Creating Enforceable Biosecurity Standards for Nucleic Acid Providers

There is broad agreement among biosecurity experts that nucleic acid synthesis providers should screen orders before sending out DNA or RNA that could facilitate the construction of dangerous biological agents. However, there is no agreed upon mechanism to verify whether a provider is implementing effective screening practices. This leads to:

1. Economic costs for responsible actors. Providers must invest resources to develop and operate a screening system, and may find it challenging to remain cost-competitive with providers that do not screen, especially given the risk of losing customers who prefer faster turnarounds and minimal review.
2. Unverifiable claims of screening. Even strong incentives for screening, which can level the playing field for responsible actors, must be supported by enforcement of minimum biosecurity standards. Existing frameworks based on voluntary guidance (as in the UK) and self-attestation (as in the USA) have encouraged adoption of screening, but practices remain highly uneven.
3. Regulatory hesitation. Government agencies are reluctant to enforce screening in the absence of an agreed standard due to fears about stifling innovation, regulatory capture, and international fragmentation.

This memo outlines a path to move from aspirational to enforceable standards via industry-led standards development, with support and participation from government regulators. We review key challenges in biosecurity for nucleic acid providers. We then present an approach to developing technical consensus on screening decisions and discuss the relationship between stages of adoption and policy change. Finally, we provide a roadmap for a structured public/private collaboration leading to the implementation of effective and enforceable biosecurity for nucleic acid providers in the United States and discuss recommended actions to implement this roadmap.

This memo was initially prepared on May 8, 2025, as part of a response from synthesis standards organizations to the May 5 US Executive Order 14292 on “Improving the Safety and Security of Biological Research.” The document was updated in July 2025 with some reference to subsequent policy and standards developments, but still largely focuses on the US context.