After weathering concerns about everything from the safety of humans eating the salmon to their impact on the environment, Aquabounty was poised to become the world’s first company to sell fish whose DNA has been altered to speed up growth.
The Food and Drug Administration in 2010 concluded that Aquabounty’s salmon was as safe to eat as the traditional variety. The agency also said that there’s little chance that the salmon could escape and breed with wild fish, which could disrupt the fragile relationships between plants and animals in nature. But more than two years later the FDA has not approved the fish, and Aquabounty is running out of money.
“It’s threatening our very survival,” says CEO Ron Stotish, chief executive of the Maynard, Mass.-based company. “We only have enough money to survive until January 2013, so we have to raise more. But the unexplained delay has made raising money very difficult.”
The FDA says it’s still working on the final piece of its review, a report on the potential environmental impact of the salmon that must be published for comment before an approval can be issued. That means a final decision could be months, even years away. While the delay could mean that the faster-growing salmon will never wind up on American dinner tables, there’s more at stake than seafood.
Aquabounty is the only U.S. company publicly seeking approval for a genetically-modified animal that’s raised to be eaten by humans. And scientists worry that its experience with the FDA’s lengthy review process could discourage other U.S. companies from investing in animal biotechnology, or the science of manipulating animal DNA to produce a desirable trait. That would put the U.S. at a disadvantage at a time when China, India and other foreign governments are pouring millions of dollars each year into the potentially lucrative field that could help reduce food costs and improve food safety.
Already, biotech scientists are changing their plans to avoid getting stuck in FDA-related regulatory limbo.