[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-Hotline@epa.gov.
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: schaeffer.john@epa.gov.
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
[[Page 20299]]
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
