Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Notices 4017

children 1–6, the most heavily-exposed

population subgroup. Given these

assumptions, the total dietary exposure

from all current and proposed uses

would be equivalent to no more than

28% of the RfD for the U.S. population,

22% for non-nursing infants and 53%

for children 1–6. These levels of

exposure are acceptable.

ii. Acute exposure. No developmental

or reproductive effects have been

observed which indicate special

perinatal sensitivity. Therefore, an

analysis of acute exposure has not been

conducted.

a. Food. Dicloran is registered for use

on apricots, snap beans, carrots, celery,

sweet cherries, cucumbers, endive,

garlic, grapes, lettuce, nectarines,

onions, peaches, plums, potatoes,

rhubarb, sweet potatoes and tomatoes.

(See 40 CFR 180.200 for specific

tolerances.) The metabolism of dicloran

in plants and animals is adequately

understood for the purposes of these

tolerances. There is a practical

analytical method for detecting and

measuring levels of dicloran in or on

food with a limit of detection that

allows monitoring of food with residues

at or above the levels set in this

tolerance.

b. Drinking water. Dicloran was not

reported in the Agency’s survey of

pesticides in ground water from 1971–

1991, nor in the Agency’s 1988–1990

survey of pesticides in drinking water

wells. The compound has not been

reported in surface water. A small scale

prospective ground water study suggests

that the average residue in ground water

is well below 0.001 ppm. The Agency

has not conducted a detailed analysis of

potential exposure to dicloran via

drinking water; however, it is believed

that chronic exposure from this source

is very small.

2. Non-dietary exposure. Dicloran has

no aquatic, lawn or residential uses.

D. Cumulative Effects

At this time the Agency has not

reviewed available information

concerning the potentially cumulative

effects of dicloran and other substances

that may have a common mechanism of

toxicity. For purposes of this petition

only, the Agency is considering only the

potential risks of dicloran in its

aggregate exposure.

E. Safety Determination

1. U.S. population—Chronic risk. If it

is assumed that all crops on which

dicloran is registered are treated, and if

all residues on crops are assumed to be

equal to the tolerance levels, then it can

be calculated that the theoretical

maximum residue concentration

(TMRC) is equal to 106% of the RfD for

the general U.S. population and 408%

of the RfD for non-nursing infants, the

most highly exposed group.

Actual chronic risk is known to be

much lower. Using anticipated residue

concentrations, it was concluded that

chronic dietary exposure to dicloran

will be no more than 28% of the RfD.

Exposures from drinking water and all

other routes is expected to be negligible.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

dicloran, EPA considered data from

developmental toxicity studies in the rat

and rabbit and reproduction studies in

the rat. The developmental toxicity

studies are designed to evaluate adverse

effects on the developing organism

resulting from pesticide exposure

during prenatal development to one or

both parents. Reproduction studies

provide information relating to effects

from exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

No teratological effects have been

observed with dicloran. The lowest

embryotoxic NOAEL in these studies

was 100 mg/kg/day, compared to a

chronic NOAEL of 2.5 mg/kg/day. There

is no indication of special perinatal

sensitivity in the absence of maternal

toxicity and thus no suggestion of

special sensitivity of infants and

children. It is concluded that there is a

reasonable certainty of no harm to

infants and children from aggregate

exposure to dicloran residues.

F. International Tolerances

There are no Codex, Canadian or

Mexican maximum residue levels for

dicloran in peanuts. Although no

numerical revisions of existing tolerance

levels are proposed for carrots or

tomatoes, it is noted that Canadian

MRL’s of 5 ppm exist for both carrots

and tomatoes. Codex MRL’s of 10 ppm

for carrots and 0.5 ppm for tomatoes

exist.

[FR Doc. 01–1352 Filed 1–16–01; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–986; FRL–6755–1]

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–986, must be

received on or before February 16, 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–961 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Sharlene Matten, Biopesticides

and Pollution Prevention Division

(7511C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

605–0514; e-mail address:

matten.sharlene@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.

4018 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Notices

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’’ 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–

986. 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–986 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–986. 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 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: January 5, 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.

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.

EPA has received a pesticide petition

PP 0F6191 from Platte Chemical

Company, j419 18th Street, Greeley, CO

80632–0667, 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 the

microbial pesticide Alternaria

destruens.

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

the FFDCA, as amended, Platte

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Notices 4019

Chemical Company has submitted the

following summary of information, data,

and arguments in support of their

pesticide petition. This summary was

prepared by Platte Chemical Company

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.

Platte Chemical Company

PP 0F6191

A. Product Name and Proposed Use

Practices

Alternaria destruens is a naturally

occurring fungus that is pathogenic to

Cuscuta spp., often referred to as

dodder, swamp dodder, largeseed

dodder, field dodder or small seed

dodder. The active ingredient will infect

and suppress dodder at early stages of

growth. Dodder is a leafless, rootless

weed that is parasitic on cranberries and

other crops, directly reducing vigor.

Dodder generally germinates in late

spring, twining stems around the host to

derive its nutrients from that plant.

Two formulations of Alternaria

destruens are proposed, one for the

control of emerging dodder and one for

the control of dodder that has attached

to and infested the host plant. Smolder

L G, a granular product, is proposed for

use on known sites of dodder

infestation, as it emerges in the spring,

to suppress dodder growth and seed

production. Smolder L WP, a sprayable

product, is proposed for use on growing

dodder, as spot or area treatment to

control further growth. Use sites include

vegetables, fruits, field crops and nonagricultural areas such as uncultivated

rights-of-way, roadsides and fallow

areas.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Alternaria

destruens is a naturally occurring

fungus that is pathogenic to Cuscuta

spp., often referred to as dodder, swamp

dodder, largeseed dodder, field dodder

or small seed dodder. The active

ingredient will infect and suppress

dodder at early stages of growth.

Alternaria destruens requires adequate

moisture and temperature during the

infection period (3 to 4 hours). In very

dry or drought conditions, when dew is

absent, the onset of the infection process

might be delayed until moisture

conditions return. Alternaria destruens

has been shown to survive in nature

only on live or dead tissue of the host

weed species. Survival on soil or nonsusceptible plant tissue would be

limited.

2. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. An analytical method for

residues is not applicable. The use of

Alternaria destruens calls for

application to field crops at an early

stage for control of dodder species.

Consequently, there is a considerable

time lag between application and

harvesting of crops. Since survival of

the organism is in part dependent on

existence of the host plant, it is unlikely

that application will result in the

presence of Alternaria destruens in food

crops. Residues of Alternaria destruens

are not expected on agricultural

commodities.

C. Mammalian Toxicological Profile

The active ingredient Alternaria

destruens has been evaluated for

toxicity through oral, dermal,

pulmonary, intraperitoneal, and eye

routes of exposure. The results of the

studies have indicated there are no

significant human health risks.

For the active ingredient, acute oral

toxicity/pathogenicity in rats is greater

than 1 X 107 cfu/animal, acute

pulmonary toxicity/pathogenicity in rats

is greater than 5 X 105 cfu/animal, and

acute intraperitoneal toxicity/

pathogenicity in rats is greater than 9.6

X 106 cfu/animal. No pathogenic or

infective effects were observed in the

studies. For the end-use wettable

powder formulation, acute dermal

toxicity in rats is greater than 5,000 mg/

kg (Toxicity Category IV), acute

inhalation toxicity in rats is greater than

2.03 mg/l (Toxicity Category IV),

minimal eye irritation in rabbits was

observed at a dose of 0.1 ml (Toxicity

Category III) and no skin irritation in

rabbits was observed at a dose of 0.5 ml

(Toxicity Category IV). Since its

discovery, no incidents of

hypersensitivity have been reported by

researchers, manufacturers or users.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Dietary

exposure from use of Alternaria

destruens, as proposed, is minimal. The

use of Alternaria destruens calls for

application to field crops at an early

stages for control of dodder species.

Consequently, there is a considerable

time lag between application and

harvesting of crops. Since survival of

the organism is in part dependent on

existence of the host plant, it is unlikely

that application will result in the

presence of Alternaria destruens in food

crops. Residues of Alternaria destruens

are not expected on agricultural

commodities.

ii. Drinking water. Similarly, exposure

to humans from residues of Alternaria

destruens in consumed drinking water

would be unlikely. Alternaria destruens

is a naturally-occurring microorganism

known to exist in terrestrial habitats in

the presence of a host plant, it is not

known to grow or thrive in aquatic

environments.

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

pose any quantifiable risk due to a lack

of residues of toxicological concern.

Person Protective Equipment (PPE)

mitigates the potential for exposure to

applicators and handlers of the

proposed products, when used in

agricultural settings.

E. Cumulative Exposure

It is not expected that, when used as

proposed, Alternaria destruens would

result in residues that would remain in

human food items.

F. Safety Determination

1. U.S. population. Alternaria

destruens is not pathogenic or infective

to mammals. There have been no reports

of toxins or secondary metabolites

associated with the organism, and acute

toxicity studies have shown that

Alternaria destruens is non-toxic, nonpathogenic, and non-irritating. Residues

of Alternaria destruens are not expected

on agricultural commodities, and

therefore, exposure to the general U.S.

population, from the proposed uses, is

not anticipated.

2. Infants and children. As mentioned

above, residues of Alternaria destruens

are not expected on agricultural

commodities. There is a reasonable

certainty of no harm for infants and

children from exposure to Alternaria

destruens from the proposed uses.

G. Effects on the Immune and Endocrine

Systems

Alternaria destruens is a naturallyoccurring microorganism. To date there

is no evidence to suggest that Alternaria

destruens functions in a manner similar

to any known hormone, or that it acts

as an endocrine disrupter.

H. Existing Tolerances

There is no U.S. EPA Tolerance for

Alternaria destruens.

4020 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Notices

I. International Tolerances

A Codex Alimentarium Commission

Maximum Residue Level (MRL) is not

required for Alternaria destruens.

