Move to establish lab biorisk management standards underway
An international delegation has unanimously approved a business plan to launch the International Laboratory Biorisk Management Standard Development Initiative.
The process, which is now underway, seeks to create a peer-designed management standard to complement current World Health Organization biosafety and biosecurity guidelines and enhance existing national regulatory requirements. It will address issues related to the management of people, facilities and working procedures.
The delegation, which launched the effort in Brussels, Belgium, early last month, was made up of more than 50 international firms. The group will meet again next month in Boston to build further support, organizers said.
"We expect a much larger participation in Boston from U.S. companies," Michael Weiss, of Atlanta, Georgia-based Working Buildings, said
The objective is a management standard which will:
- Improve laboratory performance through the adoption of recognized good practices
- Increase awareness and the adoption of management system approaches in the biosafety and biosecurity sector
- Provide organizations with a tool for internal audit and third-party certification of facilities and management systems
- Provide stakeholders with a benchmark in setting requirements for laboratory facilities
- Facilitate international exchange and collaboration
This standard is being developed using the European Committee for Standardization (CEN) Workshop Agreement process, an internationally recognized consensus-based approach. The drafting, contents and the final consensus for the standard are in the hands of participants who have opportunities to contribute at numerous points, both in person and through electronic submission. The Workshop process results in a Standard called a CEN Workshop Agreement (CWA) which is recognized internationally and included in the databases of the national standards bodies and distribution networks.
The first draft of the standard is currently being reviewed by registered workshop members. Once participants are registered, they will receive the draft and become part of the feedback and input process. Organizers are urging interested parties to register for access to the draft Standard and plan to attend the second working session on June 27-28 in Boston.
"Our goal is to have the document complete and submitted to the CEN by the end of October 2007," Weiss said.
More than forty individuals from seventeen countries are already registered for the process, representing government, industry and academia.
The Chair and Vice-Chair of this initiative, as agreed by delegates at the April 12 kickoff meeting, are Dr. Stefan Wagener (Public Health Agency of Canada) and Dr. Gary Burns (AstraZeneca PLC), respectively.
Initial coordination for this was provided by the European Biosafety Association (EBSA), the American Biological Safety Association (ABSA) and Det Norske Veritas (DNV), one of the world's foremost certification bodies. Throughout the initiative, DNV will provide project management and expertise on the standards development process. Netherlands Standardization Institute (NEN) is serving as secretariat for drafting the Standard and the European Committee for Standardization (CEN) is the administering body of the CEN Workshop Agreement process. The International Centre for Infectious Diseases (ICID) is assisting with communication and stakeholder management.
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