96-30475. Tebufenozide; Pesticide Tolerances for Emergency Exemptions  

  • [Federal Register Volume 61, Number 231 (Friday, November 29, 1996)]
    [Rules and Regulations]
    [Pages 60628-60632]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-30475]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 180
    
    [OPP-300446; FRL-5574-9]
    
    RIN 2070-AC78
    
    
    Tebufenozide; Pesticide Tolerances for Emergency Exemptions
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This regulation establishes a time-limited tolerance for 
    residues of the insecticide tebufenozide in or on the raw agricultural 
    commodity peppers in connection with EPA's granting of emergency 
    exemptions under section 18 of the Federal Insecticide, Fungicide, and 
    Rodenticide Act authorizing use of tebufenozide on peppers in Georgia 
    and New Mexico. This regulation establishes maximum permissible levels 
    for residues of tebufenozide on peppers pursuant to section 408(l)(6) 
    of the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
    Quality Protection Act of 1996. This tolerance will expire and be 
    revoked automatically without further action by EPA on November 30, 
    1997.
    DATES: This regulation becomes effective November 29, 1996. This 
    regulation expires and is revoked automatically without further action 
    by EPA on November 30, 1997. Objections and requests for hearings must 
    be received by EPA on January 28, 1997.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number, [OPP-300446], must 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 identified by the docket control number, [OPP-300446], 
    should be submitted to: Public Response and Program Resources Branch, 
    Field Operations Division (7506C), Office of Pesticide Programs, 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
    In person, bring a copy of objections and hearing requests to Rm. 1132, 
    CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. A copy of objections 
    and hearing requests filed with the Hearing Clerk may also be submitted 
    electronically by sending electronic mail (e-mail) to: 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 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-300446]. 
    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.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Margarita Collantes, 
    Registration Division (7505W), Environmental Protection Agency, 401 M 
    St., SW., Washington, DC 20460. Office location, telephone number, and 
    e-mail: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, 
    Arlington, VA 22202. (703) 308-8347, e-mail: 
    collantes.margarita@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
    section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
    (FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
    residues of the insecticide tebufenozide (benzoic acid, 3,5-dimethyl-1-
    (1,1-dimethylethyl)-2(4-ethylbenzoyl)hydrazide) in or on peppers at 0.5 
    part per million (ppm). This tolerance will expire and be revoked 
    automatically without further action by EPA on November 30, 1997.
    
    I. Background and Statutory Authority
    
        The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104170) was 
    signed into law August 3, 1996. FQPA amends both the Federal Food, 
    Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
    Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
    seq. The FQPA amendments went into effect immediately. Among other 
    things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
    activities under a new section 408 with a new safety standard and new 
    procedures.
        New section 408(b)(2)(A)(i) allows EPA to establish a tolerance 
    (the legal limit for a pesticide chemical residue in or on a food) only 
    if EPA determines that the tolerance is ``safe.'' Section 
    408(b)(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 dietary exposures 
    and all other exposures for which there is reliable information.'' This 
    includes exposure through drinking water, 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 a tolerance 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. . . .''
        Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
    agency from any provision of FIFRA, if EPA determines that ``emergency 
    conditions exist which require such exemption.'' This provision was not 
    amended by FQPA. EPA has established regulations governing such 
    emergency exemptions in 40 CFR part 166.
        Section 408(l)(6) requires EPA to establish a time-limited 
    tolerance or exemption from the requirement for a tolerance for 
    pesticide chemical residues in food that will result from the use of a 
    pesticide under an emergency exemption granted by EPA under section 18 
    of FIFRA. Section 408(l)(6) also requires EPA to promulgate regulations 
    by August 3, 1997, governing the establishment of tolerances and 
    exemptions under section 408(l)(6) and requires that the regulations be 
    consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
        Section 408(l)(6) allows EPA to establish tolerances or exemptions 
    from the requirement for a tolerance, in connection with EPA's granting 
    of FIFRA section 18 emergency exemptions, without providing notice or a 
    period for public comment. Thus, consistent with the need to act 
    expeditiously on requests for emergency exemptions under FIFRA, EPA can 
    establish such tolerances or exemptions under the authority of section 
    408(e) and (l)(6) without notice and comment rulemaking.
        In establishing section 18-related tolerances and exemptions during 
    this interim period before EPA issues the section 408(l)(6) procedural 
    regulation and before EPA makes its broad policy decisions concerning 
    the interpretation and implementation of the new section 408, EPA does 
    not intend to set precedents for the application of section 408 and the 
    new safety standard to other tolerances and exemptions. Rather, these 
    early section 18 tolerance and exemption decisions will be made on a 
    case-by-case basis and will not bind
    
