Who is considered a competent person when preparing a risk assessment?

Employer must assess the risk to employees from activities involving biological agents before commencing these activities (Section 4 (1) Biological Agents in conjunction with Section 5 of the Occupational Safety and Health Act). If the employer does not have the relevant knowledge, he must to get expert advice (Section 4 (1) of the BioStoffV). Activities involving biological substances in laboratories, animal husbandry, biotechnology and health care facilities must be subject to Protection level (1-4) (§ 5 BioStoffV) and for the implementation of the Risk assessment (GB) requires specialist knowledge (2.1 paragraph 1 TRBA 200). But who has the specialist knowledge to create a GB with a protection level assignment (here, protection level 1) according to the BioStoffV, and what specialist knowledge requirements are there for this?

Expert is someone who is qualified to perform the respective task specified in the regulation (Section 2, Paragraph 11 of the BioStoffV). This always depends on the type of task and the level of risk. For activities of Protection level 1 must be a suitable Vocational training and Professional experience be proven, e.g., by completing a degree program in life or natural sciences (at least Bachelor's degree), human, veterinary or dental medicine, or an engineering degree with bioscientific components. Alternatively, e.g., by completing training as a biological technical assistant (BTA), as a medical technical assistant (MTA), or as an animal caretaker specializing in research and clinical practice. In addition, a at least two years of experience in the laboratory, animal husbandry or biotechnology (4.2.1 para. 2 TRBA 200).

For Competence in occupational safety are knowledge of the relevant biological agents and their properties, the protective measures when these biological agents occur, the workplaces/activities, the relevant legal bases (ArbSchG, BioStoffV, TRBA, ArbMedVV, GenTG and GenTSV), the Ability to evaluate of activity processes and exposure situations, the identification and definition of protective measures, the definition of preventive measures under occupational health and safety law, as well as the identification and definition of suitable measures for inactivation, sterilization, disinfection and waste disposal. Occupational safety specialist and e.g. a (Company) doctor , but under certain circumstances also the Employer itself, in addition other persons , such as Biological Safety Officers (BBS) who have acquired the necessary occupational safety knowledge as part of their studies, training or further training (4.2.1 paragraph 3 TRBA 200).

To expand the expertise, AGCT Consulting GmbH offers the “AGCT specialist courses according to BioStoffV” In addition, a professional risk assessment (protection levels 1-2) can be carried out.