KANBrief 1/09
In 2007, an international group of experts drew up a CEN document concerning biological risks in laboratories. This document, the CEN Workshop Agreement (CWA) 15793, “Laboratory Biorisk Management Standard" (pdf), is not uncontroversial, since it contains occupational safety and health requirements which are already regulated at European or national level. It is also questionable whether CWAs are in fact suitable for addressing safety and health issues.
The CWA „Laboratory Biorisk Management Standard“ is intended to enhance safety in biological laboratories and facilities. It is to provide its user with assistance in avoiding risks associated with the handling, storage and disposal of biological agents and toxins.
German OSH representatives, and also representatives from industry and higher education, had rejected this CWA, since it impacts upon the health and safety of workers at work as governed by Article 137 of the EC Treaty. It concerns the management of conventional safety issues in biological laboratories and facilities (biosafety). A second key aspect of the document is the management of “biosecurity“. This concept encompasses protection against loss, theft, misuse and the unauthorized release of biological agents or toxins, as is conceivable in the event of a terrorist attack. Biosafety and biosecurity differ in their objectives, but are nevertheless closely linked. The document does not include technical details, but is to be regarded as a guide. Comments explain aspects such as risk assessment and the role of a biological safety officer or consultant. Occupational safety and health, mandatory vaccination, the training of personnel, good microbiological practice, and personal protective equipment are also subjects addressed by the CWA.
These issues, which concern the health and safety of workers at work, are already the subject of binding provisions, for example in the European directive on the protection of workers from risks related to exposure to biological agents (2000/54/EC), or at national level, in the German Genetic Engineering Safety Regulations, the Genetic Engineering Act, or in supporting technical rules for biological agents. European standards governing the issue also already exist. CEN rules further state that CWAs are not intended for fundamental issues such as occupational safety and health aspects.
These diverse arguments were not sufficient to prevent publication of the CWA; the German objections did however result in its content being kept very general in nature.
Experts in Europe and elsewhere are now planning to add further substance to the CWA by issuing documents detailing certain aspects, such as the certification of laboratories with reference to the CWA. Here too, the OSH lobby has the task of preventing conflicts with binding provisions. The German Federal Ministry of Labour and Social Affairs (BMAS) has therefore convened a national group of experts under the umbrella of the ABAS committee for biological agents. This sub-committee, with the title “New Developments“, is to consider the German response to the CWA, and whether it would be possible to incorporate the CWA into the existing regulatory system.
The discussion of the role of CWAs in OSHrelated issues is however of fundamental importance. Originally, the function of CWAs was not that of standardizing safety aspects, but of providing a platform for rapidly changing subjectmatter, for example in the area of information technology. CWAs are developed within a relatively short space of time by CEN workshops. The workshop participants generally represent the stakeholders only to a limited degree, even though the workshops may in principle be open to all stakeholders. Involvement of the public through a two-month public inquiry is only optional. In addition, the workshop participants decide themselves when a document is ready for adoption. Competing CWAs are permitted; provisions may therefore be duplicated.
The necessary level of consensus between all stakeholders is substantially lower than that required for conventional standards. CWAs may, however, have a considerable impact in practice. KAN regards CWAs as an unsuitable instrument for the formulation of safety or health-related provisions. The stakeholders represented in KAN consider it necessary for the European rules governing the development of such documents to be amended accordingly.
Angela Janowitz
janowitz@kan.de