Frequently Asked Questions

United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

Why are certain naturally occurring viruses that cause human disease such as SARS-CoV-2, H5N1, mpox, and bat-related coronaviruses not currently considered pathogens with pandemic potential (PPPs)?

Not all naturally occurring viruses that cause human disease are PPPs. A naturally occurring pathogen is not a PPP unless it is likely to spread uncontrollably and cause moderate to severe disease and/or mortality in humans. A pathogen may not meet these criteria for transmissibility and pathogenesis due to barriers arising from its route of transmission; present levels of population immunity; or the availability of, access to, and effectiveness of community mitigation measures and medical countermeasures – as discussed in Section B.2 of the Implementation Guidance. Although certain viruses are not PPPs in their naturally occurring forms, experiments may be subject to Category 2 oversight (as described in Section 4.2.1 of the Policy) if these are reasonably expected to result in adaptation of those pathogens to circumvent these barriers to allow wide and uncontrollable spread and moderate to severe pathogenesis.

The Policy further defines a pathogen with enhanced pandemic potential (PEPP) as resulting from experiments that enhance a PPP’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security. Furthermore, any experiment that is reasonably anticipated to modify a non-PPP to result in a pathogen that meets the transmissibility and pathogenesis definitions of a PPP is also subject to Category 2 oversight.

The Implementation Guidance provides examples of several agents that are not considered PPPs in their naturally occurring forms today but have the potential to become PPPs or PEPPs through certain experimental modifications. These would be subject to Category 2 oversight. Examples include Ebola virus, SARS-CoV-2 Omicron lineage – given population immunity as of 2024 – and Highly Pathogenic Avian Influenza (HPAI) H5 and H7 subtypes. As described in the Implementation Guidance, these agents are not currently considered PPPs because they either do not typically cause moderate to severe disease (as is the case with SARS-CoV-2) or do not currently demonstrate wide and uncontrollable spread (as is the case with HPAI and Ebola viruses). However, these agents would indeed require Category 2 oversight when subject to experiments that are reasonably anticipated to enhance transmissibility, virulence, toxicity, stability, host range, tropism, or susceptibility to preventative measures or treatments in a manner that results in a PPP or PEPP. Novel viruses that could be modified to generate a PPP or PEPP, such as novel bat-related coronaviruses, could similarly require Category 2 oversight if subject to these experiments. Finally, in addition to considering whether certain experiments may result in the need for Category 2 oversight of research involving Ebola, SARS-CoV-2, and some strains of H5N1 influenza viruses, these agents are included among the group of viruses that need to be considered for Category 1 oversight (per Section 4.1 of the Policy).

Is research with regulated select toxins, even below the permissible toxin amount described in the Select Agent Regulations, subject to review under the Policy?

Yes, while Federal Select Agent Program regulatory oversight may not apply [42 CFR 73.3(d)(7)] research involving any quantity of a toxin on the Biological Select Agents and Toxins list is subject to review under the Policy. Category 1 oversight considers the anticipated experimental outcomes described in Section 4.1.2 of the Policy, regardless of the amount of toxin involved.

Will the Policy cover all prions, or only human prions?

As Category 1 includes all non-exempted agents from the Risk Group 3 list in the NIH Guidelines, experiments with transmissible spongiform encephalopathy (TSE) agents (i.e., Creutzfeldt-Jacob disease and kuru agents) are included in consideration for this oversight. Research involving prions not explicitly specified in the NIH Guidelines that have been noted as causing Creutzfeldt-Jacob disease in humans, such as prions associated with bovine spongiform encephalopathy (BSE), should be assessed for the experimental outcomes described in Section 4.1.2 of the Policy to determine whether it requires Category 1 oversight. The Policy also encourages investigators and research institutions to review any research for anticipated Category 1 and/or Category 2 experimental outcomes, regardless of agent and funding source.

Are investigators and institutions required to review existing research projects by May 2025, or will only new research be subject to the Policy?

Investigators and institutions with existing awards that may be subject to the Policy are encouraged to consult with the federal funding agency to determine next steps. The Policy is applicable to all research funded or sponsored by grants, contracts, cooperative agreements, and other agreements and transactions issued on or after the effective date of May 6, 2025, and requirements will be reflected in the terms and conditions of the awards. Investigators and institutions are encouraged to consult with their federal funding agency whenever Category 1 and/or Category 2 scopes and experimental outcomes are identified in any research.

Is there any requirement to report non-USG funded research, and which departments or agencies should receive reports about these projects?

There is no general requirement to report non-USG funded research. However, as appropriate, and subject to available authorities, as discussed in Section 5.4 of the Policy, individual funding agencies may establish, as a condition of funding, that they require notification of non-federally funded research that meets the definitions for oversight under the Policy. In those cases, institutions should report to the funding agency issuing that requirement.

What is the appropriate communication mechanism between research institutions and funding agencies?

Institutions have flexibility to establish internal policies and processes to meet the requirements of the Policy, including mechanisms to ensure appropriate communication with federal funding agencies. Institutions conducting research covered by either Category 1 or 2 oversight requirements are required to designate an Institutional Contact for Dual Use Research (ICDUR) to serve as an internal resource for application of the Policy as well as the liaison – as necessary – between the institution and the relevant federal funding agency. However, institutions may communicate with funding agencies through whichever internal mechanism is preferred and are encouraged to copy the ICDUR on those communications with funding agencies.

What is the recommended mechanism for providing the annual formal assurance that the research institution is operating consistent with the Policy – as described in Section 5.2.N of the Policy?

Institutions should consult with their federal funding agencies regarding how the annual assurance should be provided.

What is the appropriate sequence for submitting Category 1 or 2 risk-benefit assessments and risk mitigation plans?

Federal funding agencies will implement the Policy based on their individual structure and program mechanisms. Institutions should consult with the funding agency regarding the timing for submission of required materials.

When are funding decisions finalized?

Notification that an application or proposal has passed scientific merit review does not guarantee it will be funded. Under the Policy, the funding agency and funding agency-level review entity (for Category 1 and Category 2 research) and the departmental-level review entity (for Category 2 research) must review and approve the risk-benefit assessments and risk mitigation plans, as well as address any disagreements prior to making funding decisions. Once all concerns have been addressed, the funding agency will notify the research institution and investigator whether it will fund the research identified as Category 1 or Category 2 research.

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