UC Davis

For over thirty years, the Coordinated Framework for Regulation of Biotechnology (“Coordinated Framework” or “Framework”) has guided federal regulation of biotechnology products. The Framework relies on a patchwork of laws to allocate oversight of biotechnology products among federal regulatory agencies. The Obama Administration’s 2017 update to the Framework offered the potential to account for new technological developments and to respond to criticisms of the Framework. However, as illustrated by the government’s response to the proposed experimental release of a genetically modified mosquito in the Florida Keys, this potential remains largely unrealized. Oxitec, a British biotechnology company, has genetically modified a mosquito so that male mosquitoes pass on a lethal genetic trait to any offspring. The Food and Drug Administration (“FDA”) evaluated Oxitec’s mosquito as an investigational new animal drug, determined that the proposed field trial would not significantly impact the environment, and turned the matter over to local authorities to decide whether to proceed with the release. While the federal government took these actions before finalizing the Framework update, the update did not significantly change the Framework’s basic approach. As new techniques for manipulating and editing genes offer the prospect of additional genetically modified organisms (“GMOs”), the federal government’s handling of the Oxitec mosquito offers a useful case study regarding the inadequacy of current legal frameworks for new biotechnologies. Ideally, the decision-making process for such technologies would assess and manage relevant risks, acknowledge and address sources of uncertainty and ignorance, engage stakeholders and the public and attempt to reflect their values, and build public confidence that the process is effective and legitimate.