[Federal Register Volume 62, Number 6 (Thursday, January 9, 1997)]
[Proposed Rules]
[Pages 1305-1306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-513]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50610C; FRL-5578-6]
Certain Acrylate Esters; Withdrawal of Proposed Significant New
Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Withdrawal of proposed rule.
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SUMMARY: EPA is withdrawing a proposed significant new use rule (SNUR)
for certain acrylate substances based on receipt of new toxicity data.
The data, which were generated through a voluntary industry testing
program, resulted in a significant lowering of hazard concerns for
acrylate substances such that EPA can no longer support a finding that
activities designated by the proposed SNUR are significant new uses
under section 5(a) of TSCA.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401
M St., SW., Washington, DC 20460; telephone: (202) 554-1404; TDD: (202)
554-0551; e-mail: TSCA-H[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of November 22, 1993
(58 FR 61649) (FRL-4186-2), EPA proposed a SNUR to be codified at 40
CFR 721.340 establishing significant new uses for certain acrylate
esters. EPA is withdrawing this proposal in light of additional
toxicity data received for acrylate substances
I. Rulemaking Record
The rulemaking record for the proposed rule which is being
withdrawn by today's rule was designated as OPPTS-50610. That record
includes information considered by the Agency in developing the
proposed rule and includes the test data to which the Agency has
responded with this notice of withdrawal.
II. Background
EPA is withdrawing the significant new use and recordkeeping
requirements proposed for certain acrylate esters under 40 CFR part
721, subpart E. Further background information for the substances is
contained in the rulemaking record referenced in Unit I of this
preamble.
EPA proposed a SNUR which was to be codified at 40 CFR 721.340,
establishing certain significant new uses for all acrylate substances
falling within the ``acrylate category'' description, based on EPA's
systematic regulation of this category of chemicals. The proposed SNUR
was intended to serve as a chemical category-wide substitute for the
Agency's current practice of regulating individual acrylate substances
one-at-a-time as those substances underwent premanufacture notice
review pursuant to section 5(e) of TSCA. The proposed SNUR would have
saved time and resources for both EPA and PMN submitters. The Agency
believed that available data were sufficient to warrant regulation,
including the promulgation of a category SNUR, based on the potential
unreasonable risk of cancer from uncontrolled exposure to acrylates.
While the final rule was being developed, a voluntary testing
program was being developed jointly by EPA and industry and was
subsequently conducted by a group of acrylate manufacturers affected by
acrylate regulation, the Specialty Acrylates Manufacturers (SAM). EPA
and SAM negotiated this voluntary testing program for this category of
chemicals based on SAM's commitment to conduct toxicity testing for
acrylate and methacrylate substances. The purpose of the testing
program was to cooperatively supply test data to address EPA's health
concerns for the acrylate category. SAM conducted several short term
studies on a series of acrylates and two long-term dermal bioassays on
Triethylene Glycol Diacrylate (TREGDA) and Triethylene Glycol
Dimethacrylate (TREGDMA). This testing was intended to correlate
activity in certain short term assays with longer-term carcinogenic
potential, as well as to better characterize the toxicity of the
acrylate chemical category generally.
After reviewing the test data generated by the voluntary testing
program, including the long term bioassays, EPA found that neither
TREGDA nor TREGDMA were carcinogenic under the conditions of the
studies. Based on the TREGDMA bioassay and data for other
methacrylates, EPA no longer supports the carcinogenicity concern for
methacrylates. However, in the case of TREGDA, the maximum tolerated
dose (MTD) may not have been attained because skin irritation noted in
the range finding studies was not present over the entire term of the
bioassay. Therefore, because the MTD may not have been attained in the
TREGDA study, and based on available data for other acrylates, EPA
still has concerns that some acrylates may be carcinogenic after
repeated application at higher doses.
[[Page 1306]]
Based on these findings EPA's regulation of the acrylates category
under TSCA section 5(e) has changed. EPA no longer regulates these
chemicals as a category for health concerns. However, if an acrylate or
methacrylate substance is structurally similar to a substance for which
EPA has positive toxicity data, EPA may regulate that substance under
section 5(e) of TSCA based on its potential unreasonable risk.
Henceforth this will be done on a case-by-case basis and is expected to
effectively eliminate regulation of most acrylates and methacrylates
for health concerns, especially higher molecular weight and polymeric
substances. EPA will continue to evaluate the acrylate category for
ecotoxicity; although these substances typically have low environmental
releases during their manufacture, processing, and use which will
continue to limit unreasonable risk findings under section 5(e) of TSCA
for the environmental toxicity of this class of chemicals.
Despite the fact that EPA no longer expects to make a potential
unreasonable risk finding under TSCA section 5(e) for most new
acrylates and methacrylates, EPA still recommends the use of personal
protective equipment for workers exposed to new or existing chemical
acrylates and methacrylates. In the case of dermal exposure, impervious
gloves and protective clothing are recommended, and in the case of
inhalation exposure, an appropriate National Institute of Occupational
Safety and Health (NIOSH)-approved respirator or engineering controls
to reduce or eliminate workplace exposures.
III. Objectives and Rationale of Withdrawing the Proposed Rule
Based on the review of acrylate esters that are the subject of this
withdrawal of a proposed SNUR, EPA concluded that for these substances,
regulation was warranted under section 5(a) of TSCA pending the
development of information sufficient to make reasoned evaluations of
the health effects of the substance, and EPA identified the tests
considered necessary to evaluate the risks of the substances. The basis
for such findings is referenced in Unit II of this preamble. Based on
these findings, a SNUR was proposed pending certain toxicity testing.
EPA reviewed the toxicity testing conducted for certain acrylate
substances, that were the result of a voluntary acrylates testing
program and determined that it could no longer support a finding that
activities designated by the proposed SNUR are significant new uses
under section 5(a) of TSCA.
In light of the above, EPA is withdrawing the proposed SNUR
provisions for acrylate esters.
IV. Regulatory Assessment Requirements
EPA is revoking the requirements of this rule. Any costs or burdens
associated with this rule will also be eliminated when the rule is
revoked. Therefore, EPA finds that no costs or burdens must be assessed
under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C.
605(b)), or the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials,
Recordkeeping and reporting requirements.
For the reasons set forth in the preamble, the proposed rule
published at 58 FR 61649, November 22, 1993, is withdrawn.
Dated: December 26, 1996.
Paul J. Campanella,
Acting Director, Chemical Control Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 97-513 Filed 1-8-97; 8:45 am]
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