[Federal Register Volume 64, Number 79 (Monday, April 26, 1999)]
[Notices]
[Pages 20298-20300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10390]



[[Page 20298]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42205C; FRL-6052-4]
RIN 2070-AD28


Methyl Isobutyl Ketone; Final Enforceable Consent Agreement and 
Testing Consent Order

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Under section 4 of the Toxic Substances Control Act (TSCA), 
EPA has issued a testing consent order (Order) that incorporates an 
enforceable consent agreement (ECA) with Eastman Chemical Company, 
Celanese, Ltd., Shell Chemical Company, and Union Carbide Corporation 
(the ``Companies''). The Companies have agreed to perform reproductive 
toxicity testing on methyl isobutyl ketone (MIBK). This notice 
announces the ECA and Order for MIBK and summarizes the terms of the 
ECA.

DATES: The effective date of the ECA and Order is April 26, 1999.
FOR FURTHER INFORMATION CONTACT: For general information: Christine M. 
Augustyniak, Associate Director, Environmental Assistance Division 
(7408), Office of Pollution Prevention and Toxics, Rm. ET-541, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone number: (202) 554-1404; TDD: (202) 554-0551; e-mail address: 
TSCA-H[email protected].
    For technical information: John E. Schaeffer, Jr., Project Manager, 
Chemical Control Division (7405), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 
20460; telephone number: (202) 260-1266; fax: (202) 260-1096; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION: This notice announces the ECA and Order for 
MIBK and summarizes the terms of the ECA.

I. General Information

A. Does This Notice Apply To Me?

     The ECA and Order announced in this notice only affect those 
companies that signed the ECA for MIBK (Eastman Chemical Company, 
Celanese, Ltd., Shell Chemical Company, and Union Carbide Corporation). 
However, as a result of the ECA and Order, EPA has initiated a 
rulemaking under TSCA section 12(b)(1) which, when finalized, will 
require all persons who export or intend to export MIBK to comply with 
the Agency's export notification regulations at 40 CFR 707, subpart D 
(see 63 FR 54649 (FRL-6023-9), October 13, 1998).

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Documents for This Notice?

    1. Electronically. You may obtain electronic copies of this 
document and other documents from the EPA Internet Home Page at http://
www.epa.gov/. On the Home Page, select ``Laws and Regulations'' and 
then look up the entry for this document under ``Federal Register--
Environmental Documents'' (http://www.epa.gov/fedrgstr/EPA-TOX/1999/).
    2. In person or by telephone. If you have any questions or need 
additional information about this action, you may contact the project 
manager identified in the FOR FURTHER INFORMATION CONTACT section. In 
addition, the official record for this notice, including the public 
version, has been established under docket control number OPPTS-42205B. 
The public version of this record, including printed, paper versions of 
any electronic comments, which does not include any information claimed 
as Confidential Business Information (CBI), is available for inspection 
in the TSCA Nonconfidential Information Center, EPA, Rm. NE-B607, 
Waterside Mall, 401 M St., SW., Washington, DC, from noon to 4 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the Center is (202) 260-7099.

II. Background

A. What Is MIBK?

    As described in the findings document in support of the proposed 
rule requiring health effects testing for a number of hazardous air 
pollutants (``HAPs'' or ``HAPs chemicals''), including MIBK (Ref. 1), 
MIBK is an important chemical solvent for vinyl, epoxy acrylic, and 
natural resins and for nitrocellulose and dyes. It is also used as an 
extraction solvent. Its solvent uses break out as follows: Surface 
coatings (66%); process solvent for pharmaceuticals, adhesives, and 
pesticides (15%); chemical production, including rubber-processing 
chemicals (15%); and miscellaneous (4%). Approximately 467,000 workers 
may be exposed to MIBK. The Chemical Abstract Service (CAS) registry 
number for MIBK is 108-10-1.

