The recent court case and state ballot measures regarding mandatory labels for Genetically Modified Organisms (“GMOs”) suggest the need for a deeper conversation about the federal framework for regulating biotechnology. What is it about GMOs that consumers feel they have the “right to know?” Why has a generation of federal biotechnology regulation failed to satisfy consumer concerns? Are those concerns irrational, or is the regulatory structure inadequate? This Article argues that many consumer concerns underlying the labeling movement raise important scientific and extra- scientific questions that have been apparent since the advent of the technology in the 1980s. Moreover, these concerns persist because the Coordinated Framework for Regulation of Biotechnology has failed to respond to them effectively. The Coordinated Framework was based on statutes that pre-existed the technology and thus poorly fit the unique risks of genetic engineering. Today, genetic engineering is on the verge of a radical shift in technology, a shift that has already begun to burst the seams of those old statutes, leaving agencies with no regulatory authority at all over new products. This Article reviews the evidence behind persistent concerns about GMOs, considers the failures of the Coordinated Framework to address the most valid of those concerns, and canvasses policy questions that Congress must consider to more effectively tailor agency authority to address the risks and to enhance the potential of this rapidly-changing field of technology.

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