UPDATE – Current revisions of TRBA 110

The Technical Rule for Biological Agents (TRBA) 110, "Protective Measures for Activities with Biological Agents in the Biotechnological Production of Biopharmaceuticals, Diagnostics, and Vaccines," specifies the requirements of the Biological Agents Ordinance (BioStoffV), in particular Annex III, "Additional Protective Measures for Activities in Biotechnology." In addition to the manufacture of approved biopharmaceuticals, diagnostics, vaccines, and substances produced prior to approval, this also includes activities in diagnostics manufacturing involving infectious or potentially infectious human or animal material. It was published in February 2023 and extensively supplemented in November 2024 with Section 5, "Occupational Health Care ." The old version of TRBA 110 briefly referred to the requirements of the Ordinance on Occupational Health Care (ArbMedVV). The expanded Section 5 now specifies the requirements for occupational health care for activities involving biological agents in the above-mentioned production areas and, in addition to the ArbMedVV, specifies the conditions under which mandatory, optional, or voluntary health care must be carried out. For the initiation of mandatory and optional health care , an explicit distinction is made between activities involving biological agents and activities with other hazards resulting from protective measures against biological agents. Mandatory and optional health care for activities involving biological agents is initiated with reference to Annex Part 2, Paragraph 1 and Annex Part 2, Paragraph 2 of the ArbMedVV. Activities with other hazards include, in particular, wet work and the wearing of respiratory protective equipment. The specifications listed here for mandatory and optional health care also apply accordingly to genetic engineering work involving human pathogenic organisms. Within the scope of TRBA 110, voluntary health care can be carried out , for example, in the case of skin stress resulting from exclusive hand disinfection on previously damaged or less resilient skin. According to Section 14 of the German BioStoffV (Biomaterials Ordinance), employers must provide information about the option of opting for preventive measures during annual training and facilitate this if health damage cannot be ruled out . Important! TRBA 110 only describes requirements up to protection level 3. If the risk assessment reveals that more extensive measures are necessary (e.g., for biological agents in risk group 4), TRBA 100 applies in addition. The current version of TRBA 110 can be found here.