65482 Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Notices

Categories NAICS Codes Examples of Potentially Affected Entities

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/.

To access a fact sheet which provides

more detail on this registration, go to the

Home Page for the Office of Pesticide

Programs at http://www.epa.gov/

pesticides/, and select ‘‘fact sheet.’’

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–30510A. 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 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.

In accordance with section 3(c)(2) of

FIFRA, a copy of the approved label, the

list of data references, the data and other

scientific information used to support

registration, except for material

specifically protected by section 10 of

FIFRA, are available for public

inspection in the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Rm. 119, Crystal Mall #2,

Arlington, VA (703) 305–5805. Requests

for data must be made in accordance

with the provisions of the Freedom of

Information Act and must be addressed

to the Freedom of Information Office

(A–101), 1200 Pennsylvania Ave., NW.,

Washington, DC 20460. Such requests

should: Identify the product name and

registration number and specify the data

or information desired.

A paper copy of the fact sheet, which

provides more detail on this

registration, may be obtained from the

National Technical Information Service

(NTIS), 5285 Port Royal Road,

Springfield, VA 22161.

II. Did EPA Conditionally Approve the

Application?

A conditional registration may be

granted under section 3(c)(7)(C) of

FIFRA for a new active ingredient where

certain data are lacking, on condition

that such data are received by the end

of the conditional registration period

and do not meet or exceed the risk

criteria set forth in 40 CFR 154.7; that

use of the pesticide during the

conditional registration period will not

cause unreasonable adverse effects; and

that use of the pesticide is in the public

interest. The Agency has considered the

available data on the risks associated

with the proposed use of novaluron, and

information on social, economic, and

environmental benefits to be derived

from such use. Specifically, the Agency

has considered the nature and its

pattern of use, application methods and

rates, and level and extent of potential

exposure. Based on these reviews, the

Agency was able to make basic health

and safety determinations which show

that use of novaluron during the period

of conditional registration will not cause

any unreasonable adverse effect on the

environment, and that use of the

pesticide is, in the public interest.

Consistent with section 3(c)(7)(C) of

FIFRA, the Agency has determined that

these conditional registrations are in the

public interest. Use of the pesticides are

of significance to the user community,

and appropriate labeling, use directions,

and other measures have been taken to

ensure that use of the pesticides will not

result in unreasonable adverse effects to

man and the environment.

III. Conditionally Approved

Registrations

EPA issued a notice, published in the

Federal Register of April 4, 2001 (66 FR

17882-83) (FRL 6771-8), which

announced that Makhteshim-Agan of

North America, Inc., 551 Fifth Ave.

Suite 1100, New York, NY 10176, had

submited an application to register the

pesticide products, Rimon Technical

and Rimon 10 EC.

Rimon Technical, EPA registration

number 11678-57, is used for the

manufacturing of end-use product

formulations. Rimon 10 EC, EPA

registration number 66222-35, is used

for the control of insect pests on

container grown ornamentals in

greenhouses. Both products were

approved on September 25, 2001.

List of Subjects

Environmental protection, Pesticides

and pest.

Dated: December 6, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 01–31245 Filed 12–18–01; 8:45 am]

BILLING CODE 6560– 50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1037; FRL–6795–9]

Notice of Filing a Pesticide Petition to

Establish a Tolerance fora 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

Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Notices 65483

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1037, must be

received on or before January 18, 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–1037 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Anne Ball, Biopesticides and

Pollution Prevention Division (7511C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8717; e-mail address:

ball.anne@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–

1037. 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–1037 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–1037. 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

65484 Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Notices

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,

Biopesticides, Feed additives, Food

additives, Pesticides and pests,

Pollution prevention, Reporting and

recordkeeping requirements.

Dated: December 11, 2001.

Kathleen F. Knox,

Acting Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

required by section 408(d)(3) of the

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioner.

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.

Growth Products Ltd.

PP 1G6307

EPA has received a pesticide petition

[1G6307] from Growth Products Ltd. ,

PO Box 1259, White Plains, NY 10602,

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

temporary tolerance for the microbial

pesticide Bacillus subtilis GB03.

