Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices 5399

TABLE 1. — REGISTRATIONS WITH REQUESTS FOR AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE

REGISTRATIONS—Continued

EPA Reg No. Product Name Active Ingredient Delete From Label

042750–00017 Albaugh VISKO-RHAP 2D 2,4-D 2-Ethylhexyl ester Terrestrial uses, aquatic weed control in drainage ditches, ponds, lakes, marshes, aquatic

weeds, aquatic applications

042750–00022 Albaugh SEE 2,4-D 2,4-D 2-Ethylhexyl ester Terrestrial uses, aquatic weed control, sugarcane, drainage ditch banks, aquatic applications

045639–00168 Thiodan Technical Endosulfan Alfalfa (grown for forage), artichokes, field corn,

watercress, barley, oats, rye, wheat, peas

(seed crop only), soybeans, bean cannery residue, sugar beets, safflower, sunflower

The following Table 2 includes the names and addresses of record for all registrants of the products in Table

1, in sequence by EPA company number.

TABLE 2. — REGISTRANTS REQUESTING AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS

Company No. Company Name and Address

000228 Riverdalae Chemical Co., 425 West 194th Street, Glenwood, IL 60425.

000432 AgrEvo Environmental Health, 95 Chestnut Ridge Road, Montvale, NJ 07645.

006458 AgrEvo Environmental Health, 95 Chestnut Ridge Road, Montvale, NJ 07645.

042750 Albaugh Inc., 1517 N. Ankeny Blvd., Suite A, Ankeny, IA 50021.

045639 AgrEvo USA Co., Little Falls Centre One, 2711 Centerville Road, Wilmington, DE 19808.

III. Existing Stocks Provisions

The Agency has authorized registrants

to sell or distribute product under the

previously approved labeling for a

period of 18 months after approval of

the revision, unless other restrictions

have been imposed, as in special review

actions.

List of Subjects

Environmental protection, Pesticides

and pests, Product registrations.

Dated: January 10, 1997.

Oscar Morales,

Acting Director, Program Management

Support Division, Office of Pesticide

Programs.

[FR Doc. 97–2499 Filed 2–4–97; 8:45 am]

BILLING CODE 6560–50–F

[PF-697; FRL–5584–4]

American Cyanamid Company;

Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

regulations establishing tolerances for

residues of 4-bromo-2-(4-chlorophenyl)-

1-(ethoxymethyl)-5-(trifluoromethyl)-1-

pyrrole-3-carbonitrile, (chlorfenapyr) in

or on cottonseed. This notice includes a

summary of the petition that was

prepared by the petitioner, American

Cyanamid Company.

DATES: Comments, identified by the

docket control number [PF-697], 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: Crystal Mall #2, Room

1132, 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 or by

submitting disks. Electronic comments

must be submitted either in ASCII

format (avoiding the use of special

characters and any form of encryption)

or in WordPerfect in 5.1 file format. All

comments and data in electronic form

must be identified by the docket control

number [PF-697]. Electronic comments

on this notice may be filed online at

many Federal Depository Libraries. The

official record for this notice, as well as

the public version 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.

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). The 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 Room 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:

Dennis Edwards (PM 19), 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: Crystal

Mall #2, Room 207, 1921 Jefferson Davis

Highway, Arlington, VA, 703-305-6386,
5400 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices

e-mail:

edwards.dennis@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition from

American Cyanamid Company. The

petition proposes, pursuant to section

408 of the Federal Food, Drug and

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

to amend 40 CFR part 180 to establish

tolerances for the insecticide, 4-bromo2-(4-chlorophenyl)-1(ethoxymethyl)-5-

(trifluoromethyl)-1-pyrrole-3-

carbonitrile, (chlorfenapyr), in or on the

raw agricultural commodity cottonseed.

The proposed analytical method is

capillary gas chromatography using an

electron capture detector.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act (FQPA)

Pub. L. 104-170, American Cyanamid

Company 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

American Cyanamid; EPA is in the

process of evaluating the petition. As

required by section 408(d)(3) of the

FFDCA, EPA is including the summary

as a part of this notice of filing. EPA

may have made minor edits to the

summary for the purpose of clarity.

