Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices 21971

request letters and the MOA, shipping

such stocks for export consistent with

the requirements of section 17 of FIFRA,

or proper disposal.

5. Retail and other sale or distribution

of indoor end-use products. Sale or

distribution by any person of the

existing stocks of any product identified

in Table 3 or Table 4 that bear

instructions for indoor use will not be

lawful under FIFRA after December 31,

2002, except for the purposes of returns

for re-labeling consistent with the

Technical Registrants’ cancellation

request letters and the MOA, shipping

such stocks for export consistent with

the requirements of section 17 of FIFRA,

or proper disposal.

List of Subjects

Environmental protection, Pesticides

and pests.

Dated: April 24, 2001.

Lois Rossi,

Director, Special Review and Reregistration

Division, Office of Pesticide Programs.

[FR Doc. 01–10998 Filed 5–1–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1017; FRL–6779–1]

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–1017, must be

received on or before June 1. 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–1017 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt Jamerson, Registration

Support Branch, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9368; e-mail address:

jamerson.hoyt@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–

1017. 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–1017 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–1017. 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

21972 Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices

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: April 18, 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.

Interregional Research Project Number

4 (IR-4)

PP 5E4557

EPA has received a pesticide petition

(5E4557) from Interregional Research

Project #4 (IR-4), Center for Minor Crop

Pest Management, Rutgers, The State

University of New Jersey, 681 U.S.

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 by establishing a tolerance for

residues of the fungicide dicloran, 2,6-

dichloro-4-nitroaniline, in or on the raw

agricultural commodity leafy greens

subgroup (except spinach) at 10 parts

per million (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 dicloran in peaches, lettuce and

potatoes has been studied. Parent

compound and numerous metabolites

derived by hydroxylation and

acetylation of the nitro group, along

with deamination and hydroxylation of

the amino group, were seen in all crops.

Glutathione conjugation with

simultaneous removal of one or both

chlorine atoms was shown to occur.

2. Analytical method. An adequate

analytical method electron capture/gas

liquid chromatography (EC GLC) is

available for enforcement purposes.

Parent compound is the only analyte in

the tolerance expression.

3. Magnitude of residues. Existing

tolerances for dicloran in lettuce and

endive, which are also in Crop

Subgroup 4-A, are supported by residue

studies which have been previously

reviewed by EPA. Tolerances for two

other crops in Crop Group 4, celery and

rhubarb, also exist. The existing data

support the conclusion that residues of

dicloran will not exceed 10 ppm for the

leafy greens subgroup (except spinach).

B. Toxicological Profile

1. Acute toxicity. The acute oral

lethal dose 50 (LD50) of technical

dicloran is greater than 10,000

milligrams/kilogram (mg/kg), the acute

dermal LD50 is greater than 2,000 mg/kg,

and the 4–hour acute inhalation lethal

concentration 50 (LC50) is greater than 2

mg/liter. Dicloran is not a dermal

irritant but is a sensitizer. Dicloran is a

mild eye irritant.

2. Genotoxicity. The following

genotoxicity tests were conducted: gene

mutation (Ames tests), structural

chromosome aberration (in vivo

cytogenetic assay using human

lymphocytes) and unscheduled DNA

synthesis using rat hepatocytes. Results

were generally negative; however, some

Ames tests with the bacterium S.

typhimurium showed a positive

response. Ames tests with E. coli were

negative. In view of the results of

mammalian chronic, carcinogenic and

developmental studies, however, Gowan

Company considered that the results of

the positive Ames tests are not relevant

to human toxicity.

3. Reproductive and developmental

toxicity. In a rabbit developmental

toxicity study, the maternal no observed

adverse effect level (NOAEL) was 8 mg/

kg/day and the maternal lowest

observed adverse effect level (LOAEL)

was 20 mg/kg/day. The developmental

NOAEL was greater than or equal to 50

mg/kg/day, the highest dose tested. In a

rat developmental toxicity study, the

maternal and embryotoxic NOAEL was

100 mg/kg/day, and the maternal and

embryotoxic LOAEL was 200 mg/kg/

day. The teratological NOAEL was

greater than or equal to 400 mg/kg/day,

the highest dose tested.

In a 2–generation rat reproduction

study, the NOAEL for systemic toxicity

was 250 ppm (21 mg/kg/day) on the

basis of reduced body weight gain and

increased liver and kidney weights. The

Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices 21973

NOAEL for reproductive and

developmental toxicity was also 250

ppm on the basis of reduced pup

weights. No other reproductive or

developmental parameters were affected

at any treatment level. The highest dose

tested was 1,250 ppm (110 mg/kg/day).

4. Subchronic toxicity. In 90–day rat

studies, the NOAEL was determined to

be 500 ppm in the diet (44 mg/kg/day),

and the LOAEL was based upon

increased liver weights in both sexes

and centrilobular hepatocyte

enlargement in males. Similar effects, as

well as an increase in blood cholesterol

concentration, were observed in 90–day

mouse studies, and the NOAEL was 15

mg/kg/day.

5. Chronic toxicity. EPA has

established the reference dose (RfD) for

dicloran at 0.025 mg/kg/day. The RfD is

based on a 2–year dog feeding study

with a NOAEL of 2.5 mg/kg/day and an

uncertainty factor of 100. The effect of

concern was increased liver weight and

histological changes in hepatocytes. In

an 80–week mouse study, dicloran was

not carcinogenic when administered at

dose levels up to 600 ppm (103 mg/kg/

day). Hepatotoxicity indicated this to be

the approximate maximum tolerated

dose (MTD). In a 2–year rat study,

dicloran was not carcinogenic when

administered at 1,000 ppm (59 mg/kg/

day for males and 71 mg/kg/day for

females).

6. Animal metabolism. Dicloran is

rapidly metabolized and excreted by

rats, goats and hens. Numerous

metabolites derived by reduction,

acetylation, hydroxylation, deamination

and dechlorination were observed.

7. Endocrine disruption.

Developmental toxicity studies in rats

and rabbits and a reproduction study in

rats gave no indication of any effects on

endocrine function related to

development and reproduction.

Subchronic and chronic treatment did

not induce any morphological changes

in endocrine organs and tissues.

C. Aggregate Exposure

1. Dietary exposure—i. Food. Novigen

Sciences’ DEEM version 7.62 software

was used to perform a worst-case

analysis of the proposed action. In a

theoretical maximum residue

concentration (TMRC) analysis it was

assumed that dicloran is used on 100%

of the acreage of the currently registered

crops, lettuce and endive, and that

residues on these crops are equal to the

tolerance levels. These assumptions

were then applied to all of the crops in

the leafy greens subgroup (except

spinach), and the two cases were

compared. It was found that the

proposed tolerance for the leafy greens

subgroup (except spinach) would

increase the presumed exposure from

9.7% of the RfD to 9.9% for the general

population. In the presumably most

heavily exposed population subgroup,

nursing females, exposure would

increase from 11.8% to 11.9% of the

RfD. Presumed exposure for children

ages 1–6 would increase from 7.5% to

7.9%, and the presumed exposure for

children ages 7–12 would increase from

9.0% to 9.2% of the RfD. The presumed

exposure of infants was no more than

0.2% of the RfD for any scenario.

No developmental or reproductive

effects have been observed which

indicate special perinatal sensitivity.

Therefore, an analysis of acute exposure

has not been conducted.

ii. Drinking water. Dicloran has no

aquatic uses. Dicloran was not reported

in the Agency’s survey of pesticides in

ground water from 1971–1991, nor in

the Agency’s 1988–1990 survey of

pesticides in drinking water wells. The

compound has not been reported in

surface water. A small scale prospective

ground water study suggests that the

average residue in ground water is well

below 0.001 ppm. The Agency has not

conducted a detailed analysis of

potential exposure to dicloran via

drinking water; however, Gowan

Company believes that chronic exposure

from this source is very small.

2. Non-dietary exposure. Dicloran has

no aquatic, lawn, turf or residential

uses.

D. Cumulative Effects

At this time the Agency has not

reviewed available information

concerning the potentially cumulative

effects of dicloran and other substances

that may have a common mechanism of

toxicity. For purposes of this petition

only, Gowan Company is considering

only the potential risks of dicloran in its

aggregate exposure.

E. Safety Determination

1. U.S. population. In the TMRC

analysis described in section C above, it

was concluded that the proposed action

would increase the chronic dietary

exposure to dicloran by no more than

0.2% of the RfD for the general

population. Exposure from drinking

water and all other routes is expected to

be negligible. In the TMRC analysis

described in section C above, it was

concluded that the proposed action

would increase the chronic dietary

exposure to dicloran by no more than

0.2% of the RfD for the general

population. Exposure from drinking

water and all other routes is expected to

be negligible.

2. Infants and children. It was

concluded that the proposed action

would increase the chronic dietary

exposure of infants by no more than

0.1% of the RfD, of children ages 1–6 by

no more than 0.4%, and of children ages

7–12 by no more than 0.2%.

In assessing the potential for

additional sensitivity of infants and

children to residues of dicloran, EPA

considers data from developmental

toxicity studies in the rat and rabbit and

reproduction studies in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

No developmental effects have been

observed with dicloran. The lowest

embryotoxic NOAEL in these studies

was 100 mg/kg/day, compared to a

chronic NOAEL of 2.5 mg/kg/day. There

is no indication of special perinatal

sensitivity in the absence of maternal

toxicity and thus no suggestion of

special sensitivity of infants and

children. Gowan Company concluded

that there is a reasonable certainty of no

harm to infants and children from

aggregate exposure to dicloran residues.

F. International Tolerances

Codex and Canadian maximum

residue levels of 10 ppm, identical to

the U.S. tolerance level, have been

established for lettuce, which is the

major crop in this crop subgroup.

Dicloran is not registered on a leafy

vegetable in Mexico.

[FR Doc. 01–10809 Filed 5–1–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–992; FRL–6762–8]

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.