99-2207. Fenbuconazole; Pesticide Tolerances for Emergency Exemptions  

  • [Federal Register Volume 64, Number 19 (Friday, January 29, 1999)]
    [Rules and Regulations]
    [Pages 4577-4584]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-2207]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300776; FRL-6054-3]
    RIN 2070-AB78
    
    
    Fenbuconazole; 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 
    combined residues of Fenbuconazole and its metabolites RH-9129 and RH-
    9130, expressed as the parent fenbuconazole in or on grapefruit and 
    livestock commodities . This action is in response to EPA's granting of 
    an emergency exemption under section 18 of the
    
    [[Page 4578]]
    
    Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of 
    the pesticide on grapefruit. This regulation establishes maximum 
    permissible levels for residues of fenbuconazole 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 June 30, 2000.
    
    DATES: This regulation is effective January 29, 1999. Objections and 
    requests for hearings must be received by EPA on or before March 30, 
    1999.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number, [OPP-300776], 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-300776], 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: @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 5.1/6.1 
    file format or ASCII file format. All copies of objections and hearing 
    requests in electronic form must be identified by the docket control 
    number [OPP-300776]. 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: 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: CM #2, 1921 Jefferson 
    Davis Hwy., Arlington, VA, (703) 308-9356, e-mail: 
    beard.andrea@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
    sections 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 
    combined residues of the fungicide fenbuconazole and its metabolites 
    RH-9129 and RH-9130, expressed as the parent fenbuconazole, in or on 
    whole grapefruit at 0.5 part per million (ppm), at 4.0 ppm in/on dried 
    grapefruit, at 35 ppm in/on grapefruit oil; and at 0.1 ppm in/on meat 
    and meat by-products of cattle, goats, hogs, horses, and sheep. These 
    tolerances will expire and are revoked on June 30, 2000. EPA will 
    publish a document in the Federal Register to remove the revoked 
    tolerances from the Code of Federal Regulations.
    
    I. Background and Statutory Authority
    
        The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
    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. These activities are described below 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).
        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 Fenbuconazole on Grapefruit and FFDCA 
    Tolerances
    
        The Florida Department of Agriculture and Consumer Services has 
    requested an exemption for the use of fenbuconazole on grapefruit for 
    control of the disease, greasy spot (Mycosphaerella citri). Greasy spot 
    disease has become a problem in Florida because of high relative 
    humidity (nearly 100%) and higher temperatures for prolonged periods. 
    The disease affects all citrus varieties and can be a more serious 
    problem on grapefruit, due to its low resistance. The applicant asserts 
    that this pathogen has developed resistance to a registered 
    alternative, while other alternatives have limited efficacy and can 
    cause damage to the fruit, causing them to be downgraded to juice 
    grade. A recent drop in grapefruit prices have exacerbated this 
    situation, and significant economic losses are predicted without the 
    requested fungicide. EPA has authorized under FIFRA section 18 the use 
    of fenbuconazole on grapefruit for control of greasy spot 
    (Mycosphaerella citri) in Florida. After having reviewed the 
    submission, EPA concurs that emergency conditions exist for this state.
    
    [[Page 4579]]
    
        As part of its assessment of this emergency exemption, EPA assessed 
    the potential risks presented by residues of fenbuconazole in or on 
    grapefruit and livestock commodities. In doing so, EPA considered the 
    safety standard in FFDCA section 408(b)(2), and EPA decided that the 
    necessary tolerance 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 June 30, 2000, under FFDCA section 408(l)(5), residues of 
    the pesticide not in excess of the amounts specified in the tolerance 
    remaining in or on grapefruit and animal 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 fenbuconazole 
    meets EPA's registration requirements for use on grapefruit or whether 
    permanent tolerances for this use would be appropriate. Under these 
    circumstances, EPA does not believe that these tolerances serve as a 
    basis for registration of fenbuconazole 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 Florida 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 
    fenbuconazole, contact the Agency's Registration Division at the 
    address provided above.
    
