60432 Federal Register / Vol. 65, No. 197 / Wednesday, October 11, 2000 / Notices

developed as part of EPA’s process for

making reregistration eligibility

decisions for the organophosphate

pesticides and for tolerance

reassessments consistent with the

FFDCA, as amended by the FQPA. The

Agency’s preliminary dichlorvos

(DDVP) risk assessments for the

following dichlorvos (DDVP)

organophosphate pesticides are

available in the individual

organophosphate pesticide dockets.

Included in the individual

organophosphate pesticide dockets are

the Agency’s preliminary risk

assessments. As additional comments,

reviews, and risk assessment

modifications become available, these

will also be docketed for the dichlorvos

(DDVP) organophosphate pesticides

listed in this notice. The Agency

cautions that these risk assessments are

preliminary assessments only and that

further refinements of the risk

assessments will be appropriate for

some, if not all, of these dichlorvos

(DDVP) organophosphate pesticides.

These documents reflect only the work

and analysis conducted as of the time

they were produced and it is

appropriate that, as new information

becomes available and/or additional

analyses are performed, the conclusions

they contain may change.

As the preliminary risk assessments

for the remaining organophosphate

pesticides are completed and registrants

are given a 30-day review period to

identify possible computational or other

clear errors in the risk assessment, these

risk assessments and registrant

responses will be placed in the

individual organophosphate pesticide

dockets. A notice of availability for

subsequent assessments will appear in

the Federal Register.

The Agency is providing an

opportunity, through this notice, for

interested parties to provide written

comments and input to the Agency on

the preliminary risk assessments for the

chemicals specified in this notice. Such

comments and input could address, for

example, the availability of additional

data to further refine the risk

assessments, such as percent crop

treated information or submission of

residue data from food processing

studies, or could address the Agency’s

risk assessment methodologies and

assumptions as applied to these specific

chemicals. Comments should be limited

to issues raised within the preliminary

risk assessments and associated

documents. EPA will provide other

opportunities for public comment on

other science issues associated with the

organophosphate pesticide tolerance

reassessment program. Failure to

comment on any such issues as part of

this opportunity will in no way

prejudice or limit a commenter’s

opportunity to participate fully in later

notice and comment processes. All

comments should be submitted by

December 11, 2000 using the methods in

Unit I. of the SUPPLEMENTARY

INFORMATION. Comments will become

part of the Agency record for each

individual organophosphate pesticide to

which it pertains.

List of Subjects

Environmental protection, Chemicals,

Pesticides and pests.

Dated: October 3, 2000.

Jack E. Housenger,

Acting Director, Special Review and

Reregistration Division, Office of Pesticide

Programs.

[FR Doc. 00–26067 Filed 10–10–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–979; FRL–6749–6]

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–979, must be

received on or before November 13,

2000.

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–979 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Kathryn Boyle, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6304; e-mail address:

boyle.kathryn@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–

979. 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

Federal Register / Vol. 65, No. 197 / Wednesday, October 11, 2000 / Notices 60433

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–979 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–979. 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 Comestic 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: September 29, 2000.

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 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.

Avecia Biocides

PP 0F6172

EPA has received a pesticide petition

(PP 0F6172) from Avecia Biocides, 1405

Foulk Road P.O. Box 15457 Wilmington,

DE 19859 proposing, pursuant to section

408(d) of the FFDCA, 21 U.S.C. 346a(d),

to amend 40 CFR part 180 to establish

an exemption from the requirement of a

tolerance for 1,2 benzisothiazoline-3-

one (BIT) when used as a preservative/

stabilizer in pesticide formulations

applied to animals. 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 support

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Analytical method. Because Avecia

Biocides is petitioning for an exemption

from the requirement of a tolerance, an

enforcement analytical method for BIT

is not needed.

2. Magnitude of residues. Based on

the proposed amount of BIT to be used

in the final products (0.1% or less of the

total formulation) and the recommended

frequency and rates of application to the

animals, the residues in treated animals

are expected to be essentially

undetectable and not toxicologically

significant.

B. Toxicological Profile

1. Acute toxicity. The acute oral

toxicity of technical BIT is relatively

low by oral and dermal exposure. The

60434 Federal Register / Vol. 65, No. 197 / Wednesday, October 11, 2000 / Notices

acute oral median lethal dose (MLD) of

the technical is 700–800 milligrams/

kilograms (mg/kg) (toxicity category III)

in rats and the acute dermal LD50 in rats

is >2,000 mg/kg (toxicity category III).

Technical BIT is slightly irritating to

rabbit skin following a single 4 hour

exposure and an abbreviated rabbit eye

irritation study showed technical BIT to

be a severe eye irritant. In skin

sensitization studies using guinea pigs,

technical BIT was shown to be a

moderate skin sensitizer under the

conditions of the test.

2. Genotoxicty. Generally, BIT is nonmutagenic in the Ames test with and

without metabolic activation. In cases

where the Ames test has produced

positive responses the responses are

either not reproducible or lack a dose

response effect. In a L5178Y mouse

lymphoma cell test, BIT produced a

negative response both in the presence

and absence of S9 activation, indicating

it is non-mutagenic in mammalian cells.

