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 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.

The FDA also analyzed the potential environmental impact that an approval of the original AquAdvantage Salmon application and a supplemental application would have on the quality of the human environment in the United States and issued its Environmental Assessments and Findings of No Significant Impact.

How the AquAdvantage Salmon is different from other fish

AquAdvantage Salmon has been genetically engineered to reach a growth marker important to the aquaculture industry 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.

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.

Labeling

The United States Department of Agriculture’s Agricultural Marketing Service (USDA AMS) regulates the labeling of human food from GE salmon, including AquAdvantage Salmon, under the National Bioengineered Food Disclosure Standard.

In light of the National Bioengineered Food Disclosure Standard (NBFDS) and its implementing regulations issued on December 20, 2018, the FDA is reviewing its draft guidance on labeling of GE salmon to consider what additional or new recommendations may be needed for the kinds of products or statements, including claims of non-GE content, that are not covered by the NBFDS.

As with all foods, a company may include voluntary information in labeling, provided the information is truthful and not misleading.

You can see the 2015 draft guidance here: Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon.

Containment

Under the approval and subsequent supplements to the original 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 specific land-based facilities: one in Canada, where the breeding stock are kept, and Indiana, where the fish for market will be grown out using eggs from the Canada facility.

Both the Canada and Indiana 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. 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.

The fish to be grown for food in Indiana will be an all-female, reproductively sterile population.

The FDA has inspected the Canadian and Indiana facilities. 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. In addition, the Canadian government has conducted and will continue to conduct inspections of the Canadian facility.

Evaluation of environmental effects

In compliance with requirements of the National Environmental Policy Act (NEPA), the FDA evaluated whether approval of the application and a subsequent supplement to 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 original application and subsequent supplement, the FDA found that an approval of the application and supplemental 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 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 original and supplemental application Environmental Assessments, the agency issued Findings of No Significant Impact (FONSI). 

Import Alert

In 2016, the FDA issued Import Alert 99-40 in response to a specific provision in the 2016 Omnibus Appropriations Act, which stated that the FDA may not allow the introduction or delivery for introduction into interstate commerce any food that contains GE salmon, until final labeling guidelines for informing consumers of such content were published. The provision was also included in the 2017, 2018, and 2019 Omnibus Appropriations Acts. In effect, the Import Alert meant that AquaBounty could not import AquAdvantage Salmon, including its eggs or any other food from the salmon, into the U.S.

In 2016, after FDA issued Import Alert 99-40, Congress enacted the National Bioengineered Food Disclosure Standard law, which charged the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) with promulgating regulations establishing a mandatory disclosure standard for the labeling of “bioengineered” food for human consumption. These regulations were published on December 20, 2018.

With Congress’s enactment of the National Bioengineered Food Disclosure Standard, FDA was divested of its authority over voluntary labeling to indicate the presence of GE content in human foods. FDA no longer has the authority to issue labeling guidance on this topic; however, the FDA believes this Congressional mandate has been satisfied by the U.S. Department of Agriculture’s issuance of final regulations implementing that law in late 2018 because the law and regulations require that human food containing GE salmon bear labeling indicating that it is bioengineered.

On March 8, 2019, the FDA deactivated Import Alert 99-40, which prevented the introduction or delivery for introduction into interstate commerce of food containing GE salmon, including their eggs.

With the deactivation of the Import Alert, AquaBounty Technologies is now able to sell food derived from its GE salmon in the U.S. and it may now import its GE salmon eggs to raise in an FDA approved U.S. facility.