Securing the U.S. nucleic acid synthesis industry: a case for safe-harbor information sharing

Abstract

The U.S. has issued guidelines for synthetic nucleic acid providers to screen order sequences and customers. However, these guidelines do not provide clear, enforceable requirements for the industry and place significant responsibility on providers to appropriately interpret and apply these guidelines. This, in turn, can lead to uneven implementation, inconsistent risk assessments, and exploitable vulnerabilities. We propose that a safe harbor information sharing network could function as a biosecurity force multiplier. Such a system would enable cross-provider analysis of order sequences and customer metadata, improve detection of suspicious activity, generate empirical evidence to refine definitions of sequences of concern and screening priorities, and provide a more robust foundation for the iterative improvement of policies, guidelines, and regulations.

Keywords: biosecurity; information sharing network; order screening; sequence of concern; synthetic nucleic acid.