Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Pyraclostrobin,

[Federal Register: September 27, 2002 (Volume 67, Number 188)]

[Rules and Regulations]

[Page 60886-60902]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr27se02-17]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0225; FRL-7200-7]

Pyraclostrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for combined residues of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol- 3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy metabolite methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl carbamate, expressed as parent compound, in or on almond, hulls and various other fruits and vegetables and agricultural products, and combined residues of pyraclostrobin, carbamic acid, [2-

[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl] oxy]methyl]phenyl]methoxy-, methyl ester and its metabolites convertible to 1-(4-chlorophenyl)-1H- pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound, in or on cattle, fat and various other animal products. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.

[[Page 60887]]

DATES: This regulation is effective September 27, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0225, must be received on or before November 26, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP-2002-0225 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-7740; e-mail address: giles-parker.cynthia@epa.gov.

SUPPLEMENTARY INFORMATION:

  1. General Information

    1. Does this Action Apply to Me?

      You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

      Examples of Categories

      NAICS codes

      potentially affected entities

      Industry

      111

      Crop production 112

      Animal production 311

      Food manufacturing 32532

      Pesticide manufacturing

      This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

    2. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

      1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet home page at http://www.epa.gov/. To access this document, on the home page select ``Laws and Regulations,'' ``Regulations and Proposed Rules,'' and then look up the entry for this document under the ``Federal Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/ nara/cfr/cfrhtml--00/Title--40/40cfr180--00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/ opptsfrs/home/guidelin.htm.

      2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0225. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

  2. Background and Statutory Findings

    In the Federal Register of May 23, 2001 (66 FR 28470) (FRL-6780-7), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 0F6139) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709-3528. This notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing.

    The petition requested that 40 CFR 180.582 be amended by establishing tolerances for combined residues of the fungicide pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl carbamate), expressed as parent compound, in or on almond, hulls at 1.6 parts per million (ppm); banana at 0.04 ppm; barley, grain at 0.4 ppm; barley, hay at 25 ppm; barley, straw at 6.0 ppm; bean, dry at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.2 ppm; beet, sugar, tops at 8.0 ppm; berry, group at 1.3 ppm; citrus, dried pulp at 5.5 ppm; citrus, oil at 4.0 ppm; fruit, citrus, group at 0.7 ppm; fruit, stone, group at 0.9 ppm; grain, aspirated fractions at 2.5 ppm; grape at 2.0 ppm; grape, raisin at 7.0 ppm; grass, forage at 10 ppm; grass, hay at 4.5 ppm; grass, seed screenings at 27 ppm; grass, straw at 14 ppm; nut, tree, group at 0.04 ppm; peanut, nutmeat at 0.05 ppm; peanut, refined oil at 0.1 ppm; pistachio at 0.7 ppm; radish, tops at 16 ppm; rye, grain at 0.04 ppm; rye, straw at 0.5 ppm; strawberry at 0.4 ppm; vegetable, bulb, group at 0.9 ppm; vegetable, cucurbit, group at 0.5 ppm; vegetable, fruiting, group at 1.4 ppm; vegetable, root, except sugar beet, subgroup at 0.4 ppm; vegetable, tuberous and corm, subgroup at 0.04 ppm; wheat, grain at 0.2 ppm; wheat, hay at 6.0 ppm; and wheat, straw] at 8.5 ppm, and combined residues of pyraclostrobin, (carbamic acid, [2-[[[1-(4- chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound, in or on cattle, fat at 0.1 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 0.2 ppm; goat, fat at 0.1 ppm; goat, liver at 1.5 ppm; goat, meat at 0.1 ppm; goat, meat byproducts, except liver at 0.2 ppm; hog, fat at 0.1 ppm; hog, liver at 1.5 ppm; hog, meat at 0.1 ppm; hog, meat byproducts, except liver at 0.2 ppm; horse, fat at 0.1 ppm; horse, liver at 1.5 ppm; horse, meat at 0.1 ppm; horse, meat byproducts, except liver at 0.2 ppm; milk at 0.1 ppm; sheep, fat at 0.1 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.1 ppm; and sheep, meat byproducts, except liver at 0.2 ppm.

    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

    [[Page 60888]]

    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....''

    EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

  3. 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 and to make a determination on aggregate exposure, consistent with section 408(b)(2), for the establishment of tolerances for combined residues of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl carbamate), expressed as parent compound in or on almond, hulls at 1.6 ppm; banana at 0.04 ppm; barley, grain at 0.4 ppm; barley, hay at 25 ppm; barley, straw at 6.0 ppm; bean, dry at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.2 ppm; beet, sugar, tops at 8.0 ppm; berry, group at 1.3 ppm; citrus, dried pulp at 5.5 ppm; citrus, oil at 4.0 ppm; fruit, citrus, group at 0.7 ppm; fruit, stone, group at 0.9 ppm; grain, aspirated fractions at 2.5 ppm; grape at 2.0 ppm; grape, raisin at 7.0 ppm; grass, forage at 10 ppm; grass, hay at 4.5 ppm; grass, seed screenings at 27 ppm; grass, straw at 14 ppm; nut, tree, group at 0.04 ppm; peanut, nutmeat at 0.05 ppm; peanut, refined oil at 0.1 ppm; pistachio at 0.7 ppm; radish, tops at 16 ppm; rye, grain at 0.04 ppm; rye, straw at 0.5 ppm; strawberry at 0.4 ppm; vegetable, bulb, group at 0.9 ppm; vegetable, cucurbit, group at 0.5 ppm; vegetable, fruiting, group at 1.4 ppm; vegetable, root, except sugar beet, subgroup at 0.4 ppm; vegetable, tuberous and corm, subgroup at 0.04 ppm; wheat, grain at 0.2 ppm; wheat, hay at 6.0 ppm; and wheat, straw] at 8.5 ppm, and combined residues of pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2- hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound], in or on

    [cattle, fat at 0.1 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 0.2 ppm; goat, fat at 0.1 ppm; goat, liver at 1.5 ppm; goat, meat at 0.1 ppm; goat, meat byproducts, except liver at 0.2 ppm; hog, fat at 0.1 ppm; hog, liver at 1.5 ppm; hog, meat at 0.1 ppm; hog, meat byproducts, except liver at 0.2 ppm; horse, fat at 0.1 ppm; horse, liver at 1.5 ppm; horse, meat at 0.1 ppm; horse, meat byproducts, except liver at 0.2 ppm; milk at 0.1 ppm; sheep, fat at 0.1 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.1 ppm; and sheep, meat byproducts, except liver at 0.2 ppm.] . EPA's assessment of exposures and risks associated with establishing the tolerance follows.

    1. 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 acute toxicity of pyraclostrobin is presented in the following table 1:

      Table 1.--Acute Toxicity of Pyraclostrobin

      Results/Toxicity Guideline Number

      Study Type

      Catergory

      870.1100

      Acute oral

      LD50= > 5,000 toxicity

      milligrams per kilogram (mg/kg) Toxicity category = IV

      870.1200

      Acute dermal

      LD50= > 2,000 mg/ toxicity

      kg; toxicity category = III

      870.1300

      Acute inhalation LC50= 50= 250 mg/ rat

      0, 40, 100, or 250 mg/ kg kg for 5 days/week The NOAEL = 250 mg/kg The study is unacceptable because a higher dose could have been tolerated and the limit dose is 1,000 mg/ kg/day

      870.3700

      Prenatal developmental Acceptable/guideline; The Maternal LOAEL = 25 toxicity study in

      0, 10, 25 or 50 mg/kg/ mg/kg/day, based on rodents - rat

      day

      reduced body weight, reduced body weight gain, reduced food intake, and reduced food efficiency Maternal NOAEL = 10 mg/ kg/day The Developmental LOAEL = 50 mg/kg/day, based on increased incidences of dilated renal pelvis and cervical ribs with no cartilage The Developmental NOAEL = 25 mg/kg/day

      [[Page 60890]]

      870.3700

      Prenatal developmental Acceptable/guideline; The maternal LOAEL = 10 toxicity study in

      0, 1, 3, 5, 10, or 20 mg/kg/day, based on nonrodents - rabbit mg/kg/day

      reduced body weight gain, reduced food consumption, and reduced food efficiency The maternal NOAEL = 5 mg/kg/day The developmental LOAEL = 10 mg/kg/day, based on increased resorptions/litter, increased post- implantation loss, and dams with total resorptions The Developmental NOAEL was 5 mg/kg/day

      870.3800

      2-generation

      Unacceptable/guideline; The parental systemic, reproduction and

      0, 25, 75, or 300 ppm reproductive, and fertility effects - (0 to 29.0 mg/kg/day offspring LOAELs were rat

      for F0 males; 0 to all > 300 ppmThe 30.4 mg/kg/day F0

      parental systemic, females; 0 to 35.0 mg/ reproductive, and kg/day for F1 males; 0 offspring NOAELs all = to 36.0 mg/kg/day for 300 ppm. The study is F1 females)

      unacceptable because higher doses could be tolerated

      870.4100

      1-year feeding study - Acceptable/guideline; The LOAEL = 400 ppm for dog

      0, 100, 200, or 400 both sexes, based on ppm (0, 2.7, 5.4, or increased diarrhea in 10.8 mg/kg/day in

      both sexes, clinical males; 0, 2.7, 5.4, or chemistry changes in 11.2 mg/kg/day in

      both sexes, decreased females)

      body weight gain in females, and decreased food intake and food efficiency in females The NOAEL = 200 ppm for both sexes

      870.4200

      18-month

      Unacceptable/guideline; The LOAEL was > 120 ppm carcinogenicity -

      0, 10, 30, or 120 ppm for males and > 180 mouse

      in males (0, 1.4, 4.1, ppm for females, and 17.2 mg/kg/day); because no clearly and 0, 10, 30, 120, or 180 significantly dose- ppm in females (0, related adverse 1.6, 4.8, 20.5, or effects were observed. 32.8 mg/kg/day);

      There were no 97.09% pure a.i.

      increased incidences of tumors; under the conditions of the study, there was no evidence of carcinogenic potential. However, the study is considered to be unacceptable because the maximum dosing levels were too low to satisfy the requirements for a carcinogenicity study in mice

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      870.4200

      24-Month

      Acceptable/guideline; The LOAEL = 200 ppm for carcinogenicity - rat 0, 25, 75, or 200 ppm both males and (0, 1.2, 3.4, 9.2 mg/ females, based on kg/day for males and decreases in body 0, 1.5, 4.7, and 12.6 weight and body weight mg/kg/day for females) gains in males and females; increased incidence of kidney tubular casts and atrophy in males and females; and increased incidence of necrosis of the liver, gross and microscopic evidence of erosion/ ulceration of the glandular stomach, and increased incidence of acanthosis and ulcers of the forestomach in males. The NOAEL = 75 ppm for both males and females. As to carcinogenicity, histiocytic sarcoma and lymphoma of the hemolymphoreticular system was observed in males at 25, 75, and 200 ppm, as well as in controls. There was an increase in incidence of mammary gland adenocarcinoma in females at 200 ppm, compared to controls. Testicular leydig cell tumors were observed in all male groups, but had a slightly higher incidence in each treated group than in controls. Under the conditions of this study there is evidence that pyraclostrobin may be carcinogenic

      870.4100

      24-Month chronic

      Unacceptable/guideline; The LOAEL was > 200 ppm toxicity - rats

      0, 25, 75, or 200 ppm The NOAEL = 200 ppm. (0, 1.1, 3.4, or 9.0 The study is mg/kg/day in males; 0, unacceptable because a 1.5, 4.6, or 12.3 mg/ higher dose could have kg/day in females) been tolerated

      870.5100

      Gene mutation:

      Acceptable/guideline; 0 Negative. There was no Bacterial reverse

      to 5,000 micrograms evidence of treatment- mutation

      ([mu]g)/plate tested induced mutant up to precipitating colonies above concentrations

      background levels in any assay, including in the presence or absence of an Aroclor 1,254-stimulated rat liver metabolic activation system or using the preincubation test

      870.5300

      Other genotoxic effect Acceptable/guideline; Negative. Chinese mammalian cells in (see test summary in hamster ovary (CHO) culture gene mutation results)

      cells were cultured in assay

      vitro. They were exposed to pyraclostrobin at concentrations of 0.625, 1.25, 2.5, 5.0, 10.0, and 20.0 [mu]g/ ml in the presence and absence of metabolic activation; concentrations of 3, 4, 5, 6, 7, and 8 [mu]g/mL in the absence of metabolic activation; and concentrations of 1.25, 2.5, 5.0, 10.0, and 20.0 [mu]g/mL in the presence and absence of metabolic activation. There was no evidence of induced mutant colonies over background

      [[Page 60892]]

      870.5375

      In vitro mammalian Acceptable/guideline; Negative. Chinese chromosome aberrations (see test summary in hamster V79 cell results)

      cultures were tested at concentrations of 0, 6.25, 12.5, or 25.0 micrograms per milliliter ([mu]g/mL) in the presence and absence of an Aroclor 1,254-stimulated rat liver metabolic activation system; at 0, 3.125, 6.25, or 12.5 [mu]g/mL in the presence of metabolic activation; and at 0, 0.005, 0.010, 0.050, or 0.100 [mu]g/mL in the absence of metabolic activation. There was no evidence of an increase in the number of structural or numerical chromosomal aberrations induced over background

