HALIFAX -- The U.S. Food and Drug Administration approved the first genetically engineered animal product for human consumption Thursday, raising concerns that the commercial production of the fish at a plant in P.E.I. could pose serious environmental risks.
Lucy Sharratt of the Canadian Biotechnology Action Network said the approval of the AquAdvantage Salmon means production of the fish eggs could ramp up at the AquaBounty facility in Souris, P.E.I.
"We have grave concerns about the environmental risk of producing GM fish and fish eggs," she said. "We're also very concerned about the lack of transparency for consumers on grocery store shelves."
In a statement, the FDA said it did a "comprehensive review" of the product and found it fit for human consumption. The agency said the salmon met several safety criteria, as well as being found to have a similar nutritional value to conventionally farmed salmon.
"The FDA has...determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat," said Bernadette Dunham, director of the FDA's Center for Veterinary Medicine.
Boston-based AquaBounty Technologies had been seeking regulatory approval in the States since 1995, but the process was slowed by study and significant public opposition that has led some U.S. retailers to refuse to sell what has been dubbed by some as "frankenfish."
The company sought the approval after claiming it had found a way to make Atlantic salmon grow twice as fast as normal by modifying eggs with genes from chinook salmon and an eel-like fish called the ocean pout.
It received approval from Environment Canada for the production of Atlantic salmon fish eggs at the Island hatchery, but has not received approval to market the fish for human consumption in this country.
Health Canada has confirmed it is reviewing a submission by AquaBounty to sell the salmon in Canada. A spokesman for the agency said it is aware of Thursday's decision by the FDA.
"The regulatory decision in the United States does not impact on Health Canada's review or decision-making process," said Sean Upton via email.
"Only when Health Canada has reviewed all required information to complete the assessment will a decision be made."
Ronald Stotish, AquaBounty's CEO, said the long-awaited decision means the company can provide a steady supply of salmon in a more environmentally responsible way than traditional ocean-based fish farming.
"This rich source of protein and nutrients can be farmed close to major consumer markets in a more sustainable manner," he said in a statement.
The FDA approval restricts the production of the fish only to P.E.I. and Panama, where the salmon eggs would be grown.
Environmentalists have long opposed the plan, saying the modified fish could escape its containment and mix with wild salmon populations.
The FDA said an escape is almost impossible because of redundant measures put in place to contain them in tanks. It also says that because the fish are sterile, they would not be able to breed with wild salmon.
Food and Water Watch in the States panned the approval, saying the decision "disregards AquaBounty's disastrous environmental record, which greatly raises the stakes for an environmentally damaging escape of GM salmon."
Sharratt says she is also concerned that the FDA didn't mandate the company to label the product as being genetically modified, since it found there was no material difference between GM salmon and non-GM salmon.
"That would be voluntary, so it's meaningless," she said.
The decision comes days after several environmental groups challenged Environment Canada's decision to approve the production of the genetically modified Atlantic salmon eggs.
The suit, heard Tuesday in Federal Court, contends the department did not follow its own legislated rules and do a full risk assessment before clearing AquaBounty to produce the eggs in Prince Edward Island.
