[Federal Register Volume 59, Number 74 (Monday, April 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9287]
[[Page Unknown]]
[Federal Register: April 18, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42052Q; FRL-4776-5]
Notice of Opportunity to Participate in Negotiations for Testing
of ETBE and TAME Under TSCA Section 4
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice invites manufacturers and processors of ethyl
tert-butyl ether (ETBE)(CAS No. 637-92-3) and tertiary-amyl methyl
ether (TAME)(CAS No. 994-05-8) and other interested persons who wish to
participate in or monitor consent agreement negotiations pursuant to 40
CFR 790.22(b) to contact the EPA in writing. In addition, this notice
announces a public meeting to initiate testing negotiations for these
chemicals.
DATES: A meeting to initiate testing negotiations for these chemicals
will be held at the Environmental Protection Agency from 1 p.m. to 3
p.m., May 9, 1994. For a person to be designated an ``interested
party'' for these negotiations, written notice must be received by EPA
on or before May 2, 1994.
ADDRESSES: The public meeting will be held at the Environmental
Protection Agency, Room 1605, Northeast Mall, 401 M St., SW.,
Washington, DC. Submit written requests to be designated an interested
party to TSCA Docket Receipts (7407), Office of Pollution Prevention
and Toxics, Environmental Protection Agency, Rm. ET G-99, 401 M St.,
SW., Washington, DC 20460. Submissions should bear the document control
number [OPPTS-42052Q]. The public docket supporting this action is
available for public inspection in Room ET G-102 at the above address
from 12 noon to 4 p.m., Monday through Friday, except legal holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division, (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-543B, 401
M St., SW., Washington, DC 20460, (202) 260-7335.
SUPPLEMENTARY INFORMATION: This notice announces an opportunity to
participant in negoatiations for an enforceable consent agreement for:
ETBE (Docket No. 42052Q/42179) and TAME (Docket No. 42052Q/42180).
I. Background
Requirements of the Clean Air Act (CAA), 42 U.S.C. 7401-1671q,
along with reports of adverse human health effects associated with the
use of methyl tertiary-butyl ether (MTBE) in winter-blend gasoline,
have contributed to the need for health effects testing of ETBE and
TAME.
MTBE, ETBE and TAME are fuel oxygenates which may be used to
satisfy the following requirements under the CAA. Under section 211(m)
of the CAA, 42 U.S.C. 7545, states which have certain nonattainment
areas for carbon monoxide (CO) must require that any gasoline sold or
dispensed to ultimate consumers in a specified portion of the
nonattainment area be blended, during wintertime, to contain not less
than 2.7 percent oxygen by weight (or applicable percentage to meet the
national primary air quality standard for CO by the established
attainment date). Under section 211(k), reformulated gasoline must be
used in nine major metropolitan areas designated as ozone nonattainment
areas as well as various nonattainment ``opt-in'' areas by 1995 and the
oxygen content of this gasoline must be equal to or exceed 2 percent by
weight. See Final Rule, Regulation of Fuels and Fuel Additives:
Standards for Reformulated and Conventional Gasoline, February 16, 1994
(59 FR 7716). In addition, a proposed regulation would require that at
least 30 percent of the oxygen content in reformulated gasoline come
from renewable oxygenates, which would include ETBE (Notice of Proposed
Rulemaking, Regulation of Fuels and Additives: Renewable Oxygenate
Requirement for Reformulated Gasoline, December 27, 1993 (58 FR
68343)).
Recently there have been reports from the State of Alaska and
several areas in the lower 48 of adverse human effects associated with
the use of MTBE in winter-blend gasoline. See Assessment of Potential
Health Risks of Gasoline Oxygenated with MTBE, Office of Research and
Development, U.S. EPA, November 1993.
