Fines for the project manager’s duties

We reiterate: If a task or its failure to comply with it does not constitute an offense punishable by a fine, it cannot be punished with a fine. In this respect, it is worthwhile to compare Section 14 of the GenTSV and Section 38 of the GenTG.

Section 14 paragraph 1 no. 4 GenTSV stipulates that the project manager, upon his appointment, is responsible for the adequate qualification and instruction of the employees.

Section 38 of the Genetic Engineering Act (GenTG) does not contain any provisions for imposing fines on the adequate qualification and training of employees. Therefore, the genetic engineering authority cannot impose a fine on the project manager on this basis if the staff is not adequately trained and qualified. This demonstrates that the threshold for a fine is generally only reached if the obligations arising from the approval procedure under Section 8 of the Genetic Engineering Act (GenTG) or the operator's obligations under Section 6 Nos. 1-4 of the Genetic Engineering Act (GenTG) have been violated.

Section 20 of the GenTSV also does not contain any administrative offenses for the qualification of employees.

According to Section 20 No. 2 GenTSV, anyone who fails to prepare operating instructions or fails to prepare them in a language understandable to employees, contrary to Section 12 Paragraph 2 Sentence 1 or 2 GenTSV, is committing an administrative offense. Incorrect drafting of operating instructions is therefore punishable by a fine. According to Section 12 Paragraph 2 GenTSV, the operator must prepare operating instructions for employees based on the risk assessment. This instruction must identify the potential hazards of genetic engineering work for human health and the environment and specify the necessary safety measures and rules of conduct. The operating instructions must be written in an understandable form and in a language understandable to employees and posted at a suitable location in the workplace. This is therefore expressly an operator obligation. The above-mentioned case of Section 14 Paragraph 1 No. 4 GenTSV, namely instruction by the project manager, is not covered by this.

In addition, anyone who, contrary to Section 12 Paragraph 3 Sentences 1-4 GenTSV, fails to instruct employees, fails to do so in the prescribed manner, or fails to do so in a timely manner is committing an administrative offense under Section 20 No. 3 GenTSV. According to Section 12 Paragraph 3 Sentences 1-4 GenTSV, employees who carry out genetic engineering work must be instructed on the basis of the operating instructions about the hazards that arise, particularly when handling organisms in risk groups 2-4 according to Section 5 in conjunction with Annex I, as well as about the safety measures. Women must also be informed about possible risks for expectant mothers. The instructions must be given to employees and then repeated verbally and at specific workplaces at least once a year. The content and time of the instructions must be recorded in writing and confirmed by the instructed person with their signature. In the case of genetic engineering work at safety levels 2, 3, or 4, the instructions must be given before each safety-relevant change to this work. (According to paragraph 5, which was not referred to in the administrative offense, the content and time of the instruction must be recorded in writing and confirmed by the instructed person by signature.) This obligation, in contrast to Section 12 Paragraph 2 Sentence 1 or 2 GenTSV, is not operator-related, but rather open with regard to the obligated party. Since the project manager is responsible for the instruction according to Section 14 Paragraph 1 No. 4 GenTSV, he commits an administrative offense if he

• when handling R 2 organisms, does not instruct the staff on the criteria of risk assessment and the resulting safety measures
• the instruction does not take place in the presence of the employees
• the training is not given annually and is repeated on a workplace-related basis
• the content is not recorded in writing and confirmed by the instructed person by signature
• in genetic engineering work at safety levels 2-4, training is not provided before each safety-relevant change to the work. Conversely, this means that when handling R1 organisms, training according to the above criteria is not required; in any case, no fine can be imposed for errors. In the case of work at safety level 1, no further training is required even if safety-relevant changes are made to the work. If such further training is not provided, no fine can be imposed on the project manager. Since in practice training is provided regardless of the safety level, this fine is of little relevance if the project manager adheres to the above criteria in the sense of a tabular process.

Furthermore, anyone who fails to comply with a measure specified in Section 12 (8) of the GenTSV in conjunction with Annex VI, Chapter F or G, commits an administrative offense. The latter administrative offense relates to occupational health prevention pursuant to Annex VI. However, the imposition of a fine is precluded solely because Annex VI does not contain Chapters F and G. In this respect, the fine is not legally applicable.