Fuels and Fuel Additives Registration Regulations; Final Rule |
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Carol M. Browner
Environmental Protection Agency
27 June 1994
[Federal Register Volume 59, Number 122 (Monday, June 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13784]
[[Page Unknown]]
[Federal Register: June 27, 1994]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 79
Fuels and Fuel Additives Registration Regulations; Final Rule
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 79
[FRL-4892-7]
RIN 2060-AC10
Fuels and Fuel Additives Registration Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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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.
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\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.
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\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 the large concentration
swings typical of FTP exhaust, prior to exposing the test animals. This
chamber must meet certain performance specifications based on the
average concentration of total hydrocarbons in the exhaust. That is,
the average concentration of total hydrocarbons leaving the mixing
chamber must be within ten percent of the average concentration of
total hydrocarbons entering the chamber. Much of the CVS system
concentration variability is associated with the rapidly changing
dilution ratios that result from rapidly changing exhaust flow rates.
EPA recognizes that vehicle exhaust sampling devices, such as mini-
diluters,\32\ are being developed to maintain constant dilution ratios
during transient testing. These systems will eliminate much of the
concentration variability of classical CVS exhaust. As discussed in the
Reopening Notice, these systems are currently under development and
their use at this time is limited. However, today's rule will allow
their use if they can meet the performance specifications defined above
as well as other requirements of the testing program.
---------------------------------------------------------------------------
\32\A discussion on mini-diluter technology can be found in:
American Industry/Government Emissions Research (AIGER) Cooperative
Research and Development Agreement, ``Specifications for Advanced
Emissions Test Instrumentation,'' AIGER PD-94-1, Revision 5.0,
February 1994; available in Docket A-90-07, Item No. IV-A-09.
---------------------------------------------------------------------------
The combustion emissions generated for animal testing are to be
diluted prior to delivery to the test animals. The CVS system, commonly
used to condition exhaust for sampling and analysis, provides for
controlled ambient air dilution of the combustion emissions. However,
water condensation can be a problem during CVS system sample
conditioning, depending upon vehicle fuel consumption and fuel economy,
dilution air humidity, and exhaust/diluent ratio.\33\ The use of pre-
dried dilution air will lower the sample humidity, thus permitting
lower dilution ratios and higher concentration of hydrocarbons to be
achieved without condensation of water vapor. The minimum dilution
ratio will vary with fuel composition. For example, a minimum dilution
ratio of about 1:5 raw exhaust (dewpoint about 125 deg.F) with dry,
clean filtered air is expected for gasoline fuels to reduce the water
concentration to a dewpoint of about 68 deg.F. The minimum dilution
ratio (maximum exhaust flow rate) occurs at about 200 seconds into the
UDDS transient driving cycle. The dilution ratio is expected to be
greater for methanol, ethanol, and natural gas fuels than for gasoline
fuels because the exhaust water concentrations are greater with these
alternative fuels. Heated transfer ducts or tubing can be used to avoid
water condensation in much of the system, but the dilution/mixing/
integration chamber will generally be at or near laboratory temperature
(about 70 deg.F), and CVS dilution will have to be adequate to assure
that the cumulative integrated chamber dew point remains below
laboratory temperature at all times.
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\33\An example procedure on how to deal with water vapor
condensation problems is found in Black and Snow, ``Constant Volume
Sampling System Water Condensation,'' SAE 940970, 1994. This paper
describes a ``spreadsheet'' procedure for detailed, second by
second, determination of diluted exhaust dew point and the necessary
CVS system flow rates to avoid water vapor condensation.
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After initial dilution to preserve the character of the emissions,
the exhaust stream may be further diluted to achieve the desired
biological exposure concentrations. In testing the emissions of a
particular fuel or additive/base fuel mixture, a manufacturer shall
determine an optimum range of dilutions with which to characterize the
health effects of the test substance. The range of dilutions shall
include, at a minimum, an overtly or highly toxic concentration, a
minimally toxic or non-toxic concentration, and a concentration of
emissions having an intermediate level of toxicity. The selected
concentrations must allow the determination of a concentration-response
relationship (see Section VIII.A.3). EPA recommends that manufacturers
review available literature for information on the design of inhalation
studies.\34\
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\34\An example reference is Phalen, R. F., ``Inhalation Studies:
Foundations and Techniques,'' CRC Press, Inc., Boca Raton, Florida,
1984.
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One important factor to consider in determining the exposure
concentrations or dilutions is the effect of carbon monoxide (CO)
concentration in test animals. The CO concentration in the emissions is
expected to be a limiting factor in establishing the appropriate
dilutions for the testing of F/FAs. Anoxia, among other negative health
effects from this combustion product, may mask the more subtle health
effects of F/FA emissions. EPA recommends that manufacturers review
available literature on previous toxicity studies for information on
appropriate CO concentrations that have been used in the exposure of
laboratory animals to automobile emissions.\35\\36\\37\
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\35\Stara et al., ``Long-Term Effects of Air Pollutants in
Canine Species,'' EPA/600/8-80/014, 1980.
\36\Brightwell, J. et al., ``Neoplastic and Functional Changes
in Rodents after Chronic Inhalation of Engine Exhaust Emissions,''
In: Ishinishi, N. et al., (eds), Carcinogenic and Mutagenic Effects
of Diesel Engine Exhaust, Elsevier Science Publishers, Amsterdam,
pp. 471-485, 1986; available in Docket A-90-07, Item No. IV-A-17.
\37\Pepelko, W. E. et al., ``Effect of 90 Days Exposure to
Catalytically Treated Automobile Exhaust in Rats,'' Environmental
Research, Volume 19, pp. 91-101, 1979.
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3. Verification Testing
A number of mechanisms can cause emissions to be captured in the
dilution and sampling system before they can be characterized or used
for animal exposures. Verification testing is required to determine the
ratio (``recovery factor'') of emissions that exit the sampling system
to those that enter the system. This ratio must be high in order for
subsequent emission testing to be meaningful.
EPA requires testing to verify the exposure atmosphere and to
monitor the performance of the dilution/sampling system and mixing
chamber, ensuring the repeatability of test results. Verification
testing of the dilution/sampling system must be accomplished by
injecting a known sample at the inlet and measuring the amount that
exits the sample probe. For example, an injected hydrocarbon sample
could be detected with a gas chromatograph and flame ionization
detector to estimate the recovery factor. Similar verification
procedures apply to the verification testing of the mixing chamber.
Verification procedures for the dilution/sampling system and mixing
chamber are included in Sec. 79.57(e)(2)(v) of the accompanying
regulations. Additional requirements include the monitoring of
conditions (e.g., air flow, CO levels, etc.) in the inhalation exposure
chamber and verification of test animal exposure levels (see
Sec. 79.61).
C. Evaporative Emission Generation
Section III.A.2 discusses the RVP criteria which determine the
applicability of evaporative emission testing to specific fuels and
additive/base fuel mixtures. Evaporative emissions from in-use vehicles
include diurnal, hot soak, resting and running loss emissions, and
refueling emissions. However, to simplify the generation and collection
procedures and to supply evaporative emissions of sufficient
concentration for biological exposure testing, today's rule requires
that evaporative emissions be generated using an evaporative emission
generator (EEG). Emissions to be used both for characterization tests
and biological exposure tests are to be generated in this way. The EEG
is a fuel tank or vessel to which heat is applied to cause a portion of
the fuel or additive/base fuel mixture to evaporate at a desired rate.
Manufacturers will have flexibility in the design of the EEG used to
test their particular F/FA. The size and/or number of EEG units to be
used for evaporative emission testing will depend on the rate of
emissions needed for the inhalation study. The vapor pressure of the F/
FA product may influence the required tank size, as well. Emission rate
modifications shall not be adjusted by temperature control, since
emission composition is sensitive to temperature changes.
In general, the composition of evaporative emissions from vehicles
does not resemble fully-evaporated whole samples of raw fuels or fuel
additives. This phenomenon is due to differences in the vapor pressure
of the fuel or fuel additive components and the effects of evaporative
emission control equipment. To simulate this phenomenon with the EEG,
procedures are to be followed to ensure that the evaporated fraction
contain a reasonable representation of potential evaporated emission
compounds. The EEG will be run at 1305 deg.F and will be
equipped with a drain. The fuel will be drained and replenished
periodically in order to maintain a constant composition and prevent
the build-up of heavier compounds in the non-evaporated portion. The
concentration of emissions of the evaporated fuel or additive/base fuel
mixture in the vapor space of the EEG during the time emissions are
being withdrawn for testing shall not vary more than ten percent from
the equilibrium concentration in the vapor space of emissions generated
from fresh fuel or additive/base fuel mixture in the evaporative
chamber.
EPA recognizes that other methods may also be suitable for
generating F/FA evaporative emission mixtures for the testing purposes
of this program. One possible alternative method was suggested in a
comment received by EPA in response to the Reopening Notice.\38\ Based
on the distillation properties of the test formulation, the suggested
method would involve the distillation, condensation, and storage of the
light-end components of the test fuel mixture, with revaporization of
this whole fraction to generate test atmospheres. Other alternatives
may also be valid. To accommodate these potential alternatives, the
final rule contains a provision (see Sec. 79.57(f)(5) of the
accompanying regulations) which permits manufacturers to request
approval for methods other than the EEG for generating evaporative
emission test atmospheres. To be granted, such requests must include
supporting information which demonstrates (among other requirements)
that the proposed procedures will generate emissions reasonably similar
to in-use evaporative emission mixtures and that the generated
emissions will be sufficiently concentrated to be useful in the context
of toxicology tests. Approved procedures will be placed in the public
docket.
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\38\Comments of the American Petroleum Institute on U.S. EPA's
Fuels and Fuel Additives Registration Regulations, March 28, 1994
(Item IV-D-49 in Docket A-90-07).
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For applicable F/FAs, evaporative emission characterization
requirements include the measurement of total volatile organic
compounds with speciation of the hydrocarbon compounds, alcohols,
ethers, and atypical compounds. Characterization requirements are
discussed in Section VII.B.
For biological testing, evaporative emissions will be diluted and
routed to the animal chambers in a manner similar to the method used
for combustion emissions health effects testing, as described in the
previous section, except that a mixing chamber is not required. The
rate of emission generation shall be high enough to supply the
biological exposure chamber with sufficient emissions to allow for a
minimum of fifteen air changes per hour.
The concentration of total hydrocarbons in the evaporative emission
stream routed to the biological exposure chambers is to be diluted to
three separate concentrations to establish a range of responses similar
to combustion emission testing (see previous section). Evaporative
emissions are not constrained by CO, NOX, or CO2 levels, and
hence can be used at higher concentrations than combustion emissions.
Verification testing is required for evaporative emissions in a manner
analogous to the verification testing performed for combustion
emissions.
D. Vehicle Selection
EPA is requiring that new vehicles or engines be used for the
combustion emission generation and testing of F/FAs to avoid the carry-
over effects from previously used fuels. All F/FAs must be tested in
vehicles or engines (corresponding to chassis or engine dynamometer
testing, respectively) that have been operated exclusively on the fuel
or additive/base fuel mixture to be tested.
EPA is also requiring that vehicles and engines used for the
testing of
F/FAs be unaltered from original equipment manufacturer (OEM)
specifications (with the exception of modifications in aftertreatment
devices as described in Section VI.A). Rebuilds and alteration kits
will only be allowed upon EPA's approval, when a F/FA manufacturer
demonstrates to EPA that OEM equipment suitable for their F/FA
product's testing is unavailable.
As proposed in the NPRM (57 FR 13192-13193), vehicle and engine
selection must follow the criteria outlined in Sec. 79.57(a) of the
accompanying regulations. The selection method is described in detail
in a memorandum entitled, ``Vehicle Selection Procedures for the
Proposed Fuels and Fuel Additives Rulemaking'' (see Item No. II-B-6 in
the public docket of this rule). As proposed, the final rule does not
differentiate between light-duty vehicles and light-duty trucks. Thus,
vehicles/engines are separated into two classes: light-duty and heavy-
duty. The vehicle or engine selected must be a new vehicle or engine of
the model year in which testing begins. However, vehicle selection
criteria are to be based on technology characteristics of the previous
model year. Any one of the top five selling models (based on sales
figures from the year prior to testing) with the appropriate technology
in a fuel group may be chosen. Each test vehicle or engine must be
equipped with all of the normally required and functioning emission
control equipment, with the exception of aftertreatment devices, when
applicable (see Section VI.A).
Considering the practical constraints of the rule, EPA is requiring
that only one vehicle or engine model be used to generate emissions for
these tiers. Although EPA recognizes that emission composition is
somewhat dependent on vehicle models and may even vary in replicate
tests of the same vehicle/fuel combination, the use of untreated
exhaust in the testing program will greatly reduce the significance of
these potential sources of variability. The purpose of the testing
program is to determine potential health effects of
F/FA emissions and not to establish in-use fleet average emission
levels for different types of vehicles. However, EPA reserves the right
to require the testing of F/FAs in additional vehicles or engines,
under Tier 3, if there is concern for technology-based differences in
toxicological effects. Furthermore, EPA could require the use of
catalyzed exhaust to perform tests under Tier 3.
Although EPA is routinely requiring only one vehicle or engine for
the testing of F/FAs, EPA foresees that at least one backup vehicle/
engine of the identical model may be needed to replace vehicles/engines
that wear out or malfunction during the course of testing. The
probability of needing a replacement vehicle or engine increases in the
case of testing F/FAs containing atypical elements that require
additional mileage accumulation (see next section). The decision
concerning the timing of vehicle and engine replacements is the
responsibility of the F/FA manufacturer seeking registration. EPA
recommends that backup vehicles/engines (if present) accumulate mileage
along with the primary test vehicle, so as to minimize testing
interruptions if the backup vehicle/engine is needed. Manufacturers
may, at their own discretion, alternate between backup vehicles (or
engines) during testing to further decrease the probability of problems
or interruptions. Similarly conditioned vehicles/engines (i.e., primary
and backup vehicle/engine) would be expected to generate comparable
emissions. Emissions from backup vehicles/engines must have their
emissions characterized prior to use in the biological studies. Wide
discrepancies between the emissions of primary and backup vehicle/
engine emissions may be cause to void a test.
During emission generation, vehicles and engines must be maintained
in good condition by following the OEM recommendations for service
schedule and parts replacement. If unscheduled maintenance becomes
necessary, the vehicle or engine must be repaired to OEM
specifications, using OEM or OEM-approved parts. In addition, the
manufacturer is required to measure the basic emissions (as described
in Section VII.B.2.a) after the unscheduled maintenance and before
resuming testing, to demonstrate that the post-maintenance emissions
are within 20 percent of pre-maintenance emission levels. If the basic
emissions cannot be brought within 20 percent of their previous levels,
then the manufacturer must restart testing using a new vehicle or
engine. Provisions in the regulations allow for a limited amount of
emission generation disruption without voiding the biological test.
E. Mileage Accumulation
New vehicles (or engines) to be used in emission generation for the
testing of F/FAs are required to undergo a break-in period in which the
vehicle (or engine) is run exclusively on the fuel or additive/base
fuel mixture to be tested. The mileage accumulation requirements of
this final rule follow the approaches discussed in the Reopening
Notice. These requirements serve the purpose of stabilizing the
emissions from the new vehicle or engine.
Vehicles to be used in the evaluation of baseline and non-baseline
F/FAs are required to accumulate at least 4,000 miles prior to emission
testing. For engines operated on an engine dynamometer, the minimum
break-in requirement is 125 hours of operation for testing baseline and
non-baseline F/FAs. The 4,000 mile/125 hour mileage accumulation
requirements are consistent with the emission stabilization procedures
used in EPA's new vehicle certification program.\39\ An intact
aftertreatment device must be used when accumulating mileage in the
evaluation of baseline and non-baseline F/FAs. Mileage can be
accumulated in a number of ways, i.e., on a test track, on a
dynamometer, on the street, or as part of a manufacturer's fleet. No
specific driving cycle is required, but it must include a reasonable
amount of transient operation.
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\39\40 CFR 86.094-26. Mileage and service accumulation; emission
requirements.
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For atypical F/FAs, the minimum mileage accumulation required prior
to testing is also 4,000 miles for test vehicles or 125 hours for test
engines. After completion of the 4,000 mile/125 hour minimum mileage
accumulation, an attempt should be made to identify and measure the
atypical element(s) in the emissions. Mileage accumulation must
continue until either: (1) 50 percent or more of the input mass of each
atypical element is measured in the emissions (i.e., vapor, semi-
volatile, and particulate combined), or (2) a maximum mileage
accumulation equivalent to 40 percent of the average useful life of the
applicable vehicle/engine (e.g., 40,000 miles for light-duty vehicles,
116,000 miles for heavy-duty vehicles, or engine equivalent) has been
reached. When either of these conditions has been met, emission
generation can begin for purposes of emission characterization or
biological testing. Because the presence of atypical species in
specific emission fractions will be dependent on the nature of the
particular atypical element, EPA recommends examination of all emission
fractions (i.e., vapor, semi-volatile, and particulate). The
determination of the appropriate intervals for conducting emissions
measurements is left to the manufacturer's discretion.
Manufacturers of atypical F/FAs may choose to accumulate the
required mileage using a vehicle/engine equipped with either an intact
aftertreatment device or with a non-functional aftertreatment device
(e.g., a blank catalyst without its catalytic wash coat).\40\ However,
the sampling and analysis of emissions for detecting the atypical
element(s) of interest, prior to emission characterization or
biological testing, must be done with a non-functional aftertreatment
device. A brief period of warm-up driving (i.e., 10 miles or equivalent
time) needs to precede the sampling for the detection of atypical
element(s).
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\40\If the manufacturer chooses to accumulate mileage without a
functional aftertreatment device, and if the manufacturer wishes to
do this outside of a laboratory/test track setting, then a
memorandum of exemption for product testing must be obtained by
applying to the Director of the Field Operations and Support
Division [see Sec. 79.51(e)(6)(iv) of this rule].
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During the mileage accumulation period for the testing of any fuel
or fuel additive, vehicles and engines used for emission generation
must be maintained in good condition by following the recommended
maintenance practices in the appropriate vehicle or engine owner's
manual. Maintenance requirements were described in the previous
section.
F. Special Requirements for Additives
This section describes provisions for the testing of specific types
of additives that might require modification in emission generation
requirements. These include additives used in conjunction with
aftertreatment devices, additives used infrequently, and diesel
additives produced exclusively for use in diesel #1 fuels.
As explained in the above sections, EPA is requiring that emissions
used for Tier 1 and Tier 2 testing be generated from vehicles/engines
with non-functional aftertreatment devices. In response to comments
received on the Reopening Notice, however, EPA is including in this
final rule a special allowance for specific types of additives that are
designed to work in conjunction with aftertreatment devices. In the
case of fuel additives specifically intended to enhance the
effectiveness of exhaust aftertreatment devices, the related
aftertreatment device may be used on the emission generation vehicle/
engine during all mileage accumulation and testing.
Regarding infrequently used additives, EPA recognizes that some
aftermarket additives are intended by the manufacturer (as stated in
the additive's instructions for use) to be added to the fuel tank only
at infrequent intervals. During mileage accumulation, these types of
additives may be applied according to the manufacturer's
specifications. However, during emission generation and testing, EPA
requires that each tankful of fuel used contain the fuel additive at
its maximum recommended level. In the case of bulk additives used
intermittently for the direct purpose of conditioning or treating a
fuel during storage or transport, or for treating or maintaining the
storage, pipeline, and/or other component of the fuel distribution
system (and not the vehicle/engine for which the fuel is ultimately
intended), EPA also requires that the additive be added to the base
fuel at the maximum concentration recommended by the additive
manufacturer for treatment of the fuel or distribution system
component. If the manufacturer of infrequently used aftermarket or bulk
additives (as described above) is concerned that the test vehicle/
engine may be adversely affected and/or the emissions may be subject to
artifacts due to overuse of these types of additives, then that
manufacturer may submit a request for a modification in test procedure
requirements. Any such request must include test data (e.g., emission
characterization data) to support the claim that procedural
modification is needed, as well as a suggested substitute procedure.
In order to simplify diesel additive testing and allow
comparability between the test results of all diesel additives
evaluated in this program, EPA requires that all diesel additives
(including those produced exclusively for use in #1 diesel fuels) be
tested on the #2 diesel base fuel (specified in Section V). If a
manufacturer is concerned that the emissions generated using a blend of
their #1 diesel fuel additive with the #2 diesel base fuel may be
subject to artifacts due to this blending, then that manufacturer may
submit a request for a modification in test procedures. Any such
request must include supporting data (e.g., emission characterization
data) and suggested test modifications.
VII. Tier 1 Requirements
The scope of Tier 1 encompasses: (1) a literature search for
available information on the composition and effects of F/FA emissions
on public health and welfare, (2) a chemical analysis to characterize
the emissions of fuels or additive/base fuel mixtures, and (3) a
qualitative discussion of potential exposures using information on
total production volume and market distribution patterns of the
particular fuel(s) or additive/base fuel mixture(s).
A. Literature Search
1. Scope
The registration program requires
F/FA manufacturers to conduct a comprehensive data search that will
include all relevant existing information concerning previous emission
characterization and health effects and welfare studies. The data
search must address the chemical composition and potential adverse
effects of whole combustion emissions, relevant combustion emission
fractions (e.g., particulate phase), and whole evaporative emissions,
as applicable. The literature search must also address each of the
individual combustion and evaporative (where different) emission
products identified by the required emission speciation procedures,
with the exception of carbon monoxide, carbon dioxide, nitrogen oxides,
benzene, 1,3-butadiene, acetaldehyde, and formaldehyde. Special
literature search requirements for non-baseline and atypical F/FAs are
described in Section VII.A.3.
Information considered applicable to a given fuel or additive
includes data obtained from the testing of emissions from the fuel or
additive in question or from other similar products. For this purpose,
``similar'' products are those which meet the criteria for enrollment
in the same F/FA group as the subject fuel or additive, pursuant to the
grouping system criteria discussed in Section IV. F/FA manufacturers
who choose to participate in the grouping system may pool information
about all member products for purposes of their joint submission and
may also make use of available data on other products which are not
enrolled in the group but share the designated formulation
characteristics of group members. Similarly, a manufacturer who chooses
not to participate in the grouping system could include any test
results which may be available for products which could theoretically
be assigned to the same group as the manufacturer's own product.
The survey on health effects studies is not restricted to the
particular endpoints and experimental protocols included in Tier 2.
Studies using other scientifically acceptable methods or protocols
addressing all health effects of F/FA emissions must also be included
in the Tier 1 report. Most often, data will be available from
experiments conducted with laboratory animals, but other applicable
studies must also be considered. Evidence for potential toxicity or
lack of toxicity in exposed humans may be available from
epidemiological studies, clinical studies, occupational exposures, or
case reports. In general, referenced experiments must be concerned with
the health effects of inhalation exposure to F/FA emissions (combustion
and evaporative). However, data collected from relevant studies using
other routes of exposure must also be included. Available results from
in vitro tests, comparative metabolism studies, and structure-activity
analyses are also considered relevant and must be included in the
summary report for health effects of F/FA emissions.
The data search must include available literature on welfare
effects, including, but not limited to, the exposure and response of
plants and animals to whole emissions and individual components of
emissions, the potential for bioaccumulation, and the concentration and
persistence of emission products in the air, soil, and water. Available
results of exposure modeling analyses, environmental and atmospheric
fate modeling studies, field studies, monitoring studies, accident
evaluations, or environmental simulation experiments must be included
to characterize potential exposures and the environmental impact of F/
FA emissions. Specific ecological studies addressing the potential
environmental effects of F/FA emissions on vegetation, livestock,
wildlife, aquatic species, and soil organisms must be included. In
addition, the data search must address the welfare effects of F/FA
emissions concerning their contribution to odor and visibility
nuisances.
Both public and in-house available sources must be included in the
literature survey. Information on the health and environmental effects
of
F/FAs is to be compiled from peer- reviewed scientific journals and
other literature as well as internal industry studies, government-
sponsored reports, proceedings of scientific meetings, and other
documented sources. In general, EPA will place greater confidence in
studies that have been subject to peer review. A search of appropriate
commercially available chemical, toxicological, and environmental data
bases must be conducted to obtain information from published sources.
An example list of commercially available data bases that may be used
to obtain information on potential health and environmental effects, as
well as environmental fate data, is available in the public docket of
this rule.\41\
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\41\See memorandum from Ines del C. Figueroa to Docket A-90-07
(Item No. IV-B-03) regarding ``List of Data Bases.''
---------------------------------------------------------------------------
In the NPRM, EPA proposed that literature searches cover at least
fifteen years. However, in response to public comments, EPA has
increased this time period to cover at least thirty years prior to the
date of submission, so that important information from earlier testing
will not be omitted. In addition, literature searches must be current
as of six months prior to the beginning of testing. The thirty years
are not meant to be an absolute limit for data collection. EPA
encourages F/FA manufacturers to do a comprehensive search that will
include all relevant available information, regardless of the age of
the data.
The information to be submitted to EPA as a result of the data
search includes the following items: (1) Brief text summary of the
general findings and conclusions, including references, (2) a printed
copy of the outputs from the data base searches, including reference
list and associated abstracts, (3) complete documentation in scientific
journal format of unpublished in-house or other privately-conducted
studies, and (4) tables summarizing the protocols and results of all
cited studies, organized by health or environmental endpoint and type
of emissions (e.g., whole combustion emission, individual emission
product). In addition, the person(s) or contractor(s) conducting the
literature search and summary must be identified. Further discussion on
the reporting requirements of this final rule is included in Section
XII.
2. Adequate Existing Information
The primary purpose of the literature search is to provide EPA with
a comprehensive survey of the available data on health and welfare
effects of
F/FAs. A secondary function of the literature search is to enable F/FA
manufacturers to document the extent to which the emission
characterization in Tier 1 and/or the evaluation of health effects
included in Tier 2 have already been addressed by previous adequate
testing and/or analysis. If adequate testing/analysis exists, F/FA
manufacturers may submit such previous data in compliance with the
requirements of the registration program. For example, if previous
emission characterization studies addressing the speciation
requirements of this program are available in the literature, then F/FA
manufacturers may submit those studies in lieu of new characterization
tests. Similarly, F/FA manufacturers could use the literature search to
determine the availability of adequate biological tests in compliance
with Tier 2 requirements.
To satisfy the testing requirements of Tier 1 and/or 2 with
previously conducted studies, reports of such previous tests must be
sufficiently detailed to allow EPA to judge the adequacy of protocols,
techniques, experimental design, statistical analyses, and data
interpretation. Documentation must be sufficient to determine if the
previously conducted studies were performed in a manner consistent with
generally accepted scientific principles, good laboratory practices,
and the specific testing guidelines in question. The age of the data
will be considered but will not be the ultimate determining factor in
deciding if an existing study is adequate. Although changes in
technological approaches and methodology might preclude the use of some
older studies, EPA recognizes that older literature can be useful for
the purposes of this program. Thus, the quality of the study will be
the deciding factor in determining the adequacy of existing studies,
not the age per se. Additional criteria to be used in determining the
adequacy of existing data/studies in relation to Tier 2 compliance are
provided in Section VIII.C.
3. Special Requirements for Non-Baseline and Atypical F/FAs
EPA recognizes that many of the individual chemical species that
will be present in the emissions of non-baseline and atypical F/FAs
will also be present in the emissions of baseline products in the same
fuel family. Non-baseline formulations, as defined in this rule,
contain the same elements as baseline formulations. Thus, on a
qualitative basis, the emission products from non-baseline F/FAs are
expected to overlap with those of baseline F/FAs in the same fuel
family. For atypical F/FAs, the main differentiating characteristic is
the presence of atypical element(s) which are not included in the
baseline category for a particular fuel family. The composition of the
emissions for atypical products, therefore, is expected to consist
mainly of those species present in the emissions of baseline
F/FAs (for the same fuel family), with the addition of compounds which
host the specific atypical element(s) of interest.
In addition to requiring literature data on the potential health
and welfare effects of the whole combustion and evaporative (where
different) emissions of the particular F/FA product, Tier 1 also
specifies that a literature search be conducted on each of the emission
products of the tested fuel or additive/base fuel mixture. Because of
the substantial overlap in the emission species of F/FAs in different
categories within the same fuel family, however, this requirement could
result in significant duplication of effort and waste of resources. To
avoid this outcome, as authorized under CAA section 211(e)(3)(C), this
final rule allows manufacturers of non-baseline and atypical F/FAs to
limit the literature search done for individual emission species to
only those compounds which are different from the compounds typically
present in the emissions of baseline F/FAs for the same fuel family.
In order to take advantage of this reduction in requirements,
manufacturers of non-baseline or atypical F/FAs must compare the
emission characterization results of their products with emission
characterization data for baseline F/FAs. Such data may be available
from private sources, in-house testing, or from publicly available
literature or data bases. For example, emission characterization data
for baseline gasoline are expected to be available in published
literature from studies sponsored by the Auto/Oil Program.\42\ The data
base ``SPECIATE'' might also be useful in identifying baseline
emissions species for gasoline.\43\ Other applicable literature on
gasoline and diesel emissions can be obtained in the NRC Report on
``Feasibility of Assessment of Health Risks from Vapor-Phase Organic
Chemicals in Gasoline and Diesel Exhaust.''\44\ Emission
characterization data for alternative fuels is available in a variety
of CARB reports.45,46
---------------------------------------------------------------------------
\42\An example reference is ``The Auto/Oil Air Quality
Improvement Research Program SP-920,'' (published by SAE, Inc.,
February 1992). Similar information may be obtained from other Auto/
Oil publications.
\43\``SPECIATE--VOC/PM Speciation Data Base Management System,''
Version 1.5, EPA-454/C-93-013, October 1992. This data base can be
obtained electronically from the CHIEF Bulletin Board System (modem
phone no. 919-541-5742). For information on this data base, call
919-541-5285 (INFO CHIEF).
\44\Published by National Academic Press, Washington, DC, 1983
(see Appendix A of Report).
\45\``Definition of Low-Emission Motor Vehicle in Compliance
with the Mandates of Health and Safety Code Section 39037.05,''
CARB, May 19, 1989.
\46\``Proposed Reactivity Adjustment Factors for Transitional
Low-Emission Vehicles,'' Technical Support Document, CARB, September
27, 1991.
---------------------------------------------------------------------------
B. Characterization of Emissions
1. Scope
The chemical analysis requirements of Tier 1 satisfy the provision
in CAA section 211(b)(2)(B) requiring information ``to determine the
emissions resulting from the use of the fuel or additive contained in
such fuel.'' The characterization of emissions in Tier 1 will provide a
useful inventory of potentially harmful F/FA emission products for
further study and evaluation in support of the F/FA testing program,
risk assessments, and future regulatory actions.
F/FA manufacturers are responsible for the generation, collection,
and sampling of the combustion and, if applicable, the evaporative
emissions of their F/FAs, and for the conduct of tests to determine the
identity and concentration of individual emission products. In general,
the required procedures are directed toward the detection and
measurement of selected chemical classes and compounds. The analyses
include: (1) the measurement of basic emissions (i.e., total
hydrocarbons, carbon monoxide, oxides of nitrogen, and particulates),
(2) the speciation of volatile hydrocarbon compounds, aldehydes,
ketones, alcohols, ethers, and polycyclic aromatic compounds, and (3)
the speciation of atypical emission products (when atypical elements
are known to be present in the raw fuel or additive formulation).
Speciation requirements are summarized in Table 1.
Table 1.--Emission Characterization/Measurement Requirements
----------------------------------------------------------------------------------------------------------------
Speciated Emissions
---------------------------------------------------------------------
Emission Type Basic Polycyclic
Emissionsa Hydrocarbons Ketones and Alcohols and Aromatic Atypicalsd
Aldehydes Ethersb Compoundsc
----------------------------------------------------------------------------------------------------------------
Combustion emissions:
Vapor phase............... X X X X ............ X
Semivolatile phase........ ............ ............ ............ ............ X X
Particulate phase......... X ............ ............ ............ X X
Evaporative emissions:e
Evaporative emission
generatorf............... Xg X ............ X ............ X
----------------------------------------------------------------------------------------------------------------
aBasic emissions=total hydrocarbons, carbon monoxide, oxides of nitrogen, and particulates (see Section
VII.B.2.a below).
bRequired if alcohols or ethers exist in the uncombusted fuel or additive/base fuel mixture.
cIncludes specific polycyclic aromatic hydrocarbons (PAHs), nitrated polycyclic aromatic hydrocarbons (NPAHs),
and poly-chlorinated dibenzodioxins/dibenzofurans (PCDD/PCDFs). PAH and NPAH speciation is not required for F/
FAs in the methane (CNG, LNG) and propane (LPG) families, or for F/FAs in the atypical categories of other
fuel families. Chlorine-containing atypical F/FAs are subject to the dioxins/furans speciation requirements.
dManufacturers of atypical products must examine all emission fractions for the measurement and identification
of potential atypical species.
eOnly applicable to F/FAs required to measure evaporative emissions.
fEvaporative emissions are to be generated using an evaporative emission generator as described in Section VI.C.
gThe only basic emission required to be measured for evaporative emissions is total hydrocarbons.
2. Speciation Procedures
Section VI describes the required procedures for the generation of
both combustion and evaporative emissions. Characterization of
combustion emissions must be done both for non-catalyzed emissions and
for tailpipe emissions. As discussed in Section III.A.2, the
evaporative emissions of some F/FAs are also required to undergo
emission characterization analysis. To provide an indication of the
variability, the emissions must be generated and characterized three
times on three different days. Collection and speciation of background
samples is required.
The CAA authorizes EPA to require information to characterize F/FA
emissions, while giving EPA discretion to specify the particular
protocols to be used for this purpose. The following sections identify
the general emission product categories of interest and discuss
currently available protocols which are suitable for their analyses.
EPA recognizes that scientific methods can be expected to advance in
the future. Thus, the use of the protocols referenced in this final
rule is not mandated. Rather, EPA will hold F/FA manufacturers
accountable for state-of-the-art methods and good analytical chemistry
and laboratory practices, such as those described in the article
``Principles of Environmental Analysis.''\47\
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\47\Keith et al., ACS Committee on Environmental Improvement,
``Principles of Environmental Analysis,'' The Journal of Analytical
Chemistry, Volume 55, pp. 2210-2218, 1983; available in Docket A-90-
07, Item No. II-J-12.
---------------------------------------------------------------------------
Today's rule does not discourage the use of any validated method to
perform the characterization of emissions, or the submittal of existing
speciation results obtained from validated methods, as long as the data
address the speciation requirements of the F/FA registration program.
EPA acknowledges the state-of-the-art methods of the Auto/Oil Air
Quality Improvement Research Program (Auto/Oil Program) for the
characterization of emissions. In fact, the speciation requirements
included in this rule for fuels composed primarily of hydrocarbon
compounds of twelve carbons (C12) or less (e.g., gasoline) are based on
such methodology.48, 49, 50 Where applicable, EPA will accept
results from the Auto/Oil Program as adequate data in lieu of new
testing. However, the Auto/Oil Program might not address all the
emission characterization requirements of today's rule, so additional
procedures (e.g., for the analysis of polycyclic aromatic compounds)
might be needed. EPA recognizes that characterization data have already
been submitted to EPA in relation to the Auto/Oil Program. F/FA
manufacturers need not resubmit this information, but are required to
reference these data (e.g., report number, applicable page numbers,
etc.) on the Tier 1 report so EPA can verify the adequacy of the
information being used in compliance with the F/FA registration program
for the particular
F/FA product or group representative. Although resubmission of the raw
emission data is not required, manufacturers are still responsible for
providing a summary discussion of the emission characterization results
in the Tier 1 report as outlined in Section XII.B.
---------------------------------------------------------------------------
\48\Jensen, T. E. et al., ``Advanced Emission Speciation
Methodologies for the Auto/Oil Air Quality Improvement Program--I.
Hydrocarbons and Ethers,'' SAE 920320 In: Auto Oil Air Quality
Improvement Research Program, SP-920, February 1992.
\49\Swarin, S. J. et al., ``Advanced Speciation Methodologies
for the Auto/Oil Air Quality Improvement Research Program--II.
Aldehydes, Ketones, and Alcohols,'' SAE 920321, In: Auto Oil Air
Quality Improvement Research Program, SP-920, February 1992.
\50\Siegl, W. O. et al., ``Improved Emission Speciation
Methodology for Phase II of the Auto/Oil Air Quality Improvement
Research Program--Hydrocarbons and Oxygenates,'' SAE 930142, 1993.
---------------------------------------------------------------------------
For the characterization of diesel
F/FAs, EPA recognizes the procedures under the Air Pollution Research
Advisory Council (APRAC) program. The work done by APRAC provides
speciation guidelines for unregulated diesel emissions and addresses
diesel combustion compounds of concern to EPA. As with the Auto/Oil
Program studies, existing applicable APRAC speciation studies will be
considered adequate data in lieu of new testing. However, today's rule
requires manufacturers of diesel F/FAs to perform speciation procedures
for hydrocarbons which might not be included in the APRAC program.
These are discussed in the following sections.
a. Characterization of Basic Emissions. EPA proposed to require the
characterization of ``regulated emissions'' for fuel/vehicle types for
which certification procedures existed at the time of the publication
of the NPRM (i.e., gasoline, diesel, and methanol). Today, EPA is
terming this requirement ``basic emissions,'' instead of ``regulated
emissions,'' because certification requirements are not established yet
for all the F/FAs included in this rule. To be consistent and avoid
confusion, the term ``basic emissions'' is used for all F/FA families
included in this rule. Based on the current regulated emissions and
taking into consideration the objectives of this program, EPA selected
four basic emissions for measurement, as follows: Total hydrocarbons,
carbon monoxide, oxides of nitrogen, and particulates.
The four basic emissions are to be measured in combustion emissions
as a routine requirement for all F/FA families, as shown in Table 1.
Only total hydrocarbons are required to be measured in evaporative
emissions. Manufacturers are referred to the vehicle certification
procedures in 40 CFR part 86 for general guidance on the measurement of
the basic emissions of interest to this rule.
b. Characterization of Hydrocarbons. As shown in Table 1, this rule
requires the speciation of hydrocarbons for the vapor phase of
combustion emissions and for evaporative emissions generated using an
evaporative emission generator. The speciation is to be performed using
methods that identify and determine the concentration of all
hydrocarbon compounds containing twelve or fewer carbon atoms. The
Auto/Oil Program procedures referenced above provide an acceptable
speciation method for hydrocarbons.
c. Characterization of Aldehydes and Ketones. Speciation of
aldehydes and ketones containing a maximum of eight carbon atoms is
required only for the vapor phase of combustion emissions. A test
procedure for formaldehyde measurement is included in 40 CFR part 86
for formaldehyde. F/FA manufacturers are also referred to the Auto/Oil
Program procedures referenced above for the analysis of aldehydes and
ketones. Additional applicable procedures are available in ASTM D 5197-
91, ``Standard Test Method for Determination of Formaldehyde and Other
Carbonyl Compounds in Air (Active Sampler Methodology).''
d. Characterization of Alcohols and Ethers. Alcohol and ether
compounds containing six or fewer carbon atoms are to be characterized
for both evaporative and combustion emissions, whenever the fuel or
additive/base fuel mixture under evaluation contains alcohols or
ethers. If a F/FA formulation contains an alcohol or ether with more
than six carbon atoms, then this manufacturer is required to measure
their presence in the emissions, as well as alcohols or ethers with
fewer number of carbon atoms. For example, if an ether containing seven
carbon atoms (e.g., isopropyl tertiary butyl ether) is part of a fuel
formulation being tested in this program, then its manufacturer must
characterize ethers with seven or fewer carbon atoms.
In addition to the Auto/Oil Program procedures referenced above, a
test procedure for the characterization of alcohols and ethers is
described in 40 CFR part 80, Appendix F, entitled ``Test Method for
Determination of C1-C4 Alcohols and MTBE in Gasoline by Gas
Chromatography''. This procedure can be used for the identification of
ethers in addition to MTBE, but will require appropriate modifications
for application to gas phase samples.
e. Characterization of Polycyclic Aromatic Compounds. In the NPRM,
EPA proposed a broad requirement for the identification and measurement
of polycyclic aromatic compounds. In the final rule, this requirement
is narrowed to a limited number of specified compounds which are of
significant concern in terms of their potential non-carcinogenic and/or
carcinogenic effects. Included are specified polycyclic aromatic
hydrocarbon (PAH) and nitrated polycyclic aromatic hydrocarbon (NPAH)
compounds as well as individual compounds and classes of
polychlorinated dibenzodioxins/dibenzofurans (PCDD/PCDFs).
In addition to specifying particular polycyclic aromatic compounds
for analysis, the final rule reduces the families and/or categories of
F/FAs which are subject to these requirements. PAH and NPAH speciation
need not be done for F/FAs in the methane and propane fuel families,
nor for F/FAs in the atypical categories of other fuel families.
Furthermore, speciation of dioxins/furans is required only for
F/FAs which contain chlorine as an atypical element. This is consistent
with the requirement applicable to atypical F/FAs in general, that all
emission species containing the relevant atypical elements be
identified and measured (see section f, below).
While EPA believes that characterization of dioxins/furans is also
important in the case of baseline and non-baseline
F/FAs, the NPRM did not propose to require this procedure on a wider
basis. EPA has thus refrained from including mandatory requirements for
speciation of dioxins/furans in the case of baseline and non-baseline
F/FAs. Instead, for manufacturers of
F/FAs other than chlorine-containing atypical F/FAs, dioxin/furan
characterization is included in the final rule only on a voluntary
basis. EPA strongly encourages manufacturers of baseline and non-
baseline F/FAs to collect the necessary emission samples and conduct
these voluntary procedures at the same time that mandatory emission
characterization requirements are being fulfilled. The recent attention
and concern about the potential health effects of dioxins/furans,
combined with the current dearth of information on the specific sources
and generation of these compounds, increases the likelihood that these
procedures will be prescribed under EPA's discretionary Tier 3
authority if the necessary data are not otherwise submitted on a
voluntary basis. If so, the incremental costs are likely to be
considerably higher than if the procedures were conducted in
conjunction with the standard Tier 1 emission characterization tasks.
As was proposed, the final rule requires the measurement and
speciation of polycyclic aromatic compounds in both the semi-volatile
phase and particulate phase of combustion emissions. While, in the
past, these compounds have been analyzed primarily in the particulate
phase, the quantity of these compounds in the semi-volatile phase at
the temperatures encountered in dilute exhaust may also be important.
Particulate and semi-volatile phase emissions are to be collected
using methods described in Section VI.B.1. The soluble organic fraction
(SOF) is to be extracted from the filter and polymer bed separately.
The extracts of the two phases are to be tested separately for PAHs and
NPAHs, but may be combined before testing for dioxins/furans. Examples
of protocols suitable for characterizing polycyclic aromatic compounds
are available in the literature.51, 52, 53, 54, 55, 56
---------------------------------------------------------------------------
\51\Coordinating Research Council, ``Chemical Methods for the
Measurement of Unregulated Diesel Emissions,'' CRC Report No. 551,
1987; available in Docket A-90-07, Item No. II-J-15.
\52\Tejada, S.B., ``Fluorescence Detection and Identification of
Nitro Derivatives of Polynuclear Aromatic Hydrocarbons by On-Column
Catalytic Reduction to Aromatic Amines,'' Analytical Chemistry,
Volume 58, Number 8, pp. 1827-1834, July 1986.
\53\Tejada, S.B. et al., ``Analysis of Nitroaromatics in Diesel
and Gasoline Car Emissions,'' SAE Paper No. 820775, 1982.
\54\Schuetzle D., ``Analysis of Nitrated Polycyclic Aromatic
Hydrocarbons in Diesel Particulates,'' Analytical Chemistry, Volume
54, pp. 265-271, 1982.
\55\John J. H. et al., ``A review of diesel particulate control
technology and emissions effects--1992 Horning Memorial Award
Lecture,'' SAE Technical Paper Series No. 940233, 1994.
\56\A protocol for identification and measurement of poly-
chlorinated dibenzodioxins and dibensofurans is provided in 40 CFR
part 60, Appendix A, Method 23.
---------------------------------------------------------------------------
f. Characterization of Emissions with Atypical Elements. F/FAs
containing chemical elements other than those included in the baseline
formulations for the respective fuel family are classified as atypical
formulations (see Section IV.B.2). In addition to the emission
characterization requirements described above, producers of atypical F/
FAs are required to identify and measure the emission products
containing the associated atypical element(s). For example, if a
gasoline additive product contains chlorine, then this manufacturer
must identify and measure all emission compounds that contain chlorine.
Due to the nature of atypical products, special procedures for the
generation of emissions are required (see Section VI.E).
The presence of atypical species in specific emission fractions
will be dependent on the nature of the particular atypical element/
compound of concern. In view of this, EPA recommends that manufacturers
of atypical products examine all emission fractions (i.e., vapor, semi-
volatile, and particulate) for the measurement and identification of
potential atypical species. Because of the variety of potential
elements and reaction products involved, all of the necessary chemical/
analytical procedures cannot be specified in this final rule. The
selection of the particular method(s) for measuring atypical elements
or compounds is left to the manufacturer. However, the procedures used
must be state-of-the-art and based on sound analytical chemistry
principles applicable to the atypical element or compound of concern.
3. Quality Assurance
While today's rule requires emissions to be generated and
characterized three times as a way to evaluate the repeatability of the
test results, additional quality assurance procedures are needed to
control variability during the characterization of emissions.
Laboratories conducting emission characterization/speciation analyses
are required to perform verification testing to examine the
repeatability and accuracy of test procedures. For this purpose, a
prepared mixture of chemical compounds, as appropriate for each
particular procedure, should be subjected to the speciation protocols.
The use of analytical standards and controls for calibration of
instruments is also required to assure precision and accuracy of
results.
EPA reserves the right in this final rule to audit testing
facilities involved in the generation and characterization of
emissions, as well as the health effects testing of F/FAs. Such audits
will be organized and administered by EPA at its own expense. The audit
procedures could include a requirement that facilities submit a
completed questionnaire in which equipment and procedural information
is described. EPA might make recommendations based on the submitted
information and/or might follow up with a visit to observe the
performance of the protocols. The audit could also include EPA
distribution of ``blind'' samples for analysis at participating
laboratories (at their expense). The audit will not have the purpose of
certifying that the laboratory is ``EPA approved''. Rather, it will
have the purpose of determining the weaknesses of laboratories and the
acceptability of the laboratory's current performance.
C. Exposure Analysis
In the NPRM, EPA proposed to require modeling or other analytic
methods to evaluate potential exposures, expected atmospheric
reactivity, and environmental partitioning of emission products.
However, as discussed in Section III.C., this final rule does not
require modeling analyses to be performed as routine requirements under
Tier 1. Instead, quantitative modeling efforts will be required on a
case-by-case basis as needed under Tier 3.
Nevertheless, EPA believes that exposure data are still critical
for the assessment of the potential risks associated with the emissions
of F/FAs in question. For this purpose, today's rule requires
manufacturers to provide a qualitative discussion of potential
population exposures based on the production and use of the particular
fuel or additive (or group of F/FAs) in question. This qualitative
analysis must consider the actual and/or projected total annual
production volumes and the market distribution patterns (e.g., percent
of sales by state or region) of the particular product or group of
products. Group submissions must assess the cumulative exposure
resulting from all members of the group. A quantitative analysis is
encouraged when appropriate data are available, including any existing
modeling data, to support the exposure analysis. As discussed earlier,
EPA retains the authority to require from manufacturers more exhaustive
exposure analysis for particular products of concern under Tier 3
(including modeling), based on the EPA evaluation of Tier 1 and Tier 2
results or other available information.
VIII. Tier 2 Requirements
In the NPRM, EPA proposed short-term (42-day) tests under Tier 2
for the evaluation of six health effects endpoints: carcinogenicity,
mutagenicity, teratogenicity, reproductive toxicity, neurotoxicity, and
pulmonary toxicity. EPA examined the proposed Tier 2 program and found
that similar requirements among the various proposed tests (in regard
to animal subjects, exposure scenarios, and general technical
principles) provided the opportunity to combine several endpoint tests
within the same exposure protocol. In view of this, EPA has modified
the Tier 2 testing program to allow for concurrent test performance in
a more cost-effective manner.
The revised Tier 2 testing program enhances efficiency and
feasibility, while providing better health effects information. In
fact, the design of the Tier 2 testing program makes best use of
animals (minimum number of animals used), laboratory capacity, and
financial resources. The basic Tier 2 testing framework of this final
rule consists of a 90-day subchronic inhalation study to examine
general systemic and organ toxicity (including pulmonary effects), with
the addition of ancillary tests that allow the assessment of several
specific health effect endpoints (carcinogenicity, mutagenicity,
teratogenicity, reproductive toxicity, and neurotoxicity) within the
same exposure schedule. A fertility assessment is coordinated with the
90-day study to examine reproductive and teratogenic effects.
Brief descriptions of test guidelines for the evaluation of each
health effect endpoint are provided in the sections below. Most of
these testing guidelines are modified versions of guidelines previously
published under TSCA (40 CFR part 798, revised as of July 1, 1992) and/
or the test guidelines which accompanied the NPRM. Detailed protocols
for the Tier 2 testing program are included in Sec. 79.62-Sec. 79.68 of
the accompanying regulations. Figure 4 shows a diagram of the suggested
timing and organization of the Tier 2 studies within the general 90-day
subchronic exposure schedule.
BILLING CODE 6560-50-P
TR27JN94.002
BILLING CODE 6560-50-C
A. General Methodology
1. Exposure Duration
As mentioned previously, EPA originally proposed a program that
included six separate tests for the evaluation of the endpoints of
concern. Because of cost considerations, a minimum six-week (42-day)
exposure period was proposed in the NPRM, instead of the traditional
90-day test. EPA requested comments on the adequacy of the proposed
exposure period and exposure regimen, and on the possibility of
extending these tests to 90 days for comparability to historical data.
Comments were also requested on the possible use of an alternative
approach for the testing program, the Screening Information Data Set
(SIDS) protocol developed for use by the Organization for Economic
Cooperation and Development (OECD). The standard SIDS protocol is
designed as a single-study screen (45-day) for repeat dose,
reproductive, and developmental effects.
Public comments from industry supported the 90-day test over either
the proposed 42-day test or the SIDS protocol. Commenters expressed
concern regarding both of these protocols because relatively less
scientific experience and historical comparison data are available for
these shorter test scenarios. Upon reconsideration, EPA agrees that the
90-day protocol is more suitable and more cost effective than either of
the alternatives proposed in the NPRM for purposes of the F/FA
registration program. EPA recognizes that the shorter tests might miss
some adverse health effects that might be identified with the 90-day
exposure. Apart from the study duration, the SIDS protocol includes
somewhat less information for each endpoint, in comparison with the
selected 90-day subchronic inhalation study, with relatively small
savings in time and cost. For example, the SIDS protocol includes a
fertility screen (i.e., one-generation reproductive study), but does
not include an examination of the fetus for teratogenic effects.
Thus, today's final rule requires F/FA manufacturers to use the
more standard 90-day subchronic inhalation protocol for the evaluation
of health effects, with an exposure regimen of at least six hours per
day, five days per week. EPA judges the exposure regimen of five days
per week for the 90-day protocol to be the minimum acceptable exposure
period for the purposes of the Tier 2 evaluation. Also, the 90-day
protocol provides a broad and efficient testing approach that allows
the evaluation of several endpoints at the end of the same exposure
period using the same exposed test animals. As a result, the modified
Tier 2 program provides a reduction in the number of animals needed to
perform the evaluation of the endpoints of concern and savings on
emission generation and testing costs.
2. Animal Model and Laboratory Practices
In general, the Tier 2 testing program requires the exposure of
live laboratory animals to whole F/FA emissions. Rodent species are
required and rats are specifically recommended. Animal facilities must
be operated in compliance with the ``Guide for the Care and Use of
Laboratory Animals'' (U.S. DHHS Publication (NIH) 86-23, 1985). To
ensure the quality and integrity of test results, the performance of
all studies will be required to conform with good laboratory practice
(GLP) standards. GLP standards specific to this rule are included in
Sec. 79.60. As proposed in the NPRM, the GLP standards are based on
those published in 40 CFR part 792 (revised as of July 1, 1992) for
conducting tests under TSCA, with modifications to accommodate the
specific goals of this rule. The GLP standards address facility,
equipment, organization, quality assurance, and personnel requirements,
as well as specifications for proper care of laboratory animals,
handling of test substances, instrumentation issues, conduct of
studies, record keeping, and reporting of results.
3. Exposure Route and Concentrations
With the exception of the Salmonella assay, the Tier 2 testing
program is based on the inhalation exposure of laboratory animals to
diluted whole emissions. Such studies require an exposure system
designed to ensure the controlled generation, dilution, and delivery of
F/FA emissions to the laboratory animals for prolonged periods. Section
VI describes the methodology for the generation of F/FA combustion and
evaporative emissions and the procedures to deliver the emissions to
the test animals. Requirements for hardware, maintenance, and the use
of emission generation and inhalation systems are included in
Sec. 79.57 and Sec. 79.61 of this rule.
Before testing the emissions of a particular fuel or additive/base
fuel mixture, a manufacturer must determine an appropriate range of
exposure concentrations to be used in the characterization of potential
health effects. The objective is to select exposure concentrations to
determine a reasonable concentration-response curve that may predict
the potential health risks associated with a particular exposure.
Concentrations should be spaced to produce test groups with a range of
toxic effects. In order to accomplish this, EPA requires that at least
three concentration levels be used to construct the concentration-
response curve. These levels should correspond to, at a minimum: (1) an
overtly or highly toxic concentration, (2) a concentration having an
intermediate level of toxicity, and (3) a minimally toxic or non-toxic
level. The highest concentration should result in toxic effects but not
produce a level of fatalities which would prevent a meaningful
interpretation of the resulting data. The lowest concentration should
produce minimal or no observable toxic effects. If more than one
intermediate concentration level is used, the concentrations should be
spaced to produce a gradation of toxic effects. Due to the inherent
toxicity of most vehicle emissions, it might be impossible to precisely
select an exposure level which results in no observable evidence of
toxicity, or a no- observed-adverse-effect-level (NOAEL). Thus, EPA is
not requiring manufacturers to specifically achieve a NOAEL. Instead,
EPA recommends that manufacturers use available scientific approaches
(e.g., range-finding test and extrapolation of data results) to design
the study with reasonable concentration spacing so as to improve the
probability of achieving a NOAEL. In recognition of the possibility
that the highest achievable exposure concentration (considering the
limiting CO concentration) may also be non-toxic, provisions are made
for ``limit tests,'' where appropriate. If a test at the highest
achievable concentration produces no observable toxic effect(s), then a
full study using three concentration levels might not be necessary (see
regulatory text for specific endpoint tests).
B. Subchronic Inhalation Study and Endpoint Tests
As described earlier, the Tier 2 health effects testing program
includes a 90-day subchronic inhalation study and ancillary assays/
tests for the examination of specific health effects endpoints.
Specific assays or analyses for carcinogenicity, mutagenicity,
teratogenicity, reproductive toxicity, and neurotoxicity may be
conducted at the end of the 90-day study, coordinated with the 90-day
exposure, or conducted separately.
In the NPRM, EPA proposed a separate acute pulmonary test (i.e.,
lung lavage assay) for the evaluation of pulmonary toxicity. However,
the Tier 2 testing framework of this final rule does not require a
separate test for the assessment of pulmonary effects because the 90-
day subchronic study includes gross pathology and histopathology of the
lungs and respiratory tract. Pulmonary effects in this final rule will
be examined as part of the standard 90-day inhalation study. Positive
results at the end of the exposure period for pulmonary toxicity will
be indicated by abnormal gross or histopathological findings relative
to appropriate control animals.
1. Subchronic Inhalation Study
The subchronic inhalation study is designed to determine a
concentration-response relationship for potential toxic effects in
rodents, resulting from exposure to vehicle/engine emissions over a
period of 90 days. This test will provide valuable information on
general systemic and target organ toxicity, including pulmonary
effects. This information is considered an essential component for the
assessment of potential health hazards resulting from the exposure to
F/FA emissions. The exposure period of the subchronic study (i.e., 90
days) covers approximately one tenth of the life span for the
recommended test animal species (i.e., rats). Although life-shortening
or tumors are not likely to be observed within the 90 days of exposure,
the subchronic study should be able to identify a wide variety of
adverse effects.
The specific guidelines for the subchronic inhalation study are
included in Sec. 79.62 of this final rule. The subchronic study
requires that animals be observed and weighed during the exposure
period. Ophthalmological examination, blood chemistry analysis, organ
examination, and histopathology are basic requirements of the 90-day
protocol. Hematology and clinical biochemistry determinations are
required to be carried out after 30 days of exposure and just prior to
termination. Hematology analyses include: hematocrit, hemoglobin
concentration, erythrocyte count, total and differential leukocyte
count, and a measure of clotting potential (e.g., clotting time,
prothrombin time, thromboplastin time, or platelet count). Clinical
biochemical testing includes assessment of electrolyte balance,
carbohydrate metabolism, and liver and kidney function. Other specific
biochemical tests are described in the regulatory text of the final
rule.
At the end of the exposure period, tissues and/or organs from a
subgroup of the test animals are specially preserved according to the
requirements of the neurological, pulmonary, and reproductive organ
examinations. Tissues/organs from the main test population are
preserved using standard techniques for the general toxicity
evaluation. Test animals will be subjected to a full gross necropsy
which includes examination of the external surface of the body, all
orifices, and the cranial, thoracic, and abdominal cavities and their
contents. All major organs must be weighed. Gross pathology must be
performed on the following target organs and tissues: liver, kidneys,
lungs, adrenals, brain, and gonads. Histopathology must be performed on
all gross lesions and specific organs/tissues, as follows: respiratory
tract (i.e., lungs, nasopharyngeal tissues, trachea), brain, heart,
sternum with bone marrow, salivary glands, liver, spleen, kidneys,
adrenals, pancreas, reproductive organs (i.e., uterus, cervix, ovaries,
testes, epididymides), aorta, gall bladder, esophagus, stomach,
intestinal tract, urinary bladder, representative lymph node, and
peripheral nerve/tissue. Other organs and tissues must be preserved in
a suitable medium for possible future histopathological examination, as
described in the regulatory text of the final rule.
As described earlier, the 90-day subchronic inhalation study will
serve as a basic framework for the Tier 2 testing program. The
following sections provide brief descriptions of the ancillary assays
and other additional test and/or measures performed under Tier 2.
2. Carcinogenicity and Mutagenicity Assays
For the evaluation of carcinogenicity and mutagenicity, Tier 2
includes a battery of three genotoxic assays: Salmonella, micronucleus
(MN) and sister chromatid exchange (SCE). These assays are specific for
mutagenic/carcinogenic outcomes at a cellular level, but the tests may
not be indicative of non-mutagenic or initiation/promotion cancer
mechanisms.
In general, the Tier 2 genotoxic assays are considered cost-
effective indicators of mutagenicity and, by implication, predictors of
suspect carcinogens. The rationale for using these tests for the
assessment of potential mutagenic and carcinogenic effects is based on
the general assumption that cancer is a multi-stage process involving a
variety of events that can include genotoxic steps. The general
consensus among scientists is that many of the cancers may be
attributable to adverse genetic changes. Because genotoxic steps are
generally implicated early in the process of cancer development, their
detection has assumed the status of presumptive carcinogen
identification. EPA recognizes that this working assumption has some
limitations because there is always a possibility of having false
positive (mutagenic noncarcinogens) or false negatives (nonmutagenic
carcinogens) when evaluating the carcinogenic potential of the test
substance. However, these limitations do not preclude the usefulness
and the effectiveness of the genotoxic assays (i.e., Salmonella, MN,
and SCE) as cost-effective predictors of potential mutagenic and
carcinogenic effects in the context of the Tier 2 testing program.
A description of the Tier 2 assays required for the evaluation of
carcinogenicity and mutagenicity is provided in the following sections.
The two in vivo assays (MN and SCE) can be conducted concurrently with
the 90-day subchronic inhalation study (i.e., same animal population).
The Salmonella assay is run separately, because it does not require the
exposure of live animals to emissions.
a. Salmonella Assay. The Salmonella assay is an in vitro test for
mutagenicity and, by implication, for carcinogenicity. The assay makes
use of five mutant strains of the bacterium Salmonella typhimurium
which cannot grow in a medium deficient in histidine due to an
inherited inability to produce this amino acid. Exposure to mutagenic
or carcinogenic substances can elicit reverse mutations, such that the
bacteria regain their ability to grow in a histidine-deficient medium.
In this test, bacteria will be exposed to the semi-volatile and
particulate extracts of combustion emissions (see Section VI.B.2 for
information on sampling of combustion emissions for testing). Test
procedures for this assay have been described in previous
literature.\57\ After exposure, the cells will be plated on histidine-
deficient media (both with and without metabolic activation) and
incubated for a designated period of time. The number of emissions-
induced mutant colonies (revertants) growing on the plates will then be
compared to the number of spontaneous revertants in control cultures.
The testing guidelines for the Salmonella assay are included in
Sec. 79.68 of this final rule.
---------------------------------------------------------------------------
\57\Huisingh, J.L., et al, ``Mutagenic and Carcinogenic Potency
of Extracts of Diesel and Related Environmental Emissions: Study
Design, Sample Generation, Collection, and Preparation,'' In: Health
Effects of Diesel Engine Emissions, Vol. II, W.E. Pepelko, et al.
(Eds.), US EPA, Cincinnati, EPA-600/9-80-057b, pp. 788-800, 1980;
available in Docket A-90-07, Item No. II-J-13.
---------------------------------------------------------------------------
A positive result for the Salmonella assay occurs when there is a
statistically significant concentration-related increase in the number
of revertants or a reproducible and statistically significant positive
response for at least one of the test concentrations.
b. In Vivo Micronucleus (MN) Assay. Micronuclei are sub-cellular
structures containing chromosomes and chromosome fragments not
incorporated into the main nucleus during cell division. While
micronuclei do form under natural conditions, exposure to potentially
mutagenic or carcinogenic agents can cause an increase in
micronucleated cells. In this assay, live rodents will be exposed by
inhalation to the emissions of the particular fuel or additive/base
fuel mixture (this assay is applicable to the evaluation of both
combustion and evaporative emissions). Subsequently, erythrocytes in
the bone marrow will be sampled, stained, and viewed under a light
microscope. The number of erythrocytes containing micronuclei will then
be counted and compared with erythrocytes from untreated animals. The
use of erythrocytes in this procedure facilitates the visualization of
micronuclei, since their primary nucleus is normally extruded during
cell development. The testing guidelines for the MN assay are contained
in Sec. 79.62 and Sec. 79.64 of this final rule.
A positive result for the MN assay is determined by a statistically
significant concentration-related increase in the number of
micronucleated erythrocytes or a reproducible and statistically
significant positive response for at least one of the test
concentrations.
c. In Vivo Sister Chromatid Exchange (SCE). SCEs are believed to be
caused by chromosome strand breakage resulting in exchanges of genetic
material between the halves of a chromosome ``pair'' (i.e., the
chromatids). While some SCEs occur normally, an increase in the
frequency of such exchanges may be indicative of carcinogenic activity.
In this assay, animals which have undergone inhalation exposure to the
emissions will be sacrificed (this assay is applicable to the
evaluation of both combustion and evaporative emissions). Peripheral
blood lymphocytes will then be isolated and cultured. The cells will be
treated with a DNA base analog (bromodeoxyuridine, BrdU) and with a
spindle inhibitor such as colchicine. After appropriate staining for
labeled DNA, SCEs will be scored from cells arrested in the second
mitotic division and the results compared with appropriate controls.
Details on the SCE testing procedures are included in Sec. 79.62 and
Sec. 79.65 of this final rule.
A positive result for the SCE assay is determined by a
statistically significant concentration-related increase in the number
of SCE or a reproducible and statistically significant positive
response for at least one of the test concentrations.
3. Fertility Screen for Reproductive and Teratologic Effects
The fertility screen involves mating of test animals previously
exposed (by inhalation) to F/FA emissions to examine the effects of
such exposure on conception. The females will continue their exposures
throughout pregnancy and will be assessed for teratologic effects on
their offspring. This test is applicable to the evaluation of both
combustion and evaporative emissions. The fertility assessment is
coordinated with the 90-day subchronic inhalation study and replaces
the separate reproductive and teratology studies originally proposed in
the NPRM.
The reproductive assessment includes vaginal cell smears to track
effects on the estrous cycle. Commenters discouraged the use of
frequent vaginal smearing. In response to the comments, vaginal
cyclicity determinations will be performed on the test subjects for two
weeks prior to the start of the exposure period (for culling acyclic
females), and will resume after seven weeks of exposure (for four weeks
or until the female is confirmed pregnant). The assessment for
reproductive effects also includes a mating trial and the weighing and
histopathological examination of male and female reproductive organs
(i.e., uterus, ovaries, testes, epididymis, and seminal vesicles), all
of which can be performed within the context of the 90-day subchronic
inhalation study.
As compared with appropriate control animals, positive results for
reproductive effects include: changes in the length or stages of the
estrous cycle as indicated by the vaginal cytology data, changes in
reproductive organ weights, and pathological changes found during gross
or microscopic examination of male or female reproductive organs.
Changes in fecundity, fertility or litter size (number of normal
fetuses) will also be regarded as positive results.
To assess potential teratogenic effects, each dam will be
sacrificed on the day prior to normal parturition and its uterus
examined for embryonic or fetal deaths. Viable fetuses will be counted
and then examined for skeletal and soft tissue anomalies. These results
will be evaluated relative to the number of spontaneous embryonic or
fetal deaths and abnormalities in unexposed controls. The required
analysis covers specific fetal effects outcomes, i.e., in utero death,
growth alteration, and structural abnormalities.
Although the NPRM proposed the use of two different species for the
evaluation of teratogenic effects, today's action requires the use of
only one species to satisfy the Tier 2 requirements. This modification
will reduce the number of animals needed for Tier 2 tests, as requested
by some of the commenters, while maintaining an adequate approach for
the screening of teratology effects.
The above described combined protocol will detect fertility
problems and teratogenic effects. EPA realizes that the protocol will
not detect adverse effects on reproductive development that might
appear in the offspring as they grow and mature (since pups are
examined just before birth). However, EPA judges that the combined
protocol provides a reasonable screen for both reproductive and
teratogenic effects. The testing guidelines for the fertility
assessment are included in Sec. 79.62 and Sec. 79.63 of this final
rule.
4. Neurotoxicity Screen
EPA proposed in the NPRM to require the Functional Observational
Neurotoxicity Battery (FONB) for the evaluation of neurotoxic effects.
In addition to the FONB, EPA asked for comment on the possible
inclusion of a biochemical assay to measure the level of glial
fibrillary acidic protein (GFAP). Comments were received on both
proposed tests.
The regulated industry objected to the use of the FONB on the basis
of their belief that it would be likely to give artifactual test
results. Commenters also expressed concern about the use of the GFAP
assay. They considered it to be a sensitive marker for neurotoxicity,
but discouraged its use because they perceived that adequate historical
data are not available for this test. While not necessarily agreeing
with either of these comments, EPA has reconsidered its original
proposal regarding the specific content of the Tier 2 neurotoxicity
assessment.
EPA considers the FONB to be a well-validated standard test and
recognizes its extensive use in the past. In the context of this F/FA
emissions testing program, however, EPA believes that, rather than
requiring the FONB on a standard basis within the Tier 2 testing
regimen, the FONB is more appropriately reserved for use when a
neurotoxicity concern has been identified and additional testing is
needed to clarify the nature and/or significance of the potential
adverse effects (e.g., within Tier 3).
In regard to the GFAP assay, EPA judges that concerns about the
amount of historical data are not sufficient justification to prevent
its use in the F/FA program, given its high specificity and potential
applicability as a screening test. This final rule thus includes the
GFAP assay as an element in the Tier 2 assessment of potential
neurotoxic effects.
The GFAP assay is a biochemical assay that measures the level of a
major intermediate filament protein of astrocytes (cells of the
supporting structure of the nervous system) from brain tissues. An
increase in the GFAP level is highly specific for detecting the
existence and location of chemical-induced injury to the central
nervous system (CNS) associated with astrocytic hypertrophy. However,
due to its specificity, the assay does not provide information on other
potential sites for neurotoxic effects. To provide a more comprehensive
evaluation, today's rule supplements the GFAP assay with an expanded
neurohistopathology examination as part of the 90-day subchronic
inhalation study. The neurohistopathology involves the examination of
several brain sections, including the cerebrum, cerebellum, medulla,
cervical bulb of the spinal cord, and peripheral nerves (e.g., tibial
or sciatic nerve). Testing guidelines for the neurotoxicity evaluation
are included in Sec. 79.62, Sec. 79.66 (neuropathology assessment), and
Sec. 79.67 (GFAP) of this final rule. Positive results at the end of
the exposure period for neurotoxicity will be indicated by an increase
in the GFAP level and/or abnormal gross or histopathological findings
relative to appropriate control animals. The neurotoxicity screen is
applicable to the evaluation of both combustion and evaporative
emissions.
C. Adequate Endpoint Information in Lieu of Tier 2 Tests
One of the functions of the data search requirement under Tier 1
(as discussed in Section VII.A.2) is to enable F/FA manufacturers to
examine the available literature and determine if adequate data exists
(for both combustion and evaporative emissions, as applicable) that
would satisfy the Tier 2 testing requirements, so that duplication of
effort can be avoided. In addition to existing test data from protocols
similar to those specified in the Tier 2 testing program, EPA will
consider results from other test protocols to be adequate in lieu of
new testing, as long as the alternative methods provide comparable
information. Table 2 provides criteria for determining what constitutes
adequate existing data in lieu of the specified Tier 2 tests, and
includes an example list of comparable tests for each Tier 2 endpoint.
EPA recognizes that changes and scientific advances in toxicology
testing may result in the development of additional techniques and
methods that could be applicable to the Tier 2 testing requirements of
this program in the future. In deciding if a specific protocol is
acceptable in lieu of a Tier 2 test, manufacturers must also address
other specific criteria for Tier 2 requirements, as explained below.
Table 2.--Criteria for Determining Adequacy of Existing Data in Lieu of Tier 2 (T2) Tests
----------------------------------------------------------------------------------------------------------------
Minimum requirements for
T2 testing in the absence existing data to be Examples of other existing studies
Endpoint of adequate existing data considered adequate which may be acceptable
substitutes for T2 tests
----------------------------------------------------------------------------------------------------------------
Carcinogenicity...... Salmonella assay, in vivo Salmonella assay plus two Alternative to all assays: Lifetime
Micronucleus assay, and other assays (at least cancer study.
in vivo Sister Chromatid one of which shall be in In vivo assays: Sister Chromatid
Exchange assay. vivo). Exchange (SCE), Chromosomal
Aberrations (CA), Micronucleus
(MN), Unscheduled DNA Synthesis
(UDS).
In vitro or microbial assays: E.
coli Reverse Mutation, DNA Repair,
Yeast Mutation, Yeast Mitotic
Recombination, Mouse Lymphoma, CHO/
V79 Mutation, UDS, CA, SCE, Cell
Transformation.
Mutagenicity......... Salmonella assay and in Salmonella assay plus one MN, Dominant Lethal Assay, CA,
vivo Micronucleus assay. in vivo assay. Heritable Translocation Assay,
Specific Locus Assay.
Teratogenicity....... T2 fertility/teratology FDA/Phase II (gd6-15) If fetal effects analysis is
assessment with 90-day Study. included: Two-generation study,
exposure. Reproductive Assessment by
Continuous Breeding (RACB), One-
generation study.
Adult reproductive T2 fertility/teratology T2 fertility/teratology Two-generation study, Reproductive
effects. assessment with 90-day assessment with 90-day Assessment by Continuous Breeding
exposure. exposure. (RACB), One-generation study.
Neurotoxicity........ GFAP assay and neuro- GFAP assay and neuro- Detailed characterization of
histopathology with 90- histopathology with 90- neurotoxicity using behavior,
day exposure. day exposure. neurophysiological, and/or
neurochemical assessments (e.g.,
EPA Neurotoxicity Assessment).
Pulmonary effects.... T2 respiratory tract T2 respiratory tract Chronic toxicity study, with or
pathology after 90-day pathology after 90-day without lifetime cancer study;
exposure. exposure. subchronic toxicity study.
----------------------------------------------------------------------------------------------------------------
In general, for existing information to fulfill the Tier 2 testing
requirements, it must include the in vivo inhalation exposure to whole
motor vehicle emissions (combustion or evaporative, as applicable),
except for the few in vitro studies acceptable for carcinogenicity/
mutagenicity assessment. In order to be acceptable, previous toxicity
studies must include exposure to non-catalyzed emissions, as required
in this final rule. EPA is requiring the use of an evaporative emission
generator for the evaporative emission testing. However, EPA will
accept previous inhalation exposure studies of whole evaporative
emissions in which the emissions were generated using standard
evaporative emission procedures under FTP conditions. Raw product
tests, using F/FAs in the uncombusted state, are not considered
adequate replacements for Tier 2 combustion emission testing. In
addition, studies using whole aerosolized preparations or tests on
individual emission products of the fuel or additive cannot be used as
substitutes for whole emission testing for either combustion or
evaporative emissions. The reason for this requirement is that, as
explained in Section III.A.2 of this preamble, this rule focuses on the
effects of whole emissions rather than raw F/FAs or individual emission
products. Tests performed on the emissions of F/FAs which are
classified in the same group as the subject fuel or additive are
considered relevant, but tests on products not conforming to the
grouping criteria of the subject fuel or additive do not apply.
Other important parameters to consider in determining if existing
studies are adequate include: the type and number of test subjects, the
number and adequacy of dosages, the methodology and duration of
exposure, and the technical methods used for monitoring the progress of
the test and for analyzing the results. Generally, 90-days is the
minimum acceptable length of exposure. However, an existing study
having a shorter exposure period might be considered adequate if the
test results are positive, i.e., adverse effects are observed.
Previously-conducted studies using mammals other than rodents may be
acceptable in lieu of rodent testing, if the existing studies meet all
other applicable criteria for adequacy.
For carcinogenicity and mutagenicity, the Salmonella assay is
always required because of its broad sensitivity and specificity for
detecting chemical exposures having mutagenic and/or carcinogenic
potential. Manufacturers should note (see Table 2) that when a
registrant needs to conduct new Tier 2 testing, two in vivo assays (MN
and SCE), in addition to the Salmonella assay, are required to satisfy
the carcinogenicity endpoint. However, in lieu of new testing, a
manufacturer may rely on one existing in vivo assay for
carcinogenicity, in addition to the Salmonella assay and another in
vitro assay. In other words, two in vivo tests for carcinogenicity are
required if new testing is performed, but only one in vivo study is
required if the manufacturer relies on existing carcinogenicity
information. The reason for this is that the incremental costs of
performing the two specified in vivo assays (MN and SCE) within the 90-
day inhalation protocol (as required in this final rule) is low in
comparison with the amount of useful data obtained. This approach is
cost-effective because the same animals used in the inhalation study
can also be used for the in vivo carcinogenicity assays. In fact, fewer
resources will be spent to do both the MN and SCE assays within a
single group of inhalation-exposed animals than to conduct just one of
these tests along with a separate in vitro carcinogenicity assay (in
addition to the Salmonella assay).
D. Alternative Tier 2 Provision
The Tier 2 tests described above pertain to all designated F/FAs,
unless mitigated by special provisions or comparable data from
adequately performed and documented previous studies. In general, EPA
considers this standard testing program to be necessary for the health
effects evaluation of F/FA emissions, even if further evaluation may be
required under the provisions of Tier 3. However, this final rule also
adopts the special provision discussed in the Reopening Notice, under
which EPA retains the authority to modify the standard Tier 2 test
requirements in certain instances.
The exercise of this authority will be done wholly at EPA's
initiative and discretion. The alternative Tier 2 provision is intended
to provide a degree of flexibility to EPA when available information
indicates that, in a specific case, another testing regimen is
preferable to the standard set of Tier 2 tests. There are three
scenarios under which EPA generally anticipates the possible use of
this provision.
First, for a particular fuel or fuel additive (or group),
information may be available (independent of the requirements of this
rule) which may cause EPA to be concerned about potential health
effects related to an endpoint not specifically addressed in Tier 2. In
such an instance, the alternative Tier 2 provision allows EPA to
require additional studies targeted to the identified area of concern,
even though these studies are not normally included in Tier 2. While
the standard structure of this rule also allows EPA to prescribe the
additional tests under Tier 3, the alternative Tier 2 provision enables
EPA to prescribe and receive the desired data earlier in the process.
This flexibility is particularly important given that this final rule
allows up to six years for Tier 2 submittal. When the additional
testing can be coordinated with the standard Tier 2 testing program,
the alternative Tier 2 provision will also save costs relative to
conducting the additional tests at a separate point in time.
Second, independent of the information to be submitted under this
rule for a particular F/FA product (or group), EPA may identify a
potentially significant public health risk related to a Tier 2
endpoint, such that EPA knows that more definitive testing will be
required for this endpoint than is ordinarily required under Tier 2.
Again, EPA could require such testing under Tier 3 after the evaluation
of Tier 2. However, the alternative Tier 2 provision can facilitate
earlier and potentially more efficient acquisition of the required
data. If appropriate to the case at hand, EPA would substitute the more
definitive endpoint test for the standard Tier 2 test (with appropriate
deadline adjustment). In such a case, EPA's authority to waive the
requirement to provide the respective Tier 2 test derives from its
authority in section 211(e) to provide exemptions from testing when
such testing would be duplicative. In this example, because the
substituted test would address the endpoint more rigorously than the
standard Tier 2 assessment, it would be duplicative to require both
evaluations.
Third, EPA may identify concerns about the effects of F/FA
emissions involving different engine and/or emission control
technologies than those ordinarily required for generating the
emissions tested in Tier 2. For example, biological testing using
catalyzed instead of non-catalyzed emissions might be required if
emission species of concern are present in the catalyzed exhaust of a
fuel or additive that are not represented in the untreated exhaust.\58\
In this case, EPA could prescribe a Tier 2 program using catalyzed
instead of non-catalyzed emissions under the alternative Tier 2
provision. Otherwise, the manufacturer of this product would likely be
required to conduct a second series of biological tests with catalyzed
emissions, under Tier 3.
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\58\As described in Section VI.A, the use of non-catalyzed
emissions are normally required in the Tier 2 toxicology tests.
Under Tier 1, however both catalyzed and non-catalyzed emissions are
required to be characterized.
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In summary, the alternative Tier 2 provision will give EPA the
flexibility, when indicated, to prescribe additional tests to be
performed along with the standard Tier 2 program, to substitute
different tests, and/or to modify the underlying vehicle/engine
specifications for Tier 2. When EPA exercises its authority under this
special provision, it will allow an appropriate time for completion of
the prescribed alternative tests. EPA may also use the alternative Tier
2 authority to waive certain Tier 2 endpoint evaluations (generally on
occasions when additional and/or more rigorous tests are being required
for other Tier 2 endpoints). However, Tier 2 endpoint tests will not be
waived in the absence of adequate information or requirements for more
rigorous testing of the endpoint(s).
EPA intends to exercise this special authority only in exceptional
cases. When EPA decides to use the alternative Tier 2 provision, EPA
will notify the responsible manufacturer (or group) by certified mail
letter of the specific modifications in lieu of the standard Tier 2
program, along with a schedule for compliance and submittal of test
results. The manufacturer (or group of manufacturers) will have 60 days
to comment on the prescribed alternative Tier 2 testing program and
timing requirements. If the responsible manufacturer does not provide
any comments, EPA will assume that the manufacturer has consented in
full with the prescribed testing regimen. EPA will publish a notice in
the Federal Register to inform the public of its intent to require
alternative testing for a particular F/FA manufacturer and that a copy
of the letter to the manufacturer is available in the public record of
this rule for review and comment. Additional correspondence between EPA
and the responsible manufacturer regarding alternative testing
requirements will also be placed in the public record. After receipt
and review of all comments received (or, if no comments are received),
EPA will publish a notice of final action on the proposed alternative
Tier 2 requirements in the Federal Register.
In the Reopening Notice, EPA proposed to notify manufacturers of
proposed alternative Tier 2 requirements within 18 months of
promulgation of the final rule (for registered F/FAs) or within 18
months of EPA's receipt of intent to register (for currently
unregistered F/FAs). Comments received from the industry indicated that
this notification period was too long relative to the proposed three
year deadline for submittal of Tier 2 results. However, EPA believes
the proposed notification period is reasonable, given that this final
rule allows manufacturers up to six years for submittal of Tier 2
results. Furthermore, EPA believes that restricting the time period for
exercising the alternative Tier 2 authority is unnecessary and
disadvantageous to the public interest as well as the regulated
industry, since this provision establishes a mechanism to provide
needed data on a timely basis and to eliminate unnecessary screening
studies when substitute tests will be required. Therefore, while EPA
will endeavor to notify manufacturers of proposed alternative Tier 2
requirements within 18 months, this final rule permits EPA to notify
manufacturers of proposed alternative Tier 2 requirements at any time
prior to EPA's receipt of Tier 2 data. If a manufacturer receiving such
notification has already begun the standard Tier 2 toxicology testing,
then EPA will refrain from requiring the testing; however, in such
cases, the manufacturer is required to submit the results of the
standard Tier 2 tests within one year of the date when testing began.
In other cases, EPA will consider the potential costs, burdens, and
timing factors in making its final decisions on alternative Tier 2
requirements.
IX. Tier 3 Requirements
A. Scope
On the basis of the submitted Tier 1 and/or Tier 2 data, or any
other available information, EPA will determine whether further testing
and/or analysis for the subject fuel or fuel additive is needed under
the provisions of Tier 3. Given the variety of evaluations included in
Tiers 1 and 2 and the wide range of possible interrelated outcomes
which could be obtained, EPA proposed to use its discretion in
determining the need for Tier 3 testing on a case-by-case basis.
Decisions on the need for follow-up testing within Tier 3 would depend
on expert scientific judgment as to the availability of adequate data
to enable a health risk evaluation and the need for more definitive
information for developing regulatory decisions.
EPA requested comments on the proposed discretionary nature of Tier
3 determinations and on a possible alternative approach involving the
establishment of ``automatic triggers'' for Tier 3 decisions, i.e.,
specific outcomes of Tiers 1 and 2 which would make Tier 3 testing
mandatory. Responses included both support and opposition to the
proposed Tier 3 discretionary approach. EPA evaluated all comments and
determined that decisions on Tier 3 requirements should remain at the
discretion of EPA. In order to accomplish the goals of the program, it
is essential for EPA to be able to examine the Tier 1 and Tier 2 data
prior to prescribing additional tests. The need for and content of Tier
3 testing will most often be dependent on the results of the earlier
tiers. In these cases, decisions on Tier 3 can only be reasonably
specified after EPA's review of the applicant's initial submittal. The
purpose of Tier 3 is not to fill all data gaps, but to establish a
program that provides the Administrator with the necessary and
reasonable information to make regulatory decisions. Based on this
rationale, EPA judges that it is neither practical nor desirable to
specify criteria which will automatically force F/FA manufacturers to
perform additional testing under Tier 3. Thus, EPA will use its
discretion to determine Tier 3 requirements on a case-by-case basis,
allowing EPA to target specific regulatory needs. Although EPA can use
the Tier 3 data to support regulatory actions, referral to Tier 3 level
is not mandatory before beginning actions under CAA section 211(c).
The need for Tier 3 testing and/or analysis will depend, in part,
on whether Tier 1 and/or Tier 2 data provide sufficient toxicity and
exposure information to determine the potential health risks associated
with a particular fuel or fuel additive. The endpoints to be addressed
and the nature of the studies to be performed under Tier 3 are to be
determined on a case-by-case basis. Tier 3 studies will most often be
required to further explicate the results of the tests/analyses
performed under Tiers 1 and 2 or to address other areas of concern
highlighted by the literature search. If additional toxicity testing is
required under Tier 3, the test might entail whole emissions (as in
Tier 2), or the testing of one or more individual emission species
identified to be of particular concern. EPA could also use other
information (available outside this program) to require testing under
Tier 3.
While the specific objectives and scope of Tier 3 testing will vary
depending on the concerns identified in the earlier tiers or any other
information available to EPA, examples of possible areas for further
testing are: chronic/lifetime studies, chemical disposition/metabolism
studies, exposure studies, dosimetry analyses, additional emission
characterization/speciation, additional modeling analysis,
environmental toxicity tests, testing using different emission
generation procedures or emission control systems, or any other
additional evaluation approach EPA deems necessary to assess the health
and/or welfare effects of a particular fuel or fuel additive. The
previous examples and the discussion below in no way limit the scope of
Tier 3 or EPA's authority to require further testing under this
program.
Today's rule specifically includes under Tier 3 any health effects
testing to be performed on aerosol additives (see Section X.C for
details on the special provision for aerosol products). Due to the
special nature and use of this type of product, EPA judges that any
testing needs will require non-standard test procedures that can be
better addressed under Tier 3. EPA will review the composition
information and literature data on the specific aerosol product and
will determine if health effects testing is needed on a case-by-case
basis. For example, if available literature, submitted under Tier 1,
indicates that a component of an aerosol product is highly toxic, and
the product is widely produced, then Tier 3 testing on the aerosol
product would likely be indicated.
Modeling of potential exposures, atmospheric reactivity, and/or
environmental fate/partitioning may also be required under Tier 3, as
explained in Section III.C. For example, if a fuel or additive is
widely distributed and Tier 2 data indicate serious concern for health
effects, EPA might require more extensive exposure analysis and/or
modeling under Tier 3 to better define potential risks.
Although the grouping mechanism included in this rule allows F/FA
manufacturers to submit Tier 1 and Tier 2 data on the representative of
a designated group for purposes of registration, EPA retains the
authority under Tier 3 to require testing on any member product of a
group. Thus, when follow-up testing is required under Tier 3 authority,
the specified test(s) could be required to be conducted on the selected
representative or on any other member of an existing group. Testing on
additional F/FA products could be required if EPA identifies a concern
for any member of the group other than the group representative. For
example, the testing representative for the M85 group (consisting of
methanol formulations containing 50-95 percent methanol) is an M85 base
fuel containing 85 percent methanol by volume. In the future, other
methanol fuels could enter the market and be used extensively,
triggering a concern for exposure and potential health risks. In this
case, EPA could require Tier 3 testing for another methanol formulation
within the M85 group.
Another possible Tier 3 effort could involve the testing of
combinations of oxygenates. Although groups for non-baseline gasolines
are defined on the basis of individual oxygenates, EPA could request
additional testing to address mixtures of oxygenates under Tier 3
authority. For example, if a registered non-baseline gasoline
formulation containing a mixture of oxygenates is widely produced and
used, resulting in high exposures and potential health risks, EPA could
require testing of this formulation under Tier 3. Tier 3 tests for this
formulation could involve standard Tier 1 or Tier 2 tests, testing for
other endpoints not addressed under Tier 2, or testing for other areas
of concern (e.g., exposure analysis, environmental testing, etc.).
EPA also retains the authority to require additional testing using
different vehicle/engine technologies and/or emission generation
specifications than those prescribed for Tier 1 and Tier 2 analyses. To
reduce the costs of the program, today's action requires the use of a
single vehicle model for emission generation. However, if EPA
determines that emissions from other applicable vehicle/engine
technologies might differ significantly for a given fuel or additive/
base fuel mixture, then EPA may require additional emission
characterization and/or toxicological testing under Tier 3 using
different vehicle/engine technology. Also, although standard Tier 2
tests are to be conducted using non-catalyzed emissions (as discussed
in Section VI.A), EPA could require the use of catalyzed emissions for
testing under Tier 3.
When a determination has been made that Tier 3 testing is required,
EPA will inform the responsible manufacturer by certified mail of the
purpose and nature of the testing to be performed along with a schedule
for compliance and submittal of the Tier 3 report to EPA. EPA will also
publish a notice in the Federal Register, notifying the public that the
letter to the manufacturer is available in the public record for review
and comment. The affected manufacturer's comments and EPA's response to
these comments will be placed in the public record, as well. After
receipt and review of all comments received (or, if no comments are
received), EPA will publish a notice of final action on the proposed
Tier 3 requirements in the Federal Register.
EPA proposed in the NPRM to provide the responsible manufacturer or
group a 30-day comment period to respond to EPA's requirements under
Tier 3. In their commentary, the regulated industry asked EPA to extend
this comment period to 60 days to allow for appropriate time for
review, analysis, and preparation of a written response to EPA
regarding the designated protocol(s) to be used for Tier 3 tests. EPA
judged that this request was reasonable, thus today's rule gives F/FA
manufacturers 60 days to comment on the EPA-prescribed Tier 3
requirements.
The responsible manufacturer is expected to submit detailed
protocols for review and approval by EPA prior to beginning Tier 3
testing. Tier 3 tests must comply with the pre-approved specifications
given by EPA. If manufacturers experience unforeseen difficulties while
conducting the prescribed Tier 3 tests approved by EPA (e.g., excess
mortality observed half-way through a chronic bioassay), they will be
allowed to request a modification of the requirements. This mechanism
would apply to unusual circumstances that are outside the control of
the manufacturer. If testing problems are identified, EPA must be
notified as soon as possible so that requirements can be modified.
B. Criteria for Referral to Tier 3
This section presents some of the guidelines and considerations
which EPA will use in determining the necessity for additional testing
under a discretionary Tier 3 testing approach. Consistent with the
discretionary decision-making process for Tier 3, this discussion is
not intended to provide an exhaustive, limiting, or definitive listing
of relevant criteria.
The decision to require manufacturers to submit additional testing
on the health, environmental, or welfare effects of F/FA emissions will
take into account the cumulative information provided by Tiers 1 and 2,
including previous scientific data, emissions characterization data,
biological test results, and any ancillary information which may be
available to EPA. Thus, decisions to require Tier 3 level testing will
be made only after all the requirements of Tiers 1 and 2 have been
adequately satisfied (with the exception of special cases as discussed
in Section VIII.D). Adherence to this principle will prevent
unnecessarily costly or poorly targeted decisions based on piecemeal,
out-of-context information, and will promote more precise
identification and evaluation of data gaps, and more cost-efficient
coordination of potential test requirements.
Ultimately, EPA must be able to decide whether or not the use of a
fuel or fuel additive is likely to create unacceptable health or
welfare risks. If a risk decision is made possible by the information
from Tiers 1 and 2, then Tier 3 will not be required. However, if such
a risk decision cannot be made on the basis of the Tiers 1 and 2 data,
then Tier 3 testing will be mandated. Therefore, to make a
determination on the need for Tier 3 testing, EPA scientists will
evaluate the extent to which the results of Tiers 1 and 2 are adequate
for such decisions, guided by the basic principles of risk assessment.
A risk assessment requires the merging of a health effects
assessment (including hazard identification and concentration-response
relationship) and an exposure assessment. Such an assessment can range
from a qualitative to a highly quantitative analysis, depending upon
the extent of the available data. EPA recognizes that a quantitative
assessment might not be possible at the end of Tier 2.\59\ However,
Tiers 1 and 2 might indicate that little hazard is present and that
exposures may be quite low and limited geographically. In such a case,
there may be no reason to pursue further testing at the Tier 3 level to
improve risk assessment information. On the other hand, Tiers 1 and 2
might suggest that a hazard is likely and that exposures could be
significant because of the production volume and ubiquitous use of a
product, but the data may still be inadequate for a quantitative risk
assessment. In this case, Tier 3 testing could be indicated to provide
the needed information.
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\59\However, if adequate information exists, EPA does not rule
out the possibility of conducting such risk assessment.
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In general, the principles and critical data elements of the risk
assessment process will provide a useful guide for identifying whether
meaningful information gaps remain and for determining the specific
objectives of potential Tier 3 testing. However, EPA does not intend to
conduct a formal risk assessment as part of its decision on whether to
promote a fuel or fuel additive (or group) to Tier 3. Rather, EPA will
evaluate the quality and certainty of the toxicity and concentration-
response data and consider qualitatively whether such data weighs in
favor of or against further testing. A formal risk assessment will be
more likely to be developed at such a time that there is a need for
action to control or prohibit a product under the regulatory authority
of CAA section 211(c).
The following sections discuss key factors which EPA will consider
in identifying the need for and content of Tier 3 testing.
1. Statistical Issues
As previously mentioned, scientific judgment will be exercised in
determining whether Tier 3 testing is indicated. An important factor in
such judgments will be the interpretation of and significance ascribed
to ``negative'' results obtained in Tiers 1 and 2. To address this
issue, EPA will consider statistical information such as the
probability of Type I and Type II errors.
A Type I error occurs when a false positive conclusion is made,
while a Type II error is a false negative conclusion. The acceptability
of a specific Type II error is related to the acceptability of false
negatives in the particular study being performed. For example, from a
toxicological perspective, screening assays often have a relatively
high probability of producing false negative (Type II) outcomes, since
some major aspects of organ or tissue toxicity are not being examined.
Thus, an acceptable Type II error for screening assays will typically
be high. However, the level of Type II error considered acceptable
should be tempered by the goal of the study. A higher false negative
conclusion (e.g., Type II error of 0.2) will generally be acceptable if
it refers to an effect of minimal severity at a high-exposure test
level relative to ambient concentration and if few people are likely to
be exposed. The converse will also hold true.
Scientifically sound statistical analyses are a crucial part of any
reliable study and will provide key information for EPA to make
judgments on whether or not Tier 3 testing is needed. While it is not
feasible to list all possible scenarios and results for each Tier 2
endpoint, the above discussion describes how some of the statistical
factors will be incorporated into EPA's decisions.
2. Exposure Assessment
The Tier 1 requirements will provide EPA with information on the
composition of F/FA emissions and potential exposures to F/FA products.
This information includes: (1) Types and emission rates of speciated
emission components, (2) possible literature search findings on
ambient, occupational, or epidemiological exposures, (3) literature
information on the potential fate and environmental effects, and (4) a
qualitative exposure analysis (submitted by the manufacturer or group)
based on the production and use of the F/FA product(s). As mentioned
above, this information will be considered qualitatively by EPA in
determining the extent of potential exposures and whether additional
testing or analysis is needed to assess risks quantitatively. As
discussed earlier, EPA has the authority to require exposure modeling
or analysis under Tier 3.
Significant public health concerns might sometimes be revealed by
the submitted information on product composition, total annual
production volume and market distribution data, and emissions data.
This might be the case, for example, if there was a significant annual
release of emission compounds with known toxicities, or if the
anticipated exposures approached or exceeded current estimates of
apparently safe levels of known toxicants. In the case of high-volume
fuels and their associated bulk additives, EPA will generally assume
that human and environmental exposures will be of sufficient level and
extent that significant observed adverse effects could indicate a need
for follow-up in Tier 3. This exposure assumption reflects the high
production and consumption of these products, either at the present
time or as anticipated in the future. Thus, decisions to refer these
products to Tier 3 will be based on the degree to which additional
testing is needed to clarify the results and potential health effect
and environmental implications identified in the previous tiers. On the
other hand, it cannot be assumed that fuel additives used in relatively
low concentrations or produced in relatively low volumes will
automatically be excused from Tier 3. For these products, test results
indicative of severe health effects and/or high exposure levels (e.g.,
during consumer use) might be cause for escalation to Tier 3.
3. Health Assessment
General criteria for evaluating the potential public health effects
associated with fuel and additive emissions will include: (1) The
number of positive and negative outcomes related to each endpoint, (2)
the identification of a concentration-effect relationship, (3) the
statistical sensitivity and significance of such studies, (4) the
severity of the observed effects (e.g., whether the effects will likely
lead to incapacitating or irreversible conditions), and (5) the
consistency and clarity of apparent mechanisms, target organs, and
outcomes. Additional parameters which will influence the decision on
whether to require Tier 3 will include: (1) The nature and amount of
known toxic agents in the emissions stream and (2) the observation of
lesions which specifically implicate inhalation as an important
exposure route for inducing adverse health effects.
These criteria will be evaluated in conjunction with the Tier 1 and
Tier 2 results to determine whether or not higher level testing is
needed. In this decision, both the biological and statistical
significance of the Tiers 1 and 2 results will be taken into account.
Generally, escalation to Tier 3 may be judged necessary when remaining
uncertainties about the significance of observed outcomes and/or
potential exposures interfere with EPA's ability to make reasonable
estimates of potential health risks. On the other hand, if no
statistically significant effects are obtained at any exposure level in
a scientifically sound Tier 2 study (or existing test submitted in lieu
of Tier 2 testing and not contradicted by other published reports of
equal or greater reliability), and if other major sources of concern do
not arise (e.g., toxic effects of structurally related compounds), then
Tier 3 testing is not likely to be required for the endpoint in
question.
This discussion assumes that relevant, high-quality statistical
analyses have been done to permit the negative test results to be
properly evaluated and interpreted. The statistical analyses
recommended for Tier 2, including determination of Type I and II error
(as discussed in Section IX.B.1), should enable reasonable conclusions
to be drawn as to the significance of negative findings. Factors to be
taken into account include the toxicological nature of the findings and
the exposure levels used in the test. For example, if the statistical
analyses are applied to a ``severe'' endpoint (e.g., major fetal
abnormalities, major lung pathology, etc.) and the exposure in question
is moderate, then a relatively low Type II error level may be
appropriate. In contrast, if a high concentration limit test causes a
relatively minor effect (e.g., a small change in estrous cyclicity), a
higher Type II error may be allowed, effectively increasing the chance
of false negative conclusions.
4. Evaluation of Tier 2 Results
The specific outcomes which will be considered positive and
negative results for each Tier 2 test were mentioned briefly in the
previous descriptions of Tier 2 requirements (see Section VIII.B) and
are defined and interpreted more precisely in the regulatory text of
this final rule. For example, three primary assays (i.e., Salmonella,
MN, and SCE) are included in Tier 2 for the screening of
carcinogenicity and mutagenicity. As compared with appropriate
controls, a statistically significant concentration-related positive
response in any one of these assays could be cause for concern, as will
be positive outcomes for at least one concentration in two or more of
these tests. Such outcomes will be indicative of mutagenic and/or
carcinogenic risk. Positive results will also indicate that the
emissions could initiate some of the mechanisms involved in
carcinogenesis. However, these results will generally not in themselves
be sufficient to determine whether the emissions were in fact
carcinogenic because the development of cancer is a multi-step process.
Depending on the internal and historical consistency of the results and
their relationship to projected exposures, further testing might be
required to determine the significance of the mutagenic and/or
carcinogenic activity/risks in human populations exposed by inhalation.
In contrast, if no statistically significant results are obtained in
the three assays and no conflicting results are found in the literature
or in any other Tier 2 tests, then Tier 3 follow-up of potential
carcinogenic/mutagenic effects is not likely to be required.
To take another example, determination of the need to investigate
further reproductive or teratogenic risks will take into account the
outcome of the results of the estrous cyclicity measurements, the
histopathological evaluation of reproductive organs, the outcome of the
fertility screen, and the outcome of the teratogenicity evaluation. If
negative results are obtained in the above evaluations (according to
statistically sound principles), and if these results are not refuted
by the existing literature, then additional testing is not likely to be
required at the Tier 3 level for reproductive or teratogenic effects.
Positive results for the teratogenicity study will include a decrease
in neonatal viability relative to that in control studies, a
significant change in the proportion of viable male versus female
fetuses or offspring, the presence of soft tissue or skeletal
abnormalities, and an increased rate of embryonic or fetal resorption.
Other positive outcomes related to reproductive effects, such as
decreased fertility, decreased litter size, abnormal changes in vaginal
cytology or reproductive organ histopathology, will be indicative of
hazards to the adult reproductive systems. The need for additional
evaluation under Tier 3 will depend on the specificity, severity, and
consistency of results, the presence or absence of a concentration-
effect relationship, and the significance of these outcomes in view of
projected exposures. The greater the remaining uncertainty regarding
the risk of reproductive or teratogenic effects after analysis of such
factors, the higher will be the likelihood that Tier 3 will be
required.
Similarly, consistent negative results (according to statistically
sound principles) obtained in other Tier 2 tests, in the absence of
significant related concerns raised in the literature, will (in all
likelihood) make Tier 3 unnecessary. If adverse effects are found at
Tier 2 and/or reported in the literature, EPA will determine if Tier 3
follow-up is required by attempting to evaluate the nature, severity,
and significance of the findings in light of the likely exposures. If
EPA determines that Tier 3 testing is required to resolve the remaining
uncertainties, the Tier 3 requirements will reflect both positive and
negative results. For example, if the results of Tier 2 were positive
for pulmonary effects but negative for neurotoxicity (according to
criteria discussed earlier), and if these results were consistent with
the literature, only pulmonary toxicity would be a likely candidate for
Tier 3 follow-up testing.
C. Potential Tier 3 Tests
To be most cost-effective, Tier 3 testing will be designed to
address specific data gaps regarding health effects endpoints of
concern or health and environment-related issues requiring further
analysis. For instance, Tier 3 requirements could potentially include
further emission characterization procedures, perhaps involving
additional vehicles and/or more rigorous pre-conditioning methods, to
identify and quantify harmful emission products with greater precision.
Higher-order modeling calculations or exposure field studies could be
required to resolve uncertainties in the Tier 1 emissions exposure
information. Health or welfare effects testing requirements will be
aimed at providing sufficient information to make sound conclusions
about the degree of health or welfare risk. If more than one endpoint
is of concern, EPA will attempt to reduce testing costs by permitting
combined protocols insofar as possible.
Tier 3 tests for specific endpoints could require the determination
of a NOAEL. Depending on the endpoint under evaluation, consideration
will be given to including a mid-duration examination in the case of
chronic inhalation tests. A mid-duration evaluation will be useful for
affirming the adequacy of exposure levels and, in some cases, might
enable interim risk conclusions to be drawn which will avoid the need
for further examination. Inhalation studies will generally make use of
rodent species, but higher order mammals could be required.
While Tier 3 testing requirements will be targeted to critical
areas of concern, EPA will also exercise its judgment to avoid the
false economy of establishing overly narrow requirements. Just as
requirements for too many assays would be wasteful of resources,
requirements for too few assays might result in inconclusive findings,
creating needs for still further testing at greater total expense than
would have been necessary at the start. Similarly, EPA will consider
the value of including secondary evaluations as useful and low-cost
adjuncts to tests already required. For example, if the histopathology
of a specified target organ was the primary examination required at the
conclusion of an inhalation exposure, other organs could be weighed and
saved in storage for a limited time period, at low incremental expense.
If indicated, these other organs would then be available for subsequent
examination, avoiding the possible need to repeat the chronic
inhalation procedures to assess the effects on other organs.
Because the specific health testing requirements which will be
imposed in Tier 3 will be tailored to individual circumstances, precise
test guidelines cannot be provided in advance. However, some examples
of testing scenarios which might be required under Tier 3 are cited in
Sec. 79.54 in the accompanying regulatory text. Where possible,
existing standard guidelines for these tests are referenced. It should
be recognized, however, that such guidelines might need to be revised
to accommodate emission inhalation requirements and/or to evaluate
certain structures or functions which the current guidelines do not
adequately address. Study parameters which might require modification
include exposure routes and concentrations, species selection, number
of animal subjects, examination procedures and frequencies, and
analytic requirements. Furthermore, interim advances in the underlying
science and testing technology may provide superior approaches which
could be available for use by the time Tier 3 requirements are
implemented.
X. Special Provisions
The following sections describe special provisions included in the
F/FA registration program to avoid duplication of effort, to alleviate
the financial impact on small businesses, and to ease the burdens of
the program on the regulated industry in general.
A. Experimental F/FAs
EPA requested comments on the possibility of providing a temporary
program exemption or deferment for experimental F/FAs. Eligibility for
this special provision was to be limited to unregistered products
(i.e., F/FAs which are not registered as of the effective date of this
final rule) or registered products that had not been placed into
wholesale or retail commerce prior to promulgation of this rule.
The regulated industry provided comments questioning the need for a
special provision for experimental F/FAs under this rulemaking because
a provision for experimental products already exists under existing
registration rules. EPA agrees with the comments received and today's
rule relies on existing regulations under 40 CFR 79.4(a)(3) and
79.4(b)(2) for the exemption of experimental F/FAs. 40 CFR section
79.4(a)(3) exempts fuels used for research, development or testing, and
40 CFR section 79.4(b)(2) similarly exempts fuel additives. Based on
these existing provisions, any designated F/FA product sold to
automobile, engine, or component manufacturers for research,
development or test purposes, or sold to automobile manufacturers for
factory fill, and not in any case offered for commercial sale to the
public, is exempted from the registration requirements of today's rule.
B. Relabeled Products
A company's product is registered as ``relabeled'' if it is simply
a repackaged and rebranded version of a formulation which is already
registered by another manufacturer and is procured from that
manufacturer for sale or use. Requiring companies which sell relabeled
products to conduct the testing program in today's rulemaking would
clearly duplicate the efforts of the original manufacturer. Thus, under
the authority of CAA section 211(e)(3)(C), which provides that the
Administrator may ``exempt any person from such regulations with
respect to a particular fuel or fuel additive upon a finding that any
additional testing of such fuel or fuel additive would be duplicative
of adequate existing testing,'' today's rule includes a special
provision exempting relabeled products from the evaluation and testing
requirements. For relabeled products, only basic registration
information will be required, as described below in Section XII.A.
About half of the 4,800 fuel additives registered (as of March
1994) are relabeled products. Manufacturers of these relabeled products
will therefore not be required to comply with the health and welfare
effects assessment provisions of the F/FA registration program.
C. Aerosols
Several commenters requested an exemption for aftermarket aerosol
additives because of the nature of their mode of application and their
low frequency of use. EPA examined available data on aerosol products
and concluded that the required testing procedures of this rule are not
well suited to this type of product. The evaluation of currently
registered additives indicates that aerosols include carburetor
cleaners and engine starters that are sprayed into the air intake valve
of the engine and are used only intermittently and, even then, for only
a very brief period of time (i.e., a few seconds). Because of their
intermittent use and method of use, it is unlikely that their
recommended application would affect the overall characteristics of
vehicle emissions. Direct exposure to the aerosol product itself is
likely to be a more important source of potential hazards than is
exposure to its combustion or evaporative emission products. Thus, the
evaluation of potential health and welfare effects of aerosols would
require a different testing regimen tailored to the specific nature of
these products.
Today's rule therefore establishes a special provision for
aerosols. Manufacturers of aftermarket aerosol additives are required
to provide only the basic registration data required for all F/FA
manufacturers (see Section XII.A), plus a literature survey of existing
information on their products and a discussion on the potential
exposures. Thus, the standard emission characterization and Tier 2
tests are not required for aerosol products. The literature search (as
described in Section VII.A) must include existing data on potential
health and welfare effects on the uncombusted aerosol product as a
whole and on the individual components of the product. The analysis of
potential exposures should be based on the total annual production
volume data and the market distribution of the product, as explained in
Section VII.C. EPA will review the submitted information and will
determine if there is a need to require testing on a case-by-case
basis. Thus, if testing of an aerosol is prescribed by EPA, the testing
is to be performed under Tier 3. Using this approach, EPA will be able
to tailor specific tests (as needed) addressing the particular problems
related to aerosol product exposure.
D. Small Business Provisions
In the NPRM, EPA requested comments on the possibility of
establishing special provisions for small businesses. The regulated
industry expressed concerns regarding the costs of the program and the
potential impact of the F/FA regulations on the financial status of
small companies. EPA understands that small businesses might be
particularly affected by the F/FA regulations due to their smaller
resource base, generally lower rate of representation in trade
organizations and, consequently, their potentially limited opportunity
to participate in grouping and cost-sharing arrangements. In view of
these circumstances, EPA is including in today's rule special
provisions to alleviate the economic impact of this rule on small
manufacturers of F/FAs, taking into consideration the comments
received.
EPA examined the distribution of currently registered F/FA
companies across various sales ranges and identified a sales level
which will define a ``small business'' for the purposes of this rule. A
comparison between registered fuel manufacturers and registered
additive manufacturers indicates that the distribution across sales
ranges is similar for both industries. Each industry appears to be made
up of many small companies and relatively few larger companies.
Approximately a fifth of registered fuel manufacturers and a third of
registered additive manufacturers have sales above $100 million. For
both industries, most of the companies with sales under $100 million
tend to cluster under $50 million. Thus, within each of the industries,
companies tend to cluster above $100 million and below $50 million in
sales. Furthermore, companies with sales below $50 million also tend to
have sales below $10 million, especially within the additive industry.
Based on the analysis of F/FA manufacturers' sales data, EPA
identified $50 million as a reasonable sales level for differentiating
between small and large companies within each industry.\60\ As a
result, this final rule defines a small business as any motor vehicle
fuel or fuel additive manufacturer with total annual sales of less than
$50 million.\61\ The small business provisions established for this
rule are defined below.
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\60\In cases where subsidiary, divisional, or other complex
business arrangements exist, the business entity to which this sales
level pertains is the parent company with ultimate ownership. The
``ultimate'' parent is defined as the uppermost headquarters or
topmost company encompassing all related parents, subsidiaries,
divisions, branches, or other operating units. This definition
follows that used by the Small Business Administration. It also
helps to ensure that companies will not subdivide merely to become
eligible for the small business provisions of this program.
\61\``Total annual sales'' means the average of the
manufacturer's sales revenue in each of the previous three years
(i.e., the three years prior to the submittal of the supplemental
notification form required under this rule).
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Special provisions for small
F/FA companies were developed based on assumptions regarding the degree
to which manufacturers will have the opportunity to group with other
manufacturers to share costs, and the degree to which information on
similar products can be expected to be submitted by larger companies. A
review of EPA's registration data base shows that nearly every
registered F/FA manufacturer produces at least one baseline or non-
baseline product. Hence, even if generous special provisions are
provided for small manufacturers of these products, EPA is assured that
test data on such products will still be submitted by other, larger
companies which do not qualify for the special provisions. Therefore,
in regard to registration of products in the baseline and non-baseline
categories, this final rule requires small businesses (i.e., companies
with annual sales less than $50 million) to submit only the basic
registration data for their baseline and/or non-baseline products. Such
companies are not required to meet the Tier 1 and Tier 2 requirements
in order to register their baseline and non-baseline F/FAs. Since the
larger companies will still be submitting the data for these products,
this provision does not compromise EPA's ability to get the necessary
information to evaluate the potential health and welfare effects of
baseline and non-baseline products.
The above assumption, however, is not valid in the case of atypical
F/FAs. Analysis of current registrations shows that there are fewer
atypical products than baseline products and fewer large companies that
produce atypical F/FAs. Therefore, if the same small business
provisions described above for baseline/non-baseline F/FAs were also
applied to atypical F/FAs, then there would be no data submitted for
many atypical F/FAs. EPA would then be unable to evaluate the health
and welfare effects for these atypical products. Nevertheless, EPA
realizes that the testing program will be particularly burdensome for
very small manufacturers of atypical F/FAs. In part, this is due to the
added compliance requirements for atypical products (e.g., more
rigorous mileage accumulation requirements prior to emission generation
(see Section VI.E) and more extensive emission characterization
requirements (see Section VII.B). An even greater impact results from
the fact that grouping opportunities for these manufacturers might be
quite limited. Not only do atypical products tend to be unique, but
also, the smallest manufacturers rarely are members of the dominant
trade associations which are most likely to take the lead in organizing
and administering F/FA group functions. Thus, high program costs could
fall on manufacturers with low financial resources and perhaps few
opportunities to share the costs.
Based on the above reasons, this final rule includes additional
special provisions applicable to the atypical F/FAs of small
businesses. However, these provisions apply to fewer manufacturers and
are less liberal than those established for baseline and non- baseline
products. Specifically, for manufacturers of atypical products with
less than $10 million in annual sales (rather than the $50 million
sales level applicable to manufacturers of baseline/non-baseline F/
FAs), the minimal requirements of the program include only basic
registration and Tier 1 data. These requirements fall between those
applicable to small manufacturers of baseline/non-baseline F/FAs and
the general requirements of the program for larger manufacturers.
In summary, manufacturers qualifying for small business special
provisions for their baseline and non-baseline products (having less
than $50 million annual sales) are excused from both Tier 1 and Tier 2
requirements, while small manufacturers qualifying for special
provisions for their atypical products (having less than $10 million
annual sales) are excused only from Tier 2 requirements for these
products. Since small business provisions are based on both the annual
sales and the product category, the possibility exists for a
manufacturer to have some products excused from program requirements
while having to comply with testing requirements for others. For
example, an additive manufacturer having both baseline and atypical
products and annual sales of $30 million can use the special small
business provision for the baseline additives, but not for the atypical
products.
Pursuant to CAA section 211(b), F/FAs which are excused from any
program requirements under these special provisions may still be
subject to testing under Tier 3 at EPA's discretion (on a case-by-case
basis). The Tier 3 testing might include (but would not be necessarily
limited to) information which would otherwise have been required under
the provisions of Tier 1 and/or Tier 2.
XI. Timing and Compliance Requirements
The timing and compliance requirements for the F/FA registration
program are dependent on the type of product and the registration
status of the product. As discussed in Section III.A of this preamble,
both Tier 1 and Tier 2 are mandatory requirements for all F/FAs (or
groups), except as may be modified by any applicable special
provisions. Special provisions affecting the content and/or timing of
these requirements are discussed in Sections VII.A.3, VIII.D, and X of
this preamble. For F/FAs registered as of the effective date of this
rule, Tier 1 data and evidence of a suitable contractual arrangement
for satisfactory completion of Tier 2 requirements must be submitted to
EPA within three years of the effective date. The results of Tier 2
must be submitted to EPA no later than six years from the effective
date. The schedule for completion of any Tier 3 requirements which EPA
may prescribe will be determined based on the nature of the particular
requirements. The general reporting format for submittal of all of
these requirements is described in Section XII.
For registrable F/FAs, i.e., F/FAs not registered as of the
effective date of this rule but meeting the criteria for grouping with
a currently registered fuel or bulk additive in the same fuel family,
the content and timing of requirements is essentially the same as for
the currently registered F/FAs. Thus, manufacturers of these products
will be granted registration and be permitted to market registrable F/
FAs upon EPA's receipt of basic registration data for such products. In
contrast, for manufacturers of new F/FAs (i.e., F/FAs that are not
currently registered and do not meet the registrable criteria), all
testing requirements must be completed prior to registration and
introduction into commerce, including Tier 3 when prescribed by EPA.
After receipt of Tier 1 and/or Tier 2 data, EPA will determine
whether the submitted information is in compliance with the specified
guidelines and whether further testing of a particular fuel or fuel
additive is required under the provisions of Tier 3. For registered F/
FAs, EPA intends to determine the adequacy of the submitted data within
two years after receipt. However, if EPA is unable to inform the
registered manufacturer of the adequacy of the Tier 1 and/or Tier 2
data within two years after submittal, EPA retains the authority to
require that satisfactory data be submitted if, upon subsequent review,
EPA finds that the original submittal was inadequate for compliance. In
such a case, EPA will not hold the manufacturer liable for penalties
for violating this rule from the time period between the date on which
the data were due and the date on which EPA informs the responsible
manufacturer of a violation. Regarding new F/FAs, EPA will send a
notification of compliance within six months after submission of Tier 1
and Tier 2 data. If the manufacturer of the new F/FA product does not
receive a notification of compliance with Tier 1 and Tier 2 within this
time frame, then the manufacturer should assume that the Tier 1 and
Tier 2 requirements have been satisfactorily met. EPA's determination
of the need for Tier 3 testing for new F/FAs will occur within six
months after EPA notifies the manufacturer of satisfactory compliance
with Tier 1 and Tier 2 requirements or within twelve months of the Tier
1 and Tier 2 submittal, whichever occurs first.
If Tier 3 testing is deemed necessary, EPA will notify the
responsible manufacturer (or group) by certified letter of the specific
Tier 3 requirement(s) along with a schedule for compliance and a
deadline for submittal of the Tier 3 report to EPA (see Section IX.A).
This final rule gives the responsible manufacturer (or group) 60 days
to comment on the prescribed Tier 3 requirements, compliance schedule,
and submission deadline. In the event that EPA receives no comment
within the given period, the manufacturer will be assumed to have
consented in full to the prescribed Tier 3 requirements. Compliance
with Tier 3 requirements is not optional.
Registered (and registrable) F/FAs required to undergo Tier 3
testing will retain their registration for that time determined to be
necessary for the completion of Tier 3 tests. This registration will be
contingent on the satisfactory compliance with the Tier 3 requirements
according to a timetable determined by EPA to be appropriate to those
requirements. When Tier 3 is prescribed for new F/FAs (i.e., those not
meeting the registrable criteria), EPA may withhold registration until
completion of all testing requirements. For new F/FAs, EPA will
determine whether the Tier 3 requirements have been met within one year
of receiving the Tier 3 submittal. If Tier 3 requirements are
satisfied, then EPA will send a notification to the manufacturer
granting registration to the new F/FA product. Registration of new F/
FAs will not occur until that time when EPA determines that all Tier 3
requirements have been satisfactorily met.
As described above, EPA's review times for data on new F/FAs are
shorter than those for registered F/FAs. The reason for this
discrepancy is that manufacturers of new F/FAs are barred from
marketing such products until EPA approves their compliance with all
testing requirements and grants them registration. On the other hand,
manufacturers of registered products can maintain their registration,
and thus their ability to sell their products, while EPA is reviewing
their submitted data. Thus, to ensure that undue hindrance is not
created for manufacturers of new products wanting to enter the
marketplace, EPA has abbreviated the review times for new F/FA
products.
Notwithstanding the granting of a registration (or continued
registration for registered F/FAs), if EPA determines that a fuel or
fuel additive causes or contributes to air pollution that may
reasonably be anticipated to endanger the public health or welfare,
then EPA could invoke available regulatory authority under CAA section
211(c). Referral to Tier 3 is not required for EPA to begin a
regulatory action under 211(c).
If additional testing is needed to make up for deficiencies in
information content or testing technique/procedures related to Tier 1,
Tier 2, and/or Tier 3, then the original compliance deadlines will
still be in force. Manufacturers of existing products who fail to
submit data in the prescribed time frames or who submit data from tests
that do not comply with the specified guidelines will be in violation
of this rule and will be subject to the penalties specified in CAA
section 211(d). According to CAA section 211(d), persons who fail to
submit any information or conduct any tests required by the
Administrator under CAA section 211(b) shall be liable to the United
States for a civil penalty of not more than $25,000 for every day of
such violation plus the amount of economic benefit or savings resulting
from the violation. Each day after the due date for submission of data
will constitute a separate day of violation. Civil penalties will be
assessed in accordance with CAA sections 205(b) and (c), which permit
EPA to proceed either in court or in an administrative action. If a
group of manufacturers commits to performing joint testing, each
manufacturer would separately be in violation of the rule. However, the
Administrator would retain the authority to remit or mitigate any
penalty under CAA section 211(d).
In addition to the above penalties, the district courts of the
United States have jurisdiction to compel the furnishing of information
and/or the conduct of tests required under CAA section 211(b). This
means that, in addition to the financial penalties, persons failing to
submit data or comply with the specified guidelines would still need to
submit the data originally required. Furthermore, if EPA determines
that the data requirements of the rule were not met, EPA could revoke
the registration of the fuel(s) or additive(s) in question.
Because EPA recognizes that unusual circumstances, outside the
control of the manufacturer, may occasionally interfere with the
manufacturer's ability to comply with the provisions of the rule,
today's rule contains a mechanism to allow manufacturers to request
modification of the requirements under some specific circumstances.
This special mechanism allows persons who experience unforeseen
problems or accidents in conducting the EPA-prescribed tests to request
modification of the requirements in order to avoid being in violation
of the rule. This mechanism would apply to unusual mechanical problems
or other unavoidable problems that could arise during the performance
of the required tests. The modification requests must be submitted as
soon as the manufacturer is aware of the difficulty, but not later than
thirty days following the event precipitating the request. Additional
details on this special mechanism for modification of requirements is
included in the regulatory text of this rule.
XII. Reporting Requirements
The materials to be submitted to EPA include the basic registration
data, a summary report with Tier 1 and Tier 2 results, and associated
appendices. If the results of Tiers 1 and 2 are submitted at the same
time, then the summary report must include both Tier 1 and Tier 2
information and associated appendices, as described below. If Tier 1
and Tier 2 results are submitted separately, then two individual
reports must be provided to EPA, i.e., Tier 1 report and Tier 2 report.
In such a case, each individual report must include the summary
information applicable to the respective tier (including a cover page,
executive summary, test substance information, a summary of tier
results, conclusions, and associated appendices). If the Tier 2 report
for registered F/FAs is not submitted within three years after the
effective date of the final rule, then evidence of a suitable
arrangement for completion of Tier 2 (e.g., a copy of a signed contract
with a qualified laboratory to conduct the required Tier 2 tests) must
be submitted to EPA prior to that date. F/FA manufacturers who must
conduct additional testing under Tier 3 are required to submit a Tier 3
report when the designated Tier 3 testing is complete. The nature of
the information to be included in the basic registration data, reports,
and associated appendices is described below.
A. Basic Registration Data
The basic information already required for F/FA registration
includes product and manufacturer identification, concentration and
purpose-in-use, and specific compositional data. Today's rule adds the
following items to the basic registration data requirements: total
annual production volume data, marketing distribution data,
notification about group participation, and notification on the use of
special provisions (i.e., relabeled products, aerosols, and small
business, as discussed in Section X). Manufacturers of F/FAs registered
as of the effective date of this rule must submit the additional basic
registration data items to EPA within six months of that date. Other
manufacturers are strongly encouraged to submit the basic registration
data prior to starting the evaluation tiers (i.e., Tier 1, Tier 2, and/
or Tier 3).
The production volume information is to be reported in units of
gallons per year for F/FA products that are generally sold in liquid
form and kilograms per year for F/FA products that are generally sold
in solid form. For F/FAs already in production, the submitted figure
must reflect the most recent annual period as well as the volume
projected to be produced in the third subsequent year. For products not
yet in production, the best estimate of expected total production
volume during the third year of production must be provided. Market
distribution data for each product must also be provided. For fuels and
bulk additives, the distribution data must be reported as the percent
of total annual sales volume marketed in each Petroleum Administration
for Defense District (PADD), as defined in Sec. 79.59(b)(3) of this
rule. For aftermarket additives, the distribution data must be reported
as the percent of total annual sales volume marketed in each state. For
products not yet in production, the manufacturer must report projected
distribution data by PADD or state, as applicable.
Manufacturers of F/FAs registered as of the effective date of this
rule who intend to comply with registration requirements as part of a
group must identify the person or entity which is organizing the
testing for the applicable group. Similarly, if an applicant is relying
on another manufacturer's (or group's) previous registration materials
in compliance with the testing requirements for an unregistered
product, then the other manufacturer or group must be identified. In
addition, the manufacturer of the unregistered product must provide
evidence that the original submitter has been notified and that
reimbursement will occur.
The basic registration data must be submitted (or resubmitted)
individually for each product being registered, using EPA forms which
are in effect at the time of the submittal. This requirement pertains
to all F/FA products registered as of the effective date of this rule,
including relabeled products, as well as those for which first-time
registration is sought after promulgation of this rule. If the basic
registration data previously submitted for a currently registered fuel
or additive is accurate and complete, then a statement asserting that
this is so will suffice in lieu of the submittal of duplicate
information. A finding by EPA that this information is not, in fact,
accurate and complete as claimed will result in the report being
considered inadequate.
A fuel manufacturer may at any time modify an existing fuel
registration by submitting a request to EPA to add or delete a bulk
additive to the existing registration information for such fuel
product, provided that any additional additive must be registered by
EPA for use in the specific fuel family to which the fuel product
belongs. The addition or deletion of a bulk additive to a fuel
registration does not necessarily cause the fuel to be considered
``new''. However, if the change affects the grouping of such registered
fuel, it may affect the testing responsibilities of the fuel
manufacturer.
B. Summary Report
This report will provide a summary of the evaluation procedures,
results, and conclusions, pertaining to Tier 1 and/or Tier 2
requirements.\62\ References used to support Tier 1 and/or Tier 2
conclusions must be cited in the report. A cover page must be included,
identifying the test substance, the manufacturer's name and address, a
designated contact person and phone number, and grouping information
(if applicable). The grouping information must identify the group name
or grouping criteria, all products and manufacturers to which the
report pertains, and the name and address of the responsible
organization or entity reporting for the group. The body of the summary
report must be divided into the following sections.
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\62\These reporting requirements may pertain to separate
submittals for Tier 1 and Tier 2 or a single submittal for both
tiers, depending on the relative timing of these compliance
activities.
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1. Executive Summary
This section must include a brief description of the general
results and conclusions for the tier(s) included in the report (i.e.,
Tier 1 and/or Tier 2), emphasizing information and test data which
provide evidence for potential adverse health and/or welfare effects.
2. Test Substance Information
This section must include a detailed test substance description,
including (as applicable) base fuel parameter values or test fuel
composition (if other than base fuel), and test additive composition.
The base fuel description must include the types and concentrations of
base fuel additive components and values for each of the parameters
specified in the base fuel definition for the applicable fuel family.
Similar parameter values must be identified for test fuels other than
base fuels.
3. Tier 1 Summary
This section is intended to provide an overview of Tier 1 analyses.
Detailed procedural descriptions, tables, and other outputs are to be
included in the appendices.
a. Literature Search. The search methods must be described,
including the identity of data bases and time periods accessed. Any in-
house and/or other unpublished studies included in the literature
search must also be described briefly. The results and conclusions of
the literature search with respect to potential health and welfare
effects of the subject fuel or fuel additive must be summarized. If
test documentation provided by the literature search is used to satisfy
some or all of the other program requirements, the relevant studies
must be discussed and their adequacy to fulfill the specific purposes
of the associated program requirements must be justified. Finally, the
person(s) or contractors conducting the search are to be identified.
b. Emission Generation and Characterization. This section of the
summary report must identify the vehicle selected and describe the
procedures followed in vehicle/engine preparation and maintenance and
in the generation, storage, and processing of emissions for testing.
For group submissions, the report must include a complete description
of the group representative used in the generation of emissions. A
description of the analytic methods used to characterize the F/FA
emission products must also be provided. Problems encountered in
generating and/or characterizing the emissions must be discussed,
including attempts to resolve the problems and their potential effects
on testing outcomes. The laboratories performing these procedures must
be identified.
c. Exposure Analysis. This section must include a qualitative
discussion on the potential exposures to the general, area-specific,
and/or special at-risk population groups based on the production and
use of the particular fuel or additive in question. For group
submissions, the analysis must consider potential exposures due to all
members of the group. When available, EPA recommends the use of
existing modeling data to support the exposure analysis.
4. Tier 2 Summary
For each study, the objectives, principles, and general procedures
must be outlined and the findings and conclusions summarized.
Discussion must be included regarding problems encountered during the
performance of the tests and the methods used to resolve them. This
discussion must include the impact which such problems may have had on
the study outcomes.
5. Conclusions
Further testing needs must be identified or else a discussion must
be provided explaining why the results of Tiers 1 and/or Tier 2 should
not trigger Tier 3 testing requirements.
C. Appendices
Detailed information in support of the general discussions
contained in the summary report are to be submitted as appendices to
the report. In regard to the literature search, the appendices must
contain (1) summary tables of existing studies regarding health and
environmental effects, including such information as the type of study,
species/strain used, exposure concentration(s), duration of study,
endpoints evaluated, results (incidence and statistical significance),
and references, (2) a complete copy of reference lists and associated
abstracts obtained from data base searches (in printed form or on 3\1/
2\ inch (IBM compatible) computer diskettes), (3) complete
documentation of in-house studies and other unpublished information
sources, and (4) complete documentation (e.g., copies of journal
articles) of previous studies which are being cited in satisfaction of
Tier 1 and/or Tier 2 test requirements. Appendices to the emission
characterization section must contain detailed protocols, copies of all
relevant laboratory reports, a list of all speciated emission products
and their emission rates, and documentation and results of calibration/
verification procedures. For the section that discusses potential
exposures, an appendix must be provided for detailed background
information on the production volume and market distribution data used
in the exposure analysis. If exposure models are used, background
calculations and/or model data must also be included in an appendix.
An appendix is also required for each of the tests conducted in
compliance with Tier 2 requirements. These appendices must contain the
full detailed study protocol, complete laboratory report, statistical
analysis of the findings, and scientific conclusions. These materials
must conform to the reporting requirements of the individual study
guidelines as well as the general standards for recordkeeping and
reporting specified in the GLP standards of this final rule (see
Sec. 79.60). A final appendix must be provided, containing laboratory
certifications and associated personnel credentials.
D. Tier 3 Report
Reports for additional tests required under the Tier 3 provisions
must include a cover page with identifying information as described
above for the Tier 1 and 2 summary report(s). The report must begin
with a discussion of the concerns arising under the previous tiers
which led to the Tier 3 requirements, the specific objectives of the
additional studies, and a summary of pertinent results and conclusions.
References used in support of Tier 3 conclusions must be cited in the
report. The Tier 3 summary discussion must be supported with appendices
containing the kinds of documentation discussed above with respect to
Tier 2. The laboratory conducting the required tests must be
identified, and relevant certifications and personnel credentials
provided.
E. Confidential Business Information
CAA section 211(b)(2)(B) states that the results of tests
``conducted in conformity with test procedures and protocols
established by the Administrator,'' pursuant to CAA section
211(b)(2)(A), shall not be considered confidential. Thus, health and
welfare information supplied to EPA in compliance with Tier 1, Tier 2,
and Tier 3 testing requirements will be made available to the public.
Manufacturers (or groups) claiming business confidentiality on any
information submitted under the F/FA testing program must make a claim
of confidentiality in writing at the time of submittal of the reporting
requirements. To assert a business confidentiality claim the submitter
must clearly mark the confidential information and must submit a
separate document setting forth the claim and listing each location at
which the confidential information appears in the submitted data. If
any person subsequently requests access to the test data submitted
under the F/FA testing program (other than health and welfare effects
information) and such information is subject to a claim of business
confidentiality, the request and any subsequent disclosure will be
governed by the provisions of 40 CFR part 2.
XIII. Administrative Requirements
A. Administrative Designation and Regulatory Analysis
Under Executive Order 12866 (58 FR 51735), EPA must determine
whether the regulatory action is ``significant'' and therefore subject
to the Office of Management and Budget (OMB) review and the
requirements of the Executive Order. The Order defines ``economically
significant regulatory action'' as one that is likely to result in a
rule that may: (1) Have an annual effect on the economy of $100 million
or more or adversely affect in a material way the economy, a sector of
the economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities; (2) create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the Executive
Order.
A regulatory support document which presents EPA's analysis of the
cost impacts of this final rule is available for review in the public
docket (A-90-07). EPA estimates that the costs to industry for
submittal of the requisite data for Tiers 1 and 2 would total
approximately $66 million, assumed to be incurred over the first three-
year period after promulgation of this final rule. Thus, the average
annual cost during this period would be about $22 million. In the
subsequent three years, Tier 3 requirements might cost an additional $1
million annually, per product or group. If ten products or groups were
required to conduct Tier 3 testing in the three-year period following
the initial compliance period, the cost would be $10 million per year.
These projected overall costs are far less than the $100 million annual
cost criterion which is a major determinant in defining an
``economically significant regulatory action.'' In addition, this final
rule is not expected to adversely affect in a material way the economy,
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities.
Although not ``economically significant'' based on the above
criteria, this final rule is still considered a ``significant
regulatory action'' pursuant to the terms of Executive Order 12866 and
was thus submitted to OMB for review. Any written comments from OMB and
any EPA response to OMB's comments are available in the public docket
for this rule.
B. Regulatory Flexibility Act
Under section 605 of the Regulatory Flexibility Act, 5 U.S.C. 601
et seq., the Administrator is required to assess the economic impact of
regulatory actions on small businesses. Accordingly, a Regulatory
Flexibility Analysis (RFA) has been prepared for this rule and is
presented as part of the Regulatory Support Document (available in the
public docket). The RFA compares the financial impacts of this rule on
small F/FA manufacturers to the impacts on large F/FA manufacturers.
The analysis explains the small business definition specifically
developed in this rule to provide special provisions for small F/FA
manufacturers (see Section X.D) and assesses the effectiveness of these
provisions.
This final rule defines a small business as any motor vehicle fuel
or fuel additive manufacturer with total annual sales of less than $50
million. A comparison of companies classified as small under this
definition to those classified as small by the Small Business
Administration (SBA) reveals that the F/FA program definition
classifies a larger number of F/FA manufacturers as small, and more
closely groups companies with similar financial characteristics. Based
on this analysis, EPA determined that the small business definition
established in this rule is reasonable and applicable to the F/FA
industry.
Impacts of this rule on F/FA manufacturers were determined by
projecting the effects of the estimated compliance costs on each
company's return on assets (ROA). In general, a reduction in ROA (after
compliance costs) to less than 2.5 percent is indicative of financial
distress. A ROA less than -4 percent indicates that a company is in
severe financial distress, and a ROA less than -30 percent generally
indicates closure. According to these ROA thresholds, results of the
RFA show that approximately 68 unique F/FA manufacturers (43 additive
manufacturers, 23 fuel manufacturers, and 2 that produce both fuels and
additives) could potentially be pushed into some level of financial
distress. All of these companies are classified as small (i.e., have
sales less than $50 million). The majority of these companies would
fall into the first level of financial distress; however, less than
one-fifth of them (12 companies) would potentially be in danger of
closure. In relation to the total population of F/FA manufacturers, the
companies potentially falling into some level of financial distress
account to about six percent, with about 1.2 percent potentially in
danger of closure.
As previously described, this final rule includes two types of
special provisions for small businesses. With respect to baseline and
non-baseline F/FAs, all small manufacturers (i.e., annual sales under
$50 million) are excused from all Tier 1 and Tier 2 testing
requirements. A segment of these small manufacturers, i.e., those
having sales under $10 million, are also excused from Tier 2 testing
responsibility for their atypical F/FAs. Nevertheless, all twelve of
the manufacturers who are projected to be in danger of closure as a
result of this rule are very small companies with one or more atypical
F/FAs. The RFA analysis shows that the special provision for small
manufacturers with atypical products lowers overall compliance costs
for 60 such manufacturers by roughly $20 million (as compared with
costs that would otherwise occur in the absence of this special
provision). Without this provision, an additional 15 manufacturers of
atypical products would potentially be pushed into closure.
It should be noted that the RFA has assumed no changes in prices,
sales, product mix, or financial strategies. In many cases, a portion
of regulatory costs can be actually passed on to consumers or back to
suppliers. Manufacturers also have the option of reformulating a
product to a ``baseline'' standard which has much lower compliance
costs, or even of dropping products with the greatest cost and smallest
profit potential. A more detailed discussion on circumstances which
could mitigate compliance cost impacts is provided in the RFA.
C. Recordkeeping Requirements
The information collection requirements in this rule have been
submitted for approval to OMB under the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. An Information Collection Request document has been
prepared by EPA (ICR #1696.01) and a copy may be obtained from Sandy
Farmer, Information Policy Branch, EPA, 401 M Street SW., Washington,
DC 20460 or by calling 202-260-2740. These requirements are not
effective until OMB approves them and a technical amendment to that
effect is published in the Federal Register.
This collection of information has an estimated annual reporting
and recordkeeping burden averaging 43 hours per response. These
estimates include time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this
burden to Chief, Information Policy Branch; EPA; 401 M Street, SW.,
(Mail Code 2136); Washington, DC 20460; and to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''
XIV. Electronic Availability of Rulemaking Documents
Electronic copies of the preamble, the Regulatory Support Document
and Regulatory Flexibility Analysis, the Summary and Analysis of
Comments, and the regulations for the Fuels and Fuel Additives
Registration rulemaking are available on the Office of Air Quality
Planning and Standards (OAQPS) Technology Transfer Network Bulletin
Board System (TTNBBS). Instructions for accessing TTNBBS and
downloading F/FA files are described below.
TTNBBS can be accessed using a dial-in telephone line (919-541-
5742) and a 1200, 2400, or 9600 bps modem (equipment up to 14.4 Kbps
can be accommodated). The parity of the modem should be set to N or
none, the data bits to 8, and the stop bits to 1. When first signing on
to the bulletin board, the user will be required to answer some basic
informational questions to register into the system. After registering,
proceed through the following options from a series of menus:
(M) OMS
(K) Rulemaking and Reporting
(3) Fuels
(4) Fuels/Fuel Additives
A list of ``.ZIP'' files will be displayed, all of which relate to
the Fuels and Fuel Additives Registration rulemaking. The four
documents listed will be in the form of ``.ZIP'' files and are
identified by the following titles:
``FFA--PRE.ZIP'' (Preamble)
``FFA--RSD.ZIP'' (Regulatory Support Document and Regulatory
Flexibility Analysis)
``FFA--COM.ZIP'' (Summary and Analysis of Comments)
``FFA--REG.ZIP'' (Regulations)
File information can be obtained from the ``READ.ME'' file. Choose
from the following options when prompted:
ownload,
rotocol, xamine, ew, ist, elp or to
exit.
To download a file, e.g., filename.ZIP, the user needs to
choose a file transfer protocol appropriate for the user's computer
from the options listed on the terminal. The user's computer is then
ready to receive the file by invoking the user's resident file transfer
software. Programs and instructions for de-archiving compressed files
can be found under ystems Utilities from the top menu, under
rchivers/de-archivers.
TTNBBS is available 24 hours a day, 7 days a week except Monday
morning from 8-12 EST, when the system is down for maintenance and
backup. For help in accessing the system, call the systems operator at
919-541-5384 in Research Triangle Park, North Carolina, during normal
business hours EST.
List of Subjects in 40 CFR Part 79
Environmental protection, Fuel additives, Fuels, Gasoline,
Incorporation by reference, Motor vehicle pollution, Penalties,
Reporting and recordkeeping requirements.
Dated: May 27, 1994.
Carol M. Browner,
Administrator.
Part 79 of title 40 of the Code of Federal Regulations is amended
as follows:
1. The authority citation for part 79 is revised to read as
follows:
Authority: 42 U.S.C. 7414, 7524, 7545 and 7601.
2. Section 79.2 is amended by revising paragraphs (d), (e), and (f)
to read as follows:
Sec. 79.2 Definitions.
* * * * *
(d) Fuel manufacturer means any person who, for sale or
introduction into commerce, produces, manufactures, or imports a fuel
or causes or directs the alteration of the chemical composition of, or
the mixture of chemical compounds in, a bulk fuel by adding to it an
additive.
(e) Additive means any substance that is intentionally added to a
fuel named in the designation (including any added to a motor vehicle's
fuel system) and that is not intentionally removed prior to sale or
use.
(f) Additive manufacturer means any person who produces,
manufactures, or imports an additive for use as an additive and/or
sells or imports for sale such additive under the person's own name.
* * * * *
3. Section 79.3 is revised to read as follows:
Sec. 79.3 Availability of information.
The availability to the public of information provided to, or
otherwise obtained by, the Administrator under this part shall be
governed by part 2 of this chapter except as expressly noted in subpart
F of this part.
4. Section 79.4 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 79.4 Requirement of registration.
* * * * *
(b) Additives. (1) No manufacturer of any fuel additive designated
under this part shall, after the date by which the additive must be
registered under this part, sell, offer for sale, or introduce into
commerce such additive for use in any type of fuel designated under
this part unless the Administrator has registered that additive for use
in that type of fuel.
* * * * *
5. Section 79.6 is revised to read as follows:
Sec. 79.6 Requirement for testing.
Provisions regarding testing that is required for registration of a
designated fuel or fuel additive are contained in subpart F of this
part.
6. Section 79.10 is revised to read as follows:
Sec. 79.10 Application for registration by fuel manufacturer.
Any manufacturer of a designated fuel who wishes to register that
fuel shall submit an application for registration including all of the
information set forth in Sec. 79.11. If the manufacturer produces more
than one grade or brand of a designated fuel, a manufacturer may
include more than one grade or brand in a single application, provided
that the application includes all information required for registration
of each such grade or brand by this part. Each application shall be
signed by the fuel manufacturer and shall be submitted on such forms as
the Administrator will supply on request.
7. Section 79.11 is amended by revising the introductory text of
the section, removing the period in paragraph (h) and adding a
semicolon and paragraphs (i) and (j) to read as follows:
Sec. 79.11 Information and assurances to be provided by the fuel
manufacturer.
Each application for registration submitted by the manufacturer of
a designated fuel shall include the following:
* * * * *
(i) The manufacturer of any fuel which will be sold, offered for
sale, or introduced into commerce for use in motor vehicles
manufactured after model year 1974 shall demonstrate that the fuel is
substantially similar to any fuel utilized in the certification of any
1975 or subsequent model year vehicle or engine, or that the
manufacturer has obtained a waiver under 42 U.S.C. 7545(f)(4); and
(j) The manufacturer shall submit, or shall reference prior
submissions, including all of the test data and other information
required prior to registration of the fuel by the provisions of subpart
F of this part.
8. Section 79.12 is revised to read as follows:
Sec. 79.12 Determination of noncompliance.
If the Administrator determines that an applicant for registration
of a designated fuel has failed to submit all of the information
required by Sec. 79.11, or determines within the applicable period
provided for Agency review that the applicant has not satisfactorily
completed any testing which is required prior to registration of the
fuel by any provision of subpart F of this part, he shall return the
application to the manufacturer, along with an explanation of all
deficiencies in the required information.
9. Section 79.13 is amended by revising paragraph (a) to read as
follows:
Sec. 79.13 Registration.
(a) If the Administrator determines that a manufacturer has
submitted an application for registration of a designated fuel which
includes all of the information and assurances required by Sec. 79.11
and has satisfactorily completed all of the testing required by subpart
F of this part, the Administrator shall promptly register the fuel and
notify the fuel manufacturer of such registration.
* * * * *
10. Section 79.20 is revised to read as follows:
Sec. 79.20 Application for registration by additive manufacturer.
Any manufacturer of a designated fuel additive who wishes to
register that additive shall submit an application for registration
including all of the information set forth in Sec. 79.21. Each
application shall be signed by the fuel additive manufacturer and shall
be submitted on such forms as the Administrator will supply on request.
11. Section 79.21 is amended by revising the introductory text of
the section and paragraph (d) and adding paragraphs (h) and (i) to read
as follows:
Sec. 79.21 Information and assurances to be provided by the additive
manufacturer.
Each application for registration submitted by the manufacturer of
a designated fuel additive shall include the following:
* * * * *
(d) The specific types of fuels designated under Sec. 79.32 for
which the fuel additive will be sold, offered for sale, or introduced
into commerce, and the fuel additive manufacturer's recommended range
of concentration and purpose-in-use for each such type of fuel.
* * * * *
(h) The manufacturer of any fuel additive which will be sold,
offered for sale, or introduced into commerce for use in any type of
fuel intended for use in motor vehicles manufactured after model year
1974 shall demonstrate that the fuel additive, when used at the
recommended range of concentration, is substantially similar to any
fuel additive included in a fuel utilized in the certification of any
1975 or subsequent model year vehicle or engine, or that the
manufacturer has obtained a waiver under 42 U.S.C. 7545(f)(4).
(i) The manufacturer shall submit, or shall reference prior
submissions, including all of the test data and other information
required prior to registration of the fuel additive by the provisions
of subpart F of this part.
12. Section 79.22 is revised to read as follows:
Sec. 79.22 Determination of noncompliance.
If the Administrator determines that an applicant for registration
of a designated fuel additive has failed to submit all of the
information required by Sec. 79.21, or determines within the applicable
period provided for Agency review that the applicant has not
satisfactorily completed any testing which is required prior to
registration of the fuel additive by any provision of subpart F of this
part, he shall return the application to the manufacturer, along with
an explanation of all deficiencies in the required information.
13. Section 79.23 is amended by removing paragraph (b), by
redesignating paragraph (c) as paragraph (b), and by revising paragraph
(a) to read as follows:
Sec. 79.23 Registration.
(a) If the Administrator determines that a manufacturer has
submitted an application for registration of a designated fuel additive
which includes all of the information and assurances required by
Sec. 79.21 and has satisfactorily completed all of the testing required
by subpart F of this part, the Administrator shall promptly register
the fuel additive and notify the fuel manufacturer of such
registration.
* * * * *
14. Section 79.31 is amended by revising paragraph (b) to read as
follows:
Sec. 79.31 Additives.
* * * * *
(b) All designated additives must be registered by July 7, 1976.
* * * * *
15. A new subpart F, consisting of Secs. 79.50-79.68, is added to
part 79 to read as follows:
Subpart F--Testing Requirements for Registration
Sec.
79.50 Definitions.
79.51 General requirements and provisions.
79.52 Tier 1.
79.53 Tier 2.
79.54 Tier 3.
79.55 Base fuel specifications.
79.56 Fuel and fuel additive grouping system.
79.57 Emission generation.
79.58 Special provisions.
79.59 Reporting requirements.
79.60 Good laboratory practice (GLP) standards for inhalation
exposure health effects testing.
79.61 Vehicle emissions inhalation exposure guideline.
79.62 Subchronic toxicity study with specific health effect
assessments.
79.63 Fertility assessment/teratology.
79.64 In vivo micronucleus assay.
79.65 In vivo sister chromatid exchange assay.
79.66 Neuropathology assessment.
79.67 Glial fibrillary acidic protein assay.
79.68 Salmonella typhimurium reverse mutation assay.
Subpart F--Testing Requirements for Registration
Sec. 79.50 Definitions.
The definitions listed in this section apply only to subpart F of
this part.
Additive/base fuel mixture means the mixture resulting when a fuel
additive is added in specified proportion to the base fuel of the fuel
family to which the additive belongs.
Aerosol additive means a chemical mixture in aerosol form generally
used as a motor vehicle engine starting aid or carburetor cleaner and
not recommended to be placed in the fuel tank.
Aftermarket fuel additive means a 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.
Atypical element means any chemical element found in a fuel or
additive product which is not allowed in the baseline category of the
associated fuel family, and an ``atypical fuel or fuel additive'' is a
product which contains such an atypical element.
Base fuel means a generic fuel formulated from a set of
specifications to be representative of a particular fuel family.
Basic emissions means the total hydrocarbons, carbon monoxide,
oxides of nitrogen, and particulates occurring in motor vehicle or
engine emissions.
Bulk fuel additive means a product which is 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.
Emission characterization means the determination of the chemical
composition of emissions.
Emission generation means the operation of a vehicle or engine or
the vaporization of a fuel or additive/fuel mixture under controlled
conditions for the purpose of creating emissions to be used for testing
purposes.
Emission sampling means the removal of a fraction of collected
emissions for testing purposes.
Emission speciation means the analysis of vehicle or engine
emissions to determine the individual chemical compounds which comprise
those emissions.
Engine Dynamometer Schedule (EDS) means the transient engine speed
versus torque time sequence commonly used in heavy-duty engine
evaluation. The EDS for heavy-duty diesel engines is specified in 40
CFR part 86, appendix I(f)(2).
Evaporative Emission Generator (EEG) means a fuel tank or vessel to
which heat is applied to cause a portion of the fuel to evaporate at a
desired rate.
Evaporative emissions means chemical compounds emitted into the
atmosphere by vaporization of contents of a fuel or additive/fuel
mixture.
Evaporative fuel means a fuel which has a Reid Vapor Pressure (RVP,
pursuant to 40 CFR part 80, appendix ``E'') of 2.0 pounds per square
inch or greater and is not supplied to motor vehicle engines by way of
sealed containment and delivery systems.
Evaporative fuel additive means a fuel additive which, when mixed
with its specified base fuel, causes an increase in the RVP of the base
fuel by 0.4 psi or more relative to the RVP of the base fuel alone and
results in an additive/base fuel mixture whose RVP is 2.0 psi, or
greater. Excluded from this definition are fuel additives used with
fuels which are supplied to motor vehicle engines by way of sealed
containment and delivery systems.
Federal Test Procedure (FTP) means the body of exhaust and
evaporative emissions test procedures described in 40 CFR 86 for the
certification of new motor vehicles to Federal motor vehicle emissions
standards.
Fuel family means a set of fuels and fuel additives which share
basic chemical and physical formulation characteristics and can be used
in the same engine or vehicle.
Manufacturer means a person who is a fuel manufacturer or additive
manufacturer as defined in Sec. 79.2 (d) and (f).
Nitrated polycyclic aromatic hydrocarbons (NPAH) means the class of
compounds whose molecular structure includes two or more aromatic rings
and contains one or more nitrogen substitutions.
Non-catalyzed emissions means exhaust emissions not subject to an
effective aftertreatment device such as a functional catalyst or
particulate trap.
Oxygenate compound means an oxygen-containing, ashless organic
compound, such as an alcohol or ether, which may be used as a fuel or
fuel additive.
Polycyclic aromatic hydrocarbons (PAH) means the class of
hydrocarbon compounds whose molecular structure includes two or more
aromatic rings.
Relabeled additive means a fuel additive which is registered by its
original manufacturer with EPA and is also registered and sold,
unchanged in composition, under a different label and/or by a different
entity.
Semi-volatile organic compounds means that fraction of gaseous
combustion emissions which consists of compounds with greater than
twelve carbon atoms and can be trapped in sorbent polymer resins.
Urban Dynamometer Driving Schedule (UDDS) means the 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).
Vapor phase means the gaseous fraction of combustion emissions.
Vehicle classes/subclasses means the divisions of vehicle groups
within a vehicle type, including light-duty vehicles, light-duty
trucks, and heavy-duty vehicles as specified in 40 CFR part 86.
Vehicle type means the divisions of motor vehicles according to
combustion cycle and intended fuel class, including, but not
necessarily limited to, Otto cycle gasoline-fueled vehicles, Otto cycle
methanol-fueled vehicles, diesel cycle diesel-fueled vehicles, and
diesel cycle methanol-fueled vehicles.
Whole emissions means all components of unfiltered combustion
emissions or evaporative emissions.
Sec. 79.51 General requirements and provisions.
(a) Overview of requirements. (1) All manufacturers of fuels and
fuel additives that are designated for registration under this part are
required to comply with the requirements of subpart F of this part
either on an individual basis or as a participant in a group of
manufacturers of the same or similar fuels and fuel additives, as
defined in Sec. 79.56. If manufacturers elect to comply by
participation in a group, each manufacturer continues to be
individually subject to the requirements of subpart F of this part, and
responsible for testing under this subpart. Each manufacturer, subject
to the provisions for group applications in Sec. 79.51(b) and the
special provisions in Sec. 79.58, shall submit all Tier 1 and Tier 2
information required by Secs. 79.52, 79.53 and 79.59 for each fuel or
additive, except that the Tier 1 emission characterization requirements
in Sec. 79.52(b) and/or the Tier 2 testing requirements in Sec. 79.53
may be satisfied by adequate existing information pursuant to the Tier
1 literature search requirements in Sec. 79.52(d). The adequacy of
existing information to serve in compliance with specific Tier 1 and/or
Tier 2 requirements shall be determined according to the criteria and
procedures specified in Secs. 79.52(b) and 79.53 (c) and (d). In all
cases, EPA reserves the right to require, based upon the information
contained in the application or any other information available to the
Agency, that manufacturers conduct additional testing of any fuel or
additive (or fuel/additive group) if EPA determines that there is
inadequate information upon which to base regulatory decisions for such
product(s). In any case where EPA determines that the requirements of
Tiers 1 and 2 have been satisfied but that further testing is required,
the provisions of Tier 3 (Sec. 79.54) shall apply.
(2) Laboratory facilities shall perform testing in compliance with
Good Laboratory Practice (GLP) requirements as those requirements apply
to inhalation toxicology studies. All studies shall be monitored by the
facilities' Quality Assurance units (as specified in Sec. 79.60).
(b) Group Applications. Subject to the provisions of Sec. 79.56 (a)
through (c), EPA will consider any testing requirements of this subpart
to have been met for any fuel or fuel additive when a fuel or fuel
additive which meets the criteria for inclusion in the same group as
the subject fuel or fuel additive has met that testing requirement,
provided that all fuels and additives must be individually registered
as described in Sec. 79.59(b). For purposes of this subpart, a
determination of which group contains a particular fuel or additive
will be made pursuant to the provisions of Sec. 79.56 (d) and (e).
Nothing in this subsection (b) shall be deemed to require a
manufacturer to rely on another manufacturer's testing.
(c) Application Procedures and Dates. Each application submitted in
compliance with this subpart shall be signed by the manufacturer of the
designated fuel or additive, or by the manufacturer's agent, and shall
be submitted to the address and in the format prescribed in Sec. 79.59.
A manufacturer who chooses to comply as part of a group pursuant to
Sec. 79.56 shall be covered by the group's joint application. Subject
to any modifications pursuant to the special provisions in
Secs. 79.51(f) or 79.58, the schedule for compliance with the
requirements of this subpart is as follows:
(1) Fuels and fuel additives with existing registrations. (i) The
manufacturer of a fuel or fuel additive product which, pursuant to
subpart B or C of this part, is registered as of May 27, 1994 must
submit the additional basic registration data specified in
Sec. 79.59(b) before November 28, 1994.
(ii) For these products, the manufacturer must also satisfy the
requirements and time schedules in either of the following paragraphs
(c)(1)(ii) (A) or (B) of this section:
(A) Within May 27, 1997, all applicable Tier 1 and Tier 2
requirements must be submitted to EPA, pursuant to Secs. 79.52, 79.53,
and 79.59; or
(B) Within May 27, 1997, all applicable Tier 1 requirements
(pursuant to Secs. 79.52 and 79.59), plus evidence of a contract with a
qualified laboratory (or other suitable arrangement) for completion of
all applicable Tier 2 requirements, must be submitted to EPA. For this
purpose, a qualified laboratory is one which can demonstrate the
capabilities and credentials specified in Sec. 79.53(c)(1). In
addition, within May 26, 2000, all applicable Tier 2 requirements
(pursuant to Secs. 79.53 and 79.59) must be submitted to EPA.
(iii) In the case of such fuels and fuel additives which, pursuant
to applicable special provisions in Sec. 79.58, are not subject to Tier
2 requirements, all other requirements (except Tier 3) must be
submitted to EPA before May 27, 1997.
(iv) In the event that Tier 3 testing is also required (under
Sec. 79.54), EPA shall determine an appropriate timeline for completion
of the additional requirements and shall communicate this schedule to
the manufacturer according to the provisions of Sec. 79.54(b).
(v) The manufacturer may at any time modify an existing fuel
registration by submitting a request to EPA to add or delete a bulk
additive to the existing registration information for such fuel
product, provided that any additional additive must be registered by
EPA for use in the specific fuel family to which the fuel product
belongs. However, the addition or deletion of a bulk additive to a fuel
registration may effect the grouping of such registered fuel under the
criteria of Sec. 79.56, and thus may effect the testing
responsibilities of the fuel manufacturer under this subpart.
(2) Registrable fuels and fuel additives. (i) A fuel product which
is not registered pursuant to subpart B of this part as of May 27, 1994
shall be considered registrable if, under the criteria established by
Sec. 79.56, the fuel can be enrolled in the same fuel/additive group
with one or more currently registered fuels. A fuel additive product
which is not registered for a specific type of fuel pursuant to subpart
C of this part as of May 27, 1994 shall be considered registrable for
that type of fuel if, under the criteria established by Sec. 79.56, the
fuel/additive mixture resulting from use of the additive product in the
specific type of fuel can be enrolled in the same fuel/additive group
with one or more currently registered fuels or bulk fuel additives. For
the purpose of this determination, currently registered fuels and bulk
additives are those with existing registrations as of the date on which
EPA receives the basic registration data (pursuant to Sec. 79.59(b))
for the product in question.
(ii) A manufacturer seeking to register under subpart B of this
part a fuel product which is deemed registrable under this section, or
to register under subpart C of this part a fuel additive product for a
specific type of fuel for which it is deemed registrable under this
section, shall submit the basic registration data (pursuant to
Sec. 79.59(b)) for that product as part of the application for
registration. If the Administrator determines that the product is
registrable under this section, then the Administrator shall promptly
register the product, provided that the applicant has satisfied all of
the other requirements for registration under subpart B or subpart C of
this part, and contingent upon satisfactory submission of required
information under paragraph (c)(2)(iii) of this section.
(iii) Registration of a registrable fuel or additive shall be
subject to the same requirements and compliance schedule as specified
in paragraph (c)(1) of this section for existing fuels and fuel
additives. Accordingly, manufacturers of registrable fuels or additives
may be granted and may retain registration for such products only if
any applicable and due Tier 1, 2, and 3 requirements have also been
satisfied by either the manufacturer of the product or the fuel/
additive group to which the product belongs.
(3) New fuels and fuel additives. A fuel product shall be
considered new if it is not registered pursuant to subpart B of this
part as of May 27, 1994 and if, under the criteria established by
Sec. 79.56, it cannot be enrolled in the same fuel/additive group with
one or more currently registered fuels. A fuel additive product shall
be considered new with respect to a specific type of fuel if it is not
expressly registered for that type of fuel pursuant to subpart C of
this part as of May 27, 1994 and if, under the criteria established by
Sec. 79.56, the fuel/additive mixture resulting from use of the
additive product in the specific type of fuel cannot be enrolled in the
same fuel/additive group with one or more currently registered fuels or
bulk fuel additives. For the purpose of this determination, currently
registered fuels and bulk additives are those with existing
registrations as of the date on which EPA receives the basic
registration data (pursuant to Sec. 79.59(b)) for the product in
question. For such new product, the manufacturer must satisfactorily
complete all applicable Tier 1 and Tier 2 requirements, followed by any
Tier 3 testing which the Administrator may require, before registration
will be granted.
(d) Notifications. Upon receipt of a manufacturer's (or group's)
submittal in compliance with the requirements of this subpart, EPA will
notify such manufacturer (or group) that the application has been
received and what, if any, information, testing, or retesting is
necessary to bring the application into compliance with the
requirements of this subpart. EPA intends to provide such notification
of receipt in a timely manner for each such application.
(1) Registered fuel and fuel additive notification. (i) The
manufacturer of a registered fuel or fuel additive product who is
notified that the submittal for such product contains adequate
information pursuant to the Tier 1 and Tier 2 testing and reporting
requirements (Secs. 79.52, 79.53, and 79.59 (a) through (c)) may
continue to sell, offer for sale, or introduce into commerce the
registered product as permitted by the existing registration for the
product under Sec. 79.4.
(ii) If the manufacturer of a registered fuel or fuel additive
product is notified that testing or retesting is necessary to bring the
Tier 1 and/or Tier 2 submittal into compliance, the continued sale or
importation of the product shall be conditional upon satisfactorily
completing the requirements within the time frame specified in
paragraph (c)(1) of this section.
(iii) EPA intends to notify the manufacturer of the adequacy of the
submitted data within two years of EPA's receipt of such data. However,
EPA retains the right to require that adequate data be submitted to EPA
if, upon subsequent review, EPA finds that the original Tier 1 and/or
Tier 2 submittal is not consistent with the requirements of this
subpart. If EPA does not notify the manufacturer of the adequacy of the
Tier 1 and/or Tier 2 data within two years, EPA will not hold the
manufacturer liable for penalties for violating this rule for the
period beginning when the data was due until the time EPA notifies the
manufacturer of the violation.
(iv) If the manufacturer of a registered fuel or fuel additive
product is notified (pursuant to Sec. 79.54(b)) that Tier 3 testing is
required for its product, then the manufacturer may continue to sell,
offer for sale, introduce into commerce the registered product as
permitted by the existing registration for the product under Sec. 79.4.
However, if the manufacturer fails to complete the specified Tier 3
requirements within the specified time, the registration of the product
will be subject to cancellation under Sec. 79.51(f)(6).
(v) EPA retains the right to require additional Tier 3 testing
pursuant to the procedures in Sec. 79.54.
(2) New fuel and fuel additive notification. (i) Within six months
following its receipt of the Tier 1 and Tier 2 submittal for a new
product (as defined in paragraph (c)(3) of this section), EPA shall
notify the manufacturer of the adequacy of such submittal in compliance
with the requirements of Secs. 79.52, 79.53, and 79.59 (a) through (c).
(A) If EPA notifies the manufacturer that testing, retesting, or
additional information is necessary to bring the Tier 1 and Tier 2
submittal into compliance, the manufacturer shall remedy all
inadequacies and provide Tier 3 data, if required, before EPA shall
consider the requirements for registration to have been met for the
product in question.
(B) If EPA does not notify the manufacturer of the adequacy of the
Tier 1 and Tier 2 submittal within six months following the submittal,
the manufacturer shall be deemed to have satisfactorily completed Tiers
1 and 2.
(ii) Within six months of the date on which EPA notifies the
manufacturer of satisfactory completion of Tiers 1 and 2 for a new
product, or within one year of the submittal of the Tier 1 and Tier 2
data (whichever is earlier), EPA shall determine whether additional
testing is currently needed under the provisions of Tier 3 and,
pursuant to Sec. 79.54(b), shall notify the manufacturer of its
determination.
(A) If the manufacturer of a new fuel or fuel additive product is
notified that Tier 3 testing is required for such product, then EPA
shall have the authority to withhold registration until the specified
Tier 3 requirements have been satisfactorily completed. EPA shall
determine whether the Tier 3 requirements have been met, and shall
notify the manufacturer of this determination, within one year of
receiving the manufacturer's Tier 3 submittal.
(B) If EPA does not notify the manufacturer of potential Tier 3
requirements within the prescribed timeframe, then additional testing
at the Tier 3 level is deemed currently unnecessary and the
manufacturer shall be considered to have complied with all current
registration requirements for the new fuel or additive product.
(iii) Upon completion of all current Tier 1, Tier 2, and Tier 3
requirements, and submission of an application for registration which
includes all of the information and assurances required by Sec. 79.11
or Sec. 79.21, the registration of the new fuel or additive shall be
granted, and the registrant may then sell, offer for sale, or introduce
into commerce the registered product as permitted by Sec. 79.4.
(iv) Once the new product becomes registered, EPA reserves the
right to require additional Tier 3 testing pursuant to the procedures
specified in Sec. 79.54.
(e) Inspection of a testing facility. (1) A testing facility,
emissions analysis or health and/or welfare effects, shall permit an
authorized employee or duly designated representative of EPA, at
reasonable times and in a reasonable manner, to inspect the facility
and to inspect (and in the case of records also to copy) all records
and specimens required to be maintained regarding studies to which this
rule applies. The records inspection and copying requirements shall not
apply to quality assurance unit records of findings and problems, or to
actions recommended and taken, except the EPA may seek production of
these records in litigation or informal hearings.
(2) EPA will not consider reliable for purposes of showing that a
test substance does or does not present a risk of injury to health or
the environment any data developed by a testing facility or sponsor
that refuses to permit inspection in accordance with this section. The
determination that a study will not be considered reliable does not,
however, relieve the sponsor of a required test of any obligation under
any applicable statute or regulation to submit the results of the study
to EPA.
(3) Effects of non-compliance. Pursuant to sections 114, 208, and
211(d) of the CAA, it shall be a violation of this section and a
violation of 40 CFR part 79, subpart F to deny entry to an authorized
employee or duly designated representative of EPA for the purpose of
auditing a testing facility or test data.
(f) Penalties and Injunctive Relief. (1) Any person who violates
these regulations shall be subject to a civil penalty of up to $25,000
for each and every day of the continuance of the violation and the
economic benefit or savings resulting from the violation. Action to
collect such civil penalties shall be commenced in accordance with
paragraph (b) of section 205 of the Clean Air Act or assessed in
accordance with paragraph (c) of section 205 of the Clean Air Act, 42
U.S.C. 7524 (b) and (c).
(2) Under section 205(b) of the CAA, the Administrator may commence
a civil action for violation of this subpart in the district court of
the United States for the district in which the violation is alleged to
have occurred or in which the defendant resides or has a principal
place of business.
(3) Under section 205(c) of the CAA, the Administrator may assess a
civil penalty of $25,000 for each and every day of the continuance of
the violation and the economic benefit or savings resulting from the
violation, except that the maximum penalty assessment shall not exceed
$200,000, unless the Administrator and the Attorney General jointly
determine that a matter involving a larger penalty amount is
appropriate for administrative penalty assessment. Any such
determination by the Administrator and the Attorney General shall not
be subject to judicial review.
(4) The Administrator may, upon application by the person against
whom any such penalty has been assessed, remit or mitigate, with or
without conditions, any such penalty.
