Important addendum: Approvals also possible for S 2 plants

In principle, registration and notification are the types of approval for S2 systems. This is described in detail in the AGCT-Gentechnik.report 11/2022 of 30.11.2023 and 1/2023 from 31.01.2023 For the construction and operation of an S2 facility, the type of authorization is usually a registration, and for the performance of further genetic engineering work in this S2 facility, notification is required. Nevertheless, the legislature has operator for security level 2 granted the right to vote. In deviation from the standard cases under Section 8 (2) Sentence 2 of the Genetic Engineering Act (GenTG), the operator may also apply for a permit in accordance with Section 8 (1) Sentence 2 of the Genetic Engineering Act (GenTG). The same applies to an existing facility at safety level 2: Here, too, the operator may apply for a permit instead of notifying further genetic engineering work at safety level 2 (Section 9 (2) Sentence 2 of the GenTG). In this case, the following must be noted:

• This option is not available for S1 facilities. The option is limited to S2 facilities; for S3 and S4 facilities, such an alternative is not required, as both the facilities and the subsequent genetic engineering work are generally already subject to approval.
• The option applies to the initial construction of a facility but also to the implementation of further genetic engineering work in an S2 facility
• Overall, it can be said that from a practical perspective, this option becomes relevant in a wide variety of scenarios, so a general statement cannot be made. It depends on the specific situation of the operation of the genetic engineering facility and the work actually carried out there.
• In both cases (construction of the facility and implementation of further work), the operator can select the approval procedure option in the application process. Application form A (not AZ S1, as this only applies to the construction of an S1 facility) explicitly provides for the alternative procedure type under the term "Optional: Approval" in sections 3.1 and 3.2. If the operator selects the alternative approval box here, they have exercised their right of choice, and the authority is obligated to review their procedure as an approval.

If the operator chooses a permit instead of a registration/notification, he must generally wait 3 months (exactly 90 days) for the authority’s decision, because the Approval has a concentration effect according to Section 22 GenTG. This in turn means that the licensing authority for genetic engineering must obtain opinions as a public authority (TöB) from all other authorities responsible for the construction and operation of the genetic engineering facility/work, following a defined procedure, for which deadlines must also be observed. These opinions subsequently replace their own decisions. The licensing authority under the GenTG must await their opinions and then incorporate their opinions into the approval. In short, only one procedure is carried out by one authority, and all other official decisions are included in its approval. The operator therefore does not have to worry solely about any necessary approvals under the Infection Protection Act, the Immission Control Act, the Building Code, the Animal Welfare Act, and the Animal Health Act. This is the advantage of the concentration effect, which, given the large number of authorities involved, in some cases outweighs the disadvantage of a three-month waiting period. Because this procedure is more complex for the authorities, they rarely point out the possibility of this option, and sometimes even try to persuade the operator to choose the standard procedure. However, if it is in the operator's own interest to choose the procedure with a concentration effect, they must stick to their decision once they have made it. In this case, the authority cannot handle the procedure by way of notification or application and then make a decision. I would like to point out the AGCT Refresher Project Manager Course (one-day course) focusing on the "approval procedure."