Today FDA announced the completion of their consultative review of Okanagan Specialty Fruits’ Arctic® apples, and you can review their letter to OSF here.
The FDA’s accompanying press release also announces the successful conclusion of their review of J.R. Simplot’s Innate Potato, and we invite you to read the full release either on the FDA’s website, or directly below:
FDA concludes Arctic Apples and Innate Potatoes are safe for consumption
March 20, 2015
Today, the U.S. Food and Drug Administration completed its evaluation for two varieties of apples genetically engineered by Okanagan Specialty Fruits, Inc., and for six varieties of potatoes genetically engineered by J. R. Simplot Company and concluded that these foods are as safe and nutritious as their conventional counterparts.
Okanagan’s Granny Smith and Golden Delicious varieties of apples, known collectively by the trade name “Arctic Apples,” are genetically engineered to resist browning associated with cuts and bruises by reducing levels of enzymes that can cause browning.
Simplot’s varieties of Ranger Russet, Russet Burbank and Atlantic potatoes are collectively known by the trade name “Innate” and are genetically engineered to reduce the formation of black spot bruises by lowering the levels of certain enzymes in the potatoes. In addition, they are engineered to produce less acrylamide by lowering the levels of an amino acid called asparagine and by lowering the levels of reducing-sugars. Acrylamide is a chemical that can form in some foods during high-temperature cooking, such as frying, and has been found to be carcinogenic in rodents.
Foods derived from genetically engineered plants must meet the same legal standards, including safety standards, as foods derived from traditional plant breeding methods. To help developers of foods derived from genetically engineered plants comply with their obligations under the Federal Food, Drug, and Cosmetic Act and FDA regulations, the FDA encourages them to participate in a voluntary consultation process with the agency prior to commercial distribution.
As part of its consultation process, both Okanagan, of British Columbia, Canada, and Simplot, of Boise, Idaho, submitted to the FDA a summary of their safety and nutritional assessments.
The consultation process includes a review of information provided by a company about the nature of the molecular changes and the nutritional composition of the food compared to traditionally bred varieties,” said Dennis Keefe, Ph.D., director of the FDA’s Office of Food Additive Safety. “This case-by-case safety evaluation ensures that food safety issues are resolved prior to commercial distribution.”
The FDA has no additional food safety questions at this time concerning food from these plant varieties. It is a company’s continuing responsibility to ensure that food it markets is safe and otherwise in compliance with all applicable legal and regulatory requirements. In certain circumstances, characteristics of these varieties of apples and potatoes that differ from their conventional counterparts may require disclosure to the consumer. Both companies are encouraged to consult with the FDA about potential labeling requirements.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.