AquaBounty Technologies Inc. of Waltham, Mass., has invested more than 14 years and nearly $60 million developing and seeking approval of its AquAdvantage salmon. The company says its fish look and taste like non-engineered North Atlantic salmon, consume up to 25% less food, and reach market weight in half the time.
If approved, the fish would be the nation's first genetically modified animals produced commercially for food.
"This is the culmination of a very long, very deliberate process," said AquaBounty Chief Executive Ronald Stotish. "We're pleased that the process is moving forward."
The FDA's Veterinary Medicine Advisory Committee will hold public meetings Sept. 19-20 to review the analysis.
One point of controversy has been the potential for cross-breeding with wild salmon, an issue that has been of great concern to some environmental and food safety advocates, but the scenario was deemed "unlikely" in the FDA analysis.
The company has said that it intends to sell the genetically altered eggs — which would be engineered to produce sterile female fish — to producers who would be required to raise them inland to help protect wild fish populations.
At the egg-production and farming facilities, the risk that fish might escape is "extremely small due to the presence of multiple, independent forms of physical (mechanical) containment at both facilities," the FDA analysis said.
But Wenonah Hauter, executive director at Food and Water Watch, a consumer-advocacy organization, disputed that conclusion.
"The FDA also says that [AquaBounty's] promises are potentially misleading because up to 5% of eggs sold for grow out could be fertile," Hauter said. "It seems very likely that there could be fertile salmon that are going to be put into commercial production."
Hauter said her organization planned to request a minimum six-month extension to the public comment period and additional public hearings at locations throughout the country.
"The FDA has had a number of deficiencies recently in their food safety oversight," Hauter said. "There should be more vetting and more people should be brought into this process."