99-22635. Difenoconazole; Pesticide Tolerances for Emergency Exemptions  

  • [Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
    [Rules and Regulations]
    [Pages 47680-47687]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-22635]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300904; FRL-6094-3]
    RIN 2070-AB78
    
    
    Difenoconazole; Pesticide Tolerances for Emergency Exemptions
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This regulation establishes time-limited tolerances for 
    residues of difenoconazole [[(2S,4R)/(2R,4S)/(2R,4R)/(2S,4S)]1-[2-[4-
    (4-chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-yl-methyl]-
    1H-1,2,4-triazole] in or on sweet corn commodities. This action is in 
    response to EPA's granting of an emergency exemption under section 18 
    of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
    use of the pesticide on sweet corn seed. This regulation establishes a 
    maximum permissible level for residues of difenoconazole in these food 
    and feed commodities pursuant to section 408(l)(6) of the Federal Food, 
    Drug, and Cosmetic Act, as amended by the Food Quality Protection Act 
    of 1996. The tolerances will expire and are revoked on January 31, 
    2001.
    
    DATES: This regulation is effective September 1, 1999. Objections and 
    requests for hearings must be received by EPA on or before November 1, 
    1999.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number [OPP-300904], 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-300904], must also be submitted 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, bring a copy of 
    objections and hearing requests to Rm. 119, Crystal Mall 2 (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: opp-docket@epa.gov. Copies of electronic 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 5.1/6.1 
    or ASCII file format. All copies of electronic objections and hearing 
    requests must be identified by the docket control number [OPP-300904]. 
    No Confidential Business Information (CBI) should be submitted through 
    e-mail. Copies of electronic objections and hearing requests on this 
    rule may be filed online at many Federal Depository Libraries.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Andrea Beard, Registration 
    Division (7505C), Office of Pesticide Programs, Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
    location, telephone number, and e-mail address: Rm. 271, CM #2, 1921 
    Jefferson Davis Hwy., Arlington, VA, (703) 308-9356, 
    beard.andrea@epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
    section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
    21 U.S.C. 346a, is establishing tolerances for residues of the 
    fungicide difenoconazole, in or on sweet corn seed, forage, and stover 
    at 0.1 part per million (ppm). These tolerances will expire and are 
    revoked on January 31, 2001. EPA will publish a document in the Federal 
    Register to remove the revoked tolerances from the Code of Federal 
    Regulations.
    
    I. Background and Statutory Findings
    
        The Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
    was signed into law August 3, 1996. FQPA amends both the 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. These activities are 
    described in this preamble and discussed in greater detail in the final 
    rule establishing the time-limited tolerance associated with the 
    emergency exemption for use of propiconazole on sorghum (61 FR 58135, 
    November 13, 1996) (FRL-5572-9).
    
    [[Page 47681]]
    
        New section 408(b)(2)(A)(i) of the FFDCA 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 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 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) of the FFDCA 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. Such tolerances can be established without providing notice 
    or period for public comment.
        Because decisions on section 18-related tolerances must proceed 
    before EPA reaches closure on several policy issues relating to 
    interpretation and implementation of the FQPA, EPA does not intend for 
    its actions on such tolerances to set binding precedents for the 
    application of section 408 and the new safety standard to other 
    tolerances and exemptions.
    
    II. Emergency Exemption for Difenoconazole on Sweet Corn Seed and 
    FFDCA Tolerances
    
        Idaho leads the nation in production of SH2 hybrid sweet corn seed, 
    accounting for more than 90% of the total U.S. production. SH2 hybrids 
    are used in the production of super sweet varieties of fresh market and 
    processing sweet corn. In the past, captafol was used in combination 
    with other registered fungicides as a sweet corn seed protectant. 
    However, all captafol uses were voluntarily canceled in May of 1987 as 
    a result of the captafol Special Review. According to the Applicant, 
    the currently registered fungicides available for use on sweet corn 
    provide only marginal control of dieback syndrome (brought on by fungal 
    pathogens, Penicillium, Pythium, and Fusarium species) on hybrid sweet 
    corn varieties. If difenoconazole is not available for use, stand 
    reductions of 20-60% could occur, resulting in significant economic 
    losses for Idaho's sweet corn seed producers, and sweet corn growers in 
    other States, such as Florida where the disease problem is particularly 
    severe. Prior to this year, Idaho received exemptions for use of 
    another material, imazalil, for this situation; however, issues 
    surfaced last year concerning imazalil and EPA could not make the 
    safety finding as required under FQPA for the imazalil use. EPA has 
    authorized under FIFRA section 18 the use of difenoconazole on sweet 
    corn seed for control of fungal pathogens in Idaho. After having 
    reviewed the submission, EPA concurs that emergency conditions exist 
    for this State.
        As part of its assessment of this emergency exemption, EPA assessed 
    the potential risks presented by residues of difenoconazole in or on 
    sweet corn commodities. In doing so, EPA considered the safety standard 
    in FFDCA section 408(b)(2), and EPA decided that the necessary 
    tolerances under FFDCA section 408(l)(6) would be consistent with the 
    safety standard and with FIFRA section 18. Consistent with the need to 
    move quickly on the emergency exemption in order to address an urgent 
    non-routine situation and to ensure that the resulting food is safe and 
    lawful, EPA is issuing these tolerances without notice and opportunity 
    for public comment under section 408(e), as provided in section 
    408(l)(6). Although these tolerances will expire and are revoked on 
    January 31, 2001, under FFDCA section 408(l)(5), residues of the 
    pesticide not in excess of the amounts specified in the tolerances 
    remaining in or on sweet corn commodities after that date will not be 
    unlawful, provided the pesticide is applied in a manner that was lawful 
    under FIFRA, and the residues do not exceed levels that were authorized 
    by these tolerances at the time of that application. EPA will take 
    action to revoke these tolerances earlier if any experience with, 
    scientific data on, or other relevant information on this pesticide 
    indicate that the residues are not safe.
        Because these tolerances are being approved under emergency 
    conditions, EPA has not made any decisions about whether difenoconazole 
    meets EPA's registration requirements for use on sweet corn seed or 
    whether permanent tolerances for this use would be appropriate. Under 
    these circumstances, EPA does not believe that these tolerances serve 
    as basis for registration of difenoconazole by a State for special 
    local needs under FIFRA section 24(c). Nor do these tolerances serve as 
    the basis for any State other than Idaho to use this pesticide on this 
    crop under section 18 of FIFRA without following all provisions of 
    EPA's regulations implementing section 18 as identified in 40 CFR part 
    166. For additional information regarding the emergency exemption for 
    difenoconazole, contact the Agency's Registration Division at the 
    address provided under the ``ADDRESSES'' section.
    
    III. Aggregate Risk Assessment and Determination of Safety
    
        EPA performs a number of analyses to determine the risks from 
    aggregate exposure to pesticide residues. For further discussion of the 
    regulatory requirements of section 408 and a complete description of 
    the risk assessment process, see the final rule on Bifenthrin Pesticide 
    Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
        Consistent with section 408(b)(2)(D), EPA has reviewed the 
    available scientific data and other relevant information in support of 
    this action. EPA has sufficient data to assess the hazards of 
    difenoconazole and to make a determination on aggregate exposure, 
    consistent with section 408(b)(2), for a time-limited tolerance for 
    residues of difenoconazole on sweet corn seed, stover, and forage at 
    0.1 ppm. EPA's assessment of the dietary exposures and risks associated 
    with establishing the tolerances follows.
    
    A. Toxicological Profile
    
        EPA has evaluated the available toxicity data and considered its 
    validity, completeness, and reliability as well as the relationship of 
    the results of the studies to human risk. EPA has also considered 
    available information concerning the variability of the sensitivities 
    of major identifiable subgroups of consumers, including infants and 
    children. The nature of the toxic effects caused by difenoconazole are 
    discussed in this unit.
    
    B. Toxicological Endpoints
    
        1. Acute toxicity. Based on the available acute toxicity data, EPA 
    has determined that the no observable adverse effect level (NOAEL) of 
    25
    
    [[Page 47682]]
    
    milligrams per kilograms body weight per day (mg/kg/bwt/day) from the 
    developmental study in rabbits should be used to assess risk from acute 
    toxicity. Increases in post-implantation loss and resorption, decreases 
    in fetal body weight, and decreases in body weight gains and food 
    consumption in dams, were observed at the lowest obsevable adverse 
    effect level (LOAEL) of 75 mg/kg/day. Using the uncertainty factors 
    (UFs) of 10x for interspecies and 10x for intraspecies variations, the 
    acute Reference Dose (RfD) is 0.25 mg/kg/day. The acute risk assessment 
    will evaluate acute dietary risk to females 13+ years, the population 
    subgroup of concern.
        2. Short- and intermediate-term toxicity. For short-term Margin of 
    Exposure (MOE) calculations, the developmental NOAEL of 25 mg/kg/day, 
    from the developmental rabbit study will be used, with a dermal 
    absorption factor adjustment of 75%. At the LOAEL of 75 mg/kg/day, 
    there were increased post-implantation losses and resorptions per dose, 
    a significant decrease in fetal body weight, and decrease in body 
    weight gains and food consumption in the dams.
        For intermediate-term MOE calculations, the NOAEL of 1.25 mg/kg/day 
    from the 2-generation study in rats will be used. At the LOAEL of 12.5 
    mg/kg/day, there were decreased pup weights.
        3. Chronic toxicity. EPA has established the RfD for difenoconazole 
    at 0.01 mg/kg/day. This RfD is based on cumulative decreases in body 
    weight gains at the LOAEL of 24.0 mg/kg/day from the chronic feeding/
    oncogenicity study in rats with a NOAEL of 0.96 mg/kg/day, and an 
    uncertainty factor of 100.
        4. Carcinogenicity. Difenoconazole has been classified as a Group C 
    possible carcinogen, based on statistically significant increases in 
    liver adenomas, carcinomas, and combined adenomas and carcinomas in 
    both sexes of CD-1 mice, only at doses that were considered to be 
    excessively high for carcinogenicity testing. The MOE approach was 
    recommended for risk assessments, because there was only very weak 
    evidence of carcinogenic potential at dose levels not considered to be 
    excessive, with significant changes seen only at excessive doses. 
    Additionally, there was no evidence of genotoxicity. However, at this 
    time, the Agency has not defined the acceptable level of concern for 
    cancer risk using the MOE approach. Therefore, a quantitative risk 
    analysis was conducted utilizing the Q1* approach. The 
    Q1* was calculated to be 1.57 x 10-1 (mg/kg/
    day)-1.
    
