Lab Matters Winter 2021 | Page 27

PUBLIC HEALTH PREPAREDNESS AND RESPONSE

by Michael Marsico , MS , senior specialist , Biosafety and Biosecurity

The Biosafety in Microbiological and Biomedical Laboratories ( BMBL ) guide was published by both the National Institutes of Health ( NIH ) and the US Centers for Disease Control and Prevention ( CDC ) and provides guidance and best practices for safe handling of biological hazards in laboratory settings . Since its creation in 1984 , the BMBL has become the foundation for biosafety practices across the United States . In 2016 , a stakeholders workshop was held for revisions towards the BMBL 5th edition by NIH and CDC . APHL staff and members were in attendance and , through the Biosafety and Biosecurity Committee , provided multiple recommendations including :

• Inclusion of clinical and public health representatives on the BMBL steering committee and editorial board

• Inclusion of the need for rigorous risk assessments prior to assignment of biosafety levels ( BSL )

• Recommendations for working with unknown clinical samples

• Guidelines towards pathogen inactivation

• Inclusion of a new appendix for specific diagnostic and public health laboratories ’ biosafety and biosecurity needs and to indicate the differences , in terms of risk assessment , between public health , clinical and research laboratories .

In November 2020 , CDC announced the release of the Biosafety in Microbiological and Biomedical Laboratories 6th Edition . The new chapters , agent summary statements and appendices address several biosafetyrelated topics that have evolved since the previous edition .

Figure 1 : Relevant Changes in the BMBL 6 ^th Edition Contents

Section II — Biological Risk Assessment

Section IV — Laboratory Biosafety Level ( BSL ) Criteria

Section VI — Principles of Laboratory Biosecurity

Section VII — Occupational Health Support for Biomedical Laboratories

Section VIII — Agent Summary Statements

Appendix A — Primary Containment for Biohazards

Appendix B — Decontamination & Disinfection of Laboratory Surfaces and Items

Appendix K ( New )— Inactivation and Verification

Appendix N ( New )— Clinical Laboratories

Overall the 6th edition incorporates a more robust risk assessment-based approach compared to previous editions . Figure 1 identifies some of the other major changes .

APHL will continue to review the BMBL 6th Edition through the Biosafety and Biosecurity Committee , and plans to conduct a webinar describing major updates in the near future . n

Relevant Changes

• Included the need for institutional leadership to support a culture of safety by improving risk assessment and communication among staff

• Introduced a six-step cycle to assessing risks

• Removed most of the “ should ” and “ must ” language from recommendations

• Included a detailed description of requirements needed for a written Biosafety Manual for BSL1 and BSL2 labs .

Emphasized a systematic biorisk management approach , highlighting the International Standard Organization ( ISO ) 35001 , Biorisk Management for Laboratories and Other Related Organizations Stressed the need for a risk-based approach for providing occupational health support to laboratories Included additional resources including the Public Health Agency of Canada ’ s Pathogen Safety Data Sheets and American Biological Safety Associations International ’ s Risk Group Database for agent information Recommendations provided for institutions who choose to use ultraviolet light as a disinfection method in biological safety cabinets ( BSCs )

Revised the list of chemical disinfectants to distinguish the relationship between concentration and activity levels

Written in consultation with the CDC ’ s Division of Select Agents and Toxins , the new appendix provides risk-based guidance on validation and inactivation procedures for select agents

• New appendix that emphasized the use of risk assessments and hierarchy of controls to minimize the risk from clinical samples that may contain unknown pathogens .

• Identified “ trigger points ” in the clinical laboratory setting where high-risk activities or potential pathogens can be identified that prompt staff to continue to conduct work in a BSC .

Keep in mind the BMBL is a set of best practices that may or not fit the needs and / or activities of your institution . It is your

role to determine what best practices are appropriate for your institution . And please email biosafety @ aphl . org with any biosafety or biosecurity questions .