Following what it describes as an "exhaustive and rigorous scientific review," the US Food and Drug Administration (FDA) today announced the approval of the first ever genetically-modified animal for human consumption. The engineered salmon in question has had its DNA altered in such a way that it grows to market-ready size in around half the time of regular salmon, and has now been declared safe for humans and safe for the environment.

Developed by multinational company AquaBounty Technologies, the AquAdvantage salmon takes the three year cycle for farmed Atlantic salmon to reach market size and shortens it to 16-18 months, with the help of a couple of key ingredients. A growth hormone gene from the Chinook salmon, a faster growing species, is added to its DNA, along with a promoter from an eel-like fish called ocean pout. A promoter is a sequence of DNA that switches on the expression of a gene.

The move to clear the fish for consumption has been anything but a snap decision, with AquaBounty Technologies first filing for FDA approval of its genetically-modified salmon in 1995. In the years since, it has submitted a series of scientific studies in support of its application before the agency came to recommend an approval in 2010.

Now, after two decades of careful consideration, the FDA has finally given the superfish the nod. Following evaluation of the data, around two million public objections and the release of draft environmental documents for public review, the agency says AquAdvantage salmon is as safe to eat as regular Atlantic salmon. It says it has a comparable nutritional profile, finding no relevant biological differences in key hormones including estradiol, testosterone, 11-ketotestosterone, T3, T4 and insulin-like growth factor 1 (IGF1).

One of the conditions of the approval is that the salmon be raised in land-based farms rather than sea-cages, so as to prevent them escaping into the wild and breeding with natural Atlantic salmon. One of these facilities is located in Canada, where the breeding is handled, while the fish are brought to full-size in the mountains of Panama.

The FDA has also determined that the fish will not require labeling indicating they were genetically engineered. While manufacturers selling the product will be free to do so if they wish, the agency has not made it mandatory as it says the fish is not materially different from natural Atlantic salmon. Differences that would warrant compulsory labeling might include variations in nutritional profile or functional properties.

The announcement has unsurprisingly drawn swift backlash from certain quarters, who have questioned the legitimacy of the review process. The Center for Food Safety (CFS) has already announced plans to sue the FDA and prevent the modified salmon landing on dinner plates around the country.

"The review process by FDA was inadequate, failed to fully examine the likely impacts of the salmon's introduction, and lacked a comprehensive analysis. This decision sets a dangerous precedent, lowering the standards of safety in this country. CFS will hold FDA to their obligations to the American people," executive director Andrew Kimbrell said in a statement.

For its part, AquaBounty claims the FDA approval provides the opportunity for the US to develop an its own economically viable domestic aquaculture industry, pointing out that the country currently imports more than 90 percent of all seafood, and over 95 percent of Atlantic salmon, it consumes.

Source: FDA, AquaBounty

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