ORDINANCE No 4 OF 14th OF OCTOBER 2002 ON THE PROTECTION OF THE EMPLOYEES AGANST RISKS RELATED TO THE EXPOSURE TO BIOLOGICAL AGENTS AT WORK
ISSUED BY THE MINISTRY OF LABOUR AND SOCIAL POLICY AND THE MINISTRY OF HELTH
Prom. SG. 105/8 Nov 2002
Art. 1. By this ordinance the minimum requirements for protection of the employees against existing or potential risks for the health and safety under exposition to biological agents at the working place shall be stipulated.
Art. 2. This ordinance shall be applied in the all and every enterprise, place and activity per Art. 2 of the Law for healthy and safe conditions of labour, where the employees are or may be exposed to biological agents as a result of their work.
Art. 3. (1) The biological agents shall be classified in four risk groups depending on the level of risk of infection:
1. group 1 – Bas which probably shall not cause a disease to people;
2. group 2 – Bas which can cause a disease to people and sustain a danger for the employees but is not likely to spread in the society and there is an effective prophylactic and treatment means usually;
3. group 3 – BAS which can cause a heavy disease to people and sustain a serious danger for the employees, a possible risk the disease spreads in the society is possible, but there is an effective prophylactic and treatment means usually;
4. group 4 – BAS which cause heavy diseases to people and sustain a serious danger for the employees, a possible risk the disease spreads in the society exists and there is not an effective prophylactic and treatment means usually
(2) The classified BAS shall be enlisted in the Appendix No.1.
(3) In the cases where the BA which shall be evaluated id not enlisted in the Appendix 1 and cannot be classified exactly in one of the groups detached, it shall be classified in accordance with the Para 1 classifying it to the higher risk group among the alternatives;
Art. 4. (1) The risk shall be evaluated according to the Ordinance No.5 of the order proceedings and the periodicity of performing of risk evaluation (SG 49/1999).
(2) At the risk evaluation the type, the degree and the duration of the exposure of the employees to biological agents shall be defined obligatory;
(3) In activities which are connected with exposure to different groups of biological agents, the risk shall be evaluated on the base of the danger from the all of the existing biological agents.
(4) The evaluation shall be renewed periodically and in each case of change on the conditions which impact the exposure of the employees to biological agents.
(5) The employer shall take the needed precautions for removal or reduction of the risks, depending on the results of the risk evaluation
(6) The employer shall provide the information used for the risk evaluation to the controlling bodies at their request.
Art. 5. The risk evaluation shall be performed on the base of the existing information, which shall include:
1. the classification of the biological agents which sustain or may sustain danger to the human health according to the Art. 3;
2. information of the diseases, which can appear among the employees as a result of their work;
3. possible allergic reactions and/or toxic impacts as a result of the work of the employees;
4. data about the diseases found at employees and are directly related to their work;
5. normative acts of the control over the biological agents for the purpose of employees health protection where they are or can be exposed to biological agents due to their work;
6. any other information useful for the risk evaluation.
Art. 6. (1) Where working with biological agents of the first group, including live attenuated vaccines, as well as where the results of the evaluation per Para 4 indicate that the exposure and/or the possible exposure is an exposure to biological agent of the first group and a risk for the health of the employees is not found, the principles of the production safety and hygiene shall be applied.
(2) Where the results of the risk evaluation indicate that the activities per Appendix No.2 are not directly related with biological agents but a possibility of exposure of the employees exists, the provisions of the Art. 7, 9, 12, 13, 14, 15, 16 shall be applied.
Obligations of the employers
Art. 7. Each of the employers shall avoid the usage of dangerous biological agents, by way of their substitution by biological agents which are not dangerous or are less dangerous, where the nature of the preformed work allows it.
Art. 8 (1) In the cases where the results of the risk evaluation indicate a risk for the health and safety of the employees, the employer shall be obliged to prevent their exposure to biological agents.
(2) Where the prevention is technically impossible, the employer shall reduce the risk of exposure by:
1. limiting the number of the employers who are or can be exposed;
2. arranging of the working processes and taking technical precautions in order to avoid or reduce to a minimum the contamination of the working place with biological agents.
3. providing of collective means for protection and/or personal protective means;
4. hygienic means in order to prevent or reduce the possibility of fortuitous transfer or contamination of the working place with a biological agent;
5. usage of the sign of bio-danger as per the Ordinance No. 4 of 1995 of the signs and warnings of safe labour and anti-fire precautions ( SG 77/1995) and other appropriate warning signs.
6. creating of a plan of action in emergencies related to biological agents, which plan shall include also a plan for emergency prevention of the employees from exposure to biological agents of the groups 3 and 4 at emergencies and technical accidents.
7. research (where is necessary and technically possible) for the existence of the used biological agents spread away from the places for them places;
8. providing of places for safe accumulation, keeping and termination of waste, where necessary and after the respective processing, as well as usage of safe and marked containers;
9. measures for safe proceeding and transportation of biological agents at the working place
Art. 9 (1) Whereas the results of the evaluation of risk indicate a risk for the health and safety of the employees, the employer shall provide the monitoring bodies, against their request information regarding:
1. the results of the evaluation;
2. the activities in which if involved in, the employees are or may be exposed to biological agents;
3. the number of the exposed employees;
4. the name and qualification of the body responsible for the safety and health at work;
5. the preventive and protective precautions taken, including the labour proceedings and methods;
6. the emergency actions plan per Art. 8, Para 2, item 6.
(2) The employer shall submit against request the information per Para 1 to the employees and/or their representatives.
(3) The employer shall immediately inform the respective directorate " District Labour Inspection " and the hygiene – epidemiology inspection of every accident or case of emergency which may cause contamination with biological agent and may deeply infect people and/or lead to disease.
(4) In the cases of termination of the activity of the enterprise, the list per Art. 13 shall be kept in accordance with the requirements of the Ordinance No. 14 of year 1998 on the Labour Medicine Services (SG 95/1998).
Art. 10 (1) Whereas activities with biological agents are performed and a risk for the health and safety of the employers exists, the employer shall:
1. provide the employees with the necessary protective and special garments;
2. provide the employees appropriate washing detergents including eye-rinsing and/or antiseptic substances for the skin;
3. provide the appropriate keeping of the all needed protective means at the detached for this purpose place; their testing, repair or replacing in case of defect and before further usage.
4. specifies the proceedings of taking, working with and examination of the samples of human or animal origin;
5. establish a prohibition for the employers to consume foods and drinks in the working area, where risk of contamination with biological agents exists.
(2) The personal protective means, including the working garments for which a contamination with biological agents is suspected, shall be isolated at the abandoning of the working area and shall be kept separately from the rest garments. The employer shall provide their disinfection, cleaning and termination if needed.
(3) The funds for applying the measures per previous paragraphs shall be on the account of the employer.
Art. 11. (1) The employer shall provide the employees and/or their representatives appropriate training or instructions regarding:
1. the potential risks for the health;
2. the precautions shall be taken for the prevention of exposure;
3. the hygienic requirements to the place and equipment of work;
4. how to wear and use the protective means and garments;
5. the measures which shall be taken by the employees to prevent accidents.
6. the measures which shall be taken by the employees to prevent accidents
(2) the training and instructions per Para 1:
1. shall be conducted at the start of work which work includes contact with biological agents;
2. shall be in accordance with the new or varying risks
3. shall be repeated periodically if necessary.
Art. 12. The employer shall provide at the place of work written instructions and directives regarding the proceedings which shall be followed in case of:
1. a significant emergency or accident during work with a biological agent;
2. work with a biological agent of group 4.
(2) The employees shall notify the body responsible for the safe and health conditions of labour of each emergency or accident during work with biological agent immediately
(3) The employee shall inform employers and/or their representatives of each emergency or accident which may appear as a consequence of contamination with biological agent which can cause a heavy human infection and/or disease.
(4) In case of a significant emergency or accident, the employer shall inform of the reasons, taken measures or measures which shall be taken for overcoming the situation the employers and/or their representatives as soon as possible.
Art. 13 (1) The employers shall draw a list of the employees exposed to biological agents of group 3 and/or group 4, in which list the type of the activity performed and whereas possible – and the concrete biological agent to which they are exposed, as well as the data of exposures, access of emergencies and accidents shall be enlisted.
(2) In each case of change of the circumstances, the employer shall revise the list per Para 1.
