Limited expertise of project managers

In principle, a project manager must possess demonstrable knowledge, particularly in classical molecular genetics, practical experience in dealing with microorganisms, plants, or animals, and the necessary knowledge of safety measures and occupational health and safety during genetic engineering work (Section 15 (1) Sentence 1 of the Genetic Engineering Safety Ordinance). The required expertise is demonstrated by a university degree in natural sciences, medicine, or veterinary medicine, and at least three years of experience in the field of genetic engineering, particularly microbiology, cell biology, virology, or molecular biology (Section 15 (2) Nos. 1 and 2 of the Genetic Engineering Safety Ordinance). In addition, a certificate of attendance at a training course recognized by the responsible state authority that imparts the knowledge required under paragraph 4 is required. Modified requirements for production and releases are regulated in the Genetic Engineering Safety Ordinance.

The possibility of restricting the proof of the required expertise arises from Section 15, Paragraph 3, Sentence 2 of the Genetic Engineering Ordinance (GenTSV). According to this provision, the authority may, in derogation from the relevant studies and three years of practical experience for specific genetic engineering work, restrict the proof of the required expertise.

The question is under what conditions the proof of the required expertise can be restricted. From the wording of Section 15 (2) Sentence 2 GenTSV, one could conclude that a restriction on the proof of the required expertise would depend solely on the specified genetic engineering work. This is the only thing the provision refers to according to the wording. This, in turn, would have the consequence that even a housewife who has neither a university degree in natural sciences, medicine, or veterinary medicine, nor at least three years of experience in the field of genetic engineering, in particular microbiology, cell biology, virology, or molecular biology, could receive restricted proof for certain genetic engineering work. This seems questionable. Therefore, the provision of Section 15 (2) Sentence 2 GenTG should be read in the context of Section 15 (3) Sentence 1 GenTSV. The authority may then also recognise the completion of another training, further training or continuing education course as proof of the required expertise pursuant to paragraph 2, sentence 1, numbers 1 and 2, provided that the imparting of the knowledge and skills required pursuant to paragraph 1 was the subject of the training, further training or continuing education course and, taking into account the genetic engineering work to be carried out, is to be regarded as equivalent to the requirements stated in paragraph 2, sentence 1, numbers 1 and 2. Accordingly, the prerequisite for a limited proof of expertise is in any case,

1. the implementation of another training, further training or continuing education measure,

2. where a degree has been achieved,

3. in addition, this training, further training or continuing education must have concerned the knowledge and skills required under paragraph 1 and

4. the further training measure must be considered equivalent.

Only if these requirements are met can the authority restrict the proof of the necessary expertise.
This interpretation is supported by the fact that "the proof... should be limited," not the expertise as such. Furthermore, the possibility of limiting the proof was not included in a separate paragraph, but rather as sentence 2 of Section 3, Sentence 1 of the GenTSV. The structure of the law also supports the idea that this is not intended to be a completely separate exception not bound by the requirements of Sentence 1.

The Federal/State Working Group on Genetic Engineering cites schools in connection with this regulation. Most schools, they say, lack teachers with the required university degree and three years of experience in the field of genetic engineering. To conduct exclusively genetic engineering work at safety level 1 and only with specific organisms (donor = R1, recipient = R1, vector-recipient system = biological safety measures), teachers with suitable scientific teaching qualifications can be appointed as project leaders. In these cases, the above-mentioned requirements are met, as the teachers in question have achieved a degree through their studies, which may also include knowledge of classical and molecular genetic engineering and practical experience in dealing with microorganisms, plants, or animals, as well as knowledge of safety measures and occupational health and safety during genetic engineering work. This qualification can also be provided by a degree in nutritional science with a specialization in the environment. In the aforementioned cases, the authority can then issue proof of the required expertise in full or in a restricted manner in accordance with Section 15 Paragraph 3 Sentence 2 GenTSV.

In any case, however, a certificate of attendance at a training event at which knowledge is imparted in accordance with Section 15 Paragraph 4 Sentence 1 GenTSV must be presented.

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