28470 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number OPP–34226A 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 6.1/8.0/9.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number OPP–34226A. Electronic

comments may also be filed online at

many Federal Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Offer alternative ways to improve

the notice or collection activity.

7. Make sure to submit your

comments by the deadline in this

document.

8. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. Background

A. What Action is the Agency Taking?

The Agency has issued a RED for the

pesticide active ingredient listed in this

document. Under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA), as amended in 1988, EPA

is conducting an accelerated

reregistration program to reevaluate

existing pesticides to make sure they

meet current scientific and regulatory

standards. The data base to support the

reregistration of the chemical included

in this document is substantially

complete, and the pesticide’s risks have

been mitigated so that it will not pose

unreasonable risks to people or the

environment when used according to its

approved labeling. In addition, EPA is

reevaluating existing pesticides and

reassessing tolerances under the Food

Quality Protection Act (FQPA) of 1996.

The pesticide included in this notice

also has been found to meet the FQPA

safety standard.

All registrants of pesticide products

containing the active ingredient triallate

have been sent the appropriate RED, and

must respond to labeling requirements

and product-specific data requirements

(if applicable) within 8 months of

receipt. Products also containing other

pesticide active ingredients will not be

reregistered until those other active

ingredients are determined to be eligible

for reregistration.

The reregistration program is being

conducted under Congressionallymandated time frames, and EPA

recognizes both the need to make timely

reregistration decisions and to involve

the public. Therefore, EPA is issuing

this RED as a final document with a 60–

day comment period. Although the 60–

day public comment period does not

affect the registrant’s response due date,

it is intended to provide an opportunity

for public input and a mechanism for

initiating any necessary amendments to

the RED. All comments will be carefully

considered by the Agency. If any

comment significantly affects a RED,

EPA will amend the RED by publishing

the amendment in the Federal Register.

B. What is the Agency’s Authority for

Taking this Action?

The legal authority for this RED falls

under FIFRA, as amended in 1988 and

1996. Section 4(g)(2)(A) of FIFRA

directs that, after submission of all data

concerning a pesticide active ingredient,

‘‘the Administrator shall determine

whether pesticides containing such

active ingredient are eligible for

reregistration,’’ before calling in

product-specific data on individual enduse products, and either reregistering

products or taking ‘‘other appropriate

regulatory action.’’

List of Subjects

Environmental protection, Pesticides.

Dated: May 4, 2001.

Lois Rossi,

Director, Special Review and Reregistration

Division, Office of Pesticide Programs.

[FR Doc. 01–12903 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1020; FRL–6780–7]

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.

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28471

DATES: Comments, identified by docket

control number PF–1020, must be

received on or before June 22, 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–1020 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Cynthia Giles-Parker, Fungicide

Branch, Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–7740; e-mail address: gilesparker.cynthia@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,’’ ‘‘Regulation

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–

1020. 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–1020 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–1020. 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

28472 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

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

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.

Dated: May 3, 2001.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition 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 petitioners.

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.

BASF Corporation, Agricultural

Products

PP 0F6139

EPA has received pesticide petition

number 0F6139 from BASF Corporation,

Agricultural Products, P.O. Box 13528,

Research Triangle Park, NC 27709–3528

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

tolerances for combined residues of BAS

500 F or pyraclostrobin (methyl-N-(((1-

(4-chlorophenyl)pyrazol-3-yl)oxy, otolyl)N-methoxycarbamate) and its

metabolite BF 500-3 (methyl-N-(((1-(4-

chlorophenyl pyrazol-3-yl)oxy)otolyl)carbamate); expressed as parent

compound in or on the raw agricultural

commodities almond hulls at 1.6 ppm,

banana at 0.04 parts per million (ppm),

barley (grain) at 0.4 ppm, barley (hay) at

25 ppm, barley (straw) at 6.0 ppm,

berries (crop group) at 1.0 ppm, bulb

vegetables (crop group) at 0.7 ppm,

citrus fruits (crop group) at 0.7 ppm,

cucurbits (crop group) at 0.5 ppm,

fruiting vegetables (crop group) at 1.0

ppm, grape at 2.0 ppm, grass seed (seed

screenings) at 27 ppm, grass seed (straw)

at 14.0 ppm, grass seed (forage) at 10.0

ppm, grass seed (hay) at 4.5 ppm, lentil

at 0.5 ppm, orange oil at 4.2 ppm,

orange pulp (dry) at 6.3 ppm, peanut at

0.05 ppm, peanut oil at 0.1 ppm, pea

(dry, seed ) at 0.4 ppm, radish tops at

16.0 ppm, raisin at 6.0 ppm, root

vegetables (crop subgroup 1-B) at 0.4

ppm, rye (grain) at 0.04 ppm, rye (straw)

at 0.5 ppm), stone fruits (crop group) at

0.7 ppm, strawberry at 0.4 ppm, sugar

beet (dry pulp) at 1.6 ppm, sugar beet

(root) at 0.2 ppm, sugar beet (top) at 8.0

ppm, tomato paste at 2.0 ppm, tree nuts

(crop group) at 0.04 ppm, tuberous and

corm vegetables (crop subgroup 1-C) at

0.04 ppm, wheat (grain) at 0.2 ppm,

wheat (hay) at 6.0 ppm, wheat (straw) at

6.0 ppm, cattle (fat) at 0.1 ppm, cattle

(kidney) at 0.1 ppm, cattle (liver) at 0.6

ppm, cattle (milk) at 0.03 ppm, cattle

(muscle) at 0.1 ppm, poultry (egg) at 0.1

ppm, poultry (muscle) at 0.1 ppm,

poultry (liver) at 0.1 ppm, poultry (fat)

at 0.1 ppm. 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 sufficency 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.

A. Residue Chemistry

1. Plant and animal metabolism.

Nature of the residue studies (OPPTS

860.1300) were conducted in grape,

potato and wheat as representative

crops in order to characterize the fate of

BAS 500 F in all crop matrices. BAS 500

F demonstrated a similar pathway and

fate in all three crops. In all three crops

the BAS 500 F residues of concern were

characterized as parent (BAS 500 F) and

BAS 500–3.

2. Analytical method. In plants the

method of analysis is aqueous organic

solvent extraction, column clean up and

quantitation by LC/MS/MS. In animals

the method of analysis involves base

hydrolysis, organic extraction, column

clean up and quantitation by LC/MS/MS

or derivatization (methylation) followed

by quantitation by GC/MS.

3. Magnitude of residues. Field trials

were carried out in order to determine

the magnitude of the residue in the

following crops: almond, banana,

barley, carrot, citrus, cucurbits (crop

group), peas (dry, field), grape, grass

grown for seed, lentil, onions (dry bulb

and green), peanut, pecan, peppers (bell

and chili), pistachio, potato, radish,

berries (crop group), rye, stone fruits,

strawberry, sugar beet, tomato and

wheat. The residue trials in bananas

were carried out in Latin America. Field

trials for the rest of the crops were

conducted in the United States and

Canada. Field trials were carried out

using the maximum label rate, the

maximum number of applications, and

the minimum preharvest interval for

each crop or crop group. In addition,

processing studies were conducted on

the following crops to determine

concentration factors during normal

processing of the raw agricultural

commodity into the processed

commodities: citrus, grape, peanut,

potato, stone fruits, sugar beet, tomato,

and wheat. Magnitude of the residue

trials were also carried out in cow and

poultry.

B. Toxicological Profile

1. Acute toxicity. Based on available

acute toxicity data BAS 500 F and its

formulated products do not pose acute

toxicity risks. The acute toxicity studies

place technical BAS 500 F in toxicity

category IV for acute oral, category III

for acute dermal, and category II for

acute inhalation. BAS 500 F is category

III for both eye and skin irritation and

is not a dermal sensitizer. Two

formulated end use products are

proposed, an Emulsifiable Concentrate

(EC) and an Extruded Granule (EG). The

EC has an acute oral toxicity category of

II, acute dermal of III, acute inhalation

of IV, eye and skin irritation categories

of III, and is not a dermal sensitizer. The

WG has acute oral and dermal toxicity

categories of III, acute inhalation of IV,

eye irritation of III, skin irritation of IV,

and is not a dermal sensitizer.

TABLE 1.—ACUTE TOXICITY OF

TECHNICAL BAS 500 F

Study

Type Species Results

Toxicity

Category

Oral LD50 Rat LD50*>

5,000 mg/

kg bwt

IV

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28473

TABLE 1.—ACUTE TOXICITY OF

TECHNICAL BAS 500 F—Continued

Study

Type Species Results

Toxicity

Category

Dermal

LD50

Rat LD50 >

2,000 mg/

kg bwt

III

Inhalation

LC50

Rat 0.31 <

LC50**<

1.07 mg/L

II

Eye irritationRabbit Slight irritationIII

Skin irritationRabbit Moderate irritationIII

Skin sensitizationGuinea

pig

Non-sensitizing

Acute

oral

neurotoxicity

(0, 100,

300,

and

1,000

mg/kg

bwt)

Rat No neurotoxic effects at

doses up

to 1,000

mg/kg

*Lethal Dose 50%

**Lethal Concentration 50%

TABLE 2.—ACUTE TOXICITY OF FORMULATED END-USE PRODUCT, BAS

500 00F (HEADLINE EC FUNGICIDE)

Study Type Species Results

Toxicity

Category

Oral LD50 Rat LD50 > 500

mg/kg

bwt

(males);

260 mg/

kg (200–

500 mg/

kg) bwt

(females)

II

Dermal

LD50

Rat LD50 >

4,000

mg/kg

bwt

III

Inhalation

LC50

Rat LC50 =

3.51 mg/

L

IV

Eye irritationRabbit Moderate

irritation

III

Skin irritationRabbit Moderate

irritation

III

Skin sensitizationGuinea

pig

Non-sensitizing

TABLE 3.—ACUTE TOXICITY OF FORMULATED END-USE PRODUCT,

BAS500 02F (CABRIO EG AND INSIGNIA FUNGICIDES)

