96-7448. Oxidized Pine Lignin, Sodium Salt; Tolerance Exemption  

  • [Federal Register Volume 61, Number 60 (Wednesday, March 27, 1996)]
    [Proposed Rules]
    [Pages 13476-13478]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-7448]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 180
    
    RIN 2070-AB18
    [OPP-300418; FRL-5355-6]
    
    
    Oxidized Pine Lignin, Sodium Salt; Tolerance Exemption
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Proposed rule.
    
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    SUMMARY: This document proposes that oxidized pine lignin, sodium salt 
    (CAS Reg. No. 68201-23-0) be exempted from the requirement of a 
    tolerance when used as an inert ingredient (surfactant or adjuvant to 
    surfactant) in pesticide formulations. This proposed regulation was 
    requested by LignoTech USA, Inc.
    
    DATES: Comments, identified by the docket control number [OPP-300418], 
    must be received on or before April 26, 1996.
    
    ADDRESSES: By mail, submit written comments to: Public Response and 
    Program Resources Branch, Field Operations Division (7506C), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. In person deliver comments to: Rm. 1128, Crystal 
    Mall, Building #2, 1921 Jefferson Davis Highway, Arlington, VA.
    
    ADDRESSES: The Agency invites any interested person who has concerns 
    about the implementation of this action to submit written comments in 
    triplicate to: By mail: Program Resources Section, Public Response and 
    Program Resources Branch, Field Operations Division (7506C), 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
    In person, bring comments to: Rm. 1132, Crystal Mall #2, 1921 Jefferson 
    Davis Highway, Arlington, VA.
        Comments and data may also be submitted electronically by sending 
    electronic mail (e-mail) to: opp-docket@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 ``OPP-300418.'' No Confidential Business Information 
    (CBI) should be submitted through e-mail. Electronic comments on this 
    document may be filed online at many Federal Depository Libraries. 
    Additional information on electronic submissions can be found in the 
    SUPPLEMENTARY unit of this document.
        Information submitted as a comment concerning this document may be 
    claimed confidential by marking any part or all of that information as 
    CBI. Information so marked will not be disclosed except in accordance 
    with procedures set forth in 40 CFR part 2. A copy of the comment that 
    does not contain CBI must be submitted for inclusion in the public 
    record. Information not marked confidential may be disclosed publicly 
    by EPA without prior notice. All written comments will be available for 
    public inspection in Rm. 1132 at the Virginia address given above from 
    8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
    
    For Further Information Contact: By mail: Amelia M. Acierto, 
    Registration Support Branch, Registration Division (7505W), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. Office location, telephone number, and e-mail 
    address: 2800 Crystal Drive North Tower, Arlington, VA, (703) 308-8375, 
    e-mail acierto.amelia@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: LignoTech USA, Inc., 100 Highway 51 South, 
    Rothschild, WI 54474-1998 submitted pesticide petition (PP) number 
    5E04471 to EPA requesting that the Administrator, pursuant to section 
    408(e) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(e), 
    propose to amend 40 CFR 180.1001 (c) and (e) by establishing an 
    exemption from the requirement of a tolerance for oxidized lignin, 
    sodium salt when used as a surfactant or adjuvant to surfactant in 
    pesticide formulations applied to growing crops or to raw agricultural 
    commodities after harvest or to animals. Inert ingredients are all 
    ingredients that are not active ingredients as defined in 40 CFR 
    153.125, and include, but are not limited to, the following types of 
    ingredients (except when they have a
    
