96-8142. Pesticide Tolerances for Glyphosate  

  • [Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
    [Rules and Regulations]
    [Pages 15192-15196]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-8142]
    
    
    
    =======================================================================
    -----------------------------------------------------------------------
    
    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Parts 180 and 186
    
    [PP 6F3408, 4F4312, 4F4338, 4F4369, FAP 4H5701, 4H5705/R2204; FRL-5351-
    1]
    
    
    Pesticide Tolerances for Glyphosate
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
    -----------------------------------------------------------------------
    
    SUMMARY: This document establishes tolerances and feed additive 
    regulations for residues of the herbicide glyphosate [(N-
    phosphonometyhyl)glycine]. The specific proposals are as follows: 
    establishment of tolerances for alfalfa hay at 200 parts per million 
    (ppm), alfalfa forage at 75 ppm, soybean aspirated grain fractions at 
    50 ppm; sunflower seed at 0.1 ppm, increased tolerances on the kidney 
    of cattle, goats, hog, horses, and sheep from 0.5 to 4.0 ppm; an 
    amended tolerance removing the metabolite aminomethylphosphonic acid 
    (AMPA) from the expression and increasing the established tolerance for 
    soybean forage from 15 to 100 ppm; amended tolerances removing the 
    metabolite AMPA from the expressions for the established tolerances 
    soybean, grain at 20 ppm, and soybean, hay at 200 ppm; deletion of the 
    established tolerances for soybean straw at 200 ppm; and an amended 
    feed additive regulation removing the metabolite AMPA from the 
    expression for the established tolerance soybean hulls at 100 ppm. This 
    rule also amends the current tolerance for citrus fruits and the feed 
    additive regulation for citrus pulp, dried by removing the metabolite 
    AMPA from the expressions and increasing the tolerance for citrus 
    fruits from 0.2 to 0.5 ppm and increasing the tolerance for citrus 
    pulp, dried from 1.0 to 1.5 ppm. Monsanto Company requested these 
    tolerances and feed additive regulation in petitions submitted to EPA 
    pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).
    EFFECTIVE DATES: These regulations become effective April 5, 1996.
    
    ADDRESSES: Written objection and hearing requests, identified by the 
    document control number, [PP 6F3408, 4F4312, 4F4338, 4F4369, FAP 
    4H5701, 4H5705/R2204], may be submitted to: Hearing Clerk (1900), 
    Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, 
    DC 20460. 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 any objections and hearing request 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 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
    
    [[Page 15193]]
    
