What is in this article?:
- Salmon are potentially America's first GE animal approved for human consumption; raising a host of worries among critics including the impact on the environment should they escape fish farms.
- Years ago, AquaBounty submitted an application for its GE salmon to the FDA. In late 2010, preliminary analysis by the FDA said the fish were safe for consumption. That was hardly the last word as the approval process has since moved through a handful of other federal agencies.
The other members of the panel were less glowing in their assessment of the GE fish – which AquaBounty claims have a feed efficiency 10 to 20 percent greater than unmodified salmon -- and questioned the manner regulatory agencies have approached GE animal approval and shared information.
“A year ago, I was on a year-long detail with the U.S. Geological Survey, Department of the Interior, where I ran the fisheries program,” said John Epifanio, a fish conservation geneticist with the University of Illinois. “During the public hearing process last fall, these discussions were out there in the department. … Generally, the full set of information (regarding GE salmon) wasn’t always available to us, internally.”
Epifanio was careful not to “make FDA the punching bag. They have very fine scientists. … I’ve worked with them on traditional aquatic animal drug approval processes. It’s a very meticulous, very fine process and they do reach out.” Even so, “there is some opacity to the process that could be improved.”
With respect to the risk of GE salmon escaping containment, “the documents I’ve seen to date really don’t do a full, modern quantitative risk assessment of both the individual probabilities and the likely impacts if they do (escape),” said George Leonard, aquaculture program director for the Ocean Conservancy. “In particular there is a concept called ‘failure analysis’ … that determines where along a production system there is likely to be failure and then the consequences.”
In the future, Leonard advocated allowing NOAA or Fish and Wildlife to do the environmental assessment side of GE animal applications. “And they could have a very strong (voice) – perhaps, even, a veto – if they can’t be convinced those risks are addressed. (Currently), there is some consultation but the final decision is left to FDA.”
Stotish returned to the “regulatory paradigm” and said “a coordinated framework was agreed to and proposed by the Office of Science and Technology Policy and approved in 1986. In the subsequent 25 years, there was not a regulatory paradigm for the use of the policy in the regulation of transgenic food animals. As you know there has been significant development in agricultural products.”
With that in mind, “it took the majority of the time between 1986 and 2009 to arrive (at an answer) to whether (GE) organisms needed to regulated. As (has been) pointed out, this could be modern breeding technology. And, if so, who should regulate them?”
The result was “draft guidance 187” published in 2009 by the Center for Veterinary Medicine.
Author Paul Greenberg, who has written extensively on aquaculture and world fisheries, pointed out the government is already cash-strapped, without adding the burden of policing GE salmon. “Already, when you look at (aquaculture inspections) we can’t afford it. We only test two percent of (fish imports) coming into this country from abroad. Over 80 percent of our fish come from abroad. We want to add another regulatory burden on top of that? It doesn’t seem to make any sense to me.”
The lack of proper inspection of Asian fish imports is a long-time complaint of the U.S. catfish industry.