Biological agents

Biological agents are microorganisms, including genetically modified microorganisms, cell cultures and endoparasites in humans which can lead to infection, allergic reactions or toxic effects. Microorganisms are defined as cellular or non-cellular organisms capable of propagating or transforming or transferring genetic material. Microorganisms include bacteria, viruses, fungi and protozoa (unicellular animals). Microorganisms are capable of invading the human body via wounds and mucous membranes. If inhaled or ingested, they can lead to infections in the upper respiratory system or in the digestive system. Exposure can also happen in connection with accidents, for example animal bites or stabbing on syringes.

 

The Danish Working Environment Authority must be notified of any work involving classified biological agents in risk group 2 and above. The authority does not issue a permit as such. Unless otherwise dictated by the Danish Working Environment Authority, work involving the agent in question may commence 31 days after the authority’s receipt of the notification.

 

The notification must state the following:

 

1. Company name and address, including company registration no. (CVR no.)
2. Name of occupational health and safety manager and occupational health and safety representative
3. A risk assessment/biological APV
4. The nature of the biological agent(s)
5. A description of the precautions arising from the risk assessment/biological APV

 

The biological APV, also called the risk assessment, is an important part of the notification to the Danish Working Environment Authority. Your local occupational health and safety group can assist you with preparing the biological APV/risk assessment.

 

GMOs (genetically modified organisms)

 

A laboratory which is to be used for working with GMOs must be classified by the Danish Working Environment Authority in accordance with AT guidelines C.0.4: Classification of laboratories for gene technology work. Depending on class (1-4), the guidelines contain a number of requirements with regard to layout and not least instructions and descriptions of conditions in the room.

 

The occupational health and safety group and the responsible head of group are responsible for notifying and contacting the Danish Working Environment Authority. A sign on the door will state the classification of the laboratory.

 

The University of Copenhagen’s GMO consultant is Randi Shjødt Iversen (), who is based at Panum. Please contact Randi if local colleagues are unable to answer your questions about GMOs.