98-28360. Certain Plant Regulators, Cytokinins, Auxins, Gibberellins, Ethylene, and Pelargonic Acid; Tolerance Exemptions  

  • [Federal Register Volume 63, Number 205 (Friday, October 23, 1998)]
    [Proposed Rules]
    [Pages 56882-56886]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-28360]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300690; FRL-6019-7]
    RIN 2070-AC18
    
    
    Certain Plant Regulators, Cytokinins, Auxins, Gibberellins, 
    Ethylene, and Pelargonic Acid; Tolerance Exemptions
    
    AGENCY: Environmental Protection Agency (EPA).
    ACTION: Proposed rule.
    
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    SUMMARY: EPA proposes to establish exemptions from the requirement of a 
    tolerance for residues of the active ingredients cytokinins, auxins, 
    gibberellins, ethylene, and pelargonic acid in or on all food 
    commodities, when used as plant regulators on plants, seeds, or 
    cuttings and on all food commodities after harvest. EPA also proposes 
    to remove any existing crop-specific tolerances and/or exemptions from 
    the requirement of a tolerance for the subject active ingredients as 
    well as considering such tolerances to be reassessed as required by the 
    Food Quality Protection Act of 1996 (FQPA). EPA is proposing this 
    regulation on its own initiative to facilitate the addition of new 
    crops, application rates, and uses to the labels of products containing 
    the listed active ingredients when used as plant regulators.
    DATES: Comments, identified by the docket control number [OPP-300690], 
    must be received on or before December 22, 1998.
    ADDRESSES: By mail, submit written comments to: Public Information and 
    Records Integrity Branch, Information Resources and Services Division 
    (7502C), Office of Pesticide Programs, Environmental Protection Agency, 
    401 M St., SW., Washington, DC 20460. In person, deliver comments to: 
    Rm. 119, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
        Comments and data may also be submitted electronically to: docket@epamail.epa.gov. Follow the instructions under Unit VI of this 
    document. No Confidential Business Information (CBI) should be 
    submitted through e-mail.
        Information submitted as a comment concerning this document may be 
    claimed confidential by marking any part or all of that information as 
    CBI. Information so marked will not be disclosed except in accordance 
    with procedures set forth in 40 CFR part 2. A copy of the comment that 
    does not contain CBI must be submitted for inclusion in the public 
    record. Information not marked confidential will be included in the 
    public docket by EPA without prior notice. The public docket is 
    available for public inspection in Rm. 119 at the Virginia address 
    given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
    legal holidays.
    FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway, c/o Product 
    Manager (PM) 90, Biopesticides and Pollution Prevention Division 
    (7511C), Office of Pesticide Programs, Environmental Protection Agency, 
    401 M St., SW., Washington, DC 20460. Office location, telephone number 
    and e-mail address: 9th fl., Crystal Mall #2, 1921 Jefferson 
    Davis Hwy., Arlington, VA 22202; (703) 308-8263; 
    greenway.denise@epamail.epa.gov.
    SUPPLEMENTARY INFORMATION: EPA proposes to amend 40 CFR part 180 by 
    establishing exemptions from the requirement of a tolerance for the 
    active ingredients cytokinins (specifically: aqueous extract of seaweed 
    meal and kinetin); auxins (specifically: indole-3-acetic acid and 
    indole-3-butyric acid); gibberellins [gibberellic acids (GA3 
    and GA4 + GA7), and sodium or potassium 
    gibberellate]; ethylene; and pelargonic acid, in or on all food 
    commodities, when used as plant regulators on plants, seeds or cuttings 
    and on all food commodities, after harvest, in accordance with good 
    agricultural practices. EPA concurrently proposes the revision or 
    revocation and removal of any existing crop-specific tolerances and/or 
    exemptions from the requirement of tolerances for the listed active 
    ingredients when used as plant regulators. In taking this action EPA 
    will consider those tolerances and/or exemptions to be reassessed 
    (Federal Food, Drug, and Cosmetic Act, 408(q) as amended by the FQPA of 
    1996).
        The Agency has selected this group of plant regulators as the 
    subject of this proposal due to their non-toxic mode of action, 
    toxicity profile, low application rates, and the expectation that plant 
    regulator uses will not significantly increase their intake above 
    normally consumed levels. There are additional plant regulator active 
    ingredients which may meet the selection criteria. The Agency may, in 
    the future, propose a similar document addressing other candidate plant 
    regulator active ingredients.
        All of the subject active ingredients are currently registered 
    plant regulators, with the exception of indole-3-acetic acid. The 
    Agency discourages the establishment (or existence) of tolerances, or 
    exemptions from the requirement of a tolerance, for active ingredients 
    for which there are no registered pesticide products. Therefore, any 
    Final Rule subsequent to this proposal will not include indole-3-acetic 
    acid (a naturally occurring analog of indole-3-butyric acid) in the 
    tolerance exemption for auxins, unless during the comment period 
    specific requests that it be included are received. Such requests must 
    document the intention of the commentor to promptly submit upon 
    publication of the Final Rule an application to register a plant 
    regulator product containing indole-3-acetic acid as an active 
    ingredient.
        The Agency is making this proposal upon its own initiative to 
    facilitate the addition of new crops, application rates, and uses to 
    the labels of products containing the listed active ingredients when 
    used as plant regulators. A plant regulator is defined by EPA as 
    ``...any substance or mixture of substances intended, through 
    physiological action, for accelerating or retarding the rate of growth 
    or rate of maturation, or for otherwise altering the behavior of plants 
    or the produce thereof...'' (FIFRA sec. 2 (v)). Additionally, plant 
    regulators are characterized by their low rates of application; high 
    application rates of the same compounds often are herbicidal.
    
