U.S. Food and Drug Administration's Statement on Bt 10 Corn
CFSAN/Office of Food Additive Safety
April 27, 2005
The U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA) have coordinated efforts to determine the safety of genetically engineered Bt 10 corn in food and feed. Bt 10 is closely related to Bt 11, a genetically engineered corn line which has undergone full U.S. regulatory clearance. FDA has evaluated whether the inadvertent marketing of Bt 10 presents any food or feed safety concerns.
FDA does not believe that possible unintended changes in the composition of corn pose food or feed safety risks or regulatory issues in circumstances in which the corn makes up a small part of the total food or feed supply. In this type of situation, the relevant information for food and feed safety is the safety of the new protein(s) in the corn. Therefore, in circumstances such as those surrounding the presence of Bt 10 in food and feed, the information relevant to safety assessment is limited to the safety of the proteins evaluated by EPA.
Based on EPA's finding that the genetically engineered proteins in Bt 10 are safe, the extremely low levels of Bt 10 corn in the food and feed supply, and the fact that corn does not contain any significant natural toxins or allergens, FDA has concluded that the presence of Bt 10 corn in the food and feed supply poses no safety concerns.
Thus, under these circumstances, there are no further requirements under the U.S. regulatory process for Bt 10 to be legally present in the United States food and feed supply. However, it is not legal for Bt 10 to be planted in the United States.
For more information on the respective roles of USDA-APHIS, EPA, and FDA in the federal regulation of genetically engineered plants, see the United States Agencies Unified Biotechnology Website.
FDA's Biotechnology Consultation (BNF No. 000017) on Bt 11 corn: