|
Biotechnology Consultation
Agency Response Letter
BNF No. 000093
Penny L. Hunst, Ph.D.
Regulatory Manager- Biotech
Mycogen Seeds c/o Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, IN 46268
Dear Dr. Hunst:
This is in regard to the consultation that Mycogen Seeds c/o Dow AgroSciences LLC (DAS) initiated with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center of Food Safety and Applied Nutrition) on genetically engineered maize (corn) line 6275. According to DAS, this new line is engineered to express two new proteins, Cry1F and phosphinothricin acetyltransferase (PAT).1 The Cry1F protein provides a means of controlling the European corn borer and certain other Lepidopterous pests of maize. The PAT protein confers tolerance to glufosinate-ammonium herbicides and was used as a selectable marker in the development of maize line 6275. All materials relevant to this notification have been placed in a file designated BNF 0093. 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 maize on June 30, 2003. DAS submitted additional information on September 5, November 10, and December 4, 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 maize grain and forage derived from the new variety are not materially different in composition, safety, and other relevant parameters from maize grain and forage currently on the market and that the genetically engineered maize 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 maize line 6275.
Based on the information DAS has presented to FDA, we have no further questions concerning grain and forage derived from maize line 6275 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.
Sincerely yours,
/s/
Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition
(1)In its submission, DAS refers to the phosphinothricin acetyltransferase protein encoded by the bar gene as BAR to distinguish it from the phosphinothricin acetyltransferase protein encoded by the pat gene. To be consistent with FDA's previous notes to the file and response letters regarding crops containing the phosphinothricin acetyltransferase protein encoded by the bar gene, FDA refers to the phosphinothricin acetyltransferase protein from the bar gene as PAT in the note to the file and response letter for BNF 000093.
