AquaBounty's gmo salmon application reviewed by FDA

According to a study published in this week’s issue of Science, the U.S. Food and Drug Administration’s assessment of genetically modified (GM) salmon fails to adequately weigh the impacts widespread production of the fish could have on human health and the marine environment.

The concern, according to the Duke University researchers who authored the study, is that the new animal drug application process the FDA is using to review the GM salmon evaluates its safety only by comparing its nutritional profile to non-modified salmon and screening it for known toxins and allergens. By doing so, the process ignores the potential health and environmental impacts associated with how the fish’s faster growth and need for less feed could increase farmed salmon production and consumption, argued the researchers.

The researchers said a smarter approach would be for the FDA to broaden the interpretation of the terms “safe” and “health” in FDA statutes, so the review process can include an evaluation of the overall safety of the new fish compared to other protein sources.

Instead of focusing on the safety of the food consumed one portion at a time, or whether the fish was produced through genetic modifications or classic breeding, a better approach would be to evaluate whether society is better off overall with or without the new product. This approach would allow for a fuller assessment of potential environmental impacts, such as pollution from farmed-salmon waste, disease, increased harvesting of wild fish used to feed farmed salmon and the escape of GM salmon, said the researchers.

The study was co-authored by associate professor of environmental economics Martin Smith and professor of environmental policy Jonathan Wiener of Duke’s Nicholas School of the Environment. Frank Asche of the University of Stavanger in Norway and Atle Guttormsen of the Norwegian University of Life Sciences also contributed to the study.

“The approval of genetically modified salmon will set an important precedent for other transgenic animals intended for human consumption,” said Smith. “It’s essential that FDA establishes an approval process that assesses the full portfolio of impacts to ensure that such decisions serve society’s best interests.”

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