Always surprising: New safety-relevant equipment in the laboratory

Answer: No! This is certainly not the case if the equipment is safety-relevant as defined in Annex 2 to the GenTSV. In the S1 area, this covers autoclaves (it is disputed whether this applies only to this), and in the S2 area, MSW and centrifuges (it is disputed whether this applies only to this). Changes to safety-relevant equipment are subject to notification in the S1 area and to registration in the S2 area if they change the nature or operation of the facility, which would have to be examined on a case-by-case basis. Therefore, if a device was not previously present and was not declared in the original notification/registration, its installation and commissioning would in any case constitute a significant change and would trigger a new approval procedure. Furthermore, according to Section 27 Paragraph 1 No. 7 GenTSV, the BBS would have been required to be informed in detail about the precautions required under Sections 13-26 GenTSV. According to Section 14 (1) GenTSV in conjunction with Annex 2 to the GenTSV, the necessary precautions also include changes to safety-relevant facilities, i.e. the safety-relevant facilities mentioned above. This is also likely to be lacking if the BBS only notices the new equipment during the inspection. Ultimately, the BBS can only advise the operator(s) and the respective responsible persons (PL) accordingly in accordance with Section 31 (2) (b), (c) and (e) GenTSV if it is informed in accordance with Section 27 (2) No. 7 GenTSV. This is only possible at the request of the operator(s) and the responsible person, whereby the necessity for such advice is undermined precisely by the lack of information. Therefore, it cannot really be the case that the BBS discovers equipment in a genetic laboratory during an inspection that was not present in the facility during the last inspection/when it was involved in the last application process.

A notice: The information provided to the BBS is a circumstance that is only relevant within the context of the internal audit and not within the scope of the audit by the authorities, since the official audit does not extend to the internal relationship between the PL and the BBS. Nevertheless, it is in the interest of the operator that the internal audit is carried out properly so that the operator can fulfill its licensing obligations. The operator fundamentally depends on the proper organization of internal coordination between the PL and the BBS. The internal organization of a genetic engineering facility can also be audited as part of a compliance report.