B. Why Is EPA Requiring Health Effects Testing on MIBK?

    EPA has proposed health effects testing under TSCA section 4(a) for 
a number of HAPs chemicals, including MIBK (61 FR 33178, June 26, 1996 
(FRL-4869-1), as amended by 62 FR 67466, December 24, 1997 (FRL-5742-2) 
and 63 FR 19694, April 21, 1998 (FRL-5780-6). In the HAPs proposal, the 
Agency made preliminary findings for MIBK (61 FR 33178, 33190, 33192; 
Ref. 1) that:
    1. This chemical substance may present an unreasonable risk of 
injury to human health;
    2. There is substantial production and environmental release of 
MIBK and there is or may be substantial human exposure to the chemical;
    3. There are inadequate data to determine the effects of activities 
involving MIBK; and
    4. Testing is necessary to develop health effects data. The HAPs 
rule proposed testing MIBK for acute toxicity, reproductive toxicity 
and immunotoxicity (61 FR 33178, 33198; 62 FR 67466, 67483).

III. ECA Development and Conclusion

A. How Is EPA Going To Obtain Health Effects Testing on MIBK?

    In the proposed HAPs test rule, EPA invited the submission of 
proposals for pharmacokinetics (PK) studies for the HAPs chemicals, 
which could provide the scientific basis for alternative testing to the 
testing proposed and could provide the basis for negotiation of ECAs 
(61 FR 33178, 33189). EPA uses ECAs to accomplish testing where a 
consensus exists among EPA, affected manufacturers and/or processors, 
and interested members of the public concerning the need for and scope 
of testing (40 CFR 790.1(c)).
    On December 24, 1997, in an amendment to the proposed HAPs test 
rule (62 FR 67466, 67474), EPA again provided the opportunity for the 
submission of ECA proposals for alternative testing of HAPs that could 
fulfill certain or all of the testing needs described in the proposed 
test rule, as amended. These ECA proposals did not need to include PK 
and mechanistic data development as a component of the alternative 
testing proposal. The procedures for ECA negotiations are described at 
40 CFR 790.22(b).
    In response to EPA's request for proposals for ECAs, the Chemical 
Manufacturers Association (CMA) Ketones Panel submitted a proposal for 
a testing program on December 11, 1996, as revised by their submission 
of March 30, 1998 (Refs. 2 and 3). EPA responded to this proposal in 
May 1998 (Ref. 4), indicating that this approach offered sufficient 
merit to proceed with ECA negotiations. Consequently, EPA

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published a document soliciting interested parties to monitor or 
participate in these negotiations (63 FR 32656, June 15, 1998 (FRL-
5798-3)).
    EPA held a public meeting to negotiate an ECA for MIBK on July 16, 
1998. Representatives of the Companies and other interested parties 
attended this meeting. The participants reached consensus on the 
testing to be required under the ECA. On November 25, 1998, EPA 
received the ECA signed by the Companies. On April 16, 1999, EPA signed 
the ECA and accompanying Order.

B. What Testing Does the ECA for MIBK Require?

    This ECA requires 2-generation reproductive effects testing by the 
inhalation route of exposure, as described in Table 1 in this unit. 
This testing will allow EPA to characterize the potential reproductive 
health hazards resulting from inhalation exposure to MIBK. Table 1 sets 
forth the required testing, test standard, and reporting requirements 
under the ECA for MIBK.

                                     Table 1.--Required Testing, Test Standard, and Reporting Requirements for MIBK
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                                                                                                           Deadline for final        Interim reports
              Required testing                                      Test standard                          report\1\ (Months)      required\2\ (Number)
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Reproductive effects testing by inhalation..     Sec.  799.9380 (as modified in Appendix 1 to the ECA)                       29                        4
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\1\Number of months after the effective date of the Order.
\2\ Interim reports are required every 6 months from the effective date until the final report is submitted.

C. What Are the Uses for the Test Data for MIBK?

    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) 
(61 FR 33178, 33179). The data also would be used by other Federal 
agencies (e.g., the Agency for Toxic Substances and Disease Registry 
(ATSDR), the National Institute for Occupational Safety and Health 
(NIOSH), the Occupational Safety and Health Administration (OSHA), and 
the Consumer Product Safety Commission (CPSC)) in assessing chemical 
risks and in taking appropriate actions within their programs (61 FR 
33178, 33179).

D. Does the ECA for MIBK Meet All the Testing Requirements for MIBK 
That Were Contained in the Proposed HAPs Test Rule, As Amended?

