96-9472. Prosulfuron; Pesticide Tolerance  

  • [Federal Register Volume 61, Number 75 (Wednesday, April 17, 1996)]
    [Proposed Rules]
    [Pages 16742-16745]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-9472]
    
    
    
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    DEPARTMENT OF TRANSPORTATION
    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 180
    
    [PP 5F4469/P650; FRL-5357-5]
    RIN 2070-AB18
    
    
    Prosulfuron; Pesticide Tolerance
    
    AGENCY: Environmental Protection Agency (EPA).
    
    
    [[Page 16743]]
    
    
    ACTION: Proposed rule.
    
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    SUMMARY: EPA proposes to establish time-limited tolerances for residues 
    of the herbicide prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-
    (3,3,3-trifluoropropyl)-phenylsulfonyl]-urea in or on the raw 
    agricultural commodities cereal grains group (except rice and wild 
    rice), grain at 0.01 part per million (ppm); cereal grains group 
    (except rice and wild rice), forage at 0.10 ppm; cereal grains group 
    (except rice and wild rice), fodder at 0.01 ppm, cereal grains group 
    (except rice and wild rice), straw at 0.02 ppm; and cereal grains group 
    (except rice and wild rice), hay at 0.20 part per million (ppm). The 
    Agency has not completed the regulatory assessment of our science 
    findings; therefore, the Agency is proposing these tolerances with an 
    expiration date.
    
    DATES:  Written comments, identified by the docket number [PP 5F4469/
    P650] should be submitted to EPA by May 17, 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, bring comments to: Rm. 1132, CM #2, 
    1921 Jefferson Davis Highway, Arlington, VA 22202.
        Information submitted as a comment concerning this document may be 
    claimed confidential by marking any part or all of that information as 
    ``Confidential Business Information.'' CBI should not be submitted 
    through e-mail. Information marked as CBI 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 address given above, 
    from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
    holidays.
        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 5.1 file format or ASCII file format. 
    All comments and data in electronic form must be identified by the 
    docket number [PP 5F4469/P650]. Electronic comments on this proposed 
    rule may be filed online at many Federal Depository Libraries. 
    Additional information on electronic submissions can be found below in 
    this document.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Robert J. Taylor, Product 
    Manager (PM) 25, Registration Division (7505C), Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
    location and telephone number: Rm. 245, CM #2, 1921 Jefferson Davis 
    Highway, Arlington, VA 22202, 703-305-6800, e-mail: 
    taylor.robert@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA issued a notice of filing published in 
    the Federal Register of (60 FR 27505, May 24, 1995) which requested 
    tolerances for residues of the herbicide prosulfuron, 1-(4-methoxy-6-
    methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea 
    in or on the raw agricultural commodities cereal grains (except rice/
    wild rice) group at 0.02 part per million (ppm), and cereal grains, 
    forage, fodder and straw (except rice/wild rice) group at 0.02 part per 
    million (ppm). The petitioner subsequently amended this petition by 
    submitting a revised section F which proposed tolerances in or on the 
    raw agricultural commodities cereal grains group (except rice and wild 
    rice), grain at 0.01 part per million (ppm); cereal grains group 
    (except rice and wild rice), forage at 0.10 ppm; cereal grains group 
    (except rice and wild rice), fodder at 0.01 ppm; cereal grains group 
