Biotechnology Consultation Agency Response Letter BNF 000153

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. 000153 for further details

February 21, 2017

Matthew Pence, Ph.D.
Regulatory Manager
J.R. Simplot Company
5369 West Irving Street
Boise, ID 83706

Dear Dr. Pence:

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, event X17 (X17 potato) and event Y9 (Y9 potato). According to information Simplot has provided, X17 and Y9 potatoes were derived from F10 and J3 potatoes (two of the subjects of BNF 000141).The additional traits in X17 and Y9 potatoes are intended to lower the levels of reducing-sugars, thus preventing excess darkening during frying and contributing to lower the likelihood of acrylamide formation under certain processing conditions, by lowering the levels of vacuolar invertase in the potato. In addition, X17 and Y9 potatoes express 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 000153. 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 X17 and Y9 potatoes, which FDA received on March 23, 2016. Simplot submitted additional information, received by FDA on June 2, August 3, August 30, and September 21, 2016. These communications informed FDA of the steps taken by Simplot to ensure that these products 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 from X17 and Y9 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 X17 and Y9 potatoes do not raise issues that would require premarket review or approval by FDA.

The United States Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIP), which include both the active and inert ingredients. X17 and Y9 potatoes contain the resistance protein Vnt1, a PIP, which is within the purview of EPA. It is Simplot’s responsibility to obtain all appropriate clearances, including those from EPA and the United States Department of Agriculture (USDA), before marketing food or feed derived from X17 and Y9 potatoes.

As always, it is a producer’s or distributor’s responsibility to ensure that labeling of the foods it markets meets applicable legal requirements. Companies marketing X17 and Y9 potatoes or products containing X17 and Y9 potatoes 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 under the Federal Food, Drug, and Cosmetic Act including statements relating to attributes of these potatoes and their potential to lower acrylamide levels during processing or any other type of claim.

Finally, on July 29, 2016, the National Bioengineered Food Disclosure Law (Public Law 114-216) charged the USDA’s Agricultural Marketing Service with developing a national mandatory system for disclosing the presence of bioengineered material in human food. Producers, distributors, and marketers of X17 and Y9 potatoes are responsible for following the requirements issued by USDA relevant to the labeling of their products.

Based on the information Simplot has presented to FDA, we have no further questions concerning food and feed derived from X17 and Y9 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 000153, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000153, 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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