Since the end of 2020, the WHO Laboratory Biosafety Manual has been available as a new version. On the one hand, it is aimed at state actors and serves as a guideline for the implementation and revision of regulatory requirements. On the other hand, it is aimed at non-governmental organizations that operate biosafety laboratories in countries that do not have sufficient legislation and standards of their own on the subject of biosafety.
The most important innovation lies in the risk-based approach, in which the data on laboratory accidents and technical and organizational biosafety measures are central. It is about finding good solutions for concrete problems and situations. These conditions include all factors that can influence the success of the measures, such as the availability of financial resources, competencies of the personnel, technical requirements and the supply of spare parts.
In this context, the classification of pathogens into hazard groups and laboratories into safety levels has been abandoned. This is replaced by a full-blown risk assessment, in which all specific circumstances relevant to biosafety are taken into account.
Of course, the previous national regulations, especially in Germany and Europe, will continue to exist unchanged. How the suggestions from the new WHO Laboratory Biosafety Manual can also be incorporated into the planning and operation of biosafety laboratories in Germany, Europa and other countries with developed biosafety regulations will become more apparent in the coming years.