Enforceable Consent Agreement Development for Ethylene Glycol; Solicitation of Interested Parties and Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42202B; FRL-5766-6]

Enforceable Consent Agreement Development for Ethylene Glycol;

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 ethylene glycol (CAS No.

107-21-1) 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 ethylene glycol.

DATES: EPA must receive written notification requesting designation as

an interested party for ethylene glycol on or before February 11, 1998.

Those persons who identify themselves as interested parties for

ethylene glycol 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 February 11, 1998.

The public meeting is scheduled from 9:00 a.m. to 1:00 p.m. on

February 23, 1998.

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

42202B. 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.

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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 on 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/1998/).

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 ethylene glycol from the Chemical Manufacturers Association,

Ethylene Glycol Panel (CMA EG Panel) on November 5, 1996. Based on the

PK proposal received for ethylene glycol, the Agency developed a

preliminary technical analysis. A copy of this preliminary technical

analysis was sent to the CMA EG Panel on August 26, 1997. The CMA EG

Panel reviewed EPA's analysis and notified EPA on October 6, 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

references, and correspondence 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 ethylene glycol and is providing public notice that the

Agency is hereby initiating the procedures for ECA negotiations for the

HAP chemical, ethylene glycol. 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, as amended on December 24, 1997 (62

FR 67466) (FRL-5742-2), 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, as amended. 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, as amended. 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, as amended, must be submitted under docket control

number, OPPTS-42187A, as described in the proposed HAPs test rule

published on June 26, 1996, as amended on December 24, 1997, 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 document.

Negotiations on developing an ECA for the HAP chemical, ethylene

glycol, will focus on the use of PK studies and mechanistic data to

help meet testing requirements for ethylene glycol. In addition,

discussion will include the adequacy of the available data base to be

used for extrapolation to obtain the data needs identified for ethylene

glycol in the proposed HAPs test rule, as amended. 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 ethylene glycol.

III. Identification of Interested Parties

EPA is soliciting interested parties to monitor or participate in

testing negotiations on an ECA for ethylene glycol. The CMA EG Panel,

the submitter of the PK proposal for ethylene glycol, and the member

companies of the CMA EG Panel 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 February 11, 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

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open to the public. The negotiation time schedule for ethylene glycol

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 ethylene glycol 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 Ethylene glycol

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 ethylene glycol under TSCA section 12(b)

upon the successful conclusion of an ECA for ethylene glycol.

VI. Public Record and Electronic Submissions

As described above, ethylene glycol is listed as a chemical that

would be subject to testing requirements under the proposed HAPs test

rule, as amended. This ECA negotiation process and the proposed rule,

as amended, are separate and parallel activities. The official record

for this ECA action, including the public version, has been established

under docket control number OPPTS-42202B (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, the record for the proposed HAPs

test rule, as amended, and all materials and submissions filed under

docket control number OPPTS-42187B, 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-

42202B. 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-42202B. 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).

2. ``Amended Proposed Test Rule for Hazardous Air Pollutants;

Extension of Comment Period`` (62 FR 67466; December 24, 1997).

B. PK proposal materials consisting of:

1. Chemical Manufacturers Association, Ethylene Glycol Panel,

``Proposal for Pharmacokinetic Studies of Ethylene Glycol`` (November

5, 1996).

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

Industry Pharmacokinetics (PK) Strategy for Ethylene Glycol`` and cover

letter (August 26, 1997).

List of Subjects

Environmental protection, Chemicals, Hazardous substances,

Reporting and recordkeeping requirements.

Dated: January 13, 1998.

Wardner G. Penberthy,

Acting Director, Chemical Control Division, Office of Pollution

Prevention and Toxics.

[FR Doc. 98-1357 Filed 1-20-98; 8:45 am]

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