Enforceable Consent Agreement Development for 1,1,2- Trichloroethane; Solicitation of Interested Parties and Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42198B; FRL-5763-2]

Enforceable Consent Agreement Development for 1,1,2-

Trichloroethane; Solicitation of Interested Parties and Notice of

Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is soliciting interested parties who want to monitor or

participate in negotiations on an enforceable consent agreement (ECA)

concerning the use of pharmacokinetics (PK) studies and mechanistic

data to help meet testing requirements for 1,1,2-trichloroethane (CAS

No. 79-00-5) in the proposed hazardous air pollutants (HAPs) test rule.

In addition, EPA invites all interested parties to attend a public

meeting to initiate negotiations on the ECA for 1,1,2-trichloroethane.

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DATES: EPA must receive written notification requesting designation

as an interested party for 1,1,2-trichloroethane on or before January

9, 1998. Those persons who identify themselves as interested parties

for 1,1,2-trichloroethane may submit written comments to EPA on the PK

proposal for this chemical, on EPA's preliminary technical analysis,

and on other materials in the docket for the proposed HAPs test rule,

that relate to the ECA process for this chemical by January 9, 1998.

The public meeting is scheduled from 8 a.m. to 10 a.m. on January

12, 1998.

ADDRESSES: Each comment must bear the docket control number, OPPTS-

42198B. All comments should be sent in triplicate to: OPPT Document

Control Officer (7407), Office of Pollution Prevention and Toxics,

Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower,

Washington, DC 20460.

EPA will address these comments at the public meeting.

Comments and data may also be submitted electronically to:

[email protected]. following the instructions under Unit VI. of

this document. No Confidential Business Information (CBI) should be

submitted through e-mail.

All comments which contain information claimed as CBI must be

clearly marked as such. Three sanitized copies of any comments

containing information claimed as CBI must also be submitted and will

be placed in the public record for this document. Persons submitting

information any portion of which they believe is entitled to treatment

as CBI by EPA must assert a business confidentiality claim in

accordance with 40 CFR 2.203(b) for each such portion. This claim must

be made at the time that the information is submitted to EPA. If a

submitter does not assert a confidentiality claim at the time of

submission, EPA will make the information available to the public

without further notice to the submitter.

The public meeting will be held at EPA Headquarters, 401 M St.,

SW., Washington, DC in the EPA Conference Center, North Conference Area

in Room 1.

FOR FURTHER INFORMATION CONTACT: For additional information: Susan

B. Hazen, Director, Environmental Assistance Division (7408), Rm. ET-

543B, Office of Pollution Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW., Washington, DC 20460; telephone:

(202) 554-1404, TDD: (202) 554-0551; e-mail address: TSCA-

H[email protected].

For technical information: Richard W. Leukroth, Jr., Project

Manager, Chemical Control Division (7405), Office of Pollution

Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,

Washington, DC 20460; telephone: (202) 260-0321; fax: (202) 260-8850;

e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Electronic Availability

Internet: Electronic copies of this document and various support

documents are available from the EPA Home Page at the Federal Register

--Environmental Documents entry for this document under ``Laws and

Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/1997/).

II. Background

EPA proposed health effects testing under section 4(a) of the

Toxic Substances Control Act (TSCA) on June 26, 1996, for a number of

HAPs chemicals (61 FR 33178) (FRL-4869-1). As indicated in the proposed

HAPs test rule, EPA would use the data obtained from testing to

implement several provisions of section 112 of the Clean Air Act (CAA),

including the determination of residual risk, the estimation of the

risks associated with accidental releases of chemicals, and

determinations whether substances should be removed from the CAA

section 112(b)(1) list of hazardous air pollutants (delisting). The

data also would be used by other Federal agencies (e.g. Agency for

Toxic Substances and Disease Registry (ATSDR), National Institute of

Occupational Safety and Health (NIOSH), Occupational Safety and Health

Administration (OSHA), and Consumer Product Safety Commission (CPSC))

in assessing chemical risks and in taking appropriate actions within

their programs.

In the proposed HAPs test rule, EPA invited the submission of

proposals for pharmacokinetics (PK) studies for the HAPs chemicals,

which could provide the basis for negotiation of ECAs. These PK studies

would be used to inform EPA about the use of route-to-route

extrapolation of toxicity data from routes other than inhalation to

predict the effects of inhalation exposure, as an alternative to

testing proposed under the HAPs test rule. EPA received a PK proposal

for 1,1,2-trichloroethane from the HAP Task Force on November 25, 1996.

Based on the PK proposal received for 1,1,2-trichloroethane, the Agency

developed a preliminary technical analysis. A copy of this preliminary

technical analysis was sent to the HAP Task Force on June 26, 1997. The

HAP Task Force reviewed EPA's analysis and notified EPA on July 31,

1997, that it has a continued interest in pursuing the ECA process. A

copy of the PK proposal, the EPA preliminary technical analysis and

related materials is contained in the public record for this ECA

process. These materials will be used during discussions at the

negotiating meeting. EPA has decided to proceed with the ECA process

for 1,1,2-trichloroethane and is providing public notice that the

Agency is hereby initiating the procedures for ECA negotiations for the

HAP chemical, 1,1,2-trichloroethane. The procedures for ECA

negotiations are described at 40 CFR 790.22(b). EPA intends to publish,

as appropriate, additional Federal Register documents to solicit

interested parties and announce public meetings for other HAPs

chemicals for which PK proposals were submitted.

The proposed HAPs test rule, and the ECA negotiations on chemicals

included in the proposed rule are separate and parallel activities.

While the Agency's objective of obtaining data could be accomplished by

either activity, EPA recognizes that the final testing program

performed by industry may differ depending on whether it is

accomplished under the final HAPs test rule or via the ECA process.

During the course of ECA negotiations, additional information may be

brought forward that could cause the Agency to re-evaluate the nature

of the testing requirements as stated in the proposed HAPs test rule.

This could result in the development of an ECA that would fulfill the

Agency's data needs in ways not stated in the proposed HAPs test rule.

It is therefore essential for all interested parties to recognize these

differences at the outset and respond accordingly within the framework

of these two separate and parallel activities. Comments on the proposed

HAPs test rule must be submitted under docket control number, OPPTS-

42187A, as described in the proposed HAPs test rule published on June

26, 1996, and will be addressed by EPA via the rulemaking process,

which is separate and distinct from the ECA process. Participation in

the ECA process is described in Units II. through IV. of this preamble.

Negotiations on developing an ECA for the HAP chemical, 1,1,2-

trichloroethane, will focus on the use of PK studies and mechanistic

data to help meet testing requirements for 1,1,2-trichloroethane. In

addition, discussion will include the adequacy of the available data

base to be used for extrapolation to obtain the data needs identified

for 1,1,2-trichloroethane in

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the proposed HAPs test rule. The objective of the ECA process is to

conclude an ECA that will set in place an industry-sponsored testing

program that will adequately address EPA's data needs for 1,1,2-

trichloroethane.

III. Identification of Interested Parties

EPA is soliciting interested parties to monitor or participate in

testing negotiations on an ECA for 1,1,2-trichloroethane. The HAP Task

Force, the submitter of the PK proposal for 1,1,2-trichloroethane, and

the member companies of the HAP Task Force are already considered

interested parties and do not need to respond to this document.

Additionally, any persons who respond to this document on or before

January 9, 1998 will be given the status of interested parties.

Interested parties must respond in writing to the address specified in

the ``ADDRESSES'' at the beginning of this document. These interested

parties will not incur any obligations by being so designated.

Negotiations will be conducted in one or more meetings open to the

public. The negotiation time schedule for 1,1,2-trichloroethane will be

established at the first negotiation meeting and will not exceed a

period of 4 months from the initial meeting. If an ECA is not

established in principle within this timeframe and EPA does not choose

to extend the negotiation time period, negotiations will be terminated

and testing will be required under the final HAPs test rule. If the

testing from the ECA does not meet the Agency's needs, EPA reserves the

right to enter into rulemaking.

IV. Public Participation in Negotiations

Under EPA regulations, the Agency is required to provide the

public with an opportunity to comment on and participate in the

development of ECAs. The procedural rule for ECAs (40 CFR part 790)

contains provisions to ensure that the views of interested parties are

taken into account during the ECA process.

