The use in research or teaching of biological agents, including genetically modified organisms (GMOs), biological agents (bacteria, viruses, fungi, parasites) and samples potentially contaminated with biological agents, can cause damage to human health and the environment.
According to current regulations it is mandatory to notify the competent authority of activities with biological agents that require a level 2 biological containment or higher (art. 10 and annex IV of RD 664/1997). In the case of genetically modified organisms (GMOs), this obligation affects the four levels of biological risk (Law 9/2003, RD 178/2004).
In all cases, the notifications must be previously reviewed by CBSUB before being submitted to the competent authority, and it will also be necessary to perform and document a risk assessment of the activity with biological agents.
Regardless of the fulfillment of legal requirements, and provided that the activity involves the use of biological agents and is carried out in UB facilities, a risk assessment of the activity must be carried out and documented and notified to the CBSUB.
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