AQUADVANTAGE SALMON, SCIENCE AND SOCIETY  

AquAdvantage Salmon is an Atlantic salmon which has been modified by the addition of a gene construct containing the growth hormone gene from the Chinook salmon under the control of regulatory elements from an ocean pout. The original construct and transgenic founder were produced by a team of researchers at Memorial University and the Hospital for Sick Children, University of Toronto (Growth Enhancement in Transgenic Atlantic Salmon by the Use of an "All Fish" Chimeric Growth Hormone Gene Construct. S.J.Du, Z.Gong, G.L. Fletcher, M.A.Shears, M.J. King, D.R.Idler, and C.L.Hew, 1992. Biotechnology 10 : 176- 180). The technology was licensed to AF Protein, and subsequently to AquaBounty Technologies. The AquaBounty team performed the formal development research, conducted the regulatory studies and managed the regulatory submissions. Although the formal regulatory process was initiated in 1995 in the United States, the product did not receive final regulatory approval until November 19, 2015. AquAdvantage salmon is the first genetically modified fish or food animal to be approved by the FDA, and the first in this class anywhere in the world. The scientific elements of the regulatory process will be discussed, as well as the events occurring during the development and review process which impacted both the nature and timing of the approval process itself. The attributes of AquAdvantage salmon represent a  potential for environmentally sustainable alternatives to conventional salmon aquaculture, and will be discussed in the context of the controversy surrounding the risk assessment and approval process.