\15\An example of a waiver decision can be found in 53 FR 33846.
---------------------------------------------------------------------------
EPA recognizes that there are grandfathered F/FA products (see
Section III.A above) which fall outside the regulatory domain of CAA
section 211(f). These grandfathered products include gasoline
aftermarket additives introduced prior to the 1990 CAA Amendments.
Therefore, statutory authority for the ECS evaluation and regulatory
control of grandfathered products exists under CAA sections 211 (b) and
(c) rather than section 211(f). EPA judges that requiring ECS
evaluation of all grandfathered products, without evidence of ECS
problems, would be unreasonable and unnecessarily burdensome on the
industry. Instead, today's rule provides a petition mechanism for the
ECS evaluation of grandfathered products. Under this mechanism, EPA
could require ECS testing of grandfathered products, similar to the
testing which a waiver applicant would generally conduct, if so
petitioned by outside parties or if other information available to the
Agency indicates that such evaluation is appropriate. Such information
might be obtained as a result of the emission characterization
requirements included in this final rule. In addition, vehicle
manufacturers or other outside parties are allowed to submit petitions
to EPA requesting the testing of grandfathered products based on
evidence of potential harm to vehicular ECS. If EPA judges that ECS
testing is warranted after reviewing the petition arguments, emission
characterization results and/or other available information, the
authority provided by CAA sections 211(b) and 211(c) to require
specific grandfathered products to test for ECS effects.
IV. Grouping System
A. Objectives and Rationale
CAA section 211(e) provides a number of mechanisms by which EPA may
reduce the costs and burdens of compliance with the registration
requirements set forth in CAA section 211(b). In particular, CAA
section 211(e)(3)(B) permits the Administrator to ``provide for cost-
sharing with respect to the testing of any fuel or fuel additive which
is manufactured or processed by two or more persons, or otherwise
provide for shared responsibility'' so that the program requirements
can be met without duplication of effort. In accordance with this
provision, today's rule maintains the grouping system proposed in the
NPRM, which permits manufacturers of similar F/FAs, on a voluntary
basis, to pool their resources and efforts to satisfy the registration
requirements. The groups defined by the specifications in this final
rule are the only groups permitted for satisfying the requirements of
the registration program.
As proposed in the NPRM, the grouping system allows similar fuels
and additives to be grouped together, rather than creating separate
fuel groups and additive groups. This convention recognizes that, to
meet the requirements of this final rule, an additive must be mixed
with its associated base fuel\16\ prior to generating the emissions for
testing. To the extent that the resulting additive/base fuel mixture is
similar to existing fuel formulations, the tests conducted on the
emissions of the additive/base fuel mixture will be duplicative of
tests conducted on the related fuels. To avoid potential duplication,
this final rule maintains the proposed approach, in which closely-
related fuels and additives are grouped together. Accordingly, the
manufacturers of fuels and the related additives can fulfill their
individual registration responsibilities through jointly-supported
testing rather than through duplicative independent efforts. By
grouping similar fuels and additives together, the grouping scheme also
avoids the need to define each generic product or product component as
either a ``fuel'' or an ``additive.'' This would otherwise present a
problem when a given substance (or mixture) can serve as either a fuel
or an additive (e.g., ethanol).
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\16\Base fuel specifications for each fuel family are described
in Section V.
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In the NPRM, EPA developed criteria for sorting individual F/FAs
into groups of related formulations based on similarities in the
chemical/physical properties of the ``raw'' fuel or additive/base fuel
mixture. EPA has maintained this approach in the final rule. EPA
expects F/FAs within each group to have similar emission
characteristics and thus essentially the same general effects on the
public health and welfare. Therefore, chemical or toxicologic
information associated with individual members of a given group can
reasonably be generalized to all F/FAs in the group. EPA will consider
tests performed on a selected representative of a group to apply to all
members of the group for purposes of compliance with registration
requirements, for deciding whether to require additional testing under
Tier 3, or for taking regulatory action under CAA section 211(c).
While each manufacturer of a fuel or fuel additive will still be
held individually accountable for compliance with the registration
program, the grouping system provides an opportunity for meeting the
program requirements in a more cost-effective manner. Participation in
the F/FA grouping system is strictly voluntary, and any manufacturer
may choose to fulfill the requirements on an individual basis. Those
who choose to take advantage of the grouping opportunity will be able
to share their planning efforts, research capabilities, and financial
resources to satisfy the information-gathering and testing requirements
of the F/FA registration program. To satisfy the chemical and
biological testing requirements, the required tests will be done on the
selected representative for the respective group, rather than being
repeated for each of the F/FAs in the group. The results of the tests
on the group representative will then be submitted jointly for all
members of the group, with applicable costs to be shared by the
respective manufacturers (based on their cost-sharing agreements, as
discussed in Section IV.C). Manufacturers who question whether the
results obtained for their group's representative are valid for their
own products may conduct confirmatory tests on their products on an
independent basis and at their own cost. However, until such
independent test results are made available to EPA, the original
results submitted on behalf of the group will be considered valid for
all member products, and could be applied by EPA to support regulatory
decisions under CAA section 211(c) or requirements for further testing
under CAA section 211(b).
The F/FA grouping system is expected to provide a number of
benefits to the F/FA manufacturers who are responsible for registration
while increasing the efficiency and functionality of the registration
program itself. First, the grouping system will reduce the overall
costs of the registration program by avoiding the generation and
submission of essentially redundant information by individual
manufacturers with similar products. In addition, by reducing the
number of individual formulations that will be subject to testing, the
grouping system is expected to ease the pressure and demands on limited
laboratory capacity.
B. Grouping Approach and Criteria
The basic conceptual framework for the grouping system is
illustrated in Figure 3. First, each fuel or additive is sorted into
one of six broad ``fuel families.'' F/FAs in each fuel family are then
subdivided into three ``F/FA categories.'' The categories are further
subdivided into ``F/FA groups''--the ``working'' units of the grouping
system. It is among the members of the F/FA groups that cooperative
evaluation and testing efforts can be pursued using designated group
representatives. This grouping system is very similar to the approach
that was proposed in the NPRM, with the exception that the original
proposal has been simplified in today's rule by eliminating the
separate concept of ``formulation class.'' EPA judged that the
``formulation class'' concept could be confusing, and was not necessary
for the structure or implementation of the grouping system. The key
parameters and relationships within this grouping framework are further
explained in the following sections. A summary of the grouping system
is provided in Table F94-7 (see Sec. 79.56) of the accompanying
regulatory text for this rule.
BILLING CODE 6560-50-P
TR27JN94.003
BILLING CODE 6560-50-C
Generic rules for categorization and grouping are used to determine
specific F/FA groups based on the raw composition of the particular
products under consideration. The first step entails the selection of
the applicable fuel family and category for the product according to
the criteria discussed below. Rules specific to the categories then
define the proper F/FA group. After the group is formed and
arrangements are made for cooperative testing efforts, applicable
criteria will be applied to select a representative of the group to be
used in group-sponsored testing. In determining the category and group
to which a fuel or fuel additive belongs, impurities present in trace
amounts can be ignored unless otherwise restricted in the definition of
the particular fuel family. Impurities in fuels or fuel additives are
substances which are present through contamination, or remain
naturally, after processing is completed.
1. Fuel Families
This final rule defines six fuel families, as follows: (1) Gasoline
(containing more than 50 percent gasoline by volume), (2) diesel
(containing more than 50 percent diesel by volume; includes both diesel
#1 and diesel #2 formulations), (3) methanol (containing at least 50
percent methanol by volume), (4) ethanol (containing at least 50
percent ethanol by volume), (5) methane (includes compressed natural
gas and liquified natural gas containing at least 50 mole percent
methane), and (6) propane (i.e., liquid petroleum gas containing at
least 50 percent propane by volume). A manufacturer seeking to register
a formulation which does not fit the criteria for inclusion in any of
the above fuel families shall contact EPA for guidance in classifying
and testing such formulation.
In the NPRM, EPA proposed to establish two gasoline fuel families:
unleaded and leaded. As explained previously, EPA is not including a
leaded fuel family in this final rule due to the upcoming ban of leaded
F/FAs under CAA section 211(n). Thus, the unleaded fuel family has been
renamed to become simply the ``gasoline'' fuel family in this final
rule.
Fuel families consist of a constellation of F/FA products sharing
basic characteristics in regard to their chemical/physical properties
and engine/vehicle applicability. For ease of reference, the gasoline
and diesel families are regarded as the ``conventional'' fuel families,
while the remaining four are referred to as the ``alternative'' fuel
families. If a manufacturer develops a F/FA product that does not meet
the definition of any of the fuel families included in this rule, EPA
will define additional fuel families to include such a product.
Each fuel family includes not only the fuels referenced in the name
of the family, but also bulk and aftermarket additives which are
intended for use in such fuels. Additives which are registered for use
in more than one type of fuel are assigned to each applicable fuel
family. For example, an additive product that is registered as both a
gasoline additive and a diesel additive belongs to both the gasoline
fuel family and the diesel fuel family. Furthermore, the manufacturer
of such additive product will be required to test the additive in each
applicable fuel family. The multiple testing responsibility can be
satisfied by the manufacturer individually or by participating in the
applicable groups for each fuel family. For instance, if an additive
product meets the baseline criteria for both gasoline and diesel, then
the product will be assigned to two groups, i.e., the gasoline baseline
group and the diesel baseline group. The manufacturer of such additive
product will then be able to share the costs of testing with other
manufacturers of baseline gasoline F/FAs and baseline diesel F/FAs.
Today's rule specifies the chemical and physical characteristics of
``base fuel'' formulations for each defined fuel family. These are
generic formulations (rather than any particular commercial fuel) with
average or normative characteristics for a given fuel family. Once an
additive has been assigned to the applicable fuel family or families,
determination of the proper category and group (for each applicable
fuel family) for the additive is based on the properties of the mixture
that results when the additive is mixed in the base fuel of the
applicable family at the maximum concentration recommended for use by
the additive manufacturer. Moreover, it is this mixture that is used
for the generation and testing of additive emissions.\17\ Tests
conducted on the emissions of the base fuel then serve as one control
(the other being a clean-air exposure group) against which tests on the
emissions of the additive/base fuel mixture are to be compared. Further
discussion on the definition and use of base fuels is presented in
Section V.
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\17\Special provsions related to the testing of additives are
discussed in Section VI.F.
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2. F/FA Categories
Fuel families are subdivided into three F/FA categories:
``baseline,'' ``non-baseline,'' and ``atypical.'' The baseline category
consists of fuels and associated fuel additives which resemble the
respective base fuel for a particular fuel family in terms of elemental
composition and which conform with certain quantitative limits for
particular constituents. It is important to understand that a baseline
category is not limited to base fuels; the baseline category and group
criteria defined below for each fuel family are considerably less
restrictive than the respective base fuel definitions (specified in
Section V). Non- baseline F/FAs contain no chemical elements other than
those allowed in the baseline category, but they exceed the allowable
baseline limit for certain constituents for the respective fuel family.
The atypical category consists, in general, of F/FAs that contain
chemical elements in addition to those allowed in the baseline
category. (In a few circumstances, the atypical category also includes
F/FAs that exceed specified baseline limits for certain constituents,
as discussed below.) As mentioned above, the category determination for
fuel additives is based on the properties of the mixture which results
when the additive is mixed in the appropriate base fuel at the maximum
concentration recommended for use by the additive manufacturer. If the
fuel or additive/base fuel mixture contains both non-baseline and
atypical constituents, the formulation is characterized as atypical.
Thus, atypical constituents take precedence over non-baseline
constituents.
In establishing the F/FA categories (and the groups within them),
EPA has sought to avoid overly narrow definitions which would result in
unnecessary and duplicative testing by manufacturers, as well as overly
broad definitions which would cause potentially important toxicologic
differences between F/FAs to be obscured. A basic guideline EPA has
used to find the proper balance between these two unsatisfactory
scenarios is to ask whether the emissions of a single group
representative (i.e., test substance) can reasonably be expected to
reflect the chemical and toxicologic properties of the emissions of the
F/FAs proposed to be classified together. In applying this guideline,
EPA has kept in mind both the homogenizing effect of combustion
processes, as well as the need in some cases to examine the effects of
evaporative emissions, which generally retain the characteristics of
the raw F/FA to a greater degree.
These considerations have led EPA to depend on the chemical
elements in F/FA formulations as a primary criterion for categorization
and grouping. Another key criterion is the presence of significant
amounts (by volume, weight, or potential potency) of F/FA constituents
that are likely to change the characteristics of the combustion or
evaporative emissions in substantive ways.
Accordingly, the baseline category in each fuel family is generally
comprised of F/FAs containing no elements in addition to carbon,
hydrogen, oxygen, nitrogen, and/or sulfur.\18\ These elements are the
fundamental chemical building blocks of all of the fuel families
defined in this rule. Omitting any of these elements from the list of
permissible baseline elements would eliminate all or most F/FAs from
the baseline categories. On the other hand, allowing additional
elements in the baseline definition would introduce substances not
characteristic of most F/FA products in the fuel family. If a group
representative (test substance) did not contain the additional element,
it could not reasonably be assumed to reflect the presence and activity
of F/FAs that do contain the element. Conversely, if the group
representative did contain the additional element, then the results of
the testing would be influenced by the presence and activity of this
element, and would therefore not be valid for the large majority of the
baseline F/FAs. Thus, allowing F/FAs with additional elements to be
included in the baseline categories (and groups) would violate the
principles of the grouping system and the objectives of the testing
program.
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\18\The exceptions to this generalization (discussed in later
sections) are small amounts of chlorine permitted in baseline
methanol F/FAs, and small amounts of chlorine and copper permitted
in baseline ethanol F/FAs. Also, trace contamination with elements
other than carbon, hydrogen, oxygen, nitrogen, and sulfur do not
cause F/FAs to be eliminated from baseline categories or groups.
---------------------------------------------------------------------------
F/FA formulations containing elements in addition to those allowed
in the baseline category of a fuel family are classified in the
atypical category for that family. As described further below, such F/
FAs are then subdivided into groups based primarily on which atypical
element(s) they contain. Moreover, the rules for choosing
representatives of these atypical groups emphasize the atypical
constituent(s). This approach assures separate testing of F/FA products
with unique compositional characteristics that can reasonably be
expected to appear in the emissions and may thus have distinct
emissions-based toxicologic effects. EPA believes that this approach
best effectuates CAA section 211(e) by avoiding duplicative testing of
similar F/FA products while requiring ``each'' F/FA to be tested.
Between the baseline category and the atypical category in each
fuel family is the non-baseline category. Broad generalizations about
the non-baseline F/FA categories are somewhat more difficult to make,
since they are distinguished from the respective baseline categories by
various attributes other than elemental composition. In the case of
gasoline and diesel F/FAs, the distinction is based primarily on the
presence of significant concentrations of oxygenating compounds. As
discussed further below, the presence of such compounds may have a
large impact on F/FA emission profiles. Classification of the
oxygenated F/FAs into separate categories from the baseline F/FAs (and
further subdivision into separate groups) is necessary to assure
testing of representatives that can reasonably reflect the differences
in these emission mixtures and, possibly, their health effects. Similar
principles apply to the non-baseline categories in the alternative fuel
families. In the case of alcohol fuels, non-baseline F/FAs are those
which have a substantial non-alcohol and non-gasoline component in the
formulation. Non-baseline propane and methane formulations are those
containing significant amounts of substances other than propane and
methane, respectively. In all of these cases, the non-baseline
definitions serve to ensure that F/FAs with properties that are likely
to result in significantly different emission profiles, with possibly
different toxicologic effects, are not subsumed in the baseline
category.
The following sections describe the criteria which determine F/FA
categories for each fuel family. It should be noted that the criteria
that define baseline F/FA products for each fuel family are not meant
to be fuel specifications. The baseline criteria used for grouping
purposes in this final rule consider the potential health implications
of the composition of the fuel or additive/base fuel mixture and might
differ from previously established commercial fuel specifications, such
as those established by the American Society for Testing and Materials
(ASTM), the California Air Resources Board (CARB), or federal
``substantially similar'' criteria.
a. Gasoline. EPA discussed in the NPRM two options (Option A and
Option B) for distinguishing the baseline and non-baseline categories
for the gasoline fuel family (see 57 FR 13187-13188). Today's action
uses Option A for the classification of gasoline products. A discussion
supporting this decision is included in the ``Summary and Analysis of
Comments for the Fuels and Fuel Additives Registration Regulations''
(available in public docket A-90-07). A synopsis of EPA's analysis
follows.
The major differences between the two alternative grouping options
considered by EPA in the NPRM were: (1) The cutoff point for oxygen
content to distinguish between baseline and non-baseline products, and
(2) the approach for handling F/FAs that have received a waiver under
CAA section 211(f). Under Option A, the baseline category was to be
limited to F/FAs having less than 1.5 weight percent oxygen by weight.
Because the cut-off point of 1.5 percent is consistent with the minimum
oxygen requirement for reformulated gasolines, reformulated gasolines
would not be considered baseline under Option A. Instead, gasolines
with 1.5 percent or more oxygen were to be sorted into different non-
baseline groups depending on the oxygenated compounds they contained.
In contrast, Option B used an oxygen cutoff point of 2.7 weight
percent, based on current ``substantially similar'' criteria (see 56 FR
5352). F/FAs which exceeded this limit but had been granted a waiver
for the excess oxygen were also to be designated as baseline.
After careful evaluation, EPA has selected Option A for the
grouping of gasolines in this final rule. In arriving at this decision,
EPA considered the testing and potential health effects implications of
both grouping options. The main purpose of the grouping system is to
sort F/FAs based on the similarities of their emission components.
After analyzing existing emission characterization data, EPA concluded
that Option B did not provide an adequate approach for the testing of
gasoline F/FAs because it does not distinguish between formulations
that may have significantly different emission characteristics. EPA's
evaluation showed that the emissions from oxygenated gasolines are not
the same as for non-oxygenated gasolines and that, furthermore, the
emission profiles differ according to the particular oxygenated
compound present in a fuel formulation. Differences in emission species
will affect the toxicological characteristics of the fuel or additive/
base fuel mixture. Option B was found inappropriate because it would
have allowed the grouping of gasolines containing significant amounts
of different oxygenated compounds into one single group. These
different compounds may have distinguishable toxic effects. Therefore,
EPA selected Option A for the grouping of gasolines in this final rule
in order to adequately examine the potential health effects of the
different oxygenated compounds. EPA believes this best effectuates the
goal of CAA Section(e) to require testing of each fuel or fuel
additive.
In this final rule, gasoline formulations are defined as those
containing more than 50 percent gasoline by volume. Based on current
``substantially similar'' criteria (see interpretative rule at 56 FR
5352), the sulfur content for all gasoline formulations in the gasoline
fuel family is limited to 0.1 percent by weight.
F/FAs in the baseline gasoline category must contain no elements in
addition to carbon, hydrogen, nitrogen, oxygen, and/or sulfur. Gasoline
baseline formulations must possess, at the time of manufacture, all the
physical and chemical properties of an unleaded gasoline and applicable
volatility class standards as specified in the latest version of ASTM
standard for Automotive Spark-Ignition Engine Fuel, D 4814. As
discussed above, the oxygen content of baseline gasolines must be less
than 1.5 percent by weight. The baseline gasoline category includes all
gasoline fuels and additives (evaluated as additive/base fuel mixtures)
meeting the above criteria.
The non-baseline gasoline category is comprised of F/FAs which
conform to the baseline specifications in terms of elemental
composition, but exceed the specified baseline oxygen limit. Thus, this
category includes gasoline formulations with no elements in addition to
carbon, hydrogen, oxygen, nitrogen, and/or sulfur, which have been
blended with oxygenates (i.e., alcohol, ether, ester, furan, and any
other compound used to increase the oxygen content of the gasoline
formulation), such that the total oxygen content of the gasoline-
oxygenate blend is at least 1.5 weight percent. Included in the non-
baseline gasoline category are reformulated gasolines and oxygenated
gasolines with at least 1.5 percent oxygen (by weight), including a
number of formulations which have previously been granted CAA section
211(f) waivers on oxygen content.
The atypical category in the gasoline fuel family includes F/FAs
which contain elements in addition to carbon, hydrogen, oxygen,
nitrogen, and/or sulfur. (Trace contamination by other elements does
not cause a F/FA to be classified as atypical, however.)
The baseline gasoline group is restricted to formulations that are
derived from conventional petroleum sources. Thus, gasolines derived
from synthetic crude oils are excluded from the baseline category.
Synthetic crude oils can be prepared from coal, shale and tar sands,
heavy oil deposits, and other non-conventional petroleum sources.
Compared to petroleum, these synthetic crude oils must be extensively
upgraded before they can be refined into useful products. Because of
the nature of their sources, these synthetic products are likely to
contain a variety of unknown contaminants with unknown health effects.
With little specific data currently available on their composition, EPA
believes that separate non-baseline classifications are most
appropriate for grouping these products. Gasoline formulations derived
from a particular synthetic crude oil source (e.g., coal) will be
permitted to group together. The representative of each such group will
be the first such product to seek registration.
b. Diesel. Diesel formulations are defined as those containing more
than 50 percent diesel by volume. The sulfur content for all diesel
formulations in the diesel fuel family is limited to 0.05 percent by
weight, based on current EPA limits (55 FR 34120).
The diesel fuel family includes both diesel #1 and diesel #2
formulations.
As originally proposed, the diesel baseline category includes
diesel formulations containing no elements in addition to carbon,
hydrogen, oxygen, nitrogen, and/or sulfur. Baseline diesel formulations
must also possess, at the time of manufacture, all the physical and
chemical properties of a diesel fuel as specified in the latest version
of ASTM standard D 975. Oxygen content of baseline diesel formulations
must be less than 1.0 percent by weight. The baseline diesel category
includes all diesel fuels that meet the above criteria.
The diesel baseline definition is consistent with existing
information in EPA's F/FA registration data base, which indicates that
most commercial diesel fuels, including their bulk additives, consist
of carbon, hydrogen, oxygen, nitrogen, and/or sulfur. While some
currently registered diesel fuels contain additives with additional
elements, the objectives of the testing program are inconsistent with
broadening the diesel baseline definition to include other elements
with potentially different health effects from those of basic diesel
formulations. A broader baseline definition would mean that the
atypical diesel F/FAs would not be separately examined. Limiting
baseline diesel F/FAs to those containing no elements in addition to
carbon, hydrogen, oxygen, nitrogen, and/or sulfur ensures the conduct
of separate health effects evaluations for the emissions of diesel
formulations containing atypical elements.
Similar to baseline gasoline, the baseline diesel category excludes
fuels derived from synthetic crude oil sources. Thus, such formulations
are included in the non-baseline category of the diesel family. The
non-baseline diesel category also includes diesel formulations with 1.0
percent or more oxygen by weight. Examples of non-baseline diesel
formulations are alcohol blends and biodiesel formulations.
c. Methanol. F/FAs in the methanol fuel family are defined as those
containing at least 50 percent methanol by volume. The baseline
methanol category is comprised of methanol and methanol-gasoline F/FAs
that: (1) Contain at least 50 percent methanol by volume, (2) contain
no more than 4 percent by volume of substances other than methanol and
gasoline, and (3) contain no elements in addition to carbon, hydrogen,
oxygen, nitrogen, sulfur, and/or chlorine. The sulfur content of
baseline methanol formulations is limited to 0.004 percent by weight.
Chlorine (as chloride) is limited to no more than 0.0001 percent by
weight. Chlorine is allowed in methanol baseline formulations because
it is a common contaminant remaining from methanol production.
The baseline methanol category includes all methanol fuels meeting
the above criteria and is divided into two groups: M100 group and M85
group. The M100 group includes methanol-gasoline formulations
containing at least 96 percent methanol by volume, while the M85 group
consists of methanol formulations containing 50-95 percent methanol by
volume.
F/FAs within the baseline M100 group are required to contain
odorants and bitterants. These formulations should have a distinctive
and noxious taste, for purposes of preventing purposeful or inadvertent
human consumption. The elemental composition of the odorant and
bitterant is limited to carbon, hydrogen, oxygen, nitrogen, sulfur, and
chlorine. Baseline methanol formulations in the M85 group must comply
with the elemental composition specified above for all baseline
methanol F/FAs, but need not have added odorants and bitterants.
The non-baseline methanol category is comprised of methanol
formulations (i.e., containing at least 50 percent methanol by volume)
that meet the baseline limits on elemental composition, but contain
more than 4 percent by volume of substances other than methanol and
gasoline. a
Atypical methanol F/FAs contain elements in addition to those
allowed in the baseline methanol category or exceed the specified
limits for sulfur or chlorine.
d. Ethanol. Ethanol formulations in the ethanol fuel family are
defined as those containing at least 50 percent ethanol by volume. The
final rule defines a single group (represented by E85) for the baseline
category of ethanol F/FAs. Although in the NPRM, EPA proposed two
baseline groups for the ethanol fuel family (i.e., E100 and E85), EPA
expressed its intention to establish a single group for baseline
ethanol formulations in the Reopening Notice. As discussed in the
Reopening Notice, the rationale behind this decision is that fuel
ethanol is required to contain at least five percent denaturant, which
means that, in actuality, E100 formulations contain only 95 percent
ethanol (i.e., E95). Furthermore, gasoline is normally used as the
denaturant for ethanol fuels. EPA judged that there was little
incremental value in requiring tests of E95 in addition to E85. Thus,
the final rule creates a single baseline ethanol group represented by
E85. However, EPA retains the authority to require testing on other
members of any F/FA group under Tier 3 (see Section IX.A).
The baseline ethanol category is comprised of ethanol and ethanol-
gasoline F/FAs that: (1) Contain at least 50 percent ethanol by volume,
(2) contain no more than 5 percent by volume of substances other than
ethanol and gasoline, and (3) contain no elements in addition to
carbon, hydrogen, oxygen, nitrogen, sulfur, chlorine, and/or copper.
The sulfur content of ethanol baseline formulations is limited to 0.004
percent sulfur by mass. Chlorine (as chloride) and copper are allowed
in the baseline ethanol formulations at a maximum level of 0.0004
percent by mass for chloride and 0.07 mg/l for copper. Chlorine and
copper are permitted in the baseline ethanol formulations because they
are common contaminants remaining from ethanol production. The baseline
ethanol category includes all ethanol fuels meeting the above criteria.
The non-baseline ethanol category is comprised of ethanol
formulations (i.e., containing at least 50 percent ethanol by volume)
that meet the baseline limits on elemental composition, but contain
more than 5 percent by volume of substances other than ethanol and
gasoline.
Atypical ethanol F/FAs contain elements in addition to those
specified in the baseline ethanol category or exceed the specified
limits for sulfur, chlorine, or copper.
e. Methane. Methane F/FAs are defined as those containing at least
50 mole percent methane, including both compressed natural gas (CNG)
and liquified natural gas (LNG). Baseline methane formulations must
contain no elements in addition to carbon, hydrogen, oxygen, nitrogen,
and/or sulfur, and must contain no more than 20 mole percent of non-
methane hydrocarbons. Sulfur content for baseline methane formulations
(including additives) is limited to 16 parts per million (ppm) by
volume. Methane formulations must contain added odorants with an
elemental composition that satisfies the baseline methane definition.
The baseline methane category includes all methane fuels (and
associated additives) meeting the above criteria.
Non-baseline methane formulations are those that exceed the limit
of 20 mole percent non-methane hydrocarbons. Atypical methane
formulations include products containing elements in addition to
carbon, hydrogen, nitrogen, oxygen, and/or sulfur, or exceed the
baseline sulfur limit of 16 ppm by volume.
f. Propane. Propane formulations are defined as those containing at
least 50 percent propane by volume. The baseline propane category
includes LPG formulations containing no elements in addition to carbon,
hydrogen, oxygen, nitrogen, and/or sulfur. Baseline LPG products are
restricted to a maximum of 20 percent by volume for non-propane
hydrocarbons. Sulfur content (including additives) is restricted to 123
ppm by weight. LPG formulations must have a distinctive odor. The
elemental composition of odorants added to LPG formulations is limited
to carbon, hydrogen, oxygen, nitrogen, and sulfur. The baseline propane
category includes all propane fuels (and associated additives) meeting
the above criteria.
Non-baseline propane formulations are those that exceed the
specified limit for non-propane hydrocarbons. Atypical propane
formulations include LPG products that contain elements in addition to
carbon, hydrogen, nitrogen, oxygen, and/or sulfur, or exceed the
baseline sulfur limit of 123 ppm by weight.
3. F/FA Groups
The F/FA groups are subdivisions of the F/FA categories and
represent the final level of product classification within the grouping
system. The groups are the actual operating units of the grouping
system. The objective underlying the group definitions is to sort F/FAs
together when it is reasonable to assume that their emission products
will be essentially the same on a qualitative basis.
A summary table of the F/FA grouping system is included in the
regulations (see Table F94-7 in Sec. 79.56). In this table, the fuel
families serve as column headings and the categories define the rows.
The resulting combination of fuel families and categories (i.e., the
boxes in the table) contain the F/FA groups. Within each category, one
or more groups are defined according to the presence of differing
constituents in the raw fuel or additive/base fuel mixture. The number
of groups in a particular F/FA category depends on the variability
among the products in that category. For example, the atypical category
for each fuel family potentially consists of many groups that are
defined according to the atypical element(s) or constituent(s)
specified for the particular family. Within each group, one formulation
is chosen to represent all of the member products in compliance with
the registration requirements. Related costs may be shared by
participating F/FA manufacturers within each group.
Groups within the Baseline Categories. The baseline category for
each defined fuel family contains a single F/FA group, with the
exception of the baseline methanol category. As discussed above, the
baseline methanol category includes two groups: the M100 group and the
M85 group. The representative to be used in required emission
characterization and health effects tests for each baseline group is
the designated base fuel for the respective fuel family (see Section
V). For example, all gasoline formulations meeting the gasoline
baseline criteria are sorted into one group, to be represented in
testing by the designated gasoline base fuel. The same holds true for
diesel, ethanol, methane, and propane fuel families. In the case of
methanol, baseline formulations are divided into two groups and testing
is performed on two representatives, one for each of the designated
baseline groups, i.e., M100 base fuel and M85 base fuel.
Groups within the Non-Baseline Categories. Non-baseline categories
are defined for each fuel family. F/FAs in non-baseline groups include
products that comply with the baseline elemental composition
restrictions for the respective fuel family, but do not meet
quantitative limits on certain baseline components (e.g., oxygen
content). Non-baseline groups are defined according to the
constituent(s) that differentiate the fuel or additive/base fuel
mixture from the baseline products in the respective fuel family. The
representative for each non-baseline group is the member of the group
with the highest concentration of the non-baseline constituent.
(a) Gasoline. Gasoline formulations which comply with the baseline
elemental composition criteria, except that they have a total oxygen
content of 1.5 weight percent or more, are designated as non-baseline.
These products are grouped according to the specific oxygenate compound
(e.g., any specific alcohol, ether, or methanol/co-solvent combination)
used to increase the oxygen content of the gasoline formulation. Thus,
separate non-baseline groups are defined for ethanol, methyl tertiary
butyl ether (MTBE), ethyl tertiary butyl ether (ETBE), tertiary amyl
methyl ether (TAME), diisopropyl ether (DIPE), di-methyl ether (DME),
tertiary amyl ethyl ether (TAEE), etc.
In the NPRM, EPA had proposed to define additional non-baseline
groups for fuels containing combinations of oxygenate compounds (or for
which the registration contained multiple oxygenate additives), with
separate groups defined for each combination recorded in a
registration. However, EPA decided not to require the testing of
oxygenate combinations in this final rule during the routine Tier 1 and
Tier 2 testing program. EPA believes that the testing of fuels with
individual oxygenates will satisfy the main objectives of the program
by providing basic information about the potential health effects of
particular oxygenated compounds in gasolines. Requiring routine testing
of every recorded combination was judged unreasonable, as it resulted
in a number of groups that did not reflect actual formulations in use.
If there is concern about the toxicity of specific mixtures of
oxygenated compounds, EPA may require additional testing under Tier 3
on a case-by-case basis.
An exception to this treatment of oxygenate combinations occurs in
the case of non-baseline formulations containing methanol. Existing
``substantially similar'' criteria currently limit the use of methanol
as an oxygenate in gasoline to 0.3 percent by volume (i.e., 0.1 percent
by weight), unless the formulation contains appropriate alcohol co-
solvents. Thus, methanol-containing gasoline formulations with 1.5
weight percent oxygen or more must also contain a co-solvent.
Accordingly, in the grouping system, each methanol and co-solvent
combination used in gasoline formulations defines a different non-
baseline group [e.g, methanol and isopropyl alcohol (IPA), methanol and
tertiary butyl alcohol (TBA), methanol and butanol, etc.]. Those
oxygenate compounds used as co-solvents for methanol need to be
identified as such in a fuel's registration. If an oxygenate is not
identified as a methanol co-solvent, even if it appears in a fuel
registration that also includes methanol, then EPA will assume that it
defines a gasoline/oxygenate group separate from the methanol/gasoline
mixture.
Within each non-baseline gasoline group, a formulation consisting
of the base gasoline fuel blended with the highest weight percent of
the oxygenate or methanol/co-solvent combination registered for any
member F/FA product will serve as the group representative that will be
tested to comply with the program's requirements. The selection of the
group representative is to be based on the highest actual
concentration-in-use or the highest recommended concentration-in-use,
whichever is the greater, for the particular oxygenate or oxygenate/co-
solvent blend.
EPA recognizes that current fuel registration procedures allow
manufacturers to include in the original registration a list of all the
potential additives that might be used in the marketed fuel, along with
the applicable range of concentration-in-use for each alternative.
Under these circumstances, this final rule makes the non-baseline
producer responsible for the testing of each oxygenate listed in the
registration. For example, if a gasoline fuel registration lists
methanol/co-solvent, ethanol, MTBE, and ETBE, then the manufacturer is
responsible for separately testing each of four gasoline/oxygenate
blends: gasoline-methanol/co-solvent, gasoline-ethanol, gasoline-MTBE,
and gasoline-ETBE. The multiple testing responsibility can be satisfied
by the manufacturer individually or by participating in four applicable
groups. In each group, a formulation consisting of the base gasoline
fuel blended with the highest concentration of the oxygenate listed for
any member fuel or additive/base fuel mixture would serve as the group
representative to be tested to comply with the program's requirements.
