Late last week, the U.S. Food and Drug Administration issued for public comment a draft environmental assessment related to the agency's review of an application concerning AquaAdvantage Salmon, a genetically engineered Atlantic salmon. The agency's preliminary findig is that "an approval of this application, under the specific conditions proposed in the application, would not have a significant impact on the U.S. environment," the agency said.
The Preliminary Finding of No Significant Impact being published is the next step toward approval of the salmon for eventual production and distribution into the food market. The agency had ruled more than two years ago that the salmon - engineered to grow at twice the rate of native Atlantic salmon - that the fish appears safe to eat, but then no more public action had been taken.
This latest announcement offers an environmental clearance for the biotech-enhanced salmon to be raised, clearing the way for approval of the first genetically engineered animal for human consumption. The agency also says the fish will not hurt populations of native salmon, long a concern for environmental and anti-GMO advocates. The FDA will take comments for 60 days on its findings.
In an investor document from AquaBounty, developers of the AquaAdvantage salmon, the company says the agency has not provided an indication of the process or associated timing that will occur after the comment period. Ron Stotish, CEO of AquaBounty says: "We are delighted that the Environmental Assessment is to be published for comment, which brings us a major step closer to approval. The revival of the science-based review process is encouraging and we look forward to a successful conclusion based on the merit of the product."
But detractors were quick to react to the FDA move. In a press statement the Consumers Union says the Environmental Assessment is "flawed and inadequate."
Michael Hansen, senior scientist with Consumers Union, comments: "The EA states that the FDA has found that the salmon is safe to eat. However, we are 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. 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."
The group also says FDA is putting a lot of weight on 'no significant impact' on the fact that the engineered salmon would be sterile females. "However, CU says FDA acknowledges that 95% of the salmon may be sterile, and the rest fertile. When you are talking about millions of fish, even 1% comes to thousands of fish, the group says. 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," Hansons says.
The group also says there's no way for consumers to avoid the fish since current labeling requirements would not require the fish to be labeled as having GMO content.
The AquaAdvantage salmon is engineered with a gene from the Chinook salmon, which gives the fish the potential to grow to market size in half the time of conventional salmon. The company says the AAS is identical to other Atlantic salmon and that the technology allows for an environmentally sustainable alternative to currently farmed salmon. They claim that the fish will be grown in land-based facilities with redundant biological and physical containment.