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Biosafety

What is Biosafety?

Biosafety is the application of practices, safety equipment, and facility design to prevent exposure to biological agents and toxins, protecting laboratory personnel, the campus community, the public, and the environment. A biosafety program ensures that research and teaching activities involving biological materials are conducted safely and in compliance with applicable regulations and recognized best practices.

Biosafety Review Process

Before beginning any research or instructional activity involving Biosafety Level 2 (BSL-2) or higher materials, investigators must submit a Biological Use Authorization (BUA) Form to Environmental Health & Safety (EH&S). EH&S conducts an initial review to ensure the proposed work includes appropriate containment practices, facilities, equipment, and training. The protocol is then reviewed by the Institutional Biosafety Committee (IBC), when required, which evaluates the work for compliance with applicable biosafety requirements and determines whether the activity may proceed or if modifications are needed. Work may not begin until all required approvals have been obtained.

Regulatory Basis

Institutional biosafety review is required or supported by several federal regulations, policies, and guidance documents, including:

  • NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules – Require institutions receiving NIH funding for covered research to establish an Institutional Biosafety Committee (IBC) to review and oversee applicable research.
  • Federal Select Agent Regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121) – Govern the possession, use, and transfer of select biological agents and toxins.
  • California Code of Regulations, Title 8, Section 5193 (Bloodborne Pathogens) – Requires employers to protect employees from occupational exposure to human blood and other potentially infectious materials.
  • California Code of Regulations, Title 8, Section 5199 (Aerosol Transmissible Diseases) – Applies to certain laboratory and research activities involving aerosol transmissible pathogens.
  • Cal/OSHA Laboratory Standard (Title 8, Section 5191) – Requires employers to implement laboratory safety practices, including appropriate hazard assessments and training.
  • CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) – Recognized as the national standard for biosafety practices and containment recommendations in research laboratories.

These requirements help ensure that biological research is conducted safely, that personnel receive appropriate protections and training, and that the University fulfills its regulatory and institutional responsibilities.

Institutional Biosafety Committee