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FDA Approval Process Faces Upstream Currents

FDA Approval Process Faces Upstream Currents

If it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck.” Only in this case, the animal in question is not a duck but a salmon.

Earlier this month the Food and Drug Administration gave a partial OK to AquaBounty Technologies, a Massachusetts-based biotech company, on its application to market the first genetically modified animal in the U.S. for human consumption. The FDA said salmon genetically engineered with a growth hormone gene from the Chinook salmon, to produce rapid growth to market size, are safe to eat and pose little risk to the environment. The growth acceleration is from 16-18 months vs. nearly three years.

The FDA will conduct meetings Sept. 19-21 and take public commentary on the application. The agency then plans to make a decision.

It appears this news has caught some by surprise. Robynn Shrader, chief executive officer, National Cooperative Grocers Association, who represents consumer-owned food co-ops, said she learned about this news a few weeks ago. “It was a shock to us and we are urging our members to weigh in,” she told me. NCGA is not the only group in opposition. A coalition of 31 consumer, animal welfare, environmental and fisheries groups oppose it, according to a New York Times report. The Food Marketing Institute had no immediate comment.

Opponents raise health-issue concerns, especially cancer, often associated with growth hormones. The fish may become more disease prone, and GE salmon may require more antibiotics than are already given farmed salmon. Thus, those who eat the fish could ingest increased levels of antibiotics.

NCGA warns of environmental threats to native salmon populations through cross-contamination as farmed salmon are known to escape from open-water net pens.

AquaBounty attempts to counter these objections through a backgrounder that includes myths and facts on its website: The company notes that it is the FDA that gives premarket approval and examines the environmental impact of any GE food animal.

The crux of this matter may lie with the FDA's process of approval, which many complain is not transparent. FDA also bases its decision on research presented by AquaBounty, which stands to profit from the AcuAdvantage process. “It would be much better if the data were all publicly available and available for independent scientists to evaluate it,” Anna Kapuscinski, a professor of sustainability science, Dartmouth College, told National Public Radio when asked about the FDA process in evaluating the safety of GE fish. Shrader noted the FDA is considering using the approval process intended for drugs in this case, since the DNA introduced into the salmon is intended to affect the animal's structure or function. The FDA is not required to make public the drug approval process.

Regardless of your opinion of GE foods, the public and food industry do have a right to closely examine AquaBounty's data. While it may look like the real fish, the safety and environmental debate will continue.

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