Requirements for training employees of external companies in cleaning, maintenance and repair in genetic engineering facilities

Persons who perform work in the premises of genetic engineering facilities, and thus come into contact with genetically modified organisms (GMOs), must receive written, documented training (Section 17 of the GenTSV). This also applies to persons who only enter the premises for repair, maintenance, or cleaning work. The requirements for informing them about the dangers, such as the spread of GMOs from the genetic engineering facility, are set out in Section 18 of the GenTSV. However, the relevant section of the GenTSV only applies to genetic engineering facilities at containment level 2 and above. In principle, Section 18 of the GenTSV describes the following procedure if an external company is required to carry out cleaning, maintenance, or repair work in such premises:

If a company is to enter the room, a written "clearance" of biological contamination in the room and on the equipment must first be submitted (Section 18, Paragraph 3 of the GenTSV). The employees of the companies concerned are then given "workplace-specific" training by the project manager or a person delegated this task (Section 18, Paragraph 2 of the GenTSV). For this purpose, appropriate operating instructions for such work in biological safety areas should have been drawn up. Although such operating instructions are not explicitly required by the GenTSV, they make sense, especially if the training is carried out by people outside of the project management, such as people from internal technical departments. Employees of external companies may only enter the room after the clearance and training have been completed and documented.