If you want to bury an unsavory news story, the afternoon before Christmas vacation is a good time to break it. The FDA chose December 21 to release its Environmental Assessment (EA) of the genetically modified “AquAdvantage“ salmon. This move quietly slid the fish closer to making history as the first GM animal approved for human consumption. The public was given 60 days to comment on a farmed salmon that American fish farmers wouldn’t be allowed to raise, but American consumers would nonetheless be allowed to eat.
If the announcement’s timing suggests FDA wants the application to flow smoothly, also consider that it has been 17 years since AquaBounty first applied for permission to sell its recombinant Atlantic salmon in the U.S. The company has paid a heavy price for trying to be first.
The slow and meandering path of the fish’s approval process owes more to agency machinations than any prevailing ideology. Four years is just enough time to settle into a new course before a new administration takes over and replaces your boss and, possibly, your agenda.
During the Bush II, FDA announced it would regulate AquAdvantage salmon as an animal drug rather than food, perhaps in hopes of expediting the process. More recently, according to a hypothesis espoused by Jon Entine in Slate, officials in President Obama’s inner circle conspired to delay the salmon’s approval for political gain.
Its application in bureaucratic purgatory more than a decade, AquaBounty leaked money, sold assets, was often without a clear idea of where the process was going, and flirted with bankruptcy. The tide began turning in November, 2012, when biotech giant Intrexon began acquiring AquaBounty shares (ABTX), triggering what has become a 400 percent run-up of the stock—most of the gain since the FDA’s Christmas announcement.
Meanwhile, many are still wondering how a salmon steak could be considered a drug. According to FDA logic, the drug per se is AquaBounty’s patented genetic construct, made of genes from two other fish inserted into Atlantic salmon DNA. Inserted at the animal’s one-cell stage, the gene sequence exists in every cell of the adult fish’s body.
The company claims this cluster of genes makes AquAdvantage salmon grow faster than its non-GM, farm-raised counterparts, and it hopes to sell that claim, and lots of AquAdvantage salmon eggs, to fish farmers around the world.
But unlike most other so-called animal drugs, this one is stuck in an animal that can do very well for itself in the wild. It can swim across oceans, up rivers, mate with wild fish, and pass along its drugs to the next generation.
Given the precedent that will be set in approving the first GM animal for human consumption, it’s understandable that the review process might take some time. Unfortunately, the FDA has spent most of its time figuring out how to avoid asking some tough but very important questions, such as what would happen in the unlikely event that the fish were to somehow escape into the wild.
The Christmas EA predicts “an extremely low likelihood” that AquAdvantage salmon will affect “the environment of the United States.” This conclusion spares FDA and AquaBounty the significantly more-rigorous, expensive, and time-consuming process of conducting a full Environmental Impact Statement (EIS), which would include a comprehensive failure analysis investigating the possible outcomes of worst-case scenarios at every link in the process. The EA was avoided, largely, by stipulating that no AquAdvantage salmon will be raised in the U.S.
According to the application, AquAdvantage eggs are to be produced in a facility on Prince Edward Island, Canada, and shipped to a facility in Panama to be raised in tanks. In the future, AquaBounty hopes to ship AquAdvantage eggs worldwide from Prince Edward Island—but not to the U.S., or perhaps any other country with sturdy environmental laws.
A key step in the AquAdvantage approval process came in September 2010, when FDA held a public meeting of its Veterinary Medicine Advisory Committee (VMAC) to review what was then the draft EA. Jon Entine, of the Team Obama interference hypothesis, claims that the VMAC committee “unanimously endorsed the FDA’s findings that the salmon was safe. ” But the meeting transcript paints a more nuanced picture.
VMAC member Dr. James McKean noted of AquAdvantage salmon near the end of the meeting, “It appears to be safe, but that loop has not, in my mind, been closed.” Purdue biologist Bill Muir, who commented at the VMAC, has looked extensively at risk associated with GM fish. He believes AquAdvantage salmon don’t pose much of an ecological threat. Nonetheless, as he explained to the New York Times, “Shit always happens. If shit happens and they end up somehow in the ocean … maybe it’s hypothetical to the FDA, but people would like to know what happens.”
In fact, shit did happen at AquaBounty’s Panama location in 2008, when a storm swamped the facility. As AquaBounty reported to investors, the largest batch of salmon in company history was lost. But according to the Christmas EA, curiously, “no serious damage was incurred by this event, and no problems of significance to aquaculture operations occurred.”
Entine’s story about Obama officials meddling with the FDA’s approval process struck a chord among an increasingly frustrated segment of the science-literate left who believe those who question the risk vs return on GM food are wedging themselves, and their pagan values, between science and progress.
Along these lines, Slate contributer Keith Kloor recently suggested that GM food opponents are the left wing version of climate deniers. This overlooks the fact that unlike climate deniers, which huddle to the right, those with concerns about GM food can be found left, right, and center. Lately, such vigilante defenders of science have become fond of chirping “the science is in, FDA says the salmon is safe,” as if the FDA is a scientific authority. In fact, FDA is a government organization, and decisions like this one are based as much in politics as they are in science. Ask Jon Entine.
Big Think blogger David Ropeik Tweeted, of AquAdvantage salmon, “Experts say it’s safe for humans and environment, but some deny that because it feels scary.” He assured his readers, meanwhile, that the AquAdvantage salmon is “… basically a modified hybrid salmon, but hybridized in a lab rather than the old fashioned way, in a fish tank.”
Should video surface I would be most interested to see an old-fashioned three-way between a Pacific salmon, an Atlantic salmon, and the eel-like ocean pout. But in the meantime I’m going to have to file this statement away as another sloppy and failed rendition of the tired and unscientific argument that genetic engineering is basically just like plant or animal breeding.
The arrogance runs strong in the notion that the world is worse off because people with concerns about GM food are irrationally overreacting, especially when it turns out that experts do not in fact agree on the environmental safety of AquAdvantage salmon.
Dartmouth sustainability science professor Anne Kapuscinski addressed the VMAC as well. Like the rest of the public, Kapuscinski had barely two weeks to review the hundreds of pages of documents that were released Friday before Labor Day.
Dr. Kapuscinski recently led a team of 53 scientists in writing a book about how to conduct scientifically credible risk assessment of genetically modified fish, and her lab has done ecological-risk research with GM fish. Kapuscinski was one of the most qualified people in the room, VMAC members included, to comment on the ecological risks posed by AquAdvantage salmon. Her oral comments were cut short due to time; she submitted a written transcript of those comments that I was not able to find on the online VMAC materials hub.
A transcript of those her oral comments that Kapuscinski forwarded to me stated: “The Environmental Assessment does not adequately consider the growing body of research on genetic and ecological risks of transgenic fish.”
The EA, she wrote, lacked the basic quantitative information necessary to verify its conclusions. The statistical methods were outdated, and sample sizes too small or not reported. Kapuscinski called for “a transparent Environmental Impact Statement that completes genetic and ecological risk assessment.”
In person, according to the VMAC transcript, Kapuscinski advised the committee, “FDA should require a quantitative failure mode analysis for all the confinement methods. Failure mode analysis is standard practice for technology assessment.”
The Christmas EA, in explaining the decision to not follow Kapuscinski’s recommendations, cited her work 14 times.
An EIS would be a sensible, if less convenient alternative to approving an EA that relies on an arrangement by which fish farms are exported to other people’s backyards. In order to avoid this, FDA is apparently sending U.S. agents to the ends of the earth to inspect the facilities of fish farms that want to raise AquAdvantage salmon and sell it to the U.S. Even if the fish are indeed ecologically safe, as the agency claims, this double-standard looks bad.
To claim that AquAdvantage salmon can be safe to produce somewhere else while at the same time avoiding regulating the fish’s production at home sends a mixed message to consumers, environmentalists, and industry. It reeks of fish farm colonialism.
The FDA’s apparent impotency over the course of a 17-year (and counting) approval process isn’t surprising. Why should an agency that focuses on drugs, and is advised by veterinary medicine experts, be expected to know anything about ecology? It may turn out that dumping 100 boatloads of AquAdvangage salmon in the ocean is perfectly safe. But the precedent set by this approval process isn’t.
Image description: Environmental conditions influence the differences between transgenic and non‐transgenic fish, making it very hard to predict how the transgenic fish will affect environments where it has not been studied. Modified from Sundström et al. 2007. Proc Nat Acad Sci USA 104:3889‐94. Credit Fredrik Sundström.
Cover photo credit: Shutterstock.