[Federal Register Volume 69, Number 209 (Friday, October 29, 2004)]
[Rules and Regulations]
[Pages 63083-63100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-24247]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0325; FRL-7681-9]


Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the 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-N-[[[1-(4-chlorophenyl) pyrazol-3-
yl]oxy]o-tolyl] carbamate), expressed as parent compound in or on 
apple, wet pomace; brassica, head and stem, subgroup; brassica, leafy 
greens, subgroup; corn, field, grain; corn, field, forage; corn, field, 
stover; corn, field, refined oil; corn, pop, grain; corn, pop, stover; 
corn, sweet, kernel plus cob with husks removed; corn, sweet, forage; 
corn, sweet, stover; fruit, pome, group; hop, dried cones; legume, 
forage, except peanut and soybean; pea, succulent; pea and bean, dried 
shelled, except soybean, subgroup; peppermint; soybean, forage; 
soybean, hay; soybean, hulls; soybean, seed; spearmint; sunflower; 
vegetable, leafy, except brassica, group; vegetable, leaves of root and 
tuber, except sugar beet; and vegetable, legume, edible podded, 
subgroup. This regulation also increases the tolerances for citrus, 
dried pulp; citrus, oil; fruit, citrus, group; and strawberry and 
removes the currently existing tolerance for bean, dry, seed. The 
latter tolerance is superseded by the tolerance for pea and bean, dried 
shelled, except soybean, subgroup. BASF Corporation and Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective October 29, 2004. Objections and 
requests for hearings must be received on or before December 28, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0325. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Dennis McNeilly, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 308-6742; e-mail address: mcneilly.dennis@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; commercial applicators; 
farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., food manufacturing 
plant employees; produce truck drivers; waste disposal truck drivers; 
consumers.
     Pesticide manufacturing (NAICS 32532), e.g., pesticide 
manufacturing plant employees; pesticide distribution employees; 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers.
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

 B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at  http://
www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two at http://
www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://
www.epa.gpo/opptsfrs/home/guidelin.htm/.

 II. Background and Statutory Findings

    In the Federal Register of August 13, 2003 (68 FR 48367) (FRL-7320-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of three pesticide petitions 
(PP 2E6473, 3E6548, and 3E6553) by Interregional Research Project 
Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 
08902-3390. The petitions requested that 40 CFR 180.582 be amended by 
establishing tolerances for the combined residues of the fungicide 
carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester], pyraclostrobin, and 
methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate, the 
desmethoxy metabolite of pyraclostrobin, expressed as parent compound], 
in or on brassica, head and stem, subgroup at 5 ppm (PP 3E6553); 
lettuce, head at 22 ppm (PP 2E6473); lettuce, leafy at 22 ppm (PP

[[Page 63084]]

2E6473); and vegetable, leaves of root and tuber, group at 16 ppm (PP 
3E6548).
    In the Federal Register of August 27, 2004 (69 FR 52670) (FRL-7676-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of three pesticide petitions 
(PP 0F6139, 2F6431, and 3F6581) by BASF Corporation, Research Triangle 
Park, NC 27709 and one pesticide petition (PP 3E6774) by Interregional 
Research Project Number 4 (IR-4), 681 U.S. Highway 1 South, 
North Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 
180.582 be amended by establishing tolerances for the combined residues 
of the fungicide carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester, pyraclostrobin, and 
methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate, the 
desmethoxy metabolite of pyraclostrobin, expressed as parent compound, 
in or on apple, wet pomace at 8.0 ppm (PP 2F6431); brassica, leafy 
greens, subgroup at 16.0 ppm (PP 3F6581); corn, field, grain at 0.1 ppm 
(PP 2F6431); corn, field, forage at 5.0 ppm (2F6431); corn, field, 
stover at 17.0 ppm (PP 2F6431); corn, field, refined oil at 0.2 ppm (PP 
2F6431); corn, pop, grain at 0.1 ppm (PP 2F6431); corn, pop, stover at 
17.0 ppm (PP 2F6431); corn, sweet, kernel plus cob with husks removed 
at 0.04 ppm (PP 2F6431); corn, sweet, forage at 5.0 ppm (PP 2F6431); 
corn, sweet, stover at 23.0 ppm (PP 2F6431); fruit, pome, group 11 at 
1.5 ppm (PP 2F6431); hop, dried, cones at 23.0 ppm (PP 2F6431); legume, 
forage, except peanut and soybean at 25.0 ppm (PP 2F6431); pea, 
succulent at 0.2 ppm (PP 2F6431); pea and bean, dried shelled, except 
soybean, subgroup at 0.3 ppm (PP 0F6139); peppermint at 8.0 ppm 
(PP2F6431); soybean, forage at 5.0 ppm (PP 3F6581); soybean, hay at 7.0 
ppm (PP 3F6581); soybean, hulls at 0.06 ppm (PP 3F6581); soybean, seed 
at 0.04 ppm (PP 3F6581); spearmint at 8.0 ppm (PP 2F6431); sunflower at 
0.3 ppm (PP 2F6431); vegetable, leafy, except brassica, group at 29.0 
ppm (PP 3E6774); and vegetable, legume, edible podded, subgroup at 0.5 
ppm (PP 2F6431). Tolerance petition 3F6581 also requests that 40 CFR 
180.582 be amended by increasing the tolerances for the combined 
residues of pyraclostrobin and the desmethoxy metabolite of 
pyraclostrobin, expressed as parent compound, in or on citrus, dried 
pulp to 12.5 ppm (PP 3F6581); citrus, oil to 9.0 ppm (PP 3F6581); and 
fruit, citrus, group to 2.0 ppm (PP 3F6581). Tolerance petition 0F6139 
also requests that 40 CFR 180.582 be amended by removing the tolerance 
for the combined residues of pyraclostrobin and the desmethoxy 
metabolite of pyraclostrobin, expressed as parent compound, in or on 
bean, dry, seed at 0.3 ppm. The latter tolerance has been superseded by 
the tolerance for pea and bean, dried shelled, except soybean, subgroup 
at 0.3 ppm.
    In the Federal Register of August 30, 2004 (68 FR 52891) (FRL-7676-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4F6850) by BASF Corporation, Research Triangle Park, NC 27709. The 
petition requested that 40 CFR 180.582 be amended by increasing the 
tolerance for the combined residues of the fungicide carbamic acid, [2-
[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-,methyl 
ester, pyraclostrobin, and methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-
yl]oxy]o-tolyl] carbamate, the desmethoxy metabolite of pyraclostrobin, 
expressed as parent compound, in or on strawberry to 1.5 ppm.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that`` there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA 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) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, to establish (or increase) tolerances for the 
combined residues of carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-
pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester, pyraclostrobin, 
and methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate, 
the desmethoxy metabolite of pyraclostrobin, expressed as parent 
compound in or on apple, wet pomace 8.0 ppm; brassica, head and stem, 
subgroup at 5.0 ppm; brassica, leafy greens, subgroup at 16.0 ppm; 
citrus, dried pulp at 12.5 ppm (increased from 5.5 ppm); citrus, oil at 
9.0 ppm (increased from 4.0 ppm); corn, field, grain at 0.1 ppm; corn, 
field, forage at 5.0 ppm; corn, field, stover at 17.0 ppm; corn, field, 
refined oil at 0.2 ppm; corn, pop, grain at 0.1 ppm; corn, pop, stover 
at 17.0 ppm; corn, sweet, kernel plus cob with husks removed at 0.04 
ppm; corn, sweet, forage at 5.0 ppm; corn, sweet, stover at 23.0 ppm; 
fruit, citrus, group at 2.0 ppm (increased from 0.7 ppm); fruit, pome, 
group at 1.5 ppm; hop, dried cones at 23.0 ppm; legume, forage, except 
peanut and soybean at 25.0 ppm; pea, succulent at 0.2 ppm; pea and 
bean, dried shelled, except soybean, subgroup at 0.3 ppm; peppermint at 
8.0 ppm; soybean, forage at 5.0 ppm; soybean, hay at 7.0 ppm; soybean, 
hulls at 0.06 ppm; soybean, seed at 0.04 ppm; spearmint at 8.0 ppm; 
strawberry at 1.5 ppm (a temporary increased tolerance with an 
expiration date of December 31, 2005); sunflower at 0.3 ppm; vegetable, 
legume, edible podded, subgroup at 0.5 ppm; vegetable, leafy, except 
brassica, group at 29.0 ppm; and vegetable, leaves of root and tuber, 
except sugar beet at 16.0 ppm ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by pyraclostrobin are 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

[[Page 63085]]



                            Table 1.--Subchronic, Chronic and Other Toxicity Profile
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity-rat    The study is acceptable/guideline.
                                                                     Dosing levels were 0, 50, 150, 500, 1,000,
                                                                      and 1,500 ppm (males: 0, 3.5, 10.7, 34.7,
                                                                      68.8, and 105.8 mg/kg/day; females: 0,
                                                                      4.2, 12.6, 40.8, 79.7, and 118.9 mg/kg/
                                                                      day).
                                                                     The NOAEL was 10.7 mg/kg/day.
                                                                     The LOAEL was 34.7 mg/kg/day based on
                                                                      reduced body weight and weight gain in
                                                                      males, reduced food intake in both sexes,
                                                                      increased relative liver weight and spleen
                                                                      weight in females, the histopathology of
                                                                      the duodenum and liver in males, and the
                                                                      histopathology of the spleen in both
                                                                      sexes.
----------------------------------------
870.3100                                 90-Day oral toxicity-mouse  The study is acceptable/guideline.
                                                                     Dosing levels were 0, 50, 150, 500, 1,000,
                                                                      and 1,500 ppm (males: 0, 9.2, 30.4, 119.4,
                                                                      274.4, and 475.5 mg/kg/day; females: 0,
                                                                      12.9, 40.4, 162.0, 374.1, and 634.8 mg/kg/
                                                                      day).
                                                                     The NOAEL was 9.2 mg/kg/day.
                                                                     The LOAEL was 30.4 mg/kg/day based on
                                                                      reduced body weight and body weight gain
                                                                      in males, changes in clinical chemistry
                                                                      (increased urea and decreased
                                                                      triglycerides) in both sexes, and
                                                                      increased incidences in females of lymph
                                                                      node apoptosis, thymus atrophy, and
                                                                      ulceration and erosion in the glandular
                                                                      stomach.
----------------------------------------
870.3150                                 90-Day oral toxicity-dog    The study is acceptable/guideline.
                                                                     The dosing levels were 0, 100, 200, and 450
                                                                      ppm (males: 0, 2.8, 5.8, and 12.9 mg/kg/
                                                                      day; females: 0, 3.0, 6.2, and 13.6 mg/kg/
                                                                      day).
                                                                     The NOAEL was 5.8 mg/kg/day.
                                                                     The LOAEL was 12.9 mg/kg/day based on
                                                                      increased diarrhea, clinical chemistry
                                                                      changes, and increased incidence of
                                                                      thickening and mucosal hypertrophy of the
                                                                      duodenum in both sexes; and body weight
                                                                      loss, reduced food intake, and reduced
                                                                      food efficiency in females.
----------------------------------------
870.3050                                 28-Day oral toxicity-rat    The study is acceptable/guideline.
                                                                     The dosing levels were 0, 20, 100, 500, and
                                                                      1,500 ppm (males: 0, 1.8, 9.0, 42.3, and
                                                                      120.2 mg/kg/day; females: 0, 2.0, 9.6,
                                                                      46.6, and 126.3 mg/kg/day.
                                                                     The NOAEL was 9.0 mg/kg/day.
                                                                     The LOAEL was 42.3 mg/kg/day based on
                                                                      changes in hematology parameters,
                                                                      increased absolute and relative spleen
                                                                      weight, histopathology in spleen and
                                                                      liver, and increased duodenal mucosal
                                                                      hyperplasia in both sexes.
----------------------------------------
870.3200                                 28-Day dermal toxicity-rat  This study was judged to be unacceptable/
                                                                      guideline because a higher dose could have
                                                                      been tolerated and the limit dose is 1,000
                                                                      mg/kg/day.
                                                                     The dosing levels were 0, 40, 100, 250 mg/
                                                                      kg for 5 days/wk
                                                                     The dermal NOAEL was 40 mg/kg/day.
                                                                     The dermal LOAEL was 100 mg/kg/day based on
                                                                      scale formation, hyperkeratosis, and
                                                                      epidermal thickening.
----------------------------------------
870.3465                                 28-Day inhalation toxicity- Study pending.
                                          rat                        Required due to the potential for
                                                                      occupational/residential exposure via this
                                                                      route.
----------------------------------------
870.3700                                 Prenatal development-rat    The study is acceptable/guideline.
                                                                     The dosing levels were 0, 10, 25, 50 mg/kg/
                                                                      day.
                                                                     The maternal NOAEL was 10 mg/kg/day; the
                                                                      maternal LOAEL was 25 mg/kg/day based on
                                                                      reduced body weight, body weight gain,
                                                                      food intake, and food efficiency.
                                                                     The developmental NOAEL was 25 mg/kg/day;
                                                                      the developmental LOAEL was 50 mg/kg/day
                                                                      based on increased incidences of dilated
                                                                      renal pelvis and cervical ribs with no
                                                                      cartilage.
----------------------------------------
870.3700                                 Prenatal development-       This study is acceptable/guideline.
                                          rabbit                     The dosing levels were 0, 1, 3, 5, 10, and
                                                                      20 mg/kg/day.
                                                                     The maternal NOAEL was 5 mg/kg/day
                                                                     The maternal LOAEL was 10 mg/kg/day based
                                                                      on reduced body weight gain, reduced food
                                                                      intake, and reduced food efficiency.
                                                                     The developmental NOAEL was 5 mg/kg/day;
                                                                      the developmental LOAEL was 10 mg/kg/day
                                                                      based on increased resorption and post-
                                                                      implantation loss.
----------------------------------------

[[Page 63086]]

 
870.3800                                 Two generation              This study is acceptable/guideline when
                                          reproduction study-rat      combined with the one generation
                                                                      preliminary study (below).
                                                                     The dosing levels were 0, 25, 75, and 300
                                                                      ppm (F0 males: 0, 2.5, 7.4, and 29.0 mg/kg/
                                                                      day; F0 females 0, 2.6, 7.8, and 30.4 mg/
                                                                      kg/day; F1 males: 0, 2.8, 8.6, and 35.0 mg/
                                                                      kg/day; F1 females: 0, 3.0, 9.0, and 36.0
                                                                      mg/kg/day.
                                                                     The parental/systemic NOAEL was 29 mg/kg/
                                                                      day.
                                                                     The parental/systemic LOAEL was greater
                                                                      than 29 mg/kg/day based on no observed
                                                                      effects.
                                                                     The reproductive NOAEL was 29 mg/kg/day.
                                                                     The reproductive LOAEL was greater than 29
                                                                      mg/kg/day based on no observed effects.
                                                                     The offspring NOAEL was 29 mg/kg/day.
                                                                     The offspring LOAEL was greater than 29 mg/
                                                                      kg/day based on no observed effects.
----------------------------------------
870.3800                                 One-generation              The dosing levels were 0, 200, 400, and 600
                                          reproduction study-rat      ppm (F0 males: 0, 20.5, 39.9, and 59.1 mg/
                                                                      kg/day; F0 females: 0, 21.3, 42.5, and
                                                                      60.4 mg/kg/day).
                                                                      The offspring NOAEL was less than 20.5 mg/
                                                                      kg/day.
                                                                     The offspring LOAEL was 20.5 mg/kg/day
                                                                      based on decreased pup body weight and
                                                                      body weight gain on and after post-natal
                                                                      day 7.
----------------------------------------
870.4100                                 Chronic toxicity-rat        This study was judged to be unacceptable/
                                                                      guideline.
                                                                     The dosing levels were 0, 25, 75, and 200
                                                                      ppm (males: 0, 1.1, 3.4, and 9.0 mg/kg/
                                                                      day; females: 0, 1.5, 4.6, and 12.3 mg/kg/
                                                                      day.
                                                                     The NOAEL was 9.0 mg/kg/day and the LOAEL
                                                                      was greater than 9.0 mg/kg/day, so the
                                                                      Agency judged the study to be unacceptable
                                                                      because the highest dosing level was
                                                                      insufficient to produce a significant
                                                                      toxicological response.
----------------------------------------
870.4100                                 Chronic toxicity-dog        This study is acceptable/guideline.
                                                                     The dosing levels were 0, 100, 200, and 400
                                                                      ppm (males: 0, 2.7, 5.4, and 10.8 mg/kg/
                                                                      day; female: 0, 2.7, 5.4, and 11.2 mg/kg/
                                                                      day.
                                                                     The NOAEL was 5.4 mg/kg/day.
                                                                     The LOAEL was 10.8 mg/kg/day based on
                                                                      increased diarrhea and clinical chemistry
                                                                      changes in both sexes (decreased
                                                                      cholesterol, protein, albumin, and
                                                                      globulin); and reduced body weight gain
                                                                      and food intake and efficiency in females.
----------------------------------------
870.4200                                 Carcinogenicity-rat         This study is acceptable/guideline.
                                                                     The dosing levels were 0, 25, 75, and 200
                                                                      ppm (males: 0, 1.2, 3.4, and 9.2 mg/kg/
                                                                      day; females: 0, 1.5, 4.7, and 12.6 mg/kg/
                                                                      day).
                                                                     The NOAEL was 3.4 mg/kg/day.
                                                                     The LOAEL was 9.2 mg/kg/day based on
                                                                      reduced body weight and body weight gain,
                                                                      kidney atrophy and tubular casts in both
                                                                      sexes, and hepatic necrosis plus gross and
                                                                      microscopic ulcerations and lesions in the
                                                                      glandular and fore-stomachs in males.
                                                                     There was no evidence of carcinogenicity.
----------------------------------------
870.4300                                 Carcinogenicity-mouse       This study was judged to be unacceptable/
                                                                      guideline.
                                                                     The dosing levels for males were 0, 10, 30,
                                                                      and 120 ppm (0, 1.4, 4.1, and 17.2 mg/kg/
                                                                      day).
                                                                     The dosing levels for females were 0, 10,
                                                                      30, 120, and 180 ppm (0, 1.6, 4.8, 20.5,
                                                                      and 32.8 mg/kg/day).
                                                                     The NOAEL for males was 4.1 mg/kg/day and
                                                                      for females was 32.8 mg/kg/day.
                                                                     The LOAEL for males was 17.1 mg/kg/day
                                                                      based on decrease of 20% in body weight
                                                                      gain at 13 weeks that was supported by the
                                                                      results of a 90-day study.
                                                                     The LOAEL for females was greater than 32.8
                                                                      mg/kg/day.
                                                                     The Agency judged the highest dosing level
                                                                      to be inadequate in females because it did
                                                                      not produce a significant toxicological
                                                                      response. There was no evidence of
                                                                      carcinogenicity
----------------------------------------
870.5100                                 Gene mutation: Bacterial    This study is acceptable/guideline.
                                          reverse mutation assay     The results were negative  S9
                                                                      up to 5,000 [mu]g/plate by standard plate
                                                                      and tube preincubation.
                                                                     There was no cytotoxicity at any dose but
                                                                      there was precipitation at >=2,500 [mu]g/
                                                                      plate.
----------------------------------------
870.5300                                 Gene mutation: Mammalian    This study is acceptable/guideline.
                                          cell culture               The results were negative  S9
                                                                      up to cytotoxic and precipitating
                                                                      concentration of 20 [mu]g/mL.
----------------------------------------
870.5375                                 Cytogenetics (in vitro):    This study is acceptable/guideline.
                                          Chromosomal aberrations    The results were negative  S9
                                                                      for clastogenic/aneugenic activity up to
                                                                      25 [mu]g/mL.
                                                                     Precipitation and cytotoxicity (reduced
                                                                      cell attachment and poor quality of
                                                                      metaphases) were seen at concentrations
                                                                      >='50 [mu]g/mL.
----------------------------------------