Study

Type Species Results

Toxicity

Category

Oral LD50 Rat LD50 >

2,000 mg/

kg bwt

III

TABLE 3.—ACUTE TOXICITY OF FORMULATED END-USE PRODUCT,

BAS500 02F (CABRIO EG AND INSIGNIA FUNGICIDES)—Continued

Study

Type Species Results

Toxicity

Category

Dermal

LD50

Rat LD50 >

2,000 mg/

kg bwt

III

Inhalation

LC50

Rat LC50 = 4.7

mg/L

IV

Eye irritationRabbit Slight irritationIII

Skin irritationRabbit Slight irritationIV

Skin sensitizationGuinea

pig

Non-sensitizing

2. Genotoxicity. Ames Test (one

study; point mutation): Negative; in

vitro CHO/HGPRT Locus Mammalian

Cell Mutation Assay (one study; point

mutation): Negative; in vitro V79 Cells

CHO Cytogenetic Assay (one study;

chromosome damage): Negative; in vivo

Mouse Micronucleus (one study;

chromosome damage): Negative; in vitro

Rat Hepatocyte (one study; DNA damage

and repair): Negative.

BAS 500 F has been tested in a total

of five genetic toxicology assays

consisting of in vitro and in vivo studies.

It can be stated that BAS 500 F did not

show any mutagenic, clastogenic or

other genotoxic activity when tested

under the conditions of the studies

mentioned above. Therefore, BAS 500 F

does not pose a genotoxic hazard to

humans.

TABLE 4.—SUMMARY OF GENOTOXICITY STUDIES ON BAS 500 F

Study Test Organism Concentration

Range Results

Gene mutation: Ames reverse mutation assayS. typhimurium strains TA

1535, TA 100, TA 1537

and TA 98; E. Coli strain

WP2 uvrA; with and without metabolic activation.

20 to 5,000 μg per

plate

Negative with and without metabolic activation

Gene mutation: in vitro Chinese Hamster Ovaryin vitro cell study

(HGPRT locus)

HGPRT locus of Chinese

Hamster Ovary cells, with

and without metabolic activation

0.625 to 20 μg/mL* Negative with and without activation

Chromosomal aberration:in vitro

cytogenicity

Chinese hamster V79 cells,

with and without metabolic

activation

0.005 to 25 μg/mL Negative with and without metabolic activation

Unscheduled DNA synthesis:in vitro

assay with primary rat hepatocytes

Primary hepatocytes from

Wistar rats

0.004 to 1.0 μg/mL Negative

28474 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

TABLE 4.—SUMMARY OF GENOTOXICITY STUDIES ON BAS 500 F—Continued

Study Test Organism Concentration

Range Results

Cytogenetic study in vivo:

mousemicronucleus test

NMRI mice 0, 75, 150 and 300

mg/kg bwt

Negative

*micrograms per milliliter

3. Reproductive and developmental

toxicity. The reproductive and

developmental toxicity of BAS 500 F

was investigated in a 2–generation rat

reproduction study as well as in rat and

rabbit teratology studies. There were no

adverse effects on reproduction in the

2–generation study so the no observed

adverse effect level (NOAEL) is the

highest dose tested of 300 parts per

million (ppm) (32.6 milligrams per

kilogram body weight per day (mg/kg

bwt/day)). Parental toxicity in the form

of reduced body weight gain and pup

effects were observed at the highest dose

tested only. Pup effects consisted

primarily of reduced body weight gain.

Most likely due to the small pup size,

reduced organ weights were observed in

the thymus, spleen and brain of F2

pups, and a slight delay in vaginal

opening time was observed in some F1

female pups. Therefore, the parental

systemic and developmental toxicity

NOAELs are the same at 75 ppm (8.2

mg/kg bwt).

No teratogenic effects were noted in

either the rat or rabbit developmental

studies. In the rat study, maternal

toxicity observed at the mid and high

dose consisted of decreased food

consumption and body weight gain.

There were no treatment-related

developmental effects. The maternal

NOAEL was 10 mg/kg bwt and the

developmental NOAEL was the highest

dose tested of 50 mg/kg bwt.

In the rabbit teratology study,

maternal toxicity observed at the mid

and high doses consisted of decreased

food consumption and body weight gain

(severe at the high dose). An increased

postimplantation loss was also observed

at the mid and high doses due to an

increase in early resorptions. In rabbits,

these types of effects are often observed

with significant stress on the mothers

(as seen by the body weight gain

decrease in this study) and not

indicative of frank developmental

toxicity. The NOAEL for both maternal

and developmental toxicity was 5 mg/kg

bwt.

TABLE 5.—SUMMARY OF REPRODUCTIVE AND DEVELOPMENTAL STUDIES ON BAS 500 F

Study NOAEL LOAEL * Effects at LOAEL or Higher

Multigeneration rat reproduction: 0, 25, 75, and 300

ppm (0, 2.7, 8.2, and 32.6

mg/kg bwt)

Reproductive function: 32.6

mg/kg bwt (300 ppm); systemic toxicity: 8.2 mg/kg

bwt (75 ppm); developmental toxicity: 8.2 mg/kg

bwt (75 ppm)

Reproductive function:

>32.6 mg/kg bwt (>

300 ppm); systemic

toxicity: 32.6 mg/kg

bwt (> 300 ppm); developmental toxicity:

32.6 mg/kg bwt (> 300

ppm)

No impairment of reproductive function at any of

the dose levels tested. 300 ppm: parental - reduced body weight and food consumption; pups

- reduced body weight during lactation with corresponding organ weight changes (F2) and

slightly delayed vaginal opening (F1 only)

Rat teratology: 0, 10, 25, and

50 mg/kg bwt

Maternal toxicity: 10 mg/kg

bwt; developmental toxicity: 50 mg/kg bwt

Maternal toxicity: 25 mg/

kg bwt; developmental

toxicity: > 50 mg/kg

bwt

No teratogenic effects. 25 mg/kg bwt: maternal effects were decreased body weight gain and decreased food consumption. 50 mg/kg bwt: maternal effects were a severe decrease in body

weight gain, and reduced food consumption.

Rabbit teratology: 0, 5, 10,

and 20 mg/kg bwt

Maternal: 5 mg/kg bwt; developmental toxicity: 5 mg/

kg bwt

Maternal: 10 mg/kg bwt;

developmental toxicity:

10 mg/kg bwt

No teratogenic effects. 10 mg/kg bwt: maternal effects were decreased body weight gain and

food consumption, and decreased mean gravid

uterus weight; developmental effects were increased post-implantation loss due to early resorptions, with subsequent decrease in mean

live fetuses per rabbit. 20 mg/kg bwt: maternal

effects were severely decreased body weight

gain, decreased food consumption, and decreased gravid uterus weight; developmental effects were increased postimplantation loss due

primarily to early resorptions.

*Lowest observed adverse effect level

4. Subchronic toxicity. The

subchronic toxicity of BAS 500 F was

investigated in 90–day feeding studies

with rats, mice and dogs, and in a 28–

day dermal administration study in rats.

A 90–day neurotoxicity study in rats

was also performed. Generally, mild

toxicity was observed. At high dose

levels in feeding studies, general

findings in all three species were

decreased food consumption and body

weight gain and a thickening of the

duodenum. Anemia occurred at high

dose levels in both rats and mice with

accompanying extramedullary

hematopoiesis of the spleen in rats. In

rats only, a finding of liver cell

hypertrophy was indicative of a

physiological response to the handling

of the chemical. Overall, only mild

toxicity was observed in oral subchronic

testing.

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28475

In the 28–day repeat dose dermal

study, no systemic effects were noted up

to the highest dose tested.

In a 90–day rat neurotoxicity study, a

direct neurotoxic effect was not

observed. The grip strength of forelimbs

was statistically significantly decreased

in high dose females at the end of the

study. This was assessed as being

related to the significant body weight

impairment at this dose level. This is

confirmed by the fact that functional

observational batteries and motor

activity measurement did not reveal any

other signs indicative for neurotoxicity.

Moreover, comprehensive microscopic

investigation of the central and

peripheral nervous system did not

reveal any substance-dependent

changes. This is outlined in the table.

TABLE 6.—SUMMARY OF SUBCHRONIC STUDIES FOR BAS 500 F

emsp; NOAEL LOAEL Effects at LOAEL or Higher

4–Week dermal rat: 0, 40, 100,

and 250 mg/kg bwt

250 mg/kg bwt (systemic) > 250 mg/kg bwt Skin irritation at application site;

no systemic effects related to

treatment

90-Day rat feeding study: 0, 50,

150, 500, 1000 and 1,500 ppm

(0, 3.5, 10.7, 34.7, 68.8 and

105.8 mg/kg bwt for males; 0,

4.2, 12.6, 40.8, 79.7,and 118.9

mg/kg bwt for females).

3.5 mg/kg bwt males; 4.2 mg/kg

bwt females (equivalent to 50

ppm both sexes)

10.7 mg/kg bwt males; 12.6 mg/

kg bwt females (equivalent to

150 ppm both sexes)

Generally mild toxicity at high

doses. 150 ppm (LOAEL): decreased absolute liver weight

males; increased

extramedullary hematopoiesis.

≥ 500 ppm: decreased food

consumption and body weight

change; leukocytosis; hemolytic anemia males; mild anemia females; decreased serum

liver enzymes; increased relative weights of spleen and adrenal gland (both sexes), kidney, testes, brain (males), and

liver and ovaries (females);

mucosal hyperplasia of duodenum; increased extramedullary

hematopoiesis of spleen;

hepatocellular hypertrophy.

