Biotechnology Consultation Agency Response Letter BNF No. 000121
Return to inventory: Submissions on Bioengineered New Plant Varieties
CFSAN/Office of Food Additive Safety
January 20, 2011
Dr. Cherian George
Regulatory Affairs Manager
800 North Lindbergh Boulevard
Saint Louis, Missouri 63167
Dear Dr. George:
This is in regard to Monsanto’s 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, MON 87705. According to Monsanto, soybean MON 87705 is engineered to produce increased levels of oleic acid, an associated decrease in linoleic acid, and decreased levels of palmitic acid. The modified fatty acid profile in soybean MON 87705 was achieved through the RNA-based suppression of the palmitoyl acyl carrier protein thioesterase and delta-12 desaturase. This soybean is also engineered to express a 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS). The CP4 EPSPS, which confers tolerance to glyphosate, was used as a selectable marker for transformation. All materials relevant to this notification have been placed in a file designated BNF 000121. This file will be maintained in the Office of Food Additive Safety.
As part of bringing this consultation to closure, Monsanto submitted a summary of its safety and nutritional assessment of the genetically modified soybean on October 29, 2009. Monsanto provided additional information on December 16, 2009, January 21, 2010, February 15, 2010, March 26, 2010, and June 14, 2010. 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 soybean MON 87705 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 changes in fatty acid composition, Monsanto has concluded that the common or usual name “high oleic soybean oil” is appropriate to distinguish oil from soybean MON 87705 from that of conventional soybean varieties.
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 soybean MON 87705.
Based on the information Monsanto has provided to FDA, we have no further questions concerning the new soybean variety, soybean MON 87705, 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 000121, as well as a copy of the text of FDA's Note to the File summarizing the information in BNF 000121, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition