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Guidance for Submission of Probabilistic Human Health Exposure Assessments Science Policy; Notice of Withdrawal

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Information about this document as published in the Federal Register.

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Environmental Protection Agency (EPA).




EPA announces the withdrawal of the pesticide science policy document “Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs.” This science policy document was developed to establish guidance for submission and review of probabilistic human health exposure assessments to the Agency's Office of Pesticide Programs. This guidance has been superseded by EPA's “Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity,” and by the “Guidance for Performing Aggregate Exposure and Risk Assessment.”

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David J. Miller, Health Effects Division, Office of Pesticide Programs (7509P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5352; fax number: (703) 305-5147; e-mail address:

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I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. This action, however, may be of interest to persons who produce or formulate pesticides or who register pesticide products. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. 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 Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0935. Publicly available docket materials are available either in the electronic docket at, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at​fedrgstr.

II. Background

The Food Quality Protection Act of 1996 (FQPA) significantly amended the Start Printed Page 34342Federal 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 and strengthened health protections for infants and children from pesticide risks.

During 1998 and 1999, EPA and the United States Department of Agriculture (USDA) established a subcommittee of the National Advisory Council for Environmental Policy and Technology (NACEPT), the Tolerance Reassessment Advisory Committee (TRAC), to address FFDCA 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 from May 27, 1998, through April 29, 1999.

In order to continue the constructive discussions about FFDCA, EPA and USDA established, under the auspices of NACEPT, the Committee to Advise on Reassessment and Transition (CARAT). The CARAT provided a forum for a broad spectrum of stakeholders to consult with and advise the Agency and the Secretary of Agriculture on pest and pesticide management transition issues related to the tolerance reassessment process. The CARAT was intended to further the valuable work initiated by earlier advisory committees toward the use of sound science and greater transparency in regulatory decision-making, increased stakeholder participation, and reasonable transition strategies that reduce risks without jeopardizing American agriculture and farm communities.

As a result of the 1998 and 1999 TRAC process, EPA decided that the implementation process and related policies would benefit from providing notice and comment on major science policy issues. The TRAC identified nine science policy areas it believed were key to implementation of tolerance reassessment. EPA agreed to provide one or more documents for comment on each of the nine issues by announcing their availability in the Federal Register. In a notice published in the Federal Register of October 29, 1998 (63 FR 58038) (FRL-6041-5), EPA described its intended approach. Since then, EPA has issued a series of draft and revised documents concerning the nine science policy issues. Publication of this notice is intended to update the public on the status of the science paper “Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs.”

III. Why this Policy is No Longer Needed

Historically, assessment of the potential health risks associated with exposure to pesticides has focused upon single pathways of exposure (e.g., from pesticide residues in food, water, or residential/non-occupational uses) for individual chemicals, and not on the potential for individuals to be exposed to multiple pesticides by all pathways concurrently. In 1996, the FQPA required EPA to consider potential human health risks from all pathways of dietary and non-dietary exposures to more than one pesticide acting through a common mechanism of toxicity.

The “Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs” was issued in 1998;​fedrgstr/​EPA-PEST/​1998/​November/​Day-05/​6021.pdf. The “Guidance for Submission of Probabilistic Human Health Exposure Assessments” provided general guidance on the conduct of probabilistic risk assessments. The guidance was intended to be used chiefly by persons conducting human health exposure assessments for purposes of registration or reregistration of pesticides.

EPA is withdrawing the “Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs” because it has been superseded by several other EPA policy and guidance documents. These include: (1) “General Principles for Performing Aggregate Exposure and Risk Assessments,”​pesticides/​trac/​science/​aggregate.pdf, and (2) “Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity,”​pesticides/​trac/​science/​cumulative_​guidance.pdf.

The “General Principles for Performing Aggregate Exposure and Risk Assessments” focus upon describing principles to guide the way in which aggregate exposure and risk assessment may be performed when more extensive distributional data and more sophisticated exposure assessment, methods and tools are available.

The “Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity” provides guidance for OPP scientists for evaluating and estimating the potential human risks associated with such multi-chemical and multi-pathway exposures to pesticides.

The policies and guidance mentioned above reflect EPA's most recent guidance, thus superseding the information in “Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs.” While the information in the document we are withdrawing is not necessarily inaccurate, it is outdated.

This action is also responsive to the recommendations made by EPA's Office of Inspector General during its review of EPA's implementation of FQPA. In its report “Opportunities to Improve Data Quality and Children's Health through the FQPA” issued January 10, 2006​oig/​reports/​2006/​20060110-2006-P-00009.pdf the Office of Inspector General Recommended that EPA should update the status of its science policy issue papers. This Federal Register notice updates the public on the status of one of the science policy papers which has been superseded by other guidance.

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Dated: June 30, 2009.

James Jones,

Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.

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[FR Doc. E9-16273 Filed 7-14-09; 8:45 am]