Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices 29317

the proposed uses of acetamiprid will

utilize at most 3.9% of the acute RfD for

the U.S. population, and is likely to be

much less, as more realistic data and

models are developed. EPA generally

has no concern for exposures below

100% of the RfD because the RfD

represents the level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. Therefore, there is a

reasonable certainty that no harm will

occur to the U.S. population from

aggregate exposure to acetamiprid.

2. Infants and children. In multigeneration reproduction and teratology

studies, NOAEL on reproduction were

observed in either rats or rabbits. In the

long-term, feeding studies in rats and

mice there was no evidence of

carcinogenicity. Acetamiprid was not

mutagenic under the conditions of

testing. Using the conservative exposure

assumptions described in the exposure

section above, the percent of the RfD

that will be used for short-term

aggregate exposure to residues of

acetamiprid will be 6% for children 1–

6 (the most highly exposed sub-group).

This value is based on dietary exposure

alone as only children over 7 are

expected to have residential postapplication exposure for the proposed

acetamiprid uses. The aggregate

exposure for children 7–12 (based on

dietary and residential exposure) results

in a value of 4.0% of the RfD being

used. As in the adult situation, drinking

water levels of comparison are much

higher than the worst case drinking

water estimated concentrations.

Therefore, there is a reasonable certainty

that no harm will occur to infants and

children from aggregate exposure to

residues of acetamiprid.

F. International Tolerances

Acetamiprid is registered for use in

Chile, Brazil, Mexico and Japan for use

on certain food crops for domestic

consumption only. Imported

commodities containing residues of

acetamiprid should not be encountered

in the United States at this time.

[FR Doc. 01–13420 Filed 5–29–01 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1022; FRL–6782–2]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1022 must be

received on or before June 29, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

PF–1022 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–3194; e-mail address:

brothers.shaja@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

codes

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’’, ‘‘ Regulation

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/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

1022. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, 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 Highway,

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.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–1022 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

29318 Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. You may submit

your comments electronically by e-mail

to: opp-docket@epa.gov, or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–1022. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI 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.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action Is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a. EPA has determined that

this petition contains data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petition. Additional data may be needed

before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 16, 2001.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petitions

The petitioner summary of the

pesticide petitions is printed below as

required by section 408(d)(3) of the

FFDCA. The summary of the petitions

was prepared by the petitioner and

represents the view of the petitioner.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition

summararies announce the availability

of a description of the analytical

methods available to EPA for the

detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

Interregional Research Project # 4 (IR4)

PP 0E6211, 1E6238, and 1E6264

EPA has received pesticide petitions

(0E6211, 1E6238, and 1E6264) from the

Interregional Research Project Number 4

(IR-4), [681 US Highway #1 South,

North Brunswick, NJ 08902–3390

proposing, pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

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

amend 40 CFR part 180.507 by

establishing tolerances for residues of

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

cyanophenoxy)pyrimidin-4-

yloxy]phenyl-3-methoxyacrylate) and

the Z isomer of azoxystrobin, (methyl

(Z)-2-2-6-(2- cyanophenoxy)pyrimidin4-yloxy]phenyl-3-methoxyacrylate) in or

on the following raw agricultural

commodities (RACs):

PP# 0E6211 proposes to establish

tolerances for strawberry at 10 parts per

million (ppm), mint at 30 ppm, grass

forage (from grass grown for seed) at 15

ppm, grass (from grass grown for seed)

hay at 20 ppm, and 3.0 ppm for

watercress, tropical fruits, persimmon,

paw paw, tamarind, jackfruit, and

loquat.

PP# 1E6238 proposes to establish

tolerances for bushberry subgroup,

lingonberries, juneberries, and salal at

3.0 ppm.

PP# 1E6264 proposes to establish

tolerances for the leafy brassica greens

subgroup and turnip greens at 25 ppm,

and 2.0 ppm for pepper, eggplant, and

okra.

EPA has determined that the petitions

contain data or information regarding

the elements set forth in section

408(d)(2) of the FFDCA; however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petitions. Additional data may be

needed before EPA rules on these

petitions.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of azoxystrobin as well as the nature of

the residues is adequately understood

for purposes of the tolerances.