    C. Exposures and Risks
    
        1. From food and feed uses. Permanent tolerances have been 
    established (40 CFR 180.475) for the residues of difenoconazole, in or 
    on wheat and livestock commodities ranging from 0.05 to 0.1 ppm and on 
    bananas (import) at 0.2 ppm. Risk assessments were conducted by EPA to 
    assess dietary exposures and risks from difenoconazole as follows:
        i. Acute exposure and risk. Acute dietary risk assessments are 
    performed for a food-use pesticide if a toxicological study has 
    indicated the possibility of an effect of concern occurring as a result 
    of a 1-day or single exposure. EPA's detailed acute analysis estimated 
    the distribution of single-day exposures for the subgroup Females 13+ 
    Years Old. An evaluation was not conducted for the overall U.S. 
    population and infant and children subgroups, because oral 
    toxicological studies did not demonstrate effects on these groups that 
    could be attributable to a single dose exposure. The Dietary Exposure 
    Evaluation Model (DEEM) analysis evaluated the individual food 
    consumption as reported by respondents in the USDA 1989-91 Nationwide 
    Continuing Surveys for Food Intake by Individuals (CSFII) and 
    accumulated exposure to the chemical for each commodity. This acute 
    exposure analysis was performed assuming tolerance level residues and 
    100% crop treated. Taking into account published and proposed 
    tolerances (including these for sweet corn commodities), at the 95th 
    percentile, the exposure utilized less than 1% of the RfD for the 
    population subgroup of concern, Females 13+ Yrs. Old. Therefore, the 
    level of concern is not exceeded.
        ii. Chronic exposure and risk. The chronic risk assessment was 
    conducted using mean consumption (3-day average) values, and was 
    refined using anticipated residues and percent of crop treated (PCT) 
    information for select commodities. The RfD of 0.01 mg/kg/day and an 
    uncertainty factor of 100 were used. Since it was determined that the 
    FQPA UF of 3x was not necessary, acceptable dietary exposure must not 
    exceed 100% of the chronic RfD for all population subgroups. The 
    Novigen DEEM system was used for this chronic dietary exposure 
    analysis.The subgroups listed below are: (1) the U.S. Population (48 
    contiguous States); (2) those for infants and children; and, (3) the 
    other subgroups (adult) for which the percentage of the RfD occupied is 
    greater than that occupied by the subgroup U.S. Population (48 
    contiguous States). The results are summarized below.
    
