20808 Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices

TABLE 2. — REGISTRANTS REQUESTING VOLUNTARY CANCELLATION

EPA Company

No. Company Name and Address

000100 Syngenta Crop Protection, Inc., Box 18300, Greensboro, NC 27419.

000352 E. I. Du Pont De Nemours & Company, Inc., Barley Mill Plaza, Walker’s Mill, Wilmington, DE 19880.

000400 Uniroyal Chemical Co, Inc., A Subsidiary of Crompton Corp., 74 Amity Rd, Bethany, CT 06524.

000524 Monsanto Co., 600 13th Street, NW., Suite 660, Washington, DC 20005.

000707 Rohm & Haas Co., Attn: Robert H. Larkin, 100 Independence Mall W., Philadelphia, PA 19106.

000769 Verdant Brands, Inc., Agent For: Verdant Brands, Inc., 213 S.W. Columbia St., Bend, OR 97702.

001381 Agriliance, LLC, Box 64089, St. Paul, MN 55164.

001448 Buckman Laboratories Inc., 1256 North Mclean Blvd, Memphis, TN 38108.

001706 Nalco Chemical Co., One Nalco Center, Naperville,, IL 60563.

001812 Griffin L.L.C., Box 1847, Valdosta, GA 31603.

003125 Bayer Corp., Agriculture Division, 8400 Hawthorn Rd., Box 4913, Kansas City, MO 64120.

004822 S.C. Johnson & Son Inc., 1525 Howe Street, Racine, WI 53403.

005887 Verdant Brands, Inc., Agent For: Verdant Brands, Inc., 213 S.W. Columbia St., Bend, OR 97702.

007501 Gustafson LLC, 1400 Preston Rd., Suite 400, Planos, TX 75093.

032802 Howard Johnson’s Enterprises Inc., 700 W. Virginia St., Ste 222, Milwaukee, WI 53204.

034704 Jane Cogswell, Agent For: Platte Chemical Co, Inc., Box 667, Greeley, CO 80632.

050534 GB Biosciences Corp., c/o Zeneca Ag Products, 1800 Concord Pike, Box 15458, Wilmington, DE 19850.

051036 Micro-Flo Co, Box 772099, Memphis, TN 38117.

059639 Valent U.S.A Corp., 1333 N. California Blvd, Ste 600, Walnut Creek, CA 94596.

065361 Glad-A-Way Gardens Inc., 2669 E. Clark Ave., Santa Maria, CA 93455.

067760 Cheminova Inc., Oak Hill Park, 1700 Route 23 - Ste 210, Wayne, NJ 07470.

III. What is the Agency’s Authority for

Taking this Action?

Section 6(f)(1) of FIFRA provides that

a registrant of a pesticide product may

at any time request that any of its

pesticide registrations be amended to

delete one or more uses. The Act further

provides that, before acting on the

request, EPA must publish a notice of

receipt of any such request in the

Federal Register. Thereafter, the

Administrator may approve such a

request.

IV. Procedures for Withdrawal of

Request

Registrants who choose to withdraw a

request for cancellation must submit

such withdrawal in writing to James A.

Hollins, at the address given above,

postmarked before October 22, 2001,

unless indicated otherwise. This written

withdrawal of the request for

cancellation will apply only to the

applicable 6(f)(1) request listed in this

notice. If the product(s) have been

subject to a previous cancellation

action, the effective date of cancellation

and all other provisions of any earlier

cancellation action are controlling. The

withdrawal request must also include a

commitment to pay any reregistration

fees due, and to fulfill any applicable

unsatisfied data requirements.

V. Provisions for Disposition of Existing

Stocks

The effective date of cancellation will

be the date of the cancellation order.

The orders effecting these requested

cancellations will generally permit a

registrant to sell or distribute existing

stocks for 1–year after the date the

cancellation request was received by the

Agency. This policy is in accordance

with the Agency’s statement of policy as

prescribed in Federal Register of June

26, 1991 (56 FR 29362) (FRL 3846–4).

Exception to this general rule will be

made if a product poses a risk concern,

or is in noncompliance with

reregistration requirements, or is subject

to a data call-in. In all cases, productspecific disposition dates will be given

in the cancellation orders.

Existing stocks are those stocks of

registered pesticide products which are

currently in the United States and

which have been packaged, labeled, and

released for shipment prior to the

effective date of the cancellation action.

Unless the provisions of an earlier order

apply, existing stocks already in the

hands of dealers or users can be

distributed, sold or used legally until

they are exhausted, provided that such

further sale and use comply with the

EPA-approved label and labeling of the

affected product(s). Exceptions to these

general rules will be made in specific

cases when more stringent restrictions

on sale, distribution, or use of the

products or their ingredients have

already been imposed, as in Special

Review actions, or where the Agency

has identified significant potential risk

concerns associated with a particular

chemical.

