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

Against the backdrop of an increasingly complex and unpredictable global risk of the proliferation of weapons of mass destruction, especially biological weapons, on 6 May 2024 the United States Government issued the “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” (hereinafter the Dual-Use Research Oversight Policy). This is an important step in the management of potentially dangerous research related to biosafety and biosecurity. The Dual-Use Research Oversight Policy was developed to address growing concerns about the potential risks of biological dual use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPP), while ensuring that such research is conducted safely and responsibly. The policy applies to all research involving DURC and PEPP and sets out the oversight of such research. It clearly defines the roles and responsibilities of researchers, institutions and government agencies, and provides a legal framework for conducting research in a manner that ensures biosafety and biosecurity.

Recognising the potential risks associated with DURC and PEPP research, the United States Government has put in place policies and regulations for oversight and management, with the aim of promoting responsible scientific research, preventing harm to the public and ensuring biosafety and biosecurity.

The objectives of the Dual-Use Research Oversight Policy are to: (i) promote responsible scientific research by ensuring that research involving DURC and PEPP is conducted in a manner that minimises risks to public health and safety; (ii) protect public health and safety through the oversight and management of dangerous research; (iii) prevent the misuse of DURC and PEPP research for malicious purposes such as the development of biological weapons; (iv) encourage transparency and communication among researchers, institutions and government agencies to ensure that the potential risks associated with DURC and PEPP research are closely managed and promptly addressed; and (v) ensure compliance with the regulations governing DURC and PEPP research in order to prevent the accidental or deliberate release of dangerous pathogens and biological agents.

Under the Dual-Use Research Oversight Policy, research involving DURC and PEPP is subject to oversight and management by government agencies, including the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Researchers and research institutions must comply with the regulations governing such research, including conducting risk assessments and implementing appropriate risk management procedures. The policy also requires researchers and institutions to provide and share information about their research with government agencies and other stakeholders in order to identify potential risks in DURC and PEPP research and address them before they pose a threat to public health and safety or to biosecurity.

Dual Use Research of Concern is dual-use research in the life sciences that has the potential to be used for both beneficial and harmful purposes. Such research may involve the manipulation or modification of biological agents, toxins or other hazardous biological materials.

Pathogens with Enhanced Pandemic Potential are pathogens capable of causing a pandemic (for example, influenza viruses, coronaviruses and other respiratory viruses). These pathogens may occur naturally or be modified in a laboratory setting.

The benefits of DURC research include advances in medical treatment, disease prevention and biodefence. However, the risks associated with DURC research are also considerable, such as the release of highly virulent and rapidly transmissible pathogens leading to a global pandemic. In addition, the development of new biological weapons or the modification of existing pathogens could be used for bioterrorism or biological warfare, posing a significant threat to the security of individual countries and the world as a whole.

In the Dual-Use Research Oversight Policy, the United States Government sets out the concepts of “biosafety” and “biosecurity” as follows:

Biosafety is the application of containment practices, controls and infrastructure to reduce the risk of unintentional exposure to, infection with, release of or harm from pathogens, toxins and other related biological materials.

Biosecurity is the application of security measures designed to prevent the loss, theft, misuse, diversion, unauthorised possession or intentional release of pathogens, toxins, biological materials, or related information or technology.

In the Dual-Use Research Oversight Policy, the United States Government pays particular attention to Category 1 and Category 2 research, which are subject to this policy.

Category 1 research

Category 1 research is research that meets three criteria:

1. It involves one or more of the following biological agents and toxins:

All select agents and toxins listed in the Code of Federal Regulations (CFR) at 9 CFR 121.3–121.4, 42 CFR 73.3–73.4 and 7 CFR 331.3, and regulated by the U.S. Department of Agriculture (USDA) and/or the U.S. Department of Health and Human Services (HHS).

All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules – Classification of Human Etiologic Agents on the Basis of Hazard.

A subset of Risk Group 3 pathogens listed in the NIH Guidelines.

For biological agents affecting humans that have not yet been assigned to a risk group in the NIH Guidelines, reference is made to the Biosafety in Microbiological and Biomedical Laboratories guidance.

Biological agents added through updates to the implementation guidance in the future.

2. The research is reasonably anticipated to result in, or actually results in, one of the following experimental outcomes:

Increasing the transmissibility of a pathogen within or between host species.

Increasing the virulence of a pathogen or conferring virulence on a non-pathogen.

Increasing the toxicity of a known toxin or producing a novel toxin.

Increasing the stability of a pathogen or toxin in the environment, or increasing the ability to disseminate a pathogen or toxin.

Altering the host range or tropism of a pathogen or toxin.

Decreasing the ability to detect a pathogen or toxin in humans or animals using standard diagnostic or analytical methods.

Increasing the resistance of a pathogen or toxin to clinical and/or agricultural prophylactic or therapeutic interventions.

