What are Biological Agents
Biological agents are widely found in the natural environment and as a result found in many work sectors. They include bacteria, viruses, fungi (yeasts and moulds) and parasites. Some of these agents are harmless whilst others may have potential to cause ill health.
As they are usually invisible, it is often difficult to appreciate the risks they present. As a worker you may be harmed by being infected by a biological agent, by being exposed to toxins produced by the biological agent or have an allergic reaction to the biological agent or substances it produces, for example, enzymes.
Biological agents have the ability to replicate rapidly, require minimal resources to survive and can infect at very small doses.
In the workplace, exposure to biological agents can be intentional, whereby the employee works directly with them, for example, in a laboratory or research facility or unintentional, whereby the employee is exposed to the biological agent due to the work they do, for example, a healthcare worker who is exposed to a blood borne virus, a laundry worker who receives a needlestick injury or a farmer who is exposed to an animal disease that can also affect humans (a zoonose).
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The Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 ( S.I. No. 572 of 2013) sets down the minimum requirements for the protection of workers from the health risks associated with biological agents in the workplace. The regulations must be applied to any activity where workers are actually or potentially exposed to biological agents as a result of their work. These regulations also apply to cell cultures and to Genetically Modified Micro-organisms (GMM's/GMO's). Note that GMO's are also regulated by legislation enforced by the Environmental Protection Agency
These Regulations enable the publication of some aspects of the Biological Agents Directive (i.e. the list of biological agents and their classification, together with indications concerning containment measures and levels) in a relevant Code of Practice, rather than in the Regulations themselves.
These Regulations define biological agents and apply to activities in which workers are or potentially are exposed to biological agents as a result of their work. Employers must identify the biological agent to which workers are, or may be, exposed. They must assess the risk, making use of the list of biological agents, their classification, containment levels and measures provided for in the relevant Code of Practice, and proceed in accordance with the remaining Regulations where appropriate.
These Regulations permit the Health and Safety Authority to prohibit a specific use of a Biological Agent or request that additional control measures are put in place (Regulation 4). These Regulations transpose Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work. This is a codified Directive which repealed and replaced Council Directive 90/679/EEC of 26 November, 1990, as amended.
These Directives were previously transposed in Ireland through the Safety, Health and Welfare at Work (Biological Agents) Regulations 1994 (S.I. No. 146 of 1994) and the Safety, Health and Welfare at Work (Biological Agents) (Amendment) Regulations 1998 (S.I. No. 248 of 1998). The 1994 and 1998 Regulations are repealed and replaced by the 2013 Regulations (S.I. No. 572 of 2013)
Copies of S.I. 572 of 2013 are available from the Government Publications Office, 52 St. Stephen’s Green. Dublin 2. (Tel.: 01- 6476834; Fax: 01-6476843). Price €6.60
- The Safety, Health and Welfare at Work (General Application) Regulations, 2007, (S.I. No. 299 of 2007). Some biological agents have the potential to affect certain sensitive risk groups and there is a specific legal obligation under Part 6 of the Safety, Health and Welfare at Work (General Application) Regulations, 2007, (S.I. No. 299 of 2007) for employers to assess the exposure of children and young persons and pregnant, post natal and breast feeding employees to biological agents
For example, certain biological agents such as toxoplasma and rubella virus can cause foetal harm and as a result the employer must assess exposure of pregnant employees to these viruses.
- (No. 10 of 2005). Under this legislation there are specific The Safety, Health and Welfare at Work Act, 2005 requirements in relation to substances. A substance is defined under the Act as including any natural or artificial substance, preparation or agent in solid or liquid form or in the form of a gas or vapour or as a micro-organism (i.e. a biological agent)
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Classification of Biological Agents
Biological Agents are classified in the Code of Practice to the Safety, Health and Welfare at Work (Biological Agents) Regulations, 2013, into four risk groups – groups 1, 2, 3 and 4.
The classification system is based on whether:
- The agent is pathogenic to humans
- The agent is a hazard to employees
- The agent is transmissible to the community
- There is effective treatment or prophylaxis available
Under the classification system, Group 1 agents are the least hazardous whilst Group 4 are the most hazardous.
Schedule 1 of the Code of Practice provides a non-exhaustive classification list of biological agents. Only agents in hazard groups 2 – 4 are listed. If the agent you are working with is not on the list, the categorisation will need to be determined by assessment based on the criteria above. Biological agents should not be automatically categorised into hazard group 1.
The categorisation system gives an indication of the inherent hazard of the biological agent but it does not take account of the work that may be carried out with the agent or the exposure of sensitive groups, for example, pregnant employees to the agents.
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Biological Agents Notification
Under the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013, there is a legal requirement to notify the Health and Safety Authority if working with certain groups of biological agents.
Notification is required 30 days prior to commencement of work with respect to the following:
- First time use of a group 2 biological agents
- First time use of a group 3 biological agents
- First time use of a group 4 biological agents
First time of each subsequent use of group 4 biological agent and new group 3 biological agents, where the employer provisionally classifies that biological agent.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 – 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.
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.
Re-notification is required for all groups if there are changes to processes, procedures or the biological agent, that are of importance to safety and health at work that result in the original notification being invalid or out of date.
Notifications may be submitted to the Authority:
- By email to email@example.com
- In writing to the Health and Safety Authority, Occupational Hygiene Unit, 03rd Floor Hebron House, Hebron Rd, Kilkenny.
- By fax, for the attention of the Occupational Hygiene Unit, to 01 – 6147020
Note that the notification requirement is not an approval or licensing system.
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