Download Ordinance No 4 dated 14.10.2002 on protection of workers from

Ordinance No 4 dated 14.10.2002 on protection of workers from risks connected to
exposure to biological agents during work
Issued by the Minister of Labour and Social Policy and the Minister of Health, promulgated
SG, Issue 105 dated 8.11.2002, in force as of 9.02.2003.
Section I
General
Article 1. This Ordinance determines the minimum requirements for protection of workers
from existing or potential health and safety risks in the event of exposure to biological agents at
the workplace.
Article 2. This Ordinance is subject to application in all enterprises, places/locations, and
activities pursuant to the provision of Article 2 of the Health and Safety at Work Act, when
workers are or could be exposed to biological agents as a result of their work.
Article 3. (1) The biological agents are classified in four risk groups depending on the level
of risk from infection:
1. Group 1 – biological agents, which probably may not cause illness of people;
2. Group 2 – biological agents, which may cause illness of people and may pose a hazard to
workers, but are unlikely to affect the public and usually efficient prophylaxis or treatment means
are in existence for said agents;
3. Group 3 – biological agents, which may cause grave illness of people and may pose
serious hazard to workers, possible risk for spreading of illness amongst the public, and usually
efficient prophylaxis or treatment means are in existence for said agents;
4. Group 4 – biological agents, which cause grave illness of people posing serious hazard to
workers, high risk of spreading amongst the public, and usually efficient prophylaxis or treatment
means are not in existence for said agents.
(2) The classified biological agents are specified in Appendix No 1.
(3) In cases when the biological agent, which must be assessed, is not included in Appendix
No 1 and cannot be classified in any of the specified groups, the agent is classified in line with
Paragraph 1, specifying the higher risk group amongst the alternatives.
Article 4. (1) The risk is subjected to assessment pursuant to Ordinance No 5 dated 1999 on
the order, manner, and recurrence of risk assessment execution (SG, Issue 47 dated 1999).
(2) The risk assessment must obligatorily determine the type, degree/level, and duration of
exposure of workers to biological agents.
(3) During activities connected to exposure to various biological agent groups, the risk is
subjected to assessment based upon the hazard of all present biological agents.
(4) The assessment is periodically subjected to review and in each case of change setting in
the conditions, affecting the exposure of workers to biological agents.
(5) The employer must undertake the requisite measures for elimination or reduction of risks
depending on the risk assessment results.
(6) The employer is obligated upon request to provide control authorities the information
utilized for risk assessment’s execution.
Article 5. The risk assessment is subject to execution based upon the available information,
which includes:
1. classification of biological agents, which represent or may represent hazards to human
health, pursuant to the provisions of Article 3;
2. information regarding the illnesses, which may manifest themselves in workers due to
their work;
3. possible allergic reactions and/or toxic effects resulting from the labour performed on part
of workers;
4. data regarding illnesses established in workers, directly connected to their labour
activities;
5. normative deeds for control of biological agents for the purpose of health protection of
workers, when they are or could be exposed to biological agents due to their labour activities;
6. all other information useful for risk assessment’s execution.
Article 6. (1) Upon work with biological agents of Group one, including live attenuated
vaccines, as well as in cases, in which the assessment results pursuant to Article 4 indicate that
the exposure and/or possible exposure is to a biological agent of Group one and health risk to
workers was not established, the production safety and hygiene principles are observed.
(2) In cases when the risk assessment results indicate that the activities in Appendix No 2
do not directly involve biological agents, but possibility exists for exposure of workers, the
provisions of Article 7 , 9 , 12 , 13, 14, 15, and 16 apply.
Section II
Obligations of employers
Article 7. Each employer is obligated to avoid the use of hazardous biological agents via
their replacement with biological agents, which are not hazardous or are less hazardous, when the
nature of performed work permits said action.
Article 8. (1) In cases when the risk assessment results indicate risk to health and safety of
workers, the employer is obligated to prevent their exposure to biological agents.
(2) When the prevention is technically impossible, the employer must reduce the exposure
risk by:
1. limitation of number of workers, which are or may be exposed;
2. organization of work processes and adoption of technical measures avoiding or limiting to
a minimum the contamination of the workplace with biological agents;
3. provision of collective protective means and or personal protective equipment;
4. hygienic measures for protection or reduction of possibility for accidental transfer or
contamination of the workplace with biological agents;
5. use of biohazard symbol pursuant to the provisions of Ordinance No 4 dated 1995 on
symbols and signals for labour safety and fire protection (SG, Issue 77 dated 1995) etc. suitable
warning signs/symbols;
6. drawing of action plan for accidents involving biological agents, also including
emergency action plan for protection of workers from exposure to biological agents from Group
3 or 4 in the event of accidents and technical incidents;
7. executing investigations (wherever required and technically possible) for the presence of
used biological agents, outside the specified locations;
8. provision of means for safe collection, storage, and disposal of waste, whenever required
and after the due processing, as well as use of rendered safe and marked containers;
9. measures for safe handling and transportation of biological agents at the workplace.
Article 9. (1) When the risk assessment results indicate health and safety risk to workers,
upon request of control authorities the employer must provide information regarding:
1. assessment’s results;
2. activities, under which workers are or could be exposed to biological agents;
3. number of exposed workers;
4. name and qualification of labour health and safety authority;
5. adopted protection and safety measures, including working procedures and methods;
6. emergency action plan pursuant to Article 8, Paragraph 2, Item 6.
(2) The employer is obligated upon request also to provide workers and/or their
representatives the information pursuant to Paragraph 1.
(3) The employer must immediately inform the respective directorate "Regional Labour
Inspection" and the hygienic-epidemiological inspection regarding all accidents or incidents,
which may lead to the contamination with biological agents and may cause grave infection in
people and/or illness.
(4) In cases when the enterprise terminates its activities, the list pursuant to Article 13 must
be stored at the National Social Security Institute, and the health file/dossier pursuant to Article
19 must be stored pursuant to the requirements of Ordinance No 14 dated 1998 regarding the
occupational medicine services (SG, Issue 95 dated 1998).
Article 10. (1) During actions performed with biological agents, with existing risks to health
and safety of workers, the employer:
1. provides workers the requisite protective and special clothing;
2. provides workers suitable means for washing and toilet facilities, including means for
washing of eyes and/or antiseptic preparations for the skin;
3. ensures correct storage at designated location/s of all requisite protective means,
respective inspection and cleaning, if possible prior to and after each use, as well as their repair or
replacement in case of defects and before further use;
4. specifies the procedures for obtaining, handling, and testing of samples of human or
animal origin;
5. implements a ban on workers to consume food and drink in the work zones, where risk
exists of biological agent contamination.
(2) Personal protective equipment, including work clothing, assumed as contaminated with
biological agents, must be separated upon leaving of work zone and must be stored separately
from other clothing. The employer must provide their disinfection, cleaning, or
disposal/destruction if required.
(3) The means for application of measures specified in the preceding paragraphs are to the
account of employers.
Article 11. (1) The employer must provide workers and/or their representatives suitable
training and instructions regarding:
1. potential health risks;
2. measures subject to adoption for prevention of exposure;
3. hygienic requirements regarding workplaces and working equipment;
4. wearing and use of protective means/equipment and clothing;
5. measures subject to undertaking on part of workers for protection from incidents;
6. measures subject to undertaking on part of workers in case of incidents.
(2) The training and instructions pursuant to Paragraph 1:
1. must be conducted upon commencement of work, including contact to biological agents;
2. must be coordinated in line with the new or changing risks;
3. must be repeated in the event of need.
Article 12. (1) The employer must provide at the workplace a location with written
instructions and directions regarding the procedure to be observed in the event of:
1. serious accident or incident upon work with biological agent;
2. work with biological agent of Group 4.
(2) The workers are obligated to immediately notify the labour health and safety authority
regarding all accidents or incidents pertaining to work with biological agents.
(3) The employer must immediately inform workers and/or their representatives regarding
each accident or incident, which may arise due to biological agent contamination, which may
cause grave infection to people and/or illness.
(4) During serious accidents or incidents the employer must in the speediest possible manner
inform workers and/or their representatives of the reasons, adopted measures, or measures subject
to adoption for handling the situation.
Article 13. (1) The employers must execute a list of workers, exposed to biological agents
of Group and/or Group 4, specifying the type of performed work, and whenever possible also the
specific biological agent, to which the workers were exposed, as well as data regarding the
exposures, accidents and incidents.
(2) The employer, during each change of circumstances, updates the list pursuant to
Paragraph 1.
(3) The list pursuant to Paragraph 1 and all updated lists pursuant to Paragraph 2 are stored:
1. ten years after the end of the exposure;
2. forty years in the event of exposure to biological agents, which:
a) cause persistent or latent infections;
b) may be diagnosed after a prolonged period, only after the illness manifests itself;
c) possess especially long incubation periods, before the illness develops;
d) cause illnesses, which may recur after a prolonged period, regardless of the treatment, or
e) may have grave, long-term consequences.
(4) The employer provides permanent access to the lists pursuant to Paragraph 1 and 2 to the
MD from the occupational medicine service, to the control authorities and to the labour health
and safety authorities.
(5) The employer, upon request on part of workers and/or their representatives, provides
them summary data, prepared based upon the information included in the lists pursuant to
Paragraph 1 and 2.
(6) Each worker possesses the right of access to the information pertaining to him/her,
specified in the lists pursuant to Paragraph 1 and 2.
Article 14. The Employer decides, in cooperation and after consultation with workers and/or
their representatives, all matters connected to the protection of workers from existing or potential
health and safety risks upon exposure to biological agents at the workplace.
Article 15. (1) The employer, within a term of up to 30 days prior to commencement of
work for the first time with biological agents from Groups 2, 3, and 4, and within the same term
prior to first use of each subsequent biological agent from Groups 3 and 4 (in the event the
employer alone temporarily classifies this biological agent) notifies before the control authorities
and the hygienic-epidemiological inspections its intention to perform such activity.
(2) In laboratories providing diagnostic services in connection with biological agents from
Group 4, the employer notifies only its intention for performance of such activities.
(3) Repeat notification of performed activities is executed in cases when substantial changes
are at hand in the processes and/or procedures, which may affect the labour health and safety.
(4) The notification of activity includes:
1. the registered seat and management address of the enterprise and/or institution;
2. the name and qualification of the person responsible for health and safety;
3. the risk assessment results;
4. the type of biological agent;
5. the planned measures for protection and prophylaxis.
Section III
Medical monitoring
Article 16. (1) The employer must provide medical monitoring of workers, to which health
or safety risk is at hand, established by the risk assessment. The medical monitoring is executed:
1. prior to the exposure;
2. once every year.
(2) Depending on the results of workers’ health state, the MD from the occupational
medicine service may propose to the employer reduction of the term pursuant to Paragraph 1,
Item 2.
(3) The medical monitoring must be organized in a manner providing the possibility for
application of specific measures.
(4) The monitoring pursuant to Article 16, Paragraph 1 must be executed in observation of
the requirements specified in Appendix No 3.
Article 17. (1) The workers, of which special protective measures are required, must be
determined during the risk assessment.
(2) When during the risk assessment risk to health and safety of workers is established,
which have not built up immunity to the biological agent and for which effective vaccines are in
existence, the employer is obligated to propose workers adequate vaccination.
(3) The vaccination must be executed in line with the requirements of Ordinance No 2 on
the immunization types in Republic of Bulgaria and the terms for their execution (SG, Issue 38
dated 2000).
(4) The persons executing medical monitoring must familiarize the workers with the positive
and negative consequences from the vaccination, and in the event of failure to perform
vaccination.
(5) The vaccines not subject to payment from the state budget, as well as their application,
shall be to the account of employer.
(6) The vaccination must be recorded in the vaccination passport/card of the respective
person. A copy of this must be presented to the employer and the respective occupational
medicine service. The data must be provided upon request to the control authorities.
Article 18. (1) When it is established that a worker is infected or has fallen ill as a result of
exposure to a biological agent, suitable medical monitoring must also be provided to the
remaining workers, subjected to similar exposure.
(2) In cases pursuant to Paragraph 1 repeat risk assessment must be performed.
Article 19. (1) In cases of executed medical monitoring the health file/dossier must be
stored for a term of at least 10 years after the termination of relevant exposure.
(2) The health file is subject to storage for a term of 40 years after the last known exposure
during work with biological agents, specified in Article 13, Paragraph 3, Item 2.
(3) The MD from the occupational medicine service develops and proposes to employer
respective protective and safety measures subject to undertaking for the specific worker.
(4) The workers have the right to receive information and advice regarding the medical
monitoring, which may be executed after the exposure’s termination.
(5) The workers must be provided access to the medical monitoring results pertaining to
them.
(6) The workers or the employer may require discussion with the MD from the occupational
medicine service of the results from the adopted protection and safety measures in connection
with the medical monitoring.
(7) Each case of illness or death resulting from exposure to biological agents during the time
of work must be notified pursuant to the Ordinance on the order for notification, registration,
confirmation, appeal, and recording of occupational illnesses (SG, Issue 33 dated 2001).
Section IV
Healthcare, treatment, and veterinary medical institutions
Article 20. Upon execution of risk assessment in healthcare, treatment, and veterinary
medical institutions, except for diagnostic laboratories, the following must be taken into account:
1. the possibility for presence of biological agents, which are or may be in the organism of
patients (people and animals), as well as in samples or materials obtained from them;
2. the hazard of biological agents, which are or could be in the organism of patients (people
and animals), as well as in samples or materials obtained from them;
3. the risks resulting from the nature of the work.
Article 21. For protection of health and safety of workers in institutions pursuant to Article
20 suitable measures are applied, also including:
1. specification of procedures for respective decontamination and disinfection;
2. introduction of procedures, permitting processing of waste and relevant disposal
excluding risk.
Article 22. In order to minimize the risk of infection in isolators for patients (people and
animals), which are or could be infected with biological agents from Group 3 or Group 4,
selection and application must take place of protective measures as specified in Appendix No 4,
column А.
Section V
Special measures for production processes, laboratories, and premises for animals
Article 23. (1) In the laboratories, including diagnostic laboratories, as well as in premises
for laboratory animals, infected experimentally with biological agents from Groups 2, 3, and 4 or
which are or could be carriers of such agents, as well as during activities including handling of
biological agents from Groups 2, 3, and 4 for research, experimental, training, or diagnostic
purposes, the protection measures are determined pursuant to Appendix No 4 in order to
minimize the risk.
(2) The measures pursuant to Paragraph 1 are determined in line with the risk assessment
and after ascertainment of the required level of protection for biological agents depending on the
hazard level.
(3) The activities including handling of biological agents are implemented:
1. only in work areas conforming at least to Protection level 2 for biological agents of
Group 2;
2. only in work areas conforming at least to Protection level 3 for biological agents of
Group 3;
3. only in work areas conforming at least to Protection level 4 for biological agents of
Group 4.
(4) In the course of activities including handling of materials, of which possibility exists for
presence of biological agents, which may cause illness in people, as well as during activities for
cultivation or concentration of biological agents, at least Protection level 2 must be provided. In
line with the risk assessment specification may take place Protection levels 3 or 4.
Article 24. (1) During production processes, making use of biological agents from Groups
2, 3, or 4, protection measures apply regulated in Article 23, Paragraph 2 and 3 based upon the
practical measures and respective procedures, specified in Appendix No 5.
(2) Based upon the risk assessment in connection with the use of biological agents from
Groups 2, 3, and 4 the Minister of health has the right to determine other suitable measures,
applied during the production use of these agents.
Article 25. All activities encompassed by this section, for which a final risk assessment of
biological agent is not executed, for which it is assumed that the envisioned use may pose serious
health risk to workers, may be implemented only at workplaces where the level of protection
conforms to at least level 3.
ADDITIONAL REGULATION
§ 1. Within the meaning of this Ordinance:
1. "biological agents" shall mean microorganisms, including ones being genetically
modified, cellular cultures and human endoparasites, which may provoke an infection, allergy, or
toxicity;
2. "microorganism" shall mean microbiological unit, cellular or non-cellular, capable of
reproduction or transportation of genetic material;
3. "cellular culture" shall mean in vitro growth of cell, arising from multicellular organisms;
4. "exposure" shall mean exposure of human organism to the effects of physical factors,
chemical substances, or biological agents;
5. "contamination" shall mean landing of biological agents and/or their products outside
their envisioned location;
6. "employer" shall have the meaning defined in § 1, Item 1 of the Additional Regulations of
the Labour Code, as well as each person assigning work and bearing full responsibility for the
enterprise, cooperation, or organization;
7. "labour health and safety authorities" shall mean official/s or specialized service in the
enterprise for organizing performance of activities connected to the protection and prophylaxis of
occupational risks.
TRANSITIONAL AND CONCLUDING REGULATIONS
§ 2. This Ordinance is issued pursuant to the provisions of Article 276, Paragraph 1 of the
Labour Code.
§ 3. Instructions for this Ordinance’s application are provided on part of the Ministry of
Health and the Ministry of Labour and Social Policy.
§ 4. This Ordinance enters into full force and effect 3 months after its promulgation in the
"State Gazette".
§ 5. The enterprises, workplaces, and working equipment, commissioned into operation
prior to this Ordinance’s entry into force, must be brought in line with the requirements of
Appendix No 4 and 5 no later than 3 years as of this Ordinance’s entry into force.
Appendix No 1 to Article 3, Paragraph 2
Classification of biological agents
I. General conditions upon classification of biological agents
1. The attached lists contain classifications only of biological agents known to cause
contamination of people.
During the drawing of the lists animal and plant pathogens not known to cause infection of
people went unlisted, as well as genetically modified microorganisms.
2. The classification of biological agents is based upon their effects on healthy workers. The
specific effects of biological agents on workers with altered susceptibility as a result of prior
illness, medical treatment, reduced immunity, pregnancy, or breastfeeding, etc. were not
considered. The additional risk to these workers must be evaluated upon the risk assessment’s
execution pursuant to Article 4.
3. When the biological agents are not indicated in Groups 2, 3, and 4 of the list, they must
not be automatically subjected to classification in Group 1. For biological agents, of which more
than one type of pathogens are known to man, the list must include the types, most frequently
causing illness, indicating that also other types may cause health related impairments. When an
entire line is specified in the list, this denotes exclusion of the non-pathogen types and strains.
4. When a specific strain is attenuated or has lost the genes connected to its virulent nature,
the measures required by the classification of its parent strains, do not apply obligatorily for the
said strain, e.g. when such strain may be used as a product or part of a product for prophylactic or
therapeutic purposes.
5. The utilized nomenclature conforms to the international agreements regarding the
taxonomy and nomenclature of biological agents.
6. The list of classified biological agents is subject to updating.
7. The requirements pertaining to the protection measures, conforming to the classification
of parasites, apply only to these stages of the parasite’s life cycle during which infection of
workers is possible at the workplace.
8. The list contains the respective designations in cases when: the biological agents are
probable cause of allergic or toxic reactions; an effective vaccine is available; recommendation
exists for the list of exposed workers to be stored in excess of ten years after the end of the last
known exposure, as well as in cases of specific biological agents, classified in Group 3, posing
limited risk for infection of workers, since usually airborne infection is impossible.
The designations are as follows:
"А" - possible allergic effects;
"Д" - recommendation for list of exposed workers to be stored for a period
in excess ten years;
"Т" - production of toxins;
"В" - available effective vaccine;
"(**)" – biological agents, classified in Group 3, for which the risk of infection of workers is
limited, since usually airborne infection is impossible.
II. Bacteria and other microorganisms
Biological agent
1
Classific
ation
Note
2
3
Actinobacillus
actinomycetemcomitans
2
Actinomadura madurae
2
Actinomadura pelletieri
2
Actinomyces gerencseriae
2
Actinomyces israelii
2
Actinomyces pyogenes
2
Actinomyces spp.
2
Arcanobacterium haemolyticum
(Corynebacterium haemolyticum)
2
Bacillus anthracis
3
Bacteroides fragilis
2
Bartonella bacillifonnis
2
Bartonella quintana
(Rochalimaea quintana)
2
Bartonella (Rochalinea) spp.
2
Bordetella bronchiseptica
2
Bordetella parapertussis
2
Bordetella pertussis
2
Borrelia burgdorferi
2
Borrelia duttonii
2
Borrelia recurrentis
2
Borrelia spp.
2
Brucella abortus
3
В
Brucella canis
3
Brucella melitensis
3
Brucella suis
3
Burkholderia mallei
(Pseudomonas mallei)
3
Burkholderia pseudomallei
(Pseudomonas pseudomallei)
3
Campylobacter fetus
2
Campylobacter jejuni
2
Campylobacter spp.
2
Cardiobacterium hominis
2
Chlamydia pneumoniae
2
Chlamydia trachomatis
2
Chlamydia psittaci (avian strains)
3
Chlamydia psittaci (other strains)
2
Clostridium botulinum
2
Clostridium perfringens
2
Clostridium tetani
2
Clostridium spp.
2
Corynebacterium diphtheriae
2
Corynebacterium minutissimum
2
Corynebacterium
pseudotuberculosis
2
Corynebacterium spp.
2
T
T, В
T, В
Coxiella burnetii
3
Edwardsiella tarda
2
Ehrlichia sennetsu
(Rickettsia sennetsu
2
Ehrlichia spp.
2
Eikenella corrodens
2
Enterobacter aerogenes/cloacae
2
Enterobacter spp.
2
Enterococcus spp.
2
Erysipelothrix rhusiopathiae
2
Escherichia coli (with the
exception of non-pathogenic strains)
2
Escherichia coli, verocytotoxigenic
strains (e.g. O157:H7 or O103)
Flavobacterium meningosepticum
3 (**)
2
Fluoribacter bozemanae
(Legionella)
2
Francisella tularensis (Type A)
3
Francisella tularensis (Type B)
2
Fusobacterium necrophorum
2
Gardnerella vaginalis
2
Haemophilus ducreyi
2
Haemophilus influenzae
2
Haemophilus spp.
2
Helicobacter pylori
2
Klebsiella oxytoca
2
Klebsiella pneumoniae
2
Klebsiella spp.
2
Legionella pneumophila
2
Legionella spp.
2
Leptospira interrogans
(all serovars)
2
Listeria monocytogenes
2
Listeria ivanovii
2
Morganella morganii
2
Mycobacterium africanum
3
Mycobacterium avium/intracellulare
2
В
Mycobacterium bovis
(except BCG strain)
3
Mycobacterium chelonae
2
Mycobacterium fortuitum
2
Mycobacterium kansasii
2
Mycobacterium leprae
3
Mycobacterium malmoense
2
Mycobacterium marinum
2
Mycobacterium microti
3 (**)
Mycobacterium paratuberculosis
2
Mycobacterium scrofulaceum
2
В
Mycobacterium simiae
2
Mycobacterium szulgai
2
Mycobacterium tuberculosis
3
Mycobacterium ulcerans
3 (**)
Mycobacterium xenopi
2
Mycoplasma caviae
2
Mycoplasma hominis
2
Mycoplasma pneumoniae
2
Neisseria gonorrhoeae
2
Neisseria meningitidis
2
Nocardia asteroides
2
Nocardia brasiliensis
2
Nocardia farcinica
2
Nocardia nova
2
Nocardia otitidiscaviarum
2
Pasteurella multocida
2
Pasteurella spp.
2
Peptostreptococcus anaerobius
2
Plesiomonas shigelloides
2
Porphyromonas spp.
2
Prevotella spp.
2
Proteus mirabilis
2
Proteus penneri
2
Proteus vulgaris
2
В
В
Providencia alcalifaciens
2
Providencia rettgeri
2
Providencia spp.
2
Pseudomonas aeruginosa
2
Pseudomonas mallei
3
Pseudomonas pseudomallei
3
Rhodococcus equi
2
Rickettsia akari
3 (**)
Rickettsia canada
3 (**)
Rickettsia conorii
3
Rickettsia montana
3 (**)
Rickettsia typhi (Rickettsia mooseri)
3
Rickettsia prowazekii
3
Rickettsia rickettsii
3
Rickettsia tsutsugamushi
3
Rickettsia spp.
2
Rochalimaea quintana
2
Salmonella Arizonae
2
Salmonella Enteritidis
2
Salmonella Typhimurium
2
Salmonella Paratyphi A, B, C
2
В
3 (**)
В
Salmonella Typhi
Salmonella (other serovars)
2
Serpulina spp
2
Shigella boydii
Shigella dysenteriae (Type 1)
2
3 (**)
T
Shigella dysenteriae,
other than Type 1
2
Shigella flexneri
2
Shigella sonnei
2
Staphylococcus aureus
2
Streptobacillus moniliformis
2
Streptococcus pneumoniae
2
Streptococcus pyogenes
2
Streptococcus suis
2
Streptococcus spp.
2
Treponema carateum
2
Treponema pallidum
2
Treponema pertenue
2
Treponema spp.
2
Vibrio cholerae (including El Tor)
2
Vibrio parahaemolyticus
2
Vibrio spp
2
Yersinia enterocolitica
2
Yersinia pestis
3
Yersinia pseudotuberculosis
2
Yersinia spp.
2
III. Viruses (*)
В
Biological agent
Classific
ation
Note
1
2
3
Adenoviridae
2
Arenaviridae
- I-CM-Lassa Virus Complex
(Old World arena viruses):
-- Lassa Virus
4
-- Lymphocytic (strains)
3
-- Lymphocytic choriomeningitis
virus (other strains)
-- Mopeia virus
-- Other LCM - Lassa complex
viruses
2
2
2
- Tacaribe-Virus Complex
(New World arena viruses):
-- Guanarito virus
4
-- Junin virus
4
-- Sabia virus
4
-- Machupo virus
4
-- Flexal virus
3
-- other Tacaribe complex viruses
2
Astroviridae
2
Bunyaviridae
- Belgrade (also known as Dobrava)
3
- Bhanja
2
- Bunyamwera virus
2
- Germiston
2
- Oropouche virus
3
- Sin Nombre (formerly Muerto
Canyon)
- California encephalitis virus
3
2
- Hantaviruses:
-- Hantaan (Korean haemorrhagic
fever)
3
-- Seoul virus
3
-- Puumala virus
2
-- Prospect Hill virus
2
-- Other hantaviruses
2
- Nairoviruses:
-- Crimean-Congo
-- haemorrhagic fever
4
-- Hazara virus
2
- Phleboviruses:
-- Rift Valley fever
3
-- Sandfly fever
2
-- Toscana virus
2
-- Other bunyaviridae known to be
pathogenic
2
Caliciviridae
- Hepatitis E virus
3(**)
В
- Norwalk virus
2
- Other Caliciviridae
2
Coronaviridae
2
Filoviridae
- Ebola virus
4
- Marburg virus
4
Flaviviridae
- Australia encephalitis (Murray
Valley encephalitis)
- Central European
encephalitis virus
tick-borne
3
3 (**)
- Absettarov
3
- Hanzalova
3
- Hypr
3
- Kumlinge
3
- Dengue virus type 1-4
3
В
3 (**)
Д
- Japanese B encephalitis
3
В
- Kyasanur Forest
3
В
- Hepatitis C virus
- Louping ill
3 (**)
- Omsk (a)
3
- Powassan
3
- Rocio
3
Russian
encephalitis (TBE) (a)
spring-summer
3
В
В
- St Louis encephalitis
- Wesselsbron virus
3
3 (**)
- West Nile fever virus
3
- Yellow fever
3
- Other flaviviruses known to be
pathogenic
В
2
Hepadnaviridae
- Hepatitis B virus
3 (**)
В, Д
- Hepatitis D virus (Delta) (б)
3 (**)
В, Д
Herpesviridae
- Cytomegalovirus
2
- Epstein-Barr virus
2
- Herpesvirus simiae (B virus)
3
- Herpes simplex virus types 1 and
2
- Herpesvirus varicella-zoster
2
2
- Human B-lymphotropic virus
(HBLV-HHV6)
2
- Human Herpes virus 7
2
- Human Herpes virus 8
2
Д
2
В(в)
Orthomyxoviridae
- Influenza viruses types A, B and C
- Tick-borne
Dhori and Thogoto
orthomyxoviridae:
2
Papovaviridae
- BK and JC viruses
2
Д (г)
2
Д (г)
- Measles virus
2
В
- Mumps virus
2
В
- Newcastle disease virus
2
- Human papillomaviruses
Paramyxoviridae
- Parainfluenza viruses types 1 to 4
- Respiratory syncytial virus
Parvoviridae
- Human parvovirus (B 19)
2
Picornaviridae
- Acute haemorrhagic conjunctivitis
virus (AHC)
2
- Coxsackie viruses
2
- Echo viruses
2
2
В
- Polioviruses
2
В
- Rhinoviruses
2
- Hepatitis A
enterovirus type 72)
virus
(human
Poxviridae
- Buffalopox virus (д)
2
- Cowpox virus
2
- Elephantpox virus (е)
2
- Milkers’ node virus
2
Molluscum contagiosum virus
- Monkeypox virus
3
В
- Orf virus
2
- Rabbitpox virus (ж)
2
- Vaccinia virus
2
- Variola (major and minor) virus
4
В
- Whitepox virus (“Variola virus”)
4
В
- Yatapox virus (Tana & Yaba)
2
Reoviridae
- Coltivirus
2
- Human rotaviruses
2
- Orbiviruses Reoviruses
2
Retroviridae
- Human immunodeficiency viruses
3(**)
Д
- Human T-cell lymphotropic
viruses (HTLV) types 1 and 2
3(**)
Д
- SIV(з)
3(**)
Rhabdoviridae
- Rabies virus
- Visicular stomatitis virus
3 (**)
В
2
Togaviridae
- Alfaviruses:
-- Eastern equine encephalomyelitis
3
-- Bebaru virus
2
-- Chikungunya virus
3 (**)
-- Everglades virus
3 (**)
В
-- Mayaro virus
3
-- Mucambo virus
3 (**)
-- Ndumu virus
3
-- O’nyong-nyong virus
2
-- Ross River virus
2
-- Semliki Forest virus
2
-- Sindbis virus
2
-- Tonate virus
3 (**)
-Venezuelan
encephalomyelitis
equine
3
В
-Western
encephalomyelitis
equine
3
В
-- Other known alphaviruses
2
Rubivirus (rubella)
2
Toroviridae
2
В
Unclassified viruses
- Equine morbillivirus
4
3 (**)
Д
- Creutzfeldt-Jakob disease
3 (**)
Д (г)
- Variant Creutzfeldt-Jakob disease
3 (**)
Д (г)
Bovine
spondiform
encephalopathies (BSE) and other related
animal TSEs (и)
3 (**)
Д (г)
- Gerstmann-Straeussler-Scheinker
3 (**)
Д (г)
- Hepatitis viruses not yet identified
Unconventional agents associated
with the transmissible spondiform
encephalopathies (TSEs)(и):
syndrome
Kuru
3 (**)
Д (г)
Note. The designations contained in the list were used within the following meaning:
"spp." – other types of biological agents, known as pathogens for people;
"(*)" - viruses already isolated in people not assessed and not classified in this appendix, must
be classified at least in Group 2, save for cases, where proof exists, that they probably do not cause
illness in people;
"(a)" - Tick-borne encephalitis;
"(б)" – the Hepatitis D virus is a pathogen for workers only in the event of simultaneous
presence of or secondary infection, caused by the Hepatitis B virus; hence the vaccination against
Hepatitis В shall protect the workers, not affected by the virus, causing Hepatitis В, against the
Hepatitis D virus (Delta);
"(в)" – only for type А and В;
"(г)" – recommended for work, including direct contact with these agents;
"(д)" – two viruses were identified: one type buffalopox and the other a variant of Vaccinia
virus;
"(е)" – a variant of the cowpox virus;
"(ж)" – a variant of Vaccinia;
"(з)" – currently no data exists of illness in people, caused by retroviruses of primate origin; as
protection measure Protection level 3 is recommended during work with these viruses;
"(и)" – no data in existence regarding infection of people, caused by the agents, causing Mad
cow encephalitis; nevertheless Protection level 3 (**) is recommended at least as a protective
measure for laboratory work, save for laboratory work, connected to identified agent screpie, where
Protection level 2 is adequate.
----------------------------------------------------------------------------IV. Parasites
Biological agent
Classificat
ion
Note
1
2
3
Acanthamoeba castellani
2
Ancylostoma duodenale
2
Angiostrongylus cantonensis
2
Angiostrongylus costaricensis
2
Ascaris lumbricoides
2
A
Ascaris suum
2
A
Babesia divergens
2
Babesia microti
2
Balantidium coli
2
Brugia malayi
2
Brugia pahangi
2
Capillaria philippinensis
2
Capillaria spp.
2
Clonorchis sinensis
2
Clonorchis viverrini
2
Cryptosporidium parvum
2
Cryptosporidium spp.
2
Cyclospora cayetanensis
2
Dipetalonema streptocerca
2
Diphyllobothrium latum
2
Dracunculus medinensis
2
Echinococcus granulosus
3(**)
Echinococcus multilocularis
3(**)
Echinococcus vogeli
3(**)
Entamoeba histolytica
2
Fasciola gigantica
2
Fasciola hepatica
2
Fasciolopsis buski
2
Giardia lamblia
(Giardia intestinalis)
2
Hymenolepis diminuta
2
Hymenolepis nana
2
Leishmania brasiliensis
3(**)
Leishmania donovani
3(**)
Leishmania ethiopica
2
Leishmania mexicana
2
Leishmania peruviana
2
Leishmania tropica
2
Leishmania major
2
Leishmania spp.
2
Loa loa
2
Mansonella ozzardi
2
Mansonella perstans
2
Naegleria fowleri
3
Necator americanus
2
Onchocerca volvulus
2
Opisthorchis felineus
2
Opisthorchis spp.
2
Paragonimus westermani
2
Plasmodium falciparum
3(**)
Plasmodium spp.
(human and simian)
2
Sarcocystis suihominis
2
Schistosoma haematobium
2
Schistosoma intercalatum
2
Schistosoma japonicum
2
Schistosoma mansoni
2
Schistosoma mekongi
2
Strongyloides stercoralis
2
Strongyloides spp
2
Taenia saginata
2
Taenia solium
3(**)
Toxocara canis
2
Toxoplasma gondii
2
Trichinella spiralis
2
Trichuris trichiura
2
Trypanosoma brucei brucei
2
Trypanosoma brucei gambiense
2
Trypanosoma brucei rhodesiense
3(**)
Trypanosoma cruzi
3
Wuchereria bancrofti
2
V. Fungi
Biological agent
Classificat
ion
Note
1
2
3
Aspergillus fumigatus
2
A
Blastomyces dermatitidis
(Ajellomyces dermatitidis)
3
Candida albicans
2
Candida tropicalis
2
Cladophialophora
bantiana
(formerly:
Xylohypha
bantiana,
Cladosporium
bantianum
or
trichoides)
Coccidioides immitis
A
3
3
A
Cryptococcus neoformans var.
neoformans
(Filobasidiella
neoformans var. neoformans)
2
A
Cryptococcus neoformans var.
gattii (Filobasidiella bacillispora
2
A
Emmonsia parva var. Parva
2
Emmonsia parva var. Crescens
2
Epidermophyton floccosum
2
Fonsecaea compacta
2
Fonsecaea pedrosoi
2
Histoplasma capsulatum var
capsulatum (Ajellomyces capsulatus)
3
Histoplasma capsulatum duboisii
3
Madurella grisea
2
Madurella mycetomatis
2
Microsporum spp.
2
Neotestudina rosatii
2
Paracoccidioides brasiliensis
3
Penicillium marneffei
2
Scedosporium apiospermum
(Pseudallescheria boydii)
2
A
A
A
Scedosporium
(inflatum)
prolificans
2
Sporothrix schenckii
2
Trichophyton rubrum
2
Trichophyton spp.
