97-30938. Zeta-Cypermethrin; Pesticide Tolerance  

  • [Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
    [Rules and Regulations]
    [Pages 63235-63244]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-30938]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300577; FRL-5754-8]
    RIN 2070-AB78
    
    
    Zeta-Cypermethrin; Pesticide Tolerance
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This regulation establishes tolerances for residues of zeta-
    cypermethrin in or on cabbage at 2.0 parts per million (ppm); 
    cottonseed at 0.5 ppm; lettuce, head at 10.0 ppm; onions, bulb at 0.10 
    ppm; pecans at 0.05 ppm; and the fat, meat, and meat byproducts (mbyp) 
    of cattle, goats, hogs, horses, and sheep at 0.05 ppm. It also removes 
    time limitations for tolerances for residues of zeta-cypermethrin on 
    the same commodities that expire on November 15, 1997. FMC Corporation 
    requested this tolerance under the Federal Food, Drug, and Cosmetic 
    Act, as amended by the Food Quality Protection Act of 1996.
    
    DATES: This regulation is effective November 26, 1997. Objections and 
    requests for hearings must be received by EPA on or before January 26, 
    1998.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number, OPP-300577, 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-300577, 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. 1132, Crystal Mall #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@epamail.epa.gov. Follow the instructions in 
    Unit VI. of this preamble. No Confidential Business Information (CBI) 
    should be submitted through e-mail.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Beth Edwards, 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: Crystal Mall #2, 1921 
    Jefferson Davis Hwy., Arlington, VA, (703) 305-5400, e-mail: 
    edwards.beth@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: On June 15, 1984, EPA established time-
    limited tolerances under section 408 of the Federal Food, Drug, and 
    Cosmetic Act (FFDCA), 21 U.S.C. 346a(d) and 348 for residues of 
    cypermethrin on cottonseed; fat, meat, and mbyp of cattle, goats, hogs, 
    horses, poultry, and sheep; and milk (49 FR 24864). As additional crop 
    tolerances were established, they were also made time-limited. These 
    tolerances expire on November 15, 1997. FMC Corporation, on September 
    15, 1997, requested that the time limitation for tolerances established 
    for residues of the insecticide zeta-cypermethrin in these commodities 
    be removed based on environmental effects data that they had submitted 
    as a condition of the registration. FMC Corporation also submitted a 
    summary of its petition as required under the FFDCA, as amended by the 
    Food Quality Protection Act (FQPA) of 1996 (Pub. L 104-170).
        In the Federal Register of September 25, 1997, (62 FR 50337) (FRL-
    5748-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
    U.S.C. 346a(e) announcing the filing of pesticide petitions (PP 2F2623, 
    4F2986, 3F2824, 7F3498, and 4F3011) for tolerances by FMC Corporation, 
    1735 Market St., Philadelphia, PA 19103. This notice included a summary 
    of the petition prepared by FMC Corporation, the registrant. There were 
    no comments received in response to the notice of filing.
        The petition requested that 40 CFR 180.418 be amended by removing 
    the time limitation for tolerances for residues of the insecticide and 
    pyrethroid, zeta-cypermethrin in or on cabbage at 2.0 ppm; cottonseed 
    at 0.5 ppm; lettuce, head at 10.0 ppm; onions, bulb at 0.10 ppm; and 
    pecans at 0.05 ppm. Animal commodities were not
    
    [[Page 63236]]
    
    included in the notice of filing but are being included in this final 
    rule.
        The basis for the time-limited tolerances, that expire November 15, 
    1997, was given in the October 20, 1993, Federal Register (58 FR 
    54094). These time-limited tolerances were predicated on the expiration 
    of pesticide product registrations that were made conditional due to 
    lack of certain ecological and environmental effects data. The 
    rationale for using time-limited tolerances was to encourage pesticide 
    manufacturers to comply with the conditions of registration in a timely 
    manner. There is no regulatory requirement to make tolerances time-
    limited due to the conditional status of a product registration under 
    the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as 
    amended. It is current EPA policy to no longer establish time 
    limitations on tolerance(s) with expiration dates if none of the 
    conditions of registration have any bearing on human dietary risk. The 
    current petition action meets that condition and thus the expiration 
    dates associated with specific crop tolerances are being deleted.
    
    I. Risk Assessment and Statutory Findings
    
        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) of the FFDCA 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) of the FFDCA 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. . 
    .''
        EPA performs a number of analyses to determine the risks from 
    aggregate exposure to pesticide residues. First, EPA determines the 
    toxicity of pesticides based primarily on toxicological studies using 
    laboratory animals. These studies address many adverse health effects, 
    including (but not limited to) reproductive effects, developmental 
    toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
    EPA examines exposure to the pesticide through the diet (e.g., food and 
    drinking water) and through exposures that occur as a result of 
    pesticide use in residential settings.
    
    A. Toxicity
    
        1. Threshold and non-threshold effects. For many animal studies, a 
    dose response relationship can be determined, which provides a dose 
    that causes adverse effects (threshold effects) and doses causing no-
    observed effects (the ``no-observed effect level'' or ``NOEL'').
        Once a study has been evaluated and the observed effects have been 
    determined to be threshold effects, EPA generally divides the NOEL from 
    the study with the lowest NOEL by an uncertainty factor (usually 100 or 
    more) to determine the Reference Dose (RfD). The RfD is a level at or 
    below which daily aggregate exposure over a lifetime will not pose 
    appreciable risks to human health. An uncertainty factor (sometimes 
    called a ``safety factor'') of 100 is commonly used since it is assumed 
    that people may be up to 10 times more sensitive to pesticides than the 
    test animals, and that one person or subgroup of the population (such 
    as infants and children) could be up to 10 times more sensitive to a 
    pesticide than another. In addition, EPA assesses the potential risks 
    to infants and children based on the weight of the evidence of the 
    toxicology studies and determines whether an additional uncertainty 
    factor is warranted. Thus, an aggregate daily exposure to a pesticide 
    residue at or below the RfD (expressed as 100% or less of the RfD) is 
    generally considered acceptable by EPA. EPA generally uses the RfD to 
    evaluate the chronic risks posed by pesticide exposure. For shorter 
    term risks, EPA calculates a margin of exposure (MOE) by dividing the 
    estimated human exposure into the NOEL from the appropriate animal 
    study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
    100-fold MOE is based on the same rationale as the 100-fold uncertainty 
    factor.
        Lifetime feeding studies in two species of laboratory animals are 
    conducted to screen pesticides for cancer effects. When evidence of 
    increased cancer is noted in these studies, the Agency conducts a 
    weight of the evidence review of all relevant toxicological data 
    including short-term and mutagenicity studies and structure activity 
    relationship. Once a pesticide has been classified as a potential human 
    carcinogen, different types of risk assessments (e.g., linear low-dose 
    extrapolations or MOE calculation based on the appropriate NOEL) will 
    be carried out based on the nature of the carcinogenic response and the 
    Agency's knowledge of its mode of action.
        2. Differences in toxic effect due to exposure duration. The 
    toxicological effects of a pesticide can vary with different exposure 
    durations. EPA considers the entire toxicity data base, and based on 
    the effects seen for different durations and routes of exposure, 
    determines which risk assessments should be done to assure that the 
    public is adequately protected from any pesticide exposure scenario. 
    Both short and long durations of exposure are always considered. 
    Typically, risk assessments include ``acute,'' ``short-term,'' 
    ``intermediate-term,'' and ``chronic'' risks. These assessments are 
    defined by the Agency as follows.
        Acute risk, by the Agency's definition, results from 1-day 
    consumption of food and water, and reflects toxicity which could be 
    expressed following a single-oral exposure to the pesticide residues. 
    High-end exposure to food and water residues are typically assumed.
        Short-term risk results from exposure to the pesticide for a period 
    of 1-7 days, and therefore overlaps with the acute risk assessment. 
    Historically, this risk assessment was intended to address primarily 
    dermal and inhalation exposure which could result, for example, from 
    residential pesticide applications. However, since enaction of FQPA, 
    this assessment has been expanded to include both dietary and non-
    dietary sources of exposure, and will typically consider exposure from 
    food, water, and residential uses when reliable data are available. In 
    this assessment, risks from average food and water exposure, and high-
    end residential exposure, are aggregated. High-end exposures from all 
    three sources are not typically added because of the very low 
    probability of this occurring in most cases, and because the other 
    conservative assumptions built into the assessment assure adequate 
    protection of public health. However, for cases in which high-end 
    exposure can reasonably be expected from multiple sources (e.g. 
    frequent and widespread homeowner use in a specific geographical area), 
    multiple high-end risks will be aggregated and presented as part of the 
    comprehensive risk assessment/characterization. Since the toxicological 
    endpoint considered in this assessment reflects exposure over a period 
    of at least 7 days, an additional degree of conservatism is built into 
    the assessment; i.e., the risk assessment nominally covers 1-7 days 
    exposure,
    
