Biological Safety

The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential, effective May 6, 2025, supersedes the 2012 Federal DURC Policy, the 2014 Institutional DURC Policy, and the 2017 P3CO Framework. The USG DURC-PEPP Policy complements other existing federal regulations, including the Select Agent Regulations. This Policy provides an oversight framework for research with biological agents or toxins that is within Category 1 or Category 2. It includes measures for federal funding agencies to establish and implement this research oversight framework, including in terms and conditions of funding documents for research institutions and principal investigators.

About the DURC-PEPP Policy

This Policy provides an oversight framework for research with biological agents or toxins that is within Category 1 or Category 2. It includes measures for federal funding agencies to establish and implement this research oversight framework, including in terms and conditions of funding documents for research institutions and principal investigators. The intent of research oversight is to:

• Increase the awareness of researchers, research institutions, and federal funding agencies about the biosafety and biosecurity concerns associated with certain types of research.
• Ensure that appropriate risk mitigation measures are in place to prevent biosafety incidents (e.g., unintended personal exposure or release of an agent outside of containment) or biosecurity incidents (e.g., theft or intentional misuse of information, knowledge, products, or technology).

Category 1 research is subject to oversight by research institutions and federal funding agencies, and Category 2 research is subject to oversight by research institutions, federal funding agencies, and their federal department if applicable due to heightened potential for biosafety and biosecurity risks.

Category 1 research meets these three criteria:

1. Involves one or more of the biological agents and toxins specified in Section 4.1.1 and reflected below:
   • 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.
   • 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.
   • 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.
   • 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.
   • Biological agents added during future updates to the Implementation Guidance as specified in Sections 7 and 8 Increase the virulence19 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;20 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.
2. Reasonably anticipated to result, or does result, in one of the experimental outcomes specified in Section 4.1.2.
3. Based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC as specified in Section 4.1.3.

• 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; or
• Enhance the susceptibility of a host population to a pathogen or toxin.

Category 2 research meets these three criteria:

1. It involves, or is reasonably anticipated to result in, a pathogen with pandemic potential (PPP), or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP as specified in Section 4.2.1;
2. It is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified in Section 4.2.2.
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 as specified in Section 4.2.3.

Any research that meets the definition of both Category 1 and Category 2 research is designated as Category 2 research

• 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; or
• Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.

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.

IRE– Institutional review entity (IRE) is the entity established by the research institution to execute the institutional oversight responsibilities described in Section 5.2, with the attributes described in Section 5.2.B.

PEPP– Pathogen with enhanced pandemic potential (PEPP) is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility10 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.

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– 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.

NAU is responsible for ensuring that all research taking place in university laboratories involving hazardous biological materials, regardless of funding source, is conducted in a safe manner and is compliant with regulatory guidelines and policies. It is the responsibility of the Principal Investigator to seek IBC approval, using the NAU IBC Registration/Renewal Form, for the safe handling, transport, use, and disposal of hazardous biological materials within their laboratory spaces and maintain IBC approval during the time period these materials are used and/or stored. Modifications to protocols must also be approved by the IBC.

The NAU IBC is a faculty-led committee of experts in biosafety-related fields established to oversee research involving recombinant DNA and other biohazards. The IBC is responsible for the oversight of all research activities involving recombinant and synthetic DNA and biohazardous material, as required and outlined in the NIH rDNA Guidelines and CDC’s Biosafety in Microbiological and Biomedical Laboratories (BMBL). Research involving recombinant DNA and biological materials must be reviewed and approved by the IBC prior to the initiation of research. For more information, please read the IBC manual posted below.

• Institutional Biosafety Committee Guidelines/Policy
• IBC Registration/Renewal Form
• rDNA Transgenic Animals Registration form
• Responsible Conduct of Research Training

• Exposure Control Plan
• Hepatitis B Vaccination Declination and Consent Form
• Significant Exposure Reporting Packet
• Sharps Safety and Prevention Program
• Employee Occupational Exposure Procedure Card
• Sharps Injury Report Form
• Sharps Safe Disposal Poster
• Sharps Disposal Instructions

All NAU employees who may have occupational exposure to human blood, unfixed human tissues, human cell/tissue cultures, certain other body fluids or bloodborne pathogens must receive OSHA Required Bloodborne Pathogens Training before they initiate assignments with any of these materials.

Biosafety
Required for personnel working with recombinant DNA, infectious materials, and any other research-related projects that involve Biosafety Level 2 (BSL2) containment practices. Training is tailored to meet the needs of individual groups, so please contact the Biosafety Office to schedule biosafety training.

Bloodborne Pathogens (BBP)
Required prior to the start of work for personnel working with specimens such as human blood, human body fluids/tissues, and potentially infectious human cell lines (including primary cell culture and cell lines known or likely to by infected with HIV, Hepatitis B, or Hepatitis C). This training applies for personnel when there is a potential occupational exposure or contact to blood, blood products, or other potentially infectious materials. Training is tailored to meet the needs of individual groups, so please contact the Biosafety Office to schedule biosafety training. Initial BBP training must be taken in person. The annually required refresher training may be completed in person, or online:

• Online Bloodborne Pathogens Refresher Training

NIH guidelines
Required prior to the start of work for personnel working with recombinant DNA and synthetic nucleic acid molecules.

• NIH Guidelines rDNA Training
• NIH Guidelines Training Quiz

Responsible Conduct of Research

Required prior to the start of work for personnel listed on an IBC protocol.

• CITI Training Instructions
• CITI Training

• Spill Response Poster
• Spill Response Instructions
• Working with Prairie Dogs
• Collecting Fleas from Prairie Dog Burrows
• Autoclave Operations and Verification SOP