Summary of Changes to the World Health Organization Laboratory Biosafety Manual 4th Edition
This Summary of Changes was prepared by the ABSA International Technical and Regulatory Review Committee (TRR) in collaboration with the International Relations Committee. April 2022
This Summary of Changes is not to be used as a substitute for the WHO Laboratory Biosafety Manual 4th Edition.
Table of Contents
Monographs
–Risk assessment
–Laboratory design and maintenance
–Biological safety cabinets and other primary containment devices
–Personal protective equipment
–Decontamination and waste management
–Biosafety Programme Management
–Outbreak preparedness and resilience
Section 6 Transfer and transportation (pages 65-76)
Versions v. 3 and v.4 of the WHO LSM cover the packaging, labeling, transfer and transport of infectious material and potential infectious material. The goal is to ensure safe and secure transfer/transport of potentially infectious biological materials without exposing the shipper, handler and the receiver (and/or any other public who comes across the way of transport).
Version 4 of the WHO LSM details the transport type, such as, 1) Transfer within the laboratory, 2) Transfer within a building, 3) Transfer between buildings on the same site, 4) Off-site transport of infectious substances. The other major change noted in version 4is the detailed classification of infectious substances (with UN numbers) and the summary of categorization, documentation, packaging and labelling of infectious substances for transport.
Version 4 also describes the triple packaging system in much more details; the figure of the triple packaging system is detailed and describes in P65 the system for carrying biological substances clearly.
Section 7 Biosafety programme management p. 77-82
This section describes the roles and responsibilities of nations, along with individual research organizations and institutions for an effective management of biological risks by applying nation-wide regulatory networks. The management system for an appropriate bio-risk management consists of, a) commitment and support from upper/senior management to address and manage the risk, b)proper risk identification and containment planning, c) control measures and procedure implementation and monitoring, d) framework for appropriate training of personnel, e) clear distinction of roles and responsibilities, and f) ensuring adherence to the national and international guidelines and regulations.
The section iterates the importance of having a biosafety program; either as a part of an overarching safety program or a standalone. The different components of the program consist, a)Biosafety culture, b) Biosafety policy, c) Assigned roles and responsibilities of senior management, a biosafety committee, the biosafety officer, lab personnel and support personnel, d) Biosafety manual, e) Biosafety and biosecurity risk assessment f) Supporting programs and plans, g) Reports and reviews (including incident reports/audits and inspections/and other reports).
The major change in this version (v.4 vs. v.3) is the organization of this section. In the previous version of the manual, the role of biosafety officer and the biosafety committee was covered as a unit under the part ‘Safety organization and training’. The rest of the details (mentioned in above paragraphs) was not a part of (the v.3 of the WHO) manual.
Section 8 Laboratory biosecurity (pages 83-90)
The WHO LSM 3th Edition defined biosecurity as institutional and personal security measures designed to prevent the loss, theft, misuse, diversion or intentional release of pathogens and toxins. The WHO LSM 4th Edition defines now biosecurity as institutional and personnel security measures designed to prevent the loss, theft, misuse, diversion or intentional release of biological agents being handled in the laboratory, leaving toxins out of the definition.
8.1 Biosecurity Risk Management
The WHO LSM 4th Edition provides definitions for each step of the biosecurity risk assessment following the same steps for conducting risk assessment provided in Section 2.
8.2 Inventory Control
This section provides information on how to maintain an inventory of at-risk biological agents.
8.3 Information Control
This section provides the definition of “Confidential” and provides rationale for establishing procedures to protect data.
8.4 Personnel Control
This section provides information for establishing personnel management programs, and elements to be included in biosecurity training courses.
8.5 Physical Security Control
This section provides the elements to be included in an effective physical security system.
8.6 Transport Control
This section provides the elements to consider when transferring biological agents domestically or internationally.
8.7 Emergency/Incident Response
This section outlines what should be included in the incident response plan, and the importance of conducting drills and exercises as part of preparation and planning.
8.8 Emerging Biological Risks
This section outlines additional risks that should be considered when drafting a biosecurity plan to ensure the responsible conduct of research.
Section 9 National/international biosafety oversight (pages 91- 94)
This short section is important in that it recognizes Biosafety and Biosecurity as a needed control for the global protection of human health. There is also a recognition of the need for cooperation on both a national and international level.
Some highlights of this section include an understanding that national regulations should strive for a balance between ensuring risk mitigation and allowing flexibility to operate sustainably and to continue effective research and development.
The WHO LBM expresses that national level risk assessments be performed before national regulations are created. This assessment should include the size and resources of the scientific enterprise and the potential impact a release may have on agriculture, human health and the ecosystem. Successful development of national regulations should include all stakeholders.
Importantly, regulations should not be considered static as research and development are dynamic processes. Regulations should be revisited on a regular basis.