    [[Page 63237]]
    
    and the toxicological endpoint/NOEL is selected to be adequate for at 
    least 7 days of exposure. (Toxicity results at lower levels when the 
    dosing duration is increased.)
        Intermediate-term risk results from exposure for 7 days to several 
    months. This assessment is handled in a manner similar to the short-
    term risk assessment.
        Chronic risk assessment describes risk which could result from 
    several months to a lifetime of exposure. For this assessment, risks 
    are aggregated considering average exposure from all sources for 
    representative population subgroups including infants and children.
    
    B. Aggregate Exposure
    
        In examining aggregate exposure, section 408 of the FFDCA requires 
    that EPA take into account available and reliable information 
    concerning exposure from the pesticide residue in the food in question, 
    residues in other foods for which there are tolerances, residues in 
    ground water or surface water that is consumed as drinking water, and 
    other non-occupational exposures through pesticide use in gardens, 
    lawns, or buildings (residential and other indoor uses). Dietary 
    exposure to residues of a pesticide in a food commodity are estimated 
    by multiplying the average daily consumption of the food forms of that 
    commodity by the tolerance level or the anticipated pesticide residue 
    level. The Theoretical Maximum Residue Contribution (TMRC) is an 
    estimate of the level of residues consumed daily if each food item 
    contained pesticide residues equal to the tolerance. In evaluating food 
    exposures, EPA takes into account varying consumption patterns of major 
    identifiable subgroups of consumers, including infants and children. 
    The TMRC is a ``worst case'' estimate since it is based on the 
    assumptions that food contains pesticide residues at the tolerance 
    level and that 100% of the crop is treated by pesticides that have 
    established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
    cancer risk that is greater than approximately one in a million, EPA 
    attempts to derive a more accurate exposure estimate for the pesticide 
    by evaluating additional types of information (anticipated residue data 
    and/or percent of crop treated data) which show, generally, that 
    pesticide residues in most foods when they are eaten are well below 
    established tolerances.
    
