What are basic duties?

If you ask at the beginning of the project management courses who is responsible for risk assessment and record-keeping in a laboratory, the answers are always clear. Hardly any participant would dispute that these are project management responsibilities.

However, the legislature sees this quite differently: Section 6 of the Genetic Engineering Act regulates general due diligence and record-keeping obligations, as well as hazard prevention. As in other environmental laws, these obligations are referred to as so-called basic obligations. These basic obligations include the obligation to conduct risk assessments (paragraph 1), the obligation to provide hazard prevention measures (paragraph 2), the obligation to maintain and submit records (paragraph 3), and the obligation to appoint expert personnel (paragraph 4). Only by reading the wording of the regulation carefully can one determine in several places that all of the provisions refer to the operator of the facility.

Regarding the obligation to conduct a risk assessment (paragraph 1), this is already clear from the definition: "anyone who constructs or operates genetic engineering facilities." This is unlikely to be the project manager. Furthermore, the further wording of the regulation also includes the phrase "... places on the market as operator." In this respect, risk assessment is clearly assigned to the operator's area of ​​responsibility.

Accordingly, the duty to take precautionary measures (paragraph 2) is also tied to the operator. Literally, it states that the operator must implement safety measures based on the results of the risk assessment.

This is no different with record keeping (paragraph 3). This also explicitly states that the operator must keep records of the conduct of genetic engineering work and releases and submit them to the competent authority upon request. Thus, keeping and submitting records clearly fall within the operator's responsibilities, something that hardly any university chancellor has likely fulfilled to date.

Only in the case of the appointment of expert personnel (paragraph 4) is there initially no explicit designation of the operator. However, a look at the more extensive provisions of the GenTSV shows that this lack of specificity is partly present there. Section 16, paragraph 1, sentence 1 of the GenTSV stipulates that the operator must appoint the BBS for the appointment of the biological safety officer. A corresponding provision for the project manager (PL) is missing from his job description in sections 14 and 15 of the GenTSV. However, section 21 of the GenTG is helpful here. According to this provision, the operator must notify the competent authority in advance of any changes to the project manager's appointment. The clear wording here stipulates that the operator must appoint the PL and that any change in the PL's identity must be notified to the authority. It would, of course, be better if the written appointment of the PL by the operator were clearly regulated in Sections 14 and 15 of the GenTSV.

The result is that although in practice the project manager carries out the risk assessment and maintains and submits the records due to his proximity to the projects, the operator is ultimately responsible for this.

This publication can also be found on the website of the law firm Dr. Kauch .