On the legality of official decisions in the notification and registration procedure

In the case decided by the Administrative Court, the operator – a university – had registered another genetic engineering activity at safety level 2, in which replication-defective amphotrophic retroviruses were used. Upon expiration of the statutory deadline, the work became legal by operation of law. The authority subsequently issued a notice confirming approval for the work and subsequently ordered the operator to monitor the presence of GMOs every six months using a detection method (polymerase chain reaction – PCR).
The Administrative Court has denied the authority's authority to issue declaratory decisions in notification and registration procedures. Since the operator can apply for a permit optionally, they have a right to choose if they seek a higher level of security. The authority cannot undermine this right by issuing a declaratory administrative act not provided for by law. This clarification is welcome, since issuing such administrative acts – not provided for by law – impermissibly shifts the risk of challenge and thus the associated costs to the operator.
We previously reported on this decision in the AGCT-Gentechnik.report 03/2012 . The significance of the decision lies in the fact that the authorities are no longer authorized to issue notices if the required legal consequences already arise directly from the law. This is the case with notification and registration. By operation of law, the work is permissible (legal) immediately upon receipt of the complete notification by the authorities or 45 days after receipt of the complete registration by the authorities. Here, as in many other cases under the Genetic Engineering Act, there is no reason for an additional notice. The risk is improperly transferred to the recipient of the notice. They must review the notice and, if necessary, file an appeal, even though such a notice should not even be issued in the first place. The law is intended to protect them from this by granting admissibility solely on the basis of the expiration of the deadline.

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