      870.5395

      In vivo mammalian

      Acceptable/guideline; Negative. Mouse bone cytogenetics

      0, 75, 150, or 300 mg/ marrow micronucleus kg body weight

      was assayed in vitro. There was no significant increase in the frequency of micronucleated polychromatic erythrocyte in the bone marrow at any dose level tested, at any time after treatment. It is therefore concluded that pyraclostrobin did not induce a clastogenic effect in either sex at any sacrifice time

      870.5550

      Unscheduled DNA

      Acceptable/guideline; Negative. Primary rat syntheses

      (see test summary in hepatocyte cultures results)

      were exposed to pyraclostrobin at up to cytotoxic concentrations: in one test at concentrations of 0.01, 0.03, 0.1, 0.3, or 1.0 [mu]g/mL and in a second test at 0.004, 0.02, and 0.5 [mu]g/mL. There was no evidence that pyraclostrobin induced unscheduled DNA synthesis, as determined by net nuclear silver grain counts

      870.6100

      Acute oral

      Acceptable/guideline; The Systemic Toxicity neurotoxicity - rat single doses of 0, LOAEL for males was 100, 300, or 1,000 mg/ 1,000 mg/kg body kg before sacrifice weight, based on 33% after 14 days

      decreased body weight on days 0-7 (no similar effect was detected on days 0- 14). The systemic toxicity NOAEL for males was 300 mg/kg body weight. The systemic toxicity LOAEL for females could not be determined since there were no adverse, treatment-related effects. Thus, the systemic toxicity NOAEL for females was 1,000 mg/kg body weight. The neurotoxicity LOAEL could not be determined because there were no treatment-related neurotoxic effects at any dose level tested. The neurotoxicity NOAEL was 1,000 mg/kg body weight

      [[Page 60893]]

      870.6200

      Subchronic

      Acceptable/guideline; Systemic toxicity: The neurotoxicity - rats 0, 50, 250, or 750 LOAEL was 750 ppm for (males)/1,500

      males and 1,500 ppm (females) ppm (0, 3.5, for females, based 16.9, or 49.9 mg/kg/ (for both sexes) on day for males and 0, decreased body weight 4.0, 20.4, or 111.9 mg/ gain, decreased food kg/day for females) intake, and decreased for 3 months

      food efficiency. The NOAEL was 250 ppm for both males and females. Neurotoxicity: The LOAEL could not be determined because there were no treatment-related neurotoxic effects noted at any dose level. Therefore, the NOAEL was 750 ppm for males and 1,500 ppm for females

      870.7600

      Dermal penetration - Unacceptable/guideline; The absorption rate rats

      0.375 mg/cm2could not be accurately determined because at 8 hours after dermal exposure initiation 76.4% of the administered dose remained on the dressing and only 23.6% was available for absorption. However, a conservative upper bound dermal absorption rate estimate of 14% can be calculated from the study results

    2. Toxicological Endpoints

      The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. That is the case in the pyraclostrobin risk assessment.

      For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

      For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences), the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

      The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 X 10-6or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer= point of departure/exposures) is calculated. A summary of the toxicological endpoints for pyraclostrobin used for human risk assessment is shown in the following Table 3:

      Table 3.--Summary of Toxicological Dose and Endpoints for Pyraclostrobin for Use in Human Risk Assessment*

      Dose used in Risk FQPA SF and Endpoint Study; Toxicological Exposure Scenario

      Assessment UF

      for Risk Assessment

      Endpoint

      Acute dietary (general population) NOAEL = 300 mg/kg/day Acute RfD = 3 mg/kg/day Rat acute oral UF = 100............... FQPA SF = 1X........... neurotoxicity; the Acute RfD = 3 mg/kg/day aPAD = 3 mg/kg/day..... systemic toxicity NOAEL of 300 mg/kg based on decreased body weight gain in males at 1,000 mg/kg (the LOAEL)

      [[Page 60894]]

      Acute dietary (females 13-50 years) NOAEL = 5 mg/kg/day Acute RfD = 0.05 mg/kg/ Rabbit prenatal UF = 100............... day

      developmental Acute RfD = 0.05 mg/kg/ FQPA SF = 3x........... toxicity; day.

      aPAD = 0.017 mg/kg/day. developmental toxicity findings of increased resorptions/litter and increased total resorptions (i.e., dams with complete litter loss) at 10 mg/ kg/day (the LOAEL)

      Chronic dietary

      NOAEL = 3.4 mg/kg/day Chronic RfD = 0.034 mg/ Rat oral UF = 100............... kg/day

      carcinogenicity; Chronic RfD = 0.034 mg/ FQPA SF = 3x........... decreased body weight kg/day.

      cPAD = 0.011 mg/kg/day. and body weight gain, kidney tubular casts and atrophy in both sexes, increased incidence of liver necrosis and erosion and ulceration of the glandular stomach and forestomach in males in addition to hemolymphoreticular tumors in males and mammary adenocarcinoma in females at 9.2 mg/ kg/day (the LOAEL)

      *The reference to the FQPA SF refers to any additional safety factor retained due to concerns unique to the FQPA.

    3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances are being established (40 CFR 180.582) for the residues of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl]methoxy-, methyl ester) and one or more of its metabolites, expressed as parent compound], in or on a variety of raw agricultural commodities. These tolerances include almond, hulls at 1.6 ppm; Banana at 0.04 ppm; barley, grain at 0.4 ppm; barley, hay at 25 ppm; barley, straw at 6.0 ppm; bean, dry at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.2 ppm; beet, sugar, tops at 8.0 ppm; berry, group at 1.3 ppm; cattle, fat at 0.1 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 0.2 ppm; citrus, dried pulp at 5.5 ppm; citrus, oil at 4.0 ppm; fruit, citrus, group at 0.7 ppm; fruit, stone, group at 0.9 ppm; goat, fat at 0.1 ppm; goat, liver at 1.5 ppm; goat, meat at 0.1 ppm; goat, meat byproducts, except liver at 0.2 ppm; grain, aspirated fractions at 2.5 ppm; grape at 2.0 ppm; grape, raisin at 7.0 ppm; grass, forage at 10 ppm; grass, hay at 4.5 ppm; grass, seed screenings at 27 ppm; grass, straw at 14 ppm; hog, fat at 0.1 ppm; hog, liver at 1.5 ppm; hog, meat at 0.1 ppm; hog, meat byproducts, except liver at 0.2 ppm; horse, fat at 0.1 ppm; horse, liver at 1.5 ppm; horse, meat at 0.1 ppm; horse, meat byproducts, except liver at 0.2 ppm; milk at 0.1 ppm; nut, tree, group at 0.04 ppm; peanut, nutmeat at 0.05 ppm; peanut, refined oil at 0.1 ppm; pistachio at 0.7 ppm; radish, tops at 16 ppm; rye, grain at 0.04 ppm; rye, straw at 0.5 ppm; sheep, fat at 0.1 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.1 ppm; sheep, meat byproducts, except liver at 0.2 ppm; strawberry at 0.4 ppm; vegetable, bulb, group at 0.9 ppm; vegetable, cucurbit, group at 0.5 ppm; vegetable, fruiting, group at 1.4 ppm; vegetable, root, except sugar beet, subgroup at 0.4 ppm; vegetable, tuberous and corm, subgroup at 0.04 ppm; wheat, grain at 0.2 ppm; wheat, hay at 6.0 ppm; and wheat, straw at 8.5 ppm. Risk assessments were conducted by EPA to assess dietary exposures from pyraclostrobin (carbamic acid, [2-[[[1-(4- chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester)] in food as follows:

        i. Acute exposure. 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 Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following determinations and assumptions were made for the acute exposure assessments: The aPAD for the subgroup females (13-50 years old) is much lower than the aPAD for the U.S. population group and the other subgroups assessed (see table 3 of this preamble) because of the much lower NOAEL used for the females (13-50 years old) subgroup and the 3x FQPA SF applied only to this subgroup, to protect against effects seen following in utero exposure in the developmental rabbit study. In these assessments percent crop treated data were used for a number of commodities but anticipated residues were not, so the assessments are considered to be partially refined and somewhat conservative. Concentration factors for processed commodities were also used. Refinements such as the use of anticipated residue estimates would potentially produce much lower estimates of dietary exposure. The results, at the 95thpercentile, of the acute dietary exposure analysis were that the general U.S. population and all subgroups except females (13-50 years old) had dietary exposures that were TManalysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The same cPAD was applicable to the general U.S. population and all subgroups in the chronic dietary exposure analysis. In this assessment PCT data were used for a number of commodities but anticipated residues were not, so the assessments are considered to be partially refined and somewhat conservative. Concentration factors for processed commodities were also used. Refinements such as the use of anticipated residue estimates would potentially produce much lower estimates of dietary exposure. The chronic pyraclostrobin dietary exposure analysis estimated the following exposures: (a) General U.S. population - 27% of the cPAD, (b) children (1-6 years old) - 74% of the cPAD, and (c) children

        [[Page 60895]]

        (7-12 years old) - 41% of the cPAD, infants (thpercentile the acute dietary exposure to pyraclostrobin from food will occupy 1aPAD mg/kg/ Food Exposure mg/kg/day Exposure Acute Ground Water EEC3Acute Surface Water DWLOC day

        (95thpercentile) (mg/kg/

        ([mu]g/L)

        EEC4([mu]g/L) ([mu]g/L)5 day)2

        U.S. population

        3.0

        0.0094

        3.0

        0.009

        0.009 1.0 x 105

        ------------ All Infants

        3.0

        0.014

        3.0

        3.0 x 104

        ------------ Females (13-50 years old)

        0.017

        0.0068

        0.043

        1.3 x 103

        ------------ Children (1-6 years old)

        3.0

        0.022

        3.0

        3.0 x 104

        ------------ Males (13-19 years old)

        3.0

        0.0083

        3.0

        1.0 x 105

        1Population subgroups chosen were the female subgroup with the highest food exposure (60 kg/ body weight assumed) the male subgroup with the highest food exposure (70 kg body weight assumed) and infant/child subgroups with the highest food exposure (10 kg/ body weight assumed). 2Maximum Water Exposure (mg/kg/day) = PAD (mg/kg/day) - Food Exposure from DEEM (mg/kg/day). 3Based upon SCI-GROW modeling results. 4Based upon FIRST (version 2) modeling results. 5DWLOC([mu]g/L) = maximum water exposure (mg/kg/day) x body weight (kg)/water consumption (L) x 103mg/[mu]g

      2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to

        [pyraclostrobin] from food will utilize 27% of the cPAD for the U.S. population, 31% of the cPAD for infants 1day)

        day)

        Exposure2EEC3 ([mu]g/L)

        EEC4 ([mu]g/L) ([mu]g/L) (mg/kg/day)

        U.S. population

        0.011

        0.0030 8.0 x 10-30.009

        0.79

        280

        ------------ All infants

        0.011

        0.0034 7.6 x 10-376

        ------------ Children (1-6 years)

        0.011

        0.0082 2.8 x 10-328

        ------------ Females (13-50 years old)

        0.011

        0.0022 8.8 x 10-3290

        ------------ Males (13-19 years old)

        0.011

        0.0028 8.2 x 10-3290

        1Population subgroups chosen were U.S. population (70 kg body weight assumed), the female subgroup with the highest food exposure (60 kg body weight assumed), the male subgroup (70 kg body weight assumed) with the highest food exposure, and infant/child subgroups with the highest food exposure (10 kg body weight assumed). 2Maximum Water Exposure (mg/kg/day) = PAD (mg/kg/day) - Food Exposure from DEEM (mg/kg/day) 3Based upon PRZM/EXAMS Index Reservoir modeling results. 4Based upon SCI-GROW modeling results. 5DWLOC([mu]g/L) = maximum water exposure (mg/kg/day) x body weight (kg)/water consumption (L) x 10-3mg/[mu]g

      3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyraclostrobin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

      4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyraclostrobin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

      5. Aggregate cancer risk for U.S. population. The database for carcinogenicity is incomplete. MOEs have been calculated for chronic (cancer) food exposure based on NOAELs of 3.4 and 12.6 mg/kg/day from the 2-year carcinogenicity feeding study in rats and a NOAEL of 9.0 mg/ kg/day from the 28-day rat feeding study. MOEs for drinking water exposure, using the SCI-GROW model chronic estimate of 0.009 ppb pyraclostrobin in ground water, are presented in the following table 6 as are the MOEs for food plus drinking water.

        Table 6.--Margins of Exposure (MOEs) based upon Chronic (Cancer) Aggregate Exposure (Food Plus Water Only) to Pyraclostrobin for the U.S. Population

        Exposure

        Exposure NOAEL (mg/kg/day)

        from food MOE (food) from water MOE (water) MOE (food + (mg/kg/day)

        (mg/kg/day)

        water)

        3.4

        0.0030

        1,100 2.3 x 10-51.5 x 1051,100

        9.0

        3,000

        4.2 x 1053,000

        -------------

        ------------------------- 12.6

        3,000

        4.2 x 1054,200

      6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to pyraclostrobin residues.

  4. Other Considerations

    1. Analytical Enforcement Methodology

      Two tolerance enforcement methods have been proposed by BASF for the determination of pyraclostrobin and its desmethoxy metabolite (BF 500-3) in or on plant commodities: (a) The Liquid Chromatography/Mass Spectrometry (LC/MS) method number D9808 and (b) the HPLC/UV method number D9904. The validated method limits of quantitation for pyraclostrobin and BF 500-3 for both methods are 0.02ppm for each analyte in plant matrices. Adequate independent method validation and radiovalidation data have been submitted for both methods. These methods have been forwarded to the Agency's Analytical Chemistry Laboratory for validation.

      The Agency has also received two tolerance enforcement methods for ruminant commodities: HPLC/UV method number 439/0 and 446, which consists of Gas Chromatography (GC)/MS method number 446/0 and LC/MS/MS method number 446/1. The HPLC/UV method determines residues of pyraclostrobin per se. Method number 446 has a hydrolysis step and determines residues of pyraclostrobin and its metabolites as the molecules BF 500-5 and BF 500-8. These methods have also been forwarded to the Agency's Analytical Chemistry Laboratory for validation.

      The petitioner must make any modifications or revisions to the proposed methods resulting from the Agency's validation. Upon successful

      [[Page 60899]]

      completion of the validation, the methods will be forwarded to FDA for publication in a future revision of the Pesticide Analytical Manual, Volume II (PAM-II). Before publication and upon request, the methods will be available, prior to the harvest season, from the Analytical Chemistry Branch (ACB), Biological and Economic Analysis Division (7503C), Environmental Science Center, 701 Mapes Road, Ft. George C. Meade, MD 20755-5350. Contact Francis D. Griffith, Jr., telephone (410) 305-2905, e-mail: griffith.francis@epa.gov. The analytical standards are also available from the EPA National Standard Repository at the same location.

      Pyraclostrobin was successfully evaluated through several of the FDA multiresidue method protocols, while BF 500-3 was unsuccessful in all protocols. Pyraclostrobin was completely recovered through Protocol D (in grape) and E (in grape), and partially recovered through Protocol F (in peanut). Metabolite BF 500-3 had poor peak shape and inadequate sensitivity with Protocol C columns and therefore was not further analyzed under Protocols D, E, and F. The results of the multiresidue testing for pyraclostrobin will be forwarded to FDA for inclusion in PAM Volume I.

    2. International Residue Limits

      No Codex or Mexican maximum residue levels (MRLs) have been proposed or are established for residues of pyraclostrobin. Therefore, no tolerance discrepancies exist between countries for this chemical. Since the application for registration of pyraclostrobin was reviewed jointly with the Pest Management Regulatory Agency (PMRA) of Canada, several Canadian MRLs for pyraclostrobin are proposed and are expected to be established soon. However, the joint review is expected to have eliminated the potential for discrepancies between U.S. tolerances and Canadian MRLs.

  5. Conclusion

    Therefore, tolerances are established for combined residues of pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy metabolite methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl carbamate, expressed as parent compound, in or on almond, hulls at 1.6 ppm; Banana at 0.04 ppm; barley, grain at 0.4 ppm; barley, hay at 25 ppm; barley, straw at 6.0 ppm; bean, dry at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.2 ppm; beet, sugar, tops at 8.0 ppm; berry, group at 1.3 ppm; citrus, dried pulp at 5.5 ppm; citrus, oil at 4.0 ppm; fruit, citrus, group at 0.7 ppm; fruit, stone, group at 0.9 ppm; grain, aspirated fractions at 2.5 ppm; grape at 2.0 ppm; grape, raisin at 7.0 ppm; grass, forage at 10 ppm; grass, hay at 4.5 ppm; grass, seed screenings at 27 ppm; grass, straw at 14 ppm; nut, tree, group at 0.04 ppm; peanut, nutmeat at 0.05 ppm; peanut, refined oil at 0.1 ppm; pistachio at 0.7 ppm; radish, tops at 16 ppm; rye, grain at 0.04 ppm; rye, straw at 0.5 ppm; strawberry at 0.4 ppm; vegetable, bulb, group at 0.9 ppm; vegetable, cucurbit, group at 0.5 ppm; vegetable, fruiting, group at 1.4 ppm; vegetable, root, except sugar beet, subgroup at 0.4 ppm; vegetable, tuberous and corm, subgroup at 0.04 ppm; wheat, grain at 0.2 ppm; wheat, hay at 6.0 ppm; and wheat, straw at 8.5 ppm, and combined residues of pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2- hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound, in or on cattle, fat at 0.1 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 0.2 ppm; goat, fat at 0.1 ppm; goat, liver at 1.5 ppm; goat, meat at 0.1 ppm; goat, meat byproducts, except liver at 0.2 ppm; hog, fat at 0.1 ppm; hog, liver at 1.5 ppm; hog, meat at 0.1 ppm; hog, meat byproducts, except liver at 0.2 ppm; horse, fat at 0.1 ppm; horse, liver at 1.5 ppm; horse, meat at 0.1 ppm; horse, meat byproducts, except liver at 0.2 ppm; milk at 0.1 ppm; sheep, fat at 0.1 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.1 ppm; and sheep, meat byproducts, except liver at 0.2 ppm.

