Governance of Gene-edited Plants: Insights from the History of Biotechnology Oversight and Policy Process Theory.

The history of US biotechnology oversight for genetically modified plants is analyzed in the context of policy process theories to derive insights for contemporary governance of gene-edited plants. The Advocacy Coalition Framework sheds light on how opposing coalitions with different policy beliefs struggled to influence oversight, along with coalition disputes over the scope of issues that should be considered in regulatory policy-making. The Multiple Streams Approach and Punctuated Equilibrium Theory explain how focusing events arising from these struggles opened "windows of opportunity" to put issues on the public policy agenda and force changes to oversight over time. For example, nongovernmental organizations had a prominent role in bringing legal challenges through federal courts or in raising attention to risk issues in the media—efforts that prompted advancements in federal regulations, guidance documents, or risk-mitigation practices for biotechnology oversight. These policy dynamics depended on public information to bring controversies to light and elicit a policy response. However, recent biotech regulations allow for gene-edited crops to enter the marketplace without requirements for public disclosure or tracking. Lack of transparency jeopardizes the public legitimacy of gene-edited crops, venues for public participation in biotechnology oversight, and ultimately responsiveness to adapt oversight to future biotech products and emerging risks. [ABSTRACT FROM AUTHOR]