Responsibility of the project manager and the biosafety officer

The legislature has regulated the responsibilities of the project manager and the biological safety officer differently in the Genetic Engineering Act and the Genetic Engineering Safety Ordinance. The project manager is a person who, as part of their professional duties, directly plans, manages, or supervises genetic engineering work or a release (Section 3 No. 8 GenTG). They are responsible for ensuring compliance with regulations under other specialist laws and that work or releases do not begin until the notification or registration period has expired or a legalizing decision has become final (Section 17 Para. 1 Nos. 1 and 2 GenTSV). They are also responsible for the implementation of official requirements and orders, ensuring adequate qualification and training of employees, preventive occupational health examinations, emergency plans, and reporting of hazards. They are responsible for ensuring that a qualified person is regularly present and generally available during releases (Section 17 Para. 1 Nos. 3 to 9 GenTSV). Failure to comply with these obligations will result in both fines and criminal offenses.
In contrast, it is the responsibility of the Biological Safety Officer to monitor the project manager's fulfillment of his or her duties, to advise the operator (Section 3 No. 9 GenTG), and to prepare an annual report for the operator (Section 17 GenTSV). Due to the different responsibilities within a genetic engineering facility, the project manager and the Biological Safety Officer may not be the same person. A transfer of responsibilities from the project manager to the Biological Safety Officer is therefore likely to be ruled out. Compliance with the Biological Safety Officer's duties is not directly sanctioned by fines or criminal offenses. This is likely due to the fact that the Biological Safety Officer is more likely to be on the side of the operator and, according to the law, has no proximity (in terms of responsibility) to the project manager's area of ​​responsibility.

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