96-15040. Quizalofop-P Ethyl Ester; Pesticide Tolerance and Feed Additive Regulation  

  • [Federal Register Volume 61, Number 116 (Friday, June 14, 1996)]
    [Rules and Regulations]
    [Pages 30171-30175]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-15040]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Parts 180 and 186
    
    [PP3F4268, FAP5720/R2247; FRL-5375-6]
    
    
    Quizalofop-P Ethyl Ester; Pesticide Tolerance and Feed Additive 
    Regulation
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This document increases the current tolerance for cotton seeds 
    to 0.1 part per million (ppm) for the combined residues of the 
    herbicide quizalofop-p-ethyl ester [ethyl (R)-2[4-((6-chloroquinoxalin-
    2-yl)oxy)phenoxyl]propanoate], and its acid metabolite quizalofop-p [R-
    (2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxy]) propanoic acid], and the 
    S enantiomers of both the ester and the acid, all expressed as 
    quizalofop-p-ethyl ester; establishes time limited tolerances with an 
    expiration date for quizalofop-p-ethyl ester in or on the raw 
    agricultural commodities legume vegetables (succulent or dried) group 
    at 0.25 ppm, foliage of legume vegetables (except soybeans) at 3.0 ppm, 
    sugarbeet root at 0.1 ppm, sugarbeet top at 0.5 ppm; and establishes a 
    time limited feed additive tolerance with an expiration date for 
    quizalofop-p-ethyl ester for sugarbeet molasses at 0.2 ppm. Because 
    there has been insufficient time since the imposition of the additional 
    data requirements for specific geographical representation for 
    sugarbeet and bean field trials to generate the necessary residue data 
    and additional time is necessary to further refine a revised analytical 
    method and complete the tolerance method validation (TMV), the Agency 
    is granting the tolerances for legume vegetables (succulent and dried) 
    group, foliage of legume vegetables (except soybeans), sugarbeet top 
    and sugarbeet root with a 3-year expiration date]. E.I. du Pont de 
    Nemours Co., requested these tolerances and feed additive regulations 
    in petitions submitted to the EPA pursuant to the Federal Food, Drug, 
    and Cosmetic Act (FFDCA).
    
    EFFECTIVE DATE: These regulations become effective June 14, 1996.
    
    ADDRESSES: Written objection and hearing requests, identified by the 
    document control number, [PP3F4268, FAP5H5720/R2247], may be submitted 
    to: Hearing Clerk (1900), Environmental Protection Agency, Rm. 3708, 
    401 M St., SW., Washington DC 20460. Fees accompanying objections shall 
    be labeled ``Tolerance Fees'' and forwarded to: EPA Headquarters 
    Accounting Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
    PA 15251. A copy of any objections and hearing request filed with the 
    Hearing Clerk may also 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 a copy of objections and hearing requests to: Rm. 
    1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. 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.
    
    [[Page 30172]]
    
    copies of objections and hearing requests will also be acceptable on 
    disks in Word Perfect 5.1 file format or ASCII file format. All copies 
    of objections and hearing requests electronic form must be identified 
    by the docket number [PP3F4268, FAP5H5720/R2247]. 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 submission can be found below in this 
    document.
    
    FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product 
    Manager (PM 25), Registration Division (7505C), Office of Pesticide 
    Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
    DC 20460. Office location, telephone number, and e-mail address: Rm. 
    241, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 703-305-6027; e-
    mail: taylor.robert@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
    Federal Register August 17, 1995 (60 FR 42884) (FRL-4963-7), which 
    announced that the E.I. du Pont de Nemours Co., Inc., Walkers Mill 
    Bldg, Barley Mill Plaza, Wilmington, DE 19880, had submitted pesticide 
    petition (PP) 3F4268 to EPA proposing that 40 CFR part 180 be amended 
    by establishing a regulation to permit the combined residues of the 
    herbicide quizalofop-p-ethyl ester (ethyl R-2-(4-(6-chloroquinoxalin-2-
    yl)oxy)phenoxy)propanoic acid) and the S enantiomers of the ester and 
    acid, all expressed as quizolofop-p-ethyl ester, in or on the raw 
    agricultural commodities legume vegetable (succulent or dried) group at 
    0.3 ppm, foilage of legume vegetables (except soybeans and bean hay) at 
    0.7 ppm; sugar beet root at 0.1 ppm; sugar beet top at 0.5 ppm and 
    cottonseed at 0.1 ppm. Dupont also submitted feed additive petition 
    (FAP) 5H5720 proposing to amend 40 CFR part 186 by establishing a 
    regulation to permit residues of the herbicide quizalofop-p-ethyl ester 
    [ethyl R-2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid, and 
    the senantiomers of the ester and the acid all expressed as quizalofop-
    p-ethyl ester, in or on the animal feed sugar beet molasses at 0.2 ppm.
        No comments or requests for referral to an advisory committee were 
    received in response to these notices of filing.
        Subsequently, the petitioner amended these petitions by submitting 
    revised section Fs. Amended filing notices were published in the 
    Federal Register of September 13, 1995 (60 FR 47577) (FRL-4975-3), 
    proposing these changes.
        PP 3F4268. DuPont amended this petition by proposing a regulation 
    to permit the combined residues of the herbicide quizalofop-p-ethyl 
    ester and its acid metabolite, quizalofop-p-[R-(4-((6-chloroquinoxalin-
    2-yl)oxy)phenoxy)propanoic acid), and the S enantiomers of the ester 
    and the acid all expressed as quizalofop-p-ethyl ester in or on the 
    following raw agricultural commodities (RACs): cotton seed at 0.1 ppm, 
    legume vegetable (succulent or dried) group at 0.3 ppm; foliage of 
    legume vegetable (except soybeans and bean hay) at 0.7 ppm; sugar beet 
    root at 0.1 ppm; and sugar beet top at 0.5 ppm.
        FAP 5H5720. DuPont amended this petition by proposing that 40 CFR 
    part 186 be amended by establishing a regulation to permit the combined 
    residues of the herbicide quizalofop-p-ethyl ester and its acid 
    metabolite quizalofop-p-(R-(2-(4-(6-chloroquinoxalin-2-
    yl)oxy)phenoxy)propanoic acid and the S-enantiomers of the ester and 
    the acid, all expressed as quizalofop-p-ethyl ester, in or on the feed 
    commodity sugar beet molasses at 0.5 ppm.
        The Agency received one comment opposing the tolerances stated in 
    the amended filing notices published September 13, 1995. The 
    commenter's opposition to the tolerances was based upon toxicological 
    concerns including the concept of ``NOEL'' (no observed effect level); 
    the use of animal testing to represent human reaction to potentially 
    toxic substances (pesticides); the indications of a link between 
    pesticide exposure and Parkinson's Disease (PD).
        The Agency has reviewed the comment and decided to proceed with 
    these tolerances. The Agency, made the decision that a wide variety of 
    toxicological studies would serve as the basis for determining if a 
    pesticide could be requested and used without an reasonable risk. It is 
    true that animal models do not and cannot predict every human reaction 
    to pesticides, but the general consensus is that they offer the best 
    information as to what a pesticide might do to humans. Usually, the 
    Agency requires and reviews long-term studies in rodents and non-
    rodents to determine a dose which causes no observed adverse effects. 
    The NOEL is divided by an uncertainty factor-often at least 100-to 
    arrive at doses or exposures that should not cause harmful effects on 
    humans. This is a long established procedure and EPA believes is 
    protective of public health.
        The Agency understands that the testing of one pesticide does not 
    predict all the possible adverse interactions with other pesticides--or 
    for that matter other drugs or environmental pollutants. The Agency is 
    exploring ways of testing the interactions of pesticides having a 
    similar toxicity endpoint, but progress in that area is slow. The 
    commenter presented no evidence showing quizalofop-p-ethyl ester would 
    interact with other pesticides.
        With reference to the indications of a link between pesticide 
    exposure and Parkinson's disease, the Agency is aware that many 
    researchers are investigating the potential reaction of pesticide 
    exposures to chronic neurological diseases including Parkinson`s 
    Disease, and additional research is need to study this important area. 
    Available studies in humans or animals have not yet established any 
    relationship between pesticide exposures and Parkinson's Disease.
        During the course of the review of these petitions, the Agency 
    determined that the tolerances proposed for cottonseed, legume 
    vegetables (succulent of dried), foliage of legume vegetables (except 
    soybean and bean hay), and the proposed feed additive regulation for 
    sugarbeet molasses need revisions. The petitioner subsequently 
    submitted a revised section F proposing that tolerances be established 
    for the combined residues of the herbicide quizalofop-p-ethyl ester 
    [ethyl] (R)[2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoate], and 
    its acid metabolite quizalofop-p [R-(2-4-((6-chloroquinoxalin-2-
    yl)oxy)phenoxy)propanoic acid), and the acid, all expressed as 
    quizalofop-p-ethyl ester in or on the following raw agricultural 
    commodities: cottonseed at 0.1 ppm; legume vegetable (succulent or 
    dried) group at 0.25 ppm; foliage of legume vegetables (except 
    soybeans) at 3.0 ppm; sugar beet root at 0.1 ppm; and sugar beet top at 
    0.5 ppm. A revised section F was submitted for FAP 5H5720 proposing the 
    establishment of a feed additive tolerance for the combined residues of 
    the herbicide quizalofop-p-ethyl ester [ethyl] (R)-(2-[4-((6-
    chloroquinoxalin-2-yl)oxy)phenoxy)propanoate], and its acid metabolite 
    quizalofop-p [R-(2-(4-(6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic 
    acid), and the S enantioners of the ester and the acid, all expressed 
    as quizalofop-p-ethyl ester be established on sugarbeet molasses at 0.2 
    ppm. The 3.0 ppm tolerance for foliage of legume vegetables was 
    previously proposed under PP 5F4545 on February 1, 1996 (61 FR 3696) 
    (FRL-4994-3). The proposed tolerance for sugarbeet molasses was 
    previously proposed.
    
