Abstract:
The landscape of genome editing technologies, capabilities, and applications is rapidly changing, which creates critical challenges in identifying and addressing biosecurity risks. The commercial opportunities for genome editing and its regulatory context will be key factors in determining how these tools are developed, disseminated, and used. This paper looks at these complex links and what they might mean for biosecurity and governance. The first section discusses commercial opportunities for genome editing with a focus on animal engineering, plant engineering, and industrial applications for engineered microbes. Therapeutic applications, though an important part of both the bioeconomy and the potential biosecurity risks that arise from genome editing, have been covered elsewhere and are discussed only briefly. The second section discusses the regulatory context in the U.S. for genome editing applications. Some genome edited products (e.g. many plants) are unlikely to be regulated in the same way as earlier generations of biotechnology, while there is a great deal of uncertainty for other products (e.g. many animals). The regulatory process has played an important role in the shape of the biotechnology industry to date, and recent developments could have major implications for how products are pursued (and by whom) in the future. The last section discusses some of the biosecurity and governance challenges that arise from the use of genome editing. The widespread and diffuse nature of the technology and how it is used will make it difficult to identify, scope, and prioritize biosecurity risks that deserve attention. To be successful, governance mechanisms must rely on the community (including researchers, industry, and broader scientific stakeholders) in their development and implementation.
