Food

Biotechnology Consultation Agency Response Letter BNF 000149

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. 000149 for further details

December 14, 2016

Dr. Ebrahim Firoozabady
Vice President, Research & Development and Regulatory Affairs
Del Monte Fresh Produce Company
241 Sevilla Avenue
Coral Gables, FL 33134

Dear Dr. Firoozabady:

This letter addresses Del Monte Fresh Produce Company’s (DMFPC) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM)) on genetically engineered pineapple, transformation event number EF2-114 (EF2-114 pineapple). According to information DMFPC has provided, EF2-114 pineapple is genetically engineered to have altered color. To achieve the altered color, DMFPC introduced a gene encoding phytoene synthase protein, involved in lycopene synthesis and RNA interference (RNAi) constructs intended to suppress endogenous expression of lycopene β-cyclase and lycopene ε-cyclase, which both convert lycopene to other carotenoids. DMFPC also introduced an RNAi construct intended to control flowering by suppressing endogenous expression of 1-aminocyclopropane-1-carboxylic acid synthase, which leads to ethylene biosynthesis. All materials relevant to this consultation have been placed in a file designated BNF 000149. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, DMFPC submitted to FDA a summary of its safety and nutritional assessment of the genetically engineered pineapple, which FDA received on February 15, 2015. DMFPC submitted additional information, received by FDA on January 18, 2016, and August 24, 2016. These communications informed FDA of the steps taken by DMFPC to ensure that this product complies with the legal and regulatory requirements that fall within FDA’s jurisdiction. DMFPC states that the pineapples will be grown outside of the United States (in Costa Rica). DMFPC does not intend for EF2-114 pineapples to be used in food for animals in the United States. Based on the safety and nutritional assessment DMFPC has conducted, it is our understanding that DMFPC concludes that human food from EF2-114 pineapple is not materially different in composition, safety, and other relevant parameters from pineapple-derived food currently on the market except for the intended pigment changes in EF2-114 pineapple. DMFPC also concludes that genetically engineered EF2-114 pineapple does not raise issues requiring premarket review or approval by FDA.

As always, it is a producer’s or distributor’s responsibility to ensure that labeling of the foods it markets meets applicable legal requirements. You stated that you intend to identify the food as “Extra Sweet Pink Flesh Pineapple.” We agree that this name is an accurate description of the EF2-114 pineapple. Companies marketing EF2-114 pineapples 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 pineapples or any other type of claim.

Finally, on July 29, 2016, the National Bioengineered Food Disclosure Law (Public Law 114-216) charged the United States Department of Agriculture’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 EF2-114 pineapple are responsible for following the requirements issued by USDA relevant to the labeling of their products.

Because EF2-114 pineapples will not be grown in the United States and pineapples and pineapple by-products are not significant ingredients in animal food in the United States, CVM concluded that an in-depth evaluation for use in animal food was not warranted.. Based on the information DMFPC has presented to FDA, we have no further questions concerning human food derived from EF2-114 pineapple at this time. However, as you are aware, it is DMFPC’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 000149, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000149, is available for public review and copying at http://www.fda.gov/bioconinventory.

Sincerely yours,

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

 

Page Last Updated: 12/14/2016
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