NRW: Changes for S 1 and 2 plants through general decrees

Background: The previous notices issued by the Düsseldorf Federal Court of Justice for S 1 and 2 facilities contained, among other things, strict ancillary provisions regarding disinfection procedures and the autoclaving process. Effective February 28, 2025, these are to be revised/amended by general decrees (case numbers 53-05-10-D-24-011 and -015).

The New regulation of the disinfection procedure can be found under serial number 42 in the Official Gazette (Abl. Bez. Reg. Ddf 2025 p. 66 ff.). Without further proof of effectiveness, disinfection processes from the disinfectant lists of the Robert Koch Institute (RKI list) or the Association for Applied Hygiene (VAH) or the German Veterinary Medical Society (DVG) can be used if specified criteria are observed. Exceptions exist for work with enveloped viruses and parvoviruses. If no disinfection processes are included in the RKI, VAH or DVG lists in an individual case, processes from the ECHA database or processes tested according to EU standards from the list of the Industrial Association for Hygiene and Surface Protection (IHO list) can be used without further proof of effectiveness. Overall, the use of the disinfection processes is subject to agreement with the supervisory authority.

The Supplement to the effectiveness of the autoclaving process used can be found under the serial number 43 in the Official Journal (Abl. Bez. Reg. Ddf 2025 p.68 f.).

In the future, in addition to biological indicators, suitable chemical indicators according to (DIN EU ISO 11140) or a parametric test (device-independent measurement and recording of temperature and pressure over time of the respective autoclaving process) may also be used. The results of the effectiveness test must be documented in the records.

With regard to the effectiveness of general rulings, the Federal Administrative Court (judgment of January 22, 2021 - BVerwG 6 C 26.19 -, juris) ruled that publication in the Official Gazette pursuant to Section 41 (3) Sentences 1 and 2 of the Administrative Procedure Act is only permissible if this type of announcement is permitted by law or if notification to those involved is impractical. The GenTG, the GenTSV and the GenTVfV do not permit announcement in the Official Gazette with regard to notified and registered genetic engineering facilities. Public announcement is explicitly only provided for approvals, i.e. from sentence 3 onwards (Section 12 GenTVfV). The provisions of Section 12 (6) in conjunction with Section 19 Sentence 3 GenTG in conjunction with Section 19 Sentence 3 GenTG in conjunction with In conjunction with Section 49 (1) of the North Rhine-Westphalia Administrative Procedure Act (VwVfG), only the issuance of subsequent ancillary provisions is justified, not their public publication in the Official Gazette. It is neither claimed nor apparent that publication is advisable in individual cases where the initial ancillary provisions have also been published on a case-by-case basis.

To the extent that the ancillary provisions have nevertheless been sent to the plant operators, case law has held that actual knowledge of them is sufficient for their effectiveness. Since the new ancillary provisions are likely to have a positive impact on the plant operators, legal recourse in this regard is not to be expected, so the question may not even be relevant.