95-24006. Chlorethoxyfos; Pesticide Tolerances  

  • [Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
    [Rules and Regulations]
    [Pages 49790-49793]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-24006]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 180
    
    [PP 3F4174/R2175; FRL-4979-5]
    RIN 2070-AB78
    
    
    Chlorethoxyfos; Pesticide Tolerances
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This rule establishes tolerances for residues of the 
    insecticide phosphorothioic acid, 0,0-diethyl 0-(1,2,2,2-
    tetrachloroethyl) ester (proposed common name, ``chlorethoxyfos''), in 
    or on the raw agricultural commodities of field, pop, and sweet corn at 
    0.01 part per million (ppm). E.I. Du Pont de Nemours & Co. submitted a 
    petition for the regulation to establish these maximum permissible 
    levels for residues of the insecticide pursuant to the Federal Food, 
    Drug and Cosmetic Act (FFDCA).
    
    EFFECTIVE DATE: This regulation became effective on September 18, 1995.
    
    
    [[Page 49791]]
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    document control number, [PP 3F4174/R2175], may be submitted to: 
    Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
    St., SW., Washington, DC 20460. A copy of any objections and hearing 
    requests filed with the Hearing Clerk should be identified by the 
    document control number and submitted 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 copy of objections and hearing 
    requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
    22202. Fees accompanying objections shall be labeled ``Tolerance 
    Petition Fees'' and forwarded to: EPA Headquarters Accounting 
    Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
    PA 15251.
        A copy of objections and hearing requests filed with the Hearing 
    Clerk may also be submitted electronically by sending electronic mail 
    (e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
    hearing requests must be submitted as an ASCII file avoiding the use of 
    special characters and any form of encryption. Copies of objections and 
    hearing requests will also be accepted on disks in WordPerfect in 5.1 
    file format or ASCII file format. All copies of objections and hearing 
    requests in electronic form must be identified by the docket number [PP 
    3F4174/R2175]. No Confidential Business Information (CBI) should be 
    submitted through e-mail. Electronic copies of objections and hearing 
    requests on this 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: Dennis H. Edwards, Product 
    Manager (PM-19) Registration Division (7505C), Office of Pesticide 
    Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
    DC 20460. Office location and telephone number: Rm. 207, CM #2, 1921 
    Jefferson Davis Highway, Arlington, VA 22202, (703)-305-6386; e-mail: 
    edwards.dennis@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: In the Federal Register of October 21, 1993 
    (58 FR 54353), EPA issued the initial filing of a pesticide petition, 
    PP 3F4174, from Du Pont, Agricultural Products, Walker's Mill, Barley 
    Mill Plaza, P.O. Box 80038, Wilmington, DE 19880-0038, proposing to 
    amend 40 CFR part 180 by establishing a regulation to permit residues 
    of chlorethoxyfos in or on corn; sweet corn separate from field corn 
    (corn, field, forage) at 0.01 ppm; corn, field, fodder at 0.01 ppm; 
    corn, field, silage at 0.01 ppm; corn, pop, forage at 0.01 ppm; corn, 
    pop, fodder at 0.01 ppm; corn, grain at 0.01 ppm; corn, sweet (kernels, 
    cob with husk removed) at 0.01 ppm; corn, sweet, forage at 0.01 ppm; 
    and corn, sweet, fodder at 0.01 ppm. Subsequently, EPA issued a notice 
    of amended filing, published in the Federal Register of August 17, 1995 
    (60 FR 42885), which announced that E.I. Du Pont de Nemours & Co., had 
    submitted the amended pesticide petition (PP 3F4174) to EPA requesting 
    that the Administrator, pursuant to section 408(d) of the Federal Food, 
    Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish tolerances 
    for residues of the insecticide phosphorothioic acid, 0,0-diethyl 0-
    (1,2,2,2-tetrachloroethyl) ester (``chlorethoxyfos''), in or on the raw 
    agricultural commodity corn [corn grain--field, pop; corn forage--
    field, sweet; corn fodder (stover)--field, pop, sweet; and, sweet 
    corn--kernel and cob with husk removed] at 0.01 ppm.
        There were no comments or requests for referral to an advisory 
    committee received in response to the notices of filing. All relevant 
    materials have been evaluated. The toxicology data considered in 
    support of the tolerance include:
        1. A 2-year chronic feeding/carcinogenicity study in the rat with a 
    no-observed-effect level (NOEL) of 0.154 milligram (mg)/kilogram (kg)/
    day (d) for males and 0.416 mg/kg/d for females (4 ppm) for 
    cholinesterase inhibition (ChE); and a NOEL of 0.311 mg/kg/d for males 
    and 0.416 mg/kg/d for females (8 ppm) for systemic effects.
        2. An 18-month chronic feeding/carcinogenicity study in the mouse 
    with a NOEL of 3.25 mg/kg/d for males and 4.63 mg/kg/d for females (25 
    ppm) and no treatment-related increases in neoplasms.
        3. A 2-year chronic feeding study in the dog with a NOEL of 0.063 
    mg/kg/d for males and 0.065 mg/kg/d for females (2 ppm) for ChE, and a 
    NOEL of 0.616 mg/kg/d for males and 0.591 mg/kg/d for females (20 ppm) 
    for systemic effects.
        4. A two-generation rat reproduction study with a parental NOEL of 
    0.296 mg/kg/d for males and 0.357 mg/kg/d for females (4 ppm), and a 
    reproductive NOEL of 0.607 mg/kg/d for males and 0.776 mg/kg/d for 
    females (8 ppm).
        5. A developmental toxicity study in the rat with a maternal NOEL 
    of 0.25 mg/kg/d, and a developmental NOEL of 0.25 mg/kg/d.
        6. A developmental toxicity study in the rabbit with a maternal 
    NOEL of 0.76 mg/kg/d, and a developmental NOEL of 1.38 mg/kg/d with no 
    evidence of teratogenicity.
        Chlorethoxyfos has been classified under ``Group D'' (not 
    classifiable as to human carcinogenicity) by EPA's OPP/HED's Reference 
    Dose (RFD)/Peer Review Committee.
        The reference dose (RfD), based upon the combined subchronic and 
    chronic toxicity studies in dogs with an overall NOEL of 0.061 mg/kg/d 
    for males and 0.062 mg/kg/d for females (based on cholinesterase 
    inhibition) (2 ppm), and an uncertainty factor (UF) of 100, was 
    calculated to be 0.0006 mg/kg/d. The theoretical maximum residue 
    contribution (TMRC) using proposed permanent tolerances for the 
    proposed commodities is 0.000006 mg/kg/d for the overall U.S. 
    population and 0.000015 mg/kg/d for children (1 to 6 years old). This 
    represents 1.0% and 2.4% of the RfD, respectively. This is a worst-case 
    estimate of dietary exposure with all residues at tolerance level and 
    100 percent of the commodities assumed to be treated with 
    chlorethoxyfos. Dietary exposure from the proposed use will not exceed 
    the reference dose for any subpopulation (including infants and 
    children) based on the information available from EPA's Dietary Risk 
    Evaluation System.
        The nature of the chlorethoxyfos residue in plants and animals is 
    adequately understood. The plant metabolite of chlorethoxyfos, 
    trichloroacetic acid (TCA), is not of toxicological concern at the 
    level found, and therefore will not require the establishment of 
    tolerances. Residues of chlorethoxyfos and its oxygen analog are not 
    expected to be detectable (less than 0.01 ppm, limit of quantitation 
    for each) in corn grain, corn forage and stover as a result of the 
    proposed use (by soil application). Residues of TCA are not expected to 
    be detectable (less than 0.01 ppm) in corn grain, and no greater than 
    0.04 ppm in corn forage and stover. Metabolites of chlorethoxyfos in 
    the goat via an orally administered route include carbon dioxide, 
    serine, glycine, and lactose, with insignificant levels of undegraded 
    parent and its oxygen analog. For the proposed use on corn, no 
    tolerances are required for residues in animal commodities.
        The submitted analytical methodology is adequate for enforcement 
    purposes at the proposed 0.01-ppm tolerance level. The proposed 
    enforcement methodology is a gas chromatography electron capture (GC/
    EC) method which has undergone 
    
