July 26, 2021

Volume XI, Number 207

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July 26, 2021

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FDA Appeals Order Rejecting GE Salmon Approval

The FDA is appealing a November 5, 2020 decision by the U.S. District Court for the Northern District of California which ordered the Agency to reconsider its 2015 approval of the genetically engineered (GE) AquAdvanage salmon.

In March 2016 a lawsuit was filed alleging that the FDA did not have jurisdiction to approve the GE salmon and, in the alternative, that the FDA unlawfully abused its authority by approving the GE salmon without appropriately considering its obligations under the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). The jurisdictional claims were separately addressed in a December 19, 2019 opinion in which the Court held that the FDA could regulate the GE salmon as a drug because the Federal Food, Drug, and Cosmetic Act defines drugs in part as “articles (other than food) intended to affect the structure or any function of the body of man or other animals,” and the recombinant DNA (rDNA) that was used to create the GE salmon was a non-food article that was intended to stimulate growth.

However, in the November 2020, decision, the Court held that the FDA’s approval process did not meet the Agency’s statutory obligations under NEPA and ESA. Specifically, the Court held that NEPA required the FDA to consider the environmental harms that might result if the GE salmon were to escape and establish themselves in the wild. Instead, the FDA had only evaluated the likelihood of harm, concluding that it was very unlikely that the GE salmon would establish themselves in the wild, in part because the GE salmon were required to be raised away from natural bodies of water. The Court also noted that an evaluation of the potential harm was particularly important in this case because the likelihood of escape would increase as the company grew; while the FDA’s 2015 approval was specific to the two facilities named in the original application, FDA subsequently approved production at two additional facilities. In regard to ESA, the Court held that the FDA, having not considered the potential harm to wild salmon under NEPA, could not make a determination that the approval would have no effect on the endangered Gulf of Maine Atlantic salmon. As a result, FDA was required to review its decision, and per the mandates of ESA, consult with the National Marine Fisheries Service (NFMS) and the Fish and Wildlife Service (FWS) if it determined that the approval “may affect” an endangered species.

Despite finding the FDA’s approval unlawful, the Court held that the approval should not be vacated because the short-term risk to the environment was small and revocation of the approval would result in significant loss of property and animal life that would be wasteful if the FDA cured its errors on remand.

The FDA has filed the appeal but has not yet filed its appeal briefs and we will continue to monitor and report on this case as new developments occur.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 110
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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