Requirements for risk assessment according to the BioStoffV

How should the hazards arising from working with biological substances in the laboratory be assessed? AGCT Genetic Engineering. Report from 31.01.2022 "Keeping Everything in View for the Risk Assessment?" provided an overview of the hazards that can play a role in the preparation of a risk assessment. In today's AGCT-Gentechnik.report, we would like to take a closer look at the preparation of a risk assessment for activities involving biological agents and identify possible sources of assistance.

According to Section 5 of the Occupational Safety and Health Act (ArbSchG), the employer must assess the risk to employees from activities involving biological agents before commencing work (Section 2, Section 4 of the BioStoffV). TRBA 400 also provides general guidance in this regard: First, the Identity , risk group classification and transmission routes of the biological agents must be determined (Section 4, Paragraph 3, Sentence 1 of the BioStoffV). For this purpose, TRBA 460 (fungi), 462 (viruses), 464 (parasites), 466 (bacteria, among others) and 468 (cell cultures) can be used. Also important is the The nature of the activity and the nature, duration, and frequency of employee exposure . Here, it must be clarified how long and at which workplaces the biological agent will be handled. This is followed by the so-called Substitution testing , which is intended to determine whether there are biological agents, work processes or work equipment that could pose no or at least a lower risk (Section 3, Paragraph 1 and Appendix 3 of TRGS 600). TRGS 600 contains a list of information sources for determining possible substitutions (Section 3, Paragraph 2 of TRGS 600). In addition, the employer must obtain activity-related information on stress and exposure situations (including psychological stress: assistance on this can be found in Section 6 of TRBA 400), on known illnesses and from preventative occupational health care. The company doctor can usually help with this. The risk of infection and the risk from sensitizing or toxic effects of the biological agents must always be assessed independently of one another. Information on corresponding properties can be found in TRBA/TRGS 406 and the TRBAs already mentioned here. Finally, an overall assessment is made on the basis of which the protective measures are to be determined.

For activities in laboratories, animal husbandry, and healthcare facilities, the employer must also determine whether targeted or non-targeted activities are being performed (4.3. TRBA 100) and then assign them to a protection level. The assignment is based on the risk group of the identified biological agent or the biological agent that is likely to occur. Activities that do not fall under this category do not need to be assigned to a Protection level be assigned.

All steps of the risk assessment just mentioned must be documented, regularly reviewed (at least every 2 years) and updated in the event of changes or new findings (Section 4 (2) of the BioStoffV).

The risk assessment must be carried out by the employer themselves in a professional manner. Alternatively, they must seek expert advice (Section 4 (1) of the BioStoffV). AGCT Consulting GmbH can provide employers with expert support in this regard.