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.
Furthermore, the court found the review requirement inadmissible in this specific case because it could be ruled out that genetically modified organisms capable of causing human pathogens would be created. As part of the taking of evidence, the court obtained a statement from the Central Commission for Biological Safety (ZKBS), which stated that the infection of human cells by amphotropic murine viruses is only possible under cell culture conditions. The monitoring measure ordered by the authority was not suitable for making statements about the presence of contamination. Furthermore, the court criticized the fact that the authority did not independently obtain a statement from the ZKBS during the proceedings. After all, the authority was the only one nationwide that considered such a requirement necessary, so it was a matter of principle.

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