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Pesticide News Story: EPA Releases New Guidance on Plant-Incorporated Protectants: Small-Scale Field Testing and Low-level Presence in Food
For Release: May 4, 2007
The Agency is clarifying the process by which it reviews and ensures the safety of pesticidal properties expressed by plants containing plant-incorporated protectants (PIPs). EPA is further defining 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 plants containing plant-incorporated protectants. PIPs are pesticidal substances produced by the plants themselves and include the genetic material necessary for the plant to produce the substance and any inert ingredients, such as selective markers used to insert the active ingredient in to the plant. The use of bioengineered plants for food production, including plants engineered to express PIPs, 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 because those obligations are contained in several regulations.
The Agency has issued Pesticide Registration (PR) Notice 2007-02 to facilitate understanding of the requirements and prevent potential violations. This PR notice summarizes, explains, and provides guidance regarding compliance with existing rules under the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act. EPA published a draft PR Notice last year and solicited public comments. These documents are available through www.regulations.gov under Docket ID: EPA-HQ-OPP-2006-0291. This PR Notice discusses policies described in the August 2, 2002, Federal Register 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" www.ostp.gov/html/redregbio.html. More information on plant-incorporated protectants is available on EPA’s Web site at www.epa.gov/pesticides/biopesticides/pips/index.htm. The Federal Register Notice announcing the PR notice is now available.