97-9372. Clopyralid; Pesticide Tolerance  

  • [Federal Register Volume 62, Number 73 (Wednesday, April 16, 1997)]
    [Rules and Regulations]
    [Pages 18528-18532]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-9372]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Parts 180, 185, and 186
    
    [OPP-300473; FRL-5600-2]
    RIN 2070-AB78
    
    
    Clopyralid; Pesticide Tolerance
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This document establishes tolerances for residues of the 
    herbicide clopyralid (3,6-dichloro-2-pyridine-carboxylic acid) in or on 
    the raw agricultural commodities corn, field, fodder; corn, field, 
    forage; corn, field, grain; and corn, field, milling fractions. It also 
    removes time-limited tolerances for residues of clopyralid on the same 
    commodities that expired on December 31, 1996. DowElanco requested 
    these tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA) 
    as amended by the Food Quality Protection Act of l996 (Pub. L. 104-
    170).
    
    DATES: This regulation becomes effective April 16, 1997. Written 
    objections must be received on or before June 16, 1997.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number, [OPP-300473; PP 8F3622, 0H 5597], may be 
    submitted to: Hearing Clerk (1900), Environmental Protection Agency, 
    Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees accompanying 
    objections and hearing requests 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 requests filed with the Hearing Clerk should 
    be identified by the docket 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 Highway, Arlington, VA 22202.
        A copy of objections and hearing requests filed with the Hearing 
    Clerk may also be submitted electronically to the OPP 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 [OPP-300473; PP 8F3622, 0H5597]. 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: Joanne I. Miller, Product 
    Manager (PM) 23, Registration Division (7505C), Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
    location and telephone number: Rm. 237, CM #2, 1921 Jefferson Davis 
    Hwy., Arlington, VA 22202, (703)-305-6224; e-mail: 
    miller.joanne@epamail.epa.gov.
    SUPPLEMENTARY INFORMATION: On April 25, l994 EPA established time-
    limited tolerances under sections 408 and 409 of the Federal Food Drug, 
    and Cosmetic Act (FFDCA), 2l U.S.C. 346a(d) and 348, for residues of 
    clopyralid on corn, field, fodder; corn, field, forage; corn, field, 
    grain; and corn, field, milling fractions (59 FR 19639)(FRL-4775-4). 
    These tolerances expired on December 31, l996. DowElanco, on September 
    27, l996, requested that the time-limited tolerances for residues of 
    the herbicide clopyralid in the field corn commodities under the 
    regulations mentioned above be made permanent tolerances based on 
    residue data that they had submitted as required to change the 
    tolerances from time-limited to permanent tolerances. DowElanco also 
    submitted a summary of its petition as required under the Federal Food, 
    Drug and Cosmetic Act (FFDCA) as amended by the Food Quality Protection 
    Act of l996 (Pub. L. 104-170).
        A notice announcing the filing of DowElanco's petition was 
    published in the Federal Register, (61 FR 65221-65223, December 11, 
    l996)(FRL-5574-4). The proposed analytical method for determining 
    residues is gas chromatography with electrolytic conductivity 
    detection. The method for enforcement is available from the FDA; it is 
    pending publication in the Pesticide Analytical Manual II.
        The basis for the conditional time-limited tolerances that expired 
    December 31, l996 was given in the Federal Register notice of Final 
    Rule (59 FR 19339). The required residue chemistry data have been 
    received, reviewed and found adequate by EPA to support the proposed 
    tolerances. Based on the review of the residue chemistry data, EPA 
    finds the tolerances established by this Final Rule adequately 
    supported.
        There were no comments received in response to the notices of 
    filing.
        The data submitted in the petition and other relevant material have 
    been evaluated. The toxicology data listed below were found acceptable 
    by EPA in support of these tolerances.
    
    I. Toxicological Profile
    
        1. A rat oral lethal dose (LD50) of 4,300 milligrams/kilogram 
    (mg/kg) of body weight.
        2. A 13-week mouse feeding study with a no-observed-effect level 
    (NOEL) of 750 mg/kg/day.
        3. Two 180-day dog feeding studies with NOEL > 50 mg/kg/day.
        4. A rabbit teratology study with a developmental and a maternal 
    NOEL > 250 mg/kg/day, highest dose tested (HDT).
        5. A rat teratology study with a developmental NOEL of > 250 mg/kg/
    
    [[Page 18529]]
    
    day (HDT) and a maternal toxicity NOEL of 75 mg/kg/day.
        6. A two-generation rat reproduction study with a reproductive NOEL 
    of > 1,500 mg/kg/day and a systemic NOEL of 500 mg/kg/day.
        7. A 1-year dog feeding study with a NOEL of 100 mg/kg/day.
        8. A 2-year rat chronic feeding/oncogenicity study with a NOEL of 
    50 mg/kg/day with no oncogenic potential observed under the conditions 
    of the study at doses up to and including 150 mg/kg/day (HDT). A 
    significant decrease in mean body weights of females occurred at 150 
    mg/kg/day.
        9. A repeat 2-year rat chronic feeding/oncogenicity study with a 
    systemic NOEL of 15 mg/kg/day and with no oncogenic potential observed 
    under conditions of the study up to 1,500 mg/kg/day (HDT). Hyperplasia 
    and thickening of the limiting ridge of the stomach occurred at 150 mg/
    kg/day.
        10. Three 2-year mouse oncogenicity studies with no oncogenic 
    potential observed under the conditions of the study up to and 
    including 2,000 mg/kg/day (HDT) and a systemic NOEL of 500 mg/kg/day.
        11. A dominant lethal assay, negative.
        12. In vivo rat cytogenic study, negative.
        13. In vitro Salmonella and Saccharomyces assay, negative.
        14. An in vivo mouse host-mediated assay, negative.
        15. An unscheduled DNA synthesis assay in rats, negative.
        16. In an animal metabolism study At doses of 5 mg/kg (oral), 
    radiolabeled clopyralid was excreted within 24 hours in all dosed rats. 
    Fecal elimination was minor. Detectable levels of residual radio-
    activity were observed in the carcass and stomach at 72 hours post-
    dose. Analysis of urine and fecal extracts showed no apparent 
    metabolism of clopyralid.
    