    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 
    fenbuconazole and to make a determination on aggregate exposure, 
    consistent with section 408(b)(2), for a time-limited tolerance for 
    combined residues of fenbuconazole and its metabolites RH-9129 and RH-
    9130, expressed as the parent fenbuconazole on whole grapefruit at 0.5 
    ppm, at 4.0 ppm in/on dried grapefruit, at 35 ppm in/on grapefruit oil; 
    and at 0.1 ppm in/on meat and meat by-products of cattle, goats, hogs, 
    horses, and sheep. 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 fenbuconazole are 
    discussed below.
        1. Acute toxicity. For the purposes of the acute dietary risk 
    assessment, EPA assessments are based on an acute reference dose (RfD) 
    of 0.3 milligrams/kilogram/day (mg/kg/day). This figure is derived from 
    the No Observed Adversed Effect Level (NOAEL) of 30 mg/kg/day from the 
    developmental toxicity study in rats, and an uncertainty factor of 100. 
    The observed effect was a decrease in the number of live fetuses at the 
    Lowest Effect Level (LEL) of 75 mg/kg/day.
        2. Short- and intermediate-term toxicity. No dermal or systemic 
    toxicity endpoints were identified for this exposure duration. 
    Therefore, a risk assessment is not needed.
        3. Chronic toxicity. EPA has established the chronic RfD for 
    fenbuconazole at 0.03 mg/kg/day. This RfD is based on a chronic 
    toxicity study in the rat with a NOAEL of 3.03/4.02 mg/kg/day in males/
    females, and an uncertainty factor of 100. The NOAEL is based on 
    decreased body weight gains (females), hepatocellular enlargement and 
    vaculation (females), increases in thyroid weight (both sexes) and 
    histopathological lesions in the thyroid glands (males), at the LEL of 
    30.62/43.04 mg/kg/day in males/females.
        4. Carcinogenicity. Using its Guidelines for Carcinogen Risk 
    Assessment, EPA has classified fenbuconazole as a Group C (possible 
    human carcinogen) chemical. EPA believes it is appropriate to use the 
    Q1* approach for determination of risk, and has calculated a 
    Q1* of 3.59 x 10-3 (mg/kg/day)-1.
    
    B. Exposures and Risks
    
        1. From food and feed uses. Tolerances have been established (40 
    CFR 180.480) for the combined residues or residues of fenbuconazole and 
    its metabolites RH-9129 and RH-9130, expressed as the parent 
    fenbuconazole, in or on a variety of raw agricultural commodities. 
    Time-limited tolerances have been established for residues of 
    fenbuconazole, alpha-2-(4-chlorophenyl)-ethyl-alpha-phenyl-3-(1H-1,2,4-
    triazole)-1-propanenitrile] and its metabolites, cis-5-(4-
    chlorophenyl)dihydro-3-phenyl-3-(1H 1, 2, 4-triazole-1-ylmethyl-2-3H-
    furanone, expressed as fenbuconazole in or on commodities ranging from 
    0.1 ppm in pecans to 2.0 ppm in the stone fruit crop group. Risk 
    assessments were conducted by EPA to assess dietary exposures and risks 
    from fenbuconazole 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 one day or single exposure. An acute dietary risk assessment for 
    fenbuconazole is only needed for the population subgroup, females 13+ 
    years (yrs.) old, as the effect was increased resorptions and decreased 
    live fetuses. The acute dietary risk assessment used the Theoretical 
    Maximum Residue Contribution (TMRC, tolerance level residues and 100% 
    crop treated); the tolerances used for grapefruit and animal 
    commodities are the levels given above. The Novigen Dietary Exposure 
    Evaluation Model (DEEM) analysis was used and this analysis evaluates 
    individual food consumption as reported by respondents in the USDA 
    Continuing Surveys of Food Intake by Individuals conducted in 1989 
    through 1992. The model accumulates exposure to the chemical for each 
    commodity and expresses risk as a function of dietary exposure. 
    Resulting exposure values (at the 99th percentile) and percentage of 
    the acute RfD are shown below. Values for the 99th percentile are 
    considered to be conservative as OPP policy dictates exposure estimates 
    from as low as the 95th percentile may be utilized for risk estimates 
    from acute DEEM runs. Thus,
    
    [[Page 4580]]
    
    these results are viewed as conservative estimates, and refinement 
    using anticipated residue values and percent crop treated information, 
    in conjunction with a Monte Carlo analysis, would result in lower 
    estimates of acute dietary exposure and risk. The resulting high-end 
    exposure estimates (food only, 99.9 percentiles) ranges from 0.0072 to 
    0.015 mg/kg/day for the population subgroups females 13+ yrs. old 
    (nursing), and females 13 - 19 yrs. old (not pregnant or nursing), 
    respectively. The percentages of the acute RfD utilized by these 
    exposure levels, for these two subgroups are 2.3 and 5.0%, 
    respectively.
        ii. Chronic exposure and risk. The chronic dietary risk assessment 
    is partially refined. Additional refinement would incorporate percent 
    crop treated and anticipated residues for all commodities, and would 
    result in lower exposure estimates. Again, the Novigen DEEM analysis 
    was used, as described above. Tolerance level residues were assumed for 
    all commodities, including stone fruits. Percent crop treated data were 
    used for stone fruits only and 100% crop-treated data were used for all 
    other commodities. The existing tolerances for fenbuconazole plus 
    exposures connected with the section 18 on grapefruit result in an 
    anticipated residue contribution (ARC) that is equivalent to 3.1% of 
    the RfD for non-nursing infants <1 yr.="" old,="" the="" highest="" exposed="" subpopulation.="" exposure="" for="" all="" other="" population="" subgroups="" was="" at="" a="" level="" below="" this.="" iii.="" cancer="" risk.="" fenbuconazole="" is="" classified="" as="" a="" group="" c="" carcinogen,="" with="" a="">1* of 3.59 x 10-3 
    (mg/kg/day)-1. Using the partially refined exposure 
    estimates described above under Chronic exposure and risk, the cancer 
    risk estimate for the U.S. Population is calculated to be 8.3 x 
    10-7.
        2. From drinking water. There is no established Maximum Contaminant 
    Level or Health Advisory Levels for imidacloprid in drinking water. To 
    date, there are no validated modeling approaches for reliably 
    predicting pesticide levels in drinking water. The Agency uses models 
    designed for use for ecological assessment, which are not ideal tools 
    for use in drinking water risk assessment, as they could overestimate 
    actual drinking water concentrations.
        Thus, these models are considered a coarse screening tool for 
    sorting out pesticides for which it is highly unlikely that drinking 
    water concentrations would ever exceed human health levels of concern. 
    For surface water, the Agency used PRZM1 (Pesticide Root Zone Model - 
    simulates the transport of a pesticide off the agricultural field) and 
    EXAMS (EXposure Analysis Modeling System - simulates fate and transport 
    of a pesticide in surface water) models which are used to produce 
    estimates of pesticide concentrations in a farm pond. For ground water 
    the Agency used SCI-GROW (Screening Concentration In GROund Water) 
    model to estimate the concentration of imidacloprid residues in ground 
    water. SCI-GROW is a prototype model for estimating ``worst case' 
    ground water concentrations of pesticides. This model assumes that the 
    pesticide is applied at its maximum rate in areas where the ground 
    water is particularly vulnerable to contamination. SCI-GROW is biased 
    in that studies where the pesticide is not detected in ground water are 
    not included in the data set. Thus, it is not expected that SCI-GROW 
    estimates would be exceeded. 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 estimated 
    environmental concentrations (EECs) 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 imidacloprid 
    they are further discussed in the aggregate risk sections below.
        i. Acute exposure and risk. EPA used estimated concentrations of 
    imidacloprid in surface and ground water for acute exposure analysis of 
    6.7 and 0.03 g/L parts per billion (ppb), respectively. Since the 
    ground water estimate is much less than that for surface water, only 
    the surface water estimated maximum concentration of 6.7 ppb was used 
    for comparison to the DWLOCs. The acute DWLOC was calculated for the 
    segment of the population subgroup of concern with the highest food 
    exposure, females 13 - 19 yrs. old (not pregnant or nursing). This 
    DWLOC was calculated to be 8,600 ppb.
        ii. Chronic exposure and risk. Since the estimated concentration 
    for chronic exposure to ground water (0.03 ppb) was much less than that 
    for surface water (3.6 ppb), EPA used the surface water estimate for 
    chronic exposure analysis as a worst case estimation. The chronic 
    DWLOCs were calculated for the population subgroup with the highest 
    food exposure, Non-Hispanic (other than black or white). These DWLOCs 
    were calculated to be 1,000 ppb for males and 890 ppb for females.
        3. From non-dietary exposure. Fenbuconazole is not currently 
    registered for use on any residential non-food sites: Therefore, a 
    discussion of the toxicity endpoints for non-dietary exposure and a 
    risk assessment for these uses is not germane to this review.
        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 fenbuconazole 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, 
    fenbuconazole 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 fenbuconazole 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 Bifenthrin Pesticide Tolerances (62 FR 62961, 
    November 26, 1997).
    