Altering a human or animal pathogen or toxin to disrupt the effectiveness of pre-existing immunity, acquired through immunisation or natural infection, against that pathogen or toxin.

Enhancing the susceptibility of a host population to a pathogen or toxin.

3. Based on a risk assessment:

The research is shown, or is reasonably anticipated, to provide knowledge, information, products or technologies that could be directly misapplied, without modification or with only minor modification, to pose a significant threat with potential consequences for the health and safety of humans, agricultural crops and other plants, animals, the environment, materiel or national security.

Category 2 research

Category 2 research is research that meets three criteria:

1. It involves, or is reasonably anticipated to result in, a pathogen with pandemic potential (PPP), as defined: a PPP, or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP.

2. It is reasonably anticipated to result in, or actually results in, one or more of the following experimental outcomes or actions:

Enhancing the transmissibility of the pathogen in humans.

Enhancing the virulence of the pathogen in humans.

Enhancing the immune evasion of the pathogen in humans, such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity acquired through vaccination or natural infection.

Generating, using, reconstituting or transferring an eradicated or extinct PPP, or a PEPP.

Based on a risk assessment

The research institution or federal funding agency assesses that the research is reasonably anticipated to result in the development, use or transfer of a PEPP, or of 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 defined: the research may reasonably be anticipated to result in the development, use or transfer of a PEPP, or of an eradicated or extinct PPP, that may pose a significant threat to public health, the capacity of health systems to function or national security.

In addition, the policy focuses on the following core issues:

Risk assessment: The policy requires researchers and research institutions to conduct risk assessments for research involving DURC and PEPP in order to identify potential risks and develop appropriate risk management strategies.

Review and approval process: The policy requires research involving DURC and PEPP to undergo a review and approval process by government agencies, including the NIH and CDC, to ensure that the research is conducted safely and responsibly.

Risk management plan: The policy requires researchers and institutions to develop and implement risk management plans for research involving DURC and PEPP to ensure that potential risks are minimised.

Communication: The policy requires researchers and research institutions to communicate and share information about their research with government agencies and other stakeholders in order to ensure transparency and facilitate the identification and resolution of potential risks.

Education and training: The policy requires researchers and research institutions to receive education and training on the risks associated with DURC and PEPP research and on appropriate measures to minimise or mitigate those risks.

Government agencies, including the NIH and CDC, are responsible for the oversight and management of DURC and PEPP research to ensure that it is conducted safely and responsibly. These agencies review and approve research involving DURC and PEPP, provide guidance on developing risk management plans and monitor compliance with the regulations governing the conduct of such research.

The issuance of the Dual-Use Research Oversight Policy by the United States Government is a breakthrough in promoting responsible science, providing oversight and regulation of DURC and PEPP research through risk assessment, the development of risk management plans and the communication and sharing of research information with government agencies and stakeholders, facilitating the identification and resolution of potential risks associated with DURC and PEPP research and minimising potential harm to public health, biosafety and national security. The policy has been effective in providing oversight and regulation of potentially dangerous research, requiring research involving DURC and PEPP to undergo review and approval by government agencies to ensure that it is conducted safely and responsibly. This has prevented the accidental or deliberate release of dangerous pathogens that would compromise biosafety and affect national and global security. The policy has also been effective in providing oversight and regulation of DURC and PEPP research, requiring researchers and institutions to comply with the regulations governing the conduct of such research, including conducting risk assessments and implementing appropriate risk management strategies. This has reduced the potential for the development of biological weapons or other harmful applications of DURC and PEPP research.

However, the policy also creates certain disadvantages. First, it creates an additional administrative burden for researchers and research institutions conducting DURC and PEPP research. The policy requires researchers and institutions to comply with the regulations governing the conduct of such research, including conducting risk assessments, developing risk management plans and communicating and sharing information about their research with government agencies and other stakeholders, which requires additional resources and time and may be a burden for some researchers and research institutions. Second, it may hinder scientific progress because it restricts certain types of research. Some researchers consider the policy overly cautious and believe it may impede scientific progress in research on the beneficial applications of DURC and PEPP.

The Dual-Use Research Oversight Policy provides oversight and regulation of potentially dangerous research, promotes responsible scientific conduct, protects public health and safety, prevents the misuse of research, encourages transparency and communication, and ensures regulatory compliance. The policy regulates DURC and PEPP research through risk assessment, review and approval processes, risk management plans, communication and transparency, and education and training. Although effective in achieving its objectives, the policy also creates an additional administrative burden for researchers and institutions and may limit scientific progress. Overall, it is a necessary step to promote dual-use scientific research while maintaining control over national and international safety and security in the field of biological research.

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References: 1.0USG-Policy-for-Oversight-of-DURC-and-PEPP

Dang Huy Hiep – Centre 81