    I. Risk Assessment and Statutory Findings
    
        New section 408(c)(2)(A)(i) allows EPA to establish an exemption 
    from the requirement of a tolerance (the legal limit for a pesticide 
    chemical residue in or on a food) only if EPA determines that the 
    exemption is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
    mean that ``there is a reasonable certainty that no harm will result 
    from aggregate exposure to the pesticide chemical residue, including 
    all anticipated
    
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    dietary exposures and all other exposures for which there is reliable 
    information.'' This includes exposure through drinking water and in 
    residential settings, but does not include occupational exposure. 
    Section 408(b)(2)(C) requires EPA to give special consideration to 
    exposure of infants and children to the pesticide chemical residue in 
    establishing an exemption and to ``ensure that there is a reasonable 
    certainty that no harm will result to infants and children from 
    aggregate exposure to the pesticide chemical residue...'' Additionally, 
    section 408(b)(2)(D)(v) requires that 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.''
        EPA performs a number of analyses to determine the risks from 
    aggregate exposure to pesticide residues. First, EPA determines the 
    toxicity of pesticides. Second, EPA examines exposure to the pesticide 
    through food, drinking water, and through other exposures that occur as 
    a result of pesticide use in residential settings.
    
     II. Toxicological Profile
    
        EPA has assessed the toxicology data base for the subject plant 
    regulators and has sufficient data to assess the hazards and to make a 
    determination on aggregate exposure, consistent with section 408(c)(2), 
    for the exemptions from the requirement of a tolerance. EPA's 
    assessment of the exposures, including dietary exposure, and risks 
    associated with establishing these exemptions follows.
    
    A. Waiver of Data Due to Low Toxicity
    
        Tolerance exemptions for these types of substances are usually 
    based on the results of subchronic feeding, developmental toxicity and 
    mutagenicity studies, but for many of the plant regulators some or all 
    of these study requirements have been waived because of negligible 
    exposure from very low use rates. Such use rates for these active 
    ingredients are expected to be effective when these substances are used 
    as plant regulators and these low use rates are not expected to 
    significantly increase dietary intake over that anticipated from 
    consumption of a normal diet because the subject active ingredients are 
    naturally occurring (or are synthesized to approximate the naturally 
    occurring forms) in plants. Plants are part of a normal human diet. 
    These substances are effective plant regulators when applied at low 
    rates, but are often herbicidal when applied at high rates. The 
    toxicological data presented below demonstrate that testing at high 
    doses yields few effects in laboratory animals. Doses high enough to 
    cause toxicity in animal studies would represent application rates 
    toxic to crops (high, herbicidal rates), whereas the subject of this 
    proposal is the plant regulator (low rates) use.
        Human health data requirements for indole-3-butyric acid were 
    waived for these reasons. Also, data from the published literature on 
    ethylene, and the absence of any reports of significant toxicity from 
    its widespread clinical use as an anesthetic were accepted by the 
    Agency as sufficient to support the conclusion that ethylene will be 
    nontoxic to humans under the conditions of use as a plant regulator 
    (including low application rate), and no additional toxicity data on 
    ethylene are required. No additional toxicity data are needed for 
    cytokinins since they are naturally occurring in numerous plant food 
    sources and are available as a food supplement.
        Because there are no registered pesticide products with indole-3-
    acetic acid as the active ingredient, no data have been received or 
    reviewed. Indole-3-acetic acid is a naturally occurring analog of 
    indole-3-butyric acid, for which all human health data were waived for 
    the reasons discussed above. Human health data on indole-3-acetic acid 
    would be similarly waived.
        A full Tier I data set (40 CFR 158.690) was available and reviewed 
    for the gibberellins.
        The 90-day oral toxicity study on pelargonic acid was waived on the 
    strength of the absence of toxic effects at or below a limit dose 
    (1,000 milligrams/kilogram/day (mg/kg/day)) in the 2-week range finding 
    and developmental toxicity test results.
    
    B. Data on Acute Toxicity
    
        The mammalian acute toxicity data for the plant regulators 
    considered in this exemption indicate low toxicity following single 
    oral, dermal, or inhalation exposures (Toxicity Category III or IV). 
    When tested for primary eye irritation, results for some of the subject 
    active ingredients (pelargonic acid and indole-3-butyric acid, only) 
    placed them in Toxicity Category II, but these findings do not 
    adversely affect the proposed tolerance exemptions, which are based on 
    dietary exposures. Prevention of eye irritation is addressed through 
    protective equipment required by the product labels.
    
    C. Other Toxicity Data
    
        Subchronic toxicity data and genotoxicity assays were considered 
    for gibberellins and pelargonic acid.
        In two subchronic dietary studies of GA3 and 
    GA4 + GA7 in rats, the No Observed Adverse Effect 
    Levels (NOAELs) approached or exceeded an oral limit dose (1,000 mg/kg/
    day), and the Lowest Observed Adverse Effect Levels (LOAELs) were 
    twofold to fivefold higher than the limit dose. An oral developmental 
    toxicity study with GA3 in rats resulted in maternal and 
    developmental toxicity NOAELs equal to or greater than the oral limit 
    dose (highest dose tested), but an oral developmental toxicity study 
    with GA4 + GA7 in rabbits established maternal 
    and developmental toxicity NOAELs at 300 mg/kg/day. The highest dose 
    tested (1,000 mg/kg/day) increased incidences of mortality, abortion, 
    clinical signs of toxicity and gross pathological observations. 
    GA4 + GA7 had no genotoxic effects at or below 
    limit doses in a reverse mutation assay with Salmonella typhimurium, in 
    an in vivo mouse micronucleus test, and in an in vitro UDS (unscheduled 
    DNA synthesis) assay at concentrations up to 1,260 g/ml. 
    GA3 was also negative at or below limit concentrations in S. 
    typhimurium reverse mutation assays and in an in vitro mouse lymphoma 
    cell assay. However, an in vitro cytogenetics assay in human 
    lymphocytes demonstrated chromosomal effects at 4,500 g/ml 
    with metabolic activation and at 2,500 g/ml without metabolic 
    activation which suggested a potential concern for induction of 
    chromosome damage in vitro. These two doses reduced the mitotic index 
    of test cultures by 69% and 50% compared with control cultures for the 
    4,500 and 2,500 g/ml levels, respectively, which indicated 
    that these dose levels had excessive cytotoxicity. In addition, dose 
    levels equal to or less than 2,500 g/ml with metabolic 
    activation or 1,250 g/ml in the absence of metabolic 
    activation did not induce chromosomal aberrations.
        A 14-day range finding test with pelargonic acid to determine 
    dosing concentrations for a 90-day rat oral toxicity study revealed no 
    adverse effects from pelargonic acid at any dose level, including the 
    highest dose of 20,000 ppm (2 percent of the diet), or 1,834 mg/kg/day 
    (a level exceeding the limit dose of 1,000 mg/kg/day). These results 
    and those from the developmental toxicity study described below 
    indicated that a 90-day oral toxicity study is not necessary for 
    dietary risk assessment. No evidence of maternal or developmental 
    toxicity was
    
