T96-68 Arthur Whitmore October 7, 1996 (202) 205-4144 FDA EVALUATION OF BIOENGINEERED SOYBEAN AND CORN VARIETIES We have been receiving inquiries regarding the safety of Monsanto Corp.'s soybean variety genetically engineered for resistance to the herbicide glyphosate and Ciba-Geigy Corp.'s corn variety genetically engineered for resistance to the European corn borer. Both companies consulted with FDA prior to marketing their product, and the agency found no reason to suspect that the products are unsafe for use in animal or human food products. The following may be useful for answering questions. FDA requests developers of genetically engineered plant varieties to submit summaries of nutritional and safety data on the new varieties for review by the agency to ensure that relevant scientific and safety issues are resolved before the products are marketed. This request and agency review is consistent with FDA policy guidelines on new plant varieties issued in 1992. The 1992 policy is based on existing food law and requires that genetically engineered foods meet the same rigorous safety standards required for all other foods. The law places a responsibility on producers and sellers to offer only safe food products to consumers. Federal food law requires premarket approval for food additives, whether or not they are the products of biotechnology. FDA treats substances added to food products through recombinant DNA techniques as food additives if they are significantly different in structure, function or amount than substances currently found in food. However, if a new food product developed through biotechnology does not contain substances that are significantly different from those already in the diet, it does not require premarket approval. Products that are genetically engineered to provide pesticide traits, such as resistance to the corn borer, are also subject to regulation by the Environmental Protection Agency. Monsanto initiated consultations with FDA about its new herbicide-tolerant soybean variety in June 1993. Ciba-Geigy initiated consultations with FDA about its new corn-borer resistant corn variety in March 1995. For both products, FDA biotechnology teams reviewed summary data and discussed scientific issues with company officials. The FDA teams included experts in chemistry, molecular biology, toxicology, human and animal nutrition, environmental science and the regulation of food ingredients. Data presented by the companies addressed intended use, mechanisms of intended effect, molecular alterations, safety, composition and wholesomeness. Based on the data, FDA has found no basis to disagree with the developers' determinations that neither product was significantly altered from varieties of soy and corn with a history of safe use, and that both products are safe for introduction into the marketplace. The agency has received no additional data that would cast doubt on that assessment. ####