List of Subjects

Environmental protection,

Agricultural commodities, Pesticides

and pests.

Dated: April 3, 2001.

Richard D. Schmitt,

Associate Director, Information Resources

and Services Division, Office of Pesticide

Programs.

[FR Doc. 01–10124 Filed 4–24–01; 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1009; FRL–6774–7]

Notice of Filing a Pesticide Petition to

Establish a Tolerance fora Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1009, must be

received on or before May 25, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

PF–1009 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne Miller, Registration

Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices 20809

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6224; e-mail address:

miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer or pesticide manufacturer.

Potentially affected categories and

entities may include, but are not limited

to:

Categories NAICS

codes

Examples of potentially affected

entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

1009. 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 PF–1009 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, 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 PF–1009. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a. EPA has determined that

this petition contains data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

20810 Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices

of the submitted data at this time or

whether the data support granting of the

petition. Additional data may be needed

before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

April 9, 2001.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide is printed below as required

by section 408(d)(3) of the FFDCA. The

summary of the petition was prepared

by the petitioner and represents the

view of the petitioner. EPA is

publishing the petition summary

verbatim without editing it in any way.

The petition summary announces the

availability of a description of the

analytical methods available to EPA for

the detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

Dow AgroSciences LLC

PP 0F6089

EPA has received a pesticide petition

(0F6089) from Dow AgroSciences LLC,

9330 Zionsville Road, Indianapolis, IN

46268 proposing, pursuant to section

408(d) of the Federal Food, Drug, and

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

346a(d), to amend 40 CFR part 180 by

establishing a tolerance for residues of

cyhalofop-butyl in or on the raw

agricultural commodity rice grain, rice

hull, rice bran, and polished rice at 0.03

parts per million (ppm) for grain and 8.0

ppm for straw. EPA has determined that

the petition contains data or information

regarding the elements set forth in

section 408(d)(2) of the FFDCA;

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.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of cyhalofop-butyl in plants (rice) is

adequately understood for the purposes

of this tolerance. A rotational crop study

showed no carryover of significant

cyhalofop-butyl related residues in

representative test crops.

2. Analytical method. An analytical

method has been developed and

validated to determine the residues of

total cyhalofop and the diacid

metabolite in rice grain, straw and

processed products. The method was

based on capillary gas chromatography

with mass selective detection (GC/MSD)

indicating limits of detection (LOD) and

quantitation (LOQ) for each analyte at

0.005–0.006 μg/g and 0.01–0.02 μg/g,

respectively.

3. Magnitude of residues. Metabolism

studies in livestock at exaggerated doses

of cyhalofop-butyl (nominal

concentration equivalent to 10 ppm in

the diet) indicated that about 87–90% of

the administered dose was eliminated in

the excreta. The low levels of residues

(0.001–0.08 ppm) in fat and edible

tissues, milk or eggs demonstrate that

residues due to cyhalofop-butyl would

not accumulate in the animals.

B. Toxicological Profile

1. Acute toxicity. The acute toxicity of

cyhalofop-butyl is low. The oral and

dermal LD50s were greater than 5,000

milligram/kilogram (mg/kg), and the

inhalation LC50 was greater than 5 mg/

L. In addition, cyhalofop-butyl induced

only minimal ocular and dermal

irritation, and did not cause dermal

sensitization.

2. Neurotoxicity. Cyhalofop-butyl has

been shown to have no neurotoxicologic

potential based on acute and subchronic

studies.

3. Genotoxicty. Genetic toxicity did

not occur when cyhalofop-butyl was

tested in multiple in vivo and in vitro

tests.

4. Reproductive and developmental

toxicity. Cyhalofop-butyl did not have

any effects on reproductive parameters

at dose levels that induced treatmentrelated effects in parental rats. In

addition, a teratogenic potential for

cyhalofop-butyl was not demonstrated

in either rats or rabbits at dose levels

that induced maternal toxicity.

5. Subchronic and chronic toxicity,

and oncogenicity. Cyhalofop-butyl

caused increases in liver and kidney

weights, microscopic hepatocellular

hypertrophy, renal tubular microscopic

effects, and distended gallbladders

when given at sufficiently high dose

levels to the appropriate species for 13

weeks. Similar increases in liver and

kidney weights, hepatocellular

hypertrophy, and renal effects were also

observed in chronic toxicity studies in

rodents. In addition, mice had liver

inflammation (microgranulomas).

Chronic toxicity in dogs was limited to

decreased body weight and the

occurrence of concretions in the

gallbladder.

Using the Guidelines for Carcinogen

Risk Assessment published September

24, 1986 (51 FR 33992), it is proposed

that cyhalofop and cyhalofop-butyl be

classified as Group E for carcinogenicity

(no evidence of carcinogenicity) based

on the results of carcinogenicity studies

in two species. Dow AgroSciences LLC

believes that there was no evidence of

carcinogenicity in an 18–mouse feeding

study and a 24–month rat feeding study

at all dosages tested.

