Who is responsible for what?

Especially in larger genetic engineering facilities, the operator often uses several Project managers (PL). As a rule, the procedures described in Section 27 GenTSV Responsibilities of the individual PL for the genetic engineering work planned and supervised by them in the premises of the genetic engineering facility in the internal Operating instructions (BA). The BA should also contain specifications of the PL responsibilities, e.g., for conducting employee training, documenting the regular maintenance of safety-relevant equipment, and maintaining genetic engineering records.

The more complex the genetic engineering facility is, with its various projects in each PL, the higher the requirements for the regulatory compliance of the genetic engineering work there. Continuous and seamless communication between the different PLs plays a crucial role. If a PL is Coordinator If a coordinator is assigned to all areas of the genetic engineering facility, the other PLs are required to inform this coordinator in advance of any changes (e.g., regarding the scope of the facility or safety-relevant equipment) so that this information can be forwarded to the authorities via the operator. Irrespective of this, however, all PLs in a genetic engineering facility must be familiar with the official requirements (e.g., the ancillary provisions from the facility's notice) at all times.

If repeated problems arise in communication between the PLs or if recurring deficiencies in the internal organization of a genetic engineering facility become apparent, the operator is required to respond accordingly. To prevent such situations from occurring, the PLs should contact the responsible Biological Safety Officer (BBS) at an early stage to discuss the existing problems and develop possible solutions in consultation with the operator.