99-8635. Tolerance Revocations for Certain Pesticides  

  • [Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
    [Proposed Rules]
    [Pages 16874-16880]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-8635]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Parts 180, 185 and 186
    
    [OPP-300841; FRL-6075-1]
    RIN 2070-AB78
    
    
    Tolerance Revocations for Certain Pesticides
    
    AGENCY: Environmental Protection Agency (EPA).
    
    [[Page 16875]]
    
    ACTION: Proposed rule.
     SUMMARY: This document announces the proposed revocation of tolerances 
    listed in the regulatory text for the herbicides dalapon, fluchloralin, 
    metobromuron, paraquat, and sesone; the fungicides zinc sulfate, 
    glyodin, and manganous dimethyldithiocarbamate (manam); the 
    insecticides coumaphos, hydrogen cyanide and 0-Ethyl S-phenyl 
    ethylphosphonodithioate (fonofos); the plant growth regulator N,N-
    dimethylpiperidinium chloride (mepiquat chloride); and the food 
    additive ethyl formate. Also, this notice proposes to revoke the 
    tolerance for residues of the nematocide and insecticide ethoprop in or 
    on mushrooms and soybeans; soybeans, forage; and soybeans, hay; and the 
    food additive tolerance for residues of the fungicide paraformaldehyde 
    in maple syrup. EPA expects to determine whether any individuals or 
    groups want to support these tolerances. The regulatory actions in this 
    notice are part of the Agency's reregistration program under the 
    Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the 
    tolerance reassessment requirements of the Federal Food, Drug, and 
    Cosmetic Act (FFDCA). By law, EPA is required to reassess 33% of the 
    tolerances that were in existence on August 2, 1996, by August 1999, or 
    about 3,200 tolerances. The regulatory actions proposed in this 
    document pertain to the proposed revocation of 206 tolerances and/or 
    exemptions, which would be counted among reassessments made toward the 
    August 1999 review deadline of FFDCA section 408(q), as amended by the 
    Food Quality Protection Act (FQPA) of 1996.
    DATES: Comments must be received on or before June 7, 1999.
    ADDRESSES: Comments may be submitted by mail, electronically, or in 
    person. Please follow the detailed instructions for each method as 
    provided in Unit IV of the SUPPLEMENTARY INFORMATION section of this 
    notice. Be sure to identify the appropriate docket number [OPP-300841].
    FOR FURTHER INFORMATION CONTACT: Amy Caicedo, Special Review Branch 
    (7508C), Special Review and Reregistration Division, Office of 
    Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., 
    SW., Washington, DC 20460. Office location, telephone number and e-mail 
    address: Special Review Branch, Crystal Mall 2, 6th floor, 1921 
    Jefferson Davis Highway, Arlington, Virginia, Telephone: (703) 308-
    9399; e-mail: caicedo.amy@epa.gov.
    SUPPLEMENTARY INFORMATION:
    
     I. What is the Contribution to Tolerance Reassessment?
    
         By law, EPA is required to reassess 33% of the tolerances that 
    were in existence on August 2, 1996, by August 1999, or about 3,200 
    tolerances. As of March 1999, EPA has reassessed over 2,400 tolerances. 
    The regulatory actions proposed in this document pertain to the 
    proposed revocation of 206 tolerances and/or exemptions, which would be 
    counted among reassessments made toward the August 1999 review deadline 
    of FFDCA section 408(q), as amended by the Food Quality Protection Act 
    (FQPA) of 1996.
    
    II. Does this Proposed Rule Apply to Me?
    
         You may be affected by this proposed rule if you sell, distribute, 
    manufacture, or use pesticides for agricultural applications, process 
    food, distribute or sell food, or implement governmental pesticide 
    regulations. Pesticide reregistration and other actions [see FIFRA 
    section 4(g)(2)] include tolerance and exemption reassessment under 
    FFDCA section 408. Potentially affected categories and entities may 
    include, but are not limited to:
    
    ------------------------------------------------------------------------
                                                   Examples of Potentially
                     Category                         Affected Entities
    ------------------------------------------------------------------------
    Agricultural Stakeholders.................  Growers/Agricultural Workers
                                                Contractors [Certified/
                                                 Commercial Applicators,
                                                 Handlers, Advisors, etc.]
                                                Commercial Processors
                                                Pesticide Manufacturers
                                                User Groups
                                                Food Consumers
     Food Distributors........................  Wholesale Contractors
                                                Retail Vendors
                                                Commercial Traders/Importers
    Intergovernmental Stakeholders............   State, Local, and/or Tribal
                                                 Government Agencies
    Foreign Entities..........................  Governments, Growers, Trade
                                                 Groups
    ------------------------------------------------------------------------
    
