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 V – Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities (pages 70-117)

Section V follows the basic organization and scope found in BMBL-5 Section I. The Introduction to Section V includes a paragraph which describes the training required in animal welfare, biosafety practices, PPE selection and the use of containment equipment. This section also identifies the responsibilities of the Biosafety Officer (BSO) and the Institutional Biosafety Committee (IBC) for protocol review and safety policies for the protection of personnel.

The introduction to the section covering ABSL-1 is essentially unchanged from the BMBL-5. The Standard Microbiological Practices is essentially unchanged from the BMBL-5. The material has been reorganized and edited to provide for better association between topics. Discussion of glove usage and handwashing was expanded by moving materials on these subjects from the Safety Equipment section in the BMBL-5. to this section. New guidance was added to this section identifying the risk associated with long hair and a requirement for proper restraint in the BSL-1 laboratory. The authors also added a note stating that additional PPE may be required for work with large animals.

The Standard Microbiological Practices section has been reorganized in keeping with the changes identified in the ABSL-1 section above, including the requirement for long hair being properly restrained while working in the ABSL-2 facilities. The Special Practices section was reorganized and edited slightly. This section includes new guidance requiring verification of decontamination practices. The Safety Equipment section describes the use of ventilated caging and, as was described for ABSL-1, the use of gloves and handwashing was removed from this section and placed in the discussion of standard microbiological practices above. The authors also add a note stating that additional PPE may be required for work with large animals. The Animal Facilities section now includes validation of any alternative process for carcass decontamination and disposal.

The Standard Microbiological Practices section has minor edits and reorganization. Notably, it includes guidance for the proper restraint of long hair while working in the ABSL-3 and details related to sharps policy and decontamination procedures for waste and equipment. Special Practices include added emphasis on decontamination of equipment, rooms, and waste. Details were added to the verification of decontamination processes on a routine basis. Two practices were deleted in the BMBL-6, first the collection of baseline serum samples and second, the use of eye protection if wearing contact lenses. Similar to ABSL-2, this section includes additional guidance that additional PPE may be required for persons working with large animals. Lastly, the Animal Facilities section now indicates that enhanced containment may be required for environmental or personnel protection based upon risk assessment as well as local, state, or federal regulations. Similar to ABSL-2, alternative processes for decontamination and disposal of carcasses must be validated.

The Standard Microbiological Practices section indicates that waste including carcasses, animal bedding and tissues must be decontaminated by verifiable and validated procedures before removal from the ABSL-4 facility.

Safety Equipment (Primary Barriers and Personal Protective Equipment). The Cabinet Facility section includes item #7 which states that for Class III BSCs directly connected via a double door pass through to an ABSL-4 suit facility, materials may be placed into and removed from the Class III BSC via the suit facility. Throughout this section where the BMBL-5 used the term “should” this has been replaced with “must” or “is”. The Suit Facility section contains clarification to address animal housing in open cages and large animals which cannot be housed in a primary containment system. These items are found on page 107 as Items 3 and 4 respectively.

In the Animal Facilities Cabinet Facility section, item 8.d. has added text to require all equipment and furnishing to be free of sharp edges and pinch points. Also, item 9, now includes adequate illumination for all activities as a safety requirement. Items 1-19 in the Suite Facility section are consistent with the content found in the BMBL-5 with minor edits; however, Items 23 and 24 contain new material dealing with animal housing in open caging. Item 23 describes the facilities design requirements for open caging in the ABSL-4 suit facility. Item 24 deals exclusively with loose-housed or open penned large animals and references Appendix D.

Table 3 Summary of Recommended Animal Biosafety Levels for Activities in which Experimentally or Naturally Infected Vertebrate Animals are used was not included in the BMBL-6

Section VI- Principles of Laboratory Biosecurity (pages 119-128)

Section VI describes biosecurity for microbiological and biomedical laboratories. Biosecurity has multiple definitions and applications depending on the industry and country. For the purposes of this section, laboratory biosecurity refers to measures designed to prevent loss, theft, or deliberate misuse of biological material, technology, or research-related information from laboratories or laboratory-associated facilities. The BMBL-6 refers to the ISO 350001-2019 when defining laboratory biosecurity.

The BMBL-6 added details to the term agricultural biosecurity encompassing broader measures to prevent contamination of food, health, and the environment. Included in this version are statements pertaining to personnel vetting, personnel reliability, violence prevention programs, laboratory biosecurity training, dual-use research oversight process, cybersecurity standards, material and facility control, and accountability standards. The BMBL-6 stresses the importance in balancing biosafety and biosecurity considerations when developing institutional policies or finding alternative solutions that blend the two.

Lastly, the Elements of a Laboratory Biosecurity Program remain essentially the same with a few exceptions: 1) The Personnel Management element includes clarification on personnel reliability and vetting/screening policies and 2) the objective of Information Security was expanded to include data integrity.

Section VII—Occupational Health Support for Biomedical Research (pages 130-141)

Section VII on Occupational Health (OH) has been revised with an explicit focus on a risk-based approach early and throughout the text. The section formally describes the need for, and the requisites of, an OH provider and OH program tailored to meet research needs. The title has been modified to include Occupational Health “Support for Biomedical Research” and removing “…and Immunoprophylaxis” broadening the description of Occupational Health appropriate to research.

The BMBL-6 Section VII introductory text is reduced to one paragraph which rapidly and clearly states the need for an appropriate Occupational Health Provider and biohazard-related Occupational Health Program that is risk-based with a focus that distinguishes it from, yet complements, the broader Occupational Health institutional program that serves all employees.

Text additions are quickly evident in the “Framework for Occupational Health Support of Biomedical Research” where five new subsections address the establishment, the conduct, and the compliance required of Occupational Health Programs. The varied approaches to meeting the Occupational Health need, the stakeholder collaboration, the frequent subject matter experts required, plus quality assurance are still included, previously in the introductory text, yet in a clearer presentation.

“Elements of an Occupational Health Program Supporting Biomedical Research” is a revision of the similarly titled portion in BMBL-5. Five new subsections are added to the previous for a total of eight topics. The risk of exposure (RoE) and risk of adverse health consequences or disease (RoD) are new concepts introduced in the subsection “Clinically-Oriented, Post-Exposure Risk Assessment”.

The elevated risks of handling RG3 and RG4 agents is woven throughout various portions of the text, such as under the OH program design, and is elaborated further in the expanded “Occupational Health support for High and Maximum Containment”, replacing the separate BSL-4 OH section in BMBL-5.