Service Finder
Report activities involving biological agents
Service Description
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.
Process flow
The written notification must be submitted by an authorized representative of the company. The required notification form can be downloaded here.
Who should I contact?
Please contact the Thuringian State Office for Consumer Protection, Occupational Health and Safety Department, Regional Inspection South Thuringia.
Requirements
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.
Every company that wants to carry out such activities with biosubstances needs the required specialist knowledge of its personnel in order to be able to do so.
Which documents are required?
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.
What deadlines do I have to pay attention to?
You must submit the notification at least 30 days
- before commencing notifiable activities,
- before changing the permitted or notified activities
- or before terminating an activity requiring a permit
carry out.
You must report the admission of an infected patient to a patient ward at protection level 4 immediately.
Legal basis
Applications / forms
Appeal (depending on state law, the appeal may be excluded)
Action before the administrative court
Appeal
Notification for activities involving biological agents (biological substances) in accordance with Section 16 of the Biological Agents Ordinance (BioStoffV)
What else should I know?
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.
Activities in HIV, HBV or HCV diagnostics classified in risk group 3 (**) must be notified if the activities are aimed at these biological agents and are to be carried out regularly.
Only contact with blood samples during processing is not notifiable if the activities are not aimed at these biological agents in diagnostics and are not to be carried out regularly
Supporting institutions
Notifications must be submitted to the regional inspectorate responsible for the subject of your application. They can assist you with any questions you may have regarding the application.
Further Information
Author
The text was automatically translated based on the German content.
Thuringian State Office for Consumer Protection
The text was automatically translated based on the German content.
Technically approved by
Thuringian Ministry of Labor, Social Affairs, Health, Women and Family
Professionally released on
10.12.2024
11.09.2024
Source: Zuständigkeitsfinder Thüringen (Linie6Plus)
Competent Authority
Thüringer Landesamt für Verbraucherschutz (TLV) - Regionalinspektion Mittelthüringen
Address
99947 Bad Langensalza
Remark: serves as postal address
Delivery address
99099 Erfurt
Parking spaces
Besucherparkplatz
Number: 10
Fees: no