    [[Page 30173]]
    
        The data submitted in the petition and other relevant material have 
    been evaluated. The toxicology data listed below considered in support 
    of this tolerance.
        1. Several acute toxicology studies placing technical grade 
    quizalofop ethyl in toxicity Category III.
        2. An 18-month carcinogenicity study with CD-1 mice fed dosages of 
    0, 0.3, 1.5, 12, and 48 mg/kg/day with no carcinogenic effects observed 
    under the conditions of the study at levels up to and including 12 mg/
    kg/day and a marginal increase in the incidence of hepatocellular 
    tumors at 48 mg/kg/day HDT (highest dose tested) which exceeded the 
    maximum tolerated dose (MTD). (Please see the discussion by the HED 
    Carcinogenicity Peer Review Committee.)
        3. A 2-year chronic toxicity/carcinogenicity study in rats fed 
    dosages of 0, 0.9, 3.7, and 15.5 mg/kg/day for males and 0, 1.1, 4.6, 
    and 18.6 mg/kg/day for females, with no carcinogenic effects observed 
    under the conditions of the study at levels up to and including 18.6 g/
    kg/day (HDT) and a systemic NOEL of 0.9 mg/kg/day based on altered red 
    cell parameters and slight/minimal centrilobular enlargement of the 
    liver at 3.7 mg/kg/day.
        4. A 1-year feeding study in dogs fed dosages of 0. 0.625, 2.5, and 
    10 mg/kg/day with NOEL of 10 mg/kg/day (HDT).
        5. A developmental toxicity study in rats fed dosage levels of 0, 
    30, 100, and 300 mg/kg/day (HDT), with a maternal toxicity NOEL of 30 
    mg/kg/day and a developmental toxicity NOEL of greater than 300 mg/kg/
    day (HDT).
        6. A developmental toxicity study in rabbits fed dosage levels of 
    0, 7, 20, and 60 mg/kg/day with no developmental effects noted at 60 
    mg/kg/day (HDT), and a maternal toxicity NOEL of 20 mg/kg/day based on 
    decreases in food consumption and body weight gain at 60 mg/kg/day 
    (HDT).
        7. A two-generation reproduction study in rats fed dosages of 1, 
    1.25, 5, and 20 mg/kg/day with a reproductive (developmental) NOEL of 
    1.25 mg/kg/day based on an increase in liver weight and increase in the 
    incidence of eosinophilic changes in the liver at 5.0 mg/kg/day and a 
    parental NOEL of 5.0 mg/kg/day based on decreased body weight and 
    premating weight gain in males at 20 mg/kg/day (HDT).
        8. Mutagenicity data included gene mutation assays with E. coli and 
    S. typhimurium (negative); DNA damage assays with B. subtillis 
    (negative) and a chromosomal aberration test in Chinese hamster cells 
    (negative).
        The Carcinogenicity Peer Review Committee (CPRC) of HED has 
    evaluated the rat and mouse cancer studies on quizalofop along with 
    other relevant short-term toxicity studies, mutagenicity studies, and 
    structure activity relationships. The CPRC concluded, after three 
    meetings and an evaluation by the OPP Science Advisory Panel, that the 
    classification should be a Category D (not classifiable as to human 
    cancer potential). No new cancer studies were required.
        The first CPRC review tentatively concluded that quizalofop should 
    be classified as a Category B2 (probable human carcinogen). That 
    classification was based on liver tumors in female rats, ovarian tumors 
    in female mice, and liver tumors in male mice. This classification was 
    downgraded to a Category C (possible human carcinogen) at a second CPRC 
    review. The change in classification was due to a reexamination of the 
    liver tumors in female rats and ovarian tumors in female mice. The 
    first peer review had found a statistically significant positive trend 
    for liver carcinomas in female rats. Subsequent to this conclusion the 
    tumor data was reevaluated, and the reevaluation showed a reduced 
    number of carcinomas. Although there remained a statistically 
    significant positive trend for carcinomas in the study, the CPRC 
    concluded that the carcinomas were not biologically significant given 
    the few carcinomas identified (one at the mid-dose and two at the high 
    dose). Noting that this level of carcinomas was within historical 
    levels, the CPRC concluded that administration of quizalofop did not 
    appear to be associated with the liver carcinomas.
        As to the ovarian tumors in female mice, the CPRC had first 
    attached importance to the fact that these tumors were statistically 
    significant at the high dose as compared to historical control values 
    although statistically significant when compared to concurrent 
    controls. However, review of further historical control data showed 
    that the level of ovarian tumors in the quizalofop study was similar to 
    the background rate in several other studies. Given this information 
    and that the quizalofop study showed no hyperplasia of the ovary, no 
    signs of endocrine activity related to ovarian function, and no dose 
    response relationship, the CPRC concluded that the ovarian tumors were 
    probably not compound-related.
        The findings of the second CPRC review were presented to EPA's 
    Scientific Advisory Panel (SAP). The SAP concurred with the CPRC 
    conclusion that the liver tumors in female rats and the ovary tumors in 
    female mice showed no evidence of carcinogenicity. However, the SAP 
    disagreed with CPRC's classification of quizalofop as a Category C 
    based on the liver tumors in male mice. The SAP concluded that the 
    mouse liver tumors did support such a classification because the tumors 
    occurred at a dose above the maximum-tolerated dose (MTD) and because 
    they were not statistically significant if a ``p'' value of less than 
    .01 was used instead of a ``p'' value of less than .05. The SAP 
    believed that such greater statistical rigor was appropriate for 
    variable tumor endpoints such as male mouse liver tumors.
        Following the SAP review, the CPRC changed the classification for 
    quizalofop to Category D. The Category D classification is based on an 
    approximate doubling in the incidence of male mice liver tumors between 
    controls and the high dose. This finding was not considered strong 
    enough to warrant the finding of a Category C (possible human 
    carcinogen) since the increase was of marginal statistical 
    significance, occurred at a high dose which exceeded the predicted MTD, 
    and occurred in a study in which the concurrent control for liver 
    tumors was somewhat low as compared to the historical controls, while 
    the high dose control group was at the upper end of previous historical 
    control-groups.
        EPA has found the evidence on the carcinogenicity of quizalofop-p-
    ethyl ester in animals to be equivocal and therefore concludes that 
    quizalofop-p-ethyl ester does not induce cancer in animals within the 
    meaning of the Delaney clause. Important to this conclusion was the 
    following evidence: (1) The only statistically significant tumor 
    response that appears compound-related was seen at a single dose in a 
    single sex in a single species; (2) the response was only marginally 
    statistically significant; (3) the response was only significant when 
    benign and malignant tumors were combined; (4) the tumors were in the 
    male mouse liver; (5) the tumors were within historical controls; and 
    (6) the mutagenicity studies were negative. Although in some 
    circumstances a finding of animal carcinogenicity could be made despite 
    any one, or even several, of the six factors noted, the combination of 
    all of these factors here cast sufficient doubt on the reproducibility 
    of the response in the high dose male mouse that EPA concludes the 
    evidence on carcinogenicity is equivocal.
        Based on the NOEL of 0.9 mg/kg/bwt/day in the 2-year rat feeding 
    study, and using a hundred-fold uncertainty factor, the reference dose 
    (RFD) for quiazalofop ethyl is calculated to be 0.009 mg/kg/
    
    [[Page 30174]]
    
    bwt/day. The theoretical maximum residue contribution (TMRC) is 
    0.000218 mg/kg/bwt/day for existing tolerances for the overall U.S. 
    population. The current action will increase the TMRC by less than 
    0.000260 mg/kg/bwt/day. These tolerances and previously established 
    tolerances utilize a total of 5.3 percent of the RFD for the overall 
    U.S. populations, with all exposure coming from published uses. For 
    U.S. subgroup populations, non-nursing infants and children aged 1 to 6 
    years, the current action and previously established tolerances 
    utilize, respectively a total of 18.8 percent and 11.9 percent of the 
    RfD, assuming that residue levels are at the established tolerances and 
    that 100 percent of the crop is tested.
        Data desirable but lacking for this chemical include additional 
    sugarbeet and bean residue field trials and completion of a tolerance 
    method validation (TMV) for a revised analytical method. The additional 
    residue data are needed in response to a recent change in EPA 
    guidelines. The Agency is granting the tolerances for legume vegetables 
    (succulent or dried) group, foliage of legume vegetables (except 
    soybeans), sugarbeet root and sugarbeet top with a 3-year expiration 
    date to allow the petitioner, E.I. duPont de Nemours and Company to 
    gather additional residue data and to further refine the analytical 
    method and allow the Agency to complete the TMV.
        The nature of the residue in plants and livestock is adequately 
    understood. An adequate amount of geographically represenative crop 
    field reidue data were presented which show that the proposed 
    tolerances should not be exceeded when quizalofop-p ethyl ester is 
    formulated into ASSURE II and used as directed. An adequate analytical 
    method (high-pressure liquid chromatography using either ultraviolet or 
    fluorescence detection) is available for enforcement purposes in Vol. 
    II of the Food and Drug Administration Pesticide Analytical Method (PAM 
    II, Method I). There are currently no actions pending against the 
    registration of this chemical. Any secondary residues expected to occur 
    in milk, eggs, and meat, fat, and meat byproducts of cattle, goats, 
    hogs, horses, sheep, and poultry will be covered by existing 
    tolerances.
        The pesticide is considered useful for the purpose for which the 
    regulation is sought and is capable of achieving the intended physical 
    or technical effect.
        Based on the information cited above, the Agency has determined 
    that the establishment of tolerances by amending 40 CFR part 180 will 
    protect the public health, and the establishment of feed additive 
    regulations by amending 40 CFR part 186 will be safe. Therefore, EPA is 
    establishing the tolerances and feed additive regulation 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 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 the hearing is 
    requested, the requestor`s contentions on each such issue, 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 a 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 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 [PP3F4268, FAP5H5720/R2247] (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 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.
        Written objections and hearing requests, identified by the document 
    control number [PP3F4268, FAP5H5720/R2247] 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 review by the Office of Management and Budget 
    (OMB) and the requirements of the Executive Order. Under Section 3(f), 
    the order defines a ``significant regulatory action'' as an action that 
    is likely to result in 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, completion, jobs, the 
    environment, public health or safety, or State, local, or tribal 
    governments or communities (also referred to 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 the rights and obligation of recipients 
    thereof; 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 therefore 
    not subject to OMB review.
        This action does not impose any enforceable duty, or contain any 
    ``unfunded mandates'' as described in Title II of the Unfunded Mandates 
    Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
    specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
    entitled Enhancing the Intergovernmental Partnership; or special 
    consideration as required by
    
    [[Page 30175]]
    
    Executive Order 12898 (59 FR 7629, February 16, 1994).
        Pursuant to the requirements of the Regulatory Flexibility Act (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 explaining the factual basis for this 
    determination 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.
    
