5406 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as ASCII file avoiding the use

of special characters and any form of

encryption.

The official record for this notice, as

well as the public version, as described

above will be kept in paper form.

Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

ADDRESSES at the beginning of this

document.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 22, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–2711 Filed 2–4–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–696; FRL–5584–2]

Ciba-Geigy Corporation; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

the establishment of a regulation for

residues of cyprodinil in or on members

of the stone fruit crop grouping under

an experimental use permit (EUP). This

notice contains a summary prepared by

the petitioner, Ciba-Geigy Corporation.

DATES: Comments, identified by the

docket number [PF–696], must be

received on or before March 7, 1997.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to: Rm. 1132 CM #2, 1921

Jefferson Davis Highway, Arlington, VA.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[PF–696]. Electronic comments on this

notice may be filed online at many

Federal Depository Libraries. Additional

information on electronic submissions

can be found below in this document.

Information submitted as comments

concerning this notice may be claimed

confidential by marking any part or all

of that information as ‘‘Confidential

Business Information’’ (CBI). No CBI

should be submitted through e-mail.

Information marked as CBI will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the comment that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail, Connie Welch, Product Manager

(PM) 21, Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: Rm. 227, CM #2, 1921

Jefferson Davis Highway, Arlington, VA,

(703) 305–6226; e-mail:

welch.connie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP)

5G4553 from Ciba Crop Protection,

Ciba-Geigy Corporation (‘‘Ciba’’), P.O.

Box 18300, Greensboro, NC 27419,

proposing pursuant to section 408(d) of

the Federal Food, Drug and Cosmetic

Act (FFDCA), 21 U.S.C 346a, to amend

40 CFR part 180 by establishing a

temporary tolerance for residues of the

fungicide cyprodinil (4-cyclopropyl-6-

methyl-N-phenyl-2-pyrimidinamine) in

or on the agricultural commodities for

the stone fruit crop grouping at 2.0 ppm.

The proposed analytical method is by

high performance liquid

chromatography with UV detection.

EPA has determined that the 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.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act (Pub. L.

104-170), Ciba included in the petition

a summary of the petition and

authorization for the summary to be

published in the Federal Register in a

notice of receipt of the petition. The

summary represents the views of Ciba;

EPA is in the process of evaluating the

petition. As required by section

408(d)(3), EPA is including the

summary as a part of this notice of

filing. EPA has made minor edits to the

summary for the purpose of clarity.

I. Petition Summary

A. Cyprodinil Uses

Cyprodinil is the first fungicide in a

new chemical class known as the

anilinopyrimidine and is active against

important Monilinia diseases of stone

fruit when applied at rates of 0.25 to 0.5

lb active ingredient per acre. Cyprodinil

has a unique mode of action which

controls pathogens resistant to other

chemical classes of fungicides.

B. Metabolism and Analytical Method

1. Metabolism. Ciba believes the

metabolism of cyprodinil has been well

characterized in plants and animals.

The metabolism profile supports the use

of an analytical enforcement method

that accounts for parent cyprodinil.

2. Analytical methodology. Ciba has

submitted a practical analytical method

involving extraction, filtration, and

solid phase cleanup of samples with

analysis by HPLC and UV. The limits of

quantitation (LOQ) for fruit is 0.02 ppm.

C. Magnitude of Residue

This petition is supported by field

residue trials conducted on

representative members of the Stone

Fruit Crop Grouping. All samples were

analyzed for parent residues of

cyprodinil. In stone fruit, maximum

residues ranged from 0.82 ppm to 1.7

ppm. A temporary tolerance of 2.0 ppm

has been proposed for the Stone Fruit

Crop Grouping under this EUP. Since

stone fruit commodities are not fed to

animals, potential transfer of cyprodinil

into milk and meat is not anticipated

and tolerances in milk, meat, poultry,

and eggs are not required.
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices 5407

D. International Tolerances

There are no Codex Alimentarius

Commission (CODEX) maximum

residue levels (MRLs) established for

residues of cyprodinil in or on raw

agricultural commodities.

E. Toxicological Profile of Cyprodinil

The following mammilian toxicity

studies have been conducted to support

the tolerances of cyprodinil:

A rat acute oral study for cyprodinil

with a LD50 of 2,796 mg/kg. A rat acute

dermal study for cyprodinil with a LD50

>2,000 mg/kg.

A rat inhalation study for cyprodinil

with a LC50 >1.2 mg/liter air.

A primary eye irritation study in

rabbits showing cyprodinil as minimally

irritating.

A primary dermal irritation study in

rabbits showing cyprodinil as slightly

irritating.

A skin sensitization study in guinea

pigs showing cyprodinil as a weak

sensitizer.

A 28–day dermal study in the rat with

a No-Observed Effect Level (NOEL) of 5

mg/kg based on clinical signs.

A 90–day feeding study in the dog

with a NOEL of 1,500 ppm (37.5 mg/kg)

based on reduced food intake and body

weight.

