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

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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

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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

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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

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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

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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

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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

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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

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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

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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)

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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

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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:

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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

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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:

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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

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