[Federal Register Volume 60, Number 239 (Wednesday, December 13, 1995)]
[Proposed Rules]
[Pages 64009-64010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30371]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50601G; FRL-4976-3]
Ethane, 1,1,1,2,2-pentafluoro-; 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, 1,1,1,2,2-pentafluoro-, 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 January 12, 1996.
ADDRESSES: All comments must be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 401 M Street, SW., Room G-099, East
Tower, 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-50601G. 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],gov. Electronic comments
must be submitted as 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-50601G). 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 44064), EPA issued a SNUR (FRL-4001-2) establishing
significant new uses for ethane, 1,1,1,2,2-pentafluoro-. 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, 1,1,1,2,2-pentafluoro- under 40
CFR part 721, subpart E. In this unit, EPA provides a brief description
for the substance, including its premanufacture notice (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-91-1392
Chemical name: Ethane, 1,1,1,2,2-pentafluoro-.
CAS Registry Number: Not available.
Effective date of revocation of section 5(e) consent order: February
21, 1995.
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 can no
longer support a finding that the manufacture, processing, distribution
in commerce, use, or disposal of the PMN substance may 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 PMN substance P-91-1392 was tested in a
cardiac sensitization study (epinephrine challenge in dogs), a 90-day
inhalation toxicity study in rats, and a developmental inhalation
toxicity study (rats and rabbits). The 90-day subchronic study showed
that there were no observable adverse effects at concentrations up to
50,000 parts per million (ppm). There were no observed developmental
toxicity effects at concentrations up to 50,000 ppm in the
developmental toxicity study. There was evidence of maternal toxicity
at 50,000 ppm but no maternal effects noted at 15,000 ppm. The PMN
substance P-91-1392 was found to be a cardiac sensitizer when exposures
occurred at a 10 percent concentration in air (100,000 ppm) for 10
minutes. Lower exposures did not elicit a sensitization response.
CFR Number: 40 CFR 721.3240
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
[[Page 64010]]
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-91-1392). 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-50601G (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: December 5, 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. 721.3240 [Removed]
2. By removing Sec. 721.3240.
[FR Doc. 95-30371 Filed 12-12-95; 8:45 am]
BILLING CODE 6560-50-F