A fast-growing salmon moves closer to US approval after a fishy delay.
The first genetically engineered (GE) animal meant for human consumption — a fast-growing salmon — has floated closer to the dinner table, with a piece of paperwork posted online in December by the US Food and Drug Administration (FDA).
The FDA’s draft environmental assessment concludes that the transgenic AquAdvantage salmon poses no foreseeable risk to nature. After allowing 60 days for public comment, the agency may issue a final assessment and approval — at which time AquaBounty Technologies, the biotechnology company in Maynard, Massachusetts, that developed the fish, can begin to sell it.
However, the draft assessment was dated 4 May, suggesting that the FDA had kept its conclusions under wraps for several months. Advocates on both sides of the issue speculate that political interference may be responsible. “I think it was controversial, and it was an election year,” says Patty Lovera, assistant director of Food and Water Watch in Washington DC, a group opposed to genetic engineering of food animals. An FDA spokeswoman, Morgan Liscinsky, declined to comment on whether the process had been politicized, and says that the agency might still request further studies after the public-comment period.
Delays would not shock Ron Stotish, chief executive of AquaBounty, whose company has been seeking FDA approval for the fish since 1995. When he was alerted to the decision today, he did not at first believe it. “I said, ‘I’ll wait until I see it because I’ve received calls like this before and it never happened,’” he says.
The FDA has reviewed more than 50 safety studies on the GE salmon, including one that shows that it is no more allergenic than a wild salmon. The fish is an Atlantic salmon (Salmo salar) engineered to contain a growth-hormone-regulation gene from a Chinook salmon (Oncorhynchus tshawytscha) that allows it to reach market weight in 18 months rather than three years.
Anti-GE groups still have a long list of concerns. Lovera would like to see more peer-reviewed studies on the potential health risks of the salmon done by scientists with no affiliation to AquaBounty. However, it is not clear where the money to conduct such tests would come from, as US federal funding for research on GE animals is rare.
The GE salmon are all female and are almost sterile; to further reduce the risk that they will breed with wild salmon, they are kept in enclosed, inland tanks. However, Lovera worries that once the fish are approved, stockists will try to reduce costs by filing for permits to keep them in nets in the open ocean, where they could come into contact with wild salmon. “This is basically the final step and we think the FDA has given a strong signal that they will accept the fish, and that is a mistake,” says Lovera.
Stotish counters that as part of its FDA application, AquaBounty has promised not to sell the fish to farmers who do not have enclosed, inland tanks. After 17 years and US$60 million spent trying to win FDA approval, however, Stotish is still cautious. ”We are not so foolish to think that this process will suddenly be normal for us,” he says.
Related links in Nature Research
Related external links
About this article
Cite this article
Maxmen, A. Transgenic fish swims up regulatory stream. Nature (2012). https://doi.org/10.1038/nature.2012.12130