Securing Commercial Nucleic Acid Synthesis

On-demand gene synthesis is a growing industry that has democratized access to customized synthetic deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) products used in biological research. However, the increasing availability and decreasing cost of custom synthetic nucleic acids presents a risk of misuse that could allow nefarious actors to obtain sequences of dangerous organisms or novel-engineered pathogens to construct a biological weapon. Securing nucleic acid synthesis is a policy priority for the U.S. government and the synthetic biology industry. But there is currently no legal requirement that gene synthesis providers screen their customers or their orders to ensure that the requested synthetic DNA and RNA constructs are not used for harmful purposes. Many providers screen orders voluntarily, but there is currently no universally accepted standard for screening customers or orders. In this study, the authors review government screening guidelines, industry consortium requirements, legislative proposals, and the scientific literature to assess the current state of commercial gene synthesis screening; summarize proposals for strengthening screening; and contribute recommendations for implementing comprehensive screening policies to secure commercial nucleic acid synthesis. These recommendations expand on and strengthen government communications, industry consortium rules and best practices, and proposals developed by researchers and provider organizations.