     
    ------------------------------------------------------------------------
                                        Exposure (mg/kg
           Population Subgroup             bwt/day)          % Chronic RfD
    ------------------------------------------------------------------------
    U.S. Population (48 contiguous    0.000005            < 1="" states).="" all="" infants="">< 1="" yr)............="" 0.000016="">< 1="" nursing="" infants=""><1 yr).........="" 0.000007="">< 1="" non-nursing="" infants=""><1 yr).....="" 0.000019="">< 1="" children="" (1-6="" yrs)..............="" 0.000011="">< 1="" children="" (7-12="" yrs).............="" 0.000005="">< 1="" females="" (13+="" yrs="" nursing).....="" 0.000006="">< 1="" seniors="" (55+="" yrs)...............="" 0.000006="">< 1="" non-hispanic,="" other="" than="" black/="" 0.000006="">< 1="" white.="" ------------------------------------------------------------------------="" as="" shown="" in="" the="" above="" table,="" chronic="" dietary="" risk="" does="" not="" exceed="" the="" level="" of="" concern="" for="" any="" of="" the="" population="" subgroups.="" iii.="" cancer="" exposure="" and="" risk.="" the="" agency="" previously="" classified="" difenoconazole="" as="" a="" possible="" human="" carcinogen;="" this="" chemical="" would="" now="" be="" classified="" as="" a="" likely="" human="" carcinogen="" in="" accordance="" with="" the="" agency's="" ``proposed="" guidelines="" for="" carcinogenic="" risk="" assessment''="" (april="" 10,="" 1996).="" as="" previously="" explained="" in="" this="" document,="" a="" non-="" linear,="" moe="" approach="" was="" recommended="" to="" quantify="" human="" cancer="" risk="" from="" difenoconazole.="" however,="" at="" this="" time="" the="" agency="" has="" not="" defined="" the="" acceptable="" level="" of="" concern="" for="" cancer="" risk="" using="" the="" moe="" approach.="" therefore,="" the="" linear="">1* approach was used for calculating 
    cancer risk. A Q1* of 0.157 (mg/kg/day)-1 was 
    determined based on the male mouse liver adenoma and/or carcinoma 
    combined tumor rates in the 78-week cancer study in mice. The exposure 
    analysis estimating potential cancer risks for difenoconazole was 
    performed using anticipated residues and PCT or percent imported, as 
    refinements, for selected commodities, to determine Estimated Lifetime 
    Cancer Risk for the general population. The DEEM analysis was used, as 
    described previously, and the partially refined exposure estimate 
    calculated for the U.S. population (48 contiguous States) was 0.000005 
    mg/kg/day, translating to a lifetime cancer risk estimate of 8.4 x 
    10-7 from residues in food. This cancer risk estimate does 
    not exceed the Agency's level of concern.
        Section 408(b)(2)(E) authorizes EPA to use available data and 
    information on the anticipated residue levels of pesticide residues in 
    food and the actual levels of pesticide chemicals that have
    
    [[Page 47683]]
    
