33078 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

application (see 18 CFR 4.36).

Submission of a timely notice of intent

allows an interested person to file the

competing preliminary permit

application no later than 30 days after

the specified comment date for the

particular application. A competing

preliminary permit application must

conform with 18 CFR 4.30(b) and 4.36.

n. Preliminary Permit—Any qualified

development applicant desiring to file a

competing development application

must submit to the Commission, on or

before a specified comment date for the

particular application, either a

competing development application or a

notice of intent to file such an

application. Submission of a timely

notice of intent to file a development

application allows an interested person

to file the competing application no late

than 120 days after the specified

comment date for the particular

application. A competing license

application must conform with 18 CFR

4.30(b) and 4.36.

o. Notice of Intent—A notice of intent

must specify the exact name, business

address, and telephone number of the

prospective applicant, and must include

an unequivocal statement of intent to

submit, if such an application may be

filed, either a preliminary permit

application or a development

application (specify which type of

application). A notice of intent must be

served on the applicant(s) named in this

public notice.

p. Proposed Scope of Studies Under

Permit—A preliminary permit, if issued,

does not authorize construction. The

term of the proposed preliminary permit

would be 36 months. The work

proposed under the preliminary permit

would include economic analysis,

preparation of preliminary engineering

plans, and a study of environmental

impacts. Based on the results of these

studies, the Applicant would decide

whether to proceed with the preparation

of a development application to

construct and operate the project.

q. Comments, Protests, or Motions to

Intervene—Anyone may submit

comments, a protest, or a motion to

intervene in accordance with the

requirements of Rules of Practice and

Procedure, 18 CFR 385.210, .211, .214.

In determining the appropriate action to

take, the Commission will consider all

protests or other comments filed, but

only those who file a motion to

intervene in accordance with the

Commission’s Rules may become a

party to the proceeding. Any comments,

protests, or motions to intervene must

be received on or before the specified

comment date for the particular

application.

r. Filing and Service of Responsive

Documents—Any filings must bear in

all capital letters the title

‘‘COMMENTS’’, ‘‘NOTICE OF INTENT

TO FILE COMPETING APPLICATION’’,

‘‘COMPETING APPLICATION’’,

‘‘PROTEST’’, ‘‘MOTION TO

INTERVENE’’, as applicable, and the

Project Number of the particular

application to which the filing refers.

Any of the above-named documents

must be filed by providing the original

and the number of copies provided by

the Commission’s regulations to: The

Secretary, Federal Energy Regulatory

Commission, 888 First Street, N.E.,

Washington, D.C. 20426. An additional

copy must be sent to Director, Division

of Hydropower Administration and

Compliance, Federal Energy Regulatory

Commission, at the above-mentioned

address. A copy of any notice of intent,

competing application or motion to

intervene must also be served upon each

representative of the Applicant

specified in the particular application.

s. Agency Comments—Federal, state,

and local agencies are invited to file

comments on the described application.

A copy of the application may be

obtained by agencies directly from the

Applicant. If an agency does not file

comments within the time specified for

filing comments, it will be presumed to

have no comments. One copy of an

agency’s comments must also be sent to

the Applicant’s representatives.

Linwood A. Watson, Jr.,

Acting Secretary.

[FR Doc. 01–15527 Filed 6–19–01; 8:45 am]

BILLING CODE 6717–01–M

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1029; FRL–6787–9]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1029, 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–1029 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Mike Mendelsohn, Biopesticides

and Pollution Prevention Division,

Registration Division (7511C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (703) 308–8715; email address:

mendelsohn.mike@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

Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33079

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–

1029. 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–1029 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–1029. 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: June 7, 2001.

Kathleen D. Knox,

Director, Biopesticides and Pollution

Prevention Division.

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.

The petition summary announces the

availability of a description of the

analytical methods available to EPA for

the detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

Aventis CropSciences

PP 1F6308

EPA has received a pesticide petition

[1F6308] from Aventis CropSciences, 2

TW Alexander Drive, Research Triangle

Park, NC 27709, proposing pursuant to

section 408(d) of the FFDCA, 21 U.S.C.

346a(d), to amend 40 CFR part 180 by

establishing a tolerance for residues of

the plant-pesticide Cry9C and the

genetic material necessary for its

production in or on the raw commodity

corn at 20 parts per billion (ppb).

Pursuant to section 408(d)(2)(A)(i) of

the FFDCA, as amended, Aventis

CropSciences has submitted the

following summary of information, data,

and arguments in support of their

pesticide petition. This summary was

prepared by Aventis CropSciences and

33080 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

EPA has not fully evaluated the merits

of the pesticide petition. The following

summary is directly from the Aventis

submission, and does not necessarily

reflect the findings of the EPA.

A. Product Name and Proposed Use

Practices

StarLink corn contained the insect

control protein named Cry9C, which is

derived from the common soil

bacterium, Bacillus thuringiensis subsp.

tolworthi. Aventis voluntarily canceled

the registration for StarLink corn.

However, StarLink corn grain grown in

previous growing seasons and other

corn containing Cry9C protein may

continue to be used for animal feed or

non-food industrial uses in accordance

with the existing exemption from the

requirement for a tolerance for these

uses.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. The Cry9C gene

was isolated from the B.t. tolworthi

strain, truncated, and modified before it

was stably inserted into corn plants. The

tryptic core of the microbially produced

Cry9C delta-endotoxin is similar to the

Cry9C protein found in event CBH-351.

The Cry9C protein was produced and

purified from a bacterial host, for the

purposes of mammalian toxicity studies.

2. Magnitude of residue at the time of

harvest and method used to determine

the residue. The proposed enforcement

method for use on raw corn destined for

dry milling is the EnviroLogix or

Strategic Diagnostics Inc. Lateral Flow

Strip Test, both of which have been

validated by USDA GIPSA and Aventis.

The limit of detection for these two test

is 20 ppb Cry9C protein. The method

must be used in accordance with the

recommended sampling methods (FDA

Recommendations for Sampling and

Testing Yellow Corn and Dry-milled

Yellow Corn Shipments Intended for

Human Food Use for Cry9C Protein

Residues, FDA-CFSAN, January 19,

2001).

C. Mammalian Toxicological Profile

Aventis has conducted an extensive

array of toxicological testing including

oral and intravenous administration, as

well as acute and short-term exposure.

EPA has reviewed these data and

concluded that there is no toxicological

endpoint of concern, with the possible

exception of allergenicity.

The gene for the Cry9C protein comes

from a non-allergenic common soil

bacterium, Bacillus thuringiensis. The

corn plant, into which the gene for the

Cry9C protein was inserted, is rarely

allergenic to humans. Expression of the

gene for the Cry9C protein did not

enhance the potential of corn to be

allergenic, as demonstrated by the

absence of any difference in reactivity to

StarLink corn than to wild type nontransgenic corn in radioallergosorbent

tests (RAST) performed with human

sera from corn allergic patients (MRID

Number 443844–05).

The Cry9C protein was not toxic upon

single oral or repeated dietary

administration to rats and has no linear

amino acid sequence homology to any

known human allergen or toxin (Oral

LD50 > 3,760 mg/kg/day, MRID Number

442581–07; Acute intravenous LD50 >

0.3 mg/kg/day (MRID Numbers 447343–

02); 30–day repeated dose toxicity test

in rats: up to 328 mg/kg/day produced

no adverse effects, no binding to villi or

enterocytes lining gastrointestinal tract

(GI) crypts of both large and small

intestines, MRID Numbers 447343–03,

443844–04, and 442581–09). RAST tests

performed with sera from individuals

allergic to the well-known human food

allergens, wheat; rice; buckwheat; soy;

peanut; milk; eggs; and shrimp

confirmed that even individuals with

pre-existing food allergies demonstrated

no cross-reactivity to Cry9C (MRID

Number 452464–01). The level of the

Cry9C protein in whole corn grain,

0.0129%, is a very low level of total

protein expression in the plant

compared to most allergens which are

present at 1–40% of the total plant

protein (MRID Number 450257–01).

The Cry9C protein is somewhat more

stable than the other Bt Cry proteins

already approved for food use. Cry9C

does digest in simulated stomach fluids

at pH of 1.2–1.5 within 30–60 minutes

(within normal stomach emptying time)

and does denature at temperatures

likely to be encountered during cooking

and processing (MRID Numbers

447343–05, 442581–08, 451144–01,

4451144–02). Although Aventis

interprets these data to mean that Cry9C

protein is not an allergen, regulatory

officials have not been able to confirm

this assessment.

D. Aggregate Exposure

Aventis developed an analytical

method to determine Cry9C protein

levels in intermediate and finished food

products. Studies were conducted to

assess the level of Cry9C protein

typically found in 12 representative

food products made from 100%

StarLink corn. These studies

demonstrate that there is significant

reduction (80–99.9%) of Cry9C protein

levels, relative to levels found in raw

corn, during the manufacture of food

products. Three processing factors are

responsible for destruction of Cry9C

protein: heat, shear or pressure, and

alkali treatment.

1. Dietary exposure. Aventis has

performed a new dietary risk

assessment. Worst case estimates of

potential dietary intake of Cry9C protein

were calculated using Novigen Sciences,

Inc., Food and Residue Evaluation

Program (FARE) software, food

consumption data in the 1994–1996

USDA’s Continuing Survey of Food

Intakes by Individuals (CSFII), and the

new Aventis study on reduction in

Cry9C protein levels resulting from food

processing. In essence, dietary intake of

Cry9C protein was calculated as the

product of consumption of corn proteincontaining foods and the expected

concentration of Cry9C protein in such

foods. Intakes were estimated on a ‘‘per

consumer’’ basis for the overall U.S.

population, children 1–6 years of age,

children 7–12 years of age, the Hispanic

population in the U.S., Hispanic

children 1–6 years of age, and Hispanic

children 7–12 years of age.

2. Non-dietary exposure. Since the

Cy9C protein is expressed in plant

tissues at very low levels, and since the

StarLink product will no longer be used,

exposure will be negligible to nonexistent via all non-food routes.

E. Cumulative Exposure

Common modes of toxicity are not

relevant to the consideration of the

cumulative exposure to Cry9C protein.

F. Safety Determination

1. U.S. population. Dietary exposure

will be the major route of exposure to

the U.S. population. Estimated potential

daily exposures for all subpopulations

at the 99th percentile are below 0.37

microgram per day, the exposure for the

general population. The U.S. population

in general had the highest estimated

daily intake of all subpopulations

examined. This newly refined dietary

intake estimate of the Cry9C protein is

67 times lower than the EPA’s

November 2000 upper bound estimate

for the U.S. population (25 micrograms

per day, 99th percentile), and 10 times

below the highest estimate from the

Aventis November 2000 estimate (3.9

micrograms per day for the Hispanic

population, 99th percentile). Such

exceedingly low levels of exposure,

coupled with insufficient information to

conclude whether or not Cry9C protein

is actually a human food allergen,

further support the SAP finding that the

levels of Cry9C protein present in the

human diet are insufficient to either

sensitize or cause an allergic reaction.

Therefore, the data support a finding of

reasonable certainty of no harm and

justify a tolerance at 20 ppb.

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