Fines for the project manager’s duties
Dr. Petra Kauch
Today: Fines under Section 14 Paragraph 1 No. 3 GenTSV?
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Let us reiterate: If a task or its failure to comply with it is not subject to a fine, it cannot be punished with a fine. In this respect, it is worthwhile to compare Section 14 of the GenTSV and Section 38 of the GenTG. Section 14 Paragraph 1 No. 3 GenTSV stipulates that the project manager, upon appointment, is responsible for the implementation of official requirements and orders. The official requirements and orders generally arise from the underlying notices issued by the licensing or supervisory authority.
Section 38 GenTG contains in paragraph 1 no. 8 a fine for enforceable conditions or enforceable orders.
- The first part is related to Section 16d, i.e. the operator's duty to monitor the product when placing it on the market, and therefore does not contain any fines that are relevant for the project manager.
- The second part is related to Section 19, Sentence 2 of the Genetic Engineering Act (GenTG). This refers to requirements that specifically concern certain procedures or safety precautions, or a specific quality or equipment of the genetic engineering facility. To the extent that these concern areas that the project manager can ensure themselves, the fines for such requirements also constitute an administrative offense against the project manager. To the extent that this refers to structural-related precautions, i.e., precautions to be ensured by the operator, Section 38, Paragraph 1, No. 8 of the Genetic Engineering Act (GenTG) does not constitute an administrative offense against the project manager.
- The third part concerns an enforceable condition under Section 26 GenTG; in contrast to a condition under Section 19 GenTG, which represents an authorization for the imposition of conditions by the licensing authority, Section 26 GenTG is directed at an official order for the purpose of monitoring. The point is that the authority can issue the orders necessary to eliminate identified violations or to prevent future violations of this law. However, by inference from Section 26 (2) GenTG, it follows that such an order must be addressed to the operator. It states: "If the operator of a genetic engineering facility fails to comply with a condition, etc...." Accordingly, the sanction provision of Section 38 (1) No. 8 GenTG also applies as an administrative offense to the detriment of the operator. In this respect, the genetic engineering authority can only impose a fine on the project manager on this basis if a condition is addressed directly to the project manager himself. Accordingly, operators are advised to review all requirements contained in a genetic engineering notice to determine whether they can actually be addressed to them within the scope of the catalogue of obligations set out in Section 14 of the Genetic Engineering Ordinance (GenTSV). In this way, the legislature generally also holds the operator accountable for violations of orders and requirements. Section 20 of the Genetic Engineering Ordinance also does not provide for a fine for violations of Section 14, Paragraph 1, No. 3 of the Genetic Engineering Ordinance.