Journal or Publishing Institution: Columbia Journal of Law and Social Problems
Author(s): Homer, M.B.
Article Type: Report
Record ID: 1081
Abstract: The federal regulatory system for biotechnology, and genetically engineered (GE) animals in particular, is in critical need of modification. Relying on a creative interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA), the U.S. Food and Drug Administration (FDA) has assumed sole responsibility for the regulation of GE animals, despite the agency’s lack of expertise in dealing with agricultural and environmental concerns. This Note examines the pending approval of AquaBounty’s GE salmon, the first GE animal submitted to the FDA for approval for human consumption, in order to highlight the flaws and resulting dangers in the current federal regulatory scheme for biotechnology, and proposes changes to as- sure a safer and more thorough regulation of novel GE animals. Moreover, this Note argues that the pending approval of GE salmon in particular makes these proposed changes both especially urgent and, for the first time, politically feasible.
Keywords: genetically engineered (GE) animals, Federal Food, Drug, and Cosmetic Act (FDCA), U.S. Food and Drug Administration (FDA), AquaBounty, GE salmon
Citation: Homer, M.B., 2011. Frankenfish-It’s What’s for Dinner: The FDA, Genetically Engineered Salmon, and the Flawed Regulation of Biotechnology. Columbia Journal of Law and Social Problems, 45, p.83.
