It’s been a long, hard swim upstream, but genetically engineered salmon may finally be coming to a US supermarket near you.On Friday, FDA Commissioner Scott Gottlieb announced that his agency is dropping an import alert that effectively held up the production of genetically engineered salmon in the US. The ruling is a boon to AquaBounty, whose AquAdvantage Salmon eggs can now be imported to the company’s contained grow-out facility in Indiana to be raised into salmon for food.AquAdvantage Salmon (AAS) is a genetically engineered version of Atlantic salmon, which contains a Chinook growth hormone gene. Compared to standard Atlantic salmon, AAS matures to market size in about 18 months compared to three years. It also requires 20%-25% less feed than regular farmed salmon.AquaBounty first developed the salmon in 1989 and began seeking regulatory approval within a few years. The FDA began its review in 1995, and after a 20-year review concluded that the fish is safe to eat, the genetic alterations were also safe for the animal, and AquaBounty’s claims about the fish’s growth were accurate. The FDA also assessed the fish’s potential environmental impact and found no significant threat to the environment. Thus, in 2015, AAS became the first animal with an intentional genetic alteration approved for food use in the US.Then politics happened. In December 2015, Senator Murkowski (who represents Alaska, a state known for its own salmon), successfully inserted a provision in the omnibus appropriations bill that blocked the FDA from introducing GE salmon into the market without special GE salmon labeling guidelines. This effectively directed the FDA to block GE salmon in the U.S. by implementing an import alert.The alert only applied to AquaBounty, but it had a broad chilling effect on GE food innovation and research funding in the US, with a number of innovators going outside the US to develop their products and markets. AquaBounty and Intrexon (the majority owner of AquaBounty) announced this past December that Argentina exempted its FLT tilapia from GM regulation. Unlike AAS, FLT tilapia does not contain a gene from another fish, hence the non-GMO designation. It has a bigger fillet, grows to market weight faster, and consumes less feed than conventional varieties.
In December 2018, the USDA released labeling guidelines for foods made with GMO ingredients. The FDA cited this regulation in removing the import alert on salmon, stated that the Congressional mandate has been satisfied because “the law and regulations require that human food containing GE salmon bear labeling indicating that it is bioengineered.” Therefore, the FDA deactivated the import alert preventing AAS fish and the eggs used to grow them from entering the US.The announcement comes just days after FDA Commissioner Gottlieb announced he’ll soon step down from his post. Gottlieb had earned the respect of lawmakers on both sides of the aisle, and was well liked by the biotech industry. In vacating the import alert now, Gottlieb may be trying to take any political backlash directed toward the FDA before leaving Washington DC.With the import alert removed, AquaBounty has a clear regulatory path to move ahead. Sylvia Wulf, CEO of AquaBounty, said in a press release that the company would immediately start the process to import AquAdvantage eggs from Canada to its Indiana facility. “We are delighted that FDA has lifted the import alert, which will allow AquaBounty to begin producing and marketing AquAdvantage Salmon in the United States,” she said in a press release.AquaBounty reports that about 350,000 tons of Atlantic salmon are consumed in the United States each year, with more than 95% of it imported. It says the FDA’s action will bring opportunity for investment in rural America, create American jobs, and reduce dependence on seafood imports.
Friday’s announcement should give hope to other companies developing GE food animals. One such company could be Recombinetics, whose dairy cattle are gene-edited not to have horns (the horns are normally surgically removed to prevent the animals from hurting each other or their farmers). There’s also a raft of companies working on genetically engineered food animals with important public health implications. These include Genus (PRSS-resistant pig) and others working on everything from CRISPR-edited chickens to avert the next bird flu pandemic to tuberculosis and mad cow disease resistant cattle.There are just a few standard permits now before AquaBounty can begin its production and sales operations. Then, it will be up to consumers to decide whether to ultimately adopt the environmental benefits of GE salmon, or cling to old fears.