How often does the BBS need to be installed in the system?
Dr. Petra Kauch
Internal audit: What does “regular” actually mean in the sense of Section 31 Paragraph 1 No. 1 GenTSV?
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According to Section 3 No. 9 GenTG, the task of the Biological Safety Officer (BBS) is to review the tasks of the Project Manager (PL) and to advise the operator. This can only be done to a limited extent without an inspection of the facility, and not at all without knowledge of the facility. Accordingly, in practice, the question arises as to whether the law sets time limits for the internal audit. Time limits can be found in Section 31 Paragraph 1 Nos. 1 and 2 GenTSV. Section 31 Paragraph 1 No. 1 GenTSV states that the BBS must monitor the fulfilment of the PL's tasks, "in particular through regular inspections of the genetic engineering facility". Section 31 Paragraph 2 GenTSV states that the BBS must provide the operator with an annual written report on the information pursuant to Paragraph 1, i.e., the review of the PL's fulfilment of its tasks. In any case, it can be deduced from this that the BBS must conduct an internal audit at least once a year so that it can monitor the project manager's tasks. Monitoring is therefore at least tied to the requirement to prepare a written report. In individual cases, such as when deficiencies have been identified or new work is pending, a more frequent schedule may be necessary. Accordingly, this question cannot be answered the same way for all facilities. Rather, it depends on the individual work, the individual facility, and whether a job is already underway or whether problems are occurring.