Biotechnology Consultation Agency Response Letter BNF No. 000108
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
September 21, 2007
Tracy A. Rood
Pioneer Hi-Bred International, Inc.
7250 N.W. 62nd Avenue
P.O. Box 1014
Johnston, IA 50131-1014
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 soybean variety, 356043 soybean. According to Pioneer, this new variety is engineered to express two new proteins, glyphosate N-acetyltransferase (GAT4601) and a modified soybean acetolactate synthase (GM-HRA). The GAT4601 protein confers tolerance to the herbicide glyphosate and the GM-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 0108. 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 356043 soybean on November 16, 2006. Pioneer submitted additional information dated December 4, 2006; May 29, 2007; June 5, 2007; August 22, 2007; August 27, 2007; August 30, 2007; and September 14, 2007. 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 soybean variety is not materially different in composition, safety, and other relevant parameters from soybean varieties currently on the market and that the genetically engineered soybean 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 356043 soybean.
Based on the information Pioneer has presented to FDA, we have no further questions concerning the new soybean variety, 356043 soybean, at this time. However, as you are aware, it is Pioneers's continued responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition