Biotechnology Consultation Agency Response Letter BNF 000152

Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties

See also Biotechnology: Genetically Engineered Plants for Food and Feed and about Submissions on Bioengineered New Plant Varieties

See FDA's memo on BNF No. 000152 for further details

August 19, 2016

Raina Spence
Regulatory Affairs Manager
J.R. Simplot Company
5369 W Irving Street
Boise ID 83706

Dear Ms. Spence:

This letter addresses the J.R. Simplot Company’s (Simplot’s) 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 V11 (V11 potato). According to information that Simplot has provided, V11 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 levels of endogenous enzymes in the potato. All materials relevant to this consultation have been placed in a file designated BNF 000152. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, Simplot submitted to FDA a summary of its safety and nutritional assessment of the V11 potato, which FDA received on July 10, 2015. Simplot submitted additional information, received by FDA on February 11, 2016. These communications informed FDA 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 from V11 potato are not materially different in composition, safety, and other relevant parameters from potato-derived food and feed currently on the market, and that genetically engineered V11 potato does not raise issues that would require premarket review or approval by FDA.

It is Simplot’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 V11 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 V11 potato may be used in various food applications. Depending on the particular food application, differences between V11 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 V11 potato or products containing V11 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 V11 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 000152, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000152, is available for public review and copying at

Sincerely yours,

Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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