FDA Lifts Import Alert on AquAdvantage Salmon

On March 8, the U.S. Food and Drug Administration (FDA) announced that it would be deactivating the import alert it had previously imposed on AquaBounty AquAdvantage Salmon—fish that have often been termed “frankenfish” by the media. The lifting of this ban marks the first time that a genetically engineered (GE) animal product has been cleared for sale to U.S. consumers. AquaBounty, a biotechnology company based in Massachusetts, first developed their GE salmon with a goal of increasing the productivity of aquaculture. The hybrid Atlantic salmon incorporate a growth hormone-regulating gene from Pacific Chinook salmon, as well as a promoter sequence from ocean pout that acts as an antifreeze protein, thereby enabling the fish to grow year-round instead of only during the spring and summer. The resulting fish can reportedly grow to market size in 16 to 18 months rather than the three years that conventionally cultured salmon require. While these traits may appear quite favorable in farmed fish, AquaBounty has faced significant pushback in the United States in marketing its salmon over recent years.

In November 2015, the FDA approved AquaBounty’s application to sell AquAdvantage salmon to U.S. consumers, a decision marking the first time a GE animal had ever been approved to enter the U.S. food supply. However, a rider to the 2016 Omnibus Appropriations Act banned its import until the appropriate governmental agency could mandate labels for the product. Following the Omnibus Appropriation Act’s passage, the FDA issued an import alert for the salmon, meaning that all future shipments of AquAdvantage Salmon into the United States could be refused admission without physically examining the product in each shipment. This alert severely imperiled AquaBounty’s plans to market its salmon to U.S. consumers, although the company successfully made its first sale of 4.5 tons of the fish to Canadian customers in July 2017.

In 2016, President Obama signed the National Bioengineered Food Disclosure Law (“Disclosure Law”) into effect, which amends the Agricultural Marketing Act of 1946, and requires that the federal government establish rules governing the labeling of GMO products within two years of enactment. Specifically, the Disclosure Law charged the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service with establishing a standard for disclosing the presence of bioengineered ingredients in a rule entitled the National Bioengineered Food Disclosure Standard (“National Standard”). The USDA published its final rule on the National Standard on December 21, 2018, with enforcement anticipated to commence on January 1, 2020.

Following the USDA’s issuance of final regulations implementing the Disclosure Law, the FDA stated in a press release that it believes the 2016 mandate issued as part of the Omnibus Appropriations Act has now been satisfied. Accordingly, the agency felt the time was right to lift the AquAdvantage Salmon import alert, thus allowing AquAdvantage eggs to be imported to AquaBounty’s contained grow-out facility in Indiana. Supporting this decision, the FDA reiterated its 2015 determination that the GE salmon were safe to eat and that the genetic construct added to the fish’s genome is safe for the animal. Furthermore, it restated its finding confirming AquaBounty’s claim that AquAdvantage Salmon reach a growth marker important to the aquaculture industry more rapidly than non-GE farm-raised Atlantic salmon.

Despite the FDA’s favorable comments, many environmental and public health advocates decried the decision to lift the ban. Due to the final rule language of the USDA’s National Standard, such critics have noted that guidelines wouldn’t require adequate mandatory labeling, wouldn’t require calling GE fish “genetically engineered,” and wouldn’t help consumers know what kind of fish they are buying. Furthermore, representatives of Native American tribes that culturally rely on wild salmon for food and income have remarked that the import alert’s deactivation directly attacks the Pacific Northwest Tribal communities and will put American consumers at serious risk. More than eighty retailers have said that they won’t sell AquAdvantage Salmon, despite its newfound legality.

As AquaBounty begins to cultivate its first AquAdvantage Salmon for sale, the market will indicate just how receptive the American public is to buying and consuming GE animal products. AquaBounty’s success or failure in this regard will likely have a great impact on the future of genetically engineered animal products in the United States. For more information regarding genetic engineering, AquAdvantage Salmon, and related regulations, please see the National Sea Grant Law Center’s report entitled “Genetically Modified Organisms in Aquaculture: From Present to Future,” which can be found here.