AQUABOUNTY Technologies Inc., a biotechnology company focused on enhancing productivity in the aquaculture market, announced that it received notification from the Food & Drug Administration that the environmental assessment on its new animal drug application for AquAdvantage Salmon (AAS) will be published in the Dec. 26 Federal Register.
The environmental assessment will be subject to a 60-day period for public comment. FDA also made available for comment its preliminary finding of no significant impact on AAS.
As previously reported, FDA held a public meeting of its Veterinary Medicine Advisory Committee in September 2010 to review its findings and the conclusion of its panel of experts that AAS is indistinguishable from other Atlantic salmon, is safe to eat and does not pose a threat to the environment under its conditions of use (nearby story). Subsequently, FDA has been fulfilling its obligations under the U.S. National Environmental Policy Act, which requires that all federal agencies consider the possible environmental impacts of any action they authorize.
AquaBounty chief executive officer Ron Stotish said, "We are delighted that the environmental assessment is to be published for comment, which brings us a major step closer to approval. The revival of the science-based review process is encouraging, and we look forward to a successful conclusion based on the merit of the product."