    (except rice and wild rice), straw at 0.02 ppm; and cereal grains group 
    (except rice and wild rice), hay at 0.20 part per million (ppm). These 
    tolerances with an expiration date are required by EPA to allow the 
    petitioner, Ciba-Geigy Corp. to submit additional data concerning the 
    method trial, plant metabolism and ruminant metabolism data. The 
    petitioner has submitted a method trial and it has been validated by an 
    independent laboratory. Additional time is being required to complete 
    review of this method trial and allow additional time to complete and 
    submit the required plant and animal metabolism data and new 
    developmental rabbit study with an accompanying overview (discussion of 
    all the rabbit developmental data, yet to be submitted by the 
    registrant).
        There were no comments or requests for referral to an advisory 
    committee received in response to the notice of filing.
        The data submitted in the petition and other relevant material have 
    been evaluated. The toxicology data listed below were considered in 
    support of this tolerance.
        1. Several acute toxicology studies placing technical grade 
    prosulfuron in Toxicity Category III, and an acute neurotoxicity study 
    in rats at dose levels of 0, 10, 250, 500, or 1,000 mg/kg with a NOEL 
    of 10 mg/kg based on reduced motor activity and body temperature in 
    males and impaired righting reflex in females. A 90 day neurotoxicity 
    study in rats demonstrated NOELs of >5,000 ppm in females and 10,000 
    ppm in males and 200 ppm for systemic toxicity.
        2. A 1-year feeding study with dogs fed dosages of 0, 0.33, 1.95, 
    18.6 or 41.0 mg/kg/day (males) and 0, 0.31, 1.84, 20.2, or 48.8 mg/kg/
    day (females). The NOEL was 1.84 mg/kg/day based on hematologic and 
    clinical chemistry effects and incidence of lipofuscin accumulation in 
    the liver at 18.6 mg/kg/day.
        3. An 18-month carcinogenicity study in mice fed dosages of 0, 
    1.71, 81.4, 410 or 832 mg/kg/day (males), and 0, 2.11, 100, 508 or 
    1,062 mg/kg/day (females). There was no evidence of carcinogenic 
    effects up to 1,062 mg/kg/day, the highest dose tested (HDT).
        4. A 2-year chronic feeding/carcinogenicity study in rats fed 
    dosages of 0, 0.4, 7.9, 79.9 or 160.9 (males), and 0, 0.5, 9.2, 95.7 or 
    205.8 mg/kg/day (females). There was uncertain evidence of 
    carcinogenicity with slight increases in the incidence of mammary gland 
    adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase 
    in incidence of benign testicular interstital cell tumors at 79.9 and 
    160.9 mg/kg/day (significant trend only). A systemic NOEL of 7.9 mg/kg/
    day was based on decreased body weight and body weight gain, 
    hematopoietic effects (males), and possibly increased serum GGT and 
    decreased liver, kidney and adrenal weights (females) at 79.9 mg/kg/
    day.
        5. A multigeneration reproduction study with rats fed dosages of 0, 
    0.67, 13.3, 136 or 278 (males), and 0, 0.76, 15.3, 152 or 311 mg/kg/day 
    (females) with a reproductive and a systemic NOEL of 13.3 mg/kg/day 
    based on decreased mean body weights and body weight gain observed at 
    136 mg/kg/day for both pups (at 200 ppm beginning during lactation) and 
    parental animals.
        6. A developmental toxicity study in rats at dose levels of 0, 5, 
    50, 200 and 400 mg/kg/day by gavage. The developmental NOEL was 200 mg/
    kg/day based on a statistically significant elevation of combined 
    skeletal findings at 400 mg/kg/day, and maternal toxicity NOEL of 200 
    mg/kg/day, based on marginal effects on body weight gain at 400 mg/kg/
    day.
        7. A developmental toxicity study in rabbits at dose levels of 0, 
    1.0, 10 and 100 mg/kg/day by gavage with no
    
