Summary of Changes to the Biosafety in Microbiological and Biomedical Laboratories 6th Edition (BMBL-6)

This Summary of Changes was prepared by the ABSA International Technical and Regulatory Review Committee (TRR). May 2021

This Summary of Changes is not to be used as a substitute for the CDC/NIH BMBL-6 edition.

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Table of Contents

I: Introduction

II: Biological Risk Assessment

III: Principles of Biosafety

IV: Laboratory Biosafety Criteria
   Biosafety Level 1 (BSL-1)
   Biosafety Level 2 (BSL-2)
   Biosafety Level 3 (BSL-3)
   Biosafety Level 4 (BSL-4)

V: Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities
   Animal Biosafety Level 1
   Animal Biosafety Level 2
   Animal Biosafety Level 3
   Animal Biosafety Level 4

VI: Principles of Laboratory Biosecurity

VII: Occupational Health Support for Biomedical Research

VIII-A: Bacterial Agents

VIII-B: Fungal Agents

VIII-C: Parasitic Agents

VIII-D: Rickettsial Agents

VIII-E: Viral Agents

VIII-F: Viral Agents Arboviruses and Related Zoonotic Viruses

VIII-G: Toxin Agents

VIII-H: Prion Agents

Appendix A: Primary Containment for Biohazards: Selection, Installation, and Use of Biological Safety Cabinets

Appendix B: Decontamination and Disinfection of Laboratory Surfaces and Items

Appendix C: Transportation of Infectious Substances

Appendix D: Biosafety and Biocontainment for Pathogens Affecting Agricultural Animals and Animals that are Loose-Housed or in Open Penning

Appendix E: Arthropod Containment Guidelines

Appendix F: Select Agents and Toxins

Appendix G: Integrated Pest Management

Appendix H: Working with Human, NHP, and Other Mammalian Cells and Tissues

Appendix I: Guidelines for Work with Toxins of Biological Origin

Appendix J: NIH Oversight of Research Involving Recombinant Biosafety Issues

Appendix K: Inactivation and Verification

Appendix L: Sustainability

Appendix M: Large-Scale Biosafety

Appendix N: Clinical laboratories

Section I – Introduction (pages 1-7)

The introduction provides inter-edition differences including those found in the Risk Assessment, Agent Summary Statements and Laboratory Biosecurity sections. One distinction that is clearly made in the Introduction is the idea that the BMBL 6th (BMBL-6) is not the only source of biosafety information. Stakeholders including the IBC, Biosafety Officers and others versed in biosafety concepts are included as participants when developing and performing a risk assessment.

Section II Biological Risk Assessment (pages 9-20)

All areas covered under Section II Biological Risk Assessment in both the BMBL-5 and BMBL-6 are similar. In BMBL-6, the risk assessment includes a more comprehensive detailed approach. The risk assessment is outlined in a six -step approach that provides structure to the risk management process and reinforces an ongoing positive culture of safety. This follows the PLAN, DO, CHECK, ACT principle. The role of the risk assessment is described as part of an ongoing risk management process and is both stressed and linked to the concept of fostering a positive safety culture. This section also emphasizes the need for the inclusion of a broad range of stakeholders and identifies an expanded list of stakeholders including institutional leadership and Biosafety Professionals.

Section III—Principles of Biosafety (pages 24-31)

Section III provides a brief introduction to biosafety. It also acts as a primer to Section IV. The BMBL-6 is very similar to the BMBL-5 in content and layout. Headings within this section include Facility Practices and Procedures, Safety Equipment (Primary Barriers), Personal Protective Equipment, Facility Design and Construction (Secondary Barriers), Biosafety Levels, Animal facilities, Clinical Laboratories and Laboratory Biosecurity. The Laboratory Biosecurity header replaces the Select Agent header from BMBL-5 though the content is rather similar with a few additions reflecting current requirements. Lastly, the header entitled, Importation and Interstate Shipment of Certain Biological Materials, from the BMBL-5 has been completely removed though the information in this header can be found in Appendix C. Increased emphasis is placed on the hierarchy of controls.

Section IV Laboratory Biosafety Criteria (pages 32-59)

Section IV introduces the laboratory biosafety level criteria. The essential elements begin with Biosafety Level 1 (BSL-1). From this base level, new criteria are added to describe and define Biosafety Level 2 (BSL-2), Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4). Criteria for differing biosafety levels account for the agent being used, special practices, primary barriers, personal protective equipment and facility features. The four levels are organized in ascending order by the degree of protection provided to personnel, the equipment and the community. Each successive biosafety level contains and builds upon the recommendations of the preceding level(s).

BSL-1 is suitable for activities utilizing well-characterized agents not known to consistently cause disease in immunocompetent adult humans and present minimal potential risk to laboratory personnel and the environment. Special practices involve standard microbiological practices, appropriate training and hazard communication, self-identification of any pre-existing conditions that may cause an individual to have an increased risk for infection, the laboratory having a safety manual, signage posted at laboratory doors when infectious materials are present, wearing and proper use of gloves, hand-washing, no eating drinking, smoking or applying cosmetics, sharps safety practices, decontamination of work surfaces and infectious materials before disposal, an integrated pest management plan and prohibiting any animals or plants not associated with the activities in laboratory spaces are additional criteria.

Notably, the BMBL-6 added the following Microbiological Standard Practices to work in BSL-1:

  1. having a biosafety manual specific to the facility,
  2. restraining long hair,
  3. added details for glove recommendations,
  4. decontamination and waste handling,
  5. the use of needle-safe devices when it is necessary to remove a needle from its source.

An occupational risk assessment has also been included to BSL-1 for exposure to allergens when there is animal work involved. Facility requirements now include adequate illumination.

BSL-2 is suitable for activities involving agents associated with human disease and pose moderate risk to personnel and the environment. Special practices include limiting access to laboratory spaces and integration of an occupational health program. In addition, all procedures that may generate an aerosol or splash are conducted in a biosafety cabinet (BSC). A validated process is recommended for decontamination of laboratory equipment. Lastly, it is recommended that consideration be given to respiratory protection during the risk assessment process.

BSL-3 activities involve work with indigenous or exotic agents that may cause serious or lethal disease through the inhalation route of exposure. Special practices include controlled access and that the removal of viable material from the laboratory is performed using primary and secondary containers. Viable materials are only opened in a biosafety cabinet at BSL-3 or higher. Procedures with infectious materials are conducted in a biosafety cabinet. Primary barriers and personal protective equipment include the use of a biosafety cabinet for all viable agents, solid front gowns, scrubs, or coveralls, two pairs of gloves when appropriate, protective eyewear and respiratory protection as needed. BSL-3 areas have physical separation from access corridors, access through two consecutive self-closing doors, and a hands-free sink near the exit. A ducted air ventilation system with negative airflow into the laboratory space and the availability of an autoclave, preferably in the lab space, are included in secondary barriers. Changes to the BMBL-6 include additional details to reporting occupational exposures and participation in a respiratory program (if there is need for respiratory protection), transfer of samples to lower containment, and verification of decontamination procedures. In addition, BMBL-6 includes clarification related to annual testing of facilities to ensure performance of the unit.

BSL-4 activities involve work with dangerous and exotic agents that pose high individual risk of aerosol-transmitted laboratory infections and life-threatening diseases that are frequently fatal, for which there are no vaccines or treatments, as well as related agents with unknown risk of transmission. Special practices include clothing change before entry, daily inspections of essential containment and life support systems and all waste being decontaminated prior to removal from the laboratory along with shower-out procedures. Special practices include the use of full-body, air-supplied, positive-pressure suits. Entry to these spaces is sequentially through airlocks with airtight doors. Walls, ceilings, floors are to form a sealed internal shell. Dedicated, non-recirculating ventilation systems are required, along with a double-door pass-through autoclave.