[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Rules and Regulations]
[Pages 60886-60902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24487]


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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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. 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.

B. 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.

II. 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).

III. 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.

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 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 = < 0.31
                                  toxicity            milligrams per
                                                      liter (mg/L)
                                                     LC50 = < 1.07 mg/L;
                                                      toxicity category
                                                      = II
------------------------------------------------------------------------
870.2400                         Acute eye           Minimal eye
                                  irritation          irritation;
                                                      toxicity category
                                                      = III
------------------------------------------------------------------------
870.2500                         Acute dermal        Moderate skin
                                  irritation          irritation;
                                                      toxicity ccategory
                                                      = III
------------------------------------------------------------------------
870.2600                         Skin sensitization  Not a sensitizer
------------------------------------------------------------------------

    The subchronic and chronic toxic effects caused by pyraclostrobin, 
as well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed, are discussed in the following Table 2.

[[Page 60889]]



                       Table 2.--Subchronic, Chronic, and Other Toxicity of Pyraclostrobin
----------------------------------------------------------------------------------------------------------------
                                                                 Study Classification;
           Guideline Number                   Study Type                 Dosing                  Results
----------------------------------------------------------------------------------------------------------------
Number guideline number                28-day feeding study -   Acceptable/              The LOAEL = 500 ppm for
                                        rat                      nonguideline; 0, 20,     both males and
                                                                 100, 500, or 1,500 ppm   females, based on
                                                                 (0, 1.8, 9.0, 42.3, or   changes in hematology
                                                                 120.2 mg/kg/day in       parameters, increased
                                                                 males; 0, 2.0, 9.6,      absolute and relative
                                                                 46.6, or 126.3 mg/kg/    spleen weight,
                                                                 day in females           histopathology in
                                                                                          spleen and liver, and
                                                                                          increased duodenal
                                                                                          mucosal hyperplasia
                                                                                         The NOAEL = 100 ppm for
                                                                                          both sexes
-----------------------------------------------------------------------------------------
870.3100                               13-week feeding study -  Acceptable/guideline;    The LOAEL for both
                                        rat                      0, 50, 150, 500,         sexes = 500 ppm, based
                                                                 1,000, or 1,500 ppm      on reduced body weight
                                                                 (0, 3.5, 10.7, 34.7,     and body weight gain
                                                                 68.8, or 105.8 mg/kg/    in males, reduced food
                                                                 day for males; 0, 4.2,   intake in both sexes,
                                                                 12.6, 40.8, 79.7, or     increased relative
                                                                 118.9 mg/kg/day for      liver weight and
                                                                 females)                 spleen weight in
                                                                                          females,
                                                                                          histopathology of
                                                                                          duodenum and liver in
                                                                                          males, and
                                                                                          histopathology of
                                                                                          spleen in both sexes
                                                                                         The NOAEL = 150 ppm for
                                                                                          both sexes
-----------------------------------------------------------------------------------------
870.3150                               13-week feeding study -  Acceptable/guideline;    The LOAEL for both
                                        dog                      0, 100, 200, and 450     males and females =
                                                                 ppm (0, 2.8, 5.8, and    450 ppm, based on an
                                                                 12.9 mg/kg/day for       increased incidence of
                                                                 males; 0, 3.0, 6.2,      diarrhea, clinical
                                                                 and 13.6 mg/kg/day for   chemistry changes, and
                                                                 females)                 mucosal hypertrophy of
                                                                                          the duodenum in both
                                                                                          sexes; and body weight
                                                                                          loss, decreased food
                                                                                          intake, and decreased
                                                                                          food efficiency in
                                                                                          females
                                                                                         The NOAEL = 200 ppm for
                                                                                          both sexes
-----------------------------------------------------------------------------------------
870.3150                               13-week feeding study -  Acceptable/guideline;    The LOAEL = 150 ppm for
                                        mouse                    0, 50, 150, 500,         both sexes, based on
                                                                 1,000, or 1,500 ppm      reduced body weight
                                                                 (0, 9.2, 30.4, 119.4,    and body weight gain
                                                                 274.4, or 475.5 mg/kg/   in males; changes in
                                                                 day for males; 0,        clinical chemistry
                                                                 12.9, 40.4, 162.0,       (increased urea and
                                                                 374.1, or 634.8 mg/kg/   decreased
                                                                 day for females)         triglyceride) in both
                                                                                          sexes; and increased
                                                                                          incidences of lymph
                                                                                          node apoptosis, thymus
                                                                                          atrophy, and
                                                                                          ulceration/erosionin
                                                                                          the glandular stomach
                                                                                          in females
                                                                                         The NOAEL = 50 ppm for
                                                                                          both sexes
-----------------------------------------------------------------------------------------
870.3200                               28-day dermal toxicity - Unacceptable/guideline;  The LOAEL was > 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
-----------------------------------------------------------------------------------------

