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The specific proposed limitations on the production and use (grow-out) of AquAdvantage Salmon, including the production of triploid, all-female fish populations, are designed to mitigate potential adverse environmental impacts.
The conditions proposed in the materials submitted by the sponsor in support of an NADA would limit production of eyed-eggs to a single specific facility on Prince Edward Island, Canada, for delivery to a single specific land-based facility in Panama for grow-out (i.e., rearing to market size), in secure facilities that have been verified and validated by FDA, with harvesting and processing (e.g., preparation of fish fillets, steaks, etc.) in Panama prior to retail sale in theUnited States.
In Canada, regulation of fish that are the product of biotechnology takes place under the New Substances Notification Regulations (Organisms) of the Canadian Environmental Protection Act. The Canadian governmental authorities charged with responsibility for the regulatory oversight of the research and development and the commercial deployment of transgenic aquatic organisms are Environment Canada and DFO.
Panama operates a National Biosafety Commission that coordinates activities related to the biosafety of transgenic organisms. In theRepublicofPanama, product approval and commercialization of AquAdvantage Salmon inPanamawill primarily require involvement of the Sectorial Biosafety Committee for the agriculture sector, which is involved with review of applications for research and marketing of transgenic organisms. and includes members from relevant Panamanian institutions (e.g., Agricultural Development Ministry, Food Safety Authority, Authority of Aquatic Resources).
Based on observations made and information gathered during the site visit by the FDA, the descriptions and schematics provided by the sponsor on thePanamagrow-out facility and the river and surrounding environment have been accurately represented. There are a minimum of three or four levels of containment between both the fry tanks and grow-out tanks and the river.
