List of biosafety level 4 organisms

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Biosafety level 4 (BSL-4) organisms are dangerous or exotic agents which pose high risk of life-threatening disease, aerosol-transmitted lab infections, or related agents with unknown risk of transmission.[citation needed]

US federal biocontainment regulations

Biosafety level 4 laboratories are designed for diagnostic work and research on easily respiratory-acquired viruses which can often cause severe and/or fatal disease. What follows is a list of select agents that have specific biocontainment requirements according to US federal law. Organisms include those harmful to human health, or to animal health.[1] The Plant Protection and Quarantine programs (PPQ) of the Animal and Plant Health Inspection Service (APHIS) are listed in 7 CFR Part 331. The Department of Health and Human Services (HHS) lists are located at 42 CFR Part 73.3[2] and 42 CFR Part 73.4.[3] The USDA animal safety list is located at 9 CFR Subchapter B.[4]

Not all select agents require BSL-4 handling, namely select bacteria and toxins, but most select agent viruses do (with the notable exception of SARS-CoV-1 which can be handled in BSL3). Many non-select agent viruses are often handled in BSL-4 according to facility SOPs or when dealing with new viruses closely related to viruses that require BSL-4. For instance, Andes orthohantavirus and MERS-CoV are both non-select agents that are often handled in BSL-4 because they cause severe and fatal disease in humans. Newly characterized viruses closely related to select agents and/or BSL-4 viruses (for example newly discovered henipaviruses or ebolaviruses) are typically handled in BSL-4 even if they aren't yet known to be readily transmissible or cause severe disease.[citation needed]

International BSL-4 regulations

Globally, there are no official agreements on what agents must be handled in BSL-4. However, select agents and toxins originating or ending in US BSL-4 labs must adhere to US select agent laws.[citation needed]

Select agents

HHS human threats: select agents and toxins

HHS human or animal threats: select agents and toxins

Non-select agents

References

  1. ^ "Select agents and toxins list". Centers for Disease Control and Prevention / USDA Animal and Plant Health Inspection Service. Retrieved 18 August 2019.
  2. ^ "42 CFR § 73.3 - HHS select agents and toxins". LII / Legal Information Institute. Retrieved 21 August 2019.
  3. ^ "42 CFR § 73.4 - Overlap select agents and toxins". LII / Legal Information Institute. Retrieved 21 August 2019.
  4. ^ "9 CFR Subchapter B - COOPERATIVE CONTROL AND ERADICATION OF LIVESTOCK OR POULTRY DISEASES". LII / Legal Information Institute. Retrieved 21 August 2019.

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