reviews the issues to be considered in the development of a food from new plant varieties, including the consideration of issues that can prompt a need for testing or consultation with FDA. In 1997, FDA issued Guidance on Consultation Procedures for Foods Derived from New Plant Varieties (FDA 1997c), which summarizes nine general points the FDA recommends be addressed in the development of a safety and nutritional assessment for such products as bioengineered foods.
FDA has not, however, issued guidance on the evaluation of the potential allergenicity of proteins added to foods via genetic engineering, despite assurances that it intends to. FDA coconvened a meeting on food allergy in 1994 with EPA and USDA that brought together leaders in the field to advise the agency on evaluating the allergenicity of proteins (FDA 1994b). FDA should use the results of that meeting, other scientifically relevant reports, and later research findings to develop guidance on allergenicity. The committee recommends that
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.
Publication of such guidance by FDA would be helpful both to companies consulting with FDA and to companies seeking approvals from EPA, inasmuch as EPA staff depend heavily on the expertise of FDA staff on allergenicity. For example, the committee learned of one transgenic pest-protected plant that contains an insecticidal protein that has a key biochemical characteristic of food allergens: stability in simulated gastric juices (EPA 1998c). Crops containing this protein are currently restricted to use as animal feed. Tests that the manufacturer should conduct to evaluate the potential allergenicity of this protein are not well defined, and both EPA staff and the manufacturer would benefit from guidance from FDA.
USDA has guidance documents and model submissions to help applicants determine what information is needed and how to complete a submission (USDA 1996a). The application forms provide guidance as to specific information needs, but they do not discuss the depth of information required or specifically define the methods to be used.
The committee developed a comprehensive list of data needs based on guidance documents and summaries of regulatory determinations made available by the agencies. The committee provided the agencies with a detailed consolidated list and asked them to indicate the items of most importance for their regulatory review. Individual meetings were conducted with each agency to discuss the responses.
The agency responses reveal four areas where the regulatory authori-