    II. Aggregate Exposures
    
        1. From food and feed uses.  The primary source for human exposure 
    to clopyralid will be from ingestion of both raw and processed 
    agricultural commodities as proposed in the December 11, 1996 Notice 
    for Filing cited above. Based on exposure from existing permanent 
    tolerances listed in 40 CFR 180.431(a) of the Code of Federal 
    Regulations and the subject proposed tolerances in field corn raw 
    agricultural commodities, the Theoretical Maximum Residue Contributions 
    (TMRC) for the U.S. (48 States) adult population is 0.008214 mg/kg body 
    weight/day; for non-nursing infants, 0.015400; for children 1 to 6 
    years old, 0.018454. These estimates are based on the assumption that 
    100% of the field corn commodities are derived from field corn cultured 
    with the aid of the herbicide clopyralid.
        2. From potable water. In examining aggregate exposure, FQPA 
    directs EPA to consider available information concerning exposures from 
    the pesticide residue in food and all other non-occupational exposures. 
    The primary non-food sources of exposure the Agency looks at include 
    drinking water (whether from groundwater or surface water), and 
    exposure through pesticide use in gardens, lawns, or buildings 
    (residential and other indoor uses).
        There is presently no EPA Lifetime Health Advisory level for 
    clopyralid and its degradates as drinking water contaminates. EPA does 
    not have drinking water monitoring data available to perform a 
    quantitative drinking water risk assessment. Available environmental 
    fate data, conservative screening tools, GENEEC and Leaching Index have 
    been used to estimate environmental concentrations of clopyralid in 
    surface water and the leaching potential of clopyralid. The results of 
    these screens indicate that clopyralid is moderately persistent, highly 
    mobile in a soil and water environment, and may impact ground water and 
    surface water.
        Because the Agency lacks sufficient water-related exposure data to 
    complete a comprehensive drinking water risk assessment for many 
    pesticides, EPA has commenced and nearly completed a process to 
    identify a reasonable yet conservative bounding figure for the 
    potential contribution of water related exposure to the aggregate risk 
    posed by a pesticide. In developing the bounding figure, EPA estimated 
    residue levels in water for a number of specific pesticides using 
    various data sources. The Agency then applied the estimated residue 
    levels, in conjunction with appropriate toxicological endpoints (RfD's 
    or acute dietary NOEL's) and assumptions about body weight and 
    consumption, to calculate, for each pesticide, the increment of 
    aggregate risk contributed by consumption of contaminated water. While 
    EPA has not yet pinpointed the appropriate bounding figure for 
    consumption of contaminated water, the ranges the Agency is continuing 
    to examine are all below the level that would cause clopyralid to 
    exceed the RfD if the tolerance being considered in this document were 
    granted. The Agency has therefore concluded that the potential 
    exposures associated with clopyralid in water, even at the higher 
    levels the Agency is considering as a conservative upper bound, would 
    not prevent the Agency from determining that there is a reasonable 
    certainty of no harm if the tolerance is granted.
        3. From non-dietary uses. There is only one non-dietary use 
    registered under the Federal Insecticide, Fungicide and Rodenticide 
    Act, as amended. The use is for residential weed control in turf.
        i. Short-term or intermediate-term. A part of the hazard assessment 
    process, the Agency reviews the available toxicological database to 
    determine the endpoints of concern. For clopyralid, the Agency does not 
    have a concern for a short-term or intermediate-term residential risk 
    assessment because the available data does not indicate any evidence of 
    significant toxicity by the dermal and inhalation routes. Therefore, a 
    short-term or intermediate-term residential risk assessment was not 
    required.
        ii. Chronic. As part of the hazard assessment process an endpoint 
    of concern was determined for the chronic occupational or residential 
    assessment. However, during the exposure assessment process, the 
    exposures that would result from the use of clopyralid were determined 
    to be of an intermittent nature. The frequency and duration of these 
    exposures do not exhibit a chronic exposure pattern. The exposure does 
    not occur often enough to be considered a chronic exposure; i.e, a 
    continuous exposure that occurs for at least several months. Therefore, 
    it was not deemed appropriate to aggregate exposure from the 
    residential use with exposure from food and drinking water.
        iii. Acute. As part of the hazard assessment process, the Agency 
    reviews the available toxicological database to determine the endpoints 
    of concern. For clopyralid, the Agency does not have a concern for an 
    acute dietary assessment because the available data do not indicate any 
    evidence of significant toxicity from a 1 day or single event exposure 
    by the oral route. Therefore, an acute dietary risk assessment was not 
    required.
        4. Cumulative exposure to substances with common mechanism of 
    toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
    whether to establish, modify, or revoke a tolerance, the Agency 
    consider ``available information'' concerning the cumulative effects of 
    a particular pesticide's residues and ``other substances that have a 
    common mechanism of toxicity.'' The Agency believes that ``available 
    information'' in this context might include not only toxicity, 
    chemistry, and exposure data, but also scientific policies and 
    methodologies for understanding common mechanisms of toxicity and 
    conducting cumulative risk
    
    [[Page 18530]]
    
    assessments. For most pesticides, although the Agency has some 
    information in its files that may turn out to be helpful in eventually 
    determining whether a pesticide shares a common mechanism of toxicity 
    with any other substances, EPA does not at this time have the 
    methodologies to resolve the complex scientific issues concerning 
    common mechanism of toxicity in a meaningful way. EPA has begun a pilot 
    process to study this issue further through the examination of 
    particular classes of pesticides. The Agency hopes that the results of 
    this pilot process will increase the Agency's scientific understanding 
    of this question such that EPA will be able to develop and apply 
    scientific principles for better determining which chemicals have a 
    common mechanism of toxicity and evaluating the cumulative effects of 
    such chemicals. The Agency anticipates, however, that even as its 
    understanding of the science of common mechanisms increases, decisions 
    on specific classes of chemicals will be heavily dependent on chemical 
    specific data, much of which may not be presently available.
        Although at present the Agency does not know how to apply the 
    information in its files concerning common mechanism issues to most 
    risk assessments, there are pesticides as to which the common mechanism 
    issues can be resolved. These pesticides include pesticides that are 
    toxicologically dissimilar to existing chemical substances (in which 
    case the Agency can conclude that it is unlikely that a pesticide 
    shares a common mechanism of activity with other substances) and 
    pesticides that produce a common toxic metabolite (in which case common 
    mechanism of activity will be assumed).
        EPA does not have, at this time, available data to determine 
    whether clopralid has a common mechanism of toxicity with other 
    substances or how to include this pesticide in a cumulative risk 
    assessment. Unlike other pesticides for which EPA has followed a 
    cumulative risk approach based on a common mechanism of toxicity, 
    clopyralid does not appear to produce a toxic metabolite produced by 
    other substances. For the purposes of this tolerance action, therefore, 
    EPA has not assumed that clopyralid has a common mechanism of toxicity 
    with other substances.
    
    III. Determination of Safety for U.S. Population and Non-nursing 
    Infants
    
    A. The U.S. Population
    
        Based on a NOEL of 50.80 mg/kg bwt/day from a 2-year, rat feeding 
    study with a decreased mean body weight gain effect, and using an 
    uncertainty factor of 100 to account for the interspecies extrapolation 
    and intraspecies variability, the Agency has determined a Reference 
    Dose (RfD) of 0.5 mg/kg bwt/day for this assessment of chronic risk. As 
    indicated above, there is no endpoint of concern identified with acute 
    and short- or intermediate-term exposures. Based on the available 
    toxicity data and the available exposure data identified above, the 
    proposed and existing tolerances will utilize 2% of the RfD for the 
    U.S. population. As indicated above, whatever bounding figure EPA 
    chooses for drinking water exposure, the exposure estimate for 
    clopyralid would not exceed the RfD.
    
    B. Infants and Children
    
        FFDCA section 408 provides that EPA shall apply an additional 
    tenfold margin of exposure (safety) for infants and children in the 
    case of threshold effects to account for pre- and post-natal toxicity 
    and the completeness of the database unless EPA determines that a 
    different margin of exposure (safety) will be safe for infants and 
    children. Margins of exposure (safety) are often referred to as 
    uncertainty (safety) factors. EPA believes that reliable data support 
    using the standard margin of exposure (usually 100x for combined inter- 
    and intra-species variability)) and not the additional tenfold margin 
    of exposure when EPA has a complete database under existing guidelines 
    and when the severity of the effect in infants or children or the 
    potency or unusual toxic properties of a compound do not raise concerns 
    regarding the adequacy of the standard margin of exposure.
        Based on current data requirements, the data base relative to pre- 
    and post-natal toxicity is complete. Risk to infants and children was 
    determined by use of two developmental toxicity studies and a two-
    generation reproduction study. Both developmental studies had 
    developmental NOELs of > 250 mg/kg/day, the highest dose tested. These 
    studies also demonstrated that there was no developmental (prenatal) 
    toxicity, at dosages at or below dosages that resulted in maternal 
    toxicity. The maternal NOEL was > 250 mg/kg/day in the rabbit study and 
    75 mg/kg/day in the rat study. The developmental NOELs are fivefold 
    higher in both the rat and rabbit than the NOEL used for establishing 
    the RfD. Based on current data requirements, the data base relative to 
    pre- and post-natal toxicity is complete. There were no treatment-
    related effects on any reproductive parameter in the adults or their 
    offspring. The NOEL for reproductive effects was 1,500 mg/kg bwt/day, 
    and there was no effect on reproductive parameters at > 1,500 mg/kg/day 
    nor was there an adverse effect on the morphology, growth or viability 
    of the offspring. The NOEL of the study was 30 times greater than the 
    NOEL of 50.0 mg/kg/day used for establishing the RfD. These data taken 
    together suggest minimal concern for developmental or reproductive 
    toxicity and do not indicate any increased pre- or post-natal 
    sensitivity. Therefore, EPA concludes that an additional uncertainty 
    factor is not necessary to protect the safety of infants and children 
    and that the RfD at 0.5 mg/kg/day is appropriate for assessing 
    aggregate risk to infants and children.
        The percent of the RfD that will be utilized by the aggregate 
    exposure from all tolerances to clopyralid will range from 3% for non-
    nursing infants, up to 3.6% for children (1 to 6 years of age). 
    Therefore, EPA concludes that there is a reasonable certainty that no 
    harm will result to infants and children from aggregate exposure. As 
    indicated above, whatever bounding figure EPA chooses for drinking 
    water exposure, the exposure estimate for clopyralid would not exceed 
    the RfD. Non-dietary exposures were discussed above under ``Non-Dietary 
    Exposure.''
    
