[Federal Register Volume 60, Number 177 (Wednesday, September 13, 1995)]
[Proposed Rules]
[Pages 47531-47533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22730]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50601F; FRL-4926-1]
Cyclohexanecarbonitrile, 1,3,3-trimethyl-5-oxo-; Revocation of a
Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke a significant new use rule (SNUR)
promulgated under section 5(a)(2) of the Toxic Substances Control Act
(TSCA) for cyclohexanecarbonitrile, 1,3,3-trimethyl-5-oxo- based on
receipt of new data. The data indicate that for purposes of TSCA
section 5, the substance will not present an unreasonable risk to human
health.
DATES: Written comments must be received by October 13, 1995.
ADDRESSES: All comments must be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. E-G99, 401 M St., SW., Washington,
DC 20460. Comments that are confidential must be clearly marked
confidential business information (CBI). If CBI is claimed, an
additional sanitized copy must also be submitted. Nonconfidential
versions of comments on this proposed rule will be placed in the
rulemaking record and will be available for public inspection. Comments
should include the docket control number. The docket control number for
the chemical substance in this SNUR is OPPTS-50601F. Unit III.
[[Page 47532]]
of this preamble contains additional information on submitting comments
containing CBI.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: ncic@epamail.epa.gov. Electronic comments
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number OPPTS-50601F. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found in Unit IV. of this document.
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-Hotline@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 23,
1992 (57 FR 44050), EPA issued a SNUR establishing significant new uses
for cyclohexanecarbonitrile, 1,3,3-trimethyl-5-oxo-. Because of
additional data EPA has received for this substance, EPA is proposing
to revoke this SNUR.
I. Proposed Revocation
EPA is proposing to revoke the significant new use and
recordkeeping requirements for cyclohexanecarbonitrile, 1,3,3-
trimethyl-5-oxo- under 40 CFR part 721, subpart E. In this unit, EPA
provides a brief description for the substance, including its PMN
number, chemical name (generic name if the specific name is claimed as
CBI), CAS number (if assigned), basis for the revocation of the section
5(e) consent order for the substance, and the CFR citation removed in
the regulatory text section of this proposed rule. Further background
information for the substance is contained in the rulemaking record
referenced in Unit IV. of this preamble.
PMN Number: P-90-1358
Chemical name: Cyclohexanecarbonitrile, 1,3,3-trimethyl-5-oxo-.
CAS number: 7027-11-4.
Effective date of revocation of section 5(e) consent order: October 17,
1994.
Basis for revocation of section 5(e) consent order: The order was
revoked based on test data submitted under the terms of the consent
order. Based on the Agency's analysis of the submitted data, EPA has
sufficient information to determine, for purposes of TSCA section 5,
that the manufacture, processing, distribution in commerce, use, or
disposal of the PMN substance will not present an unreasonable risk to
human health. Accordingly, EPA has determined that further regulation
under section 5(e) is not warranted at this time.
Toxicity testing results: The results of the 90-day subchronic study in
rats which included a functional observational battery, an evaluation
of motor activity, and specific histological examination of the central
and autonomic nervous system, show that the PMN substance P-90-1358 did
not produce signs of systemic toxicity in either sex of rats when
administered in feed. At the 4,500 ppm (parts per million) dose, which
was the highest dose tested, food consumption and weight gain in
females were depressed. However, it is uncertain whether the depression
of body weight in females was due to toxicity or unpalatability of the
test material. There were no signs of neurotoxicity at any dose tested.
Upon microscopic examination, there was no dose-related trend in
incidence of abnormal findings. There was no indication whether cyanide
was or was not released from the PMN substance. In addition, the study
showed that the PMN substance does not act like the analogue,
isophorone.
CFR citation: 40 CFR 721.2225
II. Background and Rationale for Proposed Revocation of the Rule
During review of the PMN submitted for the chemical substance that
is the subject of this proposed revocation, EPA concluded that
regulation was warranted under section 5(e) of TSCA pending the
development of information sufficient to make a reasoned evaluation of
the environmental effects of the substance, and that the substance is
expected to be produced in substantial quantities and there may be
significant or substantial human exposure. EPA identified the tests
necessary to make a reasoned evaluation of the risks posed by the
substance to the human health. Based on these findings, a section 5(e)
consent order was negotiated with the PMN submitter and a SNUR was
promulgated. EPA reviewed testing conducted by the PMN submitter
pursuant to the consent order for the substance and determined that the
information available was sufficient to make a reasoned evaluation of
the health effects of the substance. EPA concluded that, for the
purposes of TSCA section 5, the substance will not present an
unreasonable risk and consequently revoked the section 5(e) consent
order. The proposed revocation of SNUR provisions for the substance
designated herein is consistent with the revocation of the section 5(e)
order. In light of the above, EPA is proposing a revocation of SNUR
provisions for this chemical substance. When this revocation becomes
final, EPA will no longer require notice of any company's intent to
manufacture, import, or process this substance. In addition, export
notification under section 12(b) of TSCA will no longer be required.
III. Comments Containing Confidential Business Information
Any person who submits comments claimed as CBI must mark the
comments as ``confidential,'' ``trade secret,'' or other appropriate
designation. Comments not claimed as confidential at the time of
submission will be placed in the public file. Any comments marked as
confidential will be treated in accordance with the procedures in 40
CFR part 2. Any party submitting comments claimed to be confidential
must prepare and submit a public version of the comments that EPA can
place in the public file.
IV. Rulemaking Record
The record for the rule which EPA is proposing to revoke was
established at OPPTS-50601 (P-90-1358). This record includes
information considered by the Agency in developing the rule and
includes the test data that formed the basis for this proposal.
A record has been established for this rulemaking under docket
number OPPTS-50601F (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 12 noon to 4 p.m., Monday through Friday, excluding legal
holidays. The public record is located in the TSCA Nonconfidential
Information Center, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
Electronic comments can be sent directly to EPA at:
ncic@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept
[[Page 47533]]
in paper form. Accordingly, EPA will transfer all comments received
electronically into printed, paper form as they are received and will
place the paper copies in the official rulemaking record which will
also include all comments submitted directly in writing. The official
rulemaking record is the paper record maintained at the address in
addresses at the beginning of this document.
V. Regulatory Assessment Requirements
EPA is proposing to revoke the requirements of the rule. Any costs
or burdens associated with the 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, Reporting
and recordkeeping requirements, Significant new uses.
Dated: September 1, 1995.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
Sec. 721.2225 [Removed]
2. By removing Sec. 721.2225.
[FR Doc. 95-22730 Filed 9-12-95; 8:45 am]
BILLING CODE 6560-50-F
