By Brenda Goodman, MA
WebMD Health News
Reviewed by Hansa D. Bhargava, MD
Nov. 19, 2015 -- The FDA has approved the first genetically modified animal, a kind of salmon, meant to feed people.
The agency took nearly 2 decades to make its decision on the new breed of fish, called AquAdvantage, which was reviewed as a new drug, rather than a new food.
"After rigorous scrutiny, FDA has determined that food from AquAdvantage salmon is as safe and effective to eat as food from non-GE (genetically engineered) salmon," said Bernadette Dunham, PhD, director of the FDA's Center for Veterinary Medicine, in a news conference on Thursday.
The agency says nutritionally, there is no difference between natural and genetically modified salmon, and regulators will not require special labeling for the genetically engineered fish.
But in an apparent concession to consumers who want to stay away from genetically engineered foods, the FDA also released draft recommendations Thursday to help guide food companies that want to tell consumers if their foods -- plants or animals -- have or have not been genetically modified.
AquAdvantage contains genes from Chinook salmon and another fish called an ocean pout that allow the fish to grow faster. The inserted genes cause the fish to produce growth hormone year-round, making them ready to sell in about 18 months. That's about half the time it takes to grow natural salmon.
AquaBounty, the company that makes the new salmon, claim their farmed fish will be good for the environment, since they need about 25% less food and can be grown closer to the people who will eat them, reducing their product's carbon footprint.
But it may be a tough sell.
"Consumers and retailers are clear that they don't want the GMO salmon," says Dana Perls, a food and technology campaigner for Friends of the Earth, in Berkeley, CA. The nonprofit is leading a campaign against genetically modified seafood.
Perls says more than 60 grocery chains, including Whole Foods, Kroger, and Safeway, have already pledged not to carry the new salmon, she says.
"People don't want to eat it."
Numerous scientific organizations have issued statements saying that genetically modified plants are safe.
The World Health Organization, for instance, says that because each genetically modified food is made in a slightly different way, they should be evaluated on a case-by-case basis, but that GM foods sold around the world have passed scientific assessments and are not likely to pose risks to human health.
But critics say the approval of this new salmon is problematic, because it relies on shoddy science.
"It sets a really low bar for anything that comes after it," says Michael Hansen, PhD, senior staff scientist for Consumers Union, referring to other genetically modified animals that have been developed.
Hansen has reviewed the company-sponsored studies that were the basis of the FDA's approval in detail. He says several things should have raised serious safety questions, but didn't.
AquaBounty has promised to grow sterile females in closed, landlocked tanks to minimize the risk that the fish could escape and breed with wild salmon populations.
Hansen says the treatment the company will use fails in about 1% of fish, which could allow them to reproduce if they escaped or were released into the wild.
Tests showed the fish carried high rates of deformities, which could make them more susceptible to disease, he says.
"No information was taken on the amount of drugs or other things that might have to be used to raise them," he says.
The main change to the salmon caused them to produce more growth hormone, but tests used by the company couldn't detect how much they were making, according to Hansen.
"It was like using a radar gun that doesn't detect speeds below 125 miles per hour, and from that concluding that there's no evidence that cars and bicycles move at different speeds," Hansen says.
What's more, he points out, the FDA didn't review the safety of the actual product Americans will be eating.
He says the fish that were reviewed by the agency were grown in a facility in Canada, but the company wants to ship eggs from Canada to a "grow out" facility in Panama where the fish will be raised. The FDA didn't review data on fish grown in Panama, he says.
"We've always said that before engineered products are allowed on the market they should go through a rigorous safety assessment. This clearly hasn't happened here," he says.
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SOURCES: News briefing, FDA. Bernadette Dunham, DVM, PhD, director, Center for Veterinary Medicine, U.S. Food and Drug Administration, Rockville, MD. Michael Hansen, PhD, senior staff scientist for Consumers Union, Yonkers, N.Y. Dana Perls, food and technology campaigner, Friends of the Earth, Berkeley, CA. FDA, Environmental Assessment for AquAdvantage Salmon, Feb. 25, 2010.
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