[[Page 60891]]

 
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/cm2             could 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
----------------------------------------------------------------------------------------------------------------

B. 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 10-6 or 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.

C. 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 95th percentile, 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 < 1.0% of the aPAD. Females (13-50 years 
old) had a dietary exposure that was 41% of the aPAD.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the valuation DEEMTM analysis 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 (< 1-year old) - 31% of the 
cPAD. All other subgroups analyzed had exposures lower than that of the 
general U.S. population.
    iii. Cancer. The database for carcinogenicity for pyraclostrobin is 
incomplete because the maximum dose levels for female mice and rats in 
the carcinogenicity studies are inadequate. The Agency considered a 
method of expressing potential cancer risk using a linear (Q1*) method 
based on mammary tumors in female rats, to put an upper limit on any 
possible cancer risk. However, statistical analyses of the tumor data 
from the combined results of the rat carcinogenicity and chronic 
toxicology studies showed neither a significant increasing trend nor a 
significant difference in the pair-wise comparison of the dosed groups 
with the controls. In Consultation with the Pest Management Regulatory 
Agency (PMRA), Canada, with whom pyraclostrobin has been jointly 
reviewed, it was decided that a MOE method would be more appropriate. 
The reason is that the genotoxicity data show that pyraclostrobin is 
not mutagenic and the highest dosage level in female rats can be 
interpreted as a NOAEL for cancer. The Agency therefore believes that 
it can make a reasonable certainty of no harm determination for 
carcinogenicity by calculating MOEs, based on the following endpoints: 
(a) NOAELs of 3.4 (for males) and 12.6 (for females) mg/kg/day from the 
2-year carcinogenicity rat feeding study and (b) the NOAEL of 9.0 mg/
kg/day from the 28-day rat feeding study.
    The NOAEL of 3.4 mg/kg/day is based upon chronic toxicity findings 
at the LOAEL of 9.2 mg/kg/day, including decreased body weight and body 
weight gain, kidney tubular casts, and kidney atrophy in both sexes; 
increased incidence of liver necrosis, erosion/ulceration of the 
glandular stomach and forestomach, and hemolymphoreticular tumors in 
males; and mammary adenocarcinoma in females. However, the observed 
increase in incidences of kidney tubular casts atrophy are commonly 
found in this strain of rat and were considered by the Agency to be 
strain and/or age related. The increased incidence of acanthosis and 
ulcers of the forestomach in both sexes were seen at necropsy late in 
the study and were considered to be of equivocal toxicological 
significance, but could not be ruled out as treatment-related effects. 
The NOAEL of 12.6 mg/kg/day for a cancer scenario is the highest tested 
dose in the rat oral carcinogenicity study and, though it is considered 
to be inadequate for assessing carcinogenicity in female rats because 
they could have tolerated a higher dose, it still is suitable for use 
as a NOAEL for the possibility of cancer induction in female rats. The 
dosing in males at 200 ppm (9.2 mg/kg/day) is considered to approach an 
adequate level because there was a (minimal) decrease of 7% of body 
weight and a reduction of up to 10% in body weight gain in addition to 
the slightly increased incidence of erosion/ulceration of glandular 
stomach and forestomach. The rat carcinogenicity study, rather than the 
mouse carcinogenicity study, was used for endpoint selection because 
the NOAELs in the latter study are higher.
    The NOAEL of 9.0 mg/kg/day from the 28-day rat feeding study, based 
on increased incidences of duodenal mucosal hyperplasia in rats of both 
sexes at the LOAEL of 42.3 mg/kg/day, was selected based on the 
hypothesis that the observed hyperplasia would progress to duodenal 
neoplasia following long-term exposure to pyraclostrobin. This endpoint 
was also noted in the 13-week rat feeding study, with a NOAEL of 10.7 
mg/kg bodyweight per day, and in the range-finding reproductive 
toxicity study.
    The dietary MOEs from residues in food and water that were 
calculated from the above three endpoints were 1,100 for the NOAEL of 
3.4 mg/kg/day, 3,200 for the NOAEL of 9.6 mg/kg/day, and 4,200 for the 
NOAEL of 12.6 mg/kg/day.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(F) states that the Agency may use data on the actual 
percent of food treated for assessing chronic dietary risk only if the 
Agency can make the following findings: Condition 1, that the data used 
are reliable and provide a valid basis to show what percentage of the 
food derived from such crop is likely to contain such pesticide 
residue; condition 2, that the exposure estimate does not underestimate 
exposure for any significant subpopulation group; and condition 3, if 
data are available on pesticide use and food consumption in a 
particular area, the exposure estimate does not understate exposure for 
the population in such area. In addition, the Agency must provide for 
periodic evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by section 408(b)(2)(F), 
EPA may require registrants to submit data on PCT.
    In the pyraclostrobin risk assessment the Agency used PCT data as 
follows. PCT values of 100% were assumed where no more-refined data 
were available. EPA utilized PCT values of less than 100% for the 
following commodities: Beet, sugar; berry, group; fruit, citrus, group; 
fruit, stone, group; grain, cereal, group; grape; nut, tree, group; pea 
and bean, dried shelled, except soybean, subgroup; peanut; pistachio; 
potato; strawberry; tomato; vegetable, bulb, group; vegetable, 
cucurbit, group; and vegetable, root and tuber, group. These PCT values 
are based on projected market share information. The registrant 
provided the Agency with their anticipated market share projections. 
The Agency estimated market share projections comparing the efficacy 
spectrum of the registered alternatives to the spectrum of 
pyraclostrobin. In conducting its risk assessment, the Agency utilized 
the EPA-derived estimates. The Agency believes that this approach is 
conservative and will overestimate the potential risk. To further 
ensure the reliability of these data, as a condition of registration, 
the registrant will be required to provide annual reports on the market 
penetration and market share of pyraclostrobin for each of the 
registered crops.
    The Agency believes that the three conditions listed above have 
been met. With respect to condition 1, PCT estimates are derived from 
company-provided anticipatory data that have been reviewed by the 
Agency and are believed to be reliable and to have a valid basis. Since 
there are not any use data for a new pesticidal active ingredient prior 
to its initial registration, the Agency believes that company 
anticipatory estimates provide the best initial estimation of PCT data 
and is reasonably certain that the percentage of the food treated is 
not likely to be an underestimation. Conditions 2 and 3 are satisfied 
by the use of regional consumption data and consumption data for 
significant subpopulations in EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of these consumption data in EPA's risk assessment process 
ensures that EPA's exposure estimate does not understate exposure for 
any significant subpopulation group and allows the Agency to be 
reasonably certain that no regional population is exposed to residue 
levels higher than those estimated by the Agency. Other than the data 
available through national food consumption surveys, EPA does not have 
available information on the regional consumption of food to which 
[pyraclostrobin] may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
monitoring

