Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
See FDA's memo on BNF No. 000146 for further details
January 12, 2016
Senior Regulatory Manager
5369 West Irving Street
Boise, ID 83706
Dear Ms. Rood:
This letter addresses J.R. Simplot Company's (Simplot) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on genetically engineered potato, event W8 (W8 potato). According to information that Simplot has provided, W8 potato is genetically engineered to lower the levels of asparagine and reducing-sugars, thus lowering the potential for acrylamide formation upon heating, and to lower the potential for black spot bruising by lowering the level of endogenous enzymes in the potato. In addition, the W8 potato expresses the resistance protein Vnt1 from Solanum venturii, a wild potato species native to South America. Expression of Vnt1 is intended to increase resistance to the late blight-causing oomycete Phytophthora infestans. All materials relevant to this consultation have been placed in a file designated BNF 000146. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing the consultation to closure, Simplot submitted a summary of its safety and nutritional assessment of the genetically engineered W8 potato on April 15, 2014. Simplot provided additional information, which we received on March 10, June 11, August 6, August 17, and December 9, 2015. These communications informed us of the steps taken by Simplot 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 Simplot has conducted, it is our understanding that Simplot has concluded that food and feed derived from W8 potato are not materially different in composition or safety from potato-derived food and feed currently on the market and that genetically engineered W8 potato does not raise issues that would require premarket review or approval by FDA.
The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs), which include both active and inert ingredients. W8 potato contains the resistance protein Vnt1, a PIP that is within the purview of EPA. It is Simplot’s responsibility to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food or feed derived from W8 potato.
Finally, as always, it is a producer’s or distributor’s responsibility to ensure that labeling of the foods it markets meet applicable legal requirements, including disclosure of any material differences in the food. It is our understanding that W8 potato may be used in various food applications. Depending on the particular food application, differences between W8 potato and conventional potatoes may be considered material information requiring disclosure under Sections 201(n) and 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §321(n) and 343(a)(1)]. Companies marketing W8 potato or products containing W8 potato are advised to consult with CFSAN’s Office of Nutrition and Food Labeling, Food Labeling and Standards Staff, to discuss any required or voluntary labeling including statements relating to attributes of these potatoes and their potential for reduced acrylamide levels or reduced black spots or any other type of claim.
Based on the information Simplot has presented to FDA, we have no further questions concerning food and feed derived from W8 potato at this time. However, as you are aware, it is Simplot’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 000146, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000146, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition