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

60436 Federal Register / Vol. 65, No. 197 / Wednesday, October 11, 2000 / Notices

holidays. The PIRIB telephone number

is (703) 305–5805.

II. Background Information

On August 3, 1996, the Food Quality

Protection Act of 1996 (FQPA) was

signed into law. The FQPA significantly

amended the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

and the Federal Food, Drug, and

Cosmetic Act (FFDCA). Among other

changes, FQPA established a stringent

health-based standard (‘‘a reasonable

certainty of no harm’’) for pesticide

residues in foods to assure protection

from unacceptable pesticide exposure

and strengthened health protections for

infants and children from pesticide

risks.

Thereafter, the Agency established the

Food Safety Advisory Committee

(FSAC) as a subcommittee of the

National Advisory Council for

Environmental Policy and Technology

(NACEPT) to assist in soliciting input

from stakeholders and to provide input

to EPA on the broad policy choices

facing the Agency and on strategic

direction for the Office of Pesticide

Programs (OPP). The Agency has used

the interim approaches developed

through discussions with FSAC to make

regulatory decisions that meet the new

FFDCA standard, but that could be

revisited if additional information

became available or as the science

evolved. In addition, the Agency seeks

independent review and public

participation, generally through

presentation of the science policy issues

to the FIFRA Scientific Advisory Panel,

a group of independent, outside experts

who provide peer review and scientific

advice to OPP.

During 1998 and 1999, as directed by

Vice President Albert Gore, EPA and the

U.S. Department of Agriculture (USDA)

established a second subcommittee of

NACEPT, the Tolerance Reassessment

Advisory Committee (TRAC) to address

FFDCA issues and implementation.

TRAC comprised more than 50

representatives of affected user,

producer, consumer, public health,

environmental, states, and other

interested groups. The TRAC met from

May 27, 1998 through April 29, 1999.

In order to continue the constructive

discussions about FFDCA, EPA and

USDA have established, under the

auspices of NACEPT, the Committee to

Advise on Reassessment and Transition

(CARAT). The CARAT provides a forum

for a broad spectrum of stakeholders to

consult with and advise the Agency and

the Secretary of Agriculture on pest and

pesticide management transition issues

related to the tolerance reassessment

process. The CARAT is intended to

further the valuable work initiated by

the FSAC and TRAC toward the use of

sound science and greater transparency

in regulatory decisionmaking, increased

stakeholder participation, and

reasonable transition strategies that

reduce risks without jeopardizing

American agriculture and farm

communities. The CARAT held its first

meeting on June 23, 2000.

As a result of the 1998 and 1999

TRAC process, EPA decided that the

implementation process and related

policies would benefit from providing

notice and comment on major science

policy issues. The TRAC identified nine

science policy areas it believed were key

to implementation of tolerance

reassessment. EPA agreed to provide

one or more documents for comment on

each of the nine issues by announcing

their availability in the Federal

Register. In a notice published in the

Federal Register of October 29, 1998 (63

FR 58038), EPA described its intended

approach. Since then, EPA has been

issuing a series of draft documents

concerning the nine science policy

issues. This notice announces the

availability of the revised science policy

document concerning the role of userelated information in pesticide risk

assessment and risk management.

III. Summary of Revised Science Policy

Guidance Document

EPA is charged with regulating the

sale and use of pesticides in the United

States. In order to evaluate the risks of

pesticide use and the benefits derived

from pesticide use, and to evaluate the

potential ramifications of regulatory

decisions about the sale and use of

pesticides, regulators must have

information about how, where, when,

why, and how much each pesticide is

used in the United states

This document provides an overview

of the role of use-related information in

the regulatory process in terms that can

be understood by the educated lay

public. The document summarizes the

types of use-related data used by EPA in

pesticide risk assessment and risk

management. It further describes where

the data come from, how the Agency

employs these data, and how EPA

organizes and evaluates pesticide use

data. However, this document is not

intended to delve into the technical

details of quantitative pesticide usage

analysis, such as calculation of likely

maxima, weighting methods, and

prediction intervals.

The document goes on to describe the

role of use-related data in human health

risk assessments, including drinking

water, and in ecological risk

assessments, and, finally, the role of

use-related information in risk

management decisions. The final

discussion of future steps for improving

the quality and quantity of pesticide use

data and strengthening the Agency’s

analytical approaches highlights the

limitations of the available use-related

data.

EPA published a draft version of this

document in the Federal Register of

July 14, 1999 (64 FR 37977) (FRL–6088–

6) and comments were filed in docket

control number OPP–00609. All

comments were considered by the

Agency in revising the document. Many

of the comments were similar in

content, and pertained to general issues

concerning the proposed policy or

specific sections within the draft

document. The Agency grouped the

comments according to the nature of the

comment and the issue or section of the

document which they addressed. The

Agency’s response to the comments is

available as described in Units I.B.1.

and I.B.2.

IV. Policies Not Rules

The policy document discussed in

this notice is intended to provide

guidance to EPA personnel and

decision-makers, and to the public. As

a guidance document and not a rule, the

policy in this guidance is not binding on

either EPA or any outside parties.

Although this guidance provides a

starting point for EPA risk assessments,

EPA will depart from its policy where

the facts or circumstances warrant. In

such cases, EPA will explain why a

different course was taken. Similarly,

outside parties remain free to assert that

a policy is not appropriate for a specific

pesticide or that the circumstances

surrounding a specific risk assessment

demonstrate that a policy should not be

applied.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests.

Dated: September 27, 2000.

Susan H. Wayland,

Acting Assistant Administrator for

Prevention, Pesticides and Toxic Substances.

[FR Doc. 00–25933 Filed 10–10–00; 8:45 am]

BILLING CODE 6560–50–S