Biotechnology Consultation Agency Response Letter BNF No. 000110

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. 000110 for further details

CFSAN/Office of Food Additive Safety

January 15, 2009

Tracy A. Rood
Sr. Registration Manager for North America
Pioneer Hi-Bred International, Inc.
7250 NW 62nd Ave.
PO 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 soybean, high oleic 305423 soybean (305423 soybean). According to Pioneer, 305423 soybean is engineered to produce increased amounts of monounsaturated fatty acid (oleic) and decreased amounts of polyunsaturated fatty acids (linoleic and linolenic). This soybean is also engineered to express a new protein, a modified soybean acetolactate synthase. The modified soybean acetolactate synthase, which confers tolerance to ALS-inhibiting herbicides, was used as a selectable marker for transformation. All material relevant to this notification have been placed in a file designated BNF 00110. 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 305423 soybean on December 27, 2006. Pioneer submitted additional information on August 31, 2007, January 30, February 19, March 18, November 21, December 12, and December 19, 2008. These communications informed 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 that Pioneer has conducted, it is our understanding that Pioneer has concluded that the new soybean variety is not materially different in any respect relevant to food or feed safety compared to 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. Based on the intended change in fatty acid composition, it is also our understanding that Pioneer has concluded that the common or usual name "high oleic soybean oil" is appropriate to distinguish oil from the 305423 soybean from that of traditional soybean varieties.

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 the 305423 soybean.

Based on the information Pioneer has presented to FDA, we have no further questions concerning the new soybean variety, 305423 soybean, 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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