    II. Aggregate Risk Assessment and Determination of Safety
    
        Consistent with section 408(b)(2)(D) of the FFDCA, 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 zeta-
    cypermethrin and to make a determination on aggregate exposure, 
    consistent with section 408(b)(2) of the FFDCA, for residues of zeta-
    cypermethrin in or on cabbage at 2.0 ppm; cottonseed at 0.5 ppm; 
    lettuce, head at 10.0 ppm; onions, bulb at 0.10 ppm; pecans at 0.05 
    ppm; and the fat, meat, and mbyp of cattle, goats, hogs, horses, and 
    sheep at 0.05 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 zeta-cypermethrin 
    are discussed in this unit.
        1. Acute toxicity studies with technical zeta-cypermethrin: oral 
    LD50 in the rat is 134.4 milligram (mg)/kilogram (kg) for 
    males and 86.0 mg/kg for females--Toxicity Category II.
        2. Acute toxicity studies with cypermethrin bridged to zeta-
    cypermethrin: dermal LD50 > 2460 mg/kg in rabbits and 
    LD50 > 4920 in rats--Toxicity Category III; inhalation 
    (LC50 2.5 mg/liter (L) for females and > 2.5 mg/L in males--
    Toxicity Category III; primary eye irritation-- not irritating--
    Toxicity Category IV; primary dermal irritation, primary irritation 
    score (PIS) 0.71 --Toxicity Category IV; dermal sensitization--moderate 
    sensitizer in two studies, negative in other studies; delayed type 
    neurotoxicity in hens--no evidence of delayed type neurotoxicity in 
    hens at dose levels of 0, 2,500, 5,000, or 10,000 mg/kg; neurotoxicity 
    screen in rats--NOEL and lowest-observed effect level (LOEL) 
    established as < 20="" mg/kg--at="" 20="" mg/kg="" decreased="" motor="" activity="" and="" gait="" abnormalities.="" 3.="" in="" a="" 90-day="" feeding="" study,="" rats="" were="" dosed="" at="" 0,="" 10,="" 50,="" 150,="" 250,="" 500,="" or="" 900="" ppm="" (0,="" 0.6,="" 2.7,="" 8.4,="" 13.8,="" 28.2,="" or="" 55.7="" mg/kg/day="" for="" males="" and="" 0,="" 0.6,="" 3.3,="" 9.6,="" 16.3,="" 32.2,="" or="" 65.2="" mg/kg/day="" for="" females).="" the="" noel="" is="" 250="" ppm="" (13.9="" mg/kg/day)="" and="" the="" loel="" is="" 500="" ppm="" (28.2="" mg/kg/day)="" based="" on="" decreases="" in="" bodyweight="" and="" bodyweight="" gains="" and="" food="" consumption="" at="" 28.2="" mg/kg/day="" and="" above="" and="" deaths;="" clinical="" signs="" of="" neurotoxicity;="" decreases="" in="" erythrocyte="" and="" leukocyte="" counts,="" hemoglobin,="" and="" hematocrit,="" and="" increases="" in="" blood="" urea="" nitrogen="" (bun)="" at="" 55.7="" mg/kg/day.="" 4.="" the="" 21-day="" dermal,="" subchronic="" oral="" study="" in="" the="" dog="" and="" the="" 21-="" day="" inhalation="" studies="" are="" bridged="" from="" cypermethrin.="" in="" a="" subchronic="" toxicity="" study,="" dogs="" were="" dosed="" at="" 0,="" 5,="" 50,="" 500,="" or="" 1,500="" ppm="" (corresponding="" to="" 0,="" 125,="" 1.25,="" 12.5,="" and="" 37.5="" mg/kg/day)="" for="" 13="" weeks.="" the="" loel="" is="" 1,500="" ppm="" (37.5="" mg/kg/day,="" based="" on="" clinical="" signs="" indicating="" neurotoxicity).="" the="" noel="" is="" 500="" ppm="" (12.5="" mg/kg/day).="" in="" a="" 21-day="" dermal="" toxicity="" study,="" rabbits="" were="" dosed="" at="" 2,="" 20,="" or="" 200="" mg/kg/day="" with="" daily="" applications="" for="" 3="" weeks="" for="" a="" total="" of="" 15="" applications.="" five/sex/group="" were="" abraded="" prior="" to="" application="" of="" the="" test="" material.="" the="" loel="" is="" 200="" mg/kg/day="" based="" on="" liver="" effects.="" the="" noel="" is="" 20="" mg/kg/day.="" in="" a="" 21-day="" subchronic="" inhalation="" toxicity="" study,="" rats="" were="" dosed="" by="" nose="" only="" exposure="" at="" concentrations="" of="" 0,="" 0.01,="" 0.05,="" or="" 0.25="" mg/l="" for="" 6="" hours="" per="" day,="" 5="" days="" per="" week="" for="" a="" total="" of="" 15="" exposures.="" additional="" satellite="" groups="" of="" five/sex="" were="" included="" for="" recovery="" assessment="" and="" analysis="" of="" cypermethrin="" in="" the="" brain.="" the="" loel="" is="" 0.05="" mg/l="" based="" mainly="" on="" bodyweight="" decrease.="" the="" noel="" is="" 0.01="" mg/l.="" 5.="" the="" chronic/oncogenicity="" studies="" are="" bridged="" from="" cypermethrin.="" in="" a="" chronic="" toxicity="" study,="" dogs="" were="" dosed="" at="" 0,="" 1,="" 5,="" or="" 15="" mg/="" kg/day="" for="" 52="" weeks.="" the="" loel="" is="" 5="" mg/kg/day="" based="" on="" gastrointestinal="" effects.="" the="" noel="" is="" 1="" mg/kg/day.="" in="" a="" carcinogenicity="" study,="" mice="" were="" dosed="" at="" control-1,="" control-="" 2,="" 100,="" 400,="" and="" 1,600="" ppm="" (corresponding="" to="" 0,="" 0,="" 14,="" 57,="" or="" 229="" mg/="" kg/day)="" for="" 97="" weeks="" for="" males="" and="" 101="" weeks="" for="" females.="" the="" loel="" is="" 400="" ppm="" (57="" mg/kg/day)="" based="" on="" liver="" weight.="" the="" noel="" is="" 100="" ppm="" (14="" mg/kg/day).="" this="" study="" was="" determined="" to="" be="" positive="" for="" induction="" of="" benign="" alveologenic="" neoplasms.="" adequacy="" of="" dosing="" for="" carcinogenicity="" is="" based="" upon="" typically="" 9%="" decreases="" in="" males="" and="" 12%="" in="" females="" in="" the="" first="" months="" of="" the="" study.="" in="" a="" chronic="" toxicity/carcinogenicity="" study,="" rats="" were="" dosed="" at="" control-1,="" control-2,="" 20,="" 150,="" or="" 1,500="" ppm="" (corresponding="" to="" 0,="" 0,="" 1,="" 7.5,="" or="" 75="" mg/kg/day)="" for="" 2="" years.="" satellite="" groups="" of="" 12/sex="" were="" sacrificed="" after="" 1="" year="" of="" dosing.="" the="" loel="" is="" 1,500="" ppm="" (75="" mg/kg/day)="" based="" on="" bodyweight.="" the="" noel="" is="" 150="" ppm="" (7.5="" mg/kg/day).="" cypermethrin="" was="" not="" considered="" to="" be="" [[page="" 63238]]="" oncogenic="" in="" this="" study.="" a="" possible="" association="" with="" increased="" testicular="" interstitial="" tumors="" was="" not="" considered="" definite.="" 6.="" zeta-cypermethrin="" was="" tested="" in="" a="" developmental="" toxicity="" study="" in="" rats="" at="" the="" following="" dose="" levels:="" 0,="" 5,="" 12,="" 25,="" or="" 35="" mg/kg/day.="" groups="" of="" 25="" females="" were="" administered="" the="" test="" chemical="" by="" gavage="" on="" gestation="" days="" 6="" through="" 15="" in="" a="" volume="" of="" 5="" milliliter="" (ml)/kg="" bodyweight.="" no="" developmental="" toxicity="" was="" observed="" at="" any="" dose="" level.="" the="" maternal="" noel="" is="" 12.5="" mg/kg="" and="" the="" maternal="" loel="" is="" 25="" mg/kg="" based="" on="" decreases="" in="" bodyweight="" and="" bodyweight="" gain="" and="" food="" consumption="" and="" clinical="" signs="" of="" toxicity,="" particularly="" neurotoxicity.="" the="" developmental="" noel="" is="" 35="" mg/kg/day="" highest="" dose="" tested="" (hdt).="" the="" loel="" was="" not="" established.="" 7.="" the="" developmental="" toxicity="" study="" in="" the="" rabbit="" is="" bridged="" from="" cypermethrin.="" in="" a="" developmental="" toxicity="" study,="" rabbits="" were="" dosed="" at="" 0="" (empty="" capsule),="" 0="" (capsule="" plus="" corn="" oil),="" 3,="" 10,="" or="" 30="" mg/kg/day="" on="" days="" 6="" to="" 18="" inclusive="" of="" gestation.="" there="" were="" no="" effects="" of="" any="" kind="" reported="" on="" the="" does.="" the="" maternal="" loel="" is=""> 30 mg/kg/day. The maternal 
    NOEL is > 30 mg/kg/day. There were no treatment related effects on 
    either the skeletal or visceral structures reported. The developmental 
    LOEL is > 30 mg/kg/day. The developmental NOEL is > 30 mg/kg/day.
        In a developmental toxicity study, rabbits were dosed at 0, 100, 
    450, or 700 mg/kg/day from days 7 through 19 of gestation. The does 
    were sacrificed on day 29 of gestation. The maternal LOEL is 450 mg/kg/
    day, based on bodyweight gain. The maternal NOEL is 100 mg/kg/day. 
    There were no indications of developmental toxicity. The NOEL and LOEL 
    for developmental toxicity is > 700 mg/kg/day.
        8. Zeta-cypermethrin was tested in a two-generation reproduction 
    study in groups of 30 male and 30 female rats at the following dose 
    levels: 0, 7.5, 25, 100, 375, or 750 ppm (0, 0.5, 1.8, 7, 27, or 45 mg/
    kg/day). The parental and reproductive NOELs are 7 mg/kg/day and LOELs 
    are 27 mg/kg/day based on decreased parental and pup weight, 
    particularly during lactation, clinical signs of toxicity, and death at 
    45 mg/kg/day.
        9. Zeta-cypermethrin was tested in a reverse mutation assay in 
    salmonella typhimurium strains TA1535, TA1537, TA100, TA1538, and TA98 
    at 0, 100, 333, 1,000, 3,333, 5,000, or 10,000 microgram (g)/
    plate. It gave a very weak positive response (two-fold increase in 
    revertants/plate) in strain TA100 at 10,000 g/plate without S-
    9 activation in two-separate experiments. Doses of 3,333 and 5,000 
    g/plate gave 1.5 and 1.6-fold increases in revertants/plate, 
    respectively. Strains TA98, TA1535, TA1537, and TA1538 treated in the 
    presence and absence of mammalian S-9 activation were not affected. 
    Zeta-cypermethrin is therefore considered a possible weak mutagen under 
    the conditions of the assay.
        10. Zeta-cypermethrin was tested in an in vitro mammalian cell gene 
    mutation assay in Chinese hamster ovary (CHO) cells (CHO-K1-
    BH4, subclone D1) at the following dose levels: 
    0, 1, 10, 25, 50, 100, 400, 700, or 1,000 g/ml, both in the 
    absence and presence of S-9 activation. No evidence of increased 
    forward mutation rate at the hypoxanthine guanine phosphoribose 
    transferase (HGPRT) locus was observed at any dose tested under the 
    conditions of these assays. The solubility limit of the test compound 
    in culture media was approximately 100 g/ml.
        11. Zeta-cypermethrin was tested in an in vivo rat bone marrow 
    chromosomal aberration assay. Groups of 15 male and 15 female Sprague-
    Dawley rats were administered single doses by gavage with 0, 31.25, 
    62.5, or 125 mg/kg zeta-cypermethrin in corn oil. Five rats/sex were 
    sacrificed at 6, 18, and 30 hours-post dosing. Cyclophosphamide was 
    used as the positive control (60 mg/kg). No evidence of structural 
    chromosomal aberrations was demonstrated at either 6, 18, or 30 hours-
    post dosing.
        12. Zeta-cypermethrin was tested in an unscheduled deoxyribonucleic 
    acid (DNA) synthesis assay in male Fischer 344 rat primary hepatocyte 
    cells. The dose levels tested were 0, 14, 45, 140, 450, 1,400, or 4,500 
    g/ml. No unscheduled DNA synthesis was observed at any dose 
    level up to 4,500 g/ml in the primary hepatocyte cultures 
    under the conditions of the assay. Minimal cytotoxicity was observed at 
    the highest doses. Incomplete solubility of the test compound in 
    culture media was observed, particularly at the higher doses. The 
    positive control gave clear positive responses. The study is acceptable 
    for regulatory purposes.
        13. The metabolism studies are bridged from cypermethrin.
        Several studies with both rats, dogs, and mice are available to 
    support the requirement for metabolism in mammals. Some of these 
    studies assess individual cis- and trans-radiolabeled isomers and other 
    studies assess the metabolism of cypermethrin with the label in either 
    the cyclopropyl of the phenoxybenzyl ring. In general the following has 
    been demonstrated from these studies:
        Cypermethrin is readily absorbed from the gastrointestinal tract 
    and extensively metabolized. It is mostly excreted in the urine and 
    contains several characterized metabolites derived from conjugation of 
    the hydrolysis products of the parent compound following cleavage of 
    the esteratic linkage site. The following three executive summaries 
    describe the metabolism of cypermethrin in rats.
        First study--First group. Six/sex rats, Wistar strain rats, were 
    dosed with a single dose 0.61 mg/animal of labeled cis-cypermethrin 
    isomers in 0.5 ml of corn oil. The rats were individually housed in 
    metabolism cages and their urine and fecal matter collected daily until 
    sacrifice. Two rats of each sex were sacrificed after 24 and 72 hours 
    and after 8 days. Samples of the blood and selected tissues were 
    assessed for radioactivity content.
        Second group. Three/sex rats were dosed with 0.615 mg/animal of 
    labeled trans-cypermethrin in 0.8 ml of corn oil. In addition to the 
    urine and fecal collections, expired air was also collected from one 
    male and one female. Total recovery was from 97.2% to 100.5%. About 70% 
    of cis- and 80% of trans-cypermethrin was excreted in 24 hours. 
    Essentially all was excreted in 8 days. Most of the label was excreted 
    in the urine (> 53%) with less in the feces and (< 20%)="" for="" the="" trans="" (males="" and="" females)="" and="" cis="" (males="" only)="" groups="" and="">< 1%="" in="" the="" air="" for="" all="" groups.="" a="" sex="" difference="" with="" respect="" to="" excretion="" in="" the="" urine="" from="" the="" cis-isomer="" was="" noted="" for="" females="" since="" about="" equal="" amounts="" (35%)="" were="" found="" in="" both="" the="" urine="" and="" feces.="" several="" urinary="" and="" fecal="" metabolites="" were="" tentatively="" characterized.="" second="" study.="" one="" group="" of="" three/sex="" wistar="" strain="" rats="" was="" dosed="" with="" a="" single-oral="" dose="" (approximately="" 1.3="" mg/kg)="" of="" 14c-cyclopropyl="" labeled="" cypermethrin="" in="" corn="" oil="" (0.8="" ml).="" the="" rats="" were="" then="" placed="" in="" glass="" metabolism="" cages="" and="" their="" urine="" and="" feces="" were="" collected.="" special="" metabolism="" cages="" for="" trapping="" any="" radioactivity="" expired="" through="" their="" respiratory="" system="" were="" used="" for="" one="" male="" and="" one="" female="" rat.="" the="" rats="" were="" sacrificed="" after="" 3="" days="" and="" their="" blood="" and="" selected="" tissues="" were="" assessed="" for="" radioactivity,="" 85.5%="" for="" males="" and="" 97.2%="" for="" females="" of="" 14c="" was="" excreted="" in="" 72="" hours.="" the="" urine="" (55.8%="" for="" males="" and="" 69.4%="" for="" females)="" was="" the="" major="" route="" of="" excretion="" with="" the="" feces="" containing="" the="" balance.="" the="" air="" contained="" only="" 0.1%="" or="" less.="" tissue="" [[page="" 63239]]="" retention="" was="" highest="" in="" the="" skin="" (1.2%)="" and="" liver="" (0.74%="" for="" males="" but="" only="" 0.18%="" for="" females)="" and="" fat="" (0.57="" to="" 0.66%).="" third="" study.="" in="" a="" series="" of="" nine="" different="" studies,="" labeled="" cypermethrin="" (1="" mg/kg="" or="" less)="" in="" corn="" oil="" or="" separated="" cis-="" or="" trans-="" cypermethrin="" isomers="" were="" given="" by="" gavage="" to="" single="" or="" groups="" of="" two="" or="" three="" wistar="" strain="" rats.="" their="" urine="" and="" in="" some="" cases="" fecal="" matter="" was="" collected="" at="" various="" intervals="" such="" as="" 18="" hours="" to="" 3="" days.="" in="" another="" set="" of="" experiments,="" labeled="" cypermethrin="" was="" administered="" to="" rats="" that="" were="" fitted="" with="" bile="" duct="" cannalulas="" and="" their="" bile="" collected="" for="" 4-5="" hours="" while="" the="" rat="" was="" under="" anesthesia.="" cis-="" and="" trans-14c-cyclopropyl="" labeled="" cypermethrin="" was="" demonstrated="" to="" form="" glucuronide="" conjugations="" of="" cis-="" and="" trans-acids="" and="" hydroxyacids.="" only="" 1.6%="" or="" less="" of="" the="" total="" dose="" is="" excreted="" in="" the="" bile.="" most="" of="" the="" cypermethrin="" in="" the="" feces="" was="" unmetabolized.="" the="" glucuronide="" conjugates="" in="" the="" urine="" were="" found="" to="" be="" unstable="" and="" subject="" to="" hydrolysis.="" 14.="" acute="" delayed="" type="" neurotoxicity-hens.="" cypermethrin="" was="" tested="" in="" the="" hen="" following="" a="" protocol="" similar="" to="" the="" series="" 81-7="" guideline.="" the="" dose="" levels="" tested="" were="" 0,="" 2,500,="" 5,000,="" and="" 10,000="" mg/kg="" but="" there="" was="" no="" indication="" of="" the="" delayed="" type="" neurotoxicity="" noted.="" 15.="" acute="" neurotoxicity="" screen-rats.="" there="" are="" two="" acute="" neurotoxicity="" studies="" with="" cypermethrin.="" first="" study.="" rats="" were="" dosed="" with="" cypermethrin="" at="" dose="" levels="" of="" 0,="" 20,="" 60,="" or="" 120/100="" mg/kg.="" the="" rats="" displayed="" gait,="" muscle="" effects,="" and="" choreoathetosis.="" motor="" activity="" was="" decreased="" for="" all="" dose="" groups="" for="" males="" (estimated="" 45%,="" 66%,="" and="" 85%="" for="" the="" 20,="" 60,="" and="" 100="" mg/kg="" dose="" group="" respectively)="" and="" gait="" abnormalities="" were="" present="" in="" the="" low-dose="" group.="" body="" temperature="" was="" increased="" about="" 1="" deg.c="" in="" the="" low-dose="" male="" group="" but="" decreased="" for="" the="" higher="" groups.="" some="" 10="" other="" parameters="" were="" affected="" at="" 60="" mg/kg="" and/or="" above.="" these="" included:="" salivation,="" urination,="" arousal,="" abnormal="" motor="" movement,="" forelimb,="" or="" hindlimb="" grip="" strength,="" landing="" foot="" splay,="" touch="" response,="" and="" tail="" pinch="" response.="" the="" loel="" and="" noels="" for="" neurotoxicity="" are="">< 20="" mg/kg.="" at="" 20="" mg/kg="" decreased="" motor="" activity="" and="" gait="" abnormalities="" resulted.="" second="" study.="" rats="" were="" dosed="" with="" cypermethrin="" in="" corn="" oil="" as="" control,="" 30,="" 100,="" or="" 200="" mg/kg.="" the="" rats="" were="" assessed="" at="" pretest,="" 4="" hours="" after="" treatment="" and="" on="" days="" 7="" and="" 14="" for="" functional="" observational="" battery="" (fob)="" and="" motor="" activity.="" after="" day="" 14,="" five/sex="" were="" prepared="" for="" neurohistopathology.="" at="" 100="" mg/kg,="" ataxia="" (two="" males="" and="" two="" females)="" and="" related="" conditions="" (staggered="" or="" impaired="" gait,="" decreased="" activity,="" splayed="" hindlimbs,="" and="" limp="" condition)="" and="" decreased="" motor="" activity="" (49%,="" p="">< 0.001="" for="" males="" and="" 33%,="" p="">< 0.01="" for="" females)="" resulted.="" in="" addition,="" some="" females="" had="" salivation,="" lacrimation="" and/or="" soiled="" fur.="" at="" 200="" mg/kg,="" deaths="" resulted="" (one="" male="" and="" two="" females)="" as="" well="" as="" several="" other="" parameters="" being="" affected.="" the="" lel="" is="" 100="" mg/kg="" based="" primarily="" on="" ataxia="" and="" related="" conditions.="" the="" noel="" is="" 30="" mg/kg.="" the="" first="" study="" in="" unit="" ii.="" a.15.="" of="" this="" preamble="" is="" considered="" to="" define="" the="" neurotoxicity="" to="" cypermethrin="" because="" responses="" were="" noted="" at="" lower-dose="" levels.="" the="" second="" study="" used="" a="" variable="" and="" large="" dose="" of="" corn="" oil="" and="" a="" different="" strain="" of="" rat.="" 16.="" subchronic="" neurotoxicity="" screen="" in="" rats.="" rats="" were="" dosed="" with="" cypermethrin="" as="" control,="" 500,="" 1,300="" or="" 1,700="" ppm="" (31,="" 77,="" or="" 102="" for="" males="" and="" 37,="" 95,="" or="" 121="" for="" females="" mg/kg/day)="" for="" 90="" days="" in="" a="" subchronic="" neurotoxicity="" study.="" at="" 1,300="" ppm,="" females="" displayed="" ataxia="" (1/10),="" splayed="" hindlimbs="" (5/16),="" impaired="" gait="" (4/10),="" and="" decreased="" feces="" (4/10)="" as="" well="" as="" decreased="" bodyweight="" gain="">41%). 
    Males had only decreased bodyweight gain (27%) and 
    increased landing foot splay. At 1,700 ppm, males showed ataxia (8/10) 
    and additional related symptoms and females had decreased motor 
    activity (27%). The LEL is 1,300 ppm (77 mg/kg/day) based 
    on several effects. The NOEL is 500 ppm (31 mg/kg/day).
        Because the studies in Units II. A.15. and 16. of this preamble are 
    screens, neurotoxicity studies will be required under a special Data 
    Call-In (DCI) letter pursuant to section 3(c)(2)(B) of FIFRA. Although 
    these data are lacking, EPA has sufficient toxicity data base to 
    support these tolerances and these additional studies are not expected 
    to significantly change its risk assessment.
    