6. Animal metabolism. Orally

administered cyhalofop-butyl is rapidly

absorbed, metabolized and excreted in

the rat and dog. Once absorbed,

cyhalofop-butyl is hydrolyzed to the

acid metabolite (cyhalofop) with no

significant quantities of unchanged

parent compound present in the plasma,

tissues or excreta.

7. Metabolite toxicology. Cyhalofopbutyl is rapidly hydrolyzed from the

butyl ester to the acid in plants and the

environment. Rats and dogs have also

been shown to rapidly hydrolyze the

ester to the acid. Mammalian toxicity

studies that will test specifically the

acid (cyhalofop) in animals are not

necessary since the animals in the

toxicity studies with the butyl ester

have already been exposed to large

quantities of the acid. Plant metabolism

studies have shown the diacid to be the

major metabolite thus analyzed in the

samples from crop field trials. This

metabolite is more polar and less lipid

soluble than the acid and, therefore,

would be expected to be less toxic than

the acid. Processing of the harvested

crop does not result in any residues that

are not formed in animals, so additional

toxicity studies on residues are not

required.

8. Endocrine disruption. There is no

evidence from any of the studies to

suggest that cyhalofop-butyl is an

endocrine disrupter.

C. Aggregate Exposure

Based on the rapid degradation of

cyhalofop-butyl and its high tendency to

sorb to soils, no surface water or ground

water contamination is expected. This

agrees with EPA Tier I modeling carried

out on cyhalofop-butyl. Therefore,

drinking water will not be a significant

route of exposure. Dietary exposure is

very low as previously mentioned. In

addition, a rotational crop study showed

no carryover of cyhalofop-butyl related

residues in any representative test crop.

There are no residential uses for this

compound. As a result, the only

potential for exposure is dietary, which

is acceptable. Therefore, aggregation of

exposures is not necessary.

D. Cumulative Effects

The potential for cumulative effects of

cyhalofop-butyl, cyhalofop-acid and

Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices 20811

other substances that have a common

mechanism of toxicity is also

considered. There is no reliable

information to indicate that toxic effects

produced by cyhalofop-butyl,

cyhalofop-acid and cyhalofop-diacid

would be cumulative with those of any

other pesticide chemical. Thus, it is

appropriate to consider only the

potential risks of cyhalofop-butyl and

cyhalofop-acid in an aggregate exposure

assessment.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions

described above, and based on the

completeness and reliability of the

toxicity data, aggregate exposure to

cyhalofop-butyl, as determined under

the guidance of the FQPA, will utilize

no more than 1.3% of the reference dose

(RfD) from the dietary exposure for all

subgroups of the U.S. population.

Generally, and under the FQPA, EPA

has no concern for exposures below

100% 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. Therefore, there is a

reasonable certainty that no harm will

result from exposure to cyhalofop-butyl

residues.

2. Infants and children. Data from

developmental toxicity studies in rats

and rabbits and a multigeneration

reproduction study in the rat are

considered in assessing the potential for

additional sensitivity of infants and

children to residues of cyhalofop-butyl.

The developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development. Reproduction studies

provide information relating to effects

from exposure of both parents to the

pesticide on the reproductive capability

and potential systemic toxicity of

mating animals and on various

parameters associated with the wellbeing of offspring. 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 for cyhalofop-butyl relative to

prenatal and postnatal effects for

children is complete. Overall,

cyhalofop-butyl had no effect on

reproduction or embryo-fetal

development at any dosage tested.

Further, for cyhalofop-butyl, the no

observed adverse effect level (NOAEL)

in the chronic mouse study (0.3 mg/kg/

day), which was used to calculate the

RfD (0.003 mg/kg/day), is already lower

than the NOAELs from the

developmental studies in rats and

rabbits. Therefore, an additional FQPA

uncertainty factor is not needed and the

RfD at 0.003 mg/kg/day is appropriate

for assessing risk to infants and

children. Using the conservative

exposure assumptions previously

described, the percent RfD utilized by

the potential aggregate exposure to

residues of cyhalofop-butyl on rice is

about 1.3% for non-nursing infants, the

most sensitive population subgroup.

Therefore, based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment,

Dow AgroSciences LLC concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to cyhalofopbutyl on rice.

F. International Tolerances

There is no Codex maximum residue

level established for residues of

cyhalofop-butyl, cyhalofop-acid and

cyhalofop-diacid on any food or feed

crop.

[FR Doc. 01–10122 Filed 4–24–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1018; FRL–6778–4]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1018, must be

received on or before May 25, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

PF–1018 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Leonard Cole, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–5412; e-mail address:

cole.leonard@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer or pesticide manufacturer.

Potentially affected categories and

entities may include, but are not limited

to:

Categories NAICS

codes

Examples of potentially affected

entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

1018. 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