[Federal Register Volume 59, Number 150 (Friday, August 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19194]


[[Page Unknown]]

[Federal Register: August 5, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721

[OPPTS-50601A; FRL-4761-7]

 

Pentaerythritol, Mixed Esters with Carboxylic Acids; 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 pentaerythritol, mixed esters with carboxylic acids based on 
receipt of toxicity data. The data indicate that for purposes of TSCA 
section 5 the substance will not present an unreasonable risk to 
health.
DATES: Written comments must be received by EPA by September 6, 1994.

ADDRESSES: All comments must be sent in triplicate to: U.S. 
Environmental Protection Agency, ATTN: OPPT Document Receipt Office 
(7407), 401 M St. SW., Rm. E-G99, 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-50601A. Unit III. of this preamble contains 
additional information on submitting comments containing CBI.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, Rm. E-543B, 401 
M St., SW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 
554-0551.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 23, 
1992 (57 FR 44050), EPA issued a SNUR establishing significant new uses 
for pentaerythritol, mixed esters with carboxylic acids (P-91-1250). 
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 the following chemical substance 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 citation (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-91-1250

Chemical name: (generic) Pentaerythritol, mixed esters with carboxylic 
acids.
CAS number: Not available.
Effective date of revocation of section 5(e) consent order: December 7, 
1993.
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: A mouse micronucleus assay of the substance 
was negative. In a 28-day dietary study the No Observed Adverse Effect 
Level (NOAEL) was 1,000 ppm (parts per million) (approximately 110 mg/
kg/day). Toxicity at higher doses of 5,000 and 12,500 ppm consisted of 
mild anemia and liver effects.
CFR citation: 40 CFR 721.5660.

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 environmental 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 5(e) 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. 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-50601A (P-91-1250). This record includes 
information considered by the Agency in developing the rule and 
includes the test data that formed the basis for this proposal.

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, 
Recordkeeping and reporting requirements, Significant new uses.

    Dated: July 26, 1994.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 continues to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

Sec. 721.5660  [Removed]

    2. By removing Sec. 721.5660.
[FR Doc. 94-19194 Filed 8-4-94; 8:45 am]
BILLING CODE 6560-50-F