[Federal Register Volume 60, Number 54 (Tuesday, March 21, 1995)]
[Rules and Regulations]
[Pages 14910-14912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6766]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42180; FRL 4935-4]
RIN 2070-AB07
Testing Consent Order for Tertiary Amyl Methyl Ether
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Consent Agreement and Order.
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SUMMARY: EPA has issued a Testing Consent Order that incorporates an
Enforceable Consent Agreement (ECA) pursuant to the Toxic Substances
Control Act (TSCA) with members of the TAME Producers Group comprised
of the following companies: Amerada Hess Corporation, Chevron U.S.A.
Products Company, Citgo Petroleum, Exxon Company U.S.A., and Texaco
Refining and Marketing (the Consortium) who have agreed to perform
certain health effects tests with tertiary-amyl methyl ether (CAS No.
994-05-8) (TAME). This document summarizes the ECA and adds TAME to the
list of chemical substances and mixtures subject to ECAs. Accordingly,
export notification requirements apply to TAME.
EFFECTIVE DATE: March 21, 1995.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Rm. E-543B, 401 M St., SW., Washington, DC
20460, (202) 554-1404, TDD (202) 554-0551. Technical contact: Gary Timm
(202) 260-7335.
SUPPLEMENTARY INFORMATION: This document amends 40 CFR 799.5000 by
adding TAME to the list of chemical substances and mixtures subject to
ECAs and export notification requirements.
I. Background
The Clean Air Act (42 U.S.C. 7401-7671q) provides that beginning on
November 1, 1992, gasoline containing at least 2.7 percent oxygen by
weight is required to be used in the wintertime in 39 areas of the
county which failed to comply with the carbon monoxide (CO) National
Ambient Air Quality Standard. Carbon monoxide pollution is caused by
incomplete burning of fuels used in internal combustion engines and is
generally more severe during cold winter temperatures. Tests have shown
that the use of oxygenates in gasoline can reduce CO emissions by 15 to
20 percent (Emission Reduction and Cost Effectiveness of Oxygenated
Gasolines. Environmental Protection Agency. June, 3 1991). Methyl
tertiary-butyl ether (MTBE) and ethanol are the primary oxygenates used
in the oxygenated gasoline program.
MTBE was recommended for health effects testing by the Interagency
Testing Committee in its 19th report because of its rapidly growing use
as a fuel additive. EPA negotiated an ECA with the Oxygenated Fuel
Producers for comprehensive health effects testing in 1988 (53 FR
10391, March 31, 1988). Despite this extensive testing program and
experience using MTBE as a gasoline additive, acute health concerns
were raised in Alaska and Missoula, MT after MTBE's introduction to
these areas in November, 1992. Additional research was conducted by
EPA, the American Petroleum Institute (API), and the Oxygenated Fuels
Association to address the concerns raised by the citizens of Alaska
and assist policy decision making for the next oxyfuel season. These
studies, including human exposures, failed to confirm MTBE as the
source of the human health complaints.
A meeting between the Federal Government, State of Alaska, and
industry to plan additional research on the oxyfuels was held in
December, 1993. This group also recommended that baseline toxicity
testing information be developed for both ethyl tertiary-butyl ether
(ETBE) and TAME, widely seen as possible substitutes for MTBE, to
compare their toxic potential with that of MTBE. The research planning
workshop recommended the following tests for ETBE and TAME:1st tier
genotoxicity, 90-day inhalation subchronic, neurotoxicity developmental
toxicity, reproductive effects pharmacokinetics.
On March 1, 1994, EPA's Office of Mobile Sources requested that the
Office of Pollution Prevention and Toxics develop these data under
section 4 of the Toxic Substances Control Act (TSCA).
II. Enforceable Consent Agreement Negotiations
EPA sent letters to approximately 50 individuals in the petroleum
and oxyfuel-related industries announcing the addition of ETBE and TAME
to EPA's Master Testing List and EPA's interest in pursuing a testing
program under an ECA. On March 9, 1994, API indicated that the industry
had agreed to form a testing panel under API auspices to develop and
present a testing proposal to EPA on ETBE and TAME. On April 18, 1994,
EPA published a notice in the Federal Register inviting manufacturers
and processors of ETBE and TAME and other interested persons to
participate in ECA negotiations on these substances and announced that
a public meeting would be held on May 9, 1994.
