The “triumvirate” of a genetic engineering facility

The Genetic Engineering Act generally assumes that a genetic engineering facility requires an operator, a project manager, and a biosafety officer. This would make the operation of a genetic engineering facility almost impossible for start-up companies.
However, if one differentiates between the responsibilities of the facility operator, the project manager, and the biosafety officer, it becomes clear that the operator of a genetic engineering facility can also be the project manager. Only the biosafety officer is required to monitor the project manager's fulfillment of their responsibilities and to advise the operator. Since our law does not generally recognize internal consultation, it is clear that the operator and biosafety officer cannot be identical. A review of the fulfillment of one's own responsibilities also seems inappropriate, so that the biosafety officer and the project manager are ruled out. However, since the operator and project manager can be identical, and Section 16 (2) of the GenTSV allows for the appointment of an external biosafety officer, a single person can also legally operate a genetic engineering facility.

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