Protection level assignment according to the BioStoffV and safety classification in the GenTSV
Dr. Petra Kauch
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A frequently asked question in the context of specialist knowledge for the Biological Agents Ordinance is whether there is a counterpart in the Genetic Engineering Act to the protection level assignment (Section 5 of the Biological Agents Ordinance). The answer is: Yes! While the protection level assignment for handling biological agents is based on Section 5 (2) of the Biological Agents Ordinance and must be made with regard to their risk of infection, taking into account the following criteria:
- Highest principle for targeted activities
- The safety classification under the Genetic Engineering Act is based on the probability of occurrence, type of activity, type, duration, level, and frequency of the identified exposure during non-targeted activities, as per Section 7 of the Genetic Engineering Ordinance. This differentiates between work with microorganisms and cell cultures in the field (Section 7 (2) of the Genetic Engineering Ordinance), genetic engineering work with microorganisms and cell cultures for research purposes (Section 7 (3) of the Genetic Engineering Ordinance), and genetic engineering work with animals and plants (Section 7 (4) of the Genetic Engineering Ordinance). The relevant criteria are generally the recipient organisms, taking biological safety measures into account, the vectors, and nucleic acids transferred from the donor organism, as well as synthetic ones. Under the Genetic Engineering Safety Ordinance - unlike the Biological Agents Ordinance - the hazard potential must always be assessed taking into account the protected assets of humans (including outside the facility) and the environment. Under the Biological Agents Ordinance, the protected asset is "only" the employee (usually within the laboratory). The very extensive criteria of Section 7 GenTSV must be processed as part of the risk assessment and then, depending on their risk potential, lead to the safety levels 1-4 specified in the individual paragraphs.