    In the proposed HAPs test rule, as amended, EPA required testing of 
MIBK for reproductive toxicity, as well as other health effects (namely 
acute toxicity, which includes an appraisal of pulmonary irritation, 
and immunotoxicity). The ECA for MIBK requires testing for reproductive 
toxicity. The other health effects for which testing is necessary for 
MIBK will be included in the final HAPs rule.
    Testing for reproductive effects for MIBK that was contained in the 
HAPs proposal, as amended, will not be included in the final HAPs test 
rule because the Companies will fulfill this testing requirement by 
implementing the ECA and Order. The issuance of the ECA and Order 
constitutes final EPA action for purposes of 5 U.S.C. 704.

E. What if EPA Should Require Additional Reproductive Effects Testing 
on MIBK?

    If EPA decides in the future that it requires additional 
reproductive effects data on MIBK, the Agency will initiate a separate 
action.

IV. Other Impacts of the ECA for MIBK

    The issuance of the ECA and Order under TSCA section 4 subjects the 
Companies that signed the ECA to export notification requirements under 
TSCA section 12(b)(1), as set forth at 40 CFR part 707, subpart D, if 
they export or intend to export MIBK.
     On October 13, 1998 (63 FR 54649 (FRL-6023-9)), EPA proposed to 
amend 40 CFR 799.5000 by adding MIBK to the list of chemicals subject 
to testing consent orders. The listing of a chemical substance at 40 
CFR 799.5000 serves as notification to all persons who export or intend 
to export the chemical substance that:
    1. The chemical substance is the subject of an ECA and Order; and
    2. EPA's export notification regulations at 40 CFR part 707, 
subpart D, apply to those exporters who have signed the ECA, as well as 
those exporters who have not signed the ECA. 40 CFR 799.19.
    When a final rule based on the October 13, 1998, proposed rule is 
published in the Federal Register, all persons who export or who intend 
to export MIBK will be subject to export notification requirements.

V. Paperwork Reduction Act Notice

     The ECA and Order announced in this notice do not contain any 
information collection requirements that require additional approval by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act (PRA), 44 U.S.C. 3501 et seq. The information collection 
requirements related to test rules and ECAs issued under TSCA section 4 
have already been approved by OMB under OMB control number 2070-0033 
(EPA ICR No. 1139). The one-time public burden for this collection of 
information is estimated to be approximately 7500 hours total, of which 
the majority are due to laboratory activities as opposed to 
administration. Under the PRA, ``burden'' means the total time, effort, 
or financial resources expended by persons to generate, maintain, 
retain, or disclose or provide information to or for a Federal agency. 
For this collection it includes the time needed to review instructions; 
complete and review the collection of information; and transmit or 
otherwise disclose the information. An agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
The OMB control numbers for EPA's regulations, after initial display in 
the final rule, are listed in 40 CFR part 9. EPA will issue a final 
rule related to export notification requirements for MIBK. That rule 
will amend the listing at 40 CFR part 799, as well as the table at 40 
CFR part 9.

VI. References

    1. U.S. EPA. OPPT. ``TSCA Section 4 Findings for 21 Hazardous Air 
Pollutants: A Supporting Document for Proposed Hazardous Air Pollutants 
(HAPs) Test Rule.'' (June 25, 1996).
    2. The Ketones Panel of the Chemical Manufacturers Association. 
Letter from Langley A. Spurlock to Charles M. Auer, EPA, with 
attachment entitled:

[[Page 20300]]

``Alternative Testing Proposal for Methyl Isobutyl Ketone.'' Arlington, 
VA. (December 11, 1996).
    3. The Ketones Panel of the Chemical Manufacturers Association. 
Letter from Courtney M. Price to the U.S. EPA Document Control Office 
entitled: ``Comments of the Chemical Manufacturers Association Ketones 
Panel on EPA's Proposed Test Rule for Hazardous Air Pollutants.'' 
Arlington, VA. (March 30, 1998).
    4. U.S. EPA. Letter from Charles M. Auer to Barbara O. Francis, CMA 
Ketones Panel, re: ECA Proposal for MIBK HAPs Testing. Washington, DC. 
(May 28, 1998).

List of Subjects

    Environmental protection, Hazardous chemicals.

    Dated: April 16, 1999.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-10390 Filed 4-23-99; 8:45 am]
BILLING CODE 6560-50-F