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Understanding biosafety practitioner perspectives.

David R Gillum1,2, Christine Knight3, Kathleen M Vogel2

  • 1School of Public Health, https://ror.org/01keh0577University of Nevada, Reno, USA.

Politics and the Life Sciences : the Journal of the Association for Politics and the Life Sciences
|December 10, 2025
PubMed
Summary
This summary is machine-generated.

A new U.S. policy on Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) faced implementation challenges due to vague language and lack of guidance. Effective biosafety oversight requires input from practitioners.

Keywords:
biosafetybiosecuritydual use research of concernnational securitypolicypotential pandemic pathogens

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Area of Science:

  • Biosafety and Biosecurity
  • Public Health Policy
  • Risk Management

Background:

  • The U.S. government briefly implemented a policy in 2024 to regulate Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).
  • This policy aimed to strengthen oversight of sensitive biological research but faced immediate implementation hurdles.

Purpose of the Study:

  • To explore biosafety practitioners' interpretations and assessments of the DURC/PEPP policy.
  • To identify challenges encountered in implementing the policy from the perspective of those directly involved.

Main Methods:

  • Utilized an inductive, grounded theory approach.
  • Conducted a 2-day deliberative workshop with 45 biosafety officers, compliance professionals, and researchers.
  • Analyzed qualitative data using NVivo software.

Main Results:

  • Participants identified ambiguous policy language, insufficient federal guidance, limited legal scope, and unfunded administrative burdens as key barriers.
  • Practitioners found the policy's definitions imprecise and lacked practical examples for implementation.
  • Concerns were raised regarding the administrative and financial feasibility of compliance.

Conclusions:

  • Effective biosafety and biosecurity policies require clear definitions, actionable guidance, and practical implementation strategies.
  • Early and substantial engagement with operational practitioners is crucial for developing durable and effective oversight.
  • Future policy development should incorporate feedback from biosafety professionals to ensure feasibility and compliance.