Laboratory Biorisk Management Standard

New CEN Workshop: Development of a Guidance to the Laboratory Biorisk Management Standard CWA 15793:2008 through CEN Workshop N55

Introduction

This project has developed following initial discussions with key stakeholders including representatives of the European and American Biological Safety Associations (EBSA and ABSA respectively), the Asia Pacific Biological Safety Association, the World Health Organisation (WHO) and Det Norske Veritas (DNV). Three workshops have now taken place to discuss the background and related issues (Oslo, February 2005; Barcelona, April 2005; Brussels, June 2005). During these workshops a number of presentations have been made with associated discussion regarding the certification process, what might be regarded as best practice and where the biosafety/biosecurity community is at present in terms of standardisation, certification and their development needs.
Underlying this initiative are needs to:

• Improve performance through the adoption of recognised good practice;
• Facilitate international exchange and collaboration;
• Promote training and learning;
• Increase awareness and adoption of management system approaches within the sector;
• Provide organisations with a means for internal audit and third party certification of their facilities and management systems as a demonstration to stakeholders including regulators, funding organisations and the community that there are adequate measures in place to responsibly manage risk associated with biosafety and biosecurity;
• Provide stakeholders with a standard to be used as a benchmark in setting requirements for facilities in the areas of biosafety and biosecurity.

The key stakeholders have come to the agreement to establish this new standard in the form of a CEN Workshop Agreement (CWA).

Workshop Objectives

The objective of this CEN Workshop is to develop and promote the adoption of recognised standards for management of biological risks. It is appreciated that this is a wide ranging field, however commonly shared biorisk principles and practices do apply. Specifically, the objectives proposed will allow laboratories to:

• Establish a biosafety and biosecurity management system to minimize risk to employees, the community and the environment that may be exposed to biological materials as a consequence of its activities;
• Implement, maintain and continually improve biosafety and biosecurity management;
• Assure themselves of conformance with their stated biosafety and biosecurity policy;
• Demonstrate such conformance to others;
• Make a self-determination and declaration of conformance;
• Seek internationally recognised third party certification of their biosafety and biosecurity management system. Initially the following boundaries have been put forward, although these may need to be adjusted by agreement of the Workshop participants:
• The standard will be based around the latest edition of the WHO Laboratory Biosafety Manual and Biosecurity Guidance, although any gaps identified or necessary updates may be addressed if required (e.g. in the light of new knowledge);
• The main focus will be on all biological agents/materials in a laboratory setting, although it is intended that the format and wording used will make the information relevant and of value to others working in related areas;
• The format and content of the standard will be designed to address management system issues in order to allow for a holistic approach encompassing people, facilities and working procedures;
• The issues addressed will relate to biosafety and biosecurity management systems;
• The document will not be prescriptive in nature but will be based upon the philosophy that the operator must understand and manage risk and there may be a number of ways in which adequate control measures can be applied. However, these must be in line with evidence-based procedures or recognised good practice or be demonstrably effective through the application of risk assessment;
• Associated guidance may be produced to support organisations in identifying how adequate measures can be identified and implemented.
• The proposed standard is not intended to replace any national or subnational regulatory requirements that may apply to the laboratory/facility.

Although more specialised areas such as facilities designed to handle larger animals and or plants will not be specifically addressed by the proposed project, it is anticipated that many of the principles will be widely applicable to such areas. It is also envisaged that should further, more specialised work be required, this will be considered as part of the project process and additional specific annexes or other measures may be considered during subsequent development stages.

How to get a copy of the standard
CWAs are listed in the national catalogues of all the CEN Members, but the detailed arrangements are up to the members. Prices can vary quite a lot.

Any comments on the standard and its use may be sent to the EBSA Administration office

Please find more information on the CWA N55 here...