PROTECTION OF WORKERS FROM RISKS RELATED TO EXPOSURE TO BIOLOGICAL AGENTS AT WORK REGULATIONS

SUBSIDIARY LEGISLATION 646.17

PROTECTION OF WORKERS FROM RISKS

RELATED TO EXPOSURE TO BIOLOGICAL

AGENTS AT WORK REGULATIONS

5th September, 2003

LEGAL NOTICE 228 of 2003, as amended by Legal Notices 442 of 2020

and 4 of 2022 and Act XXXIII of 2024.

(1) The title of these regulations is the Protection of

Workers from Risks related to Exposure to Biological Agents at

Work Regulations.

(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.

(3) These regulations lay down particular minimum provisions

in this area without prejudice to any laws, regulations or other

legislative provisions stipulating general principles concerning the

prevention of occupational risks, the protection of health and

safety, the elimination of risk and accident factors, the information

to, consultation, balanced participation and training of workers and

their representatives.

(4) These regulations shall also be without prejudice to other

regulations that may be issued on the contained use of genetically

modified micro-organisms or on the deliberate release in the

environment of genetically modified organisms.

Substituted by

L.N. 4 of 2022.

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.

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

5. Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic

microbiological laboratories.

6. Work in refuse disposal plants.

7. Work in sewage purification installations.

In these regulations. unless the context otherwise requires

"Act" means the Health and Safety at Work Act;

"Authority" means the Occupational Health and Safety Authority

established by virtue of article 4 of the Act;

"biological agents" means micro-organisms, including those

which have been genetically modified, cell cultures and human

endoparasites, which may be able to provoke any infection, allergy

or toxicity, and which shall be classified into the following four

PROTECTION OF WORKERS FROM RISKS RELATED TO

EXPOSURE TO BIOLOGICAL AGENTS AT WORK

risk groups, according to their level of risk of infection

(a) group 1 biological agent means an agent that is

unlikely to cause human disease;

(b) group 2 biological agent means an agent that can cause

human disease and might be a hazard to workers; it is

unlikely to spread to the community; there is usually

effective prophylaxis or treatment available;

(c) group 3 biological agent means an agent that can cause

severe human disease and present a serious hazard to

workers; it may present a risk of spreading to the

community, but there is usually effective prophylaxis

or treatment available;

(d) group 4 biological agent means an agent that causes

severe human disease and is a serious hazard to

workers; it may present a high risk of spreading to the

community; there is usually no effective prophylaxis

or treatment available;

"cell culture" means the in-vitro growth of cells derived from

multicellular organisms;

"micro-organism" means a microbiological entity, cellular or

non-cellular, capable of replication or of transferring genetic

material.

BIOHAZARD SIGN

(Regulation 6)

Biological risk

(1) These regulations shall apply to activities in which

workers are, or are potentially exposed to biological agents as a

result of their work.

(2)

(a) In the case of any activity likely to involve a risk of

exposure to biological agents, the nature, degree and

duration of workers’ exposure must be determined in

order to make it possible to assess any risk to the

workers' health or safety and to lay down the measures

to be taken.

(b) In the case of activities involving exposure to several

groups of biological agents, the risk shall be assessed

on the basis of the danger presented by all hazardous

biological agents present.

(c) The assessment must be renewed regularly and in any

event when any change occurs in the conditions that

may affect workers’ exposure to biological agents.

(d) The employer must supply the Authority, at its request,

with the information used for making the assessment.

(3) The assessment referred to in sub-regulation (2) shall be

conducted on the basis of all available information including

(a) the classification of biological agents which are, or

which may be, a hazard to human health, as referred to

in regulation 18;

(b) any recommendations from the Authority which

indicate that the biological agent should be controlled

in order to protect workers’ health when workers are

or may be exposed to such a biological agent as a

result of their work;

(c) information on diseases which may be contracted as a

result of the work of the workers;

(d) potential allergenic or toxigenic effects as a result of

the work of the workers;

(e) knowledge of a disease from which a worker is found

to be suffering and which has a direct connection with

his work.

Substituted by

L.N. 4 of 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.

8. 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.

9. 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.

10. 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

Possible allergic effects

List of workers exposed to this biological agent to be kept for more than

ten years after the end of last known exposure

Toxin production

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

* See paragraph 7 of the introductory notes.

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

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 ( )

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)

V ( c )

Influenza C virus

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)

V ( c )

Influenza B virus

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

e

Vaccinia virus (incl. Buffalopox virus ( ), 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.

(1) If the results of the assessment referred to in regulation

3 show that the exposure and, or potential exposure is to a group 1

biological agent, with no identifiable health risk to workers,

regulations 5 to 16 shall not apply. However, point 1 of Schedule

VI should be observed.

(2) If the results of the assessment referred to in regulation 3

show that the activity does not involve a deliberate intention to

work with or use a biological agent but may result in the workers

being exposed to a biological agent, as in the course of the

activities for which an indicative list is given in Schedule I,

regulations 5 to 16 shall apply unless the results of the assessment

referred to in regulation 3 show them to be unnecessary.

PRACTICAL RECOMMENDATIONS FOR THE HEALTH SURVEILLANCE

OF WORKERS

(Regulation 14)

1. The doctor and, or the employer must be familiar with the exposure

conditions or circumstances of each worker.

2. Health surveillance of workers must be carried out in accordance with the

principles and practices of occupational medicine: it must include at least the

following measures

•

keeping records of a worker’s medical and occupational history,

•

a personalised assessment of the worker’s state of health,

•

where appropriate, biological monitoring as well as detection of early

and reversible effects.

Further tests may be decided on for each worker when he is the subject of

health surveillance, in the light of the most recent knowledge available to

occupational medicine.

The employer shall avoid the use of a harmful biological

agent if the nature of the activity so permits, by replacing it with a

biological agent that, under its conditions of use, is not dangerous

or is less dangerous to workers’ health, as the case may be, in the

present state of knowledge.

Substituted by

L.N. 4 of 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 any

No

Recom-

Yes

other activities in the same building

mended

2. The workplace is to be sealable to permit

No

Recom-

Yes

fumigation

mended

Facilities

3. Infected material, including any animal,

Where

Yes, where

Yes

is to be handled in a safety cabinet or

appropriate

infection is

isolation or other suitable containment

by airborne

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

( 1 )) or likewise

extract air

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, floor

bench,

floor

and other

walls, floor

surfaces

and ceiling

determined

by risk

assessment

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

11. Safe storage of a biological agent

Yes

Yes

Yes, secure

storage

12. Personnel should shower before leaving

No

Recom-

Recom-

the contained area

mended

mended

Waste

13. Validated inactivation process for the safe

Recom-

Yes, on or

Yes, on site

disposal of animal carcases

mended

off site

Other measures

14. A laboratory is to contain its own

No

Recom-

Yes

equipment

mended

15. An observation window, or, alternative, is

Recom-

Recom-

Yes’

to be present, so that occupants can be seen

mended

mended

( 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.

(1) Where the results of the assessment referred to in

regulation 3 reveal a risk to workers’ health or safety, workers’

exposure must be prevented.

(2) Where this is not technically practicable, having regard to

the activity and the risk assessment referred to in regulation 3, the

risk of exposure must be reduced to as low a level as necessary in

order to protect adequately the health and safety of the workers

concerned, in particular by the following measures which are to be

applied in the light of the results of the assessment referred to in

regulation 3

(a) keeping as low as possible the number of workers

exposed or likely to be exposed;

(b) by the design of work processes and engineering

control measures so as to avoid or minimise the release

of biological agents into the place of work;

(c) taking of collective protection measures and, or, where

exposure cannot be avoided by other means, individual

protection measures;

(d) adopting hygiene measures compatible with the aim of

the prevention or reduction of the accidental transfer

or release of a biological agent from the workplace;

(e) by the use of the biohazard sign depicted in Schedule

PROTECTION OF WORKERS FROM RISKS RELATED TO

EXPOSURE TO BIOLOGICAL AGENTS AT WORK

II and other relevant warning signs;

(f)

the drawing up of plans to deal with accidents

involving biological agents;

(g) testing, where it is necessary and technically possible,

for the presence, outside the primary physical

confinement, of biological agents used at work;

(h) providing means for safe collection, storage and

disposal of waste by workers including the use of

secure and identifiable containers, after suitable

treatment where appropriate;

(i)

making arrangements for the safe handling and

transport of biological agents within the workplace.

