The operating instructions – what are the requirements for them?

The provisions of the Genetic Engineering Act (GenTG) regarding operating instructions are only very basic. It merely authorizes the possibility of further specification by means of an ordinance. In this respect, it simply states that a legal ordinance must specify in more detail how and at what intervals employees are to be instructed about the hazards and measures for their prevention, and how employees are to be informed about the risks and measures for their prevention. the content of the regulations to be applied in the company in an activity-related operating instruction, taking into account safety advice must be brought to the attention of the public.

Further details are provided in Section 17, Paragraph 1 of the GenTSV (General Occupational Safety Measures). According to this Act, employees may only be commissioned to carry out genetic engineering work if they are sufficiently qualified and instructed. (2) The operator must, prior to commencement of genetic engineering work, prepare a To draw up operating instructions in which the risks of genetic engineering work for human health and the environment, as identified and assessed in accordance with Section 13 (1) GenTSV, are set out and the necessary safety measures and rules of conduct are specified.

Form, language, knowledge and revision:

The operating instructions are 1. in clear form and written in a language understandable to the employees and suitable place in the
workplace, 2. must immediately available be, 3. is as needed, but at least every two years , and updated if necessary. Employees assigned to genetic engineering work must be informed by the project manager on the basis of the operating instructions regarding the possible hazards and the necessary safety measures. instructed The Instructions must be given orally in security levels 2, 3 or 4, or orally in security level 1 orally or by electronic means of communication with success control and in each case job-related before the first employment and thereafter at least once a year be made.

Content requirements:

The operating instructions must

- tätigkeitsbezogenen sein muss und
 - auch Sicherheitsratschläge enthalten.

In terms of content, it can be summarized that it provides information about

 1. Gefahren gentechnischer Arbeiten - anhand der Risikobewertung und der Gefährdungsbeurteilung - für die
 -> menschliche Gesundheit und für die
 -> Umwelt
 2. die erforderlichen Sicherheitsmaßnahmen
 3. die Verhaltensregeln
 4. die Anweisungen für das Verhalten im Gefahrfall und für die Erste Hilfe und
 5. die Informationen über in Frage kommende Maßnahmen zur Immunisierung und zur Postexpositionsprophylaxe

must contain.

The activity-based approach, which is geared towards risk assessment in accordance with occupational health and safety regulations, requires that the operating instructions be tailored to the individual workplaces and the work to be performed there. This, in turn, is the reason why many facilities have individual workplace-specific operating instructions (short instructions) posted for individual workplaces, such as safety cabinets, autoclaves, incubators, etc. However, the subject of the individual case-specific and annual training is usually the complete operating instructions (long version) that have been prepared for all work areas in a laboratory.

In the annexes to the GenTSV, it is then only uniformly specified for all areas, namely laboratories, production facilities, greenhouses and animal husbandry facilities, that the Operating instructions , hygiene and skin protection plan at appropriate locations in the genetic engineering facility to hang out are or they must easily available elsewhere It is therefore recommended that the brief operating instructions be posted in a readily accessible location near the equipment or at least kept within easy reach in the laboratory. Keeping the operating instructions in an office, away from the safety-relevant equipment, is probably not compatible with this.

Finally, a fine is also provided for the operator. According to Section 17 Paragraph 2 Sentence 1 of the GenTSV, a fine can be imposed if an operating instruction is not drawn up or is not drawn up in a timely manner. Since the creation of an operating instruction also falls within the operator's area of ​​responsibility under the law, the fine is also directed at the operator. In this context, it should be noted that the legislature has only sanctioned the case where an operating instruction is not drawn up at all. Accordingly, errors in the operating instruction are not subject to fines. An operating instruction would not be drawn up in a timely manner if it was only drawn up after the start of work on a safety-relevant device or a safety-relevant activity.