AquAdvantage Salmon Approval
Based on a comprehensive analysis of the scientific evidence, as required by the Federal Food, Drug and Cosmetic Act (FD&C Act), the FDA has determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the FD&C Act. The salmon are safe to eat, the introduced DNA is safe for the fish itself, and the salmon meet the sponsor’s claim about faster growth. Because the sponsor has met these requirements, the FDA must approve the application.
The FDA has also analyzed the potential environmental impact that an approval of the AquAdvantage Salmon application would have on the quality of the human environment in the United States and has issued its final Environmental Assessment and Finding of No Significant Impact.
How the AquAdvantage Salmon is different from other fish
AquAdvantage Salmon has been genetically engineered to grow more rapidly than its non-GE farm-raised Atlantic salmon counterpart. It does so because it contains an rDNA construct that is composed of the growth hormone gene from Chinook salmon under the control of a promoter (a sequence of DNA that turns on the expression of a gene) from another type of fish called an ocean pout. This allows the salmon to reach a growth marker important to the aquaculture industry faster than non-GE farm-raised Atlantic salmon.
Food safety evaluation
As part of its review of the application, during which the agency held an open public meeting, took public comment, and released draft environmental documents for public review, the FDA determined that food from AquAdvantage Salmon is as safe to eat as food from non-GE Atlantic salmon. In addition, the nutritional profile of AquAdvantage Salmon is comparable to that of non-GE farm-raised Atlantic salmon.
As part of its evaluation, the FDA examined data comparing three groups of fish: non-GE farm-raised Atlantic salmon from both the sponsor’s farm and from a different commercial farm, and AquAdvantage Salmon. This study compared key hormones (including estradiol, testosterone, 11-ketotestosterone, T3, T4 and insulin-like growth factor 1 (IGF1)) and found no biologically relevant differences.
Under the approval, AquAdvantage Salmon are subject to stringent conditions to prevent the possibility of escape into the wild. The salmon cannot be raised in ocean net pens: instead, the approval allows for them to be grown only at two specific land-based facilities: one in Canada, where the breeding stock are kept, and Panama, where the fish for market will be grown out using eggs from the Canada facility.
Both the Canada and Panama facilities have multiple and redundant physical barriers to prevent eggs and fish from escaping, including metal screens on tank bottoms, stand pipes, and incubator trays to prevent the escape of eggs and fish during hatching or rearing.
The tanks also have covers, nets, jump fences, and screened overflow tanks to prevent escape over the sides of the tanks or incubators. Tank netting also keeps predators such as birds from entering the fish tanks at the outdoor facilities in Panama. The facilities in Canada are indoors. All tank drains and stand pipes have covers or sleeves permanently attached to them.
In order to prevent eggs or small fish from passing through the pipes or plumbing, there is a closed septic system and additional screens and chlorine pucks are used to kill any escaped fish or eggs in the main drain area.
In addition, particularly at the Panama grow-out facility, there are geographical/geophysical containment features, including high river and ocean water temperatures, and other conditions that would not be supportive of salmon survival. The fish to be produced for food in Panama will be an all-female, reproductively sterile population.
The FDA has inspected the Canadian facility twice and, with a representative of NOAA’s National Marine and Fisheries Service, performed an extensive site visit of the Panamanian facility. Based on the agency’s review of these facilities, the agency is confident that the possibility for escape is highly unlikely, and that the procedures in place to monitor physical containment are appropriate. The FDA will maintain regulatory oversight over the egg production and grow-out facilities for the entire duration of the product lifecycle, and will conduct inspections to confirm that adequate physical containment measures remain in place. In addition, the Canadian and Panamanian governments have conducted and will continue to conduct inspections of the facilities.
Evaluation of environmental effects
In compliance with 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.
Based on the multiple forms of physical and biological containment proposed by AquaBounty Technologies in the application, the FDA found that an approval of the application related to AquAdvantage Salmon would not cause a significant impact on the environment of the United States. This finding is based on the extremely low likelihood that AquAdvantage Salmon could escape from the Canada and Panama facilities and survive in an ocean or waterway to interbreed with wild Atlantic salmon. This is due, in part, to the physical and biological containment measures specified in the approved application. Based on the agency’s conclusion from the final Environmental Assessment, the agency issued a final Finding of No Significant Impact (FONSI).
Labeling of food products
The FDA recognizes that some consumers are interested in knowing whether the Atlantic salmon they buy is the product of genetic engineering. Under a draft Guidance released today in conjunction with the approval, manufacturers who wish to voluntarily label their food products as containing or not containing genetically engineered Atlantic salmon may do so as long as such labeling is truthful and non-misleading.
The FDA requires additional labeling of all foods, including foods from genetically engineered sources, when the food products are materially different from their conventional counterparts. Material differences include changes in features like nutritional profile, and functional properties, amongst others. The fact that a food is produced through the use of genetic engineering alone does not normally constitute a material fact requiring additional labeling under the FD&C Act.
Because the data and information evaluated show that food derived from AquAdvantage Salmon is not materially different from food derived from other Atlantic salmon, the FDA has determined that no additional labeling of food from AquAdvantage Salmon is required.