2. Analytical method. Gas

chromatography with nitrogenphosphorus detection (GC-NPD) or in

mobile phase by high performance

liquid chromatography with ultra-violet

detection (HPLC-UV), is available. The

method(s) are adequate for enforcement

purposes. Analytical methods are also

available for analyzing meat, milk,

poultry and eggs which underwent

successful independent laboratory

validations.

3. Magnitude of residues. Complete

residue data for azoxystrobin (on

legume vegetable group, hops,

bushberries, lingonberries, salal,

juneberries, forage grass, forage hay,

jackfruit, loquat, mint, fresh, paw paw,

peppermint, persimmon, spearmint,

strawberry, tamarind, tropical fruit,

watercress, eggplant, leafy brassica

subgroup, okra, peppers, and turnip

greens) have been submitted. The

Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices 29319

requested tolerances are adequately

supported.

B. Toxicological Profile

1. Acute toxicity. The acute oral

toxicity study in rats of technical

azoxystrobin resulted in a lethal dose

(LD)50 of 5,000 milligrams/kilogram

(mg/kg) for both males and females. The

acute dermal toxicity study in rats of

technical azoxystrobin resulted in

a(LD)50 of 2,000 mg/kg. The acute

inhalation study of technical

azoxystrobin in rats resulted in a lethal

concentration LC50 of 0.962 mg/liter (L)

in males and 0.698 m/L in females. In

an acute oral neurotoxicity study in rats

dosed once by gavage with 0, 200, 600,

or 2,000 mg/kg azoxystrobin, the

systemic toxicity no observed adverse

effect level (NOAEL) was <200 mg/kg

and the systemic toxicity lowest

observed adverse effect level (LOAEL)

was 200 mg/kg, based on the occurrence

of transient diarrhea in both sexes.

There was no indication of

neurotoxicity at the doses tested.

2. Genotoxicity. Azoxystrobin was

negative for mutagenicity in the

salmonella/mammalian activation gene

mutation assay, mouse micronucleus

test, and unscheduled deoxyribonucleic

acid (DNA) synthesis in rat hepatocytes/

mammalian cells in vivo/in vitro

procedure study. In the forward

mutation study using L5178 mouse

lymphoma cells in culture, azoxystrobin

tested positive for forward gene

mutation at the TK locus. In the in vitro

human lymphocytes cytogenetics assay

of azoxystrobin, there was evidence of a

concentration related induction of

chromosomal aberrations over

background in the presence of moderate

to severe cytotoxicity.

3. Reproductive and developmental

toxicity. In a prenatal development

study in rats gavaged with azoxystrobin

at dose levels of 0, 25, 100, or 300 mg/

kg/day during days 7 through 16 of

gestation, lethality at the highest dose

caused the discontinuation of dosing at

that level. The developmental NOAEL

was greater than or equal to 100 mg/kg/

day and the developmental LOAEL was

>100 mg/kg/day because no significant

adverse developmental effects were

observed. In this same study, the

maternal NOAEL was not established;

the maternal LOAEL was 25 mg/kg/day,

based on increased salivation.

In a prenatal developmental study in

rabbits gavaged with 0, 50, 150, or 500

mg/kg/day during days 8 through 20 of

gestation, the developmental NOAEL

was 500 mg/kg/day and the

developmental LOAEL was> 500 mg/kg/

day because no treatment-related

adverse effects on development were

seen. The maternal NOAEL was 150 mg/

kg/day and the maternal LOAEL was

500 mg/kg/day, based on decreased

body weight gain.

In a 2–generation reproduction study,

rats were fed 0, 60, 300, or 1,500 ppm

of azoxystrobin. The reproductive

NOAEL was 32.2 mg/kg/day. The

reproductive LOAEL was 165.4 mg/kg/

day; reproductive toxicity was

demonstrated as treatment-related

reductions in adjusted pup body

weights as observed in the F<18 and

F<2 pups dosed at 1,500 ppm (165.4

mg/kg/day).

