Biotechnology Consultation Agency Response Letter BNF No. 000111

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. 000111 for further details

CFSAN/Office of Food Additive Safety

September 9, 2008

Tracy A. Rood
Pioneer Hi-Bred International, Inc.
7250 N.W. 62nd Avenue
P.O. Box 552
Johnston, IA 50131

Dear Ms. Rood:

This is in regard to Pioneer Hi-Bred International, Inc.'s (Pioneer) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on its genetically engineered corn variety, 98140 corn. According to Pioneer, this new variety is engineered to express two new proteins, glyphosate N-acetyltransferase (GAT4621) and a modified corn acetolactate synthase (ZM-HRA). The GAT4621 protein confers tolerance to the herbicide glyphosate and the ZM-HRA protein confers tolerance to the acetolactate synthase (ALS)-inhibiting class of herbicides. All materials relevant to this notification have been placed in a file designated BNF 0111. This file will be maintained in the Office of Food Additive Safety.

As part of bringing the consultation regarding this product to closure, Pioneer submitted a summary of its safety and nutritional assessment of the genetically engineered 98140 corn on June 28, 2007. Pioneer submitted additional information on September 18, 2007; November 29, 2007; February 14, 2008; March 12, 2008; and July 10, 2008. These communications informed the FDA of the steps taken by Pioneer to ensure that this product complies with all legal and regulatory requirements that fall within FDA's jurisdiction. Based on the safety and nutritional assessment Pioneer has conducted, it is our understanding that Pioneer has concluded that the new corn variety is not materially different in composition, safety, and other relevant parameters from corn varieties currently on the market and that the genetically engineered corn does not raise issues that would require premarket review or approval by FDA.

It is Pioneer's responsibility to obtain all appropriate clearances, including those from the Environmental Protection Agency and the United States Department of Agriculture, before marketing food or feed derived from 98140 corn.

Based on the information Pioneer has presented to FDA, we have no further questions concerning the new corn variety, 98140 corn, at this time. However, as you are aware, it is Pioneer'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,

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

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