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.

Automated summary

This article analyzes the history of US biotechnology oversight for genetically modified plants, using policy process theories to provide insights for contemporary governance of gene-edited plants. The Advocacy Coalition Framework explains how opposing coalitions with different policy beliefs struggled to influence oversight, while coalition disputes over the scope of issues in regulatory policy-making were also observed. The Multiple Streams Approach and Punctuated Equilibrium Theory highlight how focusing events from these struggles created opportunities for changes in oversight. Non-governmental organizations played a significant role in bringing legal challenges and raising awareness of risk issues, prompting advances in federal regulations and risk-mitigation practices. However, recent biotech regulations do not require public disclosure or tracking for gene-edited crops, which undermines transparency and public legitimacy, as well as inhibits adaptability to future biotech products and emerging risks.