Biotechnology Consultation Agency Response Letter BNF No. 000073
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
May 18, 2001
Penny Hunst, Ph.D.
Dow AgroSciences LLC
9330 Zionsville Rd.
Indianapolis, IN 46268
Dear Dr. Hunst:
This is in regard to the consultation on genetically modified maize line 1507 that Mycogen Seeds c/o Dow AgroSciences LLC and Pioneer Hi-Bred International, Inc., initiated with the Agency on June 28, 2000. According to Dow AgroSciences, the maize line 1507 has been modified to express two new proteins, Cry1F and PAT. The Cry1F protein confers resistance to certain lepidopteran insects. The PAT protein confers tolerance to the herbicide glufosinate ammonium and was used as a selectable marker in the development of the insect resistant and glufosinate tolerant maize line 1507. All materials relevant to this consultation have been placed in a file that has been designated BNF 000073 and will be maintained by the Office of Premarket Approval.
As part of bringing the consultation regarding this product to closure, Dow Agrosciences submitted a summary of its safety and nutritional assessment of the genetically engineered maize line 1507. This communication informed FDA of the steps taken by Dow AgroSciences to ensure that this product complies with those legal and regulatory requirements that fall within FDA's jurisdiction. Based on the safety and nutritional assessment you have conducted, it is our understanding that Dow AgroSciences has concluded that the maize line 1507 is not materially different in composition, safety, or other relevant parameters from maize currently on the market, and that it does not raise issues that would require premarket review or approval of 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 Dow AgroSciences' responsibility to obtain all appropriate clearances, including those from EPA and the United States Department of Agriculture, before marketing food or feed derived from maize line1507.
Based on the information Dow AgroSciences has presented to FDA, we have no further questions concerning the bioengineered maize line 1507 at this time. However, as you are aware, it is Dow AgroSciences LLC's continued responsibility to ensure that foods the firm markets are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
The Office of Premarket Approval became the Office of Food Additive Safety on June 18, 2001.