(3) The list per Para 1 and all revises lists per Para 2 shall be kept:
1. ten years after the end of the exposure;
2. 40 years for the cases if exposures with biological agents which agents:
a) may cause persistent or non-prominent infections;
b) may be indicated after a long period when the disease occurs;
c) have extremely long incubation periods before the disease develops;
d) cause diseases which may recidivate after a long period not depending on the treatment, or:
e) may have heavy and long-term consequences.
(4) The employer shall provide a permanent access to the lists per Para 1 and 2to the physician from the labour medicine service, to the controlling bodies and the bodies responsible for the safe and health conditions of labour.
(5) At the request of the employers and/or their representatives shall provide resumed data, drawn on the base of the included in the lists per Para 1 and 2 information.
(6) Every one of the employers shall have the right of access to the information about himself included in the lists per Para 1 and 2.
Art. 14. The Employer shall decide all questions related to the protection of the employers against existing or potential risks for their health and save at exposure to biological agents at the work place in co-operation and after consultations with the employers and/or their representatives.
Art. 15 (1) The Employer shall declare before the controlling bodies and the hygienic-epidemic inspections his intention to perform the activity within 30 days from starting for the first time work with biological agents of group 2, 3 and 4 and within the same period before usage of the each next biological agent of groups 3 and 4 ( in case that the employer himself temporary classifies this biological agent).
(2) At the laboratories providing diagnostics servicing related to the biological agents of group 4, the employer shall declare his intention to perform such activity only.
(3) A repeated declaring of the preformed activity shall be executed in cases whereas a modification of the processes and/or proceedings which may impact the health or safe conditions of labour occur.
(4) The declaring of the activity shall include:
1. seat and address of management of the enterprise and/or the entity.
2. the name and qualification of the person, responsible for the safe and health.
3. the results of the risk evaluation;
4. the type of the biological agent;
5. the foreseen measures for prevention and protection.
Art. 16 (1) The employer shall provide medical monitoring of the employees for whom a risk for the health and safety exists and have been found at the risk evaluation. The medical monitoring shall be performed:
1. before the exposure
2. once annually;
(2) depending on the results of examination of the health status of the employees, the physician from the Labour Medicine Service may propose the employer to reduce the period per Para 1, item 2.
(3) The medical monitoring shall be arranged in a such way to provide possibility to apply concrete measures.
(4) The monitoring per Art. 16, Para 1 shall be performed following the requirements enlisted in the Appendix No.3
Art. 17 (1) The employers for which special protective measures are required shall be specified at the risk evaluation.
(2) Whereas at the risk evaluation is found that a risk for the health and safety of the employers who have no established immunity against the biological agent exists and effective vaccines exist, the employer shall offer the appropriate vaccination.
(3) The vaccination shall be executed in accordance with the requirements of the Ordinance No.2 on the types of immunization in the Republic of Bulgaria and terms of their execution (SG 38/2000).
(4) The persons who conduct the medical monitoring shall inform the employers of the positive and negative consequences of vaccination as well as of the avoiding vaccination.
(5) The vaccines which are not paid from the state budget as well as their application shall be on the account of the employer.
(6) The vaccination shall be entered in the immunization passport of the person, A copy of it shall be provided to the employer and the relevant Labour Medicine Service. The data shall be submitted at the request of the controlling bodies.
Art. 18. (1) If is founded that an employee ahs been infected or diseased as a result of exposure to a biological agent, the appropriate medical monitoring shall be established for the rest of the employees exposed to a similar exposure.
(2) In the cases of Para 1 a repeat risk evaluation shall be conducted.
Art. 19 (1) In the cases whereas a medical monitoring is being conducted, the health-status file shall be kept at least 10 years after the end of the exposure.
(2) The health-status file shall be kept 40 years after the final known exposure at work with biological agents of Art. 13, Para 3, item 2.
(3) The physician from the Labour Medicine Service shall develop and propose to the employer the relevant preventive and protective measures which shall be taken for the each employee.
(4) The employees shall have the right to obtain information and advice for the medical monitoring which may be conducted after the end of the exposure.
(5) Access to the results of medical monitoring related to the relevant employee shall be provided to every of the employees.
(6) The employees or the employer may request a discussion with the physician from the Labour Medicine Service the results of the taken prevention and protective measures in relation to the medical monitoring.
(7) In each case of disease or death which appear as a consequence of exposure to biological agent at work shall be reported as per the Ordinance on the order of reporting, registration, confirmation, appealing and monitoring of the professional diseases.( SG 33/2001).
