Risk assessment of microorganisms

The Biological Agents Ordinance (BioStoffV) sets the legal framework for activities involving biological substances and classifies microorganisms into four risk groups (R1-R4) depending on their hazard potential for humans. The "Technical Rule for Biological Agents (TRBA) 466: Classification of Prokaryotes (Bacteria and Archaea) into Risk Groups" lists, for example, a large number of prokaryotes and their respective Risk group (RG) specified.

The Central Commission for Biological Safety (ZKBS) publishes a comparable list, listing risk-assessed donor and recipient organisms for genetic engineering work according to Section 5, Paragraph 1 of the GenTSV in conjunction with the criteria in Annex 1 of the GenTSV. In addition to human pathogenicity, a possible hazard to other Legal interests such as plants, animals and biological systems through these organisms.

Between TRBA 466 and the ZKBS list In individual cases there are differences regarding risk group allocation (e.g. Yersinia rhodei ; TRBA 466: RG1, ZKBS list: RG2 or Leuconostoc mesenteroides ssp. mesenteroides ; TRBA 466: RG2, ZKBS list: RG1). These differences must be taken into account for the Risk assessment according to BiostoffV and the risk assessment or Security rating according to the GenTSV for the legally compliant and safe conduct of (genetic engineering) work with the corresponding organisms.