    Clerk may also be submitted electronically by sending electronic mail 
    (e-mail) to: oppdocket@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 6F3408, 4F4312, 
    4F4338, 4F4369, FAP 4H5701, 4H5705/R2204]. 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 and telephone number: Rm. 241, CM #2, 1921 
    Jefferson Davis Hwy., Arlington, VA, 703-305-6027; e- mail: 
    taylor.robert@epamail.epa.gov.
    SUPPLEMENTARY INFORMATION: EPA issued notices in the Federal Register, 
    announcing that the Monsanto Co., 700 14th St., NW., Suite #1100, 
    Washington, DC 20005, had submitted petitions proposing to amend 40 CFR 
    part 180 pursuant to section 408 (d) of the Federal Food, Drug, and 
    Cosmetic (FFDCA) (21 U.S.C. 346(a), and 40 CFR part 186 under sec 409 
    of FFDCA (21 U.S.C. 348) by establishing regulations to permit the 
    combined residues of the herbicide glyphosate [N-
    (phosphonomethyl)glycine] and its metabolite aminomethylphosphonic acid 
    (AMPA) or glyphosate in or on certain raw agricultural commodities 
    (RACs).
        1. PP 6F3408. Published in the Federal Register of September 13, 
    1995 (60 FR 47578), the notice proposed establishing a regulation to 
    permit combined residues of glyphosate and its metabolite AMPA in or on 
    sunflowers at 0.1 ppm.
        2. PP 4F4312. Published in the Federal Register of July 13, 1994 
    (59 FR 35718), the notice proposed to amend 40 CFR 180.364 by 
    establishing a regulation to permit residues of glyphosate and its 
    metabolite AMPA resulting from the application of the isopropylamine 
    salt of glyphosate and/or the monoammonium salt of glyphosate in or on 
    alfalfa, hay at 200 ppm and alfalfa forage at 75 ppm.
        3. PP 4F4338. Published in the Federal Register of November 2, 1994 
    (59 FR 54907), the notice proposed to amend 40 CFR 180.364 by 
    establishing a regulation permitting residues of glyphosate and its 
    metabolite AMPA resulting from the application of the isopropylamine 
    salt of glyphosate and/or the monoammonium salt of glyphosate in or on 
    citrus fruits at 0.5 ppm.
        4. PP 4F4369. Published in the Federal Register of February 8, 1995 
    (60 FR 7540), the notice proposed to amend 40 CFR 180.364 by 
    establishing a regulation to permit residues of glyphosate resulting 
    from the application of the isopropyl amine salt of glyphosate and/or 
    the monoammonium salt of glyphosate in or on soybean forage at 100 ppm.
        5. PP 4H5692. Published in the Federal Register of July 13, 1994 
    (59 FR 35720), the notice proposed establishing a feed additive 
    regulation to permit the combined residues of glyphosate and its 
    metabolite aminomethylphosphonic acid (AMPA) in alfalfa meal at 400 
    ppm.
        6. PP 4H4701. Published in the Federal Register of March 16, 1995 
    (60 FR 13979), the notice proposed to amend 40 CFR 186.3500 by 
    establishing a feed additive regulation to permit residues of 
    glyphosate resulting from the application of the isopropylamine salt 
    and/or monoammonium salt of glyphosate on the feed commodity soybeans, 
    aspirated grain fractions at 30 parts per million.
        7. PP 4H5705. Published in the Federal Register of November 2, 1994 
    (59 FR 54907), the notice proposed to amend 40 CFR 185.3500 by 
    establishing a feed additive regulation to permit residues of 
    glyphosate and its metabolite aminomethylphosphonic acid in or on 
    citrus pulp, dried at 1.0 ppm.
        There were no comments or requests for referral to an advisory 
    committee received in response to these notices of filing.
        Subsequently, the petitioner amended several of the petitions by 
    submitting revised Section F`s. Amended filing notices were published 
    in the Federal Register of September 13, 1995 (60 FR 47578, 79) 
    proposing these changes.
        1. PP 4F4312. Monsanto amended this petition by proposing that 40 
    CFR 180.364 be amended by removing the metabolite AMPA from the 
    expression and by establishing a regulation to permit residues of 
    glyphosate resulting from the application of the isopropylamine salt of 
    glyphosate and/or the monoammonium salt of glyphosate and/or 
    monoammonium salt of glyphosate for herbicidal and plant growth 
    regulator purposes and/or sodium sesqui salt of glyphosate for growth 
    regulator purposes in or on the kidney of cattle, goats, hogs, sheep, 
    and horses at 4.0 ppm.
        2. PP 4F4338. Monsanto amended this petition by proposing to remove 
    the metabolite AMPA from the expression.
        3. PP 4F4369. Monsanto amended this petition by proposing that 40 
    CFR 180.364 be amended by establishing a regulation to permit residues 
    of the herbicide glyphosate resulting from the application of the 
    isopropylamine salt of glyphosate in or on the raw agricultural 
    commodities (RACs) soybean grain at 20 ppm, soybean forage at 100 ppm, 
    soybean hay at 200 ppm, and soybean aspirated grain fractions at 50 
    ppm. These tolerances are to replace the existing tolerances for 
    soybeans, soybean forage, soybean hay, and soybean straw.
        4. PP 4H5701. Monsanto amended this petition by deleting the feed 
    commodity soybean, aspirated grain fractions at 30 ppm from this 
    expression and reproposing it as a raw agricultural commodity under PP 
    4F4369. Monsanto also proposed that a feed additive regulation be 
    established permitting residues of glyphosate resulting from the 
    application of the isopropylamine salt of glyphosate and/or the 
    monoammonium salt of glyphosate in or the feed commodity soybean hulls 
    at 100 ppm. This entry would replace the current entry for soybean 
    hulls.
        5. PP 4H5705. Monsanto amended this petition by proposing that 40 
    CFR part 186 be amended by establishing a regulation to permit residues 
    of glyphosate in or on the feed commodity citrus pulp, dried at 1.5 
    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 reasonable risk. It is 
    true that animal models do not and can not predict every possible human 
    reaction to pesticides, but the general consensus is that they
    
    [[Page 15194]]
    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 apparent adverse 
    effects (NOEL). 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. In our regulation of pesticides, the Agency 
    does not approve uses which will cause unreasonable adverse effects to 
    humans or the environment.
        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 for the interactions of pesticides having 
    similar toxicity endpoint, but progress in that area is low.
        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 needed 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 the Agency determined that the 
    proposed tolerance for alfalfa meal (59 FR 35720) was not necessary 
    since the proposed tolerance on alfalfa hay will cover any residue in 
    meal. This petition (4H5692) was withdrawn.
        The filing notice for PP 6F3408 was amended by submitting a revised 
    section F deleting the metabolite AMPA from the expression, Because 
    this is a deletion of a metabolite not longer regulated by the Agency, 
    there is no potential risk to humans, therefore no additional period of 
    public comment is necessary.
        The amended notice of filing for 4F4369 should have included the 
    monoammonium salt of glyphosate in the expression. The amended notice 
    of filing for 4H5701 should have not included reference to the salts of 
    glyphosate. Because these corrections are a correction of wording in 
    the expression, there is no potential increased risk to humans, 
    therefore no additional period of public comment is necessary.
        The data submitted in the petitions and other relevant material 
    have been evaluated. The glyphosate toxicological data listed below 
    were considered in support of these tolerances.
        1. Several acute toxicology studies placing technical-grade 
    glyphosate in Toxicity Category III and Toxicity Category IV.
        2. A 1-year feeding study with dogs fed dosage levels of 0, 20, 
    100, and 500 milligrams/kilogram/day (mg/kg/day) with a no-observable-
    effect level (NOEL) of 500 mg/kg/day.
        3. A 2-year carcinogenicity study in mice fed dosage levels of 0, 
    150, 750, and 4,500 mg/kg/day with no carcinogenic effect at the 
    highest dose tested (HDT) of 4,500 mg/kg/day.
        4. A chronic feeding/carcinogenicity study in male and female rats 
    fed dosage levels of 0, 3, 10, and 31 mg/kg/day (males) and 0, 3, 11, 
    or 34 mg/kg/day (females) with no carcinogenic effects observed under 
    the conditions of the study at dose levels up to and including 31 mg/
    kg/day (HDT) (males) and 34 mg/kg/day (HDT) (females) and a systemic 
    NOEL of 31 mg/kg/day (HDT)(males) and 34 mg/kg/day (HDT) (females). 
    Because a maximum tolerated dose (MTD) was not reached, this study was 
    classified as supplemental for carcinogenicity.
        5. A chronic feeding/carcinogenicity study in male and female rats 
    fed dosage levels of 0, 89, 362, and 940 mg/kg/day (males) and 0, 113, 
    457, and 1183 mg/kg/day (females) with no carcinogenic effects noted 
    under the conditions of the study at dose levels up to and including 
    940/1183 mg/kg/day (males/females) (HDT) and a systemic NOEL of 362 mg/
    kg/day (males) based on an increased incidence of cataracts and lens 
    abnormalities, decreased urinary pH, increased liver weight and 
    increased liver weight/brain ratio (relative liver weight) at 940 mg/
    kg/day (males) (HDT) and 457 mg/kg/day (females) based on decreased 
