process should be transparent, with sufficient information made available to allow subsequent applicants to benefit.

  • EPA should publicly reexamine the extent to which FIFRA adverse effects reporting is intended to apply to plant breeders, researchers, and seed distributors of conventional pest-protected plants who have never been subject to FIFRA or EPA jurisdiction. For products that meet the definition of a pesticide but are exempt from registration under FIFRA, EPA should review the extent to which existing field monitoring systems could substitute for traditional FIFRA reporting requirements.

  • USDA should clarify the scope of its coverage as there are some transgenic pest-protected plants that do not automatically meet its current definition of a plant pest.

  • EPA and FDA should develop a memorandum of understanding (MOU) that establishes a process to ensure a timely exchange of information on plant-expressed pesticidal substances that are potential food allergens. The MOU should articulate a process under which the agencies can regulate potential food allergens in a consistent fashion— by EPA through tolerance setting and by FDA through food labeling.

  • EPA, USDA, and FDA should develop a memorandum of understanding for transgenic pest-protected plant products that provides guidance to identify the regulatory issues that are the purview of each respective agency (for example, ecological risks and tolerance assessment for EPA, plant pest risks for USDA, and dietary safety of whole foods for FDA); identifies the regulatory issues for which more than one agency has responsibility (for example, gene transfer for EPA and USDA and food allergens for EPA and FDA); and establishes a process to ensure appropriate and timely exchange of information between agencies.

  • Where regulation is not warranted, agencies should look for appropriate opportunities to promote nonregulatory mechanisms to address issues associated with transgenic pest-protected plant products, including encouraging development of voluntary industry consensus standards and product stewardship programs.

  • FDA should put a high priority on finalizing and releasing preliminary guidance on the assessment of potential food allergens, while cautioning that further research is needed in this area.

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