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Guidance for Pesticide Registrants on Small-Scale Field Testing and Low-Level Presence in Food of Plant-Incorporated Protectants (PIPs); Notice of Availability

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Information about this document as published in the Federal Register.

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Environmental Protection Agency (EPA).




The Agency is announcing the availability of a Pesticide Registration Notice (PR Notice) titled “Guidance on Small-Scale Field Testing and Low-Level Presence in Food of Plant-Incorporated Protectants (PIPs).” PR Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. The PR Notice provides guidance to the registrant concerning clarification on the process by which EPA reviews and ensures the safety of low-level residues of PIPs in food or feed, and the conditions under which a tolerance or exemption from the requirement of a tolerance would be required for field tests for biotechnology-derived food and feed crop plants containing PIPs.

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Patricia Moe, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-0744; fax number: (703) 308-7026; 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. Although this action may be of particular interest to those persons who are involved in plant breeding using PIPs including but not limited to academic researchers, seed companies, and PIP registrants. 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 information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. What Guidance Does the PR Notice Provide?

The PR Notice provides guidance to the registrant concerning the policies described in the August 2, 2002 Federal Register (67 FR 50578)notice on “Proposed Federal Actions to Update Field Test Requirements for Biotechnology Derived Plants and to Establish Early Food Safety Assessments for New Proteins Produced by Such Plants” issued under the auspices of the Office of Science and Technology Policy (OSTP). The OSTP notice was issued to outline what measures federal agencies would take to prevent low levels of biotechnology derived genes and gene products from being found in commercial food and feed. The OSTP notice stated that EPA would rely on existing processes and publish guidance for individuals and organizations conducting field testing of PIPs. The PR Notice describes those existing rules along with the existing procedures related to them. Additionally, the PR Notice provides guidance on residue containment in small-scale field testing and the kinds of information that EPA has received to support the PIP tolerances issued thus far.

III. Do PR Notices Contain Binding Requirements?

The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and decision makers and to pesticide registrants. While the requirements in the statutes and Agency regulations are binding on EPA and the applicants, the PR Notice is not binding on either EPA or pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation.

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Dated: April 30, 2007,

Debra Edwards,

Director, Office of Pesticide Programs.

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[FR Doc. E7-8550 Filed 5-3-07; 8:45 am]