In this report, RAND researchers provide an overview of expert-elicited gaps in the Federal Select Agent Program (FSAP) and suggested mitigation measures for those gaps. FSAP is one way in which the federal government attempts to keep researchers and the public safe from harmful pathogens, and it is important to consider how emerging biotechnologies may affect FSAP.

Identifying and Closing Gaps in the Federal Select Agent Program

Opportunities for Improvement in an Era of Emerging Biotechnologies

Adeline E. Williams, Saskia Popescu, Allison Berke, Enrique Vazquez, Sella Nevo

ResearchPublished May 13, 2025

In this report, RAND researchers provide an overview of expert-elicited gaps in the Federal Select Agent Program (FSAP) and suggested mitigation measures for those gaps. FSAP is one way in which the federal government attempts to keep researchers and the public safe from harmful pathogens. FSAP regulates the possession, use, and transfer of dangerous biological materials. Responsibilities include setting security standards for facilities and individuals working with those materials, assessing risk and reporting the standards and limitations on the type of work that can be conducted, performing inspections and investigating incidents of noncompliance, and mandating the requirements for the destruction of materials after work with them has concluded.

It is important to consider how emerging biotechnologies and evolving biothreats may affect FSAP. The democratization of biotechnologies and recent advances in molecular and synthetic biology have enabled the development of engineered pathogens with desired functional characteristics that can exhibit enhanced capabilities. This implies the ability to create a pathogen that functionally but not taxonomically mimics the behavior (and disease-causing capability) of a select agent. Such a pathogen would not be regulated by FSAP but may be similarly dangerous. This is one example of a gap in FSAP as it stands.

Key Findings

  • The Centers for Disease Control and Prevention and U.S. Department of Agriculture have broad regulatory oversight over biological select agents and toxins (BSATs) through FSAP.
  • Biosecurity incidents have historically been the impetus to increase regulatory oversight of using BSATs through FSAP.
  • Emerging biotechnologies, including increased recombinant DNA capabilities and AI, call for a proactive review of FSAP, including gaps and potential mitigation strategies.
  • Gaps in FSAP, identified through expert interviews, fell into four broad categories: identification of new agents of concern and engineered threats, speed of response to new pathogens, transparency and nuance of designation criteria, culture surrounding security over safety.
  • There are five key types of agents not subject to FSAP.
  • Changing the FSAP structure from a list-based to a function-based program could mitigate the threats identified in the report, but the feasibility of quantifying functional variables in a timely and objective manner could be challenging.

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Williams, Adeline E., Saskia Popescu, Allison Berke, Enrique Vazquez, and Sella Nevo, Identifying and Closing Gaps in the Federal Select Agent Program: Opportunities for Improvement in an Era of Emerging Biotechnologies. Santa Monica, CA: RAND Corporation, 2025. https://www.rand.org/pubs/research_reports/RRA3628-1.html.
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This research was independently initiated using gifts for research at RAND's discretion from philanthropic supporter Open Philanthropy, as well as gifts from other RAND supporters and income from operations. The research was conducted by the Meselson Center within RAND Global and Emerging Risks.

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