Use of Alternative Analytical Test Methods in the Reformulated
Gasoline Program and Revision of the Specification for the Mixing
Chamber Associated With Animal Toxicity Testing of Fuels and Fuel
Additives
Related Material
[Federal Register: November 17, 1998 (Volume 63, Number 221)]
[Rules and Regulations]
[Page 63789-63793]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no98-5]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 79 and 80
[FRL-6187-6]
Use of Alternative Analytical Test Methods in the Reformulated
Gasoline Program and Revision of the Specification for the Mixing
Chamber Associated With Animal Toxicity Testing of Fuels and Fuel
Additives
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: This direct final rule extends the time period during which
certain alternative analytical test methods may be used in the Federal
reformulated gasoline (RFG) program to September 1, 2000. The time
period for use of these alternative methods originally expired on
January 1, 1997 and was previously extended to September 1, 1998. The
purpose of today's extension is to grant temporary flexibility until a
final performance-based analytical test method approach rulemaking is
promulgated. EPA expects to finalize the performance-based analytical
test methods approach rulemaking before September 1, 2000. This direct
final rule also makes certain revisions to the procedures applicable to
health effects testing of fuels and fuel additives.
EFFECTIVE DATE: This direct final rule is effective January 19, 1999,
unless EPA receives adverse comment or a request for a public hearing
by December 17, 1998. In the `` Proposed Rules'' section of today's
Federal Register, EPA is publishing a proposed rule that matches the
substance of this direct final rule. If the Agency receives adverse
comment or a request for a public hearing by December 17, 1998, EPA
will withdraw this direct final rule by publishing timely withdrawal in
the Federal Register.
ADDRESSES: Any person wishing to submit comments should send them (in
duplicate, if possible) to the docket address listed and to Joseph R.
Sopata, U.S. Environmental Protection Agency, Fuels and Energy
Division, 401 M Street, SW (6406J), Washington, D.C. 20460. Materials
relevant to this direct final rule have been placed in docket A-98-21
located at U.S. Environmental Protection Agency, Air Docket Section,
Room M-1500, 401 M Street, SW, Washington, D.C. 20460. The docket is
open for public inspection from 8:00 a.m. until 5:30 p.m., Monday
through Friday, except on Federal holidays. A reasonable fee may be
charged for photocopying services.
FOR FURTHER INFORMATION CONTACT: For further information about this
rule, contact Joseph R. Sopata, Chemist, Fuels & Energy Division, at
(202) 564-9034. To notify EPA of an intent to submit an adverse comment
or public hearing request, contact Joseph R. Sopata, (202) 564-9034, or
Anne-Marie C. Pastorkovich, Attorney/Advisor, Fuels & Energy Division,
(202) 564-8987.
SUPPLEMENTARY INFORMATION:
I. Regulated Entities
Entities potentially regulated by this action are those that use
analytical test methods to comply with the RFG program and
manufacturers of fuels and fuel additives. Regulated categories and
entities include:
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Category Examples of regulated entities
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Industry....................... Oil refiners, gasoline importers, oxygenate blenders, analytical testing laboratories.
Manufacturers of gasoline and diesel fuel.
Manufacturers of additives for gasoline and diesel fuel.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists all types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in this table could also be regulated. To determine whether
your business is regulated by this action, you should carefully examine
the applicability criteria in parts 79 and 80 of title 40 of the Code
of Federal Regulations. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed in the preceding section of this document.
II. RFG Standards & Test Methods Utilized at Sec. 80.46
Section 211(k) of the Clean Air Act (the Act) requires that EPA
establish standards for RFG to be used in specified ozone nonattainment
areas (covered areas), as well as anti-dumping standards for non-
reformulated, or conventional gasoline, used in the rest of the
country, beginning in January 1995. The Act requires that RFG reduce
VOC and toxics emissions from motor vehicles, not increase NOx
emissions, and meet certain content standards for oxygen, benzene, and
heavy metals. EPA published the final RFG regulations in the Federal
Register on February 16, 1994.<SUP>1</SUP>
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\1\ The RFG and anti-dumping regulations are located at 40 CFR
part 80, subparts D, E, and F. The final rule establishing the RFG
and anti-dumping standards was published in the February 16, 1994
Federal Register at 59 FR 7716. Amendments were published at 59 FR
36944 (June 20, 1994), 59 FR 39258 (August 2, 1994), 59 FR 60715
(November 28, 1994), 60 FR 2699 (January 11, 1995), 60 FR 6030
(February 1, 1995), 60 FR 35488 (July 10, 1995), 60 FR 40006 (August
1, 1995), 60 FR 65571 (December 20, 1995), 61 FR 12030 (March 25,
1996), 61 FR 20736 (May 8, 1996), 61 FR 35673 (July 8, 1996), 61 FR
58304 (November 13, 1996), 62 FR 9872 (March 4, 1997), 62 FR 12572
(March 17, 1997), and 62 FR 30260 (June 3, 1997). EPA proposed
several additional modifications to the RFG and anti-dumping
regulations at 62 FR 37338 (July 11, 1997). Some of these proposed
modifications were included in a final rule published at 62 FR 68196
(December 31, 1997), while others will be the subject of a future
final rule. Please refer to the December 31, 1997 final rule for
more information.
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[[Page 63790]]
Refiners, importers, and oxygenate blenders are required, among
other things, to test RFG and conventional gasoline for various
gasoline parameters or qualities, such as sulfur levels, aromatics,
benzene, and so on. Based upon comments received from the regulated
industry during the RFG and anti-dumping rulemaking, EPA concluded that
it would be appropriate to temporarily allow the use of alternative
analytical test methods for measuring the parameters of aromatics and
oxygenates. Language was adopted in Secs. 80.46(f)(3) and (g)(9)(i),
which permitted the use of alternative analytical test methods for
aromatics and oxygenates, respectively, until January 1, 1997. These
sections were later amended by a November 13, 1996 final rule published
in the Federal Register to permit the use of alternative analytical
test methods for these two parameters until September 1,
1998.<SUP>2</SUP>
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\2\ See 61 FR 58304 (November 13, 1996). The final rule did not
become effective until May 1, 1998, due to an inadvertent
administrative error. See the correction notice announcing the new
effective data 63 FR 24117 (May 1, 1998).
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As explained in the February 16, 1994 final rule, the Agency will
undertake a rulemaking to consider establishing a performance-based
analytical test method approach for the measurement of the reformulated
gasoline (RFG) parameters at Sec. 80.46. The Agency envisions that a
performance-based approach could provide additional flexibility to the
regulated industry in its choice of analytical test methods to be
utilized for compliance under the RFG and conventional gasoline
programs for analytical test methods that differ from the designated
analytical test method. The Agency further believes that the
establishment of a performance-based test method approach may help
advance the purposes of the ``National Technology Transfer and
Advancement Act of 1995,'' section 12(d) of Public Law 104-113 and
Office of Management and Budget (OMB) circular A-119.<SUP>3</SUP> In
general, the National Technology Transfer and Advancement Act of 1995
and OMB Circular A-119 are designed to encourage the adoption of
standards developed by ``voluntary consensus bodies'' and to reduce
reliance on government-unique standards ``where an existing voluntary
standard would suffice.'' <SUP>4</SUP> Today's direct final rule
provides an extension of deadline for use of certain alternative test
methods until such time as a notice-and-comment rulemaking to establish
performance-based standards is completed. Issues related to the
National Technology Transfer and Advancement Act of 1995 and OMB
Circular A-119 will be appropriately explored in detail in connection
with that rulemaking.
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\3\ See ``OMB Circular A-119; Federal Participation in the
Development and Use of Voluntary Consensus Standards and in
Conformity Assessment Activities,'' 63 FR 8546 (February 19, 1998).
\4\ Id.
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EPA originally expected to finalize action on such a rulemaking by
September 1, 1998; however, the Agency now realizes that it will not
complete rulemaking until after that date. Refiners and importers will
need several months to determine whether these alternative methods
qualify under the envisioned performance based analytical test method
approach. Therefore the Agency is extending the deadline for the use of
alternative test methods at Secs. 80.46(f)(3) and 80.46(g)(9) until
September 1, 2000. This extension of the deadline would allow parties
to make long-term purchasing decisions based on all the testing options
that could be made available at the conclusion of the performance-based
rulemaking. EPA reasonably expects to complete rulemaking before
September 1, 2000.
III. Revision of the Specification for the Mixing Chamber
Associated With Animal Toxicity Testing of Fuels and Fuel Additives
at Sec. 79.57(e)(2)(iii)(C)
The fuels and fuel additives registration program is authorized by
section 211 of the Clean Air Act and codified in 40 CFR part 79. In
accordance with sections 211(a) and (b)(1) of the Act, basic
registration requirements applicable to gasoline and diesel fuel have
been in existence since 1975. On June 27, 1994, EPA published a Federal
Register document announcing final additional regulations for
registration of designated fuels and fuel additives as authorized by
sections 211(b)(2) and 211(e) of the Clean Air Act as amended in
1990.<SUP>5</SUP> The additional regulations require manufacturers, as
part of the registration program, to conduct tests and submit
information related to the health effects of their fuel and fuel
additive products. The health effects testing requirements are
organized in three tiers. Tier 1 requires analysis of combustion and
evaporative emissions of fuels and fuel additives and a survey of
existing scientific information on the public health and welfare
effects of these emissions. Tier 2 requires manufacturers to conduct
specified health effects tests to screen for adverse health effects of
fuel and fuel additive emissions. Additional testing may be required
under Tier 3 at EPA's discretion.
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\5\ The fuels and fuel additives registration regulations are
located in 40 CFR part 79. Testing requirements for fuels and fuel
additives are in subpart F. The final rule establishing these
regulations was published in the June 27, 1994 Federal Register at
59 FR 33042. Amendments were published at 61 FR 36506 (July 11,
1996), 61 FR 58744 (November 18, 1996), 62 FR 12564 (March 17, 1997)
and 62 FR 12572 (March 17, 1997).
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A provision of the health effects testing regulations requires that
the emission moderation apparatus must function such that the average
concentration of hydrocarbons leaving the apparatus shall be within 10
percent of the average concentration of hydrocarbons entering the
mixing chamber. The Agency now believes that this specification for the
mixing chamber (or any alternative emission moderation apparatus) at
Secs. 79.57(e)(2)(iii)(C) and 79.57(e)(2)(v)(B) is likely unachievable
in a typical laboratory setting. Additionally, the regulations require
that the mean exposure concentration in the inhalation test chamber
shall be within 10 percent of the target concentration for the single
species being controlled on 90 percent or more of the exposure days and
that daily monitoring of CO, CO<INF>2</INF>, oxides of nitrogen, oxides
of sulfur and total hydrocarbons in the exposure chamber shall be
required. 40 CFR 79.57(e)(2)(iv)(B). EPA now believes that the required
mean exposure concentration in the inhalation test chamber is
unachievable for total hydrocarbons and particulate. The Agency
believes that the reason that these specifications are unachievable for
hydrocarbons and particulate is because of the cohesive qualities that
such compounds share. These shared cohesive tendencies result in a
tendency to fall out of the exposure atmosphere as it passes through
the apparatus.
EPA believes that a more appropriate specification for particulate
and hydrocarbon compounds would be 15%. The Agency believes the
modified emission dilution requirements at Secs. 79.57(e)(2)(iv)(B) and
79.57(e)(2)(vi)(B), will provide for sufficient quality control
assurances and thereby negate the need for Secs. 79.57(e)(2)(iii)(C)
and
[[Page 63791]]
79.57(e)(2)(v)(B).<SUP>6</SUP> Accordingly, the Agency is deleting
Secs. 79.57(e)(2)(iii)(C) and 79.57(e)(2)(v)(B), and modifying
Secs. 79.57(e)(2)(iv)(B) and 79.57(e)(2)(vi)(B).
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\6\ Sections 79.57(e)(2)(iv)(B) and 79.57(e)(2)(vi)(B) did not
previously contain reference to hydrocarbons, but have been modified
by this direct final rule to include specific requirements for both
hydrocarbons and particulate. Sections 79.57(e)(2)(iii)(C) and
79.57(e)(2)(v)(B), which are deleted by this action, specifically
addressed hydrocarbons only, and are no longer necessary.
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IV. Additional changes related to animal toxicity testing of fuels
and fuel additives
A. Vascular Perfusion Technique
Section 79.66(e)(5)(iii)(B) states that for the vascular perfusion
technique, the animals shall be perfused in situ by a generally
recognized technique.<SUP>7</SUP> Section 79.62(d)(7)(v) states that
the lungs and trachea of the whole-body perfusion-fixed test animals
are examined for inhaled particle distribution.
