Compliance with protective regulations by the project manager
Dr. Petra KauchShare
According to the Genetic Engineering Safety Ordinance (GenTSV), the project manager (PL) is expressly responsible for the implementation of official requirements and orders (Section 14 (1) No. 3 GenTSV).
Official conditions are usually included in the approval notices. They do not necessarily have to be literally stated as conditions. The term "ancillary conditions" is sometimes used. These are generally additions to the approval for a specific activity or the operation of a facility. Conditions included in a notice include both activity-related requirements, such as the obligation to inform about certain risks before an activity, and construction-related requirements, such as the requirement to retrofit viewing windows in laboratory doors by a certain date. If the project manager does not consider the provision in the notice approving the work or the facility to be effective, they must note the deadline for an appeal and, if necessary, file such an appeal within the deadline.
Official orders are generally issued independently. They can arise from the licensing authority as part of notifications, applications, and approvals. They are specifically referred to as injunctions if the prerequisites for commencing activity or operating the facility have not been met. Such orders are often also referred to as closure orders or prohibition orders. An injunction is conceivable, for example, if the project manager made errors in the risk assessment and the work requires a higher safety level than that notified or registered. However, it is also conceivable that they are issued independently by the supervisory authority as part of its monitoring activities, for example if deficiencies in facility operation are identified.
In order to reliably implement official requirements and orders, the project manager must be aware of all notices concerning his facility addressed to the Chancellor. He must read the notices and, if necessary, note the deadlines for official requirements and orders. In cases of particular urgency, official orders may also be issued with immediate execution. In this case, the project manager must comply with the order immediately. If he does not wish to do so, he must file a corresponding application for suspension of execution either with the authority or with the court. This depends on the respective state law and can certainly only be answered with the assistance of a lawyer.
This publication can also be found on the website of the law firm Dr. Kauch .