[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: [email protected]. 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-H[email protected].

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:
    [email protected]

    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