The existing fuel registration procedures also allow manufacturers
to report a range of concentration-in-use for each bulk additive listed
as a potential component of the registered fuel. Thus, it is possible
for the same registration to include formulations under both baseline
and non-baseline definitions. If so, the manufacturer is responsible
for testing formulations in both categories covered by the indicated
range listed in the registration. In other words, if the reported range
of concentration-in-use of an added oxygenate could include gasoline
formulations with less than 1.5 weight percent oxygen as well as
formulations with 1.5 weight percent oxygen or more, then the
manufacturer is responsible for testing formulations in both baseline
and non-baseline categories. For example, suppose a gasoline
registration includes two potential oxygenates with respective
concentration-in-use (shown here in terms of the resulting oxygen
content in the formulation), as follows: ethanol (0 to 3.5 percent
oxygen by weight) and ETBE (0 to 2.7 percent oxygen by weight). Because
the indicated ranges include both baseline and non-baseline
formulations, the manufacturer would be responsible for the testing of
three formulations: baseline gasoline, a non-baseline gasoline-ethanol
blend, and a non-baseline gasoline-ETBE blend. If the manufacturer
chooses to participate in grouping arrangements, then he/she would be
sharing the cost of the testing for the representative of each of these
three groups.
(b) Diesel. Non-baseline diesel formulations contain at least 1.0
percent oxygen by weight. Non-baseline formulations include alcohol
blends, ether blends, biodiesels (e.g., diesel-soy methyl ester blend),
and other formulations containing oxygenating compounds. Separate non-
baseline groups are defined for each added alcohol or ether (e.g.,
methanol, ethanol, DME, etc.) and for other oxygenating compounds by
class (e.g., peroxides, nitroso compounds, nitro compounds, alkyl
nitrites, alkyl nitrates, animal-source alkyl esters, vegetable-source
alkyl esters, furans, etc.).
Diesel fuel manufacturers are responsible for the testing of each
added alcohol, ether, or oxygenate class included in their fuel
registration. For example, if the registration includes added methanol
and soy methyl ester, the manufacturer will be responsible for testing
two non-baseline formulations: (1) A diesel-methanol blend and (2) a
diesel formulation containing a vegetable-source alkyl ester. In order
to satisfy the testing requirements, the manufacturer may perform the
tests individually or take advantage of the grouping provisions to
share the testing costs with other manufacturers of similar products.
In the above example, the manufacturer will be able to group with other
manufacturers of diesel formulations containing methanol and with other
manufacturers of formulations containing other vegetable-source alkyl
esters (e.g., rape methyl ester).
For each diesel non-baseline group defined by the presence of an
alcohol, ether, or class of oxygenating compound, the representative to
be used in testing will be a formulation consisting of the diesel base
fuel blended with the highest actual or recommended concentration-in-
use of the particular alcohol, ether, or class of oxygenating compound,
as recorded for any member of the group. For example, if manufacturers
form a group of non-baseline diesel formulations containing vegetable-
source alkyl esters, the group representative will be a diesel
formulation containing the highest volume percent of any of the
vegetable-source alkyl esters represented in the group. The alkyl ester
is to be added to the base diesel fuel for conducting the required
emission characterization and toxicity tests.
EPA recognizes that current registration procedures allow
manufacturers to include in the original diesel fuel registration a
list of all the potential oxygenating compounds that might be used in
the marketed fuel, along with the applicable range of concentration-in-
use for each alternative. As with gasoline formulations, this final
rule requires the diesel fuel producer to test each alcohol, ether, or
class of oxygenate listed in the registration. Also, if a registration
lists a range of oxygen content that defines both baseline and non-
baseline formulations, then the manufacturer is required to test both a
baseline formulation and a non-baseline formulation.
(c) Methanol. Non-baseline methanol formulations conform with the
baseline limits in terms of elemental composition, but contain more
than 4 percent by volume of substances other than methanol and
gasoline. Individual groups are defined for each non-methanol, non-
gasoline component, and for each unique combination of such components.
The representative of each non-baseline methanol group will be the
group member with the highest concentration (i.e., percent by volume)
of the non-methanol, non-gasoline component(s).
(d) Ethanol. Non-baseline ethanol formulations conform with the
baseline limits in terms of elemental composition, but contain more
than 5 percent by volume of substances other than ethanol and gasoline.
Individual groups are defined for each non-ethanol, non-gasoline
component, and for each unique combination of such components. The
representative of each non-baseline ethanol group will be the group
member with the highest concentration (i.e., percent by volume) of the
non-ethanol, non-gasoline component(s).
(e) Methane. There is only one non-baseline methane group. This
group contains all methane formulations conforming with the baseline
criteria except that they exceed the allowable limit for non-methane
hydrocarbons (i.e., 20 mole percent). The representative for the non-
baseline methane group will be the member formulation containing the
highest concentration of non-methane hydrocarbons.
(f) Propane. Non-baseline propane formulations are those which
conform with the baseline criteria except that they exceed the
allowable limit for non-propane hydrocarbons (i.e., 20 percent by
volume). All non-baseline propane formulations are sorted into a single
group. The representative for the non-baseline propane group will be
the member formulation containing the highest concentration of non-
propane hydrocarbons.
Groups within the Atypical Categories. Atypical groups within each
fuel family are defined according to the distinctive atypical
constituent(s). Separate groups are established for any single atypical
constituent and any unique combination of atypical constituent(s) which
occurs among the products in each category. For example, if a gasoline
fuel contains sodium, and no other atypical element, then this atypical
fuel will group with other gasoline fuels or additive/base fuel
mixtures containing sodium as their only atypical constituent. However,
if a gasoline fuel contains sodium and potassium, then this fuel will
define a separate group for formulations containing both sodium and
potassium. As explained previously, EPA believes that this approach is
reasonable because different atypical elements may have distinct
toxicological effects. Thus, while similarly composed F/FAs may group
together, EPA believes that testing distinct F/FAs separately best
effectuates CAA Section 211(e), which states that ``each'' F/FA shall
be tested.
Groups are further subdivided according to the presence of polymers
containing atypical element(s) in their molecular structure. F/FAs
containing polymers are considered atypical for a respective fuel
family only if the F/FA product as a whole contains one or more
atypical elements. If the polymer contains an atypical element as part
of its molecular structure, then the atypical polymer defines a
separate atypical group. For example, the presence of polyethylene in a
gasoline product does not in itself make that product atypical because
polyethylene contains no elements in addition to carbon, hydrogen,
oxygen, nitrogen, and sulfur. On the other hand, if the gasoline
product contains chlorinated polyethylene, then the product is
considered atypical because of the chlorine content (chlorine is an
atypical element for the gasoline fuel family). Such product could
group with other atypical gasoline products containing chlorinated
polymers. However, if the atypical gasoline product contains
polyethylene and chlorine as two different components of the
formulation, the product will group with other atypical gasoline
products containing chlorine in non-polymer constituents.
For groups defined by a single atypical constituent, the
representative to be used in satisfying the group's testing
requirements will be the member fuel or additive/base fuel mixture with
the highest actual or recommended concentration-in-use of the atypical
constituent. Within a group of such products containing a unique
combination of two or more atypical elements, the representative shall
be the product which has the highest total concentration of atypical
elements. In the case that two or more products within such a group
contain the same and highest concentration of atypical constituents,
the process specified for selecting the representative gives precedence
to the highest total concentration of the atypical constituents in the
following priority order: (1) Total concentration of metals, (2) total
concentration of halogens, (3) total concentration of other atypical
elements (including sulfur, if applicable), (4) total concentration of
polymers containing atypical elements, (5) total concentration of
oxygen.
As discussed previously, current fuel registration procedures allow
manufacturers to include in their registration a list of potential bulk
additives to be used in the fuel. As a result, registrations could
include several additives containing one or more atypical constituents
with the same purpose-in-use, but which are not intended by the fuel
manufacturer to be used at the same time. If several additives for the
same purpose-in-use are listed in a single registration, and if these
additives contain different atypical elements, the manufacturer is
responsible for testing each individual atypical additive separately.
This means that each unique atypical additive listed in a registration
for the same purpose-in-use will define a different testing group. On
the other hand, if a fuel registration includes additives with
different functions and different atypical elements, and if these
additives are normally blended together in the same formulation, then
the manufacturer is allowed to test them together (or to participate in
an applicable group). For example, if a diesel fuel registration lists
two atypical biocide additives, one containing boron and the other
containing chlorine, the fuel manufacturer would then be responsible
for testing two formulations (one diesel formulation containing boron
and one diesel formulation containing chlorine). However, if the
registration includes a boron-containing biocide and a chlorine-
containing detergent, then the manufacturer may test the two additives
together.
C. Implementation of Grouping System and Cost-Sharing Provisions
The grouping system included in this final rule allows
manufacturers of similar F/FAs, on a voluntary basis, to pool their
resources and efforts to satisfy the registration requirements. The
primary objectives of the grouping system and cost-sharing provisions
are to reduce the overall costs of the registration program and
maximize the efficiency of the program by avoiding duplication of
effort. The grouping and cost-sharing provisions included in today's
rule are supported by CAA section 211(e)(3)(B), which permits
manufacturers of similar F/FAs to share the testing costs of the
program so that requirements can be met without duplication. Although
this rule allows manufacturers to comply with the program's
requirements by participation in a group, each manufacturer continues
to be individually subject to this rule and responsible for testing
under this rule.
