March 31, 2016

Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

This week, a coalition of environmental, food safety and consumer groups has filed suit against the FDA for its 2015 approval of a genetically engineered (GE) salmon product in 2015 (following several decades of review). The product is AquaAdvantage, made by Aqua Bounty, Inc.  This is the first transgenic animal to be approved by the FDA for food consumption. To produce the GE salmon, Atlantic salmon is engineered to contain the growth hormone gene from Pacific Chinook salmon, which causes the fish to grow in less time; the gene is placed under the control of a promoter from ocean pout, which causes elevated expression of the hormone. The fish are to be only sterile females. The production plans submitted to the FDA describe the preparation of the GE fish eggs in Canada, and the actual production of the fish in Panama (with eventual location in the U.S. as well). Following the approval, Alaska Sen. Lisa Murkowski, an opponent of the FDA's actions (see here), inserted a legislative provision into the 2015 omnibus spending bill, requiring the FDA to develop a labeling scheme for the GE salmon before they enter the market. As a result of that maneuver, the FDA is in the process of complying with that mandate, and the GE salmon is not yet commercially available.

In their press release, the plaintiffs assert several grounds on which the agency’s action does not comply with existing federal law: 
The lawsuit challenges FDA’s claim that it has authority to approve and regulate GE animals as “animal drugs” under the 1938 Federal Food, Drug, and Cosmetic Act. Those provisions were meant to ensure the safety of veterinary drugs administered to treat disease in livestock and were not intended to address entirely new GE animals that can pass along their altered genes to the next generation. The approval of the GE salmon opens the door to other genetically engineered fish and shellfish, as well as chickens, cows, sheep, goats, rabbits and pigs that are reportedly in development. 
The lawsuit also highlights FDA’s failure to protect the environment and consult wildlife agencies in its review process, as required by federal law. U.S. Atlantic salmon, and many populations of Pacific salmon, are protected by the Endangered Species Act and in danger of extinction. Salmon is a keystone species and unique runs have been treasured by residents for thousands of years. Diverse salmon runs today sustain thousands of American fishing families, and are highly valued in domestic markets as a healthy, domestic, “green” food.
The lawsuit was filed in the Northern District of California. The suit could directly test the applicability of the FDA's determination that the insertion of new genetic material amounts to a kind of "veterinary  drug" and thus applications for approval of food from GE animals require a new drug application under the Federal Food, Drug, and Cosmetic Act. According to the FDA: 
FDA regulates GE animals under the new animal drug provisions of the law, and the agency must approve them before they are allowed on the market. Food and animal feed from GE animals will undergo FDA review before the food or feed can be marketed. The Federal Food, Drug, and Cosmetic Act defines a drug as "an article (other than food) intended to affect the structure or any function of the body of man or other animals." Therefore, the rDNA construct intended to change the structure or function of the body of the GE animal is a drug.
The suit also challenges the legitimacy of the FDA's determination that the GE salmon posed no environmental risk, based on an Environmental Assessment; the plaintiffs argue that the FDA is required to perform the more rigorous Environemntal Impact Statement (EIS). The food and restaurant industries had earlier indicated some resistance to selling the GE salmon; Red Lobster and Costco have already announced that the product will not be carried.

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