Fines in the GenTSV

Here is a sample of my favorite regulation: According to it, fines are imposed:

“if the operator intentionally or negligently violates Section 9 (1) Sentence 1 in conjunction with Annex III Part A Section III No. 3 Sentence 2, 9 Sentence 2, No. 11 or 13, Section IV Nos. 2, 3, 5, 6 or 8 or Part B Section II No. 12, Section III No. 5 Sentence 2 or 3, 8, 10, 11 Sentence 1, 2 or 3 or Section IV Nos. 1, 3, 4-7 GenTSV.”

This should make it clear to every operator what they are not allowed to do and what can be subject to a fine!?!? And this is just one of a total of eight fines! From a rule-of-law perspective, such regulations are highly questionable.
Anyone interested can try translating it themselves. For everyone else: This generally covers facility-related requirements from safety level 3 in the laboratory area. This applies to

– the locking mechanisms of the lock,
– chemical inactivation,
– the negative pressure method,
– the HEPA filter and
– replacing filters from the safety cabinet.

The measures under Section IV, which apply to safety level 4 in laboratories, will not be discussed in detail here. The same applies to the facility-specific requirements in the production area (Part B, Sections III and IV).

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