Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices 5403

behavioral changes were observed in

either F1 or F2 offsprings in the twogeneration reproduction study).

Moreover, as the NOELs for fetal/

developmental toxicity are significantly

higher than those for maternal toxicity,

the results indicate that chlorfenapyr is

neither a developmental toxicant nor a

teratogenic agent in either the SpragueDawley rat or New Zealand white rabbit.

Thus, there is no reliable information to

indicate that there would be a

variability in the sensitivities of infants

and children and adults to the effects of

exposure to chlorfenapyr.

Therefore, a chronic dietary exposure

analysis for the residues of chlorfenapyr

in cotton, meat, and milk, using the

‘‘worst case’’ proposed tolerance-level

residues, demonstrates that these levels

are well below the RfD of 0.03 mg/kg

b.w./day and thus the proposed use of

chlorfenapyr is toxicologically

supported.

F. International Tolerances

Section 408(b)(4) of the amended

FFDCA requires EPA to determine

whether a maximum residue level has

been established for the pesticide

chemical by the Codex Alimentarius

Commission.

There is neither a Codex proposal, nor

Canadian or Mexican tolerances/limits

for residues of chlorfenapyr in/on

cottonseed. Therefore, a compatibility

issue is not relevant to the proposed

tolerance.

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-697]. 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 numbers

[PF-697] (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 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

notice.

List of Subjects

Environmental protection,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping.

Dated: January 24, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–2466 Filed 2–4–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–695; FRL–5584–1]

Ciba-Geigy Corporation; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of Filing.

SUMMARY: This notice announces the

refiling of a pesticide petition proposing

the establishment of a regulation for

residues of [4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole 3

carbonitrile] (fludioxonil) in or on the

raw agricultural commodity (RAC)

potatoes. The notice contains a

summary of the petition prepared by the

petitioner, Ciba-Geigy Corporation.

DATES: Comments, identified by the

docket number [PF–695], 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 Hwy., Arlington, VA

22202.

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–695]. Electronic comments on this

proposed rule may be filed online at

many Federal Depository Libraries.

Additional information on electronic

submissions can be found in unit II of

this document.

Information submitted as comments

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not 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 4:00 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Connie Welch, PM 21, Registration

Division (7505C), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number and e-mail address:

Rm 227, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA 22202.

(703) 305–6226, e-mail:

welch.connie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP

6F4694) from Ciba-Geigy Corporation

(‘‘Ciba’’), 410 Swing Road, Greensboro,

NC 27401, 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 tolerance for residues of

the fungicide, fludioxonil, in or on the

raw agricultural commodity potatoes at

0.02 parts per million (ppm).

The proposed analytical method is

Method AG–597B. The Limit of

Detection is 0.5 ng and the Limit of

Quantitation for potatoes is 0.01 ppm. In

AG–597, a subsample of potato substrate

or processed fraction is homogenized

twice with 90 percent acetonitrile

(ACN)/10 percent water. Both extracts

are filtered through Whatman 2V and

Reeve Angel 802 paper. A 40–mL

aliquot (2–g equivalent) is taken and the
5404 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices

ACN is evaporated using rotary

evaporation. The sample is diluted with

a saturated salt solution and partitioned

twice with methyl tert-butyl ether

(MTBE). Toluene is added to the organic

phase, the MTBE is evaporated and

hexane is added to the sample. Samples

are cleaned up on a 0.5–g silica Bond

Elut column that has been

preconditioned with 10 percent

isopropyl alcohol/90 percent hexane

and rinsed with hexane. The sample is

loaded onto the column and CGA–

173506 is eluted with 50 percent DCM/

50 percent toluene. The silica column

eluate is evaporated to dryness. The

residue remaining is dissolved in

methanol and water and then loaded

onto a preconditioned 0.5–g phenyl

Bond Elut column. Fludioxonil is eluted

with acetone. The acetone solution is

evaporated to dryness, and the residue

is dissolved in an appropriate amount of

mobile phase. Residues of fludioxonil

are determined by using an Amino

column with normal phase HPLC and

ultraviolet absorbance detection at 268

nm.

EPA has determined that the petition

contains data or information regarding

the elements set forth in FFDCA 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.

I. Petition Summary

1. Chemical uses. Fludioxonil is a

non-systemic, contact fungicide that is

being developed as a seed treatment for

potatoes. Fludioxonil provides highlevel, broad-spectrum activity against a

wide range of seed-borne and soil-borne

diseases caused by Ascomycetes,

Deuteromycetes and Basidiomycetes. On

potatoes, fludioxonil provides control of

Fusarium dry rot seed decay,

Rhizoctonia stem canker, and silver

scurf. Fludioxonil represents a new

class of chemistry with a unique mode

of action. Fludioxonil is classified as a

phenylpyrrole and is structurally related

to pyrrolnitrin. Pyrrolnitrin is a

secondary metabolite of a soilinhabiting bacterium of the genus

Pseudomonas. It has significant activity

against economically important soilborne fungi. In European field trials

against foliar pathogens, fludioxonil was

highly effective against pathogens

resistant or insensitive to other chemical

classes such as the benzimidazoles and

dicarboximides.

2. Fludioxonil safety. a. Ciba has

submitted over 25 separate toxicology

studies in support of tolerances for

fludioxonil. According to Ciba,

fludioxonil has a low order of acute

toxicity by the oral, dermal, and

inhalation exposure routes. The

compound is slightly irritating to the

eye, non-irritating to skin, and is not a

dermal sensitizer. It is not a teratogen

and does not affect reproduction or

fertility. The kidney and liver have been

identified as target organs in subchronic

and chronic toxicity studies. No

mutagenic activity has been seen in

vivo. On September 19, 1996, the Health

Effects Division Carcinogenicity Peer

Review Committee issued its finding on

fludioxonil. The consensus of the

committee was that fludioxonil should

be placed in Group D - not classifiable

as to human carcinogenicity.

b. The following mammalian toxicity

studies have been conducted to support

the tolerance of fludioxonil:

i. The rat acute oral LD50 is >5,000

mg/kg.

ii. The rat acute dermal LD50 is >2,000

mg/kg.

iii. The rat acute inhalation LC50 is

>2.6 mg/liter air.

iv. The primary eye irritation study in

the rabbit showed slight irritation.

v. The primary dermal irritation study

showed no irritation.

vi. The primary dermal sensitization

study showed no sensitization.

vii. In a 28–day oral study in rats, the

no-observed-effect level (NOEL) was 10

mg/kg/day.

viii. In a 28–day dermal study in rats,

the NOEL was 40 mg/kg/day.

ix. In a 90–day subchronic dietary

toxicity study in rats, the NOEL was 10

ppm based on liver toxicity.

x. In a 90–day subchronic dietary

toxicity study in mice, the NOEL was

100 ppm based on blue urine (a

metabolite). The maximum tolerated

dose was 7,000 ppm.

xi. In a 90–day oral toxicity study in

dogs, the NOEL was 200 ppm based on

clinical observation. The maximum

tolerated dose was clearly exceeded at

15,000 ppm.

xii. In a 1–year chronic toxicity study

in dogs, the NOEL was 100 ppm based

on body weight effects. The maximum

tolerated dose was 8,000 ppm.

xiii. Two 18–month dietary

oncogenicity studies were performed in

mice. While a NOEL of 1,000 ppm was

clearly established in the first study, its

highest feeding level (3,000 ppm) did

not meet the criteria for a maximum

tolerated dose.

xiv. In the second 18–month study,

the maximum tolerated dose was

determined to be 5,000 ppm. There were

no treatment-related increases in

neoplasia at any dose level tested. In a

combined chronic toxicity/oncogenicity

study in rats, the incidence of liver

tumors in top-dose females (3,000 ppm)

was marginally higher than the controls.

