When can an external PL be appointed?

Dr. Petra Kauch

The latest amendment to the Genetic Engineering Safety Ordinance (GenTSV) also created the possibility of using an external PL.

While until March 1, 2022, the GenTSV only provided for the external appointment of a BBS, since then, the external appointment of a PL has also been provided for. According to Section 28, Paragraph 6 GenTSV, a PL can work for a third party, i.e., be appointed. In this case, the operator must provide a corresponding Application must be submitted to the competent authority (registration authority). written agreements between the project manager, the operator, and the third party. Typically, a contract is concluded between the third party and the operator, according to which the third party must provide the project manager to the operator. Furthermore, the project manager must have a contractual relationship with the third party. Within the framework of these agreements, the project manager must undertake to fulfil the tasks according to § 27 GenTSV and to Follow the operator's instructions (No. 1). This is usually agreed upon in a certificate of appointment, which must also be signed by the project manager. Furthermore, it must be clear that the project manager appointed in this way will be responsible for the tasks specified in Section 27. Tasks fulfilled properly (No. 2). The last requirement is not particularly serious, as it does not require any particular security, but is linked to the wording of the "expectation." Direct proof is therefore not required. If the third party fulfills the project manager requirements, it can generally be "expected" that they will perform their duties properly. However, this assessment point does not provide a gateway for extraneous criteria—membership of the works council, part-time employment—because it refers to Section 27 of the GenTG.

The legal consequence is that the authority can permit the appointment of the external PL. Permission is therefore at the discretion of the authority. This is likely an intentional discretion, meaning that if the aforementioned requirements are met, the operator is generally entitled to permission.

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