[Federal Register Volume 65, Number 197 (Wednesday, October 11, 2000)]
[Pages 60435-60436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25933]



[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: [email protected].


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:

                                                          Examples of
           Categories                    NAICS            potentially
                                                       affected entities
Pesticide producers               32532               Pesticide

    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 

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 Use-Related 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

[[Page 60436]]

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 use-related 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 
    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 

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 

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 

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