[[Page 63087]]

 
870.5395                                 Cytogenetics: Micronucleus  This study is acceptable/guideline.
                                          test in mouse              The results were negative for clastogenic/
                                                                      aneugenic activity up to the highest dose
                                                                      tested (HDT) (300 mg/kg). In a preliminary
                                                                      study, doses >=400 mg/kg caused death.
----------------------------------------
870.5550                                 Unscheduled DNA synthesis:  This study is acceptable/guideline.
                                          Rat hepatocyte culture     The results were negative up to a cytotoxic
                                                                      concentration of 1.0 [mu]g/mL.
----------------------------------------
870.6200                                 Acute neurotoxicity         This study is acceptable/guideline.
                                          screening-rat              The dosing levels were 0, 100, 300, and
                                                                      1,000 mg/kg.
                                                                     The neurotoxicity NOAELs were 1000 mg/kg
                                                                      and the LOAELS were greater than 1,000 mg/
                                                                      kg for both males and females.
                                                                     The systemic NOAEL was 300 mg/kg for males
                                                                      and 1,000 mg/kg for females.
                                                                     The systemic LOAEL was greater than 1,000
                                                                      mg/kg for females; it was 1,000 mg/kg for
                                                                      males based on reduced body weight gain in
                                                                      males.
----------------------------------------
870.6200                                 Subchronic neurotoxicity    This study is acceptable/guideline.
                                          screening-rat              The dosing levels were 0, 50, 250, and 750
                                                                      (males)/1500 (females) ppm (males: 0, 3.5,
                                                                      16.9, 49.9 mg/kg/day; females: 0, 4.0,
                                                                      20.4, 111.9 mg/kg/day).
                                                                     The neurotoxicity NOAEL for males was 49.9/
                                                                      111.9 mg/kg/day and for females was 111.9
                                                                      mg/kg/day.
                                                                     The neurotoxicity LOAEL for males was
                                                                      greater than 49.9 mg/kg/day and for
                                                                      females was greater than 111.9 mg/kg/day.
                                                                     The systemic NOAEL for males was 16.9 mg/kg/
                                                                      day and for females was 20.4 mg/kg/day.
                                                                     The systemic LOAEL for males was 49.9 mg/kg/
                                                                      day and for females was 111.9 mg/kg/day
                                                                      based on reduced body weight gain, food
                                                                      intake and food efficiency.
----------------------------------------
870.7485                                 Metabolism and              This study is acceptable/guideline.
                                          pharmacokinetics-rat       Nearly 35% of an oral dose of
                                                                      pyraclostrobin is absorbed, with urinary
                                                                      and fecal excretion accounting for about
                                                                      15% and 85% of excretion, respectively.
                                                                      Bile elimination accounted for about 30%.
                                                                      Two peak plasma concentrations were
                                                                      reached at 0.5 - 1 and at 8 hours with 16
                                                                      to 38% lower plasma concentrations in
                                                                      males than females during the early peak
                                                                      phase. Elimination was biphasic at a low
                                                                      dose with plasma half lives of nearly 10
                                                                      and 35 hours and monophasic at a high dose
                                                                      with a half-life of nearly 20 hours.
                                                                      Tissue distribution was fast, peaking at
                                                                      0.5 hours, and was slightly higher among
                                                                      females. Some of the highest
                                                                      concentrations were found in the liver,
                                                                      thyroid, kidney, lung, adrenal glands, and
                                                                      pancreas but all levels dropped by more
                                                                      than 20-fold within 72 hours. About 33
                                                                      metabolites were identified in urine,
                                                                      feces, and bile with no sex- or dose-
                                                                      related differences but the position of
                                                                      the label seemed to alter the profile,
                                                                      particularly in the urine. Desmethoxy
                                                                      pyraclostrobin is one of the major
                                                                      metabolites (labeled 500M07) in rat and is
                                                                      also found in large amounts in plants
                                                                      (labeled BF 500-3) and livestock (also
                                                                      labeled 500M07). The rat metabolic pathway
                                                                      included phase I reactions such as N-
                                                                      demethoxylation, various hydroxylations,
                                                                      and cleavage of the ether bond with
                                                                      subsequent oxidation; these reactions were
                                                                      followed by phase II glucuronidation and
                                                                      sulfation.
----------------------------------------
870.7600                                 Dermal penetration-rat      This study was judged to be unacceptable/
                                                                      guideline because most of the test
                                                                      material was retained on the dressing and
                                                                      was therefore unavailable for absorption.
                                                                      This makes it very difficult to determine
                                                                      the actual dose. However, the Agency was
                                                                      able to calculate a maximum possible
                                                                      dermal penetration rate of 14%.
----------------------------------------------------------------------------------------------------------------
Notes: Mg/kg = milligram(s) per kilogram; mg/kg/day = milligram(s) per kilogram per day; mL = milliliter(s);
  days/wk = days per week; [mu]g = microgram(s)

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (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.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants

[[Page 63088]]

and children primarily as a result of the FQPA. The ``default FQPA 
safety factor'' is the additional 10X safety factor that is mandated by 
the statute unless it is decided that there are reliable data to choose 
a different additional factor (potentially a traditional uncertainty 
factor or a special FQPA safety factor).
    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 an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, 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 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). Examples of how such a probability risk is expressed are 
description of the risk as one in one hundred thousand (1 X 
10-\5\), one in a million (1 X 10-\6\), or one in 
ten million (1 X 10-\7\). 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 that 
were used for human risk assessment is shown in Table 2 below.

                    Table 2.--Summary of Toxicological Dose and Endpoints for Pyraclostrobin
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                          Assessment; Inter-      Special FQPA SF and    Study and Toxicological
          Exposure Scenario             species, Intraspecies,    Level of Concern for           Effects
                                             and UF; RfD            Risk Assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of  NOAEL= 5 mg/kg/day       FQPA SF = 1X             Rabbit prenatal
 age)                                  UF = 100...............  aPAD = 0.05 mg/kg/day..   developmental toxicity
                                       Acute RfD = 0.05 mg/kg/                            study.
                                        day.                                             LOAEL = 10 mg/kg/day
                                                                                          based on developmental
                                                                                          toxicity findings of
                                                                                          increased resorptions
                                                                                          per litter and
                                                                                          increased total
                                                                                          resorptions (i.e.,
                                                                                          dams with complete
                                                                                          litter loss).
--------------------------------------
Acute Dietary (General population      NOAEL = 300 mg/kg        FQPA SF = 1X             Rat acute oral
 including infants and children)       UF = 100...............  aPAD = 3.0 mg/kg/day...   neurotoxicity study.
                                       Acute RfD = 3.0 mg/kg/                            LOAEL = 1000 mg/kg/day
                                        day.                                              based on decreased
                                                                                          body weight gain in
                                                                                          males.
--------------------------------------
Chronic Dietary (All populations)      NOAEL= 3.4 mg/kg/day     FQPA SF = 1X             Rat oral
                                       UF = 100...............  cPAD = 0.034 mg/kg/day.   carcinogenicity study.
                                       Chronic RfD = 0.034 mg/                           LOAEL = 9.2 mg/kg/day
                                        kg/day.                                           based on decreased
                                                                                          body weight and body
                                                                                          weight gain, and
                                                                                          kidney tubular casts
                                                                                          and atrophy in both
                                                                                          sexes, increased
                                                                                          incidence of liver
                                                                                          necrosis and erosion/
                                                                                          ulceration of the
                                                                                          glandular stomach and
                                                                                          forestomach in males,
                                                                                          plus
                                                                                          hemolymphoreticular
                                                                                          tumors in males and
                                                                                          mammary adenocarcinoma
                                                                                          in females.
--------------------------------------
Short-Term Incidental Oral (1-30       NOAEL= 5.8 mg/kg/day     Residential LOC for MOE  13-Week dog feeding
 days)                                                           = 100                    study. LOAEL = 12.9 mg/
                                                                Occupational LOC for      kg/day based on
                                                                 MOE = NA.                increased incidence of
                                                                                          diarrhea, clinical
                                                                                          chemistry changes,
                                                                                          duodenum mucosal
                                                                                          hypertrophy, and
                                                                                          decreased body weight,
                                                                                          food intake, and food
                                                                                          efficiency.
--------------------------------------
Intermediate-Term Incidental Oral (1-  NOAEL= 5.8 mg/kg/day     Residential LOC for MOE  13-Week dog feeding
 6 months)                                                       = 100                    study.
                                                                Occupational LOC for     LOAEL = 12.9 mg/kg/day
                                                                 MOE = NA.                based on increased
                                                                                          incidence of diarrhea,
                                                                                          clinical chemistry
                                                                                          changes, duodenum
                                                                                          mucosal hypertrophy,
                                                                                          and decreased body
                                                                                          weight, food intake,
                                                                                          and food efficiency.
--------------------------------------
Short-Term Dermal (1 to 30 days)       Oral study               Residential LOC for MOE  Rabbit prenatal
                                       NOAEL = 5.0 mg/kg/day     = 100                    developmental toxicity
                                        (dermal absorption      Occupational LOC for      study.
                                        rate = 14 %).            MOE = 100.              LOAEL = 10.0 mg/kg/day
                                                                                          based on developmental
                                                                                          toxicity findings of
                                                                                          increased resorptions
                                                                                          per litter and
                                                                                          increased total
                                                                                          resorptions (i.e.,
                                                                                          dams with complete
                                                                                          litter loss).
--------------------------------------

[[Page 63089]]

