What exactly are notifications according to §§ 9 para. 4a and para. 5 GenTG?

Following the 3 forms of admission already presented (cf. AGCT-Gentechnik.report 11/2022 of 30.11.2022 , 01/2023 from 31.01.2023 and 02./2023 of February 28, 2023 ) will be the last to address the notification. This is not really a form of approval, but rather a unilateral declaration of intent by the operator to the approval authority, which requires receipt and becomes effective upon receipt (Section 130 (1) and (3) of the German Civil Code (BGB), and therefore does not depend on confirmation by the authority. The law recognizes notifications for further genetic engineering work in Section 9 (4a) and (5) of the GenTG. Section 9 (5) GenTG regulates a special case, namely activities carried out by an international depository authority. Classic research and production units are generally not international depository authorities, so this notification is not relevant in everyday laboratory practice. The same cannot be said for the notification pursuant to Section 9 (4a) GenTG. According to this provision, the operator must notify the competent authority before commencing work if previously notified, registered, or approved genetic engineering work at safety levels 2 and 3 is to be carried out in another registered or approved genetic engineering facility of the same operator in which corresponding genetic engineering work may be carried out. This regulation is related to the other activity permits under Section 9 of the Genetic Engineering Act (GenTG). The facility permit is not affected, as this is regulated in Section 8 of the Genetic Engineering Act (GenTG). This means that Section 9 (4a) of the Genetic Engineering Act only regulates additional activities. The chain of command is difficult to understand in itself and should therefore be presented in detail with regard to its prerequisites. It concerns:

• Genetic engineering work (production of GMOs, but also propagation, storage, destruction or disposal as well as the internal transport of genetically modified organisms (Section 3 No. 2a and b GenTG)
• Safety levels 2 and 3 (S1 is not included because further genetic engineering work is exempt from authorisation (Section 9 (1) GenTG); S4 is always subject to strict authorisation (Section 9 (3) GenTG))
• the work must already be notified (further S2 work), registered (upgraded S2 work) or approved (S3 work) (i.e. it must already be permitted in a genetic engineering facility)
• there is another registered (S2) or approved (S3) genetic engineering facility = change of facility (this must be S2 or S3 (Section 8 (1) Sentence 1 2nd Alt. GenTG or Section 8 (1) Sentence 2 1st Alt. GenTG))
• the same operator (in any case, a transfer to a facility operated by another operator is not possible under Section 9 (4a) of the Genetic Engineering Act; the same operator would therefore be, for example, the chancellor for the university or a private company). However, there are some pitfalls with regard to "the same operator." In university-related areas, both the university and the university hospital sometimes operate genetic engineering facilities. Therefore, a notification would not be sufficient for a transfer from a university facility (operator 1) to a university hospital facility (operator 2). The situation would be different if – as in Münster, for example – the facilities in the hospital were also operated by the university (operator 1). In the private sector, this also depends on the operator function. If individual subsidiaries act as operators, notification is also not sufficient for a transfer of work from the facility of subsidiary 1 to a facility of subsidiary 2. However, if the parent company operates all of the group's genetic engineering facilities, notification can be used. Incidentally, there are no specifications regarding the location, which means that "institute hopping" is possible not only at campus universities, which are all located on the same premises, but also at universities whose institutes are scattered throughout the city, such as in Bonn or Münster. It also means that operators of private genetic engineering facilities, under the same conditions, can only carry out or continue work in another genetic engineering facility operated by the same operator with an S2 or S3 notification (Section 9 (4a) GenTG plus off-site transport) and continue the genetic engineering work there. This also applies to microscopy, storage of GMOs, and disposal. If a company operates an S2 genetic engineering facility in Munich and another S2 facility in Berlin, the transfer of S2 work from Munich to Berlin would also only be subject to notification. The legal justification (BT-Drs. 11/5622) does not clarify whether this is actually intended. It does state that the permits only apply to the conduct of genetic engineering work in a specific closed system. However, this statement cannot be relevant to the conversion of a genetic engineering facility, since the factual prerequisite for this is the conversion from one closed system to another. The LAG's legal interpretations do not address this either.
• before starting work (not after starting work in the new facility; but work can be started immediately after the authority receives the notification)
• from the operator (not from the PL or the BBS)
• Obligation to notify (informal, i.e., oral or written notification by letter, fax, or email is possible). It should also be noted that a violation of Section 9 (4a) GenTG is subject to a fine if the notification is not made, is not made correctly, or is not made in a timely manner (Section 38 No. 9, 1st Variant GenTG). Transferring work to another facility often involves the transport of the GMOs used. If both facilities are located on the same premises, the requirements for internal transport must be observed; otherwise, those for external transport apply. We are holding an AGCT Refresher Project Manager Course on the transport of GMOs on April 12, 2023, which will allow you to simultaneously refresh your expertise in accordance with Section 28 (3) and (5) GenTSV. Further information can be found here.