Dual Use Research of Concern

UC Davis is committed to supporting life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

Updated May 6, 2025

This webpage aims to provide guidance to researchers whose work may be subject to the United States Government policy regarding Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) as well as the University of California Office of the President (UCOP) policy on DURC/PEPP.

Key Definitions

Dual Use Research of Concern (DURC)
Defined as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.”

Pathogen with Enhanced Pandemic Potential (PEPP)
Defined as “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)
Defined as “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.”

Regulatory Context

The Federal policies define “life sciences” as those that pertain to the study of living organisms (e.g., microbes, human beings, animals, and plants) and their products, and includes all of the diverse sub-disciplines and methodologies of biology as well as all applications of the biological sciences.

The U.S. Government’s oversight of DURC/PEPP is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

Federal agencies and research institutions have a shared responsibility for minimizing the risks associated with the misuse of the products of their research.

All institutions that receive Federal funding for life sciences research and that conduct such research are subject to Federal policies regarding DURC/PEPP. The UCOP DURC/PEPP policy requires all UC campuses to apply the federal policy to all research regardless of funding source.

DURC/PEPP Review Process

DURC/PEPP determination and review follows the steps below sequentially:

  1. The Principal Investigator (PI) makes an initial assessment of whether their proposed or ongoing research may be within the scope of the Policy based upon the biological agent or toxin and the experimental outcome or actions (for Category 1 research or for Category 2 research, see below for definitions). The research institution is responsible for ensuring that PIs are aware of and executing this responsibility appropriately.
  2. The PI submits the research proposal to the federal funding agency including notification that the research may be within scope of Category 1 or Category 2 based on the biological agent or toxin and the experimental outcome.
  3. When the federal funding agency has completed merit review of the proposed research and if it is considering funding the proposed research, the federal funding agency notifies the research institution.
  4. The research institution, through our Institutional Review Entity (IRE), reviews the PI’s initial assessment and confirms whether proposed or ongoing research is within the scope of Category 1 or Category 2 research. If so, the IRE determines whether the research is Category 1 or Category 2, including based on a risk assessment under Section 4.1.3 (Category 1) or Section 4.2.3 (Category 2). The research institution notifies the federal funding agency of the results of its Category 1 or Category 2 research determination, and the federal funding agency evaluates and verifies the research institution’s assessment. Examples of risk assessment methods are described in the Implementation Guidance.
  5. If the research is assessed to be within scope of Category 1 or Category 2, the research institution, through an IRE, conducts risk-benefit assessments and develops a draft risk mitigation plan for the conduct and communication of research. The PI or research institution submits the risk-benefit assessment and a draft risk mitigation plan to the federal funding agency. Examples of risk mitigation approaches are described in the Implementation Guidance. The federal funding agency reviews the risk-benefit assessment and draft risk mitigation plan as follows:
    • For specific experiments within the research proposal determined to be within scope of Category 1, the federal funding agency evaluates the research institution’s risk-benefit assessments and determines whether the potential benefits justify the potential risks prior to the funding decision. These specific experiments will not proceed until the federal funding agency approves the risk mitigation plan.
    • For specific experiments within the research proposal determined to be within scope of Category 2, the federal funding agency refers the proposed research for federal funding agency department-level review. Upon receipt of the Category 2 research proposal, the federal funding agency department convenes a multidisciplinary review entity to evaluate the research institution’s risk-benefit assessments and risk mitigation plan prior to the federal funding agency making a funding decision on the research proposal. The multidisciplinary review entity will make recommendations to the federal funding agency regarding the risk-benefit assessments, risk mitigation plan, and research proposal funding. The specific experiments within the research proposal determined to be within scope of Category 2 will not proceed until the federal funding agency determines that the potential benefits justify the potential risks and approves the risk mitigation plan.
  6. If research is identified as potentially within the scope of Category 1 or Category 2 research during the course of experimentation, the PI halts further work, notifies the federal funding agency and research institution, and contacts their IRE to conduct the required assessments consistent with the procedures in this Policy for assessing Category 1 or Category 2 research.

Category 1 Research

The agents and toxins listed in the Federal DURC policy for Category 1 Research are:

Experimental effects of concern for Category 1 Research (the following 9 categories of experiments):

  1. Increase transmissibility of a pathogen within or between host species;
  2. Increase the virulence of a pathogen or convey virulence to a non-pathogen;
  3. Increase the toxicity of a known toxin or produce a novel toxin;
  4. Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin;
  5. Alter the host range or tropism of a pathogen or toxin;
  6. Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
  7. Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions;
  8. 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
  9. Enhance the susceptibility of a host population to a pathogen or toxin.

Category 2 Research

The agents within scope of Federal DURC policy for Category 2 Research are:

Pathogens with Pandemic Potential (PPP, defined as “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”), or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP.

Experimental effects of concern for Category 2 Research (the following 4 categories of experiments):

  1. Enhance transmissibility of the pathogen in humans;
  2. Enhance the virulence of the pathogen in humans;
  3. 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; or
  4. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.

Institutional Responsibilities

The University must:

  • Establish and implement internal policies and practices that provide for the identification and effective oversight of DURC/PEPP;
  • Designate an Institutional Contact for Dual Use Research (ICDUR) to serve as an internal resource for issues regarding compliance with and implementation of the requirements for the oversight of research that falls within the scope of Federal DURC/PEPP policy;
  • Establish an Institutional Review Entity (IRE) to execute the requirements of Federal and UCOP DURC/PEPP policies; a range of mechanisms for fulfilling the role of an IRE are acceptable as long as the review entity is appropriately constituted and authorized by the institution to conduct the DURC/PEPP review;
  • Provide education and training on DURC/PEPP for individuals conducting life sciences research that involves any of the agents and toxins listed in Federal DURC/PEPP policy; and
  • Report instances of noncompliance with Federal or UCOP DURC/PEPP policies, as well as mitigation measures undertaken by the institution to prevent recurrences of similar noncompliance, within 30 calendar days.

Principal Investigator Responsibilities

Principal investigators must:

  • Identify research that may be within scope of the Federal and UCOP DURC/PEPP policies;
  • Notify federal funding agency and IRE of assessment of research that may be Category 1 or Category 2 research;
  • Work with the IRE to assess the risks and benefits of the dual use research of concern and to develop risk mitigation measures (Risk Mitigation Plan) where appropriate;
  • Conduct research with DURC/PEPP in accordance with the provisions in the risk mitigation plan;
  • Be knowledgeable about and comply with all institutional and Federal policy and requirements for oversight of DURC/PEPP;
  • Ensure that laboratory personnel conducting life sciences that may be subject to the Federal and UCOP DURC/PEPP policies have received education and training on DURC/PEPP; and
  • Conduct and communicate such research in a responsible manner, per the Risk Mitigation Plan developed with the IRE and with the federal funding agency.

Referenced Documents and Contacts

Updated Federal Policy and Guidance
Pathogen and Toxin References
Biosafety Practices
Contacts