GE salmon gains FDA approval

U.S. regulators approved for sale a type of salmon modified to grow to market size in half the time of conventional relatives.

The modified Atlantic salmon produced by AquaBounty Technologies is the first genetically engineered food animal to gain approval from the Food and Drug Administration, which regulates the recombinant DNA construct in the fish as a drug. The agency issued the approval Nov. 19, 2015.

AquaBounty spokeswoman Genevieve Nyren said that the approval was the last one needed to sell the salmon in the U.S. She declined to say how soon the fish could be sold in the U.S. but said “there are several paths to market that are being considered.”

The modified salmon grow to market size of 3 to 4 kilograms (6.6 to 8.8 pounds) in 16 to 18 months, about half the time needed to grow conventional salmon. They contain a growth-promotion gene from Chinook salmon controlled by a promoter sequence—which activates expression of a gene—from ocean pout, according to the FDA.

The agency found that the salmon are as safe for human consumption as conventional Atlantic salmon following “exhaustive and rigorous” review since AquaBounty’s precursor organization, A/F Protein, first sought approval of the fish in 1995, according to the FDA and AquaBounty.

All the fish produced for consumption are female and sterile, reducing the likelihood they could reproduce in the wild and redirecting energy toward growth rather than reproductive development. The fish also will be produced and raised in tanks at land-based facilities with redundant barriers preventing escape, according to the FDA.

AquaBounty will produce eggs on Prince Edward Island in Canada and grow the fish in Panama.

Nyren, of AquaBounty, said the company is seeking approval to sell the fish in more countries and may seek approval to produce the salmon in “additional jurisdictions.”

Agency officials published at the same time a draft version of pending guidance for how those selling conventional salmon can distinguish their fish from those engineered by AquaBounty. The agency has ruled that labels on genetically engineered foods are voluntary if those foods lack characteristics distinguishing them from conventional alternatives.

Thus, AquaBounty and anyone who uses its fish as an ingredient in their products, for example, can label the fish as Atlantic salmon. But the FDA acknowledges that members of the public may want to know whether they are buying products of genetic engineering, so competitors can, under the draft guidance, add label statements such as “Not genetically engineered.”

Related JAVMA content:

Salmon could show path for transgenic animals (Nov. 15, 2010)

FDA considering approval of genetically engineered salmon (Nov. 1, 2010)