2
Appendix No 2 to Article 6, Paragraph 2
Activities during which contact with biological agent is possible
1. Work in food production enterprises.
2. Work in the field of agriculture.
3. Work involving contact with animals and/or products of animal origin.
4. Work in healthcare and medical treatment facilities/institutions, including isolators and
morgues.
5. Work in clinical, veterinary medical and diagnostic laboratories, save for diagnostic
microbiological laboratories.
6. Work connected to waste treatment.
7. Work in waste water treatment plants.
Appendix No 3 to Article 16, Paragraph 4
Requirements for medical monitoring of workers
1. The MDs performing medical monitoring of workers, exposed to biological agents, must
be adequately familiar with the labour conditions and exposure of each worker.
2. The medical monitoring of workers is executed in line with the principles and practices of
occupational medicine and includes the following as a minimum:
- maintenance of medical file/dossier of the worker;
- assessment of worker’s health state;
- conduction, where suitable, of biological monitoring, as well as discovery of early and
reversible effects.
3. During the health monitoring of workers application takes place of the newest
achievements in the field of occupational medicine.
Appendix No 4 to Article 22
Protection measures for minimizing risk of infection
Protection measures (А)
Protection levels (В)
2
1.
The
workplace
must
be
separated from all other activities in
the same building
no
3
4
recommended
yes
2.
The supplied air and extracted
air to/from the workplace must be
fully filtered
3.
Access permitted
specified workers
4.
The workplace can be isolated,
to perform disinfection
no
recommended
yes
5.
Specified disinfection
procedures
yes
yes
yes
6.
The
workplace
must
be
maintained under negative air
pressure, compared to atmospheric
pressure
no
recommended
yes
7.
Effective vector control, e.g.
rodents and insects
recommended
yes
yes
8.
Surfaces impermeable to water
and easy to clean
yes, for
working
furnishings
9.
Surfaces resistant to
bases, solvents, disinfectants
recommended
yes
yes
yes
yes
yes, storage
under
controlled
protection
recommended
recommended
yes
recommended
yes
yes,
where
airborne
yes
only
no
for recommended
acids,
10.
Safe storage of biological agents
11.
Provision of window or other
observation device for employed
persons
12.
The laboratory must maintain
own equipment
13.
The infected material, incl.
animals must be processed in a safe
no
wherever
required
yes, for
extracted air
yes
yes, for
working
furnishings
and floors
yes, for
supplied
and
extracted air
yes, via air
chamber
yes, for
working
furnishings,
walls,
floors, and
ceilings
chamber, isolator, or other suitable
premise
14.
Furnace for cremation of animal
corpses
infection
present
recommended
is
yes (available)
yes, on
location
Note. The measures contained in this appendix are subject to application in line with the nature
of work, the risk assessment of workers and the nature of the respective biological agent.
Appendix No 5 to Article 24, Paragraph 1
Protection measures for production processes
Protection measures
Protection levels
2
3
yes
yes
4
1.
Work with viable microorganisms
to be performed in a system physically
separating the process from the
environment
2.
Waste gasses from the closed
system must be processed in order to
reduce
release
prevent
release
prevent release
3.
Sampling, addition of materials to a
specific
closed
system
and
transportation of viable microorganisms
to another closed system must be
executed as far as to
reduce
release
prevent
release
prevent release
4.
Liquid cultures in large quantities
are not removed from the closed system,
unless the viable microorganisms are not
deactivated
via
approved
tested
means
deactivated
via
approved
tested
chemical or
physical
means
deactivated via
approved tested
chemical or
physical means
reduce
release
prevent
release
prevent release
choice
dependent
choice
dependent
yes, designated
construction
5.
6.
Insulation is designed to
The shutter systems are positioned
in a controlled zone as:
yes
a)
biohazard signs placement
b)
access permitted to specified select
persons
c)
staff wears protective clothing
means
for
choice
dependent
yes
yes
choice
dependent
yes
yes, via air
chamber
yes, work
clothing
yes
full shift
yes
yes
yes
d)
staff is provided
disinfection and washing
e)
the staff must shower, prior to
departure from the controlled zone
no
choice
dependent
yes
f)
the waste water from sinks and
showers must be collected and
deactivated prior to release
no
choice
dependent
yes
g)
the controlled zone is suitably
ventilated in order to reduce air
contamination
choice
dependent
yes
h)
the controlled zone is maintained at
negative air pressure, compared to the
atmospheric pressure
no
choice
dependent
yes
i)
The supplied air and the extracted
air to/from the workplace must be fully
filtered
no
choice
dependent
yes
j)
the controlled zone is designed in a
manner disallowing the spread of the
entire content of the closed system
no
choice
dependent
yes
k)
the controlled zone provides
sealing capabilities, for execution of
fumigation
no
choice
dependent
yes
l)
the waste water is processed prior
to final release
deactivated
via
validated
means
choice
dependent
deactivated
via
validated
chemical or
physical
means
deactivated via
validated
chemical
or
physical means
Note: Upon work with biological agents from Second, Third and Fourth group, when suitable,
may be subjected to selection or combination of protection requirements of different categories
based upon the risk assessment of each specific process or part of a process.