DURC-PEPP Frequently Asked Questions

DURC/PEPP Policy - Frequently Asked Questions:

• Why should I care about complying with the DURC/PEPP Policy?

  Awareness of the DURC (Dual Use Research of Concern) and PEPP (Pathogens with Enhanced Pandemic Potential) Policy is essential because research involving certain biological agents and toxins, while often intended to advance public health, agriculture, or national security, may also pose significant biosafety and biosecurity risks if intentionally or unintentionally misused.

  • Understanding and complying with this policy helps to:
  • Ensure that research is conducted responsibly and ethically
  • Prevent the misuse of scientific knowledge, tools, or materials
  • Fulfill institutional and federal regulatory requirements tied to funding
  • Promote safe and secure scientific practices throughout the research lifecycle
  • Maintain public trust in the scientific enterprise and support the continued advancement of life sciences research

  The policy is not just a regulatory requirement—it reflects a shared responsibility to safeguard the benefits of scientific research while minimizing its potential risks.

• How do I know if my research falls under the DURC/PEPP Policy?

  Your research falls under the DURC/PEPP Policy if it involves certain biological materials and is reasonably anticipated to produce risky experimental outcomes—like increasing a pathogen’s transmissibility, virulence, or ability to evade detection or immunity.

  You should:

  • Check if you're using biological materials listed in the policy (e.g., select agents, Risk Group 3 or 4 pathogens). See below for a list.
  • Evaluate the type of work you are doing, for example, experiments involving gene editing, host range changes, or resistance to therapeutics.
  • Use the PI Self-Assessment or consult Duke’s IBRC or ICDUR at biosafety@duke.edu for an assessment.

• What do I need to do to comply with this policy?

  If your research involves the use of biological agents, take the following steps to assist with compliance:

  1. Self-assess your research to see if it meets Category 1 or 2 criteria.
     1. The ‘PI Self-Assessment’ will be emailed to the PI of record if relevant questions are answered in the affirmative while completing the ‘Intent to Submit’ or SPS record.
  2. Notify the ICDUR if your research may be within the scope of this policy.
  3. Work with your ICDUR and the IRE to perform a risk-benefit assessment and create a risk mitigation plan.
  4. Submit that plan to your funding agency before you begin or continue that part of the research.
  5. Follow all approved safety and communication measures and provide regular progress reports (annually for Category 1/DURC, semiannually for Category 2/PEPP).

• Who is the ICDUR?

  The ICDUR is the Institutional Contact for Dual Use Research.

  Dr. Antony Schwartz, the Director of the Biological Safety Division and the Institutional Biosafety Officer is Duke’s ICDUR. You may reach him at biosafety@duke.edu. 

  The ICDUR is the designated person at Duke who:

  • Helps researchers understand and follow the DURC/PEPP Policy
  • Serves as the main liaison between Duke and the federal funding agency
  • Supports the review process, risk assessments, and development of risk mitigation plans
  • Advises the PI and IRE when DURC/PEPP risks might be involved

• What is the IRE?

  The IRE is the Institutional Review Entity. At Duke, the Institutional Biosafety Review Committee (IBRC) serves as the IRE.

  It is a committee at Duke that:

  • Reviews research to determine if it falls under Category 1 or Category 2 (as defined in the 2024 USG Policy)
  • Conducts risk-benefit assessments
  • Develops and oversees risk mitigation plans
  • Works closely with the PI and ICDUR throughout the lifecycle of an award under assessment and/or management for Category 1 or Category 2 research.

  The IBRC is responsible for making sure the institution complies with the 2024 USG policy throughout the research lifecycle.

• Who can help me if I have more questions or concerns?

  The Institutional Contact for Dual Use Research (ICDUR) is available to help answer any questions or address concerns that you may have regarding DURC/PEPP issues. The ICDUR can be reached at biosafety@duke.edu.

• What are considered ‘Biological Agents’ according to the policy?

