FDA Clears Way for AquaBounty to Raise Salmon in America’s Heartland

Xconomy Boston — 

It’s been more than three years since the FDA approved salmon from AquaBounty Technologies, but debates about labels and other requirements have kept the genetically engineered fish from reaching dining plates. On Friday, the FDA removed the last regulatory hurdle standing in the company’s way.

The FDA lifted an “import alert,” a rule that kept AquaBounty from importing its salmon eggs. Maynard, MA-based AquaBounty owns a salmon farm in Canada that will supply the salmon eggs for its U.S. fish farm in Indiana. The FDA had already cleared that farm for operation. But until now, it was not authorized to bring in the genetically engineered salmon eggs, so it’s been stocked with traditional Atlantic salmon eggs. In a prepared statement, CEO Sylvia Wulf said AquaBounty will immediately start the process of importing eggs from Canada to grow in its Indiana facility.

Shares of AquaBounty (NASDAQ: AQB) shot up 118 percent Friday afternooon, closing at $4.89.

AquaBounty’s salmon has taken a long journey to reach this point. The company’s research dates to the mid-1990s. It developed a way to take a growth hormone gene from Chinook salmon and add it to Atlantic salmon. With this gene, Atlantic salmon reach market weight faster—18 months compared to up to three years for conventional Atlantic salmon. The FDA reviewed data about the fish and concluded it met the statutory requirements for safety. In 2015, the regulator approved the company’s salmon, called AquAdvantage, making it the first genetically engineered (GE) animal FDA-approved for eating.

The FDA review also included an environmental assessment. Based on the company’s biological and physical precautions—its fish are sterile, so they can’t reproduce and they’re raised in landlocked facilities—the agency concluded AquAdvantage “would not cause a significant impact on the U.S. environment.”

Despite the FDA nod, lawmakers blocked AquaBounty from a speedy path to consumers. In 2016, Congress ordered the regulator to stop the new salmon from entering the market until labeling guidelines for consumers had been written. The FDA complied with the Congressional directive by halting imports while the labeling was worked out. Sen. Lisa Murkowski (R-AK), who represents a state that is home to the most productive wild fisheries in the U.S., was among the loudest opponents of AquaBounty’s salmon, and she urged strict labeling of the fish.

Late last year, the “National Bioengineered Food Disclosure Standard” went into effect. Under a 2016 law, the U.S. Department of Agriculture was directed to set up guidelines for food manufacturers, importers, and retailers to label bioengineered foods. When the USDA implemented these rules, it took away the FDA’s authority over labeling of GE foods, FDA commissioner Scott Gottlieb said in a prepared statement. But he added that the USDA’s actions also satisfied the labeling requirement Congress sought. “Therefore, the FDA is deactivating the import alert that prevented food from AquAdvantage Salmon, including salmon eggs used to grow the fish, from entering the U.S.” Gottlieb said.

AquaBounty officials have said that rather than competing against wild-caught salmon purveyors, they aim to provide another way to sate the growing consumer appetite for the fish. In addition to its hatchery on Prince Edward Island in Canada, the company operates a demonstration farm in Panama. In 2017, AquaBounty paid $14 million to acquire some of the assets of an Albany, IN, fish farm that raised trout. That site is where AquaBounty will raise its salmon for the U.S. market. In its release of its 2018 financial results, AquaBounty said Thursday that the Indiana farm is operational with traditional Atlantic salmon eggs, with harvest expected in the summer of 2020.

By operating facilities that are entirely enclosed and located inland, AquaBounty officials say they can prevent AquAdvantage Salmon from mixing with wild stocks of fish. Those genetically engineered salmon are already growing at the company’s Prince Edward Island facility and are expected to be ready for harvest for the Canadian market in the summer of 2020. The company says it plans to expand beyond North America and it has projects underway in Brazil, Argentina, Israel, and China.

Public domain photo of Atlantic salmon by Flickr user U.S. Fish and Wildlife Service