Biotechnology Consultation Agency Response Letter BNF No. 000118
Return to inventory: Submissions on Bioengineered New Plant Varieties
CFSAN/Office of Food Additive Safety
August 19, 2011
Isabelle Coats, Ph.D.
Bayer CropScience LP
P.O. Box 12014
Research Triangle Park, NC 27709
Dear Dr. Coats:
This is in regard to the Bayer CropScience LP’s (Bayer) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on genetically engineered cotton containing events T304-40 and GHB119. According to information Bayer has provided, cotton containing T304-40 and GHB119 are genetically engineered to express the Cry1Ab protein and the Cry2Ae protein, respectively; both events are genetically engineered to express the PAT protein. Cry1Ab and Cry2Ae are intended to confer resistance to targeted Lepidopteran pests and the PAT protein functions as a selectable marker. All materials relevant to this notification have been placed in a file designated BNF 118. This file will be maintained in the Office of Food Additive Safety.
As part of bringing the consultation regarding this product to closure, Bayer submitted a summary of its safety and nutritional assessment of the genetically engineered cotton on January 12, 2009. Bayer submitted additional information on July 10, 2009, December 19, 2009, November 2, 2010, and December 7, 2010. These communications informed FDA of the steps taken by Bayer 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 Bayer has conducted, it is our understanding that Bayer has concluded that food and feed derived from cotton T304-40 and GHB119 are not materially different in composition, safety, and other relevant parameters from cotton-derived food and feed currently on the market, and that genetically engineered cotton containing T304-40 and GHB119 does not raise issues that would require premarket review or approval by FDA.
The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIP), which include both the active and inert ingredients. Cotton T304-40 and GHB119 contain PIPs, which are within the purview of EPA. It is Bayer’s responsibility to obtain all appropriate clearances, including those from EPA and the United States Department of Agriculture, before marketing food or feed derived from cotton T304-40 and GHB119.
Based on the information Bayer has presented to FDA, we have no further questions concerning food and feed derived from cotton containing events T304-40 and GHB119 at this time. However, as you are aware, it is Bayer’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 000118, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000118, 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