The increasing availability of synthetic genetic materials may pose public health risks that may warrant new approaches to ensuring that certain materials are accessible only to researchers who will use them responsibly. The authors examine whether genetic components of microorganisms or toxins that are not currently regulated by the Federal Select Agent Program could be brought under program oversight.

Leveraging the Federal Select Agent Program to Oversee Nucleic Acids

Volume 1, Analysis of Opportunities to Control Genomes, Genes, and Gene Fragments Through the Federal Select Agent Program’s Authorities

Matt Sharkey, Anna Jean Wirth, John P. Tarangelo, Derek Roberts, Gerald L. Epstein, James M. Anderson

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 these technologies. In particular, the increasing availability of synthetic genetic materials may pose public health risks ranging from the synthesis of novel dangerous viruses or the enhancement of other microorganisms. This may warrant new approaches to ensuring that certain genetic materials are accessible only to researchers who will use them responsibly

This is the first volume of a report in which the authors consider whether genetic components of microorganisms or toxins that are not currently regulated by the Federal Select Agent Program (FSAP) could be brought under FSAP oversight. This volume includes in-depth analyses of the statutory and regulatory landscapes in which expanded FSAP oversight of certain new genetic elements may be possible but does not include a thorough assessment of how the regulatory options affect the public health risks or the life science research ecosystem, which will be addressed in Volume 2.

Key Takeaways

  • FSAP could extend its control to cover viral genomes and certain hazardous genes and gene fragments from both select agent pathogens and toxins and those that are not currently select agents, without further legislative action.
  • To lower the regulatory burden, FSAP could apply much less stringent registration and oversight standards to genetic materials encoding hazardous biological functions than the manner in which it currently regulates viable select agent pathogens and toxins.

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Sharkey, Matt, Anna Jean Wirth, John P. Tarangelo, Derek Roberts, Gerald L. Epstein, and James M. Anderson, Leveraging the Federal Select Agent Program to Oversee Nucleic Acids: Volume 1, Analysis of Opportunities to Control Genomes, Genes, and Gene Fragments Through the Federal Select Agent Program’s Authorities. Santa Monica, CA: RAND Corporation, 2026. https://www.rand.org/pubs/research_reports/RRA4496-1.html.
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