    been measured in food. If EPA relies on such information, EPA must 
    require that data be provided 5 years after the tolerance is 
    established, modified, or left in effect, demonstrating that the levels 
    in food are not above the levels anticipated. Following the initial 
    data submission, EPA is authorized to require similar data on a time 
    frame it deems appropriate. As required by section 408(b)(2)(E), EPA 
    will issue a data call-in for information relating to anticipated 
    residues to be submitted no later than 5 years from the date of 
    issuance of this tolerance.
        Anticipated residue data used in the current dietary risk analysis 
    were calculated from field trial data. The anticipated residues used 
    were 0.01 ppm for bananas; 0.000019 for eggs; 0.0000043 ppm for egg 
    whites; 0.000046 ppm for egg yolks; 0.000041 ppm for fat of cattle, 
    goats, hogs, horses, and sheep; 0.00012 ppm for kidney of cattle, 
    goats, hogs, horses, and sheep; 0.000014 ppm for meat of cattle, goats, 
    hogs, horses, and sheep; 0.00044 ppm for meat byproducts (except 
    kidney) of cattle, goats, hogs, horses, and sheep; 0.000013 ppm for 
    milk; 0.01 ppm for plantains; 0.0000030 ppm for poultry fat; 0.000034 
    ppm for poultry kidney; 0.000006 ppm for poultry meat; 0.000023 ppm for 
    poultry meat byproducts (except kidney); 0.005 ppm for sweet corn; and 
    0.005 ppm for wheat grain.
        Section 408(b)(2)(F) States that the Agency may use data on the 
    actual PCT for assessing chronic dietary risk only if the Agency can 
    make the following findings: That the data used are reliable and 
    provide a valid basis to show what percentage of the food derived from 
    such crop is likely to contain such pesticide residue; that the 
    exposure estimate does not underestimate exposure for any significant 
    subpopulation group; and if data are available on pesticide use and 
    food consumption in a particular area, the exposure estimate does not 
    understate exposure for the population in such area. In addition, the 
    Agency must provide for periodic evaluation of any estimates used. To 
    provide for the periodic evaluation of the estimate of PCT as required 
    by the section 408(b)(2)(F), EPA may require registrants to submit data 
    on PCT.
        The Agency used PCT information as follows:
        Three PCT for sweet corn, 9 PCT for wheat, and 10.5% imported for 
    barley. The percent imported data are used in the same way PCT data are 
    used. This refinement is used because difenoconazole is not registered 
    for use in the United States. The percentage means that 10.5% of the 
    barley used (potentially or actually) for human consumption in the 
    United States is imported; it is even more conservative because it also 
    assumes that all such imported barley has difenoconazole residues.
        The Agency believes that the three conditions, discussed in section 
    408(b)(2)(F) in this unit concerning the Agency's responsibilities in 
    assessing chronic dietary risk findings, have been met. The PCT 
    estimates are derived from Federal and private market survey data, 
    which are reliable and have a valid basis. Typically, a range of 
    estimates are supplied and the upper end of this range is assumed for 
    the exposure assessment. By using this upper end estimate of the PCT, 
    the Agency is reasonably certain that the percentage of the food 
    treated is not likely to be underestimated. The regional consumption 
    information and consumption information for significant subpopulations 
    is taken into account through EPA's computer-based model for evaluating 
    the exposure of significant subpopulations including several regional 
    groups. Use of this consumption information in EPA's risk assessment 
    process ensures that EPA's exposure estimate does not understate 
    exposure for any significant subpopulation group and allows the Agency 
    to be reasonably certain that no regional population is exposed to 
    residue levels higher than those estimated by the Agency. Other than 
    the data available through national food consumption surveys, EPA does 
    not have available information on the regional consumption of food to 
    which difenoconazole may be applied in a particular area.
        2. From drinking water. The Agency lacks sufficient water-related 
    exposure data to complete a comprehensive drinking water exposure 
    analysis and risk assessment for difenoconazole. Because the Agency 
    does not have comprehensive and reliable monitoring data, drinking 
    water concentration estimates must be made by reliance on some sort of 
    simulation or modeling. To date, there are no validated modeling 
    approaches for reliably predicting pesticide levels in drinking water. 
    The Agency is currently relying on GENEEC and PRZM/EXAMS for surface 
    water, which are used to produce estimates of pesticide concentrations 
    in a farm pond and SCI-GROW, which predicts pesticide concentrations in 
    ground water. None of these models include consideration of the impact 
    that processing of raw water, for distribution as drinking water, would 
    likely have on the removal of pesticides from the source water. The 
    primary use of these models by the Agency at this stage is to provide a 
    coarse screen for sorting out pesticides for which it is highly 
    unlikely that drinking water concentrations would ever exceed human 
    health levels of concern.
        In the absence of monitoring data for pesticides, drinking water 
    levels of comparison (DWLOCs) are calculated and used as a point of 
    comparison against the model estimates of a pesticide's concentration 
    in water. DWLOCs are theoretical upper limits on a pesticide's 
    concentration in drinking water in light of total aggregate exposure to 
    a pesticide in food, drinking water, and residential uses. A DWLOC will 
    vary depending on the toxic endpoint, with drinking water consumption, 
    and body weights. Different populations will have different DWLOCs. 
    DWLOCs are used in the risk assessment process as a surrogate measure 
    of potential exposure associated with pesticide exposure through 
    drinking water. DWLOC values are not regulatory standards for drinking 
    water. Since DWLOCs address total aggregate exposure to difenoconazole, 
    they are further discussed in the aggregate risk sections below.
        3. From non-dietary exposure. Difenoconazole is not currently 
    registered for use on any residential non-food sites. Therefore, there 
    are no exposures and risks from non-dietary residential exposure.
        4. Cumulative exposure to substances with common mechanism of 
    toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
    whether to establish, modify, or revoke a tolerance, the Agency 
    consider ``available information'' concerning the cumulative effects of 
    a particular pesticide's residues and ``other substances that have a 
    common mechanism of toxicity.''
        EPA does not have, at this time, available data to determine 
    whether difenoconazole has a common mechanism of toxicity with other 
    substances or how to include this pesticide in a cumulative risk 
    assessment. Unlike other pesticides for which EPA has followed a 
    cumulative risk approach based on a common mechanism of toxicity, 
    difenoconazole does not appear to produce a toxic metabolite produced 
    by other substances. For the purposes of this tolerance action, 
    therefore, EPA has not assumed that difenoconazole has a common 
    mechanism of toxicity with other substances. For more information 
    regarding EPA's efforts to determine which chemicals have a common 
    mechanism of toxicity and to evaluate the cumulative effects of such 
    chemicals, see the final rule for
    
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    Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
    
    D. Aggregate Risks and Determination of Safety for U.S. Population
    
        1. Acute risk. From the acute dietary (food only) risk assessment, 
    a high-end exposure estimate was calculated for the population subgroup 
    of concern, Females 13+ years. For this group, less than 1% of the RfD 
    is occupied by dietary (food only) exposure. This small percentage of 
    the acute RfD utilized by this exposure provides assurance that there 
    is reasonable certainty that no harm will result to both Females 13+ 
    years, and to the prenatal development of infants. Acute effects for 
    the general population are not expected.
        The maximum estimated concentrations of difenoconazole in surface 
    and ground water are less than the DWLOCs for difenoconazole as a 
    contribution to acute aggregate exposure. Therefore, EPA concludes with 
    reasonable certainty that residues of difenoconazole in drinking water 
    will not contribute significantly to the aggregate acute human health 
    risk.
        2. Chronic risk. Using the ARC exposure assumptions described in 
    this unit, EPA has concluded that aggregate exposure to difenoconazole 
    from food will utilize <1% of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-="" nursing="" infants=""><1 yr.="" old),="" still="" at=""><1% of="" the="" rfd.="" this="" is="" further="" discussed="" below="" in="" the="" section="" on="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" 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.="" the="" estimated="" concentrations="" of="" difenoconazole="" in="" surface="" and="" ground="" water="" are="" less="" than="" the="" dwlocs="" for="" difenoconazole="" as="" a="" contribution="" to="" chronic="" aggregate="" exposure.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" residues="" of="" difenoconazole="" in="" drinking="" water="" will="" not="" contribute="" significantly="" to="" the="" aggregate="" chronic="" human="" health="" risk.="" despite="" the="" potential="" for="" exposure="" to="" difenoconazole="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" since="" no="" registered="" residential="" uses="" or="" exposure="" scenarios="" were="" identified="" for="" short-="" and="" intermediate-term="" exposure,="" these="" risk="" assessments="" are="" not="" required.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" the="" deem="" dietary="" exposure="" analysis="" used="" anticipated="" residues="" and="" pct="" information="" for="" selected="" commodities,="" to="" estimate="" the="" lifetime="" cancer="" risk="" for="" the="" general="" population.="" using="" the="" dietary="" exposure="" estimate="" of="" 0.000005="" mg/="" kg/day,="" the="" lifetime="" dietary="" cancer="" risk="" was="" calculated="" to="" be="" 8.4="" x="">-7. The estimated average concentrations of difenoconazole 
    in surface and ground water are less than the DWLOCs for difenoconazole 
    as a contribution to cancer aggregate exposure. Therefore, EPA 
    concludes with reasonable certainty that residues which may occur in 
    drinking water do not contribute significantly to the aggregate chronic 
    human health risk. Thus, aggregate cancer risk estimates associated 
    with exposure to difenoconazole from food and water do not exceed 
    levels of concern.
        5. Determination of safety. Based on these risk assessments, EPA 
    concludes that there is reasonable certainty that no harm will result 
    from aggregate exposure to difenoconazole residues.
    
    E. Aggregate Risks and Determination of Safety for Infants and Children
    
        1. Safety factor for infants and children --i. In general. In 
    assessing the potential for additional sensitivity of infants and 
    children to residues of difenoconazole, 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 maternal pesticide exposure during gestation. 
    Reproduction studies provide information relating to effects from 
    exposure to the pesticide on the reproductive capability of mating 
    animals and data on systemic toxicity.
        FFDCA section 408 provides that EPA shall apply an additional 
    tenfold margin of safety for infants and children in the case of 
    threshold effects to account for prenatal and postnatal toxicity and 
    the completeness of the data base unless EPA determines that a 
    different margin of safety will be safe for infants and children. 
    Margins of safety are incorporated into EPA risk assessments either 
    directly through use of a MOE analysis or through using uncertainty 
    (safety) factors in calculating a dose level that poses no appreciable 
    risk to humans. EPA believes that reliable data support using the 
    standard MOE and uncertainty factor (usually 100 for combined 
    interspecies and intraspecies variability) and not the additional 
    tenfold MOE/uncertainty factor when EPA has a complete data base under 
    existing guidelines and when the severity of the effect in infants or 
    children or the potency or unusual toxic properties of a compound do 
    not raise concerns regarding the adequacy of the standard MOE/safety 
    factor.
        ii. Developmental toxicity studies. In a developmental study in 
    rats, the NOAEL for maternal toxicity was 20 mg/kg/day, based upon 
    statistically significant decreases in maternal body weight gain and 
    feed consumption at the LOAEL of 100 mg/kg/day. The NOAEL for 
    developmental toxicity was 100 mg/kg/day, based upon the incidence of 
    bifid or unilateral ossification of the thoracic vertebrae, and 
    significant increases in the average number of ossified hyoid and 
    decreases in the number of sternal centers of ossification. The average 
    number of ribs was also significantly increased with accompanying 
    increases in the number of thoracic vertebrae and decreases in the 
    number of lumbar vertebrae. These effects were observed at the LOAEL of 
    200 mg/kg/day.
        In a developmental study in rabbits, the NOAEL for maternal 
    toxicity was 25 mg/kg/day, based upon decreases in body weight gain and 
    food consumption seen at the LOAEL of 75 mg/kg/day. The developmental 
    toxicity NOAEL was also 25 mg/kg/day, with increases in post-
    implantation loss and resorptions, and decreases in fetal body weight, 
    seen at the LOAEL of 75 mg/kg/day.
        iii. Reproductive toxicity study. In a 2-generation reproduction 
    study in rats, the NOAEL for parental toxicity was 25 ppm (1.25 mg/kg/
    day), based upon decreased maternal body weight gain at the LOAEL of 
    250 ppm (12.5 mg/kg/day). The NOAEL for reproductive toxicity was also 
    25 ppm, based upon decreased pup weights at day 21, at the LOAEL of 250 
    ppm.
        iv. Prenatal and postnatal sensitivity. The FQPA Safety Factor 
    Committee recommended that the 10x safety factor for enhanced 
    sensitivity to infants and children be reduced to a 1x factor, since 
    the toxicology data base is complete, and there is no indication of 
    increased susceptibility of rats or rabbit fetuses to prenatal or 
    postnatal exposure.
        v. Conclusion. There is a complete toxicity data base for 
    difenoconazole and exposure data are complete or are estimated based on 
    data that reasonably accounts for potential exposures.
        2. Acute risk. An acute RfD is not established for the general 
    population, including infants and children, because there were no 
    effects observed in
    