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\7\ Standard techniques for vascular perfusion in the following
references are cited: Zeman, W., and Innes, J.R.M., Craigie's
Neuroanatomy of the Rat (New York: Academic, 1963); Hayat, M.A.,
``Vol. 1. Biological applications,'' Principles and Techniques of
Electron Microscopy (New York: Van Nostrand, Reinhold, 1970); and
Spencer, P.S., and Schaumbur, H.H., (eds.). Experimental and
Clinical Neurotoxicology (Baltimore: Williams and Wilkins, 1980).
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The methods for vascular perfusion cited in the regulation perfuse
only the systemic vascular system with fixative. Using the methods
cited, the lungs are neither fixed nor inflated. This is because no
pressure (either air or fixative) is applied to the airways to
counteract the pressure being applied through the blood vessels, so
that the airspaces of the lungs collapse under the pressure from the
vascular fixation. The collapsed, unfixed lungs are not useful for
histopathological examination, or for examination of inhaled particle
distribution.
EPA is modifying the systemic vascular perfusion fixation procedure
by including intratracheal instillation of the lungs with fixative via
the trachea during the fixation process. This would preserve the lungs
for examination and achieve the whole-body fixation needed for
neurotoxicity endpoints.
B. Correction of Animal Numbers
Section 79.62(d)(1)(ii)(B) states, in part, ``Forty rodents, 25
females and 10 males * * *'' EPA is amending this section to reflect a
correct total of 35 rodents.
V. Environmental and Economic Impacts
This rule is expected to have no negative environmental impact. The
change in the deadline for the use of certain alternative test methods
preserves the status quo of the RFG program and will result in no
reduction in the emission benefits of the program. The changes to the
fuels and fuel additives registration regulations are not expected to
have any negative environmental impact on the public health and
environmental benefits associated with the fuels and fuel additives
testing program. In fact, today's changes with regard to health testing
requirements add certainty and correct errors and, as a result, may
enhance the benefits of the program.
Today's direct final rule would have a positive impact on the great
majority of entities regulated by the RFG regulation, because it
permits continued flexibility with respect to the use of alternative
test methods. This flexibility will continue through September 1, 2000
or until such time as EPA issues final regulations for performance-
based analytical test methods. The proposed changes to the health
effects testing requirements are minor and are not expected to result
in any additional compliance costs for regulated parties.
VI. Regulatory Flexibility
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this proposed rule. EPA has
also determined that this direct final rule will not have a significant
impact on a substantial number of small entities. Small entities
include small businesses, small not-for-profit enterprises, and small
governmental jurisdictions. Today's regulation would have a positive
economic impact on the great majority of entities regulated by the RFG
regulation, including small businesses. Specifically, it grants the
regulated industry flexibility in the use of alternative test methods
until September 1, 2000 (or until such time as EPA completes final
rulemaking) and corrects certain errors in existing registration
requirements for fuels and fuel additives. It is not expected to result
in any additional compliance costs for regulated parties, including
small entities. A regulatory flexibility analysis has therefore not
been prepared.
VII. Executive Order 12866
Under Executive Order 12866,<SUP>8</SUP> the Agency must determine
whether a regulation is ``significant'' and therefore subject to OMB
review and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
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\8\ 58 FR 51736 (October 4, 1993).
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(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 of 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
this Executive Order.<SUP>9</SUP>
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\9\ Id. at section 3(f)(1)-(4).
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EPA has determined that this rule is not a ``significant regulatory
action'' under the terms of Executive Order 12866 and is therefore not
subject to OMB review.
VIII. Paperwork Reduction Act
Today's direct final rule does not impose any new information
collection burden. The Office of Management and Budget (OMB) has
previously approved the applicable information collection requirements
(ICRs) under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq., and has assigned the following OMB control numbers: 2060-
0297 (``Registration of Fuels and Fuel Additives; Health-Effects
Research Requirements for Manufacturers--40 CFR part 79, subpart F''),
2060-0150 (``Registration of Fuels and Fuel Additives: Requirements for
Manufacturers''), and 2060-0277 (``Standards for Reformulated
Gasoline''). Copies of these ICRs may be obtained from Sandy Farmer, OP
Regulatory Information Division, U.S. Environmental Protection Agency
(2137), 401 M Street, SW, Washington, DC 20460, or by calling (202)
260-2740. Include the ICR title and/or OMB number in any
correspondence. Nothing in today's direct final rule will result in any
additional reporting, recordkeeping, testing, or other informational
burdens.
