[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:

 
------------------------------------------------------------------------
                                                         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'' 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]
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