Individuals and groups who respond to this document will have the

status of interested parties. All negotiating meetings for the

development of this ECA for 1,1,2-trichloroethane will be open to the

public and minutes of each meeting will be prepared by EPA and placed

in the public docket for this ECA process. The Agency will advise

interested parties of meeting dates and make available meeting minutes,

testing proposals, background documents, and other materials exchanged

at or prepared for negotiating meetings. Where tentative agreement is

reached on an acceptable testing program, a draft ECA will be made

available for comment by interested parties and, if necessary, EPA will

hold a public meeting to discuss any comments that have been received

and determine whether revisions to the ECA are appropriate. EPA will

not reimburse costs incurred by non-EPA participants in this ECA

negotiation process.

ECAs will only be concluded where an agreement can be obtained

which is satisfactory to the Agency, manufacturers or processors who

are potential test sponsors, and other interested parties, concerning

the need for and scope of testing. In the absence of an ECA, EPA

reserves the right to proceed with rulemaking.

A. The Agency will not enter into an ECA if either:

1. EPA and affected manufacturers or processors cannot reach an

agreement on the provisions of the ECA; or

2. The draft ECA is considered inadequate by other interested

parties who have submitted timely written objections to the draft ECA.

B. EPA may reject these objections if the Agency concludes either

that:

1. They are not made in good faith;

2. They are untimely;

3. They are not related to the adequacy of the proposed testing

program or other features of the agreement that may affect EPA's

ability to fulfill the goals and purposes of TSCA; or

4. They are not accompanied by a specific explanation of the

grounds on which the draft agreement is considered objectionable.

EPA will prepare an explanation of the basis for each ECA. The

explanatory document will summarize the agreement (including the

required testing), explain the objectives of the testing, and outline

the chemical's use and exposure characteristics. The document, which

will also announce the availability of the ECA, will be published in

the Federal Register .

V. Proposal of Export Notification Requirements for 1,1,2-

trichloroethane

EPA intends to publish a proposed rule in an upcoming Federal

Register document to require export notification by all persons who

export or intend to export 1,1,2-trichloroethane under TSCA section

12(b) upon the successful conclusion of an ECA for 1,1,2-

trichloroethane.

VI. Public Record and Electronic Submissions

As described above, 1,1,2-trichloroethane is listed as a chemical

that would be subject to testing requirements under the proposed HAPs

test rule. This ECA negotiation process and the proposed rule, are

separate and parallel activities. The official record for this ECA

action, including the public version, has been established under docket

control number OPPTS-42198B (including comments and data submitted

electronically as described below). The official record for this

document also includes all material and submissions filed under docket

control number OPPTS-42187A; FRL-4869-1, the record for the proposed

HAPs test rule, and all materials and submissions filed under docket

control number OPPTS-42187B; FRL-4869-1, the record for the receipt of

alternative testing proposals for developing ECAs for HAPs chemicals.

The official record for this document, including the public

version, which does not include any information claimed as CBI, has

been established for this document under docket control number OPPTS-

42198B. The public version of this record is available for inspection

from 12 noon to 4 p.m., Monday through Friday, excluding legal

holidays. The public record is located in the TSCA Nonconfidential

Information Center, Rm. NE B-607, 401 M St., SW., Washington, DC 20460.

Electronic comments can be sent directly to EPA at:

[email protected].

Electronic comments must be submitted as an ASCII file avoiding

the use of special characters and any form of encryption. Comments and

data will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII

file format. All comments and data in electronic form must be

identified by the docket control number, OPPTS-42198B. Electronic

comments on this document may be filed online at many Federal

Depository Libraries.

The record contains the following information:

A. Federal Register notices/EPA documents pertaining to this

notice consisting of:

1. ``Proposed Test Rule for Hazardous Air Pollutants; Proposed

Rule'' (61 FR 33178, June 26, 1996).

B. PK proposal materials consisting of:

1. HAP Task Force, ``Proposal for Pharmacokinetics Study of 1,1,2-

Trichloroethane'' (November 22, 1996) and cover letter (November 25,

1996).

2. U.S. EPA, ``Preliminary EPA Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy for 1,1,2-Trichloroethane'' and

cover letter (June 26, 1997).

[[Page 66631]]

List of Subjects

Environmental protection, Chemicals, Hazardous substances,

Reporting and recordkeeping requirements.

Dated: December 17, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention

and Toxics.

[FR Doc. 97-33329 Filed 12-18-97; 8:45 am]

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