    List of Subjects in 40 CFR Part 186
    
        Environmental protection, Animals feeds, Pesticides and pests.
        Dated: May 29, 1996.
    Stephen L. Johnson,
    Director, Registration Division, Office of Pesticide Programs.
    
        Therefore, 40 CFR chapter I is amended as follows:
    
    PART 180--[AMENDED]
    
        1. In part 180:
        a. The authority citation for part 180 continues to read as 
    follows:
    
        Authority: 21 U.S.C. 346a and 371.
    
        b. In 180.441, by revising paragraph (c) and adding paragraph (d) 
    to read as follows:
    
    
    Sec. 180.441   Quizalofop ethyl; tolerances for residues.
    
        *    *    *    *    *
        (c) Tolerances are established for the combined residues of the 
    herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-
    chloroquinoxalin-2-yl)oxy)phenoxy)propanoate], and its acid metabolite 
    quizalofop-p [R-(2-(4-((6-quinoxalin-2-yl)oxy)phenoxy)propanoic acid], 
    and the S enantiomers of both the ester and the acid, all expressed as 
    quizalofop-p-ethyl ester, in or on the following raw agricultural 
    commodities;
    
                                                                            
    ------------------------------------------------------------------------
                     Commodity                        Parts per million     
    ------------------------------------------------------------------------
    cottonseed................................  0.1                         
    lentils...................................  0.05                        
    ------------------------------------------------------------------------
    
        (d) Time limited tolerances to expire on June 14, 1999 are 
    established for the combined residues of the herbicide quizalofop-p 
    ethyl ester (ethyl (R)-(2-(4-((6-chloroquinoxalin-2-
    yl)oxy)phenoxy)propanoate) and it acid metabolite quizalofop-p [R-(2-
    (4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid), and the S 
    enantiomers of both the ester and the acid, all expressed as 
    quizalofop-p-ethyl ester in or on the following raw agricultural 
    commodities:
    
                                                                            
    ------------------------------------------------------------------------
                    Commodities                       Parts per million     
    ------------------------------------------------------------------------
    foliage of legume vegetables (except        3.0                         
     soybeans).                                                             
    legume vegetables (succulent or dried)      0.25                        
     group.                                                                 
    sugarbeet, root...........................  0.1                         
    sugarbeet, top............................  0.5                         
    ------------------------------------------------------------------------
    
    PART 186--[AMENDED]
    
        2. In part 186:
        a. The authority for part 186 continues to read as follows:
    
        Authority: 21 U.S.C. 342, 348, and 701.
    
        b. In 186.5250, by redesignating the existing paragraph and table 
    as paragraph (a) and adding paragraph (b) to read as follows:
    
    
    Sec. 186.5250   Quizalofop ethyl.
    
        *    *    *    *    *
        (b) A feed additive regulation to expire (insert date 3 years from 
    date of publication in the Federal Register) is established to permit 
    the combined residues of the herbicide quizalofop-p-ethyl ester [ethyl] 
    (R)-2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoate], and its 
    acid metabolite quizalofop-p [R-(2-(4-((6-chloroquinoxalin-2-
    yl)oxy)phenoxy)propanoic acid), and the S enantiomers of the ester and 
    the acid, all expressed as quizalofop-p-ethyl ester in or on sugar beet 
    molasses at 0.2 part per million (ppm)
    
    [FR Doc. 96-15040 Filed 6-13-96; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Effective Date:
6/14/1996
Published:
06/14/1996
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-15040
Dates:
These regulations become effective June 14, 1996.
Pages:
30171-30175 (5 pages)
Docket Numbers:
PP3F4268, FAP5720/R2247, FRL-5375-6
PDF File:
96-15040.pdf
CFR: (2)
40 CFR 180.441
40 CFR 186.5250