58404 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

Inert ingredients Limits Uses

*******

Dimethyl silicone polymer with silica, Minimum number average

molecular weight (in amu) 1,100,000 daltons, CAS Reg. No.

67762–90–7

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

Hexamethyldisilizane, reaction product with silica, Minimum number average molecular weight (in amu) 645,000 daltons, CAS

Reg. No. 68909–20–6

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

Silane, dichloromethyl-, reaction product with silica, Minimum

number average molecular weight (in amu) 3,340,000 daltons,

CAS Reg. No. 68611–44–9

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

[FR Doc. 00–25050 Filed 9–28–00]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301069; FRL–6749–1]

RIN 2070–AB78

Azoxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for the combined residues of

azoxystrobin (methyl (E)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) and

its Z isomer (methyl (Z)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) in or

on barley, bran at 0.2 parts per million

(ppm); barley, grain at 0.1 ppm; barley,

hay at 15.0 ppm; barley, straw at 4.0

ppm; citrus, dried pulp at 2.0 ppm;

citrus, oil at 4.0 ppm; coriander, leaves

at 30.0 ppm; corn, field, forage at 12.0

ppm; corn, field, grain at 0.05 ppm;

corn, field, refined oil at 0.3 ppm; corn,

field, stover at 25.0 ppm; corn, pop,

grain at 0.05 ppm; corn, pop, stover at

25.0 ppm; corn, sweet, forage at 12.0

ppm; corn, sweet (kernels plus cob with

husks removed) at 0.05 ppm; corn,

sweet, stover at 25.0 ppm; cotton, gin

byproducts at 0.02 ppm; cotton,

undelinted seed at 0.02 ppm; fruit,

citrus, group at 1.0 ppm; grain, aspirated

grain fractions at 30.0 ppm; onion, dry

bulb at 1.0 ppm; onion, green at 7.5

ppm; peanut at 0.2 ppm; peanut, refined

oil at 0.6 ppm; peanut, hay at 15.0 ppm;

soybean, forage at 25.0 ppm; soybean,

hay at 55.0 ppm; soybean, hulls at 1.0

ppm; soybean, seed at 0.5 ppm;

vegetable, leafy, except Brassica, group

at 30.0 ppm; vegetable, leaves of root

and tuber, group at 50.0 ppm; vegetable,

root, subgroup at 0.5 ppm; and

vegetable, tuberous and corm, subgroup

at 0.03 ppm; and increases the tolerance

for azoxystrobin (only) in or on cattle,

fat to 0.03 ppm; cattle, meat byproducts

to 0.07 ppm; goat, fat to 0.03 ppm; goat,

meat byproducts to 0.07 ppm; horse, fat

to 0.03 ppm; horse, meat byproducts to

0.07 ppm; sheep, fat to 0.03 ppm; and

sheep, meat byproducts to 0.07 ppm.

Zeneca Ag Products requested these

tolerances in pesticide petition number

(PP#) 9F6058 under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301069,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301069 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: Dan Kenny, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: (703)305–

7546; and e-mail address:

kenny.dan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

Examples of Potentially Affected

Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically.You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58405

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301069. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of August 2,

2000 (65 FR 47498) (FRL–6592–1), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a as

amended by the Food Quality Protection

Act of 1996 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP) for tolerance by Zeneca Ag

Products, 1800 Concord Pike, P.O. Box

15458, Wilmington, DE 19850–-5458.

This notice included a summary of the

petition prepared by Zeneca Ag

Products, the registrant. There were no

comments received in response to the

notice of filing.

The petition requested that 40 CFR

180.507 be amended by establishing a

tolerance for combined residues of the

fungicide azoxystrobin (methyl (E)-2-(2-

(6-(2-cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) and

its Z isomer (methyl (Z)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate), in or

on barley, bran at 0.2 ppm; barley, grain

at 0.1 ppm; barley, hay at 15 ppm;

barley, straw at 4 ppm; citrus, dried

pulp at 2.0 ppm; citrus, oil at 4.0 ppm;

coriander, leaves at 30 ppm; corn, field,

forage at 12 ppm; corn, field, grain at

0.05 ppm; corn, field, refined oil at 0.3

ppm; corn, field, stover at 25 ppm; corn,

pop, grain at 0.05 ppm; corn, pop, stover

at 25 ppm; corn, sweet, forage at 12

ppm; corn, sweet, kernel plus cob with

husks removed at 0.05 ppm; corn,

sweet, stover at 25 ppm; cotton, gin

byproducts at 0.02 ppm; cotton,

undelinted seed at 0.02 ppm; fruit,

citrus, group at 1.0 ppm; onion, dry bulb

at 1.0 ppm; onion, green at 7.5 ppm;

