What should be done if genetic engineering work or the facility is stopped?

The regulations governing such a shutdown are rather meager in the Genetic Engineering Act (GenTG). Thus, the rumor persists that the facility must be "deregistered." However, Sections 8 to 12 GenTG do not provide for such a deregistration. Regulations governing the cessation of operations can only be found in Section 6 (2) Sentence 2 and Section 21 (1b) GenTG. If the operator intends to cease operation of a facility, he or she must immediately notify the competent supervisory authority, stating the date of cessation. Documents detailing the measures planned by the operator to fulfill the obligations arising from Section 6 (2) Sentence 2 GenTG must be attached to the notification (Section 21 (1b) GenTG). Accordingly, the operator must ensure that even after cessation of operations, the facility cannot pose any risks to the legal interests listed in Section 1 No. 1 GenTG (Section 6 (2) Sentence 2 GenTG). Accordingly, the cessation of operations only subject to notification . The unilateral notification

• by the operator
• to the supervisory authority, and curiously not to the licensing authority. The notification has
• stating the date of employment and is
• immediately, ie without undue delay (at most 3 days).
• Documentation of the measures planned by the operator should include ensuring that all genetically modified organisms (GMOs) have been autoclaved, that Form Z has been completed accordingly, that all stocks have been cleared and destroyed, that all rooms and equipment are free of GMO residues, i.e., disinfected/autoclaved, that the facility's labels have been removed, and that the records have been transferred to an archive (and, if so, to which location). Whether an archive location should be specified is questionable, since the records are the property of the operator and primarily serve to relieve him of liability in the event of damage caused by genetic engineering work (Section 34 (2) GenTG).

An official notice in the event of a cessation of operations is neither intended to provide any kind of consent to the cessation of operations nor to provide any further requirements, i.e. there is no corresponding legal basis for the authority to do so.

Legal fiction Upon registration, no written decision is issued by the authority. This is not provided for by law. Rather, the law states that in the case of safety level 2, the operator may begin carrying out the initial genetic engineering work 45 days after receipt of the registration by the competent authority, or earlier with the authority's consent. It literally states that the expiration of this period shall be deemed consent to carry out the genetic engineering work. Here, too, the law deems approval to have been granted once the 45-day period has expired. To be on the safe side, the law stipulates that the period is suspended while the authority awaits the supplementary documentation or until the required opinion from the commission on the safety classification of the planned genetic engineering work and the necessary safety measures is received. To avoid commencing genetic engineering work prematurely, the project manager must be certain at this point when the 45-day period begins and when it will definitely end. In practice, these questions repeatedly show that project managers are extremely uncertain about this. To be on the safe side, the application should be sent by registered mail with a return receipt. This will ensure that the return receipt indicates when the application was received by the authority. Again, to be on the safe side, this date should not be counted when calculating the 45-day period. 45 calendar days should be counted starting from the day after the application is received. Work can begin at the end of the 45th day. The start date of work should also be carefully calculated and noted.