Compulsory presence of the PL and the BBS in the facility

The starting point for an answer to this question is Section 11 No. 2 of the Gen TG (German Technical and Scientific Regulations): According to this, one of the approval requirements is that it must be guaranteed that the project manager and the BBS can continuously fulfill their obligations. Since the responsibilities of the PL differ from those of the BBS, this question also differs depending on the individual responsibilities.

Today, on the BBS's mandatory presence: The BBS's task (Section 3 No. 9 GenTG) is to monitor the PL's fulfillment of its duties and to advise the operator. This is usually done by the biological safety officer visiting the facility as part of the annual/regular internal audit, reviewing the project manager's genetic engineering work, drafting their BBS report, and submitting the BBS report, including the facility-specific comments, to the operator. Thus, the BBS can fulfill its obligations annually/regularly at a specific time. This does not require the BBS's permanent presence at the facility or in the immediate vicinity of the genetic engineering facility. In this respect, the statement by the LAG regarding Section 11 of the GenTG, according to which a strict standard must be applied to the continuous fulfillment of tasks by the BBS, is probably due to the fact that in practice there are genetic engineering facilities throughout Germany in which the BBS is significantly closer to the work and the facility, and is generally responsible for issues relating to risk assessment, recording, and the implementation of activities ("strong BBS"). However, such proximity of the BBS to genetic engineering work is not provided for in the law, so that a general obligation for the BBS to be present cannot be derived from this. This question is also unlikely to depend on the safety classification, since even an S3 facility does not generally trigger increased inspection and advisory activities. Therefore, both in the university sector and in the private sector, internal audit appointments are usually coordinated with the BBS in advance, ensuring that the BBS is always available at these times. Should the operator require consultation in the meantime, this will certainly be communicated via email or similar as quickly as possible in the digital age, and an on-site appointment can be scheduled at very short notice if necessary. In any case, Section 11 No. 2 of the GenTG does not require the BBS to be on call like a fire department. The mandatory presence of the PL will be discussed in the next AGCT Genetic Engineering Report.