Recognition of day training courses according to the new GenTSV (2019)?

It is questionable whether, under the new GenTSV 2019, day-long continuing education courses – such as those offered by the AGCT as update courses since 2009 – can and must be recognized by the authorities as continuing education events within the meaning of Section 28 (5) GenTSV (2019). Currently, the situation is that – at least the district government in Düsseldorf for North Rhine-Westphalia – day-long courses are not accepted as continuing education events within the meaning of Section 28 (5) GenTSV, i.e. with state recognition. Only two-day courses that meet the curriculum of the Federal/State Working Group on Genetic Engineering (LAG) are recognized. However, since these LAG requirements are not binding, the question arises as to whether organizers and universities can also apply for day-long events for continuing education purposes. This depends largely on whether a corresponding authorization basis exists and thus the legal requirements of the GenTG and the GenTSV can be met. With regard to the legal basis, only Section 28 (2) No. 3, (3) No. 3, and (5) GenTSV (2019) come into consideration. These do not provide for a distinction between different recognized continuing education courses of different lengths. In particular, Section 28 (5) GenTSV (2019) stipulates the same content for recognized continuing education courses, i.e., without differentiation. The wording of Section 28 (3) No. 3 GenTSV also shows that the legislator did not intend any differentiation. The wording reads: “The knowledge imparted during continuing education pursuant to Paragraph 2 Sentence 1 No. 3 (= state-recognized continuing education course, editor’s note) must be updated at least every five years by re-attending a recognized continuing education course (pursuant to Paragraph 2 Sentence 1 No. 3, editor’s note).” Different levels of recognition by the authorities are also not intended. It would also not be legally impossible for a "first-time" project manager to apply for recognition as a project manager with a one-day course if they actually meet the requirements of Section 28 (5) of the GenTSV (2019). Accordingly, it is questionable whether there can be an authorization basis for a one-day course that meets the requirements of the law, namely Section 28 (5) of the GenTSV (2019). This would only be the case if the requirements behind Section 28 (5) of the GenTSV could be met. The GenTG stipulates that project managers (PL) carry out the direct planning, management, or supervision of genetic engineering work or a release (Section 3 No. 8 GenTG). This assignment of tasks primarily relates to genetic engineering work, so the PL must have all the knowledge required for this planning, management, or supervision of the genetic engineering work. In contrast, the GenTG stipulates that the Biological Safety Officer (BBS) is to monitor the project manager's fulfillment of his or her duties and advise the operator (Section 3 No. 9 GenTG). This means that, because the BBS is responsible for monitoring the project manager's aforementioned work, he or she must also possess the knowledge required for planning, managing, or supervising genetic engineering work. Furthermore, because of his or her advisory function with regard to the operator, he or she must also consider the operator's facility-related duties (Sections 6, 8 et seq. GenTG) in order to be able to advise the operator in this regard.

Furthermore, Section 14 of the GenTSV assigns certain tasks to the project manager by law, for which the project manager may be required to have appropriate knowledge. These are:

• compliance with general occupational health and safety regulations as well as regulations on epidemics, animal diseases, animal welfare, species protection and plant protection
• the timely start of genetic engineering work,
• the timely start of the release
• the implementation of official requirements and orders
• the sufficient qualification and instruction of employees
• the implementation of training for employees on the basis of the operating instructions on the hazards that may occur and the recording of preventive occupational health examinations and any accidents that may occur
• detailed information to the Biosafety Officer
• the immediate implementation of appropriate measures to avert dangers in the event of a dangerous situation
• the immediate notification of an incident that does not correspond to the expected course of the genetic engineering work or release and where there is a suspicion of a threat to protected legal interests,
• ensure that a competent person is regularly present and generally available during releases.

This necessarily requires the PL to have knowledge of the IfSG, TierGesG, TierSchG, Federal Nature Conservation Act and Species Protection Ordinance, and the PflSchG (Sections 1.5 and 1.7 of the LAG criteria). Furthermore, they must be informed about the start of the approval period and the associated legal consequences in the area of ​​​​licensing for genetic engineering facilities and genetic engineering work (Sections 8-12 GenTG). They must also have knowledge of official notices and the significance of conditions and orders (Sections 19, 20, 22, 25, and 26 GenTG) that they must implement (Sections 1.1 and 1.3 of the LAG criteria). In the area of ​​​​occupational health and safety (ArbSchG and ArbSchV) and the GenTSV, they are likely to have knowledge regarding employee training, the significance of operating instructions, and preventive occupational health examinations (Section 3.3 of the LAG criteria). The same applies to knowledge of hazard prevention (Sections 6, 14-16e GenTG and GenTSV) in the individual safety levels of genetic engineering facilities (Sections 2.1 and 2.3 LAG criteria). Knowledge must also relate to the threat to legal interests during regular work, accidents, and unforeseeable events (Sections 2.1, 2.3, and 3.1, 3.4, and 3.5 LAG criteria). Section 15 (5) GenTSV must also be considered. According to this, a continuing education course must cover the essential principles of the following topics:

1. Hazard potentials of organisms during genetic engineering work in genetic engineering facilities with special consideration of microbiology and during releases = Sections 6, 14-16e GenTG and GenTSV (Sections 2.1 and 2.3 LAG criteria)
2. Safety measures for genetic engineering laboratories, genetic engineering production areas and releases GenTSV (Section 2.2.2 and 3.1 LAG criteria) and
3. Legal provisions on safety measures for genetic engineering laboratories, production areas and releases GenTSV (Sections 2.1, 2.2 and 2.3 LAG criteria)

If one now allocates these circumstances to the respective time slots stipulated by the LAG—at least 16 hours of 45 minutes each—it is easy to see that these requirements cannot be met with 8 teaching hours of 45 minutes each in one day. The learning content must remain spread over two days. It is not impossible that the time units must be carried out on two separate days in different weeks and not on two consecutive days. Given the legal situation, a reduction in the content is probably not possible if one does not want to lower the standard currently stipulated in the law. A lowering of the level is unlikely to be compatible with the wording of Section 28 Paragraph 3 Sentence 1 GenTG or with the legal justification. According to the wording, "The knowledge imparted during the further training pursuant to Paragraph 2 Sentence 1 No. 3 (= project manager courses, editor's note) must be updated at least every 5 years by re-participating in a recognized further training event." The justification is that Section 28 Paragraph 3 of the GenTSV is intended to ensure that suitable continuing education measures are mandatory for all project managers at appropriate intervals. This requires stricter requirements than the previous regulation, which certainly does not equate to a lowering of the standard. Therefore, the wording of the law stipulates that project managers and BBS must attend a basic training course every five years. The legislator clearly did not intend for differentiation into different content or a lowering of the standard. Accordingly, nationwide, it will likely remain the case that project managers and BBS must invest two days in continuing education every five years. In the next newsletter, we will address the associated costs.