    IV. Other Considerations
    
        1. Endocrine effects. There was no reported endocrine effect in any 
    of the toxicological studies reviewed in the toxicological profile of 
    this final rule.
        2. Metabolism in plants and animals. The metabolism of clopyralid 
    in plants and animals is adequately understood for the purposes of 
    these tolerances. There are no metabolites of toxicological 
    significance in plants. The residue of concern in plants and animals is 
    the parent compound, clopyralid. In animal metabolism studies with C14 
    labeled clopyralid, the residues found were clopyralid and its glycine 
    conjugate.
        3. Analytical method. There is a practical analytical method for 
    detecting and measuring levels of clopyralid in or on food with a limit 
    of detection that allows monitoring of food with residues at or above 
    the levels set in these tolerances. The analytical method for 
    determining residues is gas chromatography with electrolytic 
    conductivity detection, described in a method submitted by DowElanco.
        The quantitative limit of the method is 0.05 micrograms/gram in 
    field corn fodder and forage and grain. EPA has provided information on 
    this method to FDA. Because of the long lead time from establishing 
    these tolerances to publication, the enforcement
    
    [[Page 18531]]
    
    methodology is being made available in the interim to anyone interested 
    in pesticide enforcement when requested by mail from: Calvin Furlow, 
    Public Response Branch, Field Operations Division (7506C), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. Office location and telephone number; Rm. 1130A, 
    CM #2, l921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-
    5937.
        4.  International tolerances. There are no Codex Alimentarius 
    Commission (Codex) Maximum Residue Levels (MRLs) for clopyralid.
    
    V. Summary of Findings
    
        The analysis for clopyralid using tolerance level residues shows 
    that the proposed use in the culture of field corn will not cause 
    exposure to exceed the levels at which the Agency believes there is an 
    appreciable risk. All population subgroups examined by EPA are exposed 
    to clopyralid residues at levels below 100 percent of the RfD for 
    chronic effects.
        Based on the information cited above, the Agency has determined 
    that the establishment of these tolerances will be safe therefore, the 
    tolerances are established as set forth below.
        In addition to the tolerances being amended, since for purposes of 
    establishing tolerances FQPA has eliminated all distinctions between 
    raw and processed food, EPA is combining the tolerances that now appear 
    in Secs. 185.1100 and 186.1100 with the tolerances in Sec. 180.431 and 
    is eliminating Secs. 185.1100 and 186.1100.
    
    VI. Objections and Hearing Requests
    
        The new FFDCA section 408(g) provides essentially the same process 
    for persons to ``object'' to a tolerance regulation issued by EPA under 
    new section 408(e) and (1)(6) as was provided in the old section 408 
    and in section 409. However, the period for filing objections is 60 
    days, rather than 30 days. EPA currently has procedural regulations 
    which governs the submission of objections and hearing requests. These 
    regulations will require some modification to reflect the new law. 
    However, until those modifications can be made, EPA will continue to 
    use those procedural regulations with appropriate adjustments to 
    reflect the new law.
        Any person may, by June 16, 1997, file written objections to any 
    aspect of this 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 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 
    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). Information 
    submitted in connection with an objection or hearing request may be 
    claimed confidential by marking any part or all of that information as 
    Confidential Business Information (CBI). Information so marked will not 
    be disclosed except in accordance with procedures set forth in 40 CFR 
    part 2. A copy of the information 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.
    
    VII. Public Docket
    
        EPA has established a record for this rulemaking under docket 
    number [OPP-300473] (including any comments and data submitted 
    electronically). 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 8:30 a.m. 
    to 4 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.
        Electronic comments may be sent directly to EPA at:
        opp-docket@epamail.epa.gov.
    
        Electronic comments must be submitted as an ASCII file avoiding the 
    use of special characters and any form of encryption.
        The official record for this rulemaking, as well as the public 
    version, as described above will be kept in paper form. Accordingly, 
    EPA will transfer any copies of 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 comments submitted directly in writing. The 
    official rulemaking record is the paper record maintained at the 
    address in ``ADDRESSES'' at the beginning of this document.
    
