Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33081

2. Infants and children. As with the

rest of the population, the primary route

of exposure is dietary. The dietary

exposure assessment indicates that

children have less exposure than the

general U.S. population. Accordingly,

there is no need to apply an additional

safety factor for infants and children.

G. Effects on the Immune and Endocrine

Systems

EPA’s review of the submitted data

concluded that there is no toxicological

endpoint of concern, with the possible

exception of allergenicity.

H. Existing Tolerances

On May 22, 1998, EPA established an

exemption from the requirement of a

tolerance for residues of Cry9C protein

and the genetic material necessary for

its production in corn for feed use only;

as well as in meat, poultry, milk or eggs

resulting from animals fed such feed.

This exemption remains in effect.

I. International Tolerances

To date, no Codex, Canadian or

Mexican tolerances exist for Bt subsp.

tolworthi Cry9C protein in corn.

J. Conclusions

Aventis CropScience believes that this

petition provides adequate grounds for

the establishment of a tolerance of 20

ppb for residues of the insecticide, Bt

subsp. tolworthi Cry9C protein in or on

the raw agricultural commodity, corn.

[FR Doc. 01–15294 Filed 6–19–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1026; FRL–6785–9]

Notice of Filing Pesticide Petitions to

Establish a Tolerance for Certain

Pesticide Chemicals 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 certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by docket

control number PF–1026, must be

received on or before July 20, 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–1026 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Treva C. Alston, Registration

Support Branch, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8373; e-mail adress:

alston.treva@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–

1026. 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–1026 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

33082 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

format. All comments in electronic form

must be identified by docket control

number PF–1026. 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 certain pesticide chemicals

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 petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 20, 2001.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioner and represent

the views of the petitioners. EPA is

publishing the petition summaries

verbatim without editing them 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.

Uniqema

PP 1E6293

EPA has received a pesticide petition

(1E6293) from Uniqema, 900 Uniqema

Blvd, New Castle, DE 19720 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 to establish an exemption from the

requirement of a tolerance for modified

acrylic polymers when used as an inert

ingredient in pesticide formulations

applied to growing crops, raw

agricultural commodities after harvest,

or in pesticide formulations applied to

animals. 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

Uniqema is petitioning that modified

acrylic polymers be exempt from the

requirement of a tolerance based upon

their compliance with the low risk

polymer criteria per 40 CFR 723.250.

Therefore, an analytical method to

determine residues in raw agricultural

commodities has not been proposed. No

residue chemistry data or environmental

fate data are presented in the petition as

the Agency does not generally require

some or all of the listed studies to rule

on the exemption from the requirement

of a tolerance for a low risk polymer

inert ingredient.

B. Toxicological Profile

The Agency has established a set of

criteria which identifies categories of

polymers that present low risk. These

criteria (described in 40 CFR 723.250)

identify polymers that are relatively

unreactive and stable compared to other

chemical substances as well as polymers

that typically are not readily absorbed.

Uniqema believes that modified acrylic

polymers conform to the definition of a

polymer given in 40 CFR 723.250 and

meet the criteria used to identify a low

risk polymer. Uniqema also believes

that based on these polymers,

conformance to the above–mentioned

criteria, no mammalian toxicity is

anticipated from dietary, inhalation or

dermal exposure to polymers and that

these polymers will present minimal or

no risk.

1. These polymers are not cationic

polymers.

2. They contain as an integral part of

their composition the atomic elements

carbon, hydrogen, and oxygen.

3. They do not contain as an integral

part of their composition, except as

impurities, any elements other than

those listed in 40 CFR 723.250(d)(2)(ii).

4. These polymers are not designed or

reasonably anticipated to substantially

degrade, decompose, or depolymerize.

5. These polymers are not

manufactured or imported from

monomers and/or other reactants that

are not already on the TSCA Chemical

Substance Inventory or manufactured

under an applicable TSCA section 5

exemption.

6. They are not water absorbing

polymers.

7. The minimum average molecular

weight of the above–mentioned

polymers is greater than 1,000.

Substances with molecular weights

greater than 400 are generally not

readily absorbed through the intact skin,

and substances with molecular weights

greater than 1,000 are generally not

absorbed through the intact

gastrointestinal (GI) tract. Chemicals not

absorbed through the GI tract are

generally incapable of eliciting a toxic

response. These polymers have an

oligomer content less than 10% below

Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33083

molecular weight 500 and less than 25%

molecular weight 1,000.

Uniqema believes sufficient

information was submitted in the

petition to assess the hazards of

modified acrylic polymers. No

toxicology data were presented in the

petition as the Agency does not

generally require that polymers conform

to 40 CFR 723.250. Based on these

polymers conforming to the definition

of a polymer and meeting the criteria of

a low risk polymer under 40 CFR

723.250, Uniqema believes there are no

concerns for risks associated with

toxicity.

8. Endocrine disrupter. There is no

evidence that modified acrylic polymers

are endocrine disrupters. Substances

with molecular weights greater than 400

generally are not absorbed through the

intact skin, and substances with

molecular weights greater than 1,000

generally are not absorbed through the

GI tract. Chemicals not absorbed

through the skin or GI tract generally are

incapable of eliciting a toxic response.

The Agency at this time has not

determined whether or not it will

require information on the endocrine

effects of this substance. Congress has

allowed 3 years after August 3, 1996, for

the Agency to implement a screening

program with respect to endocrine

effects.

C. Aggregate Exposure

1. Dietary exposure. Some modified

acrylic polymers may be used in contact

with food as components of containers

used to manufacture, process, or store

food when regulated for such use under

the Federal Food, Drug, and Cosmetic

Act. Modified acrylic polymers with a

molecular weight greater than 1,000

daltons are not readily absorbed through

the intact GI tract and are considered

incapable of eliciting a toxic response.

2. Non–dietary exposure. Typical uses

of modified acrylic polymers are in the

paints & coatings and adhesives

industries. In these uses the primary

exposures are dermal, however;

modified acrylic polymers with a

molecular weight significantly greater

than 400 are not readily absorbed

through the intact skin and are

considered incapable of eliciting a toxic

response.

D. Cumulative Effects

There are data to support a conclusion

of negligible cumulative risk for

modified acrylic polymers. Polymers

with molecular weights greater than 400

generally are not absorbed through the

intact skin, and substances with

molecular weights greater than 1,000

generally are not absorbed through the

intact GI tract. Chemicals not absorbed

through the skin or GI tract generally are

incapable of eliciting a toxic response.

Therefore, there is no reasonable

expectation of increased risk due to

cumulative exposure. Based on these

polymers conforming to the definition

of a polymer and meeting the criteria of

a low risk polymer under 40 CFR

723.250, Uniqema believes there are no

concerns for risks associated with

cumulative effects.

Uniqema

PP 1E6294

EPA has received a pesticide petition

(1E6294) from Uniqema, 900 Uniqema

Blvd, New Castle, DE 19720 proposing,

pursuant to section 408(d) of the

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

CFR part 180 to establish an exemption

from the requirement of a tolerance for

vinyl acetate polymers when used as an

inert ingredient in pesticide

formulations applied to growing crops,

raw agricultural commodities after

harvest, or in pesticide formulations

applied to animals. 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 supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

Uniqema is petitioning that vinyl

acetate polymers be exempt from the

requirement of a tolerance based upon

their compliance with the low risk

polymer criteria per 40 CFR 723.250.

Therefore, an analytical method to

determine residues in raw agricultural

commodities has not been proposed. No

residue chemistry data or environmental

fate data are presented in the petition as

the Agency does not generally require

some or all of the listed studies to rule

on the exemption from the requirement

of a tolerance for a low risk polymer

inert ingredient.

B. Toxicological Profile

Acute toxicity. The Agency has

established a set of criteria which

identifies categories of polymers that

present low risk. These criteria

(described in 40 CFR 723.250) identify

polymers that are relatively unreactive

and stable compared to other chemical

substances as well as polymers that

typically are not readily absorbed.

