Subsidiary provisions in notices on the annual report of the BBS

It is not uncommon for the ancillary provisions to include a clause – usually as a requirement – ​​stating that the BBS's annual report must be submitted to the authority. However, there is no legal basis for such a provision: the BBS's annual report finds its legal basis in Section 3 No. 9 GenTG in conjunction with Section 18 Para. 2 GenTSV. According to this, the BBS's tasks include advising the operator and monitoring the project manager's fulfillment of their duties in this regard (Section 18 Para. 1 No. 1 GenTSV). To this end, as stipulated in Section 18 Para. 2 GenTSV, the BBS must submit an annual written report to the operator on the measures taken and intended pursuant to Section 18 Para. 1 GenTSV. The overall task description of the BBS is, as is often the case in environmental law, the internal inspection of an environmental facility by a particularly competent person. As is usual in similar cases, this authority is responsible for monitoring the project manager's tasks, particularly through the inspection of the genetic engineering facility. In this context, Section 18 (2) GenTSV clearly states that the BBS must submit the report to the operator. The BBS report is therefore an internal report. Accordingly, Section 18 (2) GenTSV specifically does not include an obligation to make the report available to the authority externally. The Genetic Engineering Recording Ordinance also contains no additional requirements in this regard. Accordingly, the forwarding of the BBS's internal report to the authority cannot be based on the provisions of the GenTG, the GenTSV, and the Genetic Engineering Recording Ordinance. Section 19 GenTG cannot be directly used for this purpose either. Accordingly, the authority can add ancillary provisions to its decision if this is necessary to ensure compliance with the approval requirements. The BBS report is not one of the approval requirements regulated in Section 11 GenTG.

Section 19, Sentence 2 of the Genetic Engineering Act also clarifies that conditions can only be imposed with regard to specific procedures or safety precautions, or specific characteristics or equipment of the genetic engineering facility. The internal BBS report also does not address such procedures, safety precautions, or the characteristics and equipment of the facility.

Neither the notification requirement under Section 21 GenTG nor the monitoring clause under Section 25 GenTG allow for a general obligation to release the internal BBS report in ancillary provisions. Section 21 GenTG, which applies to the issuance of official notices, is limited to the operator's obligation to notify the BBS of any change in the person. Section 25 GenTG applies only within the framework of monitoring and not to approval decisions (official notices). It gives the supervisory authority the opportunity to inspect necessary documents on site and to make photocopies and transcripts thereof (Section 25 (3) No. 3 GenTG), to obtain information, and to request aids, including control samples (Section 25 (2) GenTG). This, too, is only necessary to monitor the operation of the facility, including the corresponding official orders (Section 25 (1) GenTG). The BBS report does not count as part of the operation of the facility.

To the extent that notices contain corresponding ancillary provisions, they are therefore unlawful.

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