    B. Toxicological Endpoints
    
        1. Acute toxicity. For acute dietary risk assessment, EPA 
    recommends use of a NOEL of 0.5 mg/kg/day based on the NOEL of 1.0 mg/
    kg/day from the cypermethrin chronic toxicity study in dogs and a 
    correction factor of two to account for the differences in the 
    percentage of the biologically active isomer. The LOEL of this study of 
    5.0 mg/kg/day was based on gastrointestinal disturbances observed in 
    the first week of the study.
        2. Short- and intermediate-term toxicity. For short- and 
    intermediate-term MOE's, EPA recommends use of a NOEL of 2.5 mg/kg/day 
    based on neurotoxic signs in dogs starting at week 1. The inhalation 
    NOEL is 5.0 with a correction factor of 2. Dermal absorption rate was 
    25%. A dermal absorption rate of 25% was recommended based on the 
    weight-of-the-evidence available for structurally related pyrethroids.
        3. Chronic toxicity. EPA has established the RfD for zeta-
    cypermethrin at 0.005 mg/kg/day. This RfD is based on gastrointestinal 
    disturbances in dogs with an uncertainty factor of 200 to account for 
    differences in percent biologically active isomers in enriched product.
        Since insufficient data on zeta-cypermethrin are available to 
    establish an RfD, the data from cypermethrin were used in establishing 
    an RfD for zeta-cypermethrin. The NOELs from the cypermethrin studies 
    were divided by 2 as a correction factor, assuming the worst case that 
    the biologically active isomers are the ones which carry most of the 
    toxicity. The following paragraph summarizes the decision logic for 
    establishing the RfD for zeta-cypermethrin from the cypermethrin data 
    base.
        In general, the most sensitive species for the 10 synthetic 
    pyrethroids appears to be the dog. For zeta-cypermethrin the Agency 
    does not have any toxicity data on the dog that can be compared with 
    the dog studies conducted with cypermethrin. In addition, the Agency 
    also does not have any chronic studies on zeta-cypermethrin that can be 
    compared with those conducted with cypermethrin. Therefore, although a 
    comparison of the LEL's from the zeta-cypermethrin studies with the 
    corresponding LEL's from the cypermethrin studies does not show a 
    pronounced difference in toxicity, for risk assessment purposes, the 
    Agency has decided to use the toxicity endpoints from cypermethrin with 
    a two-fold correction factor to account for the differences in the 
    percentages of the more biologically active isomers in the enriched 
    technical product (zeta-cypermethrin). This would also apply to the 
    inhalation endpoint because the Agency has no inhalation studies with 
    zeta-cypermethrin. The Agency is making a conservative assumption that 
    most of the toxicity for cypermethrin will be from the four more 
    biologically active isomers of zeta-cypermethrin. Based on previous 
    documentation, the Agency is assuming that the percentages of the 
    isomers are approximately as follows:
        Cypermethrin, eight isomers with percentage compositions ranging 
    from 11-14% and zeta-cypermethrin, eight isomers with four 
    insecticidally less active ones at a concentration of 1% each. The 
    remaining four isomers, two
    
    [[Page 63240]]
    
    of which are regarded as being the most insecticidally active, will be 
    present at a concentration of 24% each.
        4. Carcinogenicity. No carcinogenicity studies are available for 
    zeta-cypermethrin. Using its Guidelines for Carcinogen Risk Assessment 
    published September 24, 1986 (51 FR 33992) the Carcinogenicity Peer 
    Review Committee (CPRC) has classified cypermethrin as a weak Group C 
    (possible human carcinogen) based on the increased incidence in lung 
    adenomas in female CD-1 mice, but did not recommend assignment of a 
    cancer potency factor (Q*1) for a linear quantitative cancer risk 
    assessment. An RfD approach was recommended for human risk assessment 
    purposes. It is assumed that zeta-cypermethrin would also test 
    positively for lung adenomas in female CD-1 mice.
    