On behalf of the Consortium, API submitted proposals for testing
ETBE and TAME in April. At the May 9 meeting, API stated that there was
support among Consortium members to conduct testing of TAME, but not
ETBE. The chief difference between the EPA and Consortium positions on
testing TAME was the design of the reproductive effects and fertility
study. The Consortium proposed only a one-generation study as opposed
to the two-generation study recommended by EPA. This issue was resolved
in a conference call on July 28, 1994, with the Consortium agreeing to
conduct the two-generation study. Members of the Consortium signed an
ECA for the testing of TAME in January, 1995; EPA signed the ECA in
February, 1995.
Regarding ETBE, after appropriate notification of interested
persons, EPA held a public meeting on July 14, 1994, to discuss the
development of an ECA for this substance. At that meeting, ARCO, the
only current or potential producer in attendance, stated that it had
conducted screening tests for mutagenicity but that the company had
decided not to enter into an ECA with EPA to conduct additional
testing. ETBE thus remains on EPA's Master Testing List in a queue for
rulemaking under TSCA section 4.
III. TAME Testing Program
Table I describes the tests, the test standards and reporting
requirements For TAME under the ECA. This testing program will allow
EPA to better characterize the potential health hazards resulting from
exposure to TAME.
[[Page 14911]]
Table I.-- Required Testing, Test Standards and Reporting Requirements
for TAME
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Description of Deadline for Interim Reports
Tests Test Standard\1\ Final Report\2\ Required\3\
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Pharmacokinetics 795.230 (Appendix 20 3
(Inhalation, I)
rats and mice).
90-Day Subchronic 798.2450 Amended 18 2
(Inhalation, to include
rats and mice). mitogenesis,spec
ial staining and
immunochemistry
(Appendix II)
Neurotoxicity 795.247 (Appendix 20 3
Screen. III)
Mutagenicity: CHO 798.5300 15 2
HGPRT. (Appendix)
Mutagenicity: 798.5375 15 2
Chromosomal (Appendix)
aberrations.
Reproduction and OPPTS 870.3800 30 5
Fertility
(Inhalation,
rats).
Developmental OPPTS 870.3700 15 2
toxicity
(Inhalation,
rats and mice).
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\1\Citation is to 40 CFR unless otherwise noted. The OPPTS 870 series
guidelines are available from EPA but have not been published.
\2\ Number of months after the effective date of the consent order.
\3\ Interim reports are required every 6 months from the effective date
until the final report is submitted. This column shows the number of
interim reports required for each test.
IV. Export Notification
The issuance of the ECA and Order subjects any persons who export
or intend to export the chemical substance TAME (CAS No. 994-05-8), of
any purity, to the export notification requirements of section 12(b) of
TSCA and the regulations promulgated pursuant to it at 40 CFR part 707.
The listing of the chemical substance or mixture at 40 CFR 799.5000
serves as a notification to persons who intend to export such a
chemical substance or mixture that the substance or mixture is the
subject of an ECA and Order and 40 CFR part 707 applies.
V. Rulemaking Record
EPA has established a record for this ECA and Order under docket
number OPPTS-52098, which is available for inspection Monday through
Friday, excluding legal holidays, in Rm. NE B607, 401 M St.,SW.,
Washington, DC., 20460 from 1 p.m. to 4 p.m. Confidential Business
Information (CBI), while part of the record, is not available for
public review. This record contains the basic information considered in
developing this ECA and Order, and includes the following information:
(1) Testing Consent Order for TAME with incorporated Enforceable
Consent Agreement and associated testing protocols attached as
appendices.
(2) Federal Register notice announcing the opportunity to initiate
Negotiations for a TSCA Section 4 Testing ECA (April 18, 1994; 59 FR
18399).
(3) Communications consisting of:
(a) Written Letters.
(b) Contact reports of telephone summaries.
(c) Meeting summaries.
(4) Reports -published and unpublished factual materials.
List of Subjects in 40 CFR Part 799
Chemicals, Chemical export, Environmental protection, Hazardous
substances, Health effects, Laboratories, Reporting and recordkeeping
requirements, Testing.
Dated: March 7, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR part 799 is amended as follows:
PART 799--[AMENDED]
1. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. Section 799.5000 is amended by adding tertiary-amyl methyl ether
(TAME) to the table in CAS Number order, to read as follows:
Sec. 799.5000 Testing consent agreements for substances and mixtures
with Chemical Abstract Service Registry Numbers.
* * * * *
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Substance or FR Publication
CAS Number mixture name Testing Date
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* * * *
* * *
994-05-8......... Tertiary-amyl Health effects.. March 21, 1995.
methyl ether.
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* * *
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[[Page 14912]] [FR Doc. 95-6766 Filed 3-20-95; 8:45 am]
BILLING CODE 6560-50-F
