Biological Agents Notification

Under the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 and 2020, there is a legal requirement to notify the Health and Safety Authority if working with certain risk groups of biological agents.

Notification is required 30 days prior to commencement of work with respect to the use of the following:

• First time use of group 2 biological agents - the subsequent use of further/new group 2 biological agents do not need to be notified
• First time use of group 3 biological agents - the subsequent use of new group 3 biological agents do not need to be notified except where the employer provisionally classifies that biological agent
• First time use of group 4 biological agents - all subsequent uses of any further/new group 4 biological agent must be notified.

Use of a Biological Agent

Use implies the deliberate/intentional use of a biological agent i.e. intentionally cultivating/propagating, concentrating or otherwise increasing  the risk of exposure to the biological agent.

In certain areas of work such as medical diagnostics or microbiological research, there may be a transition from non-intentional use to intentional use, for example, if the biological agent identified in the initial diagnosis is then specifically propagated for the purpose of further characterisation such as subtyping or resistance testing. In such cases, notification will then be required.

Diagnostic Laboratories

Laboratories carrying out a purely diagnostic service are not required to notify the Authority unless they are working with a group 4 biological agent. However, if the laboratory is deliberately propagating or concentrating group 2 or group 3 biological agents, then notification will be required. If a group 2, 3 or 4 biological agent is being stored in a culture collection, this will need to be notified to the Authority as the collection will need to be maintained and this will involve viability checks of the agent and deliberate propagation.

How to Notify

Notification may be made using the biological agents’ notification form  or by other suitable methods. If using an alternative method it is a legal requirement that the information as detailed in Regulation 14(1)(f) of the Biological Agents’ Regulations is included in the notification.

Sufficient information must be given about the risk assessment and preventative measures in order to demonstrate that the employer has identified the hazards and risks associated with the agents in conjunction with the planned work.

Information that must be contained in the notification include:

• The name and address of the establishment or undertaking (or both): this must relate to the place where the work is being carried out. For example, in the case of universities, the department or faculty carrying out the work must be documented including the specific location or building in question. Where eircodes are available for the building/place of work they should be provided.
• The names and capabilities of the person responsible for safety and health at work: this relates to the local area management personnel who have day-to-day responsibility for health and safety. Provide information that demonstrates whether the person has the competencies to manage or supervise work activities with the notified risk group – for example, previous experience working at the containment level, appropriate training etc.
• The results of the risk assessment: at a minimum this should include the the identified natural route of infection for the agent, how the worker may potentially be exposed to the agent during the course of the work, what the potential outcome of exposure may be etc. The risk group classification alone is not sufficient information to demonstrate that a risk assessment has been conducted.
• The species of biological agent.
• The protective and preventative measures that are envisaged – identify the control measures are to be used to prevent exposure.

Notifications may be submitted to the Authority:

• By email to bioagents_notif@hsa.ie
• In writing to the Health and Safety Authority, Occupational Health and Hygiene Policy Unit, The Metropolitan Building, James Joyce Street, Dublin 1, D01 K0Y8.

Note that the notification requirement is not an approval or licensing system.

Irrespective of this, the Health and Safety Authority under Regulation 4 of the Biological Agents' Regulations may prohibit the use of the biological agent(s) referred to in the notification or require the application of additional controls to safeguard the safety, health and welfare of employees from exposure to the notified biological agent(s). 

Re-Notification

Re-notification is required for all groups if there are substantial changes of importance to safety and health at work to either or both processes and procedures that result in the original notification being invalid or out of date. This includes where the Company/Establishment ceases to work with:

• the notified group i.e. group 2, 3 or 4 biological agents;
• the specific notified self-classified group 3 biological agent;
• a specific group 4 biological agent; or

the Company/Establishment changes its legal name or ceases business/trade.