BiostoffV: R3 organisms found by chance in environmental samples… what now?

They must then be autoclaved in a protection level 3 laboratory, which laboratories that examine environmental samples generally do not have. The reasoning is that autoclaving constitutes an activity with biological agents (biomaterials), which requires a protection level 3 laboratory. This argument is based on the Genetic Engineering Act (GenTG), which extends the definition of genetic engineering work to destruction and disposal (Section 3 No. 2 b) GenTG). It is also argued that autoclaving is in any case a targeted activity within the meaning of Section 2 Paragraph 8 BioStoffV, which, according to this logic, must take place in a protection level 3 laboratory. However, the argument from the GenTG cannot be transferred to the BioStoffV under any aspect. Firstly, the definition of activity with biological agents does not include their destruction and disposal under the BioStoffV, unlike the GenTG.

Secondly, Section 5 (1) of the Ordinance on Biological Substances (BioStoffV) assumes that a targeted activity only occurs if the activity is directly directed at one or more biological agents. This means that the biological agent(s) must be used, for example, to examine certain properties more closely (antibiogram, etc.), to obtain products during cultivation (vinegar production, beer production, etc.), or to extract certain substances (e.g., enzymes) from them. This follows from the "Guidelines for Activities with Biological Agents" of the State Committee for Occupational Health and Safety/LASI for targeted activities. The transport and destruction of biological agents are also not listed there. Accordingly, there is no indication in the Ordinance that the destruction of biological agents is a targeted activity. Therefore, it does not fall under the higher protection level.

Consequently, samples containing R3 organisms found during non-targeted environmental sampling can be properly transported in shatter-proof containers and destroyed in the autoclave of the Level 2 laboratory. A Level 3 laboratory is not required for this purpose.