The NOEL for chronic toxicity was

1,000 ppm in both sexes.

xv. In vitro point mutation test: Ames

assay - negative; Chinese hamster V79

cells - negative; hepatocyte DNA repair

- negative.

xvi. In vitro chromosome test: Chinese

hamster ovary cells - clastogenic effects

and polyploidy at or near precipitating

concentration.

xvii. In vivo mutagenicity test: rat

hepatocyte micronucleus - negative;

mouse bone marrow - negative;

cytogenetic test on Chinese hamster

bone marrow - negative; mouse

dominant lethal - negative.

xviii. In a teratology study in rats,

fludioxonil was not teratogenic at doses

up to 1,000 mg/kg. The maternal NOEL

was 100 mg/kg, while the NOEL in the

fetus was 1,000 mg/kg.

xix. In a teratology study in rabbits,

fludioxonil was not teratogenic at doses

up to 300 mg/kg. The maternal and fetal

NOELs were 10 mg/kg and 300 mg/kg,

respectively.

xx. In a multigeneration reproduction

study, fludioxonil had no adverse

effects on the reproductive performance

of the rat at doses up to 3,000 ppm.

Fetal effects (reductions in pup body

weights) were observed only at 3,000

ppm, a dose level at which there were

maternal toxic effects. The NOEL was

300 ppm.

3. Threshold effects— a. chronic

effects. Based on the available chronic

toxicity data, Ciba believes that the

Reference Dose (RfD) for fludioxonil is

0.025 mg/kg/day. This RfD is based on

a 1–year feeding study in dogs with a

NOEL of 2.5 mg/kg/day (100 ppm) and

an uncertainty factor of 100. No

additional modifying factor for the

nature of effects was judged to be

necessary as body weight was the most

sensitive indicator of toxicity in that

study.

b. Acute toxicity. Based on the

available acute toxicity data, EPA has

determined that fludioxonil does not

pose any acute dietary risks. The lowest

NOEL in a short term exposure scenario,

identified as 10 mg/kg in the rabbit

teratology study, is actually higher than

the chronic NOEL (see above). Ciba

anticipates that the margin of exposure

would be in the thousands for any

population group (margins of exposure

of 100 or more are considered

satisfactory).

4. Non-threshold effects. Using the

Guidelines for Carcinogenic Risk

Assessment published on September 24,

1986 (51 FR 33992), the USEPA has

classified fludioxonil in group D for

carcinogenicity. The compound was
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices 5405

tested in two mouse oncogenicity

studies and a 24–month rat chronic

study. Dosage levels in both the mouse

and the rat studies were adequate for

identifying cancer risk.

5. Aggregate exposure. For purposes

of assessing the potential dietary

exposure under the proposed tolerance,

Ciba has estimated aggregate exposure

based on the tolerance level of 0.02 ppm

in or on the RAC potatoes (potato

tubers). This is a worse case estimate of

dietary exposure since it is assumed that

100 percent of all crops for which

tolerances are established are treated

and that pesticide residues are present

at the tolerance levels.

Fludioxonil’s current registered use

for seed treatment on corn and sorghum

seeds does not contribute to dietary

exposure because there are no

detectable residues. EPA has ruled that

these uses are food uses not requiring

tolerances. For potato seed treatment,

the use described in this petition, a

residue tolerance level of 0.02 ppm is

being proposed although the highest

actual level seen in field trials is around

0.01 ppm. In conducting this exposure

assessment, very conservative

assumptions—100 percent of potatoes

will contain fludioxonil residues and

those residues would be at the level of

the tolerance—have been used, resulting

in an overestimate of human exposure.

Exposures of the general population

to residues of this pesticide from other

potential sources, drinking water and

other non-occupational sources, Ciba

considers to be unlikely. The movement

of fludioxonil into groundwater is

highly unlikely. The EPA has not

established a Maximum Contaminant

Level for residues of fludioxonil in

drinking water. Non-occupational

exposure for fludioxonil has not been

calculated since the current registration

for fludioxonil is limited to commercial

crop production. Since the chemical is

not used in or around the home, Ciba

considers the potential for nonoccupational exposure to the general

population to be non-existent.

Consideration of a common

mechanism of toxicity is not appropriate

at this time since Ciba is unaware of any

reliable information that indicates that

toxic effects produced by fludioxonil

would be cumulative with those of any

other chemical compounds.

Consequently, Ciba is considering only

the potential risks of fludioxonil in its

aggregate exposure assessment.

6. Determination of safety for U.S.

population. Using the conservative

exposure assumptions described above

and based on the completeness and

reliability of the toxicity data base for

fludioxonil, Ciba has calculated

aggregate exposure levels for this

chemical. The calculation shows that

only 0.09 percent of the RfD will be

utilized for the U.S. population based

on chronic toxicity endpoints. EPA

generally has no 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 fludioxonil residues.

7. Determination of safety for infants

and children. Developmental toxicity

(decreased pup weight) was observed in

the 2–generation rat reproduction study

at a maternally toxic dose. The NOEL

for this effect was established at 30 mg/

kg (300 ppm). This finding is judged to

be a nonspecific, secondary effect of

maternal toxicity. No developmental

toxicity was observed at all in any of the

teratology studies conducted. Ciba

concludes that infants and children are

not uniquely sensitive to fludioxonil.

Using the same conservative exposure

assumptions used for the determination

in the general population, Ciba has

concluded that the percentage of the

RfD that will be utilized by aggregate

exposure to residues of fludioxonil is

0.03 percent for nursing infants less

than 1 year old, 0.11 percent for nonnursing infants, 0.18 percent for

children 1 to 6 years old, and 0.13

percent for children 7 to 12 years old.

Therefore, based on the completeness

and reliability of the toxicity data base

and the conservative exposure

assessment, Ciba concludes that there is

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to fludioxonil

residues.

8. Estrogenic effects. No specific tests

have been conducted with fludioxonil

to determine whether the pesticide may

have an effect in humans that is similar

to an effect produced by a naturally

occurring estrogen or other endocrine

effects.

9. Chemical residues. The nature of

the residue is adequately understood in

animals and plants. The metabolism of

fludioxonil in plants has been

characterized in potatoes, rice, and

spring wheat. Residues of fludioxonil do

not concentrate in processed

commodities. There are no Codex

maximum residue levels established for

residues of fludioxonil on potatoes. Ciba

has submitted a practical analytical

method for detecting and measuring

levels of fludioxonil in or on food with

the limit of quantitation that allows

monitoring of food with residues at or

above the levels set in the proposed

tolerances. EPA will provide

information on this method to FDA. The

method is available to anyone who is

interested in pesticide residue

enforcement from the Field Operations

Division, Office of Pesticide Programs.

This petition is supported by 23 field

residue tests where fludioxonil, in the

form of Maxim T Potato Seed Protectant,

was applied to potato seed pieces. These

trials indicate that the maximum

residue of fludioxonil will be at or

below 0.011 ppm at the 0.7X rate of

1.75g a.i./100 kg. A tolerance of 0.02

ppm is proposed for raw agricultural

commodities (tubers) of potatoes.

No residues greater than or equal to

0.01 ppm were detected in the tubers

before processing, in peeled and rinsed

potatoes, sliced and peeled potatoes,

potato chips, or potato granules from

field trials conducted in Michigan and

North Dakota.

The results from all four processed

field trials indicate that residues in

potato processing waste (wet peel and

trimmings) and potato culls will not

exceed the tolerance established for

potato tubers.

Based on the results of rotational crop

studies, Ciba proposes a 1–year

restriction on rotation to crops other

than leafy vegetables, root and tuber

vegetables, and registered crops

(potatoes, corn, and sorghum).

Using the worst case theoretical diet

for beef and dairy cattle, no detectable

residues would be expected in tissues or

milk. Processed potato products are not

fed to poultry. Therefore, there is no

need for tolerances in meat, milk or

eggs.

10. Environmental fate. Since the

Agency classifies seed treatment uses as

‘‘Indoor,’’ the only environmental fate

data requirement is hydrolysis.

Fludioxonil is hydrolytically stable in

solution at 25°C at pH 5, 7, or 9. At pH

1 and 13, fludioxonil is extensively

degraded.

II. Public Record

EPA invites interested persons to

submit comments on this notice of

filing. Comments must bear a

notification indicating the docket

number [PF–695].

A record has been established for this

notice under docket numbers [PF–695]

(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
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.