 
Intermediate-Term Dermal (1 to 6       Oral study               Residential LOC for MOE  Rabbit prenatal
 months)                               NOAEL = 5.0 mg/kg/day     = 100                    developmental toxicity
                                        (dermal absorption      Occupational LOC for      study.
                                        rate = 14 %).            MOE = 100.              LOAEL = 10.0 mg/kg/day
                                                                                          based on developmental
                                                                                          toxicity findings of
                                                                                          increased resorptions
                                                                                          per litter and
                                                                                          increased total
                                                                                          resorptions (i.e.,
                                                                                          dams with complete
                                                                                          litter loss).
--------------------------------------
Long-Term Dermal (>6 months)           Oral study               Residential LOC for MOE  Rat oral
                                       NOAEL = 3.4 mg/kg/day     = 100                    carcinogenicity study.
                                        (dermal absorption      Occupational LOC for     LOAEL = 9.2 mg/kg/day
                                        rate = 14 %).            MOE = 100.               based in males on
                                                                                          decreased body weight
                                                                                          and body weight gain,
                                                                                          and 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,
                                                                                          plus
                                                                                          hemolymphoreticular
                                                                                          tumors in males and
                                                                                          mammary adenocarcinoma
                                                                                          in females.
--------------------------------------
Short-Term Inhalation (1 to 30 days)   Oral study               Residential LOC for MOE  Rabbit prenatal
                                       NOAEL = 5.0 mg/kg/day     = 100                    developmental toxicity
                                        (inhalation absorption  Occupational LOC for      study.
                                        rate = 100%).            MOE = 100.              LOAEL = 10.0 mg/kg/day
                                                                                          based on developmental
                                                                                          toxicity findings of
                                                                                          increased resorptions
                                                                                          per litter and
                                                                                          increased total
                                                                                          resorptions (i.e.,
                                                                                          dams with complete
                                                                                          litter loss).
--------------------------------------
Intermediate-Term Inhalation (1 to 6   Oral study               Residential LOC for MOE  Rabbit prenatal
 months)                               NOAEL = 5.0 mg/kg/day     = 100                    developmental toxicity
                                        (inhalation absorption  Occupational LOC for      study.
                                        rate = 100%).            MOE = 100.              LOAEL = mg/kg/day based
                                                                                          on developmental
                                                                                          toxicity findings of
                                                                                          increased resorptions
                                                                                          per litter and
                                                                                          increased total
                                                                                          resorptions (i.e.,
                                                                                          dams with complete
                                                                                          litter loss).
--------------------------------------
Long-Term Inhalation(>6 months)        Oral study               Residential LOC for MOE  Rat oral
                                       NOAEL = 3.4 mg/kg/day     = 100                    carcinogenicity study.
                                        (inhalation absorption  Occupational LOC for     LOAEL = 9.2 mg/kg/day
                                        rate = 100%).            MOE = 100.               based in both sexes on
                                                                                          decreased body weight
                                                                                          and body weight gain,
                                                                                          and 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,
                                                                                          plus
                                                                                          hemolymphoreticular
                                                                                          tumors in males and
                                                                                          mammary adenocarcinoma
                                                                                          in females.
--------------------------------------
Cancer (MOE Approach)                  NOAEL = 32.8                                      Mouse oral
                                                                                          carcinogenicity study.
                                                                                         Results were that
                                                                                          mortality, clinical
                                                                                          signs, body weight,
                                                                                          body weight gain, food
                                                                                          consumption, food
                                                                                          efficiency,
                                                                                          hematology, organ
                                                                                          weights, and gross and
                                                                                          microscopic findings
                                                                                          for both sexes at all
                                                                                          doses were unaffected
                                                                                          by treatment. The HDT
                                                                                          was 32.8 mg/kg/day in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Note: NA = Not Applicable

    The Agency has concluded that the rat carcinogenicity study is 
acceptable for both sexes and did not show either a significant 
increasing tumor trend or a significant difference in tumor incidence 
in the pair-wise comparison of the dosed groups with the controls. The 
Agency has also concluded that the mouse carcinogenicity study was 
acceptable for males, in which there was no evidence of 
carcinogenicity. In general, acceptable study results indicate that 
pyraclostrobin is unlikely to be a carcinogen. However, the Agency has 
also concluded that the carcinogenicity data available for 
pyraclostrobin are inadequate to allow full assessment of the human 
carcinogenic potential of this pesticide because the highest dosing 
levels for females in the mouse carcinogenicity study were not great 
enough to produce significant toxicological effects (that is, the HDT 
is the NOAEL for female mice in this study). The company is performing 
an additional carcinogenicity study in female mice to remedy this 
deficiency. Because neither of the cancer studies show any evidence of 
carcinogenicity, a non-threshold (Q-star) approach cannot be used to 
estimate cancer risk. Instead, a regulatory MOE has been chosen as a 
tool for bounding any potential chronic dietary cancer risk from 
pyraclostrobin that may exist. The regulatory MOE is derived from the 
HDT in female mice (a NOAEL of 32.8 mg/kg/day) and is 10 times higher 
than the NOAEL used for chronic non-cancer risk. This is not the 
traditional MOE approach used to assess the risks of using threshold 
carcinogens but is believed by the Agency to be appropriate in this 
situation for the following reasons:
     The genotoxicity data indicate that pyraclostrobin is not 
mutagenic,

[[Page 63090]]

     Both sex groups in the rat study and the male group in the 
mouse study showed no treatment-related increase in tumors, and
     Two structural analogs of pyraclostrobin have been found 
``not likely to be carcinogenic to humans.''
It is, as well, commonly accepted that developing cancers which have 
been triggered by non-genotoxic substances are reversible if exposure 
is discontinued prior to complete propagation of the pre-neoplastic 
lesions or the full expression of cancer.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have 
previously been established (see 40 CFR 180.582) for the 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-N-[[[1-(4-chlorophenyl) pyrazol-3-
yl]oxy]o-tolyl] carbamate), expressed as parent compound, in or on a 
variety of raw agricultural commodities, including barley, grain; beet, 
sugar, roots; berry, group; fruit, citrus, group; fruit, stone, group; 
nut, tree, group; peanut; rye, grain; vegetable, bulb, group; 
vegetable, cucurbit, group; vegetable, fruiting, group; vegetable, 
root, except sugar beet, subgroup; vegetable, tuberous and corm, 
subgroup; and wheat, grain. Tolerances have also been established for 
the 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 the fat, liver, meat, and meat byproducts except 
liver of cattle, goat, hog, horse, and sheep, and in milk. Risk 
assessments to assess dietary exposures from pyraclostrobin in food 
were conducted by EPA 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 one-day 
or single exposure.
    In conducting the acute dietary risk assessments EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\, Version 2.0), which accumulates food 
consumption (exposure) data directly from reports by respondents in the 
USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII), and accumulated exposure to the chemical for each 
commodity. EPA also used the Lifeline\TM\, Version 2.0 model to conduct 
the acute dietary risk assessments. Lifeline\TM\ also uses the CSFII, 
1994-1996 and 1998 food consumption database but accumulates exposure 
data using statistical and random samplings of the database. The 
following assumptions were made for the acute exposure assessments. 
Tolerance level pyraclostrobin residues, default processing factors, 
and a 100% crop treated assumption were used for all commodities, as 
appropriate, except as follows. The highest average field trial residue 
data were used for leafy vegetables. Mango and papaya, on which no 
action has yet been taken, were also included in this analysis.
    ii. Chronic exposure. Chronic dietary risk assessments are 
performed for a food-use pesticide if a toxicological study and the use 
pattern of the pesticide have indicated the possibility of an effect of 
concern occurring as a result of a long-term exposure.
     In conducting the chronic dietary risk assessment EPA used the 
DEEM-FCID\TM\ model, which incorporates food consumption data as 
reported by respondents in the USDA 1994-1996 and 1998 CSFII and 
accumulated exposure to the chemical for each commodity. EPA also used 
the Lifeline\TM\, Version 2.0 model to conduct the chronic dietary risk 
assessments. Lifeline\TM\ also uses the CSFII, 1994-1996 and 1998 food 
consumption database but accumulates exposure data using statistical 
and random sampling of the database. The following assumptions were 
made for the chronic exposure assessments. Tolerance level 
pyraclostrobin residues and default processing factors were used for 
raw and processed agricultural commodities, as appropriate, except as 
detailed below. Percent crop treated (PCT) data were used for most crop 
plant commodities but 100% crop treated values were assumed for banana 
commodities, mango and papaya (on which no action has been taken yet) 
commodities, and all animal commodities. The highest average field 
trial residue data (instead of tolerance level residues) were used for 
vegetables, leafy, except brassica, group. A proposed tolerance level 
residue value of 1.5 ppm was used for strawberries instead of the 
current tolerance level value of 0.4 ppm because BASF Corporation has 
petitioned for an increase in the pyraclostrobin tolerance in or on 
strawberries based on additional field trial data. No action has been 
taken on this petition yet but inclusion of the higher value adds to 
the conservatism of the exposure estimate. Finally, as noted above, 
mango and papaya, for which no action has yet been taken on proposed 
tolerances, were also included in this analysis.
    iii. Cancer. The chronic dietary risk assessment for cancer 
utilized the same models, food consumption data, and PCT and residue 
assumptions as the chronic dietary risk assessment.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated pesticide residue levels in food and the 
actual levels of pesticide chemicals that have been measured in food. 
If EPA relies on such information, EPA must require that data be 
provided 5 years after the tolerance is established, modified, or left 
in effect, demonstrating that the levels in food are not above the 
levels anticipated. Following the initial data submission, EPA is 
authorized to require similar data on a time frame it deems 
appropriate.
    Section 408(b)(2)(F) of FFDCA 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, that 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) of FFDCA, EPA may require registrants to submit 
data on PCT.
    Below is a description of how the Agency used PCT information, 
including a list of the PCT data used in the chronic cancer and 
noncancer PCT values. The value for each crop or crop group also 
applies to all raw or processed agricultural commodities that are 
encompassed by that crop or crop group. For example, the value for 
fruit, pome, group applies to such commodities as apple fruit, dried 
apples, apple juice and sauce, pear fruit, and pear juice.
Barley-- 2%
Beet, sugar--55%
Berry group--2%
Brassica, head and stem, subgroup--1%
Brassica, leafy greens, subgroup--2%