(5) The district courts of the United States shall have
jurisdiction to compel the furnishing of information and the conduct of
tests required by the Administrator under these regulations and to
award other appropriate relief. Actions to compel such actions shall be
brought by and in the name of the United States. In any such action,
subpoenas for witnesses who are required to attend a district court in
any district may run into any other district.
(6) Cancellation.
(i) The Administrator of EPA may issue a notice of intent to cancel
a fuel or fuel additive registration if the Administrator determines
that the registrant has failed to submit in a timely manner any data
required to maintain registration under this part or under section
211(b) or 211(e) of the Clean Air Act.
(ii) Upon issuance of a notice of intent to cancel, EPA will
forward a copy of the notice to the registrant by certified mail,
return receipt requested, at the address of record given in the
registration, along with an explanation of the reasons for the proposed
cancellation.
(iii) The registrant will be afforded 60 days from the date of
receipt of the notice of intent to cancel to submit written comments
concerning the notice, and to demonstrate or achieve compliance with
the specific data requirements which provide the basis for the proposed
cancellation. If the registrant does not respond in writing within 60
days from the date of receipt of the notice of intent to cancel, the
cancellation of the registration shall become final by operation of law
and the Administrator shall notify the registrant of such cancellation.
If the registrant responds in writing within 60 days from the date of
receipt of the notice of intent to cancel, the Administrator shall
review and consider all comments submitted by the registrant before
taking final action concerning the proposed cancellation. The
registrants' communications should be sent to the following address:
Director, Field Operations and Support Division, 6406J--Fuel/Additives
Registration, U.S. Environmental Protection Agency, 401 M Street SW.,
Washington, DC 20460.
(iv) As part of a written response to a notice of intent to cancel,
a registrant may request an informal hearing concerning the notice. Any
such request shall state with specificity the information the
registrant wishes to present at such a hearing. If an informal hearing
is requested, EPA shall schedule such a hearing within 60 days from the
date of receipt of the request. If an informal hearing is held, the
subject matter of the hearing shall be confined solely to whether or
not the registrant has complied with the specific data requirements
which provide the basis for the proposed cancellation. If an informal
hearing is held, the designated presiding officer may be any EPA
employee, the hearing procedures shall be informal, and the hearing
shall not be subject to or governed by 40 CFR part 22 or by 5 U.S.C.
554, 556, or 557. A verbatim transcript of each informal hearing shall
be kept and the Administrator shall consider all relevant evidence and
arguments presented at the hearing in making a final decision
concerning a proposed cancellation.
(v) If a registrant who has received a notice of intent to cancel
submits a timely written response, and the Administrator decides after
reviewing the response and the transcript of any informal hearing to
cancel the registration, the Administrator shall issue a final
cancellation order, forward a copy of the cancellation order to the
registrant by certified mail, and promptly publish the cancellation
order in the Federal Register. Any cancellation order issued after
receipt of a timely written response by the registrant shall become
legally effective five days after it is published in the Federal
Register.
(g) Modification of Regulation. (1) In special circumstances, a
manufacturer subject to the registration requirements of this rule may
petition the Administrator to modify the mandatory testing requirements
in the test standard for any test required by this rule by application
to Director, Field Operations and Support Division, at the address in
paragraph (f)(6)(iii) of this section.
(i) Such request shall be made as soon as the test sponsor is aware
that the modification is necessary, but in no event shall the request
be made after 30 days following the event which precipitated the
request.
(ii) Upon such request, the Administrator may, in circumstances
which are outside the control of the manufacturer(s) or his/their agent
and which could not have been reasonably foreseen or avoided, modify
the mandatory testing requirements in the rule if such requirements are
infeasible.
(iii) If the Administrator determines that such modifications would
not significantly alter the scope of the test, EPA will not ask for
public comment before approving the modification. The Administrator
will notify the test sponsor by certified mail of the response to the
request. EPA will place copies of each application and EPA response in
the public docket. EPA will publish a notice in the Federal Register
annually describing such changes which have occurred during the
previous year. Until such Federal Register notice is published, any
modification approved by EPA shall apply only to the person or group
who requested the modification; EPA shall state the applicability of
each modification in such notice.
(iv) Where, in EPA's judgment, the requested modification of a test
standard would significantly change the scope of the test, EPA will
publish a notice in the Federal Register requesting comment on the
request and proposed modification. However, EPA may approve a requested
modification of a test standard without first seeking public comment if
necessary to preserve the validity of an ongoing test undertaken in
good faith.
(2) [Reserved]
(h) Special Requirements for Additives. An additive which is a
direct test subject, either because it is the chosen representative of
a group or because it is not a member of a group, is subject to the
following rules:
(1) All required emission characterization and health effects
testing procedures shall be performed on the mixture which results when
the additive is combined with the base fuel for the appropriate fuel
family (as specified in Sec. 79.55) at the maximum concentration
recommended by the additive manufacturer pursuant to Sec. 79.21(d).
This combination shall be known as the additive/base fuel mixture.
(i) The appropriate fuel family to be utilized for the additive/
base fuel mixture is the fuel family which contains the specific
type(s) of fuel for which the additive is presently registered or for
which the manufacturer of the additive is seeking registration.
(ii) Fuels and additives belonging to more than one fuel family.
(A) If a fuel or additive product is registered in two or more fuel
families as of May 27, 1994, then the manufacturer of that product is
responsible for testing (or participating in group testing of) each
formulation in compliance with the requirements of this subpart for
each fuel family in which the manufacturer wishes to maintain a product
registration for its fuel or additive.
(B) If a fuel or additive manufacturer is seeking to register such
product in two or more fuel families, then the product shall be
considered, for testing and registration purposes, to be a member of
each fuel family in which the manufacturer is seeking registration. The
manufacturer is responsible for testing (or participating in group
testing of) each formulation in compliance with the requirements of
this subpart for each fuel family in which the manufacturer wishes to
obtain a product registration for its fuel or additive.
(iii) In the case of the methanol fuel family, which contains two
base fuels (M100 and M85 base fuels, pursuant to Sec. 79.55(d)), the
applicable base fuel is the one which represents the fuel/additive
group (specified in Sec. 79.56(e)(4)(i)(C)) containing fuels of which
the most gallons are sold annually.
(iv) Aftermarket additives which are intended by the manufacturer
to be added to the fuel tank only at infrequent intervals shall be
applied according to the manufacturer's specifications during mileage
accumulation, pursuant to Sec. 79.57(c). However, during emission
generation and testing, each tankful of fuel used must contain the fuel
additive at its maximum recommended level. If the additive manufacturer
believes that this maximum treatment rate will cause adverse effects to
the test engine and/or that the engine's emissions may be subject to
artifacts due to overuse of the additive, then the manufacturer may
submit a request to EPA for modification of this requirement and
related test procedures. Such request must include objective evidence
that the modification(s) are needed, along with data demonstrating the
maximum concentration of the additive which may actually reach the fuel
tanks of vehicles in use.
(v) Additives produced exclusively for use in #1 diesel fuel shall
be tested in the diesel base fuel specified in Sec. 79.55(c), even
though that base fuel is formulated with #2 diesel fuel. If a
manufacturer is concerned that emissions generated from this
combination of fuel and additive are subject to artifacts due to this
blending, then that manufacturer may submit a request for a
modification in test procedure requirements to the EPA. Any such
request must include supporting test results and suggested test
modifications.
(vi) Bulk additives which are used intermittently for the direct
purpose of conditioning or treating a fuel during storage or transport,
or for treating or maintaining the storage, pipeline, and/or other
components of the fuel distribution system itself and not the vehicle/
engine for which the fuel is ultimately intended, shall, for purposes
of this program, be added to the base fuel at the maximum concentration
recommended by the additive manufacturer for treatment of the fuel or
distribution system component. However, if the additive manufacturer
believes that this treatment rate will cause adverse effects to the
test engine and/or that the engine's emissions may be subject to
artifacts due to overuse of the additive, then the manufacturer may
submit a request to EPA for modification of this requirement and
related test procedures. Such request must include objective evidence
that the modification(s) are needed, along with data demonstrating the
maximum concentration of the additive which may actually reach the fuel
tanks of vehicles in use.
(2) EPA shall use emissions speciation and health effects data
generated in the analysis of the applicable base fuel as control data
for comparison with data generated for the additive/base fuel mixture.
(i) The base fuel control data may be:
(A) Generated internally as an experimental control in conjunction
with testing done in compliance with registration requirements for a
specific additive; or
(B) Generated externally in the course of testing different
additive(s) belonging to the same fuel family, or in the testing of a
base fuel serving as representative of the baseline group for the
respective fuel family pursuant to Sec. 79.56(e)(4)(i).
(ii) Control data generated using test equipment (including vehicle
model and/or engine, or Evaporative Emissions Generator specifications,
as appropriate) and protocols identical or nearly identical to those
used in emissions and health effects testing of the subject additive/
base fuel mixture would be most relevant for comparison purposes.
(iii) If an additive manufacturer chooses the same vehicle/engine
to independently test the base fuel as an experimental control prior to
testing the additive/base fuel mixture, then the test vehicle/engine
shall undergo two mileage accumulation periods, pursuant to
Sec. 79.57(c). The initial mileage accumulation period shall be
performed using the base fuel alone. After base fuel testing, and prior
to testing of the additive/base fuel mixture, a second mileage
accumulation period shall be performed using the additive/base fuel
mixture. The procedures outlined in this paragraph shall not preclude a
manufacturer from testing a base fuel and the manufacturer's additive/
base fuel mixture separately in identical, or nearly identical,
vehicles/engines.
(i) Multiple Test Potential for Non-Baseline Products. (1) When the
composition information reported in the registration application or
basic registration data for a gasoline or diesel product meets criteria
for classification as a non-baseline product (pursuant to
Sec. 79.56(e)(3)(i)(B) or Sec. 79.56(e)(3)(ii)(B)), then the
manufacturer is responsible for testing (or participating in group
testing) of a separate formulation for each reported oxygenating
compound, specified class of oxygenating compounds, or other substance
which defines a separate non-baseline fuel/additive group pursuant to
Sec. 79.56(e)(4)(ii)(A) or (B). For each such substance, testing shall
be performed on a mixture of the relevant substance in the appropriate
base fuel, formulated according to the specifications for the
corresponding group representatives in Sec. 79.56(e)(4)(ii).
(2) When the composition information reported in the registration
application or basic registration data for a non- baseline gasoline
product contains a range of total oxygenate concentration-in-use which
encompasses gasoline formulations with less than 1.5 weight percent
oxygen as well as gasoline formulations with 1.5 weight percent oxygen
or more, then the manufacturer is required to test (or participate in
applicable group testing of) a baseline gasoline formulation as well as
one or more non-baseline gasoline formulations as described in
paragraph (h)(1) of this section.
(3) When the composition information reported in the registration
application or basic registration data for a non- baseline diesel
product contains a range of total oxygenate concentration-in-use which
encompasses diesel formulations with less than 1.0 weight percent
oxygen as well as diesel formulations with 1.0 weight percent oxygen or
more, then the manufacturer is required to test (or participate in
applicable group testing) of a baseline diesel formulation as well as
one or more non-baseline diesel formulations as described in paragraph
(h)(1) of this section.
(j) Multiple Test Potential for Atypical Fuel Formulations. When
the composition information reported in the registration application or
basic registration data for a fuel product includes more than one
atypical bulk additive product (pursuant to Sec. 79.56(e)(2)(iii)), and
when these additives belong to different fuel/additive groups (pursuant
to Sec. 79.56(e)(4)(iii)), then:
(1) When such disparate additive products are for the same purpose-
in-use and are not ordinarily used in the fuel simultaneously, the fuel
manufacturer shall be responsible for testing (or participating in the
group testing of) a separate formulation for each such additive
product. Testing related to each additive product shall be performed on
a mixture of the additive in the applicable base fuel, as described in
paragraph (g)(1) of this section, or by participation in the costs of
testing the designated representative of the fuel/additive group to
which each separate atypical additive product belongs.
(2) When the disparate additive products are not for the same
purpose-in-use, the fuel manufacturer shall nevertheless be responsible
for testing a separate formulation for each such additive product, as
described in paragraph (g)(1) of this section, if these additives are
not ordinarily blended together in the same commercial formulation of
the fuel.
(3) When the disparate additive products are ordinarily blended
together in the same commercial formulation of the fuel, then the fuel
manufacturer shall be responsible for the testing of a single test
formulation containing all such simultaneously used atypical additive
products. Alternatively, this responsibility can be satisfied by
enrolling such fuel product in a group which includes other fuel or
additive products with the same total combination of atypical elements
as that occurring in the fuel product in question. If the basic
registration data for the subject fuel includes any alternative
additives which contain atypical elements not represented in the test
formulation, then the fuel manufacturer is also responsible for testing
a separate formulation for each such additional disparate additive
product.
(k) Emission Control System Testing. If any information submitted
in accordance with this subpart or any other information available to
EPA shows that a fuel or fuel additive may have a deleterious effect on
the performance of any emission control system or device currently in
use or which has been developed to a point where in a reasonable time
it would be in general use were such effect avoided, EPA may, in its
judgment, require testing to determine whether such effects in fact
exist. Such testing will be required in accordance with such protocols
and schedules as the Administrator shall reasonably require and shall
be paid for by the fuel or fuel additive manufacturer.
Sec. 79.52 Tier 1.
(a) General Specifications. Tier 1 requires manufacturers of
designated fuels or fuel additives (or groups of manufacturers pursuant
to Sec. 79.56) to supply to the Administrator: the identity and
concentration of certain emission products of such fuels or additives;
an analysis of potential emissions exposures; and any available
information regarding the health and welfare effects of the whole and
speciated emissions. In addition to any information required under
Sec. 79.59 and in conformance with the reporting requirements thereof,
manufacturers shall provide, pursuant to the timing provisions of
Sec. 79.51(c), the following information.
(b) Emissions Characterization. Manufacturers must provide a
characterization of the emission products which are generated by
evaporation (if required pursuant to Sec. 79.58(b)) and by combustion
of the fuel or additive/base fuel mixture in a motor vehicle. For this
purpose, manufacturers may perform the characterization procedures
described in this section or may rely on existing emission
characterization data. To be considered adequate in lieu of performing
new emission characterization procedures, the data must be the result
of tests using the product in question or using a fuel or additive/base
fuel mixture meeting the same grouping criteria as the product in
question. In addition, the emissions must be generated in a manner
reasonably similar to those described in Sec. 79.57, and the
characterization procedures must be adequately performed and documented
and must give results reasonably comparable to those which would be
obtained by performing the procedures described herein. Reports of
previous tests must be sufficiently detailed to allow EPA to judge the
adequacy of protocols, techniques, and conclusions. After the
manufacturer's submittal of such data, if EPA finds that the
manufacturer has relied upon inadequate test data, then the
manufacturer will not be considered to be in compliance until the
corresponding tests have been conducted and the results submitted to
EPA.
(1) General Provisions.
(i) The emissions to be characterized shall be generated,
collected, and stored according to the processes described in
Sec. 79.57. Characterization of combustion and evaporative emissions
shall be performed separately on each emission sample collected during
the applicable emission generation procedure.
(ii) As provided in Sec. 79.57(d), if the emission generation
vehicle/engine is ordinarily equipped with an emission aftertreatment
device, then all requirements in this section for the characterization
of combustion emissions must be completed both with and without the
aftertreatment device in a functional state. The emissions shall be
generated three times (on three different days) without a functional
aftertreatment device and, if applicable, three times (on three
different days) with a functional aftertreatment device, and each such
time shall be analyzed according to the remaining provisions in this
paragraph (b) of this section.
(iii) Measurement of background emissions. It is required that
ambient/dilution air be analyzed for levels of background chemical
species present at the time of emission sampling (for both combustion
and evaporative emissions) and that background chemical species
profiles be reported with emissions speciation data. Background
chemical species measurement/analysis during the FTP is specified in
Secs. 86.109-94(c)(5) and 86.135-94 of this chapter.
(iv) Concentrations of emission products shall be reported in units
of grams (g) per mile and in units of weight percent of measured total
hydrocarbons.
(v) Laboratory practice must be of high quality and must be
consistent with state-of-the-art methods as presented in current
environmental and analytical chemistry literature. Examples of
analytical procedures which may be used in conducting the emission
characterization/speciation requirements of this section can be found
among the references in paragraph (b)(5) of this section.
(2) Characterization of the combustion emissions shall include, for
products in all fuel families (except when expressly noted in this
section):
(i) Determination of the concentration of the basic emissions as
follows: total hydrocarbons, carbon monoxide, oxides of nitrogen, and
particulates. Manufacturers are referred to the vehicle certification
procedures in 40 CFR part 86, subparts B and D (Secs. 86.101 through
86.145 and Secs. 86.301 through 86.348) for guidance on the measurement
of the basic emissions of interest to this subpart.
(ii) Characterization of the vapor phase of combustion emissions,
as follows:
(A) Determination of the identity and concentration of individual
species of hydrocarbon compounds containing 12 or fewer carbon atoms.
Such characterization shall begin within 30 minutes after emission
collection is completed.
(B) Determination of the identity and concentration of individual
species of aldehyde and ketone compounds containing eight or fewer
carbon atoms. Characterization of these emissions captured in
cartridges shall be performed within two weeks if the cartridge is
stored at room temperature, and one month if the cartridge is stored at
0 deg.C or less. If the emissions are sampled using the impinger
method, the sample must be stored in a capped sample vial at 0 deg.C
or less and characterized within one week.
(C) Determination of the identity and concentration of individual
species of alcohol and ether compounds containing six or fewer carbon
atoms, for those fuels and additive/base fuel mixtures which contain
alcohol and/or ether compounds containing from one to six carbon atoms
in the uncombusted state. For fuel and additive formulations containing
alcohols or ethers with more than six carbon atoms in the uncombusted
state, alcohol and ether species with that higher number of carbon
atoms or less must be identified and measured in the emissions. Such
characterization shall begin within four hours after emission
collection is completed.
(iii) Characterization of the semi-volatile and particulate phases
of combustion emissions to identify and measure polycyclic aromatic
compounds, as follows:
(A) Analysis for polycyclic aromatic compounds shall not be
conducted at or soon after the start of a recommended engine lubricant
change interval.
(B) Analysis for polycyclic aromatic hydrocarbons (PAHs) and
nitrated polycyclic aromatic hydrocarbons (NPAHs), specified in
paragraph (b)(2)(iii)(D) of this section, need not be done for any
fuels and additives in the methane or propane fuel families, nor for
fuels and additives in the atypical categories of any other fuel
families, pursuant to the definitions of such families and categories
in Sec. 79.56.
(C) Analysis for poly-chlorinated dibenzodioxins and dibenzofurans
(PCDD/PCDFs), specified in paragraph (b)(2)(iii)(E) of this section, is
required only for fuels and additives which contain chlorine as an
atypical element, pursuant to paragraph (b)(2)(iv) of this section,
which requires all individual emission products containing atypical
elements to be determined for atypical fuels and additives. However,
manufacturers of baseline and nonbaseline fuels and fuel additives in
all fuel families, except those in the methane and propane fuel
families, are strongly encouraged to conduct these analyses on a
voluntary basis.
(D) The analytical method used to measure species of PAHs and NPAHs
should be capable of detecting at least 1 ppm (equivalent to 0.001
microgram (g) of compound per milligram of organic extract) of
these compounds in the extractable organic matter. The concentration of
each individual PAH or NPAH compound identified shall be reported in
units of microgram per mile. Each compound which is present at 0.001
g per mile or more must be identified, measured, and reported.
The following individual species shall be measured:
(1) PAHs:
(i) Benzo(a)anthracene;
(ii) Benzo[b]fluoranthene;
(iii) Benzo[k]fluoranthene;
(iv) Benzo(a)pyrene;
(v) Chrysene;
(vi) Dibenzo[a,h]anthracene; and
(vii) Indeno[1,2,3-c,d]pyrene.
(2) NPAHs:
(i) 7-Nitrobenzo[a]anthracene;
(ii) 6-Nitrobenzo[a]pyrene;
(iii) 6-Nitrochrysene;
(iv) 2-Nitrofluorene; and
(v) 1-Nitropyrene.
(E) The analytical method used to measure species and classes of
PCDD/PCDFs should be capable of detecting at least 1 part per trillion
(ppt) (equivalent to 0.001 picogram (pg) of compound per milligram of
organic extract) of these compounds in the extractable organic matter.
The concentration of each individual PCDD/PCDF compound identified
shall be reported in units of picograms (pg) per mile. Each compound
which is present at 0.5 pg per mile or more must be identified,
measured, and reported.
(1) With respect to measurement of PCDD/PCDFs only, the liquid
extracts from the particulate and semi-volatile emissions fractions may
be combined into one sample for analysis.
(2) The manufacturer is referred to 40 CFR part 60, appendix A,
Method 23 for a protocol which may be used to identify and measure any
potential PCDD/PCDFs which might be present in exhaust emissions from a
fuel or additive/base fuel mixture.
(3) The following individual compounds and classes of compounds of
PCDD/PCDFs shall be identified and measured:
(i) Individual tetra-chloro-substituted dibenzodioxins (tetra-
CDDs);
(ii) Individual tetra-chloro-substituted dibenzofurans (tetra-
CDFs);
(iii) Penta-CDDs and penta-CDFs, as one class;
(iv) Hexa-CDDs and hexa-CDFs, as one class;
(v) Hepta-CDDs and hepta-CDFs as one class; and
(vi) Octo-CDDs and octo-CDFs as one class.
(iv) With respect to all phases (vapor, semi-volatile, and
particulate) of combustion emissions generated from those fuels and
additive/base fuel mixtures classified in the atypical categories
(pursuant to Sec. 79.56), the identity and concentration of individual
emission products containing such atypical elements shall also be
determined.
(3) For evaporative fuels and evaporative fuel additives,
characterization of the evaporative emissions shall include:
(i) Determination of the concentration of total hydrocarbons for
the applicable vehicle type and class in 40 CFR part 86, subpart B
(Secs. 86.101 through 86.145).
(ii) Determination of the identity and concentration of individual
species of hydrocarbon compounds containing 12 or fewer carbon atoms.
Such characterization shall begin within 30 minutes after emission
collection is completed.
(iii) In the case of those fuels and additive/base fuel mixtures
which contain alcohol and/or ether compounds in the uncombusted state,
determination of the identity and concentration of individual species
of alcohol and ether compounds containing six or fewer carbon atoms.
For fuel and additive formulations containing alcohols or ethers with
more than six carbon atoms in the uncombusted state, alcohol and ether
species with that higher number of carbon atoms or less must be
identified and measured in the emissions. Such characterization shall
begin within four hours after emission collection is completed.
(iv) In the case of those fuels and additive/base fuel mixtures
which contain atypical elements, determination of the identity and
concentration of individual emission products containing such atypical
elements.
(4) Laboratory quality control. (i) At a minimum, laboratories
performing the procedures specified in this section shall conduct
calibration testing of their emissions characterization equipment
before each new fuel/additive product test start-up. Known samples
representative of the compounds potentially to be found in emissions
from the product to be characterized shall be used to calibrate such
equipment.
(ii) Laboratories performing the procedures specified in this
section shall agree to permit quality control inspections by EPA, and
for this purpose shall admit any EPA Enforcement Officer, upon proper
presentation of credentials, to any facility where vehicles are
conditioned or where emissions are generated, collected, stored,
sampled, or characterized in meeting the requirements of this section.
Such laboratory audits may include EPA distribution of ``blind''
samples for analysis by participating laboratories.
(5) References. For additional background information on the
emission characterization procedures outlined in this paragraph, the
following references may be consulted:
(i) ``Advanced Emission Speciation Methodologies for the Auto/Oil
Air Quality Improvement Program--I. Hydrocarbons and Ethers,'' Auto Oil
Air Quality Improvement Research Program, SP-920, 920320, SAE, February
1992.
(ii) ``Advanced Speciation Methodologies for the Auto/Oil Air
Quality Improvement Research Program--II. Aldehydes, Ketones, and
Alcohols,'' Auto Oil Air Quality Improvement Research Program, SP-920,
920321, SAE, February 1992.
(iii) ASTM D 5197-91, ``Standard Test Method for Determination of
Formaldehyde and Other Carbonyl Compounds in Air (Active Sampler
Methodology).''
(iv) Johnson J. H., Bagley, S. T., Gratz, L. D., and Leddy, D. G.,
``A Review of Diesel Particulate Control Technology and Emissions
Effects--1992 Horning Memorial Award Lecture,'' SAE Technical Paper
Series, SAE 940233, 1994.
(v) Keith et al., ACS Committee on Environmental Improvement,
``Principles of Environmental Analysis,'' The Journal of Analytical
Chemistry, Volume 55, pp. 2210-2218, 1983.
(vi) Perez, J.M., Jabs, R.E., Leddy, D.G., eds. ``Chemical Methods
for the Measurement of Unregulated Diesel Emissions (CRC-APRAC Project
No. CAPI-1-64), Coordinating Research Council, CRC Report No. 551,
August, 1987.
(vii) Schuetzle, D., ``Analysis of Nitrated Polycyclic Aromatic
Hydrocarbons in Diesel Particulates,'' Analytical Chemistry, Volume 54,
pp. 265-271, 1982.
(viii) Siegl, W.O., et al., ``Improved Emissions Speciation
Methodology for Phase II of the Auto/Oil Air Quality Improvement
Research Program--Hydrocarbons and Oxygenates'', SAE Technical Paper
Series, SAE 930142, 1993.
(ix) Tejada, S. B. et al., ``Analysis of Nitroaromatics in Diesel
and Gasoline Car Emissions,'' SAE Paper No. 820775, 1982.
(x) Tejada, S. B. et al., ``Fluorescence Detection and
Identification of Nitro Derivatives of Polynuclear Aromatic
Hydrocarbons by On-Column Catalytic Reduction to Aromatic Amines,''
Analytical Chemistry, Volume 58, pp. 1827-1834, July 1986.
(xi) ``Test Method for Determination of C1-C4 Alcohols and MTBE in
Gasoline by Gas Chromatography,'' 40 CFR part 80, appendix F.
(c) Exposure Analysis. Using annual and projected production
volume, marketing, and distribution data submitted as part of the basic
registration data, specified in Sec. 79.59(b), manufacturers shall
provide a qualitative discussion of the potential public health
exposure(s) of the general population and any special at-risk
populations to the emission products of their fuel or additive
product(s). The analysis accompanying a group submission shall address
the characteristics of the cumulative exposure resulting from the use
of all fuel or additive products in the group. Modeling and other
quantitative approaches to the analysis are encouraged when the
appropriate data is available.
(d) Literature Search. (1) Manufacturers of fuels and fuel
additives shall conduct a literature search and compilation of
information on the potential toxicologic, environmental, and other
public welfare effects of the emissions of such fuels and additives.
The literature search shall include all available relevant information
from in-house, industry, government, and public sources pertaining to
the emissions of the subject fuel or fuel additive or the emissions of
similar fuels or additives, with such similarity determined according
to the provisions of Sec. 79.56.
(2) The literature search shall address the potential adverse
effects of whole combustion emissions, evaporative emissions, relevant
emission fractions, and individual emission products of the subject
fuel or fuel additive except as specified in the following paragraph.
The individual emission products to be included are those identified
pursuant to the emission characterization procedures specified in
paragraph (b) of this section, other than carbon monoxide, carbon
dioxide, nitrogen oxides, benzene, 1,3-butadiene, acetaldehyde, and
formaldehyde.
(3) In the case of the individual emission products of non-baseline
or atypical fuels and additives (pursuant to Sec. 79.56(e)(2)), the
literature data need not be submitted for those emission products which
are the same as the combustion emission products of the respective base
fuel for the product's fuel family (pursuant to Sec. 79.55). For this
purpose, data on the base fuel emission products for the product's fuel
family:
(i) May be found in the literature of previously-conducted,
adequate emission speciation studies for the base fuel, or for a fuel
or additive/fuel mixture capable of grouping with the base fuel (see,
for example, the references in paragraph (b)(5) of this section).
(ii) May be compiled while gathering internal control data during
emissions characterization studies on the manufacturer's non-baseline
or atypical product; or
(iii) May be obtained from various manufacturers in the course of
their testing different additive(s) belonging to the same fuel family,
or in the testing of a base fuel serving as representative of the
baseline group for the respective fuel family.
(e) Data bases. The literature search must include the results of
searching appropriate commercially available chemical, toxicologic, and
environmental databases. The databases shall be searched using, at a
minimum, CAS numbers (when applicable), chemical names, and common
synonyms.
(f) Search period. The literature search shall cover a time period
beginning at least thirty years prior to the date of submission of the
reports specified in Secs. 79.59(b) through (c) and ending no earlier
than six months prior to the date on which testing is commenced or
reports are submitted in compliance with this subpart.
(g) References. Information on base fuel emission inventories may
be found in references in paragraphs (b)(5)(i) through (xi) of this
section, as well as in the following:
(1) Auto/Oil Air Quality Improvement Research Program, Technical
Bulletin #1, December 1990.
(2) Keith et al., ACS Committee on Environmental Improvement,
``Principles of Environmental Analysis,'' The Journal of Analytical
Chemistry, Volume 55, pp. 2210-2218, 1983.
(3) ``The Composition of Gasoline Engine Hydrocarbon Emissions--An
Evaluation of Catalyst and Fuel Effects''--SAE 902074 and ``Speciated
Hydrocarbon Emissions from Aromatic, Olefin, and Paraffinic Model
Fuels''--SAE 930373.
Sec. 79.53 Tier 2.
(a) Generally. Subject to the provisions of Sec. 79.53(b) through
(d), the combustion emissions of each fuel or fuel additive subject to
testing under this subpart must be tested in accordance with each of
the testing guidelines in Secs. 79.60 through 79.68, except that fuels
and additives in the methane and propane fuel families (pursuant to
Sec. 79.56(e)(1)(v) and (vi)) need not undergo the Salmonella
mutagenicity assay in Sec. 79.68). Similarly, subject to the provisions
of Sec. 79.53(b) through (d), the evaporative emissions of each
designated evaporative fuel and each designated evaporative fuel
additive subject to testing under this subpart must be tested according
to each of the testing guidelines in Secs. 79.60 through 79.67
(excluding Sec. 79.68, Salmonella typhimurium Reverse Mutation Assay).
(b) Manufacturer Determination. Manufacturers shall determine
whether the information gathered pursuant to the literature search in
Sec. 79.52(d) contains the results of adequately performed and
adequately documented previous testing which provides information
reasonably comparable to that supplied by the health tests described in
Secs. 79.62 through 79.68 regarding the carcinogenicity, mutagenicity,
neurotoxicity, teratogenicity, reproductive/fertility measures, and
general toxicity effects of the emissions of the fuel or additive. When
manufacturers make an affirmative determination, they need submit only
the information gathered pursuant to Sec. 79.52(d) for such tests. EPA
maintains final authority in judging whether the information is an
adequate substitution in lieu of conducting the associated tests. EPA's
determination of the adequacy of existing information shall be guided
by the considerations described in paragraph (d) of this section. If
EPA finds that the manufacturer has relied upon inadequate test data,
then the manufacturer will not be considered to be in compliance until
the corresponding tests have been conducted and the results submitted
to EPA.
(c) Testing. (1) All testing required pursuant to this section must
be done in accordance with the procedures, equipment, and facility
requirements described in Secs. 79.57, 79.60, and 79.61 regarding
emissions generation, good laboratory practices, and inhalation
exposure testing, respectively, as well as any other requirements
described in this subpart. The laboratory conducting the animal studies
shall be registered and in good standing with the United States
Department of Agriculture and regularly inspected by United States
Department of Agriculture veterinarians. In addition, the facility must
be accredited by a generally recognized independent organization which
sets laboratory animal care standards. Use of inadequate test protocols
or substandard laboratory techniques in performing any testing required
by this subpart may result in cancellation of all affected
registrations.
(2) Carcinogenic or mutagenic effects in animals from emissions
exposures shall be determined pursuant to Sec. 79.64 In vivo
Micronucleus Assay, Sec. 79.65 In vivo Sister Chromatid Exchange Assay,
and Sec. 79.68 Salmonella typhimurium Reverse Mutation Assay.
Teratogenic effects and reproductive toxicity shall be examined
pursuant to Sec. 79.63 Fertility Assessment/Teratology. General
toxicity and pulmonary effects shall be determined pursuant to
Sec. 79.62 Subchronic Toxicity Study with Specific Health Effect
Assessments. Neurotoxic effects shall be determined pursuant to
Sec. 79.66 Neuropathology Assessment and Sec. 79.67 Glial Fibrillary
Acidic Protein Assay.
(d) EPA Determination. (1) After submission of all information and
testing, EPA in its judgment shall determine whether previously
conducted tests relied upon in the registration submission are
adequately performed and documented and provide information reasonably
comparable to that which would be provided by the tests described
herein. Manufacturers' submissions shall be sufficiently detailed to
allow EPA to judge the adequacy of protocols, techniques, experimental
design, statistical analyses, and conclusions. Studies shall be
performed using generally accepted scientific principles, good
laboratory techniques, and the testing guidelines specified in these
regulations.
(2) EPA shall give appropriate weight when making this
determination to the following factors:
(i) The age of the data;
(ii) The adequacy of documentation of procedures, findings, and
conclusions;
(iii) The extent to which the testing conforms to generally
accepted scientific principles and practices;
(iv) The type and number of test subjects;
(v) The number and adequacy of exposure concentrations, i.e.,
emission dilutions;
(vi) The degree to which the tested emissions were generated by
procedures and under conditions reasonably comparable to those set
forth in Sec. 79.57; and
(vii) The degree to which the test procedures conform to the
testing guidelines set forth in Secs. 79.60 through 79.68 and/or
furnish information comparable to that provided by such testing.
(3) The test animals shall be rodents, preferably a strain of rat,
and testing shall include all of the endpoints covered in Secs. 79.62
through 79.68. All studies shall be properly executed, with appropriate
documentation, and in accord with the individual health testing
guidelines (Secs. 79.60 through 79.68) of this part, e.g., 90-day, 6-
hour per day exposure, minimum.
(4) In general, the data in a manufacturer's registration submittal
shall be adequate if the duration of a test's exposure period is at
least as long, in days and hours, as the inhalation exposure specified
in the related health test guideline(s). Data from tests with shorter
exposure durations than those specified in the guidelines may be
acceptable if the test results are positive (i.e., exhibit adverse
effects) and/or include a demonstrable concentration-response
relationship.
(5) Data in support of a manufacturer's registration submittal
shall directly address the effects of inhalation exposure to the whole
evaporative and exhaust emissions of the respective fuel or additive or
to the whole evaporative and exhaust emissions of other fuels or
additives which satisfy the criteria in Sec. 79.56 for classification
into the same group as the subject fuel or fuel additive. Data obtained
in the testing of a raw liquid fuel or additive/base fuel mixture or a
raw, aerosolized fuel or additive/base fuel mixture shall not be
adequate to support a manufacturer's registration submittal. Data from
testing of evaporative emissions cannot substitute for test data on
combustion emissions. Data from testing of combustion emissions cannot
substitute for test data on evaporative emissions.
Sec. 79.54 Tier 3.
(a) General Criteria for Requiring Tier 3 Testing. (1) Tier 3
testing shall be required of a manufacturer or group of manufacturers
at EPA's discretion when remaining uncertainties as to the significance
of observed health effects, welfare effects, and/or emissions exposures
from a fuel or fuel/additive mixture interfere with EPA's ability to
make reasonable estimates of the potential risks posed by emissions
from the fuel or additive products. Tier 3 testing may be conducted
either on an individual basis or a group basis. If performed on a group
basis, EPA may require either the same representative to be used in
Tier 3 testing as was used in Tier 2 testing or may select a different
member or members of the group to represent the group in the Tier 3
tests.
(2) In addition to the criteria specific to particular tests as
summarized and detailed in the testing guidelines (Secs. 79.62 through
79.68), EPA may consider a number of factors (including, but not
limited to):
(i) The number of positive and negative outcomes related to each
endpoint;
(ii) The identification of concentration-effect relationships;
(iii) The statistical sensitivity and significance of such studies;
(iv) The severity of the observed effects (e.g., whether the
effects would be likely to lead to incapacitating or irreversible
conditions);
(v) The type and number of species included in the reported tests;
(vi) The consistency and clarity of apparent mechanisms, target
organs, and outcomes;
(vii) The presence or absence of effective health test control data
for base-fuel-only versus additive/base fuel mixture comparisons;
(viii) The nature and amount of known toxic agents in the emissions
stream; and
(ix) The observation of lesions which specifically implicate
inhalation as an important exposure route.
(3) Consideration of exposure. EPA retains discretion to consider,
in addition to available toxicity data, any Tier 1 data on potential
exposures to emissions from a particular fuel or fuel additive (or
group of fuels and/or fuel additives) in determining whether to require
Tier 3 testing. EPA may consider, but is not limited to, the following
factors:
(i) Types and emission rates of speciated emission components;
(ii) Types and emission rates of combinations of compounds or
elements of concern;
(iii) Historical and/or projected production volumes and market
distributions; and
(iv) Estimated population and/or environmental exposures obtained
through extrapolation, modeling, or literature search findings on
ambient, occupational, or epidemiological exposures.
(b) Notice. (1) EPA will determine whether Tier 3 testing is
necessary upon receipt of a manufacturer's (or group's) submittal as
prescribed under Sec. 79.51(d). If EPA determines on the basis of the
Tier 1 and 2 data submission and any other available information that
further testing is necessary, EPA will require the responsible
manufacturer(s) to conduct testing as described elsewhere in this
section. EPA will notify the manufacturer (or group) by certified
letter of the purpose and nature of any proposed testing and of the
proposed deadline for completing the testing. A copy of the letter will
be placed in the public record. EPA will provide the manufacturer a 60-
day comment period after the manufacturer's receipt of such notice. EPA
may extend the comment period if it appears from the nature of the
issues raised that further discussion is warranted. In the event that
no comment is received by EPA from the manufacturer (or group) within
the comment period, the manufacturer (or group) shall be deemed to have
consented to the adoption by EPA of the proposed Tier 3 requirements.
(2) EPA will issue a notice in the Federal Register of its intent
to require testing under Tier 3 for a particular fuel or additive
manufacturer and that a copy of the letter to the manufacturer
outlining the Tier 3 testing for that manufacturer is available in the
public record for review and comment. The public shall have a minimum
of thirty (30) days after the publication of this notice to comment on
the proposed Tier 3 testing.
(3) EPA will include in the public record a copy of any timely
comments concerning the proposed Tier 3 testing requirements received
from the affected manufacturer or group or from the public, and the
responses of EPA to such comments. After reviewing all such comments
received, EPA will adopt final Tier 3 requirements by sending a
certified letter describing such final requirements to the manufacturer
or group. EPA will also issue a notice in the Federal Register
announcing that it has adopted such final Tier 3 requirements and that
a copy of the letter adopting the requirements has been included in the
public record.
(4) Prior to beginning any required Tier 3 testing, the
manufacturer shall submit detailed test protocols to EPA for approval.
Once EPA has determined the Tier 3 testing requirements and approves
the test protocols, any modification to the requirements shall be
governed by Sec. 79.51(f).
(c) Carcinogenicity and Mutagenicity Testing. (1) A potential need
for Tier 3 carcinogenicity and/or mutagenicity testing may be indicated
if the results of the In vivo Micronucleus Assay, required under
Sec. 79.64, the In vivo Sister Chromatid Exchange Assay, required under
Sec. 79.65, the Salmonella mutagenicity assay required under
Sec. 79.68, or relevant pathologic findings under Sec. 79.62
demonstrate a statistically significant dose-related positive response
as compared with appropriate controls. Alternatively, Tier 3
carcinogenicity testing and/or mutagenicity testing may be required if
there are positive outcomes for at least one concentration in two or
more of the tests required under Secs. 79.64, 79.65, and 79.68.
(2) The testing for carcinogenicity required under this paragraph
may, at EPA's discretion, be conducted in accordance with 40 CFR
798.3300 or 798.3320, or their equivalents (see suggested references
following each health effects testing guideline). The testing for
mutagenicity required under this paragraph may likewise be conducted in
accordance with 40 CFR 798.5195, 798.5500, 798.5955, 798.7100, and/or
other suitable equivalent testing (see suggested references following
each health effects testing guideline). EPA may supplement or modify
guidelines as required to ensure that the prescribed testing addresses
the identified areas of concern.
(d) Reproductive and Teratological Effects Testing. (1) A potential
need for Tier 3 testing may be indicated if the results of the
Fertility Assessment/Teratology study required under Sec. 79.63 or
relevant findings under Sec. 79.62 demonstrate, in comparison with
appropriate controls, a statistically significant dose-related positive
response in one or more of the possible test outcomes. Similarly, Tier
3 testing may be indicated if statistically significant positive
results are confined to either sex, or to the fetus as opposed to the
pregnant adult.
(2) The testing for reproductive and teratological effects required
under this paragraph may, at EPA's discretion, be conducted in
accordance with 40 CFR 798.4700 and/or by performance of a reproductive
assay by continuous breeding. These guidelines may be modified or
supplemented by EPA as required to ensure that the prescribed testing
addresses the identified areas of concern.
(e) Neurotoxicity Testing. (1) A potential need for Tier 3
neurotoxicity testing may be indicated if either the results of the
Neuropathology Assessment required under Sec. 79.67 shows
concentration-related effects in exposed animals or the Glial
Fibrillary Acidic Protein Assay required under Sec. 79.66 demonstrates
a statistically significant concentration-related positive response as
compared with appropriate controls. Similarly, Tier 3 neurotoxicity
testing may be indicated if relevant results under Sec. 79.62
demonstrate a statistically significant positive response in comparison
to appropriate controls.
(2) The testing for neurotoxicity required under this paragraph
may, at EPA's discretion, be conducted in accordance with 40 CFR
798.3260 and 40 CFR part 798 subpart G. These guidelines may be
modified or supplemented by EPA as required to ensure that the
prescribed testing addresses the identified areas of concern.
(f) General and Pulmonary Toxicity Testing. (1) A potential need
for Tier 3 general and/or pulmonary toxicity testing may be indicated
if, in comparison with appropriate controls, the results of the
Subchronic Toxicity Study, pursuant to Sec. 79.62, demonstrate abnormal
gross analysis or histopathological findings (especially as relates to
lung pathology from whole-body preserved test animals) or persistence
or delayed occurrence of toxic effects beyond the exposure period.
(2) A potential need for Tier 3 testing with respect to other organ
systems or endpoints not addressed by specific Tier 2 tests, e.g.,
hepatic, renal, or endocrine toxicity, may be demonstrated by findings
in the Tier 2 Subchronic Toxicity Study (pursuant to Sec. 79.62) or by
findings in the Tier 1 literature search of adverse functional,
physiologic, metabolic, or histopathologic effects of fuel or additive
emissions to such other organ systems or any other information
available to EPA. In addition, findings in the Tier 1 emission
characterization of significant levels of a known toxicant to such
other organ systems and endpoints may also indicate a need for relevant
health effects testing. The testing required under this paragraph may
include tests conducted in accordance with 40 CFR 798.3260 or 798.3320.
These guidelines may be modified or supplemented by EPA as necessary to
ensure that the prescribed testing addresses the identified areas of
concern.
(3) The testing for general/pulmonary toxicity required under this
paragraph may, at EPA's discretion, be conducted in accordance with 40
CFR 798.2450 or 798.3260. These guidelines may be modified or
supplemented by EPA as necessary to ensure that the prescribed testing
addresses the identified areas of concern. Pulmonary function
measurements, host defense assays, immunotoxicity tests, cell
morphology/morphometry, and/or enzyme assays of lung lavage cells and
fluids may be specifically required.
(g) Other Tier 3 Testing. (1) A manufacturer or group may be
required to use up-to-date modeling, sampling, monitoring, and/or
analytic approaches at the Tier 3 level to provide:
(i) Estimates of exposures to the emission products of a fuel or
fuel additive or group of products;
(ii) The expected atmospheric transformation products of such
emissions; and
(iii) The environmental partitioning of such emissions to the air,
soil, water, and biota.
(2) Additional emission characterization may be required if
uncertainty over the identity of chemical species or rate of their
emission interferes with reasonable judgments as to the presence and/or
concentration of potentially toxic substances in the emissions of a
fuel or fuel additive. The required tests may include characterization
of additional classes of emissions, the characterization of emissions
generated by additional vehicles/engines of various technology mixes
(e.g., catalyzed versus non-catalyzed emissions), and/or other more
precise analytic procedures for identification or quantification of
emissions compounds. Additional emissions testing may also be required
to evaluate concerns which may arise regarding the potential effects of
a fuel or fuel additive on the performance of emission control
equipment.
(3) A manufacturer or group may be required to conduct biological
and/or exposure studies at the Tier 3 level to evaluate directly the
potential public welfare or environmental effects of the emissions of a
fuel or additive, if significant concerns about such effects arise as a
result of EPA's review of the literature search or emission
characterization findings in Tier 1 or the results of the toxicological
tests in Tier 2.
(4) With regard to group submittals, Tier 3 studies on a fuel or
additive product(s) other than the originally specified group
representative may be required if specific differences in the product's
composition indicate that its emissions may have different toxicologic
properties from those of the original group representative.
(5) Additional emission characterization and/or toxicologic tests
may be required to evaluate the impact of different vehicle, engine, or
emission control technologies on the observed composition or health or
welfare effects of the emissions of a fuel or additive.
(6) Toxicological tests on individual emission products may be
required.
(7) Upon review of information submitted for an aerosol product
under Sec. 79.58(e), emissions characterization, exposure, and/or
toxicologic testing at a Tier 3 level may be required.
(8) A manufacturer which qualifies for and has elected to use the
special provisions for the products of small businesses (pursuant to
Sec. 79.58(d)) may be required to conduct emission characterization,
exposure, and /or toxicologic studies at the Tier 3 level for such
products, as specified in Sec. 79.58(d)(4).
(9) The examples of potential Tier 3 tests described in this
section do not in any way limit EPA's broad discretion and authority
under Tier 3.
Sec. 79.55 Base fuel specifications.
(a) General Characteristics. (1) The base fuel(s) in each fuel
family shall serve as the group representative(s) for the baseline
group(s) in each fuel family pursuant to Sec. 79.56. Also, as specified
in Sec. 79.51(h)(1), for fuel additives undergoing testing, the
designated base fuel for the respective fuel family shall serve as the
substrate in which the additive shall be mixed prior to the generation
of emissions.
(2) Base fuels shall 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. Such additives
shall be used at the minimum effective concentration-in-use for the
base fuel in question.
(3) 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 formulation.
(4) When an additive is the test subject, any additive normally
contained in the base fuel which serves the same function as the
subject additive shall be removed from the base fuel formulation. For
example, if a corrosion inhibitor were the subject of testing and if
this additive were to be tested in a base fuel which normally contained
a corrosion inhibitor, this test additive would replace the corrosion
inhibitor normally included as a component of the base fuel.
(5) Additive components of the methanol, ethanol, methane, and
propane base fuels in addition to any such additives included below
shall be limited to those recommended by the manufacturers of the
vehicles and/or engines used in testing such fuels. For this purpose,
EPA will review requests from manufacturers (or their agents) to modify
the additive specifications for the alternative fuels and, if
necessary, EPA shall change these specifications based on consistency
of those changes with the associated vehicle manufacturer's
recommendations for the operation of the vehicle. EPA shall publish
notice of any such changes to a base fuel and/or its base additive
package specifications in the Federal Register.
(b) Gasoline Base Fuel. (1) The gasoline base fuel is patterned
after the reformulated gasoline summer baseline fuel as specified in
CAA section 211(k)(10)(B)(i). The specifications and blending
tolerances for the gasoline base fuel are listed in Table F94-1. The
additive types which shall be required and/or permissible in the
gasoline base fuel are listed in Table 1 as well.
Table F94-1.--Gasoline Base Fuel Properties
API Gravity............................ 57.40.3
Sulfur, ppm............................ 33925
Benzene, vol%.......................... 1.530.3
RVP, psi............................... 8.70.3
Octane, (R+M)/2........................ 87.30.5
Distillation Parameters:
10%, deg.F.......................... 1285
50%, deg.F.......................... 2185
90%, deg.F.......................... 3305
Aromatics, vol%........................ 32.02.7
Olefins, vol%.......................... 9.22.5
Saturates, vol%........................ 58.82.0
Additive Types:
Required............................. Deposit Control
Corrosion Inhibitor
Demulsifier
Anti-oxidant
Metal Deactivator
Permissible.......................... Anti-static
(2) The additive components of the gasoline base fuel shall contain
compounds comprised of no elements other than carbon, hydrogen, oxygen,
nitrogen, and sulfur. Additives shall be used at the minimum
concentration needed to perform effectively in the gasoline base fuel.
In no case shall their concentration in the base fuel exceed the
maximum concentration recommended by the additive manufacturer. The
increment of sulfur contributed to the formulation by any additive
shall not exceed 15 parts per million sulfur by weight and shall not
cause the gasoline base fuel to exceed the sulfur specifications in
Table F94-1 of this section.
(c) Diesel Base Fuel. (1) The diesel base fuel shall be a #2 diesel
fuel having the properties and blending tolerances shown in Table F94-2
of this section. The additive types which shall be permissible in
diesel base fuel are presented in Table F94-2 as well.
Table F94-2.--Diesel Base Fuel Properties
API Gravity............................ 331
Sulfur, wt%............................ 0.050.0025
Cetane Number.......................... 45.22
Cetane Index........................... 45.72
Distillation Parameters:
10%, deg.F.......................... 4335
50%, deg.F.......................... 5165
90%, deg.F.......................... 6065
Aromatics, vol%........................ 38.42.7
Olefins, vol%.......................... 1.50.4
Saturates, vol%........................ 60.12.0
Additive Types:
Required............................. Corrosion Inhibitor
Demulsifier
Anti-oxidant
Metal Deactivator
Permitted............................ Anti-static
Flow Improver
Not Permitted........................ Deposit Control
(2) The additive components of the diesel base fuel shall contain
compounds comprised of no elements other than carbon, hydrogen, oxygen,
nitrogen, and sulfur. Additives shall be used at the minimum
concentration needed to perform effectively in the diesel base fuel. In
no case shall their concentration in the base fuel exceed the maximum
concentration recommended by the additive manufacturer. The increment
of sulfur contributed to the base fuel by additives shall not cause the
diesel base fuel to exceed the sulfur specifications in Table F94-2 of
this section.
(d) Methanol Base Fuels. (1) The methanol base fuels shall contain
no elements other than carbon, hydrogen, oxygen, nitrogen, sulfur, and
chlorine.
(2) The M100 base fuel shall consist of 100 percent by volume
chemical grade methanol.
(3) The M85 base fuel is to contain 85 percent by volume chemical
grade methanol, blended with 15 percent by volume gasoline base fuel
meeting the gasoline base fuel specifications outlined in paragraph
(b)(1) of this section. Manufacturers shall ensure the methanol
compatibility of lubricating oils as well as fuel additives used in the
gasoline portion of the M85 base fuel.
(4) The methanol base fuels shall meet the specifications listed in
Table F94-3.
Table F94-3.--Methanol Base Fuel Properties
M100:
Chemical Grade MeOH, vol%.................................. 100
Chlorine (as chlorides), wt%, max.......................... 0.0001
Water, wt%, max............................................ 0.5
Sulfur, wt%, max........................................... 0.002
M85
Chemical Grade MeOH, vol%,................................. 85
Gasoline Base Fuel, vol%................................... 15
Chlorine (as chlorides), wt%, max.......................... 0.0001
Water, wt%, max............................................ 0.5
Sulfur, wt%, max........................................... 0.004
(e) Ethanol Base Fuel. (1) The ethanol base fuel, E85, shall
contain no elements other than carbon, hydrogen, oxygen, nitrogen,
sulfur, chlorine, and copper.
(2) The ethanol base fuel shall contain 85 percent by volume
chemical grade ethanol, blended with 15 percent by volume gasoline base
fuel that meets the specifications listed in paragraph (b)(1) of this
section. Additives used in the gasoline component of E85 shall be
ethanol-compatible.
(3) The ethanol base fuel shall meet the specifications listed in
Table F94-4.
Table F94-4.--Ethanol Base Fuel Properties
E85:
Chemical Grade EtOH, vol%, min............................. 85
Gasoline Base Fuel, vol%................................... 15
Chlorine (as chloride), wt%, max........................... 0.0004
Copper, mg/L, max.......................................... 0.07
Water, wt%, max............................................ 0.5
Sulfur, wt%, max........................................... 0.004
(f) Methane Base Fuel. (1) The methane base fuel is a gaseous motor
vehicle fuel marketed commercially as compressed natural gas (CNG),
whose primary constituent is methane.
(2) The methane base fuel shall contain no elements other than
carbon, hydrogen, oxygen, nitrogen, and sulfur. The fuel shall contain
an odorant additive for leak detection purposes. The added odorant
shall be used at a level such that, at ambient conditions, the fuel
must have 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. After addition of the odorant, the
methane base fuel shall contain no more than 16 ppm sulfur by volume.
(3) The methane base fuel shall meet the specifications listed in
Table F94-5.
Table F94-5.--Methane Base Fuel Specifications
Methane, mole%, min.............................................. 89.0
Ethane, mole%, max............................................... 4.5
Propane and higher HC, mole%, max................................ 2.3
C6 and higher HC, mole%, max..................................... 0.2
Oxygen, mole%, max............................................... 0.6
Sulfur (including odorant additive) ppmv, max.................... 16
Inert gases:
Sum of CO2 and N2, mole%, max.................................. 4.0
(g) Propane Base Fuel. (1) The propane base fuel is a gaseous motor
vehicle fuel, marketed commercially as liquified petroleum gas (LPG),
whose primary constituent is propane.
(2) The propane base fuel may contain no elements other than
carbon, hydrogen, oxygen, nitrogen, and sulfur. The fuel shall contain
an odorant additive for leak detection purposes. The added odorant
shall be used at a level such that at ambient conditions the fuel must
have 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. After addition of the odorant, the propane
base fuel shall contain no more than 120 ppm sulfur by weight.
(3) The propane base fuel shall meet the specifications listed in
Table F94-6.
Table F94--6.--Propane Base Fuel Specifications
Vapor pressure at 100-F, psig, max............................... 208
Evaporative temperature, 95%, deg.F, max........................ -37
Propane, vol%, min............................................... 92.5
Propylene, vol%, max............................................. 5.0
Butane and heavier, vol%, max.................................... 2.5
Residue-evaporation of 100mL, max, mL............................ 0.05
Sulfur (including odorant additive) ppmw, max.................... 123
Sec. 79.56 Fuel and fuel additive grouping system.
(a) Manufacturers of fuels and fuel additives are allowed to
satisfy the testing requirements in Secs. 79.52, 79.53, and 79.54 and
the associated reporting requirements in Sec. 79.59 on an individual or
group basis, provided that such products meet the criteria in this
section for enrollment in the same fuel/additive group. However, each
manufacturer of a fuel or fuel additive must individually comply with
the notification requirements of Sec. 79.59(b). Further, if a
manufacturer elects to comply by participation in a group, each
manufacturer continues to be individually subject to the information
requirements of this subpart.
