67522 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Notices

Fungicide. Product type: Fungicide.

Active ingredient: Bacillus pumilus

strain GB34 at 0.28%. Proposed

classification/Use: For use as a seed

treatment for soybeans for supression of

root diseases caused by Rhizoctonia and

Fusarium.

3. File symbol: 74200-E. Applicant:

Mycologic Incorporated, Department of

Biology, University of Victoria, P.O. Box

3020, Victoria, BC Canada V8W.

Product name: Chontrol TM Paste.

Product type: Herbicide. Active

ingredient: Chondrostereum purpureum

isolate PFC 2139 at 0.67%. Proposed

classification/Use: Biological herbicide

for control of alders, aspen, and other

hardwoods in rights of way and forests.

4. File symbol: 74200-R. Applicant:

Mycologic Incorporated, Department of

Biology, University of Victoria, P.O. Box

3020, Victoria, BC Canada V8W.

Product name: CP-PFC 2139

Manufacturing Use Product. Product

type: Herbicide. Active ingredient:

Chondrostereum purpureum isolate PFC

2139 at 1.68%. Proposed classification/

Use: Manufacturing use.

List of Subjects

Environmental protection, Pesticides

and pests.

Dated: December 17, 2001.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 01–32106 Filed 12–28–01; 8:45am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1062; FRL–6813–8]

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–1062, must be

received on or before January 30, 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–1062 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–

1062. 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–1062 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

Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Notices 67523

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–1062. 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: December 14, 2001.

Janet L. Andersen,

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.

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.

Gustafson LLC

PP 1F6344

EPA has received a pesticide petition

(PP 1F6344) from Gustafson LLC, 1400

Preston Road, Suite 400, Plano, TX

75093, 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 the microbial pesticide

Bacillus pumilus GB34 when used as a

seed treatment in or on all raw

agricultural commodities and on all

food commodities after harvest.

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

the FFDCA, as amended, Gustafson LLC

has submitted the following summary of

information, data, and arguments in

support of their pesticide petition. This

summary was prepared by Gustafson

LLC 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

The active ingredient Bacillus

pumilus GB34 is formulated into the

technical product, GB34 Technical

Biological Fungicide and the end use

product GB34 Concentrate Biological

Fungicide. GB34 concentrate contains

bacteria which colonize the developing

root system of soybeans suppressing

disease organisms such as Rhizoctonia

and Fusarium that attack root systems.

GB34 concentrate is used as a seed

treatment before planting.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Bacillus

pumilus GB34 is a naturally occurring

isolate from the soil.

2. Magnitude of residue at the time of

harvest and method used to determine

the residue. Two processing studies

with soybeans were conducted. The

studies showed no uptake of Bacillus

pumilus GB34 beyond the seed hull. No

residues were found in meal, oil,

soymilk, or tofu.

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. An analytical method for

enumeration of microorganisms is

available but is not required since the

petitioner is requesting an exemption

from the requirement of a tolerance.

C. Mammalian Toxicological Profile

Bacillus pumilus GB34 was not found

to be toxic or pathogenic from acute

intravenous administration of 1.1 x 107

cfu of technical grade material. The oral

LD50 of GB34 technical was greater than

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

body weight. GB34 technical was

classified non-irritating to the skin and

mildly irritating to the eye in primary

skin irritation and eye irritation studies.

The oral LD50 of GB34 concentrate was

greater than 5,000 mg/kg of body

weight. GB34 concentrate was classified

as non-irritating to the skin and

minimally irritating to the eye in

primary skin irritation and eye irritation

studies. An avian oral pathogenicity and

toxicity study in northern Bobwhite

showed no evidence of pathogenicity

during gross necropsy. The no observed

adverse effect level (NOAEL) was

approximately 3.4 x 1011 cfu/kg/day for

5 days.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Bacillus

pumilus GB34 does not exhibit any

67524 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Notices

mammalian toxicity. Therefore, any

dietary exposure would not be harmful

to humans. Also Bacillus pumilus GB34

is a naturally occurring, ubiquitous

microorganism indigenous to the United

States.

ii. Drinking water. Bacillus pumilus is

found in the soil and the use rate of

GB34 concentrate is 0.1 ounces per 100

pounds of seed, equivalent to 1.7 grams

per acre. Bacillus pumilus GB34 is

unlikely to leach from the treated seed

and would not be distinguishable from

other naturally occurring Bacillus

pumilus.

2. Non-dietary exposure. As a

commercial seed treatment for soybeans,

the general population, including

infants and children, will have a very

low possibility of exposure.

Occupational exposure will be limited

to employees in commercial facilities

handling the seed treatment product.

Commercial seed treating equipment

minimizes occupational exposure.

Wearing protective equipment will also

minimize occupational exposure. Nondietary exposure would not be expected

to pose a quantifiable risk.

E. Cumulative Exposure

The product strain belongs to the

bacterial genus of Bacillus. Bacillus

pumilus GB34 may have a similar mode

of action in mammals as Bacillus

subtilis that has been shown to be nontoxic and non-pathogenic in mammalian

species. A similar mode of action of

Bacillus pumilus GB34 and Bacillus

subtilis would not be expected to result

in an increased adverse effect since both

were shown to be non-toxic and nonpathogenic in intravenous toxicity and

pathogenicity studies.

F. Safety Determination

1. U.S. population. Based on the low

treating rate of seed treatment use, little

evidence of toxicity or pathogenicity

and limited exposure potential,

Gustafson LLC believes there is a

reasonable certainty of no harm to the

U.S. population in general from

aggregate exposure to Bacillus pumilus

GB34 residue from all anticipated

dietary and non-dietary exposures.

2. Infants and children. Based on the

lack of toxicity and low exposure there

is a reasonable certainty that no harm to

infants, children or adults will result

from aggregate exposure to Bacillus

pumilus GB34.

G. Effects on the Immune and Endocrine

Systems

Gustafson LLC has no information to

suggest that Bacillus pumilus GB34 will

have any effect on the immune and

endocrine systems.

H. Existing Tolerances

There are no existing tolerances for

Bacillus pumilus GB34.

I. International Tolerances

Gustafson LLC is not aware of any

international tolerances, exemptions

from tolerance or maximum residue

levels for Bacillus pumilus GB34.

[FR Doc. 01–32109 Filed 12–28–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–7123–4]

Project Work Plan for Revised Air

Quality Criteria for Ozone and Related

Photochemical Oxidants

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability of external

review draft.

SUMMARY: This notice announces the

availability of the External Review Draft

of a document, Project Work Plan for

Revised Air Quality Criteria for Ozone

and Related Photochemical Oxidants,

NCEA–R–1068, prepared by the Office

of Research and Development of the

U.S. Environmental Protection Agency

(EPA). The purpose of this document is

to describe the managerial procedures

for revising EPA’s Air Quality Criteria

for Ozone and Related Photochemical

Oxidants, EPA/600/P–93/004aF,bF,cF,

July 1996. This External Review Draft of

the Project Work Plan will be reviewed

by the Clean Air Scientific Advisory

Committee (CASAC) of EPA’s Science

Advisory Board and will be revised in

light of CASAC’s review and comments

received from the general public.

Information on the date and location of

the CASAC public review meeting

(likely in March 2002) will be published

in a future Federal Register notice. The

plan may be modified and amended

from time to time, as necessary, to

reflect actual project requirements and

progress. As a result, any proposed

schedules and outlines, or any lists of

technical coordinator assignments,

authors, or reviewers are subject to

change.

DATES: Anyone who wishes to comment

on this document may do so in writing

by February 15, 2002.

ADDRESSES: To obtain a copy of the

Project Work Plan for Revised Air

Quality Criteria for Ozone and Related

Photochemical Oxidants (External

Review Draft), NCEA–R–1068, contact

Diane H. Ray, National Center for

Environmental Assessment-RTP Office

(MD–52), U.S. Environmental Protection

Agency, Research Triangle Park, NC

27711; telephone: 919–541–3637;

facsimile: 919–541–1818; E-mail:

ray.diane@epa.gov. Internet users may

obtain a copy from the EPA’s National

Center for Environmental Assessment

(NCEA) home page. The URL is http://

www.epa.gov/ncea/.

Send the written comments to the

Project Manager for Ozone Project Work

Plan, National Center for Environmental

Assessment-RTP Office (MD–52), U.S.

Environmental Protection Agency,

Research Triangle Park, NC 27711.

FOR FURTHER INFORMATION CONTACT: Mr.

James Raub, National Center for

Environmental Assessment-RTP Office

(MD–52), U.S. Environmental Protection

Agency, Research Triangle Park, NC

27711; telephone: 919–541–4157;

facsimile: 919–541–1818; E-mail:

raub.james@epa.gov.

Dated: December 20, 2001.

George W. Alapas,

Acting Director, National Center for

Environmental Assessment.

[FR Doc. 01–32089 Filed 12–28–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–7123–5]

Research Needed To Improve Health

and Ecological Risk Assessment for

Ozone

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability of external

review draft.

SUMMARY: This notice announces the

availability of the Second External

Review Draft of a document, Research

Needed to Improve Health and

Ecological Risk Assessment for Ozone,

EPA/600/R–98/031B, prepared by the

Office of Research and Development of

the U.S. Environmental Protection

Agency (EPA). The purpose of this

document is to identify the scientific

areas in which research is most needed

to improve health and ecological risk

assessment in the process of setting

National Ambient Air Quality Standards

for ozone. Many of the research needs

identified and discussed in this

document became apparent during

preparation of the Air Quality Criteria

for Ozone and Related Photochemical

Oxidants, EPA/600/P–93/004aF,bF,cF,

July 1996. The First External Review

Draft of this research needs document

was reviewed by the Clean Air

Scientific Advisory Committee (CASAC)