20976 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

inappropriate at this time because of the

unique role of cloquintocet-mexyl as a

product-specific safener.

E. Safety Determination

1. U.S. population. Acute and chronic

dietary exposure is minimal for

cloquintocet-mexyl and corresponding

hydrolysis product, CGA-153433. Both

chronic and acute exposure estimates at

the 95th percentile showed that less

than 1.0% of the reference dose is

utilized in all populations. These

exposure estimates are extremely

conservative and are based on tolerancelevel residues and assume all planted

acres are treated.

Exposure through the consumption of

drinking water is minimal from both

surface water and ground water model

estimates and in all cases less than 1%

of the risk cup is utilized. The estimated

water concentrations are very

conservative since conservative model

parameters were assumed.

There are no residential uses of

cloquintocet-mexyl that would result in

non-dietary exposure. However, there is

a remote possibility that spray drift

resulting from aerial application could

lead to residential exposure. Since

exposure from spray drift would be an

unlikely event, it is not appropriate to

include non-dietary exposure into the

aggregate assessment. Therefore, it is

concluded that there is a more than a

reasonable certainty that no harm will

result from aggregate exposure to

residues of cloquintocet-mexyl.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

cloquintocet-mexyl, data from

developmental toxicity studies in the rat

and rabbit and a 2-generation

reproduction study in the rat have been

considered. The developmental toxicity

studies are designed to evaluate adverse

effects on the developing organism

resulting from chemical exposure

during prenatal development to one or

both parents. Reproduction studies

provide information relating to effects

from exposure to a chemical on the

reproductive capability of mating

animals and data on systemic toxicity.

The highest dose level of 400 mg/kg/

day in a developmental toxicity study in

rats resulted in reduced body weight

gain of the dams and signs of retarded

fetal development. No teratogenic

activity due to the test article was

detected. The NOAEL for dams and

fetuses was 100 mg/kg/day. Although

mortality was observed in rabbit dams at

the dose level of 300 mg/kg/day, no

teratogenic effects were noted. The

maternal NOAEL was 60 mg/kg/day, but

the developmental NOAEL was > 300

mg/kg/day.

Dietary administration of

cloquintocet-mexyl over 2-generations

at levels as high as 10,000 ppm did not

affect mating performance, fertility, or

litter sizes in rats, but a slightly reduced

body weight development of adults and

pups was noted at this level. The target

organ was kidney in adults and pups.

The treatment had no effect on

reproductive organs. The parental and

developmental NOAEL was 5,000 ppm,

corresponding to a mean daily intake of

370 to 422 mg/kg/day of cloquintocetmexyl. The reproductive NOAEL was >

10,000 ppm (722 mg/kg/day). FFDCA

section 408 provides that EPA may

apply an additional safety factor for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base. Based on

the current toxicological data

requirements, the data base relative to

prenatal and postnatal effects for

children is complete. EPA’s HIARC

concluded that there was no concern for

an increased susceptibility for

cloquintocet-mexyl based on the

reproduction study in rats and the

developmental studies in rat and rabbit.

Further, for cloquintocet-mexyl, the

NOAEL of 4.3 mg/kg/day from the

combined chronic/oncogenicity study in

rats, which was used to calculate the

RfD, is already lower than the

developmental NOAEL of 100 mg/kg/

day for the rat developmental toxicity

study. Further, the developmental and

parental NOAEL of 370 mg/kg/day from

the cloquintocet-mexyl reproduction

study is nearly 100 times greater than

the NOAEL for the combined chronic/

oncogenicity rat study. These data

would indicate that there is no

additional sensitivity of infants and

children to cloquintocet-mexyl.

Therefore, it is concluded that an

additional UF is not warranted to

protect the health of infants and

children from the use of cloquintocetmexyl.

Using conservative exposure

assumptions, dietary exposure to the

most sensitive subpopulation, children

(1–6 years old), is 0.9% of the chronic

reference dose (RfD). Chronic dietary

exposure to infants (non-nursing, 1–6

years old) is 0.2% of the chronic RfD.

EPA’s HIARC concluded that no acute

dietary assessment was necessary for the

general population (infants and

children) because a suitable

toxicological endpoint (resulting from a

single dose exposure) was not identified

in either the rat or rabbit developmental

studies.

Although not required, acute dietary

exposure to infants and children was

assessed. Acute exposures for all infants

and children at the 95th percentile are

less than 1.0% of the acute RfD (0.08%

of the RfD for the most sensitive

subpopulation, children 1–6 years).

Exposures to drinking water for children

(1–6 years old) and infants utilize less

than 1% of the chronic and acute RfD

values (worst-case surface water

estimates). These results show that

aggregate exposure to residues of

cloquintocet-mexyl in the diet and

drinking water is negligible. Based on

the completeness and reliability of the

toxicity data and the conservative

nature of the exposure assumptions, it is

concluded that there is a more than

reasonable certainty that no harm will

result to infants and children from

exposure to residues of cloquintocetmexyl.

F. International Tolerances

Cloquintocet-mexyl is used as a

safener for the herbicide, clodinafoppropargyl. There are no Codex

Alimentarius Commission (CODEX)

maximum residue levels (MRLs)

established for residues of cloquintocetmexyl in or on RACs.

[FR Doc. 00–9796 Filed 4–18–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50868; FRL–6553–3]

Experimental Use Permit; Receipt of

Application

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces receipt

of an application 67986–EUP–E from

AgriPhi, Inc. requesting an experimental

use permit (EUP) for the microbial

bacteriophages. 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–50868, must be

received on or before May 19, 2000.

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

Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20977

OPP–50868 in the subject line on the

first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Linda Hollis, 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) 308–8733; and e-mail

address: hollis.linda@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 tomato greenhouse

operators and tomato farmers for

beneficial use in the control of bacterial

diseases of tomato such as: bacterial

spot of tomato and pepper, in addition

to bacterial canker, speck or wilt of

tomato, bacterial brown spot, common

or halo blight of beans, blackleg and soft

rot of potato, black rot of crucifers,

fireblight of apple and pear. 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’’ 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–50868. 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.

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 OPP–50868 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, 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 OPP–50868. 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. Offer alternative ways to improve

the notice.

7. Make sure to submit your

comments by the deadline in this

document.

8. 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. Proposed Experimental Program

AgriPhi, Inc. seeks to continue their

ongoing EUP program by requesting a 2

year experimental use permit to further

evaluate the effectiveness of

AGRIPHAGE (a bacteriophage) under

normal production conditions for its

control of bacterial speck of tomato

(Pseudomonas syringae pv. tomato) and

bacterial black spot of tomato/pepper

(Xanthomonas campestris pv.

vesicatoria). Testing will be conducted

in the states of Arizona, Florida,

Georgia, Kentucky, New Mexico, and

South Carolina on a total of 2,810 acres.

Approximately 200 pounds of the active

ingredient or 10,000 pounds of the

formulated product will be used for

testing.

20978 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

III. What Action is the Agency Taking?

Following the review of the AgriPhi,

Inc. application and any comments and

data received in response to this notice,

EPA will decide whether to issue or

deny the EUP request for this EUP

program, and if issued, the conditions

under which it is to be conducted. Any

issuance of an EUP will be announced

in the Federal Register.

List of Subjects

Environmental protection,

Experimental use permits.

Dated: April 5, 2000.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 00–9664 Filed 4–18–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00652; FRL–6552–2]

Pesticides; Guidance for Pesticide

Registrants on First Aid Instructions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability.

SUMMARY: EPA is announcing the

availability of guidance which provides

revised first aid instructions for all

pesticide products. Pesticide

Registration (PR) Notice 2000–3 is

effective now, but comments will be

accepted for 30 days, after which the

Agency may revise the notice. The first

aid instructions have been revised to

reflect more medically correct

information and to make them easier to

find and be understood.

DATES: Comments, identified by docket

control number OPP–00652, must be

received on or before May 19, 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

OPP–00652 in the subject line on the

first page of your response.

FOR FURTHER INFORMATION CONTACT:

Amy Breedlove, Field and External

Affairs Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9069; fax number:

(703) 305–5884; e-mail address:

breedlove.amy@epa.gov.

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 register or regulate pesticides, as

well as poison control centers, and the

medical community, 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 notice,

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

the PR Notice from the Office of

Pesticide Programs’ Home Page at http:/

/www.epa.gov/pesticides/. You can also

go directly to the listings 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. Fax on Demand. You may request

a faxed copy of the PR Notice titled

‘‘First Aid Statements on Pesticide

Product Labels,’’ by using a faxphone to

call (202) 401–0527 and selecting item

6126. You may also follow the

automated menu.

3. In person. The Agency has

established an official record for this

action under docket control number

OPP–00652. 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 OPP–00652 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, 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, Suite 8, or ASCII file

format. All comments in electronic form

must be identified by docket control

number OPP–00652. 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