Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28479

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1019; FRL–6780–2]

Notice of Filing a Pesticide Petition to

Establish a Tolerance fora 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–1019, must be

received on or before June 23, 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–1019 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 underFOR 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/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

1019. 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–1019 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

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–1019. 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.

28480 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

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 9, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

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

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioners.

EPA is publishing the petition summary

verbatim without editing it in any way.

The petition summary announces 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 Reseach Project Number 4

(IR-4)

PP 5E4434 and 0E6219

EPA has received pesticide petitions

(5E4434 and 0E6219) from the

Interregional Reseach Project Number 4

(IR-4), New Jersey Agricultural

Experiment Station, Rutgers University,

New Brunswick, NJ 08903 proposing,

pursuant to section 408(d) of FFDCA, 21

U.S.C. 346a(d), to amend 40 CFR part

180 by establishing tolerances for

residues of the fungicide, aluminum tris

(O-ethylphosphonate) (referred to in this

document as fosetyl-Al) in or on the raw

agricultural commodities as follows:

1. PP 5E4434 proposes the

establishment of tolerances for the

bushberrysubgroup, and lingonberry,

salal, and juneberry at 40 parts per

million (ppm).

2. PP 0E6221 proposes the

establishment of tolerances for turnip

roots and tops (leaves) at 50 ppm, peas

(succulent) at 0.3 ppm, and citrus at 5

ppm.

EPA has determined that these

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 these petitions. Additional

data may be needed before EPA rules on

these petitions.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of fosetyl-Al in plants is adequately

understood. Adequate data on the

nature of the residues in plants,

including identification of major

metabolites and degradates of fosetyl-Al,

are available. Radiolabeled studies on

the uptake, translocation and

metabolism in plants show that the

chemical proceeds through hydrolytic

cleavage of the ethyl ester. The major

residues are fosetyl-Al, phosphorus

acid, and ethanol. The tolerances are

established for the parent only, that is

fosetyl-Al.

2. Analytical method. Adequate

methods are available for enforcement

purposes. There are two analytical

methods acceptable for determining

residues of fosetyl-Al in plants: a gas

chromatography method is available for

enforcement of tolerance in pineapple

and is listed as Method I in PAM, Vol.

II; a gas chromatography/phosphorus

specific flame photometric detector

(FPD-P) method (Rhone-Poulenc

Method No. 163) for citrus has

undergone a successful method tryout

on oranges and has been sent to the

Food and Drug Administration for

inclusion in PAM as Method II.

3. Magnitude of residues. Magnitude

of residue data are adequate for the

proposed commodities.

B. Toxicological Profile

1. Acute toxicity. A complete battery

of acute toxicity studies for fosetyl-Al

technical has been conducted. The

lethal doseLD50 from the acute oral rat

is 5.4 grams/kilograms (g/kg) and the

LD50 from an acute dermal rabbit study

is>2 g/kg. The LD50 for a rat inhalation

study is >1.73 milligrams/liter (mg/L).

The acute oral rat and primary dermal

irritation studies indicate category IV

toxicity. A guinea pig dermal

sensitization study shows fosetyl-Al is

not a skin sensitizer. The primary eye

irritation study in rabbits shows fosetylAl to be an eye irritant with Category I

toxicity.

2. Genotoxicity. Fosetyl-Al is neither

mutagenic nor genotoxic. The genetic

toxicity potential of fosetyl-Al was

assessed in several assays. Eight

mutagenicity tests performed with

fosetyl-Al were negative. The tests

included two Ames assays withS.

typhimurium, two phase induction

assays usingE. coli, two micronucleus

studies in mice, one DNA repair assay

using E. coli and one mutation assay in

Saccharomyces cerevisiae.

3. Reproductive and developmental

toxicity. Fosetyl-Al is not a reproductive

toxicant and shows no evidence of

estrogenic or androgenic related effects.

i. In a three generation reproduction

study, fosetyl-Al was administered to

rats at dietary levels of 0, 6,000, 12,000

or 24,000 ppm. No adverse effects on

reproductive performance or pup

survival were observed in any dose

group. The lowest observed adverse

effect level (LOAEL) was established at

12,000 ppm based on effects on animal

weights and urinary tract changes. The

no observed adverse effect level

(NOAEL) for all effects was 6,000 ppm.

ii. A developmental study in rats

dosed via oral gavage at 500, 1,000 or

4,000 mg/kg/day showed a

developmental NOAEL of 1,000 mg/kg.

At 4,000 mg/kg, there was maternal

toxicity, as evidenced by effects on

animal weights, maternal deaths,

increased resorptions, and delayed fetal

ossification.

iii. A rabbit developmental study

showed no toxic effects at oral doses up

to 500 mg/kg. Effects of fosetyl-Al on

fetal development were observed only

in the rat at a dose producing severe

maternal toxicity. In the absence of

maternal toxicity, no adverse effects on

fetal development were observed, i.e. at

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28481

1,000 mg/kg/day in rats or at 500 mg/

kg/day in rabbits.

4. Subchronic toxicity. In subchronic

studies, no significant toxicity was

observed even at doses exceeding the

limit of 1,000 mg/kg/day.

i. A 21–day dermal study in rabbits

showed mild to moderate skin irritation

and a NOAEL of 1.5 g/kg/day.

ii. A 90–day feeding study in rats

showed a NOAEL of>5,000 ppm; the

LOAEL was 25,000 ppm with

extramedullary hematopoiesis in the

spleen.

iii. A 90–day dog feeding study

showed a NOAEL of 10,000 ppm and a

LOAEL at 50,000 ppm, at which the test

animals had a lower serum potassium

level than untreated animal.

5. Chronic toxicity. Chronic toxicity

studies have been conducted in dogs

and rats.

i. Dog. Fosetyl-Al was fed to dogs for

2 years at concentrations of 0, 10,000,

20,000, and 40,000 ppm. The NOAEL

was 10,000 ppm, equivalent to 250 mg/

kg/day. The LOAEL was 20,000 ppm

based on a slight degenerative effect on

the testes. These testicular changes, as

well as a few scattered clinical changes,

were seen in the high dose dogs. No

effects were observed in the urinary

tract.

ii. Rat. Fosetyl-Al was administered

via a mixture in the diet to CD rats at

target levels of 0, 2,000, 8,000, and

30,000/40,000 ppm for approximately 2

years. Based on these levels, respective

doses were 100, 400 and 2,000/1,500

mg/kg/day. After 2 weeks at 40,000

ppm, this dietary level was reduced to

30,000 ppm due to the occurrence of red

coloration of the urine and a decrease in

body weight gain. Although these

findings were no longer apparent after

week 2, analytical verification of dietary

levels revealed that the highest dietary

level ranged from approximately 38,000

to 61,000 ppm during the first 32 weeks

of the study. No significant differences

in body weight or food consumption

were noted at 2,000 or 8,000 ppm. No

biologically significant differences were

observed in ophthalmoscopy,

hematology, clinical chemistry, or

urinalysis for treated and control

animals. Calculi in the urinary bladder

were observed for several male and

female rats in the high dose group. Nonneoplastic findings consisted of

epithelial hyperplasia and inflammation

in the urinary bladders of males at

30,000/40,000 ppm. Increased

incidences of hydronephrosis,

inflammation, and epithelial

hyperplasia in the kidney were also

observed in males from the high dose

group. Females from the same group

exhibited increased incidences of

epithelial hyperplasia in the urinary

bladder and hydronephrosis in the

kidney. The NOAEL in the chronic rat

study was 8,000 ppm (400 mg/kg/day).

The lowest NOAEL for chronic effects of

fosetyl-Al is 10,000 ppm (250 mg/kg/

day) based on the dog study. This

NOAEL is based on minor changes at

20,000 ppm. In the rat, calculi in the

urinary bladder and related

histopathological changes in the bladder

and kidneys of males and females were

observed at 30,000/40,000 ppm.

6. Carcinogenicity. Long-term feeding

studies were conducted with technical

grade fosetyl-Al in mice and rats and

with monosodium phosphite, the

primary urinary metabolite of fosetyl-Al,

in rats. These studies, and a mechanistic

study in rats, are described below:

i. Rat. In addition to the chronic

studies previously noted, calculi in the

urinary bladder were also observed for

several male and female rats at 30,000/

40,000 ppm. Microscopic examination

revealed transitional cell carcinomas

and papillomas in the urinary bladders

of high dose males. A statistically

significant increase in adrenal

pheochromocytomas (benign and

malignant combined) was observed in

males at 8,000 and 30,000/40,000 ppm.

The adrenal slides were independently

reread by two consulting pathologists

who found no significant dose-related

increases in the incidence of

pheochromocytomas or hyperplasia.

The NOAEL for fosetyl-Al in the

chronic rat study was 8,000 ppm;

however, a subsequent mechanistic

study in rats conducted with dietary

levels of 8,000, 30,000 and 50,000 ppm

demonstrated that the massive doses of

30,000 and 50,000 ppm fosetyl-Al alter

calcium/phosphorous homeostasis

resulting in severe acute renal injury,

similar to that observed in the chromic

rat study, and the formation of calculi

in kidneys, ureters, and bladder. Under

conditions of chronic exposure, these

effects could lead to the formation of

bladder tumors as seen in the chronic

rat study. At 8,000 ppm, no evidence of

renal injury was observed, a result

consistent with the absence of bladder

tumors. Thus, the bladder tumors

induced by fosetyl-Al were the result of

acute renal injury followed by a chronic

toxic reaction rather than a true

carcinogenic effect. An carcinogenicity

study in rats was conducted with

monosodium phosphite administered

via dietary mixture at levels of 2,000,

8,000, and 32,000 ppm. No evidence of

carcinogenicity was observed in this

study.

ii. Mouse. A 2–year feeding/

carcinogenicity study was conducted in

mice fed diets containing fosetyl-Al at 0,

2,500, 10,000, or 20,000/30,000 ppm.

The 20,000 ppm dose was increased to

30,000 ppm during week 19 of the

study. The NOAEL for all effects was

20,000/30,000 ppm (3,000/4,500 mg/kg/

day). There were no carcinogenic effects

observed under the conditions of this

study.

iii. The Office of Pesticide Programs’,

Health Effects Division, Carcinogenicity

Peer Review Committee (CPRC)

concluded in their report of June 29,

1993 that the pesticidal use of fosetylAl is unlikely to pose a carcinogenic

hazard for humans given that: Tumors

develop in rats under extreme

conditions that are unlikely to be

achieved other than under laboratory

conditions (at a dose in excess of the

EPA dose limit for carcinogenicity

studies); tumors in rats are believed to

develop only at doses that produce

stones; human dietary exposure to

fosetyl-Al is only about one-500,000th

of the NOAEL for stone formation in the

rat (the most sensitive experimental

model); and the dose of fosetyl-Al

which can be absorbed dermally by

applicators is also probably too low to

result in stone formation. EPA has

therefore chosen to use the Reference

Dose (RfD) to quantify dietary risk to

humans.

7. Animal metabolism. Rat

metabolism studies showed that most of

the radiolabel rapidly appeared in

exhaled carbon dioxide. There was also

some radiolabel excreted in the urine as

phosphite, along with a smaller amount

as the unchanged parent compound. It

appears that fosetyl-Al is essentially

completely absorbed after ingestion and

extensively hydrolyzed to carbon

dioxide which is exhaled. The

phosphite is excreted in the urine

without further oxidation to phosphate.

Aluminum does not appear to be

absorbed to a significant extent from the

gastrointestinal trac.

8. Metabolite toxicology. There are no

metabolites of toxicological concern.

The tolerances are established for the

parent only, that is fosetyl-Al.

9. Endocrine disruption. No evidence

of estrogenic or androgenic effects were

noted in any study with fosetyl-Al. No

adverse effects on mating or fertility

indices and gestation, live birth, or

weaning indices were noted in a threegeneration rat reproduction study at

doses well above EPA’s limit of 1,000

mg/kg/day. Therefore, Aventis Crop

Science concludes that fosetyl-Al does

not have any effect on the endocrine

system.

C. Aggregate Exposure

1. Dietary exposure. EPA has

established the chronic RfD for fosetylVerDate 11<MAY>2000 19:28 May 22, 2001 Jkt 194001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM pfrm04 PsN: 23MYN1
28482 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

Al at 2.5 mg/kg/day. This RfD is based

on a NOAEL of 250 mg/kg/day from a

2–year feeding study in dogs and the

use of a 100 fold safety factor to account

for interspecies and intraspecies

differences. No appropriate endpoint

attributable to a single dose exposure

was identified in oral toxicity studies.

Therefore, an acute RfD was not

established and there is no expectation

of acute risk. Since no dermal or

systemic toxicity was seen at the limit

dose following repeated dermal

applications in the 21–day toxicity

study using rats, no endpoint value was

calculated for short- and intermediateterm exposure and risk. The Agency has

concluded that fosetyl-Al is unlikely to

pose a carcinogenic hazard to humans.

Therefore, a cancer exposure and risk

assessment is not appropriate.

i. Food. For all currently registered

uses of fosetyl-Al, chronic food

exposure for various subgroups of the

U.S. population was estimated by EPA

through the use of the Dietary Exposure

Evaluation Model (DEEM) software. The

DEEM analysis evaluated the individual

food consumption as reported by

respondents in the USDA 1989-1991

nationwide Continuing Surveys of Food

Intake by Individuals. As the risk

estimate was low for even the most

highly exposed subpopulation, no

anticipated residues were used. One

hundred percent crop treated and

tolerance level residues were assumed

for all crops. Based on the results of this

conservative analysis, exposure to

fosetyl-Al residues from the proposed

uses is expected to be minimal. Aventis

Crop Science concludes that dietary

exposure to fosetyl-Al resulting from the

currently registered and the proposed

uses of the product will be well below

the Agency’s level of concern.

ii. Drinking water. There is no

established maximum contaminant level

or health advisory level for fosetyl-Al.

The potential for ground water and/or

surface water contamination by fosetylAl and its degradates is expected to be

very low, in most cases, due to the rapid

degradation of the compound in soil to

non-toxic degradates under both aerobic

and anaerobic conditions. Under aerobic

laboratory conditions, the half-life of

fosetyl-Al is between 1 and 1.5 hours in

loamy sand, silt loam and clay loam and

20 minutes in sandy loam soil. The

degradation proceeds through the

hydrolysis of the ethyl ester bond,

resulting in the formation of

phosphorous acid and ethanol. The

ethanol is further degraded into carbon

dioxide. Based on the short half-life of

fosetyl-Al and the known fate of

phosphates under anaerobic conditions,

EPA determined that an anaerobic soil

metabolism study was not necessary. An

anaerobic aquatic soil metabolism study

was conducted. When anaerobic

conditions were established by flooding

soil, the half-life was 40 hours with silty

clay loam and 14 hours with sandy loam

soil. Aventis Crop Science expects that

potential fosetyl-Al residues in drinking

water are not a significant contribution

to aggregate exposure.

2. Non-dietary exposure. Fosetyl-Al is

currently registered for residential use

on turf and ornamental plants. Chronic

exposure is not expected for residential

uses. There is also no expectation of

acute risk. No appropriate endpoint

attributable to a single dose exposure

was identified in oral toxicity studies

and consequently, an acute RfD cannot

be calculated. No endpoint value is

calculable for short- and intermediateterm exposure and a risk analysis

cannot be performed since no dermal or

systemic toxicity was seen at the limit

dose following repeated dermal

applications in the 21–day toxicity

study using rats. The Agency has

previously concluded that fosetyl-Al is

unlikely to pose a carcinogenic hazard

to human. Therefore, a cancer exposure

and risk assessment is not appropriate.

Thus, Aventis Crop Science concludes

that the ornamental and turf uses do not

add significantly to the aggregate

exposure for fosetyl-Al.

D. Cumulative Effects

Effects associated with fosetyl-Al are

unlikely to be cumulative with any

other compound. The formation of

calculi and bladder tumors in rats is the

only significant toxicological effect

observed with fosetyl-Al. These effects

were observed in rat only at a dose

which not only exceeds estimated

human exposure by several orders of

magnitude but is in excess of the EPA

dose limit for carcinogenicity studies.

Therefore, an aggregate assessment

based on common mechanisms of

toxicity is not appropriate as exposure

to humans will be well below the levels

producing calculi and bladder tumors in

rats. Further, considering the rapid

elimination of fosetyl-Al in the rat

metabolism study, any effects associated

with fosetyl-Al are unlikely to be

cumulative with any other compound.

Based on these reasons, only the

potential risks of fosetyl-Al are

considered in the exposure assessment.

E. Safety Determination

1. U.S. population. Chronic risk

estimates associated with exposure to

fosetyl-Al in food and water are

expected to be well below the Agency’s

level of concern. The DEEM chronic

exposure analysis previously performed

by the Agency for all currently

registered food uses shows that

exposure to fosetyl-Al utilizes 3.1% of

the cPAD for the U.S. population, 2.7%

of the cPAD for females (13–50 years),

6.3% of the cPAD for children 1-6 years

old, and 4.2% of the cPAD for nonHispanic (other than black or white).

This analysis was conducted assuming

100% crop treated and tolerance level

residue values for all crops. The

contribution of fosetyl-Al residues in

surface and ground water to chronic

aggregate exposure is expected to be

minimal. Therefore, Aventis Crop

Science concludes that even when

considering the potential incremental

risk resulting from the proposed uses,

there is a reasonable certainty that no

harm will result from aggregate

exposure to fosetyl-Al residues.

2. Infants and children. No indication

of increased susceptibility of rat or

rabbit fetuses to in utero and/or

postnatal exposure was noted in the

developmental and reproductive

toxicity studies. The Agency has

previously determined that no

additional safety factor to protect infants

and children is necessary for this

product.

Using the conservative assumptions

described in the exposure section,

aggregate exposure to fosetyl-Al from

currently registered food uses will

utilize up to 6.3% of the RfD for infants

and children. Even when considering

the potential incremental dietary risk

resulting from the proposed uses, the

potential for exposure to residues in

drinking water and from non-dietary,

non-occupational exposure, the

aggregate exposure to fosetyl-Al is

expected to be well below 100% of the

RfD. Aventis Crop Science concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

fosetyl-Al residues.

F. International Tolerances

There are presently no Codex

Alimentarius Commission maximum

residue levels established for residues of

fosetyl-Al.

[FR Doc. 01–12906 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1023; FRL–6782–5]

Notice of Filing a Pesticide Petition to

Establish a Tolerance fora Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).