Appendix E: Biosafety Level 3 (BSL3) and Biosafety Level 4 (BSL4) Requirements and Practices

Biosafety Level 3 and 4 (BSL3/4) is the recommended containment for work with agents or toxins that may cause serious or potentially fatal disease through inhalation exposure. Work at BSL3/4 requires enhanced facility design, operational controls and special practices, which are outlined in the BSL3 Biosafety Manual and BSL4 Biosafety Manual.

BSL3/4 facilities are designed and verified with facility and ventilation features to accommodate the safe handling and containment of risk group 3/4 agents. The architectural and engineering plans, commissioning testing documents, and equipment validations and verifications for BSL3/4 facilities is reviewed and approved in advance by EHS to ensure that they in compliance with the CDC/NIH’s Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th edition requirements. Facility-specific standard operating procedures (SOPs) and annual containment verifications are reviewed by EHS and research protocols are reviewed and approved by the BU IBC to determine adequacy for the use of the proposed biological agents. Additionally, all work with BSL3 and above agents must be registered with the BPHC.

The BSL3 and BSL4 Biosafety Plans outline the general requirements for BSL3 and BSL4 facilities at Boston University. Special requirements dealing with Select Agents and Select Agent facility documentation are covered in the NEIDL-specific Laboratory Manuals.