development of an iso laboratory biorisk management standard

Development of an ISO Laboratory Biorisk Management Standard

- can ISO/AWI 35001 help in supporting the BTWC?

Gary Burns PhD CMIOSH Convenor ISO TC 212 WG5

Current CEN Workshop Agreements (CWAs) on Biorisk Management

• CWAs are documents agreed by participating individual experts • Developed by the user community for the user community • Contributors international, not limited to Europe • Published by CEN, does not have status of a Standard • Has limited lifespan (usually 3 years) • CWA15793 was published in 2008, revised 2011. due to lapse

2014: needs to be replaced by a Standard • CWA16393 published in 2012 – Guidelines for implementing

CWA15793

CWA15793/16393

• Addresses both biosafety and biosecurity – “Biorisk” • Compatible with management system standards,

such as ISO 9001 / 14001 and OSHAS 18001 • Performance-orientated and risk-based • Contains definitions, requirements and guidance • Broad scope - controls to mirror the threat / risk

associated with the activity undertaken

Key Stakeholders & Beneficiaries • Stakeholders

– Primary • Research Institutes • Clinical Laboratories • Biotech/Pharma Industries • Universities

– Secondary • European Commission • American, European and Asia Pacific Biosafety Associations • Standards organisations • WHO • Funding agencies • Regulators

• Beneficiaries – General public and the environment

Utility in International Applications - some examples of use by WHO

“In agreement with CDC and VECTOR the inspection protocol used in 2009 was used again for the inspections of 2012. The protocol is based on the publication of the international Laboratory Biorisk Management Standard, which is a consensus Workshop Agreement registered with the European Committee for Standardization (CEN) CWA 15793 (2008).”

“….The Standard is based on CWA15793, Laboratory Biorisk Management (2), the principles of the WHO Laboratory Biosafety Manual (3rd Edition, 2004) and the extensive poliovirus scientific literature spanning nearly 7 decades (10). The Standard serves as the framework for national certification and WHO verification ….”

Annex 2 Biorisk management standard for essential poliovirus facilities holding wild poliovirus …….

Other Uses…

Why is an ISO Standard being developed?

• CWA 15793 was due to expire in 2014 • ISO consensus process has worldwide recognition

and credibility • International standard would ensure continuity

and preserve CWA principles

Why ISO TC 212? • Best fit, supported by

– CWA15793 stakeholders – ISO Central Secretariat

• Applicable to Healthcare Laboratories • Applicable to IVD development & facilities • ISO 15190 needs updating – CWA 15793 content

would be helpful • Increase in expert & stakeholder contributions

ISO/AWI 35001 Biorisk Management • A New Work Item Proposal was drafted in 2014 • Voting closed in September – the NWIP was approved

by a 17-2 margin with 19 members abstaining. New project ISO/NP 35001 registered in the work programme of ISO/TC 212

• Liaisons established and experts nominated to new working group (WG5) including members of TC 34 (Food Products) and TC 276 (Biotechnology).

• Inaugural meeting held in London 13-14 January – Reviewed draft Design Specification – Drafting team appointed

• Timeline for Draft International Standard late 2016

Who’s who at a WG meeting

Presenter

Presentation Notes

Convenor: convene and lead meetings effectively with a view to reaching �consensus and ensure that all positions and views given equal �treatment , remaining impartial in debates manage projects according to agreed target dates according to�project plan from preparation to completion should be fully knowledgeable on subject and on market needs propose decisions to progress or to stop work on the basis of its �market or global relevance have basic knowledge of ISO and its procedures Project leaders appointed by the technical committee or subcommittee �(nomination made by the originator of the new work item proposal) should have access to appropriate resources for carrying out the �development work. act in a purely international capacity, divesting him- or herself of a national point of view. Experts: appointed by: ISO P-member body (NWIP) liaison organizations (category A or D) other ISO or IEC committees in liaison normally assigned to a working group associated with a project �(under either a TC or SC) act in a personal capacity and expected to input know-how

How to get involved

• Through your national standards body or liaison organizations

Many regional and international biosafety organizations have already been accepted as liaisons to the ISO WG and have appointed experts to participate in developing the standard.

A role in supporting the BTWC?

Article 4 Final declaration: “13. The Conference notes the value of national implementation measures, as appropriate, in accordance with the constitutional process of each State Party, to: (a) implement voluntary management standards on biosafety and biosecurity; …”

• ISO Standards are internationally recognised and widely adopted by industry • In the absence of a formal verification protocol could an ISO Biorisk Management Standard have a role in confidence building? (see also Gary Burns and Toon De Kesel “Can Biorisk Management Standards Contribute to Non-Proliferation of Biological Weapons” in “Setting A Standard For Stakeholdership – Industry Contribution to a Strengthened Biological and Toxin Weapons Convention” Egmont Series December 2011 Edited by Jean Pascal Zanders)

Concluding thoughts..

development of an iso laboratory biorisk management standard

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