[Federal Register Volume 63, Number 114 (Monday, June 15, 1998)]
[Notices]
[Pages 32656-32658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15856]


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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

[[Page 32657]]

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

[[Page 32658]]

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]
BILLING CODE 6065-50-F