IX. Unfunded Mandates
Under section 202 of the Unfunded Mandates Reform Act of 1995
(``UMRA''), Public Law 104-4, EPA must prepare a budgetary impact
statement to accompany any general
[[Page 63792]]
notice of proposed rulemaking or final rule that includes a Federal
mandate which may result in estimated costs to State, local, or tribal
governments in the aggregate, or to the private sector, of $100 million
or more. Under section 205, for any rule subject to section 202 EPA
generally must select the least costly, most cost-effective, or least
burdensome alternative that achieves the objectives of the rule and is
consistent with statutory requirements. Under section 203, before
establishing any regulatory requirements that may significantly or
uniquely affect small governments, EPA must take steps to inform and
advise small governments of the requirements and enable them to provide
input.
EPA has determined that this rule does not include a Federal
mandate as defined in UMRA. The rule does not include a Federal mandate
that may result in estimated annual costs to State, local or tribal
governments in the aggregate, or to the private sector, of $100 million
or more, and it does not establish regulatory requirements that may
significantly or uniquely affect small governments.
X. Effects on Tribal, State, and Local Government Entities
This direct final rule does not establish any regulatory
requirements which would significantly or uniquely affect tribal
governments within the meaning of E.O. 13084, ``Consultation and
Coordination with Indian Tribal Governments.''
XI. Executive Order 12875: Enhancing Intergovernmental Partnerships
Under Executive Order 12875, EPA may not issue a regulation that is
not required by statute and that creates a mandate upon a state, local
or tribal government, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by those
governments. If the mandate is unfunded, EPA must provide to the Office
of Management and Budget a description of the extent of EPA's prior
consultation with representatives of affected state, local and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of state, local and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's direct final rule does not create a mandate on state, local
or tribal governments. The direct final rule does not impose any
enforceable duties on these entities. Accordingly, the requirements of
section 1(a) of Executive Order 12875 do not apply to this direct final
rule.
XII. Applicability of E.O. 13045: Children's Health Protection
This direct final rule is not subject to E.O. 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it does not involve
decisions on environmental health risks or safety risks that may
disproportionately affect children.
Today's direct final rule extends the time period during which
certain alternative analytical test methods may be used. This would
preserve the status quo under the existing RFG program until such time
as a performance-based test method rule is issued. The extension will
result in no reduction in the RFG program's environmental or health
benefits and presents no health or safety risks that will adversely
affect children.
Today's changes and corrections to the health effects testing
regulations for fuels and fuel additives will add certainty and
facilitate compliance by regulated parties. As a result, any impact on
children's health resulting from these changes and corrections would
reasonably be expected to be positive.
XIII. National Technology Transfer and Advancement Act
The National Technology Transfer and Advancement Act (NTTAA),
section 12(d) of Public Law 104-113, is designed to encourage the
adoption of standards developed by ``voluntary consensus bodies'' and
to reduce reliance on government-unique standards where existing
voluntary standards would suffice.
Today's direct final rule provides an extension of deadline for use
of certain analytical test methods for the RFG program until such time
as a notice-and-comment rulemaking to establish performance-based
analytical test methods is completed. Today's action does not establish
new technical standards or analytical test methods. The Agency plans to
address the NTTAA in detail in an upcoming rulemaking to establish
performance-based analytical test methods.
For a more detailed discussion, please refer to SUPPLEMENTARY
INFORMATION, section II, ``RFG Standards and Test Methods Utilized at
Sec. 80.46,'' above.
XIV. Submission to Congress and the General Accounting Office
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Act of 1996, generally provides
that before a rule may take effect, the agency promulgating the rule
must submit a rule report, which includes a copy of the rule, to each
House of the Congress and to the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective January 19, 1999.
List of Subjects
40 CFR Part 79
Environmental protection, Fuel additives, Gasoline, Motor vehicle
pollution, Penalties, Reporting and recordkeeping requirements.
40 CFR Part 80
Environmental protection, Fuel additives, Gasoline, Imports,
Labeling.
Dated: November 3, 1998.
