Different regulations regarding incidents – why?
Dr. Petra Kauch
There are two sets of guidelines for incidents in which genetic engineering work deviates from the intended course, but they are not identical.
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The law contains provisions regarding incidents in Section 21, Paragraph 3, Sentences 1 and 2 of the GenTG and in Section 2, Paragraph 1, No. 11 of the GenTAufzV. However, the provisions are not identical.
Section 21 paragraph 3 sentences 1 and 2 GenTG initially concerns the reporting of such incidents to the authorities. According to this, the operator must immediately report any incidents to the competent authorities. Incident that does not correspond to the expected course of the genetic engineering work... and where there is a suspicion of a threat to the protected legal interests. All information necessary for the safety assessment, as well as any emergency measures planned or taken, must be communicated.
In contrast, Section 2 Paragraph 1 No. 11 GenTAufzV regulates the question of what information records must contain. According to this, each Any incident that does not correspond to the expected course of genetic engineering work and where the suspicion of a threat to protected legal interests cannot be ruled out must be recorded. Sentence 2 of Section 21 Paragraph 3 Sentence 2 GenTG, which states that the information necessary for the safety assessment as well as planned or implemented emergency measures must also be communicated, does not need to be recorded. Assuming this was a legislative oversight, the reason could be that the aforementioned information for the safety assessment as well as the planned and implemented emergency measures is only relevant to the competent authorities and therefore does not need to be recorded.
In practice, however, two tables are generally not maintained for these incidents. Therefore, it can't hurt to keep only one table for records—even if this is not required—which also contains the necessary information for the safety assessment and the planned and implemented emergency measures.