List of biosafety level 4 organisms

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, to animal health, or to plant 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 BSL4 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 BSL4 according to facility SOPs or when dealing with new viruses closely related to viruses that require BSL4. For instance, Andes orthohantavirus and MERS-CoV are both non-select agents that are often handled in BSL4 because they cause severe and fatal disease in humans. Newly characterized viruses closely related to select agents and/or BSL4 viruses (for example newly discovered henipaviruses or ebolaviruses) are typically handled in BSL4 even if they aren't yet known to be readily transmissible or cause severe disease.

International BSL4 Regulations

Globally, there are no official agreements on what agents must be handled in BSL4. However, select agents and toxins originating or ending in US BSL4 labs must adhere to US select agent laws.

Select agents

HHS human threats: select agents and toxins

HHS human or animal threats: select agents and toxins

USDA 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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