Negative responses were also seen in

vitro in a DNA repair assay. In an in vivo

mouse bone marrow micronucleus

assay, BIT produced a negative

response, indicating that it was not

cytotoxic to bone marrow cells. BIT did

not induce unscheduled DNA synthesis

in rat hepatocytes. The conclusion from

the results of these various assays is that

BIT presents no significant genotoxic

hazard, either in vitro or in vivo.

3. Reproductive and developmental

toxicity. In a rat teratology study, doses

up to 100 mg/kg/day of the technical

BIT administered from days 7–16 of

gestation did not cause any teratogenic

effects. The highest dose level was

maternally toxic and was marginally

toxic to the fetuses. The no observed

adverse effect level (NOAEL) for fetal

toxicity was 40 mg/kg/day and 10 mg/

kg/day for maternal toxicity.

4. Subchronic toxicity. NOAELs for

BIT have been determined in 2

subchronic studies. In a 90 day feeding

study conducted with rats in which the

animals received 0, 200, 900, or 4,000

ppm of BIT technical paste in the diet,

the only toxic effects observed occurred

in the high dose animals and consisted

of decreased body weights (bwts) (both

sexes) and reduced food consumption

(females). Hyperplasia of the fore

stomach observed histopathologically in

high dose animals was considered to be

due to irritation by the test material. The

toxicological NOAEL was 900 parts per

million (ppm) (about 74 mg/kg/day).

In another subchronic study, male

and female beagle dogs (4 animals sex/

dose) were dosed orally for 90 days with

0, 5, 20, or 50 mg/kg/day of the BIT

technical paste in corn oil. No

toxicologically significant effects were

seen in any dose group, resulting in a

toxicological NOAEL of 50 mg/kg/day.

The absolute NOAEL in the study was

5 mg/kg/day.

5. Chronic toxicity. Although no

chronic studies have been conducted on

BIT, the proposed use of BIT as an inert

ingredient (preservative/stabilizer) in

pesticide products applied to animals is

not expected to create or result in

chronic exposure to humans. The

combined results from various

mutagenicity studies indicate that BIT is

not genotoxic. The effects noted in the

subchronic studies in both rats and dogs

did not indicate concern for potential

chronic toxicity. Since BIT is not

structurally similar to a known

carcinogen, all current available

evidence indicates that BIT would not

be carcinogenic.

6. Animal metabolism. Rats

administered radiolabelled BIT by

gavage showed that most (86%) of the

radioactivity was excreted within 24

hours. A total of 96% (91% in urine, 5%

in feces) was excreted in 5 days.

Analysis of abdominal fat after repeated

dosing with BIT showed no

accumulation of BIT or any of its

metabolites. In another study comparing

the metabolism of BIT in the rat and

dog, the routes of metabolism in the 2

species were shown to be essentially

similar. Breakdown of BIT by both

species was rapid and was carried

essentially to completion since no

unchanged BIT was found in either rat

or dog urine.

7. Metabolite toxicology. Metabolism

studies in both the rat and dog showed

that BIT was rapidly and completely

metabolized by both species. The

metabolites identified included o-

(methylsulphinly)benzamide, and o-

(methylsulphonyl)benzamide. The

studies showed there were no

significant accumulation of BIT or its

metabolites in either species. There are,

therefore, no significant concerns

regarding the toxicity of BIT or its

metabolites.

8. Endocrine disruption. BIT does not

appear to disrupt (block, enhance, or

mimic) normal endocrine function. BIT

is not structurally similar to natural

hormones, especially estrogens,

androgens, and thyroid hormones.

C. Aggregate Exposure

1. Dietary exposure—i. Food. Based

on the toxicity data, an aggregate risk or

likelihood of the occurrence of an

adverse health effect resulting from all

routes of exposure to BIT is not

expected. There are not acute

toxicological concerns associated with

the proposed use of BIT as an inert

ingredient in animal pesticide products.

An acute dietary risk assessment,

therefore, is not required.

Chronic exposure to BIT through food

is essentially insignificant. This is

illustrated by using cattle as an example

because proposed dose rates as well as

frequency of dosing will be higher in

this species that other potential food

source animals such as sheep or swine.

The absolute maximum accumulated

dose of BIT which could be received by

an animal based on the highest number

of applications permitted at the highest

dose rates would not exceed 280 mg of

BIT per year, based on a maximum of

20 applications per animal per year.

This is assuming 100% of each dose of

the pesticide is absorbed through the

skin whether it is applied as a pour-on

or a spray. For a 500 kg cow this

amounts to 0.56 mg/kg BIT per year.

Metabolism studies show that 96% of

BIT is excreted within 5 days. If it were

assumed that the remaining 4% of BIT

is not excreted and accumulates in the

animal, this would leave 0.022 mg/kg

BIT per animal. Assuming a maximum

dietary intake of 16 ounces of beef per

day, an average 70 kg adult would ingest

0.01 mg of BIT, which is 0.0001 mg/kg

per day. A 28 kg child consuming an

average of 4 ounces of beef per day

would ingest 0.002 mg of BIT per day,

which is 0.00007 mg/kg/day. These

calculations indicate that levels of BIT

in the diet resulting from its proposed

use in animal pesticide products are

essentially insignificant in both adults

and children, even when highly

exaggerated levels of product absorption

and food consumption are used in the

calculations. It is assumed that infants

will not be consuming any beef.

