widely recognized and accepted as safe. The policy is clear, however, that in regulating foods and their byproducts derived from new plant varieties, FDA will use section 409 to require food additive petitions whenever safety questions are sufficient to warrant formal premarket review to ensure public health protection.
FDA does not generally expect that transferred genetic material itself to be subject to food additive regulation. In regulatory terms, such material is presumed to be GRAS. Substances present in food as a result of the presence of transferred genetic material, referred to as “expression products,” will typically be proteins or substances produced by the action of protein enzymes, such as carbohydrates, fats, and oils. If the intended expression product differs significantly in structure, function, or composition from substances found ordinarily in food or if it has no history of safe use in food, it might not be GRAS and might require food additive regulation. Again, the 1992 policy provides guidance to producers in evaluating the safety of food that they intend to market, including criteria and analytic steps for determining whether a product is a candidate for food additive regulation and whether consultation with FDA is appropriate. Ultimately, food producers are held accountable for the safety of their products.
As of July 1999, FDA has conducted 45 final consultations under its 1992 policy, of which 16 concerned transgenic pest-protected plants (FDA 1999b). A final consultation is evidenced by a letter from FDA acknowledging completion of the consultation process. The agency likely has had many more preliminary consultations with researchers and producers during the same period, although no public record is kept of such meetings.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a licensing statute under which EPA regulates the sale, distribution and use of pesticides (US Congress 1947). Pesticide is defined broadly as including any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating a pest (US Congress 1947, section 136(u)). The concept of pesticidal intent is critical to the definition pesticides under federal law. Pest means: 1) any insect, rodent, nematode, fungus, weed, or 2) any other form of terrestrial or aquatic plant or animal life, or virus, bacterium, or other microorganism (except viruses, bacteria, or other microorganisms on or in living humans or other living animals) that the EPA declares to be a “pest ” (US Congress 1947, section 136(t)).