    [[Page 60629]]
    
    EPA as it proceeds with further rulemaking and policy development. EPA 
    intends to act on section 18-related tolerances and exemptions that 
    clearly qualify under the new law.
    
    II. Emergency Exemptions for Tebufenozide on Peppers and FFDCA 
    Tolerances
    
        On September 4, 1996, the Georgia Department of Agriculture availed 
    of itself the authority to declare the existence of a crisis situation 
    within the state, thereby authorizing use under FIFRA section 18 of 
    tebufenozide on peppers to control the beet armyworm (BAW). The state 
    of New Mexico has also requested a specific exemption for use of this 
    chemical to control beet armyworm. Emergency conditions are determined 
    to exist due to the BAW populations demonstrating resistance to 
    registered insecticides. The available data indicate that tebufenozide 
    effectively controls BAW larvae, small and large, and will be used only 
    after the registered alternatives, methomyl and chlorpyrifos, have 
    failed.
        As part of its assessment of these applications for emergency 
    exemption, EPA assessed the potential risks presented by residues of 
    tebufenozide on peppers. In doing so, EPA considered the new safety 
    standard in FFDCA section 408(b)(2), and EPA decided to grant the 
    section 18 exemptions only after concluding that the necessary 
    tolerance under FFDCA section 408(l)(6) would clearly be consistent 
    with the new safety standard and with FIFRA section 18. This tolerance 
    for tebufenozide will permit the marketing of peppers treated in 
    accordance with the provisions of the section 18 emergency exemptions. 
    Consistent with the need to move quickly on the emergency exemptions 
    and to ensure that the resulting food is safe and lawful, EPA is 
    issuing this tolerance without notice and opportunity for public 
    comment under section 408(e) as provided in section 408(l)(6). Although 
    this tolerance will expire and be revoked automatically without further 
    action by EPA on November 30, 1997, under FFDCA section 408(l)(5), 
    residues of tebufenozide not in excess of the amount specified in the 
    tolerance remaining in or on peppers after that date will not be 
    unlawful, provided the pesticide is applied during the term of, and in 
    accordance with all the conditions of, the emergency exemptions. EPA 
    will take action to revoke this tolerance earlier if any experience 
    with, scientific data on, or other relevant information on this 
    pesticide indicate that the residues are not safe.
        EPA has not made any decisions about whether tebufenozide meets the 
    requirements for registration under FIFRA section 3 for use on peppers 
    or whether a permanent tolerance for tebufenozide for peppers would be 
    appropriate. This action by EPA does not serve as a basis for 
    registration of tebufenozide by a State for special local needs under 
    FIFRA section 24(c). Nor does this action serve as the basis for any 
    State other than Georgia or New Mexico to use this product on this crop 
    under section 18 of FIFRA without following all provisions of section 
    18 as identified in 40 CFR part 180.166. For additional information 
    regarding the emergency exemptions for tebufenozide, contact the 
    Agency's Registration Division at the address provided above.
    
