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Pesticides; Policy Issues Related to the Food Quality Protection Act

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Environmental Protection Agency (EPA).


Notice of availability.


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.

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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:

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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:

CategoriesNAICSExamples of potentially affected entities
Pesticide producers32532Pesticide 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​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 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​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 Start Printed Page 39148includes 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 Start Printed Page 39149comments 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.

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List of Subjects

  • Environmental protection
  • Administrative practice and procedure
  • Agricultural commodities
  • Pesticides and pests
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Dated: June 15, 2000.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances.

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[FR Doc. 00-15917 Filed 6-22-00; 8:45 am]