Biotechnology Consultation Agency Response Letter BNF No. 000117
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
July 30, 2012
Cherian George, Ph.D.
800 North Lindberg Blvd.
St. Louis, MO 63167
Dear Dr. George:
This letter addresses Monsanto Company's (Monsanto) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM)) on genetically engineered soybean, MON 87769. According to information Monsanto has provided, MON 87769 soybean is genetically engineered to produce stearidonic acid (or stearidonate, SDA) by expressing the Δ6 desaturase from Primula juliae and Δ15 desaturase from Neurospora crassa. Oil from MON 87769 contains approximately 20-30 percent SDA, a long chain polyunsaturated fatty acid that is an alternative source of long chain omega-3 fatty acids, and low levels of gamma linolenic acid, an omega-6 fatty acid. All materials relevant to this notification have been placed in a file designated BNF 0000117. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of completing the consultation regarding this product, Monsanto submitted a summary of its safety and nutritional assessment of the genetically engineered soybean on March 20, 2009. Monsanto submitted additional information on October 15, 2009, November 8, 2010, February 10, and March 16, 2011, and May 4, 2012. These communications informed FDA of the steps taken by Monsanto 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 Monsanto has conducted, it is our understanding that Monsanto has concluded that oil derived from MON 87769 soybean for use as an ingredient in human food is not materially different in safety and other parameters from oils of similar chemical composition produced from other sources and used as ingredients in human food. Monsanto also concluded that uses of MON 87769 soybean in human food raise no safety concerns, but noted that, due to its altered fatty acid profile, the oil will be the primary human food ingredient from this soybean. In addition, Monsanto has concluded that meal derived from MON 87769 is as safe for use in animal feed as conventional soybean meal. Use of genetically engineered MON 87769 soybean in human food and MON 87769 soybean meal in animal feed does not raise issues that require premarket review or approval by FDA. Based on the intended change in fatty acid composition, it is also our understanding that Monsanto has concluded that the common or usual name "stearidonate soybean oil" is appropriate to distinguish oil from the MON 87769 soybean from that of traditional soybean varieties. CVM, the FDA center responsible for the regulation of animal feed, may request further discussions with Monsanto regarding the common and usual name for the meal derived from MON 87769 soybean.
It is Monsanto'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 MON 87769 soybean.
Based on the information Monsanto has presented to FDA, we have no further questions concerning food ingredients derived from MON 87769 soybean and feed derived from MON 87769 soybean meal at this time. However, as you are aware, it is Monsanto'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 000117, as well as a copy of the text of FDA's memorandum summarizing the information in BNF 000117, is available for public review and copying at www.fda.gov/bioconinventory.
Dennis Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition