Biosecurity Assessments for Emerging Transdisciplinary Biotechnologies: Revisiting Biodefense in an Age of Synthetic Biology.

Introduction: Rapid advances in biotechnologies and transdisciplinary research are enhancing the ability to perform full-scale engineering of biology, contributing to worldwide efforts to create bioengineered plants, medicines, and commodities, which promise sustainability and innovative properties. Objective: This rapidly evolving biotechnology landscape is prompting focused scrutiny on biosecurity frameworks in place to mitigate harmful exploitation of biotechnology by state and non-state actors. Concerns about biosafety and biosecurity of engineering biology research have existed for decades as views about how advances in this and associated fields might provide new capabilities to malicious actors. This article considers biosecurity concerns using examples of research advances in engineering biology. Methods: The authors explore risk assessment and mitigation of transdisciplinary biotechnology research and development, using the framework developed in the National Academies' study on Results: The Synthetic Biology Assessment Framework focuses on risks of using advanced approaches and technologies to enhance or create novel pathogens and toxins. The field of engineering biology continues to advance at a pace that challenges current risk assessment frameworks. Conclusions: This framework likely is sufficient to assess new science and technology advances affecting conventional biological agents. However, the risk assessment framework may have limited applicability for technologies that are not usable with conventional biological agents and result in economic or broader national security concerns. Finally, the vast majority of discourse has been focused primarily on risks rather than benefits, and analyzing both in future evaluations is critical to balancing scientific progress with risk reduction.