Bioloogilistest ohuteguritest mõjutatud töökeskkonna töötervishoiu ja tööohutuse nõuded

§ 1. Scope

(1) This Regulation lays down occupational health and safety requirements to protect workers against biological agents affecting the working environment.

(2) The Regulation applies to all activities in the performance of which workers are or may be put at risk by biological agents.

§ 2. Classification of biological agents into risk groups

Biological agents shall be classified in four risk groups according to their level of risk of infection:

1) group 1 agents are not known to cause human disease;

2) group 2 agents may cause human disease and thereby present a hazard to the health of workers, but do not cause infections in the community; effective prophylaxis and treatment is available;

3) group 3 agents may cause severe human disease and thereby present a serious hazard to the health of workers; they may cause infections in the community, but effective prophylaxis and treatment is available;

4) group 4 agents cause severe human disease and thereby present a serious hazard to the health of workers and may cause infections in the community; there is usually no effective prophylaxis or treatment available.

§ 3. Assessing the risk to workers’ health

(1) In the case of activities involving a risk of exposure to biological agents, employers must, when assessing the risks present in the working environment, determine the nature, degree and duration of workers’ exposure and consequently assess any risk to the workers’ health and take any necessary preventive measures.

(2) If biological agents belonging to different risk groups are present in the working environment at the same time, the risk to health shall be assessed on the basis of their combined effect.

(3) The risk to workers’ health shall be assessed regularly. An additional assessment shall be conducted if any changes occur in the working environment which may affect workers’ health.

(4) When the risk to workers’ health is being assessed, the following shall be taken into account:

1) the possible effects of biological agents present in the working environment, according to their risk group;

2) any recommendation from the labour inspector or occupational doctor to take preventive measures in respect of a biological agent, if they find that workers’ health is at risk from the agent as a result of the nature of their work;

3) information concerning the diseases the workers may contract and any potential allergenic or toxigenic effects which may arise as a result of the specific work they perform;

4) information on any work-related disease which is identified during medical surveillance.

§ 4. Taking preventive measures

(1) If it becomes evident from the risk assessment of the working environment that the working environment is or may be affected only by group 1 agents and there is no significant risk to workers’ health, the employer need not take the preventive measures set out in Sections 5–16 but must follow the general occupational health, safety and hygiene requirements.

(2) If workers are not directly exposed to biological agents when performing their duties but the risk assessment shows that they may be at risk from them as a result of their working conditions or the nature of their work, the employer must take the measures set out in Sections 5 and 7–13. The activities covered include:

1) work in undertakings where food raw materials and food are handled;

2) agricultural work and forestry work;

3) work during which there is contact with animals and products of animal origin;

4) work in healthcare establishments, including isolation and post-mortem units; in care homes;

5) work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological laboratories;

6) work in refuse disposal plants;

7) work in sewage treatment plants.

§ 5. Employers’ primary responsibility

Employers must avoid using a harmful biological agent if it is possible to replace it with a biological agent that, in line with contemporary knowledge, is safe or safer.

§ 6. Reducing risks to health

(1) Where the results of the risk assessment reveal that the working environment is affected by biological agents, the employer must prevent workers’ health from being put at risk by the biological agents.

(2) If it is not possible to eliminate the risk using the measures set out in Section 5, the risk to workers’ health must be reduced to as low a level as possible by taking the following measures:

1) marking the areas of the working environment affected by biological agents and installing the biohazard warning sign in the appropriate places;

2) keeping the number of workers in the area affected by the agents as low as possible;

3) organising work processes and the handling and transport of infectious material in the undertaking in order to avoid the release of biological agents into the working environment or to keep their levels as low as possible;

4) collecting infectious waste and keeping it in specific, marked containers until it is removed from the working environment;

5) rendering infectious waste harmless to health and the environment by autoclaving, disinfection or other methods;

6) observing occupational hygiene requirements;

7) ensuring that workers who are exposed to biological agents against which there is an effective vaccine have the opportunity to be vaccinated;

8) drawing up an action plan to deal with an accident resulting from biological agents;

9) measuring the concentration of biological agents in the air of the working environment, where necessary and technically feasible;

10) taking collective protection measures or using personal protective equipment where exposure to a biological agent cannot be avoided by other means;

11) where the SARS-CoV-2 virus is spreading, by ensuring that workers who come into contact with other people in the working environment are free of infection, above all by ensuring that these workers are vaccinated against COVID-19, by checking their certificate that they have undergone vaccination against or have recovered from COVID-19, or by testing them using a SARS-CoV-2 test.

(2¹) Where a worker has had percutaneous exposure to a person, animal or object that is suspected of being infected or is carrying an infectious agent and has informed the employer without delay of this exposure, the employer is required to ensure that the worker has the opportunity to receive preventive treatment. Preventive treatment means providing the worker, without delay following this exposure, with prophylactic medicine or an anti-rabies vaccination and anti-rabies immunoglobulin. Any such percutaneous exposure, followed by preventive treatment, shall be deemed an occupational accident.

(3) The employer must consult the occupational doctor as regards the need for and appropriateness of vaccinating workers. The process of vaccinating workers shall be undertaken at the employer’s cost. A vaccination certificate must be available to the worker and the labour inspector.

(4) If it is not possible to make the working environment safe using the measures listed, personal protective equipment must be distributed to workers and rules concerning their use must be put in place.

§ 7. Occupational hygiene

(1) In order to prevent possible infection of workers, employers must take the following occupational hygiene measures:

1) ban eating and drinking in a working environment affected by biological agents;

2) provide workers with appropriate work clothing, and also provide workers working in an area affected by biological agents in risk groups 3 and 4 with protective clothing;

3) make washing facilities equipped with showers available to workers, provide them with antiseptic skin cleansing products, and, where necessary, install eyewash stations;

4) ensure that all used personal protective equipment is cleaned and checked at the end of each working day, that it is stored in a defined place, and that defective equipment is repaired or replaced before further use;

5) set rules for the handling of materials or preparations of human or animal origin.

(2) Where it is possible during work processes for work clothing or protective clothing to be contaminated by biological agents, the clothing must be removed before workers leave the working area and kept in specific, marked containers, separate from other clothing, until it is decontaminated and cleaned.

(3) Employers shall ensure that work clothing and protective clothing is cleaned and washed regularly and that, where it becomes unusable, it is treated in accordance with the Waste Act [ jäätmeseadus ] (RT I 1998, 57, 861; 1999, 23, 353).

§ 8. Training of workers

(1) Employers shall ensure that workers receive adequate and appropriate training. Workers and the working-environment specialist must be informed and instructed on all matters concerning health risks in the working environment, preventive measures to counter the effect of biological agents, hygiene requirements, how to use personal protective equipment, how to prevent dangerous situations and how to act if there is a risk of an accident.

(2) Training of workers shall be conducted before work with biological agents commences and, where necessary, on a periodic basis.

(3) Workers must also be informed if new health risks arise.

§ 9. Special cases for informing workers

(1) Employers must prepare written instructions for handling biological agents and ensure that these are available to workers and, where necessary, displayed in a visible location.

(2) The written instructions referred to in subsection 1 must include at least the following:

1) how to act if there is a risk of a serious accident, and what to do to avoid and eliminate the consequences of an accident where the risk is caused by biological agents;

2) how to handle biological agents in risk group 4, where there is or may be a risk of exposure to them in the working environment.

(3) Employers must inform the workers and the working-environment specialist without delay if there has been an accident and also of any dangerous situations in the undertaking which may lead to the spread of a biological agent in the working environment and to the infection of the workers.

(4) Employers must inform the workers and the working-environment specialist as soon as possible of any accident that has taken place, the causes and possible consequences of the accident, and the protective measures that are to be taken.

§ 10. List of persons working in a working environment affected by biological agents

(1) Employers must keep a list of workers who, for work-related reasons, are or may be at risk from biological agents in risk groups 3 and 4.

(2) The list must include the following information about each worker:

1) a description of their duties;

2) the biological agent to which the worker has been exposed and the duration of the exposure;

3) information about dangerous situations and accidents that have occurred.

(3) Employers are required to keep the information about any worker entered in the list for at least 10 years after the worker’s most recent exposure to the biological agent concerned.

(4) Employers shall ensure that, in the event of exposure to biological agents which may cause:

1) a persistent or latent infection;

2) an illness that can be diagnosed only after several years;

3) an illness with a very long incubation period;

4) an illness whose symptoms may persist despite treatment; or

5) an illness with long-term serious consequences, the information about the workers is kept for 40 years after their most recent exposure to the biological agent concerned.

(5) Workers are entitled to know what information about them has been entered in the list.

(6) Employers must give workers and the working-environment specialist the opportunity to access anonymous statistical information concerning the list.

(7) In an undertaking, the occupational doctor, the working-environment specialist and the labour inspector conducting supervision are entitled to access the list of workers.

§ 11. Health surveillance of workers

(1) On the basis of the results of the assessment of risks in the working environment, employers shall ensure that workers whose health may be affected by a biological agent in risk groups 2–4 undergo health surveillance in accordance with the procedure set out in the Occupational Health and Safety Act.

(2) Where health surveillance reveals that a worker is infected with a biological agent or is ill, the other workers who work in the same conditions must also undergo health surveillance. In this event, a further assessment of the risks in the working environment shall also be carried out. Where necessary, workers must also be given the opportunity to be vaccinated, and the need for vaccination must be explained to them.

(3) Workers are entitled to be informed of the results of their health surveillance.

(4) Employers are entitled to obtain an overview of the results of the health surveillance of their workers.

(5) Employers are required to keep the information about the health surveillance of a worker for at least 10 years after the worker’s most recent exposure to biological agents.

(6) The results of the health surveillance of workers who have been exposed to biological agents that may cause illness as referred to in Section 10(4) must be kept for 40 years after the most recent exposure to the biological agent concerned.

(7) During health surveillance, workers must also be instructed on how to monitor and check their health once their exposure to the biological agent has ended.

§ 12. Information to be provided to the labour inspector

(1) Where the labour inspector so requires, employers are required to provide the following information:

1) the results of the risk assessment of the working environment and the source data used in conducting that assessment;

2) a list of the work operations involving a risk of infection with biological agents;

3) the number of workers exposed to biological agents;

4) the name of the working-environment specialist;

5) the occupational health and safety measures to be taken at the workplace;

6) a list of the measures taken to protect workers against the effects of biological agents in risk groups 3 and 4;

7) the action plan referred to in Section 6(2)(8).

(2) Employers must inform the Labour Inspectorate of each accident and dangerous situation that has arisen and that involved or could have involved a leak of biological agents into the environment and persons being infected or becoming ill.

(2¹) The notification to be sent to the Labour Inspectorate shall include the name and contact details of the employer, the time and place at which the accident happened or the dangerous situation became evident and the circumstances thereof, the name of the biological agent involved in the accident or the dangerous situation, the measures that were or will be taken, the number of persons affected, an indication of whether the Environmental Board has been informed of the incident, and other information that may help to explain the potential impact of the accident or dangerous situation on the workers or the environment.

(3) The list of persons at risk as referred to in Section 10 of this Regulation and the results of the health surveillance of workers as referred to in Section 11 shall be made available to the Labour Inspectorate where the undertaking ceases activity.

§ 13. Prior notification of the handling of biological agents

(1) Employers are required to notify the Labour Inspectorate in writing at least 30 days before work first commences with biological agents in risk groups 2, 3 or 4.

(2) This notification process shall be repeated each time work commences with a new agent in risk group 3 or 4 and if any significant changes are made in the working environment as a result of which the content of any earlier notification becomes obsolete.

(3) Laboratories that provide diagnostic services for agents in risk group 4 need only submit a notification once, before commencing their operations.

(4) The information referred to in subsections 1–3 of this Section must include:

1) the name and address of the undertaking;

2) the name of the working-environment specialist;

3) the results of the risk assessment of the working environment;

4) the name and risk group of the biological agents affecting the working environment;

5) the protection and preventive measures to be taken.

§ 14. Undertakings providing healthcare services and undertakings involved in veterinary practice

(1) In undertakings providing healthcare services and undertakings involved in veterinary practice, account must be taken of the risk that a person or animal may be infected, that any samples taken from them may contain biological agents and that any sharp instruments used may be contaminated with a biological agent. Sharp instruments include objects and instruments necessary for the exercise of specific healthcare activities, which are able to cut or prick and cause injury and infection.

(2) In order to prevent workers from being infected, employers must put in place the necessary cleaning and disinfection procedures, determine how contaminated materials are to be handled safely until they are destroyed, and set out rules for safely examining and handling samples taken from persons and animals.

(3) In isolation units containing patients or animals infected or suspected of being infected with biological agents in risk group 3 or 4, the special measures set out in column A of Annex 1 must be taken.

§ 14¹. Use of sharp instruments

(1) In the course of the risk assessment referred to in Section 3, healthcare service providers and persons or entities involved in veterinary practice must assess all situations in which workers could injure themselves with contaminated sharp instruments or come into contact with blood or potentially infectious material.

(2) Having regard to the results of the risk assessment, employers must take preventive measures to prevent injuries to workers and thereby any potential infection which could be caused by contaminated sharp instruments.

(3) The preventive measures referred to in subsection 2 are first and foremost:

1) banning the recapping of used needle-sticks, venous cannula needles and other sharp instruments, and removing unnecessary sharp instruments from use;

2) using sharp instruments with protection mechanisms, where possible and appropriate;

3) preparing written instructions and adopting strict rules of procedure for the correct use of sharp instruments, including those with protection mechanisms, and updating those instructions and rules;

4) raising workers’ awareness of the need to prevent injuries from sharp instruments, and informing workers of the risks to health which could arise following contact with blood or other potentially infectious material;

5) preparing written instructions which workers must observe in the event of an injury caused by a sharp instrument;

6) providing guidance and training for workers on the issues referred to in indents 3–5;

7) referring a worker with an injury caused by a sharp instrument for health surveillance;

8) enacting special requirements for the disposal of sharp instruments contaminated with hazardous agents or suspected of being infectious, and ensuring that labelled containers made of material that is resistant to penetration are available for disposable sharp instruments as close as possible to the areas in which those instruments are used;

9) ensuring that workers responsible for sorting and handling waste from sharp instruments receive the necessary guidance and training to guarantee the safety of these procedures.

(4) Workers must inform their employer without delay of any injury caused by a sharp instrument and of any situation involving the use of a sharp instrument which could have caused injury.

(5) Employers shall keep records of all incidents referred to in subsection 4 of which workers have notified them.

§ 15. Diagnostic and testing laboratories

(1) In diagnostic and testing laboratories where there is exposure to biological agents in risk group 2, 3 or 4 for diagnostic, research or teaching purposes, and in premises at which infected animals or animals bearing disease agents are kept, the special measures referred to in column A of Annex 1 must be taken to reduce the risk of infection to workers, in accordance with the appropriate containment level and in line with the following principles:

1) where work is undertaken with biological agents in risk group 2, the laboratory must meet the requirements for containment level 2;

2) where work is undertaken with agents in risk group 3, the laboratory must meet the requirements for containment level 3;

3) where work is undertaken with agents in risk group 4, the laboratory must meet the requirements for containment level 4;

(2) Where a laboratory uses material in its work which may contain disease agents but is not cultivated or concentrated, the laboratory must meet the requirements for containment level 2 as a minimum.

(3) Where the effect of a biological agent being used is not known precisely but it can be presumed to put the worker’s health at serious risk, the workplace must meet the requirements for containment level 3 as a minimum.

§ 16. Industrial processes

(1) In undertakings in whose industrial processes biological agents in risk group 2, 3 or 4 are used or where there is a risk of exposure to such agents, the special measures referred to in Annex 2 must be taken in line with the principle set out in Section 15(1).

(2) Where the effect of a biological agent being used is not known precisely but its use may put the worker’s health at serious risk, the workplace must meet the requirements for containment level 3 as a minimum.

§ 17. Principles for using the list

(1) The risk groups of the biological agents entered in the list are set out in Annex 3.

(2) Only those agents that are known to cause human disease are entered in the list. The list does not include agents that cause animal and plant disease but are not known to be a risk to humans. The list does not include genetically modified micro-organisms.

(3) The basis for the classification in risk groups is the effect of the agents on a healthy human body. Account is not taken of the effect of the agents on the health of a worker who has a pre-existing disease, is using immunosuppressants, has compromised immunity, is pregnant or is breast feeding. In these cases, the additional risk resulting from the worker’s health status must be taken into account when assessing the risk to health as referred to in Section 3.

(4) Biological agents not included in this list shall not implicitly be classified in risk group 1. Where it is not possible to classify a biological agent clearly, it shall be assigned to the highest of the risk groups under consideration.

(5) Where the biological agent being handled is not included in the list, the employer must itself classify it in line with the considerations set out in Section 2.

(6) Where the genus of a micro-organism known to be a biological agent includes more than one species that poses a risk to humans, only the most widely spread species are entered in the list. The remaining species belonging to the same genus, shown by the addition of ‘spp.’ to the name of the genus, shall also be considered to be dangerous to health.

(7) Where the list refers to the genus of a micro-organism known only as a biological agent, species and strains that are known not to be pathogenic may be excluded from the list.

(8) Where a strain is attenuated or has lost virulence genes, the containment required by the classification of its parent strain need not apply if the results of the risk assessment of the working environment permit this. An attenuated strain may be used, for example, as a product or part of a product for prophylactic or therapeutic purposes.

(9) The nomenclature of biological agents set out in the list corresponds to international agreements and knowledge concerning nomenclature and taxonomy at the time it was prepared.

(10) Employers must classify all viruses isolated in humans and not included in this list in risk group 2 as a minimum, unless there is proof that they are safe to humans.

(11) Biological agents classified in risk group 3 which are indicated in the list by an asterisk (*) may cause workers to be infected only in certain circumstances, because they are not infectious by the airborne route. Where such agents are handled, employers must assess which containment measures are appropriate to take and which can be dispensed with, taking account of the nature of the activities in question and the quantity of the agent being handled.

(12) The requirements as to containment consequent on the classification of parasites need only be applied in the workplace to stages in the life cycle of the parasite in which it is infectious to humans.

(13) The list also includes information showing whether a biological agent is likely to cause allergic or toxic reactions, whether an effective vaccine is available, and for how long employers are required to keep the list of workers exposed to biological agents after their most recent exposure to the biological agent concerned. This is shown by the following information in the ‘Notes’ column:

1) A: possible allergic effects;

2) D: list of workers who worked with this agent is to be kept for more than 10 years after their most recent exposure to the agent concerned;

3) E: list of workers who worked with this agent is to be kept for 40 years after their most recent exposure to the agent concerned;

4) T: toxin production;

5) V: effective vaccine available and registered within the EU.

§ 18. Entry into force of this Regulation

(1) This Regulation shall enter into force on 1 July 2000.

(2) Undertakings whose working environment is affected by biological agents classified in risk group 2, 3 or 4 must notify the local office of the Labour Inspectorate of their activities in the manner set out in Section 13 within 6 months of the entry into force of this Regulation.