[Federal Register Volume 61, Number 125 (Thursday, June 27, 1996)]
[Rules and Regulations]
[Pages 33375-33376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16332]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPT-42030K; FRL-5363-2]
Withdrawal of Final Test Rule for Mesityl Oxide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is withdrawing the final test rule for mesityl oxide (MO;
CAS No. 141-79-7). EPA has determined that, since testing of MO has
been completed according to the terms of an enforceable consent
agreement, testing required under the test rule would be duplicative
and therefore, the test rule is no longer needed.
EFFECTIVE DATE: This final rule shall take effect on June 27, 1996.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, U.S. Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20460; telephone: (202) 554-1404, TDD: (202) 554-
0551. Internet address: TSCA-H[email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Basis for this Action
In response to the Toxic Substances Control Act Interagency Testing
Committee's designation of mesityl oxide (MO; CAS No. 141-79-7) as a
priority chemical in its Fourth Report (44 FR 13866, June 1, 1979), EPA
issued a two-phase final test rule (50 FR 51857, December 20, 1985 and
52 FR 19088, May 20, 1987), under section 4 of the Toxic Substances
Control Act (TSCA) requiring certain health effects testing to be
conducted on MO. This test rule appears at 40 CFR 799.2500. Several
manufacturers of MO obtained judicial review of the rule.
On August 19, 1987, the U.S. Court of Appeals for the Fifth Circuit
remanded the rule to EPA for reconsideration in light of additional,
post-promulgation developments (Shell Chemical Co. v. EPA, 826 F.2d 295
(5th Cir. 1987)). The Court stayed the test rule pending EPA's
reconsideration on remand. In August 1991, EPA entered into an
enforceable consent agreement (ECA) with four manufacturers of MO that
required those manufacturers to perform certain health effects tests on
MO. A notice was published in the Federal Register of September 5, 1991
(56 FR 43878) announcing the conclusion of the ECA and describing the
testing required by the consent agreement. The current notice
references previous Federal Register notices (56 FR 43878, September 5,
1991; 52 FR 19088, May 20, 1987; and 50 FR 51857, December 20, 1985),
that describe the known health effects of MO and the uses and exposures
associated with this chemical substance.
The ECA contains a three-test battery that screens MO for
mutagenic, subchronic, developmental and reproductive effects. The
protocols used to conduct testing under the ECA are modeled on the
generic protocols developed by the Organization for Economic
Cooperation and Development (OECD) for the Screening Information Data
Set (SIDS) testing program. The OECD SIDS program is an international
cooperative program for identifying and developing the test data needed
to screen and set priorities for chemical substances and mixtures
having a high production volume (HPV) worldwide. The SIDS/HPV list
includes chemicals, such as MO, for which few health or environmental
effects test data are available.
Testing of MO under these protocols has been completed. The test
results are currently being reviewed by the Risk Management Program
within EPA's Office of Pollution Prevention and Toxics, and by the
OECD.
Concurrently with the publication of the notice of the ECA, EPA
proposed a revocation of the mesityl oxide final test rule (56 FR
43897, September 5, 1991) since the needed testing would be carried out
under the ECA. No comments were received in response to this proposal.
Since the needed testing has been completed in accordance with the
terms of the ECA, by this action, EPA is withdrawing the final test
rule for MO, by removing the rule from the Code of Federal Regulations
(40 CFR 799.2500).
[[Page 33376]]
II. Rulemaking Record
EPA has established a record for this rulemaking under docket
number OPPTS-42030K. This record contains the basic information that
EPA considered in developing this final rule, and includes the
following:
(1) Testing consent order for mesityl oxide with incorporated
enforceable consent agreement and associated testing protocols attached
as appendices.
(2) Federal Register notices pertaining to this final rule and the
testing consent order and enforceable consent agreement consisting of:
(a) Fourth Report of the TSCA Interagency Testing Committee (44 FR
31866, June 1, 1979).
(b) First-phase final test rule for mesityl oxide (establishing
testing requirements) ( 50 FR 51857, December 20, 1985).
(c) Second-phase final test rule for mesityl oxide (establishing
test standards and reporting requirements) ( 52 FR 19088, May 20,
1987).
(d) Notice of enforceable consent agreement for mesityl oxide (56
FR 43878, September 5, 1991).
(e) Proposed rule to withdraw mesityl oxide final test rule (56 FR
43897, September 5, 1991).
A public version of this record which does not include any
information claimed as confidential business information (CBI) is
available for public inspection from 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, USEPA, 401 M
St., SW., Washington, DC 20460.
III. Economic Analysis
Withdrawal of the MO test rule and the consequent elimination of
the testing requirements contained in the rule will reduce testing
costs. Therefore, this action should not cause adverse economic impact.
IV. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether a regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and subject to the requirements of the Executive Order. Section
3(f) of the Order defines a ``significant regulatory action'' as an
action that is likely to result in a rule (1) having an annual effect
on the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating a serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities or the principles set forth
in the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is not ``significant'' and is therefore not
subject to OMB review.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), I
certify that this test rule will not have a significant impact on a
substantial number of small businesses because the action will relieve
the regulatory obligation to conduct chemical testing.
C. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
1 year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and to
adopt the least costly, most cost-effective or least burdensome
alternative that achieves the objectives of the rule. The provisions of
section 205 do not apply when they are inconsistent with applicable
law. Moreover, section 205 allows EPA to adopt an alternative other
than the least costly, most cost-effective or least burdensome
alternative if the Administrator publishes with the final rule an
explanation why that alternative was not adopted. Before EPA
establishes any regulatory requirements that may significantly or
uniquely affect small governments, including tribal governments, it
must have developed under section 203 of the UMRA a small government
agency plan. The plan must provide for notifying potentially affected
small governments, enabling officials of affected small governments to
have meaningful and timely input in the development of EPA regulatory
proposals with significant Federal intergovernmental mandates, and
informing, educating and advising small governments on compliance with
the regulatory requirements.
Today's rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector. This rule reduces enforceable duties
on the private sector by withdrawing a rule that requires chemical
testing.
D. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in the final test rule under the provisions of the Paperwork Reduction
Act of 1980, 44 U.S.C. 3501 et seq., and has assigned OMB Control
Number 2070-0033 (EPA ICR No. 1139). This rule reduces the public
reporting burden associated with the testing requirements under the
final test rule. A complete discussion of the reporting burden is
contained at 50 FR 51857, December 20, 1985.
List of Subjects in 40 CFR Part 799
Chemicals, Chemical export, Environmental protection, Hazardous
substances, Health effects, Laboratories, Reporting and recordkeeping
requirements, Testing.
Dated: June 20, 1996.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides, and Toxic
Substances.
Therefore, title 40 of the Code of Federal Regulations, chapter I,
subchapter R, part 799 is amended as follows:
PART 799--[AMENDED]
1. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
Sec. 799.2500 [Removed]
2. By removing Sec. 799.2500.
[FR Doc. 96-16332 Filed 6-26-96; 8:45 am]
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