    [[Page 47685]]
    
    toxicity studies (including maternal toxicity in the rabbit and rat 
    developmental studies), which were attributable to a single exposure. 
    Therefore, the Agency concludes that acute risks to infants and 
    children are negligible.
        3. Chronic risk. Using the exposure assumptions described in this 
    unit, EPA has concluded that aggregate exposure to difenoconazole from 
    food will utilize <1% of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" 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.="" the="" estimated="" average="" concentrations="" of="" difenoconazole="" in="" surface="" and="" ground="" water="" are="" less="" than="" the="" agency's="" dwloc="" for="" chronic="" exposure="" among="" nursing="" infants=""><1 year="" old)="" to="" difenoconazole.="" despite="" the="" potential="" for="" exposure="" to="" difenoconazole="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" short-="" or="" intermediate-term="" risk.="" since="" no="" registered="" residential="" uses="" or="" exposure="" scenarios="" were="" identified="" for="" short-="" and="" intermediate-term="" exposure,="" these="" risk="" assessments="" are="" not="" required.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" difenoconazole="" residues.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residues="" of="" difenoconazole="" in="" plants="" and="" animals="" is="" considered="" to="" be="" adequately="" understood.="" based="" on="" acceptable="" metabolism="" studies,="" the="" agency="" concluded="" that="" none="" of="" the="" difenoconazole="" metabolites="" warrant="" inclusion="" in="" the="" tolerance="" regulation,="" separate="" regulation,="" inclusion="" in="" the="" dietary="" risk="" assessment,="" or="" additional="" metabolism="" or="" toxicological="" studies.="" therefore,="" the="" residue="" of="" concern="" is="" the="" parent="" compound,="" difenoconazole="" per="" se,="" as="" specified="" in="" 40="" cfr="" 180.475.="" b.="" analytical="" enforcement="" methodology="" an="" adequate="" enforcement="" method="" (method="" ag-575b,="" mrid#="" 428065-04)="" is="" available="" for="" enforcement="" purposes.="" the="" method="" is="" gas-liquid="" chromatography,="" using="" a="" nitrogen/phosphorus="" detector,="" which="" has="" been="" validated="" for="" wheat,="" barley,="" and="" bananas.="" epa="" expects="" that="" this="" method="" will="" be="" adequate="" for="" these="" proposed="" tolerances="" for="" sweet="" corn="" commodities="" as="" well.="" the="" method="" may="" be="" requested="" from:="" calvin="" furlow,="" prrib,="" irsd="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" rm="" 101ff,="" cm="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5229.="" c.="" magnitude="" of="" residues.="" residues="" of="" difenoconazole="" are="" not="" expected="" to="" exceed="" 0.1="" ppm="" in/on="" corn,="" sweet="" (kernel="" +="" corn="" with="" husk="" removed);="" corn,="" sweet,="" forage;="" or="" corn,="" sweet,="" stover,="" as="" a="" result="" of="" the="" section="" 18="" use.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" a="" result="" of="" this="" use.="" d.="" international="" residue="" limits.="" there="" are="" pending="" codex="" mrls="" for="" this="" compound="" in="" mexico="" for="" oat,="" wheat,="" and="" barley.="" there="" are="" mrls="" for="" this="" compound="" in="" australia="" for="" carrots="" (0.5="" ppm),="" potatoes="" (0.02="" ppm),="" and="" bananas="" (0.5="" ppm).="" there="" are="" no="" codex="" residue="" limits="" established="" for="" difenoconazole="" in/on="" the="" sweet="" corn="" commodities="" listed="" above,="" and="" thus="" harmonization="" is="" not="" an="" issue="" for="" this="" action.="" e.="" rotational="" crop="" restrictions.="" there="" is="" a="" 30-day="" plantback="" restriction="" for="" all="" rotational="" crops.="" v.="" conclusion="" therefore,="" the="" tolerances="" are="" established="" for="" residues="" of="" difenoconazole="" [(2s,4r)/(2r,4s)/(2r,4r)/(2s,4s)]1-[2-[4-(4-="" chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-yl-methyl]-1h-="" 1,2,4-triazole="" in/on="" corn,="" sweet="" (kernel="" +="" corn="" with="" husk="" removed);="" corn,="" sweet,="" forage;="" and="" corn,="" sweet,="" stover="" at="" 0.1="" ppm.="" vi.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" 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="" november="" 1,="" 1999,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" under="" the="" ``addresses''="" section="" (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).="" epa="" is="" authorized="" to="" waive="" any="" fee="" requirement="" ``when="" in="" the="" judgement="" of="" the="" administrator="" such="" a="" waiver="" or="" refund="" is="" equitable="" and="" not="" contrary="" to="" the="" purpose="" of="" this="" subsection.''="" for="" additional="" information="" regarding="" tolerance="" objection="" fee="" waivers,="" contact="" james="" tompkins,="" registration="" division="" (7505c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location,="" telephone="" number,="" and="" e-mail="" address:="" rm.="" 239,="" cm="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5697,="">tompkins.jim@epa.gov. Requests for waiver of tolerance 
    objection fees should be sent to James Hollins, Information Resources 
    and Services Division (7502C), Office of Pesticide Programs, 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
        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 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.
    
