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Dr Kazunobu KOJIMA
World Health Organization (WHO)
WHO Laboratory Biosafety Manual (LBM) Revision Update
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Presentation overview
• Background
• Key concepts
• Aiming to achieve
• Risk (hazard) groups
• Biosafety levels
• Core Requirements, Heightened Control Measures, High Containment
• Way forward
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WHO Laboratory Biosafety Manual (LBM)
• LBM has served the global biosafety community for more than 30
years with practical guidance on biosafety
• WHO Manual (1st edition, 1983)
– Risk Group: I, II, III and IV
– “Laboratory Classification”: Basic, Containment and Maximum
Containment • “BSL” yet to be defined
• Technology
– Common diagnostic methods
– e.g. virus isolation, electron microscope
PCR PCR first demonstrated in 1983
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LBM Evolution
• BSL 1-4
• Rapidly advancing technology
• The current 3rd edition has been translated into >10 UN official and other languages and WHO continues to receive requests for translation into other languages
• Published in 2004, 13 years have passed in this fast-evolving field
• http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004
_11/en/
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WHO Extended Biosafety Advisory Group (BAG) Meetings,
Geneva, 24-25 November 2014, and 13-15 December 2016
• Key Recommendation 2014
– Revision to the WHO Biosafety
Manual is both a necessary and a
priority
• Key Recommendation 2016
– General agreement for the
proposed modifications to the
manual, the revision of which
remains a priority
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Our audience varies…
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Pragmatism?
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Issues in space and work flow
Laboratory Biosafety Manual Revision
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Issues in space and work flow
Laboratory Biosafety Manual Revision
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Pathogen (Hazard) versus Process (Likelihood)
Laboratory Biosafety Manual Revision
Pathogen Process
[Likelihood + severity of harm]
+ Risk
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“Risk Group = Biosafety Level” ??
??
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Biosafety Level 3?
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Facility
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• Sustainability:
– Funding for construction vs. operational costs
– Staff
– Scientific programme
• Technical challenges
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Good Microbiological Practices and Procedures (GMPP)
• Emphasis on risk assessment and training rather than engineering controls in GMPP
• The best designed and most engineered laboratory is only as good as its least trained worker
• Human factors are generally the cause of LAIs rather than malfunctions of engineering controls
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Proposed Way Forward
Laboratory Biosafety Manual Revision
• Ensure a practical, risk- and evidence-based approach to biosafety
• Flexibility • Uphold good microbiological practices/procedures • Encourage sustainable facilities
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How?
Laboratory Biosafety Manual Revision
• Refocusing on good microbiological practices and procedure
• Emphasising the importance of competence and on-going on-the-job training
• Highlighting what risk assessment is and how it should be performed
• To remove Risk Groups and Biosafety Levels at the global level to allow appropriate and practical measures are in place to mitigate the risk(s) identified
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Concept
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Risk (Hazard) groups Biosafety level
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Factors affecting consequence
Laboratory Biosafety Manual Revision
High severity or mortality plus: • Low infectious dose
• High communicability
• Airborne route of transmission
• No preventive or therapeutic treatment available
• History of laboratory-acquired infection
• Exotic epidemiology (non-endemic)
• Highly susceptible population (e.g. immunocompromised, naïve)
• Increasing virulence
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Procedures with high likelihood of exposure
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• Producing and using large volumes and high titres
• Procedures that might have the potential to generate aerosols e.g. sonication, or deliberate generation of aerosols
• Infecting animals
• Using sharps
• Necropsy where infection is suspected
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Procedures with low likelihood of exposure
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• Use of agar plates (e.g. streaking, spreading)
• Serial dilution
• Preparing/staining slides
• Nucleic acid extraction
• Inactivation
• Use of autoanalysers
• ELISA
• PCR
• Rapid diagnostic tests
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Risk assessment
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Likelihood of exposure
Co
nseq
uen
ce of exp
osu
re or release
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Core Requirements
Laboratory Biosafety Manual Revision
• “Core requirements” refers to a combination of elements to be implemented and used as a minimum requirement for safe working during the majority of laboratory procedures.
– codes of conduct
– competent and appropriately trained staff
– the laboratory facility/equipment
– good microbiological practices and procedures.
• Core requirements will be fundamental to safe working practices of any facility.
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Heightened Control Measures
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Control Measures to be increased with…
…increased risk
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Heightened Control Measures:
Examples
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Pathogen Process Routes of exposure
Example controls
Mycobacterium tuberculosis
Diagnostic via PCR
- Aerosol - Splash - Contact
- Gloves, (RPE) - Work within a BSC prior to inactivation
using validated methods - BSC work surface disinfection post use
Brucellosis Culture - Splash - Aerosol
- Double gloves, facial protection, RPE - Work within a BSC - Work surface disinfection on test
completion
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Maximum Containment
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Highest control
Example of when maximum containment might be required:
• Eradicated diseases such as smallpox
• Procedures with high likelihood of exposure and impact of release to the environment: – Unknown agents of potential high consequence
– Known pathogens of high consequence
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Plan of Action
• To create a central core document with
• Additional monographs that go into detail on several key aspects including – Risk assessment,
– Biosafety programme management,
– Laboratory design and maintenance,
– Biological safety cabinets and isolators,
– PPE,
– Decontamination and waste management, and
– Emergency/outbreak response
• Publication of a position paper prior to release of the LBM to outline the rationale for the changes
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Acknowledgements
Editorial Committee: Marianne Heisz, Public Health Agency, Canada
Allan Bennett, Public Health England, UK
Stuart Blacksell, Mahidol-Oxford Tropical Medicine Research Unit, Thailand
Michelle McKinney, National Institute of Health, USA
Kathrin Summermatter, Institute of Virology and Immunology, Switzerland
Catherine Makison Booth, Health & Safety Laboratory, UK
Global Partnership Program (GPP), Global Affairs Canada
Biosecurity Engagement Program (BEP), U.S. Department of State