WASHINGTON, Nov. 19, 2015 - The Food and Drug Administration has approved a fast-growing, genetically engineered salmon for commercial sale, making it the first biotech animal cleared for human consumption.

“After an exhaustive and rigorous scientific review, FDA has arrived at the decision that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious,” the agency said. 

FDA also said the multiple containment measures that the fish's developer, AquaBounty Technologies, would employ at its land-based production facilities in Panama and Canada should prevent the fish from posing an environmental risk.

The agency declined to require that the fish be labeled as genetically engineered and instead released draft guidance for labeling salmon. 

FDA says it doesn’t have the legal basis to require labeling of biotech foods that are materially the same as their conventional counterpart. 

Alaska lawmakers have fought to stop the fish’s approval, and Republican Sen. Lisa Murkowski told Agri-Pulse she will try to use the fiscal 2016 omnibus spending bill to force the fish to be labeled. 

“What we’re trying to do is provide some clarity to the consumer out there,” she said, calling the AquaBounty salmon a “science experiment.” 

She argues that biotech animal products should be treated fundamentally different than plants when it comes to labeling. “What is happening with crops in the field and the seeds that are engineered is different than a living species designed for human consumption,” she said.

Labeling considered appropriate under FDA’s voluntary guidance would include the term “genetically engineered” and statements such as: “This salmon patty was made from Atlantic salmon produced using modern biotechnology.”

The guidance explains “how to make it easy for consumers to know whether a food was produced using genetic engineering or not,” says Felicia Billingslea, director of FDA’s Division of Food Labeling and Standards.

FDA also released final guidance for voluntary labeling of foods derived from genetically engineered plants. The document includes advice on how non-GMO foods should be labeled.

For example, non-GMO statements that would be OK with the agency include: “Not bioengineered;” “Not genetically modified through the use of modern biotechnology,” and “We do not use ingredients that were produced using modern biotechnology,” and “This oil is made from soybeans that were not genetically engineered.”

AquaBounty said its salmon would "offer the opportunity for an economically viable domestic aquaculture industry while providing consumers a fresh and delicious product.” The United States currently imports 95 percent of the Atlantic salmon now on the market. 

“Land-based aquaculture systems can provide a continuous supply of fresh, safe, traceable and sustainable” salmon “with a reduced carbon footprint,” the company said. 

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But under pressure from critics of the fish, Safeway, Kroger and several major grocery chains have said they would not sell the product.

“We are deeply disappointed with the FDA’s decision to approve the AquaAdvantage salmon, said Michael Hansen, senior scientist with Consumers Union, publisher of Consumer Reports. “And it’s even more concerning that the FDA chose not to require any form of labeling, making it extremely difficult for consumers to know if the salmon is GE or not.”

The environmental activist group Friends of the Earth said the FDA action would set a precedent for commercializing other biotech animals. At least 35 other species of genetically engineered fish, along with chickens, pigs and cows, are under development, the group said.

“Despite FDA’s flawed and irresponsible approval of the first genetically engineered animal for human consumption, it’s clear that there is no place in the U.S. market for genetically engineered salmon.” said Lisa Archer, the group’s food and technology program director. 

AquaBounty said it was “too early to discuss commercialization plans but there are several paths to market that are being considered.”

The biotech industry welcomed the decision.  “Animal biotechnology can improve livestock to require less feed, produce more protein, and reduce environmental impact, while also providing for enhanced animal health and welfare,” said Jim Greenwood, CEO of the Biotechnology Industry Organization. “Other animal biotechnology applications can improve human health through faster discovery of cures, improved medicines and life-saving tissues and organs.”

(Updated 7 p.m.) 

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