Aquabounty executives say if their fish are approved for commercial sale, there are several safeguards designed to prevent the fish from escaping and breeding with wild salmon. The salmon are bred as sterile females. They also are confined to pools where the potential for escape would be low: The inland pens are isolated from natural bodies of water.
And the company says that these pens would be affordable thanks to the fast-growing nature of Aquabounty's fish, which allows farmers to raise more salmon in less time. Overall, the company estimates that it would cost 30 percent less to grow its fish than traditional salmon.
But getting the fish to market hasn't been easy.
The company began discussions with the FDA in 1993. But the agency did not yet have a formal system for reviewing genetically modified food animals.
So Aquabounty spent the next decade conducting more than two dozen studies on everything from the molecular structure of the salmon's DNA to the potential allergic reactions in humans who would eat it. By the time the FDA completed its roadmap for reviewing genetically modified animals in 2009, Aquabounty was the first company to submit its data.
After reviewing the company's data, the FDA said in a public hearing in September of 2010 that Aquabounty's salmon is "as safe as food from conventional Atlantic salmon." The FDA also said the fish "are not expected to have a significant impact" on the environment.
But as the company has inched toward FDA approval it has faced increasing pushback from natural food advocates, environmentalists and politicians from salmon-producing states. In fact, following the FDA's positive review of the fish, the House of Representatives passed a budget that included language barring the FDA from spending funds to approve a genetically engineered salmon.
"Frankenfish is uncertain and unnecessary," said Rep. Don Young of Alaska, who authored the language. The Senate did not adopt the measure.
Despite such opposition, environmental groups such as the Food and Water Watch say that FDA approval seems inevitable. "We think there is a clear bias toward approving genetically modified animals within the FDA," said Patty Lovera, assistant director of Food & Water Watch, a nonprofit that promotes environmentally friendly fishing and farming practices. "This thing is trapped in a regulatory process that is predisposed toward approving it."
But the delay could cause Aquabounty to go bankrupt before its salmon reaches supermarkets.
Aquabounty, which started in 1991 focusing on proteins used to preserve human cells, changed direction after acquiring the rights to gene-manipulation technology from researchers at the University of Toronto and Memorial University of Newfoundland. Initial financing came from Boston-area investors and biotech-focused venture capital funds, but the company has burned through more than $67 million since it started.
According to its mid-year financial report, Aquabounty had less than $1.5 million in cash and stock. And it has no other products besides genetically modified salmon in development.
In February, the cash-strapped company agreed to sell its research and development arm to its largest single shareholder, Kakha Bendukidze, a former Republic of Georgia finance minister turned investor, in return for his help raising $2 million in cash to stay afloat. Aquabounty's CEO Stotish fretted that Bendukidze, who controlled nearly 48 percent of Aquabounty's public stock, would move the company overseas. But in October Bendukidze's investment fund sold its shares to Intrexon, a biotech firm headquartered in Germantown, Md.
Stotish views the sale as a positive development, but he still worries that the U.S. government is unwilling to approve the technology at the heart of his company's work.
"This is about more than Aquabounty and more than salmon," Stotish says. "And shame on us if we allow this to slip away because of partisan bickering and people who oppose new technology."