Can individual safety-relevant devices still be considered genetic engineering facilities?

Dr. Petra Kauch

In the past, there have always been laboratory freezers (-80°C) or individual animal housings that were approved as isolated genetic engineering facilities. Whether this will still be possible after the amendment to the GenTSV is questionable.

In the past, if one did not want to permit an entire room to be used as a genetic engineering facility, the wording of the GenTSV made it possible to designate isolated areas of a large-scale laboratory, individual safety-relevant equipment such as laboratory freezers (-80°C) or individual animal housings, as genetic engineering facilities and to mark them accordingly. This practice was also used extensively in laboratories. For example, in some basements, a laboratory freezer was located with the biohazard symbol and the designation "genetic engineering facility S1 or S2." The background to this was that, under the old GenTSV, genetic engineering work could also be carried out "in demarcated areas" (A. No. 1 Appendix III I. to the GenTSV (old version) for laboratory areas). Particularly for the storage of GMOs, it was concluded that such a demarcated area could also be a laboratory freezer located in a basement or hallway. Transport from the laboratory to the freezer was then simultaneously considered internal transport and, as further genetic engineering work, could thus be carried out without any problems. With the amendment to the GenTSV on March 1, 2021, this far-reaching wording was amended. According to the current version, work should be carried out "in demarcated and sufficiently large rooms." The term "areas" has thus been dropped. Accordingly, for new facilities, it is likely that a genetic engineering facility can no longer be described solely by a technical device that does not simultaneously constitute a room. Existing facilities will also have to adapt to these environmental regulations, although longer transition periods will certainly be necessary in this case. In individual cases, those responsible should immediately check whether the room containing a laboratory freezer or animal cage can be reported/registered as a genetic engineering facility in its entirety. This should also apply to laboratory areas in an open-plan laboratory where only part of it is used as a genetic engineering facility. In some cases, difficulties are certainly to be expected due to structural conditions with regard to floors, walls, and doors.

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