    III. Risk Assessment and Statutory Findings
    
        EPA performs a number of analyses to determine the risks from 
    aggregate exposure to pesticide residues. First, EPA determines the 
    toxicity of pesticides based primarily on toxicological studies using 
    laboratory animals. These studies address many adverse health effects, 
    including (but not limited to) reproductive effects, developmental 
    toxicity, toxicity to the nervous system, and carcinogenicity. For many 
    of these studies, a dose response relationship can be determined, which 
    provides a dose that causes adverse effects (threshold effects) and 
    doses causing no observed effects (the ``no-observed effect level'' or 
    ``NOEL'').
        Once a study has been evaluated and the observed effects have been 
    determined to be threshold effects, EPA generally divides the NOEL from 
    the study with the lowest NOEL by an uncertainty factor (usually 100 or 
    more) to determine the Reference Dose (RfD). The RfD is a level at or 
    below which daily aggregate exposure over a lifetime will not pose 
    appreciable risks to human health. An uncertainty factor (sometimes 
    called a ``safety factor'') of 100 is commonly used since it is assumed 
    that people may be up to 10 times more sensitive to pesticides than the 
    test animals, and that one person or subgroup of the population (such 
    as infants and children) could be up to 10 times more sensitive to a 
    pesticide than another. In addition, EPA assesses the potential risks 
    to infants and children based on the weight of the evidence of the 
    toxicology studies and determines whether an additional uncertainty 
    factor is warranted. Thus, an aggregate daily exposure to a pesticide 
    residue at or below the RfD (expressed as 100 percent or less of the 
    RfD) is generally considered acceptable by EPA.
        Lifetime feeding studies in two species of laboratory animals are 
    conducted to screen pesticides for cancer effects. When evidence of 
    increased cancer is noted in these studies, the Agency conducts a 
    weight of the evidence review of all relevant toxicological data 
    including short-term and mutagenicity studies and structure activity 
    relationship. Once a pesticide has been classified as a potential human 
    carcinogen, different types of risk assessments (e.g., linear low dose 
    extrapolations or margin of exposure calculation based on the 
    appropriate NOEL) will be carried out based on the nature of the 
    carcinogenic response and the Agency's knowledge of its mode of action.
        In examining aggregate exposure, FFDCA section 408 requires that 
    EPA take into account available and reliable information concerning 
    exposure from the pesticide residue in the food in question, residues 
    in other foods for which there are tolerances, and other non-
    occupational exposures, such as where residues leach into groundwater 
    or surface water that is consumed as drinking water. Dietary exposure 
    to residues of a pesticide in a food commodity are estimated by 
    multiplying the average daily consumption of the food forms of that 
    commodity by the tolerance level or the anticipated pesticide residue 
    level. The Theoretical Maximum Residue Contribution (TMRC) is an 
    estimate of the level of residues consumed daily if each food item 
    contained pesticide residues equal to the tolerance. The TMRC is a 
    ``worst case'' estimate since it is based on the assumptions that food 
    contains pesticide residues at the tolerance level and that 100 percent 
    of the crop is treated by pesticides that have established tolerances. 
    If the TMRC exceeds the RfD or poses a lifetime cancer risk that is 
    greater than approximately one in a million, EPA attempts to derive a 
    more accurate exposure estimate for the pesticide by evaluating 
    additional types of information (anticipated residue data and/or 
    percent of crop treated data) which show, generally, that pesticide 
    residues in most foods when they are eaten are well below established 
    tolerances.
    
    IV. Aggregate Risk Assessment and Determination of Safety
    
        Consistent with section 408(b)(2)(D), EPA has reviewed the 
    available scientific data and other relevant information in support of 
    this action. Tebufenozide is not registered by EPA
    
    [[Page 60630]]
    
    for indoor or outdoor residential use. Existing food and feed use 
    tolerances for tebufenozide are listed in 40 CFR 180.482. EPA has also 
    assessed the toxicology data base for tebufenozide in its evaluation of 
    applications for registration on peppers. Thus, EPA has sufficient data 
    to assess the hazards of tebufenozide and to make a determination on 
    aggregate exposure, consistent with section 408(b)(2), for the time-
    limited tolerances for residues of tebufenozide on peppers at 0.5 ppm. 
    EPA's assessment of the dietary exposures and risks associated with 
    establishing these tolerances follows.
    