EPA believes that additional health effects test data on fuel
oxygenates are needed to allow government agencies and industry to
compare the health risks associated with the use of these substances to
augment or substitute for MTBE as a fuel oxygenate. For this reason,
researchers and policy makers from EPA's Office of Air and Radiation
(OAR) and Office of Research and Development (ORD) initiated a
conference with the State of Alaska, the Centers for Disease Control
and Prevention, and the chemical and petroleum industries in Research
Triangle Park, NC on December 7-8, 1993 to discuss research on the
health effects of and human exposure to fuel oxygenates.
One of the products of this meeting was a research project proposal
to conduct toxicity testing to develop a broad base of health effects
data on ETBE and TAME. The research proposal was developed to expedite
the process of identifying data needs on these substances. The research
proposal recommends testing of ETBE and TAME for the following
endpoints:
1st Tier genotoxicity
90-day inhalation subchronic
Neurotoxicity (Functional observational battery, neuropathology,
motor activity)
Developmental toxicity
Reproductive effects
Pharmacokinetics
II. Testing Program
EPA's Office of Pollution Prevention and Toxics (OPPT) administers
the Toxic Substances Control Act (TSCA) and the TSCA section 4 testing
program. Under TSCA section 4, 15 U.S.C. 2603, EPA may require, in
specific circumstances, that chemical manufacturers and processors
provide to EPA test data that can be used to assess the impact on human
health and the environment from exposure to such chemicals. In addition
to imposing section 4 testing requirements by rulemaking, OPPT has
developed an enforceable consent agreement (ECA) process for obtaining
needed testing often with less time and resources and more flexibility
than under a test rule. See 40 CFR part 790. Finally, industry may
conduct voluntary testing of specific chemicals in anticipation of data
needs.
In a memorandum dated March 1, 1994, EPA's OAR requested OPPT to
inquire regarding the likelihood that industry would develop a
voluntary testingprogram for ETBE and TAME. In the absence of such a
voluntary commitment, OAR requested that OPPT use its authority under
TSCA to require such testing.
OPPT sent out a form letter dated March 1, 1994 to approximately 45
chemical and petroleum companies. The letter described the December 7,
1993 meeting and enclosed a copy of the research proposal developed at
that meeting, and sought to establish a dialogue with industry
regarding the testing of ETBE and TAME. Subsequently, OPPT elected to
pursue the testing of ETBE and TAME through the ECA process. The
purpose of the meeting on May 9, 1994 is to initiate negotiations for
the development of an ECA for the testing of ETBE and TAME. If an ECA
approach does not appear feasible, EPA will initiate rulemaking under
section 4 of TSCA to require the development of data on ETBE and TAME.
EPA is adding ETBE and TAME to the Master Testing List (MTL), which
sets priorities for OPPT's testing agenda, because EPA considers
testing of these substances to be a high priority. EPA has been using
the MTL since 1990 to set the Agency's testing agenda and communicate
it to the public.
III. Public Docket
The following documents are available for public inspection in the
public docket. The location and hours of the public docket supporting
this action are set forth under the ``Addresses'' section above.
1. Assessment of Potential Health Risks of Gasoline Oxygenated with
MTBE, Office of Research and Development, U.S. EPA, November 1993.
2. Report of Meeting to Develop Proposed Research Projects for
Oxyfuels, Research Triangle Park, NC, December 7-8, 1993.
3. Letter from Mary T. Smith, Director of Field Operations and
Support Division, Office of Air and Radiation, to Charles M. Auer,
Director of Chemical Control Division, Office of Prevention, Pesticides
and Toxic Substances, March 1, 1994.
4. Letter from Joseph S. Carra, Deputy Director of Office of
Pollution Prevention and Toxics, to approximately 45 chemical and
petroleum companies, and attachment (plus addressee list).
5. Unsolicited proposal for testing of ETBE and TAME from the
American Petroleum Institute.
Authority: 15 U.S.C. 2603.
Dated: April 8, 1994.
Charles M. Auer,
Director, Chemical Control Division.
[FR Doc. 94-9287 Filed 4-14-93; 8:45 am]
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