Carol M. Browner,
Administrator.
For the reasons described in the preamble, parts 79 and 80 of Title
40 of the Code of Federal Regulations are amended as follows:
PART 79 [AMENDED]
1. The authority citation for part 79 continues to read as follows:
Authority: 42 U.S.C. 7414, 7524, 7545, and 7601.
* * * * *
2. Section 79.57 is amended by removing and reserving paragraphs
(e)(2)(iii)(C) and (e)(2)(v)(B) and by revising paragraphs
(e)(2)(iv)(B) and (e)(2)(vi)(B), to read as follows:
Sec. 79.57 Emission generation.
* * * * *
(e) * * *
(2) * * *
(iii) * * *
(C) [Reserved]
* * * * *
(iv) * * *
(B) These procedures include requirements that the mean exposure
concentration in the inhalation test chamber on 90 percent or more of
the
[[Page 63793]]
exposure days shall be controlled as follows:
(1) If the species being controlled is hydrocarbon or particulate,
the mean exposure concentration must be within 15 percent of the target
concentration for the single species being controlled.
(2) For other species, the mean exposure concentration must be
within 10 percent of the target concentration for the single species
being controlled.
(3) For all species, daily monitoring of CO, CO<INF>2</INF>,
NOX, SO<INF>X</INF>, 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.
* * * * *
(v) * * *
(B) [Reserved]
* * * * *
(vi) * * *
(B) These procedures include requirements that the mean exposure
concentration in the inhalation test chamber on 90 percent or more of
the exposure days shall be controlled as follows:
(1) If the species being controlled is hydrocarbon or particulate,
the mean exposure concentration must be within 15 percent of the target
concentration for the single species being controlled.
(2) For other species, the mean exposure concentration must be
within 10 percent of the target concentration for the single species
being controlled.
(3) For all species, daily monitoring of CO, CO<INF>2</INF>,
NOX, SO<INF>X</INF>, 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.
* * * * *
3. Section 79.62 is amended by revising paragraph (d)(1)(ii)(B), to
read as follows:
Sec. 79.62 Subchronic toxicity study with specific health effects
assessment.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(B) Thirty-five 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.
* * * * *
4. Section 79.66 is amended by adding a sentence to the end of
paragraph (e)(5)(iii)(B), to read as follows:
Sec. 79.66 Neuropathology assessment.
* * * * *
(e) * * *
(5) * * *
(iii) * * *
(B) Perfusion technique. * * * In addition, the lungs shall be
instilled with fixative via the trachea during the fixation process in
order to preserve the lungs and achieve whole-body fixation.
* * * * *
PART 80--[AMENDED]
5. The authority citation for part 80 continues to read as follows:
Authority: Sections 114, 211 and 301(a) of the Clean Air Act as
amended (42 U.S.C. 7414, 7545, and 7601(a)).
* * * * *
6. Section 80.46 is amended by revising paragraphs (f)(3) and
(g)(9) to read as follows:
Sec. 80.46 Measurement of reformulated gasoline fuel parameters.
* * * * *
(f) * * *
(3) Alternative test method. (i) Prior to September 1, 2000, any
refiner or importer may determine aromatics content using ASTM standard
method D-1319-93, entitled ``Standard Test Method for Hydrocarbon Types
in Liquid Petroleum Products by Flourescent Indicator Adsorption,'' for
purposes of meeting any testing requirement involving aromatics
content; provided that
(ii) The refiner or importer test result is correlated with the
method specified in paragraph (f)(1) of this section.
(g) * * *
(9)(i) Prior to September 1, 2000, and when the oxygenates present
are limited to MTBE, ETBE, TAME, DIPE, tertiary-amyl alcohol, and C1 to
C4 alcohols, any refiner, importer, or oxygenate blender may determine
oxygen and oxygenate content using ASTM standard method D-4815-93,
entitled ``Standard Test Method for Determination of MTBE, ETBE, TAME,
DIPE, tertiary-Amyl Alcohol and C1 to C4 Alcohols in Gasoline by Gas
Chromatography,'' for purposes of meeting any testing requirement;
provided that
(ii) The refiner or importer test result is correlated with the
method set forth in paragraphs (g)(1) through (g)(8) of this section.
* * * * *
[FR Doc. 98-30401 Filed 11-16-98; 8:45 am]
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