Rooms or areas, which applies now?

According to the GenTG, a genetic engineering facility is a facility in which genetic engineering work is carried out (Section 3 No. 4 GenTG). The term "facility" is not defined in the GenTG itself. European law, namely the Systems Directive, at most stipulates that it must be a closed system, otherwise the Deliberate Release Directive would apply. However, the term "facility" is defined in the Federal Immission Control Act (BImSchG), which regulates the licensing of "industrial facilities." According to Section 2 Paragraph 5 BImSchG, a facility is either a technical measure or a physical structure. It is undisputed that a physical structure, at least if it is a closed system, as is the case with laboratories, can be a genetic engineering facility. Even a technical measure meets the requirements for a closed system if genetically modified organisms (GMOs) cannot escape. This could be the case, for example, with a pond, a part of a river enclosed by land barriers, or a fenced pasture. Accordingly, technical measures can also be considered a facility and thus a genetic engineering facility within the meaning of the GenTG.

Now, however, the GenTSV (Annex 2 (to Section 14) provides for safety measures for laboratory and production areas in AI a. No. 1 stipulates that “The work must be carried out in demarcated and sufficiently large Rooms , formerly areas, are to be carried out." This means that, according to the wording, a genetic engineering facility must always be a room. This means that technical precautions such as animal cages, -80°C temperatures, or fenced pastures within the meaning of Annex 2 (to Section 14) of the GenTSV are conceptually excluded from being considered a genetic engineering facility, even though they can also be laboratory or production facilities.

However, it is questionable whether the regulatory authority is actually permitted to restrict the term "genetic engineering facility" (which is uniformly regulated by federal law) through its own definition. This is not a question of administrative enforcement, but rather a restriction of a definition prescribed by law, which in the first place opens access to the GenTG. In this respect, it is very questionable whether the regulatory authority is permitted to define the term "genetic engineering facility" more narrowly than the legislature. This is particularly so because the legislature has opted for a broad definition of a genetic engineering facility, which in turn must be compliant with European law. Doubts about the legal conformity of the GenTSV (Annex 2 (to Section 14) Safety Measures for Laboratory and Production Areas AI a. No. 1) are therefore justified.