Amendment to the GenTSV as of March 2021 regarding the required professional experience

The Genetic Engineering Safety Ordinance (GenTSV) requires project managers (PL) in S3 facilities to have at least two years of professional experience (Section 28, Paragraph 2, No. 2, Second Half Sentence GenTSV). This regulation is related to the expertise of the project manager. It states: "The expertise required under Paragraph 1 shall be demonstrated by

• at least 3 years' experience in the field of genetic engineering, in particular microbiology, cell biology, virology or molecular biology, and, if the intended project management relates to genetic engineering work at safety level 3 or 4, at least 2 years' experience within safety levels 2, 3 or 4 and...

Since Section 30, Sentence 2 of the GenTSV (German Genetic Testing Ordinance) states that the requirements for the necessary expertise and proof of this expertise are governed by the provisions of Section 28 GenTSV applicable to project managers, this requirement will also apply without restriction to BBS in the future. Accordingly, only those who have at least two years of experience at safety levels 2, 3, or 4 can be appointed as BBS for a genetic laboratory with containment level 3 or 4. For both, the question arises as to when the operator must comply with these requirements and whether the obligation only applies when new PLs or BBSs have to be appointed. This is not explicitly stated in the law. Furthermore, there has not yet been a case where the expertise requirements have been increased in the past. The answer must therefore be determined by interpretation: The wording of the regulation does not indicate that this obligation only has to be complied with when new PLs or BBSs are appointed in the future. Rather, it is based in the abstract sense on the fact that the necessary expertise must be demonstrated. However, both Section 28 Paragraph 1 Sentence 1 of the GenTSV for the PL and Section 30 Sentence 1 of the GenTSV for the BBS stipulate that only a person who possesses the necessary expertise may be appointed as PL/BBS. This could be used to stipulate that this only applies to the future appointment of expert personnel. On the other hand, Section 6 Paragraph 1 of the GenTG requires that genetic engineering facilities must always correspond to the current state of the art in science and technology, including with regard to safety measures. From this, it must be concluded that the new requirement for the expertise of the PL and BBS must also be complied with. It would be contrary to the spirit and purpose of this requirement that legal changes relating to the construction and equipment of laboratories must be regularly adapted and that this should not apply to the technically responsible personnel in the laboratory. In this respect, the update requirement during the transitional period granted until March 1, 2021, should also apply to the PL and BBS in genetic engineering facilities. Result:

Both the PL and the BBS of a genetic engineering facility at safety level 3 would be well advised to verify their at least two years of activity within the scope of safety levels 2, 3, and 4, obtain subsequent certification if necessary, submit this information to the operator, and instruct the operator to demonstrate the required expertise to the licensing authority pursuant to Section 21, Sentence 3 of the Genetic Engineering Act (GenTG) (in North Rhine-Westphalia, not to the supervisory authority). This is even if the revised Section 33 of the Genetic Engineering Ordinance (GenTSV) does not provide for a corresponding fine.