In May 2024, the United States federal government released the following policy: “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential”. The policy takes effect on May 6th, 2025 and applies to any institution that receives federal funding.
The purpose of the new policy is to combine and simplify previous dual-use research and pathogens of pandemic potential policies into a single policy. The intention of the DURC/PEPP policy is to create a culture of biosafety and biosecurity awareness and to institute risk mitigation measures to prevent potential incidents. Federally funded life sciences research on biological agents and toxins with increased biosecurity risk is now grouped into two separate categories (Category 1: DURC and Category 2: PEPP).
What is considered DURC and PEPP?
Dual-Use Research of Concern (DURC) is defined as “research conducted for legitimate purposes that generates knowledge, information, technologies, or products that can be utilized for benevolent or harmful purposes.” (Category 1)
Category 1 agents include all select agents and toxins, risk group 4 pathogens listed in Appendix B of the NIH Guidelines, a subset of risk group 3 pathogens (see listed below) and agents without a risk group that are handled at biosafety level 3 or 4 according to the BMBL.
Applicable RG3 Agents:
- Bartonella
- Orientia tsutsugamushi
- Rickettsia
- Pastuerella multocida type B
- Chikungunya virus (except vaccine strain 181/125)
- Semliki Forest Virus
- Arenavirus Flexal
- Lymphocytic choriomeningitis Virus (neurotropic strains)
- Hantaviruses
- MERS-CoV
- Japanese EEV
- Yellow Fever Virus
- High-path avian H5N1
- Transmissible spongiform encephalopathy agents
Research within the scope of Category 1 are those experimental outcomes with a biological agent or toxin outlined in the Policy (pdf) that are reasonably anticipated to:
- Increase transmissibility of a pathogen within or between host species;
- Increase the virulence of a pathogen or convey virulence to a non-pathogen;
- Increase the toxicity of a known toxin or produce a novel toxin;
- Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin;
- Alter the host range or tropism of a pathogen or toxin;
- Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
- Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions;
- Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of preexisting immunity, via immunization or natural infection, against the pathogen or toxin; or
- Enhance the susceptibility of a host population to a pathogen or toxin.
Pathogens with Enhanced Pandemic Potential (PEPP) is defined as “experiments that enhance a pathogen’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security.” (Category 2)
Research within the scope of Category 2 are those experimental outcomes or actions with a pathogen outlined in the USG Policy (pdf) that are reasonably anticipated to:
- Enhance transmissibility of the pathogen in humans;
- Enhance the virulence of the pathogen in humans;
- Enhance the immune evasion of the pathogen in humans such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infection;
- Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.
Does My Work Qualify?
For both categories, three criteria must be met for research to qualify:
- The work must involve biological agents within the category scope
- Specific experimental outcomes or actions must be reasonably anticipated
- It must carry specific potential effects should those outcomes or actions occur
If you think your work qualifies, reach out to the Stanford Biosafety Officer Susan Vleck (sevleck@stanford.edu) and Assistant Biosafety Officer, Laura Taylor (taylorlm@stanford.edu).
For frequently asked questions please visit the Administration for Strategic Preparedness and Response.
My research qualifies as DURC/PEPP. Now what?
What to do if your work falls into these categories:
- If a PI has categorized their work into category 1 or category 2, they must communicate this to their funding agency.
- Next, the PI will work with Stanford ABP to create a risk-benefit assessment and risk mitigation plan, which will be submitted to the funding agency.
- Only once the funding agency has approved of the assessment and plan may the work commence.
Questions about how this policy might impact you? Please reach out to Stanford Environmental Health and Safety, Biology and Biosecurity through the Biosafety Officer, Susan Vleck (sevleck@stanford.edu) or Assistant Biosafety Officer, Laura Taylor (Taylorlm@stanford.edu).
