Food

Biotechnology Consultation Agency Response Letter BNF 000132

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. 000132 for further details

March 20, 2015

Neal Carter
Okanagan Specialty Fruits, Inc.
PO Box 1533
Summerland, BC V0H 1Z0
CANADA

Dear Mr. Carter:

This letter addresses Okanagan Specialty Fruits, Inc.’s (OSF) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on its genetically engineered apple events, Golden Delicious 743 (GD743 apple) and Granny Smith 784 (GS784 apple). According to information OSF has provided, GD743 and GS784 apples are genetically engineered to contain reduced levels of four polyphenol oxidases. This intended effect is achieved through the introduction of DNA sequences designed to suppress four members of the apple polyphenol oxidase gene family through RNA interference. OSF states that this modification is intended to impart resistance to browning associated with slicing or bruising. GD743 and GS784 apples were also engineered to express the neomycin phosphotransferase (NPTII) selectable marker for transformation. All materials relevant to this consultation have been placed in a file designated BNF 000132. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, OSF submitted a summary of its safety and nutritional assessment of GD743 and GS784 apples on May 30, 2011. OSF submitted additional information on December 13, 2011, April 9, 2012, January 22, 2014, March 3, 2014, and February 24, 2015. These communications informed FDA of the steps taken by OSF to ensure that food and feed from GD743 and GS784 apples comply with certain legal and regulatory requirements that fall within FDA’s jurisdiction. Based on the safety and nutritional assessment OSF has conducted, it is our understanding that OSF has concluded that food and feed from GD743 and GS784 apples are not materially different in safety, nutrition, composition, or other relevant characteristics from food and feed from apples currently on the market, and that GD743 and GS784 apples do not raise issues that would require premarket review or approval by FDA.

It is OSF’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 GD743 and GS784 apples.

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 GD743 or GS784 apples may be used in various food applications. Depending on the particular food application, the non-browning aspect of the apples 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 GD743 or GS784 apples or products containing GD743 or GS784 apples 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 apples and their nonbrowning properties or any other type of claim.

Based on the information OSF has presented to FDA, we have no further questions concerning food and feed derived from GD743 and GS784 apples at this time. However, as you are aware, it is OSF’s continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and otherwise in compliance with all applicable legal and regulatory requirements. A copy of the text of this letter responding to BNF 000132, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000132, is available for public review and copying at www.fda.gov/bioconinventory.

Sincerely yours,

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

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