3696 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices

exemption from the requirement of a

tolerance for the active ingredient,

methyl anthranilate for cherries,

blueberries and grapes under 40 CFR

180.1143 became effective on April 26,

1995 as published in the Federal

Register (60 FR 20432) (FRL–4941–8).

The mode of action is physical

whereby the repellent irritates the bird’s

taste buds, olfactory sensors and skin.

For this petition, methyl anthranilate is

sprayed in a water solution at a rate of

0.2862 pounds (lbs.) per acre to corn

twice and may be reapplied at 5 to 10

day intervals until harvest. Applications

to the crop can be applied up to 2 days

before harvest.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Methyl

anthranilate is a common component of

concord and other red grapes as well as

neroli, ylang-ylang, bergamot, jasmine

and other essential oils. It is

synthetically obtained by esterifying

anthranilic acid with methanol in the

presence of hydrochloric acid. In its

crystalline form it is slightly soluble in

water and freely soluble in alcohol or

ether. Methyl anthranilate is commonly

used as a perfume for ointments and

cosmetics, and a flavoring agent in

confectionary products, drugs and

beverages. Methyl anthranilate readily

volatilizes under ultraviolet (uv) light

and elevated temperatures.

2. Magnitude of residue at the time of

harvest and method used to determine

the residue. Residue studies, using gas

chromatograph and mass spectrometry,

show no residues at the time of harvest.

No residues of methyl anthranilate are

expected to occur at the time of harvest

and thus the purpose for proposing an

exemption from the requirement of a

tolerance.

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. The analytical method for

detecting and measuring the levels of

the residue is described above.

C. Mammalian Toxicological Profile

Methyl anthranilate is approved by

the FDA for food use as an artificial

flavoring and fragrance agent. Bird

Shield Repellent Corporation has

reviewed the acute toxicological studies

associated with these approvals and

conducted additional studies for

verification. Summaries of these studies

are presented below:

1. Mammalian. Methyl anthranilate

exhibits little or no mammalian toxicity.

Methyl anthranilate metabolizes in the

intestine when consumed. The LD50

values for methyl anthranilate were

estimated to be greater than 5,000 mg/

kg in an acute oral toxicity study in rats

(Toxicity category IV) and greater than

2,000 mg/kg in an acute dermal toxicity

study in rats (Toxicity category III). The

LC50 value in an acute inhalation study

in rats was determined to be greater 2.24

mg/L (Toxicity category IV). Methyl

anthranilate was found to cause

moderate irritation in a rabbit skin

irritation assay and corneal effects that

cleared in 8 to 21 days in a rabbit eye

irritation assay.

2. Avian. Methyl anthranilate exhibits

little or no avian toxicity. Methyl

anthranilate’s irritating properties to

avian species preclude ingestion. In an

acute oral avian toxicity study, methyl

anthranilate was found to be practically

non-toxic to bobwhite quail. In a dietary

study, methyl anthranilate was

determined to be practically non-toxic

to mallard ducks. Based on these

studies, Bird Shield Repellent

Corporation concludes that methyl

anthranilate poses no unique or

additional risk to avian species.

D. Aggregate Exposure

1. Dietary exposure —i. Food. The

active ingredient in Bird Shield

Repellent Concentrate, methyl

anthranilate, is applied at a rate of

0.2862 lbs per acre. Because of the low

use rates, no active ingredient residues

are detectable using available methods

on treated crops even immediately after

application. Because of its volatility,

and degradation when exposed to

ultraviolet light and elevated

temperatures, no residues are expected

at harvest. Dietary exposure to methyl

anthranilate, via consumption of the

treated food or feed, is expected to be

low to negligible.

ii. Drinking water. The active

ingredient is unlikely to be found in

drinking water given the very low

application rate and rapid degradation

in soil.

2. Non-dietary exposure. Bird Shield

Repellent Corporation believes that the

potential for non-dietary exposure to the

general population, including infants

and children, is unlikely as the

proposed use is primarily to the

external, non-edible portions of the

crop. This mode of application would

not be expected to pose any quantifiable

risks due to lack of residues of

toxicological concern. Increased nondietary exposure of methyl anthranilate

is not considered likely because of the

low use rates and the lack of persistence

of the active ingredient.

E. Cumulative Exposure

Consideration of a common mode of

toxicity is not appropriate given there is

no indication of mammalian toxicity of

methyl anthranilate and no information

that indicates that the toxic effects

would be cumulative with any other

compounds. Moreover, methyl

anthranilate does not exhibit a toxic

mode of action in its target species.

F. Safety Determination

1. U.S. population. Methyl

anthranilate’s lack of toxicity has been

demonstrated by the results of acute

toxicity testing in mammals in which

the chemical caused no adverse effects

when dosed orally and via inhalation at

the limit dose for each study. Thus the

aggregate exposure to methyl

anthranilate over a lifetime should pose

negligible risks to human health.

2. Infants and children. Based on the

lack of toxicity and low exposure there

is reasonable certainty of no harm to

infants, children or adults from

aggregate exposure to the chemical’s

residues. Exempting methyl anthranilate

from the requirement of a tolerance

should pose no significant risk to

human health or the environment.

G. Effects on the Immune and Endocrine

Systems

Bird Shield Repellent Corporation has

no information to suggest that methyl

anthranilate will adversely affect the

immune or endocrine systems.

H. Existing Tolerances

An exemption from the requirement

of a tolerance for the active ingredient,

methyl anthranilate for cherries,

blueberries and grapes under 40 CFR

180.1143 became effective on April 26,

1995 (60 FR 20432).

I. International Tolerances

Bird Shield Repellent Corporation is

not aware of any tolerance, exemption

from tolerance or MRL’s issued for

methyl anthranilate outside the United

States.

[FR Doc. 00–1550 Filed 1–21–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–910; FRL–6484–9]

Notice of Filing a Pesticide Petition 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 a pesticide petition

proposing the establishment of

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices 3697

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–910, must be

received on or before February 23, 2000.

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–910 in the subject

line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Susanne Cerrelli, Biopesticides

and Pollution Prevention Division

(7511C), Office of Pesticide Programs,

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 308–8077; e-mail address:

Cerrelli.susanne@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 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’’ 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–

910. 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

(CM 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–910 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, Ariel Rios Bldg., 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, CM 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–910. 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

3698 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices

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 Comestic 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 supports 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, 2000.

Janet L. Andersen,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

Prophyta Biologischer Pflanzenschutz

GmbH

Pesticide Petition 9F6038

EPA has received a pesticide petition

(PP) 9F6038 from Prophyta Biologischer

Pflanzenschutz GmbH, Inselstrabe 12,

D–23999 Malchow/Poel, Germany,

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

Coniothyrium minitans strain CON/M/

91–08.

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

the FFDCA, as amended, Prophyta

Biologischer Pflanzenschutz GmbH has

submitted the following summary of

information, data, and arguments in

support of their pesticide petition. This

summary was prepared by Prophyta

Biologischer Pflanzenschutz GmbH 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

Coniothyrium minitans strain CON/

M/91–08 is proposed for use to control

Sclerotinia species in the soil of any

agricultural crop. The end-use product,

CONTANSWG, is applied as a spray to

the soil, which is followed with

mechanical incorporation (i.e., rotating)

into the first one to two inches of the

top soil layer. The product is applied as

a preplant treatment, 3 to 4 months

prior to planting the crop, or as a

postharvest treatment to plant residues.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Coniothyrium

minitans strain CON/M/91–08 is the

active ingredient in the proposed enduse product CONTANS WG.

CONTANS WG is currently registered

for use in Germany and Switzerland. An

application for inclusion of the active

ingredient (Coniothyrium minitans

strain CON/M/91–08) in Annex I of

Council Directive 91/414/EEC on the

marketing of plant-protection products

was sanctioned in 1998 and was

published in the European Union

Gazette.

Coniothyrium minitans was first

described after isolation from sclerotia

of Sclerotinia sclerotiorum in California

in 1947 and has been investigated as a

pesticide over the last 20 years. The

occurrence of Coniothyrium minitans in

the soil has been reported from many

countries all over the world.

Coniothyrium minitans strain CON/

M/91–08 is a naturally occurring soil

fungus that primarily attacks and infects

sclerotia. When the host organism

(sclerotia) is present, Coniothyrium

minitans starts to develop a vegetative

organism and infects the host. The

Coniothyrium minitans population

decreases when the number of vital

sclerotia drops. The vegetative organism

disappears and the fungus rests in a

spore stage. The spores of Coniothyrium

minitans can survive ungerminated in

disintegrated sclerotia for at least 1 year,

and the fungus can be recovered from

soil in sclerotia for up to 18 months

following application. However, at soil

temperatures above 25 °C, isolation of

Coniothyrium minitans from sclerotia is

not possible after 6 months.

2. Magnitude of residue at the time of

harvest and method used to determine

the residue. An analytical method for

detecting and measuring the levels of

residues is not applicable. Coniothyrium

minitans strain CON/M/91–08 is

applied to the soil and immediately

mixed into the top soil layer prior to

planting the crop, or after harvest. It is

not applied to growing crops directly.

Residues of Coniothyrium minitans

strain CON/M/91–08 are not expected

on agricultural commodities.

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

detecting and measuring the levels of

residues is not applicable. Coniothyrium

minitans strain CON/M/91–08 is

applied to the soil and immediately

mixed into the top soil layer prior to

planting the crop, or after harvest. It is

not applied to growing crops directly.

Residues of Coniothyrium minitans

strain CON/M/91–08 are not expected

on agricultural commodities.

C. Mammalian Toxicological Profile

CONTANS WG, the end-use product

which contains 5.3% active ingredient,

was evaluated for acute toxicity through

oral, dermal, inhalation and eye routes

of exposure. The results of the studies

indicated Toxicity Category III or IV,

which pose no significant human health

risks.

The acute oral toxicity of

Coniothyrium minitans strain CON/M/

91–08 in rats is greater than 2,500

milligrams per kilograms (mg/kg)

(Toxicity Category III), the highest dose

tested. The acute dermal toxicity of

Coniothyrium minitans strain CON/M/

91–08 in rats is greater than 2,500 mg/

kg (Toxicity Category III), the highest

dose tested. The acute intraperitoneal

toxicity of Coniothyrium minitans strain

CON/M/91–08 to rats is greater than

2,000 mg/kg, the highest does tested.

The acute inhalation of Coniothyrium

minitans strain CON/M/91–08 in rats is

greater than 12.74 milligrams per liter

(mg/L) of air (Toxicity Category IV). Eye

irritation in rabbits was not observed at

a dose of 0.1 milliliter (ml) (Toxicity

Category IV). Skin irritation in rabbits

was not observed at a dose of 0.5 ml

(Toxicity Category IV). No dermal

sensitization was observed in guinea

pigs (Toxicity Category IV). Since its

discovery in 1947, no incidents of

hypersensitivity have been reported by

researchers, manufacturers, or users.

A waiver is being requested for acute

oral toxicity/pathogenicity, acute

dermal toxicity/pathogenicity and acute

pulmonary toxicity/pathogenicity data

requirements, based on the fact that the

active ingredient is not able to grow at

temperatures above 32 °C, and thus

would not be pathogenic or infective to

humans. A growth temperature study

has been submitted to support the

waiver request. Additionally, acute

toxicity studies have determined the

end-use product containing the

organism is not toxic, irritating or

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices 3699

sensitizing to test animals. Finally, the

organism has never been reported as a

pathogen of humans, or as causing any

type of adverse effect to humans, in

published literature or through

commercial use.

D. Aggregate Exposure

1. Dietary exposure —i. Food. Dietary

exposure from use of Coniothyrium

minitans strain CON/M/91–08, as

proposed, is minimal. Coniothyrium

minitans strain CON/M/91–08 is

applied to the soil and immediately

mixed into the top soil layer prior to

planting the crop, or after harvest. It is

not applied to growing crops directly.

Residues of Coniothyrium minitans

strain CON/M/91–08 are not expected

on agricultural commodities.

ii. Drinking water. Exposure to

humans from residues of Coniothyrium

minitans strain CON/M/91–08 in

consumed drinking water would be

unlikely. In a study to investigate the

leaching behavior of Coniothyrium

minitans strain CON/M/91–08, it was

determined that there is no motility of

the organism in the soil. Thus, it would

not be possible for the organism to leach

into drinking water. Also, due to the

specific requirements for growth of

Coniothyrium minitans strain CON/M/

91–08, it is not likely that the organism

could survive or persist in water.

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 commercial,

agricultural and horticultural settings.

However, non-dietary exposures would

not be expected to pose any quantifiable

risk due to a lack of residues of

toxicological concern.

Personal protective equipment (PPE)

mitigates the potential for exposure to

applicators and handlers of the

proposed products, when used in

commercial, agricultural and

horticultural settings.

E. Cumulative Exposure

It is not expected that, when used as

proposed, Coniothyrium minitans strain

CON/M/91–08 would result in residues

that would remain in human food items.

F. Safety Determination

1. U.S. population. Coniothyrium

minitans strain CON/M/91–08 does not

grow at temperatures above 32 °C, and

thus would not be pathogenic or

infective to humans. There have been no

reports of toxins or secondary

metabolites associated with the

organism, and acute toxicity studies

have shown that Coniothyrium minitans

strain CON/M/91–08 is nontoxic,

nonirritating and nonsensitizing when

applied to test animals.

Coniothyrium minitans strain CON/

M/91–08 is applied to soil and

immediately mixed into the top soil

layer prior to planting the crop, or after

harvest. It is not applied to growing

crops directly. Residues of

Coniothyrium minitans strain CON/M/

91–08 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 Coniothyrium

minitans strain CON/M/91–08 are not

expected on agricultural commodities.

There is a reasonable certainty of no

harm for infants and children from

exposure to Coniothyrium minitans

strain CON/M/91–08 from the proposed

uses.

G. Effects on the Immune and Endocrine

Systems

Coniothyrium minitans strain CON/

M/91–08 is a naturally occurring,

nonpathogenic soil organism. To date

there is no evidence to suggest that

Coniothyrium minitans strain CON/M/

91–08 functions in a manner similar to

any known hormone, or that it acts as

an endocrine disrupter.

H. Existing Tolerances

There are no existing tolerances for

this ingredient.

I. International Tolerances

A Codex Alimentarium Commission

Maximum Residue Level (MRL) is not

required for Coniothyrium minitans

strain CON/M/91–08.

[FR Doc. 00–1552 Filed 1–21–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–181072; FRL–6485–7]

Pesticide Emergency Exemptions;

Agency Decisions and State and

Federal Agency Crisis Declarations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has granted or denied

emergency exemptions under the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA) for use of

pesticides as listed in this notice. These

exemptions or denials were issued

during the period between January 1,

1999, through December 15, 1999, to

control unforseen pest outbreaks. The

actions detailed in this document do not

represent every FIFRA section 18

emergency exemption decision issued

by EPA during the above time period.

FOR FURTHER INFORMATION CONTACT: See

each emergency exemption or denial for

the name of a contact person. The

following information applies to all

contact persons: Team Leader,

Emergency Response Team, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Building, 1200

Pennsylvania Avenue, NW.,

Washington, DC 20460; telephone

number: (703) 308–9366.

SUPPLEMENTARY INFORMATION: EPA has

granted or denied emergency

exemptions to the following State and

Federal agencies. The emergency

exemptions may take the following

form: Crisis, public health, quarantine,

or specific. EPA has also listed denied

emergency exemption requests in this

notice.

I. General Information

A. Does This Action Apply to Me?

You may be potentially affected by

this action if you petition EPA for

authorization under section 18 of FIFRA

to use pesticide products which are

otherwise unavailable for a given use.

Potentially affected categories and

entities may include, but are not limited

to:

Categories NAICS codes Examples of potentially affected entities

State and Territorial government agencies charged with pesticide authority9241 State agencies that petition EPA for section 18 pesticide use authorization

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. Other types of

entities not listed in the table in this

unit could also be regulated. The North

American Industrial Classification

System (NAICS) codes have been

provided to assist you and others in