Aqua Bounty Technologies Inc.’s genetically engineered salmon are safe to eat and unlikely to harm the environment, said U.S. regulators considering whether to approve the first gene-altered animal for human consumption.
The modified Atlantic salmon, known as AquAdvantage, are unlikely to escape into the ocean or reproduce with naturally occurring fish, Food and Drug Administration staff said today in a report. Outside advisers to the agency will meet Sept. 20 to evaluate the findings.
Aqua Bounty has been seeking FDA approval since 1995 for its salmon. They’re designed to grow to full size as much as twice as quickly as regular ones with the help of genetic material taken from two other types of fish. Environmental groups objected to the farming of such fish. If Aqua Bounty surmounts challenges, its salmon may become the first genetically modified animals approved by the FDA for food.
Data submitted by the company, and inspections by FDA officials, indicate “the likelihood is extremely small that AquAdvantage salmon will establish and reproduce” if they escape from Aqua Bounty’s facilities, agency staff said.
“No effects on stocks of wild Atlantic salmon are expected,” according to the report. There also is a “reasonable certainty” that eating the genetically modified fish won’t cause harm, FDA staff said.
Aqua Bounty, a Waltham, Massachusetts-based biotechnology company, aims to sell genetically modified salmon eggs to companies that would raise them in enclosed facilities such as land-based tanks. The gene-altered fish can grow to “market weight” of up to six kilograms (13.2 pounds) in two or three years, Ronald Stotish, chief executive officer of Aqua Bounty, said today in an interview. Natural Atlantic salmon take three to four years to reach that size, he said.
Aqua Bounty’s Atlantic salmon eggs contain a growth-hormone gene, from Chinook salmon, that is activated with a genetic “on-off” switch from an eel-like fish, the ocean pout. The modified fish, all female, are sterile, Stotish said. The company would sell the eggs only to people who agree to keep the fish isolated from wild salmon populations, and whose facilities have been inspected by the FDA, he said.
Stotish said 97 percent of the total tonnage of salmon now consumed in the U.S. is imported. While it’s too early to project the AquAdvantage eggs’ sales potential, he said the fast-growing fish could help domestic salmon fisheries gain a larger share of the market. Almost 427,000 tons of salmon, valued at $1.39 billion, were imported last year from countries led by Chile, Canada and Norway, according to U.S. Department of Agriculture data.
“The U.S. salmon industry disappeared about 15 to 20 years ago for a variety of reasons, some of them economic, some of them environmental,” Stotish said.
“This is an opportunity to rebuild a high-quality, sustainable salmon production industry in the United States,” he said. “People who farm trout today could very easily consider farming salmon, which is a higher-value fish.”
Environmentalists have raised objections to gene-modified fish. The FDA hasn’t done enough to ensure that genetically engineered salmon are safe to eat and won’t escape into the wild-salmon population, said Wenonah Hauter, executive director of Food & Water Watch, an environmental and food-safety group in Washington. Hauter’s organization was among 31 groups that urged the FDA on Aug. 27 to reject the fish.
The “critical studies” cited in the FDA report were conducted by Aqua Bounty and its contractors, Hauter said today in an interview.
“There are lot of ways this genetically engineered fish could be different, and we don’t think their process is sufficient in looking at the human health impacts,” Hauter said. FDA approval of the salmon is “the lead-up for the floodgates opening to this type of technology. We know pigs will be next.”
GTC Biotherapeutics Inc., based in Framingham, Massachusetts, won FDA approval last year for the first drug made from a genetically engineered animal. It’s an anti-clotting medicine, ATryn, made from the milk of goats bred with genes that produce a human protein that prevents blood clots.
Genetically engineered plants have been used in food for more than 20 years, according to the FDA.