The safety of genetically modified foods has been discussed and debated for some years now and is far from over.
Amid the controversy over the ethics of genetic engineering, Aqua Bounty Technologies Inc. (ABTX.L), which has been awaiting FDA approval for AquAdvantage Salmon, a genetically modified fish, for more than a decade, has moved one step closer to realization.
A draft environmental assessment related to the genetically engineered Atlantic salmon released on Friday by the FDA has concluded that the production of this fish will not result in significant effects on the quality of the human environment in the United States.
This draft environmental assessment is being prepared as part of the regulatory considerations for a possible approval of a New Animal Drug Application for AquAdvantage Salmon.
AquAdvantage Salmon, which is designed to grow faster than traditional fish, is an Atlantic salmon that contains the Chinook salmon growth hormone gene and an antifreeze protein gene from the marine fish ocean pout. AquAdvantage Salmon reaches market size twice as fast as traditional salmons but they do not grow to be larger than their conventional counterparts.
According to Massachusetts-based AquaBounty, AquAdvantage Salmon is also reproductively sterile, which eliminates the threat of interbreeding amongst themselves or with native populations, eliminating the risk to wild populations or the environment.
The company completed all submissions for its New Animal Drug Application, or NADA, for AquAdvantage Salmon with the FDA in 2010.
In September of 2010, the FDA's Center for Veterinary Medicine, or CVM, in a public meeting to address science-based issues related to the NADA for AquAdvantage Salmon, concluded that food from AquAdvantage Salmon "is as safe as food from conventional salmon, and there is a reasonable certainty of no harm from consumption of food" from these fish.
Now, more than two years, since the public hearings in September 2010, the FDA has published the environmental assessment, which is considered the final key event prior to approval of the NADA for AquAdvantage Salmon. Though the environmental assessment of AquAdvantage Salmon was completed in May of 2012 itself, it was only on Dec.21, 2012 did the FDA publish the draft.
However, critics have slammed the FDA's environmental assessment of the genetically engineered salmon saying that it is flawed and inadequate.
Here's what Michael Hansen, Senior Scientist with Consumers Union had to say, "The environmental assessment 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."
If approved, the AquAdvantage Salmon, will be the first genetically modified food animal approved in the U.S., although genetically modified food crops have been consumed for several years.
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