After years of review and endless controversy, the Food and Drug Administration on Thursday approved the nation's first genetically altered animal -- a salmon engineered to grow twice as fast as its natural counterpart.
Food-safety activists, environmental groups and the salmon fishing industry, not to mention lawmakers from Alaska, have long opposed the approval of the fish -- which they derisively refer to as "Frankenfish" -- and have argued that its existence could open the door to a broad range of potentially unsafe genetically modified animal foods. Knowing an FDA approval was likely, critics have in recent years won commitments from some of the nation's most recognizable chains — including Whole Foods, Trader Joe’s and Target — to not sell the fish.
The FDA said Thursday that its decision was "based on sound science and a comprehensive review," and that regulators are confident that the genetically altered fish is as safe to eat as a normal Atlantic salmon, with no discernible difference in its nutritional value. Officials noted that the agency held meetings, combed through thousands of public comments and conducted scientific and environmental assessments about the AquaBounty fish before finally approving it.
"All of that took time," said Laura Epstein, a senior policy analyst in the FDA's center for veterinary medicine. "As with many products that are the first of their kind, we're very careful to be sure we're getting everything right."
Salmon fishermen and environmental activists have raised concerns about the havoc that could occur if any of AquaBounty's engineered salmon made it into ocean waters and mated with wild Atlantic salmon -- a scenario they say could have unpredictable impacts and lead to the decimation of wild populations. AquaBounty has said its fish are all female and sterile, making it impossible for them to breed with other salmon, even if they somehow were to escape their land-locked production facilities. The company argues its fish actually could reduce pressure on wild fish stocks and prevent the overfishing of Atlantic salmon.
The FDA said Thursday it will require the AquaBounty salmon to be raised only in land-based, contained tanks in two specific facilities in Canada and Panama, and that it will conduct regular inspections. The approval also doesn't allow the salmon to be bred or raised in the United States for now, though FDA officials said the company could apply to have other production sites approved in the future.
Critics have argued that an FDA approval of AquaBounty’s salmon could open the floodgates for other genetically engineered animals, each with its own health and environmental concerns.
"It was a flawed and irresponsible approval ... It sets a very dangerous precedent, given our federal government agencies are ill-equipped to handle genetically engineered animals," said Dana Perls, food and technology campaigner at Friends of the Earth, an international network of environmental organizations that has vehemently fought AquaBounty's efforts. "I think it is a grave mistake we will come to regret."
Perls said her group and others would continue to try to undermine the market for the fish. "It’s clear: People don’t want to eat it," she said. "We’re going to continue to work with grocery stores and retailers to continue to listen to consumers who don’t want to eat this under-studied, unlabeled GMO fish."
Rep. Don Young (R-Alaska) has long opposed the AquaBounty fish, saying that its existence would threaten a mainstay industry of his state. He repeatedly has pushed for delays in the FDA approval process, telling the Post in a 2012 interview that he hoped such hurdles eventually would "break that company."
"This harebrained decision goes to show that our federal agencies are incapable of using common sense," Young said in a statement Thursday. "By embarking on this science experiment, the FDA ignores fundamental risk questions related to our wild fish species and food safety."
Others welcomed the FDA approval Thursday, none more than the company that has spent two decades developing genetically engineered salmon. "We're thrilled," AquaBounty chief executive Ron Stotish said when reached on his cell phone early Thursday. "We think this is good for science, we think it's good for aquaculture, we think it's good for consumers."
Stotish took over at the helm in 2008 at AquaBounty, which he said now employees 21 people, and is acutely aware of the fierce opposition among many activists to the firm's genetically engineered salmon. But he said he hopes to win over critics in time.
"We hope they understand that we understand their concerns. And we've developed a product that mitigates many of the concerns they share and we share," he said. "I hope people take the time to consider the fact that we are an environmentally sustainable product, and that this might actually be a better way to grow salmon ... We hope people consider it on its merits."
Another issue certain to remain controversial as the genetically engineered salmon moves closer to U.S. dinner tables: Labeling.
The FDA said Thursday that it can require additional labeling of genetically engineered foods only if "there is a material difference -- such as a different nutritional profile" between the genetically engineered food and its natural counterpart. In the case of the AquaAdvantage salmon, the FDA found no such differences. Thus, the agency won't require a special label, despite the outcry from consumer and health advocates who say that Americans should know if the salmon they are buying has been genetically altered.
On a conference call with reporters Thursday, FDA officials were asked how consumers eventually would be able to discern between the AquaBounty salmon and any other salmon in the grocery aisle. "[Looking for] 'wild caught' salmon would be one way you could ensure you are not eating genetically engineered salmon," said Larisa Rudenko, senior adviser for biotechnology in the agency's center for veterinary medicine.
Greg Jaffe, director of biotechnology at the advocacy group Center for Science in the Public Interest, said Thursday's approval is unlikely to impact U.S. consumers, at least in the short term. Even when AquaBounty cranks up its production to full capacity, he said, the hundreds of tons of genetically engineered salmon it could produce annually will amount to a tiny fraction of the massive market for salmon in the United States.
"It’s not going to be on the shelf tomorrow," said Jaffe, who agrees with the FDA that the genetically engineered salmon would be perfectly safe to eat. "This is not something you have to try hard to avoid. It's actually going to be hard to find."
This post has been updated.
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