The practical implementation of the grouping system involves two
major tasks: (1) The organization and administration of group
functions, and (2) the development of equitable arrangements for cost-
sharing. Backed by its experience with respect to the TSCA testing
program, EPA judges that the F/FA industry, under the aegis of its
various trade associations or other third parties, is capable of
accomplishing these tasks with little or no Agency assistance and
interference. EPA's experience with cost-shared testing under TSCA
regulations (40 CFR part 791) indicates that manufacturers prefer to
work out their own cost-sharing arrangements, and EPA anticipates that
F/FA registration applicants will likewise prefer to work out their own
cost-sharing agreements. Public comments from the regulated industry
support this assumption. Thus, EPA intends for manufacturers to work
out cost-sharing agreements by themselves. However, if F/FA
manufacturers cannot work out cost reimbursement, this rule allows F/FA
manufacturers to use procedures similar to existing TSCA procedures
[see Sec. 79.56(c) of this rule] for resolution of disputes.
In addition to establishing cost-sharing mechanisms, F/FA
manufacturers will also need to develop agreements concerning the
division of responsibilities among group members for meeting the
specific requirements of the registration program. EPA expects the
participation of industry trade associations in the formation of groups
and management of these activities. These associations should be able
to establish ``third-party'' mechanisms whereby individual
manufacturers can enroll their products in appropriate groups while
minimizing the extent to which confidential data must be revealed. Each
manufacturer needs to determine whether the grouping and cost-sharing
advantages outweigh the possible competitive risks involved.
In general, F/FA manufacturers should be able to determine the
appropriate groups for their products without EPA involvement,
according to the grouping criteria specified in this final rule, and to
enroll their products into those groups. However, EPA recognizes that
some Agency involvement might be needed in some special cases. When
appropriate, based on EPA's discretion, the Agency will provide limited
guidance for those manufacturers needing assistance with the
application of the grouping criteria to their specific products.
Manufacturers of F/FAs registered prior to the effective date of
this rule are required to notify EPA within six months after the
effective date of this rule if they intend to comply with the rule as
part of a group and, if so, to identify the person or entity which is
organizing the testing (see Section XII.A). In this case, groups of
producers would organize prospectively to complete the same program
requirements for their similar products and cost-sharing arrangements
could be reached in advance of testing.
Manufacturers of F/FAs not registered prior to the effective date
of this rule are expected to conduct the required testing individually,
unless they certify to EPA that they intend to rely on data to be
submitted (and/or previously submitted) by an existing group or
individual manufacturer of a similar registered product. The
certification needs to include assurances that the original submitter
has been notified (see Section XII.A for notification requirements) and
that the manufacturer intends to comply with reimbursement as provided
in this rule.
Under the reimbursement provisions in this rule, there will be a
fifteen years ``reimbursement period'' for the original submitter
(individual or group) to obtain reimbursement from those manufacturers
that rely on previously submitted data. This period has been lengthened
from the originally proposed five years in response to public comments.
V. Base Fuel Specifications and Formulation Requirements
In this final rule, EPA is establishing chemical and physical
specifications to represent base fuel formulations for each defined
fuel family. EPA has adopted the method proposed in the reformulated
gasoline rulemaking (56 FR 31176), which uses sales-weighted averages
of fuel survey data to determine national average chemical and physical
parameters, to establish base fuel specifications for gasoline and
diesel. Because comparable survey data are not available for
alternative fuels, the base fuels for the alternative fuel families are
based on CARB definitions and limited survey information.
The generic base fuel formulations will function as archetypes of
the F/FAs in each fuel family and will serve as the test substance or
group representatives for the baseline group(s) for the respective fuel
family. The use of consistently formulated base fuels will facilitate
the comparison of the emission and health effect test results from the
many fuel and fuel additive products within each fuel family. The base
fuels will also serve as the fuel substrates into which additives
undergoing evaluation will be mixed prior to emission generation and
testing. Tests conducted on the emissions of the base fuel will then
serve as controls against which tests on the emissions of the additive/
base fuel mixture will be compared.
In addition to defining chemical and physical parameters for each
base fuel, EPA is also specifying the allowable additive(s) to be
included in the base fuel. EPA recognizes that commercial fuels
typically contain additives to control fuel quality and enhance fuel
performance, as well as to help in fuel production and distribution.
Ideally, in order to better isolate the health effects associated with
a particular additive or fuel, the base fuel would not contain
additives unless they were the actual test subjects. However, several
bulk additive types are common to most of the fuels within a given fuel
family, and these should arguably be included as part of the base fuel.
As a practical matter, it would be difficult in some instances to find
a fuel that did not contain certain additive types used by refiners to
facilitate production or distribution. EPA is thus requiring that base
fuels contain a limited complement of the additives which are essential
for the fuel's production or distribution and/or for the successful
operation of the test vehicle/engine throughout the mileage
accumulation and emission generation periods required under this rule.
Since additives may have a substantial effect on emissions, for
purposes of standardization it is important to specify the additive
types which are to be contained in the base fuels. However, the
selection of the specific product within each specified additive
functional category is left to the formulator of the base fuel and/or
the manufacturer responsible for the testing. Unless otherwise
restricted, the presence of trace contaminants does not preclude the
use of a fuel or fuel additive as a component of a base fuel.
Additive requirements for each defined base fuel are discussed in
the following sections. Additives used as base fuel components are to
be added at the minimum treatment rate needed for effective
performance. In contrast, additives to be tested must be mixed in the
base fuel at the maximum in-use concentration recommended by their
manufacturers.\19\ When a fuel additive is tested, any additive
normally contained in the base fuel which serves the same function as
the test subject additive must be removed from the base fuel
formulation. For example, if a corrosion inhibitor is to be tested,
this test additive would replace the corrosion inhibitor normally
included as a component in the base fuel. This substitution requirement
may preclude the use of certain multi-functional additives as base fuel
components (in the case where the subject additive serves one of the
functions of the multi-functional additive), since it would not be
possible to replace a portion of a multi-functional additive with the
test subject additive.
---------------------------------------------------------------------------
\19\Special provisions related to the testing of additives are
discussed in Section VI.F.
Note: The specifications in the following sections describe the
base fuel(s) for each fuel family, which serve the test fuel
functions discussed above. These base fuel specifications are not
the same as the criteria which permit F/FAs to join the baseline
group within a fuel family. The baseline group criteria are provided
in the preceding section of this preamble.
A. Gasoline
For the gasoline base fuel, EPA is requiring the use of the
reformulated gasoline summer baseline fuel as specified in CAA Section
211(k)(10)(B)(i). This unleaded gasoline fuel, which is free of
oxygenates, was determined from fuel survey data and will be used to
represent all grades of conventional gasoline. This base fuel has the
same specifications as the industry average gasoline used in many
recent fuel emission studies, including the Auto/Oil Program\20\ and
EPA's reformulated gasoline testing program. Selecting this formulation
as the base gasoline fuel allows the comparison of emission
characterization results from the F/FA testing program with a larger
body of current emission data. The blending tolerances for the gasoline
base fuel are consistent with certain blending tolerances specified in
the RFG rule (59 FR 7716).
---------------------------------------------------------------------------
\20\Auto/Oil Air Quality Improvement Research Program, Technical
Bulletin #1, December 1990; available in Docket A-90-07, Item No.
IV-A-08.
---------------------------------------------------------------------------
The gasoline base fuel must contain the following additives:
deposit control, corrosion inhibitor, demulsifier, anti-oxidant, and
metal deactivator. In addition to the above required additives, the
final rule allows manufacturers to use anti-static additives in the
gasoline base fuel, if needed. Anti-static additives are not required
in gasoline base fuel because this type of additives is not considered
essential for the fuel's production, distribution, or the vehicle
operation. Thus, anti-static additives should be used only as a safety
measure on a case-by-case basis, as needed (e.g., when static problems
present a risk of explosion). The required and permissible gasoline
base fuel additives may contain no elements in addition to carbon,
hydrogen, oxygen, nitrogen, and/or sulfur.
In the Reopening Notice, EPA proposed to preclude the use of
sulfur-containing additives in the gasoline base fuel. However, in
response to a number of comments from the regulated industry, this
final rule permits up to 15 ppm sulfur to be included in the additives.
The total sulfur content in the base fuel, including any sulfur
contributed by the additive components, must equal 339 ppm (within a
tolerance of 25 ppm). A summary of the gasoline base fuel
specifications and its additive components is provided in the
accompanying regulations [see Table F94-1 in Sec. 79.55(b)].
B. Diesel
Reflecting its predominant usage, #2 diesel is selected in this
final rule as the base fuel for diesel. The specifications for the
diesel base fuel were determined by calculating an industry average
diesel fuel from 1990 industry and government diesel fuel survey data.
