[Federal Register Volume 63, Number 221 (Tuesday, November 17, 1998)]
[Rules and Regulations]
[Pages 63789-63793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30401]


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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, 1994.1
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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, 
1998.2
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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-119.3 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.'' 4 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 
1990.5 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, CO2, 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).6 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.7 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 12866,8 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.9
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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, 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.
* * * * *
    (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, 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.
* * * * *
    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]
BILLING CODE 6560-50-P