The fish, developed by Massachusetts-based AquaBounty Technologies (ABT), is Atlantic salmon given the growth hormone gene of the faster-growing Pacific salmon, along with DNA from the eel-like ocean pout. The company claims that the resulting AquAvantage salmon reaches maturity at twice the rate of normal Atlantic salmon, and requires 25 percent less food.
In its briefing packet – released in advance of a meeting scheduled for September 19 and 20 to discuss possible commercialization of the fish – the FDA said the salmon is “as safe to eat as food from other Atlantic salmon.”
“There is a reasonable certainty of no harm from consumption of food from triploid ABT salmon,” it said.
In addition, the agency said the fish “are not expected to have a significant impact on the quality of the human environment”, although a final conclusion will not be reached until AquaBounty’s environmental assessment has been reviewed by independent scientific experts and the public.
This is the first time that the FDA has considered the safety of genetic engineering in animals intended for human consumption, and it has no specific framework for doing so. Therefore the GE process is being assessed by its Veterinary Medicine Advisory Committee through its new animal drug approval procedure.
Meanwhile, environmentalists have criticized the FDA’s briefing document, claiming that it only contains partial data.
Senior scientist at Consumers Union Michael Hansen said: “Without the required testing and safety data we have no way to prove the transgenic salmon is safe to eat.”
And president of Friends of the Earth US Erich Pica said: “No new data relating to the environmental and economic risks that transgenic salmon will pose if they escape into the wild was included in the materials released today.”
The document does include the conclusions of AquaBounty’s environmental assessment (EA), carried out under the supervision of consulting firm Arcadis.
It found: “The production, grow-out and disposal of AquAdvantage Salmon under the conditions described in this Environmental Assessment are highly unlikely to cause any significant effects on the environment.”
Those conditions include confining fish to culture systems and geographic areas that minimize the risk of escape or subsequent survival; and production of a sterile, all-female fish population.
Commenting on the EA, the FDA said: “The EA is well written and effectively communicates information on the sites of egg production and grow-out of AquAdvantage Salmon, the phenotype of the fish, potential hazards (i.e., likelihood and consequences of escape, establishment and spread), and the containment measures that are being implemented to mitigate risks.”
The full FDA briefing document is available online here.
Details of the upcoming public meeting to evaluate the salmon’s safety are available here.