In the jungle of approvals...

If S2 work involving specific viruses that are pathogenic to humans and animals is to be conducted in a registered S2 laboratory, the PL must ensure that the operator must contact four authorities in each individual case! The questions remain: Why the PL? And why four?

Answer 1:

The PL, because compliance with parallel provisions to the GenTG according to Section 27 Paragraph 1 GenTSV is one of the statutory duties of the PL. According to this, he/she is responsible ... for compliance with the protective provisions of Sections 13 to 26 GenTSV as well as the infection control, animal health, animal welfare, species protection and plant protection regulations (No. 1). Accordingly, compliance with the Infection Protection Act (IfSG), the Animal Health Act (TierGesG), in particular the Animal Diseases Ordinance (TierSeuchErrV) and - via § 13-26 GenTSV - also the Biological Agents Ordinance (BioStoffV) are part of the The PL's testing repertoire . This is often overlooked in laboratories.

Answer 2:

When using certain viruses with the above-mentioned properties, a Notification according to GenTG (further S2 work). This is especially true if the work is not covered by the original application. Furthermore, work with biological substances is usually also likely to be included, which at least according to the BioStoffV , if it were targeted, notifiable The notification can be fulfilled by sending a copy of the genetic engineering notification to the competent occupational safety authority (Section 16 (4) of the BioStoffV). Permission according to § 44 IfSG and the Advertisement the first commencement of the activity according to § 49 IfSG with the health authority responsible under state law because of human pathogenicity and the Permission according to § 2 TierSeuchErrV and the Advertisement the first commencement of activity after § 6 Animal Disease Ordinance to the veterinary office or the competent authority under state law, if necessary, due to animal pathogenicity. In any case, all approaches must be carefully examined on a case-by-case basis.

Now you can understand why the legislator has given the applicant/operator the option of applying for a permit instead of notifying another S2 activity in these cases. This is because the relief for the applicant lies in the fact that, according to Section 22 GenTG, so-called concentration effect The concentration effect means that only a single procedure with a single authority must be carried out by the operator, and the subsequent approval under the GenTG includes all other official permits. This means that neither further official procedures nor further permits need to be obtained. This concentration effect occurs by operation of law and is not discretionary for the authorities.