Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Notices 30463

III. What is the Agency Authority for

Taking This Action?

Section 6(f)(1) of FIFRA provides that

a registrant of a pesticide product may

at any time request that any of its

pesticide registrations be amended to

delete one or more uses. The Act further

provides that, before acting on the

request, EPA must publish a notice of

receipt of any such request in the

Federal Register. Thereafter, the

Administrator may approve such a

request.

IV. How and to Whom Do I Submit

Withdrawal Requests?

1. By mail: Registrants who choose to

withdraw a request for use deletion

must submit such withdrawal in writing

to James A. Hollins, at the address given

above, postmarked July 6, 2001

2. In Person or by courier: Deliver

your withdrawal request to: Document

Processing Desk (DPD), Information

Services Branch, Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Room 266A, Crystal

Mall 2, 1921 Jefferson Davis Highway,

Arlington, VA. The DPD is open from

8:00 a.m. to 4:30 p.m., Monday through

Friday, excluding legal holidays. The

DPD telephone number is (703) 305–

5263.

3. Electronically. You may submit

your withdrawal request electronically

by e-mail to: hollins.james@epa.gov. 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.

V. Provisions for Disposition of Existing

Stocks

The Agency has authorized the

registrants to sell or distribute product

under the previously approved labeling

for a period of 18 months after approval

of the revision, unless other restrictions

have been imposed, as in special review

actions.

List of Subjects

Environmental protection, Pesticides

and pests, Product registrations.

Dated: May 14, 2001.

Richard D. Schmitt,

Associate Director, Information Resources

and Services Division, Office of Pesticide

Programs.

[FR Doc. 01–13950 Filed 6–5–01; 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1025; FRL–6785–1]

Notice of Filing Pesticide Petitions to

Establish Tolerances for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

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–1025, must be

received on or before July 6, 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–1025 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505W), 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,’’ ‘‘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–

1025. 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–1013 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

30464 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Notices

(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–1025. 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 pesticide petitions

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

these petitions contain 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 petitions.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 23, 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 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)

0E6173, 0E6217, 1E6230, 1E6236,

1E6245, 1E6255, 1E6256, and 1E6260

EPA has received pesticide petitions

from the Interregional Research Project

Number 4 (IR-4), P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903

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 the

insecticide, spinosad (spinosyn A and

spinosyn D) in or on the following raw

agricultural commodities (RACs):

1. 0E6173 proposes the establishment

of tolerances for the pome fruit group at

0.2 parts per million (ppm), and foilage

of legume vegetables at 8.0 ppm.

2. 0E6217 proposes the establishment

of a tolerance for asparagus at 0.02.

3. 1E6230 proposes the establishment

of tolerances for tree nut group, and

pistachio at 0.02 ppm.

4. 1E6236 proposes the establishment

of a tolerance for okra at 0.4 ppm.

5. 1E6245 proposes the establishment

of tolerances for beet (garden) roots and

beet (sugar) roots at 0.1 ppm, cranberry

at 0.01 ppm, and the leaves of root and

tuber vegetable group at 10 ppm.

6. 1E6255 proposes the establishment

of tolerances for the bushberry group,

juneberry, lingonberry, and salal at 0.25

ppm.

7. 1E6256 proposes the establishment

of a tolerance for globe artichoke at 0.3

ppm.

8. 1E6260 proposes the establishment

of a tolerance for strawberry at 0.75

ppm.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of spinosad in plants and animals are

adequately understood for the purposes

of these tolerances.

2. Analytical method. There is a

practical method (immun. assay) for

detecting (0.005 ppm) and measuring

(0.01 ppm) levels of spinosad in or on

food with a limit of detection that

allows monitoring of food with residues

at or above the level set for these

tolerances. The method has had a

successful method tryout in EPA’s

laboratories.

3. Magnitude of residues. The

magnitude of residues are adequately

understood for the purposes of these

tolerances.

B. Toxicological Profile

1. Acute toxicity. Spinosad has low

acute toxicity. The rat oral lethal dose

(LD)50 is 3,738 milligrams/kilograms

(mg/kg) (males) and > 5,000 mg/kg

(females); mouse oral LD50 is >5,000 mg/

Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Notices 30465

kg; rabbit dermal LD50 is >5,000 mg/kg;

and rat inhalation lethal concentration

(LC)50 is >5.18 mg/L air. In addition,

spinosad is not a skin sensitizer in

guinea pigs and does not produce

significant dermal or ocular irritation in

rabbits.

2. Genotoxicity. Short-term assays for

genotoxicity consisting of a bacterial

reverse mutation assay (Ames test), in

vitro assay for cytogenetic damage using

the Chinese hamster ovary cells,

mammalian gene mutation assay using

mouse lymphoma cells, DNA damage

and repair in rat hepatocytes, and an in

vivo cytogenetic assay in the mouse

bone marrow (micronucleus test) have

been conducted with spinosad. These

studies show a lack of genotoxicity.

3. Reproductive and developmental

toxicity. Spinosad caused decreased

body weights in maternal rats given 200

mg/kg/day by gavage highest dose tested

(HDT). This was not accompanied by

either embryo, fetal, or developmental

toxicity. The no observed adverse effect

level (NOAEL) for maternal and fetal

toxicity in rats were 50 and 200 mg/kg/

day, respectively. A developmental

study in rabbits showed that spinosad

caused decreased body weight gain and

a few abortions in maternal rabbits

given 50 mg/kg/day HDT. Maternal

toxicity was not accompanied by either

embryo, fetal, or developmental toxicity.

The NOAEL for maternal and fetal

toxicity in rabbits were 10 and 50 mg/

kg/day, respectively. In a 2-generation

reproduction study in rats, parental

toxicity was observed in both males and

females given 100 mg/kg/day HDT.

Perinatal effects (decreased litter size

and pup weight) at 100 mg/kg/day were

attributed to maternal toxicity. The

NOAEL for maternal and pup effects

was 10 mg/kg/day.

4. Subchronic toxicity. Spinosad was

evaluated in 13–week dietary studies

and showed the following NOAELs:

4.89 and 5.38 mg/kg/day, respectively

for male/female dogs; 6 and 8 mg/kg/

day, respectively for male/female mice;

and 33.9 and 38.8 mg/kg/day,

respectively for male/female rats. No

dermal irritation or systemic toxicity

occurred in a 21-day repeated dose

dermal toxicity study in rabbits given

1,000 mg/kg/day.

5. Chronic toxicity. Based on chronic

testing with spinosad in the dog and the

rat, EPA has set a reference dose (RfD)

of 0.027 mg/kg/day for spinosad. The

RfD has incorporated a 100-fold safety

factor to the NOAELs found in the

chronic dog study to account for

interspecies and intraspecies variation.

The NOAELs shown in the dog chronic

study were 2.68 and 2.72 mg/kg/day,

respectively for male and female dogs.

The NOAELs (systemic) shown in the

rat chronic/carcinogenicity/

neurotoxicity study were 9.5 and 12.0

mg/kg/day, respectively for male and

female rats. There was no evidence of

carcinogenicity in an 18–month mouse

feeding study and a 24–month rat

feeding study at all dosages tested. The

NOAELs shown in the mouse

carcinogenicity study were 11.4 and

13.8 mg/kg/day, respectively for male

and female mice. A maximum tolerated

dose was achieved at the HDT in both

of these studies based on excessive

mortality. Thus, the doses tested are

adequate for identifying a cancer risk.

Accordingly, a cancer risk assessment is

not needed.

6. Animal metabolism. There were no

major differences in the bioavailability

routes, rates of excretion, or metabolism

of spinosyn A and spinosyn D following

oral administration in rats. Urine and

fecal excretions were almost completed

in 48–hours post-dosing. In addition,

the routes and rates of excretion were

not affected by repeated administration.

7. Metabolite toxicology. The residue

of concern for tolerance setting purposes

is the parent material (spinosyn A and

spinosyn D). Thus, metabolite toxicity is

not applicable.

8. Endocrine disruption. There is no

evidence to suggest that spinosad has an

effect on any endocrine system.

C. Aggregate Exposure

1. Dietary exposure—i. Food.

Previously for the purposes of assessing

potential dietary exposure from use of

spinosad on RACs proposed within this

petition as well as from other existing

spinosad crop uses, a Tier I assessment

was conducted using 100% crop treated

and use of tolerance values within the

residue file. However, with the proposal

of several new uses including proposals

from IR-4, a refined and more realistic

assessment is needed. Information on

average residues, market share and

when available processing factors

(specific to spinosad and commodities)

has been used to estimate dietary

burden of individual commodities. The

theoretical maximum residue

contribution (TMRC) is obtained by

multiplying estimated residue levels by

the consumption data which estimates

the amount of crops and related food

consumed by various population

subgroups. The use of average residues

and market share results in a refinement

of the human exposure and a safety

determination for the use of spinosad on

crops cited in this summary that is

based on a conservative exposure

assessment.

ii. Drinking water. Based on the

available environmental studies

conducted with spinosad, its properties

show little or no mobility in soil.

Therefore, no anticipated exposure to

residues of spinosad in drinking water

is expected. In addition, no Maximum

Concentration Level (MCL) has been

established.

2. Non-dietary exposure. Spinosad is

currently registered for outdoor use on

turf and ornamentals at low rates of

application (0.04 to 0.54 lb active

ingredient per acre) and indoor use for

drywood termite control (extremely low

application rates used with no occupant

exposure expected). Localized baits for

fire ants again at low rates are also

available. Thus, the potential for nondietary exposure to the general

population is considered negligible.

D. Cumulative Effects

There is no reliable information to

indicate that toxic effects produced by

spinosad would be cumulative with

those of any other pesticide chemical.

Thus, it is appropriate to consider only

the potential risks of spinosad in an

aggregate exposure assessment.

E. Safety Determination

1. U.S. population. Using the refined

exposure assumptions and the RfD, the

aggregate exposure to spinosad use on

existing crop uses utilizes 5.5% of the

RfD for the U.S. population. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. The new crop uses

proposed have been included in this

refined dietary assessment. Thus, it is

clear that there is reasonable certainty

that no harm will result from aggregate

exposure to spinosad residues on

existing and all pending crop uses listed

in this notice.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

spinosad, data from developmental

toxicity studies in rats and rabbits and

a 2–generation reproduction study in

the rat are considered. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development. Reproduction studies

provide information relating to effects

from exposure to the pesticide on the

reproductive capability and potential

systemic toxicity of mating animals and

on various parameters associated with

the well-being of pups.

FFDCA section 408 provides that EPA

may apply an additional safety factor for

infants and children in the case of

30466 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Notices

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base. Based on

the current toxicological data

requirements, the data base for spinosad

relative to prenatal and postnatal effects

for children is complete. Further, for

spinosad, the NOAELs in the dog

chronic feeding study which was used

to calculate the RfD (0.027 mg/kg/day)

are considerably lower than the

NOAELs from the developmental

studies in rats and rabbits by a factor of

more than 10–fold.

Concerning the reproduction study in

rats, the pup effects shown at the HDT

were attributed to maternal toxicity.

Therefore, it is concluded that an

additional uncertainty factor is not

needed and that the RfD at 0.027 mg/kg/

day is appropriate for assessing risk to

infants and children.

In addition, the EPA has determined

that the 10X factor to account for

enhanced sensitivity of infants and

children is not needed because: (1) The

data provided no indication of increased

susceptibility of rats or rabbits to in

utero and/or postnatal exposure to

spinosad; (2) no neurotoxic signs have

been observed in any of the standard

required studies conducted; (3) the

toxicology data base is complete and

there are no data gaps; and (4) exposure

data are complete or are estimated based

on data that reasonably account for

potential exposure.

Using the exposure assumptions, the

percent dietary RfD utilized by the

aggregate exposure to residues of

spinosad on existing crop utilizes 15%

of the chronic population adjusted dose

(cPAD) for children 1 to 6 years old, the

most sensitive population subgroup.

The new crop uses have been included

in this assessment. Thus, based on the

completeness and reliability of the

toxicity data and the exposure

assessment, it is concluded that there is

a reasonable certainty that no harm will

result to infants and children from

aggregate exposure to spinosad residues

on the proposed uses including existing

crop uses.

F. International Tolerances

There is no Codex maximum residue

levels established for residues of

spinosad at this time.

[FR Doc. 01–14253 Filed 06–05–01; 8:45 am]

BILLING CODE 6560–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50879A; FRL–6784–2]

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: Alan Reynolds, Biopesticides and

Pollution Prevention Division (7511C),

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. 9010, Crystal

Mall #2, Arlington, VA; (703) 605–0515;

e-mail address: reynolds.alan@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

who conduct or sponsor research on

pesticides, the Agency has not

attempted to describe all the specific

entities that may be affected by this

action. If you have any questions

regarding the information in this action,

consult the designated contact person

listed for the individual EUP.

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

OPP–50879A. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

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

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

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. EUP

EPA has issued the following EUP:

524–EUP–91. Extension. Monsanto

Company, 700 Chesterfield Parkway

North, St. Louis, MO 63198. This EUP

allows the use of 181.5 grams of the

plant pesticide Bacillus thuringiensis

Cry1Ac protein and the genetic material

necessary for its production (vector PV–

GMBT02) in soybean on 199.7 acres of

soybean to evaluate the control of

soybean looper, stem borer, and

velvetbean caterpillar. The program is

authorized only in the States of

Alabama, Arkansas, Georgia, Hawaii,

Illinois, Indiana, Iowa, Kansas,

Louisiana, Maryland, Mississippi,

Missouri, North Carolina, Pennsylvania,

Puerto Rico, and Tennessee. The EUP is

effective from May 1, 2001 to April 30,

2002. This permit is issued with the

limitation that all treated crops will be

destroyed or used for research purposes

only.

Persons wishing to review this EUP

are referred to the designated contact

person. Inquiries concerning this permit

should be directed to the person cited

above. It is suggested that interested

persons call before visiting the EPA

office, so that the appropriate file may

be made available for inspection

purposes from 8 a.m. to 4 p.m., Monday

through Friday, excluding legal

holidays.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection,

Experimental use permits.