90-Day mouse feeding study: 0,

50, 150, 500, 1,000, and 1,500

ppm (0, 9.2, 30.4, 119.4, 274.4,

and 475.5 mg/kg bwt for males;

0, 12.9, 40.4, 162, 374.1, and

634.8 mg/kg bwt for females)

9.2 mg/kg bwt males; 12.9 mg/kg

bwt females (equivalent to 50

ppm for both sexes)

30.4 mg/kg bwt males; 40.4 mg/

kg bwt females (equivalent to

150 ppm both sexes)

Generally mild toxicity at high

doses. 150 ppm (LOAEL): decreased body weight gain and

hematocrit (males); decreased

triglycerides and thickening of

the duodenum (females). ≥ 500

ppm: decreased body weight

change; mild leukopenia; mild

hypochromic microcytic anemia; decreased serum protein,

globulins, and triglycerides;

thickening of the duodenal mucosa.

90–Day Beagle dog feeding study:

0, 100, 200 and 450 ppm (0,

2.8, 5.8, and 12.9 mg/kg bwt

males; 0, 3.1, 6.2, 13.6 mg/kg

bwt females)

5.8 mg/kg bwt males; 6.2 mg/kg

bwt females (equivalent to 200

ppm for both sexes)

12.9 mg/kg bwt males; 13.6 mg/

kg bwt females (equivalent to

450 ppm both sexes)

Generally mild toxicity at high

doses. 450 ppm (LOAEL): Decreased food consumption (females); slight body weight loss

and diarrhea; decreased serum

protein, albumin, and globulins;

increased platelets (females);

hypertrophy in duodenum.

90-Day rat feeding neurotoxicity

study 0, 50, 250, 750 - males,

0, 50, 250 and 1500 ppm - females (0, 3.5, 16.9, 49.9 mg/kg

bwt - males; 0, 4.0, 20.4, 49.9

and 119.9 mg/kg bwt - females)

Systemic: 3.5 mg/kg bwt (50 pm)

- males; 20.4 mg/kg bwt (250

ppm)- females

Systemic: 16.9 mg/kg bwt (250

ppm ) - males; 49.9 mg/kg bwt

(750 ppm) - females

250 ppm (males): Reduced food

and water consumption.

5. Chronic toxicity. The following are

summaries of chronic toxicity studies

submitted to EPA.

BAS 500 F was administered to

groups of five male and five female

purebred Beagle dogs in the diet at

concentrations of 0, 100, 200 and 400

ppm over a period of 12 months. Signs

of toxicity were observed at the high

dose. Diarrhea was observed throughout

the study period for both sexes. High

dose males and females initially lost

weight and body weight gain was

decreased for the entire study period for

females. Hematological changes

observed were an increase in white

blood cells in males, and an increase in

platelets in both sexes at the high dose.

Clinical chemistry demonstrated a

28476 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

decrease in serum total protein,

albumin, globulins, and cholesterol in

high dose animals of both sexes,

possibly due to the diarrhea and

reduced nutritional status of the

animals. The NOAEL was 200 ppm (ca.

5.5 mg/kg bwt/day males; 5.4 mg/kg

bwt/day females).

For the chronic toxicity portion of the

rat study, BAS 500 F was administered

to groups of 20 male and 20 female

Wistar rats at dietary concentrations of

0, 25, 75, and 200 ppm for 24 months.

For the carcinogenicity portion of the rat

study, BAS 500 F was administered to

groups of 50 male and 50 female Wistar

rats at dietary concentrations of 0, 25,

75, and 200 ppm for 24 months. The

results of a 2–year chronic toxicity

study and a 2–year carcinogenicity

study in rats indicate that a maximum

tolerated dose was clearly met at the

high dose of 200 ppm (ca. 9 mg/kg bwt

males and 12 mg/kg bwt females). This

is demonstrated by a body weight gain

depression of 10–11% in males and 14–

22% in females. The only other effect

observed was a decrease in serum

alkaline phosphatase in both sexes at

the high dose and decreased alanine

aminotransferase in high dose males.

There was no evidence that BAS 500 F

produced a carcinogenic effect in rats.

The NOAEL for the chronic rat and the

cancer rat study is 75 ppm (ca. 3.4 mg/

kg bwt/day males; 4.6 mg/kg bwt/day

females).

BAS 500 F was administered to

groups of 50 male and 50 female

B6C3F1 mice at dietary concentrations

of 0, 10, 30, 120, and 180 ppm (females

only) for 18 months. Body weights were

reduced at the highest doses tested in

both males and females. The high dose

body weight gain decreases of 27% in

females and 29% in males exceeded that

required for a maximum tolerated dose.

No other signs of toxicity were noted at

any dose level. The NOAEL was found

to be 120 ppm (ca. 20.5 mg/kg bwt/day)

for females and 30 ppm (ca. 4.1 mg/kg

bwt/day) for males. There was no

evidence that BAS 500 F produced a

carcinogenic effect in mice.