[[Page 63091]]

Cherry, sweet--53%
Cherry, tart--53%
Corn, field--1%
Corn, pop--1%
Corn, sweet--1%
Fruit, citrus, group--6%
Fruit, pome, group--7%
Fruit, stone, group--28%
Grape--16%
Hop, dried cones--2%
Nut, tree, group--1%
Pea and bean, dried shelled, except soybean, subgroup--1%
Pea, succulent--1%
Peanut--19%
Peppermint--2%
Pistachio--6%
Rye-- 2%
Soybean--1%
Spearmint--2%
Strawberry--80%
Sunflower--1%
Vegetable, bulb, group--17%
Vegetable, cucurbit, group--37%
Vegetable, fruiting, group--18%
Vegetable, leafy, except brassica, group--5%
Vegetable, leaves of root and tuber, except sugar beet--2%
Vegetable, root, except sugar beet, subgroup--6%
Vegetable, tuberous and corm, subgroup--25%
Wheat-- 2%

    The PCT data that were used in the chronic cancer and noncancer 
dietary risk analyses were derived as follows. (Note: For the acute 
analysis the Agency used 100% crop treated.) For crops that were 
already registered, the Agency used current usage data. These data were 
determined to be the best data available and were found to be reliable 
by the Agency.
    For crops pending registration, the Agency generally uses projected 
PCTs based on the highest or second highest current PCT of relatively 
new fungicide alternatives that target the same diseases as 
pyraclostrobin, while also taking into account the corresponding market 
projections for the new pyraclostrobin uses. For corn, the Agency notes 
that the use of fungicides is negligible. Even the commodity sweet 
corn, with has the highest use rate of the alternative strobilurin, has 
a percent crop treated of only 2%. Therefore, the Agency believe for 
use on corn and sweet corn a 1% estimate is conservative. The use of 
fungicides on soybean and sunflower is also negligible. The highest use 
for any alternative is only <1% and therefore, the Agency used 1%. For 
Pome fruit, the Agency used an estimated percent crop treated of 7%, 
there are two alternative one with a percent crop treated of <1% and 
another with a percent crop treated of 15%. The Agency used 7% which is 
the Agency's estimate of the likely maximum percent crop treated for 
pyraclostrobin on Pome fruit. It is possible that use could increase 
beyond this estimated percentage; however, the Agency is requiring 
annual reports that would detect this increase. For leafy vegetable, 
the two major alternatives attained a 5% crop treated; therefore, the 
Agency used a 5% crop treated estimate for leafy vegetables. For 
Brassica, head and stem, one alternative had a percent crop treated of 
2% for broccoli, cabbage and cauliflower and therefore a 2% crop 
treated estimate was used. For Vegetables, leaves of root and tubers, 
the best alternative had a maximum percent treated of 3% and the Agency 
used 2%. There are a few instances where the Agency did not use the 
maximum percent crop treated of any alternative, such as Vegetables, 
leaves of root and tubers. In these few instances (Sweet corn, Tree 
Nuts, Pome Fruit and Vegetables, leaves of roots and tubers) it is 
because in the past the Agency has found the registrants estimates of 
percent crop treated to be very reliable, more reliable that estimates 
based on the maximum percent crop treated of an alternative. The Agency 
conducted this same analysis of the major alternatives for all the 
other crops/crop groups to derive these estimates.
    As indicated above, for existing uses 2003 PCT data provided by the 
registrant were accepted as provided for use in the dietary analysis. 
The 2003 data provided by the registrant were the only actual data 
available for the registered crops and the registrant best knew, based 
on its product sales during 2003, how pyraclostrobin was allocated 
across those crops. Usage data for 2003 from USDA/NASS (National 
Agricultural Statistics Service), the Agency's proprietary source, and 
the California Department of Pesticide Regulation were not available to 
the Agency at the time of analysis. These 2003 data from the registrant 
were initially presented as market share data--the shares of acre-
treatments of pyraclostrobin in total fungicide treatments for each 
crop--as a check on the registrant's previous projections of the same 
prior to registration of these crops. These 2003 market shares were 
based on actual sales of pyraclostrobin allocated to registered crops 
during eleven months of 2003. Since dietary analysis requires PCTs, not 
market shares, the Agency converted these 2003 market shares to 2003 
PCTs by taking into account the numbers of applications and the total 
fungicide treatments to acres planted ratio for each crop. At about the 
same time the registrant did the same conversions. Each of the two sets 
of 2003 PCTs converted from 2003 market shares were almost identical, 
with small differences mainly due to different numbers of applications 
used in their calculations by each party. Since the registrant's 2003 
PCT data used numbers of applications that were consistent with those 
used in its corresponding 2003 market shares data, the registrant's 
PCTs were considered to be the more consistent of the two and thus were 
used for the dietary analysis. As a condition of registration, the 
registrant also will provide corresponding market share or PCT data for 
2004 based on sales of its products during 2004 (and, similarly, for 
following years) for these same registered crops. Generally, chronic 
dietary analysis utilizes actual PCT data, based on either usage data 
sources and/or registrant product sales, for registered uses and 
projected PCT data for pending uses.
    The Agency believes that the three conditions previously discussed 
for PCT data have been met. With respect to Condition 1, EPA finds that 
the PCT data that are listed above for pyraclostrobin use on a number 
of agricultural crops are reliable and have a valid basis. Since 
initial registration of this pesticide the Agency has required annual 
data submissions concerning the PCT of crops pyraclostrobin is 
registered for use on and the same requirement will be a condition of 
registration for crops for which tolerances are being established by 
this rule.
    As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
the consumption information 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 currently lacks 
sufficient monitoring exposure data 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

[[Page 63092]]

are made by reliance on simulation or modeling taking into account data 
on the physical characteristics of pyraclostrobin.
    The Agency used the Pesticide Root Zone Model/Exposure Analysis 
Modeling System model (PRZM/EXAMS) to estimate pesticide concentrations 
in surface water and the Screening Concentration in Groundwater (SCI-
GROW) model to predict pesticide concentrations in ground water. PRZM/
EXAMS incorporates an index reservoir environment in its analysis and 
includes a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin. The 
SCI-GROW model estimates pesticide concentrations in shallow 
groundwater.
    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 screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
LOCs.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated drinking 
water concentrations (EDWCs), which are the model estimates of a 
pesticide's concentration in water. EDWCs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead, drinking water levels of comparison (DWLOCs) are calculated 
and used as a point 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 in Unit E.
    Based on the (Tier II) PRZM/EXAMS and SCI-GROW models, the peak 
EDWCs of pyraclostrobin for acute exposures are estimated to be 22.6 
parts per billion (ppb) in surface water and 0.02 ppb in shallow ground 
water. The peak EDWCs for chronic exposures are estimated to be 1.9 ppb 
in surface water and 0.2 ppb in shallow ground water. The 36-year 
average concentration of pyraclostrobin in surface water that was 
estimated by PRZM-EXAMS for use in the chronic/cancer risk assessment 
is 1.2 ppb. These concentrations are based on maximum applications to 
turf, which has the highest labeled application rate of any 
pyraclostrobin use.
    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).
    Pyraclostrobin is proposed for application to residential turfgrass 
and recreational sites. The risk assessment was conducted using the 
following residential exposure assumptions. Turf applications will be 
made by professional pest control operators (PCOs) only, so residential 
handler exposure is not expected and was not evaluated. Postapplication 
scenarios evaluated assumed that exposure via the dermal route is 
likely for both adults and children entering treated lawns. Toddlers 
may also experience exposure via hand-to-mouth contact, object-to-mouth 
contact, and soil ingestion. The postapplication risk assessment is 
based on generic assumptions specified in the Recommended Revisions to 
the Residential SOPs (Standard Operating Procedures) and recommended 
approaches by an EPA science advisory council. It is also assumed that 
postapplication turf exposure can occur over periods of from one day to 
multiple weeks because of pyraclostrobin residue decline times and 
multiple treatments being made in a season. Thus, these exposures are 
classified as short-term (one day to one month) and intermediate-term 
(one to six months).
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to pyraclostrobin and any 
other substances. Pyraclostrobin also does not appear to produce a 
toxic metabolite that is 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 policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's web site at http:/
/www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA 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 data base on toxicity and exposure 
unless EPA determines based on reliable data 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no substantial 
evidence of increased prenatal or postnatal susceptibility following in 
utero exposure to rats. That is, the lowest-dose adverse developmental 
effects were seen at a higher dose than that which caused maternal 
toxicity. However, in the rabbit developmental toxicity study there was 
qualitative evidence of higher prenatal susceptibility: Increases in 
resorptions per litter and post-implantation losses were seen in the 
presence of maternal toxicity (decreases in body weight gain and food 
consumption). In the 2-generation reproduction study the HDT did not 
elicit maternal systemic, reproductive, or offspring toxicity. In the 
1-generation toxicity study there was an apparent quantitative 
susceptibility in pups (not seen in the 2-generation reproduction 
study) that is based on a possible marginal decline (threshold effect) 
in body weight and body weight gain at the lowest dose level of 21 mg/
kg/day (developmental LOAEL) while the parental systemic toxicity NOAEL 
and LOAEL were 40 and 60 mg/kg/day, respectively, based

[[Page 63093]]

on decreased body weight and body weight gain.
    3. Conclusion. There is an adequate toxicity data base for the 
selection of doses and endpoints for use in risk assessment for 
pyraclostrobin. Exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA has 
evaluated and reevaluated the potential for increased susceptibility of 
infants and children to pyraclostrobin and has concluded that the 
special FQPA safety factor (FQPA SF) should be reduced to 1X for all 
potential pyraclostrobin exposure scenarios because there are no 
residual uncertainties for pre- or post-natal toxicity and no 
substantial evidence of increased sensitivity of infants and children 
to pyraclostrobin. There is low concern for the qualitative 
susceptibility seen in the rabbit prenatal development study and no 
residual uncertainties because the developmental effects were seen in 
the presence of maternal toxicity and there are no clear NOAELs for 
maternal and developmental toxicities. There is also low concern for 
the quantitative susceptibility seen in the one-generation rat 
reproduction study and no residual uncertainties because:
    i. The offspring effects seen in this study were not repeated in 
the two-generation reproduction study.
    ii. The marginal increase in pup weights seen at or after post-
natal day 7 may be due to higher exposure via their diet.
    iii. The dose used for risk assessment would address the effects of 
concern seen in the offspring.
    iv. Even though the mouse cancer study must be repeated, the MOE 
approach used for cancer risk assessment provides an adequate margin of 
safety because a NOAEL was established. The repeated study will be done 
at higher doses.
    The Agency therefore concludes that the dietary (food and drinking 
water) and residential exposure assessments will not underestimate the 
potential exposure of infants, children, or women of childbearing age.

