Practical Questions for Securing Nucleic Acid Synthesis

Affordable and accurate nucleic acid synthesis is foundational to modern biotechnology, but raises security concerns because it facilitates the construction of pathogens and other potentially dangerous biological agents. Nucleic acid synthesis screening can reduce the risk of providing potentially harmful nucleic acids to those without a legitimate use for them. Governments, industry associations, and biosecurity organizations have offered guidance on synthesis screening for a decade, and are now considering how to translate industry best practices into regulatory frameworks.

A review of existing guidance documents, policy proposals, and other published literature was performed.

We distinguish five categories of practical questions for policymakers: challenges associated with customer screening, sequence screening, the interaction between domestic and global regulations, commercial implications of screening, and finally, challenges associated with benchtop nucleic acid synthesis devices. There are a number of recommendations in public literature that target the implementation of robust customer and sequence screening, several of which have been incorporated into the recent United States White House Executive Order on artificial intelligence. There appears to be fewer solutions proposed to address challenges associated with the global screening landscape, or the commercial implications of screening requirements, and limited discussion on securing the benchtop synthesis landscape.

This paper aims at providing a comprehensive resource for policymakers, outlining a set of questions governments, and other stakeholders, must answer when implementing screening requirements to secure nucleic acid synthesis.