6. Carcinogenicity. There were no

tumors associated with treatment

observed in either a 2–year rat

oncogenicity study or in an 18–month

mouse oncogenicity study. Based on

EPA Proposed Guidelines For

Carcinogen Risk Assessment, BASF

believes that BAS 500 F will be

classified as ‘‘not likely’’ to be

carcinogenic to humans. Under the

current assessment method, BASF

believes that EPA will classify BAS 500

F as Group E ‘(evidence of

noncarcinogenicity to humans).

TABLE 7.—SUMMARY OF CHRONIC TOXICITY/ONCOGENICITY STUDIES ON BAS 500 F

Study NOAEL LOAEL Comments

12–Month beagle dog feeding

study: 0, 100, 200 and 400

ppm (0, 2.8, 5.5 and 10.8 mg/

kg bwt males; 2.7, 5.4, 11.2

mg/kg bwt females)

5.5 mg/kg bwt males;

5.4 mg/kg bwt females (200 ppm both

sexes)

10.8 mg/kg bwt males;

11.2 mg/kg bwt females (400 ppm both

sexes)

Generally mild toxicity. 400 ppm: decreased body

weight gain (initially in males and throughout study in

females); decreased food consumption (females); diarrhea; decreased serum total protein, albumin,

globulins, and cholesterol; increased platelets; increased white blood cells (males).

18-Month mouse oncogenicity

study: 0, 10, 30, and 120 ppm

males (1.4, 4.1, and 17.2 mg/

kg bwt); 0, 10, 30, 120 and

180 ppm females (1.6, 4.8,

20.5, 32.8 mg/kg bwt)

4.1 mg/kg bwt males

(30 ppm); 20.5 mg/kg

bwt females (120

ppm)

17.2 mg/kg bwt males

(120 ppm); 32.8 mg/

kg bwt females (180

ppm)

Generally mild toxicity. No treatment-related tumors.

120 ppm: decreased body weight and body weight

change (males). 180 ppm (females only): Decreased

body weight and body weight change.

24-Month chronic toxicity study

in Rats: 0, 25, 75, and 200

ppm (0, 1.1, 3.4, and 9.0 mg/

kg bwt males; 0, 1.5, .4.6 and

12.3 mg/kg bwt females)

3.4 mg/kg bwt males;

4.6 mg/kg bw females (75 ppm both

sexes)

9.0 mg/kg bwt males;

12.3 mg/kg bwt females (200 ppm both

sexes)

Generally mild toxicity. 200 ppm: decreased body

weight and body weight change; decreased serum

alkaline phosphatase (both sexes) and alanine

aminotransferase (males)

24-month carcinogenicity study

in rats: 0, 25, 75 and 200 ppm

(0, 1.2, 3.4, and 9.2 mg/kg

bwt males; 0, 1.5, 4.7, and

12.6 mg/kg bw females)

3.4 mg/kg bwt males;

4.7 mg/kg bwt females (75 ppm both

sexes).

9.2 mg/kg bwt males;

12.6 mg/kg bwt females (200 ppm both

sexes)

Generally mild toxicity. No treatment-related tumors.

200 ppm: decreased body weight gain (both sexes);

decreased food consumption (males); increased liver

cell necrosis.

7. Animal metabolism. In hens the

residues of concern were determined to

be parent compound and a hydroxlated

metabolite, BAS 500–16. In goats the

residues of concern were determined to

be parent and a hydroxylated metabolite

BAS 500–10.

8. Metabolite toxicology. A

comparison of the rat metabolism

results with the plant metabolism/

residue results indicate that toxicology

studies performed with the parent

compound are sufficient to cover dietary

exposure. Therefore, no specific toxicity

studies were conducted on metabolites

of this compound.

9. Endocrine disruption. No specific

tests have been conducted with BAS

500 F to determine whether the

chemical may have an effect in humans

that is similar to an effect produced by

a naturally occurring estrogen or other

endocrine effects. However, there were

no significant findings in other relevant

toxicity studies (i.e., subchronic and

chronic toxicity, teratology, and

multigeneration reproductive studies)

which would suggest that BAS 500 F

produces endocrine-related effects.

10. Threshold effects. Based on a

review of the available chronic toxicity

data, BASF believes EPA will establish

the Reference Dose (RfD) for BAS 500 F

at 0.04 mg/kg/day. This RfD for BAS 500

F is based on the 2–year chronic and 2–

year oncogenicity studies in rats with a

threshold average NOAEL of 4 mg/kg/

day for males and females. Using an

uncertainty factor of 100, the RfD is

calculated to be 0.04 mg/kg/day. Based

on the acute toxicity data, BASF

believes that 500 F does not pose any

dietary risks.