    A. Toxicological Profile
    
        1. Chronic toxicity. Based on the available chronic toxicity data, 
    the Agency has established the RfD for tebufenozide at 0.018 
    milligrams(mg)/kilogram(kg)/day. The RfD is based on a 1 year feeding 
    study in dogs with a NOEL of 1.8 mg/kg/day and an uncertainty factor of 
    100. Decreased red blood cells, hematocrit, and hemoglobin and 
    increased heinz bodies, reticulocytes, and platelets were observed at 
    the Lowest Observed Effect Level (LOEL) of 8.7 mg/kg/day.
        2. Acute toxicity. No appropriate acute dietary endpoint was 
    identified by the Agency. This risk assessment is not required.
        3. Carcinogenicity. Using its Guidelines for Carcinogen Risk 
    Assessment published September 24, 1986 (51 FR 33992), OPP has 
    classified tebufenozide as a Group ``E'' chemical (no evidence of 
    carcinogenicity) based on the results of carcinogenicity studies in two 
    species. There was no evidence of carcinogenicity in a 2-year rat study 
    and an 18-month mouse study.
    
    B. Aggregate Exposure
    
        Tolerances for residues of tebufenozide are currently expressed as 
    benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2(4-
    ethylbenzoyl)hydrazide. Tolerances currently exist for residues on 
    apples and walnuts (see 40 CFR 180.482).
        For purposes of assessing the potential dietary exposure under this 
    tolerance, EPA assumed tolerance level residues and 100 percent of crop 
    treated to estimate the TMRC from all established food uses for 
    tebufenozide as well as the proposed use on peppers. Peppers and pepper 
    products are not considered livestock feed items; thus, there is no 
    reasonable expectation that measurable residues of tebufenozide will 
    occur in meat, milk, poultry, or eggs under the terms of these 
    emergency exemptions.
        Other potential sources of exposure of the general population to 
    residues of pesticides are residues in drinking water and exposure from 
    non-occupational sources. Review of environmental fate data by the 
    Environmental Fate and Effects Division suggests that tebufenozide is 
    moderately persistent to persistent and mobile, and could potentially 
    leach to groundwater and runoff to surface water under certain 
    environmental conditions. There is no established Maximum Concentration 
    Level for residues of tebufenozide in drinking water. No drinking water 
    health advisory levels have been established for tebufenozide.
        The Agency does not have available data to perform a quantitative 
    drinking water risk assessment for tebufenozide at this time. However, 
    in order to mitigate the potential for tebufenozide to leach into 
    groundwater or runoff to surface water, precautionary language has been 
    incorporated into the product label. Also, previous experience with 
    more persistent and mobile pesticides for which there have been 
    available data to perform quantitative risk assessments have 
    demonstrated that drinking water exposure is typically a small 
    percentage of the total exposure when compared to the total dietary 
    exposure. This observation holds even for pesticides detected in wells 
    and drinking water at levels nearing or exceeding established MCLs. 
    Considering the precautionary language on the label and based on 
    previous experience with persistent chemicals, EPA does not anticipate 
    significant exposure from residues of tebufenozide in drinking water.
        Tebufenozide is not registered for either indoor or outdoor 
    residential use. Non-occupational exposure to the general population is 
    therefore not expected and not considered in aggregate exposure 
    estimates.
        At this time, the Agency has not made a determination that 
    tebufenozide and other substances that may have a common mode of 
    toxicity would have cumulative effects. For purposes of this tolerance 
    only, the Agency is considering only the potential risks of 
    tebufenozide in its aggregate exposure.
    
