AquaBounty Environmental Assessment Published24 December 2012
US - Biotechnology company, AquaBounty Technologies, which focuses on productivity in the aquaculture market, has been notified by the US Food and Drug Administration that the Environmental Assessment on its New Animal Drug Application for AquAdvantage Salmon will be published in the Federal Register on 26 December.
The Environmental Assessment will be subject to a 60 day period for public comment. The FDA is also making available for comment its preliminary Finding of No Significant Impact (FONSI).
The 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. Subsequently, the FDA has been fulfilling its obligations under the US National Environmental Policy Act, which requires that all federal agencies consider the possible environmental impacts of any action, which they authorise.
The FDA has not provided the Company with an indication of the process or associated timing that will occur after the conclusion of the period for public comment.
Ron Stotish, Chief Executive Officer of AquaBounty, 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."
The Company's AquAdvantage® Salmon product consists of Atlantic salmon eggs that contain a growth hormone gene from the Chinook salmon, which provides the fish with the potential to reach market size in half the time of conventional Atlantic salmon. Fish grown from AAS eggs are all female and sterile. In addition, the FDA requires that, were approval of AquaBounty's NADA to be granted, the fish can only be grown in physically contained systems at approved facilities.
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