Responsibility for record-keeping in the genetic laboratory

Maintaining records of genetic engineering work and releases is one of the basic obligations under Section 6 (3) of the GenTG. However, the obligation to keep records is not one of the project manager's primary duties. It is not included in the scope of responsibility of Section 14 (1) of the GenTSV.
Section 3 (3) of the Genetic Engineering Records Ordinance only stipulates that the project manager must sign the records. If the project manager fails to do so, the violation is not subject to a fine, since the Genetic Engineering Records Ordinance only imposes fines on the operator's obligation to maintain, submit, retain, and hand over records to the authorities.
According to Section 4 (2) of the Genetic Engineering Records Ordinance (GenTAufzV), the operator can appoint the project manager to maintain the records. This requires an effective delegation of the duty in the employment contract or via a job description. If the duty has been effectively delegated, the project manager must maintain the records, i.e., create them, maintain them, complete them, and have them signed in accordance with the requirements of the Genetic Engineering Records Ordinance. In this case, too, failure to maintain records is not subject to fines for the project manager, as the administrative offense is expressly limited to the operator (Section 5 (1) of the Genetic Engineering Records Ordinance).

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