         This table is not intended to be exhaustive, but rather provides a 
    guide for readers regarding entities likely to be affected by this 
    action. Other types of entities not listed in this table could also be 
    affected. If you have any questions regarding the applicability of this 
    action to a particular entity, you can consult with the technical 
    person listed in the ``FOR FURTHER INFORMATION CONTACT'' section.
    
    III. How can I get additional information or copies of this or 
    other support documents?
    
    A. Electronically
    
         You may obtain electronic copies of this document and various 
    support documents from the EPA Internet Home Page at http://
    www.epa.gov/. On the Home Page select ``Laws and Regulations'' and then 
    look up the entry for this document under ``Federal Register- 
    Environmental Documents.'' You can also go directly to the ``Federal 
    Register'' listings at http://www.epa.gov/homepage/fedrgstr/.
    
    B. In Person or by Phone
    
         If you have any questions or need additional information about 
    this action, please contact the technical person identified in the 
    ``FOR FURTHER INFORMATION CONTACT'' section. In addition, the official 
    record for this notice, including the public version, has been 
    established under docket control number [OPP-300841], including 
    comments and data submitted electronically as described below. A public 
    version of this record (including printed paper versions of any 
    electronic comments) which does not include any information claimed as 
    Confidential Business Information (CBI), is available for inspection in 
    room 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington 
    Virginia, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
    legal holidays. The Public Information and Records Integrity Branch 
    telephone number is 703-305-5805.
    
    IV. How Can I Respond to this Notice?
    
     A. How and to Whom Do I Submit Comments To?
    
         You may submit comments through the mail, in person, or 
    electronically. Be sure to identify the appropriate docket number 
    (i.e., [OPP-300841]) in your correspondence.
         1. By mail. Submit written comments, identified by the docket 
    control number [OPP-300841], to: Public Information and Records 
    Integrity Branch, Information Resources and Services Division (7502C), 
    Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 
    M St., SW., Washington, DC 20460.
         2. In person or by courier. Deliver written comments, identified 
    by the docket control number [OPP-300841], to: Public Information and 
    Records Integrity Branch, Office of Pesticide Programs, U.S. 
    Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
    Jefferson Davis Hwy., Arlington, VA.
    
    [[Page 16876]]
    
         3. Electronically. Submit your comments and/or data electronically 
    by email to: oppt.ncic@epa.gov. Do not submit any information 
    electronically that you consider to be CBI. Submit electronic comments 
    in ASCII file format avoiding the use of special characters and any 
    form of encryption. Comment and data will also be accepted on standard 
    computer disks in WordPerfect 5.1/6.1 or ASCII file format. All 
    comments and data in electronic form must be identified by the 
    appropriate docket control number [OPP-300841]. You may also file 
    electronic comments and data online at many Federal Depository 
    Libraries.
    
     B. How Should I Handle CBI Information in My Comments?
    
         You may claim information that you submit in response to this 
    document as CBI 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. If you have any questions about CBI 
    or the procedures for claiming CBI, please consult with the technical 
    person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
    
    V. What Is a ``Tolerance''?
    
         A ``tolerance'' represents the legally allowed maximum level for 
    residues of pesticide chemicals in or on raw agricultural commodities 
    and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as 
    amended by the FQPA of 1996, Pub. L. 104-170, authorizes the 
    establishment of tolerances (maximum residue levels), exemptions from 
    the requirement of a tolerance, modifications in tolerances, and 
    revocation of tolerances for residues of pesticide chemicals in or on 
    raw agricultural commodities and processed foods (21 U.S.C. 346(a)). 
    Without a tolerance or exemption, food containing pesticide residues is 
    considered to be unsafe and therefore ``adulterated'' under section 
    402(a) of the FFDCA. If food containing pesticide residues is 
    considered to be ``adulterated,'' you can not distribute the product in 
    interstate commerce (21 U.S.C. 331(a) and 342(a)). For a food-use 
    pesticide to be sold and distributed, the pesticide must not only have 
    appropriate tolerances under the FFDCA, but also must be registered 
    under section 3 of FIFRA (7 U.S.C. et seq.). To retain these tolerances 
    and exemptions, EPA must make a finding that the tolerances and 
    exemptions are safe. To make this safety finding, EPA needs data and 
    information indicating that there is a reasonable certainty that no 
    harm will result from aggregate exposure to the pesticide residues 
    covered by the tolerances and exemptions.
         Monitoring and enforcement of pesticide tolerances and exemptions 
    are carried out by the U.S. Food and Drug Administration (FDA) and the 
    U.S. Department of Agriculture (USDA). This includes monitoring for 
    pesticide residues in or on commodities imported into the United 
    States.
    
    VI. Why Is EPA Proposing the Tolerance Actions Discussed below?
    
        EPA is proposing a number of these tolerance actions to implement 
    the tolerance recommendations made during the Reregistration 
    Eligibility Decision (RED) process, and as follow-up on canceled 
    pesticides and uses of pesticides. As part of the RED process, EPA is 
    required to determine whether each of the amended tolerances meets the 
    safety standards under the Food Quality Protection Act (FQPA). The 
    safety finding determination is found in detail in each RED for the 
    active ingredient. REDs propose certain tolerance actions to be 
    implemented to meet safety findings and change commodity names and 
    groupings in accordance with new EPA policy. Printed copies of the REDs 
    may be obtained from EPA's National Center for Environmental 
    Publications and Information (EPA/NCEPI), P.O. Box 42419, Cincinnati, 
    OH 45242-2419, telephone 1-800-490-9198; fax 513-489-8695 and from the 
    National Technical Information Service (NTIS), 5285 Port Royal Road, 
    Springfield, VA 22161, telephone 703-487-4650. Electronic copies of the 
    RED are available on the internet at http://www.epa.gov/REDs.
         Of the chemicals in this Federal Register Notice, REDs have been 
    issued for Paraquat, Coumaphos, and Mepiquat chloride. The REDs for 
    Paraquat and Mepiquat chloride were issued after passage of FQPA so 
    they contain the Agency's evaluation of the database for these 
    pesticides, including requirements for additional data on the active 
    ingredients to confirm the potential human health and environmental 
    risk assessments associated with current product uses as well as the 
    Agency's decisions and conditions under which these uses and products 
    will be eligible for registration. A determination of safety by EPA 
    includes consideration of (a) potential cumulative effects with 
    pesticides that have a common mode of toxicity, (b) aggregate risks 
    resulting from exposure to residues in food and drinking water and 
    exposure occurring due to pesticide application in residential 
    settings, and (c) special sensitivity to children. FFDCA section 
    408(b)(2)(C) requires that when determining appropriate tolerances, EPA 
    apply an additional ten-fold safety factor for infants and children to 
    take into account potential pre- and post-natal toxicity and the 
    completeness of data on toxicity and exposure unless a different margin 
    of safety, on the basis of reliable data, will be safe for infants and 
    children. Retention, reduction, or removal of the ten-fold safety 
    factor is based on a weight of evidence evaluation of all applicable 
    data. This Federal Register proposal for Paraquat and Mepiquat chloride 
    only includes the tolerances proposed for revocation. At a later date, 
    EPA will issue a Federal Register proposal for the other tolerance 
    reassessments in the Paraquat and Mepiquat chloride REDs. An FQPA 
    assessment still remains to be done for Coumaphos since this RED was 
    completed before passage of FQPA.
         In addition to implementing the tolerance recommendations found in 
    RED documents, this Federal Register notice proposes revocation for 
    canceled uses of certain pesticides. Registrations for Dalapon, Ethyl 
    Formate, Fluchloralin, Fonofos, Glyodin, Hydrogen Cyanide, Manam, 
    Metobromuron, Sesone, and Basic Zinc Sulfate were voluntarily canceled 
    by their respective registrants. It is EPA's general practice to 
    propose revocation of tolerances for residues of pesticide active 
    ingredients for which FIFRA registrations no longer exist. EPA has 
    historically expressed a concern that retention of tolerances that are 
    not necessary to cover residues in or on legally treated foods has the 
    potential to encourage misuse of pesticides within the United States. 
    However, in accordance with FFDCA section 408, EPA will not revoke any 
    tolerance or exemption proposed for revocation if any person 
    demonstrates a need for the retention of the tolerance, and if 
    retention of the tolerance will meet the tolerance standard established 
    under FQPA. Generally, interested parties support the retention of such 
    tolerances in order to permit treated commodities to be legally 
    imported into the United States, since raw agricultural commodities or 
    processed food or feed commodities containing pesticide residues not 
    covered by a tolerance or exemption are considered to be adulterated.
         For tolerances without U.S. registrations, EPA requires the same
    