    C. Aggregate Risks and Determination of Safety for U.S. Population
    
        1. Acute risk. For the population subgroups of concern, females 13+ 
    yrs. old (nursing), and females 13 - 19 yrs. old (not pregnant or 
    nursing), the percentages of the acute RfD utilized by these exposure 
    levels, for these two subgroups are 2.3 and 5.0%, respectively. EPA 
    generally has no concerns for exposures below 100% of the acute RfD. In 
    addition, for acute exposures associated with drinking water, EPA has 
    concluded that the DWLOC is 8,600 ppb. The EEC value is 6.7 ppb. This 
    leads EPA to conclude that acute exposure to fenbuconazole is within 
    acceptable limits, and there is reasonable certainty of no harm.
        2. Chronic risk. Using the ARC exposure assumptions described 
    above,
    
    [[Page 4581]]
    
    EPA has concluded that aggregate exposure to fenbuconazole from food 
    will utilize <1% of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" 3.1%="" of="" the="" chronic="" rfd="" for="" non-nursing="" infants=""><1 yr.="" old,="" which="" is="" further="" discussed="" below.="" for="" the="" rest="" of="" the="" population="" subgroups,="" the="" rfd="" utilized="" is=""><1 -="" 2.5%.="" based="" upon="" dietary="" (food="" only)="" exposure,="" the="" chronic="" dwlocs="" were="" calculated="" for="" the="" population="" subgroup="" with="" the="" highest="" food="" exposure,="" non-hispanic="" (other="" than="" black="" or="" white).="" these="" dwlocs="" were="" calculated="" to="" be="" 1,000="" ppb="" for="" males="" and="" 890="" ppb="" for="" females.="" using="" the="" rough="" screening="" models="" described="" above="" for="" ground="" and="" surface="" water,="" the="" eec="" was="" estimated="" at="" 3.6="" ppb,="" significantly="" less="" than="" the="" calculated="" dwlocs.="" 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.="" despite="" the="" potential="" for="" exposure="" to="" fenbuconazole="" 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="" endpoints="" were="" not="" identified;="" additionally,="" fenbuconazole="" has="" no="" residential="" uses.="" thus="" short-="" and="" intermediate-term="" aggregate="" risk="" assessments="" are="" not="" required.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" the="" existing="" tolerance="" plus="" this="" proposed="" tolerance="" for="" this="" exemption="" result="" in="" a="" cancer="" risk="" estimate="" of="" 8.3="" x="">-7 for the overall U.S. 
    population. The risk from the time-limited tolerances with section 18s 
    (blueberries, grapefruit, meat, and meat by-products) was not 
    amortized. This is sometimes done to account for the temporary nature 
    of the section 18 use. Based on this level, and the level considered to 
    be acceptable for cancer risk, and incorporating the usual default 
    values for body weight and drinking water consumption, a DWLOC was 
    calculated of 1.6 ppb for the U.S. Population. This is compared to the 
    EEC, as derived from the rough screening models (described above) of 
    3.6 ppb. EPA policy is that a factor of 3 will be applied to these 
    model values to determine whether a DWLOC has been exceeded. If the 
    model value is <3 times="" the="" dwloc,="" the="" pesticide="" is="" considered="" to="" have="" passed="" the="" screen="" and="" no="" further="" assessment="" is="" needed.="" in="" this="" case,="" the="" model="" value="" of="" 3.6="" ppb="" is="" less="" than="" three="" times="" the="" dwloc="" (3="" x="" 1.6="4.8" ppb),="" and="" thus="" epa="" concludes="" with="" reasonable="" certainty="" that="" residues="" of="" fenbuconazole="" in="" drinking="" water,="" considered="" along="" with="" other="" sources="" of="" chronic="" exposure,="" will="" not="" result="" in="" unacceptable="" levels="" of="" aggregate="" cancer="" risk="" estimates.="" epa="" also="" notes="" that="" the="" chronic="" food="" exposure="" estimate="" is="" only="" partially="" refined,="" and="" further="" refinement="" of="" this="" exposure="" would="" result="" in="" lower="" risk="" estimates.