Enforceable Consent Agreement Development for Methyl Isobutyl Ketone (MIBK); Solicitation of Interested Parties and Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42205B; FRL-5798-3]

Enforceable Consent Agreement Development for Methyl Isobutyl

Ketone (MIBK); 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)

for conducting a reproductive toxicity study to meet testing

requirements for the methyl isobutyl ketone (MIBK)/ECA negotiations in

the proposed Toxic Substances Control Act (TSCA) section 4 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 MIBK.

DATES: EPA must receive written notification requesting designation as

an interested party for the MIBK/ECA negotiations on or before . Those

persons who identify themselves as interested parties may submit

written comments to EPA on the reproductive toxicity study proposal for

this chemical and other materials in the docket for the proposed HAPs

test rule that relate to the ECA process for this chemical by July 6,

1998.

The public meeting is scheduled from 1 p.m. to 3 p.m. on July 16,

1998.

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

42205B. 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. The Document Control Office telephone number is

(202) 260-7093.

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 3.

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) 260-1096;

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 TSCA section 4(a) 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. On December 24,

1997, in an amendment to the proposed HAPs test rule (62 FR 67466)

(FRL-5742-2), EPA provided the opportunity for the submission of ECA

proposals for alternative testing that could fulfill the testing needs

described in the proposed HAPs test rule, as amended. The Agency

indicated that such ECA proposals may or may not include PK and

mechanistic data development as a component of the alternative testing

proposal. EPA received alternative testing proposals to perform

reproductive toxicity testing for MIBK from the Ketones Panel of the

Chemical Manufacturers Association (CMA Ketones Panel) on December 11,

1996 and March 30, 1998. The Agency has completed its preliminary

review of the CMA Ketones Panel proposal and determined that there is

sufficient merit to proceed with ECA negotiations focussed specifically

on fulfilling the proposed HAPs test rule need for a 2-generation

reproduction study of MIBK. This was documented in subsequent

correspondence between EPA and the CMA Ketones Panel. A copy of the

proposal and correspondence is contained in the public record for this

ECA process. These materials will be

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used during discussions at the negotiating meeting. EPA is hereby

initiating the procedures for ECA negotiations for the HAPs chemical,

MIBK. The procedures for ECA negotiations are described at 40 CFR

790.22(b).

The proposed HAPs test rule, as amended on December 24, 1997 (62

FR 67466) (FRL-5742-2) and on April 21, 1998 (63 FR 19694) (FRL-5780-

6), 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, as

amended, 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 MIBK will focus on 2-

generation reproductive toxicity testing. The objective of the ECA

process is to conclude an ECA that will set in place industry-sponsored

testing that will adequately address EPA's data needs for the proposed

HAPs reproductive toxicity testing requirement for MIBK.

III. Identification of Interested Parties

EPA is soliciting interested parties to monitor or participate in

testing negotiations on an ECA for MIBK. The CMA Ketones Panel, the

submitter of the 2-generation reproduction study proposal for MIBK, and

the member companies of the CMA Ketones 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

July 6, 1998 will be given the status of interested parties. Interested

parties must respond in writing to the address specified in the

``ADDRESSES'' section located 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 MIBK 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 proceed with 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 MIBK 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

acceptable testing, 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 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 MIBK

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 MIBK under TSCA section 12(b) upon the

successful conclusion of an ECA for MIBK.

VI. Public Record and Electronic Submissions

As described above, MIBK 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 on MIBK, including the public version, has been

established under docket control number OPPTS-42205B (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, as amended, 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

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claimed as CBI, has been established for this document under docket

control number OPPTS-42205B. 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-42205B. 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).

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

Extension of the Comment Period'' (63 FR 19694, April 21 1998).

B. Alternative ECA proposal materials consisting of:

1. Letter from Langley A. Spurlock, Chemical Manufacturers

Association to Charles M. Auer, EPA with attachment entitled:

``Alternative Testing Proposal for Methyl Isobutyl Ketone,'' Chemical

Manufacturers Association Ketones Panel, December 11, 1996.

2. Letter from Courtney M. Price, Chemical Manufacturers

Association, Ketones Panel to Charles M. Auer, EPA, March 30, 1998,

with attachments entitled: ``Alternative Testing Proposal for Methyl

Isobutyl Ketone,'' and ``Comments of the Chemical Manufacturers

Association Ketones Panel on EPA's Proposed Test Rule for Hazardous Air

Pollutants.''

C. Letters, facsimilies, electronic correspondence, and contact

reports consisting of:

1. Letter from Charles M. Auer, EPA to Barbara Francis, Chemical

Manufacturers Association Ketones Panel, February 26, 1997.

2. EPA Contact Report from Charles M. Auer, EPA with William

Rawson, Chemical Manufacturers Association Ketones Panel, January 5,

1998.

3. Email from Charles M. Auer, EPA to William Rawson, Chemical

Manufacturers Association Ketones Panel, March 9, 1998.

4. Email from Charles M. Auer, EPA to William Rawson, Chemical

Manufacturers Association Ketones Panel, March 13, 1998.

List of Subjects

Environmental protection, Chemicals, Hazardous substances,

Reporting and recordkeeping requirements.

Dated: June 9, 1998.

Ward Penberthy,

Acting Director, Chemical Control Division, Office of Pollution

Prevention and Toxics.

[FR Doc. 98-15856 Filed 6-12-98; 8:45 am]

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