Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 63083

Use classification Applicable criteria 

(2)(A)(i), (2)(B)(i), and (2)(B)ii, (2)(C), (2)(D) ........................................... Column D2—#s 14, 16, 18–21, 22, 23, 26, 27, 29, 30, 32, 37, 38, 42–

44, 46, 53, 54, 55, 59–62, 64, 66, 68, 73, 74, 78, 82, 85, 88–93, 95, 

96, 98, 102–105, 107–111, 115–126. 

* * * * *

[FR Doc. 04–24242 Filed 10–28–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0325; FRL–7681–9]

Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

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) pyrazol3-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The latter tolerance is superseded by the 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]otolyl] 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 

63084 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

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]otolyl] 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]otolyl] 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]otolyl] 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.

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 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 toxicitymouseThe 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 toxicityratStudy pending. 

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-rabbitThis study is acceptable/guideline. 

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.

63086 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

TABLE 1.—SUBCHRONIC, CHRONIC AND OTHER TOXICITY PROFILE—Continued

Guideline No. Study Type Results 

870.3800 Two generation reproduction study-ratThis study is acceptable/guideline when 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 reproduction study-ratThe dosing levels were 0, 200, 400, and 600 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 

reverse mutation assay

This study is acceptable/guideline. 

The results were negative ± S9 up to 5,000 μg/plate by standard plate and tube 

preincubation.

There was no cytotoxicity at any dose but there was precipitation at ≥2,500 μg/plate.

870.5300 Gene mutation: Mammalian cell cultureThis study is acceptable/guideline. 

The results were negative ± S9 up to cytotoxic and precipitating concentration of 20 

μg/mL.

870.5375 Cytogenetics (in vitro): 

Chromosomal aberrations

This study is acceptable/guideline. 

The results were negative ± S9 for clastogenic/aneugenic activity up to 25 μg/mL.

Precipitation and cytotoxicity (reduced cell attachment and poor quality of metaphases) were seen at concentrations ≥ü50 μg/mL.

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 63087

TABLE 1.—SUBCHRONIC, CHRONIC AND OTHER TOXICITY PROFILE—Continued

Guideline No. Study Type Results 

870.5395 Cytogenetics: Micronucleus test in mouseThis study is acceptable/guideline. 

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: Rat hepatocyte 

culture

This study is acceptable/guideline. 

The results were negative up to a cytotoxic concentration of 1.0 μg/mL.

870.6200 Acute neurotoxicity 

screening-rat

This study is acceptable/guideline. 

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 

screening-rat

This study is acceptable/guideline. 

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 pharmacokinetics-ratThis study is acceptable/guideline. 

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; μg = 

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 

63088 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

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

Exposure Scenario 

Dose Used in Risk Assessment; Inter- species, 

Intraspecies, and UF; RfD 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary (Females 13-50 

years of age)

NOAEL= 5 mg/kg/day 

UF = 100

Acute RfD = 0.05 mg/kg/day

FQPA SF = 1X 

aPAD = 0.05 mg/kg/day

Rabbit prenatal developmental toxicity study. 

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 including infants and 

children)

NOAEL = 300 mg/kg 

UF = 100

Acute RfD = 3.0 mg/kg/day

FQPA SF = 1X 

aPAD = 3.0 mg/kg/day

Rat acute oral neurotoxicity study. 

LOAEL = 1000 mg/kg/day based on decreased body weight gain in males.

Chronic Dietary (All populations)NOAEL= 3.4 mg/kg/day 

UF = 100

Chronic RfD = 0.034 mg/kg/

day

FQPA SF = 1X 

cPAD = 0.034 mg/kg/day

Rat oral carcinogenicity study. 

LOAEL = 9.2 mg/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 days)

NOAEL= 5.8 mg/kg/day Residential LOC for MOE 

= 100

Occupational LOC for 

MOE = NA

13-Week dog feeding study. LOAEL = 12.9 

mg/kg/day based on increased incidence of 

diarrhea, clinical chemistry changes, duodenum mucosal hypertrophy, and decreased 

body weight, food intake, and food efficiency.

Intermediate-Term Incidental 

Oral (1- 6 months)

NOAEL= 5.8 mg/kg/day Residential LOC for MOE 

= 100

Occupational LOC for 

MOE = NA

13-Week dog feeding study. 

LOAEL = 12.9 mg/kg/day 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 

NOAEL = 5.0 mg/kg/day (dermal absorption rate = 14 

%)

Residential LOC for MOE 

= 100

Occupational LOC for 

MOE = 100

Rabbit prenatal developmental toxicity study. 

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).

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 63089

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PYRACLOSTROBIN—Continued

Exposure Scenario 

Dose Used in Risk Assessment; Inter- species, 

Intraspecies, and UF; RfD 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Intermediate-Term Dermal (1 to 

6 months)

Oral study 

NOAEL = 5.0 mg/kg/day (dermal absorption rate = 14 

%)

Residential LOC for MOE 

= 100

Occupational LOC for 

MOE = 100

Rabbit prenatal developmental toxicity study. 

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 

NOAEL = 3.4 mg/kg/day (dermal absorption rate = 14 

%)

Residential LOC for MOE 

= 100

Occupational LOC for 

MOE = 100

Rat oral carcinogenicity study. 

LOAEL = 9.2 mg/kg/day 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 

NOAEL = 5.0 mg/kg/day (inhalation absorption rate = 

100%)

Residential LOC for MOE 

= 100

Occupational LOC for 

MOE = 100

Rabbit prenatal developmental toxicity study. 

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 months)

Oral study 

NOAEL = 5.0 mg/kg/day (inhalation absorption rate = 

100%)

Residential LOC for MOE 

= 100

Occupational LOC for 

MOE = 100

Rabbit prenatal developmental toxicity study. 

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 

NOAEL = 3.4 mg/kg/day (inhalation absorption rate = 

100%)

Residential LOC for MOE 

= 100

Occupational LOC for 

MOE = 100

Rat oral carcinogenicity study. 

LOAEL = 9.2 mg/kg/day 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 (Qstar) 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,

63090 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

• 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) pyrazol3-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)-1Hpyrazol-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)-1Hpyrazol-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 fooduse pesticide if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a oneday 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-FCIDTM, 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 LifelineTM, Version 2.0 

model to conduct the acute dietary risk 

assessments. LifelineTM 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-FCIDTM

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 

LifelineTM, Version 2.0 model to 

conduct the chronic dietary risk 

assessments. LifelineTM 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%

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 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 

63092 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

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 SCIGROW 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 nonoccupational, 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-tomouth 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 lowestdose 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 

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 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 postnatal 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 twogeneration 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 DEEMFCIDTM model run and 1% of the aPAD 

for the U.S. population in the LifelineTM

model run; 74% of the aPAD for females 

13 - 49 years old in the DEEM-FCIDTM

model run and 85% of the aPAD for 

females 13 - 49 years old in the 

LifelineTM model run; 3% of the aPAD 

for all infants (less than one year old) in 

the DEEM-FCIDTM model run and 3% of 

the aPAD for all infants (less than one 

year old) in the LifelineTM model run; 

and 4% of the aPAD for children 1-2 

years old in the DEEM-FCIDTM model 

run and 3% of the aPAD for children 1-

2 years old in the LifelineTM 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

Population Subgroup aPAD (mg/

kg) 

% aPAD 

(Food)*

Surface 

Water 

EDWC 

(ppb) 

Ground 

Water 

EDWC 

(ppb) 

Acute 

DWLOC 

(ppb) 

U.S. population 3.0 1 22.6 0.02 1.0 x 105

All Infants (less than 1 year old) 3.0 3 22.6 0.02 2.9 x 104

Children 1-2 years old 3.0 3 22.6 0.02 2.9 x 104

Children 3-5 years old 3.0 3 22.6 0.02 2.9 x 104

Children 6-12 years old 3.0 1 22.6 0.02 3.0 x 104

Youths 13-19 years old 3.0 1 22.6 0.02 8.9 x 104

Females 13-49 years old 0.05 85 22.6 0.02 230

The LifelineTM model results

63094 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure and the LifelineTM

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

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food)*

Surface 

Water 

EDWC 

(ppb) 

Ground 

Water 

EDWC 

(ppb) 

Chronic 

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 LifelineTM 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

Population Subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Target MOE 

Surface 

Water 

EDWC 

(ppb) 

Ground 

Water 

EDWC 

(ppb) 

Short-Term 

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 intermediateterm 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.

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 63095

TABLE 6.—AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO PYRACLOSTROBIN

Population Subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Target MOE 

Surface 

Water 

EDWC 

(ppb) 

Ground 

Water 

EDWC 

(ppb) 

IntermediateTerm 

DWLOC 

(ppb) 

U.S. population 230 100 22.6 0.02 980

Children 1-2 years old 130 100 22.6 0.02 110

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

NOAEL (mg/kg/day) 

Exposure 

from Food 

(mg/kg/day) 

MOE (food) 

Exposure 

from Water 

(mg/kg/day) 

MOE 

(water) 

Total MOE 

(food + 

water) 

32.8 0.00198 17,000 3.5 X 10-5 950,000 17,000

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 

63096 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

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 IR4 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 

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 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 

63098 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

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)-1Hpyrazol-3-

yl]oxy]methyl]phenyl]methoxy-, methyl 

ester, pyraclostrobin, and methyl-N-[[[1-

(4-chlorophenyl) pyrazol-3-yl]oxy]otolyl] 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]otolyl] 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) pyrazol3-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]otolyl] 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 14th 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 

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 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.

■ Therefore, 40 CFR chapter I is 

amended as follows:

PART 180—[AMENDED]

■ 1. The authority citation for part 180 

continues to read as follows:

63100 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Rules and Regulations 

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

■ 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:

§ 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

Commodity Parts per million 

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

Commodity Parts per million 

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 beet ................... 16.0

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)-1Hpyrazol-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

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271

[FRL–7832–2] 

Indiana: Final Authorization of State 

Hazardous Waste Management 

Program Revision

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: The EPA is granting Indiana 

final authorization of the changes to its 

hazardous waste program under the 

Resource Conservation and Recovery 

Act (RCRA). The Agency published a 

proposed rule on April 20, 2004 and 

provided for public comment. The 

public comment period ended on May 

20, 2004. We received no comments. No 

further opportunity for comment will be 

provided. EPA has determined that 

Indiana’s revisions satisfy all the 

requirements needed to qualify for final 

authorization, and is authorizing the 

State’s changes through this final action.

DATES: This final authorization will be 

effective on October 29, 2004.

ADDRESSES: You can view and copy 

Indiana’s application from 9 a.m. to 4 

p.m. at the following addresses: Indiana 

Department of Environmental 

Management, 100 North Senate, 

Indianapolis, Indiana, (mailing address 

P.O. Box 6015, Indianapolis, Indiana 

46206) contact Steve Mojonnier (317) 

233–1655, or Lynn West (317) 232–

3593, and EPA Region 5, contact Gary 

Westefer at the following address.

FOR FURTHER INFORMATION CONTACT: Gary 

Westefer, Indiana Regulatory Specialist, 

U.S. EPA Region 5, DM–7J, 77 West 

Jackson Boulevard, Chicago, Illinois 

60604, (312) 886–7450.

SUPPLEMENTARY INFORMATION: On April 

20, 2004, U.S. EPA published a 

proposed rule (69 FR 21077) proposing 

to grant Indiana authorization for 

changes to its Resource Conservation 

and Recovery Act program, listed in 

section F of that notice, which was 

subject to public comment. No 

comments were received. We hereby 

determine that Indiana’s hazardous 

waste program revisions satisfy all of 

the requirements necessary to qualify 

for final authorization. 

A. Why Are Revisions to State 

Programs Necessary? 

States which have received final 

authorization from EPA under RCRA 

section 3006(b), 42 U.S.C. 6926(b), must 

maintain a hazardous waste program 

that is equivalent to, consistent with, 

and no less stringent than the Federal 

program. As the Federal program 

changes, States must change their 

programs and ask EPA to authorize the 

changes. Changes to State programs may 

be necessary when Federal or State 

statutory or regulatory authority is 

modified or when certain other changes 

occur. Most commonly, States must 

change their programs because of 

changes to EPA’s regulations in 40 Code 

of Federal Regulations (CFR) parts 124, 

260 through 266, 268, 270, 273 and 279. 

B. What Decisions Have We Made in 

This Rule? 

We conclude that Indiana’s 

application to revise its authorized 

program meets all of the statutory and 

regulatory requirements established by 

RCRA. Therefore, we propose to grant 

Indiana Final authorization to operate 

its hazardous waste program with the