Relationship between the approval of genetic engineering facilities and future training requirements

Section 28 (3) Sentence 1 of the GenTSV (new version) stipulates that both project managers (PL) and biological safety officers (BBS) must undergo further training every five years, 18 months after its entry into force, i.e., from March 1, 2021 (Article 4 of the MantelV). Those who think they can therefore wait until spring 2021 should be aware of the following: The new regulation does not provide for any exceptions for existing project managers and project manager certificates. The new regulation also does not include a transition period for project managers currently employed as such in genetic laboratories. Accordingly, project managers whose project manager certificates date from before March 1, 2016 (five years before 2021) must already have a new project manager certificate by the time the regulation comes into force in order to be able to demonstrate their expertise within the meaning of Section 15 (1) GenTSV (old version) (then Section 28 (3) Sentence 1 GenTSV (new version)). This is also relevant for facility licensing: According to Section 11 (1) No. 2 GenTG, the project manager/biological safety officer must have the necessary expertise for the licensing and lawful operation of a genetic engineering facility. This is a prerequisite for the operation of genetic engineering facilities and for activities in such facilities. In addition to a degree and sufficient microbiological practice, this also includes a project manager certificate. Therefore, if a project manager/BBS lacks the necessary expertise at the beginning of March 2021, a basic requirement essential for operating a genetic engineering facility is also lacking. Accordingly, the genetic engineering facility is without expert personnel (Section 6 No. 4 GenTG) and will no longer meet the facility requirements. This problem is not new to the Genetic Engineering Act, by the way! At the time the Genetic Engineering Act came into force in 1990, facility permits were often directly linked to the institute directors rather than to the chancellors. This resulted – remember the year of reunification – in an institute director "taking" the personal and subject-related license (facility permit) with them when they accepted a position in the new federal states or Berlin. In this case, too, it was undisputed that the genetic engineering facility had subsequently "lost" its permit, since it could not simply be transferred to the next institute director due to the personal element of reliability. A similar situation now exists if the PL/BBS "loses" their expertise solely because they no longer have a current project manager certificate. Therefore, every plant operator must also pay sufficient attention to this circumstance and update their expert personnel (Section 6 No. 4 GenTG) before the new Section 28 Paragraph 3 Sentence 1 GenTSV (new version) comes into force if they want to counteract the risk of plant closure.