The sources of data and methods of calculations are contained in the
docket for this rulemaking.\21\ The blending tolerances for the diesel
base fuel have been set to be comparable to those used in the gasoline
base fuel. An exception to this general methodology is the base fuel
specification for sulfur level. The required sulfur level (0.05 weight
percent) reflects current on-road diesel fuel sulfur limits (55 FR
34120).
---------------------------------------------------------------------------
\21\See memorandum from James Greaves to Docket A-90-07 (Item
No. IV-B-01) regarding ``Revised Base Diesel Fuel Determination
Procedures for the Fuels and Fuel Additives Rulemaking.''
---------------------------------------------------------------------------
The additives required as diesel base fuel components are:
corrosion inhibitor, demulsifier, anti-oxidant, and metal deactivator.
In addition to the above required additives, the final rule allows the
use of anti-static and flow improver additives in the diesel base fuel,
as needed. As with gasoline, anti-static additives are not required
because they should only be used in the case of static accumulation
problems. Similarly, flow improvers may be used on a need basis to
improve cold weather handling.
As in the gasoline base fuel, the diesel base fuel additives may
contain sulfur, as well as carbon, hydrogen, oxygen, and nitrogen. The
total sulfur content in the diesel base fuel formulation, including any
sulfur contributed by the additives, may not exceed 0.05 percent by
weight. A summary of the diesel base fuel specifications and allowed
additive components is provided in the regulatory text [see Table F94-2
in Sec. 79.55(c)].
C. Alternative Fuels
EPA has used CARB definitions and other available information to
establish base fuel specifications for each alternative fuel family
(see Tables F94-3--F94-6 in Sec. 79.55). However, due to rapidly
developing technology, the fuel additive package requirements for these
fuels are not as well established as for gasoline and diesel. In fact,
there is only limited information available on the additive
requirements for the successful long-term operation of each alternative
fuel/vehicle combination. Hence, it is the responsibility of the F/FA
manufacturers who are required to test such base fuels (in consultation
with EPA), to comply with the additive requirements of the manufacturer
of the particular vehicle/engine used for the testing of alternative F/
FAs. If the manufacturer of an alternatively-fueled vehicle or engine
specifies that additives (beyond those specified in the regulations),
are essential for operation, then the F/FA manufacturer should submit a
request to EPA to use those additional additives as components of the
base fuel at the minimal effective level. EPA will publish a document
in the Federal Register whenever approving such a request to modify a
base fuel.
1. Methanol
The methanol fuel family contains two fuel groups, one for M100
fuels and one for M85 fuels. Each of these methanol groups has its own
base fuel. These base fuels may only contain the elements carbon,
hydrogen, oxygen, nitrogen, sulfur, and chlorine. The chlorine (as
chloride) is permitted as a contaminant remaining from methanol
production, and is limited to no more than 0.0001 percent by mass. The
sulfur content may not exceed 0.002 percent by mass in the base M100
fuel and may not exceed 0.004 percent by mass in the base M85 fuel.
The M100 base fuel must consist of 100 percent chemical grade
methanol by volume. The M85 base fuel is to contain 85 percent chemical
grade methanol by volume, blended with 15 volume percent base gasoline
fuel (meeting the gasoline base fuel specifications outlined in Section
V.A., above). Specifications for the methanol base fuels are listed in
Table F94-3 in Sec. 79.55(d) of the regulations.
Some gasoline detergents have been shown to cause intake system
deposits when used in M85 applications. Likewise, lubricating oils
containing calcium have been shown to cause injector tip deposits in
M100 applications. Therefore, EPA recommends that F/FA manufacturers
determine the methanol compatibility of lubricating oils as well as
fuel additives used in the gasoline portion of the M85 base fuel.
2. Ethanol
The ethanol fuel family contains one group, represented by E85 base
fuel. The E85 base fuel is to contain 85 percent chemical grade ethanol
by volume, blended with 15 volume percent base gasoline. The ethanol
base fuel may only contain the elements carbon, hydrogen, oxygen,
nitrogen, sulfur, chlorine, and copper. The chlorine (as chloride) is
permitted as a contaminant remaining from ethanol production, and is
limited to no more than 0.0004 percent by mass. The sulfur content may
not exceed 0.004 percent by mass. Copper, also a contaminant from
ethanol production, is limited to 0.07 mg/L.
Additives used in the gasoline component of E85 base fuel must be
ethanol-compatible. The base fuel specifications for E85 are summarized
in Table F94-4 in Sec. 79.55(e) of the regulatory text.
3. Methane
The methane fuel family is represented by a natural gas base fuel
whose specifications are within the proposed ranges for natural gas
certification fuel (as proposed in 57 FR 52912). This base fuel may
only contain the elements carbon, hydrogen, oxygen, nitrogen, and
sulfur, with the sulfur limited to 16 parts per million (by volume).
The methane base fuel must contain added odorant for leak detection
purposes, used at a level such that at ambient conditions the fuel has
a distinctive odor potent enough for its presence to be detected down
to a concentration in air of not over \1/5\ (one-fifth) of the lower
limit of flammability.
In the Reopening Notice, EPA proposed that any sulfur in the
methane base fuel be limited to that contained in the odorant additive.
In response to public comment, this restriction has been removed;
however, the total sulfur in the methane base fuel formulation,
including that contributed by any additives, may not exceed 16 parts
per million. The methane base fuel specifications are listed in Table
F94-5 in Sec. 79.55(f) of the accompanying regulations.
4. Propane
The propane fuel family is represented by a commercial LPG base
fuel. The propane base fuel may only contain the elements carbon,
hydrogen, oxygen, nitrogen, and sulfur, with the sulfur limited to 123
ppm (by weight). The propane base fuel must contain added odorant, for
leak detection purposes, at a level such that at ambient conditions the
fuel has a distinctive odor potent enough for its presence to be
detected down to a concentration in air of not over \1/5\ (one-fifth)
of the lower limit of flammability. As in the case of the methane base
fuel, the final rule does not require the sulfur in the formulation to
be contained only in the odorant additive. Rather, the sulfur
limitation applies to the fuel/additive mixture in combination. The
propane base fuel specifications are listed in Table F94-6 in
Sec. 79.55(g) of the regulatory text.
VI. Emission Generation
A. General Approach
As part of the registration requirements, F/FA manufacturers are
required to conduct a detailed characterization of the combustion and
evaporative emissions of their products, as well as biological tests in
which animals are exposed to these emissions. The next sections
describe the methods specified in the rule for generating the emissions
to be used in these chemical and biological tests.
As proposed in the NPRM, combustion emissions are to be generated
using applicable portions of the FTP.\22\ To control some of the
inherent variability of FTP emissions generated under transient engine
operation,\23\ this final rule requires the use of a mixing chamber or
other apparatus (see Section VI.B.2). This is one of the approaches
discussed for consideration in the Reopening Notice. EPA is permitting
the use of either the engine dynamometer or the chassis dynamometer for
emission generation during biological testing using FTP or FTP-
equivalent cycles. For the reasons discussed in the Reopening Notice,
EPA has decided to require the use of non-catalyzed emissions (i.e.,
untreated exhaust emissions)\24\ for biological testing in order to
assure that the test animals are exposed to the full range of emission
species potentially resulting from the combustion of F/FAs. A brief
summary of the rationale behind this decision is included below.
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\22\Federal Test Procedure (FTP) are the standard exhaust and
evaporative emissions test procedures described in 40 CFR part 86
and used by EPA to certify new vehicles.
\23\Transient engine operation is achieved by varying the engine
speed and/or engine load, which typically results in an emission
stream varying in quantity and composition over time.
\24\Exhaust emission not subject to an aftertreatment device
such as a functional catalyst or particulate trap.
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It is important to keep in mind that the purpose of this program is
not to test the effectiveness of emission control devices or to
directly evaluate the emission performance of various vehicles and
engines. Rather, it is to examine the potential toxicologic effects of
the emissions produced by F/FAs in use. With modern emission control
technology in place, most of the ambient air pollutant species
attributable to automobile exhaust come from two sources:
Malfunctioning vehicles (``high emitters'') and normal vehicles during
their cold start period, when their engines run rich and their
catalytic converters have not yet reached effective operating
temperatures. The variety of emissions from these two important sources
are not well represented by hot, catalyzed exhaust generated from well-
maintained, modern vehicles. Emissions during the cold-start include
hundreds of organic chemical species which are generated before the
catalytic converter reaches its effective temperature. Once the
catalytic converter is warmed-up, its efficiency increases to the point
where only a dozen or so simple compounds remain in readily measurable
amounts in the catalyzed exhaust. Thus, the use of catalyzed exhaust in
the biological testing program would exclude from the tests relevant
emission species that could potentially be harmful to human health or
the environment. In fact, laboratory animals would be exposed to only
very few of the organic emission species associated with the combustion
of the fuel or additive of interest. In contrast, the ambient air
normally contains the full range of combustion emissions, since cold-
start emissions are continuously reintroduced and some ``high
emitters'' are always in operation. Since humans experience long-term
exposure to these emissions, EPA believes it is important that they be
included in the test exposure atmosphere. EPA's analysis\25\ of non-
catalyzed emission data demonstrates that emissions that receive no
aftertreatment represent a comprehensive aggregate of characteristic
combustion products at enriched concentrations, including the species
which may otherwise be emitted only during the cold start or by high-
emitting vehicles. In order to simulate emissions that include the full
range of potential species produced in the combustion of F/FAs, EPA is
requiring the use of non-catalyzed emissions for biological testing in
this program.