peanut at 0.2 ppm; peanut, hay at 15.0

ppm; peanut, refined oil at 0.6 ppm;

soybean, forage at 25 ppm; soybean, hay

at 55 ppm; soybean, hulls at 1.0 ppm;

soybean, seed at 0.5 ppm; vegetable,

leafy, except Brassica, group at 30 ppm;

vegetable, leaves of root and tuber,

group at 50 ppm; and vegetable, root,

subgroup at 0.5 ppm; and vegetable,

tuberous and corm, subgroup at 0.03

ppm; and increase the tolerances for

residues of azoxystrobin (only) in or on

cattle, fat to 0.03 ppm; cattle, meat

byproducts to 0.07 ppm; goat, fat to 0.03

ppm; goat, meat byproducts to 0.07

ppm; horse, fat to 0.03 ppm; horse, meat

byproducts to 0.07 ppm; sheep, fat to

0.03 ppm; and sheep, meat byproducts

to 0.07 (ppm).

Section 408(b)(2)(A)(i) of the FFDCA

allows EPA to establish a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to

mean that ‘‘there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of and to make a determination

on aggregate exposure, consistent with

section 408(b)(2), for tolerances for the

combined residues of azoxystrobin

(methyl (E)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) and

its Z isomer (methyl (Z)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) on

barley, bran at 0.2 ppm; barley, grain at

0.1 ppm; barley, hay at 15.0 ppm;

barley, straw at 4.0 ppm; citrus, dried

pulp at 2.0 ppm; citrus, oil at 4.0 ppm;

coriander, leaves at 30.0 ppm; corn,

field, forage at 12.0 ppm; corn, field,

grain at 0.05 ppm; corn, field, refined oil

at 0.3 ppm; corn, field, stover at 25.0

ppm; corn, pop, grain at 0.05 ppm; corn,

pop, stover at 25.0 ppm; corn, sweet,

forage at 12.0 ppm; corn, sweet (kernels

plus cob with husks removed) at 0.05

ppm; corn, sweet, stover at 25.0 ppm;

cotton, gin byproducts at 0.02 ppm;

cotton, undelinted seed at 0.02 ppm;

fruit, citrus, group at 1.0 ppm; grain,

aspirated grain fractions at 30.0 ppm;

onion, dry bulb at 1.0 ppm; onion, green

at 7.5 ppm; peanut at 0.2 ppm; peanut,

refined oil at 0.6 ppm; peanut, hay at

15.0 ppm; soybean, forage at 25.0 ppm;

soybean, hay at 55.0 ppm; soybean,

hulls at 1.0 ppm; soybean, seed at 0.5

ppm; vegetable, leafy, except Brassica,

group at 30.0 ppm; vegetable, leaves of

root and tuber, group at 50.0 ppm;

vegetable, root, subgroup at 0.5 ppm;

and vegetable, tuberous and corm,

subgroup at 0.03 ppm; and to increase

the tolerances for residues of

azoxystrobin (only) in or on cattle, fat to

0.03 ppm; cattle, meat byproducts to

0.07 ppm; goat, fat to 0.03 ppm; goat,

meat byproducts to 0.07 ppm; horse, fat

to 0.03 ppm; horse, meat byproducts to

0.07 ppm; sheep, fat to 0.03 ppm; and

sheep, meat byproducts to 0.07 ppm.

EPA’s assessment of exposures and risks

associated with establishing or

increasing the tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by azoxystrobin, as

well as the no observed adverse effect

level (NOAEL) and the lowest observed

adverse effect level (LOAEL) from the

toxicity studies reviewed, are discussed

in the following Table 1.

58406 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results

870.3100 90-Day oral toxicity in rodents NOAEL = 20.4 mg/kg/day for both males and females

LOAEL = 211.0 mg/kg/day based on decreased body weight gain in both

sexes, clinical observations of distended abdomens, reduced body size,

and clinical pathology findings atributable to reduced nutritional status.

870.3150 90-Day oral toxicity in nonrodents NOAEL = 50 mg/kg/day

LOAEL = 250 mg/kg/day based on treatment-related clinical observations

and clinical chemistry alterations .

870.3250 21-Day dermal toxicity NOAEL = greater than or equal to 1,000 mg/kg/day (the highest dosing

regimen)

LOAEL = was not determined.

870.3700a Prenatal developmental in rodents Maternal NOAEL = not established

Maternal LOAEL = 25 mg/kg/day based on increased salivation.

Developmental NOAEL = greater than or equal to 100 mg/kg/day

Developmental LOAEL = greater than 100 mg/kg/day because no adverse

effects were observed.

870.3700b Prenatal developmental in nonrodentsMaternal NOAEL = 150 mg/kg/day

Maternal LOAEL = 500 mg/kg/day based on decreased body weightgain.

Developmental NOAEL = 500 mg/kg/day

Developmental LOAEL = greater than 500 mg/kg/day because no treatment-related adverse effects on development were seen.

870.3800 Reproduction and fertility effects Reproductive NOAEL = 32.2 mg/kg/day

Reproductive LOAEL = 165.4 mg/kg/day based on treatment-related reductions in adjusted pup body weights that were observed in the F1a

and F2a pups.

870.4100a Chronic toxicity rodents NOAEL = 18.2 mg/kg/day for males and 22.3 mg/kg/day for females

LOAEL = 34 mg/kg/day for males based on reduced body weights, food

consumption and food efficiency, and bile duct lesions and 117.1 mg/kg/

day for females based on reduced body weights.

870.4100b Chronic toxicity dogs NOAEL = 25 mg/kg/day

LOAEL = 200 mg/kg/day based on clinical observations, clinical chemistry

changes, and liver weight increases in both sexes.

870.4200 Carcinogenicity in rats Systemic toxicity NOAEL = 18.2 mg/kg/day for males and 22.3 mg/kg/day

for females

Systemic toxicity LOAEL = 34 mg/kg/day for males based on reduced

body weights, food consumption and food efficiency, and bile duct lesions and 117.1 mg/kg/day for females based on reduced body weights.

There was no evidence of carcinogenicity.

870.4300 Carcinogenicity in mice Systemic toxicity NOAEL = 37.5 mg/kg/day

Systemic toxicity LOAEL = 272.4 mg/kg/day based on reduced body

weights in both males and females. There was no evidence of carcinogenicity.

870.5100 Gene Mutation Azoxystrobin was positive for forward gene mutation in mouse lymphoma

cells, but was not mutagenic in the salmonella/mammalian activation

gene mutation assay, showed some evidence of concentration-related

induction of chromosomal aberrations over background in the presence

of moderate to severe toxicity in the in vitro mammalian cytogenetics

assay in human lymphocytes, caused no increase in the induction of

micronuclei in the mouse bone marrow micronucleus assay, and did not

increase the incidence of unscheduled DNA synthesis in rat

hepatocytes/mammalian cells.

870.6200a Acute neurotoxicity screening battery Systemic toxicity NOAEL = less than 200 mg/kg/day Systemic toxicity

Systemic toxicity LOAEL = 200 mg/kg/day based on transient diarrhea in

both sexes. There was no indication of neurotoxicity at the doses tested.

870.6200b Subchronic neurotoxicity screening

battery

Systemic toxicity NOAEL = 38.5 mg/kg/day

Systemic toxicity LOAEL = 161 mg/kg/day based on decreased body

weight and weight gain in both sexes. There were no consistent indications of treatment-related neurotoxicity.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58407

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

Guideline No. Study Type Results

870.7485 Metabolism and pharma-cokinetics Metabolism studies were conducted with azoxystrobin that was either

unlabeled or was labeled on the pyrimidinyl, phenylacrylate, or

cyanophenyl part of the molecule. Dosing was single or for a period of

14 days. Overall recovery of label was 92–104%. Absorption was widely

distributed but less than 0.5% of the dose was detected in the tissues

and carcass up to 7 days postdosing. Most absorbed azoxystrobin was

in excretion-related organs, especially the liver and kidneys. There was

no evidence of potential for bioaccumulation. Excretion via expired air

was minimal. Most excretion, in both sexes, was via the feces (73–89%)

and urine (9–18%). Absorbed azoxystrobin seemed to be metabolized.

Except for metabolite V (a glucuronide conjugate), which represented

27.4–29.3% of the administered dose, individual biliary metabolites represented less than 10% of the administered dose. A metabolic pathway

was proposed showing hydrolysis and subsequent glucuronide conjugation as the major biotransformation process. This study was considered

supplementary but can be upgraded upon acceptable additional explanations of fecal excretion data and how they pertain to assessing absorption in the two low-dose studies.

870.7600 Dermal penetration Doses of 0.01 to 13.3 mg/kg were used. No animals died as a result of the

treatment. Percutaneous absorption was minimal and did not appear to

exhibit a dose-response relationship. Limited absorption precluded accurate assessment of distribution and metabolite characterization. Both

fecal and urinary excretion were quantified, the former representing ca.

6% or less of total absorption and the latter accounting for less than

0.1% of the absorbed dose over a 24-hour period.

