Possession, Use, and Transfer of Select Agents and Toxins rule (2023)

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The Possession, Use, and Transfer of Select Agents and Toxins-Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins rule is a significant rule issued by the U.S. Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS) effective March 3, 2023, that added the SARS-CoV and SARS-CoV-2 chimeric viruses to the list of select agents and toxins that require CDC approval to manipulate. HHS issued the rule under the authority granted it by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.[1]

HIGHLIGHTS
  • Name: Possession, Use, and Transfer of Select Agents and Toxins-Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins
  • Action: Final rule
  • Type of significant rule: Other significant rule

    • Timeline

    The following timeline details key rulemaking activity:

    Background

    The U.S. Centers for Disease Control and Prevention issued an interim final rule to add SARS-CoV and SARS-CoV-2 to the HHS list of select agents and toxins in November 2021. The U.S. Department of Health and Human Services (HHS) evaluates viruses by their effect on human health if exposed to the virus, the degree and mode of contagiousness of the virus, and the available treatments for infected individuals. HHS determined that the two viruses posed a serious threat to public health and added them to the list of select agents and toxins. HHS said they promulgated the final rule because SARS-CoV and SARS-CoV-2 pose a severe threat to public health and safety, as of the time the Possession, Use, and Transfer of Select Agents and Toxins-Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins rule was published.[1]

    Summary of the rule

    The following is a summary of the rule from the rule's entry in the Federal Register:

    “ The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has amended the select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. With this final rule, regulated entities are required to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.[1][2] ”

    Summary of provisions

    The following is a summary of the provisions from the rule's entry in the Federal Register:[1]

    “ For the reasons stated above in the preamble, HHS/CDC adopts the interim final rule which was effective November 17, 2021 (86 FR 64075) as final without change. In accordance with the interim final rule, SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors are an HHS select agent. Any individual or entity that possesses SARS-CoV/SARS-CoV-2 chimeric viruses on or after November 17, 2021 must provide notice to CDC regarding their possession and must secure the agent against theft, loss, release, or unauthorized access; and by November 17, 2021, an individual or entity that intends to continue to possess, use, or transfer this agent is required to either register in accordance with 42 CFR part 73 or amend their current registration in accordance with 42 CFR 73.7(h) and meet all of the requirements of select agent regulations (42 CFR part 73). Further, experiments that involve the creation of SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors or vice versa are restricted experiments and require prior approval in accordance with 42 CFR 73.13(a)(3).[2] ”

    Significant impact

    See also: Significant regulatory action

    Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.

    Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]


    The text of the Possession, Use, and Transfer of Select Agents and Toxins-Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins rule states that OMB deemed this rule significant, but not economically significant:

    “ This rule has been determined to be a 'significant regulatory action' as defined by Executive Order 12866, section 3(f). However, this rule is not an economically significant regulatory action, as it will not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.[2] ”

    Text of the rule

    The full text of the rule is available below:[1]

    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 Federal Register, "Possession, Use, and Transfer of Select Agents and Toxins-Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins," January 22, 2024.
    2. ↑ 2.0 2.1 2.2 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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