Busy Day at FDA: Agency Approves the AquAdvantage Salmon Under Strict Conditions of Confinement, Rejects Two Related Citizen Petitions, and Issues Two GuidancesNovember 20, 2015
By Jay W. Cormier –
At long last, yesterday FDA approved AquaBounty’s AquAdvantage Salmon. The approval includes a number of related actions from FDA. As part of the approval, and as required by the National Environmental Policy Act (NEPA), FDA issued a Finding of No Significant Impact (FONSI). FDA responded to two citizen petitions that requested that FDA include the salmon as a banned food (see our detailed post on those petitions here) and requested that FDA issue an environmental impact statement regarding the production of the AquAdvantage Salmon.
FDA also issued two new guidance documents (here and here) that detail FDA’s current thinking regarding the voluntary labeling of foods with respect to the presence of genetically engineered plants and genetically engineered salmon. We will be issuing a separate blog post on the food labeling guidance documents.
FDA’s actions today will not be the end of the already 20 years of scrutiny of the genetically engineered salmon. Lawsuits will likely be filed against FDA; legislation will likely be introduced both in Congress and in various state legislatures; a public media campaign against what critics have dubbed “frankenfish” is only just beginning.
As we previously discussed, AquAdvantage Salmon is a genetically engineered Atlantic salmon that has had a single copy of a transgene inserted into its DNA. Atlantic salmon typically take around 4 years of farming (Atlantic salmon are protected as an endangered species, so fishing and sale of wild Atlantic salmon is illegal) to reach market size. During that time, the salmon only grow during specific times of the year, yet they require adequate food, clean water, and space to swim throughout the entire year. The AquAdvantage Salmon, however, are engineered to grow all year; they do not grow any larger than their non-engineered counterparts – they just reach their size sooner.
As with all FDA animal drug approvals, the sponsor must demonstrate, and FDA must conclude, a number of specific items. Under the FD&C Act, the product must be safe for its intended use under the conditions of use specified in its application; the product must be effective, which is to say that it must meet a specific claim presented by the sponsor; the product must be produced in such a way that ensures product identity, quality, purity, and potency; and if the product is intended to be administered to a food-producing animal, the product and its residues, when used according to any conditions of use (such as a withdrawal period), must be safe to consume as a part of the food products derived from the animal. Under the National Environmental Policy Act (NEPA), FDA is required to consider the potential environmental impacts associated with use of the product.
The most significant portions of the AquAdvantage Salmon approval are the extensive and multiply-redundant conditions of confinement that serve to limit the approved conditions of use. As FDA bluntly states in the approval letter, “[d]eviations from these commitments and requirements will result in the article being considered an unsafe new animal drug under section 512(a) of the FD&C Act and, therefore, an adulterated drug under section 501(a)(5) of the FD&C Act.” The conditions of use and sponsor commitments are spelled out in seven pages in an appendix to the approval letter. These commitments specify the facilities where the fish can be grown, the physical containment conditions used, the breeding process that provides biological containment measures such as an all-female population of reproductively incompetent fish, and the method for shipping fish between the two AquaBounty facilities. Each of these commitments individually, and more importantly, in toto, are intended to address concerns regarding the potential for these salmon to co-mingle with the endangered species that is wild Atlantic salmon.
Collectively, these commitments allowed FDA to conduct its environmental assessment (EA) under NEPA and conclude with a finding of no significant impact on the human environment (what is referred to by our favorite Happy Days related government acronym – a FONSI). The EA and FONSI can be found here and here.
From a food safety perspective, FDA concluded that the data and information that AquaBounty submitted supported a finding that the filets from AquAdvantage Salmon are as safe to consume as filets from non-genetically engineered salmon. (see FDA’s summary of its review, which can be found here). As noted above, we will have a subsequent post that discusses FDA’s conclusions regarding the labeling of the AquAdvantage filets and other foods that are derived from biotechnology (i.e., genetically engineered plants).
With respect to the two citizen petitions before FDA regarding the AquAdvantage Salmon, FDA denied each (here and here). They denied one that asked for additional environmental considerations, concluding that the EA and FONSI for the application presented a substantial basis for the conclusions contained in each. FDA also denied the second citizen petition that asked that the filets be a banned food due to safety concerns because FDA concluded, among other things, that the human food safety review that is part of the new animal drug approval process demonstrated that the petitioner’s concerns are unfounded.
As similar groups have done when USDA has deregulated certain genetically engineered plant varieties, we expect that various interest groups will file suit against FDA, mounting various challenges under NEPA and the Administrative Procedures Act. Given the hundreds of pages of materials released by FDA supporting the approval and FONSI for AquAdvantage Salmon (a virtually unprecedented disclosure at the time of approval for an animal drug), FDA has anticipated these legal challenges and has attempted to mount a preemptive defense.
Whether legal challenges are successful in federal court, however, may be irrelevant if challenges succeed in the court of public opinion. Already, as reported in other news articles (e.g., here), Whole Foods, Trader Joe’s, Target and Kroger have all said they are not planning to sell AquAdvantage Salmon.
We will continue to watch these developments closely and will keep you in formed. In the meantime, stay tuned for Part 2 of this issue, covering the voluntary food labeling policy.