Mandatory presence of the PL and the BBS in the genetic engineering facility

The starting point for an answer to this question is Section 11 No. 2 GenTG: According to this, one of the approval requirements is that it must be guaranteed that the project manager and the BBS can constantly fulfill their obligations. Since the area of ​​responsibility of the project manager (PL) is different from that of the biological safety officer (BBS), this question also varies with regard to the individual areas of responsibility. In the last AGCT-Gentechnik.report, we reported on the BBS's mandatory attendance. Today, on the PL's mandatory attendance: The PL (Section 3 No. 8 GenTG) is a person who, as part of their professional duties, directly plans, manages, or supervises genetic engineering work or a release. This already makes it clear that the term PL alone is primarily linked to the genetic engineering work (not to the genetic engineering facility). The (legal) duties of the project manager are comprehensively described in Section 14 Paragraph 1 Nos. 1-9 GenTSV. The legal obligation under Section 14 (1) No. 7 GenTSV is of particular importance in this regard. According to this, the project manager is responsible for ensuring that, in the event of a threat to the protected legal interests (humans and the environment), appropriate measures are taken without delay to avert this threat. Accordingly, it is the project manager's responsibility to initiate hazard prevention measures immediately, i.e., without culpable delay, in the event of a threat. Accordingly, the project manager's duty to be present will be defined more narrowly than that of the project manager's duty to be present (see AGCT-Gentechnik.report 5/2020 ). This will certainly depend on the circumstances of the individual case. Criteria for this may include the safety classification and the hazardous nature of the specific activity. In this context, simple storage of GMOs (more "passive") may be assessed differently than the initial production of a GMO or its propagation (more "active"). Accordingly, general statements, such as the project manager must be at the facility within 20 minutes, cannot be made for all facilities. In the event of a hazardous situation described in Section 14, Paragraph 1, No. 7 of the GenTSV, the question will certainly always be asked ex post where the project manager would have been if hazard prevention measures had to be taken. Against this background, the person assuming the role and responsibility of a PL must decide for themselves how to handle their presence in the facility—and thus also any possible representation.