    body weight gain 1183 mg/kg/day (females) (HDT).
        6. A developmental toxicity study in rats given doses of 0, 300, 
    1,000, and 3,500 mg/kg/day with a developmental NOEL of 1,000 mg/kg/day 
    based on an increase in number of litters and fetuses with unossified 
    sternebrae, and decrease in fetal body weight at 3,500 mg/kg/day, and a 
    maternal NOEL of 1,000 mg/kg/day based on decrease in body weight gain, 
    diarrhea, soft stools, breathing rattles, inactivity, red matter in the 
    region of nose, mouth, forelimbs, or dorsal head, and deaths at 3,500 
    mg/kg/day (HDT).
        7. A developmental toxicity study in rabbits given doses of 0, 75, 
    175, and 350 mg/kg/day with a developmental NOEL of 350 mg/kg/day 
    (HDT); a maternal NOEL of 175 mg/kg/day based on increased incidence of 
    soft stool, diarrhea, nasal discharge, and deaths at 350 mg/kg/day 
    (HDT).
        8. A multigeneration reproduction study with rats fed dosage levels 
    of 0, 3, 10, and 30 mg/kg/day with a developmental NOEL of 10 mg/kg/day 
    based on increased incidence of focal tubular dilation of the kidney 
    (both unilateral and bilateral combined) of male F3b pups.
        9. A two generation reproduction study with rats fed dosage levels 
    of 0, 100, 500, and 1,500 mg/kg/day with a developmental NOEL of 500 
    mg/kg/day based on decreased pup body weight and body weight gain on 
    lactation days 14 and 21 at 1,500 mg/kg/day (HDT), a systemic NOEL of 
    500 mg/kg/day based on soft stools in Fo and F1 males and females at 
    1500 mg/kg/day (HDT) and a reproductive NOEL of 1500 mg/kg/day (HDT).
        10. Mutagenicity data included chromosomal aberration in vitro (no 
    aberrations in Chinese hamster ovary cells were caused with and without 
    S9 activation); DNA repair in rat hepatocyte; in vivo bone marrow 
    cytogenic test in rats; rec-assay with B. subtilis; reverse mutation 
    test with S. typhimurium; Ames test with S. typhimurium; and dominant-
    lethal mutagenicity test in mice (all negative).
        The reference dose (RfD) based on a developmental study with 
    rabbits (NOEL of 175 mg/kg/ bwt/day) and using a hundred-fold safety 
    factor is calculated to be 2.0 mg/kg body weight/day. The theoretical 
    maximum residue contribution (TMRC) for published tolerances and food 
    and feed additive regulations is 0.020733 mg/kg bwt/day or 1.0 percent 
    of the RfD for the overall U.S. population. The current actions on 
    citrus fruits, citrus dried pulp, alfalfa, kidney of cattle, goats, 
    hog, horses, and sheep, sunflower, and soybean forage will contribute 
    0.000726 mg/kg/bwt/day to the TMRC. These tolerances and the food 
    additive regulation will utilize a total of 1.0 percent of the RfD for 
    the overall U.S. population.
        For both U.S. subgroup populations, nonnursing infants and children 
    1 to 6 years of age, the current action and previously established 
    tolerances and the food additive regulation utilize, a total of 2.5 
    percent of the RfD, assuming that residue levels are at the established 
    tolerance levels and that 100 percent of the crop is treated.
        There are no desirable data lacking for this pesticide. There are 
    currently no actions pending against the continued registration of this 
    pesticide. No detectable residues of N-nitrosoglyphosate, a contaminant 
    of glyphosate, are expected to be present in the commodities for which 
    tolerances
    