    [[Page 56884]]
    
    seen in an oral developmental toxicity screen with pelargonic acid at a 
    limit dose (1,500 mg/kg/day). No dermal or systemic toxicity and no 
    increased incidence of tumors were observed in a chronic dermal 
    toxicity study in mice; the mice were treated twice weekly with 50 mg 
    doses of undiluted pelargonic acid for 80 weeks. Pelargonic acid was 
    shown not to be genotoxic in bacteria (S. typhimurium) at limit 
    concentrations (5,000 g/plate) or in an in vivo mouse 
    micronucleus assay at dose levels of 1,250, 2,500 or 5,000 mg/kg. In an 
    in vitro mouse lymphoma forward mutation assay pelargonic acid induced 
    a mutagenic response at levels greater than or equal to 50 g/
    ml with metabolic activation. However, the small sizes of the mutant 
    colonies indicated that the genetic damage was associated with 
    chromosomal damage instead of specific gene mutations. Pelargonic acid 
    in the absence of metabolic activation did not induce gene mutations in 
    mouse lymphoma cells at concentrations as high as 1,200 g/ml, 
    and higher concentrations were cytotoxic. The in vivo mouse 
    micronucleus assay with pelargonic acid did not corroborate the 
    chromosomal findings in the in vitro mouse lymphoma assay.
    
    III. Aggregate Exposures
    
        In examining aggregate exposure, FQPA directs EPA to consider 
    available information concerning exposures from the pesticide residue 
    in food and drinking water and all other non-occupational exposures, 
    including exposure through pesticide use in gardens, lawns, or 
    buildings (residential and other indoor uses).
    
    A. Dietary Exposure
    
        The mammalian toxicology data for these plant regulators indicate 
    low acute toxicity following oral exposure (Toxicity Category III or 
    IV). At the levels used as plant regulators, human dietary exposure is 
    expected to be negligible and acute toxicity from such exposure is not 
    expected. Subchronic and developmental toxicity studies indicated that 
    toxicity did not occur as a result of repeated oral doses at or above 
    1,000 mg/kg of body weight, and no mutagenic activity was observed. 
    Therefore, it is unlikely that chronic dietary exposures would be high 
    enough to result in effects harmful to humans.
        1. Food. Residue analyses data, if any have been submitted, are not 
    a component of this determination since these plant regulators either 
    are naturally occurring in many food plants and are therefore a 
    component of the normal human diet, and/or are used at very low rates. 
    The Agency believes that use of the above plant regulators will result 
    in negligible to nonexistent residues in or on foods or feed.
        2. Drinking water exposure. For the purposes of assessing the 
    potential dietary exposure under these exemptions, EPA considered that 
    under these exemptions the subject active ingredients could be present 
    in all food commodities. Other potential sources of dietary exposure of 
    the general population to residues of pesticides are residues in 
    drinking water. Based on the available studies used in EPA's assessment 
    of environmental risk, EPA does not anticipate residues of the subject 
    active ingredients in drinking water.
    
    B. Other Non-occupational Exposure
    
        For the subject active ingredients, the toxicity data demonstrated 
    no toxic endpoints upon which to base a risk characterization at or 
    below 1,000 mg/kg of body weight/day (the limit dose). Any non-
    occupational risk is expected to be insignificant because of the non-
    toxic mode of action and low exposure resulting from the low plant 
    regulator application rates. Also, the subject active ingredients are 
    naturally occurring in foods and turf, or are synthetics approximating 
    the natural forms in structure and activity. Additionally, appropriate 
    label precautions will mitigate risk from exposure through residential 
    (home and garden) use.
        1. Dermal exposure. The mammalian toxicology data for these plant 
    regulators indicate low acute toxicity following dermal exposure 
    (Toxicity Category III or IV), with the following exception. Acute 
    toxicity studies placed technical pelargonic acid in Toxicity Category 
    II for primary dermal irritation.
        2. Inhalation exposure. The mammalian toxicology data for these 
    plant regulators indicate low acute toxicity following inhalation 
    exposure (Toxicity Category III or IV).
    
    IV. Other Considerations
    
    A. Endocrine Disruptors
    
        The Agency has no information to suggest that the subject plant 
    regulators will have an effect on the immune and endocrine systems. The 
    Agency is not requiring information on the endocrine effects of these 
    biological plant regulators at this time; Congress has allowed 3 years 
    after August 3, 1996, for the Agency to implement a screening program 
    with respect to endocrine effects. Because of the long-term history of 
    natural exposure in the diet, it is not anticipated that the subject 
    active ingredients will require endocrine effects screening.
    
    B. Analytical Method(s)
    
        The Agency proposes to establish exemptions from the requirement of 
    a tolerance without any numerical limitation; therefore, the Agency has 
    concluded that analytical methods are not required for enforcement 
    purposes for any of the subject active ingredients.
    
    C. Codex Maximum Residue Level
    
        There are no CODEX tolerances nor international tolerance 
    exemptions established for the subject active ingredients, when used as 
    plant regulators, at this time.
    
    V. Safety Determination for U.S. Population, 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 data base, 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. In this instance, the Agency believes that there are 
    reliable data to support the conclusion that the subject active 
    ingredients when used as plant regulators are practically non-toxic to 
    mammals, including infants and children, and, thus, there are no 
    threshold effects, and EPA has not used a margin of exposure (safety) 
    approach to assess their safety. As a result, the provision requiring 
    an additional margin of exposure (safety) does not apply.
        Consistent with section 408(b)(2)(D), EPA has reviewed the 
    available scientific data and other relevant information in support of 
    this action.
        Based on the information and data considered, the Agency has 
    determined that use of these pesticides as plant growth regulators will 
    not pose a dietary risk under reasonably foreseeable circumstances.
        As to cytokinins, auxins, and ethylene, the lack of concern 
    regarding toxic effects (as evidenced by the waivers of data on indole-
    3-butyric acid and cytokinins, and the reliance upon public literature 
    on ethylene), plus the low plant regulator application rates, and the 
    expectation that plant regulator uses will not significantly increase 
    intake of these active ingredients above normally consumed levels 
    demonstrate that there is reasonable certainty of no harm from their 
    use as plant regulators.
    
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        As to gibberillins, although there were some positive results at 
    cytotoxic doses from genotoxicity assays, the negative results from the 
    other genotoxicity assays with gibberellins, low plant regulator 
    application rates, and the expectation that plant regulator uses will 
    not significantly increase intake of gibberellins above normally 
    consumed levels demonstrate that there is reasonable certainty of no 
    harm from use of gibberellins as plant regulators.
        As to pelargonic acid, the results of the toxicity studies, 
    negative results in two of the three genotoxicity assays, low plant 
    regulator application rates, and the expectation that plant regulator 
    uses will not significantly increase intake of pelargonic acid above 
    normally consumed levels demonstrate that there is reasonable certainty 
    of no harm from use of this substance as a plant regulator.
         Accordingly, EPA concludes that, in amending 40 CFR part 180, to 
    establish the exemptions as proposed, there is a reasonable certainty 
    that no harm to the general population, including infants and children, 
    will result from aggregate exposure to the pesticide chemical residues 
    of the subject active ingredients, when used as plant regulators. The 
    safety of infants and children is supported by oral toxicity data 
    indicating that, for the subject active ingredients, the doses must 
    exceed 1,000 mg/kg/day before toxicity occurs.
    
    VI. Public Record and Electronic Submissions
    
        The official record for this rulemaking, as well as the public 
    version, has been established for this rulemaking under docket control 
    number [OPP-300690] (including comments and data submitted 
    electronically as described below). A public version of this record, 
    including printed, paper versions of electronic comments, which does 
    not include any information claimed as CBI, is available for inspection 
    from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
    holidays. The official rulemaking record is located at the Virginia 
    address in ``ADDRESSES'' at the beginning of this document.
        Electronic comments can 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. Comments and data 
    will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
    format. All comments and data in electronic form must be identified by 
    the docket control number [OPP-300690]. Electronic comments on this 
    proposed rule may be filed online at many Federal Depository Libraries.
    
    VII. Regulatory Assessment Requirements
    
    A. Certain Acts and Executive Orders
    
        This action proposes exemptions from the tolerance requirement 
    under FFDCA section 408(d). The Office of Management and Budget (OMB) 
    has exempted these types of actions from review under Executive Order 
    12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
    1993). In addition, this proposed action does not contain any 
    information collections subject to OMB approval under the Paperwork 
    Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
    duty or contain any unfunded mandate as described under Title II of the 
    Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
    it require any special considerations as required by Executive Order 
    12898, entitled Federal Actions to Address Environmental Justice in 
    Minority Populations and Low-Income Populations (59 FR 7629, February 
    16, 1994), or require OMB review in accordance with Executive Order 
    13045, entitled Protection of Children from Environmental Health Risks 
    and Safety Risks (62 FR 19885, April 23, 1997).
        In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 
    601 et seq.), the Agency previously assessed whether establishing 
    tolerances, exemptions from tolerances, raising tolerance levels or 
    expanding exemptions might adversely impact small entities and 
    concluded, as a generic matter, that there is no adverse economic 
    impact. The factual basis for the Agency's generic certification for 
    tolerance actions published on May 4, 1981 (46 FR 24950), and was 
    provided to the Chief Counsel for Advocacy of the Small Business 
    Administration.
    
    B. Executive Order 12875
    
        Under Executive Order 12875, entitled Enhancing Intergovernmental 
    Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a 
    regulation that is not required by statute and that creates a mandate 
    upon a State, local or tribal government, unless the Federal government 
    provides the funds necessary to pay the direct compliance costs 
    incurred by those governments. If the mandate is unfunded, EPA must 
    provide to OMB a description of the extent of EPA's prior consultation 
    with representatives of affected State, local and tribal governments, 
    the nature of their concerns, copies of any written communications from 
    the governments, and a statement supporting the need to issue the 
    regulation. In addition, Executive Order 12875 requires EPA to develop 
    an effective process permitting elected officials and other 
    representatives of State, local and tribal governments ``to provide 
    meaningful and timely input in the development of regulatory proposals 
    containing significant unfunded mandates.''
        Today's proposed rule does not create an unfunded Federal mandate 
    on State, local or tribal governments. The rule does not impose any 
    enforceable duties on these entities. Accordingly, the requirements of 
    section 1(a) of Executive Order 12875 do not apply to this rule.
    
    C. Executive Order 13084
    
        Under Executive Order 13084, entitled Consultation and Coordination 
    with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
    issue a regulation that is not required by statute, that significantly 
    or uniquely affects the communities of Indian tribal governments, and 
    that imposes substantial direct compliance costs on those communities, 
    unless the Federal government provides the funds necessary to pay the 
    direct compliance costs incurred by the tribal governments. If the 
    mandate is unfunded, EPA must provide OMB, in a separately identified 
    section of the preamble to the rule, a description of the extent of 
    EPA's prior consultation with representatives of affected tribal 
    governments, a summary of the nature of their concerns, and a statement 
    supporting the need to issue the regulation. In addition, Executive 
    Order 13084 requires EPA to develop an effective process permitting 
    elected and other representatives of Indian tribal governments ``to 
    provide meaningful and timely input in the development of regulatory 
    policies on matters that significantly or uniquely affect their 
    communities.''
        Today's proposed rule does not significantly or uniquely affect the 
    communities of Indian tribal governments. This action does not involve 
    or impose any requirements that affect Indian Tribes. Accordingly, the 
    requirements of section 3(b) of Executive Order 13084 do not apply to 
    this rule.
    