11. Non-threshold effects. There were

no tumors associated with treatment

observed in either a 2–year rat

oncogenicity study or in an 18–month

mouse oncogenicity study. Based on

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28477

EPA Proposed Guidelines For

Carcinogen Risk Assessment, BASF

believes that BAS 500 F will be

classified as ‘‘not likely’’ to be

carcinogenic to humans. Under the

current assessment method, BASF

believes that EPA will classify BAS 500

F as Group E (evidence of

noncarcinogenicity to humans).

C. Aggregate Exposure

BASF believes that pyraclostrobin

does not pose any acute dietary risks, so

an acute exposure analysis is not

necessary. Based on a review of the

available chronic toxicity data, BASF

believes EPA will base the chronic RfD

for pyraclostrobin on the 2–year chronic

and 2–year oncogenicity studies in rats,

which had an average threshold NOAEL

of 4 mg/kg/day for males and females.

BASF further believes that EPA will use

an uncertainty factor of 100 and

establish the RfD at 0.04 mg/kg/day. The

following table expresses the results of

the chronic aggregate analysis of

exposure to pyraclostrobin. This

analysis is discussed further below.

TABLE 8.—SUMMARY OF CHRONIC AGGREGATE EXPOSURE TO BAS 500 F

U.S. Population (% of RfD) Children 1–6 (% of RfD)

Chronic dietary exposure 5% 10%

Residential exposure* 2.5% 12.5%

Total RfD used by diet and residential exposure7.5% 22.5%

Remainder of RfD available for water (%)

(Drinking Water Level of Concern)

92.5% 77.5%

SCIGROW modelground water estimation** <1% <1%

GENEEC model (56 d) surface water

estimation**

<1% <1%

Total of RfD used by diet, water and residential7.5% 77.5%

*Acute values used as worst case

**Used highest values predicted from the model for all agricultural uses; assumes 2 liters/day consumed and 60 kg bwt for adults and 1 liter/

day and 10 kg bwt for children

1.Dietary exposure— i. Food. For

purposes of assessing the potential

dietary exposure, BASF has estimated

aggregate exposure based on the

Theoretical Maximum Residue

Contribution (TMRC) from the proposed

tolerances for BAS 500 F.

A Tier 1 worst case estimate of dietary

exposure was conducted assuming that

100% of all crops for which tolerances

are established are treated and that

pesticide residues are always found at

the tolerance levels. The TMRC from the

proposed uses of BAS 500 F on all crops

is 0.002 mg/kg bwt/day and utilizes 5%

of the RfD for the overall U.S.

population. The exposure of the most

highly exposed subgroup in the

population, children (1–6 years old), is

0.004 mg/kg bwt/day and utilizes 10%

of the RfD.

The following table summarizes the

mean dietary exposures and the

percents of RfD occupied by these

exposures.

TABLE 9.—SUMMARY OF CHRONIC DIETARY EXPOSURE TO BAS 500 F—

(DRES (DIETARY RISK EVALUATION

SYSTEM))

Group μg/kg body

weight/day %RfD

U.S. population2.004 5

All infants

(<1 year

old)

2.260 6

Children 1–6

years old

4.144 10

Children 7–

12 years

old

2.092 5

Females 13–

50 years

old

1.338 3

ii. Drinking water. Estimates of

ground water levels and surface water

levels were determined using the

Screening Concentration in

Groundwater (SCIGROW) and Generic

Estimated Environmental Concentration

(GENEEC) models, respectively. The

drinking water levels of concern

(DWLOCs) for chronic exposure are

obtained by subtracting the chronic

dietary food exposures and residential

exposures from the RfD, as outlined in

Table 10.

TABLE 10.—PERCENTAGES OF REFERENCE DOSE FOR CHRONIC WATER

EXPOSURE TO BAS 500 F

U.S.

Population (%

of RfD)

Children

1–6 (%

of RfD)

Chronic dietary exposure5% 10%

Residential

exposure*

2.5% 12.5%

Total RfD used by

diet and residential

7.5% 22.5%

Remainder of RfD

available for water

(%) (Drinking

Water Level of

Concern)

92.5% 77.5%

SCIGROW ground

water estimation**

<1% <1%

GENEEC (56 d) surface water

estimation**

<1% <1%

28478 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

TABLE 10.—PERCENTAGES OF REFERENCE DOSE FOR CHRONIC WATER

EXPOSURE TO BAS 500 F—Continued

U.S.

Population (%

of RfD)

Children

1–6 (%

of RfD)

Total of RfD used by

diet, water and

residential

7.5% 77.5%

*Acute values used as worst case

** Used highest values predicted from the

model for all agricultural uses; Assumes 2 liters/day consumed and 60 kg bwt for adult

and 1 liter/day and 10 kg bwt for child

The SCIGROW and GENEEC estimates

of ground and surface water levels for

BAS 500 F are well below the DWLOC.

Overall, using worst-case parameters the

predicted aggregate exposure by all

potential routes for both adults and

children is less than the chronic

referencedose.

2. Non-dietary exposure. BAS 500 F is

planned for use on residential lawns.

