Recognizing that traditional food safety assessments based on toxicological testing of small amounts of food components or food additives would rarely, if ever, apply to whole foods produced through biotechnology, the International Food Biotechnology Council (IFBC) was founded in 1988 to develop criteria and procedures to evaluate the safety of genetically modified foods. In its 1990 report Biotechnologies and Food: Assuring the Safety of Foods Produced by Genetic Modification, the IFBC adopted a decision tree approach to food safety assessment that has been widely recommended and adopted by numerous regulatory agencies (WHO/FAO, 1991; FDA, 1992; OECD, 1993).

Despite the limitations noted on stability to SGF (pepsin resistance), the data provide some predictive value of whether a given protein may be a food allergen when it is combined with other parameters such as the source of the gene, the homology sequence similarity, and stability to heat/processing. This testing scheme has been used for evaluation of the potential allergenicity of all the proteins inserted into the transgenic products (Astwood et al., 1996; Rasche, 1998; Harrison et al., 1996).

In cases where a gene is inserted into commonly allergenic foods, methods are available to determine if the insertion caused a change in the endogenous levels of the known allergenic proteins in that plant. These assays, immunoblot and RAST inhibition tests, are quantifiable. For example, soybeans are one of the eight commonly allergenic foods. During product development of two different transgenic soybeans, academic scientists compared the endogenous allergens in each transgenic soybean line to their respective conventional commercial varieties. The RAST inhibition tests demonstrated that the insertion of the genes did not change the level of expression of allergenic proteins in either line (Burks et al., 1995; Lehrer et al., 1997). Of course, this methodology could also be used to detect a reduction in the level of a known allergen that might have some value.