Funding News Edition: July 07, 2021 See more articles in this edition
Whether you are new to managing laboratory biosafety or an experienced veteran, take time to review the Biosafety in Microbiological and Biomedical Laboratories, 6th Edition (BMBL). CDC and NIH partner to publish these biosafety guidelines.
The BMBL is an advisory document recommending best practices for safely conducting work in biomedical and clinical laboratories from a biosafety perspective. It reflects contributions from more than 200 scientific and other relevant professionals who participated in technical working groups and served as reviewers, guest editors, and subject matter experts.
The 6th edition includes revised sections, agent summary statements, and appendices. Its recommendations are harmonized with guidance and regulations from other organizations and federal agencies. Where possible, the 6th edition clarifies language and elucidates the intent of information. To better serve the community, the BMBL 6th edition includes new appendices on the following topics: inactivation and verification; laboratory sustainability; large-scale biosafety; and clinical laboratory biosafety.
Although not authoritative, the American Biological Safety Association produced a catalogue of differences from the BMBL 5th edition (published in 2009) at Summary of Changes to the Biosafety in Microbiological and Biomedical Laboratories, 6th Edition (BMBL-6) and a BMBL-5 & BMBL-6 Side-by-Side Comparison.
Overall, the 6th edition stresses the importance of protocol-driven risk assessment. Institutions should strive to include all relevant stakeholders, e.g., biosafety office or officer, animal care staff, facilities staff, management, and the Institutional Biosafety Committee or equivalent resource, as necessary to ensure sufficient input and consensus on matters of risk assessment and mitigation.
The BMBL should not be used as a single source of biosafety information because no single set of guidelines can identify all the possible combinations of risks and mitigations feasible in biomedical and clinical laboratories. The appropriate institutional stakeholders should use the BMBL as a tool during the ongoing assessment and proposal of mitigation steps for their biomedical and clinical laboratories.
The Federal Select Agent Program (FSAP) has revised its inspection checklists to align with the Biosafety in Microbiological and Biomedical Laboratories, 6th Edition. FSAP’s Updated Inspection Checklists will be effective starting October 1, 2021.