Report activities involving biological agents

Before you work with biological substances, for example in laboratories or in the health service, you must notify the competent authority. A permit is required for work in protection levels 3 and 4, which is not covered here.

Biological agents are essentially microorganisms, such as bacteria, fungi or viruses, which can endanger humans through infections, toxic, sensitizing or other health-damaging effects. People who work in certain areas are more exposed to biological agents than the general population.

Some examples are activities in the following areas

• Healthcare,
• waste treatment,
• waste water technology,
• animal husbandry
• food production.

The legislator differentiates between targeted and non-targeted activities. A targeted activity is, for example, the planned cultivation of a known bacterium, such as a tuberculosis pathogen. However, non-targeted activities are predominantly carried out where the biological agents occur as accompanying substances or contaminants and are not the objective of the work. Examples of this are waste sorting facilities, archives or work in forestry. The organisms are classified in risk groups 1-4. This depends on the risk of infection according to the latest scientific findings. Risk group 1 means the lowest risk.

As an employer, you must report the following activities to the competent authority:

• In laboratories, in laboratory animal husbandry and in biotechnology, if
  • Your employees are working for the first time on a specific activity involving biosubstances in risk group 2 or risk group 3(**).
  • your employees are working for the first time on a non-targeted activity of protection level 2 with biosubstances of risk group 3, provided that the activities are aimed at these biosubstances, are carried out regularly and are not subject to a permit requirement.
• If the permitted or notified activities are changed and this is significant for safety and health protection. This includes, for example
  • activities aimed at increasing the virulence of the biological agent or
  • the commencement of activities involving other biosubstances of risk group 3 or 4.
• In hospitals, if an infected patient has been admitted to a patient ward of protection level 4.

when an activity requiring a permit is terminated.

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State Trade Inspectorate of Lower Saxony

Online services available: Yes, in NRW, but not yet introduced in Lower Saxony

If necessary, you must apply for a permit for activities involving pathogens (Section 44 of the Infection Protection Act, IfSG for short) or a permit for activities involving animal pathogens (Section 2 of the Animal Pathogens Ordinance, TierSEV for short). If you have already received a permit or are exempt from a permit for activities involving pathogens (Section 45 IfSG) or animal pathogens (Section 3 TierSEV), you must justify this.

Appeal (depending on state law, the appeal may be excluded)

Action before the administrative court

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You are committing an administrative offense if you

• not,
• not correctly,
• not completely
• or not in time.

If you act intentionally and endanger the life or health of an employee, you are liable to prosecution.

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