    C. Safety Determinations for U.S. Population
    
        Using the conservative exposure assumptions described above and 
    taking into account the completeness and reliability of the toxicity 
    data, EPA has concluded that dietary exposure to tebufenozide will 
    utilize 4.5 percent of the RfD for the U.S. population. EPA generally 
    has no concern for exposures below 100 percent of the RfD because the 
    RfD represents the level at or below which daily aggregate dietary 
    exposure over a lifetime will not pose appreciable risks to human 
    health. EPA concludes that there is a reasonable certainty that no harm 
    will result from aggregate exposure to tebufenozide residues.
    
    D. Determination of Safety for Infants and Children
    
        In assessing the potential for additional sensitivity of infants 
    and children to residues of tebufenozide, EPA considered data from 
    developmental toxicity studies in the rat and rabbit and a 2-generation 
    reproduction study in the rat. The developmental toxicity studies are 
    designed to evaluate adverse effects on the developing organism 
    resulting from pesticide exposure during prenatal development to one or 
    both parents. Reproduction studies provide information relating to 
    effects from exposure to the pesticide on the reproductive capability 
    of mating animals and data on systemic toxicity.
        Developmental toxicity was not observed in developmental studies 
    using rats and rabbits. The NOEL for developmental effects in both rats 
    and rabbits was 1000 mg/kg/day (HDT), which is the limit dose for 
    testing in developmental studies.
        In the two-generation reproductive toxicity study in the rat, the 
    reproductive/developmental toxicity NOEL of 12.1 mg/kg/day was 14-fold 
    higher than the parental (systemic) toxicity NOEL (0.85 mg/kg/day). The 
    reproductive (pup) LOEL of 171.1 mg/kg/day was based on a slight 
    increase in both generations in the number of pregnant females that 
    either did not deliver or had difficulty and had to be sacrificed. In 
    addition, the length of gestation increased and implantation sites 
    decreased significantly in F1 dams Because these reproductive effects 
    occurred in the presence of parental (systemic) toxicity, these data do 
    not suggest an increased post-natal sensitivity to children and infants 
    (that infants and children might be more sensitive than adults) to 
    tebufenozide exposure.
        FFDCA section 408 provides that EPA shall apply an additional 
    safety factor 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 concludes that a different margin of safety is 
    appropriate. Based on current toxicological data discussed above, EPA 
    concludes that an additional uncertainty factor is not warranted and 
    that the RfD at 0.018 mg/kg/day is appropriate for assessing aggregate 
    risk to infants and children.
    
    [[Page 60631]]
    
        Using the conservative exposure assumptions described above, EPA 
    has concluded that the percent of the RfD that will be utilized by 
    aggregate exposure to residues of tebufenozide ranges from 6.0 percent 
    for children 7-12 years old, up to 44.7 percent for non-nursing 
    infants. Therefore, taking into account the completeness and 
    reliability of the toxicity data and the conservative exposure 
    assessment, EPA concludes that there is a reasonable certainty that no 
    harm will result to infants and children from aggregate exposure to 
    tebufenozide residues.
    
    V. Other Considerations
    
        The metabolism of tebufenozide in plants is adequately understood 
    for the purposes of this tolerance. There is no Codex maximum residue 
    level established for residues of tebufenozide of peppers. There is a 
    practical analytical method (liquid chromatography with ultraviolet 
    detection) for detecting and measuring levels of tebufenozide in or on 
    food with a limit of detection that allows monitoring of food with 
    residues at or above the level set by the tebufenozide tolerance. EPA 
    has provided information on this method to FDA. The method is available 
    to anyone who is interested in pesticide residue enforcement from: By 
    mail, Calvin Furlow, Public Response and Program Resources Branch, 
    Field Operations Division (7506C), Office of Pesticide Programs, 
    Environmental Protection Agency, 401 M St. SW., Washington, DC 20460. 
    Office location and telephone number: Crystal Mall #2, Rm 1128, 1921 
    Jefferson Davis Hwy., Arlington, VA 22202, 703-305-5805.
    