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. No additional

uncertainty factors were used in this

assessment.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD), where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the LOC. For example, when

100 is the appropriate UF (10X to

account for interspecies differences and

10X for intraspecies differences) the

LOC is 100. To estimate risk, a ratio of

the NOAEL to exposures (margin of

exposure (MOE) = NOAEL/exposure) is

calculated and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk, which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10-6 or one

in a million). In certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment instead. 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 azoxystrobin used for human risk

assessment is shown in the following

Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR AZOXYSTROBIN FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF* and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Acute Dietary general population

including infants and children

NOAEL = less than 200 mg/

kg/day; UF = 300; Acute

RfD = 0.67 mg/kg/day

FQPA SF = 1; aPAD =

acute RfD FQPA SF =

0.67 mg/kg/day

Acute Neurotoxicity in the Rat

LOAEL = 200 mg/kg/day based on transient diarrhea in both sexes

58408 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR AZOXYSTROBIN FOR USE IN HUMAN RISK

ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF* and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Chronic Dietary all populations NOAEL = 18.2 mg/kg/day;

UF = 100; Chronic RfD =

0.18 mg/kg/day

FQPA SF = 1; cPAD = 0.18

mg/kg/day chronic RfD x

FQPA SF = 0.18 mg/kg/

day

Chronic/Carcinogenicity Feeding Study in Rats

LOAEL = 34 mg/kg/day for males based on reduced body weights, reduced food consumption and food efficiency, and bile duct lesions

and 117.1 mg/kg/day for females based on

reduced body weights

Short-Term Incidental Oral NOAEL = 25 mg/kg/day; UF

= 100

FQPA SF = 1 Prenatal Developmental Oral Toxicity in the Rat

LOAEL = 100 mg/kg/day based on increased

maternal diarrhea, urinary incontinence, and

salivation

Intermediate-Term Incidental

Oral

NOAEL = 20 mg/kg/day; UF

= 100

FQPA SF = 1 90-Day Feeding Study in the Rat

LOAEL = 211 mg/kg/day based on decreased

body weight gain and clinical signs indicative

of malnutrition in both sexes

Short-Term Dermal NOAEL= not applicable ............................................. 21-Day Repeated-Dose Dermal in the Rat

LOAEL = not applicable based on no dermal or

systemic effects seen at the limit dermal dose

of 1000 mg/kg/day. This risk assessment is

thus not required.

Intermediate-Term Dermal NOAEL = not applicable ............................................. 21-Day Repeated Dose Dermal in the Rat

LOAEL = not applicable based on no dermal or

systemic effects seen at the limit dermal dose

of 1000 mg/kg/day.This risk assessment is

thus not required.

Long-Term Dermal NOAEL = not applicable ............................................. This risk assessment is not required, based on

the use pattern.

Short-Term Inhalation NOAEL = 25 mg/kg/day

(route-to-route extrapolation and 100% absorption rate (default value)

used)

LOC for MOE = 100 Prenatal Development Oral Toxicity in the Rat

LOAEL = 100 mg/kg/day based on increased

maternal diarrhea, urinary incontinence, and

salivation

Intermediate-Term Inhalation NOAEL = 20 mg/kg/day

(route-to-route extrapolation and 100% absorption rate (default value)

used)

LOC for MOE = 100 90-Day Feeding Study in the Rat

LOAEL = 211 mg/kg/day based on decreased

body weight gain and clinical signs indicative

of reduced nutrition in both sexes

Long-Term Inhalation NOAEL = not applicable ............................................. This risk assessment is not applicable to the

use scenario of azoxystrobin.

Cancer ............................................. ............................................. Chronic/Carcinogenicity Feeding Study in Rats;

Carcinogenicity Feeding Study in Mice.

............................................. ............................................. There was no evidence of carcinogenic activity

in either study. This assessment is thus not

applicable and azoxystrobin is considered not

likely to be a human carcinogen.

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

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58409

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.507) for the

combined residues of azoxystrobin

(methyl (E)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) and

its Z isomer (methyl (Z)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate), in or

on a variety of raw agricultural

commodities. Tolerances for

azoxystrobin (only) have also been

established for the animal commodities

fat (0.010 ppm), meat byproducts (0.010

ppm), and meat (0.01 ppm) of cattle,

goats, hogs, horses, and sheep; and for

milk (0.006 ppm). Time-limited,

emergency exemption tolerances have

been established for azoxystrobin in/on

several raw agriculutural commodities

and animal commodities. Additional

time-limited, emergency exemption

azoxystrobin tolerances have also

recently been recommended for carrots,

roots (0.50 ppm); fruit, citrus, group (3.0

ppm); cotton, seed (0.10 ppm); beets,

garden, roots (0.50 ppm); beets, garden,

tops (50 ppm); and ginseng (0.50 ppm).

Several of the time-limited tolerances

will be replaced with permanent

tolerances by this rule. Where both a

time-limited and a permanent tolerance

are proposed or established and where

the tolerance values are not the same,

the higher of the values was used in the

dietary risk analysis. For the animal

commodities whose azoxystrobin

tolerances are proposed to be increased

in PP#9F6058, the increased tolerance

value was used in the dietary risk

analysis. Risk assessments were

conducted by EPA to assess dietary

exposures from azoxystrobin in food 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 one

day or single exposure. The Dietary

Exposure Evaluation Model (DEEM)

analysis evaluated the individual food

consumption as reported by

respondents in the USDA 1989–1992

nationwide Continuing Surveys of Food

Intake by Individuals (CSFII) and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the acute

exposure assessments: tolerance level

residues were assumed and it was also

assumed that 100% of the crops and

other commodities with proposed or

established azoxystrobin tolerances

contained those residues. Anticipated

residues, and percent crop treated (PCT)

values of less than 100%, were not used.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

DEEM analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

the chemical for each commodity. The

following assumptions were made for

the chronic exposure assessments:

tolerance level residues were assumed

and it was also assumed that 100% of

the crops and other commodities with

proposed or established azoxystrobin

tolerances contained those residues.

Anticipated residues, and percent crop

treated (PCT) values of less than 100%,

were not used.

iii. Cancer. Since carcinogenicity

studies produced no evidence that

azoxystrobin is a carcinogen, the

Agency concluded that azoxystrobin is

unlikely to be a human carcinogen.

There is also, as a consequence, no

carcinogenicity endpoint, and this

analysis was not performed.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

azoxystrobin in drinking water. Because

the Agency does not have

comprehensive monitoring data,

drinking water concentration estimates

are made by reliance on simulation or

modeling taking into account data on

the physical characteristics of

azoxystrobin.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and

Screening Concentration in Ground

Water (SCI-GROW) to predict pesticide

concentrations in ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporates an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact of the

processing (mixing, dilution, or

treatment) of raw water for distribution

that drinking water would likely have

on the removal of pesticides from the

source water. The primary use of these

models by the Agency at this stage is to

provide a coarse screen for sorting out

pesticides for which it is highly unlikely

that drinking water concentrations

would ever exceed human health levels

of concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead, drinking water levels of

comparison (DWLOCs) are calculated

and used as 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 azoxystrobin

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models the estimated environmental

concentrations (EECs) of azoxystrobin

for acute exposures are estimated to be

141 parts per billion (ppb) for surface

water and 0.064 ppb for ground water.

The EECs for chronic exposures are

estimated to be 0.064 ppb for surface

water and 127 ppb for ground water.

Agency policy allows the estimated

chronic surface water concentrations to

be divided by 3 to obtain the value that

is used in chronic risk assessment

calculations. Therefore, the value that

will be used in this type of assessment

for azoxystrobin is 42 ppb.

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).

Azoxystrobin is currently registered

for use on the following residential nondietary sites: turf and ornamentals. The

risk assessment was conducted using

the following residential exposure

assumptions:

Products containing azoxystrobin may

be applied 1–5 times per year at rates up

to 0.95 lb. of active ingredient per acre.

The current registered labels permit

homeowners to mix/load/apply both

flowable (i.e., liquid) and waterdispersable granule formulations.

Residential handlers may be exposed to

azoxystrobin for both short-term and

58410 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

intermediate-term durations. Toddlers

may also receive short-term and

intermediate-term oral exposure from

hand-to-mouth ingestion during postapplication activities. The Agency’s

Draft Standard Operating Procedures

(SOPs) for Residential Exposure

Assessments were used as the basis for

all residential handler exposure

calculations. The post-application risk

assessment is based on generic

assumptions as specified by the newly

proposed Residential SOPs and

recommended approaches by the

Agency’s Exposure Science Advisory

Committee. Changes to the Residential

SOPs have been proposed that alter the

residential post-application scenario

assumptions. The proposed

assumptions are expected to better

represent residential exposure and are

still considered to be high-end,

screening level assumptions. Agency

management has authorized the use of

the revised residential SOPs that were

presented to the FIFRA Science

Advisory Panel in September 1999.

Therefore, the current Residential SOP

assumptions have been deviated from

and the proposed assumptions have

been used to calculate exposure

estimates.

The short-term and intermediate-term

NOAELs of 25 mg/kg/day and 20 mg/kg/

day, derived from the Short-Term

Inhalation and Intermediate-Term

Inhalation scenarios (see above),

respectively, were used in the

inhalation and hand-to-mouth risk

assessment of residential exposure. As

no dermal endpoint was selected, a

dermal risk assessment was not required

for residential exposure. For residential

inhalation and oral risk assessments, the

target margin of exposure (MOE) was

100, which incorporates the FQPA

Safety Factor of 1x.

MOEs calculated for residential

handlers’ inhalation exposure and

children’s oral exposure were well

above the target of 100.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA does not have, at this time,

available data to determine whether

azoxystrobin has a common mechanism

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

azoxystrobin does not appear to produce

a toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that azoxystrobin has a

common mechanism of toxicity with

other substances. For information

regarding EPA’s efforts to determine

which chemicals have a common

mechanism of toxicity and to evaluate

the cumulative effects of such

chemicals, see the final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

D. Safety Factor for Infants and

Children

1. Safety factor for infants and

children—i. In general. FFDCA section

408 provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure unless EPA

determines that a different margin of

safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

ii. Prenatal and postnatal sensitivity.

The developmental and reproductive

toxicity data, from a Prenatal

Development Study in Rats, a Prenatal

Development Study in Rabbits, and a

Two-Generation Reproductive Toxicity

Study in Rats, did not indicate

increased susceptibility of young rats or

rabbits to in utero and/or postnatal

exposure.

iii. Conclusion. There is a complete

toxicity data base for azoxystrobin and

exposure data are complete or are

estimated based on data that reasonably

account for potential exposures. The

Agency has determined that the 10X

FQPA safety factor to protect infants

and children should be removed (that is,

set to 1) because, in addition to the

completeness of the toxicological

database and the lack of increased

susceptibility of young rats and rabbits

to pre- and postnatal exposure to

azoxystrobin, the unrefined chronic

dietary exposure estimates will

overestimate dietary exposure, and

ground and surface water modeling data

produce upper-bound concentration

estimates.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water EECs. DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water e.g., allowable chronic water

exposure (mg/kg/day) = cPAD - (average

food + residential exposure). This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint value, drinking water

consumption, and body weights. The

following default body weights and

consumption values are used by the

U.S. EPA Office of Water to calculate

DWLOCs: 2L/70 kg (adult male), 2L/60

kg (adult female), and 1L/10 kg (child).

Default body weights and drinking

water consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater 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) would not result in unacceptable

levels of aggregate human health risk at

this time. 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 azoxystrobin will

occupy 11% of the aPAD for the U.S.

population, 12% of the aPAD for

females 13 years old and older and 19%

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58411

of the aPAD for infants and children. In

addition, there is potential for acute

dietary exposure to azoxystrobin in

drinking water. After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect the aggregate exposure

to exceed 100% of the aPAD, as shown

in the following Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO AZOXYSTROBIN

Population Subgroup a PAD (mg/

kg)

% aPAD

(Food)

Surface

Water EEC

(μg/L)

Ground

Water EEC

(μg/L)

Acute

DWLOC

(μg/L)

U.S. population (total) 0.67 11 141 0.064 21,000

Infants/children 0.67 19 141 0.064 5,400

Females 13+ 0.67 12 141 0.064 18,000

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to azoxystrobin from food

will utilize 12% of the cPAD for the

U.S. population, 12% of the cPAD for

females 13 years old and older, and 18%

of the cPAD for children 1–6 years old.

Based the use pattern, chronic

residential exposure to residues of

azoxystrobin is not expected. In

addition, there is potential for chronic

dietary exposure to azoxystrobin in

drinking water. After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect the aggregate exposure

to exceed 100% of the cPAD, as shown

in the following Table 4:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO AZOXYSTROBIN

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(μg/L)

Ground

Water EEC

(μg/L)

Chronic

DWLOC

(μg/L)

U.S. Population (total) 0.18 12 42 0.064 5,600

Infants/children 0.18 18 42 0.064 1,500

Females 13+ 0.18 12 42 0.064 4,800

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).

Azoxystrobin is currently registered

for uses 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 azoxystrobin.

Using the exposure assumptions

described in this unit for short-term

exposures, EPA has concluded that food

and residential exposures aggregated

result in aggregate MOEs of 1,200 for the

U.S. population and 520 for the

subgroup children 1–6 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 EECs for

chronic exposure to azoxystrobin in

ground and surface water. After

calculating DWLOCs and comparing

them to the EECs for surface and ground

water, EPA does not expect short-term

aggregate exposure to exceed the

Agency’s level of concern, as shown in

the following Table 5:

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO AZOXYSTROBIN

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(μg/L)

Ground

Water EEC

(μg/L)

Short-Term

DWLOC

(μg/L)

U.S. population 1,200 100 42 0.064 6,900

Children 1–6 years old 520 100 42 0.064 2,000

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).

Azoxystrobin is currently registered

for uses 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 azoxystrobin.