(1) The use of the grouping provision to comply with Tier 1 and
Tier 2 testing requirements is voluntary. No manufacturer is prohibited
from testing and submitting its own data for its own product
registration, despite its qualification for membership in a particular
group.
(2) The only groups permitted are those established in this
section.
(b) Each manufacturer who chooses to enroll a fuel or fuel additive
in a group of similar fuels and fuel additives as designated in this
section may satisfy the registration requirements through a group
submission of jointly-sponsored testing and analysis conducted on a
product which is representative of all products in that group, provided
that the group representative is chosen according to the specifications
in this section.
(1) The health effects information submitted by a group shall be
considered applicable to all fuels and fuel additives in the group. A
fuel or fuel additive manufacturer who has chosen to participate in a
group may subsequently choose to perform testing of such fuel or fuel
additive on an individual basis; however, until such independent
registration information has been received and reviewed by EPA, the
information initially submitted by the group on behalf of the
manufacturer's fuel or fuel additive shall be considered applicable and
valid for that fuel or fuel additive. It could therefore be used to
support requirements for further testing under the provisions of Tier 3
or to support regulatory decisions affecting that fuel or fuel
additive.
(2) Manufacturers are responsible for determining the appropriate
groups for their products according to the criteria in this section and
for enrolling their products into those groups under industry-sponsored
or other independent brokering arrangements.
(3) Manufacturers who enroll a fuel or fuel additive into a group
shall share the applicable costs according to appropriate arrangements
established by the group. The organization and administration of group
functions and the development of cost-sharing arrangements are the
responsibility of the participating manufacturers. If manufacturers are
unable to agree on fair and equitable cost sharing arrangements and if
such dispute is referred by one or more manufacturers to EPA for
resolution, then the provisions in Sec. 79.56(c) (1) and (2) shall
apply.
(c) In complying with the registration requirements for a given
fuel or fuel additive, notwithstanding the enrollment of such fuel or
additive in a group, a manufacturer may make use of available
information for any product which conforms to the same grouping
criteria as the given product. If, for this purpose, a manufacturer
wishes to rely upon the information previously submitted by another
manufacturer (or group of manufacturers) for registration of a similar
product (or group of products), then the previous submitter is entitled
to reimbursement by the manufacturer for an appropriate portion of the
applicable costs incurred to obtain and report such information. Such
entitlement shall remain in effect for a period of fifteen years
following the date on which the original information was submitted.
Pursuant to Sec. 79.59(b)(4)(ii), the manufacturer who relies on
previously-submitted registration data shall certify to EPA that the
original submitter has been notified and that appropriate reimbursement
arrangements have been made.
(1) When private efforts have failed to resolve a dispute about a
fair amount or method of cost-sharing or reimbursement for testing
costs incurred under this subpart, then any party involved in that
dispute may initiate a hearing by filing two signed copies of a request
for a hearing with a regional office of the American Arbitration
Association and mailing a copy of the request to EPA. A copy must also
be sent to each person from whom the filing party seeks reimbursement
or who seeks reimbursement from that party. The information and fees to
be included in the request for hearing are specified in 40 CFR
791.20(b) and (c).
(2) Additional procedures and requirements governing the hearing
process are those specified in 40 CFR 791.22 through 791.50, 791.60,
791.85, and 791.105, excluding 40 CFR 791.39(a)(3) and 791.48(d).
(d) Basis for Classification. (1) Rather than segregating fuels and
fuel additives into separate groups, the grouping system applies the
same grouping criteria and creates a single set of groups applicable
both to fuels and fuel additives.
(2) Fuels shall be classified pursuant to Sec. 79.56(e) into
categories and groups of similar fuels and fuel additives according to
the components and characteristics of such fuels in their uncombusted
state. The classification of a fuel product must take into account the
components of all bulk fuel additives which are listed in the
registration application or basic registration data submitted for the
fuel product.
(3) Fuel additives shall be classified pursuant to Sec. 79.56(e)
into categories and groups of similar fuels and fuel additives
according to the components and characteristics of the respective
uncombusted additive/base fuel mixture pursuant to Sec. 79.51(h)(1).
(4) In determining the category and group to which a fuel or fuel
additive belongs, impurities present in trace amounts shall be ignored
unless otherwise noted. Impurities are those substances which are
present through contamination or which remain in the fuel or additive
naturally after processing is completed.
(5) Reference Standards. (i) American Society for Testing and
Materials (ASTM) standard D 4814-93a, ``Standard Specification for
Automotive Spark-Ignition Engine Fuel'', used to define the general
characteristics of gasoline fuels (paragraph (e)(3)(i)(A)(3) of this
section) and ASTM standard D 975-93, ``Standard Specification for
Diesel Fuel Oils'', used to define the general characteristics of
diesel fuels (paragraph (e)(3)(ii)(A)(3) of this section) have been
incorporated by reference.
(ii) This incorporation by reference was approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the American Society for Testing
and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103. Copies
may be inspected at U.S. EPA, OAR, 401 M Street SW., Washington, DC,
20460 or at the Office of the Federal Register, 800 North
Capitol Street NW., suite 700, Washington, DC.
(e) Grouping Criteria. The grouping system is represented by a
matrix of three fuel/additive categories within six specified fuel
families (see Table F94-7, Grouping System for Fuels and Fuel
Additives). Each category may include one or more groups. Within each
group, a representative may be designated based on the criteria in this
section and joint registration information may be developed and
submitted for member fuels and fuel additives.
Table F94-7.--Grouping System for Fuels and Fuel Additives
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conventional Fuel Families Alternative Fuel Families
-----------------------------------------------------------------------------------------------------------------------------------
Category Methane (CNG, LNG)
Gasoline (A) Diesel (B) Methanol(C) Ethanol(D) (E) Propane (LPG) (F)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline............ One group One group Two groups: (1) M100 One group (includes One group (includes One group
represented by represented by group (includes ethanol-gasoline both CNG and LNG), represented by LPG
gasoline base fuel. diesel base fuel. methanol-gasoline formulations with represented by CNG base fuel.
formulations with at least 50% base fuel.
at least 96% ethanol)
methanol) represented by E85
represented by M100 base fuel.
base fuel (2) M85
(includes methanol-
gasoline
formulations with
50-95% methanol)
represented by M85
base fuel.
Non-baseline........ One group for each One group for each One group for each One group for each One group to include One group to include
gasoline-oxygenate oxygen-contributing individual non- individual non- methane propane
blend or each compound or class methanol, non- ethanol, non- formulations formulations
gasoline-methanol/ of compounds; one gasoline component gasoline component exceeding the exceeding the
co-solvent blend; group for each and one group for and one group for specified limit for specified limit for
one group for each synthetic crude- each unique each unique non-methane butane and higher
synthetic crude- derived fuel. combination of such combination of such hydrocarbons. hydrocarbons.
derived fuel. components. components.
Atypical............ One group for each One group for each One group for each One group for each One group for each One group for each
atypical element/ atypical element/ atypical element/ atypical element/ atypical element/ atypical element/
characteristic, or characteristic, or characteristic, or characteristic, or characteristic, or characteristic, or
unique combination unique combination unique combination unique combination unique combination unique combination
of atypical of atypical of atypical of atypical of atypical of atypical
elements/characteri elements/characteri elements/characteri elements/characteri elements/characteri elements/characteri
stics. stics. stics. stics. stics. stics.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Fuel Families. Each of the following six fuel families (Table
F94-7, columns A-F) includes fuels of the type referenced in the name
of the family as well as bulk and aftermarket additives which are
intended for use in those fuels. When applied to fuel additives, the
criteria in these descriptions refer to the associated additive/base
fuel mixture, pursuant to Sec. 79.51(h)(1). One or more base fuel
formulations are specified for each fuel family pursuant to Sec. 79.55.
(i) The Gasoline Family includes fuels composed of more than 50
percent gasoline by volume and their associated fuel additives. The
base fuel for this family is specified in Sec. 79.55(b).
(ii) The Diesel Family includes fuels composed of more than 50
percent diesel fuel by volume and their associated fuel additives. The
Diesel fuel family includes both Diesel #1 and Diesel #2 formulations.
The base fuel for this family is specified in Sec. 79.55(c).
(iii) The Methanol Family includes fuels composed of at least 50
percent methanol by volume and their associated fuel additives. The
M100 and M85 base fuels are specified in Sec. 79.55(d).
(iv) The Ethanol Family includes fuels composed of at least 50
percent ethanol by volume and their associated fuel additives. The base
fuel for this family is E85 as specified in Sec. 79.55(e).
(v) The Methane Family includes compressed natural gas (CNG) and
liquefied natural gas (LNG) fuels containing at least 50 mole percent
methane and their associated fuel additives. The base fuel for the
family is a CNG formulation specified in Sec. 79.55(f).
(vi) The Propane Family includes propane fuels containing at least
50 percent propane by volume and their associated fuel additives. The
base fuel for this family is a liquefied petroleum gas (LPG) as
specified in Sec. 79.55(g).
(vii) A manufacturer seeking registration for formulation(s) which
do not fit the criteria for inclusion in any of the fuel families
described in this section shall contact EPA at the address in
Sec. 79.59(a)(1) for further guidance in classifying and testing such
formulation(s).
(2) Fuel/Additive Categories. Fuel/additive categories (Table F94-
7, rows 1-3) are subdivisions of fuel families which represent the
degree to which fuels and fuel additives in the family resemble the
base fuel(s) designated for the family. Three general category types
are defined in this section. When applied to fuel additives, the
criteria in these descriptions refer to the associated additive/base
fuel mixture, pursuant to Sec. 79.51(h)(1).
(i) Baseline categories consist of fuels and fuel additives which
contain no elements other than those permitted in the base fuel for the
respective fuel family and conform to specified limitations on the
amounts of certain components or characteristics applicable to that
fuel family.
(ii) Non-Baseline Categories consist of fuels and fuel additives
which contain no elements other than those permitted in the base fuel
for the respective fuel family, but which exceed one or more of the
limitations for certain specified components or characteristics
applicable to baseline formulations in that fuel family.
(iii) Atypical Categories consist of fuels and fuel additives which
contain elements or classes of compounds other than those permitted in
the base fuel for the respective fuel family or which otherwise do not
meet the criteria for either baseline or non-baseline formulations in
that fuel family. A fuel or fuel additive product having both non-
baseline and atypical characteristics pursuant to Sec. 79.56(e)(3),
shall be considered to be an atypical product.
(3) This section defines the specific categories applicable to each
fuel family. When applied to fuel additives, the criteria in these
descriptions refer to the associated additive/base fuel mixture,
pursuant to Sec. 79.51(h)(1).
(i) Gasoline Categories. (A) The Baseline Gasoline category
contains gasoline fuels and associated additives which satisfy all of
the following criteria:
(1) Contain no elements other than carbon, hydrogen, oxygen,
nitrogen, and/or sulfur.
(2) Contain less than 1.5 percent oxygen by weight.
(3) Sulfur concentration is limited to 1000 ppm per the
specifications cited in the following paragraph.
(4) Possess the physical and chemical characteristics of unleaded
gasoline as specified by ASTM standard D 4814-93a (incorporated by
reference, pursuant to paragraph (d)(5) of this section), in at least
one Seasonal and Geographical Volatility Class.
(5) Derived from conventional petroleum sources only.
(B) The Non-Baseline Gasoline category is comprised of gasoline
fuels and associated additives which conform to the specifications in
paragraph (e)(3)(i)(A) of this section for the Baseline Gasoline
category except that they contain 1.5 percent or more oxygen by weight
and/or may be derived from synthetic crudes, such as those prepared
from coal, shale and tar sands, heavy oil deposits, and other non-
conventional petroleum sources.
(C) The Atypical Gasoline category is comprised of gasoline fuels
and associated additives which contain one or more elements other than
carbon, hydrogen, oxygen, nitrogen, and sulfur.
(ii) Diesel Categories. (A) The Baseline Diesel category is
comprised of diesel fuels and associated additives which satisfy all of
the following criteria:
(1) Contain no elements other than carbon, hydrogen, oxygen,
nitrogen, and/or sulfur. Pursuant to 40 CFR 80.29, highway diesel sold
after October 1, 1993 shall contain 0.05 percent or less sulfur by
weight;
(2) Contain less than 1.0 percent oxygen by weight;
(3) Diesel formulations containing more than 0.05 percent sulfur by
weight are precluded by 40 CFR 80.29;
(4) Possess the characteristics of diesel fuel as specified by ASTM
standard D 975-93 (incorporated by reference, pursuant to paragraph
(d)(5) of this section); and
(5) Derived from conventional petroleum sources only.
(B) The Non-Baseline Diesel category is comprised of diesel fuels
and associated additives which conform to the specifications in
paragraph (e)(3)(ii)(A) of this section for the Baseline Diesel
category except that they contain 1.0 percent or more oxygen by weight
and/or may be derived from synthetic crudes, such as those prepared
from coal, shale and tar sands, heavy oil deposits, and other non-
conventional petroleum sources.
(C) The Atypical Diesel category is comprised of diesel fuels and
associated additives which contain one or more elements other than
carbon, hydrogen, oxygen, nitrogen, and sulfur.
(iii) Methanol Categories. (A) The Baseline Methanol category is
comprised of methanol fuels and associated additives which contain at
least 50 percent methanol by volume, no more than 4.0 percent by volume
of substances other than methanol and gasoline, and no elements other
than carbon, hydrogen, oxygen, nitrogen, sulfur, and/or chlorine.
Baseline methanol shall contain no more than 0.004 percent by weight of
sulfur or 0.0001 percent by weight of chlorine.
(B) The Non-Baseline Methanol category is comprised of fuel blends
which contain at least 50 percent methanol by volume, more than 4.0
percent by volume of a substance(s) other than methanol and gasoline,
and meet the baseline limitations on elemental composition in paragraph
(e)(3)(iii)(A) of this section.
(C) The Atypical Methanol category consists of methanol fuels and
associated additives which do not meet the criteria for either the
Baseline or the Non-Baseline Methanol category.
(iv) Ethanol Categories. (A) The Baseline Ethanol category is
comprised of ethanol fuels and associated additives which contain at
least 50 percent ethanol by volume, no more than five (5) percent by
volume of substances other than ethanol and gasoline, and no elements
other than carbon, hydrogen, oxygen, nitrogen, sulfur, chlorine, and
copper. Baseline ethanol formulations shall contain no more than 0.004
percent by weight of sulfur, 0.0004 percent by weight of chlorine, and/
or 0.07 mg/L of copper.
(B) The Non-Baseline Ethanol category is comprised of fuel blends
which contain at least 50 percent ethanol by volume, more than five (5)
percent by volume of a substance(s) other than ethanol and gasoline,
and meet the baseline limitations on elemental composition in paragraph
(e)(3)(iv)(A) of this section.
(C) The Atypical Ethanol category consists of ethanol fuels and
associated additives which do not meet the criteria for either the
Baseline or the Non-Baseline Ethanol categories.
(v) Methane Categories. (A) The Baseline Methane category is
comprised of methane fuels and associated additives (including at least
an odorant additive) which contain no elements other than carbon,
hydrogen, oxygen, nitrogen, and/or sulfur, and contain no more than 20
mole percent non-methane hydrocarbons. Baseline methane formulations
shall not contain more than 16 ppm by volume of sulfur, including any
sulfur which may be contributed by the odorant additive.
(B) The Non-Baseline Methane category consists of methane fuels and
associated additives which conform to the specifications in paragraph
(e)(3)(v)(A) of this section for the Baseline Methane category except
that they exceed 20 mole percent non-methane hydrocarbons.
(C) The Atypical Methane category consists of methane fuels and
associated additives which contain one or more elements other than
carbon, hydrogen, oxygen, nitrogen, and/or sulfur, or exceed 16 ppm by
volume of sulfur.
(vi) Propane Categories. (A) The Baseline Propane category is
comprised of propane fuels and associated additives (including at least
an odorant additive) which contain no elements other than carbon,
hydrogen, oxygen, nitrogen, and/or sulfur, and contain no more than 20
percent by volume non-propane hydrocarbons. Baseline Propane
formulations shall not contain more than 123 ppm by weight of sulfur,
including any sulfur which may be contributed by the odorant additive.
(B) The Non-Baseline Propane category consists of propane fuels and
associated additives which conform to the specifications in paragraph
(e)(3)(vi)(A) of this section for the Baseline Propane category, except
that they exceed the 20 percent by volume limit for butane and higher
hydrocarbons.
(C) The Atypical Propane category consists of propane fuels and
associated additives which contain elements other than carbon,
hydrogen, oxygen, nitrogen, and/or sulfur, or exceed 123 ppm by weight
of sulfur.
(4) Fuel/Additive Groups. Fuel/additive groups are subdivisions of
the fuel/additive categories. One or more group(s) are defined within
each category in each fuel family according to the presence of
differing characteristics in the fuel or additive/base fuel mixture.
For each group, one formulation (either a base fuel or a member fuel or
additive product) is chosen to represent all the member products in the
group in any tests required under this subpart. The section which
follows describes the fuel/additive groups.
(i) Baseline Groups. (A) The Baseline Gasoline category comprises a
single group. The gasoline base fuel specified in Sec. 79.55(b) shall
serve as the representative of this group.
(B) The Baseline Diesel category comprises a single group. The
diesel base fuel specified in Sec. 79.55(c) shall serve as the
representative of this group.
(C) The Baseline Methanol category includes two groups: M100 and
M85. The M100 group consists of methanol-gasoline formulations
containing at least 96 percent methanol by volume. These formulations
must contain odorants and bitterants (limited in elemental composition
to carbon, hydrogen, oxygen, nitrogen, sulfur, and chlorine) for
prevention of purposeful or inadvertent consumption. The M100 base fuel
specified in Sec. 79.55(d) shall serve as the representative for this
group. The M85 group consists of methanol-gasoline formulations
containing at least 50 percent by volume but less than 96 percent by
volume methanol. The M85 base fuel specified in Sec. 79.55(d) shall
serve as the representative of this group.
(D) The Baseline Ethanol category comprises a single group. The E85
base fuel specified in Sec. 79.55(e) shall serve as the representative
of this group.
(E) The Baseline Methane category comprises a single group. The CNG
base fuel specified in Sec. 79.55(f) shall serve as the representative
of this group.
(F) The Baseline Propane category comprises a single group. The LPG
base fuel specified in Sec. 79.55(g) shall serve as the representative
of this group.
(ii) Non-Baseline Groups-- (A) Non-Baseline Gasoline. The Non-
Baseline gasoline fuels and associated additives shall sort into groups
according to the following criteria:
(1) For gasoline fuel and additive products which contain 1.5
percent oxygen by weight or more, a separate non-baseline gasoline
group shall be defined by each oxygenate compound or methanol/co-
solvent blend listed as a component in the registration application or
basic registration data of any such fuel or additive.
(i) Examples of oxygenates occurring in non-baseline gasoline
formulations include ethanol, methyl tertiary butyl ether (MTBE), ethyl
tertiary butyl ether (ETBE), tertiary amyl methyl ether (TAME),
diisopropyl ether (DIPE), dimethyl ether (DME), tertiary amyl ethyl
ether (TAEE), and any other compound(s) which increase the oxygen
content of the gasoline formulation. A separate non-baseline gasoline
group is defined for each such oxygenating compound.
(ii) Each unique methanol and co-solvent combination (whether one,
two, or more additional oxygenate compounds) used in a non-baseline
fuel shall also define a separate group. An oxygenate compound used as
a co-solvent for methanol in a non-baseline gasoline formulation must
be identified as such in its registration. If the oxygenate is not
identified as a methanol co-solvent, then the compound shall be
regarded by EPA as defining a separate non-baseline gasoline group.
Examples of methanol/co-solvent combinations occurring in non-baseline
gasoline formulations include methanol/isopropyl alcohol, methanol/
butanol, and methanol with alcohols up to C8/octanol (Octamix).
(iii) For each such group, the representative to be used in testing
shall be a formulation consisting of the gasoline base fuel blended
with the relevant oxygenate compound (or methanol/co-solvent
combination) in an amount equivalent to the highest actual or
recommended concentration-in-use of the oxygenate (or methanol/co-
solvent combination) recorded in the basic registration data of any
member fuel or additive product. In the event that two or more products
in the same group contain the same and highest amount of the oxygenate
or methanol/co-solvent blend, then the representative shall be chosen
at random for such candidate products.
(2) An oxygenate compound or methanol/co-solvent combination to be
blended with the gasoline base fuel for testing purposes shall be
chemical-grade quality, at a minimum, and shall not contain a
significant amount of other contaminating oxygenate compounds.
(3) Separate non-baseline gasoline groups shall also be defined for
gasoline formulations derived from each particular non-conventional
petroleum source or process.
(i) Such groups may include, but are not limited to, the following:
coal-derived gasoline formulations; chemically-synthesized gasoline
formulations (including those using recycled chemical/petrochemical
products); tar sand-derived gasoline formulations; shale-derived
gasoline formulations; and other types of soil-recovered products used
in formulating gasolines.
(ii) In any such group, the first product to be registered or to
apply for EPA registration shall be the representative of that group.
If two or more such products are registered or apply for first
registration simultaneously, then the representative shall be chosen by
a random method from among such candidate products.
(4) Pursuant to Sec. 79.51(i), non-baseline gasoline products may
belong to more than one fuel/additive group.
(B) Non-Baseline Diesel. The Non-Baseline diesel fuels and
associated additives shall sort into groups according to the following
criteria:
(1) For diesel fuel and additive products which contain 1.0 percent
oxygen by weight or more, a separate non-baseline diesel group shall be
defined by each individual alcohol or ether listed as a component in
the registration application or basic registration data of any such
fuel or additive. For each such group, the representative to be used in
testing shall be a formulation consisting of the diesel base fuel
blended with the relevant alcohol or ether in an amount equivalent to
the highest actual or recommended concentration-in-use of the alcohol
or ether recorded in the basic registration data of any member fuel or
additive product.
(2) A separate non-baseline diesel group is also defined for each
of the following classes of oxygenating compounds: mixed nitroso-
compounds; mixed nitro- compounds; mixed alkyl nitrates; mixed alkyl
nitrites; peroxides; furans; mixed alkyl esters of plant origin; and
mixed alkyl esters of animal origin. For each such group, the
representative to be used in testing shall be formulated as follows:
(i) From the class of compounds which defines the group, a
particular oxygenate compound shall be chosen from among all such
compounds recorded in the registration application or basic
registration data of any fuel or additive in the group.
(ii) The selected compound shall be the one recorded in any member
product's registration application with the highest actual or
recommended maximum concentration-in-use. This compound, when mixed
into the diesel base fuel at the indicated maximum concentration, shall
serve as the group representative.
(iii) In the event that two or more oxygenate compounds in the
relevant class have the highest recorded concentration-in-use, then the
oxygenate compound to be used in the group representative shall be
chosen at random from the qualifying candidate compounds.
(3) A separate non-baseline diesel group shall also be defined for
each diesel fuel derived from a particular synthetic petroleum source
or process.
(i) Such groups include, but shall not be limited to, the
following: coal-derived diesel formulations; chemically-synthesized
diesel formulations (including those using recycled chemical/
petrochemical products); tar sand-derived diesel formulations; shale-
derived diesel formulations; and other types of soil-recovered products
used in formulating diesel fuel(s).
(ii) In any such group, the first product to be registered or to
apply for EPA registration shall be the representative of that group.
If two or more products are registered or apply for first registration
simultaneously, then the representative shall be chosen by a random
method from among such candidate products.
(4) Pursuant to Sec. 79.51(i), non-baseline diesel products may
belong to more than one fuel/additive group.
(C) Non-Baseline Methanol. The Non-Baseline methanol formulations
are sorted into groups based on the non-methanol, non-gasoline
component(s) of the blended fuel. Each such component occurring
separately and each unique combination of such components shall define
a separate group.
(1) The representative of each such non-baseline methanol group
shall be the group member with the highest percent by volume of non-
methanol, non-gasoline component(s).
(2) In case two or more such members have the same and highest
concentration of non-methanol, non-gasoline component(s), the
representative of the group shall be chosen at random from among such
equivalent member products.
(D) Non-Baseline Ethanol. The Non-Baseline ethanol formulations are
sorted into groups based on the non-ethanol, non-gasoline component(s)
of the blended fuel. Each such component occurring separately and each
unique combination of such components shall define a separate group.
(1) The representative of each such non-baseline ethanol group
shall be the group member with the highest percent by volume of non-
ethanol, non-gasoline component(s).
(2) In case two or more such members have the same and highest
concentration of non-ethanol, non-gasoline component(s), the
representative of the group shall be chosen at random from among such
equivalent member products.
(E) Non-Baseline Methane. The Non-Baseline methane category
consists of one group. The group representative shall be the member
fuel or fuel/additive formulation containing the highest concentration-
in-use of non-methane hydrocarbons. If two or more member products have
the same and the highest concentration-in-use, then the representative
shall be chosen at random from such products.
(F) Non-Baseline Propane. The Non-Baseline propane category
consists of one group. The group representative shall be the member
fuel or fuel/additive formulation containing the highest concentration-
in-use of butane and higher hydrocarbons. If two or more products have
the same and the highest concentration-in-use, then the representative
shall be chosen at random from such products.
(iii) Atypical groups.
(A) As defined for each individual fuel family in Sec. 79.56(e)(3),
fuels and additives meeting any one of the following criteria are
considered atypical.
(1) Gasoline Atypical fuels and additives contain one or more
elements in addition to carbon, hydrogen, oxygen, nitrogen, and sulfur.
(2) Diesel Atypical fuels and additives contain one or more element
in addition to carbon, hydrogen, oxygen, nitrogen, and sulfur.
(3) Methanol Atypical fuels and additives contain:
(i) one or more element in addition to carbon, hydrogen, oxygen,
nitrogen, sulfur, and chlorine, and/or
(ii) sulfur in excess of 0.004 percent by weight, and/or
(iii) chlorine in excess of 0.0001 percent by weight.
(4) Ethanol Atypical fuels and additives contain:
(i) one or more element in addition to carbon, hydrogen, oxygen,
nitrogen, sulfur, chlorine, and copper, and/or
(ii) sulfur in excess of 0.004 percent by weight, and/or
(iii) contain chlorine (as chloride) in excess of 0.0004 percent by
weight, and/or
(iv) contain copper in excess of 0.07 mg/L.
(5) Methane Atypical fuels and additives contain:
(i) one or more element in addition to carbon, hydrogen, oxygen,
nitrogen, and sulfur, and/or
(ii) sulfur in excess of 16 ppm by volume.
(6) Propane Atypical fuels and additives contain:
(i) one or more element in addition to carbon, hydrogen, oxygen,
nitrogen, and sulfur, and/or
(ii) sulfur in excess of 123 ppm by weight.
(B) General rules for sorting these atypical fuels and additives
into separate groups are as follows:
(1) Pursuant to Sec. 79.51(j), a given atypical product may belong
to more than one atypical group.
(2) Fuels and additives in different fuel families may not be
grouped together, even if they contain the same atypical element(s) or
other atypical characteristic(s).
(3) A fuel or additive containing one or more atypical elements
attached to a polymer compound must be sorted into a separate group
from atypical fuels or fuel additives containing the same atypical
element(s) in non-polymer form. However, the occurrence of a polymer
compound which does not contain an atypical element does not affect the
grouping of a fuel or additive.
(C) Specific rules for sorting each family's atypical fuels and
additives into separate groups, and for choosing each such group's
representative for testing, are as follows:
(1) A separate group is created for each atypical element (or other
atypical characteristic) occurring separately, i.e., in the absence of
any other atypical element or characteristic, in one or more fuels and/
or additives within a given fuel family.
(i) Consistent with the basic grouping guidelines provided in
Sec. 79.56(d), a fuel product which is classified as atypical because
its basic registration data or application lists a bulk additive
containing an atypical characteristic, may be grouped with that
additive and/or with other fuels and additives containing the same
atypical characteristic.
(ii) Within a group of products containing only one atypical
element or characteristic, the fuel or additive/base fuel mixture with
the highest concentration-in-use or recommended concentration-in-use of
the atypical element or characteristic shall be the designated
representative of that group. In the event that two or more fuels or
additive/base fuel mixtures within the group contain the same and
highest concentration of the single atypical element or characteristic,
then the group representative shall be selected by a random method from
among such candidate products.
(2) A separate group is also created for each unique combination of
atypical elements (and/or other specified atypical characteristics)
occurring together in one or more fuels and/or additives within a given
fuel family.
(i) Consistent with the basic grouping guidelines provided in
Sec. 79.56(d), a fuel which is classified as atypical because its basic
registration data lists one bulk additive containing two or more
atypical characteristics, may be grouped with that additive and/or with
other fuels and/or additives containing the same combination of
atypical characteristics. Grouping of fuels containing more than one
atypical additive shall be guided by provisions of Sec. 79.51(j).
(ii) Within a group of such products containing a unique
combination of two or more atypical elements or characteristics, the
designated representative shall be the product within the group which
contains the highest total concentration of the atypical elements or
characteristics.
(iii) In the event that two or more products within a given
atypical group contain the same and highest concentration of the same
atypical elements or characteristics then, among such candidate
products, the designated representative shall be the product which,
first, has the highest total concentration of metals, followed in order
by highest total concentration of halogens, highest total concentration
of other atypical elements (including sulfur concentration, as
applicable), highest total concentration of polymers containing
atypical elements, and, lastly, highest total concentration of oxygen.
(iv) If two or more products have the same and highest
concentration of the variable identified in the preceding paragraph,
then, among such products, the one with the greatest concentration of
the next highest variable on the list shall be the group
representative.
(v) This decision-making process shall continue until a single
product is determined to be the representative. If two or more products
remain tied at the end of this process, then the representative shall
be chosen by a random method from among such remaining products.
Sec. 79.57. Emission generation.
This section specifies the equipment and procedures that must be
used in generating the emissions which are to be subjected to the
characterization procedures and/or the biological tests specified in
Secs. 79.52(b) and 79.53 of these regulations. When applicable, they
may also be required in conjunction with testing under Secs. 79.54 and
79.58(c). Additional requirements concerning emission generation,
delivery, dilution, quality control, and safety practices are outlined
in Sec. 79.61.
(a) Vehicle and engine selection criteria. (1) All vehicles and
engines used to generate emissions for testing a fuel or additive/fuel
mixture must be new (i.e., never before titled) and placed into the
program with less than 500 miles on the odometer or 12 hours on the
engine chronometer. The vehicles and engines shall be unaltered from
the specifications of the original equipment manufacturer.
(2) The vehicle/engine type, vehicle/engine class, and vehicle/
engine subclass designated to generate emissions for a given fuel or
additive shall be the same type, class, and subclass which, over the
previous three years, has consumed the most gallons of fuel in the fuel
family applicable to the given fuel or additive. No distinction shall
be made between light-duty vehicles and light-duty trucks for purposes
of this classification.
(3) Within this vehicle/engine type, class, and subclass, the
specific vehicles and engines acceptable for emission generation are
those that represent the most common fuel metering system and the most
common of the most important emission control system devices or
characteristics with respect to emission reduction performance for the
model year in which testing begins. These vehicles will be determined
through a survey of the previous model year's vehicle/engine sales
within the given subclass. These characteristics shall include, but
need not be limited to, aftertreatment device(s), fuel aspiration, air
injection, exhaust gas recirculation, and feedback type.
(4) Within the applicable subclass, the five highest selling
vehicle/engine models that contain the most common such equipment and
characteristics shall be determined. Any of these five models of the
current model year (at the time testing begins) may be selected for
emission generation.
(i) If one or more of the five models is not available for the
current model year, the choice of model for emission generation shall
be limited to those remaining among the five.
(ii) If fewer than five models of the given vehicle/engine type are
available for the current model year, all such models shall be
eligible.
(5) When the fuel or fuel additive undergoing testing is not
commonly used or intended to be used in the vehicle/engine types
prescribed by this selection procedure, or when rebuilding or
alteration is required to obtain a suitable vehicle/engine for emission
generation, the manufacturer may submit a request to EPA for a
modification in test procedure requirements. Any such request must
include objective test results which support the claim that a more
appropriate vehicle/engine type is needed as well as a suggested
substitute vehicle/engine type. The vehicle/engine selection in this
case shall be approved by EPA prior to the start of testing.
(6) Once a particular model has been chosen on which to test a fuel
or additive product, all mileage accumulation and generation of
emissions for characterization and biological testing of such product
shall be conducted on that same model.
(i) If the initial test vehicle/engine fails or must be replaced
for any reason, emission generation shall continue with a second
vehicle/engine which is identical to, or resembles to the greatest
extent possible, the initial test vehicle/engine. If more than one
replacement vehicle/engine is necessary, all such vehicles/engines
shall be identical, or resemble to the greatest extent possible, the
initial test vehicle/engine.
(ii) Manufacturers are encouraged to obtain, at the start of a test
program, more than one emission generation vehicle/engine of the
identical model, to ensure the availability of back-up emission
generator(s). All backup vehicles/engines must be conditioned and must
have their emissions fully characterized, as done for the initial test
vehicle/engine, prior to their use as emission generators for
biological testing. Alternating between such vehicles/engines regularly
during the course of testing is permissible and advisable, particularly
to allow regular maintenance on such vehicles/engines during prolonged
health effects testing.
(b) Vehicle/engine operation and maintenance. (1) For the purpose
of generating combustion emissions from a fuel or additive/base fuel
mixture for which the relevant class is light duty, either a light-duty
vehicle shall be operated on a chassis dynamometer or a light-duty
engine shall be operated on an engine dynamometer. When the relevant
class is heavy duty, the emissions shall be generated on a heavy-duty
engine operated on an engine dynamometer. In both cases, the vehicle or
engine model shall be selected as described in paragraph (a) of this
section and shall have all applicable fuel and emission control systems
intact.
(2) Except as provided in Sec. 79.51(h)(2)(iii), the fuel or
additive/base fuel mixture being tested shall be used at all times
during operation of the test vehicle or engine. No other fuels or
additives shall be used in the test vehicle or engine once mileage
accumulation has begun until emission generation for emission
characterization and biological testing purposes is completed.
(3) Scheduled and unscheduled vehicle/engine maintenance.
(i) During emission generation, vehicles and engines must be
maintained in good condition by following the recommendations of the
original equipment manufacturer (OEM) for scheduled service and parts
replacement, with repairs performed only as necessary. Modifications,
adjustments, and maintenance procedures contrary to procedures found in
40 CFR part 86 for the maintenance of test vehicles/engines or
performed solely for the purpose of emissions improvement are not
allowed.
(ii) If unscheduled maintenance becomes necessary, the vehicle or
engine must be repaired to OEM specifications, using OEM or OEM-
approved parts. In addition, the tester is required to measure the
basic emissions pursuant to Sec. 79.52(b)(2)(i) after the unscheduled
maintenance and before resuming testing to ensure that the post-
maintenance emissions shall be within 20 percent of pre-maintenance
emissions levels. If the basic emissions cannot be brought within 20
percent of their previous levels, then the manufacturer shall restart
the emissions characterization and health testing of its products
combustion emissions using a new vehicle/engine.
(c) Mileage accumulation. (1) A vehicle/engine break-in period is
required prior to generating emissions for characterization and/or
biological testing under this subpart. The required mileage
accumulation may be accomplished on a test track, on the street, on a
dynamometer, or using any other conventionally accepted method.
(2) Vehicles to be used in the evaluation of baseline and non-
baseline fuels and fuel additives shall accumulate 4,000 miles prior to
emission testing. Engines to be used in the evaluation of baseline and
non-baseline fuels and fuel additives shall accumulate 125 hours of
operation on an engine dynamometer prior to emission testing.
(3) When the test formulation is classified as an atypical fuel or
fuel additive formulation (pursuant to definitions in
Sec. 79.56(e)(4)(iii)), the following additional mileage accumulation
requirements apply:
(i) The test vehicle/engine must be operated for a minimum of 4,000
vehicle miles or 125 hours of engine operation.
(ii) Thereafter, at intervals determined by the tester, all
emission fractions (i.e., vapor, semi-volatile, and particulate) shall
be sampled and analyzed for the presence and amount of the atypical
element(s) and/or other atypical constituents. Pursuant to paragraph
(d) of this section, the sampled emissions must be generated in the
absence of an intact aftertreatment device. Immediately before the
samples are taken, a brief warmup period (at least ten miles or the
engine equivalent) is required.
(iii) Mileage accumulation shall continue until either 50 percent
or more of the mass of each atypical element (or other atypical
constituent) entering the engine can be measured in the exhaust
emissions (all fractions combined), or the vehicle/engine has
accumulated mileage (or hours) equivalent to 40 percent of the average
useful life of the applicable vehicle/engine class (pursuant to
regulations in 40 CFR part 86). For example, the maximum mileage
required for light-duty vehicles is 40 percent of 100,000 miles (i.e.,
40,000 miles), while the maximum time of operation for heavy-duty
engines is the equivalent of 40 percent of 290,000 miles (i.e., the
equivalent in engine hours of 116,000 miles).
(iv) When either condition in paragraph (c)(3)(iii) of this section
has been reached, additional emission characterization and biological
testing of the emissions may begin.
(d) Use of exhaust aftertreatment devices. (1) If the selected test
vehicle/engine, as certified by EPA, does not come equipped with an
emissions aftertreatment device (such as a catalyst or particulate
trap), such device shall not be used in the context of this program.
(2) Except as provided in paragraph (d)(3) of this section for
certain specialized additives, the following provisions apply when the
test vehicle/engine, as certified by EPA, comes equipped with an
emissions aftertreatment device.
(i) For mileage accumulation:
(A) When the test formulation does not contain any atypical
elements (pursuant to definitions in Sec. 79.56(e)(4)(iii)), an intact
aftertreatment device must be used during mileage accumulation.
(B) When the test formulation does contain atypical elements, then
the manufacturer may choose to accumulate the required mileage using a
vehicle/engine equipped with either an intact aftertreatment device or
with a non-functional aftertreatment device (e.g., a blank catalyst
without its catalytic wash coat). In either case, sampling and analysis
of emissions for measurement of the mass of the atypical element(s) (as
described in Sec. 79.57(c)(3)) must be done on emissions generated with
a non-functional (blank) aftertreatment device.
(1) If the manufacturer chooses to accumulate mileage without a
functional aftertreatment device, and if the manufacturer wishes to do
this outside of a laboratory/test track setting, then a memorandum of
exemption for product testing must be obtained by applying to the
Director of the Field Operations and Support Division (see
Sec. 79.59(a)(1)).
(2) [reserved]
(ii) For Tier 1 (Sec. 79.52), the total set of requirements for the
characterization of combustion emissions (Sec. 79.52(b)) must be
completed two times, once using emissions generated with the
aftertreatment device intact and a second time with the aftertreatment
device rendered nonfunctional or replaced with a non-functional
aftertreatment device as described in paragraph (d)(2)(i)(B) of this
section.
(iii) For Tier 2 (Sec. 79.53), the standard requirements for
biological testing of combustion emissions shall be conducted using
emissions generated with a non-functioning aftertreatment device as
described in paragraph (d)(2)(i)(B) of this section.
(iv) For alternative Tier 2 requirements (Sec. 79.58(c)) or Tier 3
requirements (Sec. 79.54) which may be prescribed by EPA, the use of
functional or nonfunctional aftertreatment devices shall be specified
by EPA as part of the test guidelines.
(v) In the case where an intact aftertreatment device is not in
place, all other manufacturer-specified combustion characteristics
(e.g., back pressure, residence time, and mixing characteristics) of
the altered vehicle/engine shall be retained to the greatest extent
possible.
(3) Notwithstanding paragraphs (d)(1) and (d)(2) of this section,
when the subject of testing is a fuel additive specifically intended to
enhance the effectiveness of exhaust aftertreatment devices, the
related aftertreatment device may be used on the emission generation
vehicle/engine during all mileage accumulation and testing.
(e) Generation of combustion emissions--
(1) Generating combustion emissions for emission characterization.
(i) Combustion emissions shall be generated according to the exhaust
emission portion of the Federal Test Procedure (FTP) for the
certification of new motor vehicles, found in 40 CFR part 86, subpart B
for light-duty vehicles/engines, and subparts D, M and N for heavy-duty
vehicles/engines. The Urban Dynamometer Driving Schedule (UDDS),
pursuant to 40 CFR part 86, appendix I(a), shall apply to light-duty
vehicles/engines and the Engine Dynamometer Driving Schedule (EDS),
pursuant to 40 CFR part 86, appendix I(f)(2), shall apply to heavy-duty
vehicles/engines. The motoring portion of the heavy-duty test cycle may
be eliminated, at the manufacturer's option, for the generation of
emissions.
(A) For light-duty engines operated on an engine dynamometer, the
tester shall determine the speed-torque equivalencies (``trace'') for
its test engine from valid FTP testing performed on a chassis
dynamometer, using a test vehicle with an engine identical to that
being tested. The test engine must then be operated under these speed
and torque specifications to simulate the FTP cycle.
(B) Special procedures not included in the FTP may be necessary in
order to characterize emissions from fuels and fuel additives
containing atypical elements or to collect some types of emissions
(e.g., particulate emissions from light-duty vehicles/engines, semi-
volatile emissions from both light-duty and heavy-duty vehicles/
engines). Such alterations to the FTP are acceptable.
(ii) Pursuant to Sec. 79.52(b)(1)(i) and Sec. 79.57(d)(2)(ii),
emission generation and characterization must be repeated three times
when the selected vehicle/engine is normally operated without an
emissions aftertreatment device and six times when the selected
vehicle/engine is normally operated with an emissions aftertreatment
device. In the latter case, the emission generation and
characterization process shall be repeated three times with the intact
aftertreatment device in place and three times with a non-functioning
(blank) aftertreatment device in place.
(iii) From both light-duty and heavy-duty vehicles/engines, samples
of vapor phase, semi-volatile phase, and particulate phase emissions
shall be collected, except that semi-volatile phase, and particulate
emissions need not be sampled for fuels and additives in the methane
and propane families (pursuant to Sec. 79.56(e)(1)(v) and (vi)). The
number and type of samples to be collected and separately analyzed
during one emission generation/characterization process are as follows:
(A) In the case of combustion emissions generated from light-duty
vehicles/engines, the samples consist of three bags of vapor emissions
(one from each segment of the light-duty exhaust emission cycle) plus
one sample of particulate-phase emissions and one sample of semi-
volatile-phase emissions (collected over all segments of the exhaust
emission cycle). If the mass of particulate emissions or semi-volatile
emissions obtained during one driving cycle is not sufficient for
characterization, then the driving cycle may be performed again and the
extracted fractions combined prior to chemical analysis. Particulate-
phase emissions shall not be combined with semi-volatile-phase
emissions.
(B) In the case of combustion emissions generated from heavy-duty
engines, the samples consist of one sample of each emission phase
(vapor, particulate, and semi-volatile) collected over the entire cold-
start cycle and a second sample of each such phase collected over the
entire hot-start cycle (see 40 CFR 86.334 through 86.342).
(iv) Emission collection and storage. (A) Vapor phase emissions
shall be collected and stored in Tedlar bags for subsequent chemical
analysis. Storage conditions are specified in Sec. 79.52(b)(2).
(B) Particulate phase emissions shall be collected on a particulate
filter (or more than one, if required) using methods described in 40
CFR 86.1301 through 86.1344. These methods, ordinarily applied only to
heavy-duty emissions, are to be adapted and used for collection of
particulates from light-duty vehicles/engines, as well. The particulate
matter may be stored on the filter in a sealed container, or the
soluble organic fraction may be extracted and stored in a separate
sealed container. Both the particulate and the extract shall be
shielded from ultraviolet light and stored at -20 deg.C or less.
Particulate emissions shall be tested no later than six months from the
date they were generated.
(C) Semi-volatile emissions shall be collected immediately
downstream from the particulate collection filters using porous polymer
resin beds, or their equivalent, designed for their capture. The
soluble organic fraction of semi-volatile emissions shall be extracted
immediately and tested within six months of being generated. The
extract shall be stored in a sealed container which is shielded from
ultraviolet light and stored at -20 deg.C or less.
(D) Particulate and semi-volatile phase emission collection,
handling and extraction methods shall not alter the composition of the
collected material, to the extent possible.
(v) Additional requirements for combustion emission sampling,
storage, and characterization are specified in Sec. 79.52(b).
(2) Generating whole combustion emissions for biological testing.
(i) Biological tests requiring whole combustion emissions shall be
conducted using emissions generated from the test vehicle or engine
operated in general accordance with the FTP procedures cited in this
section. The emissions shall be generated continuously throughout the
animal exposure periods, diluted by an amount appropriate for the test
being performed as specified in Sec. 79.61(d)(3), passed through a
mixing chamber, and routed to the biological test chamber.
(ii) Light-duty test vehicles/engines shall be operated over the
Urban Dynamometer Driving Schedule (or equivalent engine dynamometer
trace, per paragraph (e)(1)(i)(A) of this section) and heavy-duty test
engines shall be operated over the Engine Dynamometer Schedule (see 40
CFR part 86, appendix I).
(A) The tolerances of the driving cycle shall be two times those of
the Federal Test Procedure and must be met 95 percent of the time.
(B) The driving cycle shall be repeated as many times as required
for the biological test session.
(C) Light-duty dynamometers shall be calibrated prior to the start
of a biological test (40 CFR 86.118-78), verified weekly (40 CFR
86.118-78), and recalibrated as required. Heavy-duty dynamometers shall
be calibrated and checked prior to the start of a biological test (40
CFR 86.1318-84), recalibrated every two weeks (40 CFR 86.1318-84(a))
and checked as stated in 40 CFR 86.1318-84(b) and (c).
(D) The fuel reservoir for the test vehicle/engine shall be large
enough to operate the test vehicle/engine throughout the daily
biological exposure period, avoiding the need for refueling during
testing.
(iii) An apparatus to integrate the large concentration swings
typical of transient-cycle exhaust is to be used between the FTP-
Constant Volume Sampler (CVS) source of emissions and the exposure
chamber containing the animal test cage(s). The purpose of such
apparatus is to decrease the variability of the biological exposure
atmosphere.
(A) A large mixing chamber is suggested for this purpose. The
mixing chamber would be charged from the CVS at a constant rate
determined by the exposure chamber purge rate. Flow to the exposure
chamber would begin at the conclusion of the initial transient cycle
with the associated mixing chamber charge.
(B) A potential alternative apparatus is a mini-diluter (see, for
example, AIGER/CRADA, February, 1994 in Sec. 79.57(g)).
(C) The mixing chamber (or any alternative emission moderation
apparatus) must function such that the average concentration of total
hydrocarbons leaving the apparatus shall be within 10 percent of the
average concentration of hydrocarbons entering the chamber.
(iv) Emission dilution. (A) Dilution air can be pre-dried to lower
the relative humidity, thus permitting a lower dilution rate and a
higher concentration of hydrocarbons to be achieved without
condensation of water vapor.
(B) With gasoline fuels, a minimum dilution ratio of about 1:5 raw
exhaust (dewpoint about 125 deg.F) with dry, clean filtered air is
required to reduce the water concentration to a dewpoint of about 68
deg.F. The minimum dilution ratio (maximum exhaust flow rate) occurs at
about 200 seconds into the UDDS transient driving cycle. Larger minimum
dilution ratios are required if the dilution air includes water vapor.
However, the minimum dilution ratio will vary with fuel composition.
Fuels which generate greater engine exhaust water concentrations (e.g.,
alcohol and natural gas fuels) will require greater initial dilutions.
Heated transfer ducts or tubing can be used to avoid water condensation
in much of the system, but the mixing chamber described in paragraph
(e)(2)(iii) of this section will generally be at or near laboratory
temperature, and CVS dilution will have to be adequate to assure that
the cumulative dew point in the chamber remains below laboratory
temperature at all times (further guidance on this topic may be found
in Black and Snow, 1994 in Sec. 79.57(g)).
(C) After the initial exhaust dilution to preserve the character of
the exhaust, the exhaust stream can be further diluted in the mixing
chamber (and/or after leaving the chamber) to achieve the desired
biological exposure concentrations.
(v) Verification procedures. (A) The entire system used to dilute
and transport whole combustion emissions (i.e., from exhaust pipe to
outlet in the biological testing chamber) shall be verified before any
animal exposures begin, and verified at least weekly during testing.
(See procedures at 40 CFR 86.119-90 for light-duty vehicles and
Sec. 86.1319-90 for heavy-duty engines.) Verification testing shall be
accomplished by introducing a known sample at the end of the vehicle/
engine exhaust pipe into the dilution system and measuring the amount
exiting the system. For example, an injected hydrocarbon sample could
be detected with a gas chromatograph (GC) and flame ionization detector
(FID) to determine the recovery factor.
(B) Verification of the integrity of the mixing chamber (or
alternative apparatus) shall be determined before animal exposures
begin and at least weekly thereafter. Composite values for weight
percent total hydrocarbons shall be determined for the test vehicle/
engine's dilute exhaust stream entering and exiting the mixing chamber
apparatus. These values must be within 10 percent of each other.
(vi) Emission exposure quality control. (A) The tester shall
incorporate the additional quality assurance and safety procedures
outlined in Sec. 79.61(d) to control variability of emissions during
the generation of exposure emissions during health effect testing.
(B) These procedures include requirements that the mean exposure
concentration in the inhalation test chamber shall be within 10 percent
of the target concentration (established in the developmental phase of
testing) on 90 percent or more of exposure days and that daily
monitoring of CO, CO2, NOX, SOX, and total hydrocarbons
in the exposure chamber shall be required. Analysis of the particle
size distribution shall also be performed to establish the stability
and consistency of particle size distribution in the test exposure.
(C) The testing facility shall allow an audit of its premises, the
qualifications, e.g., curriculum vitae, of its staff assigned to
testing, and the specimens and records of the testing for registration
purposes (as specified in Sec. 79.60).
(vii) In order to allow for unforeseen problems with the emission
generation or dilution equipment, emission generation may be
interrupted for up to four hours on a maximum of two occasions in any
four-week period of testing. The amount of time for which emission
generation was interrupted shall subsequently be added after the
equipment problem is corrected. If the equipment problem causes more
than four consecutive hours of emission generation to be interrupted,
or if more than two such occasions occurs in any four-week period
during testing, the interrupted tests shall be void. Testers shall be
aware of concerns for backup vehicles/engines cited in paragraph
(a)(7)(ii) of this section.
(3) Generating particulate and semi-volatile emissions for
biological testing. (i) Salmonella mutagenicity testing, pursuant to
Sec. 79.68, shall be conducted on extracts of the particulate and semi-
volatile emission phases separately. These emissions shall be generated
by operating the test vehicle/engine over the appropriate FTP driving
cycle (see paragraph (e)(2)(ii) of this section) and collected and
analyzed according to methods described in 40 CFR 86.1301 through 1344
(further information on this subject may be found in Perez, et al. CRC
Report No. 551, 1987 listed in Sec. 79.57(g)).
(A) Particulate emissions shall be collected on particulate filters
and extracted from the collection equipment for use in biological
tests. The particulate emissions from all segments of the FTP or from
multiple FTP cycles may be collected on one or more filters, as
necessary. The time spent collecting sufficient quantities of the test
substances in emissions samples 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.
(B) Semi-volatile emissions shall be collected immediately
downstream from the particulate collection filters using porous polymer
resin beds, or their equivalent, designed for their capture. Semi-
volatile phase emissions shall be collected on one apparatus. The time
spent collecting sufficient quantities of the test substances in
emissions samples 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.
(ii) The extraction method shall be determined by the
specifications of the biological test for which the emissions are used.
(iii) Particulate and semi-volatile emission storage requirements
are as specified in Sec. 79.57(e)(1)(iv).
(iv) Particulate and semi-volatile phase emission collection,
handling and extraction methods shall not alter the composition of the
collected material, to the extent possible.
(v) Particulate emissions shall not be combined with semi-volatile
phase emissions.
(f) Generation of evaporative emissions for characterization and
biological testing. (1) Except as provided in paragraph (f)(5) of this
section, an evaporative emissions generator shall be used to volatilize
samples of a fuel or additive/base fuel mixture for evaporative
emissions characterization and biological testing. Emissions shall be
collected and sampled using equipment and methods appropriate for use
with the compounds being characterized and the requirements of the
emission characterization analysis. In the case of potentially
explosive test substance concentrations, care must be taken to avoid
generating explosive atmospheres. The tester is referred to
Sec. 79.61(d)(8) for considerations involving explosivity.
(2) Evaporative Emissions Generator (EEG) Description. An EEG is a
fuel tank or vessel to which heat is applied causing a portion of the
fuel to evaporate at a desired rate. The manufacturer has flexibility
in designing an EEG for testing a particular fuel or fuel additive. The
sample used to generate emissions in the EEG shall be renewed at least
daily.
(i) The evaporation chamber shall be made from materials compatible
with the fuels and additives being tested and shall be equipped with a
drain.
(ii) The chamber shall be filled to 40 5 percent of its
interior volume with the fuel or additive/base fuel mixture being
tested, with the remainder of the volume containing air.
(iii) The concentration of the evaporated fuel or additive/base
fuel mixture in the vapor space of the evaporation chamber during the
time emissions are being withdrawn for testing shall not vary by more
than 10 percent from the equilibrium concentration in the vapor space
of emissions generated from the fresh fuel or additive/base fuel
mixture in the chamber.
(A) During the course of a day's emission generation period, the
level of fuel in the EEG shall be maintained to within 7 percent of its
height at the start of the daily exposure period.
(B) The fuel used in the EEG shall be drained at the end of each
daily exposure. The EEG shall be refilled with a fresh supply of the
test formulation before the start of each daily exposure.
(C) The vapor space of the evaporation chamber shall be well mixed
throughout the time emissions are being withdrawn for testing.
(iv) The size of the evaporation chamber shall be determined by the
rate at which evaporative emissions shall be needed in the test animal
exposure chambers and the rate at which the fuel or the additive/base
fuel mixture evaporates. The rate of evaporative emissions may be
adjusted by altering the size of the EEG or by using one or more
additional EEG(s). Emission rate modifications shall not be adjusted by
temperature control or pressure control.
(v) The temperature of the fuel or additive/base fuel mixture in
the evaporation chamber shall be 130 deg.F5 deg.F. The
vapors shall maintain this temperature up to the point in the system
where the vapors are diluted.
(vi) The pressure in the vapor space of the evaporation chamber and
the dilution and sampling apparatus shall stay within 10 percent of
ambient atmospheric pressure.
(vii) There shall be no controls or equipment on the evaporation
chamber system that change the concentration or composition of the
vapors generated for testing.
(viii) Manufacturers shall perform verification testing of
evaporative emissions in a manner analogous to the verification testing
performed for combustion emissions.
(3) For biological testing, vapor shall be withdrawn from the EEG
at a constant rate, diluted with air as required for the particular
study, and conducted immediately to the biological testing chamber(s)
in a manner similar to the method used in Sec. 79.57(e), excluding the
mixing chamber therein. The rate of emission generation shall be high
enough to supply the biological exposure chamber with sufficient
emissions to allow for a minimum of fifteen air changes per exposure
chamber per hour. Interruption of evaporative emissions exposures
during biological testing for more than four consecutive hours, or on
more than two separate occasions within a four-week period for less
than four consecutive hours, shall cause the affected test(s) to be
void.
(4) For characterization of evaporative emissions, samples of
equilibrated emissions to the vapor space of the EEG shall be withdrawn
into Tedlar bags, then stored and analyzed as specified in
Sec. 79.52(b).
(5) A manufacturer (or group of manufacturers) may submit to EPA a
request for approval of an alternative method of generating evaporative
emissions for use in emission characterization and biological tests
required under this subpart.
(i) To be approved by EPA, the request must fully explain the
rationale for the proposed method as well as the technical procedures,
quality control, and safety precautions to be used, and must
demonstrate that the proposed method will meet the following criteria:
(A) The emission mixture generated by the proposed procedures must
be reasonably similar to the equilibrium composition of the vapor which
occurs in the vehicle fuel tank head space when the subject fuel or
additive/base fuel mixture is in use and near-maximum in-use
temperatures are encountered.
(B) The emissions mixture generated by the proposed method must be
sufficiently concentrated to provide adequate exposure levels in the
context of the required toxicologic tests.
(C) The proposed method must include procedures to ensure that the
emissions delivered to the biologic exposure chambers will provide a
reasonably constant exposure atmosphere over time.
(ii) If EPA approves the request, EPA will place in the public
record a copy of the request, together with all supporting procedural
descriptions and justifications, and will notify the public of its
availability by publishing a notice in the Federal Register.
(g) References. For additional background information on the
emission generation procedures outlined in this paragraph (g), the
following references may be consulted. Additional references can be
found in Sec. 79.61(f).
(1) AIGER/CRADA (American Industry/Government Emissions Research
Cooperative Research and Development Agreement, ``Specifications for
Advanced Emissions Test Instrumentation'' AIGER PD-94-1, Revision 5.0,
February, 1994
(2) Black, F. and R. Snow, ``Constant Volume Sampling System Water
Condensation'' SAE #940970 in ``Testing and Instrumentation'' SP-1039,
Society of Automotive Engineers, Feb. 28-Mar. 3, 1994.
(3) Perez, J.M., Jass, R.E., Leddy, D.G., eds. ``Chemical Methods
for the Measurement of Unregulated Diesel Emissions (CRC-APRAC Project
No. CAPI-1-64), Coordinating Research Council, CRC Report No. 551,
August, 1987.
(4) Phalen, R.F., ``Inhalation Studies: Foundations and
Techniques'', CRC Press, Inc., Boca Raton, Florida, 1984.
Sec. 79.58 Special provisions.
(a) Relabeled Additives. Sellers of relabeled additives (pursuant
to Sec. 79.50) are not required to comply with the provisions of
Secs. 79.52, 79.53 or 79.59, except that such sellers are required to
comply with Sec. 79.59(b).
(b) Low Vapor Pressure Fuels and Additives. Fuels which are not
designated as ``evaporative fuels'' and fuel additives which are not
designated as ``evaporative fuel additives'' pursuant to the
definitions in Sec. 79.50 need not undergo the emission
characterization or health effects testing specified in Secs. 79.52 and
79.53 for evaporative emissions. At EPA's discretion, the evaporative
emissions of such fuels and additives may be required to undergo Tier 3
testing, pursuant to Sec. 79.54.
(c) Alternative Tier 2 Provisions. At EPA's discretion, EPA may
modify the standard Tier 2 health effects testing requirements for a
fuel or fuel additive (or group). Such modification may encompass
substitution, addition, or deletion of Tier 2 studies or study
specifications, and/or changes in underlying engine or equipment
requirements, except that a Tier 2 endpoint will not be deleted in the
absence of existing information deemed adequate by EPA or alternative
testing requirements for such endpoint. If warranted by the particular
requirements, EPA will allow additional time for completion of the
alternative Tier 2 testing program.
(1) When EPA intends to require testing in lieu of or in addition
to standard Tier 2 health testing, EPA will notify the responsible
manufacturer (or group) by certified letter of the specific tests which
EPA is proposing to require in lieu of or in addition to Tier 2, and
the proposed schedule for completion and submission of such tests. A
copy of the letter will be placed in the public record. EPA intends to
send the notification prior to November 27, 1995, or in the case of new
fuels and additives (as defined in Sec. 79.51(c)(3)), within 18 months
of EPA's receipt of an intent to register such product. However, EPA's
notification to the manufacturer (or group) may occur at any time up to
EPA's receipt of Tier 2 data for the product(s) in question. EPA will
provide the manufacturer with 60 days from the date of receipt of the
notice to comment on the tests which EPA is proposing to require and on
the proposed schedule. If the manufacturer believes that undue costs or
hardships will occur as a result of EPA's delay in providing
notification of alternative Tier 2 requirements, then the
manufacturer's comments should describe and include evidence of such
hardship. In particular, if the standard Tier 2 toxicology testing for
the fuel or additive in question has already begun at the time the
manufacturer receives EPA's notification of proposed alternative Tier 2
requirements, then EPA shall refrain from requiring alternative Tier 2
tests provided that EPA receives the standard Tier 2 data and report
(pursuant to Sec. 79.59(c)) within one year of the date on which the
toxicology testing began.
(2) EPA will issue a notice in the Federal Register announcing its
intent to require special testing in lieu of or in addition to the
standard Tier 2 testing for a particular fuel or additive manufacturer
or group, and that a copy of the letter to the manufacturer or group
describing the proposed alternative Tier 2 testing for that
manufacturer or group is available in the public record for review and
comment. The public shall have a minimum of 30 days after the
publication of this notice to comment on the proposed alternative Tier
2 testing.
(3) EPA will include in the public record a copy of any timely
comments concerning the proposed alternative Tier 2 testing
requirements received from the affected manufacturer or group or from
the public, and the responses of EPA to such comments. After reviewing
all such comments received, EPA may adopt final alternative Tier 2
requirements by sending a certified letter describing such final
requirements to the manufacturer or group. In that event, EPA will also
issue a notice in the Federal Register announcing that it has adopted
final alternative Tier 2 requirements and that a copy of the letter
adopting the requirements has been included in the public record.
(4) After EPA's receipt of a manufacturer's (or group's)
submittals, EPA will notify the responsible manufacturer (or group)
regarding the adequacy of the submittal and potential Tier 3 testing
requirements according to the same relative time intervals and by the
same procedures as specified in Sec. 79.51 (c) and (d) for routine Tier
1 and Tier 2 submittals.
(d) Small Business Provisions. (1) For purposes of these
provisions, when subsidiary, divisional, or other complex business
arrangements exist, manufacturer is defined as the business entity with
ultimate ownership of all related parents, subsidiaries, divisions,
branches, or other operating units. Total annual sales means the
average of the manufacturer's total sales revenue in each of the three
years prior to such manufacturer's submittal to EPA of the basic
registration information pursuant to Sec. 79.59 (b)(2) through (b)(5).
(2) Provisions Applicable to Baseline and Non-baseline Products. A
manufacturer with total annual sales less than $50 million is not
required to meet the requirements of Tier 1 and Tier 2 (specified in
Secs. 79.52 and 79.53) with regard to such manufacturer's fuel and/or
additive products which meet the criteria for inclusion in a Baseline
or Non-baseline group pursuant to Sec. 79.56. Upon such manufacturer's
satisfactory completion and submittal to EPA of basic registration data
specified in Sec. 79.59(b), the manufacturer may request and EPA shall
issue a registration for such product, subject to Sec. 79.51(c) and
paragraphs (d)(4) and (d)(5) of this section.
(3) Provisions Applicable to Atypical Products. A manufacturer with
total annual sales less than $10 million is not required to meet the
requirements of Tier 2 (specified in Sec. 79.53) in regard to such
manufacturer's fuel and/or additive products which meet the criteria
for inclusion in an Atypical group pursuant to Sec. 79.56. Upon such
manufacturer's satisfactory completion and submittal to EPA of basic
registration data specified in Sec. 79.59(b) and Tier 1 information
specified in Sec. 79.52 for an Atypical fuel or additive, the
manufacturer may request and EPA shall issue a registration for such
product, subject to Sec. 79.51(c) and paragraphs (d)(4) and (d)(5) of
this section. Compliance with Tier 1 requirements under this paragraph
may be accomplished by the individual manufacturer or as a part of a
group pursuant to Sec. 79.56.
(4) Any registration granted by EPA under the provisions of this
section are conditional upon satisfactory completion of any Tier 3
requirements which EPA may subsequently impose pursuant to Sec. 79.54.
In such circumstances, the Tier 3 requirements might include (but would
not necessarily be limited to) information which would otherwise have
been required under the provisions of Tier 1 and/or Tier 2.
(5) The provisions in paragraphs (d)(2) and (d)(3) of this section
are voluntary on the part of qualifying small manufacturers. Such
manufacturers may choose to fulfill the standard requirements for their
fuels and additives, individually or as a part of a group, rather than
satisfying only the requirements specified in paragraphs (d)(2) and/or
(d)(3) of this section. If a qualifying small manufacturer elects these
special provisions rather than the standard requirements for a product,
then EPA will generally assume that any additional information
submitted by other manufacturers, for fuels and additives meeting the
same grouping criteria (under Sec. 79.56) as that of the small
manufacturer's product, is pertinent to further testing and/or
regulatory decisions that may affect the small manufacturer's product.
(e) Aftermarket Aerosol Additives. (1) To obtain registration for
an aftermarket aerosol fuel additive, the manufacturer shall provide
existing information in the form of a literature search, a discussion
of the potential exposure(s) to such product, and the basic
registration data specified in Sec. 79.59(b).
(2) The literature search shall include existing data on potential
health and welfare effects due to exposure to the aerosol product
itself and its raw (uncombusted) components. The analysis for potential
exposures shall be based on the actual or anticipated production volume
and market distribution of the particular aerosol product, and its
estimated frequency of use. Other Tier 1 and Tier 2 requirements are
not routinely required for aerosol products. EPA will review the
submitted information and, at EPA's discretion, may require from the
manufacturer further information and/or testing under Tier 3 on a case-
by-case basis.
Sec. 79.59 Reporting requirements.
(a) Timing. (1) The manufacturer of each designated fuel or fuel
additive shall submit to EPA the basic registration data detailed in
paragraph (b) of this section. Forms for submitting this data may be
obtained from EPA at the following address: Director, Field Operations
and Support Division, 6406J--Fuel/Additives Registration, U.S.
Environmental Protection Agency, 401 M Street, S.W., Washington, DC
20460.
(i) For existing products (pursuant to Sec. 79.51(c)(1)),
manufacturers shall submit the basic registration data as specified in
Sec. 79.59(b) to EPA by November 28, 1994.
(ii) For registrable products (pursuant to Sec. 79.51(c)(2)),
manufacturers shall submit the basic registration data as specified in
Sec. 79.59(b) to apply for registration for such product.
(iii) For new products (pursuant to Sec. 79.51(c)(3)),
manufacturers are strongly encouraged to notify EPA of an intent to
obtain product registration by submitting the basic registration data
as specified in Sec. 79.59(b) prior to starting Tiers 1 and 2.
(2) The information specified in paragraph (c) of this section
shall be submitted to the address in paragraph (a)(1) of this section
at the conclusion of activities performed in compliance with Tiers 1
and 2 under the provisions of Secs. 79.52 and 79.53, according to the
time constraints specified in Sec. 79.51 (c) through (d).
(3) The information specified in paragraph (d) of this section
shall be submitted to EPA at the address in paragraph (a)(1) of this
section at the conclusion of activities performed in compliance with
Tier 3 under the provisions of Sec. 79.54.
(b) Basic Registration Data. Each manufacturer of a designated fuel
or fuel additive shall submit the following data in regard to such fuel
or fuel additive:
(1) The information specified in Sec. 79.11 or Sec. 79.21. If such
information has already been submitted to EPA in compliance with
subpart B or C of this part, and if such previous information is
accurate and up-to-date, the manufacturer need not resubmit this
information.
(2) Annual production volume of the fuel or fuel additive product,
in units of gallons per year if most commonly sold in liquid form or
kilograms per year if most commonly sold in solid form. For fuels and
fuel additives already in production, the most recent annual production
volume and the volume projected to be produced in the third subsequent
year shall be provided. For products not yet in production, the best
estimate of expected annual volume during the third year of production
shall be provided.
(3) Market distribution of the product. For fuels and bulk
additives, this information shall be presented as the percent of total
annual sales volume marketed in each Petroleum Administration for
Defense District (PADD). The states comprising each PADD are listed in
the following section. For aftermarket additives, the distribution data
shall be presented as the percent of total annual sales volume marketed
in each state. For a product not yet in production, the manufacturer
shall present the distribution (by PADD or state, as applicable)
projected to occur during the third year of production.
(i) The following states and jurisdictions are included in PADD I:
Connecticut
Delaware
District of Columbia
Florida
Georgia
Maine
Maryland
Massachusetts
New Hampshire
New Jersey
New York
North Carolina
Pennsylvania
Rhode Island
South Carolina
Vermont
Virginia
West Virginia
(ii) The following states are included in PADD II:
Illinois
Indiana
Iowa
Kansas
Kentucky
Michigan
Minnesota
Missouri
Nebraska
North Dakota
Ohio
Oklahoma
South Dakota
Tennessee
Wisconsin
(iii) The following states are included in PADD III:
Alabama
Arkansas
Louisiana
Mississippi
New Mexico
Texas
(iv) The following states are included in PADD IV:
Colorado
Idaho
Montana
Utah
Wyoming
(v) The following states are included in PADD V:
Alaska
Arizona
California
Hawaii
Nevada
Oregon
Washington
(4) Any applicable information pursuant to the grouping provisions
in Sec. 79.56, as follows:
(i) If the manufacturer has enrolled or intends to enroll the
product in a fuel/additive group, the relevant group and the person(s)
or entity expected to submit information on behalf of the group must be
identified.
(ii) If the manufacturer intends to rely on registration
information previously submitted by another manufacturer (or group) for
registration of other product(s) in the same fuel/additive group, then
the original submitter and its product (or product group) shall be
identified. In such cases, the manufacturer shall provide evidence that
the original submitter has been notified of the use of its registration
data and that the manufacturer has complied or intends to comply with
the proportional reimbursement required under Sec. 79.56(c) of this
rule.
(5) Any applicable information pursuant to the special provisions
in Sec. 79.58, as follows:
(i) If the manufacturer claims applicability of the special
provisions for relabeled additives, pursuant to Sec. 79.58(a), then the
manufacturer and brand name of the original product shall be given.
(ii) If the manufacturer claims applicability of any small business
provisions pursuant to Sec. 79.58(d), the average of the manufacturer's
total annual sales revenue for the previous three years shall be given.
(iii) If the manufacturer claims applicability of the special
provisions for aerosol products, pursuant to Sec. 79.58(e), then the
purpose and recommended frequency of use shall be given.
(c) Tier 1 and Tier 2 Reports. If the results of Tiers 1 and 2 are
reported to EPA at the same time, then the report shall include the
following documents in paragraphs (c)(1) through (7) of this section.
If Tier 1 and Tier 2 results are submitted to EPA separately, then the
separate Tier 1 report shall include only documents in paragraphs
(c)(1) through (4), (c)(6), and associated appendices in paragraphs
(c)(7) of this section, and the separate Tier 2 report shall include
only documents in paragraphs (c)(1) through (3), (c)(5), (c)(6), and
associated appendices in paragrpah (c)(7) of this section. In addition,
pursuant to the requirements in Sec. 79.51(c)(1)(ii)(B), if the Tier 2
report for registered fuels and fuel additives is not submitted prior
to May 27, 1997, then evidence of a suitable arrangement for completion
of Tier 2 (e.g., a copy of a signed contract with a qualified
laboratory for applicable Tier 2 services) must be submitted to EPA
prior to that date.
(1) Cover page. (i) Identification of test substance,
(ii) Name and address of the manufacturer of the test substance,
(iii) Name and phone number of a designated contact person,
(iv) Group information, if applicable, including:
(A) Group name or grouping criteria,
(B) Name and address of responsible organization or entity
reporting for the group,
(C) Product trade name and manufacturer of each member fuel and
additive to which the report pertains.
(2) Executive Summary. Text overview of the significant results and
conclusions obtained as a result of completing the requirements of Tier
1 and/or Tier 2, including references if used to support such results
and conclusions.
(3) Test Substance Information. Test substance description,
including, as applicable,
(i) Base fuel parameter values (including types and concentrations
of base fuel additives) or test fuel composition (if a fuel other than
the base fuel is used in testing). These values must be provided for
each of the fuel parameters specified in Sec. 79.55 for the applicable
fuel family.
(ii) Test additive composition and concentration
(4) Summary of Tier 1 (i) Literature Search. Pursuant to
Sec. 79.52(d), the literature search shall include a text summary of
the methods and results of the literature search, including the
following:
(A) Identification of person(s) performing the literature search,
(B) Description of data sources accessed, search strategy used,
search period, and terms included in literature search,
(C) Documentation of all unpublished in-house and other privately-
conducted studies,
(D) Tables summarizing the protocols and results of all cited
studies,
(E) Summary of significant results and conclusions with respect to
the effects of the emissions of the subject fuel or fuel additive on
the public health and welfare, including references if used to support
such results and conclusions.
(F) Statement of the extent to which the literature search has
produced adequate information comparable to that which would otherwise
be obtained through the performance of applicable emission
characterization requirements under Sec. 79.52(b) and/or health effects
testing requirements under Sec. 79.53, including justifications and
specific references.
(ii) Emission Characterization. Pursuant to Sec. 79.52(b), the
emission characterization shall include:
(A) Name, address, and telephone number of the laboratory
performing the characterization,
(B) Name and description of analytic methods used for
characterization.
(iii) Exposure Analysis. Pursuant to Sec. 79.52(c), the exposure
analysis shall include:
(A) A qualitative discussion of the potential exposure(s) of the
general and any special at-risk populations to the emission products,
based on annual and projected production volume, and market
distribution data. For group submittals, this discussion shall address
the characteristics of the cumulative exposure from the potential use
of all fuel or additive products in the group.
(B) Identification of person(s) preparing the analysis.
(5) Summary of Tier 2. For each health effects test performed
pursuant to the provisions of Sec. 79.53, the Tier 2 summary shall
contain the following information:
(i) Name, address, and telephone number of the testing facility,
(ii) Summary of procedures (including quality assurance, quality
control and compliance with Good Laboratory Practice Standards as
specified in Sec. 79.60), findings, and conclusions, including
references if used to support such results and conclusions,
(iii) Description of any problems and their resolution.
(6) Conclusions. The conclusions shall identify the need for
further testing, if that need exists, or justify that current testing
and/or available information is adequate for the tier(s) included in
the report.
(7) Appendices. The appendices shall contain detailed documentation
related to the summary information described in this section,
including, at a minimum, the following five appendices:
(i) Literature search appendices shall contain:
(A) Copies of literature source outputs, including reference lists
and associated abstracts from database searches, printed or on 3\1/2\
inch IBM-compatible computer diskettes;
(B) Summary tables organized by health or welfare endpoint and type
of emission (e.g., combustion, evaporation, individual emission
product), presenting in tabular form the following information at a
minimum: number and species of test subjects, exposure concentrations/
duration, positive (i.e., abnormal) findings including numbers of test
subjects involved, and bibliographic references;
(C) Complete documentation and/or reprints of articles for any
previous study relied upon for satisfying emission characterization
and/or Tier 2 test requirements; and
(D) Full reports for unpublished/in-house studies.
(ii) Emissions characterization appendices shall contain:
(A) Complete laboratory reports, including documentation of
calibration and verification procedures;
(B) Documentation of the emissions generation procedures used; and
(C) Lists of speciated emission products and their emission rates
reported in units of grams/mile.
(iii) Exposure analysis appendices may be submitted to report any
detailed documentation of data used in the analyses and/or calculations
determining potential exposures to population(s). If modeling data are
used, these should be included in an appendix.
(iv) Tier 2 appendices shall contain, for each test performed:
(A) Complete protocol used;
(B) Documentation of emission generation procedures; and
(C) Complete laboratory report in compliance with the reporting
standards in Sec. 79.60, including detailed test results and
conclusions, and descriptions of any problems encountered and their
resolution.
(v) Laboratory certification/accreditation information, personnel
credentials, and statements of compliance with the Good Laboratory
Practices Standards specified in Sec. 79.60 and the requirements in
Sec. 79.53(c)(1).
(d) Tier 3 Report. Subject to applicability as specified in
Sec. 79.54, each manufacturer of a designated fuel or fuel additive, or
each group of such manufacturers pursuant to the provisions of
Sec. 79.56, shall submit the following information with respect to each
Tier 3 test conducted for such fuels or fuel additives:
(1) The test objectives, including a summary of the reason(s) why
such additional testing, beyond Tiers 1 and 2, was required;
(2) Name, address, and telephone number of each testing facility;
(3) Summary of test procedures, results and conclusions;
(4) Complete documentation of test protocols and emission
generation procedures, complete laboratory reports in compliance with
the reporting standards of Sec. 79.60, detailed test results and
conclusions, including references if used to support such results and
conclusions, and descriptions of any problems encountered and their
resolution; and
(5) Laboratory certification information, personnel credentials,
and statements of compliance with the Good Laboratory Practices
Standards specified in Sec. 79.60.
(e) Availability of Information. (1) All health and safety test
data and other information concerning health and welfare effects which
is submitted by any manufacturer or group pursuant to Secs. 79.52(c),
79.53, or 79.54, shall be considered to be public information and shall
be made available to the public by EPA upon request. A reasonable fee
may be charged by EPA for copying such materials. Any manufacturer or
group who claims that any information concerning the composition of a
fuel or fuel additive product, or any other information, submitted
under this subpart is confidential business information must state this
claim in writing at the time of the submittal.
(2) To assert a business confidentiality claim concerning any
information submitted under this subpart, the submitter must:
(i) Clearly mark the information as confidential at each location
it appears in the submission; and
(ii) Submit with the information claimed as confidential a separate
document setting forth the claim and listing each location at which the
information appears in the submission.
(3) If any person subsequently requests access to information
submitted under this subpart (other than health and safety test data
and other information concerning health and welfare effects), and such
information is subject to a claim of business confidentiality, the
request and any subsequent disclosure shall be governed by the
provisions of 40 CFR part 2.
Sec. 79.60 Good laboratory practices (GLP) standards for inhalation
exposure health effects testing.
(a) General Provisions--(1) Scope. (i) This section prescribes good
laboratory practices (GLPs) for conducting inhalation exposure studies
relating to motor vehicle emissions health effects testing under this
part. These directions are intended to ensure the quality and integrity
of health effects data submitted pursuant to registration regulations
issued under sections 211(b) or 211(e) of the Clean Air Act (CAA) (42
U.S.C. 7545).
(ii) This section applies to any study described by paragraph
(a)(1)(i) of this section which any person conducts, initiates, or
supports on or after May 27, 1994.
(iii) It is EPA's policy that all health effects data developed
under sections 211(b) and (e) of CAA be in accordance with provisions
of this section. If data are not developed in accordance with the
provisions of this section, EPA may consider such data insufficient to
evaluate the health effects of a motor vehicle's fuel or fuel additive
emissions, unless the submitter provides additional information
demonstrating that the data are reliable and adequate and EPA
determines that the data are sufficient.
(2) Definitions. As used in this section, the following terms shall
have the meanings specified:
Batch means a specific quantity or lot of a test fuel, additive/
base fuel mixture, or reference substance that has been characterized
according to Sec. 79.60(f)(1)(i).
CAA means the Clean Air Act.
Carrier means any material which is combined with engine/motor
vehicle emissions or a reference substance for administration to a test
system. ``Carrier'' includes, but is not limited to, clean, filtered
air, water, feed, and nutrient media.
Control atmosphere means clean, filtered air which is administered
to the test system in the course of a study for the purpose of
establishing a basis for comparison with the test atmosphere for
chemical or biological measurements.
Experimental start date means the first date the test atmosphere is
applied to the test system.
Experimental termination date means the last date on which data are
collected directly from the study.
Person includes an individual, partnership, corporation,
association, scientific or academic establishment, government agency,
or organizational unit thereof, and any other legal entity.
Quality assurance unit means any person or organizational element,
except the study director, designated by testing facility management to
perform the duties relating to quality assurance of the studies.
Raw data means any laboratory worksheets, records, memoranda,
notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event
that exact transcripts of raw data have been prepared (e.g., tapes
which have been transcribed verbatim, dated, and verified accurate by
signature), the exact copy or exact transcript may be substituted for
the original source as raw data. ``Raw data'' may include photographs,
videotape, microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
automated instruments.
Reference substance means any chemical substance or mixture,
analytical standard, or material other than engine/motor vehicle
emissions and/or its carrier, that is administered to or used in
analyzing the test system in the course of a study. A ``reference
substance'' is used to establish a basis for comparison with the test
atmosphere for known chemical or biological measurements, i.e.,
positive or negative control substance.
Specimen means any material derived from a test system for
examination or analysis.
Sponsor means person who initiates and supports, by provision of
financial or other resources, a study or a person who submits a study
to EPA in response to the CAA Section 211(b) or 211(e) Fuels and Fuel
Additives Registration Rule or a testing facility, if it both initiates
and actually conducts the study.
Study means any experiment, at one or more test sites, in which a
test system is exposed to a test atmosphere under laboratory conditions
to determine or help predict the health effects of that exposure in
humans, other living organisms, or media.
Study completion date means the date the final report is signed by
the study director.
Study director means the individual responsible for the overall
conduct of a study.
Study initiation date means the date the protocol is signed by the
study director.
Test substance means a vapor and/or aerosol mixture composed of
engine/motor vehicle emissions and clean, filtered air which is
administered directly, or indirectly, by the inhalation route to a test
system in a study which develops data to meet the registration
requirements of CAA section 211(b) or (e).
Test system means any animal, microorganism, chemical or physical
matrix, to which the test, control, or reference substance is
administered or added for study. This definition also includes
appropriate groups or components of the system not treated with the
test, control, or reference substance.
Testing facility means a person who actually conducts a study,
i.e., actually uses the test substance in a test system. ``Testing
facility'' encompasses only those operational units that are being or
have been used to conduct studies.
TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et
seq.).
(3) Applicability to studies performed under grants and contracts.
When a sponsor or other person utilizes the services of a consulting
laboratory, contractor, or grantee to perform all or a part of a study
to which this section applies, it shall notify the consulting
laboratory, contractor, or grantee that the service is, or is part of,
a study that must be conducted in compliance with the provisions of
this section.
(4) Statement of compliance or non-compliance. Any person who
submits to EPA a test in compliance with registration regulations
issued under CAA section 211(b) or section 211(e) shall include in the
submission a true and correct statement, signed by the sponsor and the
study director, of one of the following types:
(i) A statement that the study was conducted in accordance with
this section; or
(ii) A statement describing in detail all differences between the
practices used in the study and those required by this section; or
(iii) A statement that the person was not a sponsor of the study,
did not conduct the study, and does not know whether the study was
conducted in accordance with this section.
(5) Inspection of a testing facility. (i) A testing facility shall
permit an authorized employee or duly designated representative of EPA,
at reasonable times and in a reasonable manner, to inspect the facility
and to inspect (and in the case of records also to copy) all records
and specimens required to be maintained regarding studies to which this
section applies. The records inspection and copying requirements shall
not apply to quality assurance unit records of findings and problems,
or to actions recommended and taken, except the EPA may seek production
of these records in litigation or formal adjudicatory hearings.
(ii) EPA will not consider reliable for purposes of showing that a
test substance does or does not present a risk of injury to health or
the environment any data developed by a testing facility or sponsor
that refuses to permit inspection in accordance with this section. The
determination that a study will not be considered reliable does not,
however, relieve the sponsor of a required test of any obligation under
any applicable statute or regulation to submit the results of the study
to EPA.
(6) Effects of non-compliance. (i) Pursuant to sections 114, 208,
and 211(d) of the CAA, it shall be a violation of this section and a
violation of this rule (40 CFR part 79, subpart F) if:
(A) The test is not being or was not conducted in accordance with
any requirement of this part; or
(B) Data or information submitted to EPA under part 79, including
the statement required by Sec. 79.60(a)(4), include information or data
that are false or misleading, contain significant omissions, or
otherwise do not fulfill the requirements of this part; or
(C) Entry in accordance with Sec. 79.60(a)(5) for the purpose of
auditing test data is denied.
(ii) EPA, at its discretion, may not consider reliable for purposes
of showing that a chemical substance or mixture does not present a risk
of injury to health any study which was not conducted in accordance
with this part. EPA, at its discretion, may rely upon such studies for
purposes of showing adverse effects. The determination that a study
will not be considered reliable does not, however, relieve the sponsor
of a required test of the obligation under any applicable statute or
regulation to submit the results of the study to EPA.
(iii) If data submitted in compliance with registration regulations
issued under CAA section 211(b) or section 211(e) are not developed in
accordance with this section, EPA may determine that the sponsor has
not fulfilled its obligations under 40 CFR part 79 and may require the
sponsor to develop data in accordance with the requirements of this
section in order to satisfy such obligations.
(b) Organization and Personnel. (1) Personnel. (i) Each individual
engaged in the conduct of or responsible for the supervision of a study
shall have education, training, and experience, or combination thereof,
to enable that individual to perform the assigned functions.
(ii) Each testing facility shall maintain a current summary of
training and experience and job description for each individual engaged
in or supervising the conduct of a study.
(iii) There shall be a sufficient number of personnel for the
timely and proper conduct of the study according to the protocol.
(iv) Personnel shall take necessary personal sanitation and health
precautions designed to avoid contamination of test fuel and additive/
base fuel mixtures, test and reference substances, and test systems.
(v) Personnel engaged in a study shall wear clothing appropriate
for the duties they perform. Such clothing shall be changed as often as
necessary to prevent microbiological, radiological, or chemical
contamination of test systems and test, control, and reference
substances.
(vi) Any individual found at any time to have an illness that may
adversely affect the quality and integrity of the study shall be
excluded from direct contact with test systems, fuel and fuel/additive
mixtures, test and reference substances and any other operation or
function that may adversely affect the study until the condition is
corrected. All personnel shall be instructed to report to their
immediate supervisors any health or medical conditions that may
reasonably be considered to have an adverse effect on a study.
(2) Testing facility management. For each study, testing facility
management shall:
(i) Designate a study director as described in Sec. 79.60(b)(3)
before the study is initiated.
(ii) Replace the study director promptly if it becomes necessary to
do so during the conduct of a study.
(iii) Assure that there is a quality assurance unit as described in
Sec. 79.60(b)(4).
(iv) Assure that test fuels and fuel/additive mixtures and test and
reference substances have been identified as to content, strength,
purity, stability, and uniformity, as applicable.
(v) Assure that personnel, resources, facilities, equipment,
materials and methodologies are available as scheduled.
(vi) Assure that personnel clearly understand the functions they
are to perform.
(vii) Assure that any deviations from these regulations reported by
the quality assurance unit are communicated to the study director and
corrective actions are taken and documented.
(3) Study director. For each study, a scientist or other
professional person with a doctorate degree or equivalent in toxicology
or other appropriate discipline shall be identified as the study
director. The study director has overall responsibility for the
technical conduct of the study, as well as for the interpretation,
analysis, documentation, and reporting of results, and represents the
single point of study control. The study director shall assure that:
(i) The protocol, including any changes, is approved as provided by
Sec. 79.60(g)(1)(i) and is followed;
(ii) All experimental data, including observations of unanticipated
responses of the test system are accurately recorded and verified;
(iii) Unforeseen circumstances that may affect the quality and
integrity of the study are noted when they occur, and corrective action
is taken and documented;
(iv) Test systems are as specified in the protocol;
(v) All applicable good laboratory practice regulations are
followed; and
(vi) All raw data, documentation, protocols, specimens, and final
reports are archived properly during or at the close of the study.
(4) Quality assurance unit. A testing facility shall have a quality
assurance unit which shall be responsible for monitoring each study to
assure management that the facilities, equipment, personnel, methods,
practices, records, and controls are in conformance with the
regulations in this section. For any given study, the quality assurance
unit shall be entirely separate from and independent of the personnel
engaged in the direction and conduct of that study. The quality
assurance unit shall conduct inspections and maintain records
appropriate to the study.
(i) Quality assurance unit duties. (A) Maintain a copy of a master
schedule sheet of all studies conducted at the testing facility indexed
by test substance and containing the test system, nature of study, date
study was initiated, current status of each study, identity of the
sponsor, and name of the study director.
(B) Maintain copies of all protocols pertaining to all studies for
which the unit is responsible.
(C) Inspect each study at intervals adequate to ensure the
integrity of the study and maintain written and properly signed records
of each periodic inspection showing the date of the inspection, the
study inspected, the phase or segment of the study inspected, the
person performing the inspection, findings and problems, action
recommended and taken to resolve existing problems, and any scheduled
date for re-inspection. Any problems which are likely to affect study
integrity found during the course of an inspection shall be brought to
the attention of the study director and management immediately.
(D) Periodically submit to management and the study director
written status reports on each study, noting any problems and the
corrective actions taken.
(E) Determine that no deviations from approved protocols or
standard operating procedures were made without proper authorization
and documentation.
(F) Review the final study report to assure that such report
accurately describes the methods and standard operating procedures, and
that the reported results accurately reflect the raw data of the study.
(G) Prepare and sign a statement to be included with the final
study report which shall specify the dates inspections were made and
findings reported to management and to the study director.
(ii) The responsibilities and procedures applicable to the quality
assurance unit, the records maintained by the quality assurance unit,
and the method of indexing such records shall be in writing and shall
be maintained. These items including inspection dates, the study
inspected, the phase or segment of the study inspected, and the name of
the individual performing the inspection shall be made available for
inspection to authorized employees or duly designated representatives
of EPA.
(iii) An authorized employee or a duly designated representative of
EPA shall have access to the written procedures established for the
inspection and may request test facility management to certify that
inspections are being implemented, performed, documented, and followed
up in accordance with this paragraph.
(c) Facilities--(1) General. Each testing facility shall be of
suitable size and construction to facilitate the proper conduct of
studies. Testing facilities which are not completely located within an
indoor controlled environment shall be of suitable location/proximity
to facilitate the proper conduct of studies. Testing facilities shall
be designed so that there is a degree of separation that will prevent
any function or activity from having an adverse effect on the study.
(2) Test system care facilities. (i) A testing facility shall have
a sufficient number of animal rooms or other test system areas, as
needed, to ensure proper separation of species or test systems,
quarantine or isolation of animals or other test systems, and routine
or specialized housing of animals or other test systems.
(ii) A testing facility shall have a number of animal rooms or
other test system areas separate from those described in paragraph (a)
of this section to ensure isolation of studies being done with test
systems or test, control, and reference substances known to be
biohazardous, including volatile atmospheres and aerosols, radioactive
materials, and infectious agents. The animal handling facility must
operate under the supervision of a veterinarian.
(iii) Separate areas shall be provided, as appropriate, for the
diagnosis, treatment, and control of laboratory test system diseases.
These areas shall provide effective isolation for the housing of test
systems either known or suspected of being diseased, or of being
carriers of disease, from other test systems.
(iv) Facilities shall have proper provisions for collection and
disposal of contaminated air, water, or other spent materials. When
animals are housed, facilities shall exist for the collection and
disposal of all animal waste and refuse or for safe sanitary storage of
waste before removal from the testing facility. Disposal facilities
shall be so provided and operated as to minimize vermin infestation,
odors, disease hazards, and environmental contamination.
(v) Facilities shall have provisions to regulate environmental
conditions (e.g., temperature, humidity, day length, etc.) as specified
in the protocol.
(3) Test system supply/operation areas. (i) There shall be storage
areas, as needed, for feed, bedding, supplies, and equipment. Storage
areas for feed and bedding shall be separated from areas where the test
systems are located and shall be protected against infestation or
contamination. Perishable supplies shall be preserved by appropriate
means.
(ii) Separate laboratory space and other space shall be provided,
as needed, for the performance of the routine and specialized
procedures required by studies.
(4) Facilities for handling test fuels and fuel/additive mixtures
and reference substances. (i) As necessary to prevent contamination or
mixups, there shall be separate areas for:
(A) Receipt and storage of the test fuels and fuel/additive
mixtures and reference substances;
(B) Mixing of the test fuels, fuel/additive mixtures, and reference
substances with a carrier, i.e., liquid hydrocarbon; and
(C) Storage of the test fuels, fuel/additive mixtures, and
reference substance/carrier mixtures.
(ii) Storage areas for test fuels and fuel/additive mixtures and
reference substances and for reference mixtures shall be separate from
areas housing the test systems and shall be adequate to preserve the
identity, strength, purity, and stability of the substances and
mixtures.
(5) Specimen and data storage facilities. Space shall be secured
for archives for the storage and retrieval of all raw data and
specimens from completed studies.
(d) Equipment--(1) Equipment design. Equipment used in the
generation, measurement, or assessment of data and equipment used for
facility environmental control shall be of appropriate design and
adequate capacity to function according to the protocol and shall be
suitably located for operation, inspection, cleaning, and maintenance.
(2) Maintenance and calibration of equipment. (i) Equipment shall
be adequately inspected, cleaned, and maintained. Equipment used for
the generation, measurement, or assessment of data shall be adequately
tested, calibrated, and/or standardized.
(ii) The written standard operating procedures required under
Sec. 79.60(e)(1)(ii)(K) shall set forth in sufficient detail the
methods, materials, and schedules to be used in the routine inspection,
cleaning, maintenance, testing, calibration, and/or standardization of
equipment, and shall specify, when appropriate, remedial action to be
taken in the event of failure or malfunction of equipment. The written
standard operating procedures shall designate the person responsible
for the performance of each operation.
(iii) Written records shall be maintained of all inspection,
maintenance, testing, calibrating, and/or standardizing operations.
These records, containing the date of the operation, shall describe
whether the maintenance operations were routine and followed the
written standard operating procedures. Written records shall be kept of
non-routine repairs performed on equipment as a result of failure and
malfunction. Such records shall document the nature of the defect, how
and when the defect was discovered, and any remedial action taken in
response to the defect.
(e) Testing Facilities Operation--(1) Standard operating
procedures. (i) A testing facility shall have standard operating
procedures in writing, setting forth study methods that management is
satisfied are adequate to insure the quality and integrity of the data
generated in the course of a study. All deviations in a study from
standard operating procedures shall be authorized by the study director
and shall be documented in the raw data. Significant changes in
established standard operating procedures shall be properly authorized
in writing by management.
(ii) Standard operating procedures shall be established for, but
not limited to, the following:
(A) Test system room preparation;
(B) Test system care;
(C) Receipt, identification, storage, handling, mixing, and method
of sampling of test fuels and fuel/additive mixtures and reference
substances;
(D) Test system observations;
(E) Laboratory or other tests;
(F) Handling of test animals found moribund or dead during study;
(G) Necropsy or postmortem examination of test animals;
(H) Collection and identification of specimens;
(I) Histopathology
(J) Data handling, storage and retrieval.
(K) Maintenance and calibration of equipment.
(L) Transfer, proper placement, and identification of test systems.
(iii) Each laboratory or other study area shall have immediately
available manuals and standard operating procedures relative to the
laboratory procedures being performed. Published literature may be used
as a supplement to standard operating procedures.
(iv) A historical file of standard operating procedures, and all
revisions thereof, including the dates of such revisions, shall be
maintained.
(2) Reagents and solutions. All reagents and solutions in the
laboratory areas shall be labeled to indicate identity, titer or
concentration, storage requirements, and expiration date. Deteriorated
or outdated reagents and solutions shall not be used.
(3) Animal and other test system care. (i) There shall be standard
operating procedures for the housing, feeding, handling, and care of
animals and other test systems.
(ii) All newly received test systems from outside sources shall be
isolated and their health status or appropriateness for the study shall
be evaluated. This evaluation shall be in accordance with acceptable
veterinary medical practice or scientific methods.
(iii) At the initiation of a study, test systems shall be free of
any disease or condition that might interfere with the purpose or
conduct of the study. If during the course of the study, the test
systems contract such a disease or condition, the diseased test systems
shall be isolated, if necessary. These test systems may be treated for
disease or signs of disease provided that such treatment does not
interfere with the study. The diagnosis, authorization of treatment,
description of treatment, and each date of treatment shall be
documented and shall be retained.
(iv) When laboratory procedures require test animals to be
manipulated and observed over an extended period of time or when
studies require test animals to be removed from and returned to their
housing units for any reason (e.g., cage cleaning, treatment, etc.),
these test systems shall receive appropriate identification (e.g.,
tattoo, color code, etc.). Test system identification shall conform
with current laboratory animal handling practice. All information
needed to specifically identify each test system within the test
system-housing unit shall appear on the outside of that unit. Suckling
animals are excluded from the requirement of individual identification
unless otherwise specified in the protocol.
(v) Except as specified in paragraph (e)(3)(v)(A) of this section,
test animals of different species shall be housed in separate rooms
when necessary. Test animals of the same species, but used in different
studies, shall not ordinarily be housed in the same room when
inadvertent exposure to the test or reference substances or test system
mixup could affect the outcome of either study. If such mixed housing
is necessary, adequate differentiation by space and identification
shall be made.
(A) Test systems that may be used in multispecies tests need not be
housed in separate rooms, provided that they are adequately segregated
to avoid mixup and cross-contamination.
(B) [reserved]
(vi) Cages, racks, pens, enclosures, and other holding, rearing,
and breeding areas, and accessory equipment, shall be cleaned and
sanitized at appropriate intervals.
(vii) Feed and water used for the test animals shall be analyzed
periodically to ensure that contaminants known to be capable of
interfering with the study and reasonably expected to be present in
such feed or water are not present at greater than trace levels.
Documentation of such analyses shall be maintained as raw data.
(viii) Bedding used in animal cages or pens shall not interfere
with the purpose or conduct of the study and shall be changed as often
as necessary to keep the animals dry and clean.
(ix) If any pest control materials are used, the use shall be
documented. Cleaning and pest control materials that interfere with the
study shall not be used.
(x) All test systems shall be acclimatized to the environmental
conditions of the test, prior to their use in a study.
(f) Test fuels, additive/base fuel mixtures, and reference
substances--(1) Test fuel, fuel/additive mixture, and reference
substance identity (i) The product brand name/service mark, strength,
purity, content, or other characteristics which appropriately define
the test fuel, fuel/additive mixture, or reference substance shall be
reported for each batch and shall be documented before its use in a
study. Methods of synthesis, fabrication, or derivation, as
appropriate, of the test fuel, fuel/additive mixture, or reference
substance shall be documented by the sponsor or the testing facility,
and such location of documentation shall be specified.
(ii) The stability of test fuel, fuel/additive mixture, and
reference substances under storage conditions at the test site shall be
known for all studies.
(2) Test fuel, additive/base fuel mixture, and reference substance
handling. Procedures shall be established for a system for the handling
of the test fuel, fuel/additive mixture, and reference substance(s) to
ensure that:
(i) There is proper storage.
(ii) Distribution is made in a manner designed to preclude the
possibility of contamination, deterioration, or damage.
(iii) Proper identification is maintained throughout the
distribution process.
(iv) The receipt and distribution of each batch is documented. Such
documentation shall include the date and quantity of each batch
distributed or returned.
(3) Mixtures of test emissions or reference solutions with
carriers.
(i) For test emissions or each reference substance mixed with a
carrier, tests by appropriate analytical methods shall be conducted:
(A) To determine the uniformity of the test substance and to
determine, periodically, the concentration of the test emissions or
reference substance in the mixture;
(B) When relevant to the conduct of the experiment, to determine
the solubility of each reference substance in the carrier mixture
before the experimental start date; and
(C) To determine the stability of test emissions or a reference
solution in the test substance before the experimental start date or
concomitantly according to written standard operating procedures, which
provide for periodic analysis of each batch.
(ii) Where any of the components of the reference substance/carrier
mixture has an expiration date, that date shall be clearly shown on the
container. If more than one component has an expiration date, the
earliest date shall be shown.
(iii) If a chemical or physical agent is used to facilitate the
mixing of a test substance with a carrier, assurance shall be provided
that the agent does not interfere with the integrity of the test.
(g) Protocol for and conduct of a study--(1) Protocol. (i) Each
study shall have a written protocol that clearly indicates the
objectives and all methods for the conduct of the study. The protocol
shall contain but shall not be limited to the following information:
(A) A descriptive title and statement of the purpose of the study.
(B) Identification of the test fuel, fuel/additive mixture, and
reference substance by name, chemical abstracts service (CAS) number or
code number, as applicable.
(C) The name and address of the sponsor and the name and address of
the testing facility at which the study is being conducted.
(D) The proposed experimental start and termination dates.
(E) Justification for selection of the test system, as necessary.
(F) Where applicable, the number, body weight, sex, source of
supply, species, strain, substrain, and age of the test system.
(G) The procedure for identification of the test system.
(H) A description of the experimental design, including methods for
the control of bias.
(I) Where applicable, a description and/or identification of the
diet used in the study. The description shall include specifications
for acceptable levels of contaminants that are reasonably expected to
be present in the dietary materials and are known to be capable of
interfering with the purpose or conduct of the study if present at
levels greater than established by the specifications.
(J) Each concentration level, expressed in milligrams per cubic
meter of air or other appropriate units, of the test or reference
substance to be administered and the frequency of administration.
(K) The type and frequency of tests, analyses, and measurements to
be made.
(L) The records to be maintained.
(M) The date of approval of the protocol by the sponsor and the
dated signature of the study director.
(N) A statement of the proposed statistical method.
(ii) All changes in or revisions of an approved protocol and the
reasons therefor shall be documented, signed by the study director,
dated, and maintained with the protocol.
(2) Conduct of a study. (i) The study shall be conducted in
accordance with the protocol.
(ii) The test systems shall be monitored in conformity with the
protocol.
(iii) Specimens shall be identified by test system, study, nature,
and date of collection. This information shall be located on the
specimen container or shall accompany the specimen in a manner that
precludes error in the recording and storage of data.
(iv) In animal studies where histopathology is required, records of
gross findings for a specimen from postmortem observations shall be
available to a pathologist when examining that specimen
histopathologically.
(v) All data generated during the conduct of a study, except those
that are generated by automated data collection systems, shall be
recorded directly, promptly, and legibly in ink. All data entries shall
be dated on the day of entry and signed or initialed by the person
entering the data. Any change in entries shall be made so as not to
obscure the original entry, shall indicate the reason for such change,
and shall be dated and signed or identified at the time of the change.
In automated data collection systems, the individual responsible for
direct data input shall be identified at the time of data input. Any
change in automated data entries shall be made so as not to obscure the
original entry, shall indicate the reason for change, shall be dated,
and the responsible individual shall be identified.
(h) Records and Reports--(1) Reporting of study results. (i) A
final report shall be prepared for each study and shall include, but
not necessarily be limited to, the following:
(A) Name and address of the facility performing the study and the
dates on which the study was initiated and was completed, terminated,
or discontinued.
(B) Objectives and procedures stated in the approved protocol,
including any changes in the original protocol.
(C) Statistical methods employed for analyzing the data.
(D) The test fuel, additive/base fuel mixture, and test and
reference substances identified by name, chemical abstracts service
(CAS) number or code number, strength, purity, content, or other
appropriate characteristics.
(E) Stability, and when relevant to the conduct of the study, the
solubility of the test emissions and reference substances under the
conditions of administration.
(F) A description of the methods used.
(G) A description of the test system used. Where applicable, the
final report shall include the number of animals or other test
organisms used, sex, body weight range, source of supply, species,
strain and substrain, age, and procedure used for identification.
(H) A description of the concentration regimen as daily exposure
period, i.e., number of hours, and exposure duration, i.e., number of
days.
(I) A description of all circumstances that may have affected the
quality or integrity of the data.
(J) The name of the study director, the names of other scientists
or professionals and the names of all supervisory personnel, involved
in the study.
(K) A description of the transformations, calculations, or
operations performed on the data, a summary and analysis of the data,
and a statement of the conclusions drawn from the analysis.
(L) The signed and dated reports of each of the individual
scientists or other professionals involved in the study, including each
person who, at the request or direction of the testing facility or
sponsor, conducted an analysis or evaluation of data or specimens from
the study after data generation was completed.
(M) The locations where all specimens, raw data, and the final
report are to be kept or stored.
(N) The statement, prepared and signed by the quality assurance
unit, as described in Sec. 79.60(b)(4)(i)(G).
(ii) The final report shall be signed and dated by the study
director.
(iii) Corrections or additions to a final report shall be in the
form of an amendment by the study director. The amendment shall clearly
identify that part of the final report that is being added to or
corrected and the reasons for the correction or addition, and shall be
signed and dated by the person responsible. Modification of a final
report to comply with the submission requirements of EPA does not
constitute a correction, addition, or amendment to a final report.
(iv) A copy of the final report and of any amendment to it shall be
maintained by the sponsor and the test facility.
(2) Storage and retrieval of records and data. (i) All raw data,
documentation, records, protocols, specimens, and final reports
generated as a result of a study shall be retained. Specimens obtained
from mutagenicity tests, wet specimens of blood, urine, feces, and
biological fluids, do not need to be retained after quality assurance
verification. Correspondence and other documents relating to
interpretation and evaluation of data, other than those documents
contained in the final report, also shall be retained.
(ii) All raw data, documentation, protocols, specimens, and interim
and final reports shall be archived for orderly storage and expedient
retrieval. Conditions of storage shall minimize deterioration of the
documents or specimens in accordance with the requirements for the time
period of their retention and the nature of the documents of specimens.
A testing facility may contract with commercial archives to provide a
repository for all material to be retained. Raw data and specimens may
be retained elsewhere provided that the archives have specific
reference to those other locations.
(iii) An individual shall be identified as responsible for the
archiving of records.
(iv) Access to archived material shall require authorization and
documentation.
(v) Archived material shall be indexed to permit expedient
retrieval.
(3) Retention of records. (i) Record retention requirements set
forth in this section do not supersede the record retention
requirements of any other regulations in this subchapter.
(ii) Except as provided in paragraph (h)(3)(iii) of this section,
documentation records, raw data, and specimens pertaining to a study
and required to be retained by this part shall be archived for a period
of at least ten years following the completion of the study.
(iii) Wet specimens, samples of test fuel, additive/base fuel
mixtures, or reference substances, and specially prepared material
which are relatively fragile and differ markedly in stability and
quality during storage, shall be retained only as long as the quality
of the preparation affords evaluation. Specimens obtained from
mutagenicity tests, wet specimens of blood, urine, feces, biological
fluids, do not need to be retained after quality assurance
verification. In no case shall retention be required for a longer
period than that set forth in paragraph (h)(3)(ii) of this section.
(iv) The master schedule sheet, copies of protocols, and records of
quality assurance inspections, as required by Sec. 79.60(b)(4)(iii)
shall be maintained by the quality assurance unit as an easily
accessible system of records for the period of time specified in
paragraph (h)(3)(ii) of this section.
(v) Summaries of training and experience and job descriptions
required to be maintained by Sec. 79.60(b)(1)(ii) may be retained along
with all other testing facility employment records for the length of
time specified in paragraph (h)(3)(ii) of this section.
(vi) Records and reports of the maintenance and calibration and
inspection of equipment, as required by Sec. 79.60(d)(2) (ii) and
(iii), shall be retained for the length of time specified in paragraph
(h)(3)(ii) of this section.
(vii) If a facility conducting testing or an archive contracting
facility goes out of business, all raw data, documentation, and other
material specified in this section shall be transferred to the sponsor
of the study for archival.
(viii) Records required by this section may be retained either as
original records or as true copies such as photocopies, microfilm,
microfiche, or other accurate reproductions of the original records.
Sec. 79.61. Vehicle emissions inhalation exposure guideline.
(a) Purpose. This guideline provides additional information on
methodologies required to conduct health effects tests involving
inhalation exposures to vehicle combustion emissions from fuels or
fuel/additive mixtures. Where this guideline and the other health
effects testing guidelines in 40 CFR 79.62 through 79.68 specify
differing values for the same test parameter, the specifications in the
individual health test guideline shall prevail for that health effect
endpoint.
(b) Definitions. For the purposes of this section the following
definitions apply.
Acute inhalation study means a short-term toxicity test
characterized by a single exposure by inhalation over a short period of
time (at least 4 hours and less than 24 hours), followed by at least 14
days of observation.
Aerodynamic diameter means the diameter of a sphere of unit density
that has the same settling velocity as the particle of the test
substance. It is used to compare particles of different sizes,
densities and shapes, and to predict where in the respiratory tract
such particles may be deposited. It applies to the size of aerosol
particles.
Chronic inhalation study means a prolonged and repeated exposure by
inhalation for the life span of the test animal; technically, two years
in the rat.
Concentration means an exposure level. Exposure is expressed as
weight or volume of test aerosol/substance per volume of air, usually
mg/m3 or as parts per million (ppm) over a given time period.
Micrograms per cubic meter (g/m3) or parts per billion
may be appropriate, as well.
Cumulative toxicity means the adverse effects of repeated exposures
occurring as a result of prolonged action or increased concentration of
the administered test substance or its metabolites in the susceptible
tissues.
Inhalable diameter means that aerodynamic diameter of a particle
which is considered to be inhalable for the organism. It is used to
refer to particles which are capable of being inhaled and may be
deposited anywhere within the respiratory tract from the trachea to the
alveoli.
Mass median aerodynamic diameter (MMAD) means the calculated
aerodynamic diameter, which divides the particles of an aerosol in half
based on the mass of the particles. Fifty percent of the particles in
mass will be larger than the median diameter, and fifty percent will be
smaller than the median diameter. MMAD describes the particle
distribution of any aerosol based on the weight and size of the
particles. MMAD and the geometric standard deviation describe the
particle-size distribution.
Material safety data sheet (MSDS) means documentation or
information on the physical, chemical, and hazardous characteristics of
a given chemical, usually provided by the product's manufacturer.
Reynolds number means a dimensionless number that is proportional
to the ratio of inertial forces to frictional forces acting on a fluid.
It quantitatively provides a measure of whether flow is laminar or
turbulent. A fluid traveling through a pipe is fully developed into a
laminar flow for a Reynolds number less than 2000, and fully developed
into a turbulent flow for a Reynolds number greater than 4000.
Subacute inhalation toxicity means the adverse effects occurring as
a result of the repeated daily exposure of experimental animals to a
chemical by inhalation for part (less than 10 percent) of a lifespan;
generally, less than 90 days.
Subchronic inhalation study means a repeated exposure by inhalation
for part (approximately 10 percent) of a life span of the exposed test
animal.
Toxic effect means an adverse change in the structure or function
of an experimental animal as a result of exposure to a chemical
substance.
(c) Principles and design criteria of inhalation exposure systems.
Proper conduct of inhalation toxicity studies of the emissions of fuels
and additive/fuel mixtures requires that the exposure system be
designed to ensure the controlled generation of the exposure
atmosphere, the adequate dilution of the test emissions, delivery of
the diluted exposure atmosphere to the test animals, and use of
appropriate exposure chamber systems selected to meet criteria for a
given exposure study.
(1) Emissions generation. Emissions shall be generated according to
the specifications in 40 CFR 79.57.
(2) Dilution and delivery systems.
(i) The delivery system is the means used to transport the
emissions from the generation system to the exposure system. The
dilution system is generally a component of the delivery system.
(ii) Dilution provides control of the emissions concentration
delivered to the exposure system, serving the function of diluting the
associated combustion gases, such as carbon monoxide, carbon dioxide,
nitrogen oxides, sulfur dioxide and other noxious gases and vapors, to
levels that will ensure that there are no significant or measurable
responses in the test animals as a result of exposure to the combustion
gases. The formation of particle species is strongly dependent on the
dilution rate, as well.
(iii) The engine exhaust system shall connect to the first-stage-
dilution section at 90 deg. to the axis of the dilution section. This
is then connected to a right angle elbow on the center line of the
dilution section. Engine emissions are injected through the elbow so
that exhaust flow is concurrent to dilution flow.
(iv) Materials. In designing the dilution and delivery systems, the
use of plastic, e.g., PVC and similar materials, copper, brass, and
aluminum pipe and tubing shall be avoided if there exists a possibility
of chemical reaction occurring between emissions and tubing. Stainless
steel pipe and tubing is recommended as the best choice for most
emission dilution and delivery applications, although glass and teflon
may be appropriate, as well.
(v) Flow requirements. (A) Conduit for dilute raw emissions shall
be of such dimensions as to provide residence times for the emissions
on the order of less than one second to several seconds before the
emissions are further diluted and introduced to the test chambers. With
the high flow rates in the dilute raw emissions conduit, it will be
necessary to sample various portions of the dilute emissions for
delivering differing concentrations to the test chambers. The unused
portions of the emissions stream are normally exhausted to the
atmosphere outside of the exposure facility.
(B) Dimensions of the dilute raw exhaust conduit shall be such
that, at a minimum, the flow Reynolds number is 70,000 or greater (see
Mokler, et al., 1984 in paragraph (f)(13) of this section). This will
maintain highly turbulent flow conditions so that there is more
complete mixing of the exhaust emissions.
(C) Wall losses. The delivery system shall be designed to minimize
wall losses. This can be done by sizing the tubing or pipe to maintain
laminar flow of the diluted emissions to the exposure chamber. A flow
Reynolds number of 1000-3000 will ensure minimal wall losses. Also, the
length of and number and degree of bends in the delivery lines to the
exposure chamber system shall be minimized.
(D) Whole-body exposure vs. nose-only exposure delivery systems.
Flow rates through whole-body chamber systems are of the order of 100
liters per minute to 500 liters per minute. Nose-only systems are on
the order of less than 50 liters per minute. To maintain laminar flow
conditions, the principles described in paragraph (c)(2)(v)(C) of this
section apply to both systems.
(vi) Dilution requirements. (A) To maintain the water vapor, and
dissolved organic compounds, in the raw exhaust emissions stream, a
manufacturer/tester will initially dilute one part emissions with a
minimum of five parts clean, filtered air (see Hinners, et al., 1979 in
paragraph (f)(11) of this section). Depending on the water vapor
content of a particular fuel/additive mixture's combustion emissions
and the humidity of the dilution air, initial exhaust dilutions as high
as 1:15 or 1:20 may be necessary to maintain the general character of
the exhaust as it cools, e.g., M100. At this point, it is expected that
the exhaust stream would be further diluted to more appropriate levels
for rodent health effects testing.
(B) A maximum concentration (minimum dilution) of the raw exhaust
going into the test animal cages is anticipated to lie in the range
between 1:5 and 1:50 exhaust emissions to clean, filtered air. The
minimum concentration (maximum dilution) of raw exhaust for health
effects testing is anticipated to be in range between 1:100 and 1:150.
Individual manufacturers will treat these ranges as approximations only
and will determine the optimum range of emission concentrations to
elicit effects in Tier 2 health testing for their particular fuel/fuel
additive mixture.
(3) Exposure chamber systems--(i) Referenced Guidelines. (A) The
U.S. Department of Health and Human Services ``Guide for the Care and
Use of Laboratory Animals'' (Guide), 1985 cited in paragraph
(c)(3)(ii)(A)(4), and in paragraphs (d)(2)(i), (d)(2)(ii), (d)(2)(iii),
(d)(4)(ii), and (d)(4)(iii) of this section, has been incorporated by
reference.
(B) This incorporation by reference was approved by the Director of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. Copies may be purchased from the Superintendent of Documents, U.S.
Government Printing Office, Washington, DC 20402. Copies may be
inspected at U.S. EPA, OAR, 401 M Street SW., Washington, DC, 20460 or
at the Office of the Federal Register, 800 North Capitol Street NW.,
suite 700, Washington, DC.
(ii) Exposure chambers. There are two basic types of dynamic
inhalation exposure chambers, whole-body chambers and nose-/head-only
exposure chambers (see Cheng and Moss, 1989 in paragraph (f)(8) of this
section).
(A) Whole-body chambers. (1) The flow rate through a chamber shall
be maintained at 15 air changes per hour.
(2) The chambers are usually maintained at a slightly negative
pressure (0.5 to 1.5 inch of water) to prevent leakage of test
substance into the exposure room.
(3) The exposure chamber shall be designed in such a way as to
provide uniform distribution of exposure concentrations in all
compartments (see Cheng et al., 1989 in paragraph (f)(7) of this
section).
(4) Animals are housed in separate compartments inside the chamber,
where the whole surface area of an animal is exposed to the test
material. The spaces required for different animal species shall follow
the Guide. In general, the volume of animal bodies occupy less than 5
percent of the chamber volume.
(B) Head/nose-only exposure chambers. (1) In head/nose-only
exposure chambers, only the head (oronasal) portion of the animal is
exposed to the test material.
(2) The chamber volume and flow rates are much less than in the
whole-body exposure chambers because the subjects are usually
restrained in a tube holder where the animal's breathing can be easily
monitored. The head/nose-only exposure chamber is suitable for short-
term exposures or when use of a small amount of test material is
required.
(iii) Since whole-body exposure appears to be the least stressful
mode of exposure, it is the preferred method. In general, head/nose
only exposure, which is sometimes used to avoid concurrent exposure by
the dermal or oral routes, i.e., grooming, is not recommended because
of the stress accompanying the restraining of the animals. However,
there may be specific instances where it may be more appropriate than
whole-body exposure. The tester shall provide justification for its
selection.
(d) Inhalation exposure procedures--(1) Animal selection. (i) The
rat is the preferred species for vehicle emission inhalation health
effects testing. Commonly used laboratory strains shall be used. Any
rodent species may be used, but the tester shall provide justification
for the choice of that species.
(ii) Young adult animals, approximately ten weeks of age for the
rat, shall be used. At the commencement of the study, the weight
variation of animals used shall not exceed 20 percent of
the mean weight for each sex. Animals shall be randomly assigned to
treatment and control groups according to their weight.
(iii) An equal number of male and female rodents shall be used at
each concentration level. Situations may arise where use of a single
sex may be appropriate. Females, in general, shall be nulliparous and
nonpregnant.
(iv) The number of animals used at each concentration level and in
the control group(s) depends on the type of study, number of biological
end points used in the toxicity evaluation, the pre-determined
sensitivity of detection and power of significance of the study, and
the animal species. For an acute study, at least five animals of each
sex shall be used in each test group. For both the subacute and
subchronic studies, at least 10 rodents of each sex shall be used in
each test group. For a chronic study, at least 20 male and 20 female
rodents shall be used in each test group.
(A) If interim sacrifices are planned, the number of animals shall
be increased by the number of animals scheduled to be sacrificed during
the course of the study.
(B) For a chronic study, the number of animals at the termination
of the study must be adequate for a meaningful and valid statistical
evaluation of chronic effects.
(v) A concurrent control group is required. This group shall be
exposed to clean, filtered air under conditions identical to those used
for the group exposed to the test atmosphere.
(vi) The same species/strain shall be used to make comparisons
between fuel-only and fuel/additive mixture studies. If another
species/strain is used, the tester shall provide justification for its
selection.
(2) Animal handling and care. (i) A key element in the conduct of
inhalation exposure studies is the proper handling and care of the test
animal population. Therefore, the exposure conditions must conform
strictly with the conditions for housing and animal care and use set
forth in the Guide.
(ii) In whole-body exposure chambers, animals shall be housed in
individual caging. The minimum cage size per animal will be in
accordance with instructions set forth in the Guide.
(iii) Chambers shall be cleaned and maintained in accordance with
recommendations and schedules set forth in the Guide.
(A) Observations shall be made daily with appropriate actions taken
to minimize loss of animals to the study (e.g., necropsy or
refrigeration of animals found dead and isolation or sacrifice of weak
or moribund animals). Exposure systems using head/nose-only exposure
chambers require no special daily chamber maintenance. Chambers shall
be inspected to ensure that they are clean, and that there are no
obstructions in the chamber which would restrict air flow to the
animals. Whole-body exposure chambers will be inspected on a minimum of
twice daily, once before exposures and once after exposures.
(B) Signs of toxicity shall be recorded as they are observed,
including the time of onset, degree, and duration.
(C) Cage-side observations shall include, but are not limited to:
changes in skin, fur, eye and mucous membranes, respiratory, autonomic,
and central nervous systems, somatomotor activity, and behavioral
patterns. Particular attention shall be directed to observation of
tremors, convulsions, salivation, diarrhea, lethargy, sleep, and coma.
(iv) Food and water will be withheld from animals for head/nose-
only exposure systems. For whole-body-exposure systems, water only may
be provided. When the exposure generation system is not operating, food
will be available ad libitum. During operation of the generation
system, food will be withheld to avoid possible contamination by
emissions.
(v) At the end of the study period, all survivors in the main study
population shall be sacrificed. Moribund animals shall be removed and
sacrificed when observed.
(3) Concentration levels and selection. (i) In acute and subacute
toxicity tests, at least three exposure concentrations and a control
group shall be used and spaced appropriately to produce test groups
with a range of toxic effects and mortality rates. The data shall be
sufficient to produce a concentration-response curve and permit an
acceptable estimation of the median lethal concentration.
(ii) In subchronic and chronic toxicity tests, testers shall use at
least three different concentration levels, with a control exposure
group, to determine a concentration-response relationship.
Concentrations shall be spaced appropriately to produce test groups
with a range of toxic effects. The concentration-response data may also
be sufficient to determine a NOAEL, unless the result of a limit test
precludes such findings. The criteria for selecting concentration
levels has been published (40 CFR 798.2450 and 798.3260).
(A) The highest concentration shall result in toxic effects but not
produce an incidence of fatalities which would prevent a meaningful
evaluation of the study.
(B) The lowest concentration shall not produce toxic effects which
are directly attributable to the test exposure. Where there is a useful
estimation of human exposure, the lowest concentration shall exceed
this.
(C) The intermediate concentration level(s) shall produce minimal
observable toxic effects. If more than one intermediate concentration
level is used, the concentrations shall be spaced to produce a
gradation of toxic effects.
(D) In the low, intermediate, and control exposure groups, the
incidence of fatalities shall be low to absent, so as not to preclude a
meaningful evaluation of the results.
(4) Exposure chamber environmental conditions. The following
environmental conditions in the exposure chamber are critical to the
maintenance of the test animals: flow; temperature; relative humidity;
lighting; and noise.
(i) Filtered and conditioned air shall be used during exposure, to
dilute the exhaust emissions, and during non- exposure periods to
maintain environmental conditions that are free of trace gases, dusts,
and microorganisms on the test animals. Twelve to fifteen air changes
per hour will be provided at all times to whole-body-exposure chambers.
The minimum air flow rate for head/nose-only exposure chambers will be
a function of the number of animals and the average minute volume of
the animals:
Qminimum(L/min)=2 x number of animals x average minute volume
(see Cheng and Moss, 1989 in paragraph (f)(8) of this section).
(ii) Recommended ranges of temperature for various species are
given in the Guide. The recommended temperature ranges will be used for
establishing temperature conditions of whole-body- exposure chambers.
For rodents in whole-body-exposure chambers, the recommended
temperature is 22 deg.C +/- 2 deg.C and for rabbits, it is 20 deg.C
+/- 3 deg.C. Temperature ranges have not been established for head/
nose-only tubes; however, recommended maximum temperature limits have
been established at the Inhalation Toxicology Research Institute (see
Barr, 1988 in paragraph (f)(1) of this section). Maximum temperature
for rats and mice in head/nose-only tubes is 23 deg.C.
(iii) Relative humidity. The relative humidity in the chamber air
is important for heat balance and shall be maintained between 40
percent and 60 percent, but in certain instances, this may not be
practicable. Testers shall follow Guide recommends for a 30 percent to
70 percent relative humidity range for rodents in exposure chambers.
(iv) Lighting. Light intensity of 30 foot candles at 3 ft. from the
floor of the exposure facility is recommended (see Rao, 1986 in
paragraph (f)(16) of this section).
(5) Exposure Conditions. Study animals shall be exposed to the test
atmosphere on a repeated basis for at least 6 hours per day on a 7-day
per week basis for the exposure period. However, based primarily on
practical considerations, exposure on a 5-day-per-week basis for a
minimum of 6 hours per day is the minimum acceptable exposure period.
(6) Exposure atmosphere. (i) The exposure atmosphere shall be held
as constant as is practicable and must be monitored continuously or
intermittently, depending on the method of analysis, to ensure that
exposure levels are at the target values or within stated limits during
the exposure period. Sampling methodology will be determined based on
the type of generation system and the type of exposure chamber system
specified for the exposure study.
(A) Integrated samples of test atmosphere aerosol shall be taken
daily during the exposure period from a single representative sample
port in the chamber near the breathing zone of the animals. Gas samples
shall be taken daily to determine concentrations (ppm) of the major
vapor components of the test atmosphere including CO, CO2,
NOX, SO2, and total hydrocarbons.
(B) To ensure that animals in different locations of the chamber
receive a similar exposure atmosphere, distribution of an aerosol or
vapor concentration in exposure chambers can be determined without
animals during the developmental phase of the study, or it can be
determined with animals early in the study. For head/nose-only exposure
chambers, it may not be possible to monitor the chamber distribution
during the exposure, because the exposure port contains the animal.
(C) During the development of the emissions generation system,
particle size analysis shall be performed to establish the stability of
an aerosol concentration with respect to particle size. Over the course
of the exposure, analysis shall be conducted as often as is necessary
to determine the consistency of particle size distribution.
(D) Chamber rise and fall times. The rise time required for the
exposure concentration to reach 90 percent of the stable concentration
after the generator is turned on, and the fall time when the chamber
concentration decreases to 10 percent of the stable concentration after
the generation system is stopped shall be determined in the
developmental phase of the study. Time-integrated samples collected for
calculating exposure concentrations shall be taken after the rise time.
The daily exposure time is exclusive of the rise or the fall time.
(ii) Instrumentation used for a given study will be determined
based on the type of generation system and the type of exposure chamber
system specified for the exposure study.
(A) For exhaust studies, combustion gases shall be sampled by
collecting exposure air in bags and then analyzing the collected air
sample to determine major components of the combustion gas using gas
analyzers. Exposure chambers can also be connected to gas analyzers
directly by using sampling lines and switching valves. Samples can be
taken more frequently using the latter method. Aerosol instruments,
such as photometers, or time-integrated gravimetric determination may
be used to determine the stability of any aerosol concentration in the
chamber.
(B) For evaporative emission studies, concentration of fuel vapors
can usually be determined by using a gas chromatograph (GC) and/or
infrared (IR) spectrometry. Grab samples for intermittent sampling can
be taken from the chamber by using bubble samplers with the appropriate
solvent to collect the vapors, or by collecting a small volume of air
in a syringe. Intermediate or continuous monitoring of the chamber
concentration is also possible by connecting the chamber with a GC or
IR detector.
(7) Monitoring chamber environmental conditions may be performed by
a computer system or by exposure system operating personnel.
(i) The flow-metering device used for the exposure chambers must be
a continuous monitoring device, and actual flow measurements must be
recorded at least every 30 minutes. Accuracy must be 5
percent of full scale range. Measurement of air flow through the
exposure chamber may be accomplished using any device that has
sufficient range to accurately measure the air flow for the given
chamber. Types of flow metering devices include rotameters, orifice
meters, venturi meters, critical orifices, and turbinemeters (see
Benedict, 1984 in paragraph (f)(4) and Spitzer, 1984 in paragraph
(f)(17) of this section).
(ii) Pressure. Pressure measurement may be accomplished using
manometers, electronic pressure transducers, magnehelics, or similar
devices (see Gillum, 1982 in paragraph (f)(10) of this section).
Accuracy of the pressure device must be 5 percent of full
scale range. Pressure measurements must be continuous and recorded at
least every 30 minutes.
(iii) Temperature. The temperature of exposure chambers must be
monitored continuously and recorded at least every 30 minutes.
Temperature may be measured using thermometers, RTD's, thermocouples,
thermistors, or other devices (see Benedict, 1984 in paragraph (f)(4)
of this section). It is necessary to incorporate an alarm system into
the temperature monitoring system. The exposure operators must be
notified by the alarm system when the chamber temperature exceeds 26.7
deg.C (80 deg.F). The exposure must be discontinued and emergency
procedures enacted to immediately reduce temperatures or remove test
animals from high temperature environment when chamber temperatures
exceed 29 deg.C. Accuracy of the temperature monitoring device will be
1 deg.C for the temperature range of 20-30 deg.C.
(iv) Relative humidity. The relative humidity of exposure chambers
must be monitored continuously and recorded at least every 30 minutes.
Relative humidity may be measured using various devices (see Chaddock,
1985 in paragraph (f)(6) of this section).
(v) Lighting shall be measured quarterly, or once at the beginning,
middle, and end of the study for shorter studies.
(vi) Noise level in the exposure chamber(s) shall be measured
quarterly, or once at the beginning, middle, and end of the study for
shorter studies.
(vii) Oxygen content is critical, especially in nose-only chamber
systems, and shall be greater than or equal to 19 percent in the test
cages. An oxygen sensor shall be located at a single position in the
test chamber and a lower alarm limit of 18 percent shall be used to
activate an alarm system.
(8) Safety procedures and requirements. In the case of potentially
explosive test substance concentrations, care shall be taken to avoid
generating explosive atmospheres.
(i) It is mandatory that the upper explosive limit (UEL) and lower
explosive limit (LEL) for the fuel and/or fuel additive(s) that are
being tested be determined. These limits can be found in the material
safety data sheets (MSDS) for each substance and in various reference
texts. The air concentration of the fuel or additive-base fuel mixture
in the generation system, dilution/delivery system, and the exposure
chamber system shall be calculated to ensure that explosive limits are
not present.
(ii) Storage, handling, and use of fuels or fuel/additive mixtures
shall follow guidelines given in 29 CFR 1910.106.
(iii) Monitoring for carbon monoxide (CO) levels is mandatory for
combustion systems. CO shall be continuously monitored in the immediate
area of the engine/vehicle system and in the exposure chamber(s).
(iv) Air samples shall be taken quarterly in the immediate area of
the vapor generation system and the exposure chamber system, or once at
the beginning, middle, and end of the study for shorter studies. These
samples shall be analyzed by methods described in paragraph
(d)(6)(ii)(B) of this section.
(v) With the presence of fuels and/or fuel additives, all
electrical and electronic equipment must be grounded. Also, the
dilution/delivery system and chamber exposure system must be grounded.
Guidelines for grounding are given in 29 CFR 1910.304.
(9) Quality control and quality assurance procedures--(i) Standard
operating procedures (SOPs). SOPs for exposure operations, sampling
instruments, animal handling, and analytical methods shall be written
during the developmental phase of the study.
(ii) Technicians/operators shall be trained in exposure operation,
maintenance, and documentation, as appropriate, and their training
shall be documented.
(iii) Flow meters, sampling instruments, and balances used in the
inhalation experiments shall be calibrated with standards during the
developmental phase to determine their sensitivity, detection limits,
and linearity. During the exposure period, instruments shall be checked
for calibration and documented to ensure that each instrument still
functions properly.
(iv) The mean exposure concentration shall be within 10 percent of
the target concentration on 90 percent or more of exposure days. The
coefficient of variation shall be within 25 percent of target on 90
percent or more of exposure days. For example, a manufacturer might
determine a mean exposure concentration of its product's exposure
emissions by identifying ``marker'' compound(s) typical of the
emissions of the fuel or fuel/additive mixture under study as a
surrogate for the total of individual compounds in those exposure
emissions. The manufacturer would note any concentration changes in the
level of the ``marker'' compound(s) in the sample's daily emissions for
biological testing.
(v) The spatial variation of the chamber concentration shall be 10
percent, or less. If a higher spatial variation is observed during the
developmental phase, then air mixing in the chamber shall be increased.
In any case, animals shall be rotated among the various cages in the
exposure chamber(s) to insure each animal's uniform exposure during the
study.
(e) Data and reporting. Data shall be summarized in tabular form,
showing for each group the number of animals at the start of the test,
the number of animals showing lesions, the types of lesions, and the
percentage of animals displaying each type of lesion.
(1) Treatment of results. All observed results, quantitative and
incidental, shall be evaluated by an appropriate statistical method.
Any generally accepted statistical method may be used; the statistical
methods shall be selected during the design of the study.
(2) Evaluation of results. The findings of an inhalation toxicity
study should be evaluated in conjunction with the findings of preceding
studies and considered in terms of the observed toxic effects and the
necropsy and histopathological findings. The evaluation will include
the relationship between the concentration of the test atmosphere and
the duration of exposure, and the severity of abnormalities, gross
lesions, identified target organs, body weight changes, effects on
mortality and any other general or specific toxic effects.
(3) Test conditions. (i) The exposure apparatus shall be described,
including:
(A) The vehicle/engine design and type, the dynamometer, the
cooling system, if any, the computer control system, and the dilution
system for exhaust emission generation;
(B) The evaporative emissions generator model, type, or design and
its dilution system; and
(C) Other test conditions, such as the source and quality of mixing
air, fuel or fuel/additive mixture used, treatment of exhaust air,
design of exposure chamber and the method of housing animals in a test
chamber shall be described.
(ii) The equipment for measuring temperature, humidity, particulate
aerosol concentrations and size distribution, gas analyzers, fuel vapor
concentrations, chamber distribution, and rise and fall time shall be
described.
(iii) Daily exposure results. The daily record shall document the
date, the start and stop times of the exposure, number of samples taken
during the day, daily concentrations determined, calibration of
instruments, and problems encountered during the exposure. The daily
exposure data shall be signed by the exposure operator and reviewed and
signed by the exposure supervisor responsible for the study.
(4) Exposure data shall be tabulated and presented with mean values
and a measure of variability (e.g., standard deviation), and shall
include:
(i) Airflow rates through the inhalation equipment;
(ii) Temperature and humidity of air;
(iii) Chamber concentrations in the chamber breathing zone;
(iv) Concentration of combustion exhaust gases in the chamber
breathing zone;
(v) Particle size distribution (e.g., mass median aerodynamic
diameter and geometric standard deviation from the mean);
(vi) Rise and fall time;
(vii) Chamber concentrations during the non-exposure period; and
(viii) Distribution of test substance in the chamber.
(5) Animal data. Tabulation of toxic response data by species,
strain, sex and exposure level for:
(i) Number of animals exposed;
(ii) Number of animals showing signs of toxicity; and
(iii) Number of animals dying.
(f) References. For additional background information on this
exposure guideline, the following references should be consulted.
(1) Barr, E.B. (1988) Operational Limits for Temperature and
Percent Oxygen During HM Nose-Only Exposures--Emergency Procedures
[interoffice memorandum]. Albuquerque, NM: Lovelace Inhalation
Toxicology Research Institute; May 13.
(2) Barr, E.B.; Cheng, Y.S.; Mauderly, J.L. (1990) Determination
of Oxygen Depletion in a Nose-Only Exposure Chamber. Presented at:
1990 American Association for Aerosol Research; June; Philadelphia,
PA: American Association for Aerosol Research; abstract no. P2e1.
(3) Barrow, C.S. (1989) Generation and Characterization of Gases
and Vapors. In: McClellan, R.O., Henderson, R.F. ed. Concepts in
Inhalation Toxicology. New York, NY: Hemisphere Publishing Corp.,
63-84.
(4) Benedict, R.P. (1984) Fundamentals of Temperature, Pressure,
and Flow Measurements. 3rd ed. New York, NY: John Wiley and Sons.
(5) Cannon, W.C.; Blanton, E.F.; McDonald, K.E. The Flow-Past
Chamber. (1983) An Improved Nose-Only Exposure System for Rodents.
Am. Ind. Hyg. Assoc. J. 44: 923-928.
(6) Chaddock, J.B. ed. (1985) Moisture and humidity. Measurement
and Control in Science and Industry: Proceedings of the 1985
International Symposium on Moisture and Humidity; April 1985;
Washington, D.C. Research Triangle Park, NC: Instrument Society of
America.
(7) Cheng, Y.S.; Barr, E.B.; Carpenter, R.L.; Benson, J.M.;
Hobbs, C.H. (1989) Improvement of Aerosol Distribution in Whole-Body
Inhalation Exposure Chambers. Inhal. Toxicol. 1: 153-166.
(8) Cheng,Y.S.; Moss, O.R. (1989) Inhalation Exposure Systems.
In: McClellan, R.O.; Henderson, R.F. ed. Concepts in Inhalation
Toxicology. New York, NY: Hemisphere Publishing Corp., 19-62.
(9) Cheng, Y.S.; Yeh, H.C.; Mauderly, J.L.; Mokler, B.V. (1984)
Characterization of Diesel Exhaust in a Chronic Inhalation Study.
Am. Ind. Hyg. Assoc. J. 45: 547-555.
(10) Gillum, D.R. (1982) Industrial Pressure Measurement.
Research Triangle Park, NC: Instrument Society of America.
(11) Hinners, R.G.; Burkart, J.K.; Malanchuk, M. (1979) Animal
Exposure Facility for Diesel Exhaust Studies.
(12) Kittelson, D.B.; Dolan, D.F. (1979) Diesel exhaust
aerosols. In Willeke, K. ed. Generation of Aerosols and Facilities
for Exposure Experiments. Ann Arbor, MI: Ann Arbor Science
Publishers Inc., 337-360.
(13) Mokler, B.V.; Archibeque, F.A.; Beethe, R.L.; Kelly,
C.P.J.; Lopez, J.A.; Mauderly, J.L.; Stafford, D.L. (1984) Diesel
Exhaust Exposure System for Animal Studies. Fundamental and Applied
Toxicology 4: 270-277.
(14) Moore, W.; et al. (1978) Preliminary finding on the
Deposition and Retention of Automotive Diesel Particulate in Rat
Lungs. Proc. of Annual Meeting of the Air Pollution Control Assn, 3,
paper 78-33.7.
(15) Raabe, O.G., Bennick, J.E., Light, M.E., Hobbs, C.H.,
Thomas, R.L., Tillery, M.I. (1973) An Improved Apparatus for Acute
Inhalation Exposure of Rodents to Radioactive Aerosols. Toxicol &
Applied Pharmaco.; 1973; 26: 264-273.
(16) Rao, G.N. (1986) Significance of Environmental Factors on
the Test System. In: Hoover, B.K.; Baldwin, J.K.; Uelner, A.F.;
Whitmire, C.E.; Davies, C.L.; Bristol, D.W. ed. Managing conduct and
data quality of toxicology studies. Raleigh, NC: Princeton
Scientific Publishing Co., Inc.: 173-185.
(17) Spitzer, D.W. (1984) Industrial Flow Measurement. Research
Triangle Park, NC: Instrument Society of America.
(18) 40 CFR part 798, Health effects testing guidelines.
(19) 29 CFR part 1910, Occupational safety and health standards
for general industry.
(20) Federal Register, 42 FR 26748, May 25, 1977.
Sec. 79.62 Subchronic toxicity study with specific health effect
assessments.
(a) Purpose--(1) General toxicity. This subchronic inhalation study
is designed to determine a concentration-response relationship for
potential toxic effects in rats resulting from continuous or repeated
inhalation exposure to vehicle/engine emissions over a period of 90
days. A subgroup of perfusion-fixed animals is required, in addition to
the main study population, for more exacting organ and tissue
histology. This test will provide screening information on target organ
toxicities and on concentration levels useful for running chronic
studies and establishing exposure criteria. Initial information on
effective concentrations/exposures of the test atmosphere may be
determined from the literature of previous studies or through
concentration range-finding trials prior to starting this study. This
health effects screening test is not capable of directly determining
those effects which have a long latency period for development (e.g.,
carcinogenicity and life-shortening), though it may permit the
detremination of a no-observed-adverse-effect level, or NOAEL.
(2) Specific health effects assessments (HEAs). These supplemental
studies are designed to determine the potential for reproductive/
teratologic, carcinogenic, mutagenic, and neurotoxic health effect
outcomes from vehicle/engine emission exposures. They are done in
combination with the subchronic toxicity study and paragraph (c) of
this section or may be done separately as outlined by the appropriate
test guideline.
(i) Fertility assessment/teratology. The fertility assessment is an
in vivo study designed to provide information on potential health
hazards to the fetus arising from the mother's repeated exposure to
vehicle/engine emissions before and during her pregnancy. By including
a mating of test animals, the study provides preliminary data on the
effects of repeated vehicle/engine emissions exposure on gonadal
function, conception, and fertility. The fertility assessment/
teratology guideline is found in Sec. 79.63.
(ii) Micronucleus (MN) Assay. The MN assay is an in vivo
cytogenetic test which gives information on potential carcinogenic and/
or mutagenic effects of exposure to vehicle/engine emissions. The MN
assay detects damage to the chromosomes or mitotic apparatus of cells
in the tissues of a test subject exposed repeatedly to vehicle/engine
emissions. The assay is based on an increase in the frequency of
micronucleated erythrocytes found in bone marrow from treated animals
compared to that of control animals. The guideline for the MN assay is
found in Sec. 79.64.
(iii) Sister Chromatid Exchange (SCE) Assay. The SCE assay is an in
vivo analysis which gives information on potential mutagenic and/or
carcinogenic effects of exposure to vehicle/engine emissions. The assay
detects the ability of a chemical to enhance the exchange of DNA
between two sister chromatids of a duplicating chromosome. This assay
uses peripheral blood lymphocytes isolated from an exposed rodent test
species and grown to confluence in cell culture. The guideline for the
SCE assay is found in Sec. 79.65.
(iv) Neurotoxicity (NTX) measures. NTX measures include (A)
histopathology of specified central and peripheral nervous system
tissues taken from emission-exposed rodents, and (B) an assay of brain
tissue levels of glial fibrillary acidic protein (GFAP), a major
filament protein of astrocytes, from emission-exposed rodents. The
guidelines for the neurohistopathology and GFAP studies are found in
Sec. 79.66 and Sec. 79.67, respectively.
(b) Definitions. For the purposes of this section, the following
definitions apply:
No-observed-adverse-effect-level (NOAEL) means the maximum
concentration used in a test which produces no observed adverse
effects. A NOAEL is expressed in terms of weight or volume of test
substance given daily per unit volume of air (g/L or ppm).
Subchronic inhalation toxicity means the adverse effects occurring
as a result of the continuous or repeated daily exposure of
experimental animals to a chemical by inhalation for part
(approximately 10 percent) of a life span.
(c) Principle of the test method. As long as none of the
requirements of any study are violated by the combination, one or more
HEAs may be combined with the general toxicity study through concurrent
exposures of their study populations and/or by sharing the analysis of
the same animal subjects. Requirements duplicated in combined studies
need not be repeated. Guidelines for combining HEAs with the general
toxicity study are as follows.
(1) Fertility assessment. (i) The number of study animals in the
test population is increased when the fertility assessment is run
concurrently with the 90-day toxicity study. A minimum of 40 females
per test group shall undergo vaginal lavage daily for two weeks before
the start of the exposure period. The resulting wet smears are examined
to cull those animals which are acyclic. Twenty-five females shall be
randomly assigned to a for-breeding group with the balance of females
assigned to a group for histopathologic examination.
(ii) All test groups are exposed over a period of 90 days to
various concentrations of the test atmosphere for a minimum of six
hours per day. After seven weeks of exposures, analysis of vaginal cell
smears shall resume on a daily basis for the 25 for-breeding females
and shall continue for a period of four weeks or until each female in
the group is confirmed pregnant. Following the ninth week of exposures,
each for-breeding female is housed overnight with a single study male.
Matings shall continue for as long as two weeks, or until pregnancy is
confirmed (pregnancy day 0). Pregnant females are only exposed through
day 15 of their pregnancy while daily exposures continue throughout the
course of the study for non-pregnant females and study males.
(iii) On pregnancy day 20, pregnant females are sacrificed and
their uteri are examined. Pregnancy status and fetal effects are
recorded as described in Sec. 79.63. At the end of the exposure period,
all males and non-pregnant females are sacrificed and necropsied.
Testes and epididymal tissue samples are taken from five perfusion-
fixed test subjects and histopathological examinations are carried out
on the remainder of the non-pregnant females and study males.
(2) Carcinogenicity/mutagenicity
(C/M) assessment. When combined with the subchronic toxicity study, the
main study population is used to perform both the in vivo MN and SCE
assays. Because of the constant turnover of the cells to be analyzed in
these assays, a separate study population may be used for this
assessment. A study population needs only to be exposed a minimum of
four weeks. At exposure's end, ten animals per exposure and control
groups are anaesthetized and heart punctures are performed on all
members. After separating blood components, individual lymphocyte cell
cultures are set up for SCE analysis. One femur from each study subject
is also removed and the marrow extracted. The marrow is smeared onto a
glass slide, and stained for analysis of micronuclei in erythrocytes.
(3) Neurotoxicity (NTX) measures. (i) When combined with this
subchronic toxicity study, test animals designated for whole-body
perfusion fixation/lung histology and exposed as part of the main
animal population are used to perform the neurohistology portion of
these measures. After the last exposure period, a minimum of ten
animals from each exposure group shall be preserved in situ with
fixative. Sections of brain, spinal cord, and proximal sciatic or
tibial nerve are then cut, processed further in formalin, and mounted
for viewing under a light microscope. Fibers from the sciatic or tibial
nerve sample are teased apart for further analysis under the
microscope.
(ii) GFAP assay. After the last exposure period, a minimum of ten
rodents from each exposure group shall be sacrificed, and their brains
excised and divided into regions. The tissue samples are then applied
to filter paper, washed with anti-GFAP antibody, and visualized with a
radio-labelled Protein A. The filters are quantified for degree of
immunoreactivity between the antibody and GFAP in the tissue samples. A
non-radioactive ELISA format is also referenced in the GFAP guideline
cited in paragraph (a)(2)(iv) of this section. Note: Because the GFAP
assay requires fresh, i.e., non-preserved, brain tissue, the number of
test animals may need to be increased to provide an adequate number of
test subjects to complete the histopathology requirements of both the
GFAP and the general toxicity portion of the 90-day inhalation study.
(iii) The start of the exposure period for the NTX measures study
population may be staggered from that of the main study group to more
evenly distribute the analytical work required in both study
populations. The exposures would remain the same in all other respects.
(d) Test procedures--(1) Animal selection--(i) Species and sex. The
rat is the recommended species. If another rodent species is used, the
tester shall provide justification for its selection. Both sexes shall
be used in any assessment unless it is demonstrated that one sex is
refractory to the effects of exposure.
(ii) Age and number. Rats shall be at least ten weeks of age at the
beginning of the study exposure. The number of animals necessary for
individual health effect outcomes is as follows:
(A) Thirty rodents per concentration level/group, fifteen of each
sex, shall be used to satisfy the reporting requirements of the 90-day
toxicity study. Ten animals per concentration level/group shall be
designated for whole body perfusion with fixative (by gravity) for lung
studies, and neurohistology and testes studies, as appropriate.
(B) Forty rodents, 25 females and ten males shall be added for each
test concentration or control group when combining a 90-day toxicity
study with a fertility assessment.
(C) The tester shall provide a group of 10 animals (five animals
per sex per experimental/control groups) in addition to the main test
population when performing the GFAP neurotoxicity HEA.
(2) Recovery group. The manufacturer shall include an group of 20
animals (10 animals per sex) in the test population, exposing them to
the highest concentration level for the entire length of the study's
exposure period. This group shall then be observed for reversibility,
persistence, or delayed occurrence of toxic effects during a post-
exposure period of not less than 28 days.
(3) Inhalation exposure. (i) All data developed within this study
shall be in accordance with good laboratory practice provisions under
Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(4) Observation of animals. (i) All toxicological (e.g., weight
loss) and neurological signs (e.g., motor disturbance) shall be
recorded frequently enough to observe any abnormality, and not less
than weekly for all study animals. Animals shall be weighed weekly.
(ii) The following is a minimal list of measures that shall be
noted:
(A) Body weight;
(B) Subject's reactivity to general stimuli such as removal from
the cage or handling;
(C) Description, incidence, and severity of any convulsions,
tremors, or abnormal motor movements in the home cage;
(D) Descriptions and incidence of posture and gait abnormalities
observed in the home cage;
(E) Description and incidence of any unusual or abnormal behaviors,
excessive or repetitive actions (stereotypies), emaciation,
dehydration, hypotonia or hypertonia, altered fur appearance, red or
crusty deposits around the eyes, nose, or mouth, and any other
observations that may facilitate interpretation of the data.
(iii) Any animal which dies during the test is necropsied as soon
as possible after discovery.
(5) Clinical examinations. (i) The following examinations shall be
performed on the twenty animals designated as the 90-day study
population, exclusive of pregnant dams and those study animals targeted
for perfusion by gravity:
(A) The following hematology determinations shall be carried out at
least two times during the test period (after 30 days of exposure and
just prior to terminal sacrifice at the end of the exposure period):
hematocrit, hemoglobin concentration, erythrocyte count, total and
differential leukocyte count, and a measure of clotting potential such
as prothrombin time, thromboplastin time, or platelet count.
(B) Clinical biochemistry determinations on blood shall be carried
out at least two times during the test period, after 30 days of
exposure and just prior to terminal sacrifice at the end of the
exposure period, on all groups of animals including concurrent
controls. Clinical biochemical testing shall include assessment of
electrolyte balance, carbohydrate metabolism, and liver and kidney
function. The selection of specific tests will be influenced by
observations on the mode of action of the substance. In the absence of
more specific tests, the following determinations may be made: calcium,
phosphorus, chloride, sodium, potassium, fasting glucose (with period
of fasting appropriate to the species), serum alanine aminotransferase,
serum aspartate aminotransferase, sorbitol dehydrogenase, gamma
glutamyl transpeptidase, urea nitrogen, albumen, blood creatinine,
methemoglobin, bile acids, total bilirubin, and total serum protein
measurements. Additional clinical biochemistry shall be employed, where
necessary, to extend the investigation of observed effects, e.g.,
analyses of lipids, hormones, acid/base balance, and cholinesterase
activity.
(ii) The following examinations shall initially be performed on the
high concentration and control groups only:
(A) Ophthalmological examination, using an ophthalmoscope or
equivalent suitable equipment, shall be made prior to exposure to the
test substance and at the termination of the study. If changes in the
eyes are detected, all animals shall be examined.
(B) Urinalysis is not required on a routine basis, but shall be
done when there is an indication based on expected and/or observed
toxicity.
(iii) Preservation by whole-body perfusion of fixative into the
anaesthetized animal for lung histology of ten animals from the 90-day
study population for each experimental and control group.
(6) Gross pathology. With the exception of the whole body
perfusion-fixed test animals cited in paragraph (d)(1)(ii)(A) of this
section, all rodents shall be subjected to a full gross necropsy which
includes examination of the external surface of the body, all orifices
and the cranial, thoracic, and abdominal cavities and their contents.
Gross pathology shall be performed on the following organs and tissues:
(i) The liver, kidneys, lungs, adrenals, brain, and gonads,
including uterus, ovaries, testes, epididymides, seminal vesicles (with
coagulating glands), and prostate, constitute the group of target
organs for histology and shall be weighed as soon as possible after
dissection to avoid drying. In addition, for other than rodent test
species, the thyroid with parathyroids, when present, shall also be
weighed as soon as possible after dissection to avoid drying.
(ii) The following organs and tissues, or representative samples
thereof, shall be preserved in a suitable medium for possible future
histopathological examination: All gross lesions; lungs--which shall be
removed intact, weighed, and treated with a suitable fixative to ensure
that lung structure is maintained (perfusion with the fixative is
considered to be an effective procedure); nasopharyngeal tissues;
brain--including sections of medulla/pons, cerebellar cortex, and
cerebral cortex; pituitary; thyroid/parathyroid; thymus; trachea;
heart; sternum with bone marrow; salivary glands; liver; spleen;
kidneys; adrenals; pancreas; reproductive organs: uterus; cervix;
ovaries; vagina; testes; epididymides; prostate; and, if present,
seminal vesicles; aorta; (skin); gall bladder (if present); esophagus;
stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary
bladder; representative lymph node; (mammary gland); (thigh
musculature); peripheral nerve/tissue; (eyes); (femur--including
articular surface); (spinal cord at three levels--cervical,
midthoracic, and lumbar); and (zymbal and exorbital lachrymal glands).
(7) Histopathology. Histopathology shall be performed on the
following organs and tissues from all rodents:
(i) All gross lesions.
(ii) Respiratory tract and other organs and tissues, listed in
paragraph (d)(6)(ii) of this section (except organs/tissues in
parentheses), of all animals in the control and high dose groups.
(iii) The tissues mentioned in parentheses, listed in paragraph
(d)(6)(ii) of this section, if indicated by signs of toxicity or target
organ involvement.
(iv) Lungs of animals in the low and intermediate dose groups shall
also be subjected to histopathological examination, primarily for
evidence of infection since this provides a convenient assessment of
the state of health of the animals.
(v) Lungs and trachea of the whole-body perfusion-fixed test
animals cited in paragraph (d)(1)(ii)(A) of this section are examined
for inhaled particle distribution.
(e) Interpretation of results. All observed results, quantitative
and incidental, shall be evaluated by an appropriate statistical
method. The specific methods, including consideration of statistical
power, shall be selected during the design of the study.
(f) Test report. In addition to the reporting requirements as
specified under Secs. 79.60 and 79.61(e), the following individual
animal data information shall be reported:
(1) Date of death during the study or whether animals survived to
termination.
(2) Date of observation of each abnormal sign and its subsequent
course.
(3) Individual body weight data, and group average body weight data
vs. time.
(4) Feed consumption data, when collected.
(5) Hematological tests employed and all results.
(6) Clinical biochemistry tests employed and all results.
(7) Necropsy findings.
(8) Type of stain/fixative and procedures used in preparing tissue
samples.
(9) Detailed description of all histopathological findings.
(10) Statistical treatment of the study results, where appropriate.
(g) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.2450, Inhalation toxicity.
(2) 40 CFR 798.2675, Oral Toxicity with Satellite Reproduction and
Fertility Study.
(3) General Statement of Work for the Conduct of Toxicity and
Carcinogenicity Studies in Laboratory Animals (revised April, 1987/
modifications through January, 1990) appendix G, National Toxicology
Program--U.S. Dept. of Health and Human Services (Public Health
Service), P.O. Box 12233, Research Triangle Park, NC 27709.
Sec. 79.63 Fertility assessment/teratology.
(a) Purpose. Fertility assessment/teratology is an in vivo study
designed to provide information on potential health hazards to the
fetus arising from the mother's repeated inhalation exposure to
vehicle/engine emissions before and during her pregnancy. By including
a mating of test animals, the study provides preliminary data on the
effects of repeated vehicle/engine emissions exposure on gonadal
function, conception, and fertility. Since this is a one-generation
test that ends with examination of full-term fetuses, but not of live
pups, it is not capable of determining effects on reproductive
development which would only be detected in viable offspring of treated
parents.
(b) Definitions. For the purposes of this section, the following
definitions apply:
Developmental toxicity means the ability of an agent to induce in
utero death, structural or functional abnormalities, or growth
retardation after contact with the pregnant animal.
Estrous cycle means the periodic recurrence of the biological
phases of the female reproductive system which prepare the animal for
conception and the development of offspring. The phases of the estrous
cycle for a particular animal can be characterized by the general
condition of the cells present in the vagina and the presence or
absence of various cell types.
Vaginal cytology evaluation means the use of wet vaginal cell
smears to determine the phase of a test animal's estrous cycle and the
potential for adverse exposure effects on the regularity of the
animal's cycle. In the rat, common cell types found in the smears
correlate well with the various stages of the estrous cycle and to
changes occurring in the reproductive tract.
(c) Principle of the test method. (1) For a two week period before
exposures start, daily vaginal cell smears are examined from a surplus
of female test animals to identify and cull those females which are
acyclic. After culling, testers shall randomly assign at each exposure
concentration (including unexposed) a minimum of twenty-five females
for breeding and fifteen non-bred females for later histologic
evaluation. Test animals shall be exposed by inhalation to graduated
concentrations of the test atmosphere for a minimum of six hours per
day over the next 13 weeks. Males and females in both test and control
groups are mated after nine weeks of exposure. Exposures for pregnant
females continue through gestation day 15, while exposures for males
and all non- pregnant females shall continue for the full exposure
period.
(2) Beginning two weeks before the start of the mating period,
daily vaginal smears resume for all to-be-bred females to characterize
their estrous cycles. This will continue for four weeks or until a
rat's pregnancy is confirmed, i.e., day 0, by the presence of sperm in
the cell smear. On pregnancy day 20, shortly before the expected date
of delivery, each pregnant female is sacrificed, her uterus removed,
and the contents examined for embryonic or fetal deaths, and live
fetuses. At the end of the exposure period, males and all non-pregnant
females shall be weighed, and various organs and tissues, as
appropriate, shall be removed and weighed, fixed with stain, and
sectioned for viewing under a light microscope.
(3) This assay may be done separately or in combination with the
subchronic toxicity study, pursuant to the provisions in Sec. 79.62.
(d) Limit test. If a test at one dose level of the highest
concentration that can be achieved while maintaining a particle size
distribution with a mass median aerodynamic diameter (MMAD) of 4
micrometers (m) or less, using the procedures described in
section 79.60 of this part produces no observable toxic effects and if
toxicity would not be expected based upon data of structurally related
compounds, then a full study using three dose levels might not be
necessary. Expected human exposure though may indicate the need for a
higher dose level.
(e) Test procedures--(1) Animal selection--(i) Species and strain.
The rat is the preferred species. Strains with low fecundity shall not
be used and the candidate species shall be characterized for its
sensitivity to developmental toxins. If another rodent species is used,
the tester shall provide justification for its selection.
(ii) Animals shall be a minimum of 10 weeks old at the start of the
exposure period.
(iii) Number and sex. Each test and control group shall have a
minimum of 25 males and 40 females. In order to ensure that sufficient
pups are produced to permit meaningful evaluation of the potential
developmental toxicity of the test substance, twenty pregnant test
animals are required for each exposure and control level.
(2) Observation period. The observation period shall be 13 weeks,
at a minimum.
(3) Concentration levels and concentration selection. (i) To select
the appropriate concentration levels, a pilot or trial study may be
advisable. Since pregnant animals have an increased minute ventilation
as compared to non-pregnant animals, it is recommended that the trial
study be conducted in pregnant animals. Similarly, since presumably the
minute ventilation will vary with progression of pregnancy, the animals
should be exposed during the same period of gestation as in the main
study. It is not always necessary, though, to carry out a trial study
in pregnant animals. Comparisons between the results of a trial study
in non-pregnant animals, and the main study in pregnant animals will
demonstrate whether or not the test substance is more toxic in pregnant
animals. In the trial study, the concentration producing embryonic or
fetal lethalities or maternal toxicity should be determined.
(ii) The highest concentration level shall induce some overt
maternal toxicity such as reduced body weight or body weight gain, but
not more than 10 percent maternal deaths.
(iii) The lowest concentration level shall not produce any grossly
observable evidence of either maternal or developmental toxicity.
(4) Inhalation exposure. (i) All data developed within this study
shall be in accordance with good laboratory practice provisions under
Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(f) Test performance--(1) Study conduct. Directions specific to
this study are:
(i) The duration of exposure shall be at least six hours daily,
allowing appropriate additional time for chamber equilibrium.
(ii) Where an exposure chamber is used, its design shall minimize
crowding of the test animals. This is best accomplished by individual
caging.
(iii) Pregnant animals shall not be subjected to beyond the minimum
amount of stress. Since whole-body exposure appears to be the least
stressful mode of exposure, it is the preferred method. In general
oronasal or head-only exposure, which is sometimes used to avoid
concurrent exposure by the dermal or oral routes, is not recommended
because of the associated stress accompanying the restraining of the
animals. However, there may be specific instances where it may be more
appropriate than whole-body exposure. The tester shall provide
justification/reasoning for its selection.
(iv) Measurements shall be made at least every other day of food
consumption for all animals in the study. Males and females shall be
weighed on the first day of exposure and 2-3 times per week thereafter,
except for pregnant dams.
(v) The test animal housing, mating, and exposure chambers shall be
operated on a twenty-four hour lighting schedule, with twelve hours of
light and twelve hours of darkness. Test animal exposure shall only
occur during the light portion of the cycle.
(vi) Signs of toxicity shall be recorded as they are observed
including the time of onset, degree, and duration.
(vii) Females showing signs of abortion or premature delivery shall
be sacrificed and subjected to a thorough macroscopic examination.
(viii) Animals that die or are euthanized because of morbidity will
be necropsied promptly.
(2) Vaginal cytology. (i) For a two week period before the mating
period starts, each female in the to-be-bred population shall undergo a
daily saline vaginal lavage. Two wet cell smears from this lavage shall
be examined daily for each subject to determine a baseline pattern of
estrus. Testers shall avoid excessive handling and roughness in
obtaining the vaginal cell samples, as this may induce a condition of
pseudo-pregnancy in the test animals.
(ii) This will continue for four weeks or until day 0 of a rat's
pregnancy is confirmed by the presence of sperm in the cell smear.
(3) Mating and fertility assessment. (i) Beginning nine weeks after
the start of exposure, each exposed and control group female (exclusive
of the histology group females) shall be paired during non-exposure
hours with a male from the same exposure concentration group. Matings
shall continue for a period of two weeks, or until all mated females
are determined to be pregnant. Mating pairs shall be clearly
identified.
(ii) Each morning, including weekends, cages shall be examined for
the presence of a sperm plug. When found, this shall mark gestation day
0 and pregnancy shall be confirmed by the presence of sperm in the
day's wet vaginal cell smears.
(iii) Two weeks after mating is begun, or as females are determined
to be pregnant, bred animals are returned to pre-mating housing. Daily
exposures continues through gestation day 15 for all pregnant females
or through the balance of the exposure period for non-pregnant females
and all males.
(iv) Those pairs which fail to mate shall be evaluated in the
course of the study to determine the cause of the apparent infertility.
This may involve such procedures as additional opportunities to mate
with a proven fertile partner, histological examination of the
reproductive organs, and, in males, examination of the spermatogenic
cycles. The stage of estrus for each non-pregnant female in the
breeding group will be determined at the end of the exposure period.
(4) All animals in the histology group shall be subject to
histopathologic examination at the end of the study's exposure period.
(g) Treatment of results. (1) All observed results, quantitative
and incidental, shall be evaluated by an appropriate statistical
method. The specific methods, including consideration of statistical
power, shall be selected during the design of the study.
(2) Data and reporting. In addition to the reporting requirements
specified under Secs. 79.60 and 79.61, the final test report must
include the following information:
(i) Gross necropsy. (A) All animals shall be subjected to a full
necropsy which includes examination of the external surface of the
body, all orifices, and the cranial, thoracic, and abdominal cavities
and their contents. Special attention shall be directed to the organs
of the reproductive system.
(B) The liver, kidneys, adrenals, pituitary, uterus, vagina,
ovaries, testes, epididymides and seminal vesicles (with coagulating
glands), and prostate shall be weighed wet, as soon as possible after
dissection, to avoid drying.
(i) At the time of sacrifice on gestation day 20 or at death during
the study, each dam shall be examined macroscopically for any
structural abnormalities or pathological changes which may have
influenced the pregnancy.
(ii) The contents of the uterus shall be examined for embryonic or
fetal deaths and the number of viable fetuses. Gravid uterine weights
need not be obtained from dead animals where decomposition has
occurred. The degree of resorption shall be described in order to help
estimate the relative time of death.
(iii) The number of corpora lutea shall be determined in each
pregnant dam.
(iv) Each fetus shall be weighed, all weights recorded, and mean
fetal weights determined.
(v) Each fetus shall be examined externally and the sex determined.
(vi) One-half of the rat fetuses in each litter shall be examined
for skeletal anomalies, and the remaining half shall be examined for
soft tissue anomalies, using appropriate methods.
(ii) Histopathology. (A) Histopathology on vagina, uterus, ovaries,
testes, epididymides, seminal vesicles, and prostate as appropriate for
all males and histology group females in the control and high
concentration groups and for all animals that died or were euthanized
during the study. If abnormalities or equivocal results are seen in any
of these organs/tissues, the same organ/tissue from test animals in
lower concentration groups shall be examined.
Note: Testes, seminal vesicles, epididymides, and ovaries, at a
minimum, shall be examined in perfusion-fixed (pressure or gravity
method) test subjects, when available.
(B) All gross lesions in all study animals shall be examined.
(C) As noted under mating procedures, reproductive organs of
animals suspected of infertility shall be subject to microscopic
examination.
(D) The following organs and tissues, or representative samples
thereof, shall be preserved in a suitable medium for future
histopathological examination: all gross lesions; vagina; uterus;
ovaries; testes; epididymides; seminal vesicles; prostate; liver; and
kidneys/adrenals.
(3) Evaluation of results. (i) The findings of a developmental
toxicity study shall be evaluated in terms of the observed effects and
the exposure levels producing effects. It is necessary to consider the
historical developmental toxicity data on the species/strain tested.
(ii) There are several criteria for determining a positive result
for reproductive/teratologic effects; a statistically significant dose-
related decrease in the weight of the testes for treated subjects over
control subjects, a decrease in neonatal viability, a significant
change in the presence of soft tissue or skeletal abnormalities, or an
increased rate of embryonic or fetal resorption or death. Other
criteria, e.g., lengthening of the estrous cycle or the time spent in
any one stage of estrus, changes in the proportion of viable male vs
female fetuses or offspring, the number and type of cells in vaginal
smears, or pathologic changes found during gross or microscopic
examination of male or female reproductive organs may be based upon
detection of a reproducible and statistically significant positive
response for that evaluation parameter. A positive result indicates
that, under the test conditions, the test substance does induce
reproductive organ or fetal toxicity in the test species.
