It was not exactly a do-over, but a federal court did order the Food and Drug Administration to do additional analysis and reconsider its “no effect” determination from 2015 for the AquaBounty salmon.
The FDA has completed that work this week with the announcement of the availability of a draft amended Environmental Assessment (EA) for the approval of the AquaBounty application, Atlantic salmon with an intentionally altered genome.
The agency also announced a virtual public meeting to obtain public input on the draft amended EA.
TheFDA first approved the “AquAdvantage Salmon (AAS),” an Atlantic salmon that contains an intentional genomic alteration (IGA) that enables the AAS to grow more rapidly than conventional, farm-raised Atlantic salmon without the IGA. on Nov. 19, 2015.
As part of its evaluation of the application and pursuant to the requirements of the National Environmental Policy Act (NEPA), the FDA evaluated whether approval of the application would result in significant impacts on the quality of the human environment in the United States.
The EA focused on the approved conditions, including the production of AAS eggs at the Bay Fortune facility in Prince Edward Island, Canada, and grow-out at a facility, now closed, in Panama. The FDA issued its Environmental Assessment and Finding of No Significant Impact (FONSI) at the time of approval.
Based on the findings in the 2015 EA, the FDA also made a “no effect” determination under the Endangered Species Act (ESA), concluding that AAS, when produced and reared under the conditions in the application and as described in the 2015 EA, would not jeopardize the continued existence of U.S. populations of threatened or endangered Atlantic salmon or result in the destruction or adverse modification of their critical habitat.
Subsequently, several organizations filed suit in the U.S. District Court, Northern District of California, challenging, among other things, the FDA’s evaluations under NEPA and the ESA for the 2015 approval. On Dec. 19, 2019, the court ruled that the FDA has statutory authority to approve and regulate the genomic alteration in AAS under the Food, Drug, and Cosmetic Act. On Nov. 15, 2020, the court ordered the FDA to do additional analysis and reconsider its “no effect” determination under the ESA together with a revised NEPA evaluation. The court did not vacate the approval, which remains in effect.
To address the court opinion, the FDA prepared a draft amended EA, titled “Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada,” which is now available for public comment. In this draft amended EA, the FDA has expanded its assessment beyond that in the 2015 EA to include an exhaustive analysis of the likelihood and severity of harms that could occur in the highly unlikely event that AAS or their broodstock were to escape confinement, migrate from Canada to the U.S., and be present in the U.S. aquatic environment.
The draft amended EA evaluates the potential risk to the U.S. environment from the production of AAS eggs at all currently operating facilities on Prince Edward Island, Canada, including the Bay Fortune and Rollo Bay facilities. It also takes into account potential future expansion at the Rollo Bay facility. The FDA is seeking public comment on the draft amended EA and is accepting public comments through 11:59 p.m. EST on Jan. 17, 2023.
Information and analyses in the draft amended EA reflects comments and input received from the National Marine Fisheries Service (NMFS) and the Fish and Wildlife Service (FWS) (collectively referred to as the Services) during an ESA technical assistance review initiated in June 2022 with initial discussions beginning in March 2021. The FDA intends to initiate an Informal Consultation with the Services after the close of the public comment period if the current conclusions with respect to the ESA are not altered.
The FDA is also announcing it will hold a virtual public meeting from 1 p.m. to 5 p.m. EST on Dec. 15, 2022, entitled “Public Meeting on Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.” The virtual public meeting will focus on the draft amended EA only and will not include a discussion about AAS generally or the approved application.
Registration for the virtual public meeting closes at 11:59 p.m. Eastern Time on December 9, 2022. Requests for oral presentations must be made by Nov. 28, 2022. Public comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All comment submissions received must reference Docket No. FDA-2022-N-2672 for “Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.”
To register to attend the meeting, request to make an oral presentation, or for instructions for submitting either written or electronic comments, visit FDA’s meeting webpage for more information.
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