By Scott W. Finkernagel, CBSP, Senior Biosafety Manager
The intention of this new federal policy is to provide a framework for research oversight, increasing the awareness of researchers, institutions, and federal funding agencies about the biosafety and biosecurity concerns associated with certain types of research while still allowing for beneficial scientific advancements. This policy merges previous separate frameworks for “dual-use research of concern” and “pathogens with enhanced pandemic potential” and now covers a broader range of research activities.
Oversight will apply to research with biological agents and toxins that can be considered Dual Use Research of Concern (DURC), Pathogens with Enhanced Pandemic Potential (PEPP) and Potential Pandemic Pathogens (PPP).
DURC is defined as “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.”
PEPP is defined as “a type of 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.”
PPP is 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.” A pathogen’s capability for “wide and uncontrollable spread in a human population” is a function of the pathogen’s ability to spread in a human population through an efficient means of transmission (e.g., via aerosol, respiratory droplets, direct contact, fomites, etc.).”
This new federal policy will be in effect in May 2025 and mandates that a process of biohazard and biosecurity risk assessment take place prior to conducting experiments and that appropriate risk mitigation measures are in place to prevent biosafety/biosecurity incidents. Incidents could be either unintended personal exposure, the release of an agent outside of containment, or the theft or intentional misuse of information, knowledge, products, or technology.
The types of research and experimental effects subject to additional oversight include the following:
- Increase transmissibility of a pathogen within or between host species
- Increase the virulence of a pathogen or convey virulence (i.e., the ability of a pathogen to cause disease) to a non-pathogen (pathogenicity)
- 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 (e.g., improving characteristics of the pathogen or toxin such as environmental stability and ability to be aerosolized)
- 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 (e.g., antimicrobials, antivirals, antitoxins, vaccines).
- Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of pre-existing immunity, via immunization or natural infection, against the pathogen or toxin.
- Enhance the susceptibility of a host population to a pathogen or toxin.
- 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 PEP.
At WCM, any Principal Investigator considering research with DURC, PEPP or PPP would require additional reviews to ensure that appropriate biosecurity and biocontainment are available for the research to be carried out safely and securely. Additional oversight may include the Federal funding agency's review and approval of the Research Dean, Institutional Biosafety Committee, and Institutional Biosafety Officer. Examples of agents that may require additional scrutiny in this new regulatory framework include research with H5N1 or SARS-CoV-2. DURC and Select Agents already require clearance from the Department of Justice and CDC.
References and Resources:
- United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024)
- FAQs: https://aspr.hhs.gov/S3/Pages/DURC-and-PEPP-FAQ.aspx