    [[Page 47686]]
    
    Information not marked confidential may be disclosed publicly by EPA 
    without prior notice.
    
    VII. Public Record and Electronic Submissions
    
        EPA has established a record for this regulation under docket 
    control number [OPP-300904] (including any comments and data submitted 
    electronically). A public version of this record, including printed, 
    paper versions of electronic comments, which does not include any 
    information claimed as CBI, is available for inspection from 8:30 a.m. 
    to 4 p.m., Monday through Friday, excluding legal holidays. The public 
    record is located in Rm. 119 of the Public Information and Records 
    Integrity Branch, Information Resources and Services Division (7502C), 
    Office of Pesticide Programs, Environmental Protection Agency, CM #2, 
    1921 Jefferson Davis Hwy., Arlington, VA.
        Objections and hearing requests may be sent by e-mail directly to 
    EPA at:
        opp-docket@epa.gov
    
        E-mailed objections and hearing requests must be submitted as an 
    ASCII file avoiding the use of special characters and any form of 
    encryption.
        The official record for this regulation, as well as the public 
    version, as described in this unit will be kept in paper form. 
    Accordingly, EPA will transfer any copies of objections and hearing 
    requests received electronically into printed, paper form as they are 
    received and will place the paper copies in the official record which 
    will also include all comments submitted directly in writing. The 
    official record is the paper record maintained at the Virginia address 
    in ``ADDRESSES'' at the beginning of this document.
    
    VIII. Regulatory Assessment Requirements
    
    A. Certain Acts and Executive Orders
    
        This final rule establishes a tolerance under section 408 of the 
    FFDCA. 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). This 
    final rule 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) (Public Law 104-4). Nor does it require any prior consultation 
    as specified by Executive Order 12875, entitled Enhancing the 
    Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
    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, since tolerances and exemptions that are established 
    on the basis of a petition under FFDCA section 408(l)(6), such as the 
    tolerance in this final rule, do not require the issuance of a proposed 
    rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
    U.S.C. 601 et seq.) do not apply. Nevertheless, 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 the 
    Intergovernmental Partnership (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 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 officials 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 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.
    
    IX. Submission to Congress and the Comptroller General
    
        The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
    Small Business Regulatory Enforcement Fairness Act of 1996, generally 
    provides that before a rule may take effect, the Agency promulgating 
    the rule must submit a rule report, which includes a copy of the rule, 
    to each House of the Congress and the Comptroller General of the United 
    States. EPA will submit 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 United States prior 
    to publication of the rule in the Federal Register. This rule is not a 
    ``major rule'' as defined by 5 U.S.C. 804(2).
    
    List of Subjects in 40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure,
    
    [[Page 47687]]
    
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
        Dated: August 13, 1999.
    
    James Jones,
    Director, Registration Division, 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. 321(q), 346a and 371.
    
        2. In Sec. 180.475, by adding paragraph (b) to read as follows:
    
    
    Sec. 180.475  Difenoconazole; tolerances for residues.
    
    *    *    *    *    *
        (b) Section 18 emergency exemptions. Time-limited tolerances are 
    established for residues of difenoconazole in connection with use of 
    this pesticide under a section 18 emergency exemption granted by EPA. 
    The tolerances will expire on the dates specified in the following 
    table.
    
     
    ------------------------------------------------------------------------
                                                              Expiration/
                Commodity              Parts per million    revocation date
    ------------------------------------------------------------------------
    Corn, sweet (kernel + corn with   0.1                 1/31/01
     husk removed).
    Corn, sweet, forage.............  0.1                 1/31/01
    Corn, sweet, stover.............  0.1                 1/31/01
    ------------------------------------------------------------------------
    
    *    *    *    *    *
    
    [FR Doc. 99-22635 Filed 8-31-99; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
9/1/1999
Published:
09/01/1999
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
99-22635
Dates:
This regulation is effective September 1, 1999. Objections and requests for hearings must be received by EPA on or before November 1, 1999.
Pages:
47680-47687 (8 pages)
Docket Numbers:
OPP-300904, FRL-6094-3
RINs:
2070-AB78
PDF File:
99-22635.pdf
CFR: (1)
40 CFR 180.475