AquaBounty Technologies has genetically modified the Atlantic salmon through the introduction of a growth hormone gene from the Chinook salmon, which allows the fish to reach market size almost twice as quickly as its farmed counterparts. The research began more than two decades ago. The company secured licenses for the patents that emerged out of this research, and its plans to commercialize the transgenic salmons (branded “AquAdvantage”) took shape more than a decade ago. In late 2010, the U.S. Food and Drug Administration (FDA) appeared to be on the verge of authorizing production, but, more than two years later, the company continues to await the agency’s blessing. With AquaBounty facing bankruptcy, a group of biotechnology researchers and entrepreneurs wrote President Obama to denounce the political meddling that apparently had stalled the review process. Shortly thereafter, the FDA took a tentative further step toward approval, issuing a draft environmental assessment (EA) at the end of 2012. In explaining why it would allow no more than sixty days for the submission of written comments, the agency noted that its draft EA different little from the one that it had made available more than two years earlier, which makes one wonder what exactly it had done during the interim. If history is any guide, this next step in what has become a tortuous review process does not portend imminent approval: the FDA again will receive thousands of largely duplicative adverse public comments, and members of Congress representing constituents threatened economically by approval of the AquAdvantage salmon again will pressure the agency. Will regulatory officials manage to ignore the static this time around when they seemed incapable of doing so just two years earlier?
Whatever Happened to the "Fankenfish"?: The FDA's Foot-Dragging on the Transgenic Salmom,
Me. L. Rev.
Available at: http://digitalcommons.mainelaw.maine.edu/mlr/vol65/iss2/12