Category 1 and Category 2 Research

Dual Use Research of Concern (Category 1)

Dual Use Research of Concern (Category 1) 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 1 research may involve biosafety risks. If your research could be considered Category 1, as defined below, please reach out to your campus Dual Use Research of Concern (DURC) contact. 

Category 1 research meets the following criteria (as defined in Section 4.1 of the U.S. Government Policy for Oversight of DURC & PEPP):

  1. It involves one or more of these listed biological agents and toxins (as defined in Appendix C of the Implementation Guidance for the U.S. Government Policy for Oversight of DURC & PEPP, published May 6, 2024);
  2. It is reasonably anticipated to result, or does result, in one of the following experimental outcomes:
    1. Increased transmissibility
    2. Increased virulence
    3. Increased stability/dissemination
    4. Altered host range
    5. Decreased diagnostic detectibility
    6. Increased resistance to treatments
    7. Disrupted pre-existing immunity
    8. Enhanced host susceptibility
  3. Based on current understanding, the research institution and/or federal funding agency assess that the research constitutes DURC.

Pathogens with Enhanced Pandemic Potential (Category 2)

DURC involving Pathogens with Enhanced Pandemic Potential (PEPP) is considered Category 2 research. It 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 involves biosafety risks. If your research could be considered Category 2, as defined below, please get in touch with your campus Dual Use Research of Concern (DURC) contact. 

Category 2 research meets the following criteria (as defined in Section 4.2 of the U.S. Government Policy for Oversight of DURC & PEPP, published May 6, 2024):

  1. It involves, or is reasonably anticipated to result in, any pathogen that can be modified in a way that is reasonably anticipated to result in a Pathogen with Pandemic Potential (PPP). A 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.
  2. It is reasonably anticipated to result in, or does result in, one or more of the following experimental outcomes or actions:
    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;
    4. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified Pathogen with Enhanced Pandemic Potential (PEPP).
  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.