Is recognition of third parties as PL of a genetic laboratory only permissible in exceptional cases?

Background: Section 28 (6) GenTSV stipulates that a project manager (PL) working for a third party may be authorized by the competent authority to act as a PL upon application by the operator. This requires a written contract (triangular contract). The individual requirements for this are precisely standardized in Section 28 (6) Sentence 2 GenTSV. There is no question that this is a discretionary provision ("may"). The question, however, is whether the mere fact that the appointment of a third party as PL, who is not employed by the operator and is at the discretion of the authority, can be qualified as a rule-exception principle.

As a rule, the legislature uses a corresponding literal term to describe a rule-exception principle, for example: "As a rule, a project manager must be appointed internally. Exceptionally, a project manager may be appointed if..." Section 28 (6) Sentence 1 GenTSV does not contain such a formulation. An indicative effect in the facts of the case also indicates a rule-exception principle; in this case, the following formulation is conceivable: "If the facts of the case are met, the illegality of the act is obvious." Section 28 (6) Sentence 1 GenTSV also does not contain this if-then connection.

The Handbook of Legal Formality, Federal Ministry of Justice, 3rd ed., which is generally used as a basis for the formulation of laws, also states that a rule-exception principle cannot be determined simply by granting discretion by the legislature. Rather, it is the case that the legislature must expressly permit exceptions to a specific rule as exceptions. This applies, for example, if it presumes compliance with the state of the art if certain measures are observed (e.g. Section 3 (3) of the Gashochdruckleitungsverordnung (Gas High-Pressure Pipeline Ordinance)) and then expressly permits exceptions to this presumption. Accordingly, a rule-exception principle cannot be derived solely from the granting of discretion. Rather, a rule-exception principle only exists if the legislature has expressly designated this as an exception.

However, if a rule-exception principle is not prescribed by law, this means that the appointment of an external third party as PL has been mandated by the legislature on an equal footing with the appointment of an internal employee as PL. Accordingly, it cannot be claimed within the scope of discretion that the legislature has stipulated that a PL must generally be appointed internally. This is precisely what the legislature has not prescribed. Rather, the appointment of an internal or external PL is the sole responsibility of the operator (Section 6 (4) GenTG in conjunction with Section 28 (1) Sentence 1 GenTSV). Accordingly, the operator who carries out genetic engineering work is obliged to appoint PL... The only substantive requirement is that the PL possesses the necessary expertise. Accordingly, the discretion of the authority pursuant to Section 28 (6) GenTG must also be based on this criterion, namely the necessary expertise.

This conclusion is also supported by the wording in Section 28, Paragraph 6, Sentence 1 of the GenTSV, which explicitly ties the appointment of an external PL to the PL's expertise (No. 2) and the agreement between the PL, operator, and third parties. The legislature expressly does not include any further criteria for the appointment of an external PL.

From a legal perspective, this conclusion is also supported by the fact that the standardization of an exception would affect the actual facts of the case, whereas the granting of discretion always only affects the legal consequences. Accordingly, from a dogmatic point of view, the mere granting of discretion cannot constitute an exception. Consequently, the authority's discretion must be based solely on the contract and the expertise of the PL.