Complete revision of leaflet B 004 – Viruses published

Already in May 2024 we AGCT Genetic Engineering. Report reported on changes to the Technical Rules for Biological Agents (TRBA) 462 "Classification of viruses and TSE agents in risk groups". In August 2024, a complete revision of the Leaflet B 004 “Viruses – Classification of biological agents” as part of the DGUV Information "Safe Biotechnology" (DGUV Information 213-088; previous number BGI 631) by the "Raw Materials and Chemical Industry" department. The revised edition of Information Sheet B 004 from October 2011 has been comprehensively updated to reflect the latest scientific and regulatory developments.

The changes mainly affect the Classification of new and known viruses into risk groups, based on their pathogenicity and risk of spread. In addition, Protective measures for workers handling these substances and new safety guidelines for biotechnological work areas integrated. These adjustments take into account the progress of research and current epidemiological findings. The list for classifying viruses into risk groups published in Chapter 9 of Information Sheet B 004 is published in TRBA 462. What is the difference between TRBA 462 and Information Sheet B 004?

The TRBA 462 specifies the requirements of the Biological Agents Ordinance for the safe handling of biological agents, especially viruses, and is based on the content of Information Sheet B 004. It is primarily aimed at employers to ensure the necessary protective measures. By adhering to the TRBA, the employer can assume that the corresponding requirements of the binding regulation are met. Deviations from the TRBA are always possible if the risk assessment documents that the same level of safety can be achieved by other means.

The Leaflet B 004, however, serves as a basis and supplementary source of information and provides specific guidance on the classification and handling of viruses, particularly in the biotechnology sector. Unlike TRBA 462, it contains a detailed introduction to the topic as well as comprehensive information on the identification and classification of viruses, viruses as infectious agents, exposure possibilities and risk assessment, disinfection, transport and shipping, occupational health care, and immunoprophylaxis. In general, leaflets and DGUV information are not binding legal standards, but rather important evaluation criteria from which deviations can be made if the same level of safety can be achieved by other means.