Forms for genetic engineering facilities: Which are binding?
Dr. Petra Kauch
Various forms are in circulation for approval procedures under the GenTG. Is the operator of a genetic engineering facility free to choose their own?
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This depends on whether forms are binding or not. In administrative enforcement, federal states can agree on specific forms if they are authorized to do so by federal law. For example, there are nationwide standardized forms for submitting a building permit application, which the federal states have agreed upon.
The situation is similar with the approval of genetic engineering facilities and work. The Genetic Engineering Procedure Ordinance (GenTVfV) initially only stipulates that the competent authority must approve the use of Forms for notification, registration or application for approval and may request the documents. In this regard, the LAG (Federal/State Working Group on Genetic Engineering) already took note of the forms in the version proposed by the subcommittee on "Implementation and Technical Issues" in its meeting on April 22/23, 1996 in Berlin and supplemented by its meeting on May 27/28, 2009 in Göttingen, with reference to Section 3, Sentence 2 of the GenTVfV, and recommended their application. According to the resolution, this applies to the forms used nationwide for notification, registration, and approval procedures. Since then, the forms for the approval of genetic engineering facilities and work have been published nationwide on the website of the Federal/State Working Group on Genetic Engineering (LAG-Gentechnik.de). They are binding in all federal states. Since the forms occasionally change, the Operators are advised to always check the currentness of their forms before submitting an application if their application is to be effective and to trigger the fictitious effect of Sections 10 and 12 GenTG for an S1 or S2 facility or S2 activity. In contrast, the use of the Form Z in the Genetic Engineering Records Ordinance (GenTAufzV). A regulation corresponding to Section 3, Sentence 2 of the GenTVfV is missing here. Accordingly, Form Z is not listed in the above-mentioned resolution of the LAG. This resolution only refers to the forms used nationwide for notification, registration, and approval procedures. In this case, the operator only needs to include in the records the information they are legally obligated to provide. They can therefore adapt the form to their own needs, provided the aforementioned information is included.