More about the regulatory process

U.S. and Canadian government agencies have reviewed Arctic® Golden and Arctic® Granny apples and have concluded that Arctic® apples present no unique risks, and are just as safe for humans and the enviroment as their conventional counterparts. Here’s more information about the process:

In the United States, three government agencies (two of which have reviewed Arctic® apples) are potentially responsible for reviewing the safety of foods produced through biotechnology before they can be placed in the market. In Canada, Arctic apples were reviewed by the Canadian Food Inspection Agency (CFIA) and Health Canada, who are responsible for the regulation of biotechnology foods.



The U.S. Department of Agriculture (USDA) is responsible for protecting U.S. agriculture from pests and diseases. We submitted a petition for deregulation of Arctic Golden and Arctic Granny apples to the USDA in May 2010. Specifically, we are required to demonstrate to the USDA that Arctic apple trees don’t pose a plant risk before we can earn “deregulated status.”

USDA’s review process includes opportunities for the public to comment. The first of two public comment opportunities concluded on Sept. 11, 2012, and the second opportunity concluded on Jan. 30, 2014. On February 13, 2015 the USDA announced their decision to deregulate the first two Arctic varieties.



The Food and Drug Administration (FDA) is responsible for the safety of food and animal feed. Although FDA approval of Arctic apples is not required, we are voluntarily consulting with that agency to demonstrate that Arctic apples are as allergen-free and toxin-free as are all other apples. On March 20, 2015, the FDA announced that their consultative review of Arctic apples had concluded, and stated that they "are as safe and nutritious as their conventional counterparts."



The Environmental Protection Agency (EPA) oversees the safety of pesticides, including pesticide-resistant plants. EPA is not reviewing the Arctic apple.



The Canadian Food Inspection Agency (CFIA) oversees the regulation of the environmental release of plants with novel traits. We submitted our petition for deregulation to the CFIA in December 2011, and on May 2, 2012 they posted our Notice of Submission (NOS) for public comment. The NOS is optional and describes the product under review and the data we submitted to support our request for unconfined release of Arctic apples. The CFIA offered a two-month period of opportunity for Canadians to submit comments on Arctic apples, which concluded July 3, 2012. On March 20, 2015 the CFIA notified OSF that their review had concluded, and stated that Arctic apples "are as safe and nutritious as traditional apple varieties..." Their official decision document is expected to be posted on their official website in the near future.

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Health Canada

Health Canada is responsible for administering the provisions of the Food and Drugs Act, including ensuring the safety and nutrition of new foods. Arctic apples are being reviewed by Health Canada to demonstrate that they are just as safe as conventional apples. On March 20, 2015, Health Canada announced that that their assessment had concluded, and their review has led them to conclude that an Arctic® apple "is safe for consumption, still has all its nutritional value and therefore does not differ from other apples available on the market."

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