    [[Page 49792]]
    successful independent laboratory and EPA method validation.
        There are adequate geographically representative crop field trial 
    data to show that residues of chlorethoxyfos will not exceed the 
    proposed tolerance on corn commodities at 0.01 ppm when used as 
    directed.
        The Agency is concurrently issuing a 3-year conditional 
    registration for chlorethoxyfos use on corn. Additional toxicology and 
    exposure studies are being conducted by the registrant, DuPont. These 
    data are needed to more accurately refine the Agency's risk assessment 
    for chlorethoxyfos.
        There are presently no actions pending against the registration of 
    this chemical.
        This pesticide is considered useful for the purposes for which the 
    tolerance is sought and capable of achieving the intended physical or 
    technical effect. Based on the information and data considered, the 
    Agency has determined that the tolerances established by amending 40 
    CFR part 180 will protect the public health. Therefore, the tolerance 
    is established as set forth below.
        Any person adversely affected by this regulation may, within 30 
    days after publication of this document in the Federal Register, file 
    written objections to the regulation and may also request a hearing on 
    those objections. Objections and hearing requests must be filed with 
    the Hearing Clerk, at the address given above (40 CFR 178.20). A copy 
    of the objections and/or hearing requests filed with the Hearing Clerk 
    should be submitted to the OPP docket for this rulemaking. The 
    objections submitted must specify the provisions of the regulation 
    deemed objectionable and the grounds for the objections (40 CFR 
    178.25). Each objection must be accompanied by the fee prescribed by 40 
    CFR 180.33(i). If a hearing is requested, the objections must include a 
    statement of the factual issue(s) on which a hearing is requested, the 
    requestor's contentions on such issues, and a summary of any evidence 
    relied upon by the objector (40 CFR 178.27). A request for a hearing 
    will be granted if the Administrator determines that the material 
    submitted shows the following: There is genuine and substantial issue 
    of fact; there is a reasonable possibility that available evidence 
    identified by the requestor would, if established, resolve one or more 
    of such issues in favor of the requestor, taking into account 
    uncontested claims or facts to the contrary; and resolution of the 
    factual issue(s) in the manner sought by the requestor would be 
    adequate to justify the action requested (40 CFR 178.32).
         A record has been established for this rulemaking under docket 
    number [PP 3F4174/R2175] (including objections and hearing requests 
    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 4:30 p.m., Monday through Friday, excluding 
    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.
        Written objections and hearing requests, identified by the document 
    control number [PP 3F4174/R2175], may be submitted to the Hearing Clerk 
    (1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., 
    Washington, DC 20460.
        A copy of electronic objections and hearing requests filed with the 
    Hearing Clerk can be sent directly to EPA at:
        opp-Docket@epamail.epa.gov
    
    
        A copy of electronic objections and hearing requests filed with the 
    Hearing Clerk 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 any objections and hearing requests 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 objections and hearing requests submitted directly in 
    writing. The official rulemaking record is the paper record maintained 
    at the address in ``ADDRESSES'' at the beginning of this document.
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
    Agency must determine whether the regulatory action is ``significant'' 
    and therefore subject to all the requirements of the Executive Order 
    (i.e., Regulatory Impact Analysis, review by the Office of Management 
    and Budget (OMB)). Under section 3(f), the order defines 
    ``significant'' as those actions likely to lead to a rule (1) having an 
    annual effect on the economy of $100 million or more, or adversely and 
    materially affecting a sector of the economy, productivity, 
    competition, jobs, the environment, public health or safety, or State, 
    local or tribal governments or communities (also known as 
    ``economically significant''); (2) creating serious inconsistency or 
    otherwise interfering with an action taken or planned by another 
    agency; (3) materially altering the budgetary impacts of entitlement, 
    grants, user fees, or loan programs; or (4) raising novel legal or 
    policy issues arising out of legal mandates, the President's 
    priorities, or the principles set forth in this Executive Order.
        Pursuant to the terms of this Executive Order, EPA has determined 
    that this rule is not ``significant'' and is therefore not subject to 
    OMB review.
        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 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
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
        Dated: September 15, 1995.
    
    Peter Caulkins,
    Acting Director, Office of Pesticide Programs.
    
        Therefore, 40 CFR part 180 is 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 adding new Sec. 180.486 to read as follows:
    
    
    Sec. 180.486   Phosphorothioic acid, 0,0-diethyl 0-(1,2,2,2-
    tetrachloroethyl) ester; tolerances for residues.
    
        Tolerances are established permitting the residue of the 
    insecticide phosphorothioic acid, 0,0-diethyl 0-(1,2,2,2-
    tetrachloroethyl) ester in or on the following raw agricultural 
    commodities:
    
    ------------------------------------------------------------------------
                                                                  Parts per 
                             Commodity                             million  
    ------------------------------------------------------------------------
                                                                            
    Corn, field, grain.........................................         0.01
    Corn, field, forage........................................         0.01
    Corn, field, stover (fodder)...............................         0.01
    Corn, pop, grain...........................................         0.01
    Corn, pop, stover (fodder).................................         0.01
    Corn, sweet (K + CWHR).....................................         0.01
    
    [[Page 49793]]
                                                                            
    Corn, sweet, forage........................................         0.01
    Corn, sweet,, stover (fodder)..............................         0.01
    ------------------------------------------------------------------------
    
    
    
    [FR Doc. 95-24006 Filed 9-26-95; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Effective Date:
9/18/1995
Published:
09/27/1995
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
95-24006
Dates:
This regulation became effective on September 18, 1995.
Pages:
49790-49793 (4 pages)
Docket Numbers:
PP 3F4174/R2175, FRL-4979-5
RINs:
2070-AB78
PDF File:
95-24006.pdf
CFR: (1)
40 CFR 180.486