Further S2 work in an S2 facility indicated: No suspension of the procedure!
Dr. Petra Kauch
If further S2 work is reported, the (administrative) procedure is not suspended even if additional documents are requested or the ZKBS is involved.
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The law only provides for a suspension of the procedure for the initial registration of an S2 facility. This is expressly stated in Section 12 (1).5S. 3 GenTG. Such a provision for suspending the procedure is missing for the activity-related authorisation in Section 12 Para.5aGenTG. For the notification of further S2 work, the legislator has provided for a different regulation:
According to Section 12 Para.5a p. 1According to the GenTG, further genetic engineering work can begin immediately upon receipt of notification by the competent authority in the case of safety level 2. It states:
… (5a) The operator may commence the construction and operation of the genetic engineering facility and the performance of the initial genetic engineering work in the case of safety level 1, as well as the performance of further genetic engineering work in the case of safety level 2, immediately after receipt of the notification by the competent authority. …
The legality of further S2 work takes effect immediately upon receipt of the notification by operation of law. This legalizing effect does not remain suspended. The law only recognizes a suspension of the procedure for the approval of aS2 systemaccording to Section 12 Paragraph 5 Sentence 3 GenTG. SuchHowever, there is no regulation for activity-related approval(further S2 work) in § 12 para.5aGenTG. Therefore, the legalization effect of Section 12 Paragraph 5a Sentence 1 GenTG continues to apply. This applies both in the case that the documents are incomplete and in the case that the authority has obtained an opinion from the ZKBS.