Biotechnology Consultation Agency Response Letter BNF No. 000129
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
May 1, 2012
Pioneer Hi-Bred International, Inc.
DuPont Agricultural Biotechnology
DuPont Experimental Station, E353/305C
P.O. Box 80353
Wilmington, DE 19880-0353
Dear Ms. Weber:
This letter 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 (CFSAN)) on genetically engineered canola, DP-Ø73496-4 (73496 canola). According to information that Pioneer has provided, 73496 canola is genetically engineered to express the glyphosate N-acetyltransferase (GAT4621) protein. The GAT4621 protein renders the canola tolerant to glyphosate through acetylation of glyphosate to the non-phytotoxic N-acetylglyphosate. All materials relevant to this notification have been placed in a file designated BNF 000129. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing the consultation to closure, Pioneer submitted a summary of its safety and nutritional assessment of the genetically engineered canola on February 25, 2011. Pioneer submitted additional information on September 20 and December 21, 2011, and on January 6 and April 6, 2012. These communications informed FDA of the steps taken by Pioneer 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 Pioneer has conducted, it is our understanding that Pioneer has concluded that food and feed derived from 73496 canola are not materially different in composition, safety, and other relevant parameters from canola-derived food and feed currently on the market,1 and that the genetically engineered 73496 canola 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 73496 canola.
Based on the information Pioneer has presented to FDA, we have no further questions concerning food and feed derived from 73496 canola at this time. However, as you are aware, it is Pioneer’s continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements. A copy of the text of this letter responding to BNF 000129, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000129, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
1The levels of several N-acetylated amino acids, including N-acetylated aspartate (NAA) and N-acetylated glutamate (NAG), were shown by Pioneer to be increased in 73496 canola compared to the non-transgenic control and reference canola varieties. Pioneer estimated dietary exposure to NAA and NAG in human and animal diets containing 73496 canola and considered the results of oral toxicity studies of NAA and NAG in rodents, which showed no adverse effects at doses well above those potentially consumed. On these bases, Pioneer concludes that the increased levels would not result in any safety concerns.