A 90–day feeding study in the mouse

with a NOEL of 500 ppm (75 mg/kg)

based on liver histologic changes.

A 90–day feeding study in the rat

with a NOEL of 50 ppm (5 mg/kg) based

on hematologic and histologic findings.

A 12–month feeding study in the dog

with a NOEL of 2,500 ppm (62.5 mg/kg)

based on liver histologic changes.

An 18–month oncogenicity feeding

study in the mouse with a NOEL of

2,000 ppm (300 mg/kg). The MTD was

5,000 ppm based on reduction in body

weight gain and no evidence of

oncogenicity was seen.

A 24–month chronic feeding/

oncogenicity study in the rat with a

NOEL of 75 ppm (3.75 mg/kg) based on

hematologic and histologic findings.

The MTD was 2,000 ppm based on liver

histopathology and no evidence of

oncogenicity was seen. An oral

teratology study in the rat with a

maternal NOEL of 200 mg/kg based on

reductions in body weight gain and food

consumption and a fetal NOEL of 200

mg/kg based on decreased pup weight

and delayed skeletal growth at 1,000

mg/kg. An oral teratology study in the

rabbit with a maternal NOEL of 150 mg/

kg based on reduction in body weight

gain and a fetal NOEL of 400 mg/kg

based on the absence of any fetal effects.

A 2–generation reproduction study in

the rat with a systemic NOEL of 100

ppm and a fetal NOEL of 1,000 ppm

(100 mg/kg).

A slight decrease in pup weight at

birth and subsequent body weight gain

during the lactation phase was observed

only at the maternally toxic dose of

4,000 ppm without any effects on

reproduction and fertility.

In vitro gene mutation test: Ames

assay - negative; Chinese hamster V79

cell test - negative; rat hepatocyte DNA

repair test - negative.

In vitro chromosome test: Chinese

hamster ovary cell cytogenetic test -

negative. In vivo mutagenicity test:

mouse bone marrow test - negative.

F. Threshold Effects

1. Chronic effects. Based on the

available chronic toxicity data, Ciba

believes the Reference Dose (RfD) for

cyprodinil is 0.0375 mg/kg/day. This

RfD is based on a 2–year feeding study

in rats with a NOEL of 3.75 mg/kg/day

(75 ppm) and an uncertainty factor of

100. No additional modifying factor for

the nature of effects was judged to be

necessary as liver sinusoidal dilatation

was the most sensitive indicator of

toxicity in that study.

2. Acute toxicity. The risk from acute

dietary exposure to cyprodinil is

considered to be very low. The lowest

NOEL in a short-term exposure scenario,

identified as 150 mg/kg in the rabbit

teratology study, is 40–fold higher than

the chronic NOEL. Since chronic

exposure assessment did not result in

any margin of exposure (MOE) less than

400 for even the most impacted

population subgroup, Ciba believes the

MOE is greater than 100 for any

population subgroups; EPA considers

margins of exposure of 100 or more as

satisfactory.

G. Non-threshold Effects

Using the Guidelines for Carcinogenic

Risk Assessment published September

24, 1986 (51 FR 33992), Ciba believes

cyprodinil to be in Group ‘‘E’’( no

evidence of carcinogenicity). There was

no evidence of carcinogenicity in an 18–

month feed study in mice and a 24–

month feeding in rats. Dosage levels in

both the mouse and the rat studies were

adequate for identifying a cancer risk.

H. Aggregate Exposure

1. Dietary exposure. For the purposes

of assessing the potential dietary

exposure under the proposed temporary

tolerance, Ciba has estimated aggregate

exposure based upon the Theoretical

Maximum Residue Concentration

(TMRC) from the requested tolerance for

members of the Stone Fruit Crop

Grouping at 2.0 ppm. The TMRC is a

‘‘worst case’’ estimate of dietary

exposure since it assumes 100 percent

of all crops for which tolerances are

established are treated and that

pesticide residues are at the tolerance

levels. In conducting this exposure

assessment, Ciba has made very

conservative assumptions — 100

percent of all stone fruit commodities

will contain cyprodinil residues at

tolerance levels — which result in an

overestimate of human exposure. Ciba

has also calculated aggregate exposure

based upon the scale of the requested

950–acre EUP. It is estimated that a

maximum of 0.25 percent of the stone

fruit market would receive applications

of cyprodinil under this EUP and that

dietary exposure would be

proportionately less than under the

‘‘worst case’’ assumptions given above.

2. Drinking water exposure.

Cyprodinil is rapidly degraded in the

environment via photolysis and

microbial degradation; aqueous and soil

photolysis half lives for cyprodinil are

12 days and 67 days, respectively. The

aerobic metabolism half life is 25 days

and the leaching potential for cyprodinil

is low (Koc = 1,550 to 2,030). Based on

these data, Ciba does not anticipate

exposure to residue of cyprodinil in

drinking water.

