[Federal Register Volume 63, Number 236 (Wednesday, December 9, 1998)]
[Notices]
[Pages 67877-67879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32682]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6199-7]


Final Notification of Health Effects Testing Requirements for 
Baseline Gasoline and Oxygenated Nonbaseline Gasolines and Approval of 
an Alternative Emissions Generator

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The purpose of this document is to announce that the 
Environmental Protection Agency (EPA) has notified the American 
Petroleum Institute (API) test group consortium (hereinafter 211(b) 
Research Group) for baseline gasoline and gasolines containing methyl 
tertiary butyl ether (MTBE) and other oxygenates, of the final 
Alternative Tier 2 health effects testing requirements under the fuel 
and fuel additive (F/FA) registration testing requirements of 40 CFR 
part 79. This document also announces that EPA has approved the API 
alternative evaporative emissions generator for use in animal toxicity 
testing under the F/FA registration health effects testing regulations 
at 40 CFR 79.57.

DATES: The Alternative Tier 2 health effects testing requirements are 
effective upon receipt by the 211(b) Research Group of the notification 
letter discussed in this document.

ADDRESSES: Written requests for information regarding this notification 
should be addressed to Public Docket No. A-96-16, Waterside Mall (Room 
M-1500), Environmental Protection Agency, Air Docket Section, 401 M 
Street, SW, Washington, DC 20460. Materials relevant to this 
notification have been placed in Docket A-96-16. Documents may be 
inspected between the hours of 8:00 a.m. to 5:30 p.m., Monday through 
Friday. A reasonable fee may be charged for copying docket material.

FOR FURTHER INFORMATION CONTACT: John Brophy, Environmental Scientist, 
U.S. Environmental Protection Agency, Office of Air and Radiation, 
(202) 564-9068.

SUPPLEMENTARY INFORMATION:

Regulated Entities

    Entities potentially regulated by this action are those that 
manufacture gasoline with or without the fuel additives MTBE, ethyl 
tertiary butyl ether (ETBE), ethyl alcohol (EtOH), tertiary amyl methyl 
ether (TAME), diisopropyl ether (DIPE), and tertiary butyl alcohol 
(TBA) and manufacturers

[[Page 67878]]

of these oxygenates and other gasoline 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,
                                          oxygenate and fuel additive
                                          manufacturers.
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    This table is not intended to be exhaustive, but, rather, 
illustrates the types of entities that EPA is currently aware of that 
are likely to be regulated by this action. Other types of entities not 
listed in this table could also be regulated. To determine whether an 
entity not described by the examples listed in the table is subject to 
these requirements, refer to the applicability criteria in part 79 of 
title 40 of the Code of Federal Regulations. If questions remain 
regarding the applicability of this action to a particular entity, 
consult the person listed in the preceding FOR FURTHER INFORMATION 
CONTACT section.
    In accordance with 40 CFR 79.56(a), manufacturers of F/FAs may 
satisfy the Subpart F testing requirements on a group basis. Each 
individual manufacturer that is a member of such a group, however, 
continues to be individually subject to the testing and data submission 
requirements. Thus, this notice serves as a notice to all manufacturers 
of the subject F/FAs, that are not exempted from these requirements 
under the small business provisions of 40 CFR 79.58(d), that they are 
subject to these requirements.

I. Introduction

    The Clean Air Act (CAA), as amended, required the Administrator of 
EPA to promulgate regulations requiring manufacturers of fuels and fuel 
additives to conduct tests to determine potential health effects of 
such products. The final rule, promulgated on May 27, 1994, established 
new health effects testing requirements for the registration of 
designated F/FAs as authorized by sections 211(b)(2) and 211(e) of the 
CAA.
    The registration requirements are organized within a three-tier 
structure. Tier 1 requires F/FAs manufacturers to supply to EPA (1) the 
identity and concentration of certain emission products of designated 
F/FAs and an analysis of potential emission exposures, and (2) any 
available information regarding the health and welfare effects of the 
whole and speciated emissions. 40 CFR 79.52. Tier 2 requires that 
combustion emissions of each F/FA subject to the testing requirements 
be tested for subchronic systemic and organ toxicity, as well as the 
assessment of specific health effects endpoints. 40 CFR 79.53. Tier 3 
testing may be required, at EPA's discretion, when remaining 
uncertainties as to the significance of observed health or welfare 
effects, or emissions exposures interfere with EPA's ability to 
reasonably assess the potential risks posed by emissions from a F/FA. 
40 CFR 79.54. EPA's regulations permit submission of adequate existing 
test data in lieu of conducting new duplicative tests. 40 CFR 79.53(b). 
In addition, EPA's regulations permit the health effects testing 
requirements to be satisfied by participation in groups that are 
established in accordance with the grouping criteria set forth at 40 
CFR 79.56. The regulations also include provisions for small businesses 
and certain types of products. 40 CFR 79.58.
    At its discretion, EPA may modify the standard Tier 2 health 
effects testing requirements for a F/FA (or group thereof) by 
substituting, adding, or deleting testing requirements; or changing the 
underlying vehicle/engine specifications. 40 CFR 79.58(c). EPA will 
not, however, delete a testing requirement for a specific endpoint in 
the absence of existing adequate information, or an alternative testing 
requirement for that endpoint. 40 CFR 79.58(c). When EPA exercises its 
authority under this special provision, it will allow an appropriate 
time for completion of the prescribed alternative tests.

