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A Recap of the FDA's 'Frankenfish' Hearings

The government recently held three days of meetings about whether to approve the "AquAdvantage" salmon -- genetically engineered (GE) to grow faster thanks to genes from the Chinook salmon and from the eel-like ocean pout -- for human consumption. As I reported here, the FDA special committee charged with evaluating the safety of the fish seemed likely to rubber-stamp the super-size salmon.

Well, did they? And what's next?

The New York Times first said the "Panel Leans in Favor of Engineered Salmon" but later walked that back to "Panel Advises More Aggressive FDA Analysis." The meeting on the third day, which debated whether to label the fish as genetically engineered, ended with "No Agreement Imminent On Salmon Labeling," concluded the Los Angeles Times. A "rough consensus" was reached by the committee that "if the fish is approved for market, consumers should have a way to avoid it."

Somewhat surprisingly given its veterinary and pro-industry members, the committee did act more cautiously than anticipated. Here's what really happened. 


I want a new (animal) drug

Because the FDA is regulating the GE salmon as a "New Animal Drug," in agency terminology, it convened a special Veterinary Medicine Advisory Committee (VMAC) to evaluate it. During the first two days of meetings, the FDA's Animal Biotechnology Interdisciplinary Group presented its analysis of the science behind the AquAdvantage to the committee. (You can see the agenda here.)

The committee wasn't being asked whether or not the FDA should approve the GE salmon. Rather, it was asked four specific questions, basically: Do the data and information demonstrate that the genes put into the salmon are safe for the salmon? Is there a reasonable certainty of no harm to humans from consumption of foods derived from AquAdvantage salmon? Do the AquAdvantage Salmon demonstrably grow faster than their conventional counterparts? Are any potential environmental impacts from AquAdvantage Salmon production adequately mitigated by AquaBounty Technologies' proposed conditions of use?

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