I. Petition Summary

The American Cyanamid Company

has petitioned EPA, under pesticide

petition number PP–5F4456, for a

permanent tolerance of 0.5 parts per

million (ppm) for the residues of

chlorfenapyr in or on cottonseed. As

cottonseed processed commodities fed

to food animals may be transferred to

milk and edible tissues, tolerances are

also proposed for the following

ruminant food items:

Milk: 0.01 ppm

Milk fat: 0.15 ppm

Meat: 0.01 ppm

Meat by-products (including fat): 0.10

ppm

Section 408(b)(2)(A) of the amended

FFDCA allows EPA to establish a

tolerance if it determines that the

tolerance is ‘‘safe, ’’ i.e., ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposure, and all

other exposures for which there is

reliable information.’’

All of the studies required for the

proposed use pattern have been

completed according to EPA

requirements. American Cyanamid

believes that the available information

indicates there is a reasonable certainty

that no harm will result from various

types of exposure.

The following is a summary of the

information on chlorfenapyr submitted

to the EPA which supports the

establishment, under section

408(b)(2)(D) of the amended FFDCA, of

the proposed tolerances in or on

cottonseed and in food items derived

from ruminants exposed to processed

cottonseed commodities.

A. Residue Chemistry

1. Plant metabolism. American

Cyanamid believes that the nature of the

residues of chlorfenapyr in plants is

adequately understood and that the

residue of concern in cotton consists of

the parent molecule. Expressed on a

whole seed basis, the parent compound

accounted for 59-68% of the total

radioactive residue (TRR).

2. Analytical method. Section

408(b)(3) of the amended FFDCA

requires EPA to determine that there is

a practical method for detecting and

measuring levels of the pesticide

chemical residue in or on food and that

the tolerance be set at a level at or above

the limit of detection of the designated

method. The gas chromatographic (GC)

analytical method, M2216.01, which is

proposed as the enforcement method for

the residues of chlorfenapyr in

cottonseed, has been validated at the

EPA laboratories in Beltsville, MD and

has a limit of detection (LOD) of 0.05

ppm and a limit of quantitation (LOQ)

of 0.5 ppm.

3. Magnitude of residue. Extensive

cotton field trials were conducted over

multiple growing seasons in all major

cotton growing regions of the U.S.

Residues of chlorfenapyr were ≤0.32

ppm and ≤0.31 ppm in/on cottonseed

samples harvested 21 and 28 days,

respectively following the last of 5 foliar

broadcast applications for a total of

approximately 2x the proposed current

maximum seasonal application rate of

1.05 lbs active ingredient/acre/season

(ai/acre/season). These field trial data

are adequate to support the proposed

tolerance of 0.5 ppm in/on cottonseed

harvested 21 days following the last

application. Processing studies have

also demonstrated that there is no

concentration of chlorfenapyr residues

apparent in crude or refined oils or in

the meal and hull and no tolerances are

needed for these commodities.

B. Toxicological Profile

American Cyanamid has conducted a

full battery of acute and chronic

toxicology studies to characterize any

potential toxic effects of chlorfenapyr.

The data base is complete, valid, and

reliable and all meet EPA requirements.

The following are important

conclusions from these studies:

1. Acute toxicity. Based on the EPA’s

toxicity category criteria, the acute

toxicity category for chlorfenapyr

technical and the 3SC formulation is

Category II or moderately toxic (signal

word WARNING) and the acute toxicity

category for the 2SC formulation is

Category III or slightly toxic (signal

word CAUTION). Males appear to be

more sensitive to the effects of

chlorfenapyr than females. The acute

toxicity profile indicates that absorption

by the oral route appears to be greater

than by the dermal route. The following

are the results from the acute toxicity

tests conducted on the technical

material:

Rat oral LD50 ..................................................... 441/1152 milligram/kilogram of body weight

(mg/kg b.w.)(M/F).