4. Subchronic toxicity. In a 90–day rat

feeding study the NOAEL was 20.4 mg/

kg/day for males and females. The

LOAEL was 211 mg/kg/day based on

decreased weight gain in both sexes,

clinical observations of distended

abdomens and reduced body size, and

clinical pathology findings attributable

to reduced nutritional status.

In a subchronic toxicity study in

which azoxystrobin was administered to

dogs by capsule for 92 or 93 days, the

NOAEL for both males and females was

50 mg/kg/day. The LOAEL was 250 mg/

kg/day, based on treatment-related

clinical observations and clinical

chemistry alterations at this dose.

In a 21–day repeated-dose dermal rat

study using azoxystrobin, the NOAEL

for both males and females was greater

than or equal to 1,000 mg/kg/day (the

highest dosing regimen); a LOAEL was

therefore not determined.

5. Chronic toxicity. In a 2–year

feeding study in rat fed diets containing

0, 60, 300, and 750/1,500 ppm (males/

females), the systemic toxicity NOAEL

was 18.2 mg/kg/day for males and 22.3

mg/kg/day for females. The systemic

toxicity LOAEL for males was 34 mg/kg/

day, based on reduced body weights,

food consumption and efficiency, and

bile duct lesions. The systemic toxicity

LOAEL for females was 117.1 mg/kg/

day, based on reduced body weights.

There was no evidence of carcinogenic

activity in this study.

In a 1–year feeding study in dogs to

which azoxystrobin was fed by capsule

at doses of 0, 3, 25, or 200 mg/kg/day,

the NOAEL for both males and females

was 25 mg/kg/day and the LOAEL was

200 mg/kg/day for both sexes, based on

clinical observations, clinical chemistry

changes, and liver weight increases that

were observed in both sexes.

In a 2–year carcinogenicity feeding

study in mice using dosing

concentrations of 0, 50, 300, or 2,000

ppm, the systemic toxicity NOAEL was

37.5 mg/kg/day for both males and

females. The systemic toxicity LOAEL

was 272.4 mg/kg/day for both sexes,

based on reduced body weights in both

at this dose. There was no evidence of

carcinogenicity at the dose levels tested.

According to the new proposed

guidelines for Carcinogen Risk

Assessment, the appropriate descriptor

for human carcinogenic potential of

azoxystrobin is ‘‘Not Likely.’’ The

appropriate subdescriptor is ‘‘has been

evaluated in at least two well conducted

studies in two appropriate species

without demonstrating carcinogenic

effects.’’

6. Animal metabolism. In this study,

azoxystrobin unlabeled or with a

pyrimidinyl, phenylacrylate, or

cyanophenyl label was administered to

rats by gavage as a single or 14–day

repeated doses. Less than 0.5% of the

administered dose was detected in the

tissues and carcass up to 7 days postdosing-most of it was in excretionrelated organs. There was no evidence

of potential for bioaccumulation. The

primary route of excretion was via the

feces, though 9 to 18% was detected in

the urine of the various dose groups.

Absorbed azoxystrobin appeared to be

extensively metabolized. A metabolic

pathway was proposed showing

hydrolysis and subsequent glucuronide

conjugation as the major

biotransformation process.

7. Metabolite toxicology. There are no

metabolites of concern based on the

differential metabolism between plants

and animals.

8. Endocrine disruption. There is no

evidence that azoxystrobin is an

endocrine disrupter.

C. Aggregate Exposure

1. Dietary exposure. Permanent

tolerances have been established (40

CFR 180.507(a)) for the combined

residues of azoxystrobin and its Z

isomer, in or on a variety of RACs at

levels ranging from 0.02 ppm on tree

nuts to 50.0 ppm on leaves of root and

tuber vegetables. Included in these

tolerances are animal commodities

which were established in conjunction

with tolerances for animal feed.

i. Food. For the purposes of assessing

the potential acute and chronic dietary

exposure, Syngenta has estimated acute

and chronic exposure for all registered

crops, (EPA) pending uses, and newly

proposed uses. Novigen Sciences’, Inc.

