GenTAufzV: Taking up work and starting work… is there a difference?

Indeed, the basic requirements for record-keeping are laid down by law in Section 2 of the GenTAufzV. The information contained therein is very extensive and cannot be fully reflected in the simple table of the frequently used Form Z. The Genetic Engineering Recording Ordinance (GenTAufzV) also generally distinguishes between technical work, but also between work carried out in the laboratory, at higher safety levels (safety levels 3 or 4) and during releases. The above wording is inconsistent when it comes to the general requirements for all genetic engineering work. For example, Section 2 Paragraph 1 No. 4 GenTAufzV stipulates, among other things, that for genetic engineering work pursuant to Section 9 Paragraph 1 GenTG, the time at which the genetic engineering work begins must be recorded. In contrast, Section 2 Paragraph 1 No. 7 GenTAufzV states that the time at which the genetic engineering work begins and its completion must be recorded. But what is the difference between the time at which the genetic engineering work begins and the time at which it begins?

The GenTAufzV does not address this. The wording is also not very informative in this regard. However, the following can be deduced from the factual context: Section 2 Paragraph 1 No. 4 GenTAufzV is related to the fact that the time of notification or application for genetic engineering work must always be recorded. In this context, it is stated that for genetic engineering work according to Section 9 Paragraph 1 GenTG, the time at which the genetic engineering work begins must be recorded. Section 9 Paragraph 1 GenTG, in turn, refers to further genetic engineering work. According to Section 9 Paragraph 1 GenTG, work at safety level 1 can be carried out without notification, i.e. without a new approval procedure. Consequently, only a risk assessment is required, and the work must be recorded. Since approval is no longer required, the actual start of the genetic engineering work is relevant. In this case, this will be identical to the start. The relevant risk assessment is likely to include the same point in time or possibly slightly earlier.

In contrast, Section 2 Paragraph 1 No. 7 GenTAufzV relates to the start of all genetic engineering work. Here, the time of the (actual) start and completion of the genetic engineering work must be recorded. As long as an approval procedure has been completed beforehand, the start date of the work does not have to be the same as the date of the application for approval or the date for which the application for approval was actually submitted. Due to the nature of the matter, a delay may occur, for example because materials have not yet been delivered, because vacation is still pending, or because of similar reasons, so that in these cases too, the actual start date must always be recorded. This is usually entered accordingly in the penultimate column of Form Z.

Conclusion: The case groups under Section 2 (1) Nos. 4 and 7 of the GenTAufzV concern different situations for genetic engineering work. As far as genetic engineering work at safety level 1 is concerned, the term "start of genetic engineering work" (Section 2 (1) No. 4 of the GenTAufzV) is likely to be identical to the term "beginning of genetic engineering work" (Section 2 (1) No. 7 of the GenTAufzV).