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 “Assigning Values to Non-Detected/Non-Quantified Pesticide Residues.” This notice is the sixteenth 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), Ariel Rios Bldg., 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 papers, as well as supporting information, by using a faxphone to call (202) 401-0527. Select item 6047 for the paper entitled “Assigning Values to Non-Detected/Non-Quantified Pesticide Residues.“ Select item 6048 for the paper entitled “Responses to Public Comments on the Office of Pesticide Program's Draft Science Policy Documents.“ 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-00570A. 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 for 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 many 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 October 21, 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 it believes 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 is announcing through the Federal Register the availability of a series of draft documents concerning nine science policy issues identified by the TRAC related to the implementation of FQPA. After receiving and reviewing comments from the public and others, EPA is also issuing revised science policy documents which reflect changes made in response to comments. In addition to comments received in response to these Federal Register notices, EPA will consider comments received during the TRAC meetings. Each of these issues is evolving and in a different stage of refinement. Accordingly, as the issues are further refined by EPA in consultation with USDA and others, they may also be presented to the SAP.

III. Summary of Revised Science Policy Guidance Document

Residue data are used by the EPA's Office of Pesticide Programs to support the establishment or reassessment of a pesticide tolerance associated with a particular food use. In some cases, a portion of the measurements of the levels of pesticide residue present on food shows no detection of residues. These “nondetects” (NDs) do not necessarily mean that the pesticide is not present at any level, but simply that any amount of pesticide present is below the level that could be detected or reliably quantified using a particular analytical method.

The primary science policy issue concerning NDs is what value the EPA should assign to them when estimating dietary exposure and risk from a pesticide. The reason this is an important issue stems from the new requirements that the FQPA impose on EPA. Among other things, FQPA established a stringent health-based standard (“a reasonable certainty of no harm”) for pesticide residues in foods to assure protection of the public health, including sensitive populations such as infants and children, from unacceptable pesticide exposure and risks. OPP's goal is to make exposure and risk assessments as accurate and realistic as possible while not underestimating exposure or risk, so that all humans, including infants and children, are fully protected. The specific issues addressed in this paper concern the values the Agency should assign to NDs in order to meet this goal.

In general, the OPP recommends use of a default value of \1/2\ the Limit of Detection (LOD) or \1/2\ the Limit of Quantitation (LOQ) for commodities which have been treated but for which no detectable residues are measured. This paper also describes the OPP's policy of performing a “sensitivity analysis” to determine the impact of using different assumptions (e.g., assuming NDs = full LOD or full LOQ versus NDs = zero), on the OPP's risk assessment for the pesticide under evaluation. If it is demonstrated through the sensitivity analysis that the default assumptions have no effect on the final OPP risk decision, then there is little reason for OPP to attempt to further refine these default assignments.

If OPP finds that these default assignments do have a significant effect on the risk estimate or risk decision or decides that a more refined risk estimate is needed, a second set of statistical methods can be used instead to determine the values or distribution of values for NDs. These statistical methods provide a more accurate way of estimating dietary exposure and risk than assuming that, for NDs, exposure occurs at \1/2\ LOD or some other single, finite value and allowing risk assessors to impute a series of values which represent concentrations below the stated detection limit. These methods would generally be used only in situations where the NDs comprise a significant (but less than half) portion of the data set and the rest of the data are normally or lognormally distributed, but exceptions can be considered on a case-by-case basis.

This revised document was developed from two previous draft documents entitled “Assigning Values To Nondetected/Nonquantified Pesticide Residues into Human Health Dietary Exposure Assessments”(docket control number OPP-00570) and “A Statistical Method for Incorporating Nondetected Pesticide Residues into Human Health Dietary Exposure Assessments” (docket control number OPP-00571) that were released for public comment December 4, 1998 (63 FR 67063) (FRL-6048-2). The Agency received comments from various organizations. Each of the commenters offered recommendations for improving the science policy. All comments were extensively evaluated and considered by the Agency. This revised version embodies many of the sentiments and recommendations of the commenters. A summary of the public comments, as well as the Agency's response to the comments, are being made 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