Acute exposure was estimated using

data from a BAS 500 F turf transferable

residue (TTR) study, a dermal

penetration of 2.6% and default values

from the EPA Standard Operating

Procedures for residential exposure. For

adults, the exposure estimate of 0.001

mg/kg bwt/day is equivalent to only

2.5% of the chronic reference dose.

Estimation of exposure of children

includes dermal contact on the lawn

plus oral ingestion via fingers in the

mouth, grass and dirt. Using the worstcase EPA defaults, the acute exposure

result is estimated to be 0.005 mg/kg

bwt/day which is 12.5% of the chronic

Reference Dose.

D. Cumulative Effects

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

BAS 500 F is a foliar fungicide which

belongs to the new class of strobilurin

chemistry. It is a synthetic analog of

strobilurin A, a naturally occurring

antifungal metabolite of the mushroom

Strobillurus tenacellus (Anke et. al.,

1977). The active ingredient acts in the

fungal cell through inhibition of

electron transport in the mitochondrial

respiratory chain at the position of the

cytochrome-bc1 complex. The

protective effect is due to the resultant

death of the fungal cells by

disorganization of the fungal membrane

system. BAS 500 F also acts curatively

to prevent the increase and spread of

fungal infections by inhibiting mycelial

growth and sporulation on the leaf

surface. BAS 500F inhibits spore

germination, germ tube growth and

penetration into the host tissues.

The EPA is currently developing

methodology to perform cumulative risk

assessments. At this time, there is no

available data to determine whether

BAS 500F has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity, BAS

500 F does not appear to produce a toxic

metabolite produced by other

substances

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions

described above and based on the

completeness and the reliability of the

toxicity data, BASF has estimated that

aggregate exposure to BAS 500 F will

utilize 5% of the RfD for the U.S.

population. BASF concludes that there

is a reasonable certainty that no harm

will result from the aggregate exposure

to BAS 500 F, including anticipated

dietary exposure and non-occupational

exposures.

2. Infants and children. A

developmental study was conducted via

oral gavage in rats with dosages of 0, 10,

25, and 50 mg/kg bwt/day with a

maternal NOAEL of 10 mg/kg bwt/day

and a developmental NOAEL of 50 mg/

kg bwt/day. No evidence of

developmental toxicity was observed up

to the highest dose tested. These

NOAELs are higher than the NOAEL of

4 mg/kg bwt/day from the chronic rat

study used to establish the RfD.

A developmental study was

conducted via oral gavage in rabbits

with dosages of 0, 5, 10, and 20 mg/kg

bwt/day. The NOAEL for both maternal

and developmental toxicity was 5 mg/kg

bwt/day. No teratogenic effects were

observed at any dose level, and the only

developmental effect observed was an

increase in postimplantation loss at

doses which produced maternal

toxicity. These NOAELs are higher than

the NOAEL of 4 mg/kg bwt/day from the

chronic ratstudy used to establish the

RfD.

A 2–generation reproduction study in

rats was conducted with dosages of 0,

2.7, 82, and 32.6 mg/kg bwt/day. The

NOAELs are 32.6 mg/kg bwt/day

(highest dose tested) for reproductive

function and 8.2 mg/kg bwt/day for

parental and developmental toxicity. No

impairment of reproductive function

was noted at any dose level. At the high

dose reduced parental body weight

gains were accompanied by reduced

pup weights and corresponding reduced

pup organ weights (F2 only) and slightly

delayed vaginal opening (F1 only). The

slight delay in vaginal opening was

most likely due to the smaller pups and

corresponding delay in physical

development. These NOAELs are higher

than the NOAEL of 4 mg/kg bwt/day

from the chronic rat study used to

establish the RfD.

Based on these results, no additional

safety factors to protect children are

warranted. Since developmental and

reproductive toxicity occurs at levels

above the levels shown to exhibit

parental toxicity and since these levels

are higher than those used to calculate

the RfD, BASF believes the RfD of 0.04

mg/kg/day (4 mg/kg/day and an

Uncertainty Factor of 100) is an

appropriate measure of safety for infants

and children.

Dietary exposure of the most highly

exposed subgroup in the population,

children (1–6 years old) is 0.004 mg/kg

bwt/day. This accounts for 10% of the

RfD. Worst case default predictions

indicate that residential uses of BAS 500

F will amount to 12.5% of the RfD and

that contamination of drinking water is

extremely small and amounts to <1% of

the reference dose. Aggregate exposure

of children (1–6 years old) amounts to

22.5% of the RfD. In addition, there

were no significant findings in relevant

toxicity studies (i.e., subchronic and

chronic toxicity, teratology, and multigeneration reproductive studies) which

would suggest that BAS 500 F produces

endocrine-related effects.

Therefore, based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment,

BASF concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to BAS 500 F,

including all anticipated dietary

exposure and all other non-occupational

exposures.

F. International Tolerances

A maximum residue level (MRL) has

not been established for BAS 500 F in

any crop by the Codex Alimentarius

Commission.

[FR Doc. 01–12907 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S