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The Laboratory Biorisk Management Standard and its Applicability under the BWCBWC Meeting of Experts, Geneva
Dr Paul J Huntly and Dr Morten Bremer Mærli19 August 2008
Version Slide 226 August 2008
ObjectivesDescribe the need for and background to
the Laboratory Biorisk Management
Standard
Discuss how it can be used as a tool to
support the BWC
Propose practical measures whereby the
Standard can be used
Version Slide 326 August 2008
DNV BioriskWorld Health Organisation
European Commission
A*STAR, Singapore
Eijkman Institute, Jakarta
NIHRD, Jakarta
China CDC
Canadian Science Centre, Winnipeg
Institute for Animal Health (Pirbright, UK)
GlaxoSmithKline Biologicals
Swedish National Institute of Health
GE Healthcare, Sweden
Dutch Ministry of Health
Erasmus University Medical School, Rotterdam
Version Slide 426 August 2008
Biorisk management Biorisk encompasses biosafety
and biosecurity, where the hazards are biological agents and their products
Field much wider than laboratories and principles apply anywhere there is risk associated with biological agents
Vast majority of accidents / incidents in laboratory environments are caused by management failure – same as in all other industries
European Biosafety Society ● American Biological Safety Association ● Det Norske Veritas
International Biosafety and Biosecurity Laboratory Standard Development Initiative
Version Slide 626 August 2008
BackgroundKey stakeholders
- European Commission- American, European and Asia Pacific
Biosafety Associations- Standards organisations- WHO- Universities- Research Institutes- Funding agencies- Regulators
72 participants from 24 countries, including all continents
Consultation with over 2,000 organisations and individuals
Published in February 2008
Version Slide 726 August 2008
Why develop the Standard?Many reference documents available:
- Standards- Guidelines- Codes
Can be largely technical in nature and often prescriptive
Often national / regional in nature
Other major hazard industries already use a management systems approach
Accidents and incidents in this field point towards management failures as opposed to technical inadequacies
Version Slide 826 August 2008
Laboratory Biorisk Management StandardIs performance-orientated and risk-based
Consistent with other international standards such as ISO 9001 / 14001 and OSHAS18001
Integrates biosafety and biosecurity under common all hazards approach
Has direct relevance and potential for supporting compliance with BWC
Version Slide 926 August 2008
RationaleNeed to provide assurance to the international community that risk is being managed effectively and proportionately
Operator knows risk better than anyone and is in the best position to manage
Responsibility of operator to demonstrate risks identified and managed
Requires that there is a system in place to identify and manage risk on an ongoing basis
Documented, evidence-based, transparent process, using recognised methodologies, data and standards
Version Slide 1026 August 2008
ApplicationApplicable to all organizations handling biological agents and/or toxins, regardless of type, size and biological agents handled.
Does not employ biological agent risk classification or laboratory safety / containment levels, although such approaches can be entirely compatible with this standard.
If any part of the standard is in conflict with any national legal requirement or local regulatory standards, the conflicting part of the standard may be eligible for exemption.
Voluntary
Version Slide 1126 August 2008
RequirementsManagement is responsible and ensures risk is managed responsibly
Activities are proactively planned, conducted and reviewed
Risks are identified, assessed and managed in a structured way using recognised approaches and the controls are reasonable and proportionate to the risk
Appropriate standards and norms must be identified, used and complied with (e.g. laws, codes, BWC, WHO LBM3, WHO LBG)
Version Slide 1226 August 2008
RequirementsRoles, responsibilities and authorities are clearly defined and the people are competent
Combines controls related to engineering, instructions and people
Necessary links are in place between related and dependent activities – i.e. is there a systematic approach
Workers understand and follow the system to the required level
The system is ‘alive’ – it evolves and develops in a controlled and proactive manner
Version Slide 1326 August 2008
ContentContains definitions, requirements and notes for guidance
Structure based around modern management approach as with other ISO standards (e.g. ISO 9001, ISO 14000)
Based upon a number of interrelated elements
Objective to be used at a variety of levels and controls will mirror the threat / risk associated with the activity undertaken
The Laboratory Biorisk Management
Stanard and the BWC:
Version Slide 1526 August 2008
The Standard and the BWCTool for use by organisations, governments and other agencies
Allows independent assessment / certification of responsible biorisk management
Many issues of concern under BWC specifically addressed:
- Adherence to standards and legislative requirements
- Polices and management controls- Defining and approving projects- Selection and vetting of workers- Control of inventories- General security controls
Version Slide 1626 August 2008
The Standard and the BWCOpportunity to use as basis for:
- Basis for legislation and guidance- Framework for biorisk management
systems- Audits and inspections- Customised protocols and other
tools- Certification and accreditation
activities- Pre-requisite for funding- Promote international collaboration- Agent / activity specific measures - Training / awareness requirements
Supports capacity and capability building to respond in the event of a BW incident or naturally occurring outbreak
Conclusions:
Version Slide 1826 August 2008
ConclusionsThe Laboratory Biorisk Management Standard has been developed by the community for the community
Addresses biorisk holistically and is directly applicable to control measures for hazardous biological agents and toxins
Can be used a basis to demonstrate responsible management of biorisk
The Standard has been widely welcomed by the sector most closelyassociated with management of biosafety and biosecurity in laboratories
Activities are already ongoing to implement the requirements and use the Standard as the basis for assessments
The Laboratory Biorisk Management Standard is proposed as a strong tool to support BWC compliance
Version Slide 1926 August 2008
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