Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices 29313

the aforementioned uses from any

product bearing such use. The

registrations for which amendments to

delete uses were requested are

identified in the following Table 3.

TABLE 3.—END-USE PRODUCT REGISTRATION AMENDMENT REQUESTS

Company Reg. No Product

Drexel ChemicalCompany 19713–91 Diazinon insecticide

19713–92 D–264 4E Diazinon insecticide

19713–95 D–264 14G

19713–145 D–264 Captan seed protectant

19713–263 Diazinon 5G

19713–264 Diazinon 2G

19713–317 Bug spray (SP)

19713–492 Diazinon 50 WP

Under section 6(f)(1)(A) of FIFRA,

registrants may request, at any time, that

their pesticide registrations be amended

to delete one or more pesticide uses.

Drexel Chemical Co., has requested that

EPA waive the 180–day comment

period. In light of this request, EPA is

granting the request to waive the 180–

day comment period and is providing a

30–day public comment period before

taking action on the requested

amendments to delete uses. Because of

risk concerns posed by certain uses of

diazinon, EPA intends to grant the

requested amendments to delete uses at

the close of the comment period for this

announcement.

III. Proposed Existing Stocks Provisions

The registrants have requested

voluntary cancellation of the diazinon

registrations identified in Tables 1 and

2 and submitted amendments to

terminate certain uses of the diazinon

registrations identified in Table 3.

Pursuant to section 6(f) of FIFRA, EPA

intends to grant the requests for

voluntary cancellation and amendment.

For purposes of the cancellation order

that the Agency intends to issue at the

close of the comment period for this

announcement, the term ‘‘existing

stocks’’ will be defined, pursuant to

EPA’s existing stocks policy at 56 FR

29362, June 26, 1991, as those stocks of

a registered pesticide product which are

currently in the United States, which

have been packaged, labeled, and

released for shipment prior to the

effective date of the cancellation or

amendment. Any distribution, sale, or

use of existing stocks after the effective

date of the cancellation order that the

Agency intends to issue that is not

consistent with the terms of that order

will be considered a violation of section

12(a)(2)(K) and/or 12(a)(1)(A) of FIFRA.

A. Manufacturing-Use Products

1. Distribution or sale. The

distribution or sale of existing stocks of

any MUP identified in Table 1 will not

be lawful under FIFRA as of the date of

issuance of the cancellation order

except for purposes of relabeling,

shipping such stocks for export

consistent with the requirements of

section 17 of FIFRA, or proper disposal.

2. Use for producing other products.

The use of existing stocks of any MUP

identified in Table 1 for formulation

into any other product labeled for

indoor use will not be lawful under

FIFRA effective issuance date of the

cancellation order. The use of existing

stocks of any MUP identified in Table

1 for formulation into any other product

labeled for the agricultural uses listed

above will not be lawful under FIFRA

as of June 30, 2001.

B. End-Use Products

1. Distribution or sale of products

bearing instructions for use on

agricultural crops. The distribution or

sale or of existing stocks by any person

of any product listed in Table 2 or 3 that

bears instructions for use on the above

listed agricultural crops will not be

lawful under FIFRA 1–year after the

effective date of the use deletion or

cancellation. Any use of such product

until that date must be in accordance

with the existing labeling of that

product.

2. Distribution or sale of products

bearing instructions for use on indoor

sites. The distribution or sale of existing

stocks by the registrant of any product

listed in Table 2 or 3 that bears

instructions for use at or on any indoor

sites (except mushroom houses), shall

not be lawful under FIFRA effective

issuance date of the cancellation order.

3. Retail and other distribution or

sale. The retail sale of existing stocks of

products listed in Table 2 or 3 bearing

instructions for any indoor uses except

mushroom houses will not be lawful

under FIFRA after December 31, 2002.

4. Use of existing stocks. EPA intends

to permit the use of existing stocks of

products listed in Table 2 or 3 until

such stocks areexhausted, provided

such use is in accordance with the

existing labeling of that product.

List of Subjects

Environmental protection, Pesticides

and pests.

Dated: May 18, 2001.

Lois A. Rossi,

Director, Special Review and Reregistration

Division, Office of Pesticide Programs.

[FR Doc. 01–13514 Filed 5–29–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1024; FRL–6782–9]

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.

29314 Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices

DATES: Comments, identified by docket

control number PF–1024, 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–1024 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Akiva Abramovitch, Insecticide

Rodenticide Branch, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–8328; e-mail address:

abramovitch.akiva@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–

1024. 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–1024 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–1024. 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.

Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices 29315

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 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 petitioner.

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.

Aventis CropScience (formerly, RhonePoulenc Ag Company)

PP 0F06082

EPA has received a pesticide petition

(0F06082) from Aventis CropScience

(formerly, Rhone-Poulenc Ag Company),

P.O. Box 12014, #2 T.W. Alexander

Drive, Research Triangle Park, NC 27709

proposing, pursuant to section 408(d) of

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

40 CFR part 180, by establishing

tolerances for residues of acetamiprid in

or on the raw agricultural commodity

brassica (cole crops) at 1.2 parts per

million (ppm); canola seed and mustard

seed at 1.2 ppm; citrus at 0.5 ppm;

cottonseed at 0.06 ppm; fruiting

vegetables at 0.2 ppm; grapes at 0.2

ppm; leafy vegetables at 3.0 ppm; and

pome fruits at 0.70 ppm. EPA has

determined that the petition contains

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 petition.

Additional data may be needed before

EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of acetamiprid in plants is well

understood, having been investigated in

eggplant, apples, cabbage, carrots, and

cotton. Metabolism in plants primarily

involves demethylation of the N-methyl

group with subsequent hydrolysis of the

acetamidine function to give the Nacetyl compound. This compound is

then hydrolyzed to the corresponding

amine followed by oxidation to the

alcohol and acid. Conjugation of the

alcohol with glucose is also significant.

Degradation of the side chain without

loss of the N-methyl group is seen in

carrots since this is the major metabolic

route in soil.

2. Analytical method. Based upon the

metabolism of acetamiprid in plants and

the toxicology of the parent and

metabolites, quantification of the parent

acetamiprid is sufficient to determine

toxic residues. As a result a method has

been developed which involves

extraction of acetamiprid from crops

with methanol, filtration, partitioning

and cleanup, and analysis by gas

chromatography/electron capture

detector (GC/ECD) methods. The limit of

quantification for the method is 0.01

ppm and the method detection limit

(MDL) is 0.0005 ppm.

3. Magnitude of residues. Magnitude

of residue studies were conducted in

pome fruit (apples and pears); brassica

(cole crops including broccoli, cabbage

and mustard greens); leafy vegetables

(leaf lettuce, head lettuce, celery, and

spinach); fruiting vegetables (tomatoes,

eggplant, and peppers); citrus (oranges,

grapefruit, and lemon); grapes; canola

seed; mustard seed; and cotton. Trials

were conducted in all of the major use

areas for each of the crops as specified

in the Residue Chemistry Guidelines

OPPTS 860.1500 with applications at

the maximum label use rate for each

crop. (Trials for mustard seed were

conducted in Canada.). As a result of the

field trials, the following tolerances are

proposed for each of the crop group,

crops or matrices: pome fruit at 0.70

ppm; brassica (cole crops) at 1.2 ppm;

leafy vegetables at 3.0 ppm; fruiting

vegetables at 0.2 ppm; grapes at 0.2

ppm; citrus at 0.5 ppm; canola seed at

0.01 ppm; mustard seed at 0.01 ppm;

cottonseed at 0.06 ppm; and cotton gin

trash at 20 ppm. Processing studies were

also conducted with apples, citrus,

cottonseed, grapes, and tomatoes.

Maximum processed commodity

residues exceeded 1.2x the RAC

tolerance only with citrus dry pulp

(2.22x) and tomato paste (1.65x).

Therefore, tolerances are proposed for

these processed commodities as follows:

citrus dry pulp at 1.2 ppm and tomato

paste at 0.4 ppm. Tolerances are also

proposed for milk, liver, kidney, muscle

and fat at 0.05 ppm.

B. Toxicological Profile

1. Acute toxicity. The acute oral LD50

for acetamiprid was 146 milligrams/

kilogram (mg/kg) for female SpragueDawley rats and 217 mg/kg for male

rats. The acute dermal LD50 for

acetamiprid was greater than 2,000 mg/

kg in rats. The acute 4–hour inhalation

LC50 for acetamiprid was greater than

1.15 milligrams/Liter (mg/L), the highest

attainable concentration. Acetamiprid

was not irritating to the eyes, or skin

and was not considered to be a

sensitizing agent. The no observed

adverse effect level (NOAEL) for acute

neurotoxicity was 10 mg/kg and no

evidence of neuropathy was noted.

The acute oral LD50 for Acetamiprid

70WP was 944 mg/kg for female

Sprague-Dawley rats and 1,107 mg/kg

for male rats. The acute dermal LD50 for

formulated acetamiprid was greater than

2,000 mg/kg in rats. The acute

inhalation LC50 (4–hour) for

Acetamiprid 70WP was determined to

be greater than 2.88 mg/L, the highest

attainable concentration. Acetamiprid

70WP was concluded to be a mild eye

irritant and slight skin irritant. There

were no indications of skin sensitization

for the formulated product.

2. Genotoxicty. Based on the weight of

the evidence provided by a complete

test battery, acetamiprid is neither

mutagenic nor genotoxic. The

compound was found to be devoid of

mutagenic activity (with and without

metabolic activation) in Salmonella

typhimurium and Escherichia coli

(Ames assay). Acetamiprid was also not

mutagenic in an in vitro mammalian cell

gene mutation assay on Chinese hamster

ovary (CHO) cells (Hypoxanthine

guanine phophoribosyl transferase

(HGPRT) locus, with and without

metabolic activation). Acetamiprid did

not induce unscheduled DNA synthesis

unscheduled DNA synthesis (UDS) in

either rat liver primary cell cultures or

in mammalian liver cells in vivo. In an

in vitro chromosomal aberration study

using CHO cells, acetamiprid was

positive when tested under metabolic

activation at cytotoxic dose levels; no

effect was detected without metabolic

activation. Acetamiprid was nonVerDate 11<MAY>2000 17:20 May 29, 2001 Jkt 194001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\30MYN1.SGM pfrm04 PsN: 30MYN1
29316 Federal Register / Vol. 66, No. 104 / Wednesday, May 30, 2001 / Notices

clastogenic in an in vivo chromosomal

aberration study in rat bone marrow. It

also was negative in an in vivo mouse

bone marrow micronucleus assay.

3. Reproductive and developmental

toxicity. In the multi-generation rat

reproduction study, a NOAEL of 100

ppm was established based on

decreased body weight gains and a

reproduction NOAEL of 800 ppm

(highest dose tested) was established for

reproductive performance and fertility.

In the rat teratology study, the

developmental NOAEL was 50 mg/kg/

day (maternal NOAEL of 16 mg/kg/day

based on decreased body weight and

food consumption) and in the rabbit

teratology study, the developmental

NOAEL was 30 mg/kg/day (maternal

NOAEL of 15 mg/kg/day based on

decreased body weight and food

consumption). In both the rat and rabbit

there were no fetotoxic or teratogenic

findings.

4. Subchronic toxicity.In the 3–month

dog feeding study, a NOAEL of 800 ppm

(32 mg/kg/day for both males and

females) was established based on

growth retardation and decreased food

consumption.

In the 3–month rat feeding study, a

NOAEL of 200 ppm (12.4 and 14.6 mg/

kg/day respectively for male and female

rats) was established based on liver cell

hypertrophy at a dose of 800 ppm.

In the 3–month mouse feeding study,

a NOAEL of 400 ppm (53.2 and 64.6 mg/

kg/day respectively for male and female

rats) was established based on increased

liver/body weight ratio and decreased

cholesterol in females at 800 ppm.

A 13–week dietary neurotoxicity

study, for acetamiprid established a

NOAEL of 200 ppm (14.8 and 16.3 mg/

kg/day for male and female rats) based

on reduced body weight and food

consumption decreases at 800 ppm.

There was no evidence of neurotoxicity.

A 21–day dermal study, in rabbits at

dose levels up to 1,000 mg/kg/day

caused no systemic toxicity, dermal

irritation or histomorphological lesions

in either sex tested.

5. Chronic toxicity. In the 1–year dog

study, the NOAEL was established at

600 ppm (20.5 and 21 mg/kg/day for

male and female dogs) based on growth

retardation and decrease of food

consumption at a dose of 1,500 ppm.

In the 18–month mouse study, the

NOAEL was established at 130 ppm

(20.3 and 25.2 mg/kg/day for male and

female mice) based on growth

retardation and hepatic toxicity at 400

ppm.

In the 2–year rat study, the NOAEL

was 160 ppm (7.1 and 8.8 mg/kg/day for

male and female rats) based on growth

retardation and hepatic toxicity. There

were no indications of carcinogenicity

in either the rat or mouse chronic

studies.

6. Animal metabolism. The

metabolism of acetamiprid is well

understood and the primary animal

metabolite is IM–2–1.

7. Metabolite toxicology. Testing of

IM–2–1 demonstrated that it is

significantly less toxic than the parent

acetamiprid and it is not being

considered as part of the total toxic

residue, therefore no tolerance is being

requested by the registrant. The acute

oral LD50 of IM–2–1 is 2,543 mg/kg for

male rats and 1,762 mg/kg for female

rats.

8. Endocrine disruption. Acetamiprid

does not belong to a class of chemicals

known or suspected of having adverse

effects on the endocrine system.

Developmental toxicity studies in rats

and rabbits and a reproductive study in

rats gave no indication that acetamiprid

has any effects on endocrine function.

The chronic feeding studies also did not

show any long-term effects related to

endocrine systems.

C. Aggregate Exposure

1. Dietary exposure. Acute and

chronic dietary analyses were

conducted to estimate exposure to

potential acetamiprid residues in/on the

following crops: cole crop group, citrus

crop group, fruiting vegetable crop

group, pome fruit crop group, grapes

leafy vegetables, canola oil, mustard and

cotton using the Dietary Exposure

Evaluation Model (DEEM) software.

Exposure estimates to water were made

based upon modeling.

i. Food. The acute dietary exposure

estimates at the 99.9th percentile of for

the U.S. Population was calculated to be

3.2% of the acute Reference Dose (RfD).

The population subgroup with the

highest exposure was children 1–6 at

6% of the acute RFD. The acute RfD was

based on the NOAEL of 10 mg/kg/day in

the acute neurotoxicity study. Chronic

dietary exposure estimates from

residues of acetamiprid for the U.S.

population was 0.1% of the chronic

RfD. The subpopulation with the

highest exposure wasnon-nursing

infants with 0.5% of the RfD used.

These values are based on projected

percentages for percent of crop treated

and field trial residues at maximum

label rates and minimum pre-harvest

intervals (PHI) with no reduction factors

for common washing, cooking, or

preparation practices. These can be

considered conservative values. The

chronic RfD was based on the NOAEL

of 7 mg/kg/day in the chronic study.

ii. Drinking water. EPA’s Standard

Operating Procedure (SOP) for Drinking

Water Exposure and Risk Assessments

was used to perform the drinking water

analysis for acetamiprid. This SOP

utilizes a variety of tools to conduct

drinking water assessment. These tools

include water models such as Screening

Concentration in Ground Water (SCIGROW), Generic Expected

Environmental Concentration

(GENEEC), EPA’s Pesticide Root Zone

Model/Exposure Analysis Modeling

System (PRZM/EXAMS), and

monitoring data. If monitoring data are

not available then the models are used

to predict potential residues in surface

water and ground water. In the case of

acetamiprid, monitoring data do not

exist, therefore, GENEEC and SCIGROW models were used to estimate a

water residue. The calculated drinking

water levels of comparison (DWLOC) for

acute and chronic exposures for all

adults and children greatly exceed the

modeled acetamiprid water residues,

drinking water estimated concentrations

(DWEC). The acute DWLOC values are

3,360 ppb for adults and 940 ppb for

children. The worst case DWEC for

acute scenarios is calculated to be 13.27

ppb using the GENEEC surface water

model. The chronic DWLOC values are

2,450 ppb for adults and 700 ppb for

children. The DWEC for the worst case

chronic scenario is 1.59 ppb GENEEC.

2. Non-dietary exposure. A Ready to

Use, dilute formulation of acetamiprid

will be registered for insect control on

outdoor ornamentals, vegetable and fruit

trees. Based on surrogate exposure data

obtained from a carbaryl study, the

homeowner margin of exposure (MOE)

was calculated to exceed 10 million.

Post-application exposure resulting

from contact with acetamiprid treated

foliage resulted in an MOE in excess of

500,000.

D. Cumulative Effects

EPA and ILSI are developing the

methodologies to resolve the complex

scientific issues concerning common

mechanism of toxicity and how to

cumulate pesticides in a quantitative

manner. A determination has not been

made that acetamiprid has a common

mechanism of toxicity with other

substances. Acetamiprid does not

appear to produce a common toxic

metabolite with other substances. A

cumulative risk assessment was

therefore not performed for this

analysis.

E. Safety Determination

1. U.S. population. Using the

conservative assumptions described

above, based on the completeness and

reliability of the toxicity data, it is

concluded that aggregate exposure to

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