More about the regulatory process

U.S. and Canadian government agencies are reviewing Arctic® Golden and Arctic® Granny apples. Here’s more information about the process, and how you can get involved.

In the United States, three government agencies (two of which are reviewing 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 are being 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 Goldens and Arctic Grannies to 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. A final decision on deregulation is expected early in 2015.



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.



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.

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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.

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