    [[Page 16877]]
    
    toxicology and residue chemistry data requirements as are needed to 
    support U.S. food-use registrations. For import tolerances, EPA applies 
    these data requirements on a case-by-case basis to account for specific 
    growing conditions in foreign countries. (See 40 CFR part 158 for EPA's 
    data requirements to support domestic use of a pesticide and the 
    establishment and maintenance of a tolerance. EPA is developing a 
    guidance document concerning data requirements for import tolerance 
    support. This guidance will be made available to interested persons). 
    In most cases, EPA requires residue chemistry data (crop field trials) 
    that are representative of growing conditions in exporting countries in 
    the same manner that EPA requires representative residue chemistry data 
    from different U.S. regions to support domestic use of a pesticide and 
    any resulting tolerance(s) or exemption(s). Good Laboratory Practice 
    (GLP) requirements for studies submitted in support of tolerances and 
    exemptions for import purposes only are the same as for domestic 
    purposes; i.e., the studies are required to either fully meet GLP 
    standards, or have sufficient justification presented to show that 
    deviations from GLP requirements do not significantly affect the 
    results of the studies.
    
    VII. Which Pesticides Are Covered by this Action?
    
        The following pesticides are covered by this proposed rule:
        1. Basic zinc sulfate is a fungicide used to control blight, brown 
    rot, leaf spot, and scab. It was manufactured by FMC Corp. Agricultural 
    Products Group, Griffin Corp., Marzone Inc., Puregro Co., Solaris Group 
    of The Monsanto Co., Sureco Inc., Tifchem Products Inc., and W.R. Grace 
    and Company.
        2. Coumaphos [O,O-Diethyl O-(3-chloro-4-methyl-2-oxo-2H-1-
    benzopyran-7-yl) phosphorothioate], trade names CO-Ral, Baymix, Bay 21/
    199, Muscatox, Asuntol, Ent-17957, Resitox, is an organophosphate 
    insecticide used for control of a wide variety of livestock insects, 
    including cattle grubs, screw worms, lice, scabies, flies, and ticks. 
    It is used against ectoparasites, which are insects that live on the 
    outside of host animals such as sheep, goats, horses, pigs, and 
    poultry. It is added to cattle and poultry feed to control the 
    development of fly larvae that breed in manure. It is manufactured by 
    Bayer Corporation.
        3. Dalapon (2,2-dichloropropionic acid, trade names Dalapon 85 and 
    GX Dalapon) is an herbicide used to control Bermuda grass, oxtails, 
    Johnson grass, quackgrass, and other perennial and annual grasses, as 
    well as cattails and rushes. It was manufactured by Aceto Agriculture 
    Chemicals Corp. and by Garden Exchange Ltd.
        4. Ethoprop (O-ethyl S,S-dipropyl phosphorodithioate, trade name 
    Mocap) is a nematocide and insecticide used to control aphids, beetles, 
    billbugs, grubs, nematodes, rootworms, weevils, and wireworms. It is 
    manufactured by Rhone-Poulenc AG Company.
        5. Ethyl formate is a food additive used to control the flour 
    beetle, Indian meal moth, and raisin moth. It was manufactured by Coast 
    Laboratories and by International Minerals and Chemical Corporation.
        6. Fluchloralin (N-(2-chloroethyl)-1-a,a,a-trifluoro-2,6-dinitro-N-
    propyl-p-toluidine, trade name Basalin) is a selective herbicide used 
    to control broadleaf weeds, crabgrass, oxtails, goosegrass, Johnson 
    grass, and pigweed. It was manufactured by BASF Corporation.
        7. O-Ethyl S-phenyl ethylphosphonodithioate (Fonofos, trade names 
    Dyfonate, N-2790, Ent-25,796, Stauffer N-2790) is a soil applied 
    organophosphate insecticide. It was manufactured by Zeneca Ag Products.
        8. Glyodin (2-heptadecyl-2-imidazoline acetate or 2-heptadecyl-2-
    imidazoline (base)) is a fungicide used to control black rot, black 
    spot, brown rot, leaf spot, powdery mildew, scab, and sooty blotch. It 
    was manufactured by Agway Inc., Grower Service Corp., and Union Carbide 
    Corporation.
        9. Hydrogen cyanide is an insecticide and rodenticide fumigant used 
    to control beetles, cockroaches, mealworms, mice, moths, rats, and 
    weevils. It was manufactured by Degesch America, Inc. and by Fumico 
    Incorporated.
        10. Manganous dimethyldithiocarbamate (manam, trade names Fundex, 
    Tricarbamix, and Niagara niacide) is a fungicide used to control leaf 
    spot, rust and scab. It was manufactured by Aceto Agriculture Chemicals 
    Corp., ELF Atochem North America Inc., and FMC Corp. Agricultural 
    Products Group.
        11. Metobromuron (N'-(4-bromophenyl)-N-methoxy-N-methylurea) is a 
    selective herbicide used to control barnyard grass, carpetweed, 
    chickweed, crabgrass, goose grass, pigweed, and ragweed. It was 
    manufactured by Aceto Agriculture Chemicals Corporation.
        12. N,N-dimethylpiperidinium chloride (mepiquat chloride, trade 
    name Pix) is a plant growth regulator. It is manufactured by BASF 
    Corporation.
        13. Paraformaldehyde (trade names Flomor, Ma-pel, Sapflo) is a 
    fungicide and bacteriocide used to control pathogenic fungi, pathogenic 
    bacteria, and mold/mildew. It is manufactured by Lamb Natural Flow, 
    Inc., Sugar Bush Supply Co., and Reynolds Sugar Bush Incorporated.
        14. Paraquat (trade names Cyclone, Gramoxone, and Surefire) is a 
    herbicide used to control a broad spectrum of emerged weeds. It is 
    manufactured by Zeneca Ag Products.
        15. Sesone (sodium 2,4-dichlorophenoxyethyl sulfate) is a herbicide 
    used to control barnyard grass, carpetweed, chickweed, crabgrass, 
    foxtail, and pigweed. It was manufactured by Landia Chemical Co. and by 
    Tifchem Products Incorporated.
    
