In brief
The Regulation on the Prevention of Risks from Exposure to Biological Agents divides microorganisms into four risk groups according to their ability to cause disease in humans, to spread to the community and the availability of prevention or treatment. The higher the group, the higher the minimum containment level in the laboratory; the list of workers exposed to groups 3 and 4 is kept for at least 15 years, and in some cases 40 years. Work that does not deliberately involve agents, such as healthcare, waste, water treatment, agriculture and livestock, also falls within scope through the regulation's Annex I list.
Who does the biological agents regulation cover?
A technician preparing cultures in a medical laboratory works deliberately with a biological agent. A technician maintaining pumps at a water treatment plant, a slaughterhouse worker or hospital laundry staff, on the other hand, do not work directly with the agent but may be exposed to it. The biological agents regulation, that is, the Regulation on the Prevention of Risks from Exposure to Biological Agents (Official Gazette 15.06.2013, no. 28678), covers both situations together; in both, the aim is to prevent exposure to biological agents or, where that is not possible, to minimise it. The regulation was prepared in parallel with EU Directive 2000/54/EC.
Work that does not deliberately involve agents but where exposure may occur is listed in Annex I of the regulation as follows:
- Work in food production plants,
- Work in agriculture,
- Work involving contact with animals or products of animal origin,
- Work in healthcare settings and in mortuaries, including isolation units,
- Work in clinical, veterinary and diagnostic laboratories other than microbiological diagnostic laboratories,
- Work in waste disposal plants,
- Work in sewage and wastewater treatment plants.
Food factories, hospitals and medical laboratories, municipal and OIZ (organised industrial zone) wastewater treatment plants, and livestock businesses in Bursa and the surrounding provinces fall directly within this list.
Biological risk groups: the four-group classification
Art. 5 of the regulation divides biological agents into four groups according to their ability to cause disease, to spread to the community and the availability of effective prevention or treatment. The list in Annex III shows which group each agent is in:
| Group | Definition | Example from Annex III | Minimum containment level in the laboratory |
|---|---|---|---|
| 1 | Agents unlikely to cause disease in humans | — | General principles of hygiene |
| 2 | Agents that can cause disease, are unlikely to spread to the community and usually have effective prevention or treatment | Legionella pneumophila, Leptospira interrogans, Clostridium tetani | Level 2 |
| 3 | Agents that cause severe disease, present a serious hazard to workers and may present a risk of spreading to the community | Hepatitis B and C viruses, HIV, Mycobacterium tuberculosis, Brucella melitensis and B. abortus | Level 3 |
| 4 | Agents that cause severe disease, have a high risk of spreading to the community and for which there is no effective prevention or treatment | Crimean-Congo haemorrhagic fever virus | Level 4 |
When reading the list in Annex III, the following notes are important:
- V: an agent for which an effective vaccine is available (for example hepatitis B virus, the tetanus agent).
- D: an agent for which the list of exposed workers must be kept for more than 15 years after the last known exposure.
- T: a toxin-producing agent. A: an agent with possible allergic effects.
(**): an agent in group 3 that presents a limited infection risk for workers because it is not normally airborne; hepatitis B, hepatitis C and HIV carry this mark.
How is a biological risk assessment carried out?
A biological risk assessment is part of the workplace's general risk assessment, but it needs particular attention. Under Art. 6 of the regulation, the assessment takes into account the nature, level and duration of exposure; the combined hazard from agents in more than one group; the classification of the agents; the recommendations of the competent authorities; information on diseases linked to the work; and the possible allergic or toxic effects of the agent. The assessment is renewed whenever there is a change that may affect exposure conditions.
On site, proceed in this order:
- Identify the source: patient, blood and body fluids, samples, animals, animal products, wastewater, sludge, waste.
- Write down the route of transmission: sharps injuries, skin and mucous membrane contact, droplets, aerosols, animal bites or ticks, hand-to-mouth contact with contaminated hands.
- Match the tasks: who is exposed, in which work, how often? Do not leave out cleaning, maintenance and subcontractor staff.
- Check the group and notes: the agent's group, whether a vaccine exists (V), whether the list must be kept for a long time (D).
- Assess vulnerable workers separately: pregnant and breastfeeding workers, workers with weakened immunity.
- Write down the measures: substitution and process measures first, then collective protection, and personal protection last.
The OHS specialist and the workplace physician carry out this work together. For the method, see our risk assessment page.
Level of measures by type of work: laboratories, healthcare, waste and livestock
The severity of measures varies with the agent's group and the nature of the work:
| Work | Typical exposure | Key measures |
|---|---|---|
| Clinical and diagnostic laboratories | Samples that may contain group 2 and 3 agents | Containment level according to the agent's group; at least level 2 for samples of uncertain content, level 3 where group 3 is known or suspected; restricted access and secure storage |
| Healthcare | Bloodborne viruses, tuberculosis | Decontamination and disinfection methods; safe removal of infected waste; Annex V measures in isolating patients with group 3 or 4 agents |
| Waste disposal and medical waste | Blood-contaminated waste, sharps | Segregation, closed transport, PPE, vaccination |
| Sewage and wastewater treatment | Agents in wastewater and sludge, for example Leptospira | Gloves, boots, waterproof clothing; cleaning hands and face at breaks; no eating or drinking in the work area |
| Livestock, slaughterhouses, veterinary services | Brucella, Coxiella burnetii, tick-borne Crimean-Congo haemorrhagic fever virus | Gloves and protective clothing for contact with birth products and blood; tick control and safe removal of ticks |
| Food production and agriculture | Agents from raw materials, soil-borne tetanus | Hygiene arrangements, wound care for injuries, monitoring vaccination status |
In the laboratory, if work involves agents that may present a serious health risk but cannot be definitively assessed, at least level 3 measures are taken (Art. 18). We explain measures in the medical waste chain in hospitals in our article on worker safety in medical waste management, and what to do after a needlestick in our article on sharps injuries. For planning specific to healthcare facilities, see our healthcare facilities page.
Order of measures and hygiene rules
The regulation requires substitution first: if the nature of the work allows, the harmful agent is replaced by a less hazardous one (Art. 7). If exposure cannot be prevented, the following measures are taken under Art. 8:
- The number of exposed workers is kept as low as possible.
- Working methods and technical measures are designed to prevent the agent from spreading into the environment.
- Collective protection is applied first, and personal protection if that is not enough.
- The biohazard sign in Annex II is used; the sign is a black symbol on a yellow background.
- A plan for dealing with accidents is prepared; waste is collected, stored and removed safely.
From a biosafety perspective, the hygiene rules are in Art. 10: eating and drinking are prohibited in areas with a risk of contamination; suitable protective clothing and washing facilities, including eyewash and skin antiseptics, are provided; protective equipment is stored in a designated place and checked and cleaned after each use; contaminated clothing is removed before leaving the work area and decontaminated by the employer. The cost of these measures cannot be passed on to workers.
Training is given before work with the agent begins, renewed as risks change and repeated where necessary (Art. 11).
Notification, records, vaccination and health surveillance
- Prior notification (Art. 15): an employer using an agent in group 2, 3 or 4 for the first time notifies the Provincial Directorate of the Turkish Employment Agency at least 30 days before work begins. Notification is also made for every group 4 agent and for every new agent provisionally placed in group 3.
- List and records (Art. 13): a list of workers exposed to group 3 or 4 agents is kept and retained for at least 15 years after exposure ends. In cases such as persistent or latent infections and diseases with a long incubation period, the period is at least 40 years after the last known exposure.
- Health surveillance and vaccination (Art. 16): workers undergo health surveillance before starting work with the agent and at regular intervals. Workers who are not immune are vaccinated where necessary, in cooperation with the health authorities. If an infection due to exposure is suspected in a worker, other workers with similar exposure are also placed under surveillance and the risk is reassessed.
- Urgent notification (Art. 12): any release that may cause serious infection is reported immediately.
We plan health surveillance as part of our workplace physician service and arrange the necessary tests and vaccinations with authorised laboratories and health facilities. The hygiene certificate obligation in food businesses is a separate matter; see our article on the hygiene training certificate. An illness caused by exposure is reported as an occupational disease; for the process, read our article on occupational disease diagnosis and reporting.
Frequently Asked Questions
Which workplaces does the biological agents regulation cover?
It covers laboratory and production work deliberately involving biological agents, and the work listed in Annex I that does not involve agents directly but where exposure may occur: food production, agriculture, work with animals, healthcare and mortuaries, clinical and veterinary laboratories, waste disposal plants, and sewage and wastewater treatment plants.
What is the difference between group 3 and group 4?
Both cause severe disease in humans. Group 3 agents may present a risk of spreading to the community, but effective prevention or treatment is usually available. Group 4 agents have a high risk of spreading and there is no effective prevention or treatment; at least level 4 containment is applied in the laboratory.
How long is the list of exposed workers kept?
The list of workers exposed to group 3 or 4 agents is kept for at least 15 years after exposure ends. In cases such as persistent or latent infections and long incubation periods, this period is at least 40 years after the last known exposure.
When is the biological risk assessment renewed?
Whenever there is a change that may affect exposure conditions: a new procedure, a new agent, a different type of sample, or a suspected infection due to exposure found during health surveillance. Apart from this, the renewal periods for the workplace's general risk assessment also apply.
A risk assessment that identifies and scores hazards on site, links each measure to an owner and a date, and has a clear renewal schedule.
Bursa SİSTEMER OSGB Technical Team — written from the field experience of our OHS specialists and workplace physicians. Legal information is valid as of the publication/update date; contact us for an assessment specific to your business.