[Federal Register Volume 65, Number 122 (Friday, June 23, 2000)]
[Notices]
[Pages 39147-39149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15917]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00591A; FRL-6589-8]
Pesticides; Policy Issues Related to the Food Quality Protection
Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: EPA is announcing the availability of the revised version of
the pesticide science policy document entitled ``Guidance for Refining
Anticipated Residue Estimates For Use in Acute Dietary Probabilistic
Risk Assessment.'' The Agency has also incorporated into this policy
document two other policy documents that were issued for public
comment: ``Guidance for the Conduct of Bridging Studies for Use in
Acute Dietary Probabilistic Risk Assessment'' and ``Guidance for the
Conduct of Residue Decline Studies for Use in Acute Dietary
Probabilistic Risk Assessment.'' This notice is the seventeenth in a
series concerning science policy documents related to the Food Quality
Protection Act of 1996 and developed through the Tolerance Reassessment
Advisory Committee.
FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Environmental
Protection Agency (7509C), 1200 Pennsylvania, Ave., NW., Washington, DC
20460; telephone number: (703) 308-2857; fax number: (703) 305-5147; 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
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Pesticide producers 32532 Pesticide
manufacturers
Pesticide
formulators
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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'' 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 6063 for the document
entitled ``Guidance for Refining Anticipated Residue Estimates For Use
in Acute Dietary Probabilistic Risk Assessment.'' Select item 6064 for
the document entitled ``EPA's Responses to Public Comments on the Draft
Policy Documents: Data for Refining Anticipated Residue Estimates Used
in Dietary Risk Assessments; Guidance for the Conduct of Bridging
Studies for Use in Acute Dietary Probabilistic Risk Assessment; and
Guidance for the Conduct of Residue Decline Studies for Use in Acute
Dietary Probabilistic Risk Assessment.'' 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-00591A. 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
[[Page 39148]]
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.
II. Background Information About the Tolerance Reassessment
Advisory Committee
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA)
was signed into law. Effective upon signature, 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; provided
heightened health protections for infants and children from pesticide
risks; required expedited review of new, safer pesticides; created
incentives for the development and maintenance of effective crop
protection tools for farmers; required reassessment of existing
tolerances over a 10-year period; and required periodic re-evaluation
of pesticide registrations and tolerances to ensure that scientific
data supporting pesticide registrations will remain up-to-date in the
future.
Subsequently, 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 some of 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 met FQPA's standard, but that could be revisited if
additional information became available or as the science evolved. As
EPA's approach to implementing the scientific provisions of FQPA has
evolved, the Agency has sought independent review and public
participation, often through presentation of the science policy issues
to the FIFRA Scientific Advisory Panel (SAP), a group of independent,
outside experts who provide peer review and scientific advice to OPP.
In addition, as directed by Vice President Albert Gore, EPA has
been working with the U.S. Department of Agriculture (USDA) and another
subcommittee of NACEPT, the Tolerance Reassessment Advisory Committee
(TRAC), chaired by the EPA Deputy Administrator and the USDA Deputy
Secretary, to address FQPA 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 seven times as a full committee from May 27, 1998, through
April 29, 1999.
The Agency worked with the TRAC to ensure that its science
policies, risk assessments of individual pesticides, and process for
decision making are transparent and open to public participation. An
important product of these consultations with TRAC was the development
of a framework for addressing key science policy issues. The Agency
decided that the FQPA implementation process and related policies would
benefit from initiating notice and comment on the major science policy
issues.
The TRAC identified nine science policy issue areas they believed
were key to implementation of FQPA and tolerance reassessment. The
framework calls for EPA to provide one or more documents for comment on
each of the nine issues by announcing their availability in the Federal
Register. In accordance with the framework described in a separate
notice published in the Federal Register of October 29, 1998 (63 FR
58038), EPA has been issuing a series of draft science policy documents
concerning nine science policy issues identified by the TRAC related to
the implementation of FQPA. This notice announces the availability of
the revised version of the science policy document identified in the
``SUMMARY.''
III. Summary of Revised Science Policy Guidance Document
This science policy document provides guidance to registrants,
other test sponsors and interested parties, and data reviewers on the
extent and quality of pesticide residue and ancillary data needed to
support the use of more refined ``anticipated residues'' in acute
dietary probabilistic exposure assessments. The purpose of this
guidance document is to outline the types of data OPP can use to refine
residue estimates for pesticides and explain when and how EPA may use
these data. Such data can include (as is further discussed in the
science policy document) information from cooking studies, processing
studies, and market basket surveys conducted on individual produce
items. In addition, such data can include information from ``bridging''
studies used to support the use of typical application rates in
probabilistic risk assessments or residue decline data used to support
the use of typical preharvest intervals (PHI) in probabilistic risk
assessments. This guidance also provides information on how risk-
mitigation activities (e.g., increasing PHIs and lowering maximum label
rates) can be considered in OPP risk assessments and used to adjust
tolerance levels.
It should be noted that the guidance in this science policy
document is not intended to limit or restrict the type of data that may
be submitted in support of risk-mitigation measures, and that OPP will
consider other data or information as long as they would provide a
scientifically sound basis for determining residues at typical
application rates for risk mitigation purposes.
EPA published a draft version of this science policy document on
April 7, 1999 (64 FR 16967) (FRL-6071-1) and comments were filed in
docket control number OPP-00591. In addition, EPA issued two related
draft science policy documents entitled, ``Guidance for the Conduct of
Bridging Studies for Use in Acute Dietary Probabilistic Risk
Assessment'' and ``Guidance for the Conduct of Residue Decline Studies
for Use in Acute Dietary Probabilistic Risk Assessment,'' on August 4,
1999 (64 FR 42371) (FRL-6093-2). Comments for these documents were
filed in docket control number OPP-00616. The Agency received comments
from several organizations and interested individuals. All comments on
these three draft science policy documents were considered by the
Agency in producing the revised version of the science policy document
and the response-to-comments document described in this notice.
Many of the comments were similar in content, and pertained to
general issues concerning the proposed policy or specific sections
within the draft science policy 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
[[Page 39149]]
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 be abandoned.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: June 15, 2000.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 00-15917 Filed 6-22-00; 8:45 am]
BILLING CODE 6560-50-F