97-22373. Pyridate; Pesticide Tolerances for Emergency Exemptions  

  • [Federal Register Volume 62, Number 163 (Friday, August 22, 1997)]
    [Rules and Regulations]
    [Pages 44552-44558]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-22373]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300527; FRL-5736-9]
    RIN 2070-AB78
    
    
    Pyridate; Pesticide Tolerances for Emergency Exemptions
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This regulation establishes a time-limited tolerance for 
    combined residues of pyridate in or on chickpeas . This action is in 
    response to EPA's granting of an emergency exemption
    
    [[Page 44553]]
    
    under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
    Act authorizing use of the pesticide on chickpeas. This regulation 
    establishes a maximum permissible level for residues of pyridate in 
    this food commodity 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 tolerance will expire and is revoked on December 31, 1998.
    
    DATES: This regulation is effective August 22, 1997. Objections and 
    requests for hearings must be received by EPA on or before October 21, 
    1997.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number, [OPP-300527], 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-300527], must also be submitted to: Public 
    Information and Records Integrity Branch, Information Resources and 
    Services Division (7506C), Office of Pesticide Programs, Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
    bring a copy of objections and hearing requests to Rm. 1132, CM #2, 
    1921 Jefferson Davis Hwy., Arlington, VA.
        A copy of objections and hearing requests filed with the Hearing 
    Clerk may also be submitted electronically by sending electronic mail 
    (e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
    hearing requests must be submitted as an ASCII file avoiding the use of 
    special characters and any form of encryption. Copies of objections and 
    hearing requests will also be accepted on disks in WordPerfect 5.1 file 
    format or ASCII file format. All copies of objections and hearing 
    requests in electronic form must be identified by the docket control 
    number [OPP-300527]. 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: Andrew Ertman, 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) 308-9367, e-mail: 
    ertman.andrew@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
    section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
    (FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
    combined residues of the herbicide pyridate (O- (6-chloro-3-phenyl-4-
    pyridazinyl)-S-octyl-carbonothioate), the metabolite 6-chloro-3-phenyl-
    pyridazine-4-ol and conjugates of 6-chloro-3-phenyl-pyridazine-ol, 
    expressed as pyridate, in or on chickpeas at 0.1 part per million 
    (ppm). This tolerance will expire and is revoked on December 31, 1998. 
    EPA will publish a document in the Federal Register to remove the 
    revoked tolerance 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 tolerance to set binding precedents for the 
    application of section 408 and the new safety standard to other 
    tolerances and exemptions.
    
    II. Emergency Exemption for Pyridate on Chickpeas and FFDCA 
    Tolerances
    
        The applicants state that chickpea growers in the irrigated region 
    of central Washington and north-central Oregon face an immediate crisis 
    with broadleaf weeds infesting their chickpea crop. The problem 
    occurred when there was a period of unusually cool, wet weather after 
    planting in late March to mid-April, causing a delay in both crop and 
    weed emergence. This delay, coupled with the breakdown in the pre-
    emergence herbicide used, created a condition where broadleaf weeds 
    were competing on an equal basis with the chickpea crop. Chickpeas are 
    poor competitors with broadleaf weeds. The applicants state that the 
    pre-emergence herbicides that were used (Sonalan and Prowl) have a 
    shorter period of soil activity than the most effective pre-emergence 
    herbicide available (Pursuit). However, because crop rotation includes 
    potatoes, Pursuit could not be used.
        Because there are no post-emergence herbicides that are currently 
    registered for use on chickpeas to control broadleaf weeds, the 
    applicants assert that left uncontrolled, the broadleaf weed 
    infestation could reduce crop yields by 50 to 60%. EPA has authorized 
    under FIFRA section 18 the use of pyridate on
    
    [[Page 44554]]
    
    chickpeas for control of broadleaf weeds in Washington and Oregon. 
    After having reviewed the submission, EPA concurs that emergency 
    conditions exist for these states.
        As part of its assessment of this emergency exemption, EPA assessed 
    the potential risks presented by residues of pyridate in or on 
    chickpeas. In doing so, EPA considered the new 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 new 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 this tolerance without notice and opportunity 
    for public comment under section 408(e), as provided in section 
    408(l)(6). Although this tolerance will expire and is revoked on 
    December 31, 1998, under FFDCA section 408(l)(5), residues of the 
    pesticide not in excess of the amounts specified in the tolerance 
    remaining in or on chickpeas after that date will not be unlawful, 
    provided the pesticide is applied in a manner that was lawful under 
    FIFRA. EPA will take action to revoke this tolerance earlier if any 
    experience with, scientific data on, or other relevant information on 
    this pesticide indicate that the residues are not safe.
        Because this tolerance is being approved under emergency conditions 
    EPA has not made any decisions about whether pyridate meets EPA's 
    registration requirements for use on chickpeas or whether a permanent 
    tolerance for this use would be appropriate. Under these circumstances, 
    EPA does not believe that this tolerance serves as a basis for 
    registration of pyridate by a State for special local needs under FIFRA 
    section 24(c). Nor does this tolerance serve as the basis for any 
    States other than Washington and Oregon to use this pesticide on this 
    crop under section 18 of FIFRA without following all provisions of 
    section 18 as identified in 40 CFR part 166. For additional information 
    regarding the emergency exemption for pyridate, contact the Agency's 
    Registration Division at the address provided above.
    
    III. Risk Assessment and Statutory Findings
    
        EPA performs a number of analyses to determine the risks from 
    aggregate exposure to pesticide residues. First, EPA determines the 
    toxicity of pesticides based primarily on toxicological studies using 
    laboratory animals. These studies address many adverse health effects, 
    including (but not limited to) reproductive effects, developmental 
    toxicity, toxicity to the nervous system, and carcinogenicity. 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 3 
    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
    
    [[Page 44555]]
    
    degree of conservatism is built into the assessment; i.e., the risk 
    assessment nominally covers 1-7 days exposure, 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, FFDCA section 408 requires that 
    EPA take into account available and reliable information concerning 
    exposure from the pesticide residue in the food in question, residues 
    in other foods for which there are tolerances, residues in groundwater 
    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.
        Percent of crop treated estimates are derived from federal and 
    private market survey data. Typically, a range of estimates are 
    supplied and the upper end of this range is assumed for the exposure 
    assessment. By using this upper end estimate of percent of crop 
    treated, the Agency is reasonably certain that exposure is not 
    understated for any significant subpopulation group. 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, to pesticide residues. For this 
    pesticide, the most highly exposed population subgroup (children 1-6 
    years old) was not regionally based.
    
    IV. Aggregate Risk Assessment and Determination of Safety
    
        Consistent with section 408(b)(2)(D), EPA has reviewed the 
    available scientific data and other relevant information in support of 
    this action, EPA has sufficient data to assess the hazards of pyridate 
    and to make a determination on aggregate exposure, consistent with 
    section 408(b)(2), for a time-limited tolerance for combined residues 
    of pyridate on chickpeas at 0.1 ppm. EPA's assessment of the dietary 
    exposures and risks associated with establishing the tolerance 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 pyridate are 
    discussed below.
        1. Chronic toxicity. EPA has established the RfD for pyridate at 
    0.11 milligrams/kilogram/day (mg/kg/day). This RfD is based on a two 
    year chronic feeding study in rats with a NOEL of 10.8 mg/kg/day and an 
    uncertainty factor of 100 based on body weight depression in the males 
    at the lowest effect level (LEL) of 67.5 mg/kg/day. The 3-generation 
    reproduction study was considered co-critical with a NOEL of 10.8 mg/
    kg/day and an lowest observed effect level (LOEL) of 67.5 mg/kg/day. 
    Depressed maternal and pup body weight gains were observed at the LOEL.
        2. Carcinogenicity. Pyridate has not been to the Office of 
    Pesticide Program's Cancer Peer Review Committee. However, mouse and 
    rat oncogenicity studies indicate that pyridate was negative in both 
    species for carcinogenic effects.
    
    B. Exposures and Risks
    
        1. From food and feed uses. Tolerances have been established (40 
    CFR 180.462) for the combined residues of pyridate (O- (6-chloro-3-
    phenyl-4-pyridazinyl)-S-octyl-carbonothioate), the metabolite 6-chloro-
    3-phenyl-pyridazine-4-ol and conjugates of 6-chloro-3-phenyl-
    pyridazine-ol, expressed as pyridate, in or on a variety of raw 
    agricultural commodities including cabbage, corn (grain, fodder, 
    forage, silage) and peanuts (nutmeats, hulls), all at 0.03 ppm. Risk 
    assessments were conducted by EPA to assess dietary exposures and risks 
    from pyridate as follows:
        Chronic exposure and risk. In conducting this chronic dietary risk 
    assessment, EPA has made very conservative assumptions -- 100% of 
    chickpeas and all other commodities having pyridate tolerances will 
    contain residues and those residues would be at the level of the 
    tolerance -- which result in an overestimate of human dietary exposure. 
    Thus, in making a safety determination for this tolerance, EPA is 
    taking into account this conservative exposure assessment.
        The existing pyridate tolerances (published, pending, and including 
    the necessary Section 18 tolerance(s)) result in a Theoretical Maximum 
    Residue Contribution (TMRC) that is equivalent to the following 
    percentages of the RfD:
        U.S. population at <1.0%; nursing="" infants="" at=""><1.0%; non-nursing="" infants=""><1 year="" old)="" at=""><1.0%; children="" (1-6="" years="" old)="" at=""><1.0%; and,="" children="" (7-12="" years="" old)="" at=""><1.0% the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" and,="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 2.="" from="" drinking="" water.="" based="" on="" information="" available="" to="" the="" agency,="" pyridate="" is="" not="" persistent="" and="" not="" mobile.="" there="" is="" no="" established="" maximum="" contaminant="" level="" for="" residues="" of="" (pyridate)="" in="" drinking="" water.="" no="" health="" advisory="" levels="" for="" pyridate="" in="" drinking="" water="" have="" been="" established.="" chronic="" exposure="" and="" risk.="" because="" the="" agency="" lacks="" sufficient="" water-related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" risk="" assessment="" for="" many="" pesticides,="" epa="" has="" commenced="" and="" nearly="" completed="" a="" process="" to="" identify="" a="" reasonable="" yet="" conservative="" bounding="" figure="" for="" the="" potential="" contribution="" of="" water-related="" [[page="" 44556]]="" exposure="" to="" the="" aggregate="" risk="" posed="" by="" a="" pesticide.="" in="" developing="" the="" bounding="" figure,="" epa="" estimated="" residue="" levels="" in="" water="" for="" a="" number="" of="" specific="" pesticides="" using="" various="" data="" sources.="" the="" agency="" then="" applied="" the="" estimated="" residue="" levels,="" in="" conjunction="" with="" appropriate="" toxicological="" endpoints="" (rfd's="" or="" acute="" dietary="" noel's)="" and="" assumptions="" about="" body="" weight="" and="" consumption,="" to="" calculate,="" for="" each="" pesticide,="" the="" increment="" of="" aggregate="" risk="" contributed="" by="" consumption="" of="" contaminated="" water.="" while="" epa="" has="" not="" yet="" pinpointed="" the="" appropriate="" bounding="" figure="" for="" exposure="" from="" contaminated="" water,="" the="" ranges="" the="" agency="" is="" continuing="" to="" examine="" are="" all="" below="" the="" level="" that="" would="" cause="" pyridate="" to="" exceed="" the="" rfd="" if="" the="" tolerance="" being="" considered="" in="" this="" document="" were="" granted.="" the="" agency="" has="" therefore="" concluded="" that="" the="" potential="" exposures="" associated="" with="" pyridate="" in="" water,="" even="" at="" the="" higher="" levels="" the="" agency="" is="" considering="" as="" a="" conservative="" upper="" bound,="" would="" not="" prevent="" the="" agency="" from="" determining="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" if="" the="" tolerance="" is="" granted.="" 3.="" from="" non-dietary="" exposure.="" pyridate="" is="" not="" registered="" for="" any="" residential="" uses="" at="" this="" time.="" therefore,="" no="" non-dietary,="" non-="" occupational="" exposure="" is="" anticipated.="" 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.''="" 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="" 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).="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" pyridate="" 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,="" pyridate="" 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="" pyridate="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" an="" acute="" aggregate="" risk="" is="" not="" required="" for="" pyridate="" as="" no="" acute="" toxicity="" endpoint="" has="" been="" identified.="" there="" are="" also="" no="" non-dietary="" non-occupational="" exposures.="" the="" agency="" acknowledges="" the="" potential="" for="" exposure="" to="" pyridate="" in="" drinking="" water,="" but="" does="" not="" expect="" that="" exposure="" would="" result="" in="" an="" aggregate="" (margin="" of="" exposure)="" moe="" (food="" plus="" water)="" that="" would="" exceed="" the="" agency's="" level="" of="" concern="" for="" acute="" dietary="" exposure.="" 2.="" chronic="" risk.="" using="" the="" conservative="" tmrc="" exposure="" assumptions,="" and="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" pyridate="" from="" food="" will="" utilize=""><1.0% of="" the="" rfd="" for="" the="" u.s.="" population.="" 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="" pyridate="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" pyridate="" residues.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--="" a.="" in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" pyridate,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" three-="" 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.="" 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="" 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.="" b.="" developmental="" toxicity="" studies.="" in="" the="" developmental="" study="" in="" rats,="" the="" maternal="" (systemic)="" noel="" was="" 165="" mg/kg/day,="" based="" on="" mortality="" and="" decreased="" body="" weight="" at="" the="" loel="" of="" 400="" mg/kg/day.="" the="" developmental="" (fetal)="" noel="" was="" 165="" mg/kg/day,="" based="" on="" increased="" incidence="" of="" missing="" and/or="" unossified="" sternabrae="" and="" decreased="" [[page="" 44557]]="" fetal="" body="" weight="" at="" the="" loel="" of="" 400="" mg/kg/day.="" in="" the="" developmental="" toxicity="" study="" in="" rabbits,="" the="" maternal="" (systemic)="" noel="" was="" 300="" mg/kg/day,="" based="" on="" body="" weight="" depression="" at="" the="" loel="" of="" 600="" mg/kg/day.="" the="" developmental="" (pup)="" noel="" was="" 600="" mg/kg/="" day,="" the="" highest="" dose="" tested.="" c.="" reproductive="" toxicity="" study.="" in="" the="" 3-generation="" reproductive="" toxicity="" study="" in="" rats,="" the="" maternal="" (systemic)="" noel="" was="" 10.8="" mg/kg/="" day,="" based="" on="" body="" weight="" depression="" at="" the="" loel="" of="" 67.5="" mg/kg/day.="" the="" developmental/reproductive="" (pup)="" noel="" was="" 10.8="" mg/kg/day,="" based="" on="" body="" weight="" loss="" at="" the="" loel="" of="" 67.5="" mg/kg/day.="" d.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" pyridate="" is="" complete="" with="" respect="" to="" current="" data="" requirements.="" there="" are="" no="" pre-="" or="" post-natal="" toxicity="" concerns="" for="" infants="" and="" children,="" based="" on="" the="" results="" of="" the="" rat="" and="" rabbit="" developmental="" toxicity="" studies="" and="" the="" 3-generation="" rat="" reproductive="" toxicity="" study.="" based="" on="" the="" developmental="" and="" reproductive="" toxicity="" studies="" discussed="" above,="" there="" does="" not="" appear="" to="" be="" an="" extra="" sensitivity="" for="" pre-="" or="" post-natal="" effects.="" e.="" conclusion.="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" margin="" of="" exposure/uncertainty="" factor="" and="" that="" an="" additional="" margin/factor="" is="" not="" needed="" to="" protect="" infants="" and="" children.="" 2.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" pyridate="" from="" food="" will="" utilize="" less="" than="" 1%="" of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" pyridate="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" pyridate="" residues.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" pyridate="" residue="" in="" plants="" and="" ruminants="" is="" adequately="" understood.="" the="" total="" toxic="" residue="" consists="" of="" pyridate="" (o-="" (-chloro-3-phenyl-4-pyridazinyl)="" -s-octyl-carbonothioate),="" its="" metabolite="" 6-chloro-3-phenyl-pyridazine-4-ol="" (aka="" cl9673),="" and="" conjugates="" of="" that="" metabolite,="" all="" expressed="" as="" pyridate.="" .="" b.="" analytical="" enforcement="" methodology="" a="" total="" residue="" method="" using="" uv--hplc="" is="" available="" for="" residue="" data="" gathering="" and="" enforcement="" purposes.="" the="" method="" has="" been="" adequately="" validated="" by="" recovery="" data,="" has="" passed="" a="" successful="" method="" trial,="" and="" has="" been="" forwarded="" to="" fda="" for="" publication="" in="" pam-ii.="" the="" limit="" of="" quantitation="" is="" 0.03="" ppm..="" c.="" magnitude="" of="" residues="" residues="" of="" pyridate,="" its="" metabolite="" 6-chloro-3-phenyl-pyridazine-="" 4-ol="" and="" conjugates="" of="" that="" metabolite="" all="" expressed="" as="" pyridate="" are="" not="" expected="" to="" exceed="" 0.1="" ppm="" in/on="" chickpeas.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" no="" feed="" items="" are="" associated="" with="" this="" section="" 18="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" mexican,="" or="" canadian="" mrls="" established="" for="" pyridate="" in/on="" chickpeas.="" vi.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" combined="" residues="" of="" pyridate="" (o-="" (6-chloro-3-phenyl-4-pyridazinyl)-s-octyl-carbonothioate),="" the="" metabolite="" 6-chloro-3-phenyl-pyridazine-4-ol="" and="" conjugates="" of="" 6-="" chloro-3-phenyl-pyridazine-ol,="" expressed="" as="" pyridate="" in/on="" chickpeas="" at="" 0.1="" ppm.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" october="" 21,="" 1997,="" 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="" confidential="" business="" information="" (cbi).="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" viii.="" public="" docket="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300527]="" (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="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
    
        Electronic comments must be submitted as an ASCII file avoiding the 
    use of special characters and any form of encryption.
    
    [[Page 44558]]
    
        The official record for this rulemaking, as well as the public 
    version, as described above 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 rulemaking record which 
    will also include all comments submitted directly in writing. The 
    official rulemaking record is the paper record maintained at the 
    Virginia address in ``ADDRESSES'' at the beginning of this document.
    
    IX. Regulatory Assessment Requirements
    
        This final rule establishes a tolerance under FFDCA section 408(d). 
    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 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 these 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.
    
    X. 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: August 12, 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 180.462 is amended to read as follows:
        a. By designating the existing text as paragraph (a) and adding a 
    heading.
        b. By adding paragraph (b).
        c. By adding the headings and reserving paragraphs (c) and (d).
        Section 180.462, as amended, reads as follows:
    
    
    Sec. 180.462  Pyridate; tolerances for residues.
    
        (a) General  . * * * 
        (b) Section 18 emergency exemptions. A time-limited tolerance is 
    established for the residue of the herbicide pyridate in connection 
    with use of the pesticide under section 18 emergency exemptions granted 
    by EPA. This tolerance will expire and is revoked on the date specified 
    in the following table:
    
    ------------------------------------------------------------------------
                                                                 Expiration/
                       Commodity                     Parts per    revocation
                                                      million        date   
    ------------------------------------------------------------------------
    Chickpeas.....................................          0.1     12/31/98
    ------------------------------------------------------------------------
    
        (c) Tolerances with regional registrations. [Reserved]
        (d) Indirect or inadvertent residues. [Reserved]
    
    [FR Doc. 97-22373 Filed 8-21-97; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
8/22/1997
Published:
08/22/1997
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-22373
Dates:
This regulation is effective August 22, 1997. Objections and requests for hearings must be received by EPA on or before October 21, 1997.
Pages:
44552-44558 (7 pages)
Docket Numbers:
OPP-300527, FRL-5736-9
RINs:
2070-AB78
PDF File:
97-22373.pdf
CFR: (1)
40 CFR 180.462