    [[Page 15195]]
    are established. The carcinogenic potential of glyphosate was first 
    considered by a panel, then called the Toxicology Branch AD Hoc 
    Committee, in 1985. The Committee, in a consensus review dated March 4, 
    1985, classified glyphosate as a Group C carcinogen based on an 
    increased incidence of renal tumors in male mice. The Committee also 
    concluded that dose levels tested in the 26-month rat study were not 
    adequate for assessment of glyphosate's carcinogenic potential in this 
    species. These findings, along with additional information, including a 
    reexamination of the kidney slides from the long-term mouse study, were 
    referred to the FIFRA Scientific Advisory Panel (SAP). In its report 
    dated February 24, 1986, SAP classified glyphosate as a Group D 
    Carcinogen (inadequate animal evidence of carcinogenic potential). SAP 
    concluded that, after adjusting for the greater survival in the high-
    dose mice compared to concurrent controls, that no statistically 
    significant pairwise differences existed, although the trend was 
    significant.
        The SAP determined that the carcinogenic potential of glyphosate 
    could not be determined from existing data and proposed that the rat 
    and/or mouse studies be repeated in order to classify these equivocal 
    findings. On reexamination of all information, the Agency classified 
    glyphosate as a Group D Carcinogen and requested that the rat study be 
    repeated and that a decision on the need for a repeat mouse study would 
    be made upon completion of review of the rat study.
        Upon receipt and review of the second rat chronic feeding/
    carcinogenicity study, all toxicological findings for glyphosate were 
    referred to the Health Effects Division Carcinogenicity Peer Review 
    Committee on June 26, 1991, for discussion and evaluation of the weight 
    of evidence on glyphosate with particular emphasis on its carcinogenic 
    potential. The Peer Review Committee classified glyphosate as a Group E 
    (evidence of noncarcinogenicity for humans), based upon lack of 
    convincing carcinogenicity evidence in adequate studies in two animal 
    species. This classification is based on the following findings: (1) 
    None of the types of tumors observed in the studies (pancreatic islet 
    cell adenomas in male rat, thyroid c-cell adenomas and/or carcinomas in 
    male and female rats, hepatocellular adenomas and carcinomas in male 
    rats, and renal tubular neoplasms in male mice) were determined to be 
    compound related; (2) glyphosate was tested up to the limit dose on the 
    rat and up to levels higher than the limit dose in mice; and (3) there 
    is no evidence of genotoxicity for glyphosate. Accordingly, EPA 
    concludes that glyphosate has not been ``found to induce cancer when 
    ingested by man or animal.'' 21 U.S.C. 348(c)(3).
        The nature of the residue in plants is adequately understood, 
    adequate methodology (HPLC) with flurometric detection is available for 
    enforcement purposes, and the methodology has been published in the 
    Pesticide Analytical Manual (PAM), Vol. II. Any secondary residues 
    occurring in liver of cattle, goats, horses, hogs, and sheep and liver 
    and kidney of poultry will be covered by existing tolerances. Any 
    secondary residues occurring in kidney of cattle, goats, hogs, horses, 
    and sheep will be covered by the 4.0 ppm tolerances being established 
    concurrently.
        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 regulations 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 possibly 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 [PP 6F3408, 4F4312, 4F4338, 4F4369, FAP 4H5701, 4H5705/R2204] 
    (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 6F3804, 4F4312, 4F4338, 4F4369, FAP 4h5701, 4H5705/
    R2204] 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
    
    [[Page 15196]]
    sector of the economy, productivity, competition,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 the 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 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
    
    40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides and pests.
    
    40 CFR Part 186
    
        Environmental protection, Animal feeds, Feed additives.
    
        Dated: March 22, 1996.
    
    Stephen L. Johnson,
    
    Director, Registration Division. Office of Pesticide Programs.
    
        Therefore, chapter I of title 40 of the Code of Federal Regulations 
    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 Sec. 180.364, the table in paragraph (a) is amended by 
    removing the entries for citrus, fruits at 0.2 ppm; soybean, straw at 
    200 ppm; soybeans at 20 ppm; soybeans, forage at 15 ppm; and soybeans, 
    hay at 15 ppm; by revising the entries in the table to paragraph (b) 
    for cattle, kidney; goats, kidney; hogs, kidney; horses, kidney; and 
    sheep, kidney; and in paragraph (d) by adding alphabetically the raw 
    agricultural commodities alfalfa, forage; alfalfa, hay; citrus fruits; 
    soybeans; soybeans, grain; soybeans, forage; soybeans, hay; soybeans, 
    aspirated grain fractions; and sunflower seed, to read as follows:
    
    
    Sec. 180.364 Glyphosate; tolerances for residues.
    
    *    *    *    *    *
    
        (b) *    *    *
    
    
    ------------------------------------------------------------------------
                                                                   Parts per
                              Commodity                             million 
    ------------------------------------------------------------------------
                                                                            
                      *        *        *        *        *                 
    Cattle, kidney...............................................      4.0  
                                                                            
                      *        *        *        *        *                 
    Goats, kidney................................................      4.0  
    Hogs, kidney.................................................      4.0  
                                                                            
                      *        *        *        *        *                 
    Horses, kidney...............................................      4.0  
                                                                            
                      *        *        *        *        *                 
    Sheep, kidney................................................      4.0  
                                                                            
                      *        *        *        *        *                 
    ------------------------------------------------------------------------
    
    *    *    *    *    *
        (d) *    *    *
    
    
    ------------------------------------------------------------------------
                                                                   Parts per
                              Commodity                             million 
    ------------------------------------------------------------------------
                                                                            
                      *        *        *        *        *                 
    Alfalfa, forage..............................................     75.0  
    Alfalfa, hay.................................................    200.0  
                                                                            
                      *        *        *        *        *                 
    Citrus, fruits...............................................      0.5  
    Soybeans.....................................................     20.0  
    Soybeans, grain..............................................     20.0  
    Soybeans, aspirated grain fractions..........................     50.0  
    Soybeans, forage.............................................    100.0  
    Soybeans, hay................................................    200.0  
    Sunflower seed...............................................      0.1  
                                                                            
                      *        *        *        *        *                 
    ------------------------------------------------------------------------
    
         2. In part 186:
    
    PART 186--[AMENDED]
    
        a. The authority citation for part 186 continues to read as 
    follows;
        Authority: 21 U.S.C. 348.
    
    
        b. In Sec. 186.3500 by removing from the table in paragraph (a) the 
    entries for citrus pulp, dried and soybean, hulls, and by adding new 
    paragraph (b), to read as follows:
    
    
    Sec. 186.3500   Glyphosate.
    
    *    *    *    *    *
        (b) A feed additive regulation is established permitting residues 
    of glyphosate (N-(phosphonomethyl)glycine) in or on the following feed 
    commodities.
    
    ------------------------------------------------------------------------
                                                                   Parts per
                              Commodity                             million 
    ------------------------------------------------------------------------
    Citrus pulp, dried...........................................      1.5  
    Soybean, hulls...............................................    100.0  
    ------------------------------------------------------------------------
    
    
    [FR Doc. 96-8142 Filed 4-4-96; 8:45 am]
    BILLING CODE 6560-50-F
    
    

Document Information

Effective Date:
4/5/1996
Published:
04/05/1996
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-8142
Dates:
These regulations become effective April 5, 1996.
Pages:
15192-15196 (5 pages)
Docket Numbers:
PP 6F3408, 4F4312, 4F4338, 4F4369, FAP 4H5701, 4H5705/R2204, FRL-5351- 1
PDF File:
96-8142.pdf
CFR: (2)
40 CFR 180.364
40 CFR 186.3500