Reliability of bodies defined in Section 6 of the 41st BImSchV

The basic prerequisite for the approval of a genetic engineering facility is the reliability of the operator and project manager (Section 11 No. 1 GenTG). The law stipulates that there must be no facts that give rise to concerns about the reliability of the operator and the persons responsible for the construction, management, and supervision of the operation of the facility. The Genetic Engineering Act and the genetic engineering regulations do not provide any further guidance in this regard. It is therefore logical to base the decision on the provisions of emission control law, which also govern the approval of facilities. Section 6 Paragraph 1 of the 41st BImSchV positively stipulates that reliability for emission control law purposes exists if the aforementioned group of persons is suitable, based on their personal characteristics, behavior, and abilities, to properly fulfill their duties. As a rule, the required reliability is not met if someone has been sentenced to imprisonment or a fine for violating criminal, environmental, health, or occupational safety and health law, as well as provisions of narcotics law or weapons law, or has been fined more than €500 within the last five years before the application (Section 6 (2) of the Federal Immission Control Ordinance (BImSchV). It is also sufficient if someone has repeatedly and grossly violated the aforementioned provisions without being punished or without receiving a fine of more than €500, and has intentionally or grossly negligently altered or incompletely reproduced investigation or test results. The same applies to a violation of documentation and reporting, as well as a violation of technical rules relevant to the accuracy of the investigation and test results (Section 6 (3) of the Federal Immission Control Ordinance (BImSchV). It should be noted that with so-called "general regulations," other violations can also be relevant for reliability. However, the list makes it clear that only violations of certain sub-legal regulations can be relevant for reliability.
If this is applied to the question of the reliability of operators and project managers in genetic engineering facilities, it should also apply here that only a criminal offense or a substantial fine can invalidate reliability. In the case of violations of the Genetic Engineering Safety Ordinance or other regulations governing genetic engineering, this must be examined on a case-by-case basis.

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