Thursday, January 17, 2013
If you want to bury an unsavory news story, the afternoon before Christmas vacation is a good time to break it. The FDA chose Dec. 21 to release its long awaited 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 salmon farmers won’t be allowed to raise in the U.S., but Americans would be allowed to eat.
If the timing suggests the 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 regulatory price for trying to be first.
Under Bush II, the FDA announced it would regulate AquAdvantage salmon as an animal drug rather than food, perhaps in hopes of expediting the process.
Its application in bureaucratic purgatory for decades, 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, triggering what has become a 400 percent run-up.
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. The company claims this cluster of genes, aka the drug, makes AquAdvantage salmon grow faster than its non-GM counterparts, and it hopes to sell that claim – and lots of AquAdvantage salmon eggs – to fish farmers everywhere.
But unlike most other so-called animal drugs, this one inhabits 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 genes/drugs to the next generation.
Given that precedent will be set in approving the first GM animal for human consumption, it’s understandable that the review might take some time. Unfortunately, the FDA has spent most of its time figuring out how to avoid asking questions.
The Christmas EA predicts “an extremely low likelihood” that AquAdvantage salmon will affect “the environment of the United States.” This conclusion spares the FDA and AquaBounty from conducting an Environmental Impact Statement, which would include a comprehensive failure analysis investigating the possible outcomes of worst-case scenarios.
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 to marketable size. In the future, AquaBounty hopes to ship eggs worldwide from Prince Edward Island – but not to the U.S., or any other country, apparently, 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.
Purdue biologist Bill Muir has looked extensively at risk associated with GM fish. He believes AquAdvantage salmon don’t pose much of an ecological threat, and commented at the VMAC. 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 (and presumed dead).
Dartmouth sustainability science professor Anne Kapuscinski addressed the committee as well. Like the rest of the public, Kapuscinski had barely two weeks to review the hundreds of pages of documents released Friday before Labor Day.
Dr. Kapuscinski recently led a team of 53 scientists in writing a book about how to conduct a scientifically credible risk assessment of genetically modified fish. Kapuscinski was one of the most qualified people in the room, VMAC members included, to comment on the ecological risks posed by AquAdvantage. “The Environmental Assessment does not adequately consider the growing body of research on genetic and ecological risks of transgenic fish,” she said.
The EA, she added, lacked the basic 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.”
Kapuscinski advised the FDA to “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 its 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 depends on exporting fish farming to other people’s backyards, and 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.
To claim that AquAdvantage salmon is safe, while at the same time circumventing the process of regulating its production at home, sends a mixed message to consumers, environmentalists and industry. It also reeks of colonialism, and serves as a reminder of why “animal drug” might not be the most meaningful way to describe this fish.