    [[Page 13477]]
    pesticidal efficacy of their own): solvents such as alcohols and 
    hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
    acids; carriers such as clay and diatomaceous earth; thickeners such as 
    carrageenan and modified cellulose; wetting, spreading, and dispersing 
    agents; propellants in aerosol dispensers; microencapsulating agents; 
    and emulsifiers. The term ``inert'' is not intended to imply 
    nontoxicity; the ingredient may or may not be chemically active.
        The data submitted in the petition and other relevant material have 
    been evaluated. As part of the EPA policy statement on inert 
    ingredients published in the Federal Register of April 22, 1987 (52 FR 
    13305), the Agency set forth a list of studies which would generally be 
    used to evaluate the risks posed by the presence of an inert ingredient 
    in a pesticide formulation. However, where it can be determined without 
    that data that the inert ingredient will present minimal or no risk, 
    the Agency generally does not require some or all of the listed studies 
    to rule on the proposed tolerance or exemption from the requirement of 
    a tolerance for an inert ingredient. The Agency has decided that no 
    data, in addition to that described below, for oxidized lignin, sodium 
    salt will need to be submitted. The rationale for this decision is 
    described below:
        1. Similar chemicals such as pine lignin (used as an absorbent) and 
    sulfonated kraft lignin/lignosulfonates (used as a surfactant or 
    related adjuvant to surfactant), are exempt from the requirement of a 
    tolerance when used in pesticide formulations applied to growing crops 
    or to raw agricultural commodities after harvest or to animals under 40 
    CFR 180.1001 (c) and (e).
        2. Pine lignin, also known as kraft lignin, is a derivative of a 
    natural plant polymer, lignin, which is the most abundant polymer in 
    nature. Pine lignin is used as a raw material for oxidized kraft lignin 
    as well as a starting material for pine-kraft lignin-based 
    lignosulfonates. It is produced as a coproduct during the manufacture 
    of paper via the kraft pulping process.
        3. The toxicological data show that pine lignin, sulfonated pine 
    lignin as well as oxidized pine lignin or lignosulfonates are of very 
    low acute toxicity (LD50 >2 to >5 g/kg in rats and LC50 >1000 to >3000 
    mg/l in fish).
        4. Pine lignin is classified as toxicity category IV in a skin 
    irritation and eye irritation studies.
        Based on the submitted toxicological data, physico-chemical 
    properties of the sodium salt of oxidized kraft lignin, its structural 
    similarity to related chemicals such as kraft lignin/lignosulfonates 
    and pine/kraft lignin that have already been exempted under 40 CFR 
    180.1001(c) and (e), and the review of its use, the Agency has found 
    that, when used as a surfactant or adjuvant to surfactant in pesticide 
    formulations applied preharvest, postharvest or to animals in 
    accordance with good agricultural practice, this ingredient is useful 
    and a tolerance is not necessary to protect the public health. 
    Therefore, EPA proposes that the exemption from the requirement of a 
    tolerance be established as set forth below.
        Any person who has registered or submitted an application for 
    registration of a pesticide, under the Federal Insecticide, Fungicide, 
    and Rodenticide Act (FIFRA) as amended, which contains any of the 
    ingredients listed herein, may request within 30 days after publication 
    of this document in the Federal Register that this proposal be referred 
    to an Advisory Committee in accordance with section 408(e) of the 
    Federal Food, Drug, and Cosmetic Act.
        Interested persons are invited to submit written comments on the 
    proposed regulation. Comments must bear a notation indicating the 
    document control number [OPP-300418].
         A record has been established for this proposal under docket 
    number ``OPP-300418'' (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 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
    The public record is located in Rm. 1132 of the Public Response and 
    Program Resources Branch, Field Operations Division (7506C), Office of 
    Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
    1921 Jefferson Davis Highway, Arlington, VA.
        Electronic comments can be sent directly to EPA at:
    
        opp-docket@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 the proposal 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 
    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.
        The Office of Management and Budget has exempted this proposed rule 
    from the requirements of section 3 of Executive Order 12866.
        Pursuant to the requirements of the Regulatory Flexibility Act 
    (Pub. L. 96-354 Stat. 1164, 5 U.S.C. 601-612), the Administrator has 
    determined that regulations establishing new tolerances or raising 
    tolerance levels or establishing exemptions from tolerance requirements 
    do not have a significant economic impact on a substantial number of 
    small entities. A certification statement to this effect was published 
    in the Federal Register of May 4, 1981 (46 FR 24950).
    
    List of Subjects in 40 CFR Part 180
    
        Administrative practice and procedure, Agricultural commodities, 
    Pesticides and pests, Recording and recordkeeping requirements.
    
        Dated: March 13, 1996.
    Stephen L. Johnson,
    Director, Registration Division, Office of Pesticide Programs.
        Therefore, it is proposed that 40 CFR part 180 be amended as 
    follows:
    
    PART 180--[AMENDED]
    
        1. The authority citation for part 180 continues to read as 
    follows:
    
        Authority: 21 U.S.C. 346a and 371.
    
        2. Section 180.1001 is amended by revising the table in paragraphs 
    (c) and (e) by adding and alphabetically inserting the inert 
    ingredient, oxidized pine lignin to read as follows:
    
    
    Sec. 180.1001   Exemptions from the requirement of a tolerance.
    
        *  *  *  *  *
        (c) *  *  *
    
    [[Page 13478]]
    
    
                                                                            
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            Inert ingredients               Limits               Uses       
    ------------------------------------------------------------------------
                                                                            
         *        *        *        *        *        *        *            
    Oxidized pine lignin, sodium      Maximum of 2% of    Surfactant or     
     salt (CAS Reg. No. 68201-23-0)    formulation         adjuvant to      
                                                           surfactant       
                                                                            
         *        *        *        *        *        *        *            
    ------------------------------------------------------------------------
    
        *  *  *  *  *
        (e) *  *  *
    
                                                                            
    ------------------------------------------------------------------------
            Inert ingredients               Limits               Uses       
    ------------------------------------------------------------------------
                                                                            
         *        *        *        *        *        *        *            
    Oxidized pine lignin, sodium      Maximum of 2% of    Surfactant or     
     salt (CAS Reg. No. 68201-23-0)    formulation         adjuvant to      
                                                           surfactant       
                                                                            
         *        *        *        *        *        *        *            
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    [FR Doc. 96-7448 Filed 3-26-96; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Published:
03/27/1996
Department:
Environmental Protection Agency
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
96-7448
Dates:
Comments, identified by the docket control number [OPP-300418], must be received on or before April 26, 1996.
Pages:
13476-13478 (3 pages)
Docket Numbers:
OPP-300418, FRL-5355-6
RINs:
2070-AB18
PDF File:
96-7448.pdf
CFR: (1)
40 CFR 180.1001