In light of the May 5, 2025 Executive Order on Improving the Safety and Security of Biological Research, the implementation status of the new DURC-PEPP policy is currently being assessed. The National Institutes of Health has indicated (see NOT-OD-25-112) that it intends to suspend ongoing funding for dangerous gain-of-function research until a new DURC-PEPP policy is in place.


As of May 6, 2025, a new government policy impacts the conduct and oversight of research involving Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP). DURC is a subset of life science research that could generate biological materials, knowledge, or technologies which could be used to harm public health, agricultural crops, the environment, or national security. PEPP is a specific type of DURC research where the research is reasonably anticipated to create novel pathogens that are more transmissible or lethal. 

The new government policy supersedes the previous DURC policy and significantly expands the number of biological agents and toxins and categories of experimental outcomes. Researchers who work with any of the the covered infectious agents or biological toxins should familiarize themselves with the new government policy and implementation guidance. Federal sponsors, such as NIH and NSF, will ask PIs to certify whether they are proposing research that potentially meets the criteria for DURC-PEPP research (Category 1 or 2) described in the government policy. Such research will need to be reviewed by both UCSB and the federal sponsor.
 

Principal Investigator Assessment

  • Principal Investigators (PIs) engaged in DURC-PEPP research are expected to be knowledgeable about and comply with all applicable institutional and U.S. government policies for the oversight of biological agent and toxin research.
  • PIs planning on using any covered agents or toxins shall use the Self-assessment form to determine if their research meets the criteria for DURC-PEPP research.
  • If potential DURC-PEPP research is identified, notify the relevant funding agency and UCSB ICDUR, as described in the self-assessment form.
  • PIs assist in the development of risk-benefit assessments and mitigation plans, as appropriate, that UCSB is required to submit to the federal agency. 
  • Help ensure that any laboratory personnel engaged in DURC-PEPP research receive appropriate education and training on DURC-PEPP, which may involve notifying the ICDUR about changes in personnel who intend to conduct DURC-PEPP research.
  • Continue to follow any relevant biosafety and export control policies and procedures.
     

Definitions

Involves one or more of these biological agents and toxins and is reasonably anticipated to result, or does result, in one of the following experimental outcomes:

  1. Increase transmissibility of a pathogen within or between host species;
  2. Increase the virulence (e.g. ability to cause disease) 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 (e.g. environmental stability or aerosolubility);
  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 (e.g., antimicrobials, antivirals, antitoxins, vaccines);
  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.
     

Involves, or is reasonably anticipated to result in, a pathogen with pandemic potential (PPP) and is reasonably anticipated to result in, or does result in, one or more of the 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; or
  4. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.
     

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.

The official designated by UCSB to serve as an internal resource for application of these Procedures as well as the liaison (as necessary) between UCSB and the relevant federal funding agency.

The committee established at UCSB responsible for oversight of research that may meet the criteria of Category 1 or Category 2.
 

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 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. 
 


Resources

If you have questions, please contact Barry Rowan, Director of Research Integrity, at rowan@research.ucsb.edu