Coverage: “Frankenfish” receives regulatory approval

Genetically engineered salmon received regulatory approval for commercial sale from the U.S. Food and Drug Administration, marking the first time a genetically modified animal was given the go-ahead for human consumption.

Jacob Bunge of The Wall Street Journal had the day’s news:

Federal regulators approved the production and commercial sale of a strain of salmon whose DNA has been altered to make it grow faster, marking the first U.S. approval for a genetically modified animal raised for human consumption.

The go-ahead for the AquAdvantage salmon, announced by the U.S. Food and Drug Administration on Thursday, is a milestone for agricultural biotechnology, though it is far from guaranteed that the product will become widely available. Its developer must now woo retailers and consumers, some of whom are growing increasingly wary of genetically engineered food.

The modified Atlantic salmon was developed by Maynard, Mass.-based AquaBounty Technologies, a unit of Intrexon Corp., to grow to market weight twice as fast as wild or farmed versions of that species. It does so by incorporating a gene from a larger, Pacific Ocean species, the Chinook salmon, that helps boost the Atlantic salmon’s growth-hormone production.

“This is a great thing for science in the U.S. and for consumers,” said Ronald Stotish, AquaBounty’s chief executive. “Hopefully, this will open the door for other applications,” such as modifications to prevent disease.

Andrew Pollack of The New York Times had background on what how the company produces its genetically engineered salmon:

Ronald Stotish, the chief executive of AquaBounty, which is majority-owned by Intrexon Corporation, said he was delighted and somewhat surprised by the approval after all this time. “We had no indication that approval was imminent,” he said in an interview.

Mr. Stotish declined to say what the plans were for bringing the fish to market, other than that the salmon would not be in stores immediately because it would take about two years for even these fast-growing salmon to reach market size. It is also not likely there will be much of the salmon on the market because the approved production facility, which is in Panama, has the capacity to produce only about 100 tons of fish a year — a tiny amount compared with the more than 200,000 tons of Atlantic salmon the United States imports each year.

Mr. Stotish said he did not know if approval was still needed from Panama to export the fish.

It is not clear how well the salmon will sell. Some leading supermarkets have already said, in response to the vocal opposition, that they have no plans to sell it.

The fish are supposed to be raised inland in contained tanks to lessen the chances that they will escape into the wild. AquaBounty and its supporters say this will also be less stressful on the environment than using pens in the ocean. And it could eventually allow the fish to be raised in the United States, rather than being imported, as most farmed Atlantic salmon is.

For now, however, the fish are being raised in Panama, from eggs produced in Prince Edward Island, Canada. If the salmon were bred or raised elsewhere, for marketing to Americans, that would require separate approvals.

However, moving beyond Canada and Panama seems to be the plan, according to a regulatory filing by AquaBounty a year ago. It said at that time that after winning F.D.A. approval it would look to build a hatchery in the United States and expand the one in Canada to sell more eggs to fish farmers, who would then grow the salmon to market size. AquaBounty said it might also grow salmon from the eggs itself. In addition to the United States, it said it eventually hoped to sell the salmon in Canada, Argentina, Brazil and China.

The approval could help other efforts to develop genetically modified animals. Scientists and biotechnology industry executives have complained that the long, unexplained delay in approving the salmon was a deterrent to the field. Several other attempts to develop genetically engineered animals for consumption, like a pig whose manure would be less polluting, have fallen by the wayside.

CNN’s Debra Goldschmidt described how long it took for the genetically engineered salmon to reach regulatory approval:

The FDA’s Veterinary Medicine Advisory Committee took up the issue in 2010. The genetic engineering for these salmon is a combination of a growth gene from Pacific chinook salmon (to accelerate growth) and genetic material from an eel-like fish called “ocean pout” (which allow the fish to grow year round). This results in a recombinant DNA (considered a drug by FDA definition) that is injected into the eggs of Atlantic salmon. The new genetically altered salmon are also reproductively sterile, a comforting detail to those worried about mutant offspring.

The approval specifically states that these salmon can only be raised on land-based, contained hatchery tanks at two specific facilities in Canada and Panama and no other locations in the United States or elsewhere. The approved locations have met the criteria required to properly contain the fish and prohibit any eggs or fish from escaping. These facilities will be subject to regulation and inspection from the FDA as well as from the Canadian and Panamanian governments.

This is good news for proponents like Yonathan Zohar, chairman of the department of marine biotechnology at the University of Maryland Institute of Marine and Environmental Technology. He testified before the FDA in support of approval at a 2010 hearing, warning the supply is greater than demand when it comes to consuming fish. He believes the science endorsed by the FDA on Thursday should be accepted as long as we want to continue eating fish. He said the decision is just the start, and suggested that other genetic engineering of fish in the future could help stave off disease.

Brady Dennis of The Washington Post explained the backlash the decision is already receiving:

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.