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.
A Senate hearing placed a spotlight on the regulatory tangle surrounding the approval process for genetically-engineered salmon. Potentially the country’s first GE animal for human consumption, the salmon have raised a host of worries among critics including the impact on the environment should they escape fish farms.
However, what came to the fore during the mid-December hearing was the complicated morass of government approval, oversight, and trade when dealing with the GE fish. Other GE animals are surely being developed and the current approval process outlined during the hearing seems ill-equipped to deal with the new technology.
Years ago, Massachusetts-based AquaBounty, submitted an application for its GE salmon to the FDA. In late 2010, preliminary analysis by the FDA – charged with regulating GE animals as “new animal drugs” -- said the fish were safe for consumption and were unlikely to harm the environment. That was hardly the last word as the approval process has since moved through a handful of other federal agencies.
Questions to the expert panel from the Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard mostly came from the chairman, Alaska Sen. Mark Begich, and Maine Sen. Olympia Snowe. Both have large salmon industries in their states and Begich has introduced S.1717, which would ban interstate commerce of genetically engineered salmon.
For video and written statements from the hearing, see here.
“Did you ever consult with agriculture operators?” Snowe asked Ron Stotish, president of AquaBounty. “In Maine, we’ve had a number of organizations that came together for a mutual agreement for the aquaculture operators. Ultimately that has been very successful in containing salmon. We’ve had no escape in the last seven years…
“In respect to your proposal – land-based containment facilities -- what suggests … you can contain (GE salmon) 100 percent? That it is a fail-proof system?”
Stotish said the company had consulted “extensively” with experts in the aquaculture industry and the fisheries sector. “A fundamental issue … is the existence of rigorous management procedures which are essential in the operation of any facility (as well as) the inclusion of rigorous, redundant, multiple, biological and physical containment provisions.”
The environmental assessment of the GE fish is not an FDA-only review, said Stotish. “I am aware – although not privy to the details – that the environmental assessment prepared by the Center for Veterinary Medicine has also been reviewed by NOAA (National Oceanic and Atmospheric Administration), National Marines Fisheries Service, Fish and Wildlife Service, Department of the Interior, as well as the USDA and other federal agencies. This is not a simple, one-off review by the Center for Veterinary Medicine.”
If the fish are approved, AquaBounty plans to produce and sell a triploid, all-female egg produced in Canada “to FDA-approved and inspected facilities for grow-out. The first such facility is in Panama and has already been the subject of a detailed environmental assessment and FDA.”
Any other fish farms for the GE salmon “will be approved on a case-by-case basis by submission of an environmental assessment, review, a pre-approval process and pre-approval inspection by FDA. (These will) look at the unique attributes of the site, the management provisions in place and the unique containment provisions required.”