Uniqema believes that vinyl acetate

polymers conform to the definition of a

polymer given in 40 CFR 723.250 and

meet the criteria used to identify a low

risk polymer. Uniqema also believes

that based on these polymers,

conformance to the above–mentioned

criteria, no mammalian toxicity is

anticipated from dietary, inhalation or

dermal exposure to polymers and that

these polymers will present minimal or

no risk.

1. These polymers are not cationic

polymers.

2. They contain as an integral part of

their composition the atomic elements

carbon, hydrogen, and oxygen.

3. They do not contain as an integral

part of their composition, except as

impurities, any elements other than

those listed in 40 CFR 723.250(d)(2)(ii).

4. These polymer are not designed or

reasonably anticipated to substantially

degrade, decompose, or depolymerize.

5. These polymers are not

manufactured or imported from

monomers and/or other reactants that

are not already on the TSCA Chemical

Substance Inventory or manufactured

under an applicable TSCA section 5

exemption.

6. They are not water absorbing

polymers.

7. The minimum average molecular

weight of the above–mentioned

polymers are greater than 1,000.

Substances with molecular weights

greater than 400 are generally not

readily absorbed through the intact skin,

and substances with molecular weights

greater than 1,000 are generally not

absorbed through the intact GI tract.

Chemicals not absorbed through the GI

tract are generally incapable of eliciting

a toxic response. These polymers have

an oligomer content less than 10%

below molecular weight 500 and less

than 25% molecular weight 1,000.

Uniqema believes sufficient

information was submitted in the

petition to assess the hazards of vinyl

acetate polymers. No toxicology data

were presented in the petition as the

Agency does not generally require that

polymers conform to 40 CFR 723.250.

Based on these polymers conforming to

the definition of a polymer and meeting

the criteria of a low risk polymer under

40 CFR 723.250, Uniqema believes there

are no concerns for risks associated with

toxicity.

There is no evidence that vinyl

acetate polymers are endocrine

disrupters. Substances with molecular

weights greater than 400 generally are

not absorbed through the intact skin,

and substances with molecular weights

greater than 1,000 generally are not

absorbed through the intact GI tract.

Chemicals not absorbed through the

skin or GI tract generally are incapable

of eliciting a toxic response.

33084 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

The Agency at this time has not

determined whether it will require

information on the endocrine effects of

this substance. Congress has allowed 3

years after August 3, 1996, for the

Agency to implement a screening

program with respect to endocrine

effects.

C. Aggregate Exposure

1. Dietary exposure. Some vinyl

acetate polymers may be used in contact

with food as components of containers

used to manufacture, process, or store

food when regulated for such use under

the Federal Food, Drug, and Cosmetic

Act. Vinyl acetate polymers with a

molecular weight greater than 1,000

daltons are not readily absorbed through

the intact GI tract and are considered

incapable of eliciting a toxic response.

2. Non–dietary exposure. Typical uses

of vinyl acetate polymers are in the

paints & coatings and adhesives

industries. In these uses the primary

exposures are dermal, however; vinyl

acetate polymers with a molecular

weight significantly greater than 400 are

not readily absorbed through the intact

skin and are considered incapable of

eliciting a toxic response.

D. Cumulative Effects

There are data to support a conclusion

of negligible cumulative risk for vinyl

acetate polymers. Polymers with

molecular weights greater than 400

generally are not absorbed through the

intact skin, and substances with

molecular weights greater than 1,000

generally are not absorbed through the

intact GI tract. Chemicals not absorbed

through the skin or GI tract generally are

incapable of eliciting a toxic response.

Therefore, there is no reasonable

expectation of increased risk due to

cumulative exposure. Based on these

polymers conforming to the definition

of a polymer and meeting the criteria of

a low risk polymer under 40 CFR

723.250, Uniqema believes there are no

concerns for risks associated with

cumulative effects.

[FR Doc. 01–15296 Filed 6–19–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50888; FRL–6786–3]

Issuance of Experimental Use Permits

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has granted experimental

use permits (EUPs) to the following

pesticide applicants. 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: Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460.

In person or by telephone: Contact the

designated person at the following

address at the office location, telephone

number, or e-mail address cited in each

EUP: 1921 Jefferson Davis Hwy.,

Arlington, VA.

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?

You may obtain electronic copies of

this document from the EPA Internet

Home Page at http://www.epa.gov/. 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/.

II. EUPs

EPA has issued the following EUPs:

264–EUP–130. Issuance. Aventis

CropScience USA LP, 2 T.W. Alexander

Drive, Research Triangle Park, NC

27709. This EUP allows the use of 0.63

pounds of the herbicides foramsulfuron

and iodosulfuron-methyl-sodium on 21

acres of field corn to evaluate the

control of annual and perennial grass

and broadleaf weeds. The program is

authorized only in the States of

Nebraska, Tennessee, and Texas. The

EUP is effective from April 16, 2001 to

April 17, 2002. This permit is issued

with the limitation that all treated crops

will be destroyed or used for research

purposes only. (Joanne I. Miller; Rm.

241, Crystal Mall #2; telephone number:

(703) 305–6224; e-mail address:

miller.joanne@epa.gov).

264–EUP–131. Issuance. Aventis

CropScience USA LP, 2 T.W. Alexander

Drive, Research Triangle Park, NC

27709. This EUP allows the use of 5.2

pounds of the herbicide foramsulfuron

on 136 acres of field corn to evaluate the

control of annual and perennial grass

and broadleaf weeds. The program is

authorized only in the States of

Colorado, Illinois, Indiana, Iowa,

Kansas, Kentucky, Michigan,

Minnesota, Missouri, Montana,

Nebraska, New York, North Carolina,

North Dakota, Ohio, Pennsylvania,

South Dakota, Tennessee, Texas, and

Wisconsin. The EUP is effective from

April 16, 2001 to April 17, 2002. This

permit is issued with the limitation that

all treated crops will be destroyed or

used for research purposes only. (Joanne

I. Miller; Rm. 241, Crystal Mall #2;

telephone number: (703) 305–6224; email address: miller.joanne@epa.gov).

264–EUP–132. Issuance. Aventis

CropScience USA LP, 2 T.W. Alexander

Drive, Research Triangle Park, NC

27709. This EUP allows the use of 0.735

pounds of the herbicides foramsulfuron

and iodosulfuron-methyl-sodium on 22

acres of field corn to evaluate the

control of annual and perennial grass

and broadleaf weeds. The program is

authorized only in the States of

Minnesota, Nebraska, South Dakota,

Tennessee, and Texas. The EUP is

effective from April 16, 2001 to April

17, 2002. This permit is issued with the

limitation that all treated crops will be

destroyed or used for research purposes

only. (Joanne I. Miller; Rm. 241, Crystal

Mall #2; telephone number: (703) 305–

6224; e-mail address:

miller.joanne@epa.gov).

62719–EUP–49. Issuance. Dow

AgroSciences LLC, 9330 Zionsville

Road, Indianapolis, IN 46268. This EUP

allows the use of 3 pounds of the

herbicide diclosulam on 110 acres of

peanuts to evaluate the control of

broadleaf weeds and sedges in preplant

incorporated, preemergence, and post

pest emergence testing trials. The

program is authorized only in the States

of New Mexico and Texas. The EUP is

effective from May 15, 2001 to March

31, 2002. A tolerance has been

established for residues of the active

ingredient in or on peanuts. (Dan

Rosenblatt; Rm. 239, Crystal Mall #2;

telephone number: (703) 305–5697; email address: rosenblatt.dan@epa.gov).

Persons wishing to review these EUPs

are referred to the designated contact

person. Inquiries concerning these

permits should be directed to the

persons cited above. It is suggested that

interested persons call before visiting