Select Agent Regulatory Challenges in a Patient Care Setting: Review and Recommendations

Megan C. Mears, Corrie A. Ntiforo, Lauren M. Sauer, Aneesh K. Mehta, Corri B. Levine*, Jana Broadhurst, Richard Davey, Jared Evans, Vicki Herrera, Peter Iwen, Mark Kortepeter, Anthony Lo Piccolo, Susan McLellan, Timothy Uyeki

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


The Federal Select Agent Program ensures the safe and secure possession, use, and transfer of biological select agents and toxins through the select agent regulations (42 CFR x73, 7 CFR x331, and 9 CFR x121). These regulations are primarily written for interpretation by diagnostic and research laboratories, with limited text pertaining to the care of individuals infected with a select agent. The regulations applicable to patient care settings are ambiguous, resulting in challenges with regulatory compliance. The COVID-19 pandemic called attention to these shortcomings and the need to clarify and modify the select agent regulations. In this article, we discuss 3 select agent regulation phrases regarding patient care that need clarification-specifically, the window of time to transfer, patient care setting, and conclusion of patient care-and provide recommendations for improvement. These recommendations include implementing minimum security standards to safeguard patient specimens against theft, loss, or release prior to the appropriate transfer or destruction of the material and increasing the time allowed for the transfer or destruction of specimens before entities are subject to the select agent regulations. We encourage the Federal Select Agent Program to release a policy statement clarifying the select agent regulations regarding patient care discussed herein and to lengthen the designated time to destroy or transfer agents to a registered entity. Addressing these challenges will aid in compliance with the select agent regulations in patient care settings.

Original languageEnglish
Pages (from-to)58-64
Number of pages7
JournalHealth Security
Issue number1
StatePublished - 1 Feb 2024


  • Biological select agent and toxin
  • Biosafety protection
  • Clinical research
  • Infectious diseases
  • Patient care setting
  • Regulatory Issues
  • Select agents
  • Transfer of select agent


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