Report activities involving biological agents

Source: Serviceportal Rheinland-Pfalz

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.

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.

The notification must include the following information:

Name and address of the employer,
a description of the planned activities, including the name of the premises where these activities are to be carried out.
the measures planned to protect the health and safety of employees.
the result of the risk assessment in connection with the Occupational Health and Safety Act.
- The risk assessment must be carried out by an expert.
- If the employer does not have the relevant knowledge himself, he must seek expert advice.
the type of biological substance.

You can also comply with the obligation to notify by sending the competent authority a copy of a notification, authorization or permit under another legal provision within the deadline if this contains equivalent information.

Report activities involving biological agents

Requirements

Which documents are required?

What deadlines do I have to pay attention to?

Legal basis

Applications / forms

What else should I know?

Professionally released on

Translation note