FDA nears approval as food of genetically altered salmon
Tuesday, September 7, 2010
The Food and Drug Administration is poised to approve the first genetically modified animal for human consumption, a highly anticipated decision that is stirring controversy and could mark a turning point in the way American food is produced.
FDA scientists gave a boost last week to the Massachusetts company that wants federal approval to market a genetically engineered salmon, declaring that the altered salmon is safe to eat and does not pose a threat to the environment.
"Food from AquAdvantage Salmon . . . is as safe to eat as food from other Atlantic salmon," the FDA staff wrote in a briefing document. Those findings will be presented Sept. 19 to a panel of scientific experts that will advise top officials at the FDA whether to approve the altered salmon. The panel is holding two days of meetings to hear from FDA staff members, the company behind AquAdvantage and the public.
AquAdvantage is an Atlantic salmon that has been given a gene from the ocean pout, an eel-like fish, which allows the salmon to grow twice as fast as a traditional Atlantic salmon. It also contains a growth hormone from a Chinook salmon.
AquaBounty, the Massachusetts company that first applied to the FDA for permission to sell its fish in 1995, said the modified fish is identical to the Atlantic salmon, except for the speed of its growth.
"We've been studying this fish for more than 10 years," said Ronald L. Stotish, the company's president and chief executive. "In characteristics, physiology, behavior, this is an Atlantic salmon. It looks like an Atlantic salmon. It tastes like an Atlantic salmon."
The team of scientists at the FDA that reviewed AquaBounty's application seems to agree. "We have found no biologically relevant difference between food from [AquaBounty salmon] and conventional Atlantic salmon," the briefing document said.
But independent scientists, consumer groups and environmental organizations are concerned about both the pending decision and the process that the FDA uses to determine whether the genetically modified fish is safe for human health and the environment.
The agency is evaluating the fish as if it were a new veterinary drug, which means that the FDA's deliberations are behind closed doors and that AquaBounty can claim much of the research and other supporting data it supplies to the FDA is confidential.
"Critical information about the whole process has been kept from the public and organizations that focus on these issues," said Wenonah Hauter, executive director of Food and Water Watch, part of a coalition of 31 organizations and restaurant chefs that is demanding that the FDA deny approval of the altered fish. "There's a transparency problem."
Siobhan DeLancey, an FDA spokeswoman, said the agency is following rules. "We do have obligations under the regulations to protect company confidential information," she said.
Hauter and other critics said the information shield makes it difficult for independent scientists to thoroughly analyze claims by AquaBounty or the FDA staff that the altered fish poses no long-term risk to human health or the environment.