Substituted by

L.N. 4 of 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 should

Minimise

Prevent

Prevent

be treated so as to

release

release

release

3. Sample collection, addition of materials to

Minimise

Prevent

Prevent

a closed system and transfer of viable

release

release

release

organisms to another closed system, should

be performed so as to

4. Bulk culture fluids should not be removed Inactivated by

Inactivated

Inactivated

from the closed system unless the viable organ-

validated

by validated

by vali-

isms have been

chemical or

chemical or

dated

physical

physical

chemical or

means

means

physical

means

5. Seals should be designed so as to

Minimise

Prevent

Prevent

release

release

release

6. The controlled area should be designed to

No

Recom-

Yes

contain spillage of the entire contents of the

mended

closed system

7. The controlled area should be sealable to per-

No

Recom-

Yes

mit 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

area should be HEPA ( 1 ) filtered

mended

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

12.Closed systems ( 2 ) should be located within a

Recom-

Recom-

Yes, and

mended

mended

purpose-

controlled area

built

13.Biohazard signs should be posted

Recom-

Yes

Yes

mended

14.Access should be restricted to nominated per-

Recom-

Yes

Yes, via an

sonnel 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 by

Inactivated by

Inactivated

validated

validated

by validated

chemical or

chemical or

chemical or

physical

physical

physical

means

means

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 showering facilities and preferably by

interlocking doors.

(1) Where the results of the assessment referred to in

regulation 3 reveal risk to workers’ health or safety, employers

shall, when requested, give to the Authority appropriate

information on

(a) the results of the assessment;

(b) the activities in which workers have been exposed or

may have been exposed to biological agents;

(c) the number of workers exposed;

(d) the name and capabilities of the person responsible for

health and safety at work;

(e) the protective and preventive measures

taken,

including working procedures and methods;

(f)

an emergency plan for the protection of workers from

exposure to a group 3 or a group 4 biological agent

which might result from a loss of physical

containment.

(2) Employers shall inform forthwith the Authority of any

accident or incident which may have resulted in the release of a

biological agent and which could cause severe human infection

and, or illness.

(3) The list referred to in regulation 11 and the medical records

referred to in regulation 14 shall be made available to the Authority

in cases where the undertaking ceases activity.

(1) Employers shall be obliged, in the case of all activities

for which there is a risk to the health or safety of workers due to

work with biological agents, to take appropriate measures to ensure

(a) workers do not eat or drink in working areas where

there is a risk of contamination by biological agents;

(b) workers are provided with appropriate protective

clothing or other appropriate special clothing;

(c) workers are provided with appropriate and adequate

washing and toilet facilities, which may include eye

washes and, or skin antiseptics;

(d) any necessary protective equipment is

(i) properly stored in a well-defined place,

(ii) checked and cleaned if possible before, and in

any case after, each use,

(iii) repaired, where defective, or is replaced before

further use;

(e) procedures are specified for taking, handling and

processing samples of human or animal origin.

(2)

(a) Working clothes and protective equipment, including

protective clothing referred to in sub-regulation (1),

which may be contaminated by biological agents, must

be removed on leaving the working area and, before

taking the measures referred to in paragraph (b), kept

separately from other clothing.

(b) The employer must ensure that such clothing and

protective equipment is decontaminated and cleaned

or, if necessary, destroyed.

(3) Workers may not be charged for the cost of any of the

measures referred to in these regulations.

(1) Appropriate measures shall be taken by the employer to

ensure that workers and, or any workers’ representatives in the

undertaking or establishment receive sufficient and appropriate

training, on the basis of all available information, in particular in

the form of information and instructions, concerning

(a) potential risks to health;

(b) precautions to be taken to prevent exposure;

(c) hygiene requirements;

(d) wearing and use of protective equipment and clothing;

(e) steps to be taken by workers in the case of incidents

and to prevent incidents.

(2)

The training shall be

(a) given at the beginning of work involving contact with

biological agents,

(b) adapted to take account of new or changed risks, and

(c) repeated periodically if necessary.

(1) Employers shall provide written instructions at the

workplace and, if appropriate, display notices which shall, as a

minimum, include the procedure to be followed in the case of

(a) a serious accident or incident involving the handling of

a biological agent;

(b) handling a group 4 biological agent.

(2) Workers shall immediately report any accident or incident

involving the handling of a biological agent to the person in charge,

or to the person responsible for health and safety at work.

(3)

(a) Employers shall inform forthwith the workers and, or

a ny workers’ r epre senta tives of any acc ident or

incident which may have resulted in the release of a

biological agent and which could cause severe human

infection and, or illness.

(b) In addition, employers shall inform the workers and,

or any workers’ representatives in the undertaking or

establishment as quickly as possible when a serious

accident or incident occurs, of the causes thereof and

of the measures taken or to be taken to rectify the

situation.

(4) Each worker shall have access to the information on the list

referred to in regulation 11 that relates to him personally.

(5) Workers and, or any workers’ representatives in the

undertaking or establishment shall have access to anonymous

collective information.

(6) Employers shall provide workers and, or their

representatives, at their request, with the information provided for

in regulation 7(1).

(1) Employers shall keep a list of workers exposed to

group 3 and, or group 4 biological agents, indicating the type of

work done and, whenever possible, the biological agent to which

they have been exposed, as well as records of exposures, accidents

and incidents, as appropriate.

(2)

(a) The list referred to in sub-regulation (1) shall be kept

for at least ten years following the end of exposure.

(b) In the case of those exposures which may result in

infections -

(i)

with biological agents known to be capable of

establishing persistent or latent infections;

(ii) that, in the light of present knowledge, are

undiagnosable until illness develops many years

later;

(iii) that have particularly long incubation periods

before illness develops;

(iv) that result in illnesses which recrudesce at times

over a long period despite treatment, or

(v) that may have serious long-term sequelae,

the list shall be kept for an appropriately longer time up to forty

years following the last known exposure.

(3) The doctor referred to in regulation 14 and, or the Authority

and any other person responsible for health and safety at that

particular place of work, shall have access to the list referred to in

sub-regulation (1).

(1) Employers shall consult workers and, or their

representatives and allow them to take part in discussions on all

questions relating to health and safety at work. This presupposes

-

the consultation of workers,

-

the right of workers and, or their representatives to

make proposals, and to balanced participation in

accordance with applicable laws and, or practices.

(2) Workers or workers’ representatives with specific

responsibility for the health and safety of workers shall take part in

a balanced way, in accordance with applicable laws and, or

practices, and shall be consulted in advance and in good time by the

employer with regard to

(a) any measure which may substantially affect health and

safety;

(b) the designation of worker or workers which the

employer is obliged to designate to carry out activities

related to the protection and prevention of

occupational risks for the undertaking and, or

establishment and the workers which the employer is

obliged to designate to implement measures inter alia,

for first aid, fire-fighting and the evacuation of

workers, and the activities related to the protection and

prevention of occupational risks;

(c) the following information

(i)

an assessment of the risks to health and safety at

work, including those facing groups of workers

exposed to particular risks;

(ii) the protective measures to be taken and, if

necessary, the protective equipment to be used;

(iii) a list of occupational accidents resulting in a

worker being unfit for work for more than three

working days;

(iv) reports on occupational accidents suffered by his

workers;

(v) the health and safety risks and protective and

preventive measures and activities in respect of

both the undertaking and, or establishment in

general and each type of workstation and, or job;

(vi) the measures taken in relation to first aid, fire-

fighting and the evacuation of workers;

(vii)

the appropriate measures taken so that

employers of workers from any outside

undertakings and, or establishments engaged in

work in his undertaking and, or establishment

receive adequate information concerning the

points referred to in subparagraphs (v) and (vi);

(viii) the appropriate measures taken so that workers

with specific functions in protecting the health

and

safety

of

workers,

or

workers’

representatives with specific responsibility for

the health and safety of workers may be able to

have access, to carry out their functions and to

-

the risk assessment and protective

measures referred to in subparagraphs (v)

and (vi);

-

the list and reports referred to in

subparagraphs (iii) and (iv);

-

the information yielded by protective and

preventive measures, inspection agencies

and bodies responsible for health and

safety;

(d) the enlistment, where appropriate, of the competent

services or persons outside the undertaking and, or

establishment, where such protective and preventive

measures cannot be organized for lack of competent

personnel in the undertaking and, or establishment;

(e) the planning and organization of the training to each

worker regarding adequate health and safety training,

in particular in the form of information and

instructions specific to his workstation or job

-

on recruitment,

-

in the event of a transfer or a change of job,

-

in the event of the introduction of new work

equipment or a change in equipment,

-

in the event of the introduction of any new

technology.

(3) Workers’ representatives with specific responsibility for the

health and safety of workers shall have the right to ask the

employer to take appropriate measures and to submit proposals to

him to that end to mitigate hazards for workers and, or to remove

sources of danger.

(4) The workers referred to in sub-regulation (2) and the

workers’ representatives referred to in sub-regulation (2) and (3)

may not be placed at a disadvantage because of their respective

activities referred to in sub-regulations (2) and (3).

(5) Employers must allow workers’ representatives with

specific responsibility for the health and safety of workers adequate

time during work hours, without loss of pay, and provide them with

the necessary means to enable such representatives to exercise their

rights and functions.

(6) Workers and, or their representatives are entitled to appeal,

in accordance with relevant legislation and, or practice, to the

Authority if they consider that the measures taken and the means

employed by the employer are inadequate for the purposes of

ensuring health and safety at work. Workers’ representatives must

be given the opportunity to submit their observations during

inspection visits by the Authority.

13.(1)(a) Prior notification shall be made to the Authority of the

use for the first time of

(i) group 2 biological agents;

(ii) group 3 biological agents;

(iii) group 4 biological agents.

(b) The notification shall be made at least thirty days

before the commencement of the work.

(c) Subject to sub-regulation (2), prior notification shall

also be made of the use for the first time of each

subsequent group 4 biological agent and of any

subsequent new group 3 biological agent where the

employer himself provisionally classifies that

biological agent.

(2) Laboratories providing a diagnostic service in relation to

group 4 biological agents shall be required only to make an initial

notification of their intention.

(3) Re-notification must take place in any case where there are

substantial changes of importance to safety or health at work to

processes and, or procedures which render the notification out of

(4) The notification referred to in sub-regulations (1), (2) and

(3) shall include

(a) the name and address of the undertaking and, or

establishment;

(b) the name and capabilities of the person responsible for

health and safety at work;

(c) the results of the assessment referred to in regulation

3;

(d) the species of the biological agent; and

(e) the protection and preventive measures that are

envisaged.

14.(1)(a) Where the results of the assessment referred to in

regulation 3 reveal a risk to health or safety, an

employer shall make arrangements so that each of the

workers involved shall be able to undergo relevant

health surveillance

(i) prior to exposure;

(ii) at regular intervals thereafter.

(b) Those arrangements shall be such that it is directly

possible to implement individual and occupational

hygiene measures.

(2)

(a) The assessment referred to in regulation 3 should

identify those workers for whom special protective

measures may be required.

(b) When necessary, effective vaccines should be made

available for those workers who are not already

immune to the biological agent to which they are

exposed or are likely to be exposed.

(c) When employers make vaccines available, they should

take account of the recommended code of practice set

out in Schedule VII.

(d) If a worker is found to be suffering from an infection

PROTECTION OF WORKERS FROM RISKS RELATED TO

EXPOSURE TO BIOLOGICAL AGENTS AT WORK

and, or illness which is suspected to be the result of

exposure, the doctor or the employer shall offer such

surveillance to other workers who have been similarly

exposed.

(e) In that event, a re-assessment of the risk of exposure

shall be carried out in accordance with regulation 3.

(3)

(a) In cases where health surveillance is carried out, an

individual medical record shall be kept for at least ten

years following the end of exposure.

(b) In the special cases referred to in regulation 11(2)(a)

to (e), an individual medical record shall be kept for an

appropriately longer time up to forty years following

the last known exposure.

(4) The doctor or the Authority may propose any protective or

preventive measures to be taken in respect of any individual

worker.

(5) Information and advice must be given to workers regarding

any health surveillance, which they may undergo following the end

of exposure.

(6)

Saving any other applicable laws and, or regulations

(a) workers shall have access to the results of the health

surveillance which concern them, and

(b) the workers concerned or the employer may request a

review of the results of the health surveillance.

(7) Practical recommendations for the health surveillance of

workers are given in Schedule IV.

(8) All cases of diseases or death identified in accordance with

applicable laws and, or regulations as resulting from occupational

exposure to biological agents shall be notified to the Authority.

(1) For the purpose of the assessment referred to in

regulation 3, particular attention should be paid to

(a) uncertainties about the presence of biological agents in

human patients or animals and the materials and

specimens taken from them;

(b) the hazard represented by biological agents known or

suspected to be present in human patients or animals

and materials and specimens taken from them;

(c) the risks posed by the nature of the work.

(2)

(a) Appropriate measures shall be taken in health and

veterinary care facilities in order to protect the health

and safety of the workers concerned.

(b) The measures to be taken shall include in particular

(i)

specifying appropriate decontamination and

disinfection procedures, and

(ii) implementing procedures enabling contaminated

waste to be handled and disposed of without

risk.

(3) In isolation facilities where there are human patients or

animals who are, or who are suspected of being, infected with

group 3 or group 4 biological agents, containment measures shall

be selected from those in Schedule V, column A, in order to

minimise the risk of infection.

(1) The following measures must be taken in laboratories,

including diagnostic laboratories, and in rooms for laboratory

animals which have been deliberately infected with group 2, 3 or 4

biological agents or which are or are suspected to be carriers of

such agents

(a) Laboratories carrying out work which involves the

handling of group 2, 3 or 4 biological agents for

research, development, teaching or diagnostic

purposes shall determine the containment measures in

accordance with Schedule V, in order to minimise the

risk of infection.

(b) Following the assessment referred to in regulation 3,

measures shall be determined in accordance with

Schedule V, after fixing the physical containment level

required for the biological agents according to the

degree of risk.

Activities involving the handling of a biological agent

must be carried out only

(i)

in working areas corresponding to at least

containment level 2, for a group 2 biological

agent,

(ii) in working areas corresponding to at least

containment level 3, for a group 3 biological

agent,

(iii) in working areas corresponding to at least

containment level 4, for a group 4 biological

agent.

(c) Laboratories handling materials in respect of which

there exist uncertainties about the presence of

biological agents which may cause human disease but

which do not have as their aim working with biological

agents as such (i.e. cultivating or concentrating them)

should adopt containment level 2 at least. Containment

levels 3 or 4 must be used, when appropriate, where it

is known or it is suspected that they are necessary,

except where guidelines that may be issued from time

to time by the Authority show that, in certain cases, a

lower containment level is appropriate.

(2) The following measures concerning industrial processes

using group 2, 3 or 4 biological agents must be taken

(a) The containment principles set out in the second

paragraph of sub-regulation (1)(b) should also apply to

industrial processes on the basis of the practical

measures and appropriate procedures given in

Schedule VI.

(b) In accordance with the assessment of the risk linked to

the use of group 2, 3 or 4 biological agents, the

Authority may decide on appropriate measures which

must be applied to the industrial use of such biological

agents.

(3) For all activities covered by sub-regulations (1) and (2)

where it has not been possible to carry out a conclusive assessment

of a biological agent but concerning which it appears that the use

envisaged might involve a serious health risk for workers, activities

may only be carried out in workplaces where the containment level

corresponds at least to level 3.

The Minister may by order authorise the Authority to give

access to the Commission of the European Communities of the use

made by it of the information referred to in regulation 14(8).

(1) Biological agents shall be classified in accordance

with the relative Community classification.

(2) In the absence of Community classification, the Authority

shall classify biological agents that are or may be a hazard to

human health on the basis of the definition of biological agents in

regulation 2, points 2 to 4 (groups 2 to 4).

(3) If the biological agent to be assessed cannot be classified

clearly in one of the groups referred to in sub-regulation (2), it must

be classified in the highest risk group among the alternatives.

In any proceedings for an offence under these regulations

consisting of a failure to comply with a duty or requirement to do

something, or to do something so far as is reasonably practicable, it

shall be for the accused to prove (as the case may be) that it was not

practicable or not reasonably practicable to do more than was in

faet done to satisfy the duty or requirement, or that there was no

better practicable means than was in fact used to satisfy the duty or

requirement.

Any person who knowingly or recklessly interferes with

the process of providing a safe and healthy place of work, shall be

guilty of an offence.