Curtains and paper notices in genetic engineering S2 facilities?!?

Dr. Petra Kauch

The question of paper notices in an S2 system is discussed in practice but is generally rejected by the authorities.

Even if I personally haven't "noticed" curtains during my inspection of S2 genetic engineering facilities (through the viewing window, of course), the above question has been brought to our attention by practitioners. Upon closer inspection, in addition to curtains, posted operating instructions, checklists for eyewash station inspections, calendars, and even postcards/cartoons are indeed a topic of discussion during inspections. According to some of the authorities responsible for monitoring, paper posters, green plants, and curtains are not permitted in S2 genetic engineering facilities. This is justified by Annex 2, Section A, Paragraph II. a. No. 3 of the GenTSV. According to this regulation, "surfaces in workrooms (e.g., work surfaces, walls, floors, and furniture surfaces) must be easy to clean and resistant to the substances used, as well as to cleaning agents and disinfectants. The work surfaces, adjacent wall surfaces, the floor, and the wall-floor junction must be liquid-tight." In my opinion, this does not allow any conclusions to be drawn regarding curtains or paper in an S2 facility, as the aforementioned are not covered by the wording. It is therefore questionable whether laboratory areas are covered beyond the wording (work surfaces, walls, floors, and furniture surfaces). Rather, this is contradicted by the fact that the legislature clearly already had the workplace area in mind with its wording. For example, doors, lamps, and blinds are not described, but cannot be counted as work surfaces, walls, floors, or furniture surfaces. Accordingly, the Genetic Engineering Safety Ordinance (GenTSV) does not contain any clear regulations regarding curtains, flowers, and paper.

TRGS 526 Laboratories/BG I/GUV-I 850-0 Safe Working in Laboratories, and DGUV 213-086 (German Social Accident Insurance), which address organizational measures in biological laboratories and are relevant for an S2 laboratory as occupational safety regulations via the BioStoffV and the Occupational Safety and Health Act, also provide no information in this regard. The manual, "The Conduct of GLP Inspections in Germany," 11th ed., as of January 1, 2018, contains no further information. DIN EN 12128 (Safety levels of microbiological laboratories, hazardous areas, premises, and technical safety requirements) is also not covered. Ultimately, the basic principles of good microbiological techniques (GMP) also do not apply to curtains, flowers, and paper.

A more precise formulation in the GenTSV or at least an interpretation aid via the Federal/State Working Group on Genetic Engineering (LAG) would be advisable.

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