Fines to be levied on the PL or BBS? Was that what the legislature intended?
Dr. Petra Kauch
Project managers (PL) or biosafety officers (BBS) often feel exposed to the risk of a fine in the course of their work. Rightly so?
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The concern of PL and BBS that they will be held "liable" for a defect in the facility is often heard. They fear being exposed to high fines. However, it is questionable whether this fear is justified. In any case, the prerequisite for punishing an error in the operation of a genetic engineering facility or the conduct of genetic engineering work is that the legislature actually provides for a corresponding fine for a specific omission. Accordingly, it must also be the legislature's intention to sanction a task falling within the responsibility of the BBS or the PL with a fine. This question can be answered relatively easily with regard to the tasks of the BBS. According to Section 3 No. 9 GenTG, their task is to review the PL's tasks and to advise the operator. Neither Section 38 of the Gene Technology Act (GenTSV) nor the Genetic Engineering Safety Ordinance provide for fines that would allow for the imposition of a fine for a failure to review the PL or for a failure to advise the operator. Accordingly, there is no fine against the BBS, meaning that the BBS cannot be charged with a fine. For the PL, whose task is to plan, manage, and supervise the genetic engineering work (not the facility), the question is somewhat more difficult to answer. However, for both the GenTG and the GenTSV, it can be stated that the fines are largely linked to the operator's obligations (Sections 6, 8 et seq., and 32 et seq. GenTG), which intends that operator failures should be subject to fines. This view can also be supported by a statement published by the legislature as part of the amendment to the GenTSV. The Bundestag printed matter (BT -Drs. 137/19, p. 98) states that under current law, the fines in the GenTSV are not PL-related, either. It states: "The sanctions provided for in current law apply exclusively to the operator." However, to the extent that the amendment to Section 33 of the GenTSV resulted in a more open formulation, i.e., the operator was deleted as a connecting factor, this has not resulted in any legal change, as the offenses continue to have a strong connection to the facility and not to the activity. Overall, this makes it clear that the legislature has set the bar high for conduct that is punishable by fines. This is certainly also in light of the fact that both the licensing authority and the supervisory authority have been granted numerous powers of intervention to ensure the proper operation of a genetic engineering facility and the work carried out therein.