In 2015, the United States Food and Drug Administration (FDA) approved AquaBounty Technologies, Inc.’s (AquaBounty) application to farm genetically engineered salmon, which the company branded AquAdvantage. Reflecting the globalization of food production, the FDA authorized AquaBounty to produce eggs at a facility on Canada’s Prince Edward Island and to grow the eggs into mature fish at a facility in Panama, with the fish to be sold in the United States. The fish growth technology behind AquAdvantage was developed at the University of Toronto and Memorial University of Newfoundland.
However, AquaBounty later decided to shut down the Panama facility and in 2017, it began to plan to develop a land-based fish farm in Indiana, to bring fresh salmon closer to U.S. consumers according to a timeline on the biotechnology company’s website. This timeline further shows that AquaBounty’s first batch of genetically engineered salmon eggs entered its Indiana Farm Hatchery in 2019 and it anticipates the first harvest of the company’s engineered Atlantic salmon in 2020. The year 2028 is shown on AquaBounty’s timeline as the target date for reaching 55,000 tons (or 110,000,000 pounds) of salmon annually.
In its approval of AquaBounty’s application, the FDA specified that the company’s genetically engineered fish must be created and farmed in landlocked facilities and not farmed in net pens that connect to the ocean. Why? The concern was to minimize the risk that the AquaAdvantage salmon would escape into the wild, where it might mix with normal salmon.
Nonetheless, a coalition of advocacy and industry groups concerned with the environmental implications of the FDA’s decision to approve the AquAdvantage salmon commenced litigation [Institute For Fisheries Resources, et al, vs. United States Food and Drug Administration, et al] contending that the FDA failed to adequately assess the risk that the genetically engineered salmon would escape and survive in the wild, and the consequences that would result for the environment if this risk materialized.
The coalition includes the following plaintiffs: Institute for Fisheries Resources, Pacific Coast Federation of Fishermen’s Associations, Cascadia Wildlands, Center for Biological Diversity, Center for Food Safety, Ecology Action Centre, Food and Water Watch, Friends of the Earth, Friends of Merrymeeting Bay, Golden Gate Salmon Association and the Quinault Indian Nation. The plaintiffs are represented by the Center for Food Safety and Earthjustice.
United States District Judge Vince Chhabri of the Northern District of California by his recent Order dated November 5, 2020 has determined that the FDA failed to conduct a proper hazard assessment under the National Environmental Policy Act. Given the biotechnology company’s plans to grow and commercialize the salmon in the U.S. and around the world, the FDA did not properly evaluate the intensity and context of its decision in approving AquaBounty’s application (despite the current very low risk that the genetically engineered salmon might escape, survive and establish a persistent population outside of captivity).
However, because the FDA took the risk of escape seriously and imposed conditions designed to prevent escape of the bio-engineered salmon, Judge Chhabri did not revoke the approval by the FDA of the defendant company’s operations in Indiana and Prince Edward Island. In the judge’s words: the FDA can conduct the required analysis before deciding whether to approve other facilities being contemplated, emphasizing that destroying the current stock of salmon would be a significant loss of property and animal life that would be wasteful.
In addition, Judge Chhabri also determined that the FDA should have consulted with the expert agencies, the National Marine Fisheries Service (NMFS) and Fish and Wildlife Service (FWS) to determine whether its approval of AquAdvantage salmon may effect endangered wild salmon as required by the Endangered Species Act. The judge pointed out a strange sequence of events where NMFS and FWS initially urged the FDA to consult with them regarding the AquaBounty operations. Accordingly, the FDA’s initial view was that the engineered salmon “may effect” the endangered wild salmon thereby providing a basis for consultation. But then the FWS prodded FDA to change its position to “no effect” on the endangered wild salmon by AquaBounty operations, eliminating the basis for consultation with the expert agencies. Easy to suspect political pressure or influence exerted to inhibit careful and thorough environmental review.
(Frank W. Barrie, 11/12/20)