  “Biological agents” are any microorganism (including, but not limited to, bacteria, viruses, fungi, or protozoa), infectious material, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious material, capable of causing:

  • Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
  • Deterioration of food, water, equipment, supplies, or material of any kind; or
  • Deleterious alteration of the environment.

• What does ‘Reasonably Anticipated’ mean according to the policy?

  “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.

• What is 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.

• What is Dual Use Research of Concern?

  “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.

• What is a Pathogen with Pandemic Potential?

  “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. (Pathogens with pandemic potential are often those with little to no pre-existing immunity in the human population.)

• What is a Pathogen with Enhanced Pandemic Potential?

  “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.

• What is Category 1 and Category 2 research?

  • Category 1 research involves specified biological materials and experiments that could increase transmissibility, virulence, or other dangerous traits. It is essentially DURC (Dual Use Research of Concern).
  • Category 2 research involves pathogens with enhanced pandemic potential (PEPPs) or experiments that could create or manipulate a pathogen to become a PEPP—even if it starts from a low-risk strain.

  Note: If your research qualifies as both, it's treated as Category 2 and has more frequent reporting requirements.

• What are the biological materials covered under Category 1 (DURC) research?

  • Bacteria

  1. Bacillus anthracis
  2. Bacillus anthracis Pasteur strain
  3. Bacillus cereus Biovar anthracis
  4. Bartonella
  5. Botulinum neurotoxin producing species of Clostridium
  6. Brucella abortus
  7. Brucella melitensis
  8. Brucella suis
  9. Burkholderia mallei
  10. Burkholderia pseudomallei
  11. Coxiella burnetii
  12. Francisella tularensis
  13. Mycoplasma capricolum
  14. Mycoplasma mycoides
  15. Orientia tsutsugamushi
  16. Pasteurella multocida type B
  17. Ralstonia solanacearum
  18. Rickettsia prowazekii
  19. Rickettsia spp.
  20. Yersinia pestis

  • Fungi
    1. Coniothyrium glycines
    2. Ralstonia solanacearum
    3. Rathayibacter toxicus
    4. Sclerophthora rayssiae
    5. Synchytrium endobioticum
    6. Xanthomonas oryzae
  • Prions
    1. Transmissible spongiform encephalopathies (TSE) agents (e.g., Creutzfeldt-Jacob disease, kuru agents)
  • Toxins
    1. Abrin
    2. Botulinum neurotoxins
    3. Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)
    4. Diacetoxyscirpenol (DAS)
    5. Ricin
    6. Saxitoxin
    7. Staphylococcal enterotoxins (subtypes A,B,C,D,E)
    8. T-2 toxin
    9. Tetrodotoxin
  • Viruses
    1. African swine fever virus
    2. Araguari virus
    3. Arenaviruses
       • Allpahuayo, Bear Canyon, Big Brushy Tank, Cupixi, Gairo, Loei River, Luna, Lunk, Mariental, Merino Walk, Mobala, Mopeia, Morogoro, Okahandja, Oliveros, Pirital, Solwezi, Wēnzhōu, and Whitewater Arroyo
    4. Avian influenza virus
    5. Bovine ephemeral fever virus
    6. Chapare virus
    7. Chikungunya virus
    8. Classical swine fever virus
    9. Crimean-Congo hemorrhagic fever virus
    10. Eastern equine encephalitis virus
    11. Ebolavirus
    12. Flexal virus
    13. Foot-and-mouth disease virus
    14. Goat pox virus
    15. Guanarito virus
    16. Hemorrhagic fever agents undefined
    17. Hendra virus
    18. HPAI H5Nx (e.g., H5N1)
    19. Hantaviruses
    20. Herpesvirus simiae
    21. Influenza A H2N2 (1957–1968)
    22. Japanese encephalitis virus
    23. Junín virus
    24. Kyasanur Forest disease virus
    25. Lassa fever virus
    26. Lujo virus
    27. Lumpy skin disease virus
    28. Lymphocytic choriomeningitis virus
    29. MERS-CoV
    30. Machupo virus
    31. Marburg virus
    32. Mpox virus Clade I
    33. Mpox virus clade I/II chimeric viruses
    34. Newcastle disease virus
    35. Nipah virus
    36. Omsk hemorrhagic fever virus
    37. Orthobunyaviruses
        • Akabane, Douglas, Ngaric, and Xingu
    38. Orthonairoviruses
        • Artashat, Dugbe, Issyk-Kul, Kupe, Nairobi sheep disease
    39. Peste des petits ruminants virus
    40. Phleboviruses
        • Bhanja, Escharte, Heartland, Hunter Island, Malsoor, Morolillo, Salobo, Severe fever with thrombocytopenia syndrome
    41. Reoviruses
        • African horse sickness, Banna, Bluetongue (exotic serotypes), Peruvian horse sickness, Yunnan orbivirus
    42. Rift Valley fever virus
    43. Rinderpest virus
    44. Severe acute respiratory syndrome coronavirus (SARS-CoV)
    45. SARS-CoV-2
    46. SARS-CoV/SARS-CoV-2 chimeric viruses
    47. Sabía virus
    48. Semliki Forest virus
    49. Sheep pox virus
    50. Somone virus
    51. South Bay virus
    52. Sripur virus
    53. St. Louis encephalitis virus
    54. Swine vesicular disease virus
    55. Tick-borne encephalitis virus complex
    56. Tick-borne encephalitis virus complex: Far Eastern
    57. Tick-borne encephalitis virus complex: Siberian
    58. Vaccine strains w/ recovered virulence
    59. Variola major virus
    60. Variola minor virus
    61. Venezuelan equine encephalitis virus
    62. West Nile virus
    63. Yellow fever virus
  • Other
    1. Any attenuated pathogen or vaccine strain that is currently excluded from the Select Agent Regulations that exhibits the recovery of virulence at or near the wild-type
    2. Agents added during future updates to the USG DURC-PEPP policy
    3. Biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines but are agents recommended to be handled at BSL3 or BSL4 per the guidance in the Biosafety in Microbiological and Biomedical Laboratories (BMBL)

