Biotechnology Consultation Agency Response Letter BNF No. 000085
May 10, 2004
Irene Gatti, Ph.D.
Mycogen Seeds c/o Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, IN 46268
Dear Dr. Gatti:
This is in regard to Mycogen Seeds c/o Dow AgroSciences LLC's (DAS) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on its genetically engineered cotton event 281-24-236. According to DAS, cotton event 281-24-236 is genetically engineered to express two new proteins, Cry1F and phosphinothricin acetyltransferase (PAT). Cry1F confers resistance to Lepidopteran insects; PAT confers tolerance to chemically synthesized phosphinothricin products such as glufosinate-ammonium, and is used as a selectable marker. DAS states that Cry1F cotton event 281-24-236 is intended to be marketed and sold as a stacked event product along with Cry1Ac cotton event 3006-210-23 (submitted to FDA in a separate filing designated as BNF 0092). All materials relevant to this notification have been placed in a file designated BNF 0085. This file will be maintained in the Office of Food Additive Safety.
As part of bringing the consultation regarding this product to closure, DAS submitted a summary of its safety and nutritional assessment of the genetically engineered cotton on March 17, 2003, and submitted additional information on May 30, September 5, and September 25, 2003. These communications informed the FDA of the steps taken by DAS to ensure that this product complies with the legal and regulatory requirements that fall within FDA's jurisdiction. Based on the safety and nutritional assessment DAS has conducted, it is our understanding that DAS has concluded that cottonseed, kernels, toasted meal, refined oil and hulls derived from the new variety are not materially different in composition, safety, and other relevant parameters from cottonseed, kernels, toasted meal, refined oil and hulls currently on the market and that genetically engineered cotton event 281-24-236 does not raise issues that would require premarket review or approval by FDA.
Because the Environmental Protection Agency (EPA) regulates pesticidal substances and pesticidal inert ingredients, FDA has not evaluated the information related to the safety of the Cry1F and PAT proteins. It is DAS's responsibility to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food or feed derived from cotton event 281-24-236.
Based on the information DAS has presented to FDA, we have no further questions concerning cottonseed, kernels, toasted meal, refined oil and hulls derived from cotton event 281-24-236 at this time. However, as you are aware, it is DAS's continued responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.
George H. Pauli, Ph.D.
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition