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

from White House website

United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential can be found here. (PDF)

Implementation Guidance for the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential can be found here.(PDF)

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(I am in the process of converting the PDFs to a Word-type file that can be published on regular websites like this one. Power went out this morning due to storm, again, and I will continue later today. After the break, you can read the document without downloading a PDF from White House website (cus who wants to do that these days) I will finish it later)

(Having a chat this morning after working on this for an hour, waiting for power to come back on, we agree on all kinds of stuff but when Covid came up he said 'we reacted to it pretty quick' and I asked if he meant de Santis rejecting mandates and such but no he was talking about the US in general and our glorious vaccines. So many people out there still have no idea what happened these past few years. So many.)

 

Section 1. Introduction

1.1 Purpose

The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“Policy”) is a unified federal oversight framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins. This Policy addresses oversight of research on biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security.1 It supersedes the 2012 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (Federal DURC Policy),2 the 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Institutional DURC Policy),3 and the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO Framework).4 This Policy is issued by the Office of Science and Technology Policy (OSTP) in accordance with the directives established by the 2022 National Biodefense Strategy and Implementation Plan,5 as directed by National Security Memorandum 15,6 to complete an interagency review of efforts to strengthen responsible conduct for biological research. This Policy has also been issued pursuant to Section 2315 of the Consolidated Appropriations Act, 2023 (42 U.S.C. § 6627) to achieve consistent review and oversight of life sciences research proposed for federal funding that may be reasonably anticipated to involve the creation, transfer, or use of pathogens with enhanced pandemic potential (PEPPs).7

The intent of this Policy is to strengthen oversight of life sciences research with biological agents and toxins throughout the research lifecycle by:

•  Defining an expanded scope of biological agent and toxin research subject to additional oversight by the U.S. government;
• Providing a unified framework to support the consistent identification and oversight of research proposals subject to this Policy that accounts for safety, security, and ethical considerations; and
• Delineating the roles and responsibilities of principal investigators, research institutions, and federal departments and agencies that conduct, fund, or oversee research within the scope of this Policy, with an emphasis on institutional oversight and management of this research.

This Policy will take effect one year after its release date to provide a transition period for implementation. Federal departments and agencies will update, modernize, or promulgate applicable implementing guidance consistent with this Policy and 42 U.S.C § 6627(b)(1) by the effective date of this Policy.

OSTP is also releasing the Implementation Guidance to the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“Implementation Guidance”) to aid and assist in consistent implementation of this Policy.

1.2 Applicability of Policy

This Policy applies to federal departments and agencies that fund or sponsor intramural or extramural research at research institutions in the United States and internationally with biological agents or toxins where the research is within Category 1 or Category 2 under this Policy, as described in Section 4 (“federal funding agencies”). This includes research funded or sponsored by grants, contracts, cooperative agreements, and other agreements and transactions issued on or after the effective date of this Policy. This Policy covers the research proposal stage and the full life cycle of the research. Non-federally funded research at institutions that receive federal funding is addressed in Section 5.4 of this Policy. Research that is outside of the scope of this Policy but may benefit from voluntary risk assessment and mitigation is addressed in Section 6.

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. Federal funding agencies should implement this Policy under statutory and regulatory authorities applicable to them, and should aim to develop and promote consistent processes across the agencies to the maximum extent appropriate.

1.3 Relationship to Statutes, Regulations, and Other Policies

This Policy complements existing federal statutes, regulations, other policies, and guidelines regarding biosafety and biosecurity oversight and the responsible conduct of research involving biological agents and toxins. Federal funding agencies should implement this Policy in a manner consistent with all applicable laws and regulations; all legally binding treaties, commitments, and United Nations Security Council resolutions prohibiting the development and use of pathogens and toxins as weapons; and all relevant Presidential Directives and Executive Orders. Nothing in this policy shall be construed to impair or otherwise affect the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

Nothing in this Policy should be read as superseding any federal statutory authority, including those applicable to the Department of Health and Human Services, the Department of Agriculture, and any other federal department or agency, to regulate the possession, use, or transfer of biological select agents and toxins that have the potential to pose a severe risk to public, animal, or plant health, or to animal or plant products. Nothing in this Policy should be read as superseding any regulatory authority, including the Select Agent Regulations found at 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331; the export control regulations at 15 CFR Parts 730-774 (known as the “Export Administration Regulations” [EAR]); and 22 CFR Parts 120-130 (known as the “International Traffic in Arms Regulations” [ITAR]), among others.8 The term “dual use” as used herein should not be interpreted to indicate which regulations govern the export of such items.

As stated above, this Policy supersedes the 2012 Federal DURC Policy, the 2014 Institutional DURC Policy, and the 2017 P3CO Framework.

Section 2. Background, Policy Statement, and Guiding Principles

2.1 Background

Research involving biological agents and toxins is essential to the scientific advances that underpin improvements in the health and safety of the public, agricultural crops and other plants, animals, and the environment. While this research provides enormous benefits to society, there are risks associated with certain subsets of this work that require heightened biosafety and biosecurity practices, including appropriate risk assessment and risk mitigation strategies. The U.S. Government has existing statutes, regulations, policies, and guidelines that address potential biosafety and biosecurity risks, including those associated with research oversight and management.9 Together, these authorities, policies, and guidelines provide a foundation for ensuring that scientific research is conducted safely and securely.

Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. 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 and to 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). The 2012 Federal DURC, the 2014 Institutional DURC, and the 2017 P3CO Framework policies have been key components of the federal oversight framework for research involving biological agents and toxins. Scientists, institutions, and federal funding agencies have gained valuable insight from implementing these policies over the past decade. Meanwhile, rapid advances in science and technology continue to provide societal benefits, while also posing new risks. Replacing these earlier policies with this Policy, aided by the Implementation Guidance, will enable the oversight system for research involving biological agents and toxins to better address these risks.

It is important to acknowledge that research within the scope of this Policy can increase our understanding of the biology of biological agents and toxins. This body of knowledge can support the development of new diagnostic, prevention, and treatment measures; improvements in public health and animal or plant disease surveillance; and enhancement of emergency preparedness and response efforts. Research designated within the scope of this Policy can also advance science and innovation and contribute to American research competitiveness. This Policy provides the necessary precautionary measures to ensure that potential biosafety and biosecurity risks are mitigated and research is carried out safely and securely. These measures should be applied in a manner commensurate with risk in order to minimize adverse impacts on legitimate research and preserve and foster the benefits of research.
2.2 Policy Statement
It is the policy of the U.S. Government that federally funded intramural or extramural research that meets the scope of Category 1 or Category 2 research within this Policy is subject to federal and institutional oversight. The purpose of this oversight is to preserve the benefits of such research while minimizing the biosafety and biosecurity risks, including risks that the knowledge, information, products, or technologies generated by the research could be used in a manner that results in harm to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

2.3 Guiding Principles

Federal funding agencies should follow these guiding principles, which informed development of this Policy:

    A. Life sciences research facilitates advances in public health, agriculture, the environment, and other pertinent areas, and serves to strengthen national security. It is critical that such research be conducted ethically.

    B. The goal of life sciences research is to produce beneficial knowledge, information, products, or technologies. Despite its value and benefits, some research may present biosafety and biosecurity risks, or 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. Therefore, to maintain the benefits of life sciences research, it is necessary to apply tools to assess risk and implement this Policy for the responsible oversight, conduct, and communication of such research.

    C. Life sciences research is by nature dynamic and can produce unanticipated results. Therefore, both the nature of the experiment and the information and materials it generates must be evaluated throughout the research lifecycle for biosafety and biosecurity risks.

    D. Oversight must recognize both the need for risk assessment and mitigation and the need to support the science that drives lifesaving technologies, enables medical countermeasure development, and accelerates pandemic preparedness. As such, the degree of oversight should be commensurate with the identified biosafety and biosecurity risks.

    E. Effective oversight helps maintain public trust in the life sciences research enterprise by demonstrating that the scientific community recognizes the potential implications of research and is acting responsibly to protect public welfare and preserve national security.

    F. Federal agencies, other government entities, nongovernmental entities, and institutions that fund or conduct life science research have the shared responsibility of identifying and mitigating biosafety and biosecurity risks throughout the research life cycle and ensuring that effective oversight and risk mitigation is in place.

    G. It is essential to have a common understanding of and consistent and effective implementation for research oversight across all institutions that support and conduct life sciences research.

    H. Any research oversight process should be periodically evaluated for effectiveness, impact on the research enterprise, and ability to effectively address emerging risks emanating from advances in biotechnology and associated convergent and enabling fields.

    I. The free, open, and responsible conduct and communication of federally funded life sciences research is vital to a robust scientific enterprise and will continue to be a goal of the U.S. government. It should also be a goal of all research institutions engaged in life sciences research. We collectively strive to pursue our open science goals in concert with our interests in national and economic security, research integrity, and public welfare — ensuring that knowledge is shared in a way that leads to responsible use.

    J. Educating the scientific community, industry, emergency response officials, the broader public, and others about biosafety, biosecurity, and the dual use potential of life sciences research is essential for promoting responsible research behavior.