Health-care, Medical and Veterinary sites.
Art. 20 At the risk evaluation in health-care, medical and veterinary sites, excluding the diagnostic laboratories, as set below shall be considered:
1. the possibility of existence of biological agents which are or may be located in the organism of the patients (human beings or animals), as well in samples of materials taken form them;
2. the danger of biological agents which are or may be located in the organism of patients (human beings and animals), as well as samples and materials taken form them.
3. risks as a result of the nature of the work.
Art. 21. For the purposes of protection of the health and safety of the employees in the sites per Art. 20 appropriate measures shall be applied, including:
1. specification of proceedings of the relevant disinfection;
2. establishing of proceedings which allow processing the waste and its replacement without risk.
Art. 22. In order to minimize the risk of infection in the isolators for patents ( human beings and animals) which have been or may be infected with biological agents of group 3 or group 4, protective means of the enlisted in the Appendix No.4, column A shall be selected and applied.
Special measures for production processes, laboratories and rooms for animals
Art. 23.(1) In the laboratories, including the diagnostic, as well as in the rooms and laboratories for animals which have been experimentally infected with biological agents of groups 2, 3, and 4 or which are or may be carriers of such biological agents, as well as for activities including dealing with biological agents of groups 2, 3 and 4 for research, experimental, tutorial and diagnostic purposes, the protective means shall be defined according to the Appendix No. 4 in order to minimize the risk.
(2) The measures per art. 1 shall be defined in accordance with the risk evaluation and after the requested level of protection against the biological agents depending on the degree of danger have been found.
(3) Activities which include dealing with biological agents shall be performed:
1. only in working areas which meet at least the protection level 2 for biological agent of group 2
2. only in working areas which meet at least the protection level 3 for biological agent of group 3
3. only in working areas which meet at least the protection level 4 for biological agent of group 4
(4) In cases of activities which include dealing with materials where possibility of existence of biological agents which can cause diseases to human beings exists, as well as in cases of activities of cultivation or concentration of biological agents the protection level 2 shall be established at least. In accordance with the risk evaluation protection levels 3 or 4 may be defined.
Art. 24 (1) At production processes where biological agents of groups 2, 3 and 4 are used protective measures shall be implemented as stipulated in Art. 23, Para 2 and 3 and on the base of the practical measures and relevant proceedings as enlisted in the Appendix No. 5.
(2) Accordingly to the risk evaluation in connection with usage of biological agents of groups 2, 3 and 4 the Minister of Health may define other appropriate measures which shall be applied at production usage these agents.
Art. 25. All activities included in this section at which no final risk evaluation has been performed, and about which is considered that the foreseen usage may sustain a significant health risk for the employees, may be performed only at places where the protection level meets at least the level 3.
§ 1. In the meaning of this Ordinance:
1. "biological agents" shall be micro-organisms, incl. these which are genetically modified cellular cultures and human endo-parasites which may provoke infection, allergy or toxicity.
2. "micro –organism" shall be a micro-biological unit, cellular or non-cellular able to multiple itself and to carry genetic material.
3. "cellular culture" shall be in vitro growth of cellules which origin from multi – cellular organisms.
4. "exposure" shall be the placing on of the human organism under the impact of physical factors, chemical substances or biological agents.
5. "contamination" shall be setting of biological agents and/or their products about form the detached for them place.
6. "employer" shall be as per definition of § 1, item. 1of the Additional provisions of The Labour Code as well every person or entity who assigns work and bears whole the responsibility for enterprise, cooperation or organization;
7. "bodies responsible or safe and health labour" shall be an official or specialized service at the enterprise for ogranisation and performance of the activities related to the protection and prevention of the main professional risks.
Transitional and concluding provisions
§ 2. This Ordinance is passed on the grounds of the Art. 276, Para 1 of the Labour Code.
§ 3. Instructions on application of the ordinance shall be given by the Ministry of the Labour and the Social Policy and by the Ministry of Health
§ 4. This Ordinance shall enter in force 12 months after its promulgation in the State Gazette.
§ 5. The enterprises, the work places and work equipment implemented on exploitation before this Ordinance enters in force shall be modified in accordance with the requirements of Appendixes No. 4 and 5 not later than the date of entering in force of this Ordinance.