Using the exposure assumptions

described in this unit for intermediateterm exposures, EPA has concluded that

food and residential exposures

aggregated result in an aggregate MOE of

420 for the subgroup children 1–6 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 EECs for

chronic exposure of azoxystrobin in

ground and surface water. After

calculating DWLOCs and comparing

them to the EECs for surface and ground

58412 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

water, EPA does not expect

intermediate-term aggregate exposure to

exceed the Agency’s level of concern, as

shown in the following Table 6:

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

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(μg/L)

Ground

Water EEC

(μg/L)

IntermediateTerm

DWLOC

(μg/L)

Children 1–6 years old 420 100 42 0.064 1,500

5. Aggregate cancer risk for U.S.

population. Because of the lack of

evidence of any carcinogenic potential

of azoxystrobin in long-term rat and

mouse feeding studies, the Agency has

classified it as not likely to be a human

carcinogen and there are no endpoints

or other values against which to assess

carcinogenic risk. Therefore, this risk

analysis is not applicable.

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to azoxystrobin

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate methodology is available for

enforcement of the proposed tolerances.

The registrant has previously submitted

three analytical methods for the analysis

of commodities for which azoxystrobin

tolerances exist.

1. The first method, RAM 243, is a gas

chromatography with nitrogenphosphorus detection (GC/NDP) method

previously submitted by the registrant

which can be used for the analysis of

the tolerances in or on non-oily

commodities such as barley, bran;

barley, grain; barley, hay; barley, straw;

citrus, dried pulp; coriander, leaves;

corn, field, forage; corn, field, grain;

corn, field, refined oil; corn, field,

stover; corn, pop, grain; corn, pop,

stover; corn, sweet, forage; corn, sweet

(kernels plus cob with husks removed);

corn, sweet, stover; fruit, citrus, group;

onion, dry bulb; onion, green; peanut,

hay; vegetable, leafy, except Brassica,

group; vegetable, leaves of root and

tuber, group; vegetable, root, subgroup;

vegetable, tuberous and corm, subgroup;

and non-oily processed commodities.

This method has been reviewed and

validated by the Agency, and will be

submitted to the Food and Drug

Administration (FDA) for inclusion in

Pesticide Analytical Manual (PAM) II.

2. The second method, RAM 260, is

a GC/NPD method previously submitted

by the registrant for the analysis of

azoxystrobin and its Z isomer in or on

crops of high lipid content. It is

adequate for the enforcement of

tolerances such as cotton, undelinted

seed; peanut; soybean, seed; and oily

processed commodities. This method

has also been validated by the Agency

and will be submitted to FDA for

inclusion in PAM II.

3. The third method, RAM 255/01,

also previously submitted by the

registrant, uses gas chromatography

with thermionic protection, nitrogen

mode, for analysis of animal

commodities, including the fat and meat

byproducts of cattle, goat, horse, and

sheep. This method, as well, has been

validated by the Agency for analysis of

milk and animal tissues. This method,

which will be accompanied by a written

laboratory report and an Agency

addendum, are to be submitted to FDA

for inclusion in PAM II.

The above methods may be requested

from: Calvin Furlow, PIRIB, IRSD

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW, Washington,

DC 20460; telephone number: (703)

305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

No Codex, Canadian, or Mexican

Maximum Residue Levels (MRLs) have

been established for residues of

azoxystrobin. Therefore, no tolerance

discrepencies exist between countries

for this chemical.

C. Conditions

As conditions of registration of the

use of azoxystrobin on the sites for

which tolerances are being established

in this rule, the registrant must submit

the following:

(1) In order to retain the use of the

flowable concentrate formulation for

late season uses the registrant must

either submit separate crop field trials

for the flowable concentrate or bridging

data (side-by-side field trials) on

representative crops for both the

flowable concentrate and the water

dispersible granule formulations of

azoxystrobin.

(2) The registrant must submit

additional data on the frozen storage

stability of azoxystrobin and its Z

isomer in or on one representative crop

each in the leafy vegetable group, the

root and tuber vegetable group, and the

processed commodities of a root and

tuber vegetable group member.

(3) Two additional spinach field trial

studies that reflect the maximum

proposed seasonal use pattern in each of

two Regions must be submitted.

(4) Additional rotational field crop

studies using a higher application rate

must also be submitted.

V. Conclusion

Therefore, tolerances are established

for the combined residues of

azoxystrobin (methyl (E)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) and

its Z isomer (methyl (Z)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate), , in

or on barley, bran at 0.2 ppm; barley,

grain at 0.1 ppm; barley, hay at 15.0

ppm; barley, straw at 4.0 ppm; citrus,

dried pulp at 2.0 ppm; citrus, oil at 4.0

ppm; coriander, leaves at 30.0 ppm;

corn, field, forage at 12.0 ppm; corn,

field, grain at 0.05 ppm; corn, field,

refined oil at 0.3 ppm; corn, field, stover

at 25.0 ppm; corn, pop, grain at 0.05

ppm; corn, pop, stover at 25.0 ppm;

corn, sweet, forage at 12.0 ppm; corn,

sweet (kernels plus cob with husks

removed) at 0.05 ppm; corn, sweet,

stover at 25.0 ppm; cotton, gin

byproducts at 0.02 ppm; cotton,

undelinted seed at 0.02 ppm; fruit,

citrus, group at 1.0 ppm; grain, aspirated

grain fractions at 30.0 ppm; onion, dry

bulb at 1.0 ppm; onion, green at 7.5

ppm; peanut at 0.2 ppm; peanut, refined

oil at 0.6 ppm; peanut, hay at 15.0 ppm;

soybean, forage at 25.0 ppm; soybean,

hay at 55.0 ppm; soybean, hulls at 1.0

ppm; soybean, seed at 0.5 ppm;

vegetable, leafy, except Brassica, group

at 30.0 ppm; vegetable; leaves of root

and tuber, group at 50.0 ppm; vegetable,

root, subgroup at 0.5 ppm; and

vegetable, tuberous and corm, subgroup

at 0.03 ppm; and tolerances are

increased for residues of azoxystrobin

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58413

(only) in or on cattle, fat to 0.03 ppm;

cattle, meat byproducts to 0.07 ppm;

goat, fat to 0.03 ppm; goat, meat

byproducts to 0.07 ppm; horse, fat to

0.03 ppm; horse, meat byproducts to

0.07 ppm; sheep, fat to 0.03 ppm; and

sheep, meat byproducts to 0.07 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301069 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before November 28, 2000.

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 (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. 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) 260–4865.

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.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VI.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301069, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@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 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). 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

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require OMB review 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

58414 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a petition

under FFDCA section 408(d), such as

the tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

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 21, 2000.

James Jones,,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—AMENDED

1. The authority citation for part 180

continues to read as follows:

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

371.

2. In Section 180.507, the table to

paragraph (a)(1) is amended by revising

the entries for ‘‘peanut, hay’’, and

‘‘peanuts’’, by adding new entries to

read as set forth below, and by removing

the entry for ‘‘peanut oil’’; the table in

paragraph (a)(2) is amended by revising

the entries for ‘‘cattle, fat’’; ‘‘cattle, meat

byproducts’’; ‘‘goat, fat’’; ‘‘goat, meat

byproducts’’; ‘‘horse, fat’’; ‘‘horse, meat

byproducts’’; ‘‘sheep, fat’’; and ‘‘sheep,

meat byproducts’’, and in the table to

paragraph (b) the entries for ‘‘soybean

hay’’; ‘‘soybean forage’’; ‘‘soybean

hulls’’; and ‘‘soybean seed’’ are

removed.

§ 180.507 Azoxystrobin; tolerances for

residues.

(a) * * *

(1) * * *

Commodity Parts per

million

*****

Barley, bran .............................. 0.2

Barley, grain ............................. 0.1

Barley, hay ................................ 15.0

Barley, straw ............................. 4.0

*****

Citrus, dried pulp ...................... 2.0

Citrus, oil ................................... 4.0

Coriander, leaves ..................... 30.0

Corn, field, forage ..................... 12.0

Corn, field, grain ....................... 0.05

Corn, field, refined oil ............... 0.3

Corn, field, stover ..................... 25.0

Corn, pop, grain ........................ 0.05

Corn, pop, stover ...................... 25.0

Corn, sweet, forage .................. 12.0

Corn, sweet (K+CWHR) ........... 0.05

Corn, sweet, stover .................. 25.0

Cotton, gin byproducts ............. 0.02

Cotton, undelinted seed ........... 0.02

Commodity Parts per

million

*****

Fruit, citrus, group .................... 1.0

Grain, aspirated grain fractions 30.0

*****

Onion, dry bulb ......................... 1.0

Onion, green ............................. 7.5

Peanut ...................................... 0.2

Peanut, refined oil .................... 0.6

Peanut, hay .............................. 15.0

*****

Soybean, forage ....................... 25.0

Soybean, hay ............................ 55.0

Soybean, hulls .......................... 1.0

Soybean, seed .......................... 0.5

*****

Vegetable, leafy, except Brassica, group ............................ 30.0

Vegetable, leaves of root and

tuber, group ........................... 50.0

Vegetable, root, subgroup ........ 0.5

Vegetable, tuberous and corm,

subgroup ............................... 0.03

*****

(2) * * *

Commodity Parts per

million

Cattle, fat .................................. 0.03

*** *

Cattle, meat byproducts ........... 0.07

Goat, fat .................................... 0.03

*****

Goat, meat byproducts ............. 0.07

Horse, fat .................................. 0.03

*****

Horse, meat byproducts ........... 0.07

*****

Sheep, fat ................................. 0.03

*****

Sheep, meat byproducts .......... 0.07

* * * * *

[FR Doc. 00–25051 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S