[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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