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" fenbuconazole="" residues.="" d.="" 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="" fenbuconazole,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-="" 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="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" 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="" margin="" of="" exposure="" (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="" inter-="" and="" intra-species="" 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="" the="" developmental="" toxicity="" study="" in="" rats,="" the="" maternal="" (systemic)="" noael="" was="" 30="" mg/kg/day,="" based="" on="" decreases="" in="" body="" weight="" and="" body="" weight="" gain="" at="" the="" lowest="" observed="" effectlevel="" (loel)="" of="" 75="" mg/kg/day.="" the="" developmental="" (fetal)="" noael="" was="" 30="" mg/kg/day,="" based="" on="" an="" increase="" in="" post="" implantation="" loss="" and="" a="" significant="" decrease="" in="" the="" number="" of="" live="" fetuses="" per="" dam="" at="" the="" loel="" of="" 75="" mg/kg/day.="" in="" the="" developmental="" toxicity="" study="" in="" rabbits,="" the="" maternal="" (systemic)="" noael="" was="" 10="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" gain="" at="" the="" loel="" of="" 30="" mg/kg/day.="" the="" developmental="" (pup)="" noael="" was="" 30="" mg/kg/day,="" based="" on="" increased="" resorptions="" at="" the="" loel="" of="" 60="" mg/="" kg/day.="" iii.="" reproductive="" toxicity="" study.="" in="" the="" 2-generation="" reproductive="" study="" in="" rats,="" the="" maternal="" (systemic)="" noael="" was="" 4="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" and="" food="" consumption,="" increased="" number="" of="" dams="" not="" delivering="" viable="" or="" delivering="" nonviable="" offspring,="" and="" increases="" in="" adrenal="" and="" thyroid="" weights="" at="" the="" loel="" of="" 40="" mg/kg/day.="" the="" reproductive="" (pup)="" noael="" was="" 40="" mg/kg/day,="" the="" highest="" dose="" tested="" (hdt).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-and="" post-natal="" toxicity="" for="" fenbuconazole="" is="" complete="" with="" respect="" to="" epa's="" current="" data="" requirements.="" epa="" has="" determined="" that="" the="" studies="" indicated="" no="" increased="" susceptibility="" of="" rats="" or="" rabbits="" to="" in="" utero="" and/or="" postnatal="" exposure="" to="" fenbuconazole.="" in="" the="" prenatal="" developmental="" toxicity="" studies="" in="" rats="" and="" rabbits,="" and="" the="" 2-generation="" reproduction="" study="" in="" rats,="" toxicity="" to="" the="" fetuses="" and="" offspring,="" when="" observed,="" occurred="" at="" equivalent="" or="" higher="" doses="" and="" was="" not="" judged="" to="" be="" more="" severe="" than="" toxic="" effects="" on="" the="" maternal="" and="" parental="" animals.="" based="" on="" the="" developmental="" and="" reproductive="" toxicity="" studies,="" epa="" scientists="" concluded="" that="" the="" fqpa="" 10x="" uncertainty="" factor="" may="" be="" removed.="" v.="" conclusion.="" there="" is="" a="" complete="" toxicity="" database="" for="" fenbuconazole="" and="" exposure="" data="" is="" complete="" or="" is="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" 2.="" acute="" risk.="" toxicological="" effects="" relevant="" to="" infants="" and="" children="" that="" could="" be="" attributed="" to="" a="" single="" exposure="" (dose)="" were="" not="" observed="" in="" oral="" toxicity="" studies="" including="" the="" developmental="" toxicity="" studies="" in="" rats="" and="" rabbits.="" a="" dose="" and="" endpoint="" was="" not="" identified.="" therefore,="" an="" aggregate="" risk="" assessment="" is="" not="" required="" for="" this="" subpopulation.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" fenbuconazole="" from="" food="" will="" utilize="" 3.1%="" of="" the="" rfd="" for="" the="" most="" highly="" exposed="" subgroup="" for="" infants="" and="" children,="" non-nursing="" infants=""><1 yr.