Use of Biological Agents

Italian Legislative Decree No. 81 of 9 April 2008 defines a biological agent as any micro-organism, including those which have been genetically modified, cell culture, or human endoparasite, which may cause infection, allergy or toxicity:

Biological agents are classified into the four groups listed below, according to the risk of infection:

• GROUP 1- a biological agent that is unlikely to cause human disease.
• GROUP 2- a biological agent that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available.
• GROUP 3- a biological agent that can cause severe human disease and presents a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available.
• GROUP 4- a biological agent that can cause serious human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.

CAUTION!

At least 30 days before anyone may commence activities that envisage the intentional use of biological agents in groups 2, 3 or 4 (art. 269 of Legislative Decree 81/2008), the Rector must notify the local Supervisory Body, attaching the risk assessment report for the biological agents in question.

Furthermore, if the biological agent to be used belongs to group 4, the Rector must be authorised by the Ministry of Employment, Health and Social Policies in accordance with the provisions of art. 270.

WHAT TO DO WHEN YOU INTEND TO USE A NEW BIOLOGICAL AGENT IN A LABORATORY

Before using a biological agent, you must request: the respective Safety Data Sheet, if the agent is being purchased, or, if the agent is to be provided by a laboratory/hospital/research agency, a statement as to which group the biological agent belongs (Biosafety level).

1. The document certifying the agent’s biosafety level must be forwarded to the Health and Safety Services Unit (PREP) together with the following information:

• a brief description of the planned research using the agent in question;
• the name of the laboratory where the activity will be carried out;
• a detailed description of the operating procedures from storage through to waste disposal, with information about the personal protective equipment that will be used and, where applicable, the type of fume hood under which the agent will be handled;
• a description of the emergency procedures to be followed in the event of an incident.

2. The Health and Safety Services Unit (PREP) will:

• perform the biological risk assessment;
• prepare any documents to be submitted to the Supervisory Body in the case of biological agents in group 2, 3 or 4;
• verify the adequacy of the laboratory containment level in relation to the group to which the agent belongs.

3. The research activity cannot commence until all the actions stated under point 2 have been completed.