Tox. Category II

Rabbit dermal LD50 ........................................... >2000 mg/kg b.w.(M/F) .................................... Tox. Category III

Acute inhaltion LC50 .......................................... 0.83/>2.7 mg/L (M/F) ........................................ Tox. Category III

Eye irritation ...................................................... Moderately irritating .......................................... Tox. Category III

Dermal irritation ................................................. Non-irritating ..................................................... Tox. Category IV

Dermal sensitization .......................................... Non-sensitizer ................................................... Non-sensitizer

Acute neurotoxicity ............................................ NOEL 45 mg/kg b.w. ........................................ Not an acute neurotoxicant

2. Genotoxicity. Chlorfenapyr

technical (94.5% active ingredient (ai))

was examined in a battery of in vitro

and in vivo tests to assess its

genotoxicity and its potential for

carcinogenicity.
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices 5401

These tests are summarized below:

Microbial/Microsome Mutagenicity Assay ....................................................................................... Non-mutagenic

Mammalian Cell CHO/HGPRT Mutagenicity Assay ....................................................................... Non-mutagenic

In Vivo Micronucleus Assay ............................................................................................................ Non-genotoxic

In Vitro Chromosome Aberration Assay in CHO ............................................................................ Non-clastogenic

In Vitro Chromosome Aberration Assay in CHLC .......................................................................... Non-clastogenic

Unscheduled DNA Synthesis (UDS) Assay .................................................................................... Non-genotoxic

3. Reproductive and developmental

toxicity. Chlorfenapyr is neither a

reproductive or developmental toxicant

and is not a teratogenic agent in the

Sprague-Dawley rat or the New Zealand

white rabbit. This is demonstrated by

the results of the following studies:

Rat oral teratology .............................................. NOEL for maternal toxicity 25 mg/kg b.w./day

NOEL for fetal/developmental toxicity 225 mg/kgb.w./day

Rabbit oral teratology ......................................... NOEL for maternal toxicity 5 mg/kg b.w./day

NOEL for fetal/developmental toxicity 30 mg/kg b.w./day

Rat two-generation reproduction ........................ NOEL for parental toxicity/growth and offspring development 60 ppm (5mg/kg b.w./day)

NOEL for reproductive performance 600 ppm (44 mg/kg b.w./day)

4. Subchronic toxicity. The following

are the results of the subchronic toxicity

tests that have been conducted with

chlorfenapyr:

28-Day rabbit dermal .......................................... NOEL 100 mg/kg b.w./day

28-Day rat feeding .............................................. NOEL <600 ppm (<71.6 mg/kg b.w./day)

28-Day mouse feeding ....................................... NOEL <160 ppm (<32 mg/kg b.w./day)

13-Week rat dietary ............................................ No observed adverse effects level (NOAEL) 150 ppm (11.7 mg/kg b.w./day)

13-Week mouse dietary ...................................... NOEL 40 ppm (8.2 mg/kg b.w./day)

13-Week dog dietary .......................................... NOAEL 120 ppm (4.2 mg/kg b.w./day)

5. Chronic toxicity. Chlorfenapyr is

not oncogenic in either Sprague-Dawley

rats or CD-1 mice and is not likely to be

carcinogenic in humans. The following

are the results of the chronic toxicity

tests that have been conducted with

chlorfenapyr:

1-Year neurotoxicity in rats ................................. NOEL 60 ppm (2.6/3.4 mg/kg b.w./day M/F)

1-Year dog dietary .............................................. NOEL 120 ppm (4.0/4.5 mg/kg b.w./day M/F)

24-Month rat dietary ........................................... NOEL for chronic effects 60 ppm (2.9/3.6 mg/kg b.w./day M/F)

NOEL for oncogenic effects 600 ppm (31/37 mg/kg b.w./day M/F)

18-Month mouse dietary ..................................... NOEL for chronic effects 20 ppm (2.8/3.7 mg/kg b.w./day M/F)

NOEL for oncogenic effects 240 ppm (34.5/44.5 mg/kg b.w./day M/F)

6. Endocrine effects. Collective organ

weights and histopathological findings

from the two-generation rat

reproduction study, as well as from the

subchronic and chronic toxicity studies

in two or more animal species,

demonstrate no apparent estrogenic

effects or effects on the endocrine

system. There is no information

available which suggests that

chlorfenapyr would be associated with

endocrine effects.