II. Alternative Tier 2 Testing Requirements

    The Agency notified the 211(b) Research Group on August 20, 1997, 
of proposed health effects testing required under Alternative Tier 2 
for baseline gasoline and oxygenated nonbaseline gasolines, and the 
proposed schedule for completion and submission of such tests. An 
associated Federal Register notice (62 FR 47400) initiated a 60-day 
public comment period which was extended an additional 60 days (62 FR 
60675), to accommodate both the 211(b) Research Group's request for an 
extension, and to also allow the general public an additional period of 
time to comment. Copies of the documents associated with the extension 
and notification of the proposed tests and schedule under the 
Alternative Tier 2 provisions have been placed in the Docket.
    This document announces that the EPA has notified the 211(b) 
Research Group of the final Alternative Tier 2 health effects testing 
requirements under 40 CFR 79.58(c).
    The Agency notified API, by certified letter dated November 2, 
1998, of the specific tests which the Agency is requiring under the 
Alternative Tier 2 provisions for baseline gasoline and oxygenated 
nonbaseline gasolines, and the schedule for completion and submission 
of such tests. A copy of the letter as well as the tests and schedule 
under the Alternative Tier 2 provisions have been placed in the Public 
Docket No. A-96-16, Waterside Mall (Room M-1500), Environmental 
Protection Agency, Air Docket Section, 401 M Street, SW, Washington, DC 
20460. The notification letter is also available on the internet via 
the EPA's Mobile Sources home page at http://www.epa.gov/OMSWWW/.

III. Alternative Evaporative Emissions Generator

    This document also announces that EPA has approved the 211(b) 
Research Group's alternative evaporation emissions generator for animal 
toxicity testing allowed under the F/FAs registration testing 
requirements of 40 CFR 79.57(f)(5).
    Dr. Carol J. Henry, Director of the Health and Environmental 
Sciences Department, API, and head of the 211(b) Research Group, on 
July 1, 1997, sent a certified letter to EPA requesting approval of an 
alternative method for generating evaporative emissions (known as the 
stripper still method) for use in emissions characterization and animal 
health effects testing in accordance with the Alternative Tier 2 
provisions.
    Scientists from several EPA offices have reviewed the API 
submission for an alternative evaporative emissions generation method 
and concluded that it has met the necessary criteria under 40 CFR 
79.57(f)(5). Therefore, the ``stripper still'' method has been approved 
for use in the Alternative Tier 2 animal toxicology tests.
    In accordance with the requirements under 40 CFR 79.57(f)(5)(ii), 
all supporting procedural descriptions and justifications received from 
the 211(b) Research Group have been placed in the public record, along 
with the API request letter and EPA's evaluation of the methodology.

IV. Environmental Impact

    EPA's health effects testing notification will result in no 
immediate environmental impact. Section 211(c) of the Clean Air Act, 
however, authorizes EPA to take regulatory action on fuels and fuel 
additives on the basis of information obtained from health effects 
testing conducted by manufacturers of F/FAs. Therefore, the information

[[Page 67879]]

obtained as a result of the testing required by EPA's notification may 
provide a basis for further regulatory action.

V. Economic Impact

    Although the total cost for the testing requirements is 
significant, the cost is being shared among many F/FA manufacturers. 
Therefore, the actual cost to an individual F/FA manufacturer is 
expected to be modest. The F/FAs regulations at 40 CFR 79.58(d) contain 
special provisions for those fuel or fuel additive manufacturers whose 
total annual sales are less than $50 million, exempting these parties 
from the requirements discussed in this document.

List of Subjects in 40 CFR Part 79

    Environmental protection, Air pollution control, Gasoline, 
Conventional gasoline, Oxygenates, Methyl tertiary butyl ether, Motor 
vehicle pollution.

    Dated: November 17, 1998.
Robert Perciasepe,
Assistant Administrator.
[FR Doc. 98-32682 Filed 12-8-98; 8:45 am]
BILLING CODE 6560-50-P