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\25\See memorandum from Stephen Mayotte to Docket A-90-07 (Item
No. IV-B-02) regarding ``Engine-out versus Tailpipe Emissions in
Light-duty Vehicles.''
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With the exception of exhaust after-treatment devices, this final
rule requires that all normally required emission control equipment be
present and fully operational on all test vehicles and heavy-duty
engines used in the generation of non-catalyzed emissions. In order to
maintain the appropriate operation of the exhaust system while
obtaining non-catalyzed emissions, EPA requires the use of non-
functional aftertreatment devices (e.g., a blank catalyst with no
catalytic wash coat) in order to simulate the back pressure, residence
time, and mixing characteristics usually provided by normally
functioning aftertreatment devices. Special emission generation
allowances for the testing of specific additives which are introduced
for use in conjunction with certain aftertreatment devices are
discussed in Section VI.F.
B. Combustion Emission Generation
1. For Emission Characterization
Manufacturers are required under Tier 1 to characterize the
combustion emissions of their F/FAs. Depending on the fuel family in
question, vapor-phase, semi-volatile, and particulate emissions may be
required to be characterized.\26\ As discussed in Section VII.B., the
emission characterization requirements include the measurement of
hydrocarbons, carbon monoxide, oxides of nitrogen, particulates,
aldehydes, ketones, alcohols, ethers, polycyclic aromatic compounds,
and atypical products, as applicable.
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\26\Examples of general sampling procedures for vehicle
emissions are discussed in Schuetzle, D., ``Sampling of Vehicle
Emissions for Chemical Analysis and Biological Testing,''
Environmental Health Perspectives, Volume 47, pp. 65-80, 1983.
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Both untreated (non-catalyzed) and treated (tailpipe)\27\ emissions
generated using FTP conditions are to be characterized.
Characterization of the tailpipe emissions will allow comparison of
emissions from the test F/FA product with results from other studies.
Characterization of the non-catalyzed emissions will be used to
identify the emissions to which animals will be exposed in the
biological tests.
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\27\Tailpipe emissions are emissions downstream from all
normally present emission aftertreatment devices, i.e., catalytic
converters and/or particulate traps.
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Applicable FTP procedures to be used in generating emissions are
specified in 40 CFR part 86. The Urban Dynamometer Driving Schedule
(UDDS)\28\ and the Engine Dynamometer Driving Schedule (EDS)\29\ cycles
of the FTP shall be used in the emission generation for light-duty
vehicles and heavy-duty vehicles, respectively. The motoring portion of
the heavy-duty test cycle can be eliminated, at the manufacturer's
option, for the generation of emissions. This will allow the use of
relatively inexpensive dynamometer equipment without compromising the
value of the test.
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\28\UDDS is a 1372 second transient speed driving sequence used
by EPA to simulate typical urban driving. The UDDS for light-duty
vehicles is described in 40 CFR part 86, Appendix I(a).
\29\EDS is the transient engine speed versus torque time
sequence commonly used in heavy-duty engine evaluation. The EDS for
heavy-duty diesel engines is described in 40 CFR part 86, Appendix
I(f)(2).
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As discussed earlier, this final rule allows the use of a vehicle
or engine for emission generation using FTP procedures. In the case of
F/FAs normally used in light-duty vehicle applications, if an engine is
to be used, the appropriate speed versus torque trace for the UDDS must
be determined in a vehicle on a chassis dynamometer prior to emission
generation. The engine used for emission generation in this testing
program must then be operated under specific speed and torque
conditions that simulate the UDDS.
In light-duty vehicle testing, vapor phase emission samples are to
be collected for each segment of the FTP cycle (i.e., Bag 1, Bag 2, and
Bag 3). In addition, a semi-volatile sample and a particulate sample
are to be collected during the driving cycle for light-duty vehicles.
The heavy-duty testing procedure includes two tests: a cold-start test
and a hot-start test. All three emission phases (i.e., vapor, semi-
volatile, and particulate) are to be collected for each heavy-duty
test. Some modifications to the standard FTP may be required for
collection of semi-volatile and particulate emissions, which are
required for emission characterization and in-vitro biological testing
(see next section). Special procedures may also be necessary in order
to characterize emissions from F/FAs containing atypical elements. Good
engineering and analytical chemistry practices should be followed while
modifying the applicable test cycle for the collection of fractions not
specified in 40 CFR part 86. Such modifications must be described in
detail in the discussion of emission generation procedures to be
included in the report provided to EPA, as discussed in Section XII.B.
Vapor-phase emissions are to be collected and stored in Tedlar bags
for subsequent chemical analysis. These emissions can be stored for
only a limited period of time before chemical changes may occur. The
critical time period is a function of the composition of the emissions,
storage temperature and pressure, type of storage container, exposure
to ultraviolet light, and the amount of deterioration that is
considered acceptable. The maximum allowable storage times for
emissions which are to be subjected to chemical analysis will vary
depending on the speciation protocol, and are identified in relevant
parts of the regulatory text.
The particulate fraction may be collected on a single filter
instead of on multiple filters as prescribed in the FTP. Although the
filter collection procedures outlined in the CFR were designed for
heavy-duty emission testing, these methods are applicable and can be
used in light-duty applications as well. Similarly, semi-volatile phase
emissions are to be collected on one apparatus for the entire driving
cycle. Semi-volatile emissions are collected immediately downstream
from the particulate collection filters using porous polymer beds or
other equipment designed for their capture.\30\ After collection, the
soluble organic fractions of the particulate and semi-volatile
emissions are to be separately extracted using appropriate laboratory
procedures.\32\ Because the extracted materials are much more stable
than gaseous combustion emissions, they can be stored up to six months
if protected from ultraviolet light and maintained at or below -20
deg.C. Particulate phase emissions can be stored either on the
collection filter or after extraction. Semi-volatile phase emissions
must be extracted immediately after collection. The duration of the
collection process which will be needed to obtain sufficient quantities
of the test substance will vary depending on the emission
characteristics of the engine and fuel or additive/base fuel mixture,
and on the requirements of the biological test protocol. If an
insufficient amount of particulate or semi-volatile material is
obtained during a single driving cycle, the FTP may be repeated as
required and the extracted organic fractions combined.
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\30\An example procedure using a porous polymer resin as a
trapping medium is described in Stump, F. et al., ``Trapping Gaseous
Hydrocarbons for Mutagenic Testing,'' SAE Technical Paper Series No.
820776, 1982; Available in Docket A-90-07 (Item No. II-J-14).
\31\Examples of particulate and semi-volatile emission
collection and analysis methods are described in 40 CFR
Sec. 86.1301-1344 and in Coordinating Research Council Report No.
551 (entitled ``Chemical Methods For The Measurement Of Unregulated
Diesel Emissions--Carbonyls/Aldehydes, Particulate Characterization,
Sulfates, PAH/NO2PAH,'' August 1987; available in Docket A-90-
07, Item No. II-J-15).
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2. For Biological Testing
Non-catalyzed emissions are to be generated for conducting
biological tests, following the same procedures described above for
emission characterization.
In vitro biological testing (i.e., the Salmonella assay) is to be
conducted on extracts of the particulate and semi-volatile emission
phases separately. Particulate and semi-volatile emissions are to be
collected in a manner identical to the procedure used for particulate
and semi-volatile emission characterization.
The in vivo biological testing requires the generation of whole
untreated emissions for a minimum of six hours per day, five days per
week, for 13 weeks. To generate these emissions, light-duty vehicles
(or engines) with non-functional after treatment devices (e.g., blank
catalyst with no catalytic wash coat) are to be operated under FTP or
FTP-equivalent engine conditions. The continuous generation of
emissions throughout the required exposure period requires light-duty
vehicles/engines to be driven through repeated UDDS cycles and heavy-
duty engines to be operated over repeated EDS cycles. If desired,
registrants may automate their emission generation system.
As discussed in the Reopening Notice, EPA was concerned about the
inherent variability of FTP-generated emissions. To accommodate the FTP
transient cycle within the biological testing program, this rule
requires the use of an apparatus to provide a more stable exposure
environment for biological testing. For this purpose, EPA recommends
the development and use of a large dilution/mixing/integration chamber
located between the constant volume sampling (CVS) system and the final
dilution apparatus, just prior to the exposure chamber containing the
test animals. The mixing chamber will allow the necessary adjustment of
the exhaust concentrations and integration of t
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