    C. Exposures and Risks
    
        1. From food and feed uses. Tolerances have been established (40 
    CFR 180.418) for the residues of zeta-cypermethrin in or on a variety 
    of raw agricultural commodities. Tolerances range from 0.05 ppm in 
    animal commodities to 10.0 ppm in head lettuce. Registered uses include 
    cabbage, cotton, head lettuce, onions, and pecans. Risk assessments 
    were conducted by EPA to assess dietary exposures and risks from zeta-
    cypermethrin 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. The acute dietary exposure assessment 
    used Monte Carlo modeling incorporating anticipated residues and 
    percent crop treated refinements. The acute dietary MOE at the 99.9th 
    percentile for the overall U.S. population is 126. The MOE at the 
    99.9th percentile for children 1-6 years of age is 105. EPA concludes 
    that there is a reasonable certainty of no harm for MOEs of 100 or 
    greater. Therefore, the acute dietary risk assessment for zeta-
    cypermethrin indicates a reasonable certainty of no harm.
        ii. Chronic exposure and risk. The RfD used for the chronic dietary 
    analysis is 0.005 mg/kg/day based on a NOEL of 1.0 mg/kg/day from the 
    cypermethrin chronic dog study and an uncertainty factor of 200 (used 
    to account for the differences in the percentage of the biologically 
    active isomer). The endpoint effect of concern was based on 
    gastrointestinal disturbances observed in the first week of the study 
    at the LOEL of 5.0 mg/kg/day. The chronic dietary exposure assessment 
    used anticipated residues, monitoring data, and percent of crop treated 
    information . The chronic dietary exposure estimate for the overall 
    U.S. population was calculated to be 0.000018 mg/kg/day (0.4% RfD 
    utilized) and for children 1-6 years was calculated to be 0.00027 mg/
    kg/day (0.5% RfD utilized).
        EPA notes that the acute dietary risk assessments used Monte Carlo 
    modeling (in accordance with Tier 3 of EPA June 1996 ``Acute Dietary 
    Exposure Assessment'' guidance document) incorporating anticipated 
    residues and percent of crop treated refinements. The chronic dietary 
    risk assessments used anticipated residues and percent crop treated 
    information.
        Section 408(b)(2)(E) authorizes EPA to consider available data and 
    information on the anticipated residue levels of pesticide residues in 
    food and the actual levels of pesticide chemicals that have 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 timeframe it 
    deems appropriate. Section 408(b)(2)(F) allows the Agency to use data 
    on the actual percent of crop treated when establishing a tolerance 
    only where the Agency can make the following findings:
        a. That the data used are reliable and provide a valid basis for 
    showing the percentage of food derived from a crop that is likely to 
    contain residues.
        b. That the exposure estimate does not underestimate the exposure 
    for any significant subpopulation.
        c. Where data on regional pesticide use and food consumption are 
    available, that the exposure estimate does not understate exposure for 
    any regional population.
    In addition, the Agency must provide for periodic evaluation of any 
    estimates used.
        The percent of crop treated estimates for zeta-cypermethrin were 
    derived from Federal and market survey data. EPA considers these data 
    reliable. A range of estimates are supplied by this data and the upper 
    end of this range was used for the exposure assessment. By using this 
    upper-end estimate of percent crop treated, the Agency is reasonably 
    certain that exposure is not underestimated for any significant 
    subpopulation. Further, regional consumption information is taken into 
    account through EPA's computer-based model for evaluating the exposure 
    of significant subpopulations including several regional groups. Review 
    of this regional data allows the Agency to be reasonably certain that 
    no regional population is exposed to residue levels higher than those 
    estimated by the Agency. To meet the requirement for data on 
    anticipated residues, EPA will issue a DCI notice pursuant to FFDCA 
    section 408(f) requiring submission of data on anticipated residues in 
    conjunction with approval of the registration under the FIFRA.
        2. From drinking water. Laboratory and field data have demonstrated 
    that cypermethrin is immobile in soil and will not leach into ground 
    water. Estimates of zeta-cypermethrin drinking water concentrations 
    were generated with the PRZM1 and EXAMS computer models. Based on these 
    analyses, the contribution of water to the dietary risk estimate is 
    negligible. Therefore, EPA concludes that together these data indicate 
    that residues are not expected to occur in drinking water.
        i. Acute exposure and risk. The acute drinking water exposure and 
    risk estimates are 0.000126 mg/kg/day (MOE of 3,982) and 0.000242 mg/
    kg/day (MOE of 2,069) for the overall U.S. population and non-nursing 
    infants < 1="" year="" old,="" respectively.="" ii.="" chronic="" exposure="" and="" risk.="" the="" chronic="" drinking="" water="" exposure="" and="" risk="" estimates="" are="" 0.000005="" mg/kg/day="" (0.1%="" of="" rfd="" utilized)="" and="" 0.000021="" mg/kg/day="" (0.4%="" of="" rfd="" utilized)="" for="" the="" overall="" u.s.="" population="" and="" non-nursing="" infants="">< 1="" year="" old,="" respectively.="" 3.="" from="" non-occupational="" non-dietary="" exposure.="" zeta-cypermethrin="" is="" registered="" for="" agricultural="" crop="" applications="" only;="" therefore,="" no="" non-="" occupational,="" non-dietary="" exposure="" is="" expected.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" of="" the="" ffdca="" 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.''="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data,="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" [[page="" 63241]]="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" four="" members="" of="" the="" insecticide="" class="" pyrethroids="" produce="" a="" common="" metabolite="" known="" as="" dcva="" (3-(2,2-dichloroethenyl)-2,2-="" dimethylcyclopropane="" carboxylic="" acid).="" these="" insecticides="" are="" cyfluthrin,="" cypermethrin,="" zeta-cypermethrin,="" and="" permethrin.="" although="" the="" residues="" of="" dcva="" can="" be="" estimated,="" no="" toxicology="" data="" on="" the="" compound="" per="" se="" are="" available="" to="" directly="" conduct="" a="" hazard="" evaluation="" and="" thereby="" establish="" an="" appropriate="" endpoint="" for="" use="" in="" a="" joint="" risk="" assessment.="" to="" date,="" for="" the="" purpose="" of="" assessing="" the="" risk="" of="" the="" parent="" compound,="" the="" toxicity="" of="" the="" dcva="" has="" been="" assumed="" to="" be="" equivalent="" to="" the="" parent="" compound.="" however,="" due="" to="" the="" markedly="" different="" toxicological="" profiles="" of="" cyfluthrin,="" cypermethrin,="" zeta-="" cypermethrin,="" and="" permethrin,="" epa="" does="" not="" believe="" that="" it="" would="" be="" appropriate="" to="" cumulate="" dcva="" residues="" from="" these="" pesticides,="" or="" dcva="" residues="" from="" one="" of="" these="" pesticides="" with="" the="" parent="" of="" another="" of="" these="" pesticides,="" in="" conducting="" the="" risk="" assessment="" for="" these="" pesticides.="" accordingly,="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" zeta-cypermethrin="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" a="" cumulative="" risk="" assessment.="" for="" the="" purposes="" of="" this="" tolerance="" action,="" therefore,="" epa="" has="" not="" assumed="" that="" zeta-cypermethrin="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" the="" acute="" aggregate="" risk="" assessment="" takes="" into="" account="" exposure="" from="" food="" and="" water.="" the="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" the="" overall="" u.s.="" population="" is="" 122.="" the="" agency="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" a="" moe="" of="" 100="" or="" larger.="" therefore,="" the="" agency="" has="" no="" acute="" aggregate="" concern="" due="" to="" exposure="" to="" zeta-cypermethrin="" through="" food="" and="" drinking="" water.="" 2.="" chronic="" risk.="" using="" the="" anticipated="" residue="" contribution="" (arc)="" exposure="" assumptions,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" zeta-cypermethrin="" from="" food="" and="" water="" will="" utilize="" 0.5%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest-="" aggregate="" exposure="" is="" children,="" ages="" 1-6="" years="" old,="" discussed="" in="" unit="" ii.="" f.="" of="" this="" preamble.="" 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.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" zeta-cypermethrin="" residues.="" 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.="" based="" on="" zeta-cypermethrin="" not="" being="" registered="" for="" residential="" non-food="" sites,="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-term="" risks="" do="" not="" exceed="" levels="" of="" concern="" (moe="" less="" than="" 100),="" and="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" zeta-cypermethrin="" residues.="" e.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" no="" carcinogenicity="" studies="" are="" available="" for="" zeta-cypermethrin.="" however,="" cypermethrin="" has="" been="" classified="" as="" a="" weak="" group="" c="" carcinogen="" with="" no="" q*1="" based="" on="" the="" increased="" incidence="" in="" lung="" adenomas="" in="" female="" cd-1="" mice.="" based="" on="" the="" recommendation="" that="" the="" rfd="" approach="" be="" used,="" a="" quantitative="" dietary="" cancer="" risk="" assessment="" was="" not="" performed.