3. Non-dietary exposure. Ciba believes

that the potential for non-occupational

exposure to the general public is

unlikely except for potential residues in

food crops discussed above. The

proposed uses for cyprodinil are for

agricultural crops and the product is not

used residentially in or around the

home.

Ciba believes that consideration of a

common mechanism of toxicity is not

appropriate at this time since there is no

information to indicate that toxic effects

produced by cyprodinil would be

cumulative with those of any other

chemicals. Consequently, Ciba is

considering only the potential exposure

to cyprodinil in its aggregate risk

assessment.

I. Safety To the U.S. Population

Reference dose. Using the

conservative exposure assumptions

described above (100 percent stone fruit

acres treated and tolerance level

residues) and based on the

completeness and reliability of the

toxicity data base for cyprodinil, Ciba

has calculated aggregate exposure levels

for this chemical. Based on chronic

toxicity endpoints, only 2 percent of the

RfD will be utilized for the U.S. general

population. Under the scale of this EUP

(0.25 percent stone fruit acres treated) it

is estimated that only 0.005 percent of

the RfD will be utilized for the U.S.

general population. EPA usually has no
5408 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices

concern for exposures below 100

percent of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Ciba concludes that

there is a reasonable certainty that no

harm will result from aggregate

exposure to cyprodinil residues.

J. Safety to Infants and Children

Developmental delays (reduced pup

weight and ossification) were observed

in the rat teratology study and 2–

generation rat reproduction study at

maternally toxic doses. The lowest

NOEL for this effect was established in

the 2–generation study at 100 mg/kg

(1,000 ppm). The finding is judged to be

a nonspecific, secondary effect of

maternal toxicity. No developmental

toxicity was observed in the rabbit

teratology study.

Reference dose. Using the same

conservative exposure assumptions as

employed for the determination in the

general population (100 percent stone

fruit acres treated and tolerance level

residues), Ciba has calculated the

utilization of RfD by aggregate exposure

to residues of cyprodinil to be 9 percent

for nursing infants less than 1 year old,

17 percent for non-nursing infants less

than 1 year old, 4 percent for children

1 to 6 years old, and 3 percent for

children 7 to 12 years old. Under the

scale of this EUP (0.25 percent stone

fruit acre treated) the utilization of RfD

by aggregate exposure to residues of

cyprodinil is estimated to be 0.023

percent for nursing infants less than 1

year old, 0.043 percent for non-nursing

infants less than 1 year old, 0.011

percent for children 1 to 6 years old,

and 0.007 percent for children 7 to 12

years old. Ciba believes that under the

worst case assumptions which

overestimate exposure to infants and

children, there is a reasonable certainty

that no harm will result to infants and

children from aggregate exposure to

cyprodinil residues. Under the scale of

this EUP resultant exposure will be

proportionately less.

K. Estrogenic Effects

Cyprodinil does not belong to a class

of chemicals known or suspected of

having adverse effects on the endocrine

system. Developmental toxicity studies

in rats and rabbits and a reproduction

study in rats gave no indication that

cyprodinil might have any effects on

endocrine function related to

development and reproduction. The

chronic studies also showed no

evidence of a long-term effect related to

the endocrine system.

II. Public Record

EPA invites interested persons to

submit comments on this notice of

filing. Comments must bear a

notification indicating the docket

control number [PF–696]. All written

comments filed in response to this

petition will be available, in the Public

Response and Program Resources

Branch, at the address given above from

8:30 a.m. to 4 p.m., Monday through

Friday, except legal holidays.

A record has been established for this

notice under docket control number

[PF–696] (including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this notice of

filing, as well as the public version, as

described above will be kept in paper

form. Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

ADDRESSES at the beginning of this

document.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 22, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–2468 Filed 1–4–97; 8:45 am]

BILLING CODE 6560–50–F

[OPP–181031; FRL 5584–3]

Azoxystrobin; Receipt of Application

for Emergency Exemption, Solicitation

of Public Comment

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has received a specific

exemption request from the Louisiana

Department of Agriculture and Forestry

(hereafter referred to as the

‘‘Applicant’’) to use the pesticide

azoxystrobin (CAS 131860–33–8) to

treat up to 85,000 acres of rice to control

benomyl-resistant rice panicle blast and

sheath blight. The Applicant proposes

the use of a new chemical; therefore, in

accordance with 40 CFR 166.24, EPA is

soliciting public comment before

making the decision whether or not to

grant the exemption.

DATES: Comments must be received on

or before February 20, 1997.

ADDRESSES: Three copies of written

comments, bearing the identification

notation ‘‘OPP–181031,’’ should be

submitted by mail to: Public Response

and Program Resource Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to: Rm. 1132, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[OPP–181031]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

Information submitted in any

comment concerning this notice may be

claimed confidential 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.

A copy of the comment that does not

contain CBI must be provided by the

submitter for inclusion in the public

record. Information not marked