Pesticides; Policy Issues Related to the Food Quality Protection Act

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

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: martin.kathleen@epa.gov.

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:

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.”

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