    K. No policy or set of guidelines can anticipate every possible situation. Awareness of biosafety and biosecurity risks, dual use, and good judgment are necessary for objective and responsible risk assessment and conduct of responsible research. It is incumbent on those engaged in life sciences research to adhere to the intent of this Policy, the research oversight framework described herein, and other policies and regulations that promote responsible research.

Section 3. Definitions

For the purpose of this Policy, the following terms are defined:

    A. “Biological agents” are any microorganism (including, but not limited to, bacteria, viruses, fungi, or protozoa), infectious material, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious material, capable of causing:

•  Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
•  Deterioration of food, water, equipment, supplies, or material of any kind; or
•  Deleterious alteration of the environment.

    B. “Biosafety” is the application of practices, controls, and containment infrastructure that reduces the risk of unintentional exposure to, contamination with, release of, or harm from pathogens, toxins, and other associated biological materials.

    C. “Biosecurity” is the application of security measures designed to prevent the loss, theft, misuse, diversion, unauthorized possession or material introduction, or intentional release of pathogens, toxins, biological materials, and related information and/or technology.

    D. “Dual use research” is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes.

    E. “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.

    F. “Federal funding agency” is a federal department, agency, institute, center, or office that funds or sponsors intramural or extramural research at research institutions in the United States or internationally, with biological agents or toxins where the research is within Category 1 or Category 2 under this Policy, as described in Section 4.

    G. “Institutional Contact for Dual Use Research (ICDUR)” is the official designated by the research institution to serve as an internal resource for application of this Policy as well as the liaison (as necessary) between the institution and the relevant federal funding agency.

    H. “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.

    I. “Life sciences” is the study or use of living organisms, viruses, or their products, including all disciplines, methodologies, and applications of biology (including biotechnology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and techniques).

    J. “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.

    K. “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.11

    L. “Principal investigator” (PI) is the senior/key person seeking or receiving federal research and development funding (i.e., extramural funding). This includes researchers at federal agency laboratories and facilities, as well as researchers at government-owned, contractor-operated laboratories and facilities (i.e., intramural researchers, whether or not federally employed). There may be more than one PI on a research grant or project within a single or multiple institution(s).

    M. “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.

    N. “Research institution” is any academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, government agency, or other legal entity that conducts life sciences research.

Section 4. Category 1 and Category 2 Research that is Subject to this Policy

To enable effective implementation, this Policy categorizes the research previously overseen by the 2012 Federal DURC, the 2014 Institutional DURC, and the 2017 P3CO Framework policies into Category 1 and Category 2 research. This Policy also expands the scope of research previously overseen by those policies. As outlined in more detail in Section 5, 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 applicable12 due to heightened potential for biosafety and biosecurity risks.

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

4.1 Category 1 Research

Category 1 research meets three criteria: (1) it involves one or more of the biological agents and toxins specified in Section 4.1.1; (2) it is reasonably anticipated to result, or does result, in one of the experimental outcomes specified in Section 4.1.2; and (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.

    4.1.1 Biological Agents and Toxins within Scope of Category 1 Research13

•  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.14
• 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.15
• A subset of Risk Group 3 pathogens16 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).17 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.18
• Biological agents added during future updates to the Implementation Guidance as specified in Sections 7 and 8.

    4.1.2 Category 1 Research Experimental Outcomes

Research within the scope of Category 1 are those experimental outcomes with a biological agent or toxin outlined in Section 4.1.1 that are reasonably anticipated to:

    i. Increase transmissibility of a pathogen within or between host species;
    ii. Increase the virulence19 of a pathogen or convey virulence to a non-pathogen;
    iii. Increase the toxicity of a known toxin or produce a novel toxin;
    iv. Increase the stability of a pathogen or toxin in the environment, or increase the ability to                         disseminate a pathogen or toxin;20
    v. Alter the host range or tropism of a pathogen or toxin;
    vi. Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard              diagnostic or analytical methods;

    vii. Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic             interventions;21
    viii. 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
    ix. Enhance the susceptibility of a host population to a pathogen or toxin.

Illustrative examples of Category 1 research experiments that should require PI, IRE, and federal funding agency review and approval are presented in the Implementation Guidance.

    4.1.3 Category 1 Risk Assessment

Based on current understanding, the research can be reasonably anticipated to provide, or does 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.

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As described further in Section 6, there may be additional types of life sciences research that do not involve biological agents or toxins in Section 4.1.1 or experiments in Section 4.1.2, yet pose DURC risks as described in Section 4.1.3. Principal Investigators and research institutions are encouraged to remain vigilant to such research, including work involving any other biological agent or toxin regardless of its Risk Group, and develop and apply appropriate risk mitigation measures.

See the Implementation Guidance for additional guidance on Category 1 research including illustrative examples.

4.2 Category 2 Research

Category 2 research meets three criteria: (1) it involves, or 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; and (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.