="" dietary="" risk="" concerns="" due="" to="" long-term="" consumption="" of="" cypermethrin="" are="" adequately="" addressed="" by="" the="" dres="" chronic="" exposure="" analysis="" using="" the="" rfd.="" for="" the="" u.s.="" population,="" less="" than="" 1%="" of="" the="" rfd="" is="" occupied="" by="" aggregate="" chronic="" food="" and="" water="" exposure.="" f.="" 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="" zeta-cypermethrin,="" 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="" pesticide="" exposure="" during="" prenatal="" development="" to="" one="" or="" both="" parents.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" section="" 408="" of="" the="" ffdca="" provides="" that="" epa="" shall="" apply="" an="" additional="" 10-fold="" 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="" 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="" inter-="" and="" intra-species="" variability)="" and="" not="" the="" additional="" 10-fold="" 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="" prenatal="" developmental="" toxicity="" study="" in="" rats,="" there="" was="" no="" evidence="" of="" developmental="" toxicity="" at="" the="" hdt="" (35="" mg/kg/day).="" maternal="" toxicity="" (ataxia,="" urine="" and="" feces="" stained="" fur,="" decreased="" bodyweight="" gain="" and="" food="" consumption)="" was="" observed="" at="" the="" maternal="" loel="" (25="" mg/kg/day),="" and="" the="" maternal="" noel="" was="" established="" at="" 12.5="" mg/kg/day.="" in="" [[page="" 63242]]="" addition,="" an="" acceptable="" prenatal="" developmental="" toxicity="" study="" in="" rabbits="" conducted="" with="" cypermethrin="" was="" submitted.="" iii.="" reproductive="" toxicity="" study.="" in="" the="" two-generation="" reproduction="" study="" in="" rats,="" offspring="" toxicity="" (decreased="" pup="" weight="" gain="" during="" lactation)="" was="" observed="" at="" the="" same="" treatment="" level="" which="" resulted="" in="" parental="" systemic="" toxicity="" (noel="100" ppm="" or="" 27="" mg/kg/day;="" loel="375" ppm="" or="" 45="" mg/kg/day).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" there="" is="" no="" evidence="" of="" additional="" sensitivity="" to="" young="" rats="" following="" pre-="" or="" post-natal="" exposure="" to="" zeta-cypermethrin.="" v.="" conclusion.="" the="" data="" base="" related="" to="" pre-="" and="" post-natal="" sensitivity="" is="" complete.="" based="" on="" the="" information="" in="" unit="" ii.="" f.="" of="" this="" preamble,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" uncertainty="" factor,="" and="" that="" an="" additional="" uncertainty="" factor="" is="" not="" needed="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" acute="" risk.="" the="" acute="" aggregate="" risk="" assessment="" takes="" into="" account="" exposure="" from="" food="" and="" water.="" the="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" children="" age="" 1-6="" is="" 102.="" the="" agency="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" an="" moe="" of="" 100="" or="" larger.="" therefore,="" the="" agency="" has="" no="" acute="" aggregate="" concern="" due="" to="" exposure="" to="" zeta-cypermethrin="" through="" food="" and="" drinking="" water.="" 3.="" chronic="" risk.="" using="" conservative="" exposure="" assumptions,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" zeta-cypermethrin="" from="" food="" and="" water="" will="" utilize="" 0.6%="" of="" the="" rfd="" for="" children,="" ages="" 1-6="" years="" old.="" 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.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" zeta-cypermethrin="" residues.="" 4.="" short-="" or="" intermediate-term="" risk.="" based="" on="" zeta-cypermethrin="" not="" being="" registered="" for="" residential="" non-food="" sites,="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-term="" risks="" do="" not="" exceed="" levels="" of="" concern,="" and="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result.="" 5.="" special="" docket.="" the="" complete="" acute="" and="" chronic="" exposure="" analyses="" (including="" dietary,="" non-dietary,="" drinking="" water,="" and="" residential="" exposure,="" and="" analysis="" of="" exposure="" to="" infants="" and="" children)="" used="" for="" risk="" assessment="" purposes="" can="" be="" found="" in="" the="" special="" docket="" for="" the="" fqpa="" under="" the="" title="" ``risk="" assessment="" for="" extension="" of="" tolerances="" for="" synthetic="" pyrethroids.''="" further="" explanation="" regarding="" epa's="" decision="" regarding="" the="" additional="" safety="" factor="" can="" also="" be="" found="" in="" the="" special="" docket.="" g.="" endocrine="" disrupter="" effects="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen,="" or="" such="" other="" endocrine="" effect....''="" the="" agency="" is="" currently="" working="" with="" interested="" stakeholders,="" including="" other="" government="" agencies,="" public="" interest="" groups,="" industry,="" and="" research="" scientists="" in="" developing="" a="" screening="" and="" testing="" program="" and="" a="" priority="" setting="" scheme="" to="" implement="" this="" program.="" congress="" has="" allowed="" 3="" years="" from="" the="" passage="" of="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" at="" that="" time,="" epa="" may="" require="" further="" testing="" of="" this="" active="" ingredient="" and="" end="" use="" products="" for="" endocrine="" disrupter="" effects.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolites="" found="" in="" plants="" and="" livestock="" also="" are="" formed="" in="" the="" rat.="" it="" was="" concluded="" that="" 3-phenoxybenzoic="" acid="" (pba)="" and="" its="" conjugates="" are="" not="" of="" concern="" based="" on="" toxicology="" data="" for="" pba.="" in="" the="" absence="" of="" toxicology="" data,="" the="" cis-="" and="" trans-isomers="" of="" dcva="" are="" considered="" to="" be="" of="" comparable="" toxicity="" to="" the="" parent.="" in="" light="" of="" codex="" maximum="" residue="" limits="" (mrls)="" including="" only="" the="" parent="" compound,="" the="" parent="" being="" recoverable="" by="" the="" food="" and="" drug="" administration="" (fda)="" multi-residue="" methods="" i="" and="" ii,="" and="" the="" dcva="" is="" not="" likely="" to="" be="" measured="" by="" these="" methods,="" it="" was="" concluded="" that="" tolerances="" should="" be="" set="" in="" terms="" of="" cypermethrin="" only.="" crop="" field="" trials="" should="" continue="" to="" include="" analyses="" for="" residues="" of="" cis-="" and="" trans-dcva.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology="" gas="" chromatography/electron="" capture="" detector="" (gc/ecd)="" is="" available="" in="" pesticide="" analytical="" method="" ii="" (pam="" ii)="" as="" method="" i="" to="" enforce="" the="" tolerance="" expression.="" c.="" magnitude="" of="" residues="" residue="" data="" from="" field="" trials="" and="" the="" fda="" monitoring="" program="" (1992-1995)="" and="" the="" pdp="" monitoring="" program="" (1994)="" were="" used="" to="" estimate="" chronic="" dietary="" exposure.="" for="" the="" chronic="" analyses,="" mean="" residues="" from="" fda="" monitoring="" were="" used="" for="" lettuce="" and="" onions="" (dry="" bulb).="" residue="" field="" trial="" data="" were="" used="" for="" broccoli,="" cabbage,="" cotton,="" green="" onions,="" mustard="" greens,="" and="" pecans.="" for="" acute="" dietary="" exposure="" analysis,="" field="" trial="" residue="" data,="" along="" with="" percent="" of="" crop="" treated="" data,="" were="" used="" in="" the="" monte="" carlo="" analysis.="" d.="" international="" residue="" limits="" codex="" mrls="" for="" cypermethrin="" have="" been="" established="" which="" are="" in="" harmony="" with="" the="" u.s.="" tolerances="" for="" meat="" and="" mbyp="" of="" cattle,="" goats,="" hogs,="" horses,="" and="" sheep="" (0.05="" ppm);="" milk="" (0.05="" ppm);="" and="" onions,="" bulb="" (0.10="" ppm).="" codex="" mrls="" have="" been="" established="" which="" exceed="" the="" u.s.="" tolerances="" for="" meat="" (fat="" basis)="" of="" cattle,="" goats,="" hogs,="" horses,="" and="" sheep="" (0.2="" vs.="" 0.05="" ppm).="" codex="" mrls="" have="" been="" established="" which="" are="" below="" their="" u.s.="" counterparts="" for="" cabbage="" (brassica="" vegetables)="" (1.0="" vs.="" 2.0="" ppm)="" and="" lettuce,="" head="" (2.0="" vs.="" 10.0="" ppm).="" no="" canadian="" mrls="" have="" been="" established="" for="" residues="" of="" cypermethrin.="" mexico="" has="" established="" a="" tolerance="" for="" residues="" of="" cypermethrin="" on="" cottonseed="" (0.5="" ppm)="" which="" is="" in="" harmony="" with="" the="" u.s.="" tolerance.="" as="" indicated="" in="" this="" unit,="" there="" are="" differences="" between="" the="" ffdca="" section="" 408="" tolerances="" and="" the="" codex="" mrl="" values="" for="" specific="" commodities.="" these="" differences="" could="" be="" caused="" by="" differences="" in="" methods="" to="" establish="" tolerances,="" calculations="" of="" animal="" feed="" dietary="" exposure,="" and="" as="" a="" result="" of="" different="" agricultural="" practices.="" epa="" will="" specifically="" address="" these="" differences="" when="" the="" pesticides="" are="" reregistered="" and="" the="" tolerances="" made="" permanent.="" iv.="" conclusion="" therefore,="" the="" tolerances="" are="" established="" for="" residues="" of="" zeta-="" cypermethrin="" (s-cyano(3-phenoxyphenyl)="" methyl="">) cis, trans 
    3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate) in or on 
    cabbage at 2.0 ppm; cottonseed at 0.5 ppm; lettuce, head at 10.0 ppm; 
    onions, bulb at 0.10 ppm; pecans at 0.05 ppm; and fat, meat, and mbyp 
    of cattle, goats, hogs, horses, and sheep at 0.05 ppm.
    
