The basic duties – theory and practice

The fundamental obligations of Section 6 GenTG include the obligation to conduct a risk assessment (Section 6 (1) GenTG) and the obligation to maintain records (Section 6 (3) GenTG). These obligations have been specifically defined by the legislature. They apply to the operation of a genetic engineering facility as well as to its release and placing on the market. The question is who these obligations are directed at. With regard to the obligation to conduct a risk assessment, this can be indirectly inferred from the fact that the obligation is directed at the person who constructs or operates a genetic engineering facility. This is usually the operator. In this respect, the obligation to maintain records is somewhat more precisely regulated, stating that the operator must keep records of the conduct of genetic engineering work (Section 6 (1) GenTG). Accordingly, the obligation to maintain records generally lies with the operator. This is further supported by the provision of Section 4 (2) GenTAufzV, according to which the operator can commission the project manager to maintain the records. The fact that the risk assessment and record-keeping obligations are therefore exclusively directed at the operator is often not recognized by the operator. To avoid any misunderstandings, the operator does not necessarily have to fulfill all basic obligations himself. However, effective delegation of his tasks is required. Not every operator obligation can be simply transferred to the project manager, and possibly even unilaterally and without their knowledge. The principles of delegation must be observed if delegation is to be effective.

This publication can also be found on the website of the law firm Dr. Kauch .