Laboratory Biorisk Management Standard CWA 15793:2008

The draft document for guidance on implementation of CWA 15793:2008 is now ready for public comments and input.

Both documents are directly accessible through the following link: http://www.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/Workshops/Pages/CWA15793-guide.aspx

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

The CWA 15793:2008 was well received and the concept and ideas of this performance based management system are being adopted by laboratories around the world. However, many laboratories are seeking advice and assistance in interpreting the standard. Thus, the next logical step is to develop a Guidance Document to CWA 15793:2008, a "user manual", designed to aid the end-users; laboratories and biosafety professionals. It was agreed to follow the CEN international consensus building process, to develop a CEN Workshop Agreement (CWA). EBSA, together with Asia-Pacific Biosafety Association (A-PBA) and the American Biosafety Association (ABSA) joined with support from the Global Partnership Program of Canada to take the process forward. The WHO has supported the implementation of the CWA 15793 and new tools are being developed to assess laboratories around the world according to the requirements of the standard.

Three plenary meetings have taken place during 2010, the last one on 6-7 December in Atlanta, GA, USA. The public consultation period of 60 days will start early February 2011. It will be announced to EBSA Members. If deemed necessary, following public comments, a 4th plenary meeting to approve the document is tentatively scheduled for late May 2011.

The business plan and registration information for CEN Workshop 55 can be found on the link: http://www.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/Workshops/Pages/CWA15793-guide.aspx

Laboratory Biorisk Management standard CWA 15793:2008

The Laboratory Biorisk Management standard was developed through a joint action between EBSA, the American Biosafety Association (ABSA) and Det Norske Veritas (DNV) with funding from the EC. The CEN Workshop process was used to develop a CEN Workshop Agreement (CWA). Seventy two participants from 24 countries ensured a truly international input.

The scope is to set requirements necessary to control risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.

The standard will enable organizations to:

a) establish and maintain a biorisk management system to control or minimize risk to acceptable levels in relation to employees, the community and others as well as the environment which could be directly or indirectly exposed to biological agents or toxins.
b) provide assurance that the requirements are in place and implemented effectively.
c) seek and achieve certification or verification of the biorisk management system by an independent third party.
d) provide a framework that can be used as the basis for training and raising awareness of laboratory
biosafety and laboratory biosecurity guidelines and best practices within the scientific community.

The standard is performance-based and sets out requirements for and places responsibility on organizations to demonstrate that appropriate and validated risk reduction procedures have been established and implemented. The standard is suited for certification of laboratories but there not yet a formal procedure for certification developed.

The Laboratory Biorisk Management standard CWA 15793 is freely available on the CEN web site: ftp://ftp.cenorm.be/PUBLIC/CWAs/wokrshop31/CWA15793.pdf

The free download of this CWA has been made possible through funding provided by the Government of Canada's Global Partnership Program.

Last update 22.02.2011 Webmaster

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