The New Dual Use Research of Concern and Pathogen with Enhanced Pandemic Potential Policy

On May 6th, 2024, the United States Office of Science and Technology Policy (OSTP) released the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential and an Implementation Guide. This policy takes effect on May 6th, 2025.

This policy applies to all United States federal departments and agencies that fund or sponsor research that is within the criteria for oversight. Enforcement is the responsibility of these federal entities, as non-compliance by institutions or researchers may result in the loss of current and future funding or sponsorship.

This policy, therefore, applies to any institution or person receiving US federal funding for research subject to this policy.   The NIH has issued guidance on how they will implement this policy.

Dual Use Research of Concern (DURC)

Dual Use Research of Concern (DURC) is a term that captures two key concepts: “Dual Use Research” and “of Concern.”

According to the policy, DURC research is “research conducted for legitimate purposes that generates knowledge, information, technologies, or products, that can be utilized for benevolent or harmful purposes.”

Please note that this definition does not imply any malicious intent on the part of the person or group proposing such activities. On the contrary, the term ‘legitimate purpose’ underscores the aim to contribute to scientific progress.

The definition for 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 harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, crops and other plants, animals, the environment, materiel, or national security.”

Pathogen with Enhanced Pandemic Potential (PEPP)

Like DURC, Pathogen with Enhanced Pandemic Potential (PEPP) builds on the definition of Pathogen with Pandemic Potential (PPP). 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 or mortality in humans.”

PEPP is 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.”

It is important to note that wild-type pathogens from nature are not PEPPs but may be considered PPPs because of their pandemic potential. Additionally, the wild-type pathogen (not enhanced) also does not necessarily need to begin as a PPP to result in a PEPP.

SARS CoV-2 was a PPP in 2020, is not a PPP in 2025

Research Categories Used to Define DURC and PEPP

Two research categories are used to further define DURC and PEPP and identify the research subject to this policy:

Category 1 agents include all select agents and toxins, risk group 4 pathogens listed in Appendix B of the NIH Guidelines, a subset of risk group 3 pathogens from Appendix B of the NIH Guidelines, and agents without a risk group that are handled at biosafety level 3 or 4 according to the BMBL.

Category 2 agents have a broader definition, with any PPP or agent that will be modified so that a PPP is reasonably anticipated to be created.

For both categories, three criteria must be met for research to qualify:

  1. The work must involve biological agents within the category scope
  2. Specific experimental outcomes or actions must be reasonably anticipated
  3. It must carry specific potential effects should those outcomes or actions occur

This policy applies to research from the proposal stage through funding, research activities, and publication.

First, the Principal Investigator (PI) evaluates the proposal to see if it falls under Category 1 or 2 of this policy. (PI Assessment Form)

Then, the PI notifies the funding agency that the work could be subject to the policy.

If funded, the funding agency notifies the Institutional Review Entity (IRE), which is the UCF Institutional Biosafety Committee (IBC), at the institution where the PI works that a determination needs to be made.

The IRE/IBC is responsible for confirming whether the PI’s proposed work meets either category subject to the policy.

Then, the result is communicated to the funding agency, which confirms the IRE/IBC’s determination.

The following steps depend on the outcome of the review and the assigned category:

If Category 1 is assigned: The IRE/IBC and PI work together on a risk-benefit assessment and risk mitigation plan that is then submitted to the funding agency for review and approval.

If Category 2 is assigned: The IRE/IBC and PI still create a risk-benefit assessment and a risk mitigation plan to submit to the funding agency.

In both cases: The funding agency communicates final approval to the PI and research institution, at which point work can proceed.

The policy is not limited to work at the proposal stage. PIs are responsible for continuous assessment of all of their work. If, at any stage of a project, a new experiment or unanticipated result might meet Category 1 or Category 2 criteria, the PI notifies the IRE/IBC and the funding agency promptly so that a complete assessment can be made.

If your research involves PPPs, PEPPs, or any of the agents and toxins on this list, please complete and submit the PI Assessment Form.

Contact EHS if you have questions on how these new regulations impact your research:  E-mail, Melina.Kinsey@ucf.edu.

Information regarding this policy was gathered from the University of Cincinnati Biosafety Office, Sitero, and the Implementation guide of this policy.