The new United States Government Policy for Dual Use Research or Concern and Pathogens with Enhanced Pandemic Potential (DURC-PEPP Policy) goes into effect on May 6, 2025. The DURC-PEPP Policy applies to federal funded research that involves certain biological agents and toxins or modification of pathogens. The purpose of this oversight is to preserve the benefits of biological research while minimizing the biosafety and biosecurity risks, including risks that the knowledge, information, products, or technologies generated by the research that could be used in a manner that results in harm to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. This policy supersedes the previous DURC policy.
The National Institutes of Health (NIH) has issued implementation guidance for applying the DURC-PEPP Policy to NIH awards.
DURC-PEPP Policy
EH&S and the Institutional Biosafety Committee (IBC), with assistance from the UW Office of Research, are responsible for developing and implementing the University's DURC-PEPP policy. Failure to follow the DURC-PEPP Policy may result in suspension, limitation, or termination of federal funding and loss of future federal funding opportunities for the research proposal and for other life sciences research at the research institution, as imposed by the federal funding agency.
Principal investigators (PIs) are required to do the following per the DURC-PEPP policy:
PIs are required to continually self-assess research at the proposal stage and throughout the research life cycle for changes that may alter an assessment of whether their research is Category 1 (DURC) or 2 (PEPP).
EH&S Biosafety has created a Self-Assessment Worksheet as a tool and is available for assistance as needed.
If you, the IRE, or the federal funding agency assess that research is or may be Category 1 or 2, halt or do not start this research. Research cannot begin or continue until a risk mitigation plan is approved by the federal funding agency and any other required institutional or regulatory approvals are obtained.
If research is assessed as either Category 1 or 2, communicate this to your federal funding agency and the UW IRE at ehsbio@uw.edu. The UW IRE will not initiate an assessment until requested to do so by the federal funding agency.
Submitting the DURC-PEPP Application initiates an IRE assessment. Submit an application if requested to do by a federal funding agency in these circumstances:
- Your self-assessment identified potential DURC or PEPP research,
- An IRE assessment is requested as part of grant application materials, or
- An IRE assessment is requested as part of a grant progress report.
Complete the DURC-PEPP training module at least every three years, and ensure that any research personnel associated with the project also complete the training.
For research assessed as Category 1 or Category 2, the PI must:
- Work with the IRE to develop and submit a risk-benefit assessment and draft risk mitigation plan to the funding agency.
- If approved by the IRE and funding agency, conduct Category 1 or 2 research according to the risk mitigation plan.
- Provide progress reports to the funding agency annually for Category 1 research, semiannually for Category 2 research, and as requested.
- Communicate Category 1 or 2 research in a responsible manner and in compliance with the approved risk mitigation plan.
Agents, Toxins, and Experiments within the DURC-PEPP Policy Scope
Category 1 research must meet three criteria: (1) involve agents or toxins within the scope, (2) results or is reasonably anticipated to result in one of the defined experimental outcomes, and (3) based on current understanding is reasonably anticipated to be DURC.
(1) Biological agents and toxins within the scope of Category 1 Research:
- All regulated select agents and toxins, including toxins within the permissible limits of the Federal Select Agent Program.
- All Risk Group 4 pathogens per the NIH Guidelines
- A subset of Risk Group 3 pathogens per the NIH Guidelines
- Any biological agent affecting humans recommended to be handled at BSL-3 or BSL-4 per the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).
(2) Category 1 reasonably anticipated experimental outcomes:
- Increase the transmissibility of 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
- Enhance the susceptibility of a host population to a pathogen or toxin
The following Risk Group 3 microorganisms are excluded from the scope of Category 1 (DURC) research:
- Clade II of MPVX viruses (unless containing nucleic acids coding for clade I MPVX virus virulence factors)
- Coccidioides immitis
- Coccidioides posadasii
- Histoplasma capsulatum
- Histoplasma capsulatum var. duboisii
- Human immunodeficiency virus (HIV) types 1 and 2
- Human T cell lymphotropic virus (HTLV) types 1 and 2
- Mycobacterium bovis
- Mycobacterium tuberculosis
- Simian immunodeficiency virus (SIV)
- Vesicular stomatitis virus
Category 2 (PEPP) research must meet three criteria: (1) involve, or reasonably anticipated to result in, a PPP ; (2) is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions ; and (3) based on current understanding is reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security.
(1) Biological agents and toxins within the scope of Category 2 Research:
- An existing pathogen with pandemic potential (PPP) (i.e., SARS-CoV, SARS-CoV-2, Ebolaviruses)
- Any pathogen that will be modified so as to reasonably result in a PPP
- Generation, use, reconstitution, or transfer of an extinct or eradicated PPP (i.e., Variola major, Variola minor, 1918 influenza virus)
(2) Category 2 experimental outcomes or actions:
- 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
Procedures for UW IRE Assessment of Research
The steps for UW IRE Assessment are detailed below. Also refer to the IRE DURC-PEPP Assessment Flow Chart.
| Role | Step | Action |
| PI | 1 | Self-assesses federally funded research at the proposal stage and throughout the research life cycle. (A self-assessment worksheet is available.) |
| 1a. If Category 1 or 2 research is not identified, research can commence or continue, and no further action is needed. | ||
| 1b. If identified, halts or does not start potential Category 1 or Category 2 research. | ||
| 2 | Communicates any research assessed as potential Category 1 or 2 to the federal funding agency and to the UW IRE. | |
| Federal funding agency | 3 | Requests an IRE assessment from the PI and UW IRE if the grant is likely to be funded. |
| 3a. The federal funding agency may also request an IRE assessment as part of grant application materials or as part of research progress reports. | ||
| PI | 4 | Submits a DURC-PEPP Application to initiate an IRE assessment. |
| UW IRE | 5 | Assesses the research. |
| 6 | Notifies the PI and the federal funding agency of the assessment outcome | |
| Federal funding agency | 7 | Reviews and confirms the UW IRE’s assessment |
| PI and UW IRE | 8 | Create a risk benefit assessment and risk mitigation plan |
| 9 | Submit the assessment and plan to the federal funding agency | |
| Federal funding agency | 10 | Approves the risk mitigation plan |
| PI | 11 | Commences or continues research according to the approved risk mitigation plan, pending any other required institutional or regulatory approvals |
| 12 | Continually self-assesses research |
Definitions
DUR (dual use research) is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes.
DURC (Dual Use Research of Concern) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
A PPP (pathogen with pandemic potential) is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.
Pathogen with enhanced pandemic potential (PEPP) is a type of pathogen with pandemic potential (PPP) resulting from 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. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential.
Category 1 research is DURC and meets three criteria:
(1) it involves one or more biological agents and toxins specified in the DURC-PEPP Policy;
(2) it is reasonably anticipated to result, or does result, in one of the experimental outcomes specified in the DURC-PEPP Policy; and
(3) based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC.
Category 2 research is PEPP and meets three criteria:
(1) it involves, or is reasonably anticipated to result in, a PPP as specified in the DURC-PEPP Policy;
(2) it is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions as specified in the DURC-PEPP Policy; and
(3) based on current understanding, the research institution and/or federal funding agency assesses that the research is reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security.
An IRE (Institutional Review Entity) is the entity established by the research institution to execute the institutional oversight responsibilities described in the DURC-PEPP Policy.
The UW IRE is a standing subcommittee of the UW Institutional Biosafety Committee (IBC).
“Reasonably anticipated” for the purposes of the DURC-PEPP Policy describes an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur but excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.
Emergency Response and Reporting
UW personnel are required to submit an incident report to Environmental Health & Safety for any work-related event that results in an injury, illness, exposure to hazardous materials, property damage, or fire, regardless of the work location. UW personnel are highly encouraged to submit work-related near-miss events. Visit the Incident Reporting page for more information.
Notify EH&S immediately (after first aid/medical care/emergency services) if the incident involves recombinant or synthetic nucleic acids or genetically modified organisms.
- During EH&S business hours: (8:00 a.m. to 5:00 p.m., Monday to Friday) call (206) 221-7770.
- Outside of EH&S business hours: call the UW Police Department at (206) 685-8973 to reach EH&S on-call staff.
Frequently asked questions
- Clade II of MPVX viruses (unless containing nucleic acids coding for clade I MPVX virus virulence factors)
- Coccidioides immitis
- Coccidioides posadasii
- Histoplasma capsulatum
- Histoplasma capsulatum var. duboisii
- Human immunodeficiency virus (HIV) types 1 and 2
- Human T cell lymphotropic virus (HTLV) types 1 and 2
- Mycobacterium bovis
- Mycobacterium tuberculosis
- Simian immunodeficiency virus (SIV)
- Vesicular stomatitis virus
For Category 1 (DURC) research, refer to the list of biological agents and toxins within the scope. It includes select toxins in any amount, all select agents, all Risk Group 4 organisms, and most Risk Group 3 organisms. Refer to a list of excluded Risk Group 3 organisms that are not subject to the DURC-PEPP Policy.
Biological agents within the scope of Category 2 (PEPP) research includes:
- existing PPPs SARS-CoV, SARS-CoV-2, and Ebolaviruses
- any pathogen that will be modified to reasonably result in a PPP
- extinct or eradicated PPPs (i.e., Variola major, Variola minor, 1918 influenza virus)
Yes, research with select toxins in any amount, including within the permissible limits, are within the policy scope. Although not regulated by the Federal Select Agent Program, research with select toxins in any amount must be assessed for potential DURC.
For work with biotoxins, review and implement the safe work practices including creating a toxin-specific written procedure. Refer to the EH&S Biotoxin Safety webpage.
No, you do not need to submit a DURC-PEPP application for an IRE assessment unless instructed or requested to do so by a federal funding agency. You may be asked to provide an IRE assessment along with a grant progress report. The National Institutes of Health (NIH) has issued implementation guidance for applying the DURC-PEPP Policy to NIH awards.
If you have self-assessed your research and believe that it may meet the criteria for Category 1 or 2 research as described in the DURC-PEPP policy, communicate this to your federal funding agency and the UW IRE.
Although not currently required, you are encouraged to assess non-federally funded research for potential DURC and PEPP. If identified, please contact EH&S Biosafety at ehsbio@uw.edu.
The ICDUR for UW is Zara Llewellyn, Assistant Director for EH&S Research Safety.
Contact EH&S Biosafety at ehsbio@uw.edu to request an appeal.
If the biological agent or toxin is included on your Biological Use Authorization (BUA), then you do need to assess that research for DURC-PEPP. If you aren't sure whether or not to assess research for any "inactive" biological agents or toxins, reach out to EH&S Biosafety at ehsbio@uw.edu.
You should continually assess your research for changes that may alter an assessment of whether the research is Category 1 or 2. If you assess that research has changed in such a way that it may be Category 1 or 2, halt that work and communicate this to your federal funding agency and the UW IRE.
If Category 1 or 2 research is approved, communication of research results must be done responsibly and in adherence to the measures outlined in the risk mitigation plan approved by the federal funding agency.
The DURC-PEPP Policy section at the top of the webpage outlines the PI responsibilities. More details are available in the USG DURC-PEPP Policy.
More Information
- DURC-PEPP Training -- coming soon!