7. Animal metabolism. A metabolism

study was conducted in SpragueDawley rats at approximately 20 and

200 mg/kg b.w. using radiolabeled

chlorfenapyr. Approximately 65% of the

administered dose was eliminated

during the first 24 hours (62% in feces

and 3% in urine) and by 48 hours

following dosing, approximately 85% of

the dose had been excreted (80% in

feces and 5% in urine). The absorbed

chlorfenapyr-related residues were

distributed throughout the body and

detected in tissues and organs of all

treatment groups. The principal route of

elimination was via feces, mainly as

unchanged parent plus minor Ndealkylated, debrominated, and

hydroxylated oxidation products.

The metabolic pathway of

chlorfenapyr in the laying hen and the

lactating goat was also similar to that in

laboratory rats.

8. Metabolite toxicology. The parent

molecule is the only moiety of

toxicological significance which needs
5402 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices

regulation in plant and animal

commodities.

C. Aggregate Exposure

1. Dietary exposure—i. Food. The

potential dietary exposure has been

calculated from the tolerance of

chlorfenapyr in/on cottonseed at 0.5

ppm. This exposure assessment is based

on very conservative assumptions,

namely 100% of all cotton is treated

with chlorfenapyr and that the residues

of chlorfenapyr in cottonseed are at the

tolerance level. As there are no other

established U.S. permanent tolerances

for chlorfenapyr, the only dietary

exposure to residues of chlorfenapyr in

or on food will be limited to residues in

cottonseed meal and food and feed

items derived from cottonseed. As

cottonseed meal is a dairy and beef

cattle feed item, a cold feeding study

with dairy cattle was conducted. Since

this study demonstrated that measurable

residues of chlorfenapyr may occur in

milk, meat, and meat by products,

appropriate residue tolerances for these

items are proposed. The contribution of

all these tolerances to the daily

consumption uses less than 1% (actual

0.62%) of the reference dose (RfD) for

the overall U.S. population and less

than 2% (actual 1.8%) and less than 1%

(actual 0.81%) of the RfDs for children

aged 1-6 and for non-nursing infants,

respectively.

ii. Drinking water. There is no

available information about

chlorfenapyr exposures via levels in

drinking water. There is no concern for

exposure to residues of chlorfenapyr in

drinking water because of its extremely

low-water solubility (120 parts per

billion (ppb) at 25° C). Chlorfenapyr is

also immobile in soil and does not leach

because it is strongly absorbed in all

common soil types. In addition, the

label explicitly prohibits applications

near aquatic areas. American Cyanamid

believes that there is a reasonable

certainty that no harm will result from

dietary exposure to chlorfenapyr,

because dietary exposure to residues on

food will use only a small fraction of the

RfD (including exposure of sensitive

subpopulations), and exposure through

drinking water is expected to be

insignificant.

2. Non-dietary exposure. There is no

available information quantifying nondietary exposure to chlorfenapyr.

However, based on the physicochemical characteristics of the

compound, the proposed use pattern

and available information concerning its

environmental fate, non-dietary

exposure is expected to be negligible.

The vapor pressure of chlorfenapyr is

less than 1 x 10-7millimeters (mm) of

mercury (Hg); therefore, the potential for

non-occupational exposure by

inhalation is insignificant. Moreover,

the current proposed registration is for

outdoor, terrestrial uses which severely

limit the potential for non-occupational

exposure.

D. Cumulative Effects

The pyrrole insecticides represent a

new class of chemistry with a unique

mechanism of action. The parent

molecule, AC303,630 is a proinsecticide which is converted to the

active form, CL303,268, via rapid

metabolism by mixed function oxidases

(MFOs). The active form uncouples

oxidative phosphorylation in the insect

mitochondria by disrupting the proton

gradient across the mitochondrial

membrane. The production of adenosine

triphosphate (ATP) is inhibited

resulting in the cessation of all cellular

functions. Because of this unique

mechanism of action, American

Cyanamid believes that it is highly

unlikely that toxic effects produced by

chlorfenapyr would be cumulative with

those of any other pesticide chemical.

