Actual, target and mandatory provisions in the Genetic Engineering Safety Ordinance

Annex III of the Genetic Engineering Safety Ordinance, which specifies the safety measures for laboratory and production areas, sets out requirements for the equipment of genetic engineering laboratories at the various safety levels. For example, for laboratories at safety level 1, it is stipulated that the laboratory doors must open outwards and have viewing windows (Annex III AI No. 5 GenTSV). In contrast, for laboratories at safety level 2, it is specified that the laboratory doors must open outwards and have viewing windows. For laboratories at safety level 3, an airlock must generally be installed, which must be equipped with two self-closing doors. In practice, these formulations often lead to discussions with the supervisory authorities because it is unclear whether these are mandatory requirements and what the actual difference is.
The following can be said for outward-opening doors:
The legislator has used the term "shall" for laboratories at security level 1. This means that laboratory doors do not necessarily have to open outwards at all times, and a viewing window is not required. Outward-opening shutters are the norm here; however, exceptions must be made in justified exceptional cases. This may be the case, for example, if the structural design of the building would otherwise prevent a laboratory from being set up, or if other safety aspects, such as escape routes, speak against doors opening outwards. Since the Genetic Engineering Safety Ordinance does not differentiate between work areas and storage areas, but only refers to the laboratory area, this requirement also applies to storage rooms, since the storage of GMOs constitutes genetic engineering work.
For labs at security level 2, the legislature has used the term "must." This means that laboratory doors must always open outwards and viewing windows must be present. The approval of exceptions here is not at the discretion of the supervisory authority.
For labs at security level 3, the legislator uses the term "is" and "usually." The term "is" indicates that this is a mandatory requirement. However, this mandatory requirement is usually softened by the broader term "usually." This term, in turn, clarifies that an airlock can also be deviated from in justified exceptional cases.
In detail, each requirement specified by the supervisory authority as mandatory must be examined based on its wording to determine whether it is indeed a mandatory requirement or whether the wording allows for exceptions. This cannot be stated comprehensively and conclusively in advance for the individual requirements regarding the structural equipment of a laboratory.

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