[[Page 60896]]

exposure data to allow it to complete a comprehensive dietary exposure 
analysis and risk assessment for pyraclostrobin in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling, taking into account data on the physical 
characteristics of pyraclostrobin.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce surface water estimates of pesticide concentrations in an 
index reservoir. The Screening Concentration In Ground Water (SCI-GROW) 
model is used to predict pesticide concentrations in shallow 
groundwater. For a screening-level assessment for surface water EPA 
will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS 
model includes a percent crop treated (PCT) area factor as an 
adjustment to account for the maximum percent crop coverage within a 
watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking 
water levels of comparison (DWLOCs) are calculated and used as points 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food and from residential uses. Since DWLOCs 
address total aggregate exposure to pyraclostrobin they are further 
discussed in the aggregate risk sections.
    Based on the FIRST and SCI-GROW models the EECs of pyraclostrobin 
for acute exposures are estimated to be 20.4 parts per billion (ppb) 
for surface water and 0.009 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.79 ppb for surface water and 0.009 ppb 
for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). However, 
pyraclostrobin is not registered for use on any sites that would result 
in residential exposure. .
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether pyraclostrobin 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, 
pyraclostrobin 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 pyraclostrobin has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
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.
    2. Prenatal and postnatal sensitivity. Qualitative (but not 
quantitative) evidence of increased susceptibility to pyraclostrobin of 
infants and children, as compared to adults, was seen in the prenatal 
development study in rabbits, but neither qualitative nor quantitative 
evidence of increased susceptibility to pyraclostrobin was seen in 
rats.
    3. Conclusion. There is an incomplete toxicity database for 
pyraclostrobin, but exposure data are complete or are estimated based 
on data that reasonably accounts for potential exposures. The Agency 
concluded, despite the 2-generation reproduction study of rats data 
gap, that the FQPA SF can be reduced to 3x for pyraclostrobin because: 
(a) Only qualitative susceptibility was seen and this occurred in only 
one species, (b) there is no qualitative or quantitative evidence of 
increased susceptibility following in utero exposure to pyraclostrobin 
in the prenatal development study in rats, (c) a developmental 
neurotoxicity study is not required, and (d) the dietary (food and 
drinking water) and residential exposure assessments do not 
underestimate the potential exposure for infants, children, or women of 
childbearing age. The 3x FQPA SF was derived prior to finalizing the 
FQPA SF guidance document on January 31, 2002. A formal reconsideration 
of the FQPA SF was not made but the Agency did consider the effect of 
the application of the ``weight of evidence'' approach described in the 
guidance document on the value of the safety factor. It was concluded 
that the 3x FQPA SF established prior to the completion of the guidance 
document would not increase since the developmental effects in the 
rabbit prenatal developmental toxicity study are well characterized and 
the NOAEL for these effects is established. Therefore, there is no need 
for an additional FQPA SF to address potential prenatal or postnatal 
toxicity. In other words, for acute dietary and residential exposure 
assessment of the females 13-50 years old population subgroup, the 3x 
FQPA SF would likely be reduced to 1x. Also, the 3x FQPA SF for 
assessing chronic dietary and residential exposures would not increase 
because of the data base deficiency of the 2-generation reproduction 
study. The reproduction study that was submitted was rejected solely 
because it did not test at a high enough dose to identify toxicity. In 
that study, there was no parental systemic, reproductive, or offspring 
toxicity at any dose including the top dose of 29-36

