DURC-PEPP Policy

 Pending federal policy revision

On May 6, 2025, a new US Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) (the USG DURC-PEPP Policy) will go into effect. The Policy applies to all federally funded research. The Policy supersedes the 2012 Federal DURC Policy, 2014 Institutional DURC Policy, and 2017 P3CO Framework. The Policy does not supersede, but complements, other existing federal regulations, including the Select Agent Regulations.

  • Purpose of the USG DURC-PEPP Policy

    The intent of the DURC-PEPP Policy is to strengthen oversight of life sciences research with biological agents and toxins throughout the research lifecycle by:

    • Defining an expanded scope of biological agent and toxin research subject to additional oversight by the U.S. government;
    • Providing a unified framework to support the consistent identification and oversight of research proposals subject to the DURC-PEPP Policy that accounts for safety, security, and ethical considerations; and
    • Delineating the roles and responsibilities of principal investigators, research institutions, and federal departments and agencies that conduct, fund, or oversee research within the scope of the DURC-PEPP Policy, with an emphasis on institutional oversight and management of this research.

    USG DURC-PEPP Policy Statement

    It is the policy of the U.S. Government that federally funded intramural or extramural research that meets the scope of Category 1 or Category 2 research within this Policy is subject to federal and institutional oversight. The purpose of this oversight is to preserve the benefits of such research while minimizing the biosafety and biosecurity risks, including risks that the knowledge, information, products, or technologies generated by the research 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.

  • Expand All Collapse All
    • Category 1 Research

      Category 1 research meets three criteria:

      1. It involves one or more of the Category 1 biological agents and toxins;
      2. It is reasonably anticipated to result, or does result, in one of the specified Category 1 experimental outcomes; and
      3. Based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC.

      Biological Agents and Toxins within Scope of Category 1 Research

      1. All Select Agents and Toxins listed in 9 CFR 121.3–121.4, 42 CFR 73.3–73.4, and 7 CFR 331.3 and regulated by USDA and/or HHS.
      2. All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - Classification of Human Etiologic Agents on the Basis of Hazard.
      3. A subset of Risk Group 3 pathogens listed in Appendix B of the NIH Guidelines - Classification of Human Etiologic Agents on the Basis of Hazard.
        • This subset consists of all RG3 pathogens except HIV, HTLV, SIV, Mtb (including Mycobacterium bovis), Clade II of MPVX viruses unless containing nucleic acids coding for clade I MPVX virus virulence factors, vesicular stomatitis virus, Coccidioides immitis, C. posadasii, Histoplasma capsulatum, and H. capsulatum var. duboisii.
      4. For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, refer to the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). In such cases, agents affecting humans that are recommended to be handled at Biosafety Level 3 (BSL-3) or Biosafety Level 4 (BSL-4) per the BMBL guidance are subject to this Policy.
      5. Biological agents added during future updates

      Category 1 Research Experimental Outcomes

      Research within the scope of Category 1 are those experimental outcomes with a Category 1 biological agent or toxin 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.
      • Enhance the susceptibility of a host population to a pathogen or toxin.

      Category 1 Risk Assessment

      Based on current understanding, the research can be reasonably anticipated to provide, or does 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.

    • Category 2 Research

      Category 2 research meets three criteria:

      1. It involves, or is reasonably anticipated to result in, a PPP;
      2. It is reasonably anticipated to result in, or does result in, one or more of the specified experimental outcomes or actions; 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.

      Biological Agents within Scope of Category 2 Research

      A PPP, or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP.

      Category 2 Research Experimental Outcomes or Actions

      Research within the scope of Category 2 are those experimental outcomes or actions with a Category 2 pathogen 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.

      Category 2 Risk Assessment

      The research can be 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.

    • Dual Use Research

      “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.

    • Dual Use Research of Concern (DURC)

      “Dual use research of concern (DURC)” 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.

    • Institutional Contact for Dual Use Research (ICDUR)

      “Institutional Contact for Dual Use Research (ICDUR)” is the official designated by the research institution to serve as an internal resource for application of the DURC-PEPP Policy as well as the liaison (as necessary) between the institution and the relevant federal funding agency.

    • Institutional Review Entity (IRE)

      “Institutional review entity (IRE)” is the entity established by the research institution to execute the institutional oversight responsibilities.

    • Pathogen with Enhanced Pandemic Potential (PEPP)

      “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.

    • Pathogen with Pandemic Potential (PPP)

      “Pathogen with pandemic potential (PPP)” 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.

    • Reasonably anticipated

      “Reasonably anticipated” 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.

      “Generally, individuals with scientific expertise relevant to the research in question”: Relevant scientific expertise is required to anticipate the potential and plausible results of an experiment. Scientists may have differing views on possible and likely outcomes of any particular experiment, so the general assessment of multiple individuals is likely to be more robust than the views of any single individual. The PI is not required to seek assessment from a group of individuals, but rather to use the PI’s individual expertise and experience to consider the range of assessments that individuals with relevant scientific expertise would likely make.

      “Expect this outcome to occur”: While it is impossible to know for certain the result of any experiment in advance, experiments are typically conducted to test specific hypotheses. These hypotheses constitute expectations about the possible results of an experiment, and should be included in the range of results that are “reasonably anticipated” may occur. The PI may consider, if applicable, leveraging existing literature that may have analogous experimental design and/or similar pathogens or toxins to determine potential expectations.

      “Non-trivial likelihood”: A “reasonably anticipated” outcome is not necessarily the most likely outcome, nor is it necessarily an outcome with greater than 50% likelihood. Rather, it is an outcome that has a reasonable, non-negligible chance of occurring. For example, consider an experiment on pandemic influenza that experts anticipate is most likely to result in a loss of function, but that experts also believe could possibly increase transmissibility of the pathogen. An indication of generating a pandemic influenza virus with enhanced transmissibility represents a risk of high consequence to the public if that agent were to be accidentally released. Such a study should therefore undergo Category 2 oversight because, despite the fact that generating a PEPP is not the likeliest outcome, it has a non-trivial likelihood of resulting in a PEPP.

      “Excludes experiments in which an expert would anticipate the outcome to be technically possible, but highly unlikely”: For many

      experiments it may be possible to imagine a scenario, however unlikely, in which a genetic mutation surprisingly results in an increase in virulence or transmissibility against all reasonable expectations and prior evidence. The purpose of the Policy is to prioritize oversight for experiments that may pose the greatest risks. Technically plausible outcomes with very low likelihoods, as assessed based on pre-existing evidence, are not subject to Category 2 oversight. As per the Policy, if such a result unexpectedly arises during the conduct of research, the study should be halted, immediately be flagged for the IRE and funding entity, and be subject to Category 2 assessment and risk mitigation.
    • Types of Research Typically Not Within Scope of Category 2 Research

      The following types of experiments are not typically within scope of Category 2 research because the outcomes or actions typically do not result in the enhancement of a pathogen’s transmissibility or virulence or a disruption of the effectiveness of pre-existing immunity resulting in a PEPP as outlined in Section 4.2 of the DURC-PEPP Policy. However, researchers are expected to exhibit vigilance and evaluate research in case unexpected results warrant Category 2 review for the development, use, or transfer of a PEPP.

      Surveillance activities, including collection of diagnostic and clinical specimens, sampling, sequencing, and basic viral characterization, in which the pathogen is not modified via genetic manipulation or laboratory adaptation to enhance transmissibility or virulence in humans.

      1. Research on evaluating, testing, and/or producing vaccines and related biologics such as immunoglobulins and the generation of high-growth strains.
      2. Experiments focused on evaluating and developing antivirals, including monoclonal antibodies, for treatment or prevention of disease caused by circulating human viruses.

  • UTMB adopts the USG DURC-PEPP Policy and follows the Implementation Guidance for identification, review, and oversight of life sciences research that is within Category 1 and Category 2 as defined by that policy.

    At UTMB, the DURC-PEPP Policy applies to all research, regardless of funding source, that meets the criteria for DURC-PEPP research. Federal sponsors may delay release of funds if a project identified as DURC-PEPP research does not fulfill all requirements for compliance with the DURC-PEPP Policy – this includes research that is funded or sponsored by federal grants, contracts, cooperative agreements, and other agreements.

    Responsibilities of Principal Investigators (PIs)

    • Initial and Ongoing Assessment: PIs must assess their research at the proposal stage and continuously throughout the research lifecycle to:
      • Identify if the research involves a biological agent/toxin within scope
      • Determine if the research is reasonably anticipated to lead to a Category 1 or 2 experimental outcome/action
    • Notification: If research is assessed as potentially within scope of Category 1 and/or Category 2, the PI must notify the federal funding agency and the research institution
    • Referral: Refer the research to the Institutional Review Entity (IRE)
    • Halting Work: If potential Category 1 or 2 research is identified during experimentation, the PI should halt further work pending review
    • Risk-Benefit Assessment: Work with the IRE to assess the risks and benefits of Category 1 or 2 research
    • Risk Mitigation Plan: Collaborate with the IRE to draft a risk mitigation plan
    • Submission: Submit the risk-benefit assessment and draft risk mitigation plan to the federal funding agency for review and approval (when appropriate)
    • For projects that have been identified as DURC or PEPP, reviewed by the IRE and funding agency, and received approval for risk mitigation plan, the PI must:
    • Conduct of Research: Conduct research in accordance with the approved risk mitigation plan
    • Training: Ensure all laboratory personnel under their supervision receive and maintain education and training on research oversight policies and processes
    • Progress Reports: Provide the federal funding agency annual progress reports for Category 1 research and semiannual reports for Category 2 research (and as requested)
    • Responsible Communication: Communicate Category 1 and Category 2 research in a responsible manner, following the risk mitigation plan

    All PIs conducting research involving biological agents and toxins must continuously assess their work for DURC-PEPP elements throughout the research lifecycle (even if the work was not initially considered DURC-PEPP) and notify the Institutional Contact for Dual Use Research (ICDUR) if at any time before or during a project they identify potential DURC-PEPP research.

    Responsibilities of the Institution

    • Establish an IRE: Create an Institutional Review Entity (IRE) with appropriate expertise to oversee Category 1 and 2 research
      • IRE members should have knowledge of biosafety, biosecurity, DURC/PEPP concepts, and relevant policies
      • At UTMB, the Institutional Biosafety Committee (IBC), with additional experts, serves as the IRE
    • Review PI Assessments: Review and confirm whether research falls within scope of Category 1 or 2 research
    • Risk Assessment: Conduct a risk assessment to determine if research meets the criteria for Category 1 (DURC) or Category 2 (PEPP potential)
    • Risk Mitigation Plans: Work with PIs to develop risk-benefit assessments and risk mitigation plans
    • Notification to Funding Agency: Notify the federal funding agency of Category 1 or 2 determinations and provide risk mitigation plans
    • Oversight: Assist with and oversee the implementation of the risk mitigation plan and review/modify it at least annually
    • Training: Provide education and training on research oversight for individuals conducting life sciences research that may be within scope of Category 1 or 2
    • Record Keeping: Maintain records of reviews, risk mitigation plans, and personnel training

  • If a project could fall under the USG DURC-PEPP Policy, PIs will be required to complete a DURC-PEPP Self-Assessment when seeking funding for this research.

    • If identification occurs at the proposal stage, the PI must:
      • Notify the federal funding agency when they submit the proposal
      • Refer the research to the UTMB IRE to assess whether the research meets the definition of Category 1 or Category 2 research
      • Be prepared to develop a risk-benefit assessment and a risk mitigation plan
    • If identification occurs during the course of experimentation, the PI must:
      • Halt further work
      • Notify the federal funding agency
      • Refer the research to the IRE
      • Work with the IRE to develop a risk-benefit assessment and a risk mitigation plan

        The IRE will determine whether the research is within scope of Category 1 or Category 2 using the processes outlined in the Implementation Guidance. This includes:

        1. Confirm that the research involves a PPP or is reasonably anticipated to result in a PPP.
        2. Confirm that the research is reasonably anticipated to result in, or does result in, one or more of a listed experimental outcomes or actions in scope of Category 2 research.
        3. Perform a risk assessment to determine if the research can be 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.
        4. Confirm that the research involves one or more of the biological agents or toxins listed in Section 4.1.1 of the UGS DURC-PEPP Policy.
        5. Confirm that the research is reasonably anticipated to result, or does result, in one or more of the listed experimental outcomes in scope of Category 1 research.
        6. Perform a risk assessment to determine if based on current understanding, the research can be reasonably anticipated to provide, or does 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.

    The IRE is responsible for communicating the determination to the federal funding agency. Federal funding agencies have the discretion to request additional information or review of individual research proposals or projects to determine whether they may fall within scope of Category 1 or Category 2 research.

    For projects that are identified as DURC-PEPP

    The PI and IRE will work together to conduct a risk-benefit assessment and develop a draft risk mitigation plan. The PI will submit the risk-benefit assessment and draft risk mitigation plan to the federal funding agency for review and approval.

    For funded projects with approved risk mitigation plans

    The PI is responsible for:

    • Conducting the Category 1 or Category 2 research in accordance with the approved risk mitigation plan
    • Providing annual (for Category 1) or semiannual (for Category 2) progress reports, and as requested by the federal funding agency
    • Ensuring that laboratory personnel conducting life sciences research within the scope of this Policy have received and maintain education and training on all research oversight policies and processes and demonstrated competency
    • Communicating Category 1 and Category 2 research in a responsible manner
      • Communication of research and research findings is an essential activity for all researchers and occurs throughout the research process, not only at the point of publication
      • When researchers are planning to communicate Category 1 and Category 2 research results, it is their duty to ensure that it is done in a responsible manner, and follows any measures outlined in the risk mitigation plan approved by the federal funding agency.

    The IRE is responsible for:

    • Assisting with and overseeing the implementation of the risk mitigation plan.
      • The research should be conducted in accordance with the approved risk mitigation plan and should be periodically reviewed by the research institution to determine if additional modifications to the risk mitigation plan are appropriate
    • Evaluating risk mitigation plans at least annually and modifying them as necessary for the duration of the research
      • Institutions are responsible for ensuring that the research is conducted in accordance with the risk mitigation plan

Compliance

It is the responsibility of all UTMB Principal Investigators to be knowledgeable about and comply with or follow all applicable institutional and USG policies, requirements, and regulations for oversight of biological agent and toxin research.

For PIs and research institutions, 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. Federal funding agencies will consider relevant statutory and regulatory authorities when considering appropriate actions.