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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
expanded by all three agencies to include more public information about specific products and to link agencies' decisions about specific products. The EPA pesticide fact sheets for transgenic plant pesticides should be improved because they currently do not clearly and quantitatively present the results of safety testing.
Another element in box ES.1 is consistency of regulatory scope. The scope of agency oversight, in some cases, needs to be clarified (see section 4.3.3).
With new recombinant DNA methods, USDA can no longer rely on the production of transgenic pest-protected plants with regulatory sequences 13 from plant pests (for example, Agrobacterium tumefaciens vectors and cauliflower mosaic-virus promoters). Some new products may be developed using natural plant regulatory sequences. It is not clear if USDA would consider these products “plant pests.” Therefore, the committee recommends that
The USDA should clarify the scope of its coverage as there are sometransgenic pest-protected plants that do not automatically meet itscurrent definition of a plant pest.
The delineation of lead and supporting agency jurisdiction over transgenic pest-protected plant products is generally well defined. Agency reviews generally lack duplication and achieve consistency. However, the committee identified some examples where communication and coordination could be improved.
To improve coordination among the three regulatory agencies, EPA,FDA, and USDA should develop a memorandum of understanding (MOU)for transgenic pest-protected plants that provides guidance to identifythe regulatory issues that are the purview of each agency (for example,ecological risk and pesticide tolerance assessment for EPA, plantpest risk for USDA, and dietary safety of whole foods for FDA), identifiesthe regulatory issues for which more than one agency has responsibility(for example, gene flow for EPA and USDA and food allergens for EPAand FDA), and establishes a process to ensure appropriate and timelyexchange of information between agencies.
If differences in regulatory findings remain after interagency consultations, they should be adequately explained to ensure that regulatory decisions are not in conflict and do not have the appearance of conflict.
Non-coding regions of genes which are involved in controlling the expression of genes.