In mammals, there is a lower titer of

MFOs, and chlorfenapyr is metabolized

by different pathways (including

dehalogenation, oxidation, and ring

hydroxylation) to other polar

metabolites without any significant

accumulation of the potent uncoupler,

CL303,268. In the rat, approximately

85% of the administered dose is

excreted in the feces within 48 hours,

thereby reducing the levels of

AC303,630 and CL303,268 that are

capable of reaching the mitochondria.

This differential metabolism of

AC303,630 to CL303,268 in insects,

versus to other polar metabolites in

mammals, is responsible for the

selective insect toxicity of the pyrroles.

E. Safety Determination

1. U. S. population. The RfD of 0.03

mg/kg b.w./day for the residues of

chlorfenapyr in cotton is calculated by

applying a 100-fold safety factor to the

overall no observed effect level (NOEL)

of 3 mg/kg b.w./day. This NOEL is

based on the results of the chronic

feeding studies in the rat and mouse and

the two-generation reproduction study

in the rat (see Unit I.E.2. of this

document). Therefore, the combined

exposure for the proposed chlorfenapyr

tolerances in cottonseed, milk, and meat

(0.0001866 mg/kg b.w./day) will utilize

approximately 0.62% of the RfD for the

general U.S. population.

2. Infants and children. The

theoretical maximum residue

contribution (TMRC) in milk consumed

by a non-nursing infant (<1 year of age)

is 0.0002435 mg/kg b.w./day. This will

use less than 1% (actual 0.81%) of the

RfD for non-nursing infants. The TMRC

in milk consumed by a child (1-6 years

of age) is 0.0003886 mg/kg b.w./day.

The combined TMRC for the proposed

chlorfenapyr tolerances in meat and

milk consumed by a child 1-6 years of

age is 0.0005415 mg/kg b.w./day, which

is less than 2% (actual 1.8%) of the RfD.

Therefore, American Cyanamid believes

that the results of the toxicology and

metabolism studies support both the

safety of chlorfenapyr to humans based

on the intended use as an insecticidemiticide on cotton and the granting of

the requested tolerances in cottonseed,

milk, milk fat solids, meat, and meat byproducts.

Based on the conservative

assumptions used in proposing the

above tolerances and the absence of

other non-dietary routes of exposure to

chlorfenapyr, and since the calculated

exposures are well below 100% of the

RfD, American Cyanamid believes that

there is a reasonable certainty that no

harm will result from aggregate

exposure to residues of chlorfenapyr,

including all anticipated dietary

exposure and all other non-occupational

exposures. American Cyanamid believes

that the use of a 100-fold safety factor

ensures an acceptable margin of safety

for both the overall U. S. population as

well as infants and children. American

Cyanamid concludes that the toxicology

data base (reproduction/developmental

and teratology studies) is complete,

valid, and reliable, and therefore no

additional safety factor is needed.

The 100-fold margin of safety is

adequate to assure a reasonable

certainty of no harm to infants and

children from the proposed use. As

stated earlier, the NOEL is based on the

effects observed in the rat and mouse

chronic oncogenicity studies, (reduced

body weight gains, increased globulin

and cholesterol values, and increased

liver weights in the rat and reduced

body weight gains and vacuolation of

white matter of the mouse brain), the 1-

year neurotoxicity study in the rat,

(reduced body weight gains and

vacuolar myelinopathy of the brain and

spinal cord that is completely reversible

following termination of treatment and

is not associated with any damage to

neuronal cell bodies or axons;

vacuolation of the white matter is a

consequence of edema (water) formation

between the myelin layers which result

from the unrestricted movement of ions

across the cell membranes) and the twogeneration rat reproduction study,

(reduced body weight gains for parental

animals and reduced pup body weights

for the F1 and F2 litters; however no
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