Two years after it first said that Aquabounty's genetically modified salmon was safe to eat, the US Food and Drug Administration has now given its first nod for the product to become commercially available.
On Dec. 21, the FDA released its environmental assessment of Aquabounty's AquaAdvantage fish -- which grows twice as fast as a normal salmon -- which concluded that the fish "will not have any significant impacts on the quality of the human environment of the US".
The assessment also found that the fish is unlikely to harm populations of natural salmon.
The FDA will now take public comment on the report for 60 days before making its decision final.
Already, the organization Consumers Union has come out in opposition to the FDA decision.
One of Aquabounty's argument to reassure opponents has been the fact that its fish will be sterile, thereby unable to affect wild stocks in the event of an escape.
However, the FDA indicates that only 95% of the salmon may be sterile, and the rest fertile, Michael Hansen, a senior scientist at Consumers Union, said.
"When you are talking about millions of fish, even one percent comes to thousands of fish. Moreover, perhaps even more important, the fish at the egg production facility in Prince Edward Island, Canada would obviously not be sterile—otherwise they could not produce eggs."
Since it was founded in 1991, Aquabounty has spent $67 million on developing its fish and keeping the business going, according to Associated Press.
Bred in Panama, the fish contains genes from Chinook and eels to grow faster and bigger than non-genetically modified Atlantic salmon.
The company is listed on the London Stock Exchange but the delay in getting FDA approval has thrown it in financial dire straits in the past few years. On Nov. 1 the private equity Linnaeus Capital sold 48% of the group to the US biotechnology Intrexon for $6m in cash. Intrexon has since announced it would make a buyout offer for the rest of the shares.
If the FDA approves the salmon for commercial use, it would be the first GM animal product to hit the market.
Hansen said Consumers Union is also "deeply concerned that the potential of these fish to cause allergic reactions has not been adequately researched".
"FDA has allowed this fish to move forward based on tests of allergenicity of only six engineered fish—tests that actually did show an increase in allergy-causing potential," he said. "Further, there have been no safety testing of fish grown in Panama, where Aquabounty intends to raise the salmon. The health and safety of fish can be affected by growing conditions."
In many cases consumers will also be unable to avoid the fish if they wanted to, he added. "While salmon is required by law to be labeled as to country of origin in supermarkets, this does not apply to fish markets or restaurants. While in supermarkets consumers could avoid fish from Panama, where this salmon will be grown, they will not have this ability when eating out or buying at a fish store."