What CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) - 6th Edition (2025) requires
Laboratory operators handling potentially hazardous biological agents and toxins should run a comprehensive, continually-updated biosafety risk assessment under Section II of BMBL, select the appropriate Biosafety Level (BSL-1 through BSL-4) and Animal Biosafety Level (ABSL-1 through ABSL-4) based on agent virulence, transmission route, and procedure aerosol potential, implement the combination of standard microbiological practices, primary barriers (biological safety cabinets, sealed containers, PPE), secondary barriers (facility design and engineering controls including HEPA filtration, anterooms, airlocks, controlled access), and facility practices and procedures specified for that BSL or ABSL, layer on the Section VI laboratory biosecurity controls, and implement the Section VII occupational health and immunoprophylaxis programme - documenting the entire risk-based justification so it can be reviewed on an ongoing basis as conditions change.
Pillar: Biotech & Genomics · Authority: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) · Version: 6.0.0 · Last updated:
Primary source: https://www.cdc.gov/labs/media/pdfs/2025/08/SF__19a_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf
SHA-256 integrity: a3a2b01c8de972b34b7594e2ca4c3c5736eac8423e2de29ccf3bcace68d776d3
Primary Citations — 10 traced to source
- BMBL 6th Edition Section II - Biological Risk Assessment: requires a comprehensive biosafety risk assessment as a key component of a successful biosafety program, conducted on a continual basis to address evolving risks within the laboratory environment, as part of an all-hazards risk assessment.
- BMBL 6th Edition Section III - Principles of Biosafety: defines containment as a combination of primary and secondary barriers, facility practices and procedures, and other safety equipment including PPE, with the purpose of reducing the risk of exposure to staff and the unintentional release of hazardous biological agents or toxins into the surrounding community and environment.
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