An incident... What should be done?

The tasks in the event of an incident are clearly distributed in the law
First of all, it should be noted that the term "incident" is not defined in the law itself. From the context in which the term is used, one can conclude that it must be an event in which the course of the genetic engineering work or release does not correspond to the expected course and in which there is a suspicion of a threat to the legal interests protected in Section 1 of the GenTG. A deviation from the expected course alone is not sufficient in this respect. There must also be a suspicion of a threat to humans, the environment, animals, plants, or material goods. Whether a deviation from the expected course has occurred can be determined on the basis of the documents prepared, such as the risk assessment, the records, and the notification, registration, or approval documents. In the event of deviations during the course of the work that could influence safety precautions, one must therefore assume that an incident has occurred. As an example of such an incident, the Federal-State Working Group on Genetic Engineering cites an animal infected with GMOs escaping from its cage, remaining in the facility, and causing damage. Important: An incident should not be confused with an emergency or an accident in a genetic engineering facility. An accident only occurs when a significant escape of genetically modified organisms from the facility occurs, unintentionally by the operator, and can lead to a threat to protected legal interests (Section 2 of the Ordinance on the Notification of the Release of Genetic Modifications). An incident falls well below this threshold and does not require an escape from the facility.
Section 14, Paragraph 1, No. 8 of the GenTSV stipulates that the project manager must immediately report any incident to the operator. "Immediately" means without undue delay; in short, "take note and implement." There is no such regulation requiring the incident to be reported to the BBS. There is no risk of sanctions for the project manager.
For the operator, Section 21 (3) GenTG stipulates that they must immediately notify the licensing authority – in North Rhine-Westphalia, not the supervisory authority – of any incident that does not correspond to the expected course of the genetic engineering work, release, or placing on the market and where there is a suspicion of a threat to the protected legal interests. In doing so, they must provide all information necessary for the safety assessment, as well as any emergency measures planned or implemented (Section 21 (3) Sentence 2 GenTG).

This publication can also be found on the website of the law firm Dr. Kauch .