[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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-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-Hotline@epamail.epa.gov.
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:
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 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
