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Agents at Work (Amendment) Regulations, 2022 (skedaiii)

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Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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:-

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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".

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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.".

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

Work in healthcare, including isolation and post-mortem units.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic

microbiological laboratories.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

Work in refuse disposal plants.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

Work in sewage purification installations.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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.

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

Safe storage of a biological agent

Yes

Yes

Yes,

secure

storage

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

Personnel should shower before leaving

No

Recom-

Recom-

the contained area

mended

mended

Waste

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

Validated inactivation process for the

Recom-

Yes, on or

Yes, on

safe disposal of animal carcases

mended

off site

site

Other measures

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

A laboratory is to contain its own

No

Recom-

Yes

equipment

mended

Malta Government Gazette — Legal Notice 2022 4 · Gazzetta tal-Gvern ta’ Malta Nru. 20,764 – 07.01.2022 — Agents at Work (Amendment) Regulations, 2022

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.

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