Notice of Opportunity to Participate in Negotiations for Testing of ETBE and TAME Under TSCA Section 4

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]

BILLING CODE 6560-50-F