Languages:
Based on the evidence collected and evaluated, FDA has made the preliminary determination that it is reasonable to believe that approval of the AquAdvantage Salmon NADA will not have any significant impacts on the quality of the human environment of the United States (including populations of endangered Atlantic salmon) when produced and grown under the conditions of use for the proposed action.
FDA preliminarily concludes that the development, production, and grow-out of AquAdvantage Salmon under the conditions proposed in the materials submitted by the sponsor in support of an NADA, and as described in this draft Environmental Assessment, will not result in significant effects on the quality of the human environment in theUnited States.
With respect to food safety, FDA has concluded that food from AquAdvantage Salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption of food from triploid AquAdvantage Salmon. Further, FDA has concluded that no significant food safety hazards or risks have been identified with respect to the phenotype of the AquAdvantage Salmon.
FDA, having reviewed the materials submitted in support of an NADA for AquAdvantage Salmon, has also made a “no effect” determination under the Endangered Species Act (ESA), that approval of the AquAdvantage Salmon NADA will not jeopardize the continued existence of United States populations of threatened or endangered Atlantic salmon, or result in the destruction or adverse modification of their critical habitat, when produced and reared under the conditions described within this draft Environmental Assessment.
The two federal agencies responsible for administering the ESA, the National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration (Department of Commerce) and the U.S. Fish and Wildlife Service (FWS) of the Department of Interior, have either concurred with, or indicated no disagreement with, FDA’s “no effect” determination.
