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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 report, 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.

Key Findings

  • Commercial gene synthesis presents a serious risk of misuse or accident.
  • Screening protocols vary across providers.
  • Providers currently have no way to share information about suspicious customers or orders.
  • Strengthening customer screening and verification is a promising way to help secure gene synthesis.
  • Clearer standards for reporting suspicious orders to authorities would streamline follow-up screening and improve enforcement.
  • The U.S. government currently has no mechanism for assessing the conformity of providers' screening systems with guidelines or policies.

Recommendations

  • Revise the 2023 Administration for Strategic Preparedness and Response guidelines to include specific information to be collected and decision criteria for each step of the screening pipeline.
  • Establish a third-party database to log information about synthetic nucleic acid orders and periodically check those records for evidence of suspicious activity.
  • Establish customer screening requirements, including identity verification measures.
  • Establish criteria and data requirements for sharing information about suspicious orders with law enforcement agencies.
  • Implement procedures and standards for assessing the conformity of providers' screening practices with requirements.

Research conducted by

Funding for this research was provided by gifts from RAND supporters. The research was conducted by the Meselson Center within RAND Global and Emerging Risks.

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