[[Page 60897]]

mg/kg/day, which is well above the NOAELs of other repeated dose 
toxicity studies. Thus, conduct of another reproduction study will 
better define reproductive effects at high doses but, in all 
likelihood, will have no effect on the RfD.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA are used to calculate DWLOCs: 2L/70 kg 
(adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default 
body weights and drinking water consumption values vary on an 
individual basis. This variation will be taken into account in more 
refined screening-level and quantitative drinking water exposure 
assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, at the 95th percentile the acute 
dietary exposure to pyraclostrobin from food will occupy < 1.0% of the 
aPAD for the U.S. population, 41% of the aPAD for females 13-50 years 
old, < 1.0% of the aPAD for infants (< 1-year old), and < 1.0% of the 
aPAD for children (1-6 years old). In addition, there is potential for 
acute dietary exposure to pyraclostrobin in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the aPAD, as shown in the following Table 4:

                                        Table 4.--Aggregate Risk Assessment for Acute Exposure to Pyraclostrobin.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Maximum
                                                                                 Water
         Population Subgroup1           aPAD mg/kg/  Food Exposure mg/kg/day    Exposure   Acute Ground Water EEC3    Acute Surface Water       DWLOC
                                            day         (95th percentile)       (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).
2 Maximum Water Exposure (mg/kg/day) = PAD (mg/kg/day) - Food Exposure from DEEM (mg/kg/day).
3Based upon SCI-GROW modeling results.
4 Based upon FIRST (version 2) modeling results.
5 DWLOC([mu]g/L) = maximum water exposure (mg/kg/day) x body weight (kg)/water consumption (L) x 103 mg/[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 < 1-year old, and 74% of the 
cPAD for children (1-6 years old). There are no residential uses for 
pyraclostrobin that result in chronic residential exposure to 
pyraclostrobin. However, there is potential for chronic dietary 
exposure to pyraclostrobin in drinking water. After calculating DWLOCs 
and comparing them to the EECs for surface and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the cPAD, as shown 
in the following Table 5:

[[Page 60898]]



                                  Table 5.--Summary of Chronic Drinking Water Levels of Comparison for Pyraclostrobin.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Maximum
                                        cPAD (mg/kg/  Food Exposure (mg/kg/      Water       Chronic Ground Water    Chronic Surface Water      DWLOC5
         Population Subgroup1               day)               day)            Exposure2        EEC3 ([mu]g/L)           EEC4 ([mu]g/L)       ([mu]g/L)
                                                                              (mg/kg/day)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                               0.011                   0.0030   8.0 x 10-3                    0.009                     0.79          280
------------------------------------------------------------------------------------------                                                  ------------
All infants                                   0.011                   0.0034   7.6 x 10-3                                                             76
------------------------------------------------------------------------------------------                                                  ------------
Children (1-6 years)                          0.011                   0.0082   2.8 x 10-3                                                             28
------------------------------------------------------------------------------------------                                                  ------------
Females (13-50 years old)                     0.011                   0.0022   8.8 x 10-3                                                            290
------------------------------------------------------------------------------------------                                                  ------------
Males (13-19 years old)                       0.011                   0.0028   8.2 x 10-3                                                            290
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 10-3 mg/[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 10-5    1.5 x 105        1,100
----------------------------------------------------------------------------------------------------------------
9.0                                                                 3,000                 4.2 x 105        3,000
------------------------------------------------             -------------             -------------------------
12.6                                                                3,000                 4.2 x 105        4,200
----------------------------------------------------------------------------------------------------------------

    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.

IV. Other Considerations

A. 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 0.02 ppm 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: [email protected]. 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.

B. 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.

V. 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.

VI. 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.

A. 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 [email protected], 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: [email protected]. 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.

B. 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).

VII. 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.

VIII. 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. 02-24487 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S