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FDA: Genetically engineered salmon can now be grown, sold in the US

Company overcomes decades-long battle to bring its fish to market.

The US Food and Drug Administration (FDA) announced Friday it is lifting a 2016 import alert that prevented AquaBounty's AquAdvantage genetically engineered salmon or salmon eggs from entering the United States, paving the way for the product to be raised in the United States and sold to US consumers.

The move means the company can now import AquAdvantage eggs and grow them out in its land-based salmon farm in Indiana. The resulting product can then be sold to US consumers.

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"As was determined during the FDA’s 2015 review, this fish is safe to eat, the genetic construct added to the fish’s genome is safe for the animal, and the manufacturer’s claim that it reaches a growth marker important to the aquaculture industry more rapidly than its non-GE farm-raised Atlantic salmon counterpart is confirmed," the FDA said in a statement.

“We are delighted that FDA has lifted the import alert, which will allow AquaBounty to begin producing and marketing AquAdvantage Salmon in the United States," said Sylvia Wulf, CEO of AquaBounty. We will immediately start the process to import AquAdvantage eggs from our hatchery in Canada to begin grow out at our Indiana facility.”

US-based GM salmon farmer AquaBounty Technologies, a majority-owned subsidiary of Intrexon Corporation, last year completed its the second sale in Canada of its AquAdvantage Salmon from its farm in Panama and also stocked its Indiana farm with traditional Atlantic salmon eggs while waiting for approval from the US Food and Drug Administration (FDA) to import AquAdvantage Salmon eggs.

Canada does not restrict the sale of the genetically modified salmon to consumers.

How will Alaska respond?

Today's FDA approval was a loss for leaders in Alaska who have been fighting to restrict the sale of the fish in the United States.

In January, Alaska’s senior US Senator Lisa Murkowski re-introduced a bill in Congress to require any genetically engineered salmon to be clearly labeled as such. She tried to pass similar legislation since July 2017. The Genetically Engineered Salmon Labeling Act would require genetically engineered salmon products in the US market to be clearly labeled “genetically engineered” in the market name.

Another milestone for land-based salmon

Last April, the FDA approved an application by AquaBounty Technologies to raise its AquAdvantage Salmon at a land-based facility near Albany, Indiana.

In 2015, the FDA approved a New Animal Drug Application (NADA) related to its AquAdvantage Salmon, but this approval specified that only AquaBounty’s facility on Prince Edward Island, Canada, where the salmon eggs are produced, and the company’s grow-out facility in Panama, where fish hatch from the eggs and grow to maturity, could be used for producing AquAdvantage Salmon.

In October, AquaBounty reported its Canadian division received a $1.6 million (€1.4 million) construction loan to support development efforts at its Rollo Bay property in Prince Edward Island.

The company said the loan, which is from the Department of Economic Development of the Province of Prince Edward Island, will be used to complete construction of the company’s 250-metric ton production facility on its Rollo Bay site.

The Rollo Bay site, which includes an R&D hatchery, is currently undergoing construction of a 250-metric ton production facility and a broodstock facility.

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