Agents at Work (Amendment) Regulations, 2022 (skedaiii)
Table of Provisions (19)
Statutory Text (19 Articles)
L.N. 4 of 2022
OCCUPATIONAL HEALTH AND SAFETY AUTHORITY ACT
(CAP. 424)
Protection of Workers from risks related to Exposure to Biological
Agents at Work (Amendment) Regulations, 2022
IN EXERCISE of the powers conferred by article 12 of the
Occupational Health and Safety Authority Act, the Deputy Prime
Minister and Minister for Health, after consultation with the
Occupational Health and Safety Authority, has made the following
regulations:-
The title of these regulations is the Protection of Workers
from risks related to Exposure to Biological Agents at Work
(Amendment) Regulations, 2022, and these regulations shall be read
and construed as one with the Protection of Workers from risks related
to Exposure to Biological Agents at Work Regulations, hereinafter
referred to as "the principal regulations".
COMMUNITY CLASSIFICATION
Regulation 2 (definition of biological agents) and Regulation 18
INTRODUCTORY NOTES
1. In line with the scope of these Regulations, only agents which are known to
infect humans are to be included in the classified list.
Where appropriate, indicators are given of the toxic and allergic potential of
these agents.
Animal and plant pathogens which are known not to affect man are excluded.
In drawing up this list of classified biological agents consideration has not
been given to genetically modified micro-organisms.
2. The list of classified agents is based on the effect of those agents on healthy
workers.
No specific account is taken of particular effects on those whose
susceptibility may be affected for one or other reason such as pre-existing
disease, medication, compromised immunity, pregnancy or breast feeding.
Additional risk to such workers should be considered as part of the risk
assessment required by these Regulations.
In certain industrial processes, certain laboratory work or certain work with
animals involving actual or potential exposure to biological agents of groups
3 or 4, any technical precautions taken must comply with regulation 16.
3. Biological agents which have not been classified for inclusion in groups 2 to
4 of the list are not implicitly classified in group 1.
For genera where more than one species is known to be pathogenic to man,
the list will include those species which are known to be the most frequently
responsible for diseases, together with a more general reference to the fact
that other species of the same genus may affect health.
When a whole genus is mentioned in the classified list of biological agents, it
is implicit that the species and strains known to be non-pathogenic are
excluded.
4. Where a strain is attenuated or has lost known virulence genes, then the
containment required by the classification of its parent strain need not
necessarily apply, subject to assessment appropriate for risk in the workplace.
This is the case, for example, when such a strain is to be used as a product or
part of a product for prophylactic or therapeutic purposes.
5. The nomenclature of classified agents used to establish this list reflects and is
in conformity with the latest international agreements of the taxonomy and
nomenclature of agents at the time the list was prepared.
6. The list of classified biological agents reflects the state of knowledge at the
time that it was devised.
It will be updated as soon as it no longer reflects the latest state of knowledge.
7. All viruses which have already been isolated in humans and which have not
been assessed and allocated in this Schedule are classified in group 2 as a
minimum, except in those cases where there is sufficient proof that they are
unlikely to cause disease in humans.
Sub-regulation (2) of regulation 1 of the principal
regulations shall be substituted by the following
"(2) The scope of these regulations is to
(a) protect workers against risks to their health and
safety, including the prevention of such risks, arising or
likely to arise from exposure to biological agents at work;
(b) transpose Commission Directive (EU) 2020/739
of 3 June 2020 amending Annex III to Directive 2000/54/EC
of the European Parliament and of the Council as regards the
inclusion of SARS-CoV-2 in the list of biological agents
known to infect humans and amending Commission
Directive (EU) 2019/1833;
(c) transpose Commission Directive (EU) 2019/
1833 of 24 October 2019 amending Annexes I, III, V and
VI to Directive 2000/54/EC of the European Parliament
and of the Council as regards purely technical
adjustments.".
INDICATIONS CONCERNING CONTAINMENT MEASURES AND
CONTAINMENT LEVELS
(Regulations 15(3) and 16(1)(a) and (b))
Preliminary note
The measures contained in this Schedule shall be applied according to the
nature of the activities, the assessment of risk to workers, and the nature of the
biological agent concerned.
In the table, "Recommended" means that the measures should in principle be
applied, unless the results of the assessment referred to in Regulation 3(2)
indicate otherwise.
B. Containment levels
A. Containment measures
Workplace
1. The workplace is to be separated from
No
Recom-
Yes
any other activities in the same building
mended
2. The workplace is to be sealable to permit
No
Recom-
Yes
fumigation
mended
Facilities
Where
Yes, where
Yes
3. Infected material, including any
animal, is to be handled in a safety
appropriate
infection is
cabinet or isolation or other suitable
by air-
containment
borne route
Equipment
4. Input air and extract air to the
No
Yes, on
Yes, on
workplace are to be filtered using (HEPA
extract air
input and
extract air
( 1 )) or likewise
5. The workplace is to be maintained at an
No
Recom-
Yes
air pressure negative to atmosphere
mended
6. Surfaces impervious to water and easy
Yes, for
Yes, for
Yes, for
to clean
bench and
bench,
bench,
floor
floor and
walls,
other sur-
floor and
faces deter-
ceiling
mined by
risk assess-
ment
7. Surfaces resistant to acids, alkalis,
Recom-
Yes
Yes
solvents, disinfectants
mended
System of work
8. Access is to be restricted to nominated
Recom-
Yes
Yes, via
workers only
airlock
mended
( 2 )
9. Efficient vector control, for example
Recom-
Yes
Yes
rodents and insects
mended
10. Specified disinfection procedures
Yes
Yes
Yes
Schedule I, III, V and VI of the principal regulations shall
be substituted by the following
"SCHEDULE I
INDICATIVE LIST OF ACTIVITIES
(Regulation 4(2))
Preliminary note
Where the result of the risk assessment carried out in accordance with
Regulation 3 and Regulation 4(2) of these Regulations, shows an
unintentional exposure to biological agents, there may be other work
activities, not included in this Schedule, which should be considered.
1. Work in food production plants.
2. Work in agriculture.
3. Work activities where there is contact with animals and/or products of animal
origin.
CONTAINMENT FOR INDUSTRIAL PROCESSES
(Regulation 4(1) and Regulation 16(2)(a))
Preliminary note
In the table, "Recommended" means that the measures should in principle be
applied, unless the results of the assessment referred to in Regulation 3(2)
indicate otherwise.
Group 1 biological agents
For work with group 1 biological agents including live attenuated vaccines,
the principles of good occupational safety and hygiene should be observed.
Groups 2, 3 and 4 biological agents
It may be appropriate to select and combine containment requirements from
different categories below on the basis of a risk assessment related to any
particular process or part of a process.
A. Containment measures
B. Containment levels
General
1. Viable organisms should be handled in a
Yes
Yes
Yes
system which physically separates the
process from the environment
2. Exhaust gases from the closed system
Minimise
Prevent
Prevent
should be treated so as to
release
release
release
3. Sample collection, addition of materials
Minimise
Prevent
Prevent
to a closed system and transfer of viable
release
release
release
organisms to another closed system,
should be performed so as to
Inacti-
4. Bulk culture fluids should not be removed
Inactivated
Inactivated
from the closed system unless the viable
by validated
by vali-
vated by
organisms have been
chemical or
dated
validated
physical
chemical or
chemical
means
physical
or physical
means
means
5. Seals should be designed so as to
Minimise
Prevent
Prevent
release
release
release
6. The controlled area should be designed
No
Recom-
Yes
to contain spillage of the entire contents
mended
of the closed system
7. The controlled area should be sealable to
No
Recom-
Yes
permit fumigation
mended
Facilities
8. Decontamination and washing facilities
Yes
Yes
Yes
should be provided for personnel
Equipment
9. Input air and extract air to the controlled
No
Recom-
Yes
mended
area should be HEPA ( 1 ) filtered
10.The controlled area should be maintained at
No
Recom-
Yes
an air pressure negative to atmosphere
mended
11.The controlled area should be adequately
Recom-
Recom-
Yes
ventilated to minimize air contamination
mended
mended
System of work
Recom-
Recom-
Yes, and
12.Closed systems ( 2 ) should be located within
mended
mended
purpose-
a controlled area
built
13.Biohazard signs should be posted
Recom-
Yes
Yes
mended
14.Access should be restricted to nominated
Recom-
Yes
Yes, via an
personnel only
mended
airlock ( 3 )
15.Personnel should shower before leaving the
No
Recom-
Yes
controlled area
mended
16.Personnel should wear protective clothing
Yes, work
Yes
Yes, com-
clothing
plete
change
Waste
17.Effluent from sinks and showers should be
No
Recom-
Yes
collected and inactivated before release
mended
18.Effluent treatment before final discharge
Inactivated
Inactivated
Inactivated
by validated
by validated
by vali-
chemical or
chemical or
dated
physical
physical
chemical or
means
means
physical
means
( 1 ) HEPA: High efficiency particulate air
( 2 ) Closed system: A system that physically separates the process from the environment (e.g.
incubator vats, tanks, etc.).
( 3 ) Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory.
The clean side of the airlock must be separated from the restricted side by changing or shower-
ing facilities and preferably by interlocking doors. ".
€2.16
Work in healthcare, including isolation and post-mortem units.
Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic
microbiological laboratories.
Work in refuse disposal plants.
Work in sewage purification installations.
Certain biological agents classified in group 3 which are indicated in the
appended list by two asterisks (**), may present a limited risk of infection for
workers because they are not normally infectious by the airborne route.
The Authority shall assess the containment measures to be applied to such
agents, taking account of the nature of specific activities in question and of
the quantity of the agent involved, with a view to determining whether, in
particular circumstances, some of these measures may be dispensed with.
The requirements as to containment consequent on the classification of
parasites apply only to stages in the life cycle of the parasite in which it is
liable to be infectious to humans at the workplace.
This list also gives a separate indication in cases where the biological agents
are likely to cause allergic or toxic reactions, where an effective vaccine is
available, or where it is advisable to keep a list of exposed workers for more
than ten years.
These indications are shown by the following letters
A
Possible allergic effects
D
List of workers exposed to this biological agent to be kept for more than
ten years after the end of last known exposure
T
Toxin production
V
Effective vaccine available and registered within the EU
The application of preventive vaccination should take account of the code of
practice given in Schedule VII.
BACTERIA and similar organisms
NB: For biological agents appearing on this list, the entry of the whole genus
with the addition of ‘spp.’ refers to other species belonging to this genus that have
not specifically been included in the list, but which are known pathogens in humans.
See introductory note 3 for further details.
Biological Agent
Classification
Notes
Actinomadura madurae
Actinomadura pelletieri
Actinomyces gerencseriae
Actinomyces israelii
Actinomyces spp.
Aggregatibacter actinomycetemcomitans
(Actinobacillus actinomycetemcomitans)
Anaplasma spp.
Arcanobacterium haemolyticum (Corynebacterium
haenolyticum)
Arcobacter butzleri
Bacillus anthracis
T
Bacteroides fragilis
Bacteroides spp.
Bartonella bacilliformis
Bartonella quintana (Rochalimaea quintana)
Bartonella (Rochalimea) spp.
Bordetella bronchiseptica
Bordetella parapertussis
Bordetella pertussis
T, V
Bordetella spp.
Borrelia burgdorferi
Borrelia duttonii
Borrelia recurrentis
Borrelia spp.
Brachyspira spp.
Brucella abortus
Brucella canis
Brucella inopinata
Brucella melitensis
Brucella suis
Burkholderia cepacia
Burkholderia mallei (Pseudomonas mallei)
Burkholderia pseudomallei (Pseudomonas
pseudomallei)
D
Campylobacter fetus subsp. fetus
Campylobacter fetus subsp. venerealis
Campylobacter jejuni subsp. doylei
Campylobacter jejuni subsp. jejuni
Campylobacter spp.
Cardiobacterium hominis
Cardiobacterium valvarum
Chlamydia abortus (Chlamydophila abortus)
Chlamydia caviae (Chlamydophila caviae)
Chlamydia felis (Chlamydophila felis)
Chlamydia pneumoniae (Chlamydophila
pneumoniae)
Chlamydia psittaci (Chlamydophila psittaci) (avian
strains)
Chlamydia psittaci (Chlamydophila psittaci) (other
strains)
Chlamydia trachomatis (Chlamydophila trachomatis)
Clostridium botulinum
T
Clostridium difficile
T
Clostridium perfringens
T
Clostridium tetani
T, V
Clostridium spp.
Corynebacterium diphtheriae
T, V
Corynebacterium minutissimum
Corynebacterium pseudotuberculosis
T
Corynebacterium ulcerans
T
Corynebacterium spp.
Coxiella burnetii
Edwardsiella tarda
Ehrlichia spp.
Eikenella corrodens
Elizabethkingia meningoseptica (Flavobacterium
meningosepticum)
Enterobacter aerogenes (Klebsiella mobilis)
Enterobacter cloacae subsp. cloacae (Enterobacter
cloacae)
Enterobacter spp.
Enterococcus spp.
Erysipelothrix rhusiopathiae
Escherichia coli (with the exception of non-
pathogenic strains)
Escherichia coli, verocytotoxigenic strains (e.g.
O157:H7 or O103)
3 (*)
T
Fluoribacter bozemanae (Legionella)
Francisella hispaniensis
Francisella tularensis subsp. holarctica
Francisella tularensis subsp. mediasiatica
Francisella tularensis subsp. novicida
Francisella tularensis subsp. tularensis
Fusobacterium necrophorum subsp. funduliforme
Fusobacterium necrophorum subsp. necrophorum
Gardnerella vaginalis
Haemophilus ducreyi
Haemophilus influenzae
V
Haemophilus spp.
Helicobacter pylori
Helicobacter spp.
Klebsiella oxytoca
Klebsiella pneumoniae subsp. ozaenae
Klebsiella pneumoniae subsp. pneumoniae
Klebsiella pneumoniae subsp. rhinoscleromatis
Klebsiella spp.
Legionella pneumophila subsp. fraseri
Legionella pneumophila subsp. pascullei
Legionella pneumophila subsp. pneumophila
Legionella spp.
Leptospira interrogans (all serovars)
Leptospira interrogans spp.
Listeria monocytogenes
Listeria ivanovii subsp. ivanovii
Listeria ivanovii subsp. londoniensis
Morganella morganii subsp. morganii (Proteus
morganii)
Morganella morganii subsp. sibonii
Mycobacterium abscessus subsp. abscessus
Mycobacterium africanum
V
Mycobacterium avium subsp. avium (Mycobacterium
avium)
Mycobacterium avium subsp. paratuberculosis
(Mycobacterium paratuberculosis)
Mycobacterium avium subsp. silvaticum
Mycobacterium bovis
V
Mycobacterium caprae (Mycobacterium tuberculosis
subsp. caprae)
Mycobacterium chelonae
Mycobacterium chimaera
Mycobacterium fortuitum
Mycobacterium intracellulare
Mycobacterium kansasii
Mycobacterium leprae
Mycobacterium malmoense
Mycobacterium marinum
Mycobacterium microti
3 (*)
Mycobacterium pinnipedii
Mycobacterium scrofulaceum
Mycobacterium simiae
Mycobacterium szulgai
Mycobacterium tuberculosis
V
Mycobacterium ulcerans
3 (*)
Mycobacterium xenopi
Mycoplasma hominis
Mycoplasma pneumoniae
Mycoplasma spp.
Neisseria gonorrhoeae
Neisseria meningitidis
V
Neorickettsia sennetsu (Rickettsia sennetsu, Ehrlichia
sennetsu)
Nocardia asteroides
Nocardia brasiliensis
Nocardia farcinica
Nocardia nova
Nocardia otitidiscaviarum
Nocardia spp.
Orientia tsutsugamushi (Rickettsia tsutsugamushi)
Pasteurella multocida subsp. gallicida (Pasteurella
gallicida)
Pasteurella multocida subsp. multocida
Pasteurella multocida subsp. septica
Pasteurella spp.
Peptostreptococcus anaerobius
Plesiomonas shigelloides
Porphyromonas spp.
Prevotella spp.
Proteus mirabilis
Proteus penneri
Proteus vulgaris
Providencia alcalifaciens (Proteus inconstans)
Providencia rettgeri (Proteus rettgeri)
Providencia spp.
Pseudomonas aeruginosa
T
Rhodococcus hoagii (Corynebacterium equii)
Rickettsia africae
Rickettsia akari
3 (*)
Rickettsia australis
Rickettsia canadensis
Rickettsia conorii
Rickettsia heilongjiangensis
3(*)
Rickettsia japonica
Rickettsia montanensis
Rickettsia typhi
Rickettsia prowazekii
Rickettsia rickettsii
Rickettsia sibirica
Rickettsia spp.
Salmonella enterica (choleraesuis) subsp. arizonae
Salmonella Eneritidis
Salmonella Paratyphi A, B, C
V
Salmonella Typhi
3 (*)
V
Salmonella Typhimurium
Salmonella (serotipi oħrajn)
Shigella boydii
Shigella dysenteriae (tat-Tip 1)
3 (*)
T
Shigella dysenteriae, għajr tat-Tip 1
Shigella flexneri
Shigella sonnei
Staphylococcus aureus
T
Streptobacillus moniliformis
Streptococcus agalactiae
Streptococcus dysgalactiae subsp. equisimilis
Streptococcus pneumoniae
T, V
Streptococcus pyogenes
T
Streptococcus suis
Streptococcus spp.
Treponema carateum
Treponema pallidum
Treponema pertenue
Treponema spp.
Trueperella pyogenes
Ureaplasma parvum
Ureaplasma urealyticum
Vibrio cholerae (including E1 Tor)
T, V
Vibrio parahaemolyticus (Benecka parahaemolytica)
Vibrio spp.
Yersinia enterocolitica subsp. enterolitica
Yersinia enterocolitica subsp. palearctica
Yersinia pestis
Yersinia pseudotuberculosis
Yersinia spp.
(*) See paragraph 8 of the introductory notes.
VIRUSES ( * )
NB: Viruses have been listed according to their order (O), family (F) and
genus (G).
Biological Agent
Classification
Notes
(virus species or indicated taxonomy order)
Bunyavirales (O)
Hantaviridae (F)
Orthohantavirus (G)
Andes orthohantavirus (Hantavirus species causing
Hantavirus Pulmonary Syndrome [HPS])
Bayou orthohantavirus
Black Creek Canal orthohantavirus
Cano Delgadito orthohantavirus
Choclo orthohantavirus
Dobrava-Belgrade orthohantavirus (Hantavirus species
causing Haemorrhagic Fever with Renal Syndrome
[HFRS])
El Moro Canyon orthohantavirus
Hantaan orthohantavirus (Hantavirus species causing
Haemorrhagic Fever with Renal Syndrome [HFRS])
Laguna Negra orthohantavirus
Prospect Hill orthohantavirus
Puumala orthohantavirus (Hantavirus species causing
Nephropathia Epidemica [NE])
Seoul orthohantavirus (Hantavirus species causing
Haemorrhagic Fever with Renal Syndrome [HFRS])
Sin Nombre orthohantavirus (Hantavirus species causing
Hantavirus Pulmonary Syndrome [HPS])
Other hantaviruses known to be pathogenic
* See paragraph 7 of the introductory notes.
Nairoviridae (F)
Orthonairovirus (G)
Crimean-Congo haemorrhagic fever orthonairovirus
Dugbe orthonairovirus
Hazara orthonairovirus
Nairobi sheep disease orthonairovirus
Other nairoviruses known to be pathogenic
Peribunyaviridae (F)
Orthobunyavirus (G)
Bunyamwera orthobunyavirus (Germiston virus)
California encephalitis orthobunyavirus
Oropouche orthobunyavirus
Other orthobunyaviruses known to be pathogenic
Phenuiviridae (F)
Phlebovirus (G)
Bhanja phlebovirus
Punta Toro phlebovirus
Rift Valley fever phlebovirus
Sandfly fever Naples phlebovirus (Toscana Virus)
SFTS phlebovirus (Severe Fever with Thrombocytopenia
Syndrome-Virus)
Other phleboviruses known to be pathogenic
Herpesvirales (O)
Herpesviridae (F)
Cytomegalovirus (G)
Human betaherpesvirus 5 (Cytomegalovirus)
Lymphocryptovirus (G)
Human gammaherpesvirus 4 (Epstein-Barr virus)
Rhadinoovirus (G)
Human gammaherpesvirus 8
D
Roseolovirus (G)
Human betaherpesvirus 6A (Human B- lymphotropic
virus)
Human betaherpesvirus 6B
Human betaherpesvirus 7
Simplexvirus (G)
Macacine alphaherpesvirus 1 (Herpesvirus simiae,
Herpes B virus)
Human alphaherpesvirus 1 (Human herpesvirus 1,
Herpes simplex virus type 1)
Human alphaherpesvirus 2 (Human herpesvirus 2,
Herpes simplex virus type 2)
Varicellovirus (G)
Human alphaherpesvirus 3 (Herpesvirus varicella-zoster)
V
Mononegavirales (O)
Filoviridae (F)
Ebolavirus (G)
Marburgvirus (G)
Marburg marburgvirus
Paramyxoviridae (F)
Avulavirus (G)
Newcastle disease virus
Henipavirus (G)
Hendra henipavirus
Nipah henipavirus
Morbillivirus (G)
Measles morbillivirus
V
Respirovirus (G)
Human respirovirus 1 (Parainfluenza virus 1)
Human respirovirus 3 (Parainfluenza virus 3)
Rubulavirus (G)
Mumps rubulavirus
V
Human rubulavirus 2 (Parainfluenza virus 2)
Human rubulavirus 4 (Parainfluenza virus 4)
Pneumoviridae (F)
Metapneumovirus (G)
Orthopneumovirus (G)
Human orthopneumovirus (Respiratory syncytial virus)
Rhabdoviridae (F)
Lyssavirus (G)
Australian bat lyssavirus
3 (**)
V
Duvenhage lyssavirus
3 (**)
V
European bat lyssavirus 1
3 (**)
V
European bat lyssavirus 2
3 (**)
V
Lagos bat lyssavirus
3 (**)
Mokola lyssavirus
Rabies lyssavirus
3 (**)
V
Vesiculovirus (G)
Vesicular stomatitis virus, Alagoas vesiculovirus
Vesicular stomatitis virus, Indiana vesiculovirus
Vesicular stomatitis virus, New Jersey vesiculovirus
Piry vesiculovirus (Piry virus)
Nidovirales (O)
Coronaviridae (F)
Betacoronavirus (G)
Severe acute respiratory syndrome-related coronavirus
(SARS-virus)
Severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) ( *** )
Middle East respiratory syndrome coronavirus (MERS-
virus)
Other Coronaviridae known to be pathogenic
Picornavirales (O)
Picornaviridae (F)
Cardiovirus (G)
Saffold virus
Cosavirus (G)
Cosavirus A
Enterovirus (G)
Enterovirus (A)
Enterovirus (B)
Enterovirus (C)
Enterovirus (D), Human Enterovirus type 70 (Acute
haemorrhagic conjunctivitis virus)
Rhinoviruses
Poliovirus, type 1 and 3
V
Poliovirus, type 2 ( 1 )
V
Hepatovirus (G)
Hepatovirus A (Hepatitis A virus, Human Enterovirus
type 72)
V
Kobuvirus (G)
Aichivirus A (Aichi virus 1)
Parechovirus (G)
Parechoviruses A
Parechoviruses B (Ljungan virus)
Other Picornaviridae known to be pathogenic
Unassigned (O)
Adenoviridae (F)
Astroviridae (F)
Arenaviridae (F)
Mammarenavirus (G)
Brazilian mammarenavirus
Chapare mammarenavirus
Flexal mammarenavirus
Guanarito mammarenavirus
Junín mammarenavirus
Lassa mammarenavirus
Lujo mammarenavirus
Lymphocytic choriomeningitis mammarenavirus,
neurotropic strains
Lymphocytic choriomeningitis mammarenavirus (other
strains)
Machupo mammarenavirus
Mobala mammarenavirus
Mopeia mammarenavirus
Tacaribe mammarenavirus
Whitewater Arroyo mammarenavirus
Caliciviridae (F)
Norovirus (G)
Norovirus (Norwalk virus)
Other Caliciviridae known to be pathogenic
Hepadnaviridae (F)
Orthohepadnavirus (G)
Hepatitis B virus
3 (**)
V, D
Hepeviridae (F)
Orthohepevirus (G)
Orthohepevirus A (Hepatitis E virus)
Flaviviridae (F)
Flavivirus (G)
Dengue virus
Japanese encephalitis virus
V
Kyasanur Forest disease virus
V
Louping ill virus
3 (**)
Murray Valley encephalitis virus (Australia encephalitis
virus)
Omsk haemorrhagic fever virus
Powassan virus
Rocio virus
St. Louis encephalitis virus
Tick-borne encephalitis virus
Absettarov virus
Hanzalova virus
Hypr virus
Kumlinge virus
Negishi virus
Russian spring-summer encephalitis ( a )
V
Tick-borne encephalitis virus Central European subtype
3 (**)
V
Tick-borne encephalitis virus Far Eastern subtype
Tick-borne encephalitis virus Siberian subtype
V
Wesselsbron virus
3 (**)
West Nile fever virus
Yellow fever virus
V
Zika virus
Other flaviviruses known to be pathogenic
Hepacivirus (G)
Hepacivirus C (Hepatitis C virus)
3 (**)
D
Orthomyxoviridae (F)
Gammainfluenzavirus (G)
Influenza C virus
V ( c )
Influenzavirus A (G)
Highly Pathogenic Avian Influenza Viruses HPAIV
(H5), e.g. H5N1
Highly Pathogenic Avian Influenza Viruses HPAIV
(H7), e.g. H7N7, H7N9
Influenza A virus
V ( c )
Influenza A virus A/New York/1/18 (H1N1) (Spanish
flu 1918)
Influenza A virus A/Singapore/1/57 (H2N2)
Low Pathogenic Avian Influenza Virus (LPAI) H7N9
Influenzavirus B (G)
Influenza B virus
V ( c )
Thogoto virus (G)
Dhori virus (Tick-borne orthomyxoviridae: Dhori)
Thogoto virus (Tick-borne orthomyxoviridae: Thogoto)
Papillomaviridae (F)
D ( d )
Parvoviridae (F)
Erythroparvovirus (G)
Primate erythroparvovirus 1 (Human parvovirus, B 19
virus)
Polyomaviridae (F)
Betapolyomavirus (G)
Human polyomavirus 1 (BK virus)
D ( d )
Human polyomavirus 2 (JC virus)
D ( d )
Poxviridae (F)
Molluscipoxvirus (G)
Molluscum contagiosum virus
Orthopoxvirus (G)
Cowpox virus
Monkeypox virus
V
Vaccinia virus (incl. Buffalopox virus ( e ), Elephantpox
virus ( f ), Rabbitpox virus ( g ))
Variola (major and minor) virus
V
Parapoxvirus (G)
Orf virus
Pseudocowpox virus (Milkers’ node virus, parapoxvirus
bovis)
Yatapoxvirus (G)
Tanapox virus
Yaba monkey tumor virus
Reoviridae (F)
Seadornavirus (G)
Banna virus
Coltivirus (G)
Rotaviruses (G)
Orbivirus (G)
Retroviridae (F)
Deltaretrovirus (G)
Primate T-lymphotropic virus 1 (Human T-cell
lymphotropic virus, type 1)
3 (**)
D
Primate T-lymphotropic virus 2 (Human T-cell
lymphotropic virus, type 2)
3 (**)
D
Lentivirus (G)
Human immunodeficiency virus 1
3 (**)
D
Human immunodeficiency virus 2
3 (**)
D
Simian Immunodeficiency Virus (SIV) ( h )
Togaviridae (F)
Alphavirus (G)
Cabassouvirus
Eastern equine encephalomyelitis virus
V
Bebaru virus
Chikungunya virus
3 (**)
Everglades virus
3 (**)
Mayaro virus
Mucambo virus
3 (**)
Ndumu virus
3 (**)
O’nyong-nyong virus
Ross River virus
Semliki Forest virus
Sindbis virus
Tonate virus
3 (**)
Venezuelan equine encephalomyelitis virus
V
Western equine encephalomyelitis virus
V
Other alphaviruses known to be pathogenic
Rubivirus (G)
Rubella virus
V
Unassigned (F)
Deltavirus (G)
Hepatitis delta virus ( b )
V, D
(*) See paragraph 7 of the introductory notes.
( 1 ) Classification according to WHO Global Action Plan to minimize poliovirus facility-
associated risk after type-specific eradication of wild polioviruses and sequential cessation of
oral polio vaccine use.
(**) See paragraph 8 of the introductory notes.
(***) In line with regulation 16(1)(c), non-propagative diagnostic laboratory work involving
SARS-CoV-2 should be conducted at a facility using procedures equivalent to at least
containment level 2. Propagative work involving SARS-CoV-2 should be conducted at a
containment level 3 laboratory with air pressure negative to atmosphere.
( a ) Tick-borne encephalitis
( b ) Hepatitis delta virus is pathogenic in workers only in the presence of simultaneous or
secondary infection caused by hepatitis B virus. Vaccination against hepatitis B virus will
therefore protect workers who are not affected by hepatitis B virus against hepatitis delta virus.
( c ) Only for types A and B.
( d ) Recommended for work involving direct contact with these agents.
( e ) Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia
virus.
( f ) Variant of cowpox virus.
( g ) Variant of Vaccinia.
( h ) At present there is no evidence of disease in humans caused by the other retroviruses of
simian origin. As a precaution containment level 3 is recommended for work with them.
PRION DISEASE AGENTS
Biological Agent
Classification
Notes
Agent of Creutzfeldt-Jakob disease
3(*)
D ( a )
Variant Agent of Creutzfeldt-Jakob disease
3(*)
D ( a )
Agent of Bovine Spongiform Encephalopathy (BSE)
3(*)
D ( a )
and other related animal TSEs
Agent of Gerstmann-Sträussler-Scheinker syndrome
3(*)
D ( a )
Agent of Kuru
3(*)
D ( a )
Agent of Scrapie
(*) See paragraph 8 of the introductory notes.
( a ) Recommended for work involving direct contact with these agents.
PARASITES
NB: For biological agents appearing on this list, the entry of the whole genus
with the addition of ‘spp.’ refers to other species belonging to this genus that have
not specifically been included in the list, but which are known pathogens in humans.
See introductory note 3 for further details.
Biological Agent
Classification
Notes
Acanthamoeba castellani
Ancylostoma duodenale
Angiostrongylus cantonensis
Angiostrongylus costaricensis
Anisakis simplex
A
Ascaris lumbricoides
A
Ascaris suum
A
Babesia divergens
Babesia microti
Balamuthia mandrillaris
Balantidium coli
Brugia malayi
Brugia pahangi
Brugia timori
Capillaria philippinensis
Capillaria spp.
Clonorchis sinensis (Opisthorchis sinensis)
Clonorchis viverrini (Opisthorcis viverrini)
Cryptosporidium hominis
Cryptosporidium parvum
Cyclospora cayetanensis
Dicrocoelium dentriticum
Dipetalonema streptocerca
Diphyllobothrium latum
Dracunculus medinensis
Echinococcus granulosus
3 (*)
Echinococcus multilocularis
3 (*)
Echinococcus oligarthrus
3 (*)
Echinococcus vogeli
3 (*)
Entamoeba histolytica
Enterobius vermicularis
Enterocytozoon bieneusi
Fasciola gigantica
Fasciola hepatica
Fasciolopsis buski
Giardia lamblia (Giardia duodenalis, Giardia
intestinalis)
Heterophyes spp.
Hymenolepis diminuta
Hymenolepis nana
Leishmania aethiopica
Leishmania braziliensis
3 (*)
Leishmania donovani
3 (*)
Leishmania guyanensis (Viannia guyanensis)
3 (*)
Leishmania infantum (Leishmania chagasi)
3 (*)
Leishmania major
Leishmania mexicana
Leishmania panamensis (Viannia panamensis)
3 (*)
Leishmania peruviana
Leishmania tropica
Leishmania spp.
Loa loa
Mansonella ozzardi
Mansonella perstans
Mansonella streptocerca
Metagonimus spp.
Naegleria fowleri
Necator americanus
Onchocerca volvulus
Opisthorchis felineus
Opisthorchis spp.
Paragonimus westermani
Paragonimus spp.
Plasmodium falciparum
3 (*)
Plasmodium knowlesi
3 (*)
Plasmodium spp. (human and simian)
Sarcocystis suihominis
Schistosoma haematobium
Schistosoma intercalatum
Schistosoma japonicum
Schistosoma mansoni
Schistosoma mekongi
Strongyloides stercoralis
Strongyloides spp.
Taenia saginata
Taenia solium
3 (*)
Toxocara canis
Toxocara cati
Toxoplasma gondii
Trichinella nativa
Trichinella nelsoni
Trichinella pseudospiralis
Trichinella spiralis
Trichomonas vaginalis
Trichostrongylus orientalis
Trichostrongylus spp.
Trichuris trichiura
Trypanosoma brucei brucei
Trypanosoma brucei gambiense
Trypanosoma brucei rhodesiense
3 (*)
Trypanosoma cruzi
3 (*)
Wuchereria bancrofti
(*) See paragraph 8 of the introductory notes.
FUNGI
NB: For biological agents appearing on this list, the entry of the whole genus
with the addition of ‘spp.’ refers to other species belonging to this genus that have
not specifically been included in the list, but which are known pathogens in humans.
See introductory note 3 for further details.
Biological Agent
Classification
Notes
Aspergillus flavus
A
Aspergillus fumigatus
A
Aspergillus spp.
Blastomyces dermatitidis (Ajellomyces dermatitidis)
Blastomyces gilchristii
Candida albicans
A
Candida dubliniensis
Candida glabrata
Candida parapsilosis
Candida tropicalis
Cladophialophora bantiana (Xylohypha bantiana,
Cladosporium bantianum, trichoides)
Cladophialophora modesta
Cladophialophora spp.
Coccidioides immitis
A
Coccidioides posadasii
A
Cryptococcus gattii (Filobasidiella neoformans var.
bacillispora)
A
Cryptococcus neoformans (Filobasidiella
neoformans var. neoformans)
A
Emmonsia parva var. parva
Emmonsia parva var. crescens
Epidermophyton floccosum
A
Epidermophyton spp.
Fonsecaea pedrosoi
Histoplasma capsulatum
Histoplasma capsulatum var. farciminosum
Histoplasma duboisii
Madurella grisea
Madurella mycetomatis
Microsporum spp.
A
Nannizzia spp.
Neotestudina rosatii
Paracoccidioides brasiliensis
A
Paracoccidioides lutzii
Paraphyton spp.
Rhinocladiella mackenziei
Scedosporium apiospermum
Scedosporium prolificans (inflatum)
Sporothrix schenckii
Talaromyces marneffei (Penicillium marneffei)
A
Trichophyton rubrum
A
Trichophyton tonsurans
A
Trichophyton spp.
Safe storage of a biological agent
Yes
Yes
Yes,
secure
storage
Personnel should shower before leaving
No
Recom-
Recom-
the contained area
mended
mended
Waste
Validated inactivation process for the
Recom-
Yes, on or
Yes, on
safe disposal of animal carcases
mended
off site
site
Other measures
A laboratory is to contain its own
No
Recom-
Yes
equipment
mended
An observation window, or, alternative,
Recom-
Recom-
Yes’
is to be present, so that occupants can be
mended
mended
seen
( 1 ) HEPA: High efficiency particulate air
( 2 ) Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory.
The clean side of the airlock must be separated from the restricted side by changing or
showering facilities and preferably by interlocking doors.