94-19194. Pentaerythritol, Mixed Esters with Carboxylic Acids; Revocation of a Significant New Use Rule  

  • [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]
    
    
    -----------------------------------------------------------------------
    
    
    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.
    
    -----------------------------------------------------------------------
    
    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
    
    
    

Document Information

Published:
08/05/1994
Department:
Environmental Protection Agency
Entry Type:
Uncategorized Document
Action:
Proposed rule.
Document Number:
94-19194
Dates:
Written comments must be received by EPA by September 6, 1994.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: August 5, 1994, OPPTS-50601A, FRL-4761-7
CFR: (1)
40 CFR 721.5660