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 EDWCs. 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 EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/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 EDWCs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) will 
not result in unacceptable levels of aggregate human health risk. 
Because OPP 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, OPP 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, the acute dietary exposure from food to 
pyraclostrobin is estimated to occupy 2% of the aPAD for the U.S. 
population in the DEEM-FCID\TM\ model run and 1% of the aPAD for the 
U.S. population in the Lifeline\TM\ model run; 74% of the aPAD for 
females 13 - 49 years old in the DEEM-FCID\TM\ model run and 85% of the 
aPAD for females 13 - 49 years old in the Lifeline\TM\ model run; 3% of 
the aPAD for all infants (less than one year old) in the DEEM-FCID\TM\ 
model run and 3% of the aPAD for all infants (less than one year old) 
in the Lifeline\TM\ model run; and 4% of the aPAD for children 1-2 
years old in the DEEM-FCID\TM\ model run and 3% of the aPAD for 
children 1-2 years old in the Lifeline\TM\ model run. In addition, 
there is the potential for acute dietary exposure to pyraclostrobin in 
drinking water. After calculating DWLOCs and comparing them to the 
EDWCs for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD, as shown in Table 3 below.

                    Table 3.--Aggregate Risk Assessment for Acute Exposure to Pyraclostrobin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EDWC   Water EDWC  Acute DWLOC
                                                     kg)        (Food)*       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                          3.0            1         22.6         0.02  1.0 x 10\5\
------------------------------------------------
All Infants (less than 1 year old)                       3.0            3         22.6         0.02  2.9 x 10\4\
------------------------------------------------
Children 1-2 years old                                   3.0            3         22.6         0.02  2.9 x 10\4\
------------------------------------------------
Children 3-5 years old                                   3.0            3         22.6         0.02  2.9 x 10\4\
------------------------------------------------
Children 6-12 years old                                  3.0            1         22.6         0.02  3.0 x 10\4\
------------------------------------------------
Youths 13-19 years old                                   3.0            1         22.6         0.02  8.9 x 10\4\
------------------------------------------------
Females 13-49 years old                                 0.05           85         22.6         0.02          230
----------------------------------------------------------------------------------------------------------------
The Lifeline\TM\ model results


[[Page 63094]]

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure and the Lifeline\TM\ model, EPA has concluded 
that exposure to pyraclostrobin from food will utilize 6% of the cPAD 
for the U.S. population, 10% of the cPAD for the subgroup all infants 
(less than 1 year old), 16% of the cPAD for the subgroup children 3-5 
years old, and 5% of the cPAD for the subgroup females 13-49 years old. 
Based on the use pattern, chronic residential exposure to residues of 
pyraclostrobin is not expected. In addition, there is the potential for 
chronic dietary exposure to pyraclostrobin in drinking water. After 
calculating DWLOCs and comparing them to the EDWCs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as Table 4 demonstrates.

             Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyraclostrobin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EDWC   Water EDWC    Chronic
                                                     day        (Food)*       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.034            6          1.9         0.02         1100
------------------------------------------------
All Infants (less than 1 year old)                     0.034           10          1.9         0.02          310
------------------------------------------------
Children 1-2 years old                                 0.034           21          1.9         0.02          270
------------------------------------------------
Children 3-5 years old                                 0.034           16          1.9         0.02          290
------------------------------------------------
Children 6-12 years old                                0.034            9          1.9         0.02          310
------------------------------------------------
Youths 13-19 years old                                 0.034            4          1.9         0.02          980
------------------------------------------------
Females 13-49 years old                                0.034            5          1.9         0.02          970
----------------------------------------------------------------------------------------------------------------
* The Lifeline\TM\ model results

    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 proposed to be registered for application, by 
professional pest control operators only, to residential and 
recreational turfgrass sites that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and short-term 
exposures for pyraclostrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that aggregated food and residential 
exposures result in aggregate MOEs of 230 for the U.S. population as a 
whole and 130 for the subgroup children 1-2 years old. These aggregate 
MOEs do not exceed the Agency's level of concern for aggregate exposure 
to food and residential uses. In addition, short-term DWLOCs were 
calculated and compared to the EDWCs for chronic exposure of 
pyraclostrobin in ground and surface water. After calculating DWLOCs 
and comparing them to- the EDWCs for surface and ground water, EPA does 
not expect short-term aggregate exposure to exceed the Agency's level 
of concern, as shown in Table 5 below.

                  Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Pyraclostrobin
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate                  Surface       Ground
              Population Subgroup                MOE (Food +   Target MOE   Water EDWC   Water EDWC   Short-Term
                                                Residential)                  (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                          230          100         22.6         0.02          980
-----------------------------------------------
Children 1-2 years old                                   130          100         22.6         0.02          110
----------------------------------------------------------------------------------------------------------------

    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 currently registered for use(s) that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for pyraclostrobin.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 230 for 
the U.S. population as a whole and 130 for the subgroup children 1-2 
years old. These aggregate MOEs do not exceed the Agency's level of 
concern for aggregate exposure to food and residential uses. In 
addition, intermediate-term DWLOCs were calculated and compared to the 
EDWCs for chronic exposure of pyraclostrobin in ground and surface 
water. After calculating DWLOCs and comparing them to the EDWCs for 
surface and ground water, EPA does not expect (see Table 6) 
intermediate-term aggregate exposure to exceed the Agency's level of 
concern.

[[Page 63095]]



              Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Pyraclostrobin
----------------------------------------------------------------------------------------------------------------
                                                Aggregate                  Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +   Target MOE   Water EDWC   Water EDWC    Term DWLOC
                                              Residential)                  (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        230          100         22.6         0.02           980
 
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. The Agency has 
calculated aggregate MOEs (food and drinking water exposure) for 
pyraclostrobin. The SCI-GROW model estimates that the chronic 
concentration of pyraclostrobin in shallow ground water from the 
proposed use on turf grasses is 0.2 ppb. The PRZM/EXAMS model estimates 
that the 36-year average chronic/cancer concentration is 1.2 ppb. The 
aggregate regulatory bounded MOE for food plus drinking water is 
therefore estimated to be 17,000, as detailed in Table 7 below.

   Table 7.-- Margins of Exposure (MOEs) for Cancer Based Upon Chronic Aggregate Exposure (Food Plus Water) to
                                     Pyraclostrobin for the U.S. Population
----------------------------------------------------------------------------------------------------------------
                                                   Exposure                  Exposure                 Total MOE
               NOAEL (mg/kg/day)                  from Food    MOE (food)   from Water  MOE (water)    (food +
                                                 (mg/kg/day)               (mg/kg/day)                  water)
----------------------------------------------------------------------------------------------------------------
32.8                                                 0.00198       17,000    3.5 X 10-      950,000       17,000
                                                                                   \5\
----------------------------------------------------------------------------------------------------------------

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

IV. Other Considerations

A. Analytical Enforcement Methodology

    1. Enforcement methods for plant commodities. The petitioner has 
proposed two tolerance enforcement methods for the determination of 
residues of pyraclostrobin and its desmethoxy metabolite (BF 500-3) in/
on plant commodities: Liquid chromatography/mass spectrometry/mass 
spectrometry (LC/MS/MS) method D9808 and high pressure liquid 
chromatography/ultraviolet (HPLC/UV) method D9904. The validated method 
levels of quantitation (LOQs) for pyraclostrobin and BF 500-3 for both 
the LC/MS/MS and HPLC/UV methods are 0.02 ppm for each analyte in plant 
matrices. Adequate independent method validation and radiovalidation 
data have been submitted for both methods.
    2. Enforcement methods for livestock commodities. The proposed 
enforcement methods were used for data collection in the ruminant and 
poultry feeding studies. The concurrent method validation recoveries 
demonstrate that the methods are adequate for data collection. The 
petitioner has proposed two tolerance enforcement methods for ruminant 
commodities: HPLC/UV method 439/0 and Method 446, consisting of gas 
chromatography/mass spectrometry (GC/MS) method 446/0 and LC/MS/MS 
method 446/1. Radiovalidation data submitted for the GC/MS and LC/MS/MS 
methods are adequate for liver, milk, and muscle. The HPLC/UV method 
determines residues of pyraclostrobin per se. Method 446 has a 
hydrolysis step and determines residues of pyraclostrobin and its 
metabolites as BF 500-5 and BF 500-8. Independent method validation 
data for the HPLC/UV and LC/MS/MS methods are acceptable.
    3. Multiresidue methods. Pyraclostrobin was successfully evaluated 
through several of the FDA protocols, while recovery of 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 have been forwarded to FDA for 
inclusion in PAM (Pesticide Analytical Methods) Volume I.
    Adequate enforcement methodology (such as gas chromatography) is 
therefore available to enforce the tolerance expression. The methods 
may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    No Codex or Mexican maximum residue limits (MRLs) have been 
proposed or are established for residues of pyraclostrobin. It appears 
that Canadian MRLs for pyraclostrobin have not yet been published.