Dietary Exposure Evaluation Model

(DEEM), which is licensed to Syngenta,

was used to estimate the chronic and

acute dietary exposure.

a. Acute. The DEEM model was used

for analysis of individual food

consumption as reported by the USDA

using the Tier I analysis. The Tier I

analysis used tolerance values as

anticipated residues. Syngenta’s acute

dietary exposure assessment estimated

29320 Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices

percent of the acute population adjusted

dose (aPAD) and corresponding margins

of exposure (MOE) for the overall U.S.

population, infants/children, and

females 13+ as presented in Table 1.

TABLE 1.—ACUTE DIETARY RISK ASSESSMENT FOR AZOXYSTROBIN

Population Subgroup Exposure (mg/kg/day) Percent aPAD

U.S. population (total) 0.094350 14.0%

Infants/children 0.151589 22.6%

Females 13+ 0.088553 13.2%

b. Chronic. In conducting this chronic

dietary risk assessment Syngenta has

made very conservative assumptions—

100% of all commodities having

azoxystrobin tolerances or proposed

tolerances will contain azoxystrobin

residues at the level of the tolerance.

Default concentration factors have been

removed where data show no

concentration of residues (grape juice,

grapes, raisins; tomatoes juice, tomatoes,

puree; and white/dry potatoes). The

chronic reference dose (RfD) = 0.18 mg/

kg/day.

The existing azoxystrobin tolerances

published and pending result in a

theoretical maximum residue

contribution (TMRC) that is equivalent

to the following percentage of the

Chronic RfD. As the 10X safety factor

was removed by EPA, the chronic RfD

is equal to the PAD (populationadjusted dose). As a result, the exposure

given as a percentage of the total

allowable is reported as %PAD. These

results are presented in Table 2.

TABLE 2.—CHRONIC DIETARY RISK ASSESSMENT FOR AZOXYSTROBIN

Population Subgroup Exposure (mg/kg/day) Percent Reference Dose1 (%Chronic PAD/

RfD)

U.S. population (total) 0.028977 16.1%

All infants <1 year 0.026769 14.9%

Nursing infants <1 year 0008527 4.7%

Non-nursing infants <1 year 0.032107 17.8%

Children (1–6 years old) 0.047504 26.4%

Children (7–12 years old) 0.031544 17.5%

Western region 0.031923 17.7%

Non-hispanic/non-white/non-black 0.044724 24.8%

Females 13+ (nursing) 0.031485 17.5%

1 Percentage reference dose (%Chronic PAD)= Exposure x 100% (as RfD=PAD in this case) Chronic PAD

ii. Drinking water. There is no

established Maximum Concentration

Level for residues of azoxystrobin in

drinking water. No health advisory

levels for azoxystrobin in drinking water

have been established. The

concentration of azoxystrobin in surface

water based on GENEEC (Generic

Estimated Environmental Concentration

) modeling and in ground water based

on Screening Concentration in Ground

Water (SCI-GROW) modeling.

Based on the chronic dietary (food)

exposure estimated, chronic drinking

water levels of concern (DWLOC) for

azoxystrobin were calculated and

summarized in the table below. EPA has

estimated the highest EEC of

azoxystrobin in surface water is from

the application of azoxystrobin on

grapes (39 μg/L). The estimated

environmental concentration (EEC) for

ground water is 0.064 μg/L resulting

from use on turf. For purposes of risk

assessment, the maximum EEC for

azoxystrobin in drinking water (39 μg/

L) should be used for comparison to the

back-calculated human health drinking

water levels of comparison (DWLOC) for

the chronic (non-cancer) endpoint.

These DWLOCs for various populations

categories are summarized in Tables 3

and 4.

TABLE 3.—DRINKING WATER LEVELS OF COMPARISON FOR ACUTE EXPOSURE TO AZOXYSTROBIN

Subgroup1 aPAD (mg/kg/day) Food Exposure (mg/kg/

day)

Maximum Water Exposure

(mg/kg/day) DWLOC (μg/L)

U.S. population 0.67 0.094350 0.57565 20147.7 5

Females 13+ (nursing) 0.67 0.088553 0.581447 17443.41

Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices 29321

TABLE 3.—DRINKING WATER LEVELS OF COMPARISON FOR ACUTE EXPOSURE TO AZOXYSTROBIN—Continued

Subgroup1 aPAD (mg/kg/day) Food Exposure (mg/kg/

day)

Maximum Water Exposure

(mg/kg/day) DWLOC (μg/L)

Children (1-6 years old) 0.67 0.151589 0.518411 5184.11

1Within each of these categories, the subgroup with the highest food exposure was selected.

TABLE 4.—DRINKING WATER LEVEL OF COMPARISON FOR CHRONIC EXPOSURE TO AZOXYSTROBIN

Subgroup1 cPAD (mg/kg/

day) Food Exposure (mg/kg/day) Max Water Exposure2 (mg/kg/day) DWLOC 3,4,5 (μg/L)

U.S. population 0.18 0.028977 0.151023 5285.805

Females 13+ (nursing) 0.18 0.031485 0.148515 4455.45

Children (1–6 years old) 0.18 0.047504 0.132496 1324.96

1 Within each of these categories, the subgroup with the highest food exposure was selected. 2 Maximum Water Exposure (Chronic) (mg/kg/day) = Chronic RfD(mg/kg/day)–Food Exposure (mg/kg/day). 3 DWLOC (μg/L) = Max. water exposure (mg/kg/day) x body wt (kg) ÷ (10–3 μg/μg) * water consumed daily (L/day). 4 HED default body weights are: General U.S. population, 70 kg; Females 13+ years old 60 kg; infants and children 10 kg. 5 HED Default daily drinking rates are 2 L/day for adults and 1 L/day for children.

2. Non-dietary exposure.

Azoxystrobin is registered for

residential use on ornamentals and turf.

The Agency evaluated the existing

toxicological data base for azoxystrobin

and assessed appropriate toxicological

endpoints and dose levels of concern

that should be assessed for risk

assessment purposes. Dermal absorption

data indicate that absorption is less than

or equal to 4%. Azoxystrobin is

currently registered for uses that could

result in intermediate-term residential

exposure and the Agency has

determined that is appropriate to

aggregate chronic food and water and

intermediate-term exposures for

azoxystrobin. EPA has concluded that

food and residential exposures

aggregated result in MOEs of 520

(aggregate short-term), and 420

(aggregate intermediate term) for the

subgroup children 1–6 years old.

D. Cumulative Effects

Azoxystrobin is related to the

naturally occurring strobilurins.

Syngenta concluded that further

consideration of a common mechanism

of toxicity is not appropriate at this time

since there are no data to establish

whether a common mechanism exists

with any other substance.

E. Safety Determination

1. U.S. population. Based on the

exposure assessments described and

completeness and reliability of the

toxicity data, it can be concluded that

there is reasonable certainty that no

harm will result from aggregate

exposure to azoxystrobin. Total

aggregate exposures for all label uses

will utilize less than 16.1% of the cPAD

for the chronic dietary exposures.

2. Infants and children. 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 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 analysis or through using

uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans. In either

case, EPA generally defines the level of

appreciable risk as exposure that is

greater than 1/100 of the NOAEL in the

animal study appropriate to the

particular risk assessment. This

hundredfold uncertainty (safety) factor/

margin of exposure (safety) is designed

to account for combined inter- and

intra-species variability. EPA believes

that reliable data support using the

standard hundredfold margin/factor not

the additional tenfold margin/factor

when EPA has a complete data base

under existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard margin/factor. The Agency’s

Food Quality Protection Act (FQPA)

Safety Factor Committee removed the

additional 10X safety factor to account

for sensitivity of infants and children.

F. International Tolerances

There are no Codex Maximum

Residue Level’s established for

azoxystrobin.

[FR Doc. 01–13515 Filed 5–29–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50886; FRL–6781–3]

Issuance of an Experimental Use

Permit

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has granted an

experimental use permit (EUP) to the

following pesticide applicant. An EUP

permits use of a pesticide for

experimental or research purposes only

in accordance with the limitations in

the permit.

FOR FURTHER INFORMATION CONTACT: By

mail: Cynthia Giles-Parker, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

1921 Jefferson Davis Hwy., Rm. 249,

Crystal Mall #2, Arlington, VA; (703)

305–7740; e-mail address: gilesparker.cynthia@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. Although this action may be

of particular interest to those persons