[Federal Register Volume 65, Number 134 (Wednesday, July 12, 2000)]
[Notices]
[Pages 43009-43011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17493]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00576A; FRL-6589-6]


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 ``Available EPA 
Information on Assessing Exposure to Pesticides in Food--A User's 
Guide.'' This notice is the nineteenth 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:

[[Page 43010]]



 
------------------------------------------------------------------------
                                                         Examples of
           Categories                   NAICS            potentially
                                                      affected entities
------------------------------------------------------------------------
Pesticide producers                          032532  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 6061 for the document 
entitled ``Available EPA Information on Assessing Exposure to 
Pesticides in Food-A User's Guide.'' Select item 6062 for the document 
entitled ``Response to Comments for Available EPA Information on 
Assessing Exposure to Pesticides in Food-A User's Guide.'' 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-00576A. 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 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 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.''

[[Page 43011]]

III. Summary of Revised Science Policy Guidance Document

    The Agency's Office of Pesticide Programs regulates pesticides to 
ensure that their use does not pose unreasonable risks to human health 
or the environment and that pesticide residues in food are safe. These 
determinations rely on the process of risk assessment. In assessing 
risk, the Agency considers all routes of exposure (e.g., food, drinking 
water, incidental exposure in and around the home and school) and the 
inherent toxicity of the pesticide.
    The purpose of this ``User's Guide'' is to provide the reader with 
a comprehensive discussion and listing of EPA, USDA, and Food and Drug 
Administration (FDA) guidance, policy documents, and databases that 
provide detailed, specific ``how-to'' information and/or data on 
assessing exposure to pesticides from the foods that we eat. To put 
this exposure information in context, this guide first provides a basic 
overview of risk assessment for exposure resulting from pesticide 
residues in food.
    This guide does not address aggregate exposure and risk assessment, 
which is the process of combining exposure to a single pesticide from 
all sources of exposure: food, drinking water, and non-occupational 
sources such as homes and recreational areas. And, this guide does not 
address cumulative risk assessment, which is the process of combining 
exposure and risk from all pesticides with a common mechanism of 
toxicity.
    The first section of the guide, ``A Primer on Pesticide Exposure 
and Risk from Food,'' provides a very simple overview of EPA's approach 
to estimating risk and exposure from pesticide residues in food. The 
following section, ``Information Sources: Where to Find Guidance, Data, 
and Other Information on Assessing Exposure to Pesticides in Food,'' 
provides specifics on how to obtain or generate the data and/or 
information EPA uses in its assessments of exposure and risk from 
pesticides in food. Finally, a list of ``Where to Find's'' is provided 
along with the bibliography.
    EPA published the draft science policy document on January 4, 1999 
(64 FR 162) (FRL-6054-8) and comments were filed in docket control 
number OPP-00576. The public comment period ended on March 5, 1999. The 
Agency received comments from several organizations. All comments were 
considered by the Agency in the revised version of the science policy 
document.
    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 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 21, 2000.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 00-17493 Filed 7-11-00; 8:45 am]
BILLING CODE 6560-50-F