C. Conditions

    The following conditions are placed upon the initial registration 
of the uses that are the subject of this rule.
    1. Additional data requirements.
    i. A 28-day inhalation toxicity study that follows the 90-day 
inhalation toxicity protocol is required due to the potential 
occupational exposure via this route.
    ii. A new carcinogenicity study in female mice, using higher 
dosing, because no systemic toxicity was seen in the initial study at 
the HDT.
    iii. To support the tolerance for vegetable, leafy, except 
brassica, group, six additional analyses of residue samples of head 
lettuce with wrapper leaves are required from the submitted field 
trials and one additional field trial from either Region 1 or 2 is 
required for leaf lettuce.
    iv. To support the tolerance for brassica, head and stem, subgroup, 
analyses of four more samples of cabbage with wrapper leaves are 
required from the submitted field trials.
    v. To support the tolerance for brassica, leafy greens, subgroup, 
three additional field trials on mustard greens

[[Page 63096]]

are required, one each from Regions 2, 3, and 10.
    vi. To support the tolerance for pea and bean, dried shelled, 
subgroup, one additional field trial is required from Region 11.
    vii. To support the tolerances for soybean, forage and soybean, 
hay, two additional field trials from Region 5 and one more from Region 
4 are required.
    viii. To support the increased tolerance for strawberry, one final 
study of residues from field trials in California is required.
    ix. Percent crop treated data will be required at the end of each 
year for 5 years after registration of the new crop uses for which 
tolerances are established in this final rule.
    2. Other.
    A reasonable amount of new analytical standard for pyraclostrobin 
(BAS 500 F) and the desmethoxy metabolite of pyraclostrobin (BF 500-3) 
must be submitted to the Agency.


V. Comments

    Two communications were received from B. Sachau of New Jersey in 
response to the notices of filing. The communications objected to 
establishment of the proposed tolerances for several reasons and mostly 
involve generalized and unsubstantiated disagreement with EPA's risk 
assessment methodologies or safety findings. Each comment is listed 
below, followed by the Agency response.
    1. Ms. Sachau feels that establishment of these tolerances would 
add to the pesticide body load that is already carried by the human 
population.
    Agency response: When new or amended tolerances are requested for 
the presence of the residues of a pesticide and its toxicologically 
significant metabolite(s) in food or feed, the Agency, as is required 
by Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), 
estimates the risk of the potential exposure to these residues by 
performing an aggregate risk assessment. Such a risk assessment 
integrates the individual assessments that are conducted for food, 
drinking water, and residential exposures. Additionally, the Agency, as 
is further required by Section 408 of the FFDCA, considers available 
information concerning what are termed the cumulative toxicological 
effects of the residues of that pesticide and of other substances 
having a common mechanism of toxicity with it. The Agency has concluded 
after this assessment that there is a reasonable certainty that no harm 
will result from exposure to the residues of interest. Therefore, the 
proposed tolerance(s) are found to be acceptable. These assessments 
consider body residue loads of the pesticide, as well as available 
information concerning the potential that other substances have a 
common mechanism of toxicity, in reaching a conclusion as to whether or 
not the reasonable certainty of no harm decision can be made.
    2. Ms. Sachau does not want American universities to use tax 
dollars to promote pesticides (Interregional Research Project Number 4 
is affiliated with Rutgers University).
    Agency response: Although Ms. Sachau's concerns regarding use of 
tax dollars to seek pesticide tolerances and registrations are not 
germane to EPA's statutory basis for acting on the pyraclostrobin 
tolerance petitions, and thus technically no response is required to 
this comment, EPA can provide the following information regarding the 
Interregional Research Project Number4 (IR-4). The Interregional 
Research Project Number 4 (IR-4) Program was created by Congress in 
1963 to assist the growers of minor crops in obtaining registration of 
pesticides for those uses that might otherwise be uneconomic for 
pesticide companies to pursue. The IR-4 National Coordinating 
Headquarters is located at Rutgers University in New Jersey and 
receives the majority (90%) of its funding from the U.S. Department of 
Agriculture (USDA). It is the only publicly funded program that 
conducts research, submits petitions for tolerances, and operates in 
collaboration with USDA, the Land Grant University System, the 
agrochemical industry, commodity associations, and the EPA. The IR-4 
program takes the lead in identifying and prioritizing minor crop 
pesticide needs, and in conducting the research needed to obtain the 
tolerances for use on these crops. Under the Pesticide Registration 
Improvement Act (PRIA), IR-4 works in cooperation with the pesticide 
registrant to request a waiver of the fees that are charged for the 
registration services provided by EPA. The waiver will be granted if 
the labeling containing the use(s) of interest is closely associated 
with submission of a tolerance petition by IR-4 and if it is in the 
public interest. This fee waiver serves as an incentive to the IR-4 
program to pursue registration of minor uses. In addition to the work 
performed for minor use crop pesticide registration, IR-4 also develops 
risk mitigation measures for existing registered products.
    3. Ms. Sachau feels that animal testing is cruel to the animals, is 
inaccurate, and is potentially even irrelevant to the issue being 
researched.
    Agency response: Animal testing is used because it is currently the 
only reasonably accurate and acceptable way in which the potential 
impacts of the use of new chemicals (including pesticides) on humans 
can be determined. The EPA Test Guidelines recommend the types of 
animals to be used as test animals in acute irritation studies as well 
as in longer term, subchronic and chronic, studies such as 
developmental toxicity, reproduction, and carcinogenicity studies. 
Results obtained from these animal studies are generally felt by the 
scientific community to be relevant to humans because the cells and 
molecules of the selected test species are very similar to those of 
humans. Therefore, if a pesticide causes toxicity in the test animals, 
it is likely to do so in humans as well. That said, EPA supports 
efforts to use the least possible number of animals in the studies that 
are required to support pesticide registration actions. Concerning 
alternatives, the use of humans as test subjects is widely felt to be 
morally unacceptable and there are no in vitro type studies that can 
adequately address the concerns the animal studies satisfy. The EPA is 
currently working with the Interagency Coordinating Committee on the 
Validation of Alternative Methods (ICCVAM) to investigate in vitro 
methods that can acceptably investigate the toxicological concerns 
associated with the use of pesticides but the use of animal tests is 
still necessary if the Agency is to make the reasonable certainty of no 
harm decisions that it is legally required to make.
    4. Ms. Sachau feels that the end point effects noted for 
pyraclostrobin are, by themselves, sufficient that the Agency should 
reject use of pyraclostrobin for any pesticidal purpose in the U.S.
    Agency response: As is the case with almost all conventional 
pesticides, numerous tests have been performed to study the 
toxicological effects of pyraclostrobin. The various tests use doses 
that range from quite low to many times higher than virtually any 
member of the population of the U.S. could ever be exposed to. The 
highest doses are, in fact, deliberately chosen to try to elicit 
toxicological symptoms because a description of these symptoms and the 
dose levels at which they occur is one of the desired outcomes of the 
studies. Virtually any chemical (vitamins, for example) is toxic if 
taken in excessively large doses. Risk, however, is a function of the 
exposure levels that actually occur in the population in comparison to 
the threshold exposure level at which

[[Page 63097]]

