Critics call it “Frankenfish,” but the trade name is AquAdvantage—an Atlantic salmon endowed with DNA and growth hormones from both the Chinook salmon and an eel-like ocean pout.
The result is a fish that reaches market weight in one-half the normal time.
Once approval is granted—and it is expected to come soon—the transgenic salmon will be the world’s first genetically engineered animal available for human consumption. It’s a worrisome prospect for some, but to the biotech industry, the road to approval has been one frustrating delay after another.
The fast-growing AquAdvantage salmon has a competitive edge over conventional fish farming, but getting the new fish to market has taken much longer than expected. Massachusetts-based AquaBounty Technologies first sought U.S. Food and Drug Administration (FDA) approval in 1989, and their creation has remained under scrutiny ever since.
AquaBounty admitted that public acceptance of bioengineered salmon is a big risk for the business, but final approval will protect their market. Much like bioengineered crops, once approved, AquAdvantage salmon can keep its genetically modified identity a secret from consumers.
After many years, approval has been elusive, although regulators have been eager to grant it. The FDA has already concluded that the genetically modified organism (GMO) is not only safe to eat but also virtually indistinguishable from conventional Atlantic salmon, and that it poses no environmental threat.
The biggest obstacle has been from lawmakers who have used their power to stall the process.
The latest congressional roadblock came at the start of 2013. A farm spending bill amendment backed by the most ardent GMO salmon critic of the U.S. House—Rep. Don Young (R-Alaska)—prevents the FDA from spending any money approving AquaBounty’s application.
Interfering With Science
In a December 2012 statement, AquaBounty CEO and President Ronald Stotish said that his company does not have the funding to survive the regulatory limbo much longer. But the hindered approval process also impacts other businesses. Many animal-derived GMO innovations are waiting in the wings, but they need a green light on GMO salmon to open their doors to consumers.
A group of 40 scientists sent a letter to President Barack Obama last September complaining of the holdup. They said that the approval process for GMO salmon, one that ought to be guided by serious science, was instead mired in politics. In an effort to avoid further interference, the letter cautioned against what Stotish described as “legislators’ misinformed paranoia.”
“The Administration’s often-stated commitment to sound science will only ring true if it is followed up [with] prompt regulatory action,” states the letter. “There is much more at stake here than just a fish.”
But not everyone believes that the FDA inquiry is up to snuff. Charlotte Vallaeys, director of Farm and Food Policy at the Cornucopia Institute, said that lawmakers are smart to stall because the evaluation thus far still leaves too many important questions unanswered.
“Are they really interfering with sound science, or are they actually saying, ‘we want more science?”’ said Vallaeys.
When the public comment period on the FDA’s environmental safety evaluation ends next month, regulators are expected once again to grant approval. But critics insist that it is still too soon.
Food safety advocates such as the Cornucopia Institute—a research-driven promoter of organic farming—are calling for more independent testing before the fish can be approved.
Critics have been frustrated for years with the FDA’s approval process—an evaluation based solely on studies the company has submitted—but concern is even more pronounced with cases involving controversial GMOs.
According to Vallaeys, when science is conducted with a profit motive in mind, the research is suspect.
“It is very unlikely that [AquaBounty] would spend so much time and money to submit any safety tests that would raise red flags,” she said. “We believe that the safety testing needs to be independent from the company that stands to profit from the results.”
Dr. Pamela Coleman, plant pathologist and policy analyst with Cornucopia, is familiar with the tricks companies use to ensure that only favorable results are published. According to her, there is a big difference between how the FDA conducts examinations and what an actual scientific investigation entails.
“If someone with a PhD in science works for a company that is selling a product like GMO seeds, they will claim that if you express concerns about the safety of GMOs, you’re anti-science,” said Coleman. “Well, I’m definitely pro-science, but I feel there’s much, much more science that needs to be done to understand what’s going on here before we release new genetically modified organisms.”
Stotish boasts that his AquAdvantage salmon is the most studied fish in history, and according to company research, the GMO fish is even safer than traditional aquaculture.
Coleman said that businesses and regulators are actually the ones standing in the way of real understanding. According to her, many independent scientists want to examine the issue more closely, but are prevented from doing so.
“In science, just the fact that people want to do research is an indication that they think something has not been fully investigated,” she said. “If we already knew all the answers, nobody would want to do an experiment again.”
In the run-up to the Feb. 25 end date for public comment on FDA decisions, many are urging regulators to observe a more independent perspective. Coleman said that in order to address safety and environmental concerns thoroughly, the FDA should conduct a legitimate scientific review.
“That’s what I would like to see for the GMO salmon: have a published peer-reviewed study where we can all understand what the science was. Have someone else repeat it, and then we would know,” she said. “That hasn’t been done.”
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