Practical Questions for Securing Nucleic Acid Synthesis
Sophie Rose1, Tessa Alexanian2, Max Langenkamp3
1The Centre for Long-Term Resilience, London, United Kingdom.
Summary
Nucleic acid synthesis screening is vital for biosecurity, yet policymakers face challenges in implementation. This review outlines key questions for governments to secure synthesis practices.
Area of Science:
- Biosecurity and Biotechnology
- Regulatory Science
Background:
- Affordable nucleic acid synthesis is crucial for biotechnology but poses security risks due to potential misuse in creating dangerous agents.
- Nucleic acid synthesis screening is a key measure to mitigate these risks by preventing access to harmful sequences.
- Existing guidance from governments and industry is evolving towards regulatory frameworks for synthesis screening.
Purpose of the Study:
- To provide a comprehensive resource for policymakers on implementing nucleic acid synthesis screening.
- To identify and categorize critical questions governments and stakeholders must address for effective screening.
Main Methods:
- A comprehensive review of existing guidance documents, policy proposals, and relevant literature was conducted.
- Analysis focused on identifying practical challenges and policy considerations for nucleic acid synthesis screening.
Main Results:
- Five key policy challenge areas were identified: customer screening, sequence screening, domestic/global regulatory interaction, commercial impacts, and benchtop device security.
- While customer and sequence screening have seen some policy integration (e.g., US Executive Order), global and commercial aspects, and benchtop device security require further solutions.
- Existing literature offers recommendations for robust screening but lacks comprehensive solutions for all identified challenges.
Conclusions:
- Policymakers require a structured approach to address the multifaceted challenges of nucleic acid synthesis screening.
- Further development of policies is needed to address global harmonization, commercial implications, and the security of novel synthesis technologies.
