In a commentary piece published in the August edition of Nature Biotechnology, animal scientists Alison Van Eenennaam of UC Davis and William Muir of Purdue University recap the regulatory review saga of AquAdvantage salmon, a fast-growing genetically engineered salmon.

“Although the first genetically engineered animals were developed almost 30 years ago, none has been approved for food production,” said Van Eenennaam, a Cooperative Extension animal genomics and biotechnology specialist in UC Davis’ Department of Animal Science.

“The protracted evaluation of the AquAdvantage salmon, and continuing uncertainties in the regulatory process and timeline, have essentially halted commercial investment in the development of genetically engineered animals for agricultural applications in the United States,” said Van Eenennaam, who served on the U.S. Food and Drug Administration's Veterinary Medicine Advisory Committee, which was charged with reviewing a proposal to commercialize the AquAdvantage salmon.

The AquAdvantage salmon, developed by Aqua Bounty Technologies, carries a gene from Chinook salmon that speeds growth and improves feed efficiency in farm-raised fish. The fast-growing, genetically engineered salmon has been under federal regulatory review by the FDA since 1995.

The FDA concluded that AquAdvantage salmon were safe to eat and were not expected to have a significant environmental impact, given the proposed containment measures. But critics continue to charge that the regulatory agency has not adequately addressed their concerns, and have mounted political efforts to block the final approval necessary before the fish can be commercialized.

Muir and Van Eenennaam maintain that the lengthy review process – now in its 16th year for the AquAdvantage salmon – is uncalled for, especially given that similar review is not required for food animals with traits developed through conventional breeding.

“We realize that any new technology can have risks, and those risks need to be assessed in a thorough and convincing manner,” Muir said. “However, once the assessment has been completed and the agency concludes from the weight of evidence that risks of harm, either to the environment or to consumers, is negligible, the next step, which is to allow production and sale of the product, needs to be taken.”

For additional background information please see the following material:

• AquaBounty Technologies (AquAdvantage ® Fish);
• FDA (Environmental Assessment for AquAdvantage ® Salmon);
• Food Safety at msnbc.com (Super salmon or 'Frankenfish'? FDA to decide)

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