Potential exposure to BIT through milk

consumption, even to children during

the years of highest consumption of

cows’ milk, is considered to be

negligible.

ii. Drinking water. Contamination of

drinking water would not be expected to

occur under the proposed use

conditions of BIT as an inert

preservative/stabilizer in very low

concentrations in pesticide products

intended for topical applications only.

The end use product would be applied

principally to cattle and other domestic

animals as either a direct pour-on

application or as a spray. Neither

method of application is expected to

contaminate water supplies intended for

human consumption.

2. Non-dietary exposure. The

proposed use of BIT as a preservative/

stabilizer in end-use animal pesticide

formulations is not expected to result in

any significant non-dietary exposure

due to the low concentration of BIT

employed in the formulation and the

Federal Register / Vol. 65, No. 197 / Wednesday, October 11, 2000 / Notices 60435

extremely low probability of significant

contact by the general public following

animal treatment.

D. Cumulative Effects

The cumulative exposure assessment

provides an estimate of the extent to

which a defined population is exposed

to two or more chemicals that share a

common mechanism of toxicity by all

relevant routes and from all relevant

sources. Essentially all exposure from

this proposed use of BIT will occur via

the diet in the form of meat consumed

from animals treated topically with

products intended to control external

parasites. As discussed above, the levels

consumed should not exceed 0.0001

mg/kg/day for adults and 0.00007 mg/

kg/day for children. No additional

exposure of the general public is

expected from either drinking water or

non-dietary sources. Even using

extremely conservative assumptions, the

calculated exposure levels are so low as

to be insignificant. The risk of

cumulative effects and/or toxicity from

BIT is negligible.

E. Safety Determination

1. U.S. population. No adverse effects

of any kind would be expected from the

extremely low dietary levels of BIT that

may result from the proposed use of BIT

in animal pesticide formulations.

2. Infants and children. Nothing in

the available literature would suggest

that infants and children are more

sensitive to the effects of BIT than

adults. Since the calculated dietary

exposure of children to BIT is even less

than adults, this proposed use of BIT

should not pose a risk to this population

subgroup. Exposure of infants to BIT

resulting from its proposed use is

expected to be negligible based on the

fact that beef is not a normal dietary

component for this population. In

summary the proposed use of BIT as an

inert ingredient in certain animal

pesticides formulations will not put

infants and children at risk.

F. International Tolerances

No Codex maximum residue levels

have been established for BIT.

[FR Doc. 00–25751 Filed 10–10–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00609A; FRL–6741–2]

The Role of Use-Related Information in

Pesticide Risk Assessment and Risk

Management

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability.

SUMMARY: EPA announces the

availability of the revised version of the

pesticide science policy document

entitled ‘‘The Role of Use-Related

Information in Pesticide Risk

Assessment and Risk Management.’’

This notice is one in a series concerning

science policy documents related to the

implementation of the Federal Food,

Drug and Cosmetic Act, as amended by

the Food Quality Protection Act.

FOR FURTHER INFORMATION CONTACT:

Deborah Sisco, Environmental

Protection Agency (7503C), 1200

Pennsylvania, Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8121; fax number (703) 308–8090;

e-mail address: sisco.deborah@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you manufacture or

formulate pesticides. Potentially

affected categories and entities may

include, but are not limited to:

Categories NAICS

Examples of potentially affected

entities

Pesticide

producers

32532 Pesticide manufacturers

Pesticide formulators

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 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 notice affects certain entities. If you

have any 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 or Other Related Documents?

1. Electronically. You may obtain

electronic copies of this document, the

science policy documents, and certain

other related documents that might be

available from the Office of Pesticide

Programs’ Home Page at http://

www.epa.gov/pesticides. On the Office

of Pesticide Programs’ Home Page select

‘‘FQPA’’ and then look up the entry for

this document under ‘‘Science

Policies.’’ You can also go directly to the

listings at the EPA Home page at http:/

/www.epa.gov. On the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry to this document under

‘‘Federal Register—Environmental

Documents.’’ You can go directly to the

Federal Register listings at http://

www.epa.gov/fedrgstr.

2. Fax-on-demand. You may request a

faxed copy of the science policy

documents, as well as supporting

information, by using a faxphone to call

(202) 401–0527. Select item 6069 for the

document entitled ‘‘The Role of UseRelated Information in Pesticide Risk

Assessment and Risk Management.’’

Select item 6070 for the document

entitled ‘‘EPA’s Responses to Public

Comments on the Draft Policy

Document.’’ You may also follow the

automated menu.

3. In person. The Agency has

established an official record for this

action under docket control number

OPP–00609A. In addition, the

documents referenced in the framework

notice, which published in the Federal

Register on October 29, 1998 (63 FR

58038) (FRL–6041–5) have also been

inserted in the docket under docket

control number OPP–00557. The official

record consists of the documents

specifically referenced in this action,

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