Institute for Fisheries Resources v. Hahn

Background

The Institute for Fisheries Resources and other environmental and industry groups challenged the Food and Drug Administration’s approval of AquaBounty Technologies, Inc.’s AquAdvantage salmon. The salmon were genetically engineered using a recombinant DNA construct, meaning a piece of genetic material designed to produce a particular trait. The construct causes Atlantic salmon to grow to full size in roughly half the usual time.

The FDA approved the construct as a new animal drug in November 2015. The approval limited production to specified, physically contained, freshwater facilities and imposed other conditions intended to reduce the risk that the genetically engineered salmon would escape, mix with ordinary salmon, or breed with them.

At this stage of the lawsuit, the plaintiffs challenged the FDA’s general authority to regulate genetically engineered animals, the FDA’s guidance document explaining that authority and the application process, and the meaning of safety under the Food, Drug, and Cosmetic Act. The court left other challenges to the particular approval for a later phase.

Claims 8 and 13: FDA guidance document

Claim 8 alleged that the FDA should have prepared a program-wide environmental impact statement for its guidance document under the National Environmental Policy Act. Claim 13 alleged that the FDA should have used public notice-and-comment procedures under the Administrative Procedure Act before issuing the guidance.

The court held that the guidance document was not “final agency action,” which is generally required before a court can review an agency action under the Administrative Procedure Act. The document’s interpretation that a recombinant DNA construct can be a drug did not itself impose direct legal consequences on these plaintiffs, who did not wish to use, market, or distribute such constructs. Its discussion of the application process was also tentative and advisory, and did not change existing legal requirements.

Because the guidance document was not final agency action, the court held that it lacked jurisdiction over Claims 8 and 13 and dismissed those claims. The government’s motion for judgment on the pleadings was granted as to Claims 8 and 13, and the plaintiffs’ cross-motion for summary judgment on those claims was denied.

Claim 1: FDA authority under the Food, Drug, and Cosmetic Act

Claim 1 challenged the FDA’s statutory authority to regulate the integration of a recombinant DNA construct into an animal’s genome under the agency’s authority over drugs.

The court ruled for the government. The Food, Drug, and Cosmetic Act defines “drug” to include an article, other than food, intended to affect the structure or any function of the body of a person or animal. The court concluded that the recombinant DNA construct is an article, is not food, and is intended to affect the salmon’s structure or function by promoting faster growth. It therefore qualifies as a drug and, more specifically, a new animal drug.

The court rejected the plaintiffs’ reliance on the ordinary meaning of “drug,” explaining that the statutory definition controls even though it is broader than the word’s everyday meaning. The court also concluded that later legislation concerning genetically engineered animals did not create a separate regulatory system that displaced the FDA’s authority. The FDA could impose conditions on the salmon themselves because regulating the fish was a practical way to regulate the construct and its effects.

The government’s motion for judgment on the pleadings was granted as to Claim 1. The plaintiffs’ cross-motion for summary judgment on Claim 1 was denied.

Claim 12: Environmental safety

Claim 12 argued that a new animal drug creating environmental risks is not “safe” under the Food, Drug, and Cosmetic Act and that the AquAdvantage salmon failed that statutory safety requirement. The government argued that “safe” refers only to the effects on the genetically engineered animals and the people who consume food from them, while environmental effects are addressed only through the National Environmental Policy Act.

The court did not resolve that dispute. It identified arguments supporting both sides, including the statute’s reference to the health of people or animals, its reference to “other relevant factors,” and regulations indicating that environmental mitigation may be considered during approval. The court also noted that the parties had not adequately explained how their interpretations would affect judicial review or interact with the National Environmental Policy Act.

Both the government’s motion for judgment on the pleadings and the plaintiffs’ motion for summary judgment were denied as to Claim 12, without prejudice to raising the issue again during the next phase of the case.

Disposition

Judge Vince Chhabria ordered that the government’s motion for judgment on the pleadings be granted as to Claims 8, 13, and 1, and denied as to Claim 12. The plaintiffs’ motion for summary judgment was denied as to Claims 8, 13, and 1, and denied as to Claim 12, without prejudice to raising that issue again at the next phase.