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Toxin
Select agent
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    Select agent

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    Under United States law, Biological select agents or toxins (BSATs) — or simply select agents for short — are bio-agents which (since 1997) have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety". The agents are divided into (1) HHS select agents and toxins affecting humans; (2) USDA select agents and toxins affecting agriculture; and (3) overlap select agents and toxins affecting both.

    The U.S. Centers for Disease Control and Prevention (CDC) regulates the laboratories which may possess, use, or transfer select agents within the United States in its Select Agent Program (SAP) — also called the Federal Select Agent Program (FSAP) — since 2001. The SAP was established to satisfy requirements of the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which were enacted in the wake of the September 11, 2001 attacks and the subsequent 2001 anthrax attacks.

    Using BSATs in biomedical research prompts concerns about dual use. The federal government created the National Science Advisory Board for Biosecurity which promotes biosecurity in life science research. It is composed of government, education and industry experts who provide policy recommendations on ways to minimize the possibility that knowledge and technologies emanating from biological research will be misused to threaten public health or national security.

    Regulation

    The CDC has regulated the laboratories which may possess, use, or transfer select agents within the United States under the SAP since 2001. The SAP was established to satisfy requirements of the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which were enacted in the wake of the September 11, 2001 attacks and the subsequent 2001 anthrax attacks.

    Using select agents in biomedical research prompts concerns about dual use. The federal government created the National Science Advisory Board for Biosecurity to promote biosecurity in life science research. It is composed of government, education and industry experts who provide policy recommendations on ways to minimize the possibility that knowledge and technologies emanating from biological research will be misused to threaten public health or national security.

    Violations

    In July 2015, Gregory E. Demske, chief counsel to the inspector general in the HHS Office of Inspector General (OIG), testified that 30 civil violations of the SAP rules had been identified in the past 13 years, and that violators had paid about $2.4 million in fines. He explained that when the CDC's Division of Select Agents and Toxins detects possible SAP misconduct by an HHS worker, it coordinates with the OIG to gather facts. If it concludes that a civil violation might have occurred, it turns the case over to the OIG for possible enforcement. But if it suspects a crime, it pursues the matter with the FBI. Since passage of the Bioterrorism Act of 2002, the OIG had received 68 referrals from the CDC for possible Select Agent enforcement and found violations in 30 of those cases. Notices of violation were sent to 5 federal entities, 3 universities, and 2 other private organizations, all unnamed in his testimony. Demske remarked that no federal agencies had been fined for SAP violations.

    List of select agents

    Tier 1 BSATs are indicated by an asterisk (*).

    HHS select agents and toxins

    Bacteria

    Viruses

    Toxins

    As of April 2021 these biological agents and toxins are considered to "have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products".

    Overlap select agents and toxins

    Bacteria

    Viruses

    USDA select agents and toxins

    For animals

    Bacteria
    • Mycoplasma mycoides subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia)
    Viruses

    For plants

    Bacteria
    Fungi or fungus-like pathogens

    List of former select agents

    Select agent regulations were revised in October 2012 to remove 19 BSATs from the list (7 Human and Overlap Agents and 12 Animal Agents).

    Human and overlap agents

    Animal agents

    See also

    Further reading

    • National Research Council (US) Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins. (2009). "Chapter 1. Introduction". Responsible Research with Biological Select Agents and Toxins. Washington DC: National Academies Press.

    External links

    • "Home". Federal Select Agent Program. – The FSAP is composed jointly of the Centers for Disease Control and Prevention/Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service/Agriculture Select Agent Services, and oversees the possession, use and transfer of biological select agents and toxins.
    • "National Science Advisory Board for Biosecurity (NSABB)". Office of Science Policy. 7 April 2020. A federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the United States Government.

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