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

Summary

This article examines how scientists and policymakers are working to ensure that powerful new biotechnology tools are used safely and securely. As genetic engineering and artificial intelligence become more accessible, frameworks are needed to identify potential risks while allowing beneficial research to continue. The authors discuss three emerging areas—microbiome therapies, biohybrid materials, and AI applications—and explain how existing safety frameworks may need updating to address new types of risks beyond traditional biological weapons concerns.

Background

Rapid advances in biotechnologies and transdisciplinary research are enhancing full-scale engineering of biology, contributing to worldwide efforts to create bioengineered plants, medicines, and commodities. Policy and governance frameworks for biosafety and biosecurity have evolved, though often reactively to scientific disruption rather than in parallel. This article explores biosecurity frameworks in place to mitigate harmful exploitation of biotechnology by state and non-state actors.

Objective

This article explores risk assessment and mitigation of transdisciplinary biotechnology research and development using the framework developed in the National Academies’ study on Biodefense in an Age of Synthetic Biology. The authors evaluate how specific key conclusions and recommendations from this framework have held up in light of recent and anticipated advances in engineering biology and related fields.

Results

The Synthetic Biology Assessment Framework focuses on risks of using advanced approaches and technologies to enhance or create novel pathogens and toxins through examination of technology usability, weapon usability, actor requirements, and mitigation potential. Case studies demonstrate that while the framework is sufficient for assessing conventional biological agents, it has limited applicability for technologies not usable with conventional agents and those presenting economic or broader national security concerns.

Conclusion

The field of engineering biology advances at a pace challenging current risk assessment frameworks. The Synthetic Biology Assessment Framework is likely sufficient for conventional biological agents but may have limited applicability for emerging technologies presenting economic or national security risks. The vast majority of discourse focuses on risks rather than benefits; analyzing both in future evaluations is critical to balancing scientific progress with risk reduction.
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