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