="" old.="" epa="" generally="" has="" no="" concern="" for="" [[page="" 4582]]="" 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.="" despite="" the="" potential="" for="" exposure="" to="" fenbuconazole="" 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.="" short-="" and="" intermediate-term="" endpoints="" were="" not="" identified;="" additionally,="" fenbuconazole="" has="" no="" residential="" uses.="" thus="" short-="" and="" intermediate-term="" aggregate="" 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="" fenbuconazole="" residues.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" of="" fenbuconazole="" in="" plants="" and="" livestock="" is="" adequately="" understood,="" for="" this="" action.="" the="" residue="" of="" concern="" is="" fenbuconazole="" (alpha-[2-4-chlorophenyl)-ethyl]="" alpha-phenyl-3-(1h-="" 1,2,4-triazole)-1-propanenitrile]="" and="" its="" metabolites,="" cis-5-(4-="" chlorophenyl)dihydro-3-phenyl-3-(1h-1,2,4-triazole-1-ylmethyl)-2-3h-="" furanoneandtrans-5-(4-chlorophenyl)dihydro-3-phenyl-3-(1h-1,2,4-="" triazole-1-ylmethyl)-2-3h-furanone="" (also="" known="" as="" rh-9129="" and="" rh-="" 9130,respectively),="" expressed="" as="" fenbuconazole="" as="" specified="" in="" 40="" cfr="" 180.480.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology="" (gas="" chromatography="" with="" a="" nitrogen="" phosphorus="" detector)="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" the="" method="" has="" not="" yet="" appeared="" in="" the="" pesticide="" analytical="" manual="" ii,="" but="" may="" be="" requested="" from:="" calvin="" furlow,="" pirib,="" 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="" fenbuconazole="" and="" its="" regulated="" metabolites="" are="" not="" expected="" to="" exceed="" 0.5="" ppm="" in/on="" whole="" grapefruit,="" 4.0="" ppm="" in="" dried="" citrus="" pulp,="" and="" 35="" ppm="" in="" citrus="" oil.="" grapefruit="" pulp="" is="" not="" a="" poultry="" feed,="" but="" may="" be="" fed="" to="" other="" livestock.="" therefore,="" residues="" are="" not="" expected="" to="" exceed="" 0.01="" ppm="" in="" or="" on="" meat="" and="" meat="" by-products="" of="" cattle,="" goats,="" hogs,="" horses,="" and="" sheep.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" maximum="" residue="" limits="" (mrls)="" for="" fenbuconazole="" on="" grapefruit="" or="" livestock="" commodities.="" thus,="" harmonization="" is="" not="" an="" issue="" for="" this="" use.="" e.="" rotational="" crop="" restrictions="" grapefruit="" is="" not="" rotated="" to="" other="" crops,="" and="" therefore,="" rotational="" crop="" restrictions="" are="" not="" germane="" to="" this="" action.="" v.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" combined="" residues="" of="" fenbuconazole="" and="" its="" metabolites="" rh-9129="" and="" rh-9130,="" expressed="" as="" the="" parent="" fenbuconazole="" in="" grapefruit="" at="" 0.5="" ppm,="" in="" grapefruit="" pulp,="" dried,="" at="" 4.0="" ppm,="" in="" grapefruit="" oil="" at="" 35="" ppm,="" and="" in="" meat="" and="" meat="" by-products="" of="" cattle,="" goats,="" hogs,="" horses,="" and="" sheep="" at="" 0.01="" 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="" march="" 30,="" 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="" un="" der="" 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="" wave="" 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. 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-300776] (including any comments and data submitted 
    electronically). A public version of this record, including printed, 
    paper versions of electronic comments, which does not include any 
    information claimed as CBI, is available for inspection from 8:30 a.m. 
    to 4 p.m., Monday through Friday, excluding legal holidays. The public 
    record is located in Room 119 of the Public Information and Records 
    Integrity Branch, Information Resources and Services Division (7502C) 
    Office of Pesticide Programs,
    