    VIII. What Action Is Being Taken?
    
         This notice proposes revocation of all FFDCA tolerances for 
    residues of the herbicides dalapon, 40 CFR 180.150, 185.1500, and 
    186.1500; fluchloralin, Sec. 180.363; metobromuron Sec. 180.250; and 
    sesone, Sec. 180.102; the fungicides basic zinc sulfate, Sec. 180.244; 
    glyodin, Sec. 180.124; and manganous dimethyldithiocarbamate, 
    Sec. 180.161; the insecticides fonofos, Sec. 180.221; and hydrogen 
    cyanide, Sec. 180.130; and the food additive ethyl formate, 
    Sec. 180.520; because no registered uses exist. The registrations for 
    these pesticide chemicals were canceled because the registrant failed 
    to pay the required maintenance fee and/or the registrant voluntarily 
    canceled all registered uses of the pesticide.
        For the following pesticides, certain tolerances for specific 
    commodities are proposed to be removed.
        1. Ethoprop. The following tolerances for residues in 40 CFR 
    180.262(a) on mushrooms; soybeans; soybeans, forage; and soybeans, hay 
    are being proposed for revocation for Ethoprop because uses no longer 
    exist for mushrooms, and the registrant voluntarily canceled the 
    soybean uses.
        2. Paraformaldehyde. The paraformaldehyde tolerance in 40 CFR 
    185.4650 for residues in maple syrup is being proposed for revocation 
    because the use was voluntarily canceled by the registrant.
        3. Coumaphos. The tolerances in 40 CFR 180.189 for residues of 
    coumaphos for residues on eggs; poultry, fat; poultry, meat 
    byproducts(mbyp); and poultry, meat are being proposed for revocation 
    because these uses were voluntarily canceled by the registrant.
        4. N,N-dimethylpiperidinium chloride. This notice also proposes 
    revocation of FFDCA tolerances in 40 CFR 180.384 for residues of the 
    plant
    
    [[Page 16878]]
    
    growth regulator N,N-dimethylpiperidinium chloride (mepiquat chloride) 
    in or on cotton, forage because it is no longer considered a 
    significant livestock feed item. Tolerances on eggs; milk; poultry, 
    fat; poultry, mbyp; poultry, meat are being proposed for revocation 
    because there is no reasonable expectation of finite residues and 
    therefore a tolerance is unnecessary (40 CFR 180.6(b)). The tolerance 
    for cottonseed meal is being revoked because it will be covered within 
    the reassessed raw agricultural commodities tolerance.
        5. Paraquat. EPA proposes to revoke the tolerances for rye grain 
    and oat grain in 40 CFR 180.205(a) because no registered uses exist. 
    The Agency proposes to revoke the tolerances for poultry, fat; meat; 
    and poultry, mbyp in 40 CFR 180.205(a) because data indicate that no 
    residues are expected. The statement of policy is given in 40 CFR 
    180.6(a)(3). In such cases, the Agency proposes to revoke the existing 
    tolerances because they are unnecessary. Also, the Agency proposes to 
    revoke the tolerances for bean straw; hops, fresh; hop vines; lentil, 
    hay; peanut, vines; and sunflower, seed hulls in 40 CFR 180.205(a) 
    because they are no longer considered raw agricultural commodities.
         It is EPA's general practice to propose revocation of those 
    tolerances for residues of pesticide chemicals for which there are no 
    active registrations. These revocations will become final unless any 
    person in commenting on the proposal demonstrates a need for the 
    tolerance to cover residues in or on imported commodities or domestic 
    commodities legally treated.
    
    IX. When Do These Actions Become Effective?
    
         EPA proposes that these actions become effective 90 days following 
    publication of a final rule in the Federal Register. EPA is proposing 
    this effective date because EPA believes that by this date all existing 
    stocks of pesticide products labeled for the uses associated with the 
    tolerances proposed for revocation will have been exhausted for more 
    than 1 year; giving ample time for any treated fresh produce to clear 
    trade channels. Therefore, EPA believes revocation after a 90-day 
    period should be reasonable. However, if EPA is presented with 
    information that there are existing stocks still available for use and 
    that information is verified, EPA will consider extending the 
    expiration date of the tolerance. If you have comments regarding 
    existing stocks and whether the effective date accounts for these 
    stocks, please submit comments as described in Unit IV of the 
    SUPPLEMENTARY INFORMATION section of this notice.
         Any commodities listed in the regulatory text of this notice that 
    are treated with the pesticides subject to this notice, and that are in 
    the channels of trade following the tolerance revocations, shall be 
    subject to FFDCA section 408(1)(5), as established by FQPA. Under this 
    section, any residue of these pesticides in or on such food shall not 
    render the food adulterated so long as it is shown to the satisfaction 
    of FDA that, (1) the residue is present as the result of an application 
    or use of the pesticide at a time and in a manner that was lawful under 
    FIFRA, and (2) the residue does not exceed the level that was 
    authorized at the time of the application or use to be present on the 
    food under a tolerance or exemption from tolerance. Evidence to show 
    that food was lawfully treated may include records that verify the 
    dates that the pesticide was applied to such food.
    
    X. What Can I Do If I Wish the Agency to Maintain a Tolerance That 
    the Agency Proposes to Revoke?
    
         In addition to submitting comments in response to this proposed 
    rule, you may also submit an objection. EPA subsequently issues a final 
    rule after considering the comments that are submitted in response to 
    this notice. If you fail to file an objection to the final rule within 
    the time period specified, you will have waived the right to raise any 
    issues resolved in the final rule. After the specified time, the issues 
    resolved in the final rule cannot be raised again in any subsequent 
    proceedings.
         This proposal provides 60 days for any interested person to 
    demonstrate a need for retaining a tolerance, if retention of the 
    tolerance will meet the tolerance standard established under FQPA. If 
    EPA receives a comment to that effect, EPA will not proceed to revoke 
    the tolerance immediately. However, EPA will take steps to ensure the 
    submission of any needed supporting data and will issue an order in the 
    Federal Register under FFDCA section 408(f) if needed. The order would 
    specify the data needed, the time frames for its submission, and would 
    require that within 90 days some person or persons notify EPA that they 
    will submit the data. If the data are not submitted as required in the 
    order, EPA will take appropriate action under FIFRA or FFDCA.
    
    XI. How Do the Regulatory Assessment Requirements Apply to this 
    Action?
    
    A. Is this a ``Significant Regulatory Action''?
    
         No. Under Executive Order 12866, entitled Regulatory Planning and 
    Review (58 FR 51735, October 4, 1993), this action is not a 
    ``significant regulatory action.'' The Office of Management and Budget 
    (OMB) has determined that tolerance actions, in general, are not 
    ``significant'' unless the action involves the revocation of a 
    tolerance that may result in a substantial adverse and material affect 
    on the economy. In addition, this action is not subject to Executive 
    Order 13045, entitled Protection of Children from Environmental Health 
    Risks and Safety Risks (62 FR 19885, April 23, 1997), because this 
    action is not an economically significant regulatory action as defined 
    by Executive Order 12866. Nonetheless, environmental health and safety 
    risks to children are considered by the Agency when determining 
    appropriate tolerances. Under FQPA, EPA is required to apply an 
    additional 10-fold safety factor to risk assessments in order to ensure 
    the protection of infants and children unless reliable data supports a 
    different safety factor.
    
    B. Does this Action Contain Any Reporting or Recordkeeping 
    Requirements?
    
         No. This action does not impose any information collection 
    requirements subject to OMB review or approval pursuant to the 
    Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
    
    C. Does this Action Involve Any ``Unfunded Mandates''?
    
         No. 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).
    
    D. Do Executive Orders 12875 and 13084 Require EPA to Consult with 
    States and Indian Tribal Governments Prior to Taking the Action in this 
    Notice?
    
         No. 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 the Office of Management
    
    [[Page 16879]]
    
    and Budget (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 proposed 
    rule.
         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 proposed rule.
    
    E. Does this Action Involve Any Environmental Justice Issues?
    
         No. This proposed rule does not involve special considerations of 
    environmental-justice related issues pursuant to Executive Order 12898, 
    entitled ``Federal Actions to Address Environmental Justice in Minority 
    Populations and Low-Income Populations'' (59 FR 7629, February 16, 
    1994).
    
    F. Does this Action Have a Potentially Significant Impact on a 
    Substantial Number of Small Entities?
    
        No. The Agency has certified that tolerance actions, including the 
    tolerance actions in this document, are not likely to result in a 
    significant adverse economic impact on a substantial number of small 
    entities. The factual basis for the Agency's determination, along with 
    its generic certification under section 605(b) of the Regulatory 
    Flexibility Act (RFA) (5 U.S.C. 601 et seq.), appears at 63 FR 55565, 
    October 16, 1998 (FRL-6035-7). This generic certification has been 
    provided to the Chief Counsel for Advocacy of the Small Business 
    Administration.
    
    G. Does this Action Involve Technical Standards?
    
         No. This tolerance action does not involve any technical standards 
    that would require Agency consideration of voluntary consensus 
    standards pursuant to section 12(d) of the National Technology Transfer 
    and Advancement Act of 1995 (NTTAA), Pub. L. 104-113, Section 12(d) (15 
    U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus 
    standards in its regulatory activities unless doing so would be 
    inconsistent with applicable law or otherwise impractical. Voluntary 
    consensus standards are technical standards (e.g., materials 
    specifications, test methods, sampling procedures, business practices, 
    etc.) that are developed or adopted by voluntary consensus standards 
    bodies. The NTTAA requires EPA to provide Congress, through OMB, 
    explanation when the Agency decides not to use available and applicable 
    voluntary consensus standards. EPA invites public comment on this 
    conclusion.
    
    H. Are There Any International Trade Issues Raised by this Action?
    
        These revocations will not become final if comments are received 
    which demonstrate the need to maintain the tolerance to cover residues 
    in or on imported commodities. However, data must be submitted that 
    support the continued tolerance. The U.S. EPA is developing guidance 
    concerning data requirements for import tolerance support. This 
    guidance will be made available to interested persons.
    
    I. Is this Action Subject to Review under the Congressional Review Act?
    
         No. This action is not a final rule. Under 5 U.S.C. 801(a)(1)(A) 
    of the Administrative Procedure Act (APA) as amended by the Small 
    Business Regulatory Enforcement Fairness Act of 1996 (Title II of Pub. 
    L. 104-121, 110 Stat. 847), only final rules must be submitted to the 
    U.S. Senate, the U.S. House of Representatives, and the Comptroller 
    General of the United States prior to publication in the Federal 
    Register.
    
