Agency Proposes New Guidance on Small-Scale Field Testing and...

Agency Proposes New Guidance on Small-Scale Field Testing and Low-level Intermittent Presence in Food of Plant-Incorporated Protectants

In a draft Pesticide Registration (PR) Notice issued by EPA, the Agency is clarifying the process by which it reviews and ensures the safety of residues of plant-incorporated protectants (PIPs) in food or feed and the conditions under which a tolerance (maximum allowable residue limit) or an exemption from a tolerance would be required for field tests for biotechnology-derived food and feed crop plants containing PIPs. Plant-Incorporated Protectants are pesticidal substances produced by plants, including the genetic material necessary for the plant to produce the substance. PIPs also include any inert ingredients, such as selective markers used to insert the active ingredient in to the plant. The Federal Register Notice announcing a 60-day public comment period is available at ,a hhttp://www.epa.gov/fedrgstr/EPAFR-CONTENTS/2006/September/Day-29/contents.htm The draft Pesticide Registration notice can be found at: http://www.regulations.gov/fdmspublic/component/main. Under "Keyword", type in docket number: EPA-HQ-OPP-2006-0291.

This PR Notice does not present new rules, policies, or interpretations, but rather summarizes, explains, and provides guidance regarding compliance with existing rules under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). This PR Notice elaborates on policies described in the August 2, 2002, Federal Register Notice, 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. ( http://www.ostp.gov/html/redregbio.html). The use of bioengineered plants for food production, including plants engineered to express plant-incorporated protectants, has markedly increased over the past decade. Some researchers and other users of PIPs may not be aware of their obligations regarding small-scale field studies, and because those obligations are contained in several regulations, the Agency seeks to facilitate understanding of the requirements and prevent potential violations. More information on plant-incorporated protectants is available on EPA's Web site at http://www.epa.gov/pesticides/biopesticides/pips/index.htm.

Close Window