How should environmental samples be handled in accordance with the Biological Agents Ordinance? – Part 2

In the AGCT-Gentechnik.report of 31 October 2023 "How should environmental samples be handled in accordance with the BioStoffV? – Part 1" The focus was on activities involving environmental samples that usually fall under protection level 1. This newsletter focuses on when activities involving environmental samples fall under protection level 2.

As soon as environmental samples Suspicions of special burdens of environmental habitats through human pathogenic biological agents present, the risk assessment must determine whether activities can be carried out under the conditions of Protection level 2 must be carried out in accordance with section 5.3 of TRBA 100 (4.4.2, paragraph 1, sentence 3 of TRBA 100). These protective measures then serve to prevent employees' exposure to biological agents that can cause an infectious disease.

Activities with enriched microbial fractions must also be carried out under protection level 2 if a Concentration of biological substances RG2 can be assumed (4.4.2 para. 1 TRBA 100). Wastewater and sewage sludge always contain varying amounts of human-pathogenic biological agents (Appendix 2 TRBA 220). Although isolated activities can still be carried out under protection level 1, regular and more extensive activities but only under Protection level 2 (4.4.2 para. 2 TRBA 100). Samples from waste and compost usually contain biological substances of RG 1 and 2. These include, in particular, bacteria, molds, and viruses (3.3 para. 1 TRBA 214). Can this be detected during the investigation? Enrichment of infectious biological agents activities are carried out under conditions of Protection level 2 to be carried out (4.4.2 paragraph 3 TRBA 100).

The use of the TRGS and TRBA mentioned in parts 1 and 2 of the newsletter for classifying environmental samples and a structured approach to preparing the risk assessment can be helpful in determining whether the samples should be assigned to protection level 1 or 2. For the assignment of environmental samples to protection level 2, the main questions are whether there is particular contamination from human-pathogenic biological agents, whether these agents accumulate during the work, and whether the activities are regular and extensive.