    [[Page 16744]]
    
    indications of developmental toxixicy at dose levels up to 100 mg/kg/
    day. A new rabbit developmental study has received preliminary 
    evaluation. Based upon this evaluation, the maternal NOEL appears to be 
    20 mg/kg/day. The developmental NOEL can not be determined without a 
    complete evaluation of this study. However, it is unlikely that the 
    NOEL would be less than 20 mg/kg/day in this study. A data gap remains 
    for the rabbit developmental until this study, all other as yet 
    unsubmitted deveopmental studies (both rangefinding and definitive) and 
    an accompanying overview (discussion of all the rabbit developmental 
    data, yet to be submitted by the registrant) has been completely 
    evaluated and approved by the Agency.
        8. Three acceptable mutagenicity studies were reviewed for 
    prosulfuron. These include assays with Salmonella typhimurium strains 
    TA1535 TA1537, TA98, and TA100 or E. coli WP2 uvrA exposed in either 
    the presence or absence of mammalian metabolic activation; unscheduled 
    DNA synthesis (UDS) in primary rat hepatocytes; and a structural 
    chromosomal aberration micronucleus test in mice. All these tests were 
    negative for mutagenicity.
        The prosulfuron Reference Dose (RfD) was established at 0.02 mg/kg/
    day based on a NOEL of 1.84 mg/kg bwt/day on the 1-year dog chronic 
    feeding study with an uncertainty factor of 100. The theoretical 
    maximum residue contribution (TMRC) for tolerances on the cereal grains 
    group, straw, forage and hay, and milk, meat and meat by-products 
    utilizes 1.5% of the RfD for the total U.S. population. The most highly 
    exposed subgroups, children (1 to 6) and non-nursing infants (less than 
    one year old), utilize 4.4% of the RfD.
        The HED RfD/Peer Review Committee classified this chemical as a 
    Class D oncogen based on the conclusion that there was uncertain 
    evidence of carcinogenicity with slight increases in the incidence of 
    mammary gland adenocarcinomas in female rats at 95.7 and 205.8 mg/kg/
    day, but significant only at 95.7 mg/ kg/day, a slight increase in 
    incidence of benign testicular interstital cell tumors in rats at 79.9 
    and 160.9 mg/kg/day, and no evidence of carcinogenicity in mice.
        The committee also decided that prosulfuron was not associated with 
    any significant reproductive or develpmental toxicity under the 
    conditions of testing. However, this evaluation does not include 
    evaluation of the new rabbit developmental study (already at EPA) or 
    any other rabbit developmental studies that have been conducted but not 
    yet submitted by the registrant.
        Data which are desirable include the submission of stability data 
    (storage and chemical), information on accuracy of the method used to 
    verify the certified limits, experimental details of all solubility 
    determinations, and additional plant and ruminant metabolism data.
        Based on the information cited above, the Agency has determined 
    that when used in accordance with good agricultural practice, this 
    ingredient is useful and the tolerances will protect the public health. 
    Therefore, EPA is proposing to establish the tolerances as described 
    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 
    active ingredients listed herein, may request within 30 days after 
    publication of this notice in the Federal Register that this rulemaking 
    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 
    docket number [PP 5F4469/P650]. All written comments filed in response 
    to this petition will be available in the Public Response and Program 
    Resources Branch, at the Virginia address given above from 8 a.m. to 
    4:30 p.m., Monday throught Friday, except legal holidays.
        Information submitted as a comment concerning this document may be 
    claimed confidential by marking any or all of that information as 
    ``Confidential Business Information'' (CBI). EPA will not disclose 
    information so marked, except in accordance with procedures set forth 
    in 40 CFR part 2. A second copy of such comments, with the CBI deleted, 
    must also be submitted for inclusion in the public record. EPA may 
    publicly disclose without prior notice information not marked 
    confidential.
        EPA has established a record for this proposed rule under docket 
    number [PP-5F4469/P650] (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 4:00 p.m., Monday through Friday, except legal holidays. 
    The public record is located in Room 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
    
        The official record for this proposed rule, 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 proposed rule record which will also include all comments 
    submitted directly in writing. The official proposed rule record is the 
    paper record maintained at the ``ADDRESSES'' listed at the beginning of 
    this document.
        The Office of Management and Budget has exempted this rule from the 
    requirements of section 3 of Executive Order 12866.
        Pursuant to the requirements of the Regulatory Flexibility Act 
    (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
    has determined that regulations establishing new tolerances or food 
    additive regulations 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
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
        Dated: April 3, 1996.
    
    Susan Lewis,
    
    Acting 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. By revising Sec. 180.481 to read as follows:
    
    
    Sec. 180.481   Prosulfuron; tolerances for residues.
    
        Tolerances that expire on December 31, 1999 are being established 
    for residues of the herbicide prosulfuron 1-(4-methoxy-6-methyl-
    triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-
    
    [[Page 16745]]
    
    urea in or on the following raw agricultural commodities:
    
    
    ------------------------------------------------------------------------
                                                                      Parts 
                               Commodity                               per  
                                                                     million
    ------------------------------------------------------------------------
    Cereal grains group (except rice and wild rice), grain.........    0.01 
    Cereal grains group (except rice and wild rice), forage........    0.10 
    Cereal grains group (except rice and wild rice), fodder........    0.01 
    Cereal grains group (except rice and wild rice), straw.........    0.02 
    Cereal grains group (except rice and wild rice), hay...........    0.20 
    ------------------------------------------------------------------------
    
    [FR Doc. 96-9472 Filed 4-16-96; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Published:
04/17/1996
Department:
Environmental Protection Agency
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
96-9472
Dates:
Written comments, identified by the docket number [PP 5F4469/ P650] should be submitted to EPA by May 17, 1996.
Pages:
16742-16745 (4 pages)
Docket Numbers:
PP 5F4469/P650, FRL-5357-5
RINs:
2070-AB18
PDF File:
96-9472.pdf
CFR: (1)
40 CFR 180.481