[FR Doc. 01–1353 Filed 1–16–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50873; FRL–6740–2]

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 and amended

certain previously granted EUPs. 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: Biopesticides and Pollution

Prevention Division (7511C), 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:

524–EUP–90, 524–EUP–92, and 524–

EUP–93. Issuance. Monsanto Company,

700 Chesterfield Parkway North, St.

Louis, MO 63198. The issuance of these

EUPs allows the use of the plantpesticides Bacillus thuringiensis Cry3Bb

protein and the genetic material

necessary for its production (vector

ZMIR14L) in corn, Bacillus

thuringiensis Cry3Bb protein and the

genetic material necessary for its

production (vector ZMIR12L) in corn,

and Bacillus thuringiensis Cry3Bb

protein and the genetic material

necessary for its production (vector

ZMIR13L) in corn, respectively . A

notice of receipt for these EUPs was

published in the Federal Register on

December 8, 1999 (64 FR 68681) (FRL–

6398–3). The EUPs were granted on

April 6, 2000 and amended on May 15,

2000. 524–EUP–90 allows the planting

of 1,343 acres of corn to test and

evaluate genetically modified corn that

has been developed to provide control

of corn rootworm (Diabrotica spp.). The

program is authorized only in the States

of California, Colorado, Georgia, Hawaii,

Illinois, Indiana, Iowa, Louisiana,

Kansas, Michigan, Minnesota, Missouri,

North Carolina, Nebraska, New York,

North Dakota, Ohio, Oklahoma,

Pennsylvania, Puerto Rico, South

Dakota, Tennessee, Texas, Virginia, and

Wisconsin. 524–EUP–92 allows the

planting of 416 acres of corn to test and

evaluate genetically modified corn that

has been developed to provide control

of corn rootworm (Diabrotica spp.). The

program is authorized only in the States

of California, Georgia, Hawaii, Illinois,

Indiana, Iowa, Louisiana, Kansas,

Michigan, Minnesota, Missouri, North

Carolina, Nebraska, Oklahoma, Puerto

Rico, South Dakota, Tennessee, Texas,

Virginia, and Wisconsin. 524–EUP–93

allows the planting of 1,092 acres of

corn to test and evaluate genetically

modified corn that has been developed

to provide control of corn rootworm

(Diabrotica spp.). The program is

authorized only in the States of

California, Colorado, Georgia, Hawaii,

Illinois, Indiana, Iowa, Louisiana,

Kansas, Michigan, Minnesota, Missouri,

North Carolina, Nebraska, New York,

North Dakota, Ohio, Oklahoma,

Pennsylvania, Puerto Rico, South

Dakota, Tennessee, Texas, Virginia, and

Wisconsin. These EUPs are effective

from April 6, 2000 to April 31, 2001.

These permits are issued with the

limitation that all treated crops will be

genetically contained and destroyed or

used for research purposes only. Nine

comments were received in reply to the

Federal Register notice announcing

receipt of these applications. Non-target

insect risks, ecological effects of

biopesticides, the need for a transparent

and scientifically rigorous process for

setting conditions for registration and

use of independent expert advice, insect

resistance management, contamination

levels of neighboring crops, and the

participation of land grant university

corn IPM experts in the EUP were

concerns expressed during the comment

period. Health, environmental, and

agricultural benefits of corn rootworm

protected Bt corn were also noted.

Insect resistance management and

non-target organism research will be

part of the testing taking place under

these EUPs. Researchers will be looking

at field and population levels for a wide

variety of soil and surface dwelling

organisms, including all major

coleopteran species that are found in

corn systems. This will include work on

insects like collembola, carabids, and

other soil invertebrates like earthworms.

Land grant university researchers are

involved in many of these

investigations. Testing is not permitted

in the vicinity of endangered beetle

habitats. Based on the information

submitted, no significant or irreversible

hazards from Cry3Bb corn to non-target

organisms are anticipated for the

duration of these limited acreage

programs. These EUPs are crop destruct

and genetically contained. (Mike

Mendelsohn; Rm. 910W16, Crystal Mall

#2; telephone number: (703) 308–8715;

e-mail address:

mendelsohn.mike@epa.gov).

68467–EUP–2. Extensions/

Amendments. Mycogen Seeds c/o Dow

AgroSciences LLC, 9330 Zionsville

Road, Indianapolis, IN 46268. The

amendments and extensions to this EUP

allow the use of the plant–pesticide

Bacillus thuringiensis Cry1F protein and

the genetic material necessary for its

production (plasmid insert PHI8999) in

corn plants. Notice of the original

issuance of the EUP was published in

the Federal Register on May 5, 1999 (64

FR 24161) (FRL–6078–2). Notices of

receipt for several amendments were

published in the Federal Register on

February 25, 2000 (65 FR 10081) (FRL–

6492–1) and on March 3, 2000 (65 FR

11575) (FRL–6495–8). On May 11, 1999,

the EUP was amended to modify the

containment provisions. On June 18,

1999, the EUP was amended to switch

acreage between different protocols in

the program at the same sites. On

January 27, 2000, the EUP was amended

to permit the planting of 55 acres in

Puerto Rico for agronomic observation