    [[Page 4583]]
    
    Environmental Protection Agency, CM #2, 1921 Jefferson Davis Highway, 
    Arlington, VA.
        Electronic comments may be sent directly to EPA at:
        opp-docket@epamail.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 time-limited tolerances under FFDCA 
    section 408(l)(6). 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) (Pub. L. 104-4). Nor does it require any 
    special considerations as required by Executive Order 12898, entitled 
    Federal Actions to Address Environmental Justice in Minority 
    Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
    or require OMB review in accordance with Executive Order 13045, 
    entitled Protection of Children from Environmental Health Risks and 
    Safety Risks (62 FR 19885, April 23, 1997).
        In addition, since tolerances and exemptions that are established 
    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 has 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 to 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 to 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, 
    Agricultural commodities, Pesticides and pests, Reporting and 
    recordkeeping requirements.
    
        Dated: January 20, 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. 346a and 371.
    
        2. In Sec. 180.480, paragraph (b) by alphabetically inserting the 
    following commodities to the table to read as follows:
    
    
    Sec. 180.480  Fenbuconazole; tolerances for residues.
    
    * * * * *
        (b) * * *
    
    [[Page 4584]]
    
    
    
     
    ------------------------------------------------------------------------
                                                              Expiration/
                Commodity              Parts per million    Revocation Date
    ------------------------------------------------------------------------
                                  * * * * * * *
    Cattle, fat.....................  0.01                6/30/00
    Cattle, mbyp....................  0.01                6/30/00
    Cattle, meat....................  0.01                6/30/00
    Goats, fat......................  0.01                6/30/00
    Goats, mbyp.....................  0.01                6/30/00
    Goats, meat.....................  0.01                6/30/00
    Grapefruit......................  0.5                 6/30/00
    Grapefruit pulp, dried..........  4.0                 6/30/00
    Grapefruit oil..................  35                  6/30/00
    Hogs, fat.......................  0.01                6/30/00
    Hogs, mbyp......................  0.01                6/30/00
    Hogs, meat......................  0.01                6/30/00
    Horses, fat.....................  0.01                6/30/00
    Horses, mbyp....................  0.01                6/30/00
    Horses, meat....................  0.01                6/30/00
                                  * * * * * * *
    Sheep, fat......................  0.01                6/30/00
    Sheep, mbyp.....................  0.01                6/30/00
    Sheep, meat.....................  0.01                6/30/00
                                  * * * * * * *
    ------------------------------------------------------------------------
    
    * * * * *
    
    [FR Doc. 99-2207 Filed 1-28-99; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
1/29/1999
Published:
01/29/1999
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
99-2207
Dates:
This regulation is effective January 29, 1999. Objections and requests for hearings must be received by EPA on or before March 30, 1999.
Pages:
4577-4584 (8 pages)
Docket Numbers:
OPP-300776, FRL-6054-3
RINs:
2070-AB78
PDF File:
99-2207.Pdf
CFR: (1)
40 CFR 180.480