On the appointment of project managers and biosafety officers

The appointment of the biological safety officer is expressly regulated in Section 16 of the Genetic Engineering Ordinance (GenTSV). According to this, the operator, after consulting the works council or staff council, must appoint one or, if necessary in view of the nature or extent of the genetic engineering work or releases to protect the legal interests listed in Section 1 No. 1 of the Genetic Engineering Act, several biological safety officers (Biological Safety Committee) in writing. If several biological safety officers are appointed, the duties assigned to each biological safety officer must be precisely specified (Section 16 (1) of the Genetic Engineering Ordinance). Furthermore, the authority may, upon request, permit the operator to appoint one or more biological safety officers who are not employees of the company, provided that this ensures the proper fulfillment of the duties specified in Section 18 in the same way (Section 16 (2) of the Genetic Engineering Ordinance). The wording and provisions of Section 6 (4) of the GenTG, which stipulates that anyone conducting genetic engineering work or releases is obligated, among other things, to appoint expert personnel, indicate that the appointment is made unilaterally and in writing by the operator. This is usually done through a certificate of appointment.
There is no corresponding provision for the appointment of project managers in the GenTSV, nor is there a reference to Section 16 GenTSV. However, this does not mean, conversely, that project managers do not have to be appointed by the operator. Rather, the operator's obligation under Section 6 (4) GenTG remains, according to which the operator must appoint project managers to carry out the genetic engineering work. What is missing is a specific specification from the GenTSV and thus the written form requirement, so that an oral appointment is not prohibited by law. Therefore, the appointment of the project manager can be made orally or in the form of a service or operating instruction. Implied appointment as a project manager is also possible, for example, by project managers signing applications. Even if the law does not stipulate a strict written form requirement for the appointment of project managers, the project manager should be appointed in writing so that the operator does not face difficulties in providing evidence when having to prove fulfillment of their obligation under Section 6 (4) GenTG. For evidential reasons alone, the appointment should be made in writing, as otherwise the effective appointment according to Section 6 Paragraph 4 GenTG may not be able to be proven.
It should be expressly pointed out that the appointment of expert personnel by the operator must be distinguished from his obligation under Section 21 Paragraph 1 GenTG to notify the authority in advance of any changes relating to the PL and the BBS.

This publication can also be found on the website of the law firm Dr. Kauch .