adverse symptoms begin to be elicited . For a toxicologically average 
person, if actual exposure is less than the adverse symptom exposure 
threshold, no such symptoms are expected to be seen. However, in order 
to make the reasonable certainty of no harm determination the Agency 
requires more assurance than this that the use of animals (instead of 
humans) for testing, variations in susceptibility among members of the 
U.S. population, greater sensitivity of infants and children, etc., has 
been accounted for in the risk assessment process. Therefore, safety 
factors are used in conjunction with dosing levels at which no or only 
the first symptoms of exposure to the pesticide were seen to provide a 
substantial additional margin of safety. This mechanism helps assure 
that toxicological symptoms will not be elicited in members of the U.S. 
population by beneficial, labeled uses of the pesticide. The fact that 
very high doses of a pesticide cause toxicological symptoms is not, by 
itself, enough to make approval of uses of that pesticide unreasonable.
    5. Ms. Sachau feels that if all data are not available, the Agency 
should not proceed with establishment of the tolerances.
    Agency response: The studies the Agency still requires for 
reasonably complete data support of the currently registered uses and 
the additional uses that will be enabled by the establishment of the 
tolerances in this rule are as follow, along with the reasons why they 
do not interfere with the completion of this rule. It should also be 
noted that there are always more data that could theoretically be 
required, and that data requirements do change through time. Data gaps 
such as those discussed below are, in general, considered to simply be 
supplementary or confirmatory to the large body of acceptable data that 
has already been submitted to the Agency in support of the tolerances 
and uses that are contemplated by this rule.
     A 28-day inhalation toxicity study. - This study has been 
required so that the Agency can confirm that repeated exposure of the 
lungs to pyraclostrobin, an irritating chemical, is reasonably safe. 
Since no incidents are known to the Agency, after two years of 
registration, where exposure to pyraclostrobin has lead to lung damage, 
continued use of this fungicide while this study is being completed 
does not seem unreasonable.
     A new carcinogenicity study of female mice. - Two 
carcinogenicity studies of pyraclostrobin have been completed. One, 
testing both sexes of rats, was acceptable for both sexes and produced 
no evidence of carcinogenicity. The other, testing both sexes of mice, 
was acceptable for males and produced no evidence of carcinogenicity. 
It was unacceptable for females because there was no evidence of 
carcinogenicity and no significant evidence of toxicity even at the 
highest dose. Because of this, and despite the lack of evidence of 
carcinogenicity to date, the Agency wants confirmation that 
pyraclostrobin is not a carcinogen. Despite the lack of carcinogenicity 
in the acceptable carcinogenicity studies to date, the Agency performed 
an MOE threshold-type analysis based on the NOAEL for female mice to 
produce a worst-case cancer risk assessment and found there to be no 
risk of concern.
     Six more residue samples from previous studies of head 
lettuce with wrapper leaves, one more residue field trial on head 
lettuce, and one more residue field trial on leaf lettuce. - A total of 
6 acceptable head lettuce and 6 acceptable leaf lettuce residue field 
trials were submitted and, along with 12 acceptable celery and 8 
acceptable spinach residue field trials, provide strong support for 
establishment of a pyraclostrobin tolerance of 29 ppm on leafy 
vegetables (except brassica). The Agency therefore believes that the 
additional studies, while required by our standard operating procedure, 
will simply serve to confirm the results of the acceptable data we have 
already evaluated.
     Four more treated samples of cabbage with wrapper leaves. 
- A total of 8 acceptable residue field trials on cabbage have already 
been submitted and, together with 7 broccoli field trials, provide 
strong support for establishment of pyraclostrobin tolerances of 16 ppm 
in/on brassica head and stem vegetables. The Agency therefore believes 
that the additional studies, while required by our standard operating 
procedure, will simply serve to confirm the results of the acceptable 
data we have already evaluated.
     Three more residue field trial on mustard greens. - A 
total of 5 acceptable residue field trials on mustard greens have 
already been submitted and provide strong support for establishment of 
pyraclostrobin tolerances of 16 ppm in/on brassica leafy greens. The 
Agency therefore believes that the additional studies, while required 
by our standard operating procedure, will simply serve to confirm the 
results of the acceptable data we have already evaluated.
     One more residue field trial on dried shelled peas. - A 
total of 9 acceptable residue field trials on dried shelled peas have 
already been submitted and, along with acceptable residue data 
previously submitted for dried shelled beans, provide substantial 
support for establishment of a pyraclostrobin tolerance of 0.3 ppm in/
on dried shelled peas and beans. The Agency therefore believes that the 
additional study, while required by our standard operating procedure, 
will simply serve to confirm the results of the acceptable data we have 
already evaluated.
     Three more residue field trials on soybean forage and hay. 
- A total of 17 acceptable residue field trials on soybean forage and 
hay have already been submitted and provide strong support for 
establishment of pyraclostrobin tolerances of 5 ppm in/on soybean 
forage and 7 ppm in/on soybean hay. The Agency therefore believes that 
the additional studies, while required by our standard operating 
procedure, will simply serve to confirm the results of the acceptable 
data we have already evaluated.
    6. Ms. Sachau feels that the lack of data on endocrine disruption 
show that the ``product'' is not ready to be used in the U.S.
    Agency response: EPA is required by the FFDCA, as amended by the 
Food Quality Protection Act (FQPA), to develop a screening program to 
determine whether certain substances (including all pesticide product 
active and other ingredients) ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
other such endocrine effects as the [EPA] Administrator may 
designate.'' Following the recommendations of its Endocrine Disruptor 
and Testing Advisory Committee (EDSTAC), EPA determined that there was 
a scientific basis for including, as part of the program, the androgen 
and thyroid hormone systems, in addition to the estrogen hormone 
system. EPA also adopted EDSTAC's recommendation that the Program 
include evaluations of potential effects on wildlife. For pesticide 
chemicals EPA will use Federal Fungicide, Insecticide and Rodenticide 
Act (FIFRA) and, to the extent that effects in wildlife may help 
determine whether a substance may have an effect in humans, FFDCA 
authority the wildlife evaluations. As the science develops and 
resources allow, screening of additional hormone systems may be added 
to the Endocrine Disruptor Screening Program (EDSP). In the available 
toxicity studies on pyraclostrobin, there was no estrogen, androgen, 
and/or thyroid mediated toxicity. When additional appropriate

[[Page 63098]]

screening and/or testing protocols being considered under the Agency's 
EDSP have been developed, pyraclostrobin may be subjected to further 
screening and/or testing to better characterize effects related to 
endocrine disruption. The Agency will respond to new information in 
such a way as is appropriate at that time, but currently has no 
evidence that pyraclostrobin is an endocrine disruptor.
    Furthermore and in conclusion, Ms. Sachau's comments contained no 
scientific data or other substantive evidence to rebut the Agency's 
conclusion that there is a reasonable certainty that no harm will 
result from aggregate exposure to pyraclostrobin from the establishment 
of these tolerances.

VI. Conclusion

    Therefore, tolerances are established for the combined residues of 
carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester, pyraclostrobin, and 
methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate, the 
desmethoxy metabolite of pyraclostrobin, expressed as parent compound, 
in or on apple, wet pomace at 8.0 parts per million (ppm); brassica, 
head and stem, subgroup at 5.0 ppm; brassica, leafy greens, subgroup at 
16.0 ppm; corn, field, grain at 0.1 ppm; corn, field, forage at 5.0 
ppm; corn, field, stover at 17.0 ppm; corn, field, refined oil at 0.2 
ppm; corn, pop, grain at 0.1 ppm; corn, pop, stover at 17.0 ppm; corn, 
sweet, kernel plus cob with husks removed at 0.04 ppm; corn, sweet, 
forage at 5.0 ppm; corn, sweet, stover at 23.0 ppm; fruit, pome, group 
at 1.5 ppm; hop, dried cones at 23.0 ppm; legume, forage, except peanut 
and soybean at 25.0 ppm; pea, succulent at 0.2 ppm; pea and bean, dried 
shelled, except soybean, subgroup at 0.3 ppm; peppermint at 8.0 ppm; 
soybean, forage at 5.0 ppm; soybean, hay at 7.0 ppm; soybean, hulls at 
0.06 ppm; soybean, seed at 0.04 ppm; spearmint at 8.0 ppm; sunflower at 
0.3 ppm; vegetable, leafy, except brassica, group at 29.0 ppm; 
vegetable, leaves of root and tuber, except sugar beet at 16.0; and 
vegetable, legume, edible podded, subgroup at 0.5 ppm. Tolerances are 
increased for the combined residues of carbamic acid, [2-[[[1-(4-
chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester, 
pyraclostrobin, and methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-
tolyl] carbamate, the desmethoxy metabolite of pyraclostrobin, 
expressed as parent compound, in or on citrus, dried pulp to 12.5 ppm; 
citrus, oil to 9.0 ppm; and fruit, citrus, group to 2.0 ppm, and 
deletes the currently existing tolerance in 40 CFR 180.582 for the 
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-N-[[[1-(4-chlorophenyl) pyrazol-
3-yl]oxy]o-tolyl] carbamate), expressed as parent compound in or on 
bean, dry, seed at 0.3 ppm. The latter tolerance is superseded by the 
tolerance for pea and bean, dried shelled, except soybean, subgroup at 
0.3 ppm. A temporary tolerance is established for the combined residues 
of (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester), pyraclostrobin, and 
methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate, the 
desmethoxy metabolite of pyraclostrobin, expressed as parent compound, 
in or on strawberry at 1.5 ppm, the increased tolerance expiring on 
December 31, 2005.

VII. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA 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) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. 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-2004-0325 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 December 
28, 2004.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. 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 (202) 564-6255.
    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 refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    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

[[Page 63099]]

Ave., NW., Washington, DC 20460-0001.
    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 PIRIB for its inclusion in 
the official record that is described in ADDRESSES. Mail your copies, 
identified by docket ID number OPP-2004-0325, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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).

VIII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). 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 section 408(d) of FFDCA, such as the tolerances in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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 section 408(n)(4) of FFDCA. 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.

IX. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: September 30, 2004.

Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:


[[Page 63100]]


    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.582 is amended as follows:
    i. In paragraph (a)(1) by alphabetically adding commodities to the 
table; by revising the tolerance levels for ``Citrus, dried pulp, '' 
``Citrus, oil'' and ``Fruit, citrus, group'', and by removing the 
commodity ``Bean, dry, seed''.
    ii. By adding paragraph (a)(3).
    The amendments to paragraph (a) read as follows:


Sec.  180.582  Pyraclostrobin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Apple, wet pomace....................................                8.0
                                * * * * *
Brassica, head and stem, subgroup....................                5.0
Brassica, leafy greens, subgroup.....................               16.0
Citrus, dried pulp...................................               12.5
Citrus, oil..........................................                9.0
Corn, field, forage..................................                5.0
Corn, field, grain...................................                0.1
Corn, field, refined oil.............................                0.2
Corn, field, stover..................................               17.0
Corn, pop, grain.....................................                0.1
Corn, pop, stover....................................               17.0
Corn, sweet, forage..................................                5.0
Corn, sweet, kernel plus cob with husks removed......               0.04
Corn, sweet, stover..................................               23.0
Fruit, citrus, group.................................                2.0
Fruit, pome, group...................................                1.5
                                * * * * *
Hop, dried cones.....................................               23.0
Legume, forage, except peanut and soybean, subgroup..               25.0
                                * * * * *
Pea, succulent.......................................                0.2
Pea and bean, dried shelled, except soybean, subgroup                0.3
                                * * * * *
Peppermint...........................................                8.0
                                * * * * *
Soybean, forage......................................                5.0
Soybean, hay.........................................                7.0
Soybean, hulls.......................................               0.06
Soybean, seed........................................               0.04
Spearmint............................................                8.0
                                * * * * *
Sunflower............................................                0.3
                                * * * * *
Vegetable, leafy, except brassica, group.............               29.0
Vegetable, leaves of root and tuber, except sugar                   16.0
 beet................................................
Vegetable, legume, edible podded, subgroup...........                0.5
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (3) 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 commodity:

----------------------------------------------------------------------------------------------------------------
                        Commodity                             Parts per million      Expiration/Revocation Date
----------------------------------------------------------------------------------------------------------------
Strawberry...............................................                      1.5                      12/31/05
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 04-24247 Filed 10-28-04; 8:45 am]
BILLING CODE 6560-50-S