Biotechnology Consultation Agency Response Letter BNF 000141

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. 000141 for further details

March 20, 2015

Tracy Rood
Senior Regulatory Manager
J.R. Simplot Company
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 potatoes, events F10, E12, J3, J55, G11, and H50. According to information Simplot has provided, F10, E12, J3, J55, G11, and H50 potatoes are 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 000141. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, Simplot submitted a summary of its safety and nutritional assessment of the genetically engineered potatoes on February 12, 2013. Simplot submitted additional information on September 30, 2013, August 25, 2014, and October 30, 2014. These communications informed FDA of the steps taken by Simplot to ensure that food and feed from F10, E12, J3, J55, G11, and H50 potatoes comply 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 F10, E12, J3, J55, G11, and H50 potatoes 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 F10, E12, J3, J55, G11, and H50 potatoes do 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 F10, E12, J3, J55, G11, and H50 potatoes.

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 F10, E12, J3, J55, G11, and H50 potatoes may be used in various food applications. Depending on the particular food application, differences between the F10, E12, J3, J55, G11, and H50 potatoes 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 F10, E12, J3, J55, G11, and H50 potatoes or products containing F10, E12, J3, J55, G11, and H50 potatoes are advised to consult with CFSAN’s Office of Nutrition, Labeling, and Dietary Supplements, 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 F10, E12, J3, J55, G11, and H50 potatoes 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 000141, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000141, 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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