The increasing availability of synthetic genetic materials poses public health risks that may warrant new approaches to ensuring they are accessible only to legitimate researchers. The authors examine whether certain hazardous genetic materials not currently regulated by the Federal Select Agent Program could be brought under its oversight and analyze the benefits of risk reduction and the burdens on industry and the research community.

Leveraging the Federal Select Agent Program to Oversee Nucleic Acids

Volume 2, Potential Benefits and Burdens, Recommendations, and Implementation Considerations

Matt Sharkey, Anna Jean Wirth, John P. Tarangelo, Gerald L. Epstein

ResearchPublished Aug 24, 2026

More individuals than ever before have access to the reagents and techniques needed to develop lifesaving medicines, materials with new and useful properties, and innovative approaches to producing complicated chemistries. This democratization has also increased the risk of malign or irresponsible use of biotechnologies. In particular, the increasing availability of synthetic genetic materials may pose public health risks ranging from de novo synthesis of dangerous viruses to the enhancement of other microorganisms through the transfer of hazardous genes. This may warrant new approaches to ensuring that certain genetic materials are accessible only to legitimate researchers.

In this volume of a two-volume report, the authors consider how regulations can be extended to encompass genetic components of microorganisms or toxins that are not currently regulated by the Federal Select Agent Program (FSAP) and offer recommendations for implementing new regulations. The recommendations are framed in terms of maximizing the benefits of biosecurity risk reduction and minimizing the unintended burdens on industry and the research community.

Key Takeaways

  • It is clear that its authorizing statutes would allow FSAP to regulate genetic materials in addition to the limited set of viral genomes and toxin genes that it currently regulates.
  • FSAP’s authorizing statutes would also allow the regulation of additional viral genomes, genes encoding hazardous pathogen traits or toxins, and fragments of those genes in a much less burdensome manner than FSAP currently oversees the possession, use, and transfer of select agent pathogens and toxins. This new and less burdensome oversight framework can be referred to as Tier 3 oversight.
  • Application of FSAP authorities to oversee genetic materials would complement new authorities granted to the U.S. Department of Commerce (DOC) to ensure the safe and secure provision, use, and transfer of hazardous genetic materials at their points of sale and throughout their life cycles as synthetic biological reagents.
  • The U.S. Department of Health and Human Services’ (HHS’s) Centers for Disease Control and Prevention (CDC) has strengths and capabilities that would allow the secure possession and handling of and also ensure recordkeeping about hazardous genetic materials throughout their life cycles.
  • DOC has strengths and capabilities that are especially suitable for ensuring that synthetic nucleic acid providers behave responsibly when participating in the domestic market for genetic materials.

Recommendations

  • To prevent introducing unreasonable friction into the research process, the Secretary of HHS should instruct CDC to adopt a phased implementation timeline to establish new regulations.
  • During the first year of phased implementation, CDC should notify stakeholders about the extension of regulations to all full-length select agent viral genomes.
  • CDC should also determine which genes from select agent pathogens should be subject to regulation and publish the intended categories of genes to be subject to regulation for stakeholder review and feedback and should also determine which non–select agents may have genes that pose risks that may be appropriate for regulatory control
  • During the second year, CDC should publish notices of which select agent genes and which non–select agent organisms (and genes) it has determined are appropriate for regulatory control and the manner in which regulations governing the possession, use, and transfer of certain genes from select agents and non-–select agents will be formulated.
  • During the third year, CDC should publish final regulations overseeing the possession, use, and transfer of certain genes from select agents and non–select agents and publish a notice that fragments of certain lengths from the regulated viral genomes and the newly regulated genes will also be encompassed by new regulations.
  • Beyond the third year, CDC should extend regulatory control over fragments of the regulated genes.

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Sharkey, Matt, Anna Jean Wirth, John P. Tarangelo, and Gerald L. Epstein, Leveraging the Federal Select Agent Program to Oversee Nucleic Acids: Volume 2, Potential Benefits and Burdens, Recommendations, and Implementation Considerations. Santa Monica, CA: RAND Corporation, 2026. https://www.rand.org/pubs/research_reports/RRA4496-2.html.
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