    VI. Conclusion
    
        Therefore, a tolerance in connection with the FIFRA section 18 
    emergency exemptions is established for residues of tebufenozide in 
    peppers at 0.5 ppm. This tolerance will expire and be automatically 
    revoked without further action by EPA on November 30, 1997.
    
    VII. 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 (l)(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 govern 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 January 28, 1997, file written objections to any 
    aspect of this regulation (including the automatic revocation 
    provision) 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 issues on which a hearing is requested, the 
    requestor's contentions on such issues, and a summary of any evidence 
    relied upon by the requestor (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 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 issues 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.
    
    VIII. Public Docket
    
        A record has been established for this rulemaking under docket 
    number [OPP-300446]. A public version of this record, which does not 
    include any information claimed as CBI, is available for inspection 
    from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
    holidays. The public record is located in Room 1132 of the Public 
    Response and Program Resources Branch, Field Operations Division 
    (7506C), Office of Pesticide Programs, Environmental Protection Agency, 
    Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
        The official record for this rulemaking, as well as the public 
    version, as described above, is kept in paper form. Accordingly, in the 
    event there are objections and hearing requests, 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. The official rulemaking 
    record is the paper record maintained at the address in ``ADDRESSES'' 
    at the beginning of this document.
    
    IX. Regulatory Assessment Requirements
    
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
    action is not a ``significant regulatory action'' and, since this 
    action does not impose any information collection requirements as 
    defined by 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 mandate as described in the Unfunded Mandates Reform Act 
    of 1995 (Pub. L. 104-4), or require prior consultation with State 
    officials as specified by Executive Order 12875 (58 FR 58093, October 
    28, 1993), or special considerations as required by Executive Order 
    12898 (59 FR 7629, February 16, 1994).
        Because FFDCA section 408(l)(6) permits establishment of this 
    regulation without a notice of proposed rulemaking, the regulatory 
    flexibility analysis requirements of the Regulatory Flexibility Act, 5 
    U.S.C. 604(a), do not apply.
        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), 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 not a ``major rule'' as 
    defined by 5 U.S.C. 804(2) of the APA as amended.
    
    List of Subjects in 40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, Pesticides
    
    [[Page 60632]]
    
    and pests, Reporting and recordkeeping requirements.
    
        Dated: November 20, 1996.
    Daniel M. Barolo,
    Director, Office of Pesticide Programs.
        Therefore, 40 CFR Chapter I is 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.
    
        2. In 180.482, by redesignating the existing section as paragraph 
    (a) and adding a new paragraph (b) to read as follows:
    
    
    Sec. 180.482   Benzoic acid, tolerances for resdues  .
    
        *    *    *    *    *
        (b) A time-limited tolerance is established for residues of the 
    insecticide benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2(4-
    ethylbenzoyl)hydrazide, in connection with use of the pesticide under 
    section 18 emergency exemptions granted by EPA. The tolerance is 
    specified in the following table. This tolerance expires and is 
    automatically revoked on the date specified in the table without 
    further action by EPA.
    
                                                                            
    ------------------------------------------------------------------------
                                                              Expiration/   
                Commodity              Parts per million    Revocation Date 
    ------------------------------------------------------------------------
    Peppers.........................  0.5                 November 30, 1997 
    ------------------------------------------------------------------------
    
    
    [FR Doc. 96-30475 Filed 11-27-96; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
11/29/1996
Published:
11/29/1996
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-30475
Dates:
This regulation becomes effective November 29, 1996. This regulation expires and is revoked automatically without further action by EPA on November 30, 1997. Objections and requests for hearings must be received by EPA on January 28, 1997.
Pages:
60628-60632 (5 pages)
Docket Numbers:
OPP-300446, FRL-5574-9
RINs:
2070-AC78: Guidance on Environmentally Preferable Purchasing for Federal Agencies
RIN Links:
https://www.federalregister.gov/regulations/2070-AC78/guidance-on-environmentally-preferable-purchasing-for-federal-agencies
PDF File:
96-30475.pdf
CFR: (1)
40 CFR 180.482