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U.S. Department of Health and Human Services


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Biotechnology Consultation Agency Response Letter BNF No. 000081

Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties

See also Biotechnology: Genetically Engineered Plants for Food and Feed and about Submissions on Bioengineered New Plant Varieties

See FDA's memo on BNF No. 000081 for further details

October 4, 2004

Penny L. Hunst, Ph.D.
Mycogen Seeds c/o Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, IN 46268

Dear Dr. Hunst:

This is in regard to Mycogen Seeds c/o Dow AgroSciences LLC's (DAS) and Pioneer Hi-bred International, Inc.'s (PHI) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on their genetically engineered corn event DAS-59122-7. According to DAS/PHI, corn event DAS- 59122-7 is genetically engineered to express three new proteins, Cry34Ab1, Cry35Ab1, and phosphinothricin acetyltransferase (PAT). Cry34Ab1 and Cry35Ab1 confer resistance to Coleopteran insects; PAT confers tolerance to chemically synthesized phosphinothricin products such as glufosinate-ammonium, and is used as a selectable marker. All materials relevant to this notification have been placed in a file designated BNF 0081. This file will be maintained in the Office of Food Additive Safety.

As part of bringing the consultation regarding this product to closure, DAS/PHI submitted a summary of their safety and nutritional assessment of the genetically engineered corn on December 11, 2003, and submitted additional information on March 5 and March 12, 2004. These communications informed the FDA of the steps taken by DAS/PHI 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/PHI have conducted, it is our understanding that DAS/PHI have concluded that corn grain and forage derived from the new variety are not materially different in composition, safety, and other relevant parameters from corn grain and forage currently on the market and that genetically engineered corn event DAS-59122-7 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 Cry34Ab1, Cry35Ab1, and PAT proteins. It is DAS/PHI'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 corn event DAS-59122-7.

Based on the information DAS/PHI have presented to FDA, we have no further questions concerning grain and forage derived from corn event DAS-59122-7 at this time. However, as you are aware, it is DAS/PHI's continued responsibility to ensure that foods marketed by the firms are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.

Sincerely yours,

Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition