E7-14685. Pesticides; Science Policy; Notice of Withdrawal

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA announces the withdrawal of the revised version of the pesticide science policy document “Standard Operating Procedures for Incorporating Screening-Level Estimates of Drinking Water Exposure into Aggregate Risk Assessments” http://www.epa.gov/​oppfead1/​trac/​science/​screeningsop.pdf. This science policy document was developed during the implementation of the new safety standard in section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). EPA's assessment of exposure to pesticide residues in drinking water no longer involves performing screening level assessments as described in this policy paper. Accordingly, EPA is withdrawing this science policy document. Instead, the Agency now routinely develops estimates of exposure to pesticides in drinking water using the more advanced methods that EPA has described in other science policy papers.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

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-2007-0218. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, 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 [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

II. Background

On August 3, 1996, FQPA was signed into law. The FQPA significantly amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and 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 U.S. 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, in 2000 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 two of the FQPA science policy papers.

III. Summary: Why the Policy Is No Longer Needed

As a result of the new procedures for estimating concentrations of pesticide residues in drinking water, this notice announces the withdrawal of “Standard Operating Procedures for Incorporating Screening-Level Estimates of Drinking Water Exposure into Aggregate Risk Assessments” http://www.epa.gov/​fedrgstr/​EPA-PEST/​2000/​October/​Day-11/​p25934.htm.

In assessing the risks of pesticide exposure, scientists frequently use mathematical models to predict pesticide concentrations in food, water, residential, and occupational environments. This notice pertains to how the Agency determines pesticide risk from drinking water. (For more information on the models the Agency uses to estimate concentrations of pesticides in drinking water see http://www.epa.gov/​oppefed1/​models/​water/​models4.htm). This approach provides a more realistic estimate of exposure through drinking water since actual drinking water consumption data and reported body weight from the Combined Survey of Food Intake by Individuals (CSFII) are used, rather than the standard assumptions used in the Drinking Water Level of Comparison approach.

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 http://www.epa.gov/​oigearth/​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 rendered obsolete by the availability of more robust data and models.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests

Dated: July 20, 2007.

James B. Gulliford,

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