By Ari LeVaux
On November 19, the FDA approved a genetically modified Atlantic salmon for human consumption. Salmon are well-known for their travels, during which they log thousands of miles through the world’s oceans before returning to the streams in which they hatched in order to lay the next generation of eggs. The genetically modified fish, dubbed AquAdvantage, has been on an epic journey of its own, through a tangled regulatory process that treats the genetic modification, which makes them grow extra fast. They are considered an animal drug, not a food. Unlike most drugs, this one has been programmed into every cell of the animal’s body, calling for the constant production of a growth hormone that makes the fish grow twice as fast as its non-modified counterparts. But while most drugs don’t have the ability to mate and reproduce, living beings do. This concerns activists and consumers, who worry that if the fish are able to escape they will spread their fast-growing genes among wild salmon. The fact that it’s the first GM animal approved for human consumption, as well as the strange regulatory route it has taken, is a big reason why this epic journey to approval has taken more than 20 years.
The company that makes this fish, AquaBounty Technologies, has promised that escapes will never happen. Plus, the fish are all female, and sterile, so that even if there were an escape the fish would not be able to mate.
Nonetheless, the AquAdvantage salmon’s approval is contingent on the fish being raised outside the U.S., because neither the FDA or AquaBounty appears too keen to conduct an environmental impact statement (EIS).
Ann Kapuscinski, professor of sustainability science at Dartmouth and an expert on ecological hazards presented by GM fish, tells Food + City that the EIS would include, among other things, an analysis of what might happen should any of these fish escape. The lack of EIS is a problem, she says, and sets a bad precedent.
“Federal decision-makers stopped short of requiring ‘quantitative failure mode analysis’ of the confinement system,” Kapuscinski wrote in a statement when the fish were approved. The FDA, she wrote, “accepted the company’s assertion that the fish will never escape from the land-based farm in Panama. This undermines credibility of this application and shakes our faith that the FDA will require more scientific rigor in future, more risky applications.”
Kapuscinski and her colleague Fredrik Sundström have been advocating for a failure analysis for years, and submitted 18 pages of testimony to that effect in April of 2013. This advice was not heeded. In fact, Kapuscinski tells Food + City, her comments weren’t even made public on the FDA website. The agency is allowed to omit comments, Kapuscinski says, if they "contain private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign.”
“None of these reasons fit the extensive scientific comments submitted by me and Dr. Sundström,” Kapuscinski notes.
By avoiding the EIS and its requisite failure analysis, the FDA is sentencing the fish to a different kind of regulatory limbo, as current U.S. law will not allow the fish to be grown on U.S. territory without these extra analyses. Thus, the AquAdvantage salmon will, for the foreseeable future, be embarking on a journey so epic that you would think its modification included a sequence of frequent flier miles.
It starts in Canada, on Prince Edward Island, where non-GM Atlantic salmon eggs are fertilized with sperm from a GM “neomale,” which is a female that’s been treated with hormones to produce sperm. The fertilized eggs are sexed, male eggs are removed, and the remaining eggs are treated so that they create sterile offspring, via a process that doubles the amount of chromosomes in each cell.
Then the sterilized female eggs are placed in coolers that have been designed to survive a plane crash — just in case — and the coolers are loaded onto a Panama-bound plane.
In Panama, the eggs are trucked to a facility at the headwaters of the Rio Caldera, a trout-containing stream that flows out of Volcan Baru National Park. There, confined to steel tanks, the fish are raised to market size, which will take about half as long as would a typical Atlantic salmon. Aquabounty argues that the fast-growing fish consume fewer resources than normal farmed salmon.
When they are market size, the fish will be killed, cleaned and shipped to the U.S., where residents are allowed to eat the fish that aren’t allowed to be grown there. This long, circuitous path befits such a globetrotting species. But it also creates numerous opportunities for escape.
In 2008, for example, when the first large batch trial of the AquAdvantage salmon was being raised, an unintended leg was added to the fish’s itinerary. A letter to AquaBounty investors detailed how “an unusually severe storm” washed all of these fish into the Rio Caldera. The memo referred to these fish as “lost.”
While this represented a blow to investors, a larger issue is the fact that these fish ended up in a river just 60 miles from the Pacific Ocean. To a salmon, 60 miles is like a lap around the block; they have evolved over the ages to swim down rivers and out into the ocean. Hopefully they were all indeed female and sterile, as the company likes to remind us. But the sterilization process isn’t perfect: It’s only 98.9 percent effective. And the FDA would allow it to be as low as 95 percent.
It’s likely that the lost fish all died in the warm Panama river water before they reached the ocean, as warm water doesn’t contain enough oxygen for salmon to survive. But without a failure analysis, we don’t know how likely that is. We also don’t know how likely it is that those escaped fish aren’t exploring strange rivers, looking for their place of birth that doesn’t really exist. But maybe they are. And without a failure analysis having been completed, if these lost fish are indeed out there running wild, we wouldn’t even know where to look for them.