The WHO is revising the Laboratory Biosafety Manual to incorporate recent developments in biosafety practices and technologies over the past 13 years. The revision will feature a risk-based approach and emphasize good microbiological practices and procedures. It will include a core document along with additional monographs providing more detailed guidance on topics like risk assessment, laboratory design, and biosafety program management.

1. Dr Kazunobu KOJIMA
WHO Headquarters, Geneva
WHO Laboratory Biosafety Manual
Revision Update
Laboratory Design Monograph Working Group Meeting
Oxford, United Kingdom
07-08 February 2019

2. Presentation overview
• WHO Biosafety Manual
– Key concepts – “Evidence”
and risk-based approach
– Way forward

3. WHO Laboratory Biosafety Manual (LBM)
• First published in 1983 and
included:
– Risk Group: I, II, III and IV
– Laboratory Classification:
Basic, Containment and
Maximum Containment
“BSL” yet to be defined
• The current 3rd edition was
published in 2004
• 13 years have passed in
this fast-evolving field with
advancing technologies
• Therefore need for revision

4. Our audience varies…

5. Pragmatism?

6. Evidence- and risk-based approach
• Evidence-based biosafety
– Tjeerd G. Kimman, Eric Smit, and Miche`l R. Klein
– “Evidence-Based Biosafety: a Review of the Principles and
Effectiveness of Microbiological Containment Measures”
– CLINICAL MICROBIOLOGY REVIEWS, Vol. 21, No. 3 July 2008, p. 403–
425
• Risk-based approach
– OIE revision of Terrestrial Manual, 2015
– Ch. 1.1.4
• ‘Biosafety and biosecurity: standard for managing biological risk
in the veterinary laboratory and animal facilities’

7. Recent development…
• “Surveillance of laboratory exposures to human
pathogens and toxins: Canada 2016”
– A total of 100 people exposed with no reports of secondary
exposure
– Most incidents: RG2, BSL-2 (>90%)
– Area for improvement?
• SOP: 72%
• Equipment: 17%
• EU Directive 2000/54/EC - biological agents at work
– Annexes under revision
• e.g. classification, containment measures
https://www.canada.ca/en/public-health/services/reports-publications/canada-
communicable-disease-report-ccdr/monthly-issue/2017-43/ccdr-volume-43-11-
november-2-2017/surveillance-laboratory-exposures-human-pathogens-toxins-
canada-2016.html?wbdisable=true

8. Pathogen (Hazard) versus Process (Likelihood)
Laboratory Biosafety Manual Revision
Pathogen Process
[Likelihood + severity of harm]
+
Risk

9. “Risk Group = Biosafety Level” ??
??

10. Concept
Laboratory Biosafety Manual Revision
Risk group Biosafety level
(Hazard group)

11. Biosafety Level 3?
Laboratory Biosafety Manual Revision

12. 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.

13. Heightened Control Measures
Laboratory Biosafety Manual Revision
Control Measures to be increased with…
…increased risk

14. Maximum Containment
Laboratory Biosafety Manual Revision
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

15. 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 competent worker
• Human factors are generally the cause
of LAIs rather than malfunctions of
engineering controls

16. Risk assessment
Laboratory Biosafety Manual Revision

17. WHO Laboratory Biosafety Manual 4th
edition (LBM4)

18. Plan of Action
• To create a central core document with
• Additional monographs that go into detail on several key
aspects including
– Risk assessment,
– Laboratory design and maintenance,
– Biological safety cabinets and isolators,
– PPE,
– Decontamination and waste management,
– Biosafety programme management, and
– Emergency/outbreak response
• Publication of a position paper: Science 20 APRIL 2018 • VOL
360 ISSUE 6386, 260-262

19. Projected timeline
• Consultation 1: small group
– ongoing to be closed at the end of September
– collation of comments, review and modifications
• Editing
• LBM4 Editorial Committee review
• Formatting/illustration
• Consultation 2: broader and extensive stakeholders
– institutional, all sectors
– April to early June 2019
• Monograph production
• Further modifications
• Finalisation/editorial work
• Release  late 2019??

20. WHO “model regulations”
• Regulatory situation is heterogeneous among Member States
– Highly regulated countries with detailed legislation in the field of biosafety
and biosecurity
• well-defined responsibilities and processes
– Other countries that almost completely lack regulatory guidance as
legislation, standards and regulations
• Project
– Analysis of the biosafety and biosecurity legislative framework of different
WHO Member States
• Proposition for a harmonized international approach for assuring state-of-the art
legislation for biosafety and biosecurity in biomedical laboratories
• University of Applied Sciences Lübeck, Germany
– Pilot mission to Ethiopia, 23-26 July 2018
– Consultative meeting, Geneva, 26-28 September 2018

21. Acknowledgements
WHO Laboraatory Biosafety Manual 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
University of Applied Sciences Lübeck, Germany
Prof Folker Spitzenberger & Ms Arpitha Rao
Global Partnership Program (GPP), Global Affairs Canada
Biosecurity Engagement Program (BEP), U.S. Department of State
Fund raising efforts continue…