    V. Objections and Hearing Requests
    
        The new section 408(g) of the FFDCA provides essentially the same 
    process for persons to ``object'' to a tolerance regulation issued by 
    EPA under new section 408(e) and (l)(6) of the FFDCA as was provided in 
    the old section 408 and in section 409 of the FFDCA. However, the 
    period for filing objections is 60 days, rather than 30 days. EPA 
    currently has procedural regulations
    
    [[Page 63243]]
    
    which govern the submission of objections and hearing requests. These 
    regulations will require some modification to reflect the new law. 
    However, until those modifications can be made, EPA will continue to 
    use those procedural regulations with appropriate adjustments to 
    reflect the new law.
        Any person may, by January 26, 1998 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 above (40 CFR 178.20). A copy of 
    the objections and/or hearing requests filed with the Hearing Clerk 
    should be submitted to the OPP Docket for this rulemaking. The 
    objections submitted must specify the provisions of the regulation 
    deemed objectionable and the grounds for the objections (40 CFR 
    178.25). Each objection must be accompanied by the fee prescribed by 40 
    CFR 180.33(i). If a hearing is requested, the objections must include a 
    statement of the factual issues on which a hearing is requested, the 
    requestor's contentions on such issues, and a summary of any evidence 
    relied upon by the requestor (40 CFR 178.27). A request for a hearing 
    will be granted if the Administrator determines that the material 
    submitted shows the following: There is genuine and substantial issue 
    of fact; there is a reasonable possibility that available evidence 
    identified by the requestor would, if established, resolve one or more 
    of such issues in favor of the requestor, taking into account 
    uncontested claims or facts to the contrary; and resolution of the 
    factual issues in the manner sought by the requestor would be adequate 
    to justify the action requested (40 CFR 178.32).
        Information submitted in connection with an objection or hearing 
    request may be claimed confidential by marking any part or all of that 
    information as 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.
    
    VI. Public Record and Electronic Submissions
    
        The official record for this rulemaking, as well as the public 
    version, has been established for this rulemaking under docket control 
    number OPP-300577 (including comments and data submitted electronically 
    as described below). A public version of this record, including 
    printed, paper versions of electronic comments, which does not include 
    any information claimed as CBI, is available for inspection from 8:30 
    a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
    official rulemaking record is the paper record maintained at the 
    Virginia address in ``ADDRESSES'' at the beginning of this document.
        Electronic comments may be sent directly to EPA at:
        opp-docket@epamail.epa.gov.
    
    
        Electronic objections and hearing requests must be submitted as an 
    ASCII file avoiding the use of special characters and any form of 
    encryption. Objections and hearing requests will also be accepted on 
    disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of 
    objections and hearing requests in electronic form must be identified 
    by the docket control number, OPP-300577. No 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.
    
    VII. Regulatory Assessment Requirements
    
        This final rule establishes tolerances under section 408(d) of the 
    FFDCA in response to a petition submitted to the Agency. 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 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 FR7 629, 
    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 these tolerances and exemptions that are 
    established on the basis of a petition under section 408(d) of the 
    FFDCA, such as the tolerances 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.
    
    VIII. Submission to Congress and the General Accounting Office
    
        Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
    Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
    report containing this rule and other required information to the U.S. 
    Senate, the U.S. House of Representatives, and the Comptroller General 
    of the General Accounting Office prior to publication of this rule in 
    today's Federal Register. This 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: November 14, 1997.
    James Jones,
    Acting 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. Section 180.418 is amended by adding a new paragraph (a)(2) to 
    read as follows:
    
    
    Sec. 180.418  Cypermethrin and an isomer zeta-cypermethrin; tolerances 
    for residues.
    
        (a)         *        *        *
        (2) Tolerances are established for residues of the insecticide 
    zeta-cypermethrin (s-cyano(3-phenoxyphenyl) methyl () cis, 
    trans 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate) in 
    or on the following commodities:
    
    [[Page 63244]]
    
    
    
                                                                            
    ------------------------------------------------------------------------
                       Commodity                        Parts per million   
    ------------------------------------------------------------------------
    Cabbage........................................                      2.0
    Cattle, fat....................................                     0.05
    Cattle, mbyp...................................                     0.05
    Cattle, meat...................................                     0.05
    Cottonseed.....................................                      0.5
    Goats, fat.....................................                     0.05
    Goats, mbyp....................................                     0.05
    Goats, meat....................................                     0.05
    Hogs, fat......................................                     0.05
    Hogs, mbyp.....................................                     0.05
    Hogs, meat.....................................                     0.05
    Horses, fat....................................                     0.05
    Horses, mbyp...................................                     0.05
    Horses, meat...................................                     0.05
    Lettuce, head..................................                     10.0
    Milk...........................................                     0.05
    Onions, bulb...................................                     0.10
    Pecans.........................................                     0.05
    Sheep, fat.....................................                     0.05
    Sheep, mbyp....................................                     0.05
    Sheep, meat....................................                     0.05
    ------------------------------------------------------------------------
    
    * * * * *
    
    [FR Doc. 97-30938 Filed 11-25-97; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
11/26/1997
Published:
11/26/1997
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-30938
Dates:
This regulation is effective November 26, 1997. Objections and requests for hearings must be received by EPA on or before January 26, 1998.
Pages:
63235-63244 (10 pages)
Docket Numbers:
OPP-300577, FRL-5754-8
RINs:
2070-AB78
PDF File:
97-30938.pdf
CFR: (1)
40 CFR 180.418