    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, Pesticide and pest.
    
    40 CFR Part 186
    
         Environmental Protection, Animal feeds, Pesticide and pest.
    
        Dated: March 31, 1999.
    
    Lois Rossi,
    
    Director, Special Review and Reregistration Division, Office of 
    Pesticide Programs.
         Therefore, it is proposed that 40 CFR parts 180, 185 and 186 be 
    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. 321(q), 346a and 371.
    
    Secs. 180.102, 180.124, 180.130, 180.150, and 180.161 [Removed]
    
         b. By removing Secs. 180.102, 180.124, 180.130, 180.150 and 
    180.161.
         c. Section 180.189 is revised to read as follows:
    
    
    Sec. 180.189   Coumaphos; tolerances for residues.
    
         Tolerances for residues of the insecticide coumaphos (O,O-diethyl 
    0-3-chloro-4-methyl-2-oxo- 2H-1-benzopyran-7-yl phosphorothioate and 
    its oxygen analog (O,O-diethyl 0-3-chloro-4-methyl-2-oxo- 2H-1-
    benzopyran-7-yl phosphate) in or on raw food commodities as follows:
    
    ------------------------------------------------------------------------
                                                                  Parts per
                             Commodity                             million
    ------------------------------------------------------------------------
    Cattle, fat................................................          1.0
    Cattle, meat...............................................          1.0
    
    [[Page 16880]]
    
     
    Cattle, mbyp...............................................          1.0
    Goat, fat..................................................          1.0
    Goat, meat.................................................          1.0
    Goat, mbyp.................................................          1.0
    Hog, fat...................................................          1.0
    Hog, meat..................................................          1.0
    Hog, mbyp..................................................          1.0
    Horse, fat.................................................          1.0
    Horse, meat................................................          1.0
    Horse, mbyp................................................          1.0
    Milk, fat (=n in whole milk)...............................          0.5
    Sheep, fat.................................................          1.0
    Sheep, meat................................................          1.0
    Sheep, mbyp................................................          1.0
    ------------------------------------------------------------------------
    
    Sec. 180.205 [Amended]
    
        d. By removing from Sec. 180.205(a), Paraquat, the entries for bean 
    straw; hops, fresh; hop vines; lentil, hay; oat grain; peanut, vines; 
    poultry, fat; poultry, meat; poultry, mbyp; rye grain, and sunflower, 
    seed hulls.
    
    Secs. 180.221, 180.244, and 180.250 [Removed]
    
        e. By removing Secs. 180.221, 180.244, and 180.250.
    
    Sec. 180.262 [Amended]
    
        f. By removing, from Sec. 180.262(a), Ethoprop; tolerances for 
    residues, the entry for mushrooms.
    
    Sec. 180.363 [Removed]
    
        g. By removing Sec. 180.363.
    
     Sec. 180.384 [Amended]
    
        h. By removing from Sec. 180.384(a), N,N-dimethylpiperidinium 
    chloride; tolerances for residues, the entries for cotton forage; 
    cottonseed; cottonseed meal; eggs; milk; poultry, fat; poultry, mbyp; 
    and poultry, meat.
    
    Sec.  180.520 [Removed]
    
        i. By removing Sec.  180.520.
    
    PART 185--[AMENDED]
    
         1. In part 185:
         a. The authority citation for part 185 continues to read as 
    follows:
        Authority: 21 U.S.C. 346a, 348.
    
    Secs. 185.1500 and 185.4650 [Removed]
    
         b. By removing Secs.  185.1500 and 185.4650.
    
     PART 186--[AMENDED]
    
        1. In part 186:
        a. The authority citation for part 186 continues to read as 
    follows:
        Authority: 21 U.S.C. 342, 348, and 371.
    
    Secs. 186.1500 [Removed]
    
         b. By removing Sec. 186.1500.
    
    [FR Doc. 99-8635 Filed 4-6-99; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
04/07/1999
Department:
Environmental Protection Agency
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
99-8635
Dates:
Comments must be received on or before June 7, 1999.
Pages:
16874-16880 (7 pages)
Docket Numbers:
OPP-300841, FRL-6075-1
RINs:
2070-AB78
PDF File:
99-8635.pdf
CFR: (6)
40 CFR 180.189
40 CFR 180.205
40 CFR 180.262
40 CFR 180.363
40 CFR 180.384
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