(iii) A test substance which does not produce either a
statistically significant dose-related change in the reproductive
organs or cycle or a statistically significant and reproducible
positive response at any one of the test points may not induce
reproductive organ toxicity in this test species, but further
investigation , e.g., to establish absorption and bioavailability of
the test substance, should be considered.
(h) Test report. In addition to the reporting requirements as
specified under 40 CFR 79.60 and the vehicle emissions inhalation
toxicity guideline as published in 40 CFR 79.61, the following specific
information shall be reported:
(1) Individual animal data. (i) Time of death during the study or
whether animals survived to termination.
(ii) Date of onset and duration of each abnormal sign and its
subsequent course.
(iii) Feed and body weight data.
(iv) Necropsy findings.
(v) Male test subjects.
(A) Testicle weight, and body weight: testicle weight ratio.
(B) Detailed description of all histopathological findings,
especially for the testes and the epididymides.
(vi) Female test subjects.
(A) Uterine weight data.
(B) Beginning and ending collection dates for vaginal cell smears.
(C) Estrous cycle length compared within and between groups
including mean cycle length for groups.
(D) Percentage of time spent in each stage of cycle.
(E) Stage of estrus at time of mating/sacrifice and proportion of
females in estrus between concentration groups.
(F) Detailed description of all histopathological findings,
especially for uterine/ovary samples.
(vii) Pregnancy and litter data. Toxic response data by exposure
level, including but not limited to, indices of fertility and time-to-
mating, including the number of days until mating and the number of
full or partial estrous cycles until mating.
(A) Number of pregnant animals,
(B) Number and percentage of live fetuses, resorptions.
(viii) Fetal data. (A) Numbers of each sex.
(B) Number of fetuses with any soft tissue or skeletal
abnormalities.
(2) Type of stain/fixative and procedures used in preparing tissue
samples.
(3) Statistical treatment of the study results.
(i) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.2675, Oral Toxicity with Satellite Reproduction
and Fertility Study.
(2) 40 CFR 798.4350, Inhalation Developmental Toxicity Study.
(3) Chapin, R.E. and J.J. Heindel (1993) Methods in Toxicology,
Vol. 3, Parts A and B: Reproductive Toxicology, Academic Press,
Orlando, FL.
(4) Gray, L.E., et al. (1989) ``A Dose-Response Analysis of
Methoxychlor-Induced Alterations of Reproductive Development and
Function in the Rat'' Fund. App. Tox. 12, 92-108.
(5) Leblond, C.P. and Y. Clermont (1952) ``Definition of the
Stages of the Cycle of the Seminiferous Epithelium of the Rat.''
Ann. N. Y. Acad. Sci. 55:548-73.
(6) Morrissey, R.E., et al. (1988) ``Evaluation of Rodent Sperm,
Vaginal Cytology, and Reproductive Organ Weight Data from National
Toxicology Program 13-week Studies.'' Fundam. Appl. Toxicol. 11:343-
358.
(7) Russell, L.D., Ettlin, R.A., Sinhattikim, A.P., and Clegg,
E.D (1990) Histological and Histopathological Evaluation of the
Testes, Cache River Press, Clearwater, FL.
Sec. 79.64 In vivo micronucleus assay.
(a) Purpose. The micronucleus assay is an in vivo cytogenetic test
which uses erythrocytes in the bone marrow of rodents to detect
chemical damage to the chromosomes or mitotic apparatus of mammalian
cells. As the erythroblast develops into an erythrocyte (red blood
cell), its main nucleus is extruded and may leave a micronucleus in the
cell body; a few micronuclei form under normal conditions in blood
elements. This assay is based on an increase in the frequency of
micronucleated erythrocytes found in bone marrow from treated animals
compared to that of control animals. The visualization of micronuclei
is facilitated in these cells because they lack a main nucleus.
(b) Definitions. For the purposes of this section the following
definitions apply:
Micronuclei mean small particles consisting of acentric fragments
of chromosomes or entire chromosomes, which lag behind at anaphase of
cell division. After telophase, these fragments may not be included in
the nuclei of daughter cells and form single or multiple micronuclei in
the cytoplasm.
Polychromatic erythrocyte (PCE) means an immature red blood cell
that, because it contains RNA, can be differentiated by appropriate
staining techniques from a normochromatic erythrocyte (NCE), which
lacks RNA. In one to two days, a PCE matures into a NCE.
(c) Test method--(1) Principle of the test method. (i) Groups of
rodents are exposed by the inhalation route for a minimum of 6 hours/
day over a period of not less than 28 days to three or more
concentrations of a test substance in air. Groups of animals are
sacrificed at the end of the exposure period and femoral bone marrow is
extracted. The bone marrow is then smeared onto glass slides, stained,
and PCEs are scored for micronuclei. Researchers may need to run a
trial at the highest tolerated concentration of the test atmosphere to
optimize the sample collection time for micronucleated cells.
(ii) This assay may be done separately or in combination with the
subchronic toxicity study, pursuant to the provisions in Sec. 79.62.
(2) Species and strain. (i) The rat is the recommended test animal.
Other rodent species may be used in this assay, but use of that species
will be justified by the tester.
(ii) If a strain of mouse is used in this assay, the tester shall
sample peripheral blood from an appropriate site on the test animal,
e.g., the tail vein, as a source of normochromatic erythrocytes.
Results shall be reported as outlined later in this guideline with
``normochromatic'' interchanged for ``polychromatic'', where specified.
(3) Animal number and sex. At least five female and five male
animals per experimental/sample and control group shall be used. The
use of a single sex or a smaller number of animals shall be justified.
(4) Positive control group. A single concentration of a compound
known to produce micronuclei in vivo is adequate as a positive control
if it shows a significant response at any one time point; additional
concentration levels may be used. To select an appropriate
concentration level, a pilot or trial study may be advisable.
Initially, one concentration of the test substance may be used, the
maximum tolerated dose or that producing some indication of toxicity,
e.g., a drop in the ratio of polychromatic to normochromatic
erythrocytes. Intraperitoneal injection of 1,2-dimethyl-benz-anthracene
or benzene are examples of positive control exposures. A concentration
of 50-80 percent of an LD50 may be a suitable guide.
(d) Test performance--(1) Inhalation exposure. (i) All data
developed within this study shall be in accordance with good laboratory
practice provisions under Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(2) Preparation of slides and sampling times. Within twenty-four
hours of the last exposure, test animals will be sacrificed. One femur
from each test animal will be removed and placed in fetal bovine serum.
The bone marrow is removed, cells processed, and two bone marrow smears
are made for each animal on glass microscope slides. The slides are
stained with acridine- orange (AO) or another appropriate stain (Giemsa
+ Wright's, etc.) and examined under a microscope.
(3) Analysis. Slides shall be coded for study before microscopic
analysis. At least 1,000 first-division erythrocytes per animal shall
be scored for the incidence of micronuclei. Sexes will be analyzed
separately.
(e) Data and report--(1) Treatment of results. In addition to the
reporting requirements specified under Secs. 79.60 and 79.61, the final
test report must include the criteria for scoring micronuclei.
Individual data shall be presented in a tabular form including both
positive and negative controls and experimental groups. The number of
polychromatic erythrocytes scored, the number of micronucleated
erythrocytes, the percentage of micronucleated cells, and, where
applicable, the percentage of micronucleated erythrocytes shall be
listed separately for each experimental and control animal. Absolute
numbers shall be included if percentages are reported.
(2) Interpretation of data. (i) There are several criteria for
determining a positive response, one of which is a statistically
significant dose-related increase in the number of micronucleated
polychromatic erythrocytes. Another criterion may be based upon
detection of a reproducible and statistically significant positive
response for at least one of the test substance concentrations.
(ii) A test substance which does not produce either a statistically
significant dose-related increase in the number of micronucleated
polychromatic erythrocytes or a statistically significant and
reproducible positive response at any one of the test points is
considered nonmutagenic in this system.
(3) Test evaluation. (i) Positive results in the micronucleus test
provide information on the ability of a chemical to induce micronuclei
in erythrocytes of the test species under the conditions of the test.
This damage may have been the result of chromosomal damage or damage to
the mitotic apparatus.
(ii) Negative results indicate that under the test conditions the
test substance does not produce micronuclei in the bone marrow of the
test species.
(f) Test report. In addition to the reporting recommendations as
specified under Sec. 79.60, the following specific information shall be
reported:
(1) Test atmosphere concentration(s) used and rationale for
concentration selection.
(2) Rationale for and description of treatment and sampling
schedules, toxicity data, negative and positive controls.
(3) Historical control data (negative and positive), if available.
(4) Details of the protocol used for slide preparation.
(5) Criteria for identifying micronucleated erythrocytes.
(6) Micronucleus analysis by animal and by group for each
concentration (sexes analyzed separately).
(i) Ratio of polychromatic to normochromatic erythrocytes.
(ii) Number of polychromatic erythrocytes with micronuclei.
(iii) Number of polychromatic erythrocytes scored.
(7) Statistical methodology chosen for test analysis.
(g) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.5395, In Vivo, Mammalian Bone Marrow Cytogenetics
Tests: Micronucleus Assay.
(2) Cihak, R. ``Evaluation of Benzidine by the Micronucleus
Test.'' Mutation Research, 67: 383-384 (1979).
(3) Evans, H.J. ``Cytological Methods for Detecting Chemical
Mutagens.'' Chemical Mutagens: Principles and Methods for Their
Detection, Vol. 4. Ed. A. Hollaender (New York and London: Plenum
Press, 1976) pp. 1-29.
(4) Heddle, J.A., et al. ``The Induction of Micronuclei as a
Measure of Genotoxicity. A Report of the U.S. Environmental
Protection Agency Gene-Tox Program.'' Mutation Research, 123:61-118
(1983).
(5) Preston, J.R. et al. ``Mammalian In Vivo and In Vitro
Cytogenetics Assays: Report of the Gene-Tox Program.'' Mutation
Research, 87:143-188 (1981).
(6) Schmid, W. ``The micronucleus test for cytogenetic
analysis'', Chemical Mutagens, Principles and Methods for their
Detection. Vol. 4 Hollaender A, (Ed. A ed. (New York and London:
Plenum Press, (1976) pp. 31-53.
(7) Tice, R.E., and Al Pellom ``User's guide: Micronucleus assay
data management and analysis system'', NTIS Order no. PB-90-212-
598AS.
Sec. 79.65 In vivo sister chromatid exchange assay.
(a) Purpose. The in vivo sister chromatid exchange (SCE) assay
detects the ability of a chemical to enhance the exchange of DNA
between two sister chromatids of a duplicating chromosome. The most
commonly used assays employ mammalian bone marrow cells or peripheral
blood lymphocytes, often from rodent species.
(b) Definitions. For the purposes of this section, the following
definitions apply:
C-metaphase means a state of arrested cell growth typically seen
after treatment with a spindle inhibitor, i.e., colchicine.
Sister chromatid exchange means a reciprocal interchange of the two
chromatid arms within a single chromosome. This exchange is visualized
during the metaphase portion of the cell cycle and presumably requires
the enzymatic incision, translocation and ligation of at least two DNA
helices.
(c) Test method--(1) Principle of the test method. (i) Groups of
rodents are exposed by the inhalation route for a minimum of 6 hours/
day over a period of not less than 28 days to three or more
concentrations of a test substance in air. Groups of animals are
sacrificed at the end of the exposure period and blood lymphocyte cell
cultures are prepared from study animals. Cell growth is suspended
after a time and cells are harvested, fixed and stained before scoring
for SCEs. Researchers may need to run a trial at the highest tolerated
concentration of the test atmosphere to optimize the sample collection
time for second division metaphase cells.
(ii) This assay may be done separately or in combination with the
subchronic toxicity study, pursuant to the provisions in Sec. 79.62.
(2) Description. (i) The method described here employs peripheral
blood lymphocytes (PBL) of laboratory rodents exposed to the test
atmosphere.
(ii) Within twenty-four hours of the last exposure, test animal
lymphocytes are obtained by heart puncture and duplicate cell cultures
are started for each animal. Cultures are grown in bromo-deoxyuridine
(BrdU), and then a spindle inhibitor (e.g., colchicine) is added to
arrest cell growth. Cells are harvested, fixed, and stained and their
chromosomes are scored for SCEs.
(3) Species and strain. The rat is the recommended test animal.
Other rodent species may be used in this assay, but use of that species
will be justified by the tester.
(4) Animal number and sex. At least five female and five male
animals per experimental and control group shall be used. The use of a
single sex or different number of animals shall be justified.
(5) Positive control group. A single concentration of a compound
known to produce SCEs in vivo is adequate as a positive control if it
shows a significant response at any one time point; additional
concentration levels may be used. To select an appropriate
concentration level, a pilot or trial study may be advisable.
Initially, one concentration of the test substance may be used, the
maximum tolerated dose or that producing some indication of toxicity as
evidenced by animal morbidity (including death) or target cell
toxicity. Intraperitoneal injection of 1,2-dimethyl-benz-anthracene or
benzene are examples of positive control exposures. A concentration of
50-80 percent of an LD50 would also be a suitable guide.
(6) Inhalation exposure. (i) All data developed within this study
shall be in accordance with good laboratory practice provisions under
Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(d) Test performance--(1) Treatment. At the conclusion of the
exposure period, all test animals are anaesthetized and heart punctures
are performed. Lymphocytes are isolated over a Ficoll gradient and
replicate cell cultures are started for each animal. After some 21
hours, the cells are treated with BrdU and returned to incubation. The
following day, a spindle inhibitor (e.g., colchicine) is added to
arrest cell growth in c-metaphase. Cells are harvested 4 hours later
and second-division metaphase cells are washed and fixed in
methanol:acetic acid, stained, and chromosome preparations are scored
for SCEs.
(2) Staining method. Staining of slides to reveal SCEs can be
performed according to any of several protocols. However, the
fluorescence plus Giemsa method is recommended.
(3) Number of cells scored. (i) A minimum of 25 well-stained,
second-division metaphase cells shall be scored for each animal for
each cell type.
(ii) At least 100 consecutive metaphase cells shall be scored for
the number of first, second, and third division metaphases for each
animal for each cell type.
(iii) At least 1000 consecutive PBL's shall be scored for the
number of metaphase cells present.
(iv) The number of cells to be analyzed per animal shall be based
upon the number of animals used, the negative control frequency, the
pre-determined sensitivity and the power chosen for the test. Slides
shall be coded before microscopic analysis.
(e) Data and report--(1) Treatment of results. In addition to the
reporting requirements specified under Secs. 79.60 and 61, data shall
be presented in tabular form, providing scores for both the number of
SCE for each metaphase. Differences among animals within each group
shall be considered before making comparisons between treated and
control groups.
(2) Statistical evaluation. Data shall be evaluated by appropriate
statistical methods.
(3) Interpretation of results. (i) There are several criteria for
determining a positive result, one of which is a statistically
significant dose-related increase in the number of SCE. Another
criterion may be based upon detection of a reproducible and
statistically significant positive response for at least one of the
test concentrations.
(ii) A test substance which does not produce either a statistically
significant dose-related increase in the number of SCE or a
statistically significant and reproducible positive response at any one
of the test concentrations is considered not to induce rearrangements
of DNA segments in this system.
(iii) Both biological and statistical significance shall be
considered together in the evaluation.
(4) Test evaluation. (i) A positive result in the in vivo SCE assay
for either, or both, the lung or lymphocyte cultures indicates that
under the test conditions the test substance induces reciprocal
interchanges of DNA in duplicating chromosomes from lung or lymphocyte
cells of the test species.
(ii) Negative results indicate that under the test conditions the
test substance does not induce reciprocal interchanges in lung or
lymphocyte cells of the test species.
(5) Test report. In addition to the reporting recommendations as
specified under Secs. 79.60 and 79.61, the following specific
information shall be reported:
(i) Test concentrations used, rationale for concentration
selection, negative and positive controls;
(ii) Toxic response data by concentration;
(iii) Schedule of administration of test atmosphere, BrdU, and
spindle inhibitor;
(iv) Time of harvest after administration of BrdU;
(v) Identity of spindle inhibitor, its concentration and timing of
treatment;
(vi) Details of the protocol used for cell culture and slide
preparation;
(vii) Criteria for scoring SCE;
(viii) Replicative index, i.e., [percent 1st division+(2 x percent
2nd division) + (3 x percent 3rd division) metaphases]/100; and
(ix) Mitotic activity, i.e., # of metaphases/1000 cells.
(f) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.5915, In vivo Sister Chromatid Exchange Assay.
(2) Kato, H. ``Spontaneous Sister Chromatid Exchanges Detected
by a BudR-Labeling Method.'' Nature, 251:70-72 (1974).
(4) Kligerman, A. D., et al. ``Sister Chromatid Exchange
Analysis in Lung and Peripheral Blood Lymphocytes of Mice Exposed to
Methyl Isocyanate by Inhalation.'' Environmental Mutagenesis 9:29-36
(1987).
(5) Kligerman, A.D., et al., ``Cytogenetic Studies of Rodents
Exposed to Styrene by Inhalation'', IARC Monographs no. 127
``Butadiene and Styrene: Assesment of Health Hazards'' (Sorsa, et
al., eds), pp 217-224, 1993.
(6) Kligerman, A., et al., ``Cytogenetic Studies of Mice Exposed
to Styrene by Inhalation.'', Mutation Research, 280:35-43, 1992.
(7) Wolff, S., and P. Perry. ``Differential Giemsa Staining of
Sister Chromatids and the Study of Sister Chromatid Exchanges
Without Autoradiography.'' Chromosoma 48: 341-53 (1974).
Sec. 79.66 Neuropathology assessment.
(a) Purpose. (1) The histopathological and biochemical techniques
in this guideline are designed to develop data in animals on
morphologic changes in the nervous system associated with repeated
inhalation exposures to motor vehicle emissions. These tests are not
intended to provide a detailed evaluation of neurotoxicity.
Neuropathological evaluation should be complemented by other
neurotoxicity studies, e.g. behavioral and neurophysiological studies
and/or general toxicity testing, to more completely assess the
neurotoxic potential of an exposure.
(2) [Reserved]
(b) Definition. Neurotoxicity (NTX) or a neurotoxic effect is an
adverse change in the structure or function of the nervous system
following exposure to a chemical substance.
(c) Principle of the test method. (1) Laboratory rodents are
exposed to one of several concentration levels of a test atmosphere for
at least six hours daily over a period of 90 days. At the end of the
exposure period, the animals are anaesthetized, perfused in situ with
fixative, and tissues in the nervous system are examined grossly and
prepared for microscopic examination. Starting with the highest dosage
level, tissues are examined under the light microscope for morphologic
changes, until a no-observed-adverse-effect level is determined. In
cases where light microscopy has revealed neuropathology, the NOAEL may
be confirmed by electron microscopy.
(2) The tests described herein may be combined with any other
toxicity study, as long as none of the requirements of either are
violated by the combination. Specifically, this assay may be combined
with a subchronic toxicity study, pursuant to provisions in Sec. 79.62.
(d) Limit test. If a test at one dose level of the highest
concentration that can be achieved while maintaining a particle size
distribution with a mass median aerodynamic diameter (MMAD) of 4
micrometers (m) or less, using the procedures described in
paragraph (a) of this section, produces no observable toxic effects and
if toxicity would not be expected based upon data of structurally
related compounds, then a full study using three dose levels might not
be necessary. Expected human exposure though may indicate the need for
a higher dose level.
(e) Test procedures--(1) Animal selection--(i) Species and strain.
Testing shall be performed in the species being used in other NTX
tests. A standard strain of laboratory rat is recommended. The choice
of species shall take into consideration such factors as the
comparative metabolism of the chemical and species sensitivity to the
toxic effects of the test substance, as evidenced by the results of
other studies, the potential for combined studies, and the availability
of other toxicity data for the species.
(ii) Age. Animals shall be at least ten weeks of age at the start
of exposure.
(iii) Sex. Both sexes shall be used unless it is demonstrated that
one sex is refractory to the effects of exposure.
(2) Number of Animals. A minimum of ten animals per group shall be
used. The tissues from each animal shall be examined separately.
(3) Control Groups. (i) A concurrent control group, exposed to
clean, filtered air only, is required.
(ii) The laboratory performing the testing shall provide positive
control data, e.g., results from repeated acrylamide exposure, as
evidence of the ability of their histology procedures to detect
neurotoxic endpoints. Positive control data shall be collected at the
time of the test study unless the laboratory can demonstrate the
adequacy of historical data for the planned study.
(iii) A satellite group of 10 female and 10 male test subjects
shall be treated with the highest concentration level for the duration
of the exposure and observed thereafter for reversibility, persistence,
or delayed occurrence of toxic effects during a post-treatment period
of not less than 28 days.
(4) Inhalation exposure. (i) All data developed within this study
shall be in accordance with good laboratory practice provisions under
Sec. 79.60.
(ii) The general conduct of this study shall be in accordance with
the vehicle emissions inhalation exposure guideline in Sec. 79.61.
(5) Study conduct--(i) Observation of animals. All toxicological
(e.g., weight loss) and neurological signs (e.g., motor disturbance)
shall be recorded frequently enough to observe any abnormality, and not
less than weekly.
(ii) The following is a minimal list of measures that shall be
noted:
(A) Body weight;
(B) Subject's reactivity to general stimuli such as removal from
the cage or handling;
(C) Description, incidence, and severity of any convulsions,
tremors, or abnormal motor movements in the home cage;
(D) Descriptions and incidence of posture and gait abnormalities
observed in the home cage; and
(E) Description and incidence of any unusual or abnormal behaviors,
excessive or repetitive actions (stereotypies), emaciation,
dehydration, hypotonia or hypertonia, altered fur appearance, red or
crusty deposits around the eyes, nose, or mouth, and any other
observations that may facilitate interpretation of the data.
(iii) Sacrifice of animals--(A) General. The goal of the techniques
outlined for sacrifice of animals and preparation of tissues is
preservation of tissue morphology to simulate the living state of the
cell.
(B) Perfusion technique. Animals shall be perfused in situ by a
generally recognized technique. For fixation suitable for light or
electronic microscopy, saline solution followed by buffered 2.5 percent
glutaraldehyde or buffered 4.0 percent paraformaldehyde, is
recommended. While some minor modifications or variations in procedures
are used in different laboratories, a detailed and standard procedure
for vascular perfusion may be found in the text by Zeman and Innes
(1963), Hayat (1970), and Spencer and Schaumburg (1980) under paragraph
(g) of this section. A more sophisticated technique is described by
Palay and Chan-Palay (1974) under paragraph (g) of this section.
(C) Removal of brain and cord. After perfusion, the bony structure
(cranium and vertebral column) shall be exposed. Animals shall then be
stored in fixative-filled bags at 4 deg.C for 8-12 hours. The cranium
and vertebral column shall be removed carefully by trained technicians
without physical damage of the brain and cord. Detailed dissection
procedures may be found in the text by Palay and Chan-Palay (1974)
under paragraph (g) of this section. After removal, simple measurement
of the size (length and width) and weight of the whole brain (cerebrum,
cerebellum, pons-medulla) shall be made. Any abnormal coloration or
discoloration of the brain and cord shall also be noted and recorded.
(D) Sampling. Cross-sections of the following areas shall be
examined: The forebrain, the center of the cerebrum, the midbrain, the
cerebellum, and the medulla oblongata; the spinal cord at the cervical
swelling (C3-C6), and proximal sciatic nerve (mid-thigh and
sciatic notch) or tibial nerve (at knee). Other sites and tissue
elements (e.g., gastrocnemius muscle) shall be examined if deemed
necessary. Any observable gross changes shall be recorded.
(iv) Specimen storage. Tissue samples from both the central and
peripheral nervous system shall be further immersion fixed and stored
in appropriate fixative (e.g., 10 percent buffered formalin for light
microscopy; 2.5 percent buffered gluteraldehyde or 4.0 percent buffered
paraformaldehyde for electron microscopy) for future examination. The
volume of fixative versus the volume of tissues in a specimen jar shall
be no less than 25:1. All stored tissues shall be washed with buffer
for at least 2 hours prior to further tissue processing.
(v) Histopathology examination--(A) Fixation. Tissue specimens
stored in 10 percent buffered formalin may be used for this purpose.
All tissues must be immersion fixed in fixative for at least 48 hours
prior to further tissue processing.
(B) Dehydration. All tissue specimens shall be washed for at least
1 hour with water or buffer, prior to dehydration. (A longer washing
time is needed if the specimens have been stored in fixative for a
prolonged period of time.) Dehydration can be performed with increasing
concentration of graded ethanols up to absolute alcohol.
(C) Clearing and embedding. After dehydration, tissue specimens
shall be cleared with xylene and embedded in paraffin or paraplast.
Multiple tissue specimens (e.g. brain, cord, ganglia) may be embedded
together in one single block for sectioning. All tissue blocks shall be
labelled showing at least the experiment number, animal number, and
specimens embedded.
(D) Sectioning. Tissue sections, 5 to 6 microns in thickness, shall
be prepared from the tissue blocks and mounted on standard glass
slides. It is recommended that several additional sections be made from
each block at this time for possible future needs for special
stainings. All tissue blocks and slides shall be filed and stored in
properly labeled files or boxes.
(E) Histopathological techniques. The following general testing
sequence is proposed for gathering histopathological data:
(1) General staining. A general staining procedure shall be
performed on all tissue specimens in the highest treatment group.
Hematoxylin and eosin (H&E) shall be used for this purpose. The
staining shall be differentiated properly to achieve bluish nuclei with
pinkish background.
(2) Peripheral nerve teasing. Peripheral nerve fiber teasing shall
be used. Detailed staining methodology is available in standard
histotechnological manuals such as AFIP (1968), Ralis et al. (1973),
and Chang (1979) under paragraph (g) of this section. The nerve fiber
teasing technique is discussed in Spencer and Schaumberg (1980) under
paragraph (g) of this section. A section of normal tissue shall be
included in each staining to assure that adequate staining has
occurred. Any changes shall be noted and representative photographs
shall be taken. If a lesion(s) is observed, the special techniques
shall be repeated in the next lower treatment group until no further
lesion is detectable.
(F) Examination. All stained microscopic slides shall be examined
with a standard research microscope. Examples of cellular alterations
(e.g., neuronal vacuolation, degeneration, and necrosis) and tissue
changes (e.g., gliosis, leukocytic infiltration, and cystic formation)
shall be recorded and photographed.
(f) Data collection, reporting, and evaluation. In addition to
information meeting the requirements stated under 40 CFR 79.60 and
79.61, the following specific information shall be reported:
(1) Description of test system and test methods. (i) A description
of the general design of the experiment shall be provided. This shall
include a short justification explaining any decisions where
professional judgment is involved such as fixation technique and choice
of stains; and
(ii) Positive control data from the laboratory performing the test
that demonstrate the sensitivity of the procedures being used.
Historical data may be used if all essential aspects of the
experimental protocol are the same.
(2) Results. All observations shall be recorded and arranged by
test groups. This data may be presented in the following recommended
format:
(i) Description of signs and lesions for each animal. For each
animal, data must be submitted showing its identification (animal
number, treatment, dose, duration), neurologic signs, location(s)
nature of, frequency, and severity of lesion(s). A commonly-used scale
such as 1+, 2+, 3+, and 4+ for degree of severity ranging from very
slight to extensive may be used. Any diagnoses derived from neurologic
signs and lesions including naturally occurring diseases or conditions,
shall also be recorded;
(ii) Counts and incidence of lesions, by test group. Data shall be
tabulated to show:
(A) The number of animals used in each group, the number of animals
displaying specific neurologic signs, and the number of animals in
which any lesion was found; and
(B) The number of animals affected by each different type of
lesion, the average grade of each type of lesion, and the frequency of
each different type and/or location of lesion.
(iii) Evaluation of data. (A) An evaluation of the data based on
gross necropsy findings and microscopic pathology observations shall be
made and supplied. The evaluation shall include the relationship, if
any, between the animal's exposure to the test atmosphere and the
frequency and severity of any lesions observed; and
(B) The evaluation of dose-response, if existent, for various
groups shall be given, and a description of statistical method must be
presented. The evaluation of neuropathology data shall include, where
applicable, an assessment in conjunction with any other neurotoxicity
studies, electrophysiological, behavioral, or neurochemical, which may
be relevant to this study.
(g) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.6400, Neuropathology.
(2) AFIP Manual of Histologic Staining Methods. (New York: McGraw-
Hill (1968).
(3) Chang, L.W. A Color Atlas and Manual for Applied Histochemistry.
(Springfield, IL: Charles C. Thomas, 1979).
(4) Dunnick, J.K., et.al. Thirteen-week Toxicity Study of N-Hexane
in B6C3F1 Mice After Inhalation Exposure (1989) Toxicology, 57, 163-
172.
(5) Hayat, M.A. ``Vol. 1. Biological applications,'' Principles and
techniques of electron microscopy. (New York: Van Nostrand Reinhold,
1970).
(6) Palay S.L., Chan-Palay, V. Cerebellar Cortex: Cytology and
Organization. (New York: Springer-Verlag, 1974).
(7) Ralis, H.M., Beesley, R.A., Ralis, Z.A. Techniques in
Neurohistology. (London: Butterworths, 1973).
(8) Sette, W. ``Pesticide Assessment Guidelines, Subdivision F,
Neurotoxicity Test Guidelines.'' Report No. 540/09-91-123 U.S.
Environmental Protection Agency 1991 (NTIS #PB91-154617).
(9) Spencer, P.S., Schaumburg, H.H. (eds). Experimental and Clinical
Neurotoxicology. (Baltimore: Williams and Wilkins, 1980).
(10) Zeman, W., Innes, J.R.M. Craigie's Neuroanatomy of the Rat.
(New York: Academic, 1963).
Sec. 79.67 Glial fibrillary acidic protein assay.
(a) Purpose. Chemical-induced injury of the nervous system, i.e.,
the brain, is associated with astrocytic hypertrophy at the site of
damage (see O'Callaghan, 1988 in paragraph (e)(3) in this section).
Assays of glial fibrillary acidic protein (GFAP), the major
intermediate filament protein of astrocytes, can be used to document
this response. To date, a diverse variety of chemical insults known to
be injurious to the central nervous system have been shown to increase
GFAP. Moreover, increases in GFAP can be seen at concentrations below
those necessary to produce cytopathology as determined by routine Nissl
stains (standard neuropathology). Thus it appears that assays of GFAP
represent a sensitive approach for documenting the existence and
location of chemical-induced injury of the central nervous system.
Additional functional, histopathological, and biochemical tests are
necessary to assess completely the neurotoxic potential of any
chemical. This biochemical test is intended to be used in conjunction
with neurohistopathological studies.
(b) Principle of the test method. (1) This guideline describes the
conduct of a radioimmunoassay for measurement of the amount of GFAP in
the brain of vehicle emission-exposed and unexposed control animals. It
is based on modifications (O'Callaghan & Miller 1985 in paragraph
(e)(5), O'Callaghan 1987 in paragraph (e)(1) of this section) of the
dot-immunobinding procedure described by Jahn et al. (1984) in
paragraph (e)(2) of this section. Briefly, brain tissue samples from
study animals are assayed for total protein, diluted in dot-
immunobinding buffer, and applied to nitrocellulose sheets. The spotted
sheets are then fixed, blocked, washed and incubated in anti-GFAP
antibody and [I125] Protein A. Bound protein A is then quantified
by gamma spectrometry. In lieu of purified protein standards, standard
curves are constructed from dilution of a single control sample. By
comparing the immunoreactivity of individual samples (both control and
exposed groups) with that of the sample used to generate the standard
curve, the relative immunoreactivity of each sample is obtained. The
immunoreactivity of the control groups is normalized to 100 percent and
all data are expressed as a percentage of control. A variation on this
radioimmunoassay procedure has been proposed (O'Callaghan 1991 in
paragraph (e)(4) of this section) which uses a ``sandwich'' of GFAP,
anti-GFAP, and a chromophore in a microtiter plate format enzyme-link
immunosorbent assay (ELISA). The use of this variation shall be
justified.
(2) This assay may be done separately or in combination with the
subchronic toxicity study, pursuant to the provisions of Sec. 79.62.
(c) Test procedure--(1) Animal selection--(i) Species and strain.
Test shall be performed on the species being used in concurrent testing
for neurotoxic or other health effect endpoints. This will generally be
a species of laboratory rat. The use of other rodent or non-rodent
species shall be justified.
(ii) Age. Based on other concurrent testing, young adult rats shall
be used. Study rodents shall not be older than ten weeks at the start
of exposures.
(iii) Number of animals. A minimum of ten animals per group shall
be used. The tissues from each animal shall be examined separately.
(iv) Sex. Both sexes shall be used unless it is demonstrated that
one sex is refractory to the effects.
(2) Materials. The materials necessary to perform this study are
[I125] Protein A (2-10 Ci/g), Anti-sera to GFAP,
nitrocellulose paper (0.1 or 0.2 m pore size), sample
application template (optional; e.g., ``Minifold II'', Schleicher &
Schuell, Keene, NH), plastic sheet incubation trays.
(3) Study conduct. (i) All data developed within this study shall
be in accordance with good laboratory practice provisions under
Sec. 79.60.
(ii) Tissue Preparation. Animals are euthanized 24 hours after the
last exposure and the brain is excised from the skull. On a cold
dissecting platform, the following six regions are dissected freehand:
cerebellum; cerebral cortex; hippocampus; striatum; thalamus/
hypothalamus; and the rest of the brain. Each region is then weighed
and homogenized in 10 volumes of hot (70-90 deg.C) 1 percent (w/v)
sodium dodecyl sulfate (SDS). Homogenization is best achieved through
sonic disruption. A motor driven pestle inserted into a tissue grinding
vessel is a suitable alternative. The homogenized samples can then be
stored frozen at -70 deg.C for at least 4 years without loss of GFAP
content.
(iii) Total Protein Assay. Aliquots of the tissue samples are
assayed for total protein using the method of Smith et al. (1985) in
paragraph (e)(7) of this section. This assay may be purchased in kit
form (e.g., Pierce Chemical Company, Rockford, IL).
(iv) Sample Preparation. Dilute tissue samples in sample buffer
(120 mM KCl, 20 mM NaCl, 2 mM MgCl2), 5 mM Hepes, pH 7.4, 0.7
percent Triton X-100) to a final concentration of 0.25 mg total protein
per ml (5 g/20 l).
(v) Preparation of Standard Curve. Dilute a single control sample
in sample buffer to give at least five standards, between 1 and 10
g total protein per 20 l. The suggested values of
total protein per 20 l sample buffer are 1.25, 2.50, 3.25,
5.0, 6.25, 7.5, 8.75, and 10.0 g.
(vi) Preparation of Nitrocellulose Sheets. Nitrocellulose sheets of
0.1 or 0.2 micron pore size are rinsed by immersion in distilled water
for 5 minutes and then air dried.
(vii) Sample Application. Samples can be spotted onto the
nitrocellulose sheets free-hand or with the aid of a template. For
free-hand application, draw a grid of squares approximately 2
centimeters by 2 centimeters (cm) on the nitrocellulose sheets using a
soft pencil. Spot 5-10 l portions to the center of each square
for a total sample volume of 20 l. For template aided sample
application a washerless microliter capacity sample application
manifold is used. Position the nitrocellulose sheet in the sample
application device as recommended by the manufacturer and spot a 20
l sample in one application. Do not wet the nitrocellulose or
any support elements prior to sample application. Do not apply vacuum
during or after sample application. After spotting samples (using
either method), let the sheets air dry. The sheets can be stored at
room temperature for several days after sample application.
(viii) Standard Incubation Conditions. These conditions have been
described by Jahn et al. (1984) in paragraph (e)(2) of this section.
All steps are carried out at room temperature on a flat shaking
platform (one complete excursion every 2-3 seconds). For best results,
do not use rocking or orbital shakers. Perform the following steps in
enough solution to cover the nitrocellulose sheets to a depth of 1 cm.
(A) Incubate 20 minutes in fixer (25 percent (v/v) isopropanol, 10
percent (v/v) acetic acid).
(B) Discard fixer, wash several times in deionized water to
eliminate the fixer, and then incubate for 5 minutes in Tris-buffered
saline (TBS): 200 mM NaCL, 60 mM Tris-HCl to pH 7.4.
(C) Discard TBS and incubate 1 hour in blocking solution (0.5
percent gelatin (w/v)) in TBS.
(D) Discard blocking solution and incubate for 2 hours in antibody
solution (anti-GFAP antiserum diluted to the desired dilution in
blocking solution containing 0.1 percent Triton X-100). Serum anti-
bovine GFAP, which cross reacts with GFAP from rodents and humans, can
be obtained commercially (e.g., Dako Corp.) and used at a dilution of
1:500.
(E) Discard antibody solution, and wash in 4 changes of TBS for 5
minutes each time. Then wash in TBS for 10 minutes.
(F) Discard TBS and incubate in blocking solution for 30 minutes.
(G) Discard blocking solution and incubate for 1 hour in Protein A
solution ([I\125\]-labeled Protein A diluted in blocking solution
containing 0.1 percent Triton X-100, sufficient to produce 2000 counts
per minute (cpm) per 10 l of Protein A solution).
(H) Remove Protein A solution (it may be reused once). Wash in 0.1
percent Triton X-100 in TBS (TBSTX) for 5 minutes, 4 times. Then wash
in TBSTX for 2-3 hours for 4 additional times. An overnight wash in a
larger volume can be used to replace the last 4 washes.
(I) Hang sheets to air-dry. Cut out squares or spots and count
radioactivity in a gamma counter.
(ix) Expression of data. Compare radioactivity counts for samples
obtained from control and treated animals with counts obtained from the
standard curve. By comparing the immunoreactivity (counts) of each
sample with that of the standard curve, the relative amount of GFAP in
each sample can be determined and expressed as a percent of control.
(d) Data Reporting and Evaluation--(1) Test Report. In addition to
information meeting the requirements stated under 40 CFR 79.60, the
following specific information shall be reported:
(i) Body weight and brain region weights at time of sacrifice for
each subject tested;
(ii) Indication of whether each subject survived to sacrifice or
time of death;
(iii) Data from control animals and blank samples; and
(iv) Statistical evaluation of results;
(2) Evaluation of Results. (i) Results shall be evaluated in terms
of the extent of change in the amount of GFAP as a function of
treatment and dose. GFAP assays (of any brain region) from a minimum of
6 samples typically will result in a standard error of the mean of +/-
5 percent. In this case, a chemically-induced increase in GFAP of 115
percent of control is likely to be statistically significant.
(ii) The results of this assay shall be compared to and evaluated
with any relevant behavioral and histopathological data.
(e) References. For additional background information on this test
guideline the following references should be consulted.
(1) Brock, T.O and O'Callaghan, J.P. 1987. Quantitative changes in
the synaptic vesicle proteins, synapsin I and p38 and the astrocyte
specific protein, glial fibrillary acidic protein, are associated
with chemical-induced injury to the rat central nervous system, J.
Neurosci. 7:931-942.
(2) Jahn, R., Schiebler, W. Greengard, P. 1984. A quantitative dot-
immunobinding assay for protein using nitrocellulose membrane
filters. Proc. Natl. Acad. Sci. U.S.A. 81:1684-1687.
(3) O'Callaghan, J.P. 1988. Neurotypic and gliotypic protein as
biochemical markers of neurotoxicity. Neurotoxicol. Teratol. 10:445-
452.
(4) O'Callaghan, J.P. 1991. Quantification of glial fibrillary
acidic protein: comparison of slot-immunobinding assays with a novel
sandwich ELISA. Neurotoxicol. Teratol. 13:275-281.
(5) O'Callaghan, J.P. and Miller, D.B. 1985. Cerebellar hypoplasia
in the Gunn rat is associated with quantitative changes in
neurotypic and gliotypic proteins. J. Pharmacol. Exp. Ther. 234:522-
532.
(6) Sette, W.F. ``Pesticide Assessment Guidelines, Subdivision `F',
Hazard Evaluation: Human and Domestic Animals, Addendum 10,
Neurotoxicity, Series 81, 82, and 83'' US-EPA, Office of Pesticide
Programs, EPA-540/09-91-123, March 1991.
(7) Smith, P.K., Krohn, R.I., Hermanson, G.T., Mallia, A.K.,
Gartner, F.H., Provenzano, M.D., Fujimoto, E.K., Goeke, N.M., Olson,
B.J., Klenk, D.C. 1985. Measurement of protein using bicinchoninic
acid. Annal. Biochem. 150:76-85.
Sec. 79.68 Salmonella typhimurium reverse mutation assay.
(a) Purpose. The Salmonella typhimurium histidine (his) reversion
system is a microbial assay which measures his- his+
reversion induced by chemicals which cause base changes or frameshift
mutations in the genome of the microorganism Salmonella typhimurium.
(b) Definitions. For the purposes of this section, the following
definitions apply:
Base pair mutagen means an agent which causes a base change in DNA. In
a reversion assay, this change may occur at the site of the original
mutation or at a second site in the chromosome.
Frameshift mutagen is an agent which causes the addition or deletion of
single or multiple base pairs in the DNA molecule.
Salmonella typhimurium reverse mutation assay detects mutation in a
gene of a histidine-requiring strain to produce a histidine independent
strain of this organism.
(c) Reference substances. These may include, but need not be
limited to, sodium azide, 2-nitrofluorene, 9-aminoacridine, 2-
aminoanthracene, congo red, benzopurpurin 4B, trypan blue or direct
blue 1.
(d) Test method.--(1) Principle. Motor vehicle combustion emissions
from fuel or additive/base fuel mixtures are, first, filtered to trap
particulate matter and, then, passed through a sorbent resin to trap
semi-volatile gases. Bacteria are separately exposed to the extract
from both the filtered particulates and the resin-trapped organics.
Assays are conducted using both test mixtures with and without a
metabolic activation system and exposed cells are plated onto minimal
medium. After a suitable period of incubation, revertant colonies are
counted in test cultures and compared to the number of spontaneous
revertants in unexposed control cultures.
(2) Description. Several methods for performing the test have been
described. The procedures described here are for the direct plate
incorporation method and the azo-reduction method. Among those used
are:
(i) Direct plate incorporation method;
(ii) Preincubation method;
(iii) Azo-reduction method;
(iv) Microsuspension method; and
(v) Spiral assay.
(3) Strain selection--(i)Designation. Five tester strains shall be
used in the assay. At the present time, TA1535, TA1537, TA98, and TA100
are designated as tester strains. The fifth strain will be chosen from
the pool of Salmonella strains commonly used to determine the degree to
which nitrated organic compounds, i.e., nitroarenes, contribute to the
overall mutagenic activity of a test substance. TA98/1,8-DNP6 or
other suitable Rosenkranz nitro-reductase resistant strains will be
considered acceptable. The choice of the particular strain is left to
the discretion of the researcher. However, the researcher shall justify
the use of the selected bacterial tester strains.
(ii) Preparation and storage of bacterial tester strains.
Recognized methods of stock culture preparation and storage shall be
used. The requirement of histidine for growth shall be demonstrated for
each strain. Other phenotypic characteristics shall be checked using
such methods as crystal violet sensitivity and resistance to
ampicillin. Spontaneous reversion frequency shall be in the range
expected as reported in the literature and as established in the
laboratory by historical control values.
(iii) Bacterial growth. Fresh cultures of bacteria shall be grown
up to the late exponential or early stationary phase of growth
(approximately 108-109 cells per ml).
(4) Exogenous metabolic activation. Bacteria shall be exposed to
the test substance both in the presence and absence of an appropriate
exogenous metabolic activation system. For the direct plate
incorporation method, the most commonly used system is a cofactor-
supplemented postmitochondrial fraction prepared from the livers of
rodents treated with enzyme-inducing agents, such as Aroclor 1254. For
the azo-reduction method, a cofactor- supplemented postmitochondrial
fraction (S-9) prepared from the livers of untreated hamsters is
preferred. For this method, the cofactor supplement shall contain
flavin mononucleotide, exogenous glucose 6-phosphate dehydrogenase,
NADH and excess of glucose-6-phosphate.
(5) Control groups--(i) Concurrent controls. Concurrent positive
and negative (untreated) controls shall be included in each experiment.
Positive controls shall ensure both strain responsiveness and efficacy
of the metabolic activation system.
(ii) Strain specific positive controls shall be included in the
assay. Examples of strain specific positive controls are as follows:
(A) Strain TA1535, TA100: sodium azide;
(B) TA98: 2-nitrofluorene (without activation), 2-anthramine (with
activation);
(C) TA1537: 9-aminoacridine; and
(D) TA98/1,8-DNP6: benzo(a)pyrene (with activation).
The papers by Claxton et al., 1991 and 1992 in paragraph (g) in
this section will provide helpful information for the selection of
positive controls.
(iii) Positive controls to ensure the efficacy of the activation
system. The positive control reference substances for tests including a
metabolic activation system shall be selected on the basis of the type
of activation system used in the test. 2-Aminoanthracene is an example
of a positive control compound in plate-incorporation tests using
postmitochondrial fractions from the livers of rodents treated with
enzyme-inducing agents such as Aroclor-1254. Congo red is an example of
a positive control compound in the azo-reduction method. Other positive
control reference substances may be used.
(iv) Class-specific positive controls. The azo-reduction method
shall include positive controls from the same class of compounds as the
test agent wherever possible.
(6) Sampling the test atmosphere.--(i) Extracts of test emissions
are collected on Teflon-coated glass fiber filters using an
exhaust dilution setup. The particulates are extracted with
dichloromethane (DCM) using Soxhlet extraction techniques. Extracts in
DCM can be stored at dry ice temperatures until use.
(ii) Gaseous hydrocarbons passing through the filter are trapped by
a porous, polymer resin, like XAD-2/styrene-divinylbenzene, or an
equivalent product. Methylene chloride is used to extract the resin and
the sample is evaporated to dryness before storage or use.
(iii) Samples taken from this material are then used to expose the
cells in this assay. Final concentration of extracts in solvent/
vehicle, or after solvent exchange, shall not interfere with cell
viability or growth rate. The paper by Stump (1982) in paragraph (g) of
this section is useful for preparing extracts of particulate and semi-
volatile organic compounds from diesel and gasoline exhaust stream.
(iv) Exposure concentrations. (A) The test should initially be
performed over a broad range of concentrations. Among the criteria to
be taken into consideration for determining the upper limits of test
substance concentration are cytotoxicity and solubility. Cytotoxicity
of the test chemical may be altered in the presence of metabolic
activation systems. Toxicity may be evidenced by a reduction in the
number of spontaneous revertants, a clearing of the background lawn or
by the degree of survival of treated cultures. Relatively insoluble
samples shall be tested up to the limits of solubility. The upper test
chemical concentration shall be determined on a case by case basis.
(B) Generally, a maximum of 5 mg/plate for pure substances is
considered acceptable. At least 5 different concentrations of test
substance shall be used with adequate intervals between test points.
(C) When appropriate, a single positive response shall be confirmed
by testing over a narrow range of concentrations.
(e) Test performance. All data developed within this study shall be
in accordance with good laboratory practice provisions under
Sec. 79.60.
(1) Direct plate incorporation method. When testing with metabolic
activation, test solution, bacteria, and 0.5 ml of activation mixture
containing an adequate amount of postmitochondrial fraction shall be
added to the liquid overlay agar and mixed. This mixture is poured over
the surface of a selective agar plate. Overlay agar shall be allowed to
solidify before incubation. At the end of the incubation period,
revertant colonies per plate shall be counted. When testing without
metabolic activation, the test sample and 0.1 ml of a fresh bacterial
culture shall be added to 2.0 ml of overlay agar.
(2) Azo-reduction method. When testing with metabolic activation,
0.5 ml of activation mixture containing 150 l of
postmitochondrial fraction and 0.1 ml of bacterial culture shall be
added to a test tube kept on ice. 0.1 ml of test solution shall be
added, and the tubes shall be incubated with shaking at 30 deg.C for
30 minutes. At the end of the incubation period, 2.0 ml of agar shall
be added to each tube, the contents mixed and poured over the surface
of a selective agar plate. Overlay agar shall be allowed to solidify
before incubation. At the end of the incubation period, revertant
colonies per plate shall be counted. For tests without metabolic
activation, 0.5 ml of buffer shall be used in place of the 0.5 ml of
activation mixture. All other procedures shall be the same as those
used for the test with metabolic activation.
(3) Other methods/modifications may also be appropriate.
(4) Media. An appropriate selective medium with an adequate overlay
agar shall be used.
(5) Incubation conditions. All plates within a given experiment
shall be incubated for the same time period. This incubation period
shall be for 48-72 hours at 37 deg.C.
(6) Number of cultures. All plating shall be done at least in
triplicate.
(f) Data and report--(1) Treatment of results. Data shall be
presented as number of revertant colonies per plate, revertants per
kilogram (or liter) of fuel, and as revertants per kilometer (or mile)
for each replicate and dose. These same measures shall be recorded on
both the negative and positive control plates. The mean number of
revertant colonies per plate, revertants per kilogram (or liter) of
fuel, and revertants per kilometer (or mile), as well as individual
plate counts and standard deviations shall be presented for the test
substance, positive control, and negative control plates.
(2) Statistical evaluation. Data shall be evaluated by appropriate
statistical methods. Those methods shall include, at a minimum, means
and standard deviations of the reversion data.
(3) Interpretation of results. (i) There are several criteria for
determining a positive result, one of which is a statistically
significant dose-related increase in the number of revertants. Another
criterion may be based upon detection of a reproducible and
statistically significant positive response for at least one of the
test substance concentrations.
(ii) A test substance which does not produce either a statistically
significant dose-related increase in the number of revertants or a
statistically significant and reproducible positive response at any one
of the test points is considered nonmutagenic in this system.
(iii) Both biological and statistical significance shall be
considered together in the evaluation.
(4) Test evaluation. (i) Positive results from the Salmonella
typhimurium reverse mutation assay indicate that, under the test
conditions, the test substance induces point mutations by base changes
or frameshifts in the genome of this organism.
(ii) Negative results indicate that under the test conditions the
test substance is not mutagenic in Salmonella typhimurium.
(5) Test report. In addition to the reporting recommendations as
specified under 40 CFR 79.60, the following specific information shall
be reported:
(i) Sampling method(s) used and manner in which cells are exposed
to sample solution;
(ii) Bacterial strains used;
(iii) Metabolic activation system used (source, amount and
cofactor); details of preparation of postmitochondrial fraction;
(vi) Concentration levels and rationale for selection of
concentration range;
(v) Description of positive and negative controls, and
concentrations used, if appropriate;
(vi) Individual plate counts, mean number of revertant colonies per
plate, number of revertants per mile (or kilometer), and standard
deviation; and
(vii) Dose-response relationship, if applicable.
(g) References. For additional background information on this test
guideline, the following references should be consulted.
(1) 40 CFR 798.5265, The Salmonella typhimurium reverse mutation
assay.
(2) Ames, B.N., McCann, J., Yamasaki, E. ``Methods for detecting
carcinogens and mutagens with the Salmonella/mammalian microsome
mutagenicity test,'' Mutation Research 31:347-364 (1975).
(3) Huisingh, J.L., et al.,``Mutagenic and Carcinogenic Potency of
Extracts of Diesel and Related Environmental Emissions: Study
Design, Sample Generation, Collection, and Preparation''. In: Health
Effects of Diesel Engine Emissions, Vol. II, W.E. Pepelko, R., M.,
Danner and N. A. Clarke (Eds.), US EPA, Cincinnati, EPA-600/9-80-
057b, pp. 788-800 (1980).
(5) Claxton, L.D., Allen, J., Auletta, A., Mortelmans, K., Nestmann,
E., Zeiger, E. ``Guide for the Salmonella typhimurium/mammalian
microsome tests for bacterial mutagenicity'' Mutation Research
189(2):83-91 (1987).
(6) Claxton, L., Houk, V.S., Allison, J.C., Creason, J.,
``Evaluating the relationship of metabolic activation system
concentrations and chemical dose concentrations for the Salmonella
Spiral and Plate Assays'' Mutation Research 253:127-136 (1991).
(7) Claxton, L., Houk, V.S., Monteith, L.G., Myers, L.E., Hughes,
T.J., ``Assessing the use of known mutagens to calibrate the
Salmonella typhimurium mutagenicity assay: I. Without exogenous
activation.'' Mutation Research 253:137-147 (1991).
(8) Claxton, L., Houk, V.S., Warner, J.R., Myers, L.E., Hughes,
T.J., ``Assessing the use of known mutagens to calibrate the
Salmonella typhimurium mutagenicity assay: II. With exogenous
activation.'' Mutation Research 253:149-159 (1991).
(9) Claxton, L., Creason, J., Lares, B., Augurell, E., Bagley, S.,
Bryant, D.W., Courtois, Y.A., Douglas, G., Clare, C.B., Goto, S.,
Quillardet, P., Jagannath, D.R., Mohn, G., Neilsen, P.A., Ohnishi,
Y., Ong, T., Pederson, T.C., Shimizu, H., Nylund, L., Tokiwa, H.,
Vink, I.G.R., Wang, Y., Warshawsky, D., ``Results of the IPCS
Collaborative Study on Complex Mixtures'' Mutation Research 276:23-
32 (1992).
(10) Claxton, L., Douglas, G., Krewski, D., Lewtas, J., Matsushita,
H., Rosenkranz, H., ``Overview, conclusions, and recommendations of
the IPCS Collaborative Study on Complex Mixtures'' Mutation Research
276:61-80 (1992).
(11) Houk, V.S., Schalkowsky, S., and Claxton, L.D., ``Development
and Validation of the Spiral Salmonella Assay: An Automated Approach
to Bacterial Mutagenicity Testing'' Mutation Research 223:49-64
(1989).
(12) Jones, E., Richold, M., May, J.H., and Saje, A. ``The
Assessment of the Mutagenic Potential of Vehicle Engine Exhaust in
the Ames Salmonella Assay Using a Direct Exposure Method'' Mutation
Research 97:35-40 (1985).
(13) Maron, D., and Ames, B. N., Revised methods for the Salmonella
mutagenicity test, Mutation Research, 113:173-212 (1983).
(14) Prival, M.J., and Mitchell, V.D. ``Analysis of a method for
testing azo dyes for mutagenic activity in Salmonella typhimurium in
the presence of flavin mononucleotide and hamster liver S-9,''
Mutation Research 97:103-116 (1982).
(15) Rosenkranz, H.S., et.al. ``Nitropyrenes: Isolation,
identification, and reduction of mutagenic impurities in carbon
black and toners'' Science 209:1039-43 (1980).
(16) Stump, F., Snow, R., et.al., ``Trapping gaseous hydrocarbons
for mutagenic testing'' SAE Technical Paper Series, No. 820776
(1982).
(17) Vogel, H.J., Bonner, D.M. ``Acetylornithinase of E. coli:
partial purification and some properties,'' Journal of Biological
Chemistry. 218:97-106 (1956).
[FR Doc. 94-13784 Filed 6-24-94; 8:45 am]
BILLING CODE 6560-50-P