    List of Subjects in 40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
    
    [[Page 56886]]
    
    
        Dated: October 13, 1998.
    
    Janet L. Andersen,
    
    Director, Biopesticides and Pollution Prevention Division, Office of 
    Pesticide Programs.
        Therefore, it is proposed that 40 CFR chapter I be amended as 
    follows:
    
    PART 180--[AMENDED]
    
        1. The authority citation for part 180 continues to read as 
    follows:
        Authority: 21 U.S.C. 346a and 371.
    
    Sec. 180.224 [Removed]
    
        2. By removing Sec. 180.224 Gibberellins; tolerances for residues.
        3. In Sec. 180.1016 by revising paragraph (a) to read as follows:
    
    
    Sec. 180.1016  Ethylene; exemption from the requirement of a tolerance.
    
    *      *      *      *      *
        (a) For all food commodities, it is used as a plant regulator on 
    plants, seeds, or cuttings and on all food commodities after harvest 
    and when applied in accordance with good agricultural practices.
    *      *      *      *      *
    
     Sec. 180.1042 [Removed]
    
        4. By removing Sec. 180.1042 Aqueous extract of seaweed meal; 
    exemption from the requirement of a tolerance.
        5. By revising Sec. 180.1098, to read as follows:
    
    
     Sec. 180.1098  Gibberellins [Gibberellic Acids (GA3 and 
    GA4 + GA7), and Sodium or Potassium 
    Gibberellate]; exemption from the requirement of a tolerance.
    
        An exemption from the requirement of a tolerance is established for 
    residues of gibberellins [gibberellic acids (GA3 and 
    GA4 + GA7), and sodium or potassium gibberellate] 
    in or on all food commodities when used as plant regulators on plants, 
    seeds, or cuttings and on all food commodities after harvest in 
    accordance with good agricultural practices.
    
    Sec. 180.1099 [Removed]
    
        6. By removing Sec. 180.1099 Indole butyric acid (IBA); exemption 
    from the requirement of a tolerance.
        7. In Sec. 180.1159 by revising paragraph (a) to read as follows:
    
    
    Sec. 180.1159   Pelargonic acid; exemption from the requirement of 
    tolerances.
    
        (a) An exemption from the requirement of a tolerance is established 
    for residues of pelargonic acid in or on all food commodities when used 
    as a plant regulator on plants, seeds, or cuttings and on all food 
    commodities after harvest in accordance with good agricultural 
    practices.
    *      *      *      *      *
        8. By adding new Sec. 180.1157 and Sec. 180.1158 to read as 
    follows:
    
    
    Sec. 180.1157   Cytokinins; exemption from the requirement of a 
    tolerance.
    
        An exemption from the requirement of a tolerance is established for 
    residues of cytokinins (specifically; aqueous extract of seaweed meal 
    and kinetin) in or on all food commodities when used as plant 
    regulators on plants, seeds, or cuttings and on all food commodities 
    after harvest in accordance with good agricultural practices.
    
    
    Sec. 180.1158   Auxins; exemption from the requirement of a tolerance.
    
        An exemption from the requirement of a tolerance is established for 
    residues of auxins (specifically; indole-3-acetic acid and indole-3-
    butyric acid) in or on all food commodities when used as plant 
    regulators on plants, seeds, or cuttings and on all food commodities 
    after harvest in accordance with good agricultural practices.
    
    [FR Doc. 98-28360 Filed 10-22-98; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
10/23/1998
Department:
Environmental Protection Agency
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
98-28360
Dates:
Comments, identified by the docket control number [OPP-300690], must be received on or before December 22, 1998.
Pages:
56882-56886 (5 pages)
Docket Numbers:
OPP-300690, FRL-6019-7
RINs:
2070-AC18
PDF File:
98-28360.pdf
CFR: (8)
40 CFR 180.224
40 CFR 180.1016
40 CFR 180.1042
40 CFR 180.1098
40 CFR 180.1099
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