• Which Risk Group 3 biological materials are excluded from the Policy?

  • Coccidioides immitis
  • Coccidioides posadasii
  • Histoplasma capsulatum
  • Histoplasma capsulatum var. Duboisii
  • Human immunodeficiency viruses (HIV) types 1 and 2
  • Human T-lymphotropic virus 1 (HTLV) types 1 and 2
  • Mpox virus Clade II, unless containing nucleic acids coding for clade I Mpox virus virulence factors
  • Mycobacterium bovis
  • Mycobacterium tuberculosis
  • Simian immunodeficiency virus (SIV)
  • Vesicular stomatitis virus
  • Excluded strains as listed in the NIH Guidelines and Select Agents and Toxins Exclusions

• What are the biological materials covered under Category 2 (PEPP) research?

  Category 2 research involves pathogens with pandemic potential (PPPs) — either existing or those created or modified in ways that could make them more transmissible, virulent, or able to evade immunity.

  While there is no fixed list of Category 2 pathogens, some examples are listed below. For Category 2 research, a pathogen is considered within scope if:

  • It already has pandemic potential, or
  • It is being experimentally enhanced in ways that could give it pandemic potential, or
  • It is an eradicated or extinct pathogen being reconstituted (e.g., 1918 H1N1 influenza, Variola major

  Examples that could fall under Category 2 include:

  • SARS-CoV-2 and engineered SARS-CoV/SARS-CoV-2 chimeric viruses
  • Highly Pathogenic Avian Influenza (HPAI H5Nx, H7)
  • 1918 pandemic influenza virus
  • Variola virus (smallpox)
  • Nipah virus, MERS-CoV, Hendra virus (if modified)
     

  Category 2 applies to any pathogen—not just those on a list—if it’s reasonably anticipated to result in a pathogen with enhanced pandemic potential (PEPP) due to the type of research being conducted.

  For definitive determination, the PI should consult with the ICDUR and IBRC and refer to the 2024 USG Policy's Section 4.2 and Implementation Guidance.