The Regulatory Pathway for Genetically Engineered AquAdvantage® Salmon

A rapid-growth transgenic salmon (AquAdvantage® Salmon) has been on the cusp of regulatory approval for over 3 years. With stagnating global capture fishery, increasing per-capita demand for fish, and an increasing population, increased aquaculture production is widely recognized as the only tractable solution for meeting growing demand for seafood. Techniques including the careful application of transgenics should be considered to make nutritious, high protein foods available to a growing population.  AquaBounty Technologies has been working with AquAdvantage® Salmon for more than 15 years.  This line possess a single additional gene, a growth hormone from Chinook salmon, under the control of regulatory elements from an antifreeze protein gene from the ocean pout.  In addition to the challenges of developing a genetically engineered animal with improved production traits, challenges exist in securing the regulatory approvals necessary to deploy such technology.  Genetically engineered food animals are regulated by the U.S. Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act.  Significant resources have been devoted to systematically addressing scientific questions relevant to FDA evaluation of this line.  Studies including assessment of the safety, effectiveness, and nutritional composition of this line have been completed. No biologically relevant differences between food from AquaBounty’s salmon and conventional Atlantic salmon were found.  AquaBounty has committed to production of AquaAdvantage® Salmon as a triploid (a procedure commonly used to induce sterility in fish), all-female, genetically engineered salmon with a single copy of the transgene confirmed located at a specific genomic location, to be grown only in FDA-approved, physically contained, land-based facilities.  This combination of biological and physical containment is designed to prevent any escape.