Biotechnology Consultation Agency Response Letter BNF No. 000114
Return to inventory: Submissions on Bioengineered New Plant Varieties
See FDA's memo on BNF No. 000114 for further details
CFSAN/Office of Food Additive Safety
February 17, 2012 (corrected from February 1, 2012)
Ms. Angela McKean
BASF Plant Science, L.L.C.
26, Davis Drive
Research Triangle Park, NC 27709
Dear Ms. McKean:
This is in regard to BASF Plant Science L.L.C.’s (BASF) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on genetically engineered soybean, BPS-CV127-9 (CV127 soybean). According to information that BASF has provided, CV127 soybean is genetically engineered to confer tolerance to imidizolinone herbicides through introduction of the csr1-2 gene from Arabidopsis thaliana. The A. thaliana csr1-2 gene encodes a modified large subunit of acetohydroxyacid synthase, which prevents binding of imidizolinone herbicides to the acetohydroxyacid synthase enzyme. Acetohydroxyacid synthases catalyze the first step in the biosynthesis of branched-chain essential amino acids. All materials relevant to this notification have been placed in a file designated BNF 000114. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing the consultation regarding this product to closure, BASF submitted a summary of its safety and nutritional assessment of the genetically engineered soybean on January 26, 2009. BASF submitted additional information on May 29, 2009 and May 10, 2011. These communications informed FDA of the steps taken by BASF 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 BASF has conducted, it is our understanding that BASF has concluded that food and feed derived from CV127 soybean are not materially different in composition, safety, and other relevant parameters from soybean-derived food and feed currently on the market, and that genetically engineered CV127 soybean does not raise issues that would require premarket review or approval by FDA.
It is BASF’s responsibi lity 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 CV127 soybean. Based on the information BASF has presented to FDA, we have no further questions concerning food and feed derived from CV127 soybean at this time. However, as you are aware, it is BASF’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 000114, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000114, 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