Regulation and Commercialization of Transgenics in the Livestock Sector

The first transgenic livestock were produced in 1985; however, none have yet been commercialized for food purposes. In the U.S., genetically engineered (GE) animals are regulated by the Food and Drug Administration’s (FDA) Center for Veterinary Medicine under the new animal drug provisions of the federal Food, Drug and Cosmetics Act.  In this context, the recombinant DNA construct is the new drug, not the animal itself.  In a multistep scientific review process, the FDA considers the safety of the rDNA construct with respect to the health and well-being of the animal, the safety of the products generated from the transgenic animal, and any potential environmental impacts.  The first GE animal food product to go through this regulatory process is the fast-growing AquAdvantage^® Salmon.  The company behind this product, AquaBounty Technologies, began seeking guidance for approval of this fish for human consumption in 1993 and a formal request for commercial approval was submitted in 1995.  A briefing package containing all of the scientific data and an environmental assessment was made available to the FDA’s Veterinary Medicine Advisory Committee (VMAC) and the public in 2010.  Considerable controversy surrounded the AquAdvantage^® VMAC meeting, and a protracted period of political interference and resultant regulatory inaction ensued.  As of November 2013, the FDA had not announced a decision regarding the AquAdvantage^® application. Despite the development of promising new technologies to obtain targeted genetic modifications and meritorious livestock applications, the immense regulatory costs and associated uncertainties may impede the commercialization of transgenics in the livestock sector.