Biotechnology Consultation Agency Response Letter
BNF No. 000138
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
See FDA's memo on BNF No. 000138 for further details
CFSAN/Office of Food Additive Safety
December 27, 2013
Michael D. Hall, Ph.D.
800 North Lindbergh Boulevard
Saint Louis, Missouri 63167
Dear Dr. Hall:
This letter addresses the consultation of Monsanto Company (Monsanto) and Forage Genetics International, LLC (FGI) with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on genetically engineered alfalfa event KK179 (KK179 alfalfa). According to information provided by Monsanto and FGI, KK179 alfalfa is genetically engineered to produce single-stranded ribonucleic acid (RNA) with an inverted repeat sequence that results in the suppression of endogenous S-adenosyl-L-methionine: trans-caffeoyl CoA 3-O-methyltransferase (commonly referred to as CCOMT) RNA transcript levels via the RNA interference pathway. The resulting reduction in CCOMT protein levels leads to a decrease in production of the guaiacyl lignin monomeric subunit. This alters the profile of monomeric lignin subunits that are available for cell wall lignin synthesis. All materials relevant to this notification have been placed in a file designated BNF 000138. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing this consultation to closure, Monsanto and FGI submitted a summary of their safety and nutritional assessment of the genetically engineered alfalfa on August 24, 2012. Monsanto and FGI submitted additional information on March 1, 2013. These communications informed FDA of the steps taken by Monsanto and FGI 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 and FGI have conducted, it is our understanding that Monsanto and FGI have concluded that food and feed derived from KK179 alfalfa are not materially different in composition, safety, and other relevant parameters from alfalfa-derived food and feed currently on the market, and that genetically engineered KK179 alfalfa does not raise issues that would require premarket review or approval by FDA.
It is the responsibility of Monsanto and FGI 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 KK179 alfalfa.
Based on the information Monsanto and FGI provided to FDA, we have no further questions concerning food and feed derived from KK179 alfalfa at this time. However, as you are aware, it is the continuing responsibility of Monsanto and FGI to ensure that food and feed marketed by the firms are safe, wholesome, and in compliance with all applicable legal and regulatory requirements. A copy of the text of this letter responding to BNF 000138, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 00138, is available for public review and copying at http://www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition