Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices 64819

2002, Contact: John Mahan (440) 964–

0277.

Amended Notices

EIS No. 010305, DRAFT SUPPLEMENT,

FAA, MN, Flying Cloud Airport,

Substantive Changes to Alternatives

and New Information, Extension of

the Runways 9R/27L and 9L/27R,

Long-Term Comprehensive

Development, In the City of Eden

Prairie, Hennepin County, MN,

Comment Period Ends: December 07,

2001, Contact: Glen Orcutt (612) 713–

4354. Revision of FR Notice Published

on 08/24/2001: CEQ. Comment Period

Ending on 12/07/2001 has been

Extended to 01/31/2002.

EIS No. 010401, DRAFT SUPPLEMENT,

FHW, MI, US–31 Petoskey Area

Improvement Study, To Reduce

Congestion on US–31 in the City of

Petoskey and Resort and Bear Creek

Townships, COE Section 404 Permit,

Emmet County, MI, Comment Period

Ends: December 17, 2001, Contact:

James A. Kirschensteiner (517) 702–

1835. Revision of FR Notice Published

on 11/02/2001: CEQ. Comment Period

Ending 12/17/2001 has been extended

to 01/15/2002.

EIS No. 010500, DRAFT SUPPLEMENT,

BIA, NV, Moapa Paiute Energy

Center/Associated Facilities

Construction, Operation and

Maintenance of a 760 Megawatt (MW)

Baseload Natural Gas-Fired Combined

Cycle Power Plant, New Information

concerning Structural, Route and

Substation Location Changes, Moapa

River Indian Reservation and Bureau

of Land Management Lands, Clark

County, NV, Comment Period Ends:

January 14, 2002, Contact: Amy L.

Heuslien (602) 379–6750. Revision of

FR notice published on 11/30/2001:

CEQ Comment Period Ending 01/04/

2002 has been Corrected to 01/14/

2002.

Dated: December 11, 2001.

Joseph C. Montgomery,

Director, NEPA Compliance Division, Office

of Federal Activities.

[FR Doc. 01–30932 Filed 12–13–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[ER–FRL–6624–6]

Environmental Impact Statements and

Regulations; Availability of EPA

Comments

Availability of EPA comments

prepared pursuant to the Environmental

Review Process (ERP), under section

309 of the Clean Air Act and section

102(2)(c) of the National Environmental

Policy Act as amended. Requests for

copies of EPA comments can be directed

to the Office of Federal Activities at

(202) 564–7167.

An explanation of the ratings assigned

to draft environmental impact

statements (EISs) was published in FR

dated May 18, 2001 (66 FR 27647).

Draft EISs

ERP No. D–AFS–L65388–WA Rating

EC2, Crystal Mountain Master

Development Plan, To Provide Winter

and Summer Recreational Use, SpecialUse-Permit, Mt. Baker-Snoqualmie

National Forest, Silver Creek Watershed,

Pierce County, WA.

Summary: EPA expressed

environmental concerns related to the

purpose and need statement, the No

Action Alternative, impacts to water

quality and quantity, improved intergovernmental coordination, and more

fully disclosed indirect and cumulative

effects.

ERP No. D–CGD–A59014–00 Rating

EC2, Programmatic EIS—Integrated

Deepwater System Project, Surface, Air,

Logistics Communication and Sensor

Systems, Aging Nation-Wide System

Replacement

Summary: EPA expressed concerns

regarding potential impacts to the

marine environment and air quality, and

requested clarification of the

methodology used to analyze

cumulative impacts and potential

impacts from hazardous wastes.

ERP No. D–SFW–A65170–00 Rating

LO, Light Goose Management Plan,

Implementation, Reducing and

Stabilizing Specific Populations ‘‘Light

Geese’’ in North America.

Summary: EPA did not identify any

environmental concerns with the

Service’s preferred alternative of

modifying harvest regulations and

refuge management in order to reduce

high population levels of light geese.

EPA recommended that following

selection of a management approach,

the Service should carefully monitor its

implementation and remain open to

exploring other options as necessary

and appropriate.

Final EISs

ERP No. F–AFS–J65344–MT Burned

Area Recovery, Proposal to Reduce

Fuels, Improve Watershed Conditions

and Reforest Burned Lands, Sula, Darby,

West Fork and Stevensville Ranger

Districts, Bitterroot National Forest,

Ravalli County, MT.

Summary: While the development of

a new preferred alternative, Alternative

F, was responsive to EPA’s

environmental concerns about sediment

production and increased water yield

from fuels reduction treatments, EPA

still has concerns about sediment

production from ground based logging

systems.

Dated: December 11, 2001.

Joseph C. Montgomery,

Director, NEPA Compliance Division, Office

of Federal Activities.

[FR Doc. 01–30933 Filed 12–13–01; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1061; FRL–6813–5]

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–1061, must be

received on or before January 14, 2002.

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–1061 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: William G. Sproat, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–8587; e-mail address:

sproat.william@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:

64820 Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices

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–

1061. 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–1061 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–1061. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

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

this petition contains data or

information regarding the elements set

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

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petition. Additional data may be needed

before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 29, 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

Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices 64821

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.

Dow AgroSciences LLC

PP EUP-LN

EPA has received a pesticide petition

(PP EUP-LN) from Dow AgroSciences

LLC, 9330 Zionsville Road,

Indianapolis, IN 46268 proposing,

pursuant to section 408(d) of the

FFDCA, 21 U.S.C. 346a(d), to amend 40

CFR part 180 by establishing a tolerance

for residues of spinosad in or on the raw

agricultural commodity stored grain

(wheat, barley, corn, oats, rice, and

sorghum/milo) at 3 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 spinosad in plants (apples, cabbage,

cotton, tomato, and turnip) and animals

(goats and poultry), are adequately

understood for the purposes of these

tolerances. A rotational crop study

showed no carryover of measurable

spinosad-related residues in

representative test crops.

2. Analytical method. There is a

practical method (immunoassay) 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. Tolerances

as high as 10 ppm (Brassica) and 8 ppm

(leafy vegetables) have been previously

established for crop commodities

treated with spinosad. Magnitude of

residue studies were conducted at three

sites for artichokes. Residues found in

these studies ranged from 0.062 ppm to

0.156 ppm. Magnitude of residue

studies were conducted at three sites for

asparagus. Residues found in these

studies were all less than 0.009 ppm.

Magnitude of residues studies were

conducted at five sites for garden beet

tops (one of the representative crops for

the leaves of root and tuber vegetable

crop group). Residues found in these

studies ranged from 0.03 ppm to 4.0

ppm. Previously submitted data used in

support of the established residue

tolerance on Brassica (cole) leafy

vegetables are also to be used in support

of the proposed residue tolerance for

leaves of root and tuber vegetables.

Magnitude of residue studies were

conducted at six sites for pears (one of

the representative crops for the pome

fruit crop group). Residues found in

these studies ranged from nondetectable to 0.08 ppm. Previously

submitted data used in support of the

established residue tolerance on apples

are to be used in support of the

proposed residue tolerance for pome

fruit. Magnitude of residue studies were

conducted at four sites on pecans (one

of the representative crops for the tree

nut crop group). Residues found in

these studies ranged from less than

0.0010 ppm to 0.0076 ppm. Previously

submitted data used in support of the

established residue tolerance on

almonds are also to be used in support

of the proposed residue tolerance for

tree nuts and pistachio. A magnitude of

residue study was conducted at 20 sites

on tomatoes and peppers (two of the

representative crops for the fruiting

vegetables crop group). Residues found

in this study ranged from less than 0.01

ppm to 0.13 ppm in tomatoes, and 0.01

ppm to 0.18 ppm in peppers. Previously

submitted data used in support of the

established residue tolerance on fruiting

vegetables (except cucurbits) are to be

used in support of the proposed residue

tolerance for okra. Magnitude of residue

studies were conducted at six sites for

cranberry. No quantifiable residues

(>0.01 ppm) were observed in any test

sample. Magnitude of residue studies

were conducted at five sites for garden

beet roots (one of the representative

crops for the root and tuber vegetable

crop group) and tops (one of the

representative crops for the leaves of

root and tuber vegetable crop group).

Residues found in beet tops ranged from

0.03 ppm to 4.0 ppm. Previously

submitted data used in support of the

established residue tolerance on

Brassica (cole) leafy vegetables are also

to be used in support of the proposed

residue tolerance for leaves of root and

tuber vegetables. This data support

tolerances of 0.1 ppm in garden and

sugar beet roots and a 10.0 ppm

tolerance for Crop Group 2.

B. Toxicological Profile

1. Acute toxicity. Spinosad has low

acute toxicity. The rat oral LD50 is 3,738

milligrams/kilograms (mg/kg) for males

and >5,000 mg/kg for females, whereas

the mouse oral LD50 is >5,000 mg/kg.

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

and the rat inhalation LC50 is >5.18

miligram/liter (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. End use formulations of

spinosad that are water based

suspension concentrates have similar

low acute toxicity profiles.

2. Genotoxicity. Short-term assays for

genotoxicity consisting of a bacterial

reverse mutation assay (Ames test), an

in vitro assay for cytogenetic damage

using the chinese hamster ovary (CHO)

cells, an in vitro mammalian gene

mutation assay using mouse lymphoma

cells, an in vitro assay for 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 toxicity,

fetal toxicity, or teratogenicity. The no

observed adverse effect levels (NOAELs)

for maternal and fetal toxicity in rats

were 50 and 200 mg/kg/day,

respectively. A teratology study in

rabbits showed that spinosad caused

decreased body weight gain and a few

abortions in maternal rabbits given 50

mg/kg/day highest dose tested (HDT).

Maternal toxicity was not accompanied

by either embryo toxicity, fetal toxicity,

or teratogenicity. The NOAELs 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 highest dose tested (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 NOAELs of 4.89 and 5.38

mg/kg/day, respectively in male and

female dogs; 6 and 8 mg/kg/day,

respectively in male and female mice;

and 33.9 and 38.8 mg/kg/day,

respectively, in male and female rats.

No dermal irritation or systemic toxicity

occurred in a 21–day repeated dose

64822 Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices

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. Using the Guidelines for

Carcinogen Risk Assessment published

in the Federal Register September 24,

1986 (51 FR 33992), it is proposed that

spinosad be classified as Group E for

carcinogenicity (no evidence of

carcinogenicity) based on the results of

carcinogenicity studies in two species.

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

oncogenicity study were 11.4 and 13.8

mg/kg/day, respectively for male and

female mice. A maximum tolerated dose

was achieved at the top dosage level

tested 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.

Spinosad did not cause neurotoxicity

in rats in acute, subchronic, or chronic

toxicity studies.

6. Animal metabolism. There were no

major differences in the bioavailability,

routes or 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, there is no need to

address metabolite toxicity.

8. Endocrine disruption. There is no

evidence to suggest that spinosad has an

effect on any endocrine system.

C. Aggregate Exposure

1. Dietary exposure. For purposes of

assessing the potential dietary exposure

from use of spinosad on the raw

agricultural commodities listed in this

notice, as well as from other existing

spinosad crop uses, a conservative

estimate of aggregate exposure is

determined by basing the theoretical

maximum residue contribution (TMRC)

on the proposed tolerance level for

spinosad and assuming that 100% of the

proposed new crops and other existing

(registered for use) crops grown in the

U.S. were treated with spinosad. The

TMRC is obtained by multiplying the

tolerance residue levels by the

consumption data which estimates the

amount of crops and related foodstuffs

consumed by various population

subgroups. The use of a tolerance level

and 100% of crop treated clearly results

in an overestimate of 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. In addition, for the use of

dermal application of spinosad to cattle,

the risk assessment applies a

conservative (overestimate) 35% of

market share for the dermal application

to cattle, to the tolerance levels for

animal commodities based on existing

crop uses.

Drinking water. Another potential

source of dietary exposure is residues in

drinking water. Based on the available

environmental studies conducted with

spinosad wherein its properties show

little or no mobility in soil, there is no

anticipated exposure to residues of

spinosad in drinking water. In addition,

there is no established maximum

concentration level (MCL) for residues

of spinosad in drinking water.

2. Non-dietary exposure. Spinosad is

currently registered for use on a number

of crops including cotton, fruits, and

vegetables in the agriculture

environment. Spinosad is also 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). Thus, the potential

for non-dietary exposure to the general

population is considered negligible.

D. Cumulative Effects

The potential for cumulative effects of

spinosad and other substances that have

a common mechanism of toxicity is also

considered. In terms of insect control,

spinosad causes excitation of the insect

nervous system, leading to involuntary

muscle contractions, prostration with

tremors, and finally paralysis. These

effects are consistent with the activation

of nicotinic acetylcholine receptors by a

mechanism that is clearly novel and

unique among known insecticidal

compounds. Spinosad also has effects

on the gamma aminobatopic acid

(GABA) receptor function that may

contribute further to its insecticidal

activity. Based on results found in tests

with various mammalian species,

spinosad appears to have a mechanism

of toxicity like that of many amphiphilic

cationic compounds. 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.

Spinosad is classified in a mechanismof-action group of its own for the

purpose of resistance management in

insects and for rotation with other crop

protection products.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions and

the RfD described above, the aggregate

exposure to spinosad use on existing

crop uses utilizes 36.9% of the RfD for

the U.S. population from a previous

EPA assessment based on the chronic

population adjusted dose (cPAD) (as

posted in the Federal Register of May 3,

2000 (65 FR 25721) (FRL–6555–9)). 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 in this notice are minor ones

and are expected to contribute only a

negligible impact to the RfD. 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 is 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

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

Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices 64823

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 already 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 (UF) is

not needed and that the RfD at 0.027

mg/kg/day is appropriate for assessing

risk to infants and children. In addition,

EPA has determined that the 10X factor

to account for enhanced sensitivity of

infants and children is not needed

because:

i. The data provided no indication of

increased susceptibility of rats or rabbits

to in utero and/or postnatal exposure to

spinosad. In the prenatal developmental

toxicity studies in rats and rabbits and

2–generation reproduction in rats,

effects in the offspring were observed

only at or below treatment levels that

resulted in evidence of parental toxicity.

ii. No neurotoxic signs have been

observed in any of the standard required

studies conducted.

iii. The toxicology data base is

complete and there are no data gaps.

iv. Exposure data are complete or is

estimated based on data that reasonably

account for potential exposure.

Using the conservative exposure

assumptions previously described

(tolerance level residues), the percent

RfD utilized by the aggregate exposure

to residues of spinosad on existing crop

uses is 81.9% for children 1 to 6 years

old, the most sensitive population

subgroup from an EPA assessment based

on the cPAD (as posted in the Federal

Register of May 3, 2000). Additional

refinements to the dietary exposure

based on market share information

would reduce the exposure of children

1 to 6 years old to less than 50% the

cPAD. Grain treated under a temporary

tolerance is expected to contribute only

a negligible impact to the RfD. Thus,

based on the completeness and

reliability of the toxicity data and the

conservative 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

above proposed uses, including existing

crop uses.

F. International Tolerances

There is no Codex maximum residue

levels established for residues of

spinosad.

[FR Doc. 01–30913 Filed 12–13–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1060; FRL–6813–2]

Notice of Filing Pesticide Petitions 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 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–1060, must be

received on or before January 14, 2002.

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–1060 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,’’ ‘‘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–

1060. 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