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

the FFDCA, as amended, Growth

Products Ltd. has submitted the

following summary of information, data,

and arguments in support of their

pesticide petition. This summary was

prepared by Growth Products Ltd. and

EPA has not fully evaluated the merits

of the pesticide petition. The summary

may have been edited by EPA if the

terminology used was unclear, the

summary contained extraneous

material, or the summary

unintentionally made the reader

conclude that the findings reflected

EPA’s position and not the position of

the petitioner.

A. Product name and Proposed Use

Practices

Companion Liquid Biological

Fungicide 00.03% Bacillus subtilis

GB03 is to be used on ≤200 acres in five

states to obtain efficacy and

phytotoxicity data, evaluate application

rates and evaluate timing to establish

disease control over a large geographical

area on many important specialty crops.

Disease severity and intensity will be

observed, as well as measurements of

root growth in both length and mass,

leaf color, and tissue analysis of nutrient

levels, all of which are indicators of

healthy plants. Food crops to be treated

include apples, broccoli, celery, citrus,

cotton, grapes (raisin, table and wine),

lettuce (iceberg and leaf), melons,

onions, potatoes, herbs and spices,

strawberries, sunflower, tobacco and

tomatoes. The proposed time period for

the permit is 2 years.

B. Product Identity/Chemistry

1. Identity of the pesticide. The active

ingredient is Bacillus subtilis GB03

which is the biological pesticide

KodiakTM Concentrate Biological

Fungicide which has the EPA Reg. No.

7501-144 maintained by the company

Gustafson LLC for use as a seed

treatment of agricultural commodities.

The company has established a

tolerance exemption specific to that use

(40 CFR 180.1111). In storage the

product is stable for at least 1 year when

stored in original packaging according

to label directions. The mode of action

of Bacillus subtilis GB03 results from its

colonization of the developing root

system of plants, thereby suppressing

and controlling root diseases by

competition. The organism has been

shown to increase root mass and plant

health on various agricultural

commodities.

2. Analytical method. An analytical

method for residues is not applicable.

Residues of Bacillus subtilis GB03 are

not expected on agricultural

commodities.

C. Mammalian Toxicological Profile

Toxicological data on the active

ingredient had been previously accepted

to support the current exemption from

the requirement of a tolerance for

residues for seed treatment of

agricultural commodities See 40 CFR

180.1111). These studies include an

acute oral toxicity/pathogenicity study

in the rat, an acute dermal toxicity study

in the rabbit, an acute pulmonary

toxicity/pathogenicity study in the rat,

an acute intravenous toxicity/

pathogenicity study in the rat and a

primary eye irritation study in the

rabbit. EPA found from a review of these

studies that the active ingredient was

not toxic to test animals when

administered via the oral, dermal,

intravenous, or pulmonary routes of

exposure. The active ingredient was not

infective or pathogenic to test animals

when administered via the oral,

pulmonary, and intravenous routes. No

reports of hypersensitivity had been

reported from personnel working with

this organism.

Toxicological data on the end-use

product Companion Liquid Biological

Fungicide had been previously accepted

to support a registration for non-food

greenhouse use. An acute oral toxicity

study showed no toxicity at a dose of

5,000 milligrams/kilograms (mg/kg) in

rats (Toxicity category IV), a primary

eye irritation study showed mild

irritation at a dose of 0.1 milliliters (mL)

in rabbits (Toxicity Category IV), and a

primary dermal irritation study showed

moderate dermal irritation at a dose of

0.5 mL in rabbits (Toxicity Category III).

The results of the above studies indicate

that there are no significant human

health risks associated with the active

ingredient or end use product.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Dietary

exposure from use of Bacillus subtilis

GB03 is expected to be minimal. Its use

involves low levels of the active

ingredient applied to growing plants

prior to harvest. Residues if Bacillus

subtilis GB03 are not expected to be on

agricultural commodities. However

should any residues occur they would

not be of any toxicological concern.

ii. Drinking water. Exposure to

humans from residues of Bacillus

subtilis GB03 in consumed drinking

water would be unlikely. Bacillus

subtilis GB03 is a naturally occurring

soil micro-organism and it is not known

to thrive in aquatic environments.

Potential exposure to surface water

would be negligible and exposure to

drinking water (well or ground water)

would be impossible to measure.

2. Non-dietary exposure. The

potential for non-dietary exposure to the

general population, including infants

and children, is unlikely as the

proposed use sites are agricultural

settings. However, non-dietary

exposures would not be expected to

Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Notices 65485

pose any quantifiable risk due to a lack

of residues of toxicological concern.

Personal protective equipment (PPE)

mitigates the possibility of exposure for

applicators and handlers of the

proposed products, when used in

agricultural settings.

E. Cumulative Exposure

It is not expected that, when used as

proposed, products containing Bacillus

subtilis GB03 would result in residues

that would remain in human food items.

The organism is not pathogenic or

infective to mammals. There have been

no reports of toxins or secondary

metabolites associated with this

organism, and acute toxicity studies

have shown that Bacillus subtilis GB03

is non-toxic and non-pathogenic.

F. Safety Determination

1. U.S. population. Acute toxicity

studies have shown that Bacillus

subtilis GB03 is not toxic. Residues of

this organism are not expected to be on

agricultural commodities; however,

should residues occur they would not

be of toxicological concern. There is a

reasonable certainty of no harm to the

general U.S. population from exposure

to this active ingredient.

2. Infants and children. As mentioned

above, residues of Bacillus subtilis GB03

are not expected to be on agricultural

commodities. There is a reasonable

certainty of no harm for infants and

children from exposure to Bacillus

subtilis GB03 from the proposed uses.

G. Effects on the Immune and Endocrine

Systems

To date there is no evidence to

suggest that Bacillus subtilis GB03

functions in a manner similar to any

known hormone, or that it acts as an

endocrine disrupter.

H. Existing Tolerances

There is an existing EPA tolerance in

40 CFR 180.1111: Bacillus subtilis

GB03; exemption from the requirement

of a tolerance. The biofungicide Bacillus

subtilis GB03 is exempted from the

requirement of a tolerance in or on all

raw agricultural commodities when

applied as a seed treatment for growing

agricultural crops in accordance with

good agricultural practices (established

June 30, 1992).

I. International Tolerances

A codex Alimentarium Commission

Maximum Residue Level (MRL) is not

required for Bacillus subtilis GB03.

[FR Doc. 01–31249 Filed 12–18–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50891; FRL–6815–3]

Experimental Use Permit; Receipt of

Application

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces receipt

of an application 56228–EUP–O from

the Animal and Plant Health Inspection

Service, U.S. Department of Agriculture

(USDA/APHIS) requesting an

experimental use permit (EUP) for the

use of sodium cyanide in M–44 Cyanide

Capsules in M–44 spring-loaded ejectors

to control coyotes (Canis latrans), red

fox (Vulpes vulpes), gray fox (Urocyon

cinereoargenteus) and wild dogs in

Idaho and Utah in nesting areas of sage

grouse (Centrocercus urophasianus and

C. minimus). The Agency has

determined that the application may be

of regional and national significance.

Therefore, in accordance with 40 CFR

172.11(a), the Agency is soliciting

comments on this application.

DATES: Comments, identified by docket

control number OPP–50891, must be

received on or before January 18, 2002.

ADDRESSES: Comments and data 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

OPP–50891 in the subject line on the

first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: William W. Jacobs, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6406; and e-mail

address: jacobs.bill@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. This action may, however, be

of interest to those interested in

programs for protecting native wildlife

species of declining numbers before

they are imperiled to such an extent that

they are listed as threatened or

endangered species. All predacidal uses

of sodium cyanide were canceled in

1972. Since that time, use of the

compound in M–44 capsules has been

reinstated for controlling canids that

prey on livestock, that prey on

threatened or endangered species, or

that are vectors of comminicable

diseases. Use of M–44s to protect

wildlife that are not yet listed as

threatened or endangered has not been

directly authorized. The proposed

research program is intended to explore

the feasibility of use of M–44s to protect

sage grouse and Gunnison sage grouse

and to obtain new evidence regarding

the units’ utility and safety when used

in that capacity. Since other entities

may also be interested, 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 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

OPP–50891. 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.