Agency Response Letter for FMF No. 000763 on Bt 10 Corn
September 15, 2006
Agency Response Letter
FMF No. 000763
Director, Federal Government Relations
Syngenta America, Inc.
1339 New York Avenue, NW Suite 750
Washington, DC 20005z
Dear Ms. Felner:
This letter is in regard to Syngenta Seeds, Inc.'s (Syngenta) communications to the U.S. Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) about grain derived from genetically engineered corn event Bt 10 (Bt 10 corn). According to Syngenta, Bt 10 corn is genetically engineered to express two new proteins, Cry1Ab and phosphinothricin acetyltransferase (PAT). The Cry1Ab protein provides resistance to certain lepidopteran insects. The PAT protein confers tolerance to glufosinate ammonium herbicides and was used as a selectable marker in the development of Bt 10 corn. Syngenta explains that event Bt 10 was introduced into several corn lines when event Bt 10 was mistakenly thought to be corn event Bt 11, the subject of a previously completed consultation with FDA (BNF 000017).
FDA, in coordination with the U.S. Environmental Protection Agency (EPA), evaluated the safety of genetically engineered Bt 10 corn in food and feed in response to the inadvertent marketing of Bt 10 corn. EPA stated on April 27, 2005, that the Cry1Ab and PAT proteins present in Bt 10 corn fall within existing exemptions from a tolerance for these proteins (http://www.epa.gov/pesticides/biopesticides/pips/bt10_statement.htm). On the same date, FDA issued a statement explaining that, based on EPA's finding that the genetically engineered proteins in Bt 10 corn 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 had concluded that the presence of Bt 10 corn in the food and feed supply poses no safety concerns (http://wcms.fda.gov/FDAgov/Food/Biotechnology/Announcements/ucm109424.htm).
Although Syngenta has stated that it has no intention of marketing Bt 10 corn, on June 8, 2005, Syngenta provided FDA with the firm's safety data and information. Syngenta supplied further clarification on subsequent dates. We placed the data and information provided by Syngenta into Food Master File (FMF) Number 763.
Based on the safety and nutritional assessment Syngenta has conducted, it is our understanding that Syngenta has concluded that corn grain derived from the new variety is not materially different in composition, safety, and other relevant parameters from corn grain currently on the market.
FDA evaluated the data and information provided by Syngenta and summarized our findings in a Memorandum to the File dated August 29, 2006 (see attached), which along with this letter, will be available on our Internet site. FDA finds that the data and information in Syngenta's submissions are consistent with and provide additional support for FDA's April 27, 2005, statement that the presence of Bt 10 corn grain in the food and feed supply poses no safety concerns, and are consistent with and provide support for Syngenta's conclusion that grain from Bt 10 corn is not materially different in composition, safety or other relevant parameters from corn grain now grown, marketed, and consumed.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
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