[Federal Register Volume 60, Number 177 (Wednesday, September 13, 1995)]
[Proposed Rules]
[Pages 47533-47534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22731]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721

[OPPTS-50608C; FRL-4911-5]


Ethane, 1,1,1-Trifluoro-; 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 ethane, 1,1,1-trifluoro-, 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: TSCA Document 
Receipt Office (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, three additional 
sanitized copies 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-50608C. Unit III. 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-50608C. 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 June 8, 1993 (58 
FR 32238), EPA issued a SNUR establishing significant new uses for 
ethane, 1,1,1-trifluoro-. 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 ethane, 1,1,1-trifluoro- 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-92-341

Chemical name: Ethane, 1,1,1-
trifluoro-.
CAS number: 420-46-2.
Effective date of revocation of section 5(e) consent order: August 29, 
1994.
Basis for revocation of section 5(e) consent order: The order was 
revoked based on test data submitted by the PMN submitter 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) of TSCA is not 
warranted at this time.
Toxicity testing results: Cardiac sensitization (dogs): The PMN 
substance was found to be a cardiac sensitizer when exposures occurred 
at a 30 percent concentration in air (300,000 ppm (parts per million)) 
for 10 minutes. Lower exposures did not elicit a sensitization 
response. The substance is not mutagenic in the micronucleus assay. 
There were no observed adverse effects at concentrations up to 40,000 
ppm in the developmental or 90-day subchronic study.
CFR citation: 40 CFR 721.3254.

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 health 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 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 


[[Page 47534]]
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 person'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-50608 (P-92-341). 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-50608C (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 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. 721.3254  [Removed]

    2. By removing Sec. 721.3254.
[FR Doc. 95-22731 Filed 9-12-95; 8:45 am]
BILLING CODE 6560-50-F