  6. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

    1. What Do I Need to Do to File an Objection or Request a Hearing?

      You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0225 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2002.

      1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). 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.

        Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your written request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

      2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''

        EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or

        [[Page 60900]]

        refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e- mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

        If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

      3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0225, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

    2. When Will the Agency Grant a Request for a Hearing?

      A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a 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(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

  7. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 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). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

  8. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final

    [[Page 60901]]

    rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and record keeping requirements.

    Dated: September 20, 2002. James Jones, Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as follows:

      Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.582 is added to read as follows:

      Sec. 180.582 Pyraclostrobin; tolerances for residues.

      (a) General. (1)Tolerances are established for combined residues of the fungicide pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)- 1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy metabolite methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl carbamate, expressed as parent compound, in or on the following raw agricultural commodities.

      Commodity

      Parts per million

      Almond, hulls.........................................

      1.6 Banana................................................

      0.04 Barley, grain.........................................

      0.4 Barley, hay...........................................

      25 Barley, straw.........................................

      6.0 Bean, dry.............................................

      0.3 Beet, sugar, dried pulp...............................

      1.0 Beet, sugar, roots....................................

      0.2 Beet, sugar, tops.....................................

      8.0 Berry group...........................................

      1.3 Citrus, dried pulp....................................

      5.5 Citrus, oil...........................................

      4.0 Fruit, citrus, group..................................

      0.7 Fruit, stone, group...................................

      0.9 Grain, aspirated fractions............................

      2.5 Grape.................................................

      2.0 Grape, raisin.........................................

      7.0 Grass, forage.........................................

      10 Grass, hay............................................

      4.5 Grass, seed screenings................................

      27 Grass, straw grown for seed...........................

      14 Nut, tree, group......................................

      0.04 Peanut................................................

      0.05 Peanut, refined oil...................................

      0.1 Pistachio.............................................

      0.7 Radish, tops..........................................

      16 Rye, grain............................................

      0.04 Rye, straw............................................

      0.5 Strawberry............................................

      0.4 Vegetable, bulb.......................................

      0.9 Vegetable, cucurbit, group............................

      0.5 Vegetable, fruiting, group............................

      1.4 Vegetable, root, except sugarbeet, subgroup...........

      0.4 Vegetable, tuberous and corm, subgroup................

      0.04 Wheat, grain..........................................

      0.02 Wheat, hay............................................

      6.0 Wheat, straw..........................................

      8.5

      (2) Tolerances are established for combined residues of the fungicide pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4- chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound, in or on the following raw agricultural commodities.

      Commodity

      Parts per million

      Cattle, fat...........................................

      0.1 Cattle, liver.........................................

      1.5 Cattle, meat..........................................

      0.1 Cattle, meat byproducts, except liver.................

      0.2 Goat, fat.............................................

      0.1 Goat, liver...........................................

      1.5 Goat, meat............................................

      0.1 Goat, meat byproducts, except liver...................

      0.2 Hog, fat..............................................

      0.1 Hog, liver............................................

      1.5

      [[Page 60902]]

      Hog, meat.............................................

      0.1 Hog, meat byproducts, except liver....................

      0.2 Horse, fat............................................

      0.1 Horse, liver..........................................

      0.1 Horse, meat...........................................

      0.1 Horse, meat byproducts, except liver..................

      0.2 Milk..................................................

      0.1 Sheep, fat............................................

      0.1 Sheep, liver..........................................

      1.5 Sheep, meat...........................................

      0.1 Sheep, meat byproducts, except liver..................

      0.2

      (b) Section 18 emergency exemptions. [Reserved]

      (c) Tolerances with regional registrations. [Reserved]

      (d) Indirect or inadvertent residues. [Reserved]

      [FR Doc. 02-24487Filed9-26-02; 8:45 am]

      BILLING CODE 6560-50-S

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