Poster: Biotech Risk Assessment

Abs # 898: Evaluation of Bioengineered Foods during the Consultation Process at the U.S. Food and Drug Administration

Presenter:	Carlson, Susan J., scarlson@cfsan.fda.gov
Authors	Carlson, Susan J. (A)
Affiliations:	(A): U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety

The current approach to the assessment of bioengineered foods at FDA is derived from two documents issued by FDA; the 1992 “Statement of Policy: Foods Derived from New Plant Varieties” and the proposed rule, “Premarket Notice Concerning Bioengineered Foods.” These two documents articulate the agency’s thinking regarding the regulatory status and potential safety issues presented by bioengineered foods. Because of the nature of modern molecular biology, bioengineered foods have a greater potential to have specific new substances introduced or have a significantly different composition from their conventional counterparts. FDA addresses these issues during its consultation with industry sponsors. The consultation includes an evaluation by FDA scientists as to whether any unresolved issues exist regarding the food derived from the new plant variety. Examples of such unresolved issues may include significantly altered levels of toxicants, anti-nutrients, or nutrients, the introduction of a new allergen, or the presence in the food of an unapproved food additive. During FDA’s evaluation, the totality of the data, including molecular biology, genetic, and compositional analyses are considered in addressing the safety and regulatory-status issues. I will present the typical data components of a biotechnology consultation with FDA.