Can additional S1 work in an S1 facility trigger notification obligations?

Dr. Petra Kauch

Section 21 paragraph 3 GenTG requires the operator to report incidents that do not follow the expected course.

In addition to the licensing requirements, Section 21 (3) GenTG stipulates a notification obligation for the operator. Notification obligations can be fulfilled informally, as the Federal/State Working Group on Genetic Engineering (LAG-Gentechnik) has not provided any forms for this purpose. According to this, the operator must immediately notify the authority responsible for notification, registration, licensing, and monitoring of any incident that does not correspond to the expected course of the genetic engineering work or the release or placing on the market, and which is suspected of endangering the legal interests designated in Section 1 No. 1, i.e., humans and the environment. All information necessary for the safety assessment, as well as planned or implemented emergency measures, must be reported. This obligation itself suggests a high priority because it refers to planned and implemented emergency measures, the operator must comply with it immediately, and the addressee of the notification is both the authority responsible for monitoring and licensing. But how likely is such an incident in an S1 facility? This would have to be an incident in which – presumably what is meant – the planned work does not correspond to the expected course. This is of course also conceivable for S1 work. However, work that then still remains S1 work is likely to lack the second prerequisite, namely that there is a suspicion of a danger to people and the environment based on the actual course of events . According to Section 7 Paragraph 1 No. 1 GenTG, S1 work is characterized precisely by the fact that there is no danger to people or the environment. In this respect, S1 work does not fall under Section 21 Paragraph 3 GenTG even if its planned course changes but it does not leave the safety level after a properly reviewed risk assessment. For S1 work that remains S1 work even if the course changes, the prerequisites are therefore not met. This does not trigger any notification obligations for the operator. Should the risk assessment based on the S1 work's course of action indicate that the work requires a higher rating, this would constitute further S2 genetic engineering work, which, according to Section 9 (2) of the Genetic Engineering Act (GenTG), would have to be reported as additional work if an S2 facility were present. If an S2 facility did not exist, such a facility would first have to be registered, and the organisms would have to be destroyed immediately beforehand. In both cases, however, a formal approval procedure would be required, so a mere notification would not suffice.

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