    VIII. Regulatory Assessment Requirements
    
        Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), this 
    action is not a ``significant regulatory action'' and since this action 
    does not impose any information collection requirements subject to 
    approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it 
    is not subject to review by the Office of Management and Budget. In 
    addition, 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, l993, special considerations as required by Executive Order 
    12898 (59 FR 7629, February 16, l994).
        Because tolerances established on the basis of a petition under 
    section 408(d) of FFDCA do not require issuance of a proposed rule, the 
    regulatory flexibility analysis requirements of the Regulatory 
    Flexibility Act (RFA), 5 U.S.C. 604(a), do not apply. Prior to the 
    recent amendment of the FFDCA, EPA had treated such rulemakings as 
    subject to the RFA; however, the amendments to the FFDCA clarify that 
    no proposal is required for such rulemakings and hence that the RFA is 
    inapplicable. Nonetheless, the Agency has previously assessed whether 
    establishing tolerances or exemptions from tolerance, raising tolerance 
    levels, or expanding exemptions adversely impact small entities and 
    concluded, as a generic matter, that there is no adverse impact. (46 FR 
    24950) (May 4, l981).
        Pursuant to 5 U.S.C. 801(a)(1)(A), EPA submitted a report 
    containing this rule and other required information to the U.S. Senate, 
    the U.S. House of Representatives and the Comptroller General of the 
    General Accounting Office prior to publication of the rule in today's 
    Federal Register. This rule is
    
    [[Page 18532]]
    
    not a major rule as defined by 5 U.S.C. 804(2).
    
    List of Subjects
    
    40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
    40 CFR Part 185
    
        Environmental protection, Food additives, Pesticides and pests.
    
    40 CFR Part 186
    
        Environmental protection, Animal feeds, Pesticides and pests.
    
        Dated: April 4, 1997.
    
    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. Section 180.431 is amended as follows:
        i. In paragraph (a) by revising the introductory text, and adding 
    new entries to the table.
        ii. In paragraph (b) by removing the text, and adding a paragraph 
    heading.
        iii. In paragraph (c) by the redesignating the text as paragraph 
    (b), by adding a new paragraph heading, and by reserving it.
        iv. By adding paragraph (d) with a paragraph heading only and 
    reserving it.
    
    
    Sec. 180.431   Clopyralid; tolerances for residues.
    
        (a) General. Tolerances are established for combined residues of 
    the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid) in or 
    on the following commodities:
    
    ------------------------------------------------------------------------
                                                                  Parts per 
                             Commodity                             million  
    ------------------------------------------------------------------------
                                                                            
                          *      *      *      *      *                     
    Corn, field, fodder........................................         10.0
    Corn, field, forage........................................          3.0
    Corn, field, grain.........................................          1.0
    Corn, field, milling fractions.............................          1.5
                          *      *      *      *      *                     
    ------------------------------------------------------------------------
    
        (b) Section 18 emergency exemptions. *  *  *
        (c)  Tolerances with regional registrations. [Reserved]
        (d)  Indirect or inadvertent residues. [Reserved]
    
    PART 185--[AMENDED]
    
        2. In part 185:
        a. The authority citation for part 185 continues to read as 
    follows:
        Authority: 21 U.S.C. 346a and 348.
    
    Sec. 185.1100  [Removed]
    
        b. By removing Sec. 185.1100 Clopyralid.
    
    PART 186--[AMENDED]
    
        3. In part 186:
        a. The authority citation for part 186 continues to read as 
    follows:
        Authority: 21 U.S.C. 342, 348 and 701.
    
    Sec. 186.1100  [Removed]
    
        b. By removing Sec. 186.1100 Clopyralid.
    
    [FR Doc. 97-9372 Filed 4-15-97; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
4/16/1997
Published:
04/16/1997
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-9372
Dates:
This regulation becomes effective April 16, 1997. Written objections must be received on or before June 16, 1997.
Pages:
18528-18532 (5 pages)
Docket Numbers:
OPP-300